X | ||||||||||
- Definition Boolean flag that is true when the XBRL content amends previously-filed or accepted submission. No definition available.
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X | ||||||||||
- Definition Area code of city No definition available.
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X | ||||||||||
- Definition End date of current fiscal year in the format --MM-DD. No definition available.
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- Definition Fiscal period values are FY, Q1, Q2, and Q3. 1st, 2nd and 3rd quarter 10-Q or 10-QT statements have value Q1, Q2, and Q3 respectively, with 10-K, 10-KT or other fiscal year statements having FY. No definition available.
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- Definition This is focus fiscal year of the document report in CCYY format. For a 2006 annual report, which may also provide financial information from prior periods, fiscal 2006 should be given as the fiscal year focus. Example: 2006. No definition available.
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X | ||||||||||
- Definition The end date of the period reflected on the cover page if a periodic report. For all other reports and registration statements containing historical data, it is the date up through which that historical data is presented. If there is no historical data in the report, use the filing date. The format of the date is CCYY-MM-DD. No definition available.
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- Definition Boolean flag that is true only for a form used as an quarterly report. Reference 1: http://www.xbrl.org/2003/role/presentationRef
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- Definition Boolean flag that is true only for a form used as a transition report. Reference 1: http://www.xbrl.org/2003/role/presentationRef
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X | ||||||||||
- Definition The type of document being provided (such as 10-K, 10-Q, 485BPOS, etc). The document type is limited to the same value as the supporting SEC submission type, or the word 'Other'. No definition available.
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X | ||||||||||
- Definition Address Line 1 such as Attn, Building Name, Street Name No definition available.
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X | ||||||||||
- Definition Address Line 2 such as Street or Suite number No definition available.
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X | ||||||||||
- Definition Name of the City or Town No definition available.
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X | ||||||||||
- Definition Code for the postal or zip code No definition available.
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X | ||||||||||
- Definition Name of the state or province. No definition available.
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X | ||||||||||
- Definition A unique 10-digit SEC-issued value to identify entities that have filed disclosures with the SEC. It is commonly abbreviated as CIK. Reference 1: http://www.xbrl.org/2003/role/presentationRef
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X | ||||||||||
- 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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X | ||||||||||
- Definition Indicate 'Yes' or 'No' whether registrants (1) have filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that registrants were required to file such reports), and (2) have been subject to such filing requirements for the past 90 days. This information should be based on the registrant's current or most recent filing containing the related disclosure. No definition available.
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- Definition Indicate if registrant meets the emerging growth company criteria. Reference 1: http://www.xbrl.org/2003/role/presentationRef
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- Definition Commission file number. The field allows up to 17 characters. The prefix may contain 1-3 digits, the sequence number may contain 1-8 digits, the optional suffix may contain 1-4 characters, and the fields are separated with a hyphen. No definition available.
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X | ||||||||||
- Definition Indicate whether the registrant is one of the following: Large Accelerated Filer, Accelerated Filer, Non-accelerated Filer. Definitions of these categories are stated in Rule 12b-2 of the Exchange Act. This information should be based on the registrant's current or most recent filing containing the related disclosure. Reference 1: http://www.xbrl.org/2003/role/presentationRef
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X | ||||||||||
- Definition Two-character EDGAR code representing the state or country of incorporation. No definition available.
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X | ||||||||||
- Definition Boolean flag that is true when the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Reference 1: http://www.xbrl.org/2003/role/presentationRef
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X | ||||||||||
- Definition The exact name of the entity filing the report as specified in its charter, which is required by forms filed with the SEC. Reference 1: http://www.xbrl.org/2003/role/presentationRef
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X | ||||||||||
- Definition Boolean flag that is true when the registrant is a shell company as defined in Rule 12b-2 of the Exchange Act. Reference 1: http://www.xbrl.org/2003/role/presentationRef
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X | ||||||||||
- Definition Indicates that the company is a Smaller Reporting Company (SRC). Reference 1: http://www.xbrl.org/2003/role/presentationRef
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X | ||||||||||
- Definition The Tax Identification Number (TIN), also known as an Employer Identification Number (EIN), is a unique 9-digit value assigned by the IRS. Reference 1: http://www.xbrl.org/2003/role/presentationRef
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X | ||||||||||
- Definition Local phone number for entity. No definition available.
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X | ||||||||||
- Definition Title of a 12(b) registered security. Reference 1: http://www.xbrl.org/2003/role/presentationRef
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X | ||||||||||
- Definition Name of the Exchange on which a security is registered. Reference 1: http://www.xbrl.org/2003/role/presentationRef
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X | ||||||||||
- Definition Trading symbol of an instrument as listed on an exchange. No definition available.
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X | ||||||||||
- References No definition available.
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X | ||||||||||
- Definition The amount of license rights. No definition available.
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X | ||||||||||
- 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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X | ||||||||||
- Definition Amount, after allowance for credit loss, of right to consideration from customer for product sold and service rendered in normal course of business, classified as current. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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X | ||||||||||
- Definition Value received from shareholders in common stock-related transactions that are in excess of par value or stated value and amounts received from other stock-related transactions. Includes only common stock transactions (excludes preferred stock transactions). May be called contributed capital, capital in excess of par, capital surplus, or paid-in capital. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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X | ||||||||||
- 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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X | ||||||||||
- 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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X | ||||||||||
- References No definition available.
|
X | ||||||||||
- 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 after one year or beyond the normal operating cycle, if longer. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- 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. Excludes cash and cash equivalents within disposal group and discontinued operation. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
|
X | ||||||||||
- 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
|
X | ||||||||||
- 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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X | ||||||||||
- Definition Sum of the carrying amounts of all intangible assets, excluding goodwill, as of the balance sheet date, net of accumulated amortization and impairment charges. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- 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
|
X | ||||||||||
- 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
|
X | ||||||||||
- 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
|
X | ||||||||||
- 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
|
X | ||||||||||
- References No definition available.
|
X | ||||||||||
- Definition Amount after unamortized (discount) premium and debt issuance costs of long-term debt classified as noncurrent and excluding amounts to be repaid within one year or the normal operating cycle, if longer. Includes, but not limited to, notes payable, bonds payable, debentures, mortgage loans and commercial paper. Excludes capital lease obligations. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- References No definition available.
|
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
|
X | ||||||||||
- Definition Amount of assets classified as other. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- References No definition available.
|
X | ||||||||||
- Definition Amount of liabilities classified as other, due within one year or the normal operating cycle, if longer. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- 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
|
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
|
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
|
X | ||||||||||
- Definition The cumulative amount of the reporting entity's undistributed earnings or deficit. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
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
|
X | ||||||||||
- References No definition available.
|
CONSOLIDATED BALANCE SHEETS (Parenthetical) - USD ($) |
Jun. 30, 2019 |
Dec. 31, 2018 |
---|---|---|
Statement of Financial Position [Abstract] | ||
Allowance for doubtful accounts | $ 764,102 | $ 596,602 |
Preferred stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Preferred stock, authorized | 10,000,000 | 10,000,000 |
Common stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Common stock, authorized | 350,000,000 | 350,000,000 |
Common stock, issued | 241,221,840 | 240,462,439 |
Common stock, outstanding | 241,221,840 | 240,462,439 |
X | ||||||||||
- Definition Amount of allowance for credit loss on accounts receivable, classified as current. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
|
X | ||||||||||
- Definition Face amount or stated value per share of common stock. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- 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
|
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
|
X | ||||||||||
- 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
|
X | ||||||||||
- 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
|
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
|
X | ||||||||||
- References No definition available.
|
CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited) - USD ($) |
3 Months Ended | 6 Months Ended | ||
---|---|---|---|---|
Jun. 30, 2019 |
Jun. 30, 2018 |
Jun. 30, 2019 |
Jun. 30, 2018 |
|
Income Statement [Abstract] | ||||
Revenues, net | $ 6,078,865 | $ 3,763,010 | $ 10,025,516 | $ 7,536,402 |
Cost of goods sold | 1,248,860 | 454,161 | 2,011,687 | 1,087,784 |
Gross profit | 4,830,005 | 3,308,849 | 8,013,829 | 6,448,618 |
Operating expenses: | ||||
Sales, general, and administrative | 41,387,451 | 29,466,770 | 76,251,533 | 50,224,007 |
Research and development | 4,964,368 | 6,798,380 | 11,282,250 | 13,837,677 |
Depreciation and amortization | 115,059 | 65,603 | 221,997 | 125,224 |
Total operating expenses | 46,466,878 | 36,330,753 | 87,755,780 | 64,186,908 |
Operating loss | (41,636,873) | (33,021,904) | (79,741,951) | (57,738,290) |
Other (expense) income | ||||
Gain (Loss) on Extinguishment of Debt | (10,057,632) | (10,057,632) | ||
Miscellaneous income | 486,597 | 334,238 | 1,175,318 | 648,795 |
Interest expense | (4,028,609) | (531,382) | (6,118,627) | (531,382) |
Total other (expense) income | (13,599,644) | (197,144) | (15,000,941) | 117,413 |
Loss before income taxes | (55,236,517) | (33,219,048) | (94,742,892) | (57,620,877) |
Net loss | $ (55,236,517) | $ (33,219,048) | $ (94,742,892) | $ (57,620,877) |
Loss per share, basic and diluted: | ||||
Net loss per share, basic and diluted (in dollars per share) | $ (0.23) | $ (0.15) | $ (0.39) | $ (0.27) |
Weighted average number of common shares outstanding, basic and diluted (in shares) | 241,221,840 | 216,640,186 | 241,114,532 | 216,583,067 |
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
|
X | ||||||||||
- Definition The current period expense charged against earnings on long-lived, physical assets not used in production, and which are not intended for resale, to allocate or recognize the cost of such assets over their useful lives; or to record the reduction in book value of an intangible asset over the benefit period of such asset; or to reflect consumption during the period of an asset that is not used in production. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- References No definition available.
|
X | ||||||||||
- Definition The amount of net income or loss for the period per each share in instances when basic and diluted earnings per share are the same amount and reported as a single line item on the face of the financial statements. Basic earnings per share is the amount of net income or loss for the period per each share of common stock or unit outstanding during the reporting period. Diluted earnings per share includes the amount of net income or 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/2009/role/commonPracticeRef
|
X | ||||||||||
- Definition Difference between the fair value of payments made and the carrying amount of debt which is extinguished prior to maturity. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition Aggregate revenue less cost of goods and services sold or operating expenses directly attributable to the revenue generation activity. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
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
|
X | ||||||||||
- References No definition available.
|
X | ||||||||||
- Definition Amount of the cost of borrowed funds accounted for as interest expense. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
|
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
|
X | ||||||||||
- Definition The aggregate amount of income or expense from ancillary business-related activities (that is to say, excluding major activities considered part of the normal operations of the business). Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition Generally recurring costs associated with normal operations except for the portion of these expenses which can be clearly related to production and included in cost of sales or services. Includes selling, general and administrative expense. No definition available.
|
X | ||||||||||
- References No definition available.
|
X | ||||||||||
- Definition The net result for the period of deducting operating expenses from operating revenues. No definition available.
|
X | ||||||||||
- Definition Amount of income related to nonoperating activities, classified as other. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- References No definition available.
|
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, 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
|
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
|
X | ||||||||||
- Definition Average number of shares or units issued and outstanding that are used in calculating basic and diluted earnings per share (EPS). No definition available.
|
X | ||||||||||
- Definition Amount of increase to additional paid-in capital (APIC) for recognition of cost for award under share-based payment arrangement. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- 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
|
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
|
X | ||||||||||
- Definition Number of shares of stock issued attributable to transactions classified as other. No definition available.
|
X | ||||||||||
- Definition Number of share options (or share units) exercised during the current period. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition Value of shares of stock issued attributable to transactions classified as other. No definition available.
|
X | ||||||||||
- Definition Value of stock issued as a result of the exercise of stock options. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
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
|
X | ||||||||||
- Definition Amount of expense related to operating lease costs. No definition available.
|
X | ||||||||||
- References No definition available.
|
X | ||||||||||
- Definition Amount of amortization expense attributable to debt issuance costs. Reference 1: http://www.xbrl.org/2009/role/commonPracticeRef
|
X | ||||||||||
- Definition The aggregate expense charged against earnings to allocate the cost of intangible assets (nonphysical assets not used in production) in a systematic and rational manner to the periods expected to benefit from such assets. As a noncash expense, this element is added back to net income when calculating cash provided by or used in operations using the indirect method. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- 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. Excludes cash and cash equivalents within disposal group and discontinued operation. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
|
X | ||||||||||
- Definition Amount of increase (decrease) in cash. Cash is the 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. Includes effect from exchange rate changes. No definition available.
|
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
|
X | ||||||||||
- Definition Difference between the fair value of payments made and the carrying amount of debt which is extinguished prior to maturity. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- 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
|
X | ||||||||||
- Definition The increase (decrease) during the reporting period in amount due within one year (or one business cycle) from customers for the credit sale of goods and services. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- 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
|
X | ||||||||||
- References No definition available.
|
X | ||||||||||
- Definition Amount of increase (decrease) in current assets classified as other. Reference 1: http://www.xbrl.org/2009/role/commonPracticeRef
|
X | ||||||||||
- Definition Amount of increase (decrease) in current liabilities classified as other. Reference 1: http://www.xbrl.org/2009/role/commonPracticeRef
|
X | ||||||||||
- Definition The net cash inflow or outflow for the increase (decrease) associated with funds that are not available for withdrawal or use (such as funds held in escrow) and are associated with underlying transactions that are classified as investing activities. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition Amount of cash paid for interest, excluding capitalized interest, classified as operating activity. Includes, but is not limited to, payment to settle zero-coupon bond for accreted interest of debt discount and debt instrument with insignificant coupon interest rate in relation to effective interest rate of borrowing attributable to accreted interest of debt discount. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
|
X | ||||||||||
- 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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- References No definition available.
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X | ||||||||||
- 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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X | ||||||||||
- References No definition available.
|
X | ||||||||||
- 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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X | ||||||||||
- References No definition available.
|
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
|
X | ||||||||||
- Definition Amount of expense or loss included in net income that result in no cash flow, classified as other. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition The cash outflow for loan and debt issuance costs. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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X | ||||||||||
- Definition The cash outflow to acquire asset without physical form usually arising from contractual or other legal rights, excluding goodwill. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- 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
|
X | ||||||||||
- Definition Amount of cash inflow from debt classified as other. 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 Amount of expense (reversal of expense) for expected credit loss on accounts receivable. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
|
X | ||||||||||
- Definition Amount of cash outflow for the payment of debt classified as other, maturing after one year or the operating cycle, if longer. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition Amount of noncash expense for share-based payment arrangement. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
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- References No definition available.
|
THE COMPANY |
6 Months Ended |
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Jun. 30, 2019 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
THE COMPANY |
NOTE
1 – THE COMPANY
TherapeuticsMD, Inc., a Nevada
corporation, or TherapeuticsMD or the Company, has three wholly
owned subsidiaries, vitaMedMD, LLC, a Delaware limited liability company, or VitaMed; BocaGreenMD, Inc., a Nevada
corporation, or BocaGreen; and VitaCare Prescription Services, Inc., a Florida corporation, or VitaCare. Unless the context
otherwise requires, TherapeuticsMD, VitaMed, BocaGreen, and VitaCare collectively are sometimes referred to as “our
company,” “we,” “our,” or “us.”
