Cover
Cover - USD ($) | 12 Months Ended | ||
Dec. 31, 2019 | Feb. 17, 2020 | Jun. 28, 2019 | |
Cover [Abstract] | |||
Document Type | 10-K | ||
Amendment Flag | false | ||
Document Annual Report | true | ||
Document Transition Report | false | ||
Document Period End Date | Dec. 31, 2019 | ||
Document Fiscal Period Focus | FY | ||
Document Fiscal Year Focus | 2019 | ||
Current Fiscal Year End Date | --12-31 | ||
Entity File Number | 001-00100 | ||
Entity Registrant Name | TherapeuticsMD, Inc. | ||
Entity Central Index Key | 0000025743 | ||
Entity Tax Identification Number | 87-0233535 | ||
Entity Incorporation, State or Country Code | NV | ||
Entity Address, Address Line One | 951 Yamato Rd. | ||
Entity Address, Address Line Two | Suite 220 | ||
Entity Address, City or Town | Boca Raton | ||
Entity Address, State or Province | FL | ||
Entity Address, Postal Zip Code | 33431 | ||
City Area Code | (561) | ||
Local Phone Number | 961-1900 | ||
Title of 12(b) Security | Common Stock, par value $0.001 per share | ||
Trading Symbol | TXMD | ||
Security Exchange Name | NASDAQ | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
Entity Current Reporting Status | Yes | ||
Entity Interactive Data Current | Yes | ||
Entity Filer Category | Large Accelerated Filer | ||
Entity Small Business | false | ||
Entity Emerging Growth Company | false | ||
Entity Shell Company | false | ||
Entity Public Float | $ 539,237,585 | ||
Entity Common Stock, Shares Outstanding | 271,526,176 | ||
Entity Common Stock Held by Non-affiliates | 207,399,071 |
CONSOLIDATED BALANCE SHEETS
CONSOLIDATED BALANCE SHEETS - USD ($) | Dec. 31, 2019 | Dec. 31, 2018 |
Current Assets: | ||
Cash | $ 160,829,713 | $ 161,613,077 |
Accounts receivable, net of allowance for doubtful accounts of $904,040 and $596,602, respectively | 24,395,958 | 11,063,821 |
Inventory | 11,860,716 | 3,267,670 |
Other current assets | 11,329,793 | 10,834,693 |
Total current assets | 208,416,180 | 186,779,261 |
Fixed assets, net | 2,507,775 | 472,683 |
Other Assets: | ||
License rights, net | 39,221,308 | 20,000,000 |
Intangible assets, net | 5,258,211 | 4,092,679 |
Right of use asset | 10,109,154 | |
Other assets | 473,009 | 639,301 |
Total other assets | 55,061,682 | 24,731,980 |
Total assets | 265,985,637 | 211,983,924 |
Current Liabilities: | ||
Accounts payable | 19,181,212 | 22,743,841 |
Other current liabilities | 33,823,613 | 18,334,948 |
Total current liabilities | 53,004,825 | 41,078,789 |
Long-Term Liabilities: | ||
Long-term debt | 194,634,643 | 73,381,014 |
Operating lease liability | 9,145,049 | |
Total liabilities | 256,784,517 | 114,459,803 |
Stockholders’ Equity: | ||
Preferred stock - par value $0.001; 10,000,000 shares authorized; no shares issued and outstanding | ||
Common stock - par value $0.001; 350,000,000 shares authorized: 271,177,076 and 240,462,439 issued and outstanding, respectively | 271,177 | 240,463 |
Additional paid-in capital | 704,351,222 | 616,559,938 |
Accumulated deficit | (695,421,279) | (519,276,280) |
Total stockholders’ equity | 9,201,120 | 97,524,121 |
Total liabilities and stockholders’ equity | $ 265,985,637 | $ 211,983,924 |
CONSOLIDATED BALANCE SHEETS (Pa
CONSOLIDATED BALANCE SHEETS (Parenthetical) - USD ($) | Dec. 31, 2019 | Dec. 31, 2018 |
Statement of Financial Position [Abstract] | ||
Allowance for doubtful accounts | $ 904,040 | $ 596,602 |
Preferred Stock, Par or Stated Value Per Share | $ 0.001 | $ 0.001 |
Preferred Stock, Shares Authorized | 10,000,000 | 10,000,000 |
Preferred Stock, Shares Issued | 0 | 0 |
Preferred Stock, Shares Outstanding | 0 | 0 |
Common Stock, Par or Stated Value Per Share | $ 0.001 | $ 0.001 |
Common Stock, Shares Authorized | 350,000,000 | 350,000,000 |
Common Stock, Shares, Issued | 271,177,076 | 240,462,439 |
Common Stock, Shares, Outstanding | 271,177,076 | 240,462,439 |
CONSOLIDATED STATEMENTS OF OPER
CONSOLIDATED STATEMENTS OF OPERATIONS - USD ($) | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Total revenue, net | $ 49,646,937 | $ 16,099,460 | $ 16,777,713 |
Cost of goods sold | 6,334,585 | 2,737,652 | 2,636,943 |
Gross profit | 43,312,352 | 13,361,808 | 14,140,770 |
Operating expenses: | |||
Sales, general, and administrative | 174,112,612 | 115,988,954 | 57,703,370 |
Research and development | 19,792,212 | 27,299,138 | 33,852,993 |
Depreciation and amortization | 612,786 | 293,886 | 213,117 |
Total operating expenses | 194,517,610 | 143,581,978 | 91,769,480 |
Operating loss | (151,205,258) | (130,220,170) | (77,628,710) |
Other (expense) income | |||
Loss on extinguishment of debt | (10,057,632) | ||
Miscellaneous income | 2,500,106 | 2,280,844 | 695,631 |
Interest expense | (17,382,215) | (4,677,834) | |
Accreted interest | 7,699 | ||
Total other (expense) income | (24,939,741) | (2,396,990) | 703,330 |
Loss before income taxes | (176,144,999) | (132,617,160) | (76,925,380) |
Provision for income taxes | |||
Net loss | $ (176,144,999) | $ (132,617,160) | $ (76,925,380) |
Loss per share, basic and diluted: | |||
Net loss per share, basic and diluted | $ (0.72) | $ (0.59) | $ (0.37) |
Weighted average number of common shares outstanding, basic and diluted | 246,353,318 | 225,026,300 | 205,523,288 |
Product [Member] | |||
Total revenue, net | $ 34,140,537 | $ 16,099,460 | $ 16,777,713 |
License and Service [Member] | |||
Total revenue, net | $ 15,506,400 |
CONSOLIDATED STATEMENTS OF STOC
CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY - USD ($) | Common Stock [Member] | Additional Paid-in Capital [Member] | Retained Earnings [Member] | Total |
Beginning balance, value at Dec. 31, 2016 | $ 196,688 | $ 436,995,052 | $ (309,702,319) | $ 127,489,421 |
Beginning balance (in shares) at Dec. 31, 2016 | 196,688,222 | |||
Shares issued in offerings, net of cost | $ 12,400 | 68,560,235 | 68,572,635 | |
Shares issued in offerings, net of cost (in shares) | 12,400,000 | |||
Shares issued for exercise of options, net | $ 103 | 212,512 | $ 212,615 | |
Shares issued for exercise of options, net (in shares) | 102,546 | 102,546 | ||
Shares issued for exercise of warrants, net | $ 7,239 | 3,791,760 | $ 3,798,999 | |
Shares issued for exercise of warrants, net (in shares) | 7,238,874 | |||
Share-based compensation | 6,760,425 | 6,760,425 | ||
Adoption of ASU 2016-09 at Dec. 31, 2016 | 31,421 | (31,421) | ||
Net loss | (76,925,380) | (76,925,380) | ||
Ending balance, value at Dec. 31, 2017 | $ 216,430 | 516,351,405 | (386,659,120) | 129,908,715 |
Ending balance (in shares) at Dec. 31, 2017 | 216,429,642 | |||
Shares issued in offerings, net of cost | $ 18,578 | 89,889,219 | 89,907,797 | |
Shares issued in offerings, net of cost (in shares) | 18,578,430 | |||
Shares issued for exercise of options, net | $ 5,455 | 1,660,753 | 1,666,208 | |
Shares issued for exercise of options, net (in shares) | 5,454,367 | |||
Share-based compensation | 8,658,561 | 8,658,561 | ||
Net loss | (132,617,160) | (132,617,160) | ||
Ending balance, value at Dec. 31, 2018 | $ 240,463 | 616,559,938 | (519,276,280) | $ 97,524,121 |
Ending balance (in shares) at Dec. 31, 2018 | 240,462,439 | 240,462,439 | ||
Shares issued in offerings, net of cost | $ 29,900 | 77,001,358 | $ 77,031,258 | |
Shares issued in offerings, net of cost (in shares) | 29,900,000 | |||
Share-based compensation | 10,682,084 | 10,682,084 | ||
Net loss | (176,144,999) | (176,144,999) | ||
Shares issued for exercise of options and warrants, net | $ 814 | 107,842 | 108,656 | |
Shares issued for exercise of options and warrants, net (in shares) | 814,637 | |||
Ending balance, value at Dec. 31, 2019 | $ 271,177 | $ 704,351,222 | $ (695,421,279) | $ 9,201,120 |
Ending balance (in shares) at Dec. 31, 2019 | 271,177,076 | 271,177,076 |
CONSOLIDATED STATEMENTS OF CASH
CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
CASH FLOWS FROM OPERATING ACTIVITIES | |||
Net loss | $ (176,144,999) | $ (132,617,160) | $ (76,925,380) |
Adjustments to reconcile net loss to net cash used in operating activities: | |||
Depreciation of fixed assets | 415,193 | 181,412 | 141,601 |
Amortization of intangible assets | 197,593 | 112,474 | 71,516 |
Write off of patent and trademark cost | 78,864 | ||
Non-cash operating lease expense | 1,062,318 | ||
Provision for doubtful accounts | 307,438 | 216,022 | 4,206 |
Loss of extinguishment of debt | 10,057,632 | ||
Share-based compensation | 10,693,662 | 8,661,967 | 6,889,323 |
Amortization of intellectual property license fee | 778,692 | ||
Amortization of deferred financing costs | 856,302 | 269,859 | |
Changes in operating assets and liabilities: | |||
Accounts receivable | (13,639,575) | (6,951,041) | 167,691 |
Inventory | (8,593,046) | (1,782,312) | (409,037) |
Other assets | (1,880,048) | (2,657,190) | (4,434,130) |
Accounts payable | (3,562,629) | 18,646,241 | (3,260,914) |
Accrued expenses and other liabilities | 13,675,008 | 9,107,947 | 1,599,510 |
Net cash used in operating activities | (165,697,595) | (106,811,781) | (76,155,614) |
CASH FLOWS FROM INVESTING ACTIVITIES | |||
Payment for intellectual property license | (20,000,000) | (20,000,000) | |
Patent costs | (1,441,989) | (1,105,407) | (765,291) |
Purchase of fixed assets | (2,450,285) | (217,040) | (61,817) |
Payment of security deposit | (20,420) | (175,410) | |
Net cash used in investing activities | (23,912,694) | (21,497,857) | (827,108) |
CASH FLOWS FROM FINANCING ACTIVITIES | |||
Proceeds from exercise of options and warrants | 108,656 | 1,666,208 | 4,011,614 |
Proceeds from sale of common stock, net of costs | 77,031,258 | 89,907,797 | 68,572,635 |
Proceeds from Financing Agreement | 200,000,000 | ||
Proceeds from Credit Agreement | 75,000,000 | ||
Payment of deferred financing fees | (6,652,270) | (3,786,918) | |
Repayment of Credit Agreement | (81,660,719) | ||
Net cash provided by financing activities | 188,826,925 | 162,787,087 | 72,584,249 |
(Decrease) increase in cash | (783,364) | 34,477,449 | (4,398,473) |
Cash, beginning of period | 161,613,077 | 127,135,628 | 131,534,101 |
Cash, end of period | 160,829,713 | 161,613,077 | 127,135,628 |
Supplemental disclosure of cash flow information | |||
Interest paid | $ 17,787,903 | $ 1,890,166 |
THE COMPANY
THE COMPANY | 12 Months Ended |
Dec. 31, 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 Nature of Business We are a women’s healthcare company with a mission of creating and commercializing innovative products to support the lifespan of women from pregnancy prevention through 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 a patient-controlled, long-lasting contraceptive to advanced hormone therapy pharmaceutical products. We also manufacture and distribute branded and generic prescription prenatal vitamins under the vitaMedMD and BocaGreenMD brands. Our portfolio of products focused on women’s health allows us to efficiently leverage our sales and marketing plan to grow our recently approved products. During 2018, the U.S. Food and Drug Administration, or FDA, approval of our pharmaceutical products has transitioned our company from predominately focused on conducting research and development to one focused on commercializing our pharmaceutical products. 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 our FDA-approved product BIJUVA (estradiol and progesterone) capsules , our hormone therapy combination of bio-identical 17ß-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. In October 2019, we began a test and learn market introduction for our FDA-approved product ANNOVERA (segesterone acetate and ethinyl estradiol vaginal system), the first and only patient-controlled, procedure-free, reversible prescription contraceptive option for women. We expect the full commercial launch of ANNOVERA in the first quarter of 2020. On July 30, 2018, we entered into an exclusive license agreement, or the Population Council License Agreement, with the Population Council, Inc., or the Population Council, to commercialize ANNOVERA in the U.S. In addition, on July 30, 2018, we entered into a license and supply agreement , or the Knight License Agreement, |
SUMMARY OF SIGNIFICANT ACCOUNTI
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | 12 Months Ended |
Dec. 31, 2019 | |
Accounting Policies [Abstract] | |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | NOTE 2 – SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES Principles of Consolidation The accompanying consolidated financial statements include the accounts of our company and our wholly owned subsidiaries, VitaMed, BocaGreen and VitaCare. All intercompany balances and transactions have been eliminated in consolidation. Cash We maintain cash at financial institutions that at times may exceed the Federal Deposit Insurance Corporation, or the FDIC, insured limits of $ 250,000 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 evaluate trade accounts receivable aged more than 90 days for delinquency. 