Cover Page - shares |
9 Months Ended | |
|---|---|---|
Sep. 30, 2019 |
Nov. 08, 2019 |
|
| Cover [Abstract] | ||
| Document Type | 10-Q | |
| Amendment Flag | false | |
| Document Period End Date | Sep. 30, 2019 | |
| Document Fiscal Year Focus | 2019 | |
| Document Fiscal Period Focus | Q3 | |
| Entity Registrant Name | CATALYST PHARMACEUTICALS, INC. | |
| Entity Central Index Key | 0001369568 | |
| Current Fiscal Year End Date | --12-31 | |
| Entity Current Reporting Status | Yes | |
| Entity Shell Company | false | |
| Entity Filer Category | Accelerated Filer | |
| Trading Symbol | CPRX | |
| Entity Emerging Growth Company | false | |
| Entity Small Business | true | |
| Entity Address, State or Province | FL | |
| Entity Interactive Data Current | Yes | |
| Title of 12(b) Security | Common Stock | |
| Security Exchange Name | NASDAQ | |
| Entity Common Stock, Shares Outstanding | 103,047,033 |
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- Definition Indicate number of shares or other units outstanding of each of registrant's classes of capital or common stock or other ownership interests, if and as stated on cover of related periodic report. Where multiple classes or units exist define each class/interest by adding class of stock items such as Common Class A [Member], Common Class B [Member] or Partnership Interest [Member] onto the Instrument [Domain] of the Entity Listings, Instrument. No definition available.
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- Definition Carrying value as of the balance sheet date of liabilities incurred (and for which invoices have typically been received) and payable to vendors for goods and services received that are used in an entity's business. Used to reflect the current portion of the liabilities (due within one year or within the normal operating cycle if longer). Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition Carrying value as of the balance sheet date of obligations incurred and payable, pertaining to costs that are statutory in nature, are incurred on contractual obligations, or accumulate over time and for which invoices have not yet been received or will not be rendered. Examples include taxes, interest, rent and utilities. Used to reflect the current portion of the liabilities (due within one year or within the normal operating cycle if longer). Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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| X | ||||||||||
- Definition Accumulated change in equity from transactions and other events and circumstances from non-owner sources, net of tax effect, at period end. Excludes Net Income (Loss), and accumulated changes in equity from transactions resulting from investments by owners and distributions to owners. Includes foreign currency translation items, certain pension adjustments, unrealized gains and losses on certain investments in debt and equity securities, other than temporary impairment (OTTI) losses related to factors other than credit losses on available-for-sale and held-to-maturity debt securities that an entity does not intend to sell and it is not more likely than not that the entity will be required to sell before recovery of the amortized cost basis, as well as changes in the fair value of derivatives related to the effective portion of a designated cash flow hedge. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition Excess of issue price over par or stated value of the entity's capital stock and amounts received from other transactions involving the entity's stock or stockholders. Includes adjustments to additional paid in capital. Some examples of such adjustments include recording the issuance of debt with a beneficial conversion feature and certain tax consequences of equity instruments awarded to employees. Use this element for the aggregate amount of additional paid-in capital associated with common and preferred stock. For additional paid-in capital associated with only common stock, use the element additional paid in capital, common stock. For additional paid-in capital associated with only preferred stock, use the element additional paid in capital, preferred stock. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition Sum of the carrying amounts as of the balance sheet date of all assets that are recognized. Assets are probable future economic benefits obtained or controlled by an entity as a result of past transactions or events. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition Sum of the carrying amounts as of the balance sheet date of all assets that are expected to be realized in cash, sold, or consumed within one year (or the normal operating cycle, if longer). Assets are probable future economic benefits obtained or controlled by an entity as a result of past transactions or events. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- References No definition available.
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- Definition Amount of currency on hand as well as demand deposits with banks or financial institutions. Includes other kinds of accounts that have the general characteristics of demand deposits. Also includes short-term, highly liquid investments that are both readily convertible to known amounts of cash and so near their maturity that they present insignificant risk of changes in value because of changes in interest rates. Excludes cash and cash equivalents within disposal group and discontinued operation. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition Represents the caption on the face of the balance sheet to indicate that the entity has entered into (1) purchase or supply arrangements that will require expending a portion of its resources to meet the terms thereof, and (2) is exposed to potential losses or, less frequently, gains, arising from (a) possible claims against a company's resources due to future performance under contract terms, and (b) possible losses or likely gains from uncertainties that will ultimately be resolved when one or more future events that are deemed likely to occur do occur or fail to occur. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition Aggregate par or stated value of issued nonredeemable common stock (or common stock redeemable solely at the option of the issuer). This item includes treasury stock repurchased by the entity. Note: elements for number of nonredeemable common shares, par value and other disclosure concepts are in another section within stockholders' equity. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition Carrying value of amounts transferred to third parties for security purposes that are expected to be returned or applied towards payment after one year or beyond the operating cycle, if longer. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition Amount after valuation and LIFO reserves of inventory expected to be sold, or consumed within one year or operating cycle, if longer. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition Sum of the carrying amounts as of the balance sheet date of all liabilities that are recognized. Liabilities are probable future sacrifices of economic benefits arising from present obligations of an entity to transfer assets or provide services to other entities in the future. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition Amount of liabilities and equity items, including the portion of equity attributable to noncontrolling interests, if any. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition Total obligations incurred as part of normal operations that are expected to be paid during the following twelve months or within one business cycle, if longer. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- References No definition available.
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- Definition The total amount of investments that are intended to be held for an extended period of time (longer than one operating cycle). Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition Amount of lessee's right to use underlying asset under operating lease. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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- Definition Amount of expenses incurred but not yet paid classified as other, due after one year or the normal operating cycle, if longer. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition Aggregate par or stated value of issued nonredeemable preferred stock (or preferred stock redeemable solely at the option of the issuer). This item includes treasury stock repurchased by the entity. Note: elements for number of nonredeemable preferred shares, par value and other disclosure concepts are in another section within stockholders' equity. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition Amount of asset related to consideration paid in advance for costs that provide economic benefits in future periods, and amount of other assets that are expected to be realized or consumed within one year or the normal operating cycle, if longer. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition Amount after accumulated depreciation, depletion and amortization of physical assets used in the normal conduct of business to produce goods and services and not intended for resale. Examples include, but are not limited to, land, buildings, machinery and equipment, office equipment, and furniture and fixtures. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition The cumulative amount of the reporting entity's undistributed earnings or deficit. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition Amount of investments including trading securities, available-for-sale securities, held-to-maturity securities, and short-term investments classified as other and current. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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| X | ||||||||||
- Definition Total of all stockholders' equity (deficit) items, net of receivables from officers, directors, owners, and affiliates of the entity which are attributable to the parent. The amount of the economic entity's stockholders' equity attributable to the parent excludes the amount of stockholders' equity which is allocable to that ownership interest in subsidiary equity which is not attributable to the parent (noncontrolling interest, minority interest). This excludes temporary equity and is sometimes called permanent equity. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- References No definition available.
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Consolidated Balance Sheets (Parenthetical) - $ / shares |
Sep. 30, 2019 |
Dec. 31, 2018 |
|---|---|---|
| Statement of Financial Position [Abstract] | ||
| Preferred stock, par value | $ 0.001 | $ 0.001 |
| Preferred stock, shares authorized | 5,000,000 | 5,000,000 |
| Preferred stock, shares issued | 0 | 0 |
| Preferred stock, shares outstanding | 0 | 0 |
| Common stock, par value | $ 0.001 | $ 0.001 |
| Common stock, shares authorized | 150,000,000 | 150,000,000 |
| Common stock, shares issued | 103,041,033 | 102,739,257 |
| Common stock, shares outstanding | 103,041,033 | 102,739,257 |
| X | ||||||||||
- Definition Face amount or stated value per share of common stock. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition The maximum number of common shares permitted to be issued by an entity's charter and bylaws. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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| X | ||||||||||
- Definition Total number of common shares of an entity that have been sold or granted to shareholders (includes common shares that were issued, repurchased and remain in the treasury). These shares represent capital invested by the firm's shareholders and owners, and may be all or only a portion of the number of shares authorized. Shares issued include shares outstanding and shares held in the treasury. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition Number of shares of common stock outstanding. Common stock represent the ownership interest in a corporation. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition Face amount or stated value per share of preferred stock nonredeemable or redeemable solely at the option of the issuer. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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| X | ||||||||||
- Definition The maximum number of nonredeemable preferred shares (or preferred stock redeemable solely at the option of the issuer) permitted to be issued by an entity's charter and bylaws. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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| X | ||||||||||
- Definition Total number of nonredeemable preferred shares (or preferred stock redeemable solely at the option of the issuer) issued to shareholders (includes related preferred shares that were issued, repurchased, and remain in the treasury). May be all or portion of the number of preferred shares authorized. Excludes preferred shares that are classified as debt. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition Aggregate share number for all nonredeemable preferred stock (or preferred stock redeemable solely at the option of the issuer) held by stockholders. Does not include preferred shares that have been repurchased. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- References No definition available.
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Consolidated Statements of Operations and Comprehensive Income (Loss) - USD ($) |
3 Months Ended | 9 Months Ended | ||
|---|---|---|---|---|
Sep. 30, 2019 |
Sep. 30, 2018 |
Sep. 30, 2019 |
Sep. 30, 2018 |
|
| Revenues: | ||||
| Product revenue, net | $ 30,897,444 | $ 72,183,782 | ||
| Type of Revenue [Extensible List] | us-gaap:ProductMember | us-gaap:ProductMember | ||
| Operating costs and expenses: | ||||
| Cost of sales | $ 4,387,461 | $ 10,360,874 | ||
| Type of Cost, Good or Service [Extensible List] | us-gaap:ProductMember | us-gaap:ProductMember | ||
| Research and development | $ 4,597,039 | $ 4,538,369 | $ 12,534,362 | $ 11,502,235 |
| Selling, general and administrative | 8,067,792 | 3,644,234 | 25,471,974 | 8,949,663 |
| Total operating costs and expenses | 17,052,292 | 8,182,603 | 48,367,210 | 20,451,898 |
| Operating income (loss) | 13,845,152 | (8,182,603) | 23,816,572 | (20,451,898) |
| Other income, net | 393,415 | 343,730 | 1,187,091 | 947,993 |
| Net income (loss) before income taxes | 14,238,567 | (7,838,873) | 25,003,663 | (19,503,905) |
| Provision for income taxes | 608,388 | 1,058,039 | ||
| Net income (loss) | $ 13,630,179 | $ (7,838,873) | $ 23,945,624 | $ (19,503,905) |
| Net income (loss) per share: | ||||
| Basic | $ 0.13 | $ (0.08) | $ 0.23 | $ (0.19) |
| Diluted | $ 0.13 | $ (0.08) | $ 0.23 | $ (0.19) |
| Weighted average shares outstanding: | ||||
| Basic | 102,974,105 | 102,641,504 | 102,864,571 | 102,598,740 |
| Diluted | 107,045,234 | 102,641,504 | 105,821,609 | 102,598,740 |
| Net income (loss) | $ 13,630,179 | $ (7,838,873) | $ 23,945,624 | $ (19,503,905) |
| Other comprehensive income (loss): | ||||
| Unrealized gain (loss) on available-for-sale securities | (2,330) | (9,450) | 39,676 | (45,948) |
| Comprehensive income (loss) | $ 13,627,849 | $ (7,848,323) | $ 23,985,300 | $ (19,549,853) |
| X | ||||||||||
- Definition Total operating expenses. No definition available.
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| X | ||||||||||
- Definition Amount after tax of increase (decrease) in equity from transactions and other events and circumstances from net income and other comprehensive income, attributable to parent entity. Excludes changes in equity resulting from investments by owners and distributions to owners. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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| X | ||||||||||
- Definition The aggregate costs related to goods produced and sold and services rendered by an entity during the reporting period. This excludes costs incurred during the reporting period related to financial services rendered and other revenue generating activities. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition The amount of net income (loss) for the period per each share of common stock or unit outstanding during the reporting period. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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- References No definition available.
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| X | ||||||||||
- Definition The amount of net income (loss) for the period available to each share of common stock or common unit outstanding during the reporting period and to each share or unit that would have been outstanding assuming the issuance of common shares or units for all dilutive potential common shares or units outstanding during the reporting period. Reference 1: http://www.xbrl.org/2003/role/exampleRef
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| X | ||||||||||
- Definition Amount of income (loss) from continuing operations, including income (loss) from equity method investments, before deduction of income tax expense (benefit), and income (loss) attributable to noncontrolling interest. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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| X | ||||||||||
- Definition Amount of current income tax expense (benefit) and deferred income tax expense (benefit) pertaining to continuing operations. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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| X | ||||||||||
- Definition The portion of profit or loss for the period, net of income taxes, which is attributable to the parent. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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- References No definition available.
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| X | ||||||||||
- Definition The net result for the period of deducting operating expenses from operating revenues. No definition available.