Nature of Business We are a women’s healthcare company focused on creating and commercializing innovative products to support the lifespan of women and championing awareness of women’s healthcare issues, specifically, for pregnancy prevention, pregnancy, childbirth, nursing, pre-menopause, and menopause. At TherapeuticsMD, we combine entrepreneurial spirit, clinical expertise, and business leadership to develop and commercialize health solutions that enable new standards of care for women. Our solutions range from advanced hormone therapy pharmaceutical products to patient-controlled, long-acting contraceptive. We also manufacture and distribute branded and generic prescription prenatal vitamins under the vitaMedMD® and BocaGreenMD® brands.
With our SYMBODA™ technology, we are developing and commercializing advanced hormone therapy pharmaceutical products to enable delivery of bio-identical hormones through a variety of dosage forms and administration routes. Our track record of commercialization allows us to efficiently leverage and grow our marketing and sales organization to commercialize our recently approved products.
During 2018 , U.S. Food and Drug Administration, or FDA, approval of our drugs has transitioned our company from predominately focused on conducting research and development to one focused on commercializing our drugs. In July 2018, we launched our FDA-approved product, IMVEXXY® (estradiol vaginal inserts) for the treatment of moderate-to-severe dyspareunia (vaginal pain associated with sexual activity), a symptom of vulvar and vaginal atrophy, or VVA, due to menopause. In April 2019, we launched BIJUVA®, our hormone therapy combination of bio-identical 17 ß-estradiol and bio-identical progesterone in a single, oral softgel capsule, for the treatment of moderate-to-severe vasomotor symptoms, or VMS, due to menopause in women with a uterus. We are also focused on commercialization activities necessary for launch of ANNOVERA™ (segesterone acetate/ethinyl estradiol vaginal system), the first and only patient-controlled, procedure-free, reversible prescription contraceptive that can prevent unintended pregnancy for up to a full year, which was approved by the FDA on August 10, 2018. On July 30, 2018, we entered into a license and supply agreement with Knight Therapeutics Inc., or Knight, pursuant to which we granted Knight an exclusive license to commercialize IMVEXXY and BIJUVA in Canada and Israel. In addition, on July 30, 2018, we entered into an exclusive license agreement, or the Council License Agreement, with the Population Council, Inc., or the Population Council, to commercialize ANNOVERA in the U.S. On June 6, 2019, we entered into an exclusive license and supply agreement with Theramex HQ UK Limited, or Theramex, a leading, global specialty pharmaceutical company dedicated to women’s health, to commercialize BIJUVA and IMVEXXY outside of the U.S., excluding Canada and Israel.
|
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- Definition The entire disclosure for the nature of an entity's business, major products or services, principal markets including location, and the relative importance of its operations in each business and the basis for the determination, including but not limited to, assets, revenues, or earnings. For an entity that has not commenced principal operations, disclosures about the risks and uncertainties related to the activities in which the entity is currently engaged and an understanding of what those activities are being directed toward. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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- References No definition available.
|
BASIS OF PRESENTATION AND RECENTLY ISSUED ACCOUNTING PRONOUNCEMENTS |
6 Months Ended |
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Basis Of Presentation And Recently Issued Accounting Pronouncements | |
BASIS OF PRESENTATION AND RECENTLY ISSUED ACCOUNTING PRONOUNCEMENTS |
NOTE 2 – BASIS OF PRESENTATION AND RECENTLY ISSUED ACCOUNTING PRONOUNCEMENTS Interim Financial Statements The accompanying unaudited interim consolidated financial statements of TherapeuticsMD, Inc., which include our wholly owned subsidiaries, should be read in conjunction with the audited consolidated financial statements and notes thereto included in our Annual Report on Form 10-K for the year ended December 31, 2018, as filed with the Securities and Exchange Commission, or the SEC, from which we derived the accompanying consolidated balance sheet as of December 31, 2018. The accompanying unaudited interim consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America, or GAAP, for interim financial information and with the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, since they are interim statements, the accompanying unaudited interim consolidated financial statements do not include all of the information and notes required by GAAP for complete financial statements. The accompanying unaudited interim consolidated financial statements reflect all adjustments, consisting of normal recurring adjustments, that are, in the opinion of our management, necessary to a fair statement of the results for the interim periods presented. Interim results are not necessarily indicative of results for a full year or any other interim period in the future. Recently Issued Accounting Pronouncements In August 2018, the Financial Accounting Standards Board, or the FASB, issued Accounting Standards Update, or ASU, 2018-13 which eliminates certain disclosure requirements for fair value measurements for all entities, requires public entities to disclose certain new information and modifies some disclosure requirements. The FASB developed the amendments to ASC 820 as part of its broader disclosure framework project, which aims to improve the effectiveness of disclosures in the notes to financial statements by focusing on requirements that clearly communicate the most important information to users of the financial statements. The new guidance is effective for all entities for fiscal years beginning after December 15, 2019 and for interim periods within those fiscal years. An entity is permitted to early adopt either the entire standard or only the provisions that eliminate or modify requirements. We are currently evaluating the effect of this guidance on our disclosures.
In June 2018, the FASB issued ASU 2018 -07 to simplify the accounting for share-based payments to nonemployees by aligning it with the accounting for share-based payments to employees, with certain exceptions. The new guidance expands the scope of ASC 718 to include share-based payments granted to nonemployees in exchange for goods or services used or consumed in an entity’s own operations and supersedes the guidance in ASC 505-50. The guidance is effective for public business entities in annual periods beginning after December 15, 2018, and interim periods within those annual periods. Early adoption is permitted, including in an interim period for which financial statements have not been issued, but not before an entity adopts ASC 606. We adopted this standard on January 1, 2019 and the adoption of this standard did not have a material effect on our consolidated financial statements.
In February 2016, the FASB issued ASU 2016 -02 , Leases. This guidance requires lessees to record most leases on their balance sheets while recognizing expenses on their income statements in a manner similar to current accounting. The guidance also eliminates current real estate-specific provisions for all entities. For lessors, the guidance modifies the classification criteria and the accounting for sales-type and direct financing leases. The standard is effective for public business entities for annual periods beginning after December 15, 2018, and interim periods within those years. Early adoption is permitted for all entities. In July 2018, the FASB amended the new leases standard and issued ASU 2018 -11 , Leases, (Topic 842): Targeted Improvements to give entities another option for transition and to provide lessors with a practical expedient. We adopted ASU 2016 -02 on January 1, 2019 utilizing the alternative transition method allowed for under ASU 2018 -11 and we recorded a $3.8 million right of use asset and a $4.1 million liability related to adoption of this standard. Comparative financial information was not adjusted and will continue to be reported under ASC 840. We also elected the transition relief package of practical expedients and as a result we did not assess ( 1 ) whether existing or expired contracts contain leases, ( 2 ) lease classification for any existing or expired leases, and ( 3 ) whether lease origination costs qualified as initial direct costs. We elected the short-term lease practical expedient by establishing an accounting policy to exclude leases with a term of 12 months or less. We elected not to separate lease components from non-lease components for our specified asset classes. Additionally, the adoption of the new standard resulted in increased disclosure requirements in our quarterly and annual filings.
Other recent accounting pronouncements issued by the FASB (including its Emerging Issues Task Force), the American Institute of Certified Public Accountants and the SEC did not, and are not expected to, have a material effect on our results of operations or financial position.
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- References No definition available.
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- Definition The entire disclosure of the basis of accounting and adoption of new accounting pronouncements, that describes the new methods, amount and effects on financial statement line items. No definition available.
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SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES |
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Accounting Policies [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES |
NOTE 3 – SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES Fair Value of Financial Instruments Our financial instruments consist primarily of cash, accounts receivable, accounts payable, accrued expenses and long-term debt. The carrying amount of cash, accounts receivable, accounts payable and accrued expenses approximates their fair value because of the short-term maturity of such instruments, which are considered Level 1 assets under the fair value hierarchy. The carrying amount for long-term debt as of June 30, 2019 (as disclosed in Note 9), approximates fair value based on market activity for other debt instruments with similar characteristics and comparable risk (Level 2).
We categorize our assets and liabilities that are valued at fair value on a recurring basis into a three-level fair value hierarchy as defined by Accounting Standards Codification, or ASC, 820,
Fair Value Measurements. The fair value hierarchy gives the highest priority to quoted prices in active markets for identical assets and liabilities (Level 1) and lowest priority to unobservable inputs (Level 3). Assets and liabilities recorded in the consolidated balance sheet at fair value are categorized based on a hierarchy of inputs, as follows:
At June 30, 2019 and 2018, we had no assets or liabilities that were valued at fair value on a recurring basis.
The fair value of indefinite-lived assets or long-lived assets is measured on a non-recurring basis using significant unobservable inputs (Level 3) in connection with the Company’s impairment test on an annual basis.
Trade Accounts Receivable and Allowance for Doubtful Accounts Trade accounts receivable are customer obligations due under normal trade terms. We review accounts receivable for uncollectible accounts and credit card chargebacks and provide an allowance for doubtful accounts, which is based upon a review of outstanding receivables, historical collection information, and existing economic conditions. We consider trade accounts receivable past due for more than 90 days to be delinquent. We write off delinquent receivables against our allowance for doubtful accounts based on individual credit evaluations, the results of collection efforts, and specific circumstances of customers. We record recoveries of accounts previously written off when received as an increase in the allowance for doubtful accounts. To the extent data we use to calculate these estimates does not accurately reflect bad debts, adjustments to these reserves may be required. Revenue Recognition We adopted ASC 606 on January 1, 2018 using the modified retrospective method for all contracts not completed as of the date of adoption. ASC 606 states that a contract is considered “completed” if all (or substantially all) of the revenue was recognized in accordance with revenue guidance that was in effect before the date of initial application. Because all (or substantially all) of the revenue related to sales of our products has been recognized under ASC 605 prior to the date of initial application of the new standard, the contracts are considered completed under ASC 606. Based on our evaluation of ASC 606, we concluded that a cumulative adjustment was not necessary upon implementation of ASC 606 on January 1, 2018. In accordance with ASC 606, revenue is recognized when a customer obtains control of promised goods or services. The amount of revenue recognized reflects the consideration to which we expect to be entitled to receive in exchange for these goods or services. The provisions of ASC 606 include a five-step process by which we determine revenue recognition, depicting the transfer of goods or services to customers in amounts reflecting the payment to which we expect to be entitled in exchange for those goods or services. ASC 606 requires us to apply the following steps: (1) identify the contract with the customer; (2) identify the performance obligations in the contract; (3) determine the transaction price; (4) allocate the transaction price to the performance obligations in the contract; and (5) recognize revenue when, or as, we satisfy the performance obligation.
Prescription Products As of June 30, 2019, our products consisted primarily of prescription vitamins and our FDA-approved products: IMVEXXY, which we began selling during the third quarter of 2018, and BIJUVA, which we began selling in the second quarter of 2019. We sell our name brand and generic prescription products primarily through wholesale distributors and retail pharmacies. We have one performance obligation related to prescription products sold through wholesale distributors, which is to transfer promised goods to a customer, and two performance obligations related to products sold through retail pharmacies, which are to: (1) transfer promised goods and (2) provide customer service for an immaterial fee. We treat shipping as a fulfillment activity rather than as a separate obligation. We recognize prescription revenue only when we satisfy performance obligations by transferring a promised good or service to a customer. A good or service is considered to be transferred when the customer receives the goods or service or obtains control. Control refers to the customer’s ability to direct the use of, and obtain substantially all of the remaining benefits from, an asset. In consignment arrangements, control of the product is transferred at the point in time when the goods are removed from consignment stock and sold to the end customer. We typically satisfy our performance obligations and recognize revenue at a point in time, generally when products are shipped to the customer, depending on the terms underlying each arrangement. In circumstances where our products are on consignment, revenue is generally recognized when the prescription is filled.
Based on our contracts, we invoice customers once our performance obligations have been satisfied, at which point payment is unconditional. We disclose receivables from contracts with customers separately in the statement of financial position. Payment for goods or services sold by us is typically due between 30 and 60 days after an invoice is sent to the customer.
The transaction price of a contract is the amount of consideration which we expect to be entitled to in exchange for transferring promised goods or services to a customer. Prescription products are sold at fixed wholesale acquisition cost, or WAC, determined based on our list price. However, the total transaction price is variable as it is calculated net of estimated product returns, chargebacks, rebates, coupons, discounts and wholesaler fees. These estimates are based on the amounts earned or to be claimed on the related sales and are classified as reductions of accounts receivable (if the amount is payable to the customer) or a current liability (if the amount is payable to a party other than a customer). In order to determine the transaction price, we estimate the amount of variable consideration at the outset of the contract either utilizing the expected value or most likely amount method, depending on the facts and circumstances relative to the contract or each variable consideration. The estimated amount of variable consideration is included in the transaction price only to the extent that it is probable that a significant reversal in the amount of cumulative revenue recognized will not occur when the uncertainty associated with the variable consideration is subsequently resolved. In determining amounts of variable consideration to include in a contract’s transaction price, we rely on our historical experience and other evidence that supports our qualitative assessment of whether revenue would be subject to a significant reversal. We consider all the facts and circumstances associated with both the risk of a revenue reversal arising from an uncertain future event and the magnitude of the reversal if that uncertain event were to occur. Actual amounts of consideration ultimately received may differ from our estimates. If actual results in the future vary from our original estimates, we will adjust these estimates, which would affect net product revenue and earnings in the period such changes in estimates become known.
We accept returns of unsalable
prescription products sold through wholesale distributors within a return period of
six months prior to and up to 12 months
following product expiration. Our prescription products currently have a shelf life of 24 months
from the date of manufacture. We do not allow product returns for prescription products that have been dispensed to a
patient. We estimate the amount of our product sales that may be returned by our customers and record this estimate as a
reduction of revenue in the period the related product revenue is recognized. Where historical rates of return exist, we use
history as a basis to establish a returns reserve for products shipped to wholesalers. For our newly launched products, for
which the right of return exists but for which we currently do not have history of product returns, we estimate returns based
on available industry data, our own sales information and our visibility into the inventory remaining in the distribution
channel. At the end of each reporting period, we may decide to constrain revenue for product returns based on information
from various sources, including channel inventory levels and dating and sell-through data, the expiration dates of products
currently being shipped, price changes of competitive products and any introductions of generic products. We recognize the
amount of expected returns as a refund liability, representing the obligation to return the customer’s consideration.
Since our returns primarily consist of expired and short dated products that will not be resold, we do not record a return
asset for the right to recover the goods returned by the customer at the time of the initial sale (when recognition of
revenue is deferred due to the anticipated return). Return estimates are recorded in the accrued expenses and other current
liabilities on the consolidated balance sheet.
We offer various rebate and discount programs in an effort to maintain a competitive position in the marketplace and to promote sales and customer loyalty. We estimate the allowance for consumer rebates and coupons that we have offered based on our experience and industry averages, which is reviewed, and adjusted if necessary, on a quarterly basis. Estimates relating to these rebates and coupons are deducted from gross product revenues at the time the revenues are recognized. We record distributor fees based on amounts stated in contracts. Rebate and coupon estimates and distributor fees are recorded in accrued expenses and other current liabilities on the consolidated balance sheet. We estimate chargebacks based on number of units sold during the period taking into account prices stated in contracts and our historical experience. Estimates related to distributors fees, rebates, coupons and returns are disclosed in Note 8. We provide invoice discounts to our customers for prompt payment. Estimates relating to invoice discounts and chargebacks are deducted from gross product revenues at the time the revenues are recognized.