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. At December 31, 2019, four different customers represented 36 21 16 11 42 24 13 Inventories Inventories represent pharmaceutical products, packaged vitamins and raw materials which are valued at the lower of cost or net realizable value. Our pharmaceutical products are valued using first in first out method and our vitamins are valued using the average-cost method. We review our inventory for excess or obsolete inventory and write-down obsolete or otherwise unmarketable inventory to its estimated net realizable value. Obsolescence may occur due to product expiring or product improvements rendering previous versions obsolete. Pre-Launch Inventory Pre-launch inventory costs associated with product candidates that have not yet received regulatory approval are capitalized if we believe there is probable future commercial use and future economic benefit. If the probability of future commercial use and future economic benefit cannot be reasonably determined, then pre-launch inventory costs associated with such product candidates are expensed as research and development expenses during the period the costs are incurred. We have not capitalized any pre-launch inventory to date. Fixed Assets We state fixed assets at cost, net of accumulated depreciation. We charge maintenance costs, which do not significantly extend the useful lives of the respective assets, and repair costs to operating expenses as incurred. We compute depreciation using the straight-line method over the estimated useful lives of the related assets, which range from three seven We capitalize software and software development costs incurred to create and acquire computer software for internal use, principally related to software coding and application development. We begin to capitalize software development costs when both the preliminary project stage is completed and it is probable that the software will be used as intended. Capitalized software costs include only external direct costs and services utilized in developing or obtaining computer software. Capitalized software costs are amortized on a straight-line basis when placed into service over the estimated useful life, generally five seven Intangible Assets We have adopted the provisions of Financial Accounting Standards Board, or FASB, Accounting Standards Codification, or ASC, 350, Intangibles - Goodwill and Other 29 30 Impairment of Long-Lived Assets We review the carrying values of fixed assets and long-lived intangible assets to be held and used for impairment whenever events or changes in circumstances indicate that their carrying values may not be recoverable. Such events or circumstances may include, among others, the following: ● significant declines in an asset’s market price; ● significant deterioration in an asset’s physical condition; ● significant changes in the nature or extent of an asset’s use or operation; ● significant adverse changes in the business climate that could impact an asset’s value, including adverse actions or assessments by regulators; ● accumulation of costs significantly in excess of original expectations related to the acquisition or construction of an asset; ● current-period operating or cash flow losses combined with a history of such losses or a forecast that demonstrates continuing losses associated with an asset’s use; and ● expectations that it is more likely than not that an asset will be sold or otherwise disposed of significantly before the end of its previously estimated useful life. If impairment indicators are present, we determine whether an impairment loss should be recognized by testing the applicable asset or asset group’s carrying value for recoverability. This test requires long-lived assets to be grouped at the lowest level for which identifiable cash flows are largely independent of the cash flows of other assets and liabilities, the determination of which requires judgment. We estimate the undiscounted future cash flows expected to be generated from the use and eventual disposal of the assets and compare that estimate to the respective carrying values in order to determine if such carrying values are recoverable. This assessment requires the exercise of judgment in assessing the future use of and projected value to be derived from the eventual disposal of the assets to be held and used. In our assessments, we also consider changes in asset utilization, including, if applicable, the temporary idling of capacity and the expected timing for placing this capacity back into production. If the carrying value of the assets is not recoverable, then we record a loss for the difference between the assets’ fair value and respective carrying values. We determine the fair value of the assets using an “income approach” based upon a forecast of all the expected discounted future net cash flows associated with the subject assets. Some of the more significant estimates and assumptions include market size and growth, market share, projected selling prices, manufacturing cost, and discount rate. We base estimates upon historical experience, our commercial relationships, market conditions, and available external information about future trends. We believe our current assumptions and estimates are reasonable and appropriate. Unanticipated events and changes in market conditions, however, could affect such estimates, resulting in the need for an impairment charge in future periods. There was no impairment of long-lived assets to be held and used during the years ended December 31, 2019, 2018, and 2017. We perform impairment tests for intangible assets with indefinite useful lives annually, in the fourth quarter, or more frequently if events occur or circumstances change that would more likely than not reduce the fair value of an intangible asset below its carrying value. The impairment test for assets with indefinite lives consists of a comparison of the fair value of the asset with its carrying amount. If the carrying amount of an intangible asset exceeds its fair value, an impairment loss is recognized in an amount equal to that excess. 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. 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. T he carrying amount for long-term debt as of December 31, 2019 and 2018 (as disclosed in Note 8), 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 ASC 820, Fair Value Measurements Level 1 unadjusted quoted prices in active markets for identical assets or liabilities; Level 2 quoted prices for similar assets or liabilities in active markets or inputs that are observable for the asset or liability, either directly or indirectly through market corroboration, for substantially the full term of the financial instrument; and Level 3 unobservable inputs for the assets or liabilities. At December 31, 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 is measured on a non-recurring basis using significant unobservable inputs (Level 3) in connection with any required impairment test. During the year ended December 31, 2019, we wrote off $78,864 in costs related to trademarks and patents, including the net carrying amount of our OPERA software patent. There was no impairment of intangible assets during the years ended December 31, 2018, and 2017. Income Taxes We account for income taxes under the asset and liability method. We recognize deferred tax assets and liabilities for the estimated future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax basis. We measure deferred tax assets and liabilities using enacted tax rates expected to apply to taxable income in the years in which the related temporary differences are expected to be recovered or settled. We recognize the effect on deferred tax assets and liabilities of a change in tax rates when the rate change is enacted. Valuation allowances are recorded to reduce deferred tax assets to the amount that will more likely than not be realized. In accordance with ASC 740, Income Taxes We recognize both interest and penalties related to uncertain tax positions as part of the income tax provision. At December 31, 2019 and 2018, we had no tax positions relating to open tax returns that were considered to be uncertain. Our U.S. federal and state tax returns since 2011, which was the first year we generated net operating losses, remain open to examination. 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. 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 of options 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 non-employees 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 non-employees 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. Revenue Recognition We adopted ASC 606, Revenue from Contracts with Customers Prescription Products As of December 31, 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 started selling ANNOVERA in the third quarter of 2019 and we expect the full commercial launch of ANNOVERA in the first quarter of 2020. 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. 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 12 24 18 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 7. 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 commercial launches for our FDA-approved prescription products, we introduced a co-pay assistance program for eligible enrolled patients whose out of pocket costs are reduced to a more affordable price. This allows patients to access the product at a reasonable cost and is in line with our responsible pricing approach. We reimburse pharmacies for this discount through third-party vendors. We consider certain 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 our prescription products 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 our prescription products is susceptible to such changes in coverage levels, which are outside the influence of the Company. As a result, we constrain variable consideration for our prescription products to an amount that will not result in a significant revenue reversal in future periods. Our ability to estimate the net transaction price for our prescription products is constrained by our estimates of the amount to be paid for the co-pay assistance program 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 variable consideration each reporting period. License Revenue License arrangements may consist of non-refundable upfront license fees, exclusive licensed rights to patented or patent pending technology, and various performance or sales milestones and future product royalty payments. Some of these arrangements may include multiple performance obligations. Non-refundable up-front fees that are not contingent on any future performance by us, and do not require continuing involvement on our part, are recognized as revenue when the right to use functional IP is transferred to the customer. License Agreement with Knight Therapeutics Inc. On July 30, 2018, we entered into 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 purchased 3,921,568 5.10 20,000,000 License Agreement with Theramex On June 6, 2019, we entered into the Theramex License Agreement with Theramex to commercialize BIJUVA and IMVEXXY in the Theramex 14 million 15,506,400 2 million 27.5 million Theramex 25 million 100 million 5 Theramex Theramex Theramex Disaggregation of revenue The following table provides information about disaggregated revenue by product mix for the years ended December 31, 2019, 2018, and 2017: For the Years Ended December 31, 2019 2018 2017 Prescription vitamins $ 9,885,493 $ 15,041,259 $ 16,744,831 IMVEXXY 16,252,045 1,058,201 — BIJUVA 1,836,443 — — ANNOVERA 6,166,556 — — License revenue 15,506,400 — — OTC products — — 32,882 Net revenue $ 49,646,937 $ 16,099,460 $ 16,777,713 Shipping and Handling Costs We expense all shipping and handling costs as incurred. We include these costs in cost of goods sold on the accompanying consolidated financial statements. Segment Reporting We are managed and operated as one Cost of Sales Cost of sales includes the cost of inventory, manufacturing, manufacturing overhead and supply chain costs, and product shipping and handling costs. The Population Council License Agreement requires payment of royalties based on the sale of future products. Such royalties are recorded as a component of cost of sales. Additionally, the amortization of license fees or milestone payments related to licensed products are classified as components of cost of sales to the extent such payments become due in the future. Advertising Costs We expense advertising costs when incurred. Advertising costs were $ 9,045,571 1,682,746 448,288 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 other 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. These consulting 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 to expenses in the period in which the facts that give rise to the revision become known. Earnings Per Share We calculate earnings per share, or EPS, in accordance with ASC 260, Earnings Per Share 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. As of December 31, 2019 2018 2017 Stock options 25,030,234 20,872,824 23,365,225 Warrants 1,832,571 3,007,571 3,115,905 Restricted stock awards 1,240,000 1,040,000 — 28,102,805 24,920,395 26,481,130 Concentration of Credit Risk and other Risks and Uncertainties Financial instruments that potentially expose us to concentrations of credit risk consist primarily of cash and trade accounts receivable. Cash is on deposit with financial institutions in the United States and these deposits generally exceed the amount of insurance provided by the FDIC. We have not experienced any historical losses on our deposits of cash. Concentration of credit risk with respect to our trade accounts receivable from our customers is primarily limited to drug wholesalers and retail pharmacy distributors. Credit is extended to our customers based on an evaluation of a customer’s financial condition, and collateral is not required. Use of Estimates Our consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America, or GAAP. The preparation of these financial statements requires us to make significant estimates and judgments that affect the reported amounts of assets, liabilities, revenue, expenses, and related disclosure of contingent assets and liabilities. We evaluate our estimates, including those related to contingencies, on an ongoing basis. We base our estimates on historical experience and on various other assumptions that we believe to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ, at times in material amounts, from these estimates under different assumptions or conditions. Recently Issued Accounting Pronouncements In August 2018, 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 do not expect that the adoption of this standard will have a material effect on our disclosures. In June 2018, the FASB issued ASU 2018-07 to simplify the accounting for share-based payments to non-employees 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 non-employees 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 was effective for public business entities for annual periods beginning after December 15, 2018, and interim periods within those years. 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 4.1 million 7.4 million 7.2 million 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. |
INVENTORY
INVENTORY | 12 Months Ended |
Dec. 31, 2019 | |
Inventory Disclosure [Abstract] | |
INVENTORY | NOTE 3 – INVENTORY Inventory consists of the following: December 31, 2019 2018 Finished products $ 4,976,910 $ 2,908,958 Work in process 1,182,059 339,312 Raw materials 5,701,747 19,400 TOTAL INVENTORY $ 11,860,716 $ 3,267,670 |
OTHER CURRENT ASSETS
OTHER CURRENT ASSETS | 12 Months Ended |
Dec. 31, 2019 | |
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] | |
OTHER CURRENT ASSETS | NOTE 4 – OTHER CURRENT ASSETS Other current assets consist of the following: December 31, 2019 2018 Prepaid sales and marketing costs $ 1,583,698 $ 5,148,789 Debt financing fees on undrawn tranches (Note 8) 550,757 1,898,074 Prepaid insurance 1,812,135 790,465 Prepaid manufacturing 2,595,721 — Other prepaid costs 4,787,482 2,997,365 TOTAL OTHER CURRENT ASSETS $ 11,329,793 $ 10,834,693 |
FIXED ASSETS, NET
FIXED ASSETS, NET | 12 Months Ended |
Dec. 31, 2019 | |
Property, Plant and Equipment [Abstract] | |
FIXED ASSETS, NET | NOTE 5 – FIXED ASSETS, NET Fixed assets, net consist of the following: December 31, 2019 2018 Accounting system $ 301,096 $ 301,096 Equipment 1,619,646 490,576 Furniture and fixtures 1,406,858 116,542 Computer hardware 80,211 80,211 Leasehold improvements 68,788 37,888 TOTAL FIXED ASSETS 3,476,599 1,026,313 Accumulated depreciation (968,824 ) (553,630 ) TOTAL FIXED ASSETS, NET $ 2,507,775 $ 472,683 Depreciation expense for the years ended December 31, 2019, 2018, and 2017 was $ 415,193 181,412 141,601 |