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- References No definition available.
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| X | ||||||||||
- Definition Amount after tax, before reclassification adjustments, of unrealized holding gain (loss) on available-for-sale securities. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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- Definition Amount of income (expense) related to nonoperating activities, classified as other. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition The aggregate costs incurred (1) in a planned search or critical investigation aimed at discovery of new knowledge with the hope that such knowledge will be useful in developing a new product or service, a new process or technique, or in bringing about a significant improvement to an existing product or process; or (2) to translate research findings or other knowledge into a plan or design for a new product or process or for a significant improvement to an existing product or process whether intended for sale or the entity's use, during the reporting period charged to research and development projects, including the costs of developing computer software up to the point in time of achieving technological feasibility, and costs allocated in accounting for a business combination to in-process projects deemed to have no alternative future use. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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| X | ||||||||||
- Definition Amount, excluding tax collected from customer, of revenue from satisfaction of performance obligation by transferring promised good or service to customer. Tax collected from customer is tax assessed by governmental authority that is both imposed on and concurrent with specific revenue-producing transaction, including, but not limited to, sales, use, value added and excise. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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- References No definition available.
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| X | ||||||||||
- Definition The aggregate total costs related to selling a firm's product and services, as well as all other general and administrative expenses. Direct selling expenses (for example, credit, warranty, and advertising) are expenses that can be directly linked to the sale of specific products. Indirect selling expenses are expenses that cannot be directly linked to the sale of specific products, for example telephone expenses, Internet, and postal charges. General and administrative expenses include salaries of non-sales personnel, rent, utilities, communication, etc. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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| X | ||||||||||
- Definition Indicates type of cost from product sold and service rendered. Reference 1: http://www.xbrl.org/2009/role/commonPracticeRef
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| X | ||||||||||
- Definition Indicates type of revenue from product and service. Includes, but is not limited to, revenue from contract with customer and other sources. No definition available.
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- Definition The average number of shares or units issued and outstanding that are used in calculating diluted EPS or earnings per unit (EPU), determined based on the timing of issuance of shares or units in the period. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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| X | ||||||||||
- References No definition available.
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| X | ||||||||||
- Definition Number of [basic] shares or units, after adjustment for contingently issuable shares or units and other shares or units not deemed outstanding, determined by relating the portion of time within a reporting period that common shares or units have been outstanding to the total time in that period. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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Consolidated Statement of Changes in Stockholders' Equity - USD ($) |
Total |
Preferred Stock [Member] |
Common Stock [Member] |
Additional Paid-in Capital [Member] |
Accumulated Deficit [Member] |
Accumulated Other Comprehensive Gain (Loss) [Member] |
|---|---|---|---|---|---|---|
| Beginning Balance at Dec. 31, 2017 | $ 80,963,812 | $ 102,549 | $ 207,421,710 | $ (126,560,447) | ||
| Issuance of stock options for services | 971,340 | 971,340 | ||||
| Exercise of stock options for common stock | 33,032 | 37 | 32,995 | |||
| Other comprehensive gain (loss) | (21,826) | $ (21,826) | ||||
| Net income (loss) | (5,699,892) | (5,699,892) | ||||
| Ending Balance at Mar. 31, 2018 | 76,246,466 | 102,586 | 208,426,045 | (132,260,339) | (21,826) | |
| Beginning Balance at Dec. 31, 2017 | 80,963,812 | 102,549 | 207,421,710 | (126,560,447) | ||
| Net income (loss) | (19,503,905) | |||||
| Ending Balance at Sep. 30, 2018 | 64,076,598 | 102,689 | 210,084,209 | (146,064,352) | (45,948) | |
| Beginning Balance at Mar. 31, 2018 | 76,246,466 | 102,586 | 208,426,045 | (132,260,339) | (21,826) | |
| Issuance of common stock, net | 10,549 | 3 | 10,546 | |||
| Issuance of stock options for services | 776,510 | 776,510 | ||||
| Exercise of stock options for common stock | 8,500 | 10 | 8,490 | |||
| Other comprehensive gain (loss) | (14,672) | (14,672) | ||||
| Net income (loss) | (5,965,140) | (5,965,140) | ||||
| Ending Balance at Jun. 30, 2018 | 71,062,213 | 102,599 | 209,221,591 | (138,225,479) | (36,498) | |
| Issuance of stock options for services | 758,176 | 758,176 | ||||
| Exercise of stock options for common stock | 104,532 | 90 | 104,442 | |||
| Other comprehensive gain (loss) | (9,450) | (9,450) | ||||
| Net income (loss) | (7,838,873) | (7,838,873) | ||||
| Ending Balance at Sep. 30, 2018 | 64,076,598 | 102,689 | 210,084,209 | (146,064,352) | (45,948) | |
| Beginning Balance at Dec. 31, 2018 | 50,783,809 | 102,739 | 211,265,279 | (160,563,961) | (20,248) | |
| Issuance of stock options for services | 933,411 | 933,411 | ||||
| Exercise of stock options for common stock | 89,350 | 65 | 89,285 | |||
| Other comprehensive gain (loss) | 13,560 | 13,560 | ||||
| Net income (loss) | (644,503) | (644,503) | ||||
| Ending Balance at Mar. 31, 2019 | 51,175,627 | 102,804 | 212,287,975 | (161,208,464) | (6,688) | |
| Beginning Balance at Dec. 31, 2018 | 50,783,809 | 102,739 | 211,265,279 | (160,563,961) | (20,248) | |
| Net income (loss) | 23,945,624 | |||||
| Ending Balance at Sep. 30, 2019 | 77,982,538 | 103,041 | 214,478,406 | (136,618,337) | 19,428 | |
| Beginning Balance at Mar. 31, 2019 | 51,175,627 | 102,804 | 212,287,975 | (161,208,464) | (6,688) | |
| Issuance of stock options for services | 924,996 | 924,996 | ||||
| Exercise of stock options for common stock | 192,550 | 125 | 192,425 | |||
| Other comprehensive gain (loss) | 28,446 | 28,446 | ||||
| Net income (loss) | 10,959,948 | 10,959,948 | ||||
| Ending Balance at Jun. 30, 2019 | 63,281,567 | 102,929 | 213,405,396 | (150,248,516) | 21,758 | |
| Issuance of stock options for services | 817,060 | 817,060 | ||||
| Exercise of stock options for common stock | 256,062 | 112 | 255,950 | |||
| Other comprehensive gain (loss) | (2,330) | (2,330) | ||||
| Net income (loss) | 13,630,179 | 13,630,179 | ||||
| Ending Balance at Sep. 30, 2019 | $ 77,982,538 | $ 103,041 | $ 214,478,406 | $ (136,618,337) | $ 19,428 |
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- Definition Amount of increase to additional paid-in capital (APIC) for recognition of cost for option under share-based payment arrangement. No definition available.
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- Definition Total of all stockholders' equity (deficit) items, net of receivables from officers, directors, owners, and affiliates of the entity which are attributable to the parent. The amount of the economic entity's stockholders' equity attributable to the parent excludes the amount of stockholders' equity which is allocable to that ownership interest in subsidiary equity which is not attributable to the parent (noncontrolling interest, minority interest). This excludes temporary equity and is sometimes called permanent equity. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition Amount of currency on hand as well as demand deposits with banks or financial institutions. Includes other kinds of accounts that have the general characteristics of demand deposits. Also includes short-term, highly liquid investments that are both readily convertible to known amounts of cash and so near their maturity that they present insignificant risk of changes in value because of changes in interest rates. Excludes cash and cash equivalents within disposal group and discontinued operation. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition Amount of increase (decrease) in cash and cash equivalents, and cash and cash equivalents restricted to withdrawal or usage; excluding effect from exchange rate change. Cash includes, but is not limited to, currency on hand, demand deposits with banks or financial institutions, and other accounts with general characteristics of demand deposits. Cash equivalents include, but are not limited to, short-term, highly liquid investments that are both readily convertible to known amounts of cash and so near their maturity that they present insignificant risk of changes in value because of changes in interest rates. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition The amount of expense recognized in the current period that reflects the allocation of the cost of tangible assets over the assets' useful lives. Includes production and non-production related depreciation. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition The increase (decrease) during the reporting period in the aggregate amount of liabilities incurred (and for which invoices have typically been received) and payable to vendors for goods and services received that are used in an entity's business. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition Amount of increase (decrease) in accrued expenses, and obligations classified as other. Reference 1: http://www.xbrl.org/2009/role/commonPracticeRef
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- Definition The increase (decrease) during the reporting period in the aggregate value of all inventory held by the reporting entity, associated with underlying transactions that are classified as operating activities. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition Amount of cash inflow (outflow) from financing activities, including discontinued operations. Financing activity cash flows include obtaining resources from owners and providing them with a return on, and a return of, their investment; borrowing money and repaying amounts borrowed, or settling the obligation; and obtaining and paying for other resources obtained from creditors on long-term credit. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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- Definition Amount of cash inflow (outflow) from investing activities, including discontinued operations. Investing activity cash flows include making and collecting loans and acquiring and disposing of debt or equity instruments and property, plant, and equipment and other productive assets. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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- Definition Amount of cash inflow (outflow) from operating activities, including discontinued operations. Operating activity cash flows include transactions, adjustments, and changes in value not defined as investing or financing activities. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition Amount before tax, after reclassification adjustments, of appreciation (loss) in value of unsold available-for-sale securities. Excludes amounts related to other than temporary impairment (OTTI) loss. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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- Definition The cash outflow associated with the acquisition of long-lived, physical assets that are used in the normal conduct of business to produce goods and services and not intended for resale; includes cash outflows to pay for construction of self-constructed assets. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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Organization and Description of Business |
9 Months Ended | |||
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| Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||||
| Organization and Description of Business |
Catalyst Pharmaceuticals, Inc. and subsidiary (collectively, the Company) is a biopharmaceutical company focused on developing and commercializing innovating therapies for people with rare debilitating, chronic neuromuscular and neurological diseases, including Lambert-Eaton Myasthenic Syndrome (LEMS), Anti-MuSK antibody positive myasthenia gravis (MuSK-MG), Congenital Myasthenic Syndromes (CMS), and Spinal Muscular Atrophy (SMA) Type 3. On November 28, 2018, the U.S. Food and Drug Administration, or FDA, granted approval of Firdapse ® for the treatment of adults with LEMS. On January 15, 2019, the Company launched its first product, Firdapse® , in the United States for the treatment of adults with LEMS (age 17 and above). Since inception, the Company has devoted substantially all of its efforts to business planning, research and development, recruiting management and technical staff, acquiring operating assets, raising capital, and selling its product. The Company incurred operating losses in each period from inception through March 31, 2019, and started reporting operating income in the three and six month periods ended June 30, 2019. The Company has been able to fund its cash needs to date through several public and private offerings of its securities and from revenues from its product sales. See Note 12. Capital Resources While there can be no assurance, based on currently available information, the Company estimates that it has sufficient resources to support its operations for at least the next 12 months from the issuance date of this Form 10-Q. The Company may raise required funds in the future through public or private equity offerings, debt financings, corporate collaborations, governmental research grants or other means. The Company may also seek to raise new capital to fund additional product development efforts, even if it has sufficient funds for its planned operations. Any sale by the Company of additional equity or convertible debt securities could result in dilution to the Company’s current stockholders. There can be no assurance that any required additional funding will be available to the Company at all or available on terms acceptable to the Company. Further, to the extent that the Company raises additional funds through collaborative arrangements, it may be necessary to relinquish some rights to the Company’s drug candidates or grant sublicenses on terms that are not favorable to the Company. If the Company is not able to secure additional funding when needed, the Company may have to delay, reduce the scope of, or eliminate one or more research and development programs, which could have an adverse effect on the Company’s business. |
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Basis of Presentation and Significant Accounting Policies |
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| Accounting Policies [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Basis of Presentation and Significant Accounting Policies |
In the opinion of management, the accompanying unaudited interim consolidated financial statements of the Company contain all adjustments (consisting of only normal recurring adjustments) necessary to present fairly the financial position of the Company as of the dates and for the periods presented. Accordingly, these consolidated statements should be read in conjunction with the financial statements and notes thereto for the year ended December 31, 2018 included in the 2018 Annual Report on Form 10-K filed by the Company with the SEC. The results of operations for the nine months ended September 30, 2019 are not necessarily indicative of the results to be expected for any future period or for the full 2019 fiscal year.