As part of the commercial launch for IMVEXXY during the third quarter of 2018 and for BIJUVA in the second quarter of 2019, we introduced a co-pay assistance program where eligible enrolled patients do not pay more than $35 for prescription fills. This allows patients to access the product at a reasonable cost regardless of insurance coverage. We reimburse pharmacies for this discount through third-party vendors. We consider these payments as consideration paid to the customer and reflect such payments as a reduction of the transaction price as we do not receive a distinct good or service related to these payments. The variable consideration is estimated based on contract prices, the estimated percentage of patients that will utilize the copay assistance, the average assistance paid, the estimated levels of inventory in the distribution channel and the current level of prescriptions covered by patients’ insurance. Payers may change coverage levels for IMVEXXY or BIJUVA positively or negatively, at any time up to the time that we have formally contracted coverage with the payer. As such, the net transaction price of IMVEXXY and BIJUVA is susceptible to such changes in coverage levels, which are outside the influence of the Company. As a result, we constrain revenue recognized for IMVEXXY and BIJUVA to an amount that will not result in a significant revenue reversal in future periods. Our ability to estimate the net transaction price for IMVEXXY and BIJUVA is constrained by our estimates of the amount to be paid for the co-pay assistance program for IMVEXXY and BIJUVA which is directly related to the level of prescriptions paid for by insurance. As such, we record an accrual to reduce gross sales for the estimated co-pay and other patient assistance based on currently available third-party data and our internal analyses. We re-evaluate any constraint each reporting period.
Disaggregation of revenue The following table provides information about disaggregated revenue by product mix for the three and six months ended June 30, 2019 and 2018:
Share-Based Compensation We measure the compensation costs of share-based compensation arrangements based on the grant-date fair value and recognize the costs in the financial statements over the period during which employees are required to provide services. Share-based compensation arrangements include options, restricted stock, restricted stock units, performance-based awards, share appreciation rights, and employee share purchase plans. We amortize such compensation amounts, if any, over the respective service periods of the award. We use the Black-Scholes-Merton option pricing model, or the Black-Scholes Model, an acceptable model in accordance with ASC 718, Compensation-Stock Compensation, to value options. Option valuation models require the input of assumptions, including the expected life of the stock-based awards, the estimated stock price volatility, the risk-free interest rate, and the expected dividend yield. The risk-free interest rate assumption is based upon observed interest rates on zero coupon U.S. Treasury bonds whose maturity period is appropriate for the term of the instrument. Estimated volatility is a measure of the amount by which our stock price is expected to fluctuate each year during the term of the award. Prior to January 1, 2017, the expected volatility of share options was estimated based on a historical volatility analysis of peer entities whose stock prices were publicly available that were similar to the Company with respect to industry, stage of life cycle, market capitalization, and financial leverage. On January 1, 2017, we began using our own stock price in our volatility calculation along with the other peer entities whose stock prices were publicly available that were similar to our company and in 2019 we started using only our own stock price in the volatility calculation. Our calculation of estimated volatility is based on historical stock prices over a period equal to the expected term of the awards. The average expected life is based on the contractual terms of the stock option using the simplified method. We utilize a dividend yield of zero based on the fact that we have never paid cash dividends and have no current intention to pay cash dividends. Calculating share-based compensation expense requires the input of highly subjective judgment and assumptions, estimates of expected life of the share-based award, stock price volatility and risk-free interest rates. The assumptions used in calculating the fair value of share-based awards represent our best estimates, but these estimates involve inherent uncertainties and the application of management judgment. As a result, if factors change and we use different assumptions, our share-based compensation expense could be materially different in the future. We recognize the compensation expense for share-based compensation granted based on the grant date fair value estimated in accordance with ASC 718. We generally recognize the compensation expense on a straight-line basis over the employee’s requisite service period. Effective January 1, 2017, we account for forfeitures when they occur.
On January 1, 2019, we adopted ASU 2018-07 which simplified the accounting for share-based payments to nonemployees by aligning it with the accounting for share-based payments to employees, with certain exceptions. The new guidance expanded the scope of ASC 718 to include share-based payments granted to nonemployees in exchange for goods or services used or consumed in an entity’s own operations and superseded the guidance in ASC 505-50. Prior to January 1, 2019, equity instruments issued to non-employees were recorded on a fair value basis, as required by ASC 505, Equity - Based Payments to Non-Employees.
Research and Development Expenses Research and development, or R&D, expenses include internal R&D activities, services of external contract research organizations, or CROs, costs of their clinical research sites, manufacturing, scale-up and validation costs, and other activities. Internal R&D activity expenses include laboratory supplies, salaries, benefits, and non-cash share-based compensation expenses. CRO activity expenses include preclinical laboratory experiments and clinical trial studies. Other activity expenses include regulatory consulting and legal fees and costs. The activities undertaken by our regulatory consultants that were classified as R&D expenses include assisting, consulting with, and advising our in-house staff with respect to various FDA submission processes, clinical trial processes, and scientific writing matters, including preparing protocols and FDA submissions. Legal activities that were classified as R&D expenses include professional research and advice regarding R&D, patents and regulatory matters. These consulting and legal expenses were direct costs associated with preparing, reviewing, and undertaking work for our clinical trials and investigative drugs. We charge internal R&D activities and other activity expenses to operations as incurred. We make payments to CROs based on agreed-upon terms, which may include payments in advance of a study starting date. We expense nonrefundable advance payments for goods and services that will be used in future R&D activities when the activity has been performed or when the goods have been received rather than when the payment is made. We review and accrue CRO expenses and clinical trial study expenses based on services performed and rely on estimates of those costs applicable to the completion stage of a study as provided by CROs. Estimated accrued CRO costs are subject to revisions as such studies progress to completion. We charge revisions expense in the period in which the facts that give rise to the revision become known.
Segment Reporting We are managed and operated as one business, which is focused on creating and commercializing products targeted exclusively for women. Our business operations are managed by a single management team that reports to the President of our company. We do not operate separate lines of business with respect to any of our products and we do not prepare discrete financial information with respect to separate products. All product sales are derived from sales in the United States. Accordingly, we view our business as one reportable operating segment.
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- References No definition available.
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- Definition The entire disclosure for all significant accounting policies of the reporting entity. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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INVENTORY |
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INVENTORY |
NOTE 4 – INVENTORY
Inventory consists of the following:
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- References No definition available.
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- Definition The entire disclosure for inventory. Includes, but is not limited to, the basis of stating inventory, the method of determining inventory cost, the classes of inventory, and the nature of the cost elements included in inventory. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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OTHER CURRENT ASSETS |
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Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
OTHER CURRENT ASSETS | NOTE 5 – OTHER CURRENT ASSETS Other current assets consist of the following:
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- References No definition available.
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- Definition The entire disclosure for other current assets. No definition available.
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FIXED ASSETS, NET |
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Property, Plant and Equipment [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
FIXED ASSETS, NET |
NOTE 6 – FIXED ASSETS, NET Fixed assets, net consist of the following:
Depreciation expense for the three months ended June 30, 2019 and 2018 was $66,556 and $40,777 , respectively, and for the six months ended June 30, 2019 and 2018 was $133,049 and $79,201 , respectively.
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- References No definition available.
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Intangible Assets, Net (Excluding Goodwill) [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
INTANGIBLE ASSETS |
NOTE 7 – INTANGIBLE ASSETS The following table sets forth the gross carrying amount, accumulated amortization and net carrying amount of our intangible assets as of June 30, 2019 and December 31, 2018:
We capitalize external costs, consisting primarily of legal costs, related to securing our patents and trademarks. Once a patent is granted, we amortize the approved hormone therapy drug candidate patents using the straight-line method over the estimated useful life of approximately20 years, which is the life of intellectual property patents. If the patent is not granted, we write-off any capitalized patent costs at that time. Trademarks are perpetual and are not amortized. During the six months ended June 30, 2019, we wrote off $78,864 in costs related to trademarks and patents, including the net carrying amount of the OPERA patent.
As of June 30, 2019, we had 26 issued domestic, or U.S., patents and 27 issued foreign patents, including:
Amortization expense was $48,503 and $24,826 for the three months ended June 30, 2019 and 2018, respectively and $88,948 and $46,023 for the six months ended June 30, 2019 and 2018, respectively. Estimated amortization expense for the next five years for the patent costs currently being amortized is as follows:
License Agreement with the Population Council On July 30, 2018, we entered into the Council License Agreement to commercialize in the U.S. ANNOVERA. We currently estimate that ANNOVERA will be commercially available as early as the third quarter of 2019 with a planned full commercial launch by the first quarter of 2020.
Under the terms of the Council License
Agreement, we paid the Population Council a milestone payment of $20,000,000 within
30 days following approval by the FDA of the NDA for ANNOVERA and will be required to pay the Population Council
$20,000,000 within
30 days following the release of the first commercial batch of ANNOVERA. The Population Council is also eligible to receive
milestone payments and royalties from commercial sales of ANNOVERA. We will assume responsibility for marketing expenses
related to the commercialization of ANNOVERA. The milestone payment of $20,000,000 upon
the FDA’s approval of ANNOVERA in the third quarter of 2018 was recorded as a finite-lived intangible asset in the
consolidated balance sheet and will be amortized on a straight-line basis once it becomes available for use which is expected
to be upon release of first commercial batch of ANNOVERA. In addition, we are required to pay the Population Council, on a
quarterly basis, step-based royalty payments based on annual net sales of ANNOVERA in the U.S. by the Company and its
affiliates and permitted licensees as follows: (i) if annual net sales are less than or equal to $50,000,000 ,
a royalty of 5 %
of net sales; (ii) for annual net sales greater than $50,000,000 and
less than or equal to $150,000,000 ,
a royalty of 10 %
of such net sales; and (iii) for net sales greater than $150,000,000 ,
a royalty of 15 %
of such net sales. The annual royalty rate will be reduced to 50 %
of the initial rate during the six-month period beginning on the date of the first arms-length commercial sale of a generic
equivalent of the one-year vaginal contraceptive system that is launched by a third party in the U.S., and thereafter will be
reduced to 20 %
of the initial rate. The Population Council has agreed to perform and pay the costs and expenses associated with four
post-approval studies required by the FDA for ANNOVERA and we have agreed to perform and pay the costs and expenses
associated with a post approval study required by the FDA to measure risk for venous thromboembolism, provided that if the
costs and expenses associated with such post-approval study exceed $20,000,000, half of such excess will be offset against
royalties or other payments owed by us to the Population Council under the Council License Agreement. We and the Population
Council have agreed to form a joint product committee responsible for overseeing activities under the Council License
Agreement. We will be responsible for all aspects of promotion, product positioning, pricing, education programs,
publications, sales messages and any additional desired clinical studies for the one-year vaginal contraceptive system,
subject to oversight and decisions made by the joint product committee. The Council License Agreement includes exclusive
rights for us to negotiate co-development of two other investigational vaginal contraceptive systems in development by the
Population Council.
We assess our intangible assets for impairment if indicators are present or changes in circumstance suggest that impairment may exist. If impairment indicators are present or changes in circumstance suggest that impairment may exist, we perform a recoverability test by comparing the sum of the estimated undiscounted cash flows of each intangible asset to its carrying value on the consolidated balance sheet. If the undiscounted cash flows used in the recoverability test are less than the carrying value, we would determine the fair value of the intangible asset and recognize an impairment loss if the carrying value of the intangible asset exceeds its fair value. We also evaluate the remaining useful life of intangible assets subject to amortization on a periodic basis to determine whether events and circumstances would indicate impairment or warrant a revision to the remaining useful life. If the estimate of an intangible asset’s remaining useful life is changed, we will amortize the remaining carrying value of the intangible asset prospectively over the revised remaining useful life.
License Agreement with Knight Therapeutics Inc. On July 30, 2018, we entered into a license and supply agreement, or the Knight License Agreement, with Knight pursuant to which we granted Knight an exclusive license to commercialize IMVEXXY and BIJUVA in Canada and Israel. Pursuant to the terms of the Knight License Agreement, Knight will pay us a milestone fee upon first regulatory approval in Canada of each of IMVEXXY and BIJUVA, sales milestone fees based upon certain aggregate annual sales in Canada and Israel of each of IMVEXXY and BIJUVA and royalties based on aggregate annual sales of each of IMVEXXY and BIJUVA in Canada and Israel. Knight will be responsible for all regulatory and commercial activities in Canada and Israel related to IMVEXXY and BIJUVA. We may terminate the Knight License Agreement if Knight does not submit all regulatory applications, submissions and/or registrations required for regulatory approval to use and commercialize IMVEXXY and BIJUVA in Canada and Israel within certain specified time periods. We also may terminate the Knight License Agreement if Knight challenges our patents. Either party may terminate the Knight License Agreement for any material breach by the other party that is not cured within certain specified time periods or if the other party files for bankruptcy or other related matters. In connection with the Knight License Agreement, Knight entered into a subscription agreement with us, pursuant to which Knight purchased3,921,568 shares of our Common Stock concurrent with the closing of the underwritten public offering of Common Stock at a price of $5.10 , for proceeds of $20,000,000 , on August 6, 2018.
License Agreement with Theramex On June 6, 2019, we entered into an
exclusive license and supply agreement, or the License Agreement, with Theramex, a leading, global specialty pharmaceutical
company dedicated to women’s health, to commercialize BIJUVA and IMVEXXY outside of the U.S., excluding Canada and
Israel, or the Territory. Under the terms of the License Agreement, Theramex paid us EUR14 million
in cash as an upfront fee on August 5, 2019. Within thirty days of signing License Agreement, we are required to provide
Theramex the regulatory materials and clinical data that are necessary for Theramex to obtain marketing authorizations and
other applicable regulatory approvals for commercializing BIJUVA and IMVEXXY. The revenue related to fees received by us will
be recognized once our performance obligations have been satisfied. We are eligible to receive additional milestone payments
comprised of (i) up to an aggregate of EUR 2 million
in regulatory milestone payments based on regulatory approvals for BIJUVA and IMVEXXY in certain specified markets and (ii)
up to an aggregate of EUR 27.5 million
in sales milestone payments to be paid in escalating tranches based on Theramex first attaining certain aggregate annual net
sales milestones of BIJUVA and IMVEXXY in the Territory ranging from EUR 25 million
to EUR100 million.
We are also entitled to receive quarterly royalty payments on net sales of BIJUVA and IMVEXXY in the Territory. Theramex will
be responsible for all regulatory and commercial activities for BIJUVA and IMVEXXY in the Territory. Theramex may sublicense
its rights to commercialize BIJUVA and IMVEXXY in the Territory, except for certain specified markets. We may terminate the
License Agreement if Theramex does not submit all regulatory applications, submissions and/or registrations required for
regulatory approval to use and commercialize BIJUVA and IMVEXXY within certain specified time periods. We also may terminate
the License Agreement if Theramex challenges our patents. Either party may terminate the License Agreement for any material
breach by the other party that is not cured within certain specified time periods or if the other party files for bankruptcy
or other related matters.
