Document and Entity Information
Document and Entity Information - shares | 9 Months Ended | |
Sep. 30, 2016 | Nov. 09, 2016 | |
Document And Entity Information [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Sep. 30, 2016 | |
Document Fiscal Year Focus | 2,016 | |
Document Fiscal Period Focus | Q3 | |
Trading Symbol | ITCI | |
Entity Registrant Name | Intra-Cellular Therapies, Inc. | |
Entity Central Index Key | 1,567,514 | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Large Accelerated Filer | |
Entity Common Stock, Shares Outstanding | 43,268,243 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) | Sep. 30, 2016 | Dec. 31, 2015 |
Current assets: | ||
Cash and cash equivalents | $ 200,388,020 | $ 47,159,303 |
Investment securities, available-for-sale | 337,405,780 | 428,041,021 |
Accounts receivable | 1,309 | 30,660 |
Prepaid expenses and other current assets | 4,023,405 | 8,025,147 |
Total current assets | 541,818,514 | 483,256,131 |
Property and equipment, net | 677,703 | 775,522 |
Other assets | 75,765 | 71,875 |
Total assets | 542,571,982 | 484,103,528 |
Current liabilities: | ||
Borrowing under secured line of credit | 125,000,000 | |
Accounts payable | 5,417,451 | 1,632,905 |
Accrued and other current liabilities | 7,520,073 | 3,423,464 |
Accrued employee benefits | 2,752,381 | 1,207,143 |
Total current liabilities | 140,689,905 | 6,263,512 |
Long-term liabilities | 2,563,809 | 1,597,105 |
Total liabilities | 143,253,714 | 7,860,617 |
Stockholders' equity: | ||
Common stock, $.0001 par value: 100,000,000 shares authorized; 43,268,243 and 43,155,875 shares issued and outstanding at September 30, 2016 and December 31, 2015, respectively | 4,327 | 4,316 |
Additional paid-in capital | 681,475,390 | 669,878,103 |
Accumulated deficit | (281,990,327) | (193,049,098) |
Accumulated comprehensive loss | (171,122) | (590,410) |
Total stockholders' equity | 399,318,268 | 476,242,911 |
Total liabilities and stockholders' equity | $ 542,571,982 | $ 484,103,528 |
Condensed Consolidated Balance3
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares | Sep. 30, 2016 | Dec. 31, 2015 |
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 | 43,268,243 | 43,155,875 |
Common stock, shares outstanding | 43,268,243 | 43,155,875 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2016 | Sep. 30, 2015 | Sep. 30, 2016 | Sep. 30, 2015 | |
Income Statement [Abstract] | ||||
Revenues | $ 4,362 | $ 232,807 | $ 60,705 | |
Costs and expenses: | ||||
Research and development | 23,918,232 | $ 28,457,631 | 72,652,520 | 64,852,576 |
General and administrative | 6,270,528 | 3,891,744 | 17,806,565 | 11,649,169 |
Total costs and expenses | 30,188,760 | 32,349,375 | 90,459,085 | 76,501,745 |
Loss from operations | (30,184,398) | (32,349,375) | (90,226,278) | (76,441,040) |
Interest expense | (12,260) | (12,260) | ||
Interest income | 763,949 | 188,892 | 2,129,927 | 482,415 |
Net loss before income tax | (29,432,709) | (32,160,483) | (88,108,611) | (75,958,625) |
Income tax expense | (832,618) | (832,618) | ||
Net loss | $ (30,265,327) | $ (32,160,483) | $ (88,941,229) | $ (75,958,625) |
Net loss per common share: | ||||
Basic & Diluted | $ (0.70) | $ (0.91) | $ (2.06) | $ (2.25) |
Weighted average number of common shares: | ||||
Basic & Diluted | 43,253,429 | 35,320,046 | 43,229,087 | 33,716,032 |
Condensed Consolidated Stateme5
Condensed Consolidated Statements of Comprehensive Loss - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2016 | Sep. 30, 2015 | Sep. 30, 2016 | Sep. 30, 2015 | |
Statement of Comprehensive Income [Abstract] | ||||
Net loss | $ (30,265,327) | $ (32,160,483) | $ (88,941,229) | $ (75,958,625) |
Other comprehensive loss: | ||||
Unrealized gain (loss) on investment securities | (230,935) | 33,303 | 419,288 | 85,259 |
Comprehensive loss | $ (30,496,262) | $ (32,127,180) | $ (88,521,941) | $ (75,873,366) |
Condensed Consolidated Stateme6
Condensed Consolidated Statements of Cash Flows - USD ($) | 9 Months Ended | |
Sep. 30, 2016 | Sep. 30, 2015 | |
Cash flows provided by (used in) operating activities | ||
Net loss | $ (88,941,229) | $ (75,958,625) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation | 146,784 | 92,594 |
Share-based compensation expense | 10,975,931 | 7,466,595 |
Issuance of common stock for services | 171,059 | 136,984 |
Amortization of premiums on investment securities | 420,275 | 520,328 |
Changes in operating assets and liabilities: | ||
Accounts receivable | 29,351 | 51,603 |
Prepaid expenses and other assets | 3,997,852 | (244,886) |
Accounts payable | 3,784,546 | (1,347,722) |
Accrued liabilities | 5,641,847 | 1,177,654 |
Deferred rent | 966,704 | 881,143 |
Net cash used in operating activities | (62,806,880) | (67,224,332) |
Cash flows provided by (used in) investing activities | ||
Purchases of investments | (320,098,309) | (231,146,274) |
Maturities of investments | 410,732,563 | 121,128,184 |
Purchases of property and equipment | (48,965) | (823,585) |
Net cash provided by (used in) investing activities | 90,585,289 | (110,841,675) |
Cash flows provided by (used in) financing activities | ||
Proceeds from secured line of credit | 125,000,000 | |
Proceeds from stock option exercises | 450,308 | 317,508 |
Gross proceeds of public offering | 449,996,887 | |
Payment of costs of public offering | (745,143) | |
Net cash provided by financing activities | 125,450,308 | 449,569,252 |
Net increase in cash and cash equivalents | 153,228,717 | 271,503,245 |
Cash and cash equivalents at beginning of period | 47,159,303 | 61,325,044 |
Cash and cash equivalents at end of period | $ 200,388,020 | $ 332,828,289 |
Organization
Organization | 9 Months Ended |
Sep. 30, 2016 | |
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, ITI-007, is in Phase 3 clinical development as a novel treatment for schizophrenia, bipolar depression and agitation associated with dementia, including Alzheimer’s disease. ITI was incorporated in the State of Delaware on May 22, 2001 under the name “Intra-Cellular Therapies, Inc.” and commenced operations in June 2002. ITI was founded to discover and develop drugs for the treatment of neurological and psychiatric disorders. On August 29, 2013, ITI completed a reverse merger (the “Merger”) with a public shell company named Oneida Resources Corp. (“Oneida”). As a result of the Merger and related transactions, ITI survived as a wholly-owned subsidiary of Oneida, Oneida changed its fiscal year end from March 31 to December 31, and Oneida changed its name to Intra-Cellular Therapies, Inc. On March 11, 2015, the Company completed a public offering of common stock in which the Company sold 5,411,481 shares of common stock, which included the exercise of the underwriters’ option to purchase an additional 661,481 shares, at an offering price of $24.00 per share for aggregate gross proceeds of approximately $129.9 million. After deducting underwriting discounts, commissions and offering expenses, the net proceeds to the Company were approximately $121.8 million. On September 28, 2015, the Company completed a public offering of common stock in which the Company sold 7,935,000 shares of common stock, which included the exercise of the underwriters’ option to purchase an additional 1,035,000 shares, at an offering price of $43.50 per share for aggregate gross proceeds of approximately $345.2 million. After deducting underwriting discounts, commissions and offering expenses, the net proceeds to the Company were approximately $327.4 million. In September 2016, we licensed certain intellectual property rights to our 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 condensed consolidated statements of operations, the transaction generated a taxable gain in the U.S., and we are utilizing a portion of our available federal and state net operating loss carryforwards to offset the majority of this gain. Any taxes incurred related to intercompany transactions are treated as tax expense in our condensed consolidated statement of operations. In addition to the license, we also entered into a research and development agreement with ITI Limited pursuant to which the Company will conduct research and development services related to the license agreement and charge ITI Limited for these services. In order to further its research projects and support its collaborations, the Company will require additional financing until such time, if ever, that revenue streams are sufficient to generate consistent positive cash flow from operations. Possible sources of funds include public or private sales of the Company’s equity securities, sales of debt securities, the incurrence of debt from commercial lenders, strategic collaborations, licensing a portion or all of the Company’s product candidates and technology and, to a lesser extent, grant funding. On September 2, 2016, the Company filed a universal shelf registration statement on Form S-3, which was declared effective by the Securities and Exchange Commission (the “SEC”) on September 14, 2016, to register $350 million of the Company’s common stock, preferred stock, various series of debt securities, warrants, rights and purchase contracts to purchase any of such securities, either individually or in units, for issuance from time to time at prices and on terms to be determined at the time of any such offering (including the approximately $4.8 million of securities that remained available for issuance under the Company’s previous shelf registration). This registration statement will remain in effect for up to three years from the initial effective date. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 9 Months Ended |