INTANGIBLE ASSETS, NET
INTANGIBLE ASSETS, NET | 12 Months Ended |
Dec. 31, 2019 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
INTANGIBLE ASSETS, NET | NOTE 6 – INTANGIBLE ASSETS, NET The following table sets forth the gross carrying amount, accumulated amortization and net carrying amount of our intangible assets as of December 31, 2019 and 2018: December 31, 2019 Gross Carrying Amount Accumulated Amortization Net Weighted- Amortizable intangible assets: Approved hormone therapy drug candidate patents $ 3,463,082 $ (478,983 ) $ 2,984,099 13 Hormone therapy drug candidate patents (pending) 1,979,299 — 1,979,299 n/a Non-amortizable intangible assets: Multiple trademarks 294,813 — 294,813 indefinite TOTAL $ 5,737,194 $ (478,983 ) $ 5,258,211 December 31, 2018 Gross Carrying Amount Accumulated Amortization Net Weighted- Average Amortizable intangible assets: OPERA software patent $ 31,951 $ (10,484 ) $ 21,467 10.75 Development costs of corporate website 91,743 (91,743 ) — n/a Approved hormone therapy drug candidate patents 2,234,129 (282,485 ) 1,951,644 14 Hormone therapy drug candidate patents (pending) 1,855,279 — 1,855,279 n/a Non-amortizable intangible assets: Multiple trademarks 264,289 — 264,289 indefinite TOTAL $ 4,477,391 $ (384,712 ) $ 4,092,679 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 approximately 20 78,864 As of December 31, 2019, we had 29 30 ● 12 six three ● Six domestic patents ( five utility and one 13 three ten ● One ● One seven foreign patents that relate to our transdermal-patch candidates, which are owned by us. The domestic utility patent will expire in 2032. The foreign patents will expire no earlier than 2033. We have pending patent applications with respect to our transdermal-patch candidates in the U.S., Brazil, Canada, Mexico, and South Africa; ● Three domestic utility patents that relate to TX-009HR, a progesterone and estradiol product candidate, which are owned by us and will expire in 2037. We have pending patent applications with respect to TX-009HR in the U.S., Argentina, Australia, Brazil, Canada, Europe, Israel, Japan, Mexico, New Zealand, Russia, South Africa, and South Korea. ● Two domestic and four will expire 2032 . The foreign patents will expire no earlier than 2033. In addition, we have pending patent applications with respect formulations containing progesterone in the U.S., Argentina, Australia, Brazil, Canada, Europe, Israel, Japan, Mexico, Russia, South Africa, and South Korea; ● One Amortization expense was $ 197,593 112,474 71,516 Estimated amortization expense, based on current patent cost being amortized, for the next five years is as follows: Year Ending Estimated 2020 $229,546 2021 $229,546 2022 $229,546 2023 $229,546 2024 $229,546 License Agreement with the Population Council On July 30, 2018, we entered into the Population Council License Agreement to commercialize ANNOVERA in the U.S. ANNOVERA became commercially available in the third quarter of 2019 and we expect the full commercial launch of ANNOVERA in the first quarter of 2020. Under the terms of the Population Council License Agreement, we paid the Population Council a milestone payment of $ 20,000,000 20,000,000 20,000,000 778,692 The Population Council is also eligible to receive milestone payments and royalties from commercial sales of ANNOVERA. We are responsible for marketing expenses related to the commercialization 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 5 50,000,000 150,000,000 10 150,000,000 15 50 20 40 million 200 million 400 million 1 billion 20,000,000 |
OTHER CURRENT LIABILITIES
OTHER CURRENT LIABILITIES | 12 Months Ended |
Dec. 31, 2019 | |
Payables and Accruals [Abstract] | |
OTHER CURRENT LIABILITIES | NOTE 7 – OTHER CURRENT LIABILITIES Other current liabilities consist of the following: December 31, 2019 2018 Accrued payroll, bonuses and commission costs $ 8,040,278 $ 6,854,002 Allowance for coupons and returns 10,316,298 5,294,120 Accrued sales and marketing costs 3,285,662 2,288,028 Accrued compensated absences 1,463,878 1,178,110 Allowance for wholesale distributor fees 2,347,122 792,891 Accrued legal and accounting expense 422,336 385,824 Accrued research and development 1,049,603 388,675 Accrued rent — 365,155 Operating lease liability 1,501,539 — Accrued rebates 3,916,672 412,570 Other accrued expenses 1,480,225 375,573 TOTAL OTHER CURRENT LIABILITIES $ 33,823,613 $ 18,334,948 |
DEBT
DEBT | 12 Months Ended |
Dec. 31, 2019 | |
Debt Disclosure [Abstract] | |
DEBT | NOTE 8 – DEBT On April 24, 2019, we entered into a Financing Agreement, as amended on December 27, 2019, 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 our subsidiaries party thereto from time to time as guarantors, which provides us with a $ 300,000,000 200,000,000 50,000,000 50,000,000 11,000,000 3-month LIBOR 7.75 2.70 prime rate 6.75 5.2 four 30.0 5.0 3.0 1.0 2.5 50,000,000 60,000,000 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 three one-month LIBOR 1.50 7.75 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 4 4 10,057,632 1,816,747 120,146 as interest expense in our accompanying consolidated financial statements uring the year ended December 31, 2018, we amortized $ 269,859 As of December 31, 2019, we had $ 200,000,000 6,652,270 6,101,513 736,156 of deferred financing fees related to the first tranche as interest expense in the accompanying consolidated financial statements. Interest on amounts borrowed under the Financing Agreement is due and payable quarterly in arrears. Interest expense for the year ended December 31, 2019 was $ 14,709,166 . The overall effective interest rate under the Financing Agreement was approximately 11 % as of December 31, As of December 31, 2019 and 2018, the carrying value of our debt consisted of the following: As of December 31, 2019 2018 Financing Agreement $ 200,000,000 $ — Credit Agreement — 75,000,000 Debt discount and financing fees (5,365,357 ) (1,618,986 ) TOTAL LONG-TERM DEBT $ 194,634,643 $ 73,381,014 |
STOCKHOLDERS_ EQUITY
STOCKHOLDERS’ EQUITY | 12 Months Ended |
Dec. 31, 2019 | |
Equity [Abstract] | |
STOCKHOLDERS’ EQUITY | NOTE 9 – STOCKHOLDERS’ EQUITY Preferred Stock At December 31, 2019, we had 10,000,000 0.001 no Common Stock At December 31, 2019, we had 350,000,000 271,177,076 Issuances During 2019 On October 24, 2019, we entered into an underwriting agreement with J.P. Morgan Securities LLC, as representative of the underwriters, relating to an underwritten public offering of 26,000,000 2.75 30 days 3,900,000 77,031,000 During the year ended December 31, 2019, certain individuals exercised stock options to purchase an aggregate of 331,619 108,656 12,097 11,834 Issuances During 2018 On August 1, 2018, we entered into an underwriting agreement with Goldman Sachs & Co. LLC, as representative of the underwriters, relating to an underwritten public offering of 12,745,098 5.10 30 days 1,911,764 69,908,000 3,921,568 5.10 20,000,000 During the year ended December 31, 2018, certain individuals exercised stock options to purchase an aggregate of 5,444,526 1,666,208 10,000 9,841 Issuances During 2017 On September 25, 2017, we entered into an underwriting agreement with J.P. Morgan Securities LLC relating to an underwritten public offering of 12,400,000 5.55 68,573,000 12,400,000 During the year ended December 31, 2017, certain individuals exercised stock options to purchase an aggregate of 102,546 212,615 Warrants to Purchase Common Stock As of December 31, 2019, we had warrants outstanding to purchase an aggregate of 1,832,571 1.95 0.24 8.20 2.62 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 yield and the term of the warrant. During the year ended December 31, 2019, we granted warrants to purchase an aggregate of 75,000 12 February 13, 2024 175,000 12 March 15, 2023 125,000 12 March 15, 2022 We recorded share-based compensation expense related to warrants previously issued of $ 254,970 494,136 313,271 26,446 0.1 Summary of our Warrant activity during the year ended December 31, 2019: Number of Shares Under Warrants Weighted Average Exercise Price Weighted Average Remaining Contractual Life in Years Aggregate Intrinsic Value Balance at December 31, 2018 3,007,571 $ 2.78 1.58 $ 4,826,403 Granted 75,000 $ 5.63 Exercised (1,250,000 ) $ 3.20 $ 2,420,000 Expired — — — Cancelled/Forfeited — — — Balance at December 31, 2019 1,832,571 $ 2.62 1.95 $ 2,447,929 Vested and Exercisable at December 31, 2019 1,820,071 $ 2.60 1.90 $ 2,447,929 Unvested at December 31, 2019 12,500 $ 5.63 9.13 — The weighted average fair value per share of warrants issued and the assumptions used in the Black-Scholes Model during the years ended December 31, 2019, 2018, and 2017 are set forth in the table below. 2019 2018 2017 Weighted average exercise price $ 5.63 $ 5.16 $ 6.83 Weighted average grant date fair value $ 3.00 $ 2.79 $ 3.67 Risk-free interest rate 2.52 % 2.36 % 1.47 % Volatility 60.8 % 62.12 % 63.24 % Term (in years) 5 5 5 Dividend yield 0.00 % 0.00 % 0.00 % Warrant exercises During the year ended December 31, 2019, warrants to purchase an aggregate of 1,250,000 471,184 no During the year ended December 31, 2017, certain individuals exercised warrants to purchase an aggregate of 2,476,666 3,798,999 6,590,000 4,762,208 Options to Purchase Common Stock of the Company 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. As of December 31, 2019, there were non-qualified stock options to purchase an aggregate of 15,017,759 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. As of December 31, 2019, there were non-qualified stock options to purchase an aggregate of 6,316,474 1,040,000 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 December 31, 2019, there were 13,599,382 11,103,999 2,395,333 100,050 3,696,001 200,000 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 ranges of assumptions used in the Black-Scholes Model during the years ended December 31, 2019, 2018, and 2017 are set forth in the table below. 2019 2018 2017 Weighted average exercise price $ 3.10 $ 5.45 $ 6.60 Weighted average grant date fair value $ 1.82 $ 3.24 $ 3.82 Risk-free interest rate 1.64 2.54 % 2.38 2.89 % 1.84 2.05 % Volatility 61.25 64.49 % 59.45 64.04 % 61.56 64.25 % Term (in years) 5.5 6.5 5.1 6.25 5.5 6.25 Dividend yield 0.00 % 0.00 % 0.00 % A summary of activity under the 2009, 2012 and 2019 Plans and related information during the year ended December 31, 2019 is as follows: Number of Shares Under Options Weighted Average Exercise Price Weighted Average Remaining Contractual Life in Years Aggregate Intrinsic Value Balance at December 31, 2018 20,872,824 $ 4.93 5.94 $ 12,239,876 Granted 4,620,501 $ 3.10 Exercised (343,716 ) $ 0.32 $ 1,426,828 Expired (26,375 ) $ 5.57 Cancelled/Forfeited (93,000 ) $ 5.16 Balance at December 31, 2019 25,030,234 $ 4.65 5.84 $ 3,668,171 Vested and Exercisable at December 31, 2019 18,025,819 $ 4.88 4.62 $ 3,319,621 Unvested at December 31, 2019 7,004,415 $ 4.05 8.96 $ 348,550 At December 31, 2019, our outstanding options had exercise prices ranging from $ 0.19 8.92 8,798,707 8,091,294 6,447,154 11,460,000 2.4 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 an aggregate of 1,040,000 4.06 150,000 200,000 2.18 1,628,407 73,132 2,711,000 2.0 1,240,000 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 |
INCOME TAXES
INCOME TAXES | 12 Months Ended |
Dec. 31, 2019 | |
Income Tax Disclosure [Abstract] | |
INCOME TAXES | NOTE 10 – INCOME TAXES For financial reporting purposes, income before taxes includes the following components: 2019 2018 2017 United States $ (176,144,999 ) $ (132,617,160 ) $ (76,925,380 ) Total $ (176,144,999 ) $ (132,617,160 ) $ (76,925,380 ) For the years ended December 31, 2019, 2018, and 2017, there was no provision for income taxes, current or deferred. At December 31, 2019, we had a federal net operating loss carry forward of approximately $ 620,354,163 338,775,332 20 years 2031 281,578,831 A reconciliation between taxes computed at the federal statutory rate and the consolidated effective tax rate is as follows: 2019 2018 2017 Federal statutory tax rate 21.0 % 21.0 % 34.0 % State tax rate, net of federal tax benefit 4.0 % 5.2 % 5.0 % Adjustment in valuation allowances (22.5 )% (31.2 )% 22.6 % Excess stock benefits 0.2 % 5.3 % — % Federal income tax rate change 0 % — % (60.8 )% Permanent and other differences (2.7 )% (0.3 )% (0.8 )% Provision (benefit) for income taxes — — — Deferred income taxes result from temporary differences between the amount of assets and liabilities recognized for financial reporting and tax purposes. The components of the net deferred income tax asset as of December 31, 2019, 2018, and 2017 are as follows: 2019 2018 2017 Deferred Income Tax Assets: Net operating losses $ 180,520,709 $ 140,891,764 $ 99,596,321 R&D Credit 186,347 186,347 186,347 Total deferred income tax asset 180,707,056 141,078,111 99,782,668 Valuation allowance (180,707,056 ) (141,078,111 ) (99,782,668 ) Deferred income tax assets, net $ — $ — $ — We believe that it is more likely than not that we will not generate sufficient future taxable income to realize the tax benefits related to the deferred tax assets on our balance sheet and as such, a valuation allowance has been established against the deferred tax assets for the period ended December 31, 2019. Unrecognized Tax Benefits As of the period ended December 31, 2019, we have no unrecognized tax benefits. On December 22, 2017, the U.S. federal government enacted comprehensive tax legislation commonly referred to as the Tax Cuts and Jobs Act, or the Tax Act. The Tax Act makes broad and complex changes to the U.S. federal tax code, including, but not limited to reducing the U.S. federal corporate tax rate from 34 21 46.7 million |
RELATED PARTIES
RELATED PARTIES | 12 Months Ended |
Dec. 31, 2019 | |
Related Party Transactions [Abstract] | |
RELATED PARTIES | NOTE 11 – 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 years ended December 31, 2019, 2018 and 2017, we were billed by Catalent approximately $ 6,101,000 $ 4,111,000 3,646,000 , respectively, for manufacturing activities related to our clinical trials, scale-up, registration batches, stability and validation testing. As of December 31, 2019 and 2018, there were amounts due to Catalent of approximately $ 35,000 and $ 88,000 , respectively. In addition, we have minimum purchase requirements in place with Catalent as disclosed in Note 13, Commitments and Contingencies. |
BUSINESS CONCENTRATIONS
BUSINESS CONCENTRATIONS | 12 Months Ended |
Dec. 31, 2019 | |
Risks and Uncertainties [Abstract] | |