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OTHER CURRENT LIABILITIES |
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OTHER CURRENT LIABILITIES |
NOTE 8 – OTHER CURRENT LIABILITIES Other current liabilities consist of the following:
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DEBT |
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Debt Disclosure [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||
DEBT |
NOTE 9 – DEBT On April 24, 2019, we entered into a
Financing Agreement, or the Financing Agreement, with TPG Specialty Lending, Inc., as administrative agent, or the
Administrative Agent, various lenders from time to time party thereto, and certain of the Company’s subsidiaries party
thereto from time to time as guarantors, which provides us with a $300,000,000 first
lien secured term loan credit facility, or the Facility. The Facility provides for availability to us in three tranches:
(i) $200,000,000 was
drawn upon entering into the Financing Agreement; (ii) $50,000,000 will
be available to us upon the designation of our ANNOVERA product as a new category of birth control by the FDA on or prior to
December 31, 2019 and satisfaction (or waiver) of other customary conditions precedent; and (iii) $50,000,000 will
be available to us upon our achieving $11,000,000 in
net revenues, as defined in the Financing Agreement, from our IMVEXXY, BIJUVA and ANNOVERA products for the fourth quarter of
2019 and satisfaction (or waiver) of other customary conditions precedent. Borrowings under the Facility accrue interest at
either (i)3-month
LIBOR plus7.75%,
subject to a LIBOR floor of 2.70%
or (ii) the
prime rate plus6.75%,
subject to a prime rate floor of 5.20%,
as selected by us. Interest on amounts borrowed under the Facility will be payable quarterly. The outstanding principal
amount of the Facility is payable in four equal quarterly installments beginning on June 30, 2023, with the Facility maturing
on March 31, 2024. We have the right to prepay borrowings under the Facility in whole or in part at any time, subject to a
prepayment fee on the principal amount being prepaid of (i)30.0%
for the first two years following the initial funding date of the applicable borrowing, (ii)5.0%
for the third year following the initial funding date of the applicable borrowing, (iii)3.0%
for the fourth year following the initial funding date of the applicable borrowing and (iv)1.0%
for the fifth year following the initial funding date of the applicable borrowing but prior to March 31, 2024. In connection
with the initial borrowing under the Facility, we paid, for the benefit of the lenders, a facility fee equal to 2.5%
of the initial amount borrowed and will be required to pay such a facility fee in connection with any subsequent borrowings
under the Facility. We are also required to pay the Administrative Agent and the lenders an annual administrative fee in
addition to other fees and expenses. The Financing Agreement contains customary mandatory prepayments, restrictions and
covenants applicable to us that are customary for financings of this type. Among other requirements, we are required to (i)
maintain a minimum unrestricted cash balance of $50,000,000,
which will increase to $60,000,000 if
we draw either the second or third tranche of the Facility, and (ii) achieve certain minimum consolidated net revenue amounts
attributable to commercial sales of our IMVEXXY, BIJUVA and ANNOVERA products beginning with the fiscal quarter ending
December 31, 2020. The Financing Agreement also includes other representations, warranties, indemnities and events of default
that are customary for financings of this type, including an event of default relating to a change of control of the Company.
Upon or after an event of default, the Administrative Agent and the lenders may declare all or a portion of our obligations
under the Financing Agreement to be immediately due and payable and exercise other rights and remedies provided for under the
Financing Agreement. The obligations of our company and its subsidiaries under the Financing Agreement are secured, subject
to customary permitted liens and other agreed upon exceptions, by a first priority perfected security interest in all
existing and after-acquired assets of our company and its subsidiaries. The obligations under the Financing Agreement will be
guaranteed by each of our future direct and indirect subsidiaries, subject to certain exceptions.
On May 1, 2018, we entered into a Credit and Security Agreement, or the Credit Agreement, with MidCap Financial Trust, or MidCap, as agent, or Agent, and as lender, and the additional lenders party thereto from time to time (together with MidCap as a lender, the Lenders), as amended. The Credit Agreement provided a secured term loan facility in an aggregate principal amount of up to $200,000,000, or the Term Loan. Under the terms of the Credit Agreement, the Term Loan was available to be made in three separate tranches, with each tranche to be made available to us, at our option, upon our achievement of certain milestones. Amounts borrowed under the Term Loan bore interest at a rate equal to the sum of (i) one-month LIBOR (subject to a LIBOR floor of1.50%) plus (ii)7.75% per annum.
On April 24, 2019, we terminated
the Credit Agreement. A portion of the initial tranche of borrowing under the Financing Agreement in the amount of
approximately $81,661,000 was
used to repay all amounts outstanding under the Credit Agreement, which included a prepayment fee of 4%,
a repayment fee of 4%
and other fees and expenses payable to the lenders under the Credit Agreement. As a result of the termination of the
Credit Agreement, we recorded $10,057,632 in
loss on extinguishment of debt in the accompanying unaudited consolidated financial statements. Interest on amounts
borrowed under the Term Loan was due and payable monthly in arrears. Interest expense for the six months ending June 30, 2019
related to the Credit Agreement was $1,816,747.
During the six months ended June 30, 2019, and prior to the repayment of the Credit Agreement, we amortized $120,146 of
deferred financing fees as interest expense in the accompanying unaudited consolidated financial statements.
As of June 30, 2019, we had
$200,000,000 in
borrowings outstanding under the Financing Agreement, which are classified as long-term debt in the accompanying unaudited
consolidated financial statements. We incurred $6,652,270 in
deferred financing fees related to the Financing Agreement. Deferred financing fees related to the entire Financing Agreement
have been allocated pro rata between the funded and unfunded portions of each tranche. Allocated deferred financing fees
related to Tranche 1 of $6,101,513 have
been reflected as a debt discount and are accreted to interest expense using the effective interest method. Deferred
financing fees associated with unfunded tranches were deferred as assets until the Tranche 2 and Tranche 3 milestones have
been met. As of June 30, 2019, deferred financing fees related to Tranche 2 and Tranche 3 were included in other current
assets in the accompanying consolidated financial statements. During both the three and six months ended June 30, 2019, we
amortized $196,734 of
deferred financing fees related to Tranche 1 as interest expense in the accompanying unaudited consolidated financial
statements. Interest on amounts borrowed under the Financing Agreement is due and payable quarterly in arrears. Interest
expense for both the three and six months ending June 30, 2019 was $3,985,000.
The overall effective interest rate under the Financing Agreement was approximately 11%
as of June 30, 2019. As of June 30, 2019 and December 31, 2018, the carrying value of debt consisted of the following:
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NET LOSS PER SHARE |
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Loss per share, basic and diluted: | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
NET LOSS PER SHARE |
NOTE 10– NET LOSS PER SHARE We calculate earnings per share, or EPS, in accordance with ASC 260, Earnings Per Share, which requires the computation and disclosure of two EPS amounts: basic and diluted. We compute basic EPS based on the weighted-average number of shares of common stock, par value $0.001 per share, or Common Stock, outstanding during the period. We compute diluted EPS based on the weighted-average number of shares of our Common Stock outstanding plus all potentially dilutive shares of our Common Stock outstanding during the period. Such potentially dilutive shares of our Common Stock consist of options, warrants and restricted stock awards and were excluded from the calculation of diluted earnings per share because their effect would have been antidilutive due to the net loss reported by us. The table below presents potentially dilutive securities that could affect our calculation of diluted net loss per share allocable to common stockholders for the periods presented.
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STOCKHOLDERS' EQUITY |
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Stockholders' Equity: | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
STOCKHOLDERS' EQUITY |
NOTE 11 – STOCKHOLDERS’ EQUITY Preferred Stock At June 30, 2019, we had 10,000,000 shares
of preferred stock, par value $0.001 per share, authorized for issuance, of which no shares of preferred stock were issued or
outstanding.
Common Stock At June 30, 2019, we had 350,000,000 shares
of Common Stock authorized for issuance, of which 241,221,840 shares
of Common Stock were issued and outstanding.
Issuances During the Three and Six Months Ended June 30, 2019 During the three months ended June 30,
2019, no options to purchase shares of Common Stock were exercised. During the six months ended June 30, 2019, certain
individuals exercised stock options to purchase 276,383 shares
of Common Stock for $100,107 in
cash. Also, during the same period, stock options to purchase 12,097 shares
of Common Stock were exercised pursuant to the options’ cashless exercise provisions, wherein 11,834 shares
of Common Stock were issued.
Issuances During the Three and Six Months Ended June 30, 2018 During the three months ended June
30, 2018, certain individuals exercised stock options to purchase 249,785 shares
of Common Stock for $1,084,939 in
cash. During the six months ended June 30, 2018, certain individuals exercised stock options to purchase 394,576 shares
of Common Stock for $1,128,996 in
cash. Also, during the six months ended June 30, 2018, stock options to purchase 10,000 shares
of Common Stock were exercised pursuant to the options’ cashless exercise provisions, wherein 9,841 shares
of Common Stock were issued.
Warrants to Purchase Common Stock As of June 30, 2019, we had
warrants outstanding to purchase an aggregate of 1,832,571 shares
of Common Stock with a weighted-average contractual remaining life of approximately 2.5 years,
and exercise prices ranging from $0.24 to
$8.20 per
share, resulting in a weighted average exercise price of $2.62 per
share.
The valuation methodology used to determine the fair value of our warrants is the Black-Scholes Model. The Black-Scholes Model requires the use of a number of assumptions, including volatility of the stock price, the risk-free interest rate, dividend rate and the term of the warrant.
During the six months ended June
30, 2019, we granted warrants to purchase75,000 shares
of Common Stock to outside consultants at an exercise price of $5.63 .
The fair value for these warrants was determined by using the Black-Scholes Model on the date of the grant using a term of 5 years;
volatility of 60.8 %;
risk free rate of 2.52 %;
and dividend yield of 0 %.
The grant date fair value of the warrants was $3.00 per
share. The warrants are vesting ratably over a 12-month period and have an expiration date of February 12, 2024. During
the six months ended June 30, 2018, we granted warrants to purchase175,000 shares
of Common Stock to outside consultants at an exercise price of $5.16 .
The fair value for these warrants was determined by using the Black-Scholes Model on the date of the grant using a term of 5 years;
volatility of 62.1 %;
risk free rate of 2.36 %;
and dividend yield of 0 %.
The grant date fair value of the warrants was $2.79 per
share. The warrants vest ratably over a 12-month period and have an expiration date of March 15, 2023.
During the three months ended June 30, 2019 and 2018, we recorded $56,172 and $164,840 , respectively, and during the six months ended June 30, 2019 and 2018, we recorded $141,888 and $256,315 , respectively, as share based compensation expense in the accompanying consolidated financial statements related to warrants. As of June 30, 2019, total unrecognized estimated compensation expense related to the unvested portion of these warrants was approximately $139,000 , which is expected to be recognized over a weighted-average period of0.6 years.
During the three months ended June 30, 2019 and 2018, no warrants to purchase shares of Common Stock were exercised. During the six months ended June
30, 2019, warrants to purchase 1,250,000 shares
of Common Stock were exercised pursuant to the options’ cashless exercise provisions, wherein 471,184 shares
of Common Stock were issued. During the six months ended June 30, 2018, no warrants were exercised.
Options to Purchase Common Stock In 2009, we adopted the 2009 Long Term
Incentive Compensation Plan, or the 2009 Plan, to provide financial incentives to employees, directors, advisers, and
consultants of our company who are able to contribute towards the creation of or who have created stockholder value by
providing them stock options and other stock and cash incentives, or the Awards. The Awards available under the 2009 Plan
consist of stock options, stock appreciation rights, restricted stock, restricted stock units, performance stock, performance
units, and other stock or cash awards as described in the 2009 Plan. Generally, the options vest annually over four years or
as determined by our board of directors, upon each option grant. Options may be exercised by paying the price for shares or
on a cashless exercise basis after they have vested and prior to the specified expiration date provided and applicable
exercise conditions are met, if any. The expiration date is generally ten years from the date the option is issued. As of
June 30, 2019, there were non-qualified stock options to purchase 15,116,995 shares
of Common Stock outstanding under the 2009 Plan. Effective upon our adoption of the TherapeuticsMD, Inc. 2019 Stock Incentive
Plan, or the 2019 Plan, on June 20, 2019, no future awards may be made under the 2009 Plan.
In 2012, we adopted the 2012
Stock Incentive Plan, or the 2012 Plan, a non-qualified plan that was amended in August 2013. The 2012 Plan was designed to
serve as an incentive for retaining qualified and competent key employees, officers, directors, and certain consultants
and advisors of our company. The Awards available under the 2012 Plan consist of stock options, stock appreciation
rights, restricted stock, restricted stock units, performance stock, performance units, and other stock or cash awards as
described in the 2012 Plan. Generally, the options vest annually over four years or as determined by our board of directors,
upon each option grant. Options may be exercised by paying the price for shares or on a cashless exercise basis after they
have vested and prior to the specified expiration date provided and applicable exercise conditions are met, if any. The
expiration date is generally ten years from the date the option is issued. As of June 30, 2019, there were non-qualified
stock options to purchase 6,317,974 shares
of Common Stock outstanding and 1,040,000 restricted
stock awards under the 2012 Plan. Effective upon our adoption of the 2019 Plan on June 20, 2019, no future awards may be
made under the 2012 Plan.
On June 20, 2019, we adopted the 2019 Plan to serve as an incentive for retaining qualified and competent key employees, officers, directors, and certain consultants and advisors of our company. The Awards available under the 2019 Plan consist of stock options, stock appreciation rights, restricted stock, restricted stock units, performance stock, performance units, and other stock or cash awards as described in the 2019 Plan. Generally, the options vest annually over four years or as determined by our board of directors, upon each option grant. Options may be exercised by paying the price for shares or on a cashless exercise basis after they have vested and prior to the specified expiration date provided and applicable exercise conditions are met, if any. The expiration date is generally ten years from the date the option is issued. As of June 30, 2019, there were16,812,383 shares of Common Stock authorized for issuance thereunder, consisting of (i)14,362,500 new shares, (ii)2,393,833 unallocated shares previously available for issuance under the 2012 Plan that were not then subject to outstanding “Awards” (as defined in the 2012 Plan), and (iii)56,050 unallocated shares previously available for issuance under the 2009 Plan that were not then subject to outstanding “Awards” (as defined in the 2009 Plan). Any shares subject to outstanding options or other equity “Awards” under the 2019 Plan, the 2012 Plan and the 2009 Plan that are forfeited, expire or otherwise terminate without issuance of the underlying shares, or if any such Award is settled for cash or otherwise does not result in the issuance of all or a portion of the shares subject to such Award (other than shares tendered or withheld in connection with the exercise of an Award or the satisfaction of withholding tax liabilities), the shares to which those Awards were subject, shall, to the extent of such forfeiture, expiration, termination, cash settlement or non-issuance, again be available for delivery with respect to Awards under the 2019 Plan. As of June 30, 2019, there were non-qualified stock options to purchase 637,500 shares of Common Stock outstanding under the 2019 Plan.
The valuation methodology used to determine the fair value of stock options is the Black-Scholes Model. The Black-Scholes Model requires the use of a number of assumptions including volatility of the stock price, the risk-free interest rate, and the expected life of the stock options. The assumptions used in the Black-Scholes Model for options granted during the six months ended June 30, 2019 and 2018 are set forth in the table below.
A summary of activity under the 2009, 2012 and 2019 Plans and related information follows:
At June 30, 2019, our outstanding stock options had exercise prices ranging from $0.10 to $8.92 per share. The weighted average grant date fair value per share of options granted was $2.57 and $3.15 during the six months ended June 30, 2019 and 2018, respectively. Share-based compensation expense for options recognized in our results of operations for the three months ended June 30, 2019 and 2018 ($2,230,829 and $2,212,241 , respectively) and for the six months ended June 30, 2019 and 2018 ($4,374,069 and $3,872,125 , respectively) is based on vested awards. At June 30, 2019, total unrecognized estimated compensation expense related to unvested options granted prior to that date was approximately $11,606,000 which may be adjusted for future changes in forfeitures. This cost is expected to be recognized over a weighted-average period of2.1 years. No tax benefit was realized due to a continued pattern of operating losses.
Restricted Stock Restricted stock awards granted under our 2009, 2012 and 2019 Plans entitle the holder to receive, at the end of vesting period, a specified number of shares of our Common Stock. Share-based compensation expense is measured by the market value of our Common Stock on the day of the grant. The shares vest ratably over the period specified in the grant. There is no partial vesting and any unvested portion is forfeited.