Short-Term Bond Fund The short-term bond fund is classified in trading securities. Trading securities are recorded at fair value based on the closing market price of the security. For trading securities, the Company recognizes realized gains and losses and unrealized gains and losses to earnings. At September 30, 2019 and December 31, 2018, the only investment classified as trading securities was the short-term bond fund. Realized losses on trading securities were $0 and $4,980, respectively, for the three and nine months ended September 30, 2019. There were no sales of trading securities for the three and nine months ended September 30, 2018. Unrealized gain (loss) on trading securities was $0 and $89,405, respectively, for the three and nine months ended September 30, 2019, and $0 and ($29,430 ), respectively for the three and nine months ended September 30, 2018 and is included in other income, net in the accompanying consolidated statements of operations. , U.S. Treasuries U.S. Treasuries are classified as available-for-sale available-for-sale Available-for-sale non-current investments in the accompanying consolidated balance sheets. The Company records available-for-sale available-for-sale available-for-sale
Products that have been approved by the FDA or other regulatory authorities, such as Firdapse ® , are also used in clinical programs to assess the safety and efficacy of the products for usage in treating diseases that have not been approved by the FDA or other regulatory authorities. The form of Firdapse® utilized for both commercial and clinical programs is identical and, as a result, the inventory has an “alternative future use” as defined in authoritative guidance. Raw materials and purchased drug product associated with clinical development programs are included in inventory and charged to research and development expense when the product enters the research and development process and no longer can be used for commercial purposes and, therefore, does not have an “alternative future use”. The Company evaluates for potential excess inventory by analyzing current and future product demand relative to the remaining product shelf life. The Company builds demand forecasts by considering factors such as, but not limited to, overall market potential, market share, market acceptance, and patient usage.
Level 1 inputs utilize quoted prices (unadjusted) in active markets for identical assets or liabilities that the Company has the ability to access at the measurement date. Level 2 inputs are inputs other than quoted prices included in Level 1 that are observable for the asset or liability, either directly or indirectly. Level 2 inputs may include quoted prices for similar assets and liabilities in active markets, as well as inputs that are observable for the asset or liability (other than quoted prices), such as interest rates, foreign exchange rates, and yield curves that are observable at commonly quoted intervals. Level 3 inputs are unobservable inputs for the asset or liability, which are typically based on an entity’s own assumptions, as there is little, if any, related market activity. In instances where the determination of the fair value measurement is based on inputs from different levels of the fair value hierarchy, the level in the fair value hierarchy within which the entire fair value measurement falls is based on the lowest level input that is significant to the fair value measurement in its entirety. The Company’s assessment of the significance of a particular input to the fair value measurement in its entirety requires judgment, and considers factors specific to the asset or liability.
Operating lease ROU assets and operating lease liabilities are recognized based on the present value of the future minimum lease payments over the lease term at commencement date. As the Company’s leases do not provide an implicit rate, the Company uses its incremental borrowing rate based on the information available at commencement date in determining the present value of future payments. The operating lease ROU asset also includes any lease payments made and excludes lease incentives and initial direct costs incurred. The Company’s lease terms do not include options to extend or terminate the lease as it is not reasonably certain that it will exercise these options. Lease expense for minimum lease payments is recognized on a straight-line basis over the lease term. The Company has lease agreements with lease and non-lease components, which are generally accounted for separately. Refer to Note 2.r. for discussion on adoption method.
To determine revenue recognition for arrangements that are within the scope of Topic 606, the Company performs the following five steps: (i) identify the contract(s) with a customer, (ii) identify the performance obligations in the contract, (iii) determine the transaction price, (iv) allocate the transaction price to the performance obligations in the contract, and (v) recognize revenue when (or as) the entity satisfies a performance obligation. The Company only applies the five-step model to arrangements that meet the definition of a contract under Topic 606, including when it is probable that the Company will collect the consideration it is entitled to in exchange for the goods or services it transfers to the customer. At contract inception, once the contract is determined to be within the scope of Topic 606, the Company assesses the goods or services promised within each contract and determines those that are performance obligations and assesses whether each promised good or service is distinct. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied. For a complete discussion of accounting for product revenue, see Product Revenue, Net below. The Company also generates revenues from payments received under a collaborative agreement. Collaborative agreement payments may include nonrefundable fees at the inception of the agreements, milestone and event-based payments for specific achievements designated in the collaborative agreements, and/or royalties on sales of products resulting from a collaborative arrangement. For a complete discussion of accounting for collaborative arrangements, see Revenues from Collaborative Arrangement below. Product Revenue, Net: ® to a Customer (its exclusive distributor) who subsequently resells Firdapse® to both a small group of SPs who have exclusive contracts with the Company to distribute the Company’s products to patients and potentially to medical centers or hospitals on an emergency basis. In addition to the distribution agreement with its Customer, the Company enters into arrangements with health care providers and payors that provide for government-mandated and/or privately negotiated rebates, chargebacks, and discounts with respect to the purchase of the Company’s products. The Company recognizes revenue on product sales when the Customer obtains control of the Company’s product, which occurs at a point in time (upon delivery). Product revenue is recorded net of applicable reserves for variable consideration, including discounts and allowances. The Company’s payment terms range between 15 and 60 days. Shipping and handling costs for product shipments occur prior to the customer obtaining control of the goods, and are recorded in cost of sales. If taxes should be collected from the Customer relating to product sales and remitted to governmental authorities, they will be excluded from revenue. The Company expenses incremental costs of obtaining a contract when incurred, if the expected amortization period of the asset that the Company would have recognized is one year or less. However, no such costs were incurred during the three and nine months ended September 30, 2019. As of September 30, 2019, all of the Company’s sales are to its Customer. Reserves for Variable Consideration: The amount of variable consideration which is included in the transaction price may be constrained, and is included in the net sales price only to the extent that it is probable that a significant reversal in the amount of the cumulative revenue recognized under the contract will not occur in a future period. The Company’s analyses also contemplated application of the constraint in accordance with the guidance, under which it determined a material reversal of revenue would not occur in a future period for the estimates detailed below as of September 30, 2019 and, therefore, the transaction price was not reduced further during the three and nine months ended September 30, 2019. Actual amounts of consideration ultimately received may differ from the Company’s estimates. If actual results in the future vary from the Company’s estimates, the Company will adjust these estimates, which would affect net product revenue and earnings in the period such variances become known. Trade Discounts and Allowances: ® to the Customer, these payments are classified in selling, general and administrative expenses in the Company’s consolidated statement of operations and comprehensive income (loss). However, if the Company has determined such services received to date are not distinct from the Company’s sale of products to the Customer, these payments have been recorded as a reduction of revenue within the statement of operations and comprehensive income (loss) through September 30, 2019, as well as a reduction to accounts receivables, net on the consolidated balance sheets. Funded Co-pay Assistance Program:co-pay assistance program intended to provide financial assistance to qualified insured patients. The calculation of the accrual for co-pay assistance is based on an estimate of claims and the cost per claim that the Company expects to receive associated with Firdapse® that has been recognized as revenue, but remains in the distribution channel at the end of each reporting period. These payments are considered payable to the customer and the related reserve is recorded in the same period the related revenue is recognized, resulting in a reduction of product revenue and the establishment of a current liability which is included in accrued expenses and other current liabilities in the consolidated balance sheets.Product Returns: Provider Chargebacks and Discounts: Government Rebates: Bridge and Patient Assistance Programs: ® to uninsured patients who satisfy pre-established criteria for either the Bridge Program or the Patient Assistance Program. Patients who meet the Bridge Program eligibility criteria and are transitioning from investigational product while they are waiting for a coverage determination, or later, for patients whose access is threatened by the complications arising from a change of insurer may receive a temporary supply of free Firdapse® while the Company is determining the patient’s third-party insurance, prescription drug benefit or other third-party coverage for Firdapse® . The Patient Assistance Program provides free Firdapse® for longer periods of time for those who are uninsured or functionally uninsured with respect to Firdapse® because they are unable to obtain coverage from their payer despite having health insurance. The Company does not recognize any revenue related to these free products and the associated costs are classified in selling, general and administrative expenses in the Company’s consolidated statements of operations.Revenues from Collaborative Arrangement: ® (vigabatrin) tablets. Pursuant to the terms of this agreement, collaborators could be required to make various payments to the Company, including upfront license fees, milestone payments based on achievement of regulatory approvals, and royalties on sales of products resulting from collaborative agreement. Nonrefundable upfront license fees are recognized upon receipt as persuasive evidence of an arrangement exists, the price to the collaborator is fixed or determinable and collectability is reasonably assured. For the three and nine months ended September 30, 2019 and 2018, no revenue was recognized. Refer to Note 8, Collaborative Arrangement, for further discussion on the Company’s collaborative arrangement.
The Company currently has a single product with limited commercial sales experience, which makes it difficult to evaluate its current business, predict its future prospects and forecast financial performance and growth. The Company has invested a significant portion of its efforts and financial resources in the development and commercialization of the lead product, Firdapse ® , and expects Firdapse® to constitute virtually all of product revenue for the foreseeable future. The Company’s success depends on its ability to effectively commercialize Firdapse® . The Company relies exclusively on third parties to formulate and manufacture Firdapse ® and its drug candidates. The commercialization of Firdapse® and any other drug candidates, if approved, could be stopped, delayed or made less profitable if those third parties fail to provide sufficient quantities of product or fail to do so at acceptable quality levels or prices. The Company does not intend to establish its own manufacturing facilities. The Company is using the same third-party contractors to manufacture, supply, store and distribute drug supplies for clinical trials and the commercialization of Firdapse® . If the Company is unable to continue its relationships with one or more of these third-party contractors, it could experience delays in the development or commercialization efforts as it locates and qualifies new manufacturers. The Company intends to rely on one or more third-party contractors to manufacture the commercial supply of drugs.
Diluted net income per common share is computed by dividing net income (loss) by the weighted average number of common shares outstanding, increased by the assumed conversion of other potentially dilutive securities during the period. The following table reconciles basic and diluted weighted average common shares:
Outstanding common stock equivalents totaling approximately 0.4 million and 2.9 million, respectively, were excluded from the calculation of diluted net income (loss) per common share for the three and nine months ended September 30, 2019 as their effect would be anti-dilutive. For the three and nine months ended September 30, 2018, approximately 8.1 million shares of outstanding stock options were excluded from the calculation of diluted net loss per common share because a net loss was reported in each of these periods and therefore their effect was anti-dilutive. Potentially dilutive options to purchase common stock for both the three and nine months ended September 30, 2018, had exercise prices ranging from $0.79 to $4.64.
In June 2018, the FASB issued ASU No. 2018-07, Compensation—Stock Compensation (Topic 718): Improvements to Nonemployee Share-Based Payment Accounting that largely aligns the accounting for share-based payment awards issued to employees and nonemployees. Under this ASU, most of the guidance on such payments to nonemployees would be aligned with the requirements for share-based payments granted to employees. ASU 2018-07 is effective for all entities for annual reporting periods beginning after December 15, 2018, including interim reporting periods within each annual reporting period, with early adoption permitted. The Company has adopted this standard as of January 1, 2019. The adoption of this standard did not have a material impact on the Company’s consolidated financial statements.In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments — Credit Losses (Topic 326), Measurement of Credit Losses on Financial Instruments. The standard amends the impairment model by requiring entities to use a forward-looking approach based on expected losses to estimate credit losses for most financial assets and certain other instruments that aren’t measured at fair value through net income. For available-for-sale
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- Definition The entire disclosure for the basis of presentation and significant accounting policies concepts. Basis of presentation describes the underlying basis used to prepare the financial statements (for example, US Generally Accepted Accounting Principles, Other Comprehensive Basis of Accounting, IFRS). Accounting policies describe all significant accounting policies of the reporting entity. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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Investments |
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| Investments, Debt and Equity Securities [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Investments |
Available-for-sale
There were no realized gains or losses from available-for-sale The Company did not hold any securities in an unrealized loss position for more than 12 months as of September 30, 2019. The estimated fair values of available-for-sale
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- References No definition available.
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- Definition The entire disclosure for investments in certain debt and equity securities. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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Prepaid Expenses and Other Current Assets |
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| Prepaid Expenses and Other Current Assets |
Prepaid expenses and other current assets consist of the following:
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- Definition The entire disclosure for the carrying amount as of the balance sheet date of expenditures made in advance of the timing of recognition of expenses which are expected to be charged against earnings within one year or the normal operating cycle, if longer. Includes, but is not limited to, prepaid research, prepaid product development activities and prepaid insurance. No definition available.
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- References No definition available.
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Operating Leases |
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| Disclosure of Operating Leases [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Operating Leases |
The Company has operating lease agreements for its corporate office. The leases include options to ex t end the leases for up to 1 year and options to terminate the lease within 1 year . There are no obligations under finance leases. The components of lease expense were as follows:
Supplemental cash flow information related to leases was as follows:
Supplemental balance sheet information related to leases was as follows:
Payments of lease liabilities as of September 30, 2019 were as follows:
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- Definition Disclosure of Operating Leases No definition available.
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- Definition The entire disclosure for operating leases of lessee. Includes, but is not limited to, description of operating lease and maturity analysis of operating lease liability. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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Property and Equipment, net |
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| Property and Equipment, net |
Property and equipment, net consists of the following:
Depreciation expense was $6,532 and $26,718, respectively, for the three and nine-month periods ended September 30, 2019 and $9,294 and $25,485, respectively for the three and nine-month periods ended September 30, 2018. |
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- References No definition available.