BUSINESS CONCENTRATIONS | NOTE 12 – BUSINESS CONCENTRATIONS We purchase our prescription products from several suppliers with approximately 24 27 35 three 43 33 24 three 100 one We sell our prescription 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 each of the years ended December 31, 2019, 2018 and 2017, four 10 73 76 59 During the year ended December 31, 2019, McKesson Corporation accounted for approximately $ 3,911,000 12,676,000 3,927,000 4,551,000 1,610,000 5,075,000 3,246,000 2,308,000 2,667,000 1,959,000 2,559,000 2,715,000 |
COMMITMENTS AND CONTINGENCIES
COMMITMENTS AND CONTINGENCIES | 12 Months Ended |
Dec. 31, 2019 | |
Commitments and Contingencies Disclosure [Abstract] | |
COMMITMENTS AND CONTINGENCIES | NOTE 13 – COMMITMENTS AND CONTINGENCIES Operating Leases 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 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 In October 2018, we entered into a lease for new corporate offices in Boca Raton, Florida. The lease includes 56,212 7,561 48,651 11 years two five years 6,536 Supplemental lease information Right-of-use asset $ 10,109,154 Short-term operating lease liability (included in Other current liabilities) $ 1,501,539 Long-term operating lease liability $ 9,145,049 Weighted average remaining term 9 Years Weighted average discount rate 8.25 % Supplemental cash flow information for the year ended December 31, 2019 Cash paid for amounts included in the measurement of lease liabilities for operating lease $ 1,164,234 Right-of-use assets obtained in exchange for lease obligation $ 11,171,471 The following table reconciles the undiscounted cash flows for all operating leases at December 31, 2019 to the operating lease liabilities recorded on the balance sheet: Years Ending December 31, 2020 $ 1,566,617 2021 2,198,541 2022 1,262,302 2023 1,293,859 2024 1,326,206 Thereafter 8,036,931 Total undiscounted lease payments 15,684,456 Less: imputed interest (5,037,868 ) Present value of lease payments $ 10,646,588 During the year ended December 31, 2019, operating lease expense related to our real estate leases was $ 1,558,794 , and variable lease expense was insignificant. The rental expense during the years ended December 31, 2018 and 2017 was $ 1,068,275 1,029,205 Intellectual Property Licenses The Population Council License Agreement provides for future milestone payments to be paid by us for access to certain technologies. In addition, we pay royalties as a percent of revenue as described in Note 6, Intangible Assets, to these consolidated financial statements. Purchase Commitments We have manufacturing and supply agreements whereby we are required to purchase from Catalent a minimum number of softgels during the first contract year and a higher number of softgels after the first contract year. If the minimum order quantities of specific products are not met, we are required to pay Catalent 50 5,650,853 4,000,035 5,643,291 6,445,301 6,758,945 1,049,750 Legal Proceedings From time to time, we are involved in litigation and proceedings in the ordinary course of business. We are not currently involved in any legal proceeding that we believe would have a material effect on our consolidated financial condition, results of operations, or cash flows. Off-Balance Sheet Arrangements As of December 31, 2019, 2018, and 2017, we had no off-balance sheet arrangements that have had or are reasonably likely to have current or future effects on our financial condition, changes in financial condition, revenues or expenses, results of operations, liquidity, capital expenditures or capital resources that are material to investors. Employment Agreements We have entered into employment agreements with certain of our executives that provide for compensation and certain other benefits. Under certain circumstances, including a change in control, some of these agreements provide for severance or other payments, if those circumstances occur during the term of the employment agreement. |
SELECTED QUARTERLY FINANCIAL DA
SELECTED QUARTERLY FINANCIAL DATA (UNAUDITED) | 12 Months Ended |
Dec. 31, 2019 | |
Quarterly Financial Information Disclosure [Abstract] | |
SELECTED QUARTERLY FINANCIAL DATA (UNAUDITED) | NOTE 14 – SELECTED QUARTERLY FINANCIAL DATA (UNAUDITED) Summarized quarterly financial data for fiscal years 2019 and 2018 is as follows: 2019 (In thousands, except per share) First Second Quarter (1) Third (2) Fourth Quarter Revenues $ 3,947 $ 6,079 $ 23,719 $ 15,902 Gross profit $ 3,184 $ 4,830 $ 22,275 $ 13,023 Net loss $ (39,506 ) $ (55,237 ) $ (31,967 ) $ (49,435 ) Loss per common share, basic and diluted $ (0.16 ) $ (0.23 ) $ (0.13 ) $ (0.19 ) 2018 (In thousands, except per share) First Second Quarter Third Fourth Quarter Revenues $ 3,773 $ 3,763 $ 3,474 $ 5,089 Gross profit $ 3,139 $ 3,309 $ 2,775 $ 4,139 Net loss $ (24,402 ) $ (33,219 ) $ (35,605 ) $ (39,391 ) Loss per common share, basic and diluted $ (0.11 ) $ (0.15 ) $ (0.16 ) $ (0.17 ) (1) During the second quarter of 2019, we recorded $ 10.1 million (2) During the third quarter of 2019, we recorded $ 15.5 million Theramex License Agreement |
SUBSEQUENT EVENTS
SUBSEQUENT EVENTS | 12 Months Ended |
Dec. 31, 2019 | |
Subsequent Events [Abstract] | |
SUBSEQUENT EVENTS | NOTE 15 – SUBSEQUENT EVENTS On February 18, 2020, we received $ 50,000,000 11,000,000 |
SUMMARY OF SIGNIFICANT ACCOUN_2
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies) | 12 Months Ended |
Dec. 31, 2019 | |
Accounting Policies [Abstract] | |
Principles of Consolidation | Principles of Consolidation The accompanying consolidated financial statements include the accounts of our company and our wholly owned subsidiaries, VitaMed, BocaGreen and VitaCare. All intercompany balances and transactions have been eliminated in consolidation. |
Cash | Cash We maintain cash at financial institutions that at times may exceed the Federal Deposit Insurance Corporation, or the FDIC, insured limits of $ 250,000 |
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 evaluate trade accounts receivable aged more than 90 days for delinquency. 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. At December 31, 2019, four different customers represented 36 21 16 11 42 24 13 |
Inventories | Inventories Inventories represent pharmaceutical products, packaged vitamins and raw materials which are valued at the lower of cost or net realizable value. Our pharmaceutical products are valued using first in first out method and our vitamins are valued using the average-cost method. We review our inventory for excess or obsolete inventory and write-down obsolete or otherwise unmarketable inventory to its estimated net realizable value. Obsolescence may occur due to product expiring or product improvements rendering previous versions obsolete. Pre-Launch Inventory Pre-launch inventory costs associated with product candidates that have not yet received regulatory approval are capitalized if we believe there is probable future commercial use and future economic benefit. If the probability of future commercial use and future economic benefit cannot be reasonably determined, then pre-launch inventory costs associated with such product candidates are expensed as research and development expenses during the period the costs are incurred. We have not capitalized any pre-launch inventory to date. |
Fixed Assets | Fixed Assets We state fixed assets at cost, net of accumulated depreciation. We charge maintenance costs, which do not significantly extend the useful lives of the respective assets, and repair costs to operating expenses as incurred. We compute depreciation using the straight-line method over the estimated useful lives of the related assets, which range from three seven We capitalize software and software development costs incurred to create and acquire computer software for internal use, principally related to software coding and application development. We begin to capitalize software development costs when both the preliminary project stage is completed and it is probable that the software will be used as intended. Capitalized software costs include only external direct costs and services utilized in developing or obtaining computer software. Capitalized software costs are amortized on a straight-line basis when placed into service over the estimated useful life, generally five seven |
Intangible Assets | Intangible Assets We have adopted the provisions of Financial Accounting Standards Board, or FASB, Accounting Standards Codification, or ASC, 350, Intangibles - Goodwill and Other 29 30 |
Impairment of Long-Lived Assets | Impairment of Long-Lived Assets We review the carrying values of fixed assets and long-lived intangible assets to be held and used for impairment whenever events or changes in circumstances indicate that their carrying values may not be recoverable. Such events or circumstances may include, among others, the following: ● significant declines in an asset’s market price; ● significant deterioration in an asset’s physical condition; ● significant changes in the nature or extent of an asset’s use or operation; ● significant adverse changes in the business climate that could impact an asset’s value, including adverse actions or assessments by regulators; ● accumulation of costs significantly in excess of original expectations related to the acquisition or construction of an asset; ● current-period operating or cash flow losses combined with a history of such losses or a forecast that demonstrates continuing losses associated with an asset’s use; and ● expectations that it is more likely than not that an asset will be sold or otherwise disposed of significantly before the end of its previously estimated useful life. If impairment indicators are present, we determine whether an impairment loss should be recognized by testing the applicable asset or asset group’s carrying value for recoverability. This test requires long-lived assets to be grouped at the lowest level for which identifiable cash flows are largely independent of the cash flows of other assets and liabilities, the determination of which requires judgment. We estimate the undiscounted future cash flows expected to be generated from the use and eventual disposal of the assets and compare that estimate to the respective carrying values in order to determine if such carrying values are recoverable. This assessment requires the exercise of judgment in assessing the future use of and projected value to be derived from the eventual disposal of the assets to be held and used. In our assessments, we also consider changes in asset utilization, including, if applicable, the temporary idling of capacity and the expected timing for placing this capacity back into production. If the carrying value of the assets is not recoverable, then we record a loss for the difference between the assets’ fair value and respective carrying values. We determine the fair value of the assets using an “income approach” based upon a forecast of all the expected discounted future net cash flows associated with the subject assets. Some of the more significant estimates and assumptions include market size and growth, market share, projected selling prices, manufacturing cost, and discount rate. We base estimates upon historical experience, our commercial relationships, market conditions, and available external information about future trends. We believe our current assumptions and estimates are reasonable and appropriate. Unanticipated events and changes in market conditions, however, could affect such estimates, resulting in the need for an impairment charge in future periods. There was no impairment of long-lived assets to be held and used during the years ended December 31, 2019, 2018, and 2017. We perform impairment tests for intangible assets with indefinite useful lives annually, in the fourth quarter, or more frequently if events occur or circumstances change that would more likely than not reduce the fair value of an intangible asset below its carrying value. The impairment test for assets with indefinite lives consists of a comparison of the fair value of the asset with its carrying amount. If the carrying amount of an intangible asset exceeds its fair value, an impairment loss is recognized in an amount equal to that excess. 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. |
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. T he carrying amount for long-term debt as of December 31, 2019 and 2018 (as disclosed in Note 8), 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 ASC 820, Fair Value Measurements Level 1 unadjusted quoted prices in active markets for identical assets or liabilities; Level 2 quoted prices for similar assets or liabilities in active markets or inputs that are observable for the asset or liability, either directly or indirectly through market corroboration, for substantially the full term of the financial instrument; and Level 3 unobservable inputs for the assets or liabilities. At December 31, 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 is measured on a non-recurring basis using significant unobservable inputs (Level 3) in connection with any required impairment test. During the year ended December 31, 2019, we wrote off $78,864 in costs related to trademarks and patents, including the net carrying amount of our OPERA software patent. There was no impairment of intangible assets during the years ended December 31, 2018, and 2017. |
Income Taxes | Income Taxes We account for income taxes under the asset and liability method. We recognize deferred tax assets and liabilities for the estimated future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax basis. We measure deferred tax assets and liabilities using enacted tax rates expected to apply to taxable income in the years in which the related temporary differences are expected to be recovered or settled. We recognize the effect on deferred tax assets and liabilities of a change in tax rates when the rate change is enacted. Valuation allowances are recorded to reduce deferred tax assets to the amount that will more likely than not be realized. In accordance with ASC 740, Income Taxes We recognize both interest and penalties related to uncertain tax positions as part of the income tax provision. At December 31, 2019 and 2018, we had no tax positions relating to open tax returns that were considered to be uncertain. Our U.S. federal and state tax returns since 2011, which was the first year we generated net operating losses, remain open to examination. |
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. 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 of options 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 non-employees 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 non-employees 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. |