On December 13, 2018, we granted 1,040,000 restricted
stock units to certain executive employees which will vest at the end of the third year. The grant date fair value
was $4.06 per
unit. During the three and six months ended June 30, 2019 we recorded $350,263 and
$696,676 ,
respectively, in share-based compensation expense related to restricted stock units. At June 30, 2019, total
unrecognized estimated compensation expense related to unvested restricted stock units was approximately $3,453,000 ,
which may be adjusted for future changes in forfeitures. This cost is expected to be recognized over a
weighted-average period of 2.5 years.
At June 30, 2019,1,040,000 restricted
stock awards remained outstanding.
Cash-Settled Stock Appreciation Rights (SARs) On July 1, 2018, we issued cash-settled SARs to certain consultants and employees. The SARs plan year began on July 1, 2018 and ended on or immediately following June 30, 2019. SARs were granted with a grant price equal to the market value of a share of our Common Stock on the date of grant. Cash-settled SARs provided for the cash payment of the excess of the fair market value of our Common Stock on June 30, 2019 over the grant price. Cash-settled SARs have no effect on dilutive shares or shares outstanding as any appreciation of our Common Stock over the grant price is paid in cash and not in Common Stock.
Cash settled SARs were recorded in our consolidated balance sheets as a liability until the date of exercise. The fair value of each SAR award was estimated using the Black-Scholes valuation model. In accordance with ASC Topic 718, “Stock Compensation,” the fair value of each SAR award was recalculated at the end of each reporting period and the liability and expense adjusted based on the new fair value and the percent vested. At June 30, 2019, the fair market value of our Common Stock was lower than the grant price of SARs and, as a result, the recorded liability was reversed and no cash payment was made.
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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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INCOME TAXES |
6 Months Ended |
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Jun. 30, 2019 | |
Income Tax Disclosure [Abstract] | |
INCOME TAXES |
NOTE 12 – INCOME TAXES Deferred income tax assets and liabilities
are determined based upon differences between the financial reporting and tax basis of assets and liabilities and are measured
using the enacted tax rates and laws that will be in effect when the differences are expected to reverse. We do not expect to pay
any significant federal or state income tax for 2019 as a result of (i) the losses recorded during the six months ended June 30,
2019, (ii) additional losses expected for the remainder of 2019, and/or (iii) net operating loss carry forwards from prior years.
Accounting standards require the consideration of a valuation allowance for deferred tax assets if it is “more likely than
not” that some component or all of the benefits of deferred tax assets will not be realized. As of June 30, 2019, we maintain
a full valuation allowance for all deferred tax assets. Based on these requirements, no provision or benefit for income taxes has
been recorded. There were no recorded unrecognized tax benefits at the end of the reporting period.
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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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RELATED PARTIES |
6 Months Ended |
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Jun. 30, 2019 | |
Related Party Transactions [Abstract] | |
RELATED PARTIES |
NOTE 13 – RELATED PARTIES
In July 2015, J. Martin Carroll, a director of our company, was appointed to the board of directors of Catalent, Inc. From time to time, we have entered into agreements with Catalent, Inc. and its affiliates, or Catalent, in the normal course of business. Agreements with Catalent have been reviewed by independent directors of our company or a committee consisting of independent directors of our company since July 2015. During the three months ended June 30, 2019 and 2018, we were billed by Catalent approximately $
974,000
and $
1,266,000
, respectively, for manufacturing activities related to our clinical trials, scale-up, registration batches, stability and validation testing. During the six months ended June 30, 2019 and 2018, we were billed by Catalent approximately $
2,371,000
and $
2,040,000
, respectively, for manufacturing activities related to our clinical trials, scale-up, registration batches, stability and validation testing. As of June 30, 2019 and December 31, 2018, there were amounts due to Catalent of approximately $
243,000
and $
88,000
, respectively.
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- References No definition available.
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- Definition The entire disclosure for related party transactions. Examples of related party transactions include transactions between (a) a parent company and its subsidiary; (b) subsidiaries of a common parent; (c) and entity and its principal owners; and (d) affiliates. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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BUSINESS CONCENTRATIONS |
6 Months Ended |
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Jun. 30, 2019 | |
Risks and Uncertainties [Abstract] | |
BUSINESS CONCENTRATIONS | NOTE 14 – BUSINESS CONCENTRATIONS We purchase our prescription products
from several suppliers with approximately 14%,18%,31%
and37%
of our purchases were supplied by four vendors each, respectively, during the six months ended June 30, 2019 and
approximately 100%
of our purchases were supplied from one vendor for the six months ended June 30, 2018.
We sell our prescription prenatal
vitamin products to wholesale distributors, specialty pharmacies, specialty distributors, and chain drug stores that
generally sell products to retail pharmacies, hospitals, and other institutional customers. During the six months ended June
30, 2019, three customers each generated more than 10%
of our total revenues. During the six months ended June 30, 2018, four customers each generated more than 10%
of our total revenues. Revenue generated from the three customers combined accounted for approximately 60%
of our recognized revenue for the six months ended June 30, 2019 and revenue generated from the four customers combined
accounted for approximately71%
of our recognized revenue for the six months ended June 30, 2018.
During the six months ended June 30, 2019, Pillpack, Inc. accounted for approximately $3,615,000of our revenue, AmerisourceBergen accounted for approximately $1,365,000of our revenue and Cardinal Health accounted for approximately $1,048,000of our revenue. During the six months ended June 30, 2018, PI Services generated approximately $981,000of our revenue, Pillpack, Inc. generated approximately $2,088,000of our revenue, AmerisourceBergen generated approximately $1,283,000of our revenue and Cardinal Health generated approximately $971,000of our revenue.
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- Definition The entire disclosure for any concentrations existing at the date of the financial statements that make an entity vulnerable to a reasonably possible, near-term, severe impact. This disclosure informs financial statement users about the general nature of the risk associated with the concentration, and may indicate the percentage of concentration risk as of the balance sheet date. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- References No definition available.
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COMMITMENTS AND CONTINGENCIES |
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Commitments and Contingencies Disclosure [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
COMMITMENTS AND CONTINGENCIES |
NOTE 15 – COMMITMENTS AND CONTINGENCIES We adopted ASC 842 effective January 1, 2019. Substantially all our operating lease right-of-use assets and operating lease liabilities represent leases for office space used to conduct our business. Upon adoption, we have recognized a right-of-use asset and a lease liability for all leases that have commenced as of January 1, 2019. The right-of-use assets represent the right to use the leased asset for the lease term. The lease liabilities represent the present value of the lease payments under the lease. The right-of-use asset is initially measured at cost, which primarily comprises the initial amount of the lease liability, plus any initial direct costs incurred, less any lease incentives received. All right-of-use assets are reviewed for impairment. The lease liability is initially measured at the present value of the lease payments, discounted using our secured incremental borrowing rate for the same term as the underlying lease because the rates are not implicit in the leases. Some of our leases contain variable lease payments, including payments based on an index or rate. Variable lease payments based on an index or rate are initially measured using the index or rate in effect at lease commencement. Additional payments based on the change in an index or rate, or payments based on a change in our portion of the operating expenses are recorded as a period expense when incurred. Lease modifications result in remeasurement of the lease liability. Included in lease expense are any variable lease payments incurred in the period that were not included in the initial lease liability.
We lease administrative office space in Boca Raton, Florida pursuant to a non-cancelable operating lease that commenced on July 1, 2013 and originally provided for a 63-month term. On February 18, 2015, we entered into an agreement with the same lessors to lease additional administrative office space in the same location, pursuant to an addendum to such lease. In addition, on April 26, 2016, we entered into an agreement with the same lessors to lease additional administrative office space in the same location. This agreement was effective beginning May 1, 2016 and extended the original expiration of the lease term to October 31, 2021. On October 4, 2016, we entered into an agreement with the same lessors to lease additional administrative office space in the same location, pursuant to an addendum to such lease. This addendum is effective beginning November 1, 2016.
In October 2018, we entered into a lease for new corporate offices in Boca Raton, Florida. The lease includes 56,212 rentable square feet, or the full premises, of which lease on 7,561 square feet commenced in 2018 and the lease on the remaining 48,651 square feet will commence sometime in the third quarter of 2019, or the full premises commencement date. The lease will expire 11 years after full premises commencement date, unless terminated earlier in accordance with the terms of the lease. We have the option to extend the term of the lease for two additional consecutive periods of five years. The extension option is not included in the determination of the lease term as it is not reasonably certain to be exercised. The term of the lease includes escalating rent and free rent periods. We are also responsible for certain other operating costs under the lease, including electricity and utility expenses. In addition, we will be entitled to reimbursement from the landlord of up to $1,800,000 for tenant improvements. In June 2019, we entered into an agreement with the same lessors to lease additional 6,536 square feet of administrative office space in the same location, pursuant to an addendum to such lease, which is expected to commence as soon as the fourth quarter of 2019.
The following table reconciles the undiscounted cash flows for all operating leases at June 30, 2019 to the operating lease liabilities recorded on the balance sheet:
As of June 30, 2019, we estimated undiscounted fixed future minimum rental commitments of approximately $13,300,000 and estimated undiscounted variable future minimum rental commitments of approximately $6,400,000 over the term of the lease related to the operating lease for the new corporate office that we entered into in October 2018 and an additional suite that we entered into in 2019 that had not commenced yet, as disclosed above. During the three and six months ended June 30, 2019, operating lease expense related to our real estate leases was approximately $295,000 and $590,000 , respectively, and variable lease expense was insignificant for the three and six months ended June 30, 2019. Rent expense totaled $257,000 and $515,000 during the three and six months ended June 30, 2018, respectively.
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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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SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies) |
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Accounting Policies [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Fair Value of Financial Instruments |
Fair Value of Financial Instruments Our financial instruments consist primarily of cash, accounts receivable, accounts payable, accrued expenses and long-term debt. The carrying amount of cash, accounts receivable, accounts payable and accrued expenses approximates their fair value because of the short-term maturity of such instruments, which are considered Level 1 assets under the fair value hierarchy. The carrying amount for long-term debt as of June 30, 2019 (as disclosed in Note 9), approximates fair value based on market activity for other debt instruments with similar characteristics and comparable risk (Level 2).
We categorize our assets and liabilities that are valued at fair value on a recurring basis into a three-level fair value hierarchy as defined by Accounting Standards Codification, or ASC, 820,
Fair Value Measurements. The fair value hierarchy gives the highest priority to quoted prices in active markets for identical assets and liabilities (Level 1) and lowest priority to unobservable inputs (Level 3). Assets and liabilities recorded in the consolidated balance sheet at fair value are categorized based on a hierarchy of inputs, as follows:
At June 30, 2019 and 2018, we had no assets or liabilities that were valued at fair value on a recurring basis.
The fair value of indefinite-lived assets or long-lived assets is measured on a non-recurring basis using significant unobservable inputs (Level 3) in connection with the Company’s impairment test on an annual basis.
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Trade Accounts Receivable and Allowance for Doubtful Accounts |
Trade Accounts Receivable and Allowance for Doubtful Accounts Trade accounts receivable are customer obligations due under normal trade terms. We review accounts receivable for uncollectible accounts and credit card chargebacks and provide an allowance for doubtful accounts, which is based upon a review of outstanding receivables, historical collection information, and existing economic conditions. We consider trade accounts receivable past due for more than 90 days to be delinquent. We write off delinquent receivables against our allowance for doubtful accounts based on individual credit evaluations, the results of collection efforts, and specific circumstances of customers. We record recoveries of accounts previously written off when received as an increase in the allowance for doubtful accounts. To the extent data we use to calculate these estimates does not accurately reflect bad debts, adjustments to these reserves may be required. |
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Revenue Recognition |
Revenue Recognition We adopted ASC 606 on January 1, 2018 using the modified retrospective method for all contracts not completed as of the date of adoption. ASC 606 states that a contract is considered “completed” if all (or substantially all) of the revenue was recognized in accordance with revenue guidance that was in effect before the date of initial application. Because all (or substantially all) of the revenue related to sales of our products has been recognized under ASC 605 prior to the date of initial application of the new standard, the contracts are considered completed under ASC 606. Based on our evaluation of ASC 606, we concluded that a cumulative adjustment was not necessary upon implementation of ASC 606 on January 1, 2018. In accordance with ASC 606, revenue is recognized when a customer obtains control of promised goods or services. The amount of revenue recognized reflects the consideration to which we expect to be entitled to receive in exchange for these goods or services. The provisions of ASC 606 include a five-step process by which we determine revenue recognition, depicting the transfer of goods or services to customers in amounts reflecting the payment to which we expect to be entitled in exchange for those goods or services. ASC 606 requires us to apply the following steps: (1) identify the contract with the customer; (2) identify the performance obligations in the contract; (3) determine the transaction price; (4) allocate the transaction price to the performance obligations in the contract; and (5) recognize revenue when, or as, we satisfy the performance obligation.
Prescription Products As of June 30, 2019, our products consisted primarily of prescription vitamins and our FDA-approved products: IMVEXXY, which we began selling during the third quarter of 2018, and BIJUVA, which we began selling in the second quarter of 2019. We sell our name brand and generic prescription products primarily through wholesale distributors and retail pharmacies. We have one performance obligation related to prescription products sold through wholesale distributors, which is to transfer promised goods to a customer, and two performance obligations related to products sold through retail pharmacies, which are to: (1) transfer promised goods and (2) provide customer service for an immaterial fee. We treat shipping as a fulfillment activity rather than as a separate obligation. We recognize prescription revenue only when we satisfy performance obligations by transferring a promised good or service to a customer. A good or service is considered to be transferred when the customer receives the goods or service or obtains control. Control refers to the customer’s ability to direct the use of, and obtain substantially all of the remaining benefits from, an asset. In consignment arrangements, control of the product is transferred at the point in time when the goods are removed from consignment stock and sold to the end customer. We typically satisfy our performance obligations and recognize revenue at a point in time, generally when products are shipped to the customer, depending on the terms underlying each arrangement. In circumstances where our products are on consignment, revenue is generally recognized when the prescription is filled.
Based on our contracts, we invoice customers once our performance obligations have been satisfied, at which point payment is unconditional. We disclose receivables from contracts with customers separately in the statement of financial position. Payment for goods or services sold by us is typically due between 30 and 60 days after an invoice is sent to the customer.
The transaction price of a contract is the amount of consideration which we expect to be entitled to in exchange for transferring promised goods or services to a customer. Prescription products are sold at fixed wholesale acquisition cost, or WAC, determined based on our list price. However, the total transaction price is variable as it is calculated net of estimated product returns, chargebacks, rebates, coupons, discounts and wholesaler fees. These estimates are based on the amounts earned or to be claimed on the related sales and are classified as reductions of accounts receivable (if the amount is payable to the customer) or a current liability (if the amount is payable to a party other than a customer). In order to determine the transaction price, we estimate the amount of variable consideration at the outset of the contract either utilizing the expected value or most likely amount method, depending on the facts and circumstances relative to the contract or each variable consideration. The estimated amount of variable consideration is included in the transaction price only to the extent that it is probable that a significant reversal in the amount of cumulative revenue recognized will not occur when the uncertainty associated with the variable consideration is subsequently resolved. In determining amounts of variable consideration to include in a contract’s transaction price, we rely on our historical experience and other evidence that supports our qualitative assessment of whether revenue would be subject to a significant reversal. We consider all the facts and circumstances associated with both the risk of a revenue reversal arising from an uncertain future event and the magnitude of the reversal if that uncertain event were to occur. Actual amounts of consideration ultimately received may differ from our estimates. If actual results in the future vary from our original estimates, we will adjust these estimates, which would affect net product revenue and earnings in the period such changes in estimates become known.