Sep. 30, 2016 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Policies Basis of Presentation The accompanying financial statements 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 as found 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. 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. In conjunction with the capitalization of ITI Limited, the Company entered into a short term line of credit with a lender collateralized by Company investments held by the lender. On September 30, 2016, the Company drew down $125.0 million under the line of credit and used those funds to capitalize ITI Limited. On September 30, 2016, ITI Limited made a $125.0 million payment to the Company in connection with the license of certain intellectual property from the Company to ITI Limited. On October 3, 2016, the Company repaid $125.0 million to the lender and the line of credit was terminated on October 6, 2016. Investment Securities Investment securities consisted of the following (in thousands): September 30, 2016 Amortized Cost Unrealized Gains Unrealized (Losses) Estimated Fair Value (unaudited) U.S. Government Agency Securities $ 66,026 $ 18 $ (25 ) $ 66,019 FDIC Certificates of Deposit (1) 31,037 3 — 31,040 Certificates of Deposit 82,000 — — 82,000 Commercial Paper 59,960 19 (66 ) 59,913 Corporate Notes/Bonds 98,554 7 (127 ) 98,434 $ 337,577 $ 47 $ (218 ) $ 337,406 December 31, 2015 Amortized Cost Unrealized Gains Unrealized (Losses) Estimated Fair Value U.S. Government Agency Securities $ 61,510 $ — $ (271 ) $ 61,239 FDIC Certificates of Deposit (1) 41,343 1 (11 ) 41,333 Certificates of Deposit 219,500 — — 219,500 Commercial Paper 30,122 — (48 ) 30,074 Corporate Notes/Bonds 76,157 — (262 ) 75,895 $ 428,632 $ 1 $ (592 ) $ 428,041 (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 September 30, 2016 and December 31, 2015, the Company held $66.1 million and $142.4 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 December 31, 2015, the Company had approximately $9.2 million of investments that had been held for greater than one year which had a temporary impairment of approximately $19,000. As of September 30, 2016, the Company had no investments that had been held for greater than one year which had a temporary impairment. The Company attributes the unrealized losses on the available-for-sale securities as of September 30, 2016 and December 31, 2015, to the variability 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 • 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 September 30, 2016 and December 31, 2015. The carrying value of cash held in money market funds of approximately $16.0 million as of September 30, 2016 and $31.1 million as of December 31, 2015, is included in cash and cash equivalents and approximates market value based on quoted market price or Level 1 inputs. The Company’s borrowings under its secured line of credit approximate the fair value because of their relatively short maturity at September 30, 2016. 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 September 30, 2016 Quoted Prices in Active Markets for Identical Assets (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) Money Market Funds $ 15,986 $ 15,986 $ — $ — U.S. Government Agency Securities 66,019 — 66,019 — FDIC Certificates of Deposit 31,040 — 31,040 — Certificates of Deposit 82,000 — 82,000 — Commercial Paper 59,913 — 59,913 — Corporate Notes/Bonds 98,434 — 98,434 — $ 353,392 $ 15,986 $ 337,406 $ — Fair Value Measurements at Reporting Date Using December 31, Quoted Prices Significant Significant Money Market Funds $ 31,114 $ 31,114 $ — $ — U.S. Government Agency Securities 61,239 — 61,239 — FDIC Certificates of Deposit 41,333 — 41,333 — Certificates of Deposit 219,500 — 219,500 — Commercial Paper 30,074 — 30,074 — Corporate Notes/Bonds 75,895 — 75,895 — $ 459,155 $ 31,114 $ 428,041 $ — Financial Instruments The Company considers the recorded costs of its financial assets and liabilities, which consist of cash equivalents, accounts receivable, borrowings under secured line of credit, accounts payable and accrued liabilities, to approximate their fair value because of their relatively short maturities at September 30, 2016 and December 31, 2015. Management believes that the risks associated with its financial instruments are minimal as the counterparties are various corporations, financial institutions and government agencies of high credit standing. Concentration of Credit Risk Cash equivalents are held with major financial institutions in the United States. Certificates of deposit 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 remote. 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 September 30, 2016 and December 31, 2015, as the Company has a history of collecting on all of its accounts, including government agencies and collaborations funding its research. Property and Equipment Property and equipment is stated at cost and depreciated on a straight-line basis over estimated useful lives ranging from three to five years. Leasehold improvements are amortized using the straight-line method over the shorter of the estimated useful life of the assets or the term of the related lease. Expenditures for maintenance and repairs are charged to operations as incurred. When indicators of possible impairment are identified, the Company evaluates the recoverability of the carrying value of its long-lived assets based on the criteria established in ASC Topic 360, Property, Plant and Equipment Revenue Recognition Revenue is recognized when all terms and conditions of the agreements have been met, including persuasive evidence of an arrangement, delivery has occurred or services have been rendered, price is fixed or determinable and collectability is reasonably assured. The Company is reimbursed for certain costs incurred on specified research projects under the terms and conditions of grants, collaboration agreements, and awards. The Company records the amount of reimbursement as revenues on a gross basis in accordance with ASC Topic 605-45, Revenue Recognition/Principal Agent Considerations The Company has entered into arrangements involving the delivery of more than one element. Each required deliverable is evaluated to determine whether it qualifies as a separate unit of accounting. For the Company, this determination is generally based on whether the deliverable has “stand-alone value” to the customer. The Company adopted this accounting standard on a prospective basis for all Multiple-Deliverable Revenue Arrangements (“MDRAs”) entered into on or after January 1, 2011, and for any MDRAs that were entered into prior to January 1, 2011, but materially modified on or after that date. The Company has adopted ASC Topic 605-28, Milestone Method • The milestone payments are non-refundable; • Achievement of the milestone involves a degree of risk and was not reasonably assured at the inception of the arrangement; • Substantive effort on the Company’s part is involved in achieving the milestone; • The amount of the milestone payment is reasonable in relation to the effort expended or the risk associated with achievement of the milestone; and • A reasonable amount of time passes between the up-front license payment and the first milestone payment, as well as between each subsequent milestone payment. Determination as to whether a payment meets the aforementioned conditions involves management’s judgment. If any of these conditions are not met, the resulting payment would not be considered a substantive milestone, and therefore, the resulting payment would be considered part of the consideration for the single unit of accounting and be recognized as revenue in accordance with the revenue models described above. In addition, the determination that one such payment was not a substantive milestone could prevent the Company from concluding that subsequent milestone payments were substantive milestones. As a result, any additional milestone payments could also be considered part of the consideration for the single unit of accounting and would be recognized as revenue as such performance obligations are performed under either the proportional performance or straight-line methods, as applicable . 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 pre-clinical analytical testing, outside services, providers, materials and consulting fees. Costs for certain development activities, such as clinical trials, are recognized based on an evaluation of the progress to completion of specific tasks using data such as subject enrollment, clinical site activations or information provided to the Company by its vendors with respect to their actual costs incurred. Payments for these activities are based on the terms of the individual arrangements, which may differ from the pattern of costs incurred, and are reflected in the financial statements as prepaid or accrued research and development expense, as the case may be. As part of the process of preparing its financial statements, the Company is required to estimate its expenses resulting from its obligations under contracts with vendors, clinical research organizations and consultants and under clinical site agreements in connection with conducting clinical trials. The financial terms of these contracts are subject to negotiations, which vary from contract to contract and may result in payment flows that do not match the periods over which materials or services are provided under such contracts. The Company’s objective is to reflect the appropriate clinical trial expenses in its financial statements by matching those expenses with the period in which services are performed and efforts are expended. The Company accounts for these expenses according to the progress of the clinical trial as measured by subject progression and the timing of various aspects of the trial. The Company determines accrual estimates through financial models taking into account discussion with applicable personnel and outside service providers as to the progress or state of consummation of trials, or the services completed. During the course of a clinical trial, the Company adjusts its clinical expense recognition if actual results differ from its estimates. The Company makes estimates of its accrued expenses as of each balance sheet date based on the facts and circumstances known to it at that time. The Company’s clinical trial accruals are dependent upon the timely and accurate reporting of contract research organizations 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 and nine months ended September 30, 2016 and 2015, there were no material adjustments to the Company’s prior period estimates of accrued expenses for clinical trials. Income Taxes Income taxes are accounted for using the liability method. Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the year in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date. Valuation allowances are established when necessary to reduce net deferred tax assets to the amount expected to be realized. Income tax expense is the tax payable for the period and the change during the period in deferred tax assets and liabilities. The Company accounts for uncertain tax positions pursuant to ASC Topic 740 (previously included in FASB Interpretation No. 48, Accounting for Uncertainty in Income Taxes—an Interpretation of FASB Statement No. 109 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 For all awards granted with time-based vesting conditions, expense is amortized using the straight-line attribution method. For awards that contain a performance vesting condition, expense is amortized using the accelerated attribution method. As share-based compensation expense recognized in the statements of operations for the three and nine months ended September 30, 2016 and 2015 is based on share-based awards ultimately expected to vest, it has been reduced for estimated forfeitures. ASC Topic 718 requires forfeitures to be estimated at the time of grant and revised, if necessary, in subsequent periods if actual forfeitures differ from those estimates. Pre-vesting forfeitures are based on the Company’s historical experience for the three and nine months ended September 30, 2016 and 2015, and have not been material. 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 historical volatility of the Company’s common stock, historical volatility of the common stock of comparable publicly traded entities in the Company’s industry and other factors. The expected life of stock options is the period of time for which the stock options are expected to be outstanding. Given the lack of historic exercise data, the expected life is determined using the “simplified method” which is defined as the midpoint between the vesting dates and the end of the contractual term. The risk-free interest rates are based on the U.S. Treasury yield for a period consistent with the expected term of the option in effect at the time of the grant. The Company has not paid dividends to its stockholders since its inception and does not plan to pay cash dividends in the foreseeable future. Therefore, the Company has assumed an expected dividend rate of zero. Prior to January 1, 2014, given that there was no active market for the Company’s common stock, the exercise price of the stock options on the date of grant was determined and approved by the board of directors using several factors, including progress and milestones achieved in the Company’s business development and performance, the price per share of its convertible preferred stock offerings and general industry and economic trends. In establishing the estimated fair value of the common stock, the Company considered the guidance set forth in American Institute of Certified Public Accountants Practice Guide, Valuation of Privately-Held-Company Equity Securities Issued as Compensation A restricted stock unit (“RSU”) is a stock award that entitles the holder to receive shares of the Company’s common stock as the award vests. The fair value of each RSU is based on the closing price of the Company’s stock on the date of grant. The Company has granted RSUs with service conditions that vest in three equal annual installments provided that the employee remains employed with the Company. As of September 30, 2016, there was $3,402,792 of unrecognized compensation costs related to unvested RSUs. Under ASC Topic 718, the cumulative amount of compensation cost recognized for instruments classified as equity that ordinarily would result in a future tax deduction under existing tax law shall be considered to be a deductible difference in applying ASC Topic 740, Income Taxes Since the Company had net operating loss carryforwards as of September 30, 2016 and 2015, no excess tax benefits for the tax deductions related to share-based awards were recognized in the statements of operations. Equity instruments issued to non-employees are accounted for under the provisions of ASC Topic 718 and ASC Topic 505-50, Equity/Equity-Based Payments to Non-Employees Loss Per Share Basic net loss per common share is determined by dividing the net loss by the weighted-average number of common shares outstanding during the period, without consideration of common stock equivalents. Diluted net loss per share is computed by dividing the net loss by the weighted-average number of common stock equivalents outstanding for the period. The treasury stock method is used to determine the dilutive effect of the Company’s stock option grants and RSUs. The following common stock equivalents were excluded in the calculation of diluted loss per share because their effect would be anti-dilutive as applied to the loss from operations for the three and nine months ended September 30, 2016 and 2015: Three Months Ended September 30, Nine Months Ended September 30, 2016 2015 2016 2015 Stock options 1,528,266 1,746,502 1,528,266 1,742,555 RSUs 39,420 — 38,844 — Recently Issued Accounting Standards In May 2014, the FASB issued Accounting Standards Update No. 2014-09, Revenue from Contracts with Customers (“ASU 2014-09”). ASU 2014-09 will eliminate transaction-specific and industry-specific revenue recognition guidance under current GAAP and replace it with a principles-based approach for determining revenue recognition. ASU 2014-09 will require that companies recognize revenue based on the value of transferred goods or services as they occur in the contract. ASU 2014-09 also will require additional disclosure about the nature, amount, timing and uncertainty of revenue and cash flows arising from customer contracts, including significant judgments and changes in judgments and assets recognized from costs incurred to obtain or fulfill a contract. In July 2015, the FASB decided to defer the effective date of the standard from January 1, 2017 to January 1, 2018, with an option that permits companies to adopt the standard as early as the original effective date. Early application prior to the original effective date is not permitted. The standard permits the use of either the retrospective or cumulative effect transition method. Presently, the Company is assessing what effect the adoption of this standard will have on the Company’s consolidated financial statements and accompanying notes. In January 2016, the FASB issued Accounting Standards Update 2016-01, Recognition and Measurement of Financial Assets and Financial Liabilities (“ASU 2016-01”). ASU 2016-01 eliminates the requirement to disclose the methods and significant assumptions used to estimate the fair value that is required to be disclosed for financial instruments measured at amortized cost on the balance sheet. The standard also clarifies the need to evaluate a valuation allowance on a deferred tax asset related to available-for-sale securities in combination with the Company’s other deferred tax assets. ASU 2016-01 is effective for annual reporting periods beginning after December 15, 2017. The adoption of this standard is not expected to have a material impact on the Company’s financial statements. In February 2016, the FASB issued Accounting Standards Update 2016-02, Leases (“ASU 2016-02”). ASU 2016-02 allows 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 adoption of this standard is not expected to have a material impact on the Company’s financial statements. In March 2016, the FASB issued Accounting Standards Update 2016-09, Compensation—Stock Compensation (“ASU 2016-09”). ASU 2016-09 simplifies several areas of accounting for stock compensation, including simplification of the accounting for income taxes, classification of excess tax benefits on the Statement of Cash Flows and forfeitures. ASU 2016-09 is effective for annual reporting periods beginning after December 15, 2016. An entity that elects early adoption must adopt all of the amendments in the same period. The Company did not early adopt ASU 2016-09 as of and for the period ended September 30, 2016. The adoption of this standard is not expected to have a material impact on the Company’s financial statements. |
Property and Equipment
Property and Equipment | 9 Months Ended |
Sep. 30, 2016 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment | 3. Property and Equipment Property and equipment consist of the following: September 30, 2016 December 31, 2015 Computer equipment $ 39,095 $ 42,064 Furniture and fixtures 292,423 266,695 Scientific equipment 2,844,866 2,823,601 3,176,384 3,132,360 Less accumulated depreciation (2,498,681 ) (2,356,838 ) $ 677,703 $ 775,522 Depreciation expense for the nine months ended September 30, 2016 and 2015 was $146,784 and $92,594 respectively. |
Share-Based Compensation
Share-Based Compensation | 9 Months Ended |