Revenue Recognition | Revenue Recognition We adopted ASC 606, Revenue from Contracts with Customers Prescription Products As of December 31, 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 started selling ANNOVERA in the third quarter of 2019 and we expect the full commercial launch of ANNOVERA in the first quarter of 2020. 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. 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 12 24 18 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 7. 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 commercial launches for our FDA-approved prescription products, we introduced a co-pay assistance program for eligible enrolled patients whose out of pocket costs are reduced to a more affordable price. This allows patients to access the product at a reasonable cost and is in line with our responsible pricing approach. We reimburse pharmacies for this discount through third-party vendors. We consider certain 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 our prescription products 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 our prescription products is susceptible to such changes in coverage levels, which are outside the influence of the Company. As a result, we constrain variable consideration for our prescription products to an amount that will not result in a significant revenue reversal in future periods. Our ability to estimate the net transaction price for our prescription products is constrained by our estimates of the amount to be paid for the co-pay assistance program 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 variable consideration each reporting period. License Revenue License arrangements may consist of non-refundable upfront license fees, exclusive licensed rights to patented or patent pending technology, and various performance or sales milestones and future product royalty payments. Some of these arrangements may include multiple performance obligations. Non-refundable up-front fees that are not contingent on any future performance by us, and do not require continuing involvement on our part, are recognized as revenue when the right to use functional IP is transferred to the customer. License Agreement with Knight Therapeutics Inc. On July 30, 2018, we entered into 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 purchased 3,921,568 5.10 20,000,000 License Agreement with Theramex On June 6, 2019, we entered into the Theramex License Agreement with Theramex to commercialize BIJUVA and IMVEXXY in the Theramex 14 million 15,506,400 2 million 27.5 million Theramex 25 million 100 million 5 Theramex Theramex Theramex Disaggregation of revenue The following table provides information about disaggregated revenue by product mix for the years ended December 31, 2019, 2018, and 2017: For the Years Ended December 31, 2019 2018 2017 Prescription vitamins $ 9,885,493 $ 15,041,259 $ 16,744,831 IMVEXXY 16,252,045 1,058,201 — BIJUVA 1,836,443 — — ANNOVERA 6,166,556 — — License revenue 15,506,400 — — OTC products — — 32,882 Net revenue $ 49,646,937 $ 16,099,460 $ 16,777,713 Shipping and Handling Costs We expense all shipping and handling costs as incurred. We include these costs in cost of goods sold on the accompanying consolidated financial statements. |
Segment Reporting | Segment Reporting We are managed and operated as one |
Cost of Sales | Cost of Sales Cost of sales includes the cost of inventory, manufacturing, manufacturing overhead and supply chain costs, and product shipping and handling costs. The Population Council License Agreement requires payment of royalties based on the sale of future products. Such royalties are recorded as a component of cost of sales. Additionally, the amortization of license fees or milestone payments related to licensed products are classified as components of cost of sales to the extent such payments become due in the future. |
Advertising Costs | Advertising Costs We expense advertising costs when incurred. Advertising costs were $ 9,045,571 1,682,746 448,288 |
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 other 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. These consulting 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 to expenses in the period in which the facts that give rise to the revision become known. |
Earnings Per Share | Earnings Per Share We calculate earnings per share, or EPS, in accordance with ASC 260, Earnings Per Share 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. As of December 31, 2019 2018 2017 Stock options 25,030,234 20,872,824 23,365,225 Warrants 1,832,571 3,007,571 3,115,905 Restricted stock awards 1,240,000 1,040,000 — 28,102,805 24,920,395 26,481,130 |
Concentration of Credit Risk and other Risks and Uncertainties | Concentration of Credit Risk and other Risks and Uncertainties Financial instruments that potentially expose us to concentrations of credit risk consist primarily of cash and trade accounts receivable. Cash is on deposit with financial institutions in the United States and these deposits generally exceed the amount of insurance provided by the FDIC. We have not experienced any historical losses on our deposits of cash. Concentration of credit risk with respect to our trade accounts receivable from our customers is primarily limited to drug wholesalers and retail pharmacy distributors. Credit is extended to our customers based on an evaluation of a customer’s financial condition, and collateral is not required. |
Use of Estimates | Use of Estimates Our consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America, or GAAP. The preparation of these financial statements requires us to make significant estimates and judgments that affect the reported amounts of assets, liabilities, revenue, expenses, and related disclosure of contingent assets and liabilities. We evaluate our estimates, including those related to contingencies, on an ongoing basis. We base our estimates on historical experience and on various other assumptions that we believe to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ, at times in material amounts, from these estimates under different assumptions or conditions. |
Recently Issued Accounting Pronouncements | Recently Issued Accounting Pronouncements In August 2018, 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 do not expect that the adoption of this standard will have a material effect on our disclosures. In June 2018, the FASB issued ASU 2018-07 to simplify the accounting for share-based payments to non-employees 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 non-employees 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 was effective for public business entities for annual periods beginning after December 15, 2018, and interim periods within those years. 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 4.1 million 7.4 million 7.2 million 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. |
SUMMARY OF SIGNIFICANT ACCOUN_3
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Accounting Policies [Abstract] | |
The following table provides information about disaggregated revenue by product mix for the years ended December 31, 2019, 2018, and 2017: | The following table provides information about disaggregated revenue by product mix for the years ended December 31, 2019, 2018, and 2017: For the Years Ended December 31, 2019 2018 2017 Prescription vitamins $ 9,885,493 $ 15,041,259 $ 16,744,831 IMVEXXY 16,252,045 1,058,201 — BIJUVA 1,836,443 — — ANNOVERA 6,166,556 — — License revenue 15,506,400 — — OTC products — — 32,882 Net revenue $ 49,646,937 $ 16,099,460 $ 16,777,713 |
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. | 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. As of December 31, 2019 2018 2017 Stock options 25,030,234 20,872,824 23,365,225 Warrants 1,832,571 3,007,571 3,115,905 Restricted stock awards 1,240,000 1,040,000 — 28,102,805 24,920,395 26,481,130 |
INVENTORY (Tables)
INVENTORY (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Inventory Disclosure [Abstract] | |
Inventory consists of the following: | Inventory consists of the following: December 31, 2019 2018 Finished products $ 4,976,910 $ 2,908,958 Work in process 1,182,059 339,312 Raw materials 5,701,747 19,400 TOTAL INVENTORY $ 11,860,716 $ 3,267,670 |
OTHER CURRENT ASSETS (Tables)
OTHER CURRENT ASSETS (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] | |
Other current assets consist of the following: | Other current assets consist of the following: December 31, 2019 2018 Prepaid sales and marketing costs $ 1,583,698 $ 5,148,789 Debt financing fees on undrawn tranches (Note 8) 550,757 1,898,074 Prepaid insurance 1,812,135 790,465 Prepaid manufacturing 2,595,721 — Other prepaid costs 4,787,482 2,997,365 TOTAL OTHER CURRENT ASSETS $ 11,329,793 $ 10,834,693 |
FIXED ASSETS, NET (Tables)
FIXED ASSETS, NET (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Property, Plant and Equipment [Abstract] | |
Fixed assets, net consist of the following: | Fixed assets, net consist of the following: December 31, 2019 2018 Accounting system $ 301,096 $ 301,096 Equipment 1,619,646 490,576 Furniture and fixtures 1,406,858 116,542 Computer hardware 80,211 80,211 Leasehold improvements 68,788 37,888 TOTAL FIXED ASSETS 3,476,599 1,026,313 Accumulated depreciation (968,824 ) (553,630 ) TOTAL FIXED ASSETS, NET $ 2,507,775 $ 472,683 |
INTANGIBLE ASSETS, NET (Tables)
INTANGIBLE ASSETS, NET (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
The following table sets forth the gross carrying amount, accumulated amortization and net carrying amount of our intangible assets as of December 31, 2019 and 2018: | The following table sets forth the gross carrying amount, accumulated amortization and net carrying amount of our intangible assets as of December 31, 2019 and 2018: December 31, 2019 Gross Carrying Amount Accumulated Amortization Net Weighted- Amortizable intangible assets: Approved hormone therapy drug candidate patents $ 3,463,082 $ (478,983 ) $ 2,984,099 13 Hormone therapy drug candidate patents (pending) 1,979,299 — 1,979,299 n/a Non-amortizable intangible assets: Multiple trademarks 294,813 — 294,813 indefinite TOTAL $ 5,737,194 $ (478,983 ) $ 5,258,211 December 31, 2018 Gross Carrying Amount Accumulated Amortization Net Weighted- Average Amortizable intangible assets: OPERA software patent $ 31,951 $ (10,484 ) $ 21,467 10.75 Development costs of corporate website 91,743 (91,743 ) — n/a Approved hormone therapy drug candidate patents 2,234,129 (282,485 ) 1,951,644 14 Hormone therapy drug candidate patents (pending) 1,855,279 — 1,855,279 n/a Non-amortizable intangible assets: Multiple trademarks 264,289 — 264,289 indefinite TOTAL $ 4,477,391 $ (384,712 ) $ 4,092,679 |
Estimated amortization expense, based on current patent cost being amortized, for the next five years is as follows: | Estimated amortization expense, based on current patent cost being amortized, for the next five years is as follows: Year Ending Estimated 2020 $229,546 2021 $229,546 2022 $229,546 2023 $229,546 2024 $229,546 |
OTHER CURRENT LIABILITIES (Tabl
OTHER CURRENT LIABILITIES (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Payables and Accruals [Abstract] | |
Other current liabilities consist of the following: | Other current liabilities consist of the following: December 31, 2019 2018 Accrued payroll, bonuses and commission costs $ 8,040,278 $ 6,854,002 Allowance for coupons and returns 10,316,298 5,294,120 Accrued sales and marketing costs 3,285,662 2,288,028 Accrued compensated absences 1,463,878 1,178,110 Allowance for wholesale distributor fees 2,347,122 792,891 Accrued legal and accounting expense 422,336 385,824 Accrued research and development 1,049,603 388,675 Accrued rent — 365,155 Operating lease liability 1,501,539 — Accrued rebates 3,916,672 412,570 Other accrued expenses 1,480,225 375,573 TOTAL OTHER CURRENT LIABILITIES $ 33,823,613 $ 18,334,948 |
DEBT (Tables)
DEBT (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Debt Disclosure [Abstract] | |
As of December 31, 2019 and 2018, the carrying value of our debt consisted of the following: | As of December 31, 2019 and 2018, the carrying value of our debt consisted of the following: As of December 31, 2019 2018 Financing Agreement $ 200,000,000 $ — Credit Agreement — 75,000,000 Debt discount and financing fees (5,365,357 ) (1,618,986 ) TOTAL LONG-TERM DEBT $ 194,634,643 $ 73,381,014 |
STOCKHOLDERS_ EQUITY (Tables)
STOCKHOLDERS’ EQUITY (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Equity [Abstract] | |
Summary of our Warrant activity during the year ended December 31, 2019: | Summary of our Warrant activity during the year ended December 31, 2019: Number of Shares Under Warrants Weighted Average Exercise Price Weighted Average Remaining Contractual Life in Years Aggregate Intrinsic Value Balance at December 31, 2018 3,007,571 $ 2.78 1.58 $ 4,826,403 Granted 75,000 $ 5.63 Exercised (1,250,000 ) $ 3.20 $ 2,420,000 Expired — — — Cancelled/Forfeited — — — Balance at December 31, 2019 1,832,571 $ 2.62 1.95 $ 2,447,929 Vested and Exercisable at December 31, 2019 1,820,071 $ 2.60 1.90 $ 2,447,929 Unvested at December 31, 2019 12,500 $ 5.63 9.13 — |
The weighted average fair value per share of warrants issued and the assumptions used in the Black-Scholes Model during the years ended December 31, 2019, 2018, and 2017 are set forth in the table below. | The weighted average fair value per share of warrants issued and the assumptions used in the Black-Scholes Model during the years ended December 31, 2019, 2018, and 2017 are set forth in the table below. 2019 2018 2017 Weighted average exercise price $ 5.63 $ 5.16 $ 6.83 Weighted average grant date fair value $ 3.00 $ 2.79 $ 3.67 Risk-free interest rate 2.52 % 2.36 % 1.47 % Volatility 60.8 % 62.12 % 63.24 % Term (in years) 5 5 5 Dividend yield 0.00 % 0.00 % 0.00 % |
The ranges of assumptions used in the Black-Scholes Model during the years ended December 31, 2019, 2018, and 2017 are set forth in the table below. | The ranges of assumptions used in the Black-Scholes Model during the years ended December 31, 2019, 2018, and 2017 are set forth in the table below. 2019 2018 2017 Weighted average exercise price $ 3.10 $ 5.45 $ 6.60 Weighted average grant date fair value $ 1.82 $ 3.24 $ 3.82 Risk-free interest rate 1.64 2.54 % 2.38 2.89 % 1.84 2.05 % Volatility 61.25 64.49 % 59.45 64.04 % 61.56 64.25 % Term (in years) 5.5 6.5 5.1 6.25 5.5 6.25 Dividend yield 0.00 % 0.00 % 0.00 % |