We accept returns of unsalable
prescription products sold through wholesale distributors within a return period of
six months prior to and up to 12 months
following product expiration. Our prescription products currently have a shelf life of 24 months
from the date of manufacture. We do not allow product returns for prescription products that have been dispensed to a
patient. We estimate the amount of our product sales that may be returned by our customers and record this estimate as a
reduction of revenue in the period the related product revenue is recognized. Where historical rates of return exist, we use
history as a basis to establish a returns reserve for products shipped to wholesalers. For our newly launched products, for
which the right of return exists but for which we currently do not have history of product returns, we estimate returns based
on available industry data, our own sales information and our visibility into the inventory remaining in the distribution
channel. At the end of each reporting period, we may decide to constrain revenue for product returns based on information
from various sources, including channel inventory levels and dating and sell-through data, the expiration dates of products
currently being shipped, price changes of competitive products and any introductions of generic products. We recognize the
amount of expected returns as a refund liability, representing the obligation to return the customer’s consideration.
Since our returns primarily consist of expired and short dated products that will not be resold, we do not record a return
asset for the right to recover the goods returned by the customer at the time of the initial sale (when recognition of
revenue is deferred due to the anticipated return). Return estimates are recorded in the accrued expenses and other current
liabilities on the consolidated balance sheet.
We offer various rebate and discount programs in an effort to maintain a competitive position in the marketplace and to promote sales and customer loyalty. We estimate the allowance for consumer rebates and coupons that we have offered based on our experience and industry averages, which is reviewed, and adjusted if necessary, on a quarterly basis. Estimates relating to these rebates and coupons are deducted from gross product revenues at the time the revenues are recognized. We record distributor fees based on amounts stated in contracts. Rebate and coupon estimates and distributor fees are recorded in accrued expenses and other current liabilities on the consolidated balance sheet. We estimate chargebacks based on number of units sold during the period taking into account prices stated in contracts and our historical experience. Estimates related to distributors fees, rebates, coupons and returns are disclosed in Note 8. We provide invoice discounts to our customers for prompt payment. Estimates relating to invoice discounts and chargebacks are deducted from gross product revenues at the time the revenues are recognized.
As part of the commercial launch for IMVEXXY during the third quarter of 2018 and for BIJUVA in the second quarter of 2019, we introduced a co-pay assistance program where eligible enrolled patients do not pay more than $35 for prescription fills. This allows patients to access the product at a reasonable cost regardless of insurance coverage. We reimburse pharmacies for this discount through third-party vendors. We consider these payments as consideration paid to the customer and reflect such payments as a reduction of the transaction price as we do not receive a distinct good or service related to these payments. The variable consideration is estimated based on contract prices, the estimated percentage of patients that will utilize the copay assistance, the average assistance paid, the estimated levels of inventory in the distribution channel and the current level of prescriptions covered by patients’ insurance. Payers may change coverage levels for IMVEXXY or BIJUVA positively or negatively, at any time up to the time that we have formally contracted coverage with the payer. As such, the net transaction price of IMVEXXY and BIJUVA is susceptible to such changes in coverage levels, which are outside the influence of the Company. As a result, we constrain revenue recognized for IMVEXXY and BIJUVA to an amount that will not result in a significant revenue reversal in future periods. Our ability to estimate the net transaction price for IMVEXXY and BIJUVA is constrained by our estimates of the amount to be paid for the co-pay assistance program for IMVEXXY and BIJUVA which is directly related to the level of prescriptions paid for by insurance. As such, we record an accrual to reduce gross sales for the estimated co-pay and other patient assistance based on currently available third-party data and our internal analyses. We re-evaluate any constraint each reporting period.
Disaggregation of revenue The following table provides information about disaggregated revenue by product mix for the three and six months ended June 30, 2019 and 2018:
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Share-Based Compensation |
Share-Based Compensation We measure the compensation costs of share-based compensation arrangements based on the grant-date fair value and recognize the costs in the financial statements over the period during which employees are required to provide services. Share-based compensation arrangements include options, restricted stock, restricted stock units, performance-based awards, share appreciation rights, and employee share purchase plans. We amortize such compensation amounts, if any, over the respective service periods of the award. We use the Black-Scholes-Merton option pricing model, or the Black-Scholes Model, an acceptable model in accordance with ASC 718, Compensation-Stock Compensation, to value options. Option valuation models require the input of assumptions, including the expected life of the stock-based awards, the estimated stock price volatility, the risk-free interest rate, and the expected dividend yield. The risk-free interest rate assumption is based upon observed interest rates on zero coupon U.S. Treasury bonds whose maturity period is appropriate for the term of the instrument. Estimated volatility is a measure of the amount by which our stock price is expected to fluctuate each year during the term of the award. Prior to January 1, 2017, the expected volatility of share options was estimated based on a historical volatility analysis of peer entities whose stock prices were publicly available that were similar to the Company with respect to industry, stage of life cycle, market capitalization, and financial leverage. On January 1, 2017, we began using our own stock price in our volatility calculation along with the other peer entities whose stock prices were publicly available that were similar to our company and in 2019 we started using only our own stock price in the volatility calculation. Our calculation of estimated volatility is based on historical stock prices over a period equal to the expected term of the awards. The average expected life is based on the contractual terms of the stock option using the simplified method. We utilize a dividend yield of zero based on the fact that we have never paid cash dividends and have no current intention to pay cash dividends. Calculating share-based compensation expense requires the input of highly subjective judgment and assumptions, estimates of expected life of the share-based award, stock price volatility and risk-free interest rates. The assumptions used in calculating the fair value of share-based awards represent our best estimates, but these estimates involve inherent uncertainties and the application of management judgment. As a result, if factors change and we use different assumptions, our share-based compensation expense could be materially different in the future. We recognize the compensation expense for share-based compensation granted based on the grant date fair value estimated in accordance with ASC 718. We generally recognize the compensation expense on a straight-line basis over the employee’s requisite service period. Effective January 1, 2017, we account for forfeitures when they occur.
On January 1, 2019, we adopted ASU 2018-07 which simplified the accounting for share-based payments to nonemployees by aligning it with the accounting for share-based payments to employees, with certain exceptions. The new guidance expanded the scope of ASC 718 to include share-based payments granted to nonemployees in exchange for goods or services used or consumed in an entity’s own operations and superseded the guidance in ASC 505-50. Prior to January 1, 2019, equity instruments issued to non-employees were recorded on a fair value basis, as required by ASC 505, Equity - Based Payments to Non-Employees.
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Research and Development Expenses |
Research and Development Expenses Research and development, or R&D, expenses include internal R&D activities, services of external contract research organizations, or CROs, costs of their clinical research sites, manufacturing, scale-up and validation costs, and other activities. Internal R&D activity expenses include laboratory supplies, salaries, benefits, and non-cash share-based compensation expenses. CRO activity expenses include preclinical laboratory experiments and clinical trial studies. Other activity expenses include regulatory consulting and legal fees and costs. The activities undertaken by our regulatory consultants that were classified as R&D expenses include assisting, consulting with, and advising our in-house staff with respect to various FDA submission processes, clinical trial processes, and scientific writing matters, including preparing protocols and FDA submissions. Legal activities that were classified as R&D expenses include professional research and advice regarding R&D, patents and regulatory matters. These consulting and legal expenses were direct costs associated with preparing, reviewing, and undertaking work for our clinical trials and investigative drugs. We charge internal R&D activities and other activity expenses to operations as incurred. We make payments to CROs based on agreed-upon terms, which may include payments in advance of a study starting date. We expense nonrefundable advance payments for goods and services that will be used in future R&D activities when the activity has been performed or when the goods have been received rather than when the payment is made. We review and accrue CRO expenses and clinical trial study expenses based on services performed and rely on estimates of those costs applicable to the completion stage of a study as provided by CROs. Estimated accrued CRO costs are subject to revisions as such studies progress to completion. We charge revisions expense in the period in which the facts that give rise to the revision become known.
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Segment Reporting |
Segment Reporting We are managed and operated as one business, which is focused on creating and commercializing products targeted exclusively for women. Our business operations are managed by a single management team that reports to the President of our company. We do not operate separate lines of business with respect to any of our products and we do not prepare discrete financial information with respect to separate products. All product sales are derived from sales in the United States. Accordingly, we view our business as one reportable operating segment.
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- References No definition available.
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- 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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- Definition Disclosure of accounting policy for costs it has 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. 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 segment reporting. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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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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SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Tables) |
6 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Jun. 30, 2019 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Accounting Policies [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of disaggregated revenue |
The following table provides information about disaggregated revenue by product mix for the three and six months ended June 30, 2019 and 2018:
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- References No definition available.
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- Definition Tabular disclosure of disaggregation of revenue into categories depicting how nature, amount, timing, and uncertainty of revenue and cash flows are affected by economic factor. Reference 1: http://www.xbrl.org/2009/role/commonPracticeRef
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INVENTORY (Tables) |
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Jun. 30, 2019 | ||||||||||||||||||||||||||||||||||||||||||||||
Inventory Disclosure [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||
Schedule of inventory |
Inventory consists of the following:
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- References No definition available.
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- Definition Tabular disclosure of the carrying amount as of the balance sheet date of merchandise, goods, commodities, or supplies held for future sale or to be used in manufacturing, servicing or production process. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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OTHER CURRENT ASSETS (Tables) |
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Jun. 30, 2019 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of other current assets |
Other current assets consist of the following:
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X | ||||||||||
- References No definition available.
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- Definition Tabular disclosure of the carrying amounts of other current assets. No definition available.
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FIXED ASSETS, NET (Tables) |
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Jun. 30, 2019 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Property, Plant and Equipment [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of fixed assets |
Fixed assets, net consist 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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INTANGIBLE ASSETS (Tables) |
6 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Jun. 30, 2019 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Intangible Assets, Net (Excluding Goodwill) [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of intangible assets |
The following table sets forth the gross carrying amount, accumulated amortization and net carrying amount of our intangible assets as of June 30, 2019 and December 31, 2018:
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Schedule of estimated amortization expense |
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- Definition Tabular disclosure of intangible assets, which may be broken down by major class. No definition available.
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- References No definition available.
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- Definition Tabular disclosure of the amount of amortization expense expected to be recorded in succeeding fiscal years for finite-lived intangible assets. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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OTHER CURRENT LIABILITIES (Tables) |
6 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Jun. 30, 2019 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Payables and Accruals [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Other Current Liabilities [Table Text Block] |
Other current liabilities consist of the following:
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X | ||||||||||
- Definition Tabular disclosure of other current liabilities. No definition available.
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X | ||||||||||
- References No definition available.
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DEBT (Tables) |
6 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||
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Jun. 30, 2019 | ||||||||||||||||||||||||||||||||||||||||||||||
Debt Disclosure [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||
Schedule of debt |
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X | ||||||||||
- References No definition available.
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X | ||||||||||
- Definition Tabular disclosure of information pertaining to short-term and long-debt instruments or arrangements, including but not limited to identification of terms, features, collateral requirements and other information necessary to a fair presentation. No definition available.
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NET LOSS PER SHARE (Tables) |
6 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Jun. 30, 2019 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
Loss per share, basic and diluted: | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of potentially dilutive securities |
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X | ||||||||||
- References No definition available.
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X | ||||||||||
- Definition Tabular disclosure of securities (including those issuable pursuant to contingent stock agreements) that could potentially dilute basic earnings per share (EPS) in the future that were not included in the computation of diluted EPS because to do so would increase EPS amounts or decrease loss per share amounts for the period presented, by antidilutive securities. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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STOCKHOLDERS' EQUITY (Tables) |
6 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Stockholders' Equity: | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of assumptions used in the Black-Scholes Model of stock options |
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Schedule of activity of 2009 and 2012 Plans |
A summary of activity under the 2009, 2012 and 2019 Plans and related information follows:
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X | ||||||||||
- Definition Tabular disclosure for stock option plans. Includes, but is not limited to, outstanding awards at beginning and end of year, grants, exercises, forfeitures, and weighted-average grant date fair value. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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X | ||||||||||
- Definition Tabular disclosure of the significant assumptions used during the year to estimate the fair value of stock options, including, but not limited to: (a) expected term of share options and similar instruments, (b) expected volatility of the entity's shares, (c) expected dividends, (d) risk-free rate(s), and (e) discount for post-vesting restrictions. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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X | ||||||||||
- References No definition available.
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COMMITMENTS AND CONTINGENCIES (Tables) |
6 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||
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Jun. 30, 2019 | |||||||||||||||||||||||||||||||||||||||||||||||||||
Commitments and Contingencies Disclosure [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of supplemental lease information and cash flow information |
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Reconciliation of undiscounted cash flows for all operating leases to the operating lease liabilities |
The following table reconciles the undiscounted cash flows for all operating leases at June 30, 2019 to the operating lease liabilities recorded on the balance sheet:
|
X | ||||||||||
- Definition Disclosure of supplementary lease and cash flow information. No definition available.
|
X | ||||||||||
- References No definition available.
|
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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THE COMPANY (Details) |
Jun. 30, 2019 |
---|---|
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Number of Subsidiares | 3 |
X | ||||||||||
- Definition Number of subsidiaries. No definition available.
|
X | ||||||||||
- References No definition available.
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BASIS OF PRESENTATION AND RECENTLY ISSUED ACCOUNTING PRONOUNCEMENTS (Details Narrative) - USD ($) |
Jun. 30, 2019 |
Jan. 01, 2019 |
---|---|---|
Right of use asset | $ 3,316,436 | $ 3,800,000 |
Lease liability | $ 3,675,130 | $ 4,100,000 |
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 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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SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details) - USD ($) |
3 Months Ended | 6 Months Ended | ||
---|---|---|---|---|
Jun. 30, 2019 |
Jun. 30, 2018 |
Jun. 30, 2019 |
Jun. 30, 2018 |
|
Revenues, net | $ 6,078,865 | $ 3,763,010 | $ 10,025,516 | $ 7,536,402 |
BIJUVA [Member] | ||||
Revenues, net | 134,282 | 134,282 | ||
Prescription Vitamins [Member] | ||||
Revenues, net | 2,822,872 | $ 3,763,010 | 4,758,844 | $ 7,536,402 |
IMVEXXY [Member] | ||||
Revenues, net | $ 3,121,711 | $ 5,132,390 |
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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- Details
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- Details
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SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details Narrative) |
6 Months Ended |
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Jun. 30, 2019
USD ($)
| |
Shelf life of prescription products following product expiration | 24 months |
Enrolled patients | $ 35 |
Minimum [Member] | |
Return period of unsalable prescription products | 6 months |
Maximum [Member] | |
Return period of unsalable prescription products | 12 months |
X | ||||||||||
- Definition The maximum amount that enrolled patients will pay per prescription refill. No definition available.
|
X | ||||||||||
- Definition Period the company accepts returns of unsalable prescription products from customers following product expiration. No definition available.
|
X | ||||||||||
- Definition Period shelf life of prescription products from date of manufacture. No definition available.