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- Definition The entire disclosure for long-lived, physical assets used in the normal conduct of business and not intended for resale. Includes, but is not limited to, accounting policies and methodology, roll forwards, depreciation, depletion and amortization expense, including composite depreciation, accumulated depreciation, depletion and amortization expense, useful lives and method used, income statement disclosures, assets held for sale and public utility disclosures. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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Accrued Expenses and Other Liabilities |
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| Accrued Expenses and Other Liabilities |
Accrued expenses and other liabilities consist of the following:
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- Definition The entire disclosure for accounts payable and accrued liabilities at the end of the reporting period. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- References No definition available.
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Collaborative Arrangement |
9 Months Ended | |||
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Sep. 30, 2019 | ||||
| Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||||
| Collaborative Arrangement |
In December 2018, the Company entered into a collaboration and license agreement (collaboration) with Endo International plc’s subsidiary, Endo Ventures Limited (Endo), for the further development and commercialization of generic Sabril ® (vigabatrin) tablets through Endo’s U.S. Generic Pharmaceuticals segment, doing business as Par Pharmaceutical. Endo has assumed all development, manufacturing, clinical, regulatory, sales and marketing costs under the collaboration, while the Company is responsible for exercising commercially reasonable efforts to develop, or cause the development of, a final finished, stable dosage form of generic Sabril ® tablets. Under the terms of the Collaboration, the Company has received an that is up-front payment, and will receive milestone payments based on achievement of regulatory approvals, a sharing of defined net profits upon commercialization from Endo consisting of a mid-double digit percent of net sales of generic Sabril® and a sharing of certain development expenses. Unless terminated earlier in accordance with its terms, the collaboration continues in effect until the dateten years following the commercial launch. For the year ended December 31, 2018, a $500,000 upfront license fee was recognized.For the three and nine-month period s ending September 30, 2019, no collaborative arrangement revenue has been received or recognized. Expenses incurred, net, in connection with the collaborative arrangement for the three and nine months ended September 30, 2019 was approximately $31,924 and $70,102, respectively, and have been included in research and development expenses in the accompanying consolidated statements of operations. |
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- Definition The entire disclosure for collaborative arrangements in which the entity is a participant, including a) information about the nature and purpose of such arrangements; b) its rights and obligations thereunder; c) the accounting policy for collaborative arrangements; and d) the income statement classification and amounts attributable to transactions arising from the collaborative arrangement between participants. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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- References No definition available.
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Commitments and Contingencies |
9 Months Ended | |||
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Sep. 30, 2019 | ||||
| Commitments and Contingencies Disclosure [Abstract] | ||||
| Commitments and Contingencies |
In 2018, the Company became aware that certain patents granted to Northwestern University (which patents have been licensed by Northwestern to a third party) for a new GABA aminotransferase inhibitor were developed from CPP-115, which had previously been licensed to the Company by Northwestern. As a result, on October 26, 2018, the Company terminated the license agreement for CPP-115 and commenced an arbitration proceeding against Northwestern seeking damages for alleged breaches of the license agreement. Shortly thereafter, Northwestern filed counterclaims against the Company in the arbitration action seeking damages for alleged breaches by the Company of the license agreement. On May 21, 2019, the Company entered into a settlement agreement with Northwestern that resolved all pending disputes between the parties with no admission of liability by either party, released all claims of liability or wrongdoing between the Company and Northwestern, and dismissed the pending arbitration. Under the settlement agreement, the Company received a $100,000 payment on May 21, 2019, which is reported as income in other income, net in the consolidated statement of operations. The Company is also entitled to receive certain contingent compensation that will be reported when and if received.In May 2019, the FDA approved an NDA for Jacobus Pharmaceuticals for Ruzurgi ® , their version of amifampridine (3,4-DAP), for the treatment of pediatric LEMS patients (ages 6 to under 17). The Company believes that Jacobus is offering Ruzurgi® at a lower price than the Company is offering Firdapse® . In addition, while the NDA for Ruzurgi® only covers pediatric patients, the Company believes Ruzurgi® is being prescribed off label to adult LEMS patients. If Jacobus is able to successfully sell Ruzurgi® off-label to adult LEMS patients, it could have a material adverse effect on the Company’s business, financial condition and results of operations. The Company believes that the FDA’s approval of Ruzurgi ® violated its statutory rights and was in multiple other respects arbitrary, capricious and contrary to law. As a result, in June 2019 the Company filed suit against the FDA and several related parties challenging this approval and related drug labeling. The Company’s complaint, which was filed in the federal district court for the Southern District of Florida, alleges that the FDA’s approval of Ruzurgi® violated multiple provisions of FDA regulations regarding labeling, resulting in misbranding in violation of the Federal Food, Drug, and Cosmetic Act (FDCA); violated its statutory rights to Orphan Drug Exclusivity and New Chemical Entity Exclusivity under the FDCA; and was in multiple other respects arbitrary, capricious, and contrary to law, in violation of the Administrative Procedure Act. Among other remedies, the suit seeks an order vacating the FDA’s approval of Ruzurgi® . The FDA has answered the Company’s complaint and the matter is currently in the discovery phase. There can be no assurance as to the outcome of this lawsuit. Additionally, from time to time the Company may become involved in legal proceedings arising in the ordinary course of business. Except as set forth above, the Company believes that there is no other litigation pending at this time that could have, individually or in the aggregate, a material adverse effect on its results of operations, financial condition or cash flows. |
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- References No definition available.
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- Definition The entire disclosure for commitments and contingencies. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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Agreements |
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| Text Block [Abstract] | ||||||||||
| Agreements |
On May 29, 2019, the Company entered into an amendment to its License Agreement with BioMarin for Firdapse ® . Under the amendment, the Company has expanded its commercial territory for Firdapse® , which originally was comprised of North America, to include Japan. Additionally, the Company has an option to further expand its territory under the license agreement to include most of Asia, as well as Central and South America, upon the achievement of certain milestones in Japan. Under the amendment, the Company will pay royalties on net sales in Japan of a similar percentage to the royalties that the Company is currently paying under its original license agreement for North America.
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- Definition Agreements. No definition available.
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- References No definition available.
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Income Taxes |
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Sep. 30, 2019 | ||||
| Income Tax Disclosure [Abstract] | ||||
| Income Taxes |
The Company’s effective income tax rate is the ratio of income tax expense (benefit) over its income (loss) before income taxes. The effective income tax rate was 4.18% and 0.00% for the nine months ended September 30, 2019 and 2018, respectively. Differences in the effective tax and the statutory Federal income tax rate of 21% is driven by state income taxes and anticipated annual permanent differences, including orphan drug credit expense limitations and other items. The Company had no uncertain tax positions as of September 30, 2019 and December 31, 2018. The Company has a full valuation allowance at September 30, 2019 and December 31, 2018. |
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- References No definition available.
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- Definition The entire disclosure for income taxes. Disclosures may include net deferred tax liability or asset recognized in an enterprise's statement of financial position, net change during the year in the total valuation allowance, approximate tax effect of each type of temporary difference and carryforward that gives rise to a significant portion of deferred tax liabilities and deferred tax assets, utilization of a tax carryback, and tax uncertainties information. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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Stockholders' Equity |
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| Equity [Abstract] | ||||
| Stockholders' Equity |
2016 Shelf Registration Statement On December 23, 2016, the Company filed a shelf Registration Statement on Form S-3 (the 2016 Shelf Registration Statement) with the SEC to sell up to approximately $33.8 million of common stock. The 2016 Shelf Registration Statement (file No. 333-215315) was declared effective by the SEC on January 9, 2017. No sales have been conducted to date under the 2016 Shelf Registration Statement.2017 Shelf Registration Statement On July 12, 2017, the Company filed a universal shelf Registration Statement on Form S-3 (the 2017 Shelf Registration Statement) with the SEC to sell up to $150 million of common stock, preferred stock, warrants to purchase common stock, or debt securities (including debt securities that may be convertible or exchangeable for common stock or other securities), which securities may be offered separately or together in units or multiple series. The 2017 Shelf Registration Statement (file No. 333-219259) was declared effective by the SEC on July 26, 2017.On November 28, 2017, the Company filed a prospectus supplement and offered for sale 16,428,572 shares of its common stock at a price of $3.50 per share in an underwritten public offering under the 2017 Shelf Registration. The Company received gross proceeds in the public offering of approximately $57.5 million before underwriting commission and incurred expenses of approximately $3.7 million. At September 30, 2019, there is approximately $92.5 million available for future sale under the 2017 Shelf Registration Statement. |
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- References No definition available.
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- Definition The entire disclosure for shareholders' equity comprised of portions attributable to the parent entity and noncontrolling interest, including other comprehensive income. Includes, but is not limited to, balances of common stock, preferred stock, additional paid-in capital, other capital and retained earnings, accumulated balance for each classification of other comprehensive income and amount of comprehensive income. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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Stock Compensation |
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| Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Stock Compensation |
For the three and nine-month periods ended September 30, 2019 and 2018, the Company recorded stock-based compensation expense as follows:
Stock Options As of September 30, 2019, there were outstanding stock options to purchase 10,135,334 shares of common stock, of which stock options to purchase 5,345,825 shares of common stock were exercisable as of September 30, 2019. During the three and nine-month periods ended September 30, 2019, the Company granted seven During the three and nine-month periods ended September 30, 2018, the Company granted seven During the three and nine-month periods ended September 30, 2019, options to purchase 108,332 shares and 298,332 shares, respectively, of the Company’s common stock were exercised, with proceeds of $256,062 and $537,962, respectively, to the Company. During both the three and nine-month periods ended September 30, 2019, options to purchase 6,666 shares of the Company’s common stock were exercised on a “cashless” basis, resulting in the issuance of an aggregate of 3,444 shares of the Company’s common stock. During the three and nine-month periods ended September 30, 2018, options to purchase 89,999 shares and 136,665 shares, respectively, of the Company’s common stock were exercised, with proceeds of $104,532 and $146,064, respectively, to the Company. As of September 30, 2019, there was approximately $6,400,076 of unrecognized compensation expense related to non-vested stock option awards granted under the 2014 and 2018 Stock Incentive Plans. The cost is expected to be recognized over a weighted average period of approximately 2.0 years.Common Stock There were no grants of common stock to employees during the three and nine-month periods ended September 30, 2019. During both the three and nine-month periods ended September 30, 2018, the Company granted 3,094 net shares of common stock to employees as compensation. The Company recorded stock-based compensation related to common stock issued to employees totaling $0 and approximately $15,000, respectively, during the three and nine-month periods ended September 30, 2018. |
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- Definition The entire disclosure for share-based payment arrangement. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- References No definition available.
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Basis of Presentation and Significant Accounting Policies (Policies) |
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| Accounting Policies [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| INTERIM FINANCIAL STATEMENTS |
In the opinion of management, the accompanying unaudited interim consolidated financial statements of the Company contain all adjustments (consisting of only normal recurring adjustments) necessary to present fairly the financial position of the Company as of the dates and for the periods presented. Accordingly, these consolidated statements should be read in conjunction with the financial statements and notes thereto for the year ended December 31, 2018 included in the 2018 Annual Report on Form
10-K filed by the Company with the SEC. The results of operations for the nine months ended September 30, 2019 are not necessarily indicative of the results to be expected for any future period or for the full 2019 fiscal year. |
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| PRINCIPLES OF CONSOLIDATION. |
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| USE OF ESTIMATES |
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| CASH AND CASH EQUIVALENTS |
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| INVESTMENTS |
Short-Term Bond Fund The short-term bond fund is classified in trading securities. Trading securities are recorded at fair value based on the closing market price of the security. For trading securities, the Company recognizes realized gains and losses and unrealized gains and losses to earnings. At September 30, 2019 and December 31, 2018, the only investment classified as trading securities was the short-term bond fund. Realized losses on trading securities were $0 and $4,980, respectively, for the three and nine months ended September 30, 2019. There were no sales of trading securities for the three and nine months ended September 30, 2018. Unrealized gain (loss) on trading securities was $0 and $89,405, respectively, for the three and nine months ended September 30, 2019, and $0 and ($29,430 ), respectively for the three and nine months ended September 30, 2018 and is included in other income, net in the accompanying consolidated statements of operations. , U.S. Treasuries U.S. Treasuries are classified as
available-for-sale available-for-sale Available-for-sale non-current investments in the accompanying consolidated balance sheets. The Company records available-for-sale available-for-sale available-for-sale |
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| ACCOUNTS RECEIVABLE, NET |
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| INVENTORY |
Products that have been approved by the FDA or other regulatory authorities, such as Firdapse ® , are also used in clinical programs to assess the safety and efficacy of the products for usage in treating diseases that have not been approved by the FDA or other regulatory authorities. The form of Firdapse® utilized for both commercial and clinical programs is identical and, as a result, the inventory has an “alternative future use” as defined in authoritative guidance. Raw materials and purchased drug product associated with clinical development programs are included in inventory and charged to research and development expense when the product enters the research and development process and no longer can be used for commercial purposes and, therefore, does not have an “alternative future use”. The Company evaluates for potential excess inventory by analyzing current and future product demand relative to the remaining product shelf life. The Company builds demand forecasts by considering factors such as, but not limited to, overall market potential, market share, market acceptance, and patient usage. |
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| PREPAID EXPENSES AND OTHER CURRENT ASSETS |
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| FAIR VALUE OF FINANCIAL INSTRUMENTS |
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| FAIR VALUE MEASUREMENTS |
Level 1 inputs utilize quoted prices (unadjusted) in active markets for identical assets or liabilities that the Company has the ability to access at the measurement date. Level 2 inputs are inputs other than quoted prices included in Level 1 that are observable for the asset or liability, either directly or indirectly. Level 2 inputs may include quoted prices for similar assets and liabilities in active markets, as well as inputs that are observable for the asset or liability (other than quoted prices), such as interest rates, foreign exchange rates, and yield curves that are observable at commonly quoted intervals. Level 3 inputs are unobservable inputs for the asset or liability, which are typically based on an entity’s own assumptions, as there is little, if any, related market activity. In instances where the determination of the fair value measurement is based on inputs from different levels of the fair value hierarchy, the level in the fair value hierarchy within which the entire fair value measurement falls is based on the lowest level input that is significant to the fair value measurement in its entirety. The Company’s assessment of the significance of a particular input to the fair value measurement in its entirety requires judgment, and considers factors specific to the asset or liability.