Sep. 30, 2016 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Share-Based Compensation | 4. Share-Based Compensation The Company sponsors the Intra-Cellular Therapies, Inc. Amended and Restated 2013 Equity Incentive Plan (the “2013 Plan”) to provide 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. In August 2013, in connection with the Merger, the Company assumed the ITI 2003 Equity Incentive Plan, as amended (the “2003 Plan”), which expired by its terms in July 2013. As of September 30, 2016, there were options to purchase 685,660 shares of common stock outstanding under the 2003 Plan and options to purchase 2,425,267 shares of common stock outstanding under the 2013 Plan. Effective in November 2013, the Company adopted the 2013 Plan. The Company initially reserved 2,850,000 shares of common stock for issuance under the 2013 Plan. In both January 2015 and 2014, the number of shares of common stock reserved for issuance under the 2013 Plan automatically increased by 800,000 pursuant to the evergreen provisions of the 2013 Plan. On June 16, 2015, the stockholders of the Company approved, at the Company’s 2015 Annual Meeting of Stockholders, an amendment to the 2013 Plan to increase the number of shares of common stock available for issuance under the plan by 3,100,000 shares, to increase by 100,000 shares the maximum number of shares available for the issuance of options, stock appreciation rights and other similar awards to any one participant in any calendar year for purposes of meeting the requirements for qualified performance-based compensation under Section 162(m) of the Internal Revenue Code of 1986, as amended (the “Code”), and to eliminate the evergreen provisions of the 2013 Plan under which 800,000 shares were automatically added to the plan on each of January 1, 2014 and 2015. Stock options granted under the 2013 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 two 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 2013 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 three and nine months ended September 30, 2016 and 2015, was comprised of the following: Three Months Ended September 30, Nine Months Ended September 30, 2016 2015 2016 2015 Research and development $ 1,045,547 $ 1,220,602 $ 3,400,324 $ 2,892,258 General and administrative 2,641,199 1,645,388 7,575,607 4,574,337 Total share-based compensation expense $ 3,686,746 $ 2,865,990 $ 10,975,931 $ 7,466,595 The following table describes the weighted-average assumptions used for calculating the value of options granted during the nine months ended September 30, 2016 and 2015: 2016 2015 Dividend yield 0 % 0 % Expected volatility 80 % 80 % Weighted-average risk-free interest rate 1.7 % 1.8 % Expected term 5.9 years 6.3 years Information regarding the stock options activity, including with respect to grants to employees, directors and consultants as of September 30, 2016 and changes during the nine-month period then ended, is summarized as follows: Number of Shares Weighted- Average Exercise Price Weighted- Average Contractual Life Outstanding at December 31, 2015 2,737,657 $ 13.72 7.6 years Options granted 478,265 $ 49.47 5.9 years Options exercised (104,995 ) $ 4.29 3.7 years Options canceled or expired — $ — — Outstanding at September 30, 2016 3,110,927 $ 19.53 7.4 years Vested or expected to vest at September 30, 2016 3,110,927 $ 19.53 Exercisable at September 30, 2016 1,836,573 $ 11.74 6.7 years The fair value of an RSU is based on the closing price of the Company’s stock on the date of grant. Information regarding RSU activity, including with respect to grants to employees as of September 30, 2016 and changes during the nine-month period then ended, is summarized as follows: Number of Shares Weighted- Average Grant Date Fair Value Outstanding at December 31, 2015 5,272 $ 56.90 RSU’s granted in 2016 78,806 $ 53.63 Outstanding at September 30, 2016 84,078 $ 53.84 The Company recognized non-cash stock-based compensation expense related to RSU’s for the nine months ending September 30, 2016 and 2015 of approximately $1.1 million and $0, respectively. |
Line of Credit
Line of Credit | 9 Months Ended |
Sep. 30, 2016 | |
Debt Disclosure [Abstract] | |
Line of Credit | 5. Line of Credit On September 30, 2016, the Company entered into a secured line of credit with a lender for an amount not to exceed $150.8 million. This line of credit was secured by approximately $150.8 million of collateral held by the lender. The interest on advances under this line of credit was fixed at LIBOR plus 2.991% on the date of advance. The Company borrowed $125.0 million on September 30, 2016 and repaid the entire amount on October 3, 2016. Interest expense under this secured line of credit was $12,260 for the quarter ended September 30, 2016. On October 6, 2016, the line of credit was terminated by the Company. The fair value of this line of credit was $125.0 million on September 30, 2016. |
Collaborations and License Agre
Collaborations and License Agreements | 9 Months Ended |
Sep. 30, 2016 | |
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 ITI-007 and other specified compounds (the “BMS Agreement”). The BMS 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 ITI-007 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 BMS 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 BMS 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 ITI-007 for patients with schizophrenia. Possible milestone payments remaining total $12.0 million. Under the agreement, the Company may be obliged to make other milestone payments to BMS for each licensed product of up to an aggregate of approximately $14.75 million. The Company is also obliged to make tiered single digit percentage royalty payments on sales of licensed products. The Company is obliged to pay to BMS a percentage of non-royalty payments made in consideration of any sublicense. The BMS Agreement extends, and royalties are payable, on a country-by-country and product-by-product basis, through the later of ten years after first commercial sale of a licensed product in such country, expiration of the last licensed patent covering a licensed product, 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. The Takeda Pharmaceutical License and Collaboration Agreement and Termination Agreement On February 25, 2011, the Company entered into a license and collaboration agreement (the “Takeda License Agreement”) with Takeda Pharmaceutical Company Limited (“Takeda”) under which the Company agreed to collaborate to research, develop and commercialize its proprietary compound ITI-214 and other selected compounds that selectively inhibit phosphodiesterase type 1 (“PDE1”) for use in the prevention and treatment of human diseases. As part of the agreement, the Company assigned to Takeda certain patents owned by the Company that claim ITI-214 and granted Takeda an exclusive license to develop and commercialize compounds identified in the conduct of the research program that satisfy specified criteria. However, the Company retained rights to all compounds that do not meet the specified criteria and the Company continues to develop PDE1 inhibitors outside the scope of the agreement. On October 31, 2014, the Company entered into an agreement with Takeda terminating the Takeda License Agreement, pursuant to which all rights granted under the Takeda License Agreement were returned to the Company. On September 15, 2015, Takeda completed the transfer of the Investigational New Drug Application (“IND”) for ITI-214 to the Company. ITI-214 is the first compound in its class to successfully advance into Phase 1 clinical trials. The Company intends to explore the development of its PDE program, including ITI-214 for the treatment of several CNS and non-CNS conditions, which may include cognition in Parkinson’s disease, cognition in Alzheimer’s disease, cognition in schizophrenia and in other non-CNS indications. Other compounds in the PDE portfolio are also being advanced for the treatment of various indications. Other License Agreement In May 2002, the Company entered into a license agreement (the “License”) and research agreement with a university. Under the provisions of the License, the Company is entitled to use this organization’s patented technology and other intellectual property relating to diagnosis and treatment of central nervous system disorders. The License expires upon expiration of the patent rights or 15 years subsequent to the first sale of products developed through this License. ITI is required to make future milestone payments for initiation of clinical trials and approval of a New Drug Application (“NDA”). Should ITI commercialize the technology related to this License, ITI would be required to make royalty payments, and would also be required to pay fees under any sublicense agreements with third parties. In addition, ITI is required to use at least $1.0 million annually of its resources for the development and commercialization of the technology until ITI submits an NDA. ITI met its spending requirements in 2015 and 2016. There were no other payments made or required for the nine months ended September 30, 2016 and 2015. |
Summary of Significant Accoun13
Summary of Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 2016 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation The accompanying financial statements 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 as found 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. |
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. In conjunction with the capitalization of ITI Limited, the Company entered into a short term line of credit with a lender collateralized by Company investments held by the lender. On September 30, 2016, the Company drew down $125.0 million under the line of credit and used those funds to capitalize ITI Limited. On September 30, 2016, ITI Limited made a $125.0 million payment to the Company in connection with the license of certain intellectual property from the Company to ITI Limited. On October 3, 2016, the Company repaid $125.0 million to the lender and the line of credit was terminated on October 6, 2016. |