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X | ||||||||||
- Details
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X | ||||||||||
- Details
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INVENTORY (Details) - USD ($) |
Jun. 30, 2019 |
Dec. 31, 2018 |
---|---|---|
Inventory | ||
Finished product | $ 4,382,969 | $ 2,908,958 |
Work in process | 439,993 | 339,312 |
Raw material | 2,671,478 | 19,400 |
TOTAL INVENTORY | $ 7,494,440 | $ 3,267,670 |
X | ||||||||||
- Definition Amount before valuation and LIFO reserves of completed merchandise or goods expected to be sold within one year or operating cycle, if longer. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- 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
|
X | ||||||||||
- References No definition available.
|
X | ||||||||||
- Definition Gross amount of unprocessed materials to be used in manufacturing or production process and supplies that will be consumed. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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X | ||||||||||
- Definition Amount before valuation and LIFO reserves of merchandise or goods in the production process expected to be completed within one year or operating cycle, if longer. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
OTHER CURRENT ASSETS (Details) - USD ($) |
Jun. 30, 2019 |
Dec. 31, 2018 |
---|---|---|
Other Current Assets | ||
Prepaid sales and marketing costs | $ 2,568,100 | $ 5,148,789 |
Debt financing fees (Note 9) | 550,757 | 1,898,074 |
Prepaid insurance | 686,891 | 790,465 |
Other prepaid costs | 3,933,300 | 2,997,365 |
TOTAL OTHER CURRENT ASSETS | $ 7,739,048 | $ 10,834,693 |
X | ||||||||||
- References No definition available.
|
X | ||||||||||
- Definition It refers to the amount of prepaid sales and marketing costs incurred. No definition available.
|
X | ||||||||||
- Definition Amount, after accumulated amortization, of debt issuance costs classified as current. Includes, but is not limited to, legal, accounting, underwriting, printing, and registration costs. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
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
|
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
|
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
|
FIXED ASSETS, NET (Details) - USD ($) |
Jun. 30, 2019 |
Dec. 31, 2018 |
---|---|---|
Property, Plant and Equipment [Line Items] | ||
TOTAL FIXED ASSETS, GROSS | $ 2,118,817 | $ 1,026,313 |
Accumulated depreciation | (686,680) | (553,630) |
TOTAL FIXED ASSETS, NET | 1,432,137 | 472,683 |
Acounting System [Member] | ||
Property, Plant and Equipment [Line Items] | ||
TOTAL FIXED ASSETS, GROSS | 301,096 | 301,096,000 |
Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
TOTAL FIXED ASSETS, GROSS | 581,150 | 490,576 |
Furniture And Fixtures [Member] | ||
Property, Plant and Equipment [Line Items] | ||
TOTAL FIXED ASSETS, GROSS | 940,963 | 116,542 |
Computer hardware [Member] | ||
Property, Plant and Equipment [Line Items] | ||
TOTAL FIXED ASSETS, GROSS | 220,820 | 80,211 |
Leasehold improvements [Member] | ||
Property, Plant and Equipment [Line Items] | ||
TOTAL FIXED ASSETS, GROSS | $ 74,788 | $ 37,888 |
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
|
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
|
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 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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X | ||||||||||
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FIXED ASSETS, NET (Details Narrative) - USD ($) |
3 Months Ended | 6 Months Ended | ||
---|---|---|---|---|
Jun. 30, 2019 |
Jun. 30, 2018 |
Jun. 30, 2019 |
Jun. 30, 2018 |
|
Property, Plant and Equipment [Abstract] | ||||
Depreciation expense | $ 66,556 | $ 40,777 | $ 133,049 | $ 79,201 |
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
|
X | ||||||||||
- References No definition available.
|
X | ||||||||||
- Definition Accumulated amount of amortization of assets, excluding financial assets and goodwill, lacking physical substance with a finite life. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
|
X | ||||||||||
- Definition Amount before amortization of assets, excluding financial assets and goodwill, lacking physical substance with a finite life. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
|
X | ||||||||||
- Definition Amount after amortization of assets, excluding financial assets and goodwill, lacking physical substance with a finite life. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- References No definition available.
|
X | ||||||||||
- Definition Remaining amortization period of finite-lived intangible assets, in 'PnYnMnDTnHnMnS' format, for example, 'P1Y5M13D' represents the reported fact of one year, five months, and thirteen days. No definition available.
|
X | ||||||||||
- Definition Amount of assets, excluding financial assets and goodwill, lacking physical substance and having a projected indefinite period of benefit. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
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- References No definition available.
|
X | ||||||||||
- Definition Carrying amount (original costs adjusted for previously recognized amortization and impairment) as of the balance sheet date for the rights acquired through registration of a trademark to gain or protect exclusive use of a business name, symbol or other device or style for a projected indefinite period of benefit. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition Amount before accumulated amortization of intangible assets, excluding goodwill. No definition available.
|
X | ||||||||||
- Definition Sum of the carrying amounts of all intangible assets, excluding goodwill, as of the balance sheet date, net of accumulated amortization and impairment charges. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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INTANGIBLE ASSETS (Details 1) |
Jun. 30, 2019
USD ($)
|
---|---|
Year Ending December 31, | |
2019 (9 months) | $ 96,008 |
2020 | 196,017 |
2021 | 196,017 |
2022 | 196,017 |
2023 | $ 196,017 |
X | ||||||||||
- Definition Amount of amortization expense for assets, excluding financial assets and goodwill, lacking physical substance with a finite life expected to be recognized during the next fiscal year following the latest fiscal year. Excludes interim and annual periods when interim periods are reported on a rolling approach, from latest balance sheet date. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition Amount of amortization expense for assets, excluding financial assets and goodwill, lacking physical substance with a finite life expected to be recognized during the fifth fiscal year following the latest fiscal year. Excludes interim and annual periods when interim periods are reported on a rolling approach, from latest balance sheet date. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition Amount of amortization expense for assets, excluding financial assets and goodwill, lacking physical substance with a finite life expected to be recognized during the fourth fiscal year following the latest fiscal year. Excludes interim and annual periods when interim periods are reported on a rolling approach, from latest balance sheet date. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition Amount of amortization expense for assets, excluding financial assets and goodwill, lacking physical substance with a finite life expected to be recognized during the third fiscal year following the latest fiscal year. Excludes interim and annual periods when interim periods are reported on a rolling approach, from latest balance sheet date. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition Amount of amortization expense for assets, excluding financial assets and goodwill, lacking physical substance with a finite life expected to be recognized during the second fiscal year following the latest fiscal year. Excludes interim and annual periods when interim periods are reported on a rolling approach, from latest balance sheet date. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- References No definition available.
|
X | ||||||||||
- Definition Annual net sale milestones in the Territory per license agreement. No definition available.
|
X | ||||||||||
- Definition The reduction in royalty rate of initial rate six-months after the first arms-length commercial sale of a generic equivalent of the one-year vaginal contraceptive system that is launched by a third party in the U.S. No definition available.
|
X | ||||||||||
- Definition The reduction in royalty rate of the initial rate during the six-month period beginning on the date of the first arms-length commercial sale of a generic equivalent of the one-year vaginal contraceptive system that is launched by a third party in the U.S. No definition available.
|
X | ||||||||||
- Definition The amount of cash due as an upfront fee per signed agreement. No definition available.
|
X | ||||||||||
- Definition THe amount of intangibles written off. No definition available.
|
X | ||||||||||
- Definition The amount of milestone payments payable after release of first commercial batch. No definition available.
|
X | ||||||||||
- Definition The amount of milestone payments payable upon FDA approval. No definition available.
|
X | ||||||||||
- Definition The net sales amount as defined in license agreement for step-based royalty payments. No definition available.
|
X | ||||||||||
- Definition Number of issued patents. No definition available.
|
X | ||||||||||
- Definition The cash inflow from the additional capital contribution to the entity. No definition available.
|
X | ||||||||||
- Definition Amount of regulatory milestone payments based on regulatory approvals for each of BIJUVA and IMVEXXY in certain specified markets. No definition available.
|
X | ||||||||||
- Definition The percent of the net sales to be paid as royalty per license agreement. No definition available.
|
X | ||||||||||
- Definition Amount of sales milestone payments to be paid in escalating tranches based on Theramex first attaining certain aggregate annual net sales milestones in the Territory. No definition available.
|
X | ||||||||||
- Definition The aggregate expense charged against earnings to allocate the cost of intangible assets (nonphysical assets not used in production) in a systematic and rational manner to the periods expected to benefit from such assets. As a noncash expense, this element is added back to net income when calculating cash provided by or used in operations using the indirect method. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition Useful life of finite-lived intangible assets, in 'PnYnMnDTnHnMnS' format, for example, 'P1Y5M13D' represents the reported fact of one year, five months, and thirteen days. No definition available.
|
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 increase in assets, excluding financial assets, lacking physical substance with a definite life, from an acquisition. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
|
X | ||||||||||
- Definition Per share amount received by subsidiary or equity investee for each share of common stock issued or sold in the stock transaction. No definition available.
|
X | ||||||||||
- Definition Number of new stock issued during the period. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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OTHER CURRENT LIABILITIES (Details) - USD ($) |
Jun. 30, 2019 |
Dec. 31, 2018 |
---|---|---|
Payables and Accruals [Abstract] | ||
Accrued payroll, bonuses and commission costs | $ 5,115,082 | $ 6,854,002 |
Allowance for coupons and returns | 6,340,450 | 5,294,120 |
Accrued sales and marketing costs | 2,107,696 | 2,288,028 |
Accrued compensated absences | 1,492,131 | 1,178,110 |
Allowance for wholesale distributor fees | 2,077,444 | 792,891 |
Operating lease liability - short term | 1,187,029 | |
Accrued legal and accounting expense | 367,898 | 385,824 |
Accrued research and development | 1,402,600 | 388,675 |
Accrued rent | 365,155 | |
Accrued rebates | 2,251,047 | 412,570 |
Other accrued expenses | 35,240 | 375,573 |
TOTAL OTHER CURRENT LIABILITIES | $ 22,376,617 | $ 18,334,948 |
X | ||||||||||
- Definition Carrying value as of the balance sheet date of the obligations incurred through that date and payable forrebates. 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 the obligations incurred through that date and payable for research and development. 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 the obligations incurred through that date and payable for wholesale distributor 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 Aggregate allowance consisting of: (i) sales discounts given by the entity, including, but not limited to, early payments of accounts due, (ii) the total deduction from sales during the period arising from goods returned by customers (other than under warranty provisions), and (iii) price reductions (allowance, price protection agreements) given by the entity. Discounts, returns and allowances are a deduction from gross revenue in arriving at net revenue. No definition available.
|
X | ||||||||||
- Definition Sum of the carrying values as of the balance sheet date of obligations incurred through that date and due within one year (or the operating cycle, if longer), including liabilities incurred (and for which invoices have typically been received) and payable to vendors for goods and services received, taxes, interest, rent and utilities, accrued salaries and bonuses, payroll taxes and fringe benefits. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition Carrying value as of the balance sheet date of obligations incurred through that date and payable for the marketing, trade and selling of the entity's goods and services. Marketing costs would include expenditures for planning and executing the conception, pricing, promotion, and distribution of ideas, goods, and services; costs of public relations and corporate promotions; and obligations incurred and payable for sales discounts, rebates, price protection programs, etc. offered to customers and under government programs. 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 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
|
X | ||||||||||
- Definition Carrying value as of the balance sheet date of obligations incurred through that date and payable for contractual rent under lease arrangements. 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
|
X | ||||||||||
- Definition Carrying value as of the balance sheet date of the obligations incurred through that date and payable for employees' services provided. 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
|
X | ||||||||||
- Definition Carrying value as of the balance sheet date of obligations incurred and payable for unused vacation time owed to employees based on the entity's vacation benefit given to its employees. 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
|
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
|
X | ||||||||||
- Definition Amount of liabilities classified as other, due within one year or the normal operating cycle, if longer. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- References No definition available.
|
DEBT (Details) - USD ($) |
6 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Jun. 30, 2019 |
Dec. 31, 2018 |
||||||||||||||||||||||||||||||||||||||||||||||
Schedule of debt |
|
||||||||||||||||||||||||||||||||||||||||||||||
Debt discount and financing fees | $ (5,904,780) | $ (1,618,986) | |||||||||||||||||||||||||||||||||||||||||||||
TOTAL LONG-TERM DEBT | 194,095,220 | 73,381,014 | |||||||||||||||||||||||||||||||||||||||||||||
Line of Credit [Member] | |||||||||||||||||||||||||||||||||||||||||||||||
Borrowings outstanding | $ 200,000,000 | ||||||||||||||||||||||||||||||||||||||||||||||
Unsecured Debt [Member] | |||||||||||||||||||||||||||||||||||||||||||||||
Borrowings outstanding | $ 75,000,000 |
X | ||||||||||
- Definition Amount, before unamortized (discount) premium and debt issuance costs, of long-term debt. Includes, but is not limited to, notes payable, bonds payable, commercial loans, mortgage loans, convertible debt, subordinated debt and other types of debt. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
|
X | ||||||||||
- Definition Amount of unamortized debt discount (premium) and debt issuance costs. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
|
X | ||||||||||
- Definition Amount after unamortized (discount) premium and debt issuance costs of long-term debt classified as noncurrent and excluding amounts to be repaid within one year or the normal operating cycle, if longer. Includes, but not limited to, notes payable, bonds payable, debentures, mortgage loans and commercial paper. Excludes capital lease obligations. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition Tabular disclosure of information pertaining to short-term and long-debt instruments or arrangements, including but not limited to identification of terms, features, collateral requirements and other information necessary to a fair presentation. No definition available.
|
X | ||||||||||
- Details
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X | ||||||||||
- Details
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X | ||||||||||
- Definition This element represents the amortization of deferred financing fees incurred and amortized over the term of the debt. No definition available.
|
X | ||||||||||
- References No definition available.
|
X | ||||||||||
- Definition The facility fee expressed as a percentage paid or payable to the Agent for the benefit of lenders, under the terms of Credit Agreement. No definition available.
|
X | ||||||||||
- Definition The minimum LIBOR rate under credit and security agreement. No definition available.
|
X | ||||||||||
- Definition Represents libor floor rate. No definition available.
|
X | ||||||||||
- Definition The minimum cash balance the Borrower must maintain under the credit and secuirty agreement. No definition available.
|
X | ||||||||||
- Definition The number of seperate tranches under terms of the Credit Agreement. No definition available.
|
X | ||||||||||
- Definition The prepayment fee, expressed as a percentage of the tranche funding being repaid, No definition available.
|
X | ||||||||||
- Definition Percent of debt allowed to be prepaid per agreement. No definition available.
|
X | ||||||||||
- Definition The prime rate floor as defined in agreement. No definition available.
|
X | ||||||||||
- Definition Represents repayment fee percent. No definition available.
|
X | ||||||||||
- Definition Amount of the repayment of debt including all fees by borrowing funds from a new credit facility. No definition available.
|
X | ||||||||||
- Definition Amount of amortization expense attributable to debt issuance costs. Reference 1: http://www.xbrl.org/2009/role/commonPracticeRef
|
X | ||||||||||
- Definition Percentage points added to the reference rate to compute the variable rate on the debt instrument. No definition available.
|
X | ||||||||||
- Definition Amount, before unamortized (discount) premium and debt issuance costs, of long-term debt. Includes, but is not limited to, notes payable, bonds payable, commercial loans, mortgage loans, convertible debt, subordinated debt and other types of debt. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
|
X | ||||||||||
- Definition The reference rate for the variable rate of the debt instrument, such as LIBOR or the US Treasury rate and the maturity of the reference rate used, such as three months or six months LIBOR. No definition available.