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| OPERATING LEASES |
Operating lease ROU assets and operating lease liabilities are recognized based on the present value of the future minimum lease payments over the lease term at commencement date. As the Company’s leases do not provide an implicit rate, the Company uses its incremental borrowing rate based on the information available at commencement date in determining the present value of future payments. The operating lease ROU asset also includes any lease payments made and excludes lease incentives and initial direct costs incurred. The Company’s lease terms do not include options to extend or terminate the lease as it is not reasonably certain that it will exercise these options. Lease expense for minimum lease payments is recognized on a straight-line basis over the lease term. The Company has lease agreements with lease and
non-lease components, which are generally accounted for separately. Refer to Note 2.r. for discussion on adoption method. |
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| REVENUE RECOGNITION |
To determine revenue recognition for arrangements that are within the scope of Topic 606, the Company performs the following five steps: (i) identify the contract(s) with a customer, (ii) identify the performance obligations in the contract, (iii) determine the transaction price, (iv) allocate the transaction price to the performance obligations in the contract, and (v) recognize revenue when (or as) the entity satisfies a performance obligation. The Company only applies the five-step model to arrangements that meet the definition of a contract under Topic 606, including when it is probable that the Company will collect the consideration it is entitled to in exchange for the goods or services it transfers to the customer. At contract inception, once the contract is determined to be within the scope of Topic 606, the Company assesses the goods or services promised within each contract and determines those that are performance obligations and assesses whether each promised good or service is distinct. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied. For a complete discussion of accounting for product revenue, see Product Revenue, Net below. The Company also generates revenues from payments received under a collaborative agreement. Collaborative agreement payments may include nonrefundable fees at the inception of the agreements, milestone and event-based payments for specific achievements designated in the collaborative agreements, and/or royalties on sales of products resulting from a collaborative arrangement. For a complete discussion of accounting for collaborative arrangements, see Revenues from Collaborative Arrangement below. Product Revenue, Net: ® to a Customer (its exclusive distributor) who subsequently resells Firdapse® to both a small group of SPs who have exclusive contracts with the Company to distribute the Company’s products to patients and potentially to medical centers or hospitals on an emergency basis. In addition to the distribution agreement with its Customer, the Company enters into arrangements with health care providers and payors that provide for government-mandated and/or privately negotiated rebates, chargebacks, and discounts with respect to the purchase of the Company’s products. The Company recognizes revenue on product sales when the Customer obtains control of the Company’s product, which occurs at a point in time (upon delivery). Product revenue is recorded net of applicable reserves for variable consideration, including discounts and allowances. The Company’s payment terms range between 15 and 60 days. Shipping and handling costs for product shipments occur prior to the customer obtaining control of the goods, and are recorded in cost of sales. If taxes should be collected from the Customer relating to product sales and remitted to governmental authorities, they will be excluded from revenue. The Company expenses incremental costs of obtaining a contract when incurred, if the expected amortization period of the asset that the Company would have recognized is one year or less. However, no such costs were incurred during the three and nine months ended September 30, 2019. As of September 30, 2019, all of the Company’s sales are to its Customer. Reserves for Variable Consideration: The amount of variable consideration which is included in the transaction price may be constrained, and is included in the net sales price only to the extent that it is probable that a significant reversal in the amount of the cumulative revenue recognized under the contract will not occur in a future period. The Company’s analyses also contemplated application of the constraint in accordance with the guidance, under which it determined a material reversal of revenue would not occur in a future period for the estimates detailed below as of September 30, 2019 and, therefore, the transaction price was not reduced further during the three and nine months ended September 30, 2019. Actual amounts of consideration ultimately received may differ from the Company’s estimates. If actual results in the future vary from the Company’s estimates, the Company will adjust these estimates, which would affect net product revenue and earnings in the period such variances become known. Trade Discounts and Allowances: ® to the Customer, these payments are classified in selling, general and administrative expenses in the Company’s consolidated statement of operations and comprehensive income (loss). However, if the Company has determined such services received to date are not distinct from the Company’s sale of products to the Customer, these payments have been recorded as a reduction of revenue within the statement of operations and comprehensive income (loss) through September 30, 2019, as well as a reduction to accounts receivables, net on the consolidated balance sheets. Funded Co-pay Assistance Program:co-pay assistance program intended to provide financial assistance to qualified insured patients. The calculation of the accrual for co-pay assistance is based on an estimate of claims and the cost per claim that the Company expects to receive associated with Firdapse® that has been recognized as revenue, but remains in the distribution channel at the end of each reporting period. These payments are considered payable to the customer and the related reserve is recorded in the same period the related revenue is recognized, resulting in a reduction of product revenue and the establishment of a current liability which is included in accrued expenses and other current liabilities in the consolidated balance sheets.Product Returns: Provider Chargebacks and Discounts: Government Rebates: Bridge and Patient Assistance Programs: ® to uninsured patients who satisfy pre-established criteria for either the Bridge Program or the Patient Assistance Program. Patients who meet the Bridge Program eligibility criteria and are transitioning from investigational product while they are waiting for a coverage determination, or later, for patients whose access is threatened by the complications arising from a change of insurer may receive a temporary supply of free Firdapse® while the Company is determining the patient’s third-party insurance, prescription drug benefit or other third-party coverage for Firdapse® . The Patient Assistance Program provides free Firdapse® for longer periods of time for those who are uninsured or functionally uninsured with respect to Firdapse® because they are unable to obtain coverage from their payer despite having health insurance. The Company does not recognize any revenue related to these free products and the associated costs are classified in selling, general and administrative expenses in the Company’s consolidated statements of operations.Revenues from Collaborative Arrangement: ® (vigabatrin) tablets. Pursuant to the terms of this agreement, collaborators could be required to make various payments to the Company, including upfront license fees, milestone payments based on achievement of regulatory approvals, and royalties on sales of products resulting from collaborative agreement. Nonrefundable upfront license fees are recognized upon receipt as persuasive evidence of an arrangement exists, the price to the collaborator is fixed or determinable and collectability is reasonably assured. For the three and nine months ended September 30, 2019 and 2018, no revenue was recognized. Refer to Note 8, Collaborative Arrangement, for further discussion on the Company’s collaborative arrangement. |
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| CONCENTRATION OF CREDIT RISK |
The Company currently has a single product with limited commercial sales experience, which makes it difficult to evaluate its current business, predict its future prospects and forecast financial performance and growth. The Company has invested a significant portion of its efforts and financial resources in the development and commercialization of the lead product, Firdapse ® , and expects Firdapse® to constitute virtually all of product revenue for the foreseeable future. The Company’s success depends on its ability to effectively commercialize Firdapse® . The Company relies exclusively on third parties to formulate and manufacture Firdapse ® and its drug candidates. The commercialization of Firdapse® and any other drug candidates, if approved, could be stopped, delayed or made less profitable if those third parties fail to provide sufficient quantities of product or fail to do so at acceptable quality levels or prices. The Company does not intend to establish its own manufacturing facilities. The Company is using the same third-party contractors to manufacture, supply, store and distribute drug supplies for clinical trials and the commercialization of Firdapse® . If the Company is unable to continue its relationships with one or more of these third-party contractors, it could experience delays in the development or commercialization efforts as it locates and qualifies new manufacturers. The Company intends to rely on one or more third-party contractors to manufacture the commercial supply of drugs. |
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| ROYALTIES |
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| STOCK-BASED COMPENSATION |
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| COMPREHENSIVE INCOME (LOSS) |
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| NET INCOME (LOSS) PER COMMON SHARE |
Diluted net income per common share is computed by dividing net income (loss) by the weighted average number of common shares outstanding, increased by the assumed conversion of other potentially dilutive securities during the period. The following table reconciles basic and diluted weighted average common shares:
Outstanding common stock equivalents totaling approximately 0.4 million and 2.9 million, respectively, were excluded from the calculation of diluted net income (loss) per common share for the three and nine months ended September 30, 2019 as their effect would be anti-dilutive. For the three and nine months ended September 30, 2018, approximately 8.1 million shares of outstanding stock options were excluded from the calculation of diluted net loss per common share because a net loss was reported in each of these periods and therefore their effect was anti-dilutive. Potentially dilutive options to purchase common stock for both the three and nine months ended September 30, 2018, had exercise prices ranging from $0.79 to $4.64. |
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| RECENTLY ISSUED ACCOUNTING STANDARDS |
In June 2018, the FASB issued ASU No. 2018-07, Compensation—Stock Compensation (Topic 718): Improvements to Nonemployee Share-Based Payment Accounting that largely aligns the accounting for share-based payment awards issued to employees and nonemployees. Under this ASU, most of the guidance on such payments to nonemployees would be aligned with the requirements for share-based payments granted to employees. ASU 2018-07 is effective for all entities for annual reporting periods beginning after December 15, 2018, including interim reporting periods within each annual reporting period, with early adoption permitted. The Company has adopted this standard as of January 1, 2019. The adoption of this standard did not have a material impact on the Company’s consolidated financial statements.In June 2016, the FASB issued ASU
No. 2016-13, Financial Instruments — Credit Losses (Topic 326), Measurement of Credit Losses on Financial Instruments. The standard amends the impairment model by requiring entities to use a forward-looking approach based on expected losses to estimate credit losses for most financial assets and certain other instruments that aren’t measured at fair value through net income. For available-for-sale |
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| RECLASSIFICATIONS |
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| X | ||||||||||
- Definition Disclosure of accounting policy for interim financial statements. No definition available.
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| X | ||||||||||
- Definition Disclosure of accounting policy for prepaid expenses and other current assets. This disclosure may include the types of prepaid expenses and other current assets and how these are recognize in expenses. No definition available.
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| X | ||||||||||
- Definition Royalties Expense No definition available.
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| X | ||||||||||
- References No definition available.
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| X | ||||||||||
- Definition Disclosure of accounting policy for cash and cash equivalents, including the policy for determining which items are treated as cash equivalents. Other information that may be disclosed includes (1) the nature of any restrictions on the entity's use of its cash and cash equivalents, (2) whether the entity's cash and cash equivalents are insured or expose the entity to credit risk, (3) the classification of any negative balance accounts (overdrafts), and (4) the carrying basis of cash equivalents (for example, at cost) and whether the carrying amount of cash equivalents approximates fair value. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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| X | ||||||||||
- Definition Disclosure of accounting policy for comprehensive income. No definition available.
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| X | ||||||||||
- Definition Disclosure of accounting policy for credit risk. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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| X | ||||||||||
- Definition Disclosure of accounting policy regarding (1) the principles it follows in consolidating or combining the separate financial statements, including the principles followed in determining the inclusion or exclusion of subsidiaries or other entities in the consolidated or combined financial statements and (2) its treatment of interests (for example, common stock, a partnership interest or other means of exerting influence) in other entities, for example consolidation or use of the equity or cost methods of accounting. The accounting policy may also address the accounting treatment for intercompany accounts and transactions, noncontrolling interest, and the income statement treatment in consolidation for issuances of stock by a subsidiary. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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| X | ||||||||||
- Definition Disclosure of accounting policy for computing basic and diluted earnings or loss per share for each class of common stock and participating security. Addresses all significant policy factors, including any antidilutive items that have been excluded from the computation and takes into account stock dividends, splits and reverse splits that occur after the balance sheet date of the latest reporting period but before the issuance of the financial statements. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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| X | ||||||||||
- Definition Disclosure of accounting policy for fair value measurements of financial and non-financial assets, liabilities and instruments classified in shareholders' equity. Disclosures include, but are not limited to, how an entity that manages a group of financial assets and liabilities on the basis of its net exposure measures the fair value of those assets and liabilities. No definition available.