Investment Securities | Investment Securities Investment securities consisted of the following (in thousands): September 30, 2016 Amortized Cost Unrealized Gains Unrealized (Losses) Estimated Fair Value (unaudited) U.S. Government Agency Securities $ 66,026 $ 18 $ (25 ) $ 66,019 FDIC Certificates of Deposit (1) 31,037 3 — 31,040 Certificates of Deposit 82,000 — — 82,000 Commercial Paper 59,960 19 (66 ) 59,913 Corporate Notes/Bonds 98,554 7 (127 ) 98,434 $ 337,577 $ 47 $ (218 ) $ 337,406 December 31, 2015 Amortized Cost Unrealized Gains Unrealized (Losses) Estimated Fair Value U.S. Government Agency Securities $ 61,510 $ — $ (271 ) $ 61,239 FDIC Certificates of Deposit (1) 41,343 1 (11 ) 41,333 Certificates of Deposit 219,500 — — 219,500 Commercial Paper 30,122 — (48 ) 30,074 Corporate Notes/Bonds 76,157 — (262 ) 75,895 $ 428,632 $ 1 $ (592 ) $ 428,041 (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 September 30, 2016 and December 31, 2015, the Company held $66.1 million and $142.4 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 December 31, 2015, the Company had approximately $9.2 million of investments that had been held for greater than one year which had a temporary impairment of approximately $19,000. As of September 30, 2016, the Company had no investments that had been held for greater than one year which had a temporary impairment. The Company attributes the unrealized losses on the available-for-sale securities as of September 30, 2016 and December 31, 2015, to the variability 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 • 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 September 30, 2016 and December 31, 2015. The carrying value of cash held in money market funds of approximately $16.0 million as of September 30, 2016 and $31.1 million as of December 31, 2015, is included in cash and cash equivalents and approximates market value based on quoted market price or Level 1 inputs. The Company’s borrowings under its secured line of credit approximate the fair value because of their relatively short maturity at September 30, 2016. 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 September 30, 2016 Quoted Prices in Active Markets for Identical Assets (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) Money Market Funds $ 15,986 $ 15,986 $ — $ — U.S. Government Agency Securities 66,019 — 66,019 — FDIC Certificates of Deposit 31,040 — 31,040 — Certificates of Deposit 82,000 — 82,000 — Commercial Paper 59,913 — 59,913 — Corporate Notes/Bonds 98,434 — 98,434 — $ 353,392 $ 15,986 $ 337,406 $ — Fair Value Measurements at Reporting Date Using December 31, Quoted Prices Significant Significant Money Market Funds $ 31,114 $ 31,114 $ — $ — U.S. Government Agency Securities 61,239 — 61,239 — FDIC Certificates of Deposit 41,333 — 41,333 — Certificates of Deposit 219,500 — 219,500 — Commercial Paper 30,074 — 30,074 — Corporate Notes/Bonds 75,895 — 75,895 — $ 459,155 $ 31,114 $ 428,041 $ — |
Financial Instruments | Financial Instruments The Company considers the recorded costs of its financial assets and liabilities, which consist of cash equivalents, accounts receivable, borrowings under secured line of credit, accounts payable and accrued liabilities, to approximate their fair value because of their relatively short maturities at September 30, 2016 and December 31, 2015. Management believes that the risks associated with its financial instruments are minimal as the counterparties are various corporations, financial institutions and government agencies of high credit standing. |
Concentration of Credit Risk | Concentration of Credit Risk Cash equivalents are held with major financial institutions in the United States. Certificates of deposit 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 remote. 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 September 30, 2016 and December 31, 2015, as the Company has a history of collecting on all of its accounts, including government agencies and collaborations funding its research. |
Property and Equipment | Property and Equipment Property and equipment is stated at cost and depreciated on a straight-line basis over estimated useful lives ranging from three to five years. Leasehold improvements are amortized using the straight-line method over the shorter of the estimated useful life of the assets or the term of the related lease. Expenditures for maintenance and repairs are charged to operations as incurred. When indicators of possible impairment are identified, the Company evaluates the recoverability of the carrying value of its long-lived assets based on the criteria established in ASC Topic 360, Property, Plant and Equipment |
Revenue Recognition | Revenue Recognition Revenue is recognized when all terms and conditions of the agreements have been met, including persuasive evidence of an arrangement, delivery has occurred or services have been rendered, price is fixed or determinable and collectability is reasonably assured. The Company is reimbursed for certain costs incurred on specified research projects under the terms and conditions of grants, collaboration agreements, and awards. The Company records the amount of reimbursement as revenues on a gross basis in accordance with ASC Topic 605-45, Revenue Recognition/Principal Agent Considerations The Company has entered into arrangements involving the delivery of more than one element. Each required deliverable is evaluated to determine whether it qualifies as a separate unit of accounting. For the Company, this determination is generally based on whether the deliverable has “stand-alone value” to the customer. The Company adopted this accounting standard on a prospective basis for all Multiple-Deliverable Revenue Arrangements (“MDRAs”) entered into on or after January 1, 2011, and for any MDRAs that were entered into prior to January 1, 2011, but materially modified on or after that date. The Company has adopted ASC Topic 605-28, Milestone Method • The milestone payments are non-refundable; • Achievement of the milestone involves a degree of risk and was not reasonably assured at the inception of the arrangement; • Substantive effort on the Company’s part is involved in achieving the milestone; • The amount of the milestone payment is reasonable in relation to the effort expended or the risk associated with achievement of the milestone; and • A reasonable amount of time passes between the up-front license payment and the first milestone payment, as well as between each subsequent milestone payment. Determination as to whether a payment meets the aforementioned conditions involves management’s judgment. If any of these conditions are not met, the resulting payment would not be considered a substantive milestone, and therefore, the resulting payment would be considered part of the consideration for the single unit of accounting and be recognized as revenue in accordance with the revenue models described above. In addition, the determination that one such payment was not a substantive milestone could prevent the Company from concluding that subsequent milestone payments were substantive milestones. As a result, any additional milestone payments could also be considered part of the consideration for the single unit of accounting and would be recognized as revenue as such performance obligations are performed under either the proportional performance or straight-line methods, as applicable . |
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 pre-clinical analytical testing, outside services, providers, materials and consulting fees. Costs for certain development activities, such as clinical trials, are recognized based on an evaluation of the progress to completion of specific tasks using data such as subject enrollment, clinical site activations or information provided to the Company by its vendors with respect to their actual costs incurred. Payments for these activities are based on the terms of the individual arrangements, which may differ from the pattern of costs incurred, and are reflected in the financial statements as prepaid or accrued research and development expense, as the case may be. As part of the process of preparing its financial statements, the Company is required to estimate its expenses resulting from its obligations under contracts with vendors, clinical research organizations and consultants and under clinical site agreements in connection with conducting clinical trials. The financial terms of these contracts are subject to negotiations, which vary from contract to contract and may result in payment flows that do not match the periods over which materials or services are provided under such contracts. The Company’s objective is to reflect the appropriate clinical trial expenses in its financial statements by matching those expenses with the period in which services are performed and efforts are expended. The Company accounts for these expenses according to the progress of the clinical trial as measured by subject progression and the timing of various aspects of the trial. The Company determines accrual estimates through financial models taking into account discussion with applicable personnel and outside service providers as to the progress or state of consummation of trials, or the services completed. During the course of a clinical trial, the Company adjusts its clinical expense recognition if actual results differ from its estimates. The Company makes estimates of its accrued expenses as of each balance sheet date based on the facts and circumstances known to it at that time. The Company’s clinical trial accruals are dependent upon the timely and accurate reporting of contract research organizations 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 and nine months ended September 30, 2016 and 2015, there were no material adjustments to the Company’s prior period estimates of accrued expenses for clinical trials. |