A summary of activity under the 2009, 2012 and 2019 Plans and related information during the year ended December 31, 2019 is as follows: | A summary of activity under the 2009, 2012 and 2019 Plans and related information during the year ended December 31, 2019 is as follows: Number of Shares Under Options Weighted Average Exercise Price Weighted Average Remaining Contractual Life in Years Aggregate Intrinsic Value Balance at December 31, 2018 20,872,824 $ 4.93 5.94 $ 12,239,876 Granted 4,620,501 $ 3.10 Exercised (343,716 ) $ 0.32 $ 1,426,828 Expired (26,375 ) $ 5.57 Cancelled/Forfeited (93,000 ) $ 5.16 Balance at December 31, 2019 25,030,234 $ 4.65 5.84 $ 3,668,171 Vested and Exercisable at December 31, 2019 18,025,819 $ 4.88 4.62 $ 3,319,621 Unvested at December 31, 2019 7,004,415 $ 4.05 8.96 $ 348,550 |
INCOME TAXES (Tables)
INCOME TAXES (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Income Tax Disclosure [Abstract] | |
For financial reporting purposes, income before taxes includes the following components: | For financial reporting purposes, income before taxes includes the following components: 2019 2018 2017 United States $ (176,144,999 ) $ (132,617,160 ) $ (76,925,380 ) Total $ (176,144,999 ) $ (132,617,160 ) $ (76,925,380 ) |
A reconciliation between taxes computed at the federal statutory rate and the consolidated effective tax rate is as follows: | A reconciliation between taxes computed at the federal statutory rate and the consolidated effective tax rate is as follows: 2019 2018 2017 Federal statutory tax rate 21.0 % 21.0 % 34.0 % State tax rate, net of federal tax benefit 4.0 % 5.2 % 5.0 % Adjustment in valuation allowances (22.5 )% (31.2 )% 22.6 % Excess stock benefits 0.2 % 5.3 % — % Federal income tax rate change 0 % — % (60.8 )% Permanent and other differences (2.7 )% (0.3 )% (0.8 )% Provision (benefit) for income taxes — — — |
The components of the net deferred income tax asset as of December 31, 2019, 2018, and 2017 are as follows: | The components of the net deferred income tax asset as of December 31, 2019, 2018, and 2017 are as follows: 2019 2018 2017 Deferred Income Tax Assets: Net operating losses $ 180,520,709 $ 140,891,764 $ 99,596,321 R&D Credit 186,347 186,347 186,347 Total deferred income tax asset 180,707,056 141,078,111 99,782,668 Valuation allowance (180,707,056 ) (141,078,111 ) (99,782,668 ) Deferred income tax assets, net $ — $ — $ — |
COMMITMENTS AND CONTINGENCIES (
COMMITMENTS AND CONTINGENCIES (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Commitments and Contingencies Disclosure [Abstract] | |
Supplemental lease information | Supplemental lease information Right-of-use asset $ 10,109,154 Short-term operating lease liability (included in Other current liabilities) $ 1,501,539 Long-term operating lease liability $ 9,145,049 Weighted average remaining term 9 Years Weighted average discount rate 8.25 % Supplemental cash flow information for the year ended December 31, 2019 Cash paid for amounts included in the measurement of lease liabilities for operating lease $ 1,164,234 Right-of-use assets obtained in exchange for lease obligation $ 11,171,471 |
The following table reconciles the undiscounted cash flows for all operating leases at December 31, 2019 to the operating lease liabilities recorded on the balance sheet: | The following table reconciles the undiscounted cash flows for all operating leases at December 31, 2019 to the operating lease liabilities recorded on the balance sheet: Years Ending December 31, 2020 $ 1,566,617 2021 2,198,541 2022 1,262,302 2023 1,293,859 2024 1,326,206 Thereafter 8,036,931 Total undiscounted lease payments 15,684,456 Less: imputed interest (5,037,868 ) Present value of lease payments $ 10,646,588 |
SELECTED QUARTERLY FINANCIAL _2
SELECTED QUARTERLY FINANCIAL DATA (UNAUDITED) (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Quarterly Financial Information Disclosure [Abstract] | |
Summarized quarterly financial data for fiscal years 2019 and 2018 is as follows: | Summarized quarterly financial data for fiscal years 2019 and 2018 is as follows: 2019 (In thousands, except per share) First Second Quarter (1) Third (2) Fourth Quarter Revenues $ 3,947 $ 6,079 $ 23,719 $ 15,902 Gross profit $ 3,184 $ 4,830 $ 22,275 $ 13,023 Net loss $ (39,506 ) $ (55,237 ) $ (31,967 ) $ (49,435 ) Loss per common share, basic and diluted $ (0.16 ) $ (0.23 ) $ (0.13 ) $ (0.19 ) 2018 (In thousands, except per share) First Second Quarter Third Fourth Quarter Revenues $ 3,773 $ 3,763 $ 3,474 $ 5,089 Gross profit $ 3,139 $ 3,309 $ 2,775 $ 4,139 Net loss $ (24,402 ) $ (33,219 ) $ (35,605 ) $ (39,391 ) Loss per common share, basic and diluted $ (0.11 ) $ (0.15 ) $ (0.16 ) $ (0.17 ) (1) During the second quarter of 2019, we recorded $ 10.1 million (2) During the third quarter of 2019, we recorded $ 15.5 million Theramex License Agreement |
THE COMPANY (Details Narrative)
THE COMPANY (Details Narrative) | Dec. 31, 2019 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Number of subsidiaires | 3 |
The following table provides in
The following table provides information about disaggregated revenue by product mix for the years ended December 31, 2019, 2018, and 2017: (Details) - USD ($) | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2019 | Sep. 30, 2019 | Jun. 30, 2019 | Mar. 31, 2019 | Dec. 31, 2018 | Sep. 30, 2018 | Jun. 30, 2018 | Mar. 31, 2018 | Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Product Information [Line Items] | |||||||||||
Net revenue | $ 15,902,000 | $ 23,719,000 | $ 6,079,000 | $ 3,947,000 | $ 5,089,000 | $ 3,474,000 | $ 3,763,000 | $ 3,773,000 | $ 49,646,937 | $ 16,099,460 | $ 16,777,713 |
Prescription Vitamins [Member] | |||||||||||
Product Information [Line Items] | |||||||||||
Net revenue | 9,885,493 | 15,041,259 | 16,744,831 | ||||||||
Imvexxy [Member] | |||||||||||
Product Information [Line Items] | |||||||||||
Net revenue | 16,252,045 | 1,058,201 | |||||||||
BIJUVA [Member] | |||||||||||
Product Information [Line Items] | |||||||||||
Net revenue | 1,836,443 | ||||||||||
ANNOVERA [Member] | |||||||||||
Product Information [Line Items] | |||||||||||
Net revenue | 6,166,556 | ||||||||||
License and Service [Member] | |||||||||||
Product Information [Line Items] | |||||||||||
Net revenue | $ 15,506,400 | ||||||||||
OTC Products [Member] | |||||||||||
Product Information [Line Items] | |||||||||||
Net revenue | $ 32,882 |
The table below presents potent
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. (Details) - shares | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount | 28,102,805 | 24,920,395 | 26,481,130 |
Warrant [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount | 1,832,571 | 3,007,571 | 3,115,905 |
Share-based Payment Arrangement, Option [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount | 25,030,234 | 20,872,824 | 23,365,225 |
Restricted Stock [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount | 1,240,000 | 1,040,000 |
SUMMARY OF SIGNIFICANT ACCOUN_4
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details Narrative) | Aug. 05, 2019USD ($) | Aug. 05, 2019EUR (€) | Jun. 06, 2019EUR (€) | Aug. 06, 2018USD ($)$ / sharesshares | Dec. 31, 2019USD ($) | Dec. 31, 2018USD ($) | Dec. 31, 2017USD ($) | Aug. 31, 2019USD ($) | Jan. 02, 2019USD ($) |
Product Information [Line Items] | |||||||||
Federal insurance limits | $ 250,000 | ||||||||
Number of issued patents domestic. | 29 | ||||||||
Number of issued patents foreign | 30 | ||||||||
Stock Issued During Period, Value, New Issues | $ 77,031,258 | $ 89,907,797 | $ 68,572,635 | ||||||
Number of operating segments | 1 | ||||||||
Advertising costs | $ 9,045,571 | 1,682,746 | $ 448,288 | ||||||
Right of use asset | 10,109,154 | $ 7,400,000 | |||||||
Lease liability | $ 10,646,588 | $ 7,200,000 | |||||||
Accounting Standards Update 2016-02 [Member] | |||||||||
Product Information [Line Items] | |||||||||
Right of use asset | $ 3,800,000 | ||||||||
Lease liability | $ 4,100,000 | ||||||||
License Agreement Theramex | |||||||||
Product Information [Line Items] | |||||||||
Cash upfront payment received | $ 15,506,400 | € 14,000,000 | |||||||
Subscription Agreement Knight [Member] | |||||||||
Product Information [Line Items] | |||||||||
Stock Issued During Period, Shares, New Issues | shares | 3,921,568 | ||||||||
Sale of Stock, Price Per Share | $ / shares | $ 5.10 | ||||||||
Stock Issued During Period, Value, New Issues | $ 20,000,000 | ||||||||
Vitamins and IMVEXXY [Member] | |||||||||
Product Information [Line Items] | |||||||||
Shelf life of prescription products following product expiration | 24 months | ||||||||
BIJUVA and ANNOVERA [Member] | |||||||||
Product Information [Line Items] | |||||||||
Shelf life of prescription products following product expiration | 18 months | ||||||||
BIJUVA and ANNOVERA [Member] | License Agreement Theramex | |||||||||
Product Information [Line Items] | |||||||||
Quarterly royalty payments percentage | 5.00% | ||||||||
Minimum [Member] | |||||||||
Product Information [Line Items] | |||||||||
Return period of unsalable prescription products | 6 months | ||||||||
Minimum [Member] | License Agreement Theramex | |||||||||
Product Information [Line Items] | |||||||||
Sales milestone | € | € 25,000,000 | ||||||||
Maximum [Member] | |||||||||
Product Information [Line Items] | |||||||||
Return period of unsalable prescription products | 12 months | ||||||||
Maximum [Member] | License Agreement Theramex | |||||||||
Product Information [Line Items] | |||||||||
Regulatory milestone payments | € | 2,000,000 | ||||||||
Sales milestone payment | € | 27,500,000 | ||||||||
Sales milestone | € | € 100,000,000 | ||||||||
Land and Building [Member] | Minimum [Member] | |||||||||
Product Information [Line Items] | |||||||||
Useful life of assets | 3 years | ||||||||
Land and Building [Member] | Maximum [Member] | |||||||||
Product Information [Line Items] | |||||||||
Useful life of assets | 7 years | ||||||||
Software and Software Development Costs [Member] | Minimum [Member] | |||||||||
Product Information [Line Items] | |||||||||
Useful life of assets | 5 years | ||||||||
Software and Software Development Costs [Member] | Maximum [Member] | |||||||||
Product Information [Line Items] | |||||||||
Useful life of assets | 7 years | ||||||||
Accounts Receivable [Member] | Customer A [Member] | |||||||||
Product Information [Line Items] | |||||||||
Concentration risk | 36.00% | 42.00% | |||||||
Accounts Receivable [Member] | Customer B [Member] | |||||||||
Product Information [Line Items] | |||||||||
Concentration risk | 21.00% | 24.00% | |||||||
Accounts Receivable [Member] | Customer C [Member] | |||||||||
Product Information [Line Items] | |||||||||
Concentration risk | 16.00% | 13.00% | |||||||
Accounts Receivable [Member] | Customer D [Member] | |||||||||
Product Information [Line Items] | |||||||||
Concentration risk | 11.00% |
Inventory consists of the follo
Inventory consists of the following: (Details) - USD ($) | Dec. 31, 2019 | Dec. 31, 2018 |
Inventory Disclosure [Abstract] | ||
Finished products | $ 4,976,910 | $ 2,908,958 |
Work in process | 1,182,059 | 339,312 |
Raw materials | 5,701,747 | 19,400 |
TOTAL INVENTORY | $ 11,860,716 | $ 3,267,670 |
Other current assets consist of
Other current assets consist of the following: (Details) - USD ($) | Dec. 31, 2019 | Dec. 31, 2018 |
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] | ||
Prepaid sales and marketing costs | $ 1,583,698 | $ 5,148,789 |
Debt financing fees on undrawn tranches (Note 8) | 550,757 | 1,898,074 |
Prepaid insurance | 1,812,135 | 790,465 |
Prepaid manufacturing | 2,595,721 | |
Other prepaid costs | 4,787,482 | 2,997,365 |
TOTAL OTHER CURRENT ASSETS | $ 11,329,793 | $ 10,834,693 |
Fixed assets, net consist of th
Fixed assets, net consist of the following: (Details) - USD ($) | Dec. 31, 2019 | Dec. 31, 2018 |
Property, Plant and Equipment [Line Items] | ||
TOTAL FIXED ASSETS | $ 3,476,599 | $ 1,026,313 |
Accumulated depreciation | (968,824) | (553,630) |
TOTAL FIXED ASSETS, NET | 2,507,775 | 472,683 |
Software and Software Development Costs [Member] | ||
Property, Plant and Equipment [Line Items] | ||
TOTAL FIXED ASSETS | 301,096 | 301,096 |
Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
TOTAL FIXED ASSETS | 1,619,646 | 490,576 |
Furniture and Fixtures [Member] | ||
Property, Plant and Equipment [Line Items] | ||
TOTAL FIXED ASSETS | 1,406,858 | 116,542 |
Computer Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
TOTAL FIXED ASSETS | 80,211 | 80,211 |
Leasehold Improvements [Member] | ||
Property, Plant and Equipment [Line Items] | ||
TOTAL FIXED ASSETS | $ 68,788 | $ 37,888 |
FIXED ASSETS, NET (Details Narr
FIXED ASSETS, NET (Details Narrative) - USD ($) | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Property, Plant and Equipment [Abstract] | |||
Depreciation expense | $ 415,193 | $ 181,412 | $ 141,601 |
The following table sets forth
The following table sets forth the gross carrying amount, accumulated amortization and net carrying amount of our intangible assets as of December 31, 2019 and 2018: (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Finite-Lived Intangible Assets [Line Items] | ||
Finite-Lived Intangible Assets, Accumulated Amortization | $ (478,983) | $ (384,712) |
Intangible Assets, Gross (Excluding Goodwill) | 5,737,194 | 4,477,391 |
Intangible Assets, Net (Excluding Goodwill) | 5,258,211 | 4,092,679 |
Hormone Therapy Drug Candidate Patents - (Pending) [Member] | ||
Finite-Lived Intangible Assets [Line Items] | ||
Finite-Lived Intangible Assets, Gross | 1,979,299 | 1,855,279 |
Finite-Lived Intangible Assets, Net | 1,979,299 | 1,855,279 |
Multiple Trademarks [Member] | ||
Finite-Lived Intangible Assets [Line Items] | ||
Indefinite-Lived Trademarks | 294,813 | 264,289 |
Indefinite-lived Intangible Assets (Excluding Goodwill) | 294,813 | 264,289 |
Approved Hormone Therapy Drug Candidate Patents [Member] | ||
Finite-Lived Intangible Assets [Line Items] | ||
Finite-Lived Intangible Assets, Gross | 3,463,082 | 2,234,129 |
Finite-Lived Intangible Assets, Accumulated Amortization | (478,983) | (282,485) |
Finite-Lived Intangible Assets, Net | $ 2,984,099 | $ 1,951,644 |
Finite-Lived Intangible Assets, Remaining Amortization Period | 13 years | 14 years |
Computer Software, Intangible Asset [Member] | ||
Finite-Lived Intangible Assets [Line Items] | ||
Finite-Lived Intangible Assets, Gross | $ 31,951 | |
Finite-Lived Intangible Assets, Accumulated Amortization | (10,484) | |
Finite-Lived Intangible Assets, Net | $ 21,467 | |
Finite-Lived Intangible Assets, Remaining Amortization Period | 10 years 9 months | |
Internet Domain Names [Member] | ||
Finite-Lived Intangible Assets [Line Items] | ||
Finite-Lived Intangible Assets, Gross | $ 91,743 | |
Finite-Lived Intangible Assets, Accumulated Amortization | $ (91,743) |
Estimated amortization expense,
Estimated amortization expense, based on current patent cost being amortized, for the next five years is as follows: (Details) | Dec. 31, 2019USD ($) |
Goodwill and Intangible Assets Disclosure [Abstract] | |