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| X | ||||||||||
- Definition Disclosure of accounting policy for determining the fair value of financial instruments. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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| X | ||||||||||
- Definition Disclosure of inventory accounting policy for inventory classes, including, but not limited to, basis for determining inventory amounts, methods by which amounts are added and removed from inventory classes, loss recognition on impairment of inventories, and situations in which inventories are stated above cost. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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| X | ||||||||||
- Definition Disclosure of accounting policy for investment in financial asset. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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| X | ||||||||||
- Definition Disclosure of accounting policy for leasing arrangement entered into by lessee. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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| X | ||||||||||
- Definition Disclosure of accounting policy pertaining to new accounting pronouncements that may impact the entity's financial reporting. Includes, but is not limited to, quantification of the expected or actual impact. No definition available.
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| X | ||||||||||
- Definition Disclosure of accounting policy for reclassifications that affects the comparability of the financial statements. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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| X | ||||||||||
- Definition Disclosure of accounting policy for revenue. Includes revenue from contract with customer and from other sources. Reference 1: http://www.xbrl.org/2003/role/exampleRef
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| X | ||||||||||
- Definition Disclosure of accounting policy for award under share-based payment arrangement. Includes, but is not limited to, methodology and assumption used in measuring cost. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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| X | ||||||||||
- Definition Disclosure of accounting policy for accounts receivable. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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| X | ||||||||||
- Definition Disclosure of accounting policy for the use of estimates in the preparation of financial statements in conformity with generally accepted accounting principles. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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Basis of Presentation and Significant Accounting Policies (Tables) |
9 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Sep. 30, 2019 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Accounting Policies [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Fair Value Measurement Specific to Assets or Liability |
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| Basic and Dilutive Weighted Average Common Shares | The following table reconciles basic and diluted weighted average common shares:
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| X | ||||||||||
- References No definition available.
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| X | ||||||||||
- Definition Tabular disclosure of assets and liabilities, including [financial] instruments measured at fair value that are classified in stockholders' equity, if any, that are measured at fair value on a recurring basis. The disclosures contemplated herein include the fair value measurements at the reporting date by the level within the fair value hierarchy in which the fair value measurements in their entirety fall, segregating fair value measurements using quoted prices in active markets for identical assets (Level 1), significant other observable inputs (Level 2), and significant unobservable inputs (Level 3). Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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| X | ||||||||||
- Definition Tabular disclosure of the weighted average number of shares used in calculating basic net earnings per share (or unit) and diluted earnings per share (or unit). Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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Investments (Tables) |
9 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Sep. 30, 2019 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Investments, Debt and Equity Securities [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Summary of Available-for-Sale Investments by Security type | Available-for-sale
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| Estimated Fair Values of Available for Sale Securities | The estimated fair values of available-for-sale
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| X | ||||||||||
- Definition Available For Sale Securities By Amortized Cost Unrealized Gains Or Losses And Fair Value Table Text Block. No definition available.
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| X | ||||||||||
- Definition Tabular disclosure of available-for-sale securities which includes, but is not limited to, changes in the cost basis and fair value, fair value and gross unrealized gain (loss), fair values by type of security, contractual maturity and classification, amortized cost basis, contracts to acquire securities to be accounted for as available-for-sale, debt maturities, transfers to trading, change in net unrealized holding gain (loss) net of tax, continuous unrealized loss position fair value, aggregate losses qualitative disclosures, other than temporary impairment (OTTI) losses or other disclosures related to available for sale securities. No definition available.
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| X | ||||||||||
- References No definition available.
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Prepaid Expenses and Other Current Assets (Tables) |
9 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Sep. 30, 2019 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Text Block [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Prepaid expenses and other current assets | Prepaid expenses and other current assets consist of the following:
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| X | ||||||||||
- Definition Tabular disclosure of prepaid expenses and other current assets. No definition available.
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| X | ||||||||||
- References No definition available.
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Operating Leases (Tables) |
9 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Sep. 30, 2019 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Disclosure of Operating Leases [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Lease, Cost | The components of lease expense were as follows:
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| Schedule of Supplemental Cash Flow Information Related To Lease | Supplemental cash flow information related to leases was as follows:
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| Schedule of Supplemental Balance Sheet related To Lease | Supplemental balance sheet information related to leases was as follows:
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| Lessee, Operating Lease, Liability, Maturity | Payments of lease liabilities as of September 30, 2019 were as follows:
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| X | ||||||||||
- Definition Disclosure of Operating Leases No definition available.
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| X | ||||||||||
- Definition Tabulor Disclosure of Supplemental balance Sheet Information Related To Lease. No definition available.
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| X | ||||||||||
- Definition Tabulor Disclosure of Supplemental Cash Flow Information Related To Lease. No definition available.
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| X | ||||||||||
- Definition Tabular disclosure of lessee's lease cost. Includes, but is not limited to, interest expense for finance lease, amortization of right-of-use asset for finance lease, operating lease cost, short-term lease cost, variable lease cost and sublease income. Reference 1: http://www.xbrl.org/2009/role/commonPracticeRef
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| X | ||||||||||
- Definition Tabular disclosure of undiscounted cash flows of lessee's operating lease liability. Includes, but is not limited to, reconciliation of undiscounted cash flows to operating lease liability recognized in statement of financial position. Reference 1: http://www.xbrl.org/2009/role/commonPracticeRef
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Property and Equipment, net (Tables) |
9 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Sep. 30, 2019 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Property, Plant and Equipment [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Property and Equipment, net | Property and equipment, net consists of the following:
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| X | ||||||||||
- References No definition available.
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| X | ||||||||||
- Definition Tabular disclosure of physical assets used in the normal conduct of business and not intended for resale. Includes, but is not limited to, balances by class of assets, depreciation and depletion expense and method used, including composite depreciation, and accumulated deprecation. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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Accrued Expenses and Other Liabilities (Tables) |
9 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Sep. 30, 2019 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Payables and Accruals [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Schedule of Accrued Expenses and Other Liabilities | Accrued expenses and other liabilities consist of the following:
|
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| X | ||||||||||
- References No definition available.
|
| X | ||||||||||
- Definition Tabular disclosure of the (a) carrying value as of the balance sheet date of liabilities incurred (and for which invoices have typically been received) and payable to vendors for goods and services received that are used in an entity's business (accounts payable); (b) other payables; and (c) accrued liabilities. Examples include taxes, interest, rent and utilities. Used to reflect the current portion of the liabilities (due within one year or within the normal operating cycle if longer). An alternative caption includes accrued expenses. No definition available.
|
Stock Compensation (Tables) |
9 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Sep. 30, 2019 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Stock-Based Compensation Expense | For the three and nine-month periods ended September 30, 2019 and 2018, the Company recorded stock-based compensation expense as follows:
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- References No definition available.
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| X | ||||||||||
- Definition Tabular disclosure of allocation of amount expensed and capitalized for award under share-based payment arrangement to statement of income or comprehensive income and statement of financial position. Includes, but is not limited to, corresponding line item in financial statement. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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| X | ||||||||||
- Definition Maximum length of time to maturity for instruments included as cash equivalents. No definition available.
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| X | ||||||||||
- Definition Minimum amount of time in which compensation cost from stock options is amortized on a straight line basis. No definition available.
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| X | ||||||||||
- Definition Summary of basis of presentation and significant accounting policies. No definition available.
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| X | ||||||||||
- Definition Trading securities sales No definition available.
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| X | ||||||||||
- Definition Securities (including those issuable pursuant to contingent stock agreements) that could potentially dilute basic earnings per share (EPS) or earnings per unit (EPU) in the future that were not included in the computation of diluted EPS or EPU because to do so would increase EPS or EPU amounts or decrease loss per share or unit amounts for the period presented. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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| X | ||||||||||
- Definition Amount of unrealized gain (loss) on investment in debt security measured at fair value with change in fair value recognized in net income (trading). Reference 1: http://www.xbrl.org/2009/role/commonPracticeRef
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| X | ||||||||||
- Definition Date which lease or group of leases is set to expire, in CCYY-MM-DD format. No definition available.
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| X | ||||||||||
- Definition Amount of revenue recognized from goods sold, services rendered, insurance premiums, or other activities that constitute an earning process. Includes, but is not limited to, investment and interest income before deduction of interest expense when recognized as a component of revenue, and sales and trading gain (loss). Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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| X | ||||||||||
- Definition The floor of a customized range of exercise prices for purposes of disclosing shares potentially issuable under outstanding stock option awards on all stock option plans and other required information pertaining to awards in the customized range. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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| X | ||||||||||
- Definition The ceiling of a customized range of exercise prices for purposes of disclosing shares potentially issuable under outstanding stock option awards on all stock option plans and other required information pertaining to awards in the customized range. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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| X | ||||||||||
- Definition Amount of gain (loss) realized from securities classified as trading. No definition available.
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| X | ||||||||||
- Details
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| X | ||||||||||
- Details
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| X | ||||||||||
- Details
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| X | ||||||||||
- Details
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| X | ||||||||||
- Definition Fair value portion of currency on hand as well as demand deposits with banks or financial institutions. Includes other kinds of accounts that have the general characteristics of demand deposits. Also includes short-term, highly liquid investments that are both readily convertible to known amounts of cash and so near their maturity that they present insignificant risk of changes in value because of changes in interest rates. No definition available.
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| X | ||||||||||
- Definition Line items represent financial concepts included in a table. These concepts are used to disclose reportable information associated with domain members defined in one or many axes to the table. No definition available.
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| X | ||||||||||
- Definition Fair value portion of investment securities, including, but not limited to, marketable securities, derivative financial instruments, and investments accounted for under the equity method. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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| X | ||||||||||
- Definition The total amount of investments that are intended to be held for an extended period of time (longer than one operating cycle). Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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| X | ||||||||||
- Details
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| X | ||||||||||
- Details
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| X | ||||||||||
- Details
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| X | ||||||||||
- Details
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| X | ||||||||||
- Details
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Basis of Presentation and Significant Accounting Policies - Schedule Of Reconcile Basic And Dilutive Weighted Average Common Shares (Details) - shares |
3 Months Ended | 9 Months Ended | ||
|---|---|---|---|---|
Sep. 30, 2019 |
Sep. 30, 2018 |
Sep. 30, 2019 |
Sep. 30, 2018 |
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| Accounting Policies [Abstract] | ||||
| Basic weighted average common shares outstanding | 102,974,105 | 102,641,504 | 102,864,571 | 102,598,740 |
| Effect of dilutive securities: | ||||
| Common stock issuable upon the exercise of stock options | 4,071,129 | 2,957,038 | ||
| Diluted weighted average common shares outstanding | 107,045,234 | 102,641,504 | 105,821,609 | 102,598,740 |
| X | ||||||||||
- References No definition available.
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| X | ||||||||||
- Definition Additional shares included in the calculation of diluted EPS as a result of the potentially dilutive effect of share based payment arrangements using the treasury stock method. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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| X | ||||||||||
- References No definition available.
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| X | ||||||||||
- Definition The average number of shares or units issued and outstanding that are used in calculating diluted EPS or earnings per unit (EPU), determined based on the timing of issuance of shares or units in the period. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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| X | ||||||||||
- Definition Number of [basic] shares or units, after adjustment for contingently issuable shares or units and other shares or units not deemed outstanding, determined by relating the portion of time within a reporting period that common shares or units have been outstanding to the total time in that period. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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Investments - Additional Information (Detail) - USD ($) |
3 Months Ended | 9 Months Ended | ||
|---|---|---|---|---|
Sep. 30, 2019 |
Sep. 30, 2018 |
Sep. 30, 2019 |
Sep. 30, 2018 |
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| Investments, Debt and Equity Securities [Abstract] | ||||
| Realized gains losses from available for sale securities | $ 0 | $ 0 | $ 0 | $ 0 |
| X | ||||||||||
- Definition This item represents the difference between the gross realized gains and losses realized on the sale of debt or equity securities categorized neither as held-to-maturity nor trading securities. Additionally, this item would include any losses recognized for other than temporary impairments (OTTI) of the subject investments in debt and equity securities. No definition available.
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| X | ||||||||||
- References No definition available.
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Investment - Summary of Available-for-Sale Investments by Security type (Detail) - USD ($) |
9 Months Ended | 12 Months Ended |
|---|---|---|
Sep. 30, 2019 |
Dec. 31, 2018 |
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| Net Investment Income [Line Items] | ||
| Amortized cost | $ 19,946,272 | $ 15,409,355 |
| Gross Unrealized Gains | 19,428 | |
| Gross Unrealized Losses | (20,248) | |
| Estimated Fair Value | 19,965,700 | 15,389,107 |
| U.S. Treasuries - ST [Member] | ||
| Net Investment Income [Line Items] | ||
| Amortized cost | 14,947,106 | 10,382,699 |
| Gross Unrealized Gains | 9,794 | |
| Gross Unrealized Losses | (1,835) | |
| Estimated Fair Value | 14,956,900 | 10,380,864 |
| U.S. Treasuries - LT [Member] | ||
| Net Investment Income [Line Items] | ||
| Amortized cost | 4,999,166 | 5,026,656 |
| Gross Unrealized Gains | 9,634 | |
| Gross Unrealized Losses | (18,413) | |
| Estimated Fair Value | $ 5,008,800 | $ 5,008,243 |
| X | ||||||||||
- Definition Amount of investment in debt and equity securities categorized neither as held-to-maturity nor trading. No definition available.