Income Taxes | Income Taxes Income taxes are accounted for using the liability method. Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the year in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date. Valuation allowances are established when necessary to reduce net deferred tax assets to the amount expected to be realized. Income tax expense is the tax payable for the period and the change during the period in deferred tax assets and liabilities. The Company accounts for uncertain tax positions pursuant to ASC Topic 740 (previously included in FASB Interpretation No. 48, Accounting for Uncertainty in Income Taxes—an Interpretation of FASB Statement No. 109 |
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 For all awards granted with time-based vesting conditions, expense is amortized using the straight-line attribution method. For awards that contain a performance vesting condition, expense is amortized using the accelerated attribution method. As share-based compensation expense recognized in the statements of operations for the three and nine months ended September 30, 2016 and 2015 is based on share-based awards ultimately expected to vest, it has been reduced for estimated forfeitures. ASC Topic 718 requires forfeitures to be estimated at the time of grant and revised, if necessary, in subsequent periods if actual forfeitures differ from those estimates. Pre-vesting forfeitures are based on the Company’s historical experience for the three and nine months ended September 30, 2016 and 2015, and have not been material. 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 historical volatility of the Company’s common stock, historical volatility of the common stock of comparable publicly traded entities in the Company’s industry and other factors. The expected life of stock options is the period of time for which the stock options are expected to be outstanding. Given the lack of historic exercise data, the expected life is determined using the “simplified method” which is defined as the midpoint between the vesting dates and the end of the contractual term. The risk-free interest rates are based on the U.S. Treasury yield for a period consistent with the expected term of the option in effect at the time of the grant. The Company has not paid dividends to its stockholders since its inception and does not plan to pay cash dividends in the foreseeable future. Therefore, the Company has assumed an expected dividend rate of zero. Prior to January 1, 2014, given that there was no active market for the Company’s common stock, the exercise price of the stock options on the date of grant was determined and approved by the board of directors using several factors, including progress and milestones achieved in the Company’s business development and performance, the price per share of its convertible preferred stock offerings and general industry and economic trends. In establishing the estimated fair value of the common stock, the Company considered the guidance set forth in American Institute of Certified Public Accountants Practice Guide, Valuation of Privately-Held-Company Equity Securities Issued as Compensation A restricted stock unit (“RSU”) is a stock award that entitles the holder to receive shares of the Company’s common stock as the award vests. The fair value of each RSU is based on the closing price of the Company’s stock on the date of grant. The Company has granted RSUs with service conditions that vest in three equal annual installments provided that the employee remains employed with the Company. As of September 30, 2016, there was $3,402,792 of unrecognized compensation costs related to unvested RSUs. Under ASC Topic 718, the cumulative amount of compensation cost recognized for instruments classified as equity that ordinarily would result in a future tax deduction under existing tax law shall be considered to be a deductible difference in applying ASC Topic 740, Income Taxes Since the Company had net operating loss carryforwards as of September 30, 2016 and 2015, no excess tax benefits for the tax deductions related to share-based awards were recognized in the statements of operations. Equity instruments issued to non-employees are accounted for under the provisions of ASC Topic 718 and ASC Topic 505-50, Equity/Equity-Based Payments to Non-Employees |
Loss Per Share | Loss Per Share Basic net loss per common share is determined by dividing the net loss by the weighted-average number of common shares outstanding during the period, without consideration of common stock equivalents. Diluted net loss per share is computed by dividing the net loss by the weighted-average number of common stock equivalents outstanding for the period. The treasury stock method is used to determine the dilutive effect of the Company’s stock option grants and RSUs. The following common stock equivalents were excluded in the calculation of diluted loss per share because their effect would be anti-dilutive as applied to the loss from operations for the three and nine months ended September 30, 2016 and 2015: Three Months Ended September 30, Nine Months Ended September 30, 2016 2015 2016 2015 Stock options 1,528,266 1,746,502 1,528,266 1,742,555 RSUs 39,420 — 38,844 — |
Recently Issued Accounting Standards | Recently Issued Accounting Standards In May 2014, the FASB issued Accounting Standards Update No. 2014-09, Revenue from Contracts with Customers (“ASU 2014-09”). ASU 2014-09 will eliminate transaction-specific and industry-specific revenue recognition guidance under current GAAP and replace it with a principles-based approach for determining revenue recognition. ASU 2014-09 will require that companies recognize revenue based on the value of transferred goods or services as they occur in the contract. ASU 2014-09 also will require additional disclosure about the nature, amount, timing and uncertainty of revenue and cash flows arising from customer contracts, including significant judgments and changes in judgments and assets recognized from costs incurred to obtain or fulfill a contract. In July 2015, the FASB decided to defer the effective date of the standard from January 1, 2017 to January 1, 2018, with an option that permits companies to adopt the standard as early as the original effective date. Early application prior to the original effective date is not permitted. The standard permits the use of either the retrospective or cumulative effect transition method. Presently, the Company is assessing what effect the adoption of this standard will have on the Company’s consolidated financial statements and accompanying notes. In January 2016, the FASB issued Accounting Standards Update 2016-01, Recognition and Measurement of Financial Assets and Financial Liabilities (“ASU 2016-01”). ASU 2016-01 eliminates the requirement to disclose the methods and significant assumptions used to estimate the fair value that is required to be disclosed for financial instruments measured at amortized cost on the balance sheet. The standard also clarifies the need to evaluate a valuation allowance on a deferred tax asset related to available-for-sale securities in combination with the Company’s other deferred tax assets. ASU 2016-01 is effective for annual reporting periods beginning after December 15, 2017. The adoption of this standard is not expected to have a material impact on the Company’s financial statements. In February 2016, the FASB issued Accounting Standards Update 2016-02, Leases (“ASU 2016-02”). ASU 2016-02 allows 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 adoption of this standard is not expected to have a material impact on the Company’s financial statements. In March 2016, the FASB issued Accounting Standards Update 2016-09, Compensation—Stock Compensation (“ASU 2016-09”). ASU 2016-09 simplifies several areas of accounting for stock compensation, including simplification of the accounting for income taxes, classification of excess tax benefits on the Statement of Cash Flows and forfeitures. ASU 2016-09 is effective for annual reporting periods beginning after December 15, 2016. An entity that elects early adoption must adopt all of the amendments in the same period. The Company did not early adopt ASU 2016-09 as of and for the period ended September 30, 2016. The adoption of this standard is not expected to have a material impact on the Company’s financial statements. |
Summary of Significant Accoun14
Summary of Significant Accounting Policies (Tables) | 9 Months Ended |
Sep. 30, 2016 | |
Accounting Policies [Abstract] | |
Schedule of Investment Securities | Investment securities consisted of the following (in thousands): September 30, 2016 Amortized Cost Unrealized Gains Unrealized (Losses) Estimated Fair Value (unaudited) U.S. Government Agency Securities $ 66,026 $ 18 $ (25 ) $ 66,019 FDIC Certificates of Deposit (1) 31,037 3 — 31,040 Certificates of Deposit 82,000 — — 82,000 Commercial Paper 59,960 19 (66 ) 59,913 Corporate Notes/Bonds 98,554 7 (127 ) 98,434 $ 337,577 $ 47 $ (218 ) $ 337,406 December 31, 2015 Amortized Cost Unrealized Gains Unrealized (Losses) Estimated Fair Value U.S. Government Agency Securities $ 61,510 $ — $ (271 ) $ 61,239 FDIC Certificates of Deposit (1) 41,343 1 (11 ) 41,333 Certificates of Deposit 219,500 — — 219,500 Commercial Paper 30,122 — (48 ) 30,074 Corporate Notes/Bonds 76,157 — (262 ) 75,895 $ 428,632 $ 1 $ (592 ) $ 428,041 (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 September 30, 2016 Quoted Prices in Active Markets for Identical Assets (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) Money Market Funds $ 15,986 $ 15,986 $ — $ — U.S. Government Agency Securities 66,019 — 66,019 — FDIC Certificates of Deposit 31,040 — 31,040 — Certificates of Deposit 82,000 — 82,000 — Commercial Paper 59,913 — 59,913 — Corporate Notes/Bonds 98,434 — 98,434 — $ 353,392 $ 15,986 $ 337,406 $ — Fair Value Measurements at Reporting Date Using December 31, Quoted Prices Significant Significant Money Market Funds $ 31,114 $ 31,114 $ — $ — U.S. Government Agency Securities 61,239 — 61,239 — FDIC Certificates of Deposit 41,333 — 41,333 — Certificates of Deposit 219,500 — 219,500 — Commercial Paper 30,074 — 30,074 — Corporate Notes/Bonds 75,895 — 75,895 — $ 459,155 $ 31,114 $ 428,041 $ — |