2020 | $ 229,546 |
2021 | 229,546 |
2022 | 229,546 |
2023 | 229,546 |
2024 | $ 229,546 |
INTANGIBLE ASSETS, NET (Details
INTANGIBLE ASSETS, NET (Details Narrative) | 3 Months Ended | 12 Months Ended | ||
Sep. 30, 2019USD ($) | Dec. 31, 2019USD ($) | Dec. 31, 2018USD ($) | Dec. 31, 2017USD ($) | |
Finite-Lived Intangible Assets [Line Items] | ||||
Impairment of Intangible Assets, Indefinite-lived (Excluding Goodwill) | $ 78,864 | |||
Amortization of Intangible Assets | 197,593 | $ 112,474 | $ 71,516 | |
Amortization of Other Deferred Charges | $ 778,692 | |||
Council License Agreement [Member] | ||||
Finite-Lived Intangible Assets [Line Items] | ||||
Annual royalty rate reduction of initial rate during the six-month period from commercial sale of a generic equivalent | 50.00% | |||
Annual royalty rate reduction of initial rate after the six-month period from commercial sale of a generic equivalent | 20.00% | |||
Required milestone payments upon cumulative net sales of specified levels | $ 40,000,000 | |||
Specified level one of cumulative net sales for required milestone payments | 200,000,000 | |||
Specified level two of cumulative net sales for required milestone payments | 400,000,000 | |||
Specified level three of cumulative net sales for required milestone payments | 1,000,000,000 | |||
Maximum costs and expenses for post approval | $ 20,000,000 | |||
Council License Agreement Step 1 | ||||
Finite-Lived Intangible Assets [Line Items] | ||||
Royalty (percent) | 5.00% | |||
Council License Agreement Step 1 | Maximum [Member] | ||||
Finite-Lived Intangible Assets [Line Items] | ||||
Net sales amount per step-based royalty | $ 50,000,000 | |||
Council License Agreement Step 2 | ||||
Finite-Lived Intangible Assets [Line Items] | ||||
Royalty (percent) | 10.00% | |||
Council License Agreement Step 2 | Maximum [Member] | ||||
Finite-Lived Intangible Assets [Line Items] | ||||
Net sales amount per step-based royalty | $ 150,000,000 | |||
Council License Agreement Step 2 | Minimum [Member] | ||||
Finite-Lived Intangible Assets [Line Items] | ||||
Net sales amount per step-based royalty | $ 50,000,000 | |||
Council License Agreement Step 3 | ||||
Finite-Lived Intangible Assets [Line Items] | ||||
Royalty (percent) | 15.00% | |||
Council License Agreement Step 3 | Minimum [Member] | ||||
Finite-Lived Intangible Assets [Line Items] | ||||
Net sales amount per step-based royalty | $ 150,000,000 | |||
ANNOVERA [Member] | Council License Agreement [Member] | ||||
Finite-Lived Intangible Assets [Line Items] | ||||
Milestone payment upon FDA Approval | $ 20,000,000 | |||
Milestone payments (payment after release of first commercial batch) | 20,000,000 | |||
License rights acquired | $ 20,000,000 | |||
Amortization of Other Deferred Charges | $ 778,692 | |||
Approved Hormone Therapy Drug Candidate Patents [Member] | ||||
Finite-Lived Intangible Assets [Line Items] | ||||
Finite-Lived Intangible Asset, Useful Life | 20 years | |||
Domestic US Patents | ||||
Finite-Lived Intangible Assets [Line Items] | ||||
Number of issued patents | 29 | |||
Foreign Patents Member | ||||
Finite-Lived Intangible Assets [Line Items] | ||||
Number of issued patents | 30 | |||
Domestic Patents BIJUVA | ||||
Finite-Lived Intangible Assets [Line Items] | ||||
Number of issued patents | 12 | |||
Foreign Patents BIJUVA | ||||
Finite-Lived Intangible Assets [Line Items] | ||||
Number of issued patents | 6 | |||
Domestic Patents NonApproved BIJUVA | ||||
Finite-Lived Intangible Assets [Line Items] | ||||
Number of issued patents | 3 | |||
Domestic US Patents IMVEXXY | ||||
Finite-Lived Intangible Assets [Line Items] | ||||
Number of issued patents | 6 | |||
Domestic US Utility Patents IMVEXXY | ||||
Finite-Lived Intangible Assets [Line Items] | ||||
Number of issued patents | 5 | |||
Domestic US Design Patents IMVEXXY | ||||
Finite-Lived Intangible Assets [Line Items] | ||||
Number of issued patents | 1 | |||
Foreign Patents IMVEXXY | ||||
Finite-Lived Intangible Assets [Line Items] | ||||
Number of issued patents | 13 | |||
Foreign Utility Patents IMVEXXY | ||||
Finite-Lived Intangible Assets [Line Items] | ||||
Number of issued patents | 3 | |||
Foreign Design Patents IMVEXXY | ||||
Finite-Lived Intangible Assets [Line Items] | ||||
Number of issued patents | 10 | |||
Domestic US Patents Topical Cream | ||||
Finite-Lived Intangible Assets [Line Items] | ||||
Number of issued patents | 1 | |||
Domestic Utility Patent Transdermal Patch | ||||
Finite-Lived Intangible Assets [Line Items] | ||||
Number of issued patents | 1 | |||
Foreign Utility Patent Transdermal Patch | ||||
Finite-Lived Intangible Assets [Line Items] | ||||
Number of issued patents | 7 | |||
Domestic Utility Patent TX009HR | ||||
Finite-Lived Intangible Assets [Line Items] | ||||
Number of issued patents | 3 | |||
Domestic Patents Progesterone Formulations | ||||
Finite-Lived Intangible Assets [Line Items] | ||||
Number of issued patents | 2 | |||
Foreign Patents Progesterone Formulations | ||||
Finite-Lived Intangible Assets [Line Items] | ||||
Number of issued patents | 4 | |||
Domestic Utility Patent Opera | ||||
Finite-Lived Intangible Assets [Line Items] | ||||
Number of issued patents | 1 |
Other current liabilities consi
Other current liabilities consist of the following: (Details) - USD ($) | Dec. 31, 2019 | Dec. 31, 2018 |
Payables and Accruals [Abstract] | ||
Accrued payroll, bonuses and commission costs | $ 8,040,278 | $ 6,854,002 |
Allowance for coupons and returns | 10,316,298 | 5,294,120 |
Accrued sales and marketing costs | 3,285,662 | 2,288,028 |
Accrued compensated absences | 1,463,878 | 1,178,110 |
Allowance for wholesale distributor fees | 2,347,122 | 792,891 |
Accrued legal and accounting expense | 422,336 | 385,824 |
Accrued research and development | 1,049,603 | 388,675 |
Accrued rent | 365,155 | |
Operating lease liability | 1,501,539 | |
Accrued rebates | 3,916,672 | 412,570 |
Other accrued expenses | 1,480,225 | 375,573 |
TOTAL OTHER CURRENT LIABILITIES | $ 33,823,613 | $ 18,334,948 |
As of December 31, 2019 and 201
As of December 31, 2019 and 2018, the carrying value of our debt consisted of the following: (Details) - USD ($) | Dec. 31, 2019 | Dec. 31, 2018 |
Debt Instrument [Line Items] | ||
Debt discount and financing fees | $ (5,365,357) | $ (1,618,986) |
TOTAL LONG-TERM DEBT | 194,634,643 | 73,381,014 |
Financing Agreement [Member] | ||
Debt Instrument [Line Items] | ||
Long-term Debt, Gross | $ 200,000,000 | |
Credit Agreement Member | ||
Debt Instrument [Line Items] | ||
Long-term Debt, Gross | $ 75,000,000 |
DEBT (Details Narrative)
DEBT (Details Narrative) | Feb. 18, 2020USD ($) | Apr. 24, 2019USD ($) | May 01, 2018USD ($) | Dec. 31, 2019USD ($) | Sep. 30, 2019USD ($) | Jun. 30, 2019USD ($) | Mar. 31, 2019USD ($) | Dec. 31, 2018USD ($) | Sep. 30, 2018USD ($) | Jun. 30, 2018USD ($) | Mar. 31, 2018USD ($) | Dec. 31, 2019USD ($) | Dec. 31, 2018USD ($) | Dec. 31, 2017USD ($) |
Debt Instrument [Line Items] | ||||||||||||||
Proceeds from Lines of Credit | $ 200,000,000 | |||||||||||||
Net revenue | $ 15,902,000 | $ 23,719,000 | $ 6,079,000 | $ 3,947,000 | $ 5,089,000 | $ 3,474,000 | $ 3,763,000 | $ 3,773,000 | 49,646,937 | 16,099,460 | 16,777,713 | |||
Loss on extinguishment of debt | $ (10,100,000) | (10,057,632) | ||||||||||||
Amortization of Debt Issuance Costs | 856,302 | 269,859 | ||||||||||||
Payments of Financing Costs | 6,652,270 | $ 3,786,918 | ||||||||||||
Debt Instrument, Unamortized Discount | $ 6,101,513 | $ 6,101,513 | ||||||||||||
Debt Instrument, Interest Rate, Effective Percentage | 11.00% | 11.00% | ||||||||||||
Financing Agreement [Member] | ||||||||||||||
Debt Instrument [Line Items] | ||||||||||||||
Long-term Debt, Gross | $ 200,000,000 | $ 200,000,000 | ||||||||||||
Interest Expense, Borrowings | 14,709,166 | |||||||||||||
IMVEXXY, BIJUVA and ANNOVERA [Member] | Minimum [Member] | ||||||||||||||
Debt Instrument [Line Items] | ||||||||||||||
Net revenue | $ 11,000,000 | |||||||||||||
Subsequent Event [Member] | Financing Agreement [Member] | ||||||||||||||
Debt Instrument [Line Items] | ||||||||||||||
Proceeds from Lines of Credit | $ 50,000,000 | |||||||||||||
Tranche 1 [Member] | ||||||||||||||
Debt Instrument [Line Items] | ||||||||||||||
Amortization of Debt Issuance Costs | 736,156 | |||||||||||||
Financing Agreement [Member] | ||||||||||||||
Debt Instrument [Line Items] | ||||||||||||||
Debt Instrument, Description of Variable Rate Basis | 3-month LIBOR | |||||||||||||
Debt Instrument, Basis Spread on Variable Rate | 7.75% | |||||||||||||
LIBOR floor rate | 2.70% | |||||||||||||
Number of quarterly principal installment payments | 4 | |||||||||||||
Prepayment fee for first two years funding (percent) | 30.00% | |||||||||||||
Prepayment fee third year funding (percent) | 5.00% | |||||||||||||
Prepayment fee fourth year funding (percent) | 3.00% | |||||||||||||
Prepayment fee fifth year funding (percent) | 1.00% | |||||||||||||
Facility fee paid (percent) | 2.50% | |||||||||||||
Minimum cash balance requirement under credit agreement | $ 50,000,000 | |||||||||||||
Financing Agreement [Member] | Prime Rate [Member] | ||||||||||||||
Debt Instrument [Line Items] | ||||||||||||||
Debt Instrument, Description of Variable Rate Basis | prime rate | |||||||||||||
Debt Instrument, Basis Spread on Variable Rate | 6.75% | |||||||||||||
LIBOR floor rate | 5.20% | |||||||||||||
Financing Agreement [Member] | Tranche 1 [Member] | ||||||||||||||
Debt Instrument [Line Items] | ||||||||||||||
Proceeds from Lines of Credit | $ 200,000,000 | |||||||||||||
Financing Agreement [Member] | Tranche Two [Member] | ||||||||||||||
Debt Instrument [Line Items] | ||||||||||||||
Line of Credit Facility, Maximum Borrowing Capacity | 50,000,000 | |||||||||||||
Financing Agreement [Member] | Tranche 3 [Member] | Subsequent Event [Member] | ||||||||||||||
Debt Instrument [Line Items] | ||||||||||||||
Proceeds from Lines of Credit | $ 50,000,000 | |||||||||||||
Financing Agreement [Member] | Tranche Two Three Member | ||||||||||||||
Debt Instrument [Line Items] | ||||||||||||||
Minimum cash balance requirement under credit agreement | 60,000,000 | |||||||||||||
Credit Agreement [Member] | ||||||||||||||
Debt Instrument [Line Items] | ||||||||||||||
Repayment of debt with new credit facility | $ 81,661,000 | |||||||||||||
Prepayment fee percentage | 4.00% | |||||||||||||
Repayment fee percentage | 4.00% | |||||||||||||
Interest Expense, Debt | 1,816,747 | |||||||||||||
Amortization of Debt Issuance Costs | $ 120,146 | |||||||||||||
Revolving Credit Facility [Member] | ||||||||||||||
Debt Instrument [Line Items] | ||||||||||||||
Debt Instrument, Basis Spread on Variable Rate | 7.75% | |||||||||||||
Revolving Credit Facility [Member] | Financing Agreement [Member] | ||||||||||||||
Debt Instrument [Line Items] | ||||||||||||||
Line of Credit Facility, Maximum Borrowing Capacity | $ 300,000,000 | |||||||||||||
Secured Debt [Member] | ||||||||||||||
Debt Instrument [Line Items] | ||||||||||||||
Line of Credit Facility, Maximum Borrowing Capacity | $ 200,000,000 | |||||||||||||
Debt Instrument, Description of Variable Rate Basis | one-month LIBOR | |||||||||||||
LIBOR floor rate | 1.50% | |||||||||||||
Number of tranches under term loan facility | 3 |
Summary of our Warrant activity
Summary of our Warrant activity during the year ended December 31, 2019: (Details) - Warrant [Member] - USD ($) | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Class of Warrant or Right [Line Items] | ||
Number of shares under warrants outstanding beginning | 3,007,571 | |
Weighted average exercise price warrants outstanding beginning | $ 2.78 | |
Weighted average remaining contractual life, warrants outstanding | 1 year 11 months 12 days | 1 year 6 months 29 days |
Aggregate intrinsic value, warrants outstanding beginning | $ 4,826,403 | |
Number of shares under warrants granted | 75,000 | |
Weighted average exercise price warrants granted | $ 5.63 | |
Number of shares under warrants exercised | (1,250,000) | |
Weighted average exercise price warrants exercised | $ 3.20 | |
Aggregate intrinsic value, warrants exercised | $ 2,420,000 | |
Number of shares under warrants outstanding ending | 1,832,571 | 3,007,571 |
Weighted average exercise price warrants outstanding ending | $ 2.62 | $ 2.78 |
Aggregate intrinsic value, warrants outstanding ending | $ 2,447,929 | $ 4,826,403 |
Number of shares under warrants vested and exercisable ending | 1,820,071 | |
Weighted average exercise price warrants vested and exercisable ending | $ 2.60 | |
Weighted average remaining contractual life, vested and exercisable ending | 1 year 10 months 24 days | |
Aggregate intrinsic value, vested and exercisable ending | $ 2,447,929 | |
Number of shares under warrants unvested ending | 12,500 | |
Weighted average exercise price warrants unvested ending | $ 5.63 | |
Weighted average remaining contractual life, warrants unvested ending | 9 years 1 month 17 days |
The weighted average fair value
The weighted average fair value per share of warrants issued and the assumptions used in the Black-Scholes Model during the years ended December 31, 2019, 2018, and 2017 are set forth in the table below. (Details) - Warrant [Member] - $ / shares | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Class of Warrant or Right [Line Items] | |||
Weighted average exercise price | $ 5.63 | $ 5.16 | $ 6.83 |
Weighted average grant date fair value | $ 3 | $ 2.79 | $ 3.67 |
Risk-free interest rate | 2.52% | 2.36% | 1.47% |
Volatility | 60.80% | 62.12% | 63.24% |
Term | 5 years | 5 years | 5 years |
Dividend yield | 0.00% | 0.00% | 0.00% |
The ranges of assumptions used
The ranges of assumptions used in the Black-Scholes Model during the years ended December 31, 2019, 2018, and 2017 are set forth in the table below. (Details) - Share-based Payment Arrangement, Option [Member] - $ / shares | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Weighted average exercise price | $ 3.10 | $ 5.45 | $ 6.60 |
Weighted average grant date fair value | $ 1.82 | $ 3.24 | $ 3.82 |
Risk-free interest rate - minimum | 1.64% | 2.38% | 1.84% |
Risk-free interest rate - maximum | 2.54% | 2.89% | 2.05% |
Volatility - minimum | 61.25% | 59.45% | 61.56% |
Volatility - maximum | 64.49% | 64.04% | 64.25% |
Dividend yield | 0.00% | 0.00% | 0.00% |
Minimum [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Term | 5 years 6 months | 5 years 1 month 6 days | 5 years 6 months |
Maximum [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Term | 6 years 6 months | 6 years 3 months | 6 years 3 months |
A summary of activity under the
A summary of activity under the 2009, 2012 and 2019 Plans and related information during the year ended December 31, 2019 is as follows: (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Number of shares under options, exercised | (102,546) | ||