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| X | ||||||||||
- Definition This item represents the cost of debt and equity securities, which are categorized neither as held-to-maturity nor trading, net of adjustments including accretion, amortization, collection of cash, previous other-than-temporary impairments recognized in earnings (less any cumulative-effect adjustments recognized, as defined), and fair value hedge accounting adjustments, if any. No definition available.
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| X | ||||||||||
- Definition Amount of unrealized gain before deducting unrealized loss on investments in debt and equity securities classified as available-for-sale securities. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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| X | ||||||||||
- Definition Amount of unrealized loss before deducting unrealized gain on investments in available-for-sale securities. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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| X | ||||||||||
- Definition Line items represent financial concepts included in a table. These concepts are used to disclose reportable information associated with domain members defined in one or many axes to the table. No definition available.
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| X | ||||||||||
- Details
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| X | ||||||||||
- Details
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Investment - Estimated Fair Values of Available for Sale Securities (Detail) - USD ($) |
Sep. 30, 2019 |
Dec. 31, 2018 |
|---|---|---|
| Investments, Debt and Equity Securities [Abstract] | ||
| Due in one year or less | $ 19,965,700 | |
| Estimated Fair Value | $ 19,965,700 | $ 15,389,107 |
| X | ||||||||||
- Definition Available for sale securities due within one year fair value. No definition available.
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| X | ||||||||||
- Definition Amount of investment in debt and equity securities categorized neither as held-to-maturity nor trading. No definition available.
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| X | ||||||||||
- References No definition available.
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Prepaid Expenses and Other Current Assets - Prepaid Expenses and Other Current Assets (Detail) - USD ($) |
Sep. 30, 2019 |
Dec. 31, 2018 |
|---|---|---|
| Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] | ||
| Prepaid research fees | $ 372,784 | $ 358,209 |
| Prepaid insurance | 151,474 | 800,261 |
| Prepaid commercialization fees | 112,356 | 17,030 |
| Prepaid subscriptions fees | 537,587 | 170,552 |
| Prepaid manufacturing | 1,734,360 | |
| Other | 430,838 | 303,729 |
| Total prepaid expenses and other current assets | $ 3,339,399 | $ 1,649,781 |
| X | ||||||||||
- Definition Prepaid manufacturing expense. No definition available.
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| X | ||||||||||
- Definition Amount of asset related to consideration paid in advance for pre-commercialization fees that provide economic benefits with a future period of one year or the normal operating cycle, if longer. No definition available.
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| X | ||||||||||
- Definition Amount of asset related to consideration paid in advance for research and product development activities that provide economic benefits within a future period of one year or the normal operating cycle, if longer. No definition available.
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| X | ||||||||||
- Definition Amount of asset related to consideration paid in advance for subscription fees that provides economic benefits within a future period of one year of the normal operating cycle, if longer. No definition available.
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| X | ||||||||||
- References No definition available.
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| X | ||||||||||
- Definition Amount of asset related to consideration paid in advance for other costs that provide economic benefits within a future period of one year or the normal operating cycle, if longer. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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| X | ||||||||||
- Definition Amount of asset related to consideration paid in advance for costs that provide economic benefits in future periods, and amount of other assets that are expected to be realized or consumed within one year or the normal operating cycle, if longer. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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| X | ||||||||||
- Definition Amount of asset related to consideration paid in advance for insurance that provides economic benefits within a future period of one year or the normal operating cycle, if longer. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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Operating Leases - Operating Leases (Detail) - USD ($) |
3 Months Ended | 9 Months Ended |
|---|---|---|
Sep. 30, 2019 |
Sep. 30, 2019 |
|
| Disclosure of Operating Leases [Abstract] | ||
| Operating lease cost | $ 74,079 | $ 222,237 |
| X | ||||||||||
- Definition Disclosure of Operating Leases No definition available.
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| X | ||||||||||
- Definition Amount of single lease cost, calculated by allocation of remaining cost of lease over remaining lease term. Includes, but is not limited to, single lease cost, after impairment of right-of-use asset, calculated by amortization of remaining right-of-use asset and accretion of lease liability. Reference 1: http://www.xbrl.org/2003/role/exampleRef
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Operating Leases - Schedule of Supplemental Cash Flow Information Related To Lease (Detail) |
9 Months Ended |
|---|---|
|
Sep. 30, 2019
USD ($)
| |
| Cash paid for amounts included in the measurement of lease liabilities: | |
| Operating cash flows | $ 245,663 |
| Right-of-use assets obtained in exchange for lease obligations: | |
| Operating leases | $ 15,915 |
| X | ||||||||||
- Definition Operating Lease Measurement No definition available.
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| X | ||||||||||
- Definition Right of Use Assets Obtained No definition available.
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| X | ||||||||||
- Definition Amount of cash outflow from operating lease, excluding payments to bring another asset to condition and location necessary for its intended use. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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| X | ||||||||||
- Definition Amount of increase in right-of-use asset obtained in exchange for operating lease liability. Reference 1: http://www.xbrl.org/2003/role/exampleRef
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Operating Leases -Schedule of Supplemental Balance Sheet related To Lease (Detail) |
Sep. 30, 2019
USD ($)
|
|---|---|
| Disclosure of Operating Leases [Line Items] | |
| Operating lease right-of-use assets | $ 952,340 |
| Accrued Expenses and Other Liabilities - Schedule of Accrued Expenses and Other Liabilities (Detail) | 294,433 |
| Operating lease liabilities, net of current portion | 725,700 |
| Total operating lease liabilities | $ 1,020,133 |
| Weighted Average Remaining Lease Term | 3 years 2 months 12 days |
| Weighted Average Discount Rate | 4.81% |
| X | ||||||||||
- Definition Disclosure of Operating Leases No definition available.
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| X | ||||||||||
- Definition Present value of lessee's discounted obligation for lease payments from operating lease. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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| X | ||||||||||
- Definition Present value of lessee's discounted obligation for lease payments from operating lease, classified as current. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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| X | ||||||||||
- Definition Present value of lessee's discounted obligation for lease payments from operating lease, classified as noncurrent. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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| X | ||||||||||
- Definition Amount of lessee's right to use underlying asset under operating lease. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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| X | ||||||||||
- Definition Weighted average discount rate for operating lease calculated at point in time. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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| X | ||||||||||
- Definition Weighted average remaining lease term for operating lease, in 'PnYnMnDTnHnMnS' format, for example, 'P1Y5M13D' represents reported fact of one year, five months, and thirteen days. Reference 1: http://www.xbrl.org/2003/role/exampleRef
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Operating Leases -Lessee, Operating Lease, Liability, Maturity (Detail) |
Sep. 30, 2019
USD ($)
|
|---|---|
| Disclosure of Operating Leases [Line Items] | |
| 2019 (remaining six months) | $ 84,061 |
| 2020 | 339,605 |
| 2021 | 349,788 |
| 2022 | 329,662 |
| Total lease payments | 1,103,116 |
| Less imputed interest | (82,983) |
| Total | $ 1,020,133 |
| X | ||||||||||
- Definition Disclosure of Operating Leases No definition available.
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| X | ||||||||||
- Definition Amount of lessee's undiscounted obligation for lease payments for operating lease. No definition available.
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| X | ||||||||||
- Definition Amount of lessee's undiscounted obligation for lease payments for operating lease. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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| X | ||||||||||
- Definition Amount of lessee's undiscounted obligation for lease payments for operating lease, due in next fiscal year following latest fiscal year. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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| X | ||||||||||
- Definition Amount of lessee's undiscounted obligation for lease payments for operating lease, due in third fiscal year following latest fiscal year. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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| X | ||||||||||
- Definition Amount of lessee's undiscounted obligation for lease payments for operating lease, due in second fiscal year following latest fiscal year. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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| X | ||||||||||
- Definition Amount of lessee's undiscounted obligation for lease payments for operating lease having an initial or remaining lease term in excess of one year due in remainder of fiscal year following latest fiscal year. Reference 1: http://www.xbrl.org/2009/role/commonPracticeRef
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| X | ||||||||||
- Definition Amount of lessee's undiscounted obligation for lease payments in excess of discounted obligation for lease payments for operating lease. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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Operating Leases - Additional Information (Detail) |
9 Months Ended |
|---|---|
Sep. 30, 2019 | |
| Disclosure of Operating Leases [Line Items] | |
| Operating Lease, Weighted Average Remaining Lease Term | 3 years 2 months 12 days |
| Lessor, Operating Lease, Option to Extend | 1 year |
| Lessor, Operating Lease, Option to Terminate | 1 year |
| X | ||||||||||
- Definition Disclosure of Operating Leases No definition available.
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| X | ||||||||||
- Definition Description of terms and conditions of option to extend lessor's operating lease. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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| X | ||||||||||
- Definition Description of terms and conditions of option to terminate lessor's operating lease. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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| X | ||||||||||
- Definition Weighted average remaining lease term for operating lease, in 'PnYnMnDTnHnMnS' format, for example, 'P1Y5M13D' represents reported fact of one year, five months, and thirteen days. Reference 1: http://www.xbrl.org/2003/role/exampleRef
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Property and Equipment, Net - Property and Equipment, Net (Detail) - USD ($) |
Sep. 30, 2019 |
Dec. 31, 2018 |
|---|---|---|
| Property, Plant and Equipment [Line Items] | ||
| Property and equipment, gross | $ 281,645 | $ 442,572 |
| Less: Accumulated depreciation | (140,557) | (197,147) |
| Total property and equipment, net | 141,088 | 245,425 |
| Computer Equipment [Member] | ||
| Property, Plant and Equipment [Line Items] | ||
| Property and equipment, gross | 50,904 | 52,704 |
| Furniture and Equipment [Member] | ||
| Property, Plant and Equipment [Line Items] | ||
| Property and equipment, gross | $ 230,741 | 212,451 |
| Leasehold Improvements [Member] | ||
| Property, Plant and Equipment [Line Items] | ||
| Property and equipment, gross | $ 177,417 |
| X | ||||||||||
- Definition Amount of accumulated depreciation, depletion and amortization for physical assets used in the normal conduct of business to produce goods and services. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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| X | ||||||||||
- Definition Amount before accumulated depreciation, depletion and amortization of physical assets used in the normal conduct of business and not intended for resale. Examples include, but are not limited to, land, buildings, machinery and equipment, office equipment, and furniture and fixtures. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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| X | ||||||||||
- Definition Line items represent financial concepts included in a table. These concepts are used to disclose reportable information associated with domain members defined in one or many axes to the table. No definition available.
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| X | ||||||||||
- Definition Amount after accumulated depreciation, depletion and amortization of physical assets used in the normal conduct of business to produce goods and services and not intended for resale. Examples include, but are not limited to, land, buildings, machinery and equipment, office equipment, and furniture and fixtures. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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| X | ||||||||||
- Details
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| X | ||||||||||
- Details
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| X | ||||||||||
- Details
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Property and Equipment, Net - Additional Information (Detail) - USD ($) |
3 Months Ended | 9 Months Ended | ||
|---|---|---|---|---|
Sep. 30, 2019 |
Sep. 30, 2018 |
Sep. 30, 2019 |
Sep. 30, 2018 |
|
| Property, Plant and Equipment [Abstract] | ||||
| Depreciation expenses | $ 6,532 | $ 9,294 | $ 26,718 | $ 25,485 |
| X | ||||||||||
- Definition The amount of expense recognized in the current period that reflects the allocation of the cost of tangible assets over the assets' useful lives. Includes production and non-production related depreciation. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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| X | ||||||||||
- References No definition available.
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Accrued Expenses and Other Liabilities - Schedule of Accrued Expenses and Other Liabilities (Detail) - USD ($) |
Sep. 30, 2019 |
Dec. 31, 2018 |
|---|---|---|
| Payables and Accruals [Abstract] | ||
| Accrued preclinical and clinical trial expenses | $ 768,114 | $ 821,633 |
| Accrued professional fees | 1,232,567 | 1,311,061 |
| Accrued compensation and benefits | 1,739,719 | 1,941,449 |
| Accrued license fees | 6,880,265 | 3,000,000 |
| Operating lease liability | 294,433 | |
| Accrued variable consideration | 1,330,981 | |
| Deferred rent and lease incentive | 33,408 | |
| Accrued income tax | 1,058,039 | |
| Other | 531,174 | 66,436 |
| Current accrued expenses and other liabilities | 13,835,292 | 7,173,987 |
| Lease liability - non-current | 725,700 | |
| Deferred rent and lease incentive - non-current | 154,799 | |
| Non-current accrued expenses and other liabilities | 725,700 | 154,799 |
| Total accrued expenses and other liabilities | $ 14,560,992 | $ 7,328,786 |
| X | ||||||||||
- Definition Carrying value as of the balance sheet date of obligations incurred through that date and payable for license fees. Used to reflect the current portion of the liabilities (due within one year or within the normal operating cycle if longer). No definition available.
|
| X | ||||||||||
- Definition Carrying value as of the balance sheet date of obligations incurred through that date and payable pertaining to non clinical and clinical trial expenses. Used to reflect the current portion of the liabilities (due within one year or within the normal operating cycle if longer). No definition available.