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 and nine months ended September 30, 2016 and 2015: Three Months Ended September 30, Nine Months Ended September 30, 2016 2015 2016 2015 Stock options 1,528,266 1,746,502 1,528,266 1,742,555 RSUs 39,420 — 38,844 — |
Property and Equipment (Tables)
Property and Equipment (Tables) | 9 Months Ended |
Sep. 30, 2016 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment | Property and equipment consist of the following: September 30, 2016 December 31, 2015 Computer equipment $ 39,095 $ 42,064 Furniture and fixtures 292,423 266,695 Scientific equipment 2,844,866 2,823,601 3,176,384 3,132,360 Less accumulated depreciation (2,498,681 ) (2,356,838 ) $ 677,703 $ 775,522 |
Share-Based Compensation (Table
Share-Based Compensation (Tables) | 9 Months Ended |
Sep. 30, 2016 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
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 three and nine months ended September 30, 2016 and 2015, was comprised of the following: Three Months Ended September 30, Nine Months Ended September 30, 2016 2015 2016 2015 Research and development $ 1,045,547 $ 1,220,602 $ 3,400,324 $ 2,892,258 General and administrative 2,641,199 1,645,388 7,575,607 4,574,337 Total share-based compensation expense $ 3,686,746 $ 2,865,990 $ 10,975,931 $ 7,466,595 |
Weighted-Average 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 nine months ended September 30, 2016 and 2015: 2016 2015 Dividend yield 0 % 0 % Expected volatility 80 % 80 % Weighted-average risk-free interest rate 1.7 % 1.8 % Expected term 5.9 years 6.3 years |
Stock Option Activity | Information regarding the stock options activity, including with respect to grants to employees, directors and consultants as of September 30, 2016 and changes during the nine-month period then ended, is summarized as follows: Number of Shares Weighted- Average Exercise Price Weighted- Average Contractual Life Outstanding at December 31, 2015 2,737,657 $ 13.72 7.6 years Options granted 478,265 $ 49.47 5.9 years Options exercised (104,995 ) $ 4.29 3.7 years Options canceled or expired — $ — — Outstanding at September 30, 2016 3,110,927 $ 19.53 7.4 years Vested or expected to vest at September 30, 2016 3,110,927 $ 19.53 Exercisable at September 30, 2016 1,836,573 $ 11.74 6.7 years |
Summary of Information Regarding RSU Activity | Information regarding RSU activity, including with respect to grants to employees as of September 30, 2016 and changes during the nine-month period then ended, is summarized as follows: Number of Shares Weighted- Average Grant Date Fair Value Outstanding at December 31, 2015 5,272 $ 56.90 RSU’s granted in 2016 78,806 $ 53.63 Outstanding at September 30, 2016 84,078 $ 53.84 |
Organization - Additional Infor
Organization - Additional Information (Detail) - USD ($) | Sep. 14, 2016 | Sep. 28, 2015 | Mar. 11, 2015 | Sep. 30, 2015 | Sep. 30, 2016 |
Organization Consolidation And Presentation Of Financial Statements Disclosure [Line Items] | |||||
Initial public offering of common stock | 7,935,000 | ||||
Underwriters' option to purchase shares | 1,035,000 | 661,481 | |||
Common stock price per share | $ 43.50 | ||||
Gross proceeds of public offering | $ 345,200,000 | $ 129,900,000 | $ 449,996,887 | ||
Net proceeds of public offering | $ 327,400,000 | $ 121,800,000 | |||
SADSAD | |||||
Universal shelf registration statement, effective date value | $ 350,000,000 | ||||
Securities remained available for issuance under the Company's previous shelf registration | 4,800,000 | ||||
IPO [Member] | |||||
Organization Consolidation And Presentation Of Financial Statements Disclosure [Line Items] | |||||
Initial public offering of common stock | 5,411,481 | ||||
Common stock price per share | $ 24 |
Summary of Significant Accoun18
Summary of Significant Accounting Policies - Additional Information (Detail) - USD ($) | Oct. 03, 2016 | Sep. 30, 2016 | Sep. 30, 2015 | Dec. 31, 2015 |
Significant Accounting Policies [Line Items] | ||||
Maturity of highly liquid investments | Three months or less | |||
Maturity of certificates of deposit, commercial paper, corporate notes and corporate bonds | More than three months | |||
Line of credit used to capitalize ITI Limited | $ 125,000,000 | |||
Line of credit facility termination date | Oct. 6, 2016 | |||
Investment securities, available-for-sale | $ 337,405,780 | $ 428,041,021 | ||
Investment securities, available for sale noncurrent | 0 | 9,200,000 | ||
Investment securities, unrealized loss | 19,000 | |||
Carrying value of cash held in money market funds | 16,000,000 | 31,100,000 | ||
Allowance recorded | $ 0 | 0 | ||
Assumed expected dividend rate | 0.00% | 0.00% | ||
Unrecognized compensation costs related to unvested RSUs | $ 3,402,792 | |||
Service period for granted RSUs, vest in annual installment | 3 years | |||
Excess tax benefits for tax deductions | $ 0 | $ 0 | ||
Intellectual Property [Member] | ||||
Significant Accounting Policies [Line Items] | ||||
License fee received | 125,000,000 | |||
Subsequent Event [Member] | ||||
Significant Accounting Policies [Line Items] | ||||
Line of credit repaid | $ 125,000,000 | |||
Significant Unobservable Inputs (Level 3) [Member] | ||||
Significant Accounting Policies [Line Items] | ||||
Assets measured using quoted prices | 0 | 0 | ||
Liabilities measured using quoted prices | 0 | 0 | ||
Contractual Maturity Dates More Than One Year and Less Than Two Years [Member] | ||||
Significant Accounting Policies [Line Items] | ||||
Investment securities, available-for-sale | $ 66,100,000 | $ 142,400,000 | ||
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 Accoun19
Summary of Significant Accounting Policies - Schedule of Investment Securities (Detail) - USD ($) | Sep. 30, 2016 | Dec. 31, 2015 |
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | $ 337,577,000 | $ 428,632,000 |
Unrealized Gains | 47,000 | 1,000 |
Unrealized (Losses) | (218,000) | (592,000) |
Estimated Fair Value | 337,405,780 | 428,041,021 |
U.S. Government Agency Securities [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 66,026,000 | 61,510,000 |
Unrealized Gains | 18,000 | |
Unrealized (Losses) | (25,000) | (271,000) |
Estimated Fair Value | 66,019,000 | 61,239,000 |
FDIC Certificates of Deposit [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 31,037,000 | 41,343,000 |
Unrealized Gains | 3,000 | 1,000 |
Unrealized (Losses) | (11,000) | |
Estimated Fair Value | 31,040,000 | 41,333,000 |
Certificates of Deposit [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 82,000,000 | 219,500,000 |
Estimated Fair Value | 82,000,000 | 219,500,000 |
Commercial Paper [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 59,960,000 | 30,122,000 |
Unrealized Gains | 19,000 | |
Unrealized (Losses) | (66,000) | (48,000) |
Estimated Fair Value | 59,913,000 | 30,074,000 |
Corporate Notes/Bonds [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 98,554,000 | 76,157,000 |
Unrealized Gains | 7,000 | |
Unrealized (Losses) | (127,000) | (262,000) |
Estimated Fair Value | $ 98,434,000 | $ 75,895,000 |
Summary of Significant Accoun20
Summary of Significant Accounting Policies - Schedule of Investment Securities (Parenthetical) (Detail) - USD ($) | Sep. 30, 2016 | Dec. 31, 2015 |
Maximum [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Deposits under FDIC Certificates of Deposit | $ 250,000 | $ 250,000 |
Summary of Significant Accoun21
Summary of Significant Accounting Policies - Schedule of Fair Value Measurements of Cash Equivalents and Available-for-Sale Investment Securities (Detail) - USD ($) $ in Thousands | Sep. 30, 2016 | Dec. 31, 2015 |
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
Available-for-sale investment securities | $ 353,392 | $ 459,155 |
Money Market Funds [Member] | ||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
Available-for-sale investment securities | 15,986 | 31,114 |
U.S. Government Agency Securities [Member] | ||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
Available-for-sale investment securities | 66,019 | 61,239 |
FDIC Certificates of Deposit [Member] | ||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
Available-for-sale investment securities | 31,040 | 41,333 |
Certificates of Deposit [Member] | ||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
Available-for-sale investment securities | 82,000 | 219,500 |
Commercial Paper [Member] | ||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
Available-for-sale investment securities | 59,913 | 30,074 |
Corporate Notes/Bonds [Member] | ||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
Available-for-sale investment securities | 98,434 | 75,895 |
Quoted Prices in Active Markets for Identical Assets (Level 1) [Member] | ||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
Available-for-sale investment securities | 15,986 | 31,114 |
Quoted Prices in Active Markets for Identical Assets (Level 1) [Member] | Money Market Funds [Member] | ||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
Available-for-sale investment securities | 15,986 | 31,114 |