|
X | ||||||||||
- Definition Effective interest rate for the funds borrowed under the debt agreement considering interest compounding and original issue discount or premium. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
|
X | ||||||||||
- Definition Aggregate amount of interest expense on all borrowings. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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X | ||||||||||
- Definition Amount of current borrowing capacity under the credit facility considering any current restrictions on the amount that could be borrowed (for example, borrowings may be limited by the amount of current assets), but without considering any amounts currently outstanding under the facility. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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X | ||||||||||
- Definition Maximum borrowing capacity under the credit facility without consideration of any current restrictions on the amount that could be borrowed or the amounts currently outstanding under the facility. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition Amount, after unamortized (discount) premium and debt issuance costs, of long-term debt. Includes, but not limited to, notes payable, bonds payable, debentures, mortgage loans and commercial paper. Excludes capital lease obligations. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
|
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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NET LOSS PER SHARE (Details) - shares |
3 Months Ended | 6 Months Ended | ||
---|---|---|---|---|
Jun. 30, 2019 |
Jun. 30, 2018 |
Jun. 30, 2019 |
Jun. 30, 2018 |
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Anti-dilutive shares excluded from earnings per share calculation | 24,945,040 | 28,218,470 | 24,945,040 | 28,218,470 |
Warrants [Member] | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Anti-dilutive shares excluded from earnings per share calculation | 1,832,571 | 3,007,571 | 1,832,571 | 3,007,571 |
Stock Options [Member] | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Anti-dilutive shares excluded from earnings per share calculation | 22,072,469 | 25,210,899 | 22,072,469 | 25,210,899 |
Restricted Stock [Member] | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Anti-dilutive shares excluded from earnings per share calculation | 1,040,000 | 1,040,000 |
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
|
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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STOCKHOLDERS' EQUITY (Details) |
6 Months Ended | |
---|---|---|
Jun. 30, 2019 |
Jun. 30, 2018 |
|
Maximum [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Term | 6 years 3 months | 6 years 3 months |
Stock Options [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Risk-free interest rate - minimum | 2.19% | 2.38% |
Risk-free interest rate - maximum | 2.54% | 2.63% |
Volatility - minimum | 61.25% | 61.82% |
Volatility - maximum | 61.85% | 64.04% |
Dividend yield | 0.00% | 0.00% |
Stock Options [Member] | Minimum [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Term | 5 years 6 months | 5 years 1 month 6 days |
X | ||||||||||
- Definition The estimated dividend rate (a percentage of the share price) to be paid (expected dividends) to holders of the underlying shares over the option's term. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition The estimated measure of the maximum percentage by which a share price is expected to fluctuate during a period. Volatility also may be defined as a probability-weighted measure of the dispersion of returns about the mean. The volatility of a share price is the standard deviation of the continuously compounded rates of return on the share over a specified period. That is the same as the standard deviation of the differences in the natural logarithms of the stock prices plus dividends, if any, over the period. No definition available.
|
X | ||||||||||
- Definition The estimated measure of the minimum percentage by which a share price is expected to fluctuate during a period. Volatility also may be defined as a probability-weighted measure of the dispersion of returns about the mean. The volatility of a share price is the standard deviation of the continuously compounded rates of return on the share over a specified period. That is the same as the standard deviation of the differences in the natural logarithms of the stock prices plus dividends, if any, over the period. No definition available.
|
X | ||||||||||
- Definition The maximum risk-free interest rate assumption that is used in valuing an option on its own shares. No definition available.
|
X | ||||||||||
- Definition The minimum risk-free interest rate assumption that is used in valuing an option on its own shares. No definition available.
|
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 Expected term of 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
|
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- Details
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X | ||||||||||
- Details
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X | ||||||||||
- Details
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X | ||||||||||
- Definition Weighted average remaining contractual term for unvested options, in 'PnYnMnDTnHnMnS' format, No definition available.
|
X | ||||||||||
- References No definition available.
|
X | ||||||||||
- Definition Weighted average price at which grantees can acquire unvested shares reserved for issuance. No definition available.
|
X | ||||||||||
- References No definition available.
|
X | ||||||||||
- Definition Amount of accumulated difference between fair value of underlying shares on dates of exercise and exercise price on options exercised (or share units converted) into shares. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition Number of options or other stock instruments for which the right to exercise has lapsed under the terms of the plan agreements. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition Gross number of share options (or share units) granted during the period. No definition available.
|
X | ||||||||||
- Definition Amount by which the current fair value of the underlying stock exceeds the exercise price of options outstanding. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition Number of options outstanding, including both vested and non-vested options. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition A roll forward is a reconciliation of a concept from the beginning of a period to the end of a period. No definition available.
|
X | ||||||||||
- Definition Weighted average price at which grantees can acquire the shares reserved for issuance under the stock option plan. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- References No definition available.
|
X | ||||||||||
- Definition Number of fully vested and expected to vest options outstanding that can be converted into shares under option plan. Includes, but is not limited to, unvested options for which requisite service period has not been rendered but that are expected to vest based on achievement of performance condition, if forfeitures are recognized when they occur. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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X | ||||||||||
- Definition Weighted-average exercise price, at which grantee can acquire shares reserved for issuance, for fully vested and expected to vest options outstanding. Includes, but is not limited to, unvested options for which requisite service period has not been rendered but that are expected to vest based on achievement of performance condition, if forfeitures are recognized when they occur. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition Weighted average price at which option holders acquired shares when converting their stock options into shares. No definition available.
|
X | ||||||||||
- Definition Weighted average price at which grantees could have acquired the underlying shares with respect to stock options of the plan that expired. No definition available.
|
X | ||||||||||
- Definition Weighted average per share amount at which grantees can acquire shares of common stock by exercise of options. No definition available.
|
X | ||||||||||
- Definition Amount of difference between fair value of the underlying shares reserved for issuance and exercise price of vested portions of options outstanding and currently exercisable. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition Weighted average remaining contractual term for vested portions of options outstanding and currently exercisable or convertible, in 'PnYnMnDTnHnMnS' format, for example, 'P1Y5M13D' represents the reported fact of one year, five months, and thirteen days. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition Number of non-vested options outstanding. No definition available.
|
X | ||||||||||
- Definition Weighted average remaining contractual term for option awards outstanding, in 'PnYnMnDTnHnMnS' format, for example, 'P1Y5M13D' represents the reported fact of one year, five months, and thirteen days. 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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STOCKHOLDERS' EQUITY (Details Narrative) - USD ($) |
3 Months Ended | 6 Months Ended | |||
---|---|---|---|---|---|
Jun. 30, 2018 |
Mar. 31, 2018 |
Jun. 30, 2019 |
Jun. 30, 2018 |
Dec. 31, 2018 |
|
Preferred stock, par value (in dollars per share) | $ 0.001 | $ 0.001 | |||
Preferred stock, authorized | 10,000,000 | 10,000,000 | |||
Common stock, authorized | 350,000,000 | 350,000,000 | |||
Common stock, issued | 241,221,840 | 240,462,439 | |||
Value of common stock issued during period for stock options exercised | $ 1,084,939 | $ 44,056 | $ 100,107 | ||
Number of stock options exercised (in shares) | 276,383 | ||||
Number of stock options exercised in cashless exercise (in shares) | 12,097 | 10,000 | |||
Number of common stock issued during period for stock options exercised in cashless exercise (in shares) | 11,834 | 9,841 | |||
Stock Options [Member] | |||||
Value of common stock issued during period for stock options exercised | $ 1,084,939 | $ 1,128,996 | |||
Number of stock options exercised (in shares) | 249,785 | 394,576 |
X | ||||||||||
- Definition Number of shares of common stock issued attributable to stock options exercised in cashless transaction. No definition available.
|
X | ||||||||||
- Definition Number of share options (or share units) exercised during the current period. No definition available.
|
X | ||||||||||
- Definition Number of options exercised in the cashless transaction. No definition available.
|
X | ||||||||||
- 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
|
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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X | ||||||||||
- 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
|
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
|
X | ||||||||||
- Definition Value of stock issued as a result of the exercise of stock options. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Details
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X | ||||||||||
- References No definition available.
|
X | ||||||||||
- Definition This item provides the weighted-average contractual remaining life of warrants. No definition available.
|
X | ||||||||||
- Definition Weighted average price at which warrant holders can acquire the shares reserved for issuance. No definition available.
|
X | ||||||||||
- Definition Exercise price per share or per unit of warrants or rights outstanding. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
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 noncash expense for share-based payment arrangement. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition The weighted average fair value at grant date for nonvested equity-based awards issued during the period on other than stock (or unit) option plans (for example, phantom stock or unit plan, stock or unit appreciation rights plan, performance target plan). Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition Number of non-option equity instruments exercised by participants. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition Net number of non-option equity instruments granted to participants. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition The estimated dividend rate (a percentage of the share price) to be paid (expected dividends) to holders of the underlying shares over the expected term of a nonvested share or option award issued to other than an employee. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition Period an equity-based award is expected to be outstanding, in 'PnYnMnDTnHnMnS' format, for example, 'P1Y5M13D' represents the reported fact of one year, five months, and thirteen days. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition The estimated measure of the percentage amount by which a share price is expected to fluctuate during the expected term of a nonvested share or option award issued to other than an employee. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition The risk-free interest rate assumption that is used in valuing a nonvested share or option award issued to other than an employee. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition Number of shares issued during the period as a result of the conversion of convertible securities. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition Value of outstanding derivative securities that permit the holder the right to purchase securities (usually equity) from the issuer at a specified price. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Details
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X | ||||||||||
- Details
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- Details
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X | ||||||||||
- Details
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X | ||||||||||
- Definition The exercise price of the option. No definition available.
|
X | ||||||||||
- Definition Number of new shares authorized for stock awards. No definition available.
|
X | ||||||||||
- Definition Unallocated shares previously available for issuance under the award plan that were not then subject to outstanding Awards as defined in the Plan. No definition available.
|
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
|
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 cost to be recognized for option under share-based payment arrangement. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition Amount of noncash expense for share-based payment arrangement. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition The weighted average fair value at grant date for nonvested equity-based awards issued during the period on other than stock (or unit) option plans (for example, phantom stock or unit plan, stock or unit appreciation rights plan, performance target plan). Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition Number of equity instruments other than options outstanding, including both vested and non-vested instruments. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition Number of shares authorized for issuance under share-based payment arrangement. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition Gross number of share options (or share units) granted during the period. No definition available.
|
X | ||||||||||
- Definition The weighted average grant-date fair value of options granted during the reporting period as calculated by applying the disclosed option pricing methodology. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition Number of options outstanding, including both vested and non-vested options. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition Weighted average price at which grantees can acquire the shares reserved for issuance under the stock option plan. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
|
X | ||||||||||
- Definition Value of shares of stock issued attributable to transactions classified as other. No definition available.
|
X | ||||||||||
- Details
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X | ||||||||||
- Details
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X | ||||||||||
- Details
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- Details
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- Details
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- Details
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- Details
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RELATED PARTIES (Details Narrative) - USD ($) |
3 Months Ended | 6 Months Ended | |||
---|---|---|---|---|---|
Jun. 30, 2019 |
Jun. 30, 2018 |
Jun. 30, 2019 |
Jun. 30, 2018 |
Dec. 31, 2018 |
|
Related Party Transaction [Line Items] | |||||
Manufacturing activities billed from related party | $ 974,000 | $ 1,266,000 | |||
Payable - related party | $ 243,000 | $ 243,000 | $ 88,000 | ||
Director [Member] | |||||
Related Party Transaction [Line Items] | |||||
Manufacturing activities billed from related party | $ 2,371,000 | $ 2,040,000 |
X | ||||||||||
- Definition Amount for accounts payable to related parties. 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
|
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 Purchases during the period (excluding transactions that are eliminated in consolidated or combined financial statements) with related party. No definition available.
|
X | ||||||||||
- Details
|
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 For an entity that discloses a concentration risk in relation to quantitative amount, which serves as the "benchmark" (or denominator) in the equation, this concept represents the concentration percentage derived from the division. 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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- Details
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- Details
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- Details
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- Details
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X | ||||||||||
- Details
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COMMITMENTS AND CONTINGENCIES (Details) - USD ($) |
3 Months Ended | |
---|---|---|
Jun. 30, 2019 |
Jan. 01, 2019 |
|
Commitments and Contingencies Disclosure [Abstract] | ||
Right of use asset | $ 3,316,436 | $ 3,800,000 |
Short-term operating lease liability | 1,187,029 | |
Long-term operating lease liability | $ 2,488,101 | |
Weighted average remaining term | 5 years | |
Weighted average discount rate | 8.25% | |
Cash paid for amounts included in the measurement of lease liabilities for operating lease | $ 564,092 | |
Right-of-use assets obtained in exchange for lease obligation | $ 3,760,171 |
X | ||||||||||
- References No definition available.
|
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
|
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
|
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
|
X | ||||||||||
- Definition Amount of lessee's right to use underlying asset under operating lease. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
|
X | ||||||||||
- Definition Weighted average discount rate for operating lease calculated at point in time. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
|
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
|
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
|
COMMITMENTS AND CONTINGENCIES (Details 1) - USD ($) |
Jun. 30, 2019 |
Jan. 01, 2019 |
---|---|---|
Years ending December 31, | ||
2019 | $ 595,649 | |
2020 | 1,292,914 | |
2021 | 1,135,467 | |
2022 | 172,651 | |
2023 | 176,968 | |
Thereafter | 1,228,504 | |
Total undiscounted lease payments | 4,602,153 | |
Less: Imputed interest | (927,023) | |
Present value of lease payments | $ 3,675,130 | $ 4,100,000 |
X | ||||||||||
- Definition The amount of computed imputed interest for operating lease liability. No definition available.
|
X | ||||||||||
- References No definition available.
|
X | ||||||||||
- Definition Amount of lessee's undiscounted obligation for lease payments for operating lease. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
|
X | ||||||||||
- Definition Amount of lessee's undiscounted obligation for lease payments for operating lease, due after fifth fiscal year following latest fiscal year. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
|
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
|
X | ||||||||||
- Definition Amount of lessee's undiscounted obligation for lease payments for operating lease, due in fifth fiscal year following latest fiscal year. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
|
X | ||||||||||
- Definition Amount of lessee's undiscounted obligation for lease payments for operating lease, due in fourth fiscal year following latest fiscal year. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
|
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
|
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
|
X | ||||||||||
- Definition Present value of lessee's discounted obligation for lease payments from operating lease. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
|
COMMITMENTS AND CONTINGENCIES (Details Narrative) |
3 Months Ended | 6 Months Ended |
---|---|---|
Jun. 30, 2019
USD ($)
|
Jun. 30, 2019
USD ($)
|
|
Rental expense | $ 257,000 | $ 515,000 |
Operating lease expense | 295,000 | 590,000 |
Reimbursement from landlord - tenant improvements | 1,800,000 | 1,800,000 |
Estimated fixed future minimum rental commitment | 13,300,000 | 13,300,000 |
Estimated variable future minimum rental commitment | $ 6,400,000 | $ 6,400,000 |
X | ||||||||||
- Definition Amount of estimated variable future minimum rental payments for operating lease over the term of the lease. No definition available.
|
X | ||||||||||
- Definition The amount reimbursable from the landlord for tenant improvements per lease agreement. No definition available.
|
X | ||||||||||
- Definition Amount of rent expense incurred for leased assets, including but not limited to, furniture and equipment, that is not directly or indirectly associated with the manufacture, sale or creation of a product or product line. No definition available.
|
X | ||||||||||
- Definition Amount of operating lease expense. Excludes sublease income. Reference 1: http://www.xbrl.org/2009/role/commonPracticeRef
|
X | ||||||||||
- Definition Amount of required minimum rental payments for leases having an initial or remaining non-cancelable letter-terms in excess of one year. Reference 1: http://fasb.org/us-gaap/role/ref/otherTransitionRef
|