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| X | ||||||||||
- Definition Accrued variable consideration. No definition available.
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| X | ||||||||||
- Definition Other noncurrent accrued expenses and other liabilities. No definition available.
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| X | ||||||||||
- Definition Carrying amount as of the balance sheet date of the unpaid sum of the known and estimated amounts payable to satisfy all currently due domestic and foreign income tax obligations. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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| X | ||||||||||
- Definition Carrying value as of the balance sheet date of obligations incurred and payable, pertaining to costs that are statutory in nature, are incurred on contractual obligations, or accumulate over time and for which invoices have not yet been received or will not be rendered. Examples include taxes, interest, rent and utilities. Used to reflect the current portion of the liabilities (due within one year or within the normal operating cycle if longer). Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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| X | ||||||||||
- Definition Carrying value as of the balance sheet date of obligations incurred and payable, pertaining to costs that are statutory in nature, are incurred on contractual obligations, or accumulate over time and for which invoices have not yet been received or will not be rendered. Examples include taxes, interest, rent and utilities. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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| X | ||||||||||
- Definition Carrying value as of the balance sheet date of obligations incurred through that date and payable for professional fees, such as for legal and accounting services received. Used to reflect the current portion of the liabilities (due within one year or within the normal operating cycle if longer). Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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| X | ||||||||||
- Definition Carrying value as of the balance sheet date of obligations incurred through that date and due after one year (or beyond the operating cycle if longer) for contractual rent under lease arrangements. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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| X | ||||||||||
- Definition For a classified balance sheet, the cumulative difference as of the balance sheet date between the payments required by a lease agreement and the rental income or expense recognized on a straight-line basis, or other systematic and rational basis more representative of the time pattern in which use or benefit is granted or derived from the leased property, expected to be recognized in income or expense, by the lessor or lessee, respectively, within one year of the balance sheet date. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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| X | ||||||||||
- Definition Total of the carrying values as of the balance sheet date of obligations incurred through that date and payable for obligations related to services received from employees, such as accrued salaries and bonuses, payroll taxes and fringe benefits. Used to reflect the current portion of the liabilities (due within one year or within the normal operating cycle if longer). Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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| X | ||||||||||
- Definition Present value of lessee's discounted obligation for lease payments from operating lease, classified as current. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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| X | ||||||||||
- Definition Present value of lessee's discounted obligation for lease payments from operating lease, classified as noncurrent. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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| X | ||||||||||
- Definition Amount of expenses incurred but not yet paid classified as other, due within one year or the normal operating cycle, if longer. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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| X | ||||||||||
- References No definition available.
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Collaborative Arrangement - Additional Information (Detail) - USD ($) |
3 Months Ended | 9 Months Ended | 12 Months Ended | ||
|---|---|---|---|---|---|
Sep. 30, 2019 |
Sep. 30, 2018 |
Sep. 30, 2019 |
Sep. 30, 2018 |
Dec. 31, 2018 |
|
| Collaborative Arrangement [Line Items] | |||||
| Expenses In Connection With Collaborative Arrangement | $ 4,597,039 | $ 4,538,369 | $ 12,534,362 | $ 11,502,235 | |
| Collaborative Arrangement [Member] | |||||
| Collaborative Arrangement [Line Items] | |||||
| Upfront license fee | 0 | $ 0 | $ 500,000 | ||
| Period of collaboration agreement | 10 years | ||||
| Expenses In Connection With Collaborative Arrangement | $ 31,924 | $ 70,102 | |||
| X | ||||||||||
- Definition Period Of Collaboration Agreement No definition available.
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| X | ||||||||||
- Definition Line items represent financial concepts included in a table. These concepts are used to disclose reportable information associated with domain members defined in one or many axes to the table. No definition available.
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| X | ||||||||||
- Definition The aggregate costs incurred (1) in a planned search or critical investigation aimed at discovery of new knowledge with the hope that such knowledge will be useful in developing a new product or service, a new process or technique, or in bringing about a significant improvement to an existing product or process; or (2) to translate research findings or other knowledge into a plan or design for a new product or process or for a significant improvement to an existing product or process whether intended for sale or the entity's use, during the reporting period charged to research and development projects, including the costs of developing computer software up to the point in time of achieving technological feasibility, and costs allocated in accounting for a business combination to in-process projects deemed to have no alternative future use. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
| X | ||||||||||
- Definition Amount of revenue recognized from goods sold, services rendered, insurance premiums, or other activities that constitute an earning process. Includes, but is not limited to, investment and interest income before deduction of interest expense when recognized as a component of revenue, and sales and trading gain (loss). Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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| X | ||||||||||
- Details
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Commitments and Contingencies - Additional Information (Detail) |
1 Months Ended |
|---|---|
|
May 21, 2019
USD ($)
| |
| Settlement Agreement [Member] | Other Income [Member] | |
| Commitments [Line Items] | |
| Litigation Settlement Received | $ 100,000 |
| X | ||||||||||
- Definition Commitments. No definition available.
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| X | ||||||||||
- Definition Amount awarded from other party in judgment or settlement of litigation. No definition available.
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| X | ||||||||||
- Details
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| X | ||||||||||
- Details
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Agreements - Additional Information (Detail) - License Agreement with BioMarin [Member] $ in Millions |
9 Months Ended |
|---|---|
|
Sep. 30, 2019
USD ($)
| |
| License Agreement [Line Items] | |
| Date on which strategic collaboration is entered into | Oct. 26, 2012 |
| Royalty agreement period | 7 years |
| Net sales royalty threshold | $ 100 |
| Minimum [Member] | |
| License Agreement [Line Items] | |
| Percentage of royalty on net sales | 7.00% |
| Maximum [Member] | |
| License Agreement [Line Items] | |
| Percentage of royalty on net sales | 10.00% |
| X | ||||||||||
- Definition License Agreement [Line Items] No definition available.
|
| X | ||||||||||
- Definition Represents the amount used to determine the percentage of royalties for the period from the first commercial sale equal to the minimum percentage of net sales in North America for any calendar year for sales up to the amount, and maximum percentage of net sales in North America in any calendar year in excess of the amount. No definition available.
|
| X | ||||||||||
- Definition Represents the percentage applied to net sales to determine the amount payable as part of the agreement. No definition available.
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| X | ||||||||||
- Definition The term of the royalty payments from the first commercial sale of product under the agreement. No definition available.
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| X | ||||||||||
- Definition Strategic collaboration date. No definition available.
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| X | ||||||||||
- Details
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| X | ||||||||||
- Details
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| X | ||||||||||
- Details
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Income Taxes - Additional Information (Detail) - USD ($) |
9 Months Ended | ||
|---|---|---|---|
Sep. 30, 2019 |
Sep. 30, 2018 |
Dec. 31, 2018 |
|
| Income Tax Disclosure [Abstract] | |||
| Effective Statutory Income Tax Rate | 4.18% | 0.00% | |
| Change In Effective and Statutory Income Tax rate | 21.00% | ||
| Uncertain tax Position | $ 0 | $ 0 | |
| X | ||||||||||
- Definition Percentage of domestic federal statutory tax rate applicable to pretax income (loss). Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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| X | ||||||||||
- Definition Percentage of the difference between reported income tax expense (benefit) and expected income tax expense (benefit) computed by applying the domestic federal statutory income tax rates to pretax income (loss) from continuing operations attributable to other adjustments. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
| X | ||||||||||
- References No definition available.
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| X | ||||||||||
- Definition Amount recognized for uncertainty in income taxes classified as current. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
Stockholders' Equity (2016 Shelf Registration Statement) - Additional Information (Detail) |
Dec. 23, 2016
USD ($)
|
|---|---|
| 2016 Shelf Registration Statement [Member] | |
| Stockholders' Equity [Line Items] | |
| Maximum dollar amount of common stock to be issued under shelf registration statement | $ 33,800,000 |
| X | ||||||||||
- Definition Maximum dollar amount of common stock to be issued under shelf registration statement. No definition available.
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| X | ||||||||||
- Definition Stockholders' equity. No definition available.
|
| X | ||||||||||
- Details
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Stockholders' Equity (2017 Shelf Registration Statement) - Additional Information (Detail) - USD ($) |
9 Months Ended | ||
|---|---|---|---|
Nov. 28, 2017 |
Sep. 30, 2019 |
Jul. 12, 2017 |
|
| Underwritten Public Offering [Member] | |||
| Stockholders' Equity [Line Items] | |||
| Number of common stock sold in offering | 16,428,572 | ||
| Common stock issued, price per share | $ 3.50 | ||
| Gross proceeds from issuance of common stock | $ 57,500,000 | ||
| Offering expenses | $ 3,700,000 | ||
| 2017 Shelf Registration Statement [Member] | |||
| Stockholders' Equity [Line Items] | |||
| Maximum dollar amount of securities to be issued under shelf registration statement | $ 150,000,000 | ||
| Value of common stock available for future sale | $ 92,500,000 |
| X | ||||||||||
- Definition Value of common stock available for future sale. No definition available.
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| X | ||||||||||
- Definition Maximum amount of securities that can be issued under shelf registration statement. No definition available.
|
| X | ||||||||||
- Definition Stockholders' equity. No definition available.
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| X | ||||||||||
- Definition The cash outflow for cost incurred directly with the issuance of an equity security. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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| X | ||||||||||
- Definition The cash inflow from the additional capital contribution to the entity. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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| X | ||||||||||
- Definition Price of a single share of a number of saleable stocks of a company. No definition available.
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| X | ||||||||||
- Definition Number of new stock issued during the period. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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| X | ||||||||||
- Details
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| X | ||||||||||
- Details
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Stock Compensation - Stock-Based Compensation Expense (Detail) - USD ($) |
3 Months Ended | 9 Months Ended | ||
|---|---|---|---|---|
Sep. 30, 2019 |
Sep. 30, 2018 |
Sep. 30, 2019 |
Sep. 30, 2018 |
|
| Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||||
| Stock-based compensation | $ 817,060 | $ 758,176 | $ 2,675,467 | $ 2,521,023 |
| Research and Development [Member] | ||||
| Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||||
| Stock-based compensation | 242,867 | 240,122 | 803,800 | 820,062 |
| Selling, General and Administrative [Member] | ||||
| Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||||
| Stock-based compensation | $ 574,193 | $ 518,054 | $ 1,871,667 | $ 1,700,961 |
| X | ||||||||||
- Definition Line items represent financial concepts included in a table. These concepts are used to disclose reportable information associated with domain members defined in one or many axes to the table. No definition available.
|
| X | ||||||||||
- Definition Amount of noncash expense for share-based payment arrangement. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
| X | ||||||||||
- Details
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| X | ||||||||||
- Details
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| X | ||||||||||
- Definition Range of contractual term of option awards. No definition available.
|
| X | ||||||||||
- Definition Stock issued during period shares stock options exercised cashless basis. No definition available.
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| X | ||||||||||
- Definition Amount of expense for award under share-based payment arrangement. Excludes amount capitalized. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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| X | ||||||||||
- Definition Aggregate number of common shares reserved for future issuance. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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| X | ||||||||||
- Definition Amount of cost not yet recognized for nonvested award under share-based payment arrangement. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
| X | ||||||||||
- Definition Weighted-average period over which cost not yet recognized is expected to be recognized for award under share-based payment arrangement, in 'PnYnMnDTnHnMnS' format, for example, 'P1Y5M13D' represents reported fact of one year, five months, and thirteen days. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
| X | ||||||||||
- Definition Amount of cash inflow from exercise of option under share-based payment arrangement. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
| X | ||||||||||
- Definition Line items represent financial concepts included in a table. These concepts are used to disclose reportable information associated with domain members defined in one or many axes to the table. No definition available.
|
| X | ||||||||||
- Definition Gross number of share options (or share units) granted during the period. No definition available.
|
| X | ||||||||||
- Definition The number of shares reserved for issuance pertaining to the outstanding exercisable stock options as of the balance sheet date in the customized range of exercise prices for which the market and performance vesting condition has been satisfied. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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| X | ||||||||||
- Definition Number of options vested. No definition available.
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| X | ||||||||||
- Definition Number of new stock issued during the period. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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| X | ||||||||||
- Definition Number of share options (or share units) exercised during the current period. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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| X | ||||||||||
- Details
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| X | ||||||||||
- Details
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