Significant Other Observable Inputs (Level 2) [Member] | ||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
Available-for-sale investment securities | 337,406 | 428,041 |
Significant Other Observable Inputs (Level 2) [Member] | U.S. Government Agency Securities [Member] | ||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
Available-for-sale investment securities | 66,019 | 61,239 |
Significant Other Observable Inputs (Level 2) [Member] | FDIC Certificates of Deposit [Member] | ||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
Available-for-sale investment securities | 31,040 | 41,333 |
Significant Other Observable Inputs (Level 2) [Member] | Certificates of Deposit [Member] | ||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
Available-for-sale investment securities | 82,000 | 219,500 |
Significant Other Observable Inputs (Level 2) [Member] | Commercial Paper [Member] | ||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
Available-for-sale investment securities | 59,913 | 30,074 |
Significant Other Observable Inputs (Level 2) [Member] | Corporate Notes/Bonds [Member] | ||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
Available-for-sale investment securities | $ 98,434 | $ 75,895 |
Summary of Significant Accoun22
Summary of Significant Accounting Policies - Common Stock Equivalents Excluded in Calculation of Diluted Loss Per Share (Detail) - shares | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2016 | Sep. 30, 2015 | Sep. 30, 2016 | Sep. 30, 2015 | |
Stock Options [Member] | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Number of anti-dilutive securities excluded from computation of earnings per share | 1,528,266 | 1,746,502 | 1,528,266 | 1,742,555 |
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 | 39,420 | 38,844 |
Property and Equipment - Proper
Property and Equipment - Property and Equipment (Detail) - USD ($) | Sep. 30, 2016 | Dec. 31, 2015 |
Property, Plant and Equipment [Line Items] | ||
Property plant and equipment, gross | $ 3,176,384 | $ 3,132,360 |
Less accumulated depreciation | (2,498,681) | (2,356,838) |
Property Plant and Equipment Net | 677,703 | 775,522 |
Computer Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property plant and equipment, gross | 39,095 | 42,064 |
Furniture and Fixtures [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property plant and equipment, gross | 292,423 | 266,695 |
Scientific Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property plant and equipment, gross | $ 2,844,866 | $ 2,823,601 |
Property and Equipment - Additi
Property and Equipment - Additional Information (Detail) - USD ($) | 9 Months Ended | |
Sep. 30, 2016 | Sep. 30, 2015 | |
Property, Plant and Equipment [Abstract] | ||
Depreciation expense | $ 146,784 | $ 92,594 |
Share-Based Compensation - Addi
Share-Based Compensation - Additional Information (Detail) - USD ($) $ in Millions | 9 Months Ended | ||||
Sep. 30, 2016 | Sep. 30, 2015 | Dec. 31, 2015 | Jan. 31, 2015 | Jan. 31, 2014 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Purchase of common stock | 3,110,927 | 2,737,657 | |||
Options, maximum term | 10 years | ||||
RSUs [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Non-cash stock-based compensation expense recognized | $ 1.1 | $ 0 | |||
Minimum [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Incentive stock options (ISOs), vesting period | 2 years | ||||
Maximum [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Incentive stock options (ISOs), vesting period | 3 years | ||||
2013 Equity Incentive Plan [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Purchase of common stock | 2,425,267 | ||||
Shares of common stock reserved for issuance | 2,850,000 | 800,000 | 800,000 | ||
Number of shares of common stock available for issuance under the plan | 3,100,000 | ||||
Increase in maximum number of shares available for issuance of options, stock appreciation rights and other similar awards | 100,000 | ||||
2003 Equity Incentive Plan [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Purchase of common stock | 685,660 |
Share-Based Compensation - Tota
Share-Based Compensation - Total Stock-Based Compensation Expense (Detail) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2016 | Sep. 30, 2015 | Sep. 30, 2016 | Sep. 30, 2015 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Total share-based compensation expense | $ 3,686,746 | $ 2,865,990 | $ 10,975,931 | $ 7,466,595 |
Research and Development [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Total share-based compensation expense | 1,045,547 | 1,220,602 | 3,400,324 | 2,892,258 |
General and Administrative [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Total share-based compensation expense | $ 2,641,199 | $ 1,645,388 | $ 7,575,607 | $ 4,574,337 |
Share-Based Compensation - Weig
Share-Based Compensation - Weighted-Average Assumptions Used for Calculating Value of Options Granted (Detail) | 9 Months Ended | |
Sep. 30, 2016 | Sep. 30, 2015 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | ||
Dividend yield | 0.00% | 0.00% |
Expected volatility | 80.00% | 80.00% |
Weighted-average risk-free interest rate | 1.70% | 1.80% |
Expected term | 5 years 10 months 24 days | 6 years 3 months 18 days |
Share-Based Compensation - Stoc
Share-Based Compensation - Stock Options Activity (Detail) - $ / shares | 9 Months Ended | 12 Months Ended |
Sep. 30, 2016 | Dec. 31, 2015 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | ||
Outstanding at beginning of period, Number of Shares | 2,737,657 | |
Options granted, Number of Shares | 478,265 | |
Options exercised, Number of Shares | (104,995) | |
Options canceled or expired, Number of Shares | 0 | |
Outstanding at end of period, Number of Shares | 3,110,927 | 2,737,657 |
Vested or expected to vest at end of period, Number of Shares | 3,110,927 | |
Exercisable at end of period, Number of Shares | 1,836,573 | |
Outstanding at beginning of period, Weighted-Average Exercise Price | $ 13.72 | |
Options granted, Weighted-Average Exercise Price | 49.47 | |
Options exercised, Weighted-Average Exercise Price | 4.29 | |
Options canceled or expired, Weighted-Average Exercise Price | 0 | |
Outstanding at end of period, Weighted-Average Exercise Price | 19.53 | $ 13.72 |
Vested or expected to vest at end of period, Weighted-Average Exercise Price | 19.53 | |
Exercisable at end of period, Weighted-Average Exercise Price | $ 11.74 | |
Options granted, Weighted-Average Contractual Life | 5 years 10 months 24 days | |
Options exercised, Weighted-Average Contractual Life | 3 years 8 months 12 days | |
Options canceled or expired, Weighted-Average Contractual Life | 0 years | |
Outstanding at end of period, Weighted-Average Contractual Life | 7 years 4 months 24 days | 7 years 7 months 6 days |
Exercisable at end of period, Weighted-Average Contractual Life | 6 years 8 months 12 days |
Share-Based Compensation - Summ
Share-Based Compensation - Summary of Information Regarding RSU Activity (Detail) - RSUs [Member] | 9 Months Ended |
Sep. 30, 2016$ / sharesshares | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Outstanding at beginning of period, Number of Shares | shares | 5,272 |
RSU's granted, Number of Shares | shares | 78,806 |
Outstanding at end of period, Number of Shares | shares | 84,078 |
Outstanding at beginning of period, Weighted-Average Grant Date Fair Value | $ / shares | $ 56.90 |
RSU's granted, Weighted-Average Grant Date Fair Value | $ / shares | 53.63 |
Outstanding at end of period, Weighted-Average Grant Date Fair Value | $ / shares | $ 53.84 |
Line of Credit - Additional Inf
Line of Credit - Additional Information (Detail) | 3 Months Ended | 9 Months Ended |
Sep. 30, 2016USD ($) | Sep. 30, 2016USD ($) | |
Line of Credit Facility [Line Items] | ||
Interest expense | $ 12,260 | $ 12,260 |
Secured Line of Credit [Member] | ||
Line of Credit Facility [Line Items] | ||
Line of credit maximum amount | 150,800,000 | 150,800,000 |
Line of credit, collateral amount held by the lender | 150,800,000 | $ 150,800,000 |
Variable interest rate | 2.991% | |
Line of credit borrowed amount | 125,000,000 | $ 125,000,000 |
Repayment of line of credit | $ 125,000,000 | |
Description of variable rate basis | LIBOR plus 2.991% | |
Interest expense | 12,260 | |
Line of credit fair value | $ 125,000,000 | $ 125,000,000 |
Collaborations and License Ag31
Collaborations and License Agreements - Additional Information (Detail) - USD ($) | May 31, 2005 | Dec. 31, 2014 | Dec. 31, 2013 | Sep. 30, 2016 | Sep. 30, 2015 | Sep. 30, 2016 |
Bristol-Myers Squibb Company [Member] | ||||||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||||||
Company made an upfront payment | $ 1,000,000 | |||||
Company made milestone payment | $ 1,500,000 | $ 1,250,000 | ||||
Company remaining milestone payment | $ 12,000,000 | |||||
Obliged to make milestone payments | $ 14,750,000 | $ 14,750,000 | ||||
License expiration period | Through the later of ten years after first commercial sale of a licensed product in such country, expiration of the last licensed patent covering a licensed product. | |||||
Takeda Pharmaceutical Company Limited [Member] | ||||||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||||||
Date of termination agreement | Oct. 31, 2014 | |||||
University [Member] | Licensing Agreements [Member] | ||||||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||||||
License expiration period | Upon expiration of the patent rights or 15 years subsequent to the first sale of products developed through this License. | |||||
Other payments | $ 0 | $ 0 | ||||
University [Member] | Licensing Agreements [Member] | Minimum [Member] | ||||||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||||||
Annual spending requirements for development and commercialization of technology expense | $ 1,000,000 |