Share-based Payment Arrangement, Option [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Number of shares under options, beginning | 20,872,824 | ||
Weighted average exercise price, beginning | $ 4.93 | ||
Weighted average remaining contractual life | 5 years 10 months 2 days | 5 years 11 months 8 days | |
Aggregate intrinsic value, beginning | $ 12,239,876 | ||
Number of shares under options, granted | 4,620,501 | ||
Weighted average exercise price, granted | $ 3.10 | ||
Number of shares under options, exercised | (343,716) | ||
Weighted average exercise price, exercised | $ 0.32 | ||
Aggregate intrinsic value, exercised | $ 1,426,828 | ||
Number of shares under options, expired | (26,375) | ||
Weighted average exercise price, expired | $ 5.57 | ||
Number of shares under options, cancelled forfeited | (93,000) | ||
Weighted average exercise price, cancelled forfeited | $ 5.16 | ||
Number of shares under options, ending | 25,030,234 | 20,872,824 | |
Weighted average exercise price, ending | $ 4.65 | $ 4.93 | |
Aggregate intrinsic value, ending | $ 3,668,171 | $ 12,239,876 | |
Number of shares under options, vested and exercisable ending | 18,025,819 | ||
Weighted average exercise price, vested and exercisable ending | $ 4.88 | ||
Weighted average remaining contractual life, vested and exercisable | 4 years 7 months 13 days | ||
Aggregate intrinsic value, vested and exercisable ending | $ 3,319,621 | ||
Number of shares under options, unvested ending | 7,004,415 | ||
Weighted average exercise price, unvested ending | $ 4.05 | ||
Weighted average remaining contractual life, unvested | 8 years 11 months 15 days | ||
Aggregate intrinsic value, unvested ending | $ 348,550 |
STOCKHOLDERS_ EQUITY (Details N
STOCKHOLDERS’ EQUITY (Details Narrative) - USD ($) | Oct. 29, 2019 | Jul. 30, 2019 | Dec. 13, 2018 | Aug. 06, 2018 | Aug. 06, 2018 | Sep. 28, 2017 | Sep. 25, 2017 | Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 |
Class of Warrant or Right [Line Items] | ||||||||||
Preferred Stock, Shares Authorized | 10,000,000 | 10,000,000 | ||||||||
Preferred Stock, Par or Stated Value Per Share | $ 0.001 | $ 0.001 | ||||||||
Preferred Stock, Shares Issued | 0 | 0 | ||||||||
Preferred Stock, Shares Outstanding | 0 | 0 | ||||||||
Common Stock, Shares Authorized | 350,000,000 | 350,000,000 | ||||||||
Common Stock, Shares, Issued | 271,177,076 | 240,462,439 | ||||||||
Common Stock, Shares, Outstanding | 271,177,076 | 240,462,439 | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercises in Period | 102,546 | |||||||||
Stock Issued During Period, Value, Stock Options Exercised | $ 1,666,208 | $ 212,615 | ||||||||
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 Issued During Period, Value, New Issues | $ 77,031,258 | $ 89,907,797 | 68,572,635 | |||||||
Warrants and Rights Outstanding | $ 1,832,571 | |||||||||
Weighted-average contractual remaining life | 1 year 11 months 12 days | |||||||||
Share-based Payment Arrangement, Noncash Expense | $ 10,693,662 | 8,661,967 | 6,889,323 | |||||||
Shares issued for exercise of warrants, net | 3,798,999 | |||||||||
Share-based Payment Arrangement, Expense | 8,798,707 | 8,091,294 | 6,447,154 | |||||||
Share-based Payment Arrangement, Nonvested Award, Option, Cost Not yet Recognized, Amount | 11,460,000 | |||||||||
Restricted Stock or Unit Expense | 1,628,407 | 73,132 | ||||||||
Share-based Payment Arrangement, Nonvested Award, Excluding Option, Cost Not yet Recognized, Amount | $ 2,711,000 | |||||||||
2009 Long Term Incentive Compensation Plan [Member] | ||||||||||
Class of Warrant or Right [Line Items] | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Number | 15,017,759 | |||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Authorized | 100,050 | |||||||||
2012 Stock Incentive Plan [Member] | ||||||||||
Class of Warrant or Right [Line Items] | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Number | 6,316,474 | |||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Authorized | 2,395,333 | |||||||||
Plan 2019 [Member] | ||||||||||
Class of Warrant or Right [Line Items] | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Number | 3,696,001 | |||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Authorized | 13,599,382 | |||||||||
Plan awards number of new shares | 11,103,999 | |||||||||
Minimum [Member] | ||||||||||
Class of Warrant or Right [Line Items] | ||||||||||
Range - exercise price of options | $ 0.19 | |||||||||
Maximum [Member] | ||||||||||
Class of Warrant or Right [Line Items] | ||||||||||
Range - exercise price of options | $ 8.92 | |||||||||
Warrants Member | ||||||||||
Class of Warrant or Right [Line Items] | ||||||||||
Share-based Payment Arrangement, Noncash Expense | $ 254,970 | $ 494,136 | $ 313,271 | |||||||
Share-based Payment Arrangement, Nonvested Award, Cost Not yet Recognized, Amount | $ 26,446 | |||||||||
Share-based Payment Arrangement, Nonvested Award, Cost Not yet Recognized, Period for Recognition | 1 month 6 days | |||||||||
Warrants exercised | 2,476,666 | |||||||||
Number of stock issued in cashless exercise of warrants | 0 | |||||||||
Shares issued for exercise of warrants, net | $ 3,798,999 | |||||||||
Warrants Member | Minimum [Member] | ||||||||||
Class of Warrant or Right [Line Items] | ||||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 0.24 | |||||||||
Warrants Member | Maximum [Member] | ||||||||||
Class of Warrant or Right [Line Items] | ||||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | 8.20 | |||||||||
Warrant [Member] | ||||||||||
Class of Warrant or Right [Line Items] | ||||||||||
Weighted average exercise price of warrants (in dollars per share) | $ 2.62 | $ 2.78 | ||||||||
Warrants granted | 75,000 | |||||||||
Warrants exercised | 1,250,000 | |||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Nonvested, Number | 12,500 | |||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Non-Option Equity Instruments, Outstanding, Number | 1,832,571 | 3,007,571 | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Grants in Period, Weighted Average Grant Date Fair Value | $ 3 | $ 2.79 | $ 3.67 | |||||||
Outside Consultants Warrants [Member] | ||||||||||
Class of Warrant or Right [Line Items] | ||||||||||
Warrants granted | 175,000 | 125,000 | ||||||||
Warrants vesting period | 12 months | 12 months | 12 months | |||||||
Warrants expiration date | Feb. 13, 2024 | Mar. 15, 2023 | Mar. 15, 2022 | |||||||
Warrants - Cashless Exercise [Member] | ||||||||||
Class of Warrant or Right [Line Items] | ||||||||||
Warrants exercised | 6,590,000 | |||||||||
Number of stock issued in cashless exercise of warrants | 471,184 | 4,762,208 | ||||||||
Equity Option [Member] | ||||||||||
Class of Warrant or Right [Line Items] | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercises in Period | 331,619 | 5,444,526 | ||||||||
Stock Issued During Period, Value, Stock Options Exercised | $ 108,656 | $ 1,666,208 | ||||||||
Restricted Stock [Member] | ||||||||||
Class of Warrant or Right [Line Items] | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Nonvested, Number | 1,240,000 | |||||||||
Restricted Stock [Member] | 2012 Stock Incentive Plan [Member] | ||||||||||
Class of Warrant or Right [Line Items] | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Nonvested, Number | 1,040,000 | |||||||||
Restricted Stock [Member] | Plan 2019 [Member] | ||||||||||
Class of Warrant or Right [Line Items] | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Non-Option Equity Instruments, Outstanding, Number | 200,000 | |||||||||
Share-based Payment Arrangement, Option [Member] | ||||||||||
Class of Warrant or Right [Line Items] | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercises in Period | 343,716 | |||||||||
Share-based Payment Arrangement, Nonvested Award, Cost Not yet Recognized, Period for Recognition | 2 years 4 months 24 days | |||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Number | 25,030,234 | 20,872,824 | ||||||||
Restricted Stock Units (RSUs) [Member] | ||||||||||
Class of Warrant or Right [Line Items] | ||||||||||
Share-based Payment Arrangement, Nonvested Award, Cost Not yet Recognized, Period for Recognition | 2 years | |||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Grants in Period | 200,000 | 1,040,000 | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Grants in Period, Weighted Average Grant Date Fair Value | $ 2.18 | $ 4.06 | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Vested in Period | 150,000 | |||||||||
Underwriting Agreement JP Morgan Chase | ||||||||||
Class of Warrant or Right [Line Items] | ||||||||||
Stock Issued During Period, Shares, New Issues | 26,000,000 | 12,400,000 | 12,400,000 | |||||||
Shares Issued, Price Per Share | $ 2.75 | $ 5.55 | ||||||||
Period exercisable underwriters option | 30 days | |||||||||
Underwriters option granted in period shares | 3,900,000 | |||||||||
Proceeds from issuance public offering | $ 77,031,000 | $ 68,573,000 | ||||||||
Underwriting Agreement Goldman Sachs [Member] | ||||||||||
Class of Warrant or Right [Line Items] | ||||||||||
Stock Issued During Period, Shares, New Issues | 12,745,098 | |||||||||
Shares Issued, Price Per Share | $ 5.10 | $ 5.10 | ||||||||
Period exercisable underwriters option | 30 days | |||||||||
Underwriters option granted in period shares | 1,911,764 | |||||||||
Proceeds from issuance public offering | $ 69,908,000 | |||||||||
Subscription Agreement Knight [Member] | ||||||||||
Class of Warrant or Right [Line Items] | ||||||||||
Stock Issued During Period, Shares, New Issues | 3,921,568 | |||||||||
Shares Issued, Price Per Share | $ 5.10 | $ 5.10 | ||||||||
Stock Issued During Period, Value, New Issues | $ 20,000,000 |
For financial reporting purpose
For financial reporting purposes, income before taxes includes the following components: (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Operating Loss Carryforwards [Line Items] | |||
Income (Loss) from Continuing Operations before Income Taxes, Domestic | $ (176,144,999) | $ (132,617,160) | $ (76,925,380) |
Domestic Tax Authority [Member] | |||
Operating Loss Carryforwards [Line Items] | |||
Income (Loss) from Continuing Operations before Income Taxes, Domestic | $ (176,144,999) | $ (132,617,160) | $ (76,925,380) |
A reconciliation between taxes
A reconciliation between taxes computed at the federal statutory rate and the consolidated effective tax rate is as follows: (Details) | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Income Tax Disclosure [Abstract] | |||
Federal statutory tax rate | 21.00% | 21.00% | 34.00% |
State tax rate, net of federal tax benefit | 4.00% | 5.20% | 5.00% |
Adjustment in valuation allowances | (22.50%) | (31.20%) | 22.60% |
Excess stock benefits | 0.20% | 5.30% | |
Federal income tax rate change | 0.00% | (60.80%) | |
Permanent and other differences | (2.70%) | (0.30%) | (0.80%) |
Provision (benefit) for income taxes | 0.00% | 0.00% | 0.00% |
The components of the net defer
The components of the net deferred income tax asset as of December 31, 2019, 2018, and 2017 are as follows: (Details) - USD ($) | Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 |
Deferred Income Tax Assets: | |||
Net operating losses | $ 180,520,709 | $ 140,891,764 | $ 99,596,321 |
R Credit | 186,347 | 186,347 | 186,347 |
Total deferred income tax asset | 180,707,056 | 141,078,111 | 99,782,668 |
Valuation allowance | (180,707,056) | (141,078,111) | (99,782,668) |
Deferred income tax assets, net | $ 0 | $ 0 | $ 0 |
INCOME TAXES (Details Narrative
INCOME TAXES (Details Narrative) - USD ($) | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Operating Loss Carryforwards [Line Items] | |||
Federal statutory tax rate | 21.00% | 21.00% | 34.00% |
Tax Cuts and Jobs Act, provisional net tax expense | $ 46,700,000 | ||
Internal Revenue Service (IRS) [Member] | |||
Operating Loss Carryforwards [Line Items] | |||
Net operating loss carry forward | $ 620,354,163 | ||
Internal Revenue Service (IRS) [Member] | Expiration Period 20 Years [Member] | |||
Operating Loss Carryforwards [Line Items] | |||
Net operating loss carry forward | $ 338,775,332 | ||
NOL carry forward period | 20 years | ||
NOL carry forward expiration year | 2031 | ||
Internal Revenue Service (IRS) [Member] | Expiration Period Indefinite [Member] | |||
Operating Loss Carryforwards [Line Items] | |||
Net operating loss carry forward | $ 281,578,831 |
RELATED PARTIES (Details Narrat
RELATED PARTIES (Details Narrative) - Affiliated Entity [Member] - USD ($) | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Related Party Transaction [Line Items] | |||
Amount billed | $ 6,101,000 | $ 4,111,000 | $ 3,646,000 |
Amounts due to related party | $ 35,000 | $ 88,000 |
BUSINESS CONCENTRATIONS (Detail
BUSINESS CONCENTRATIONS (Details Narrative) - USD ($) | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Concentration Risk [Line Items] | |||
Number of vendors - suppliers | 3 | 3 | |
Supplier Concentration Risk [Member] | |||
Concentration Risk [Line Items] | |||
Concentration risk | 24.00% | 43.00% | 100.00% |
Number of vendors - suppliers | 1 | ||
Supplier 2 | |||
Concentration Risk [Line Items] | |||
Concentration risk | 27.00% | 33.00% | |
Supplier 3 | |||
Concentration Risk [Line Items] | |||
Concentration risk | 35.00% | 24.00% | |
Customer Concentration Risk [Member] | Revenue Benchmark [Member] | |||
Concentration Risk [Line Items] | |||
Concentration risk | 10.00% | 10.00% | 10.00% |
Number of customers - revenue | 4 | 4 | 4 |
Four Customers Concentration Risk Member | Revenue Benchmark [Member] | |||
Concentration Risk [Line Items] | |||
Concentration risk | 73.00% | 76.00% | 59.00% |
McKesson Corporation - Major Customer | Revenue Benchmark [Member] | |||
Concentration Risk [Line Items] | |||
Revenues | $ 3,911,000 | $ 1,610,000 | $ 1,959,000 |
PillPack - Major Customer | Revenue Benchmark [Member] | |||
Concentration Risk [Line Items] | |||
Revenues | 12,676,000 | 5,075,000 | |
AmerisourceBergen - Major Customer | Revenue Benchmark [Member] | |||
Concentration Risk [Line Items] | |||
Revenues | 3,927,000 | 3,246,000 | 2,667,000 |
Cardinal Health - Major Customer | Revenue Benchmark [Member] | |||
Concentration Risk [Line Items] | |||
Revenues | $ 4,551,000 | $ 2,308,000 | 2,559,000 |
Pharmacy Innovations PA - Major Customer | Revenue Benchmark [Member] | |||
Concentration Risk [Line Items] | |||
Revenues | $ 2,715,000 |
Supplemental lease information
Supplemental lease information (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2019 | Aug. 31, 2019 | Dec. 31, 2018 | |
Commitments and Contingencies Disclosure [Abstract] | |||
Right-of-use asset | $ 10,109,154 | $ 7,400,000 | |
Short-term operating lease liability (included in Other current liabilities) | 1,501,539 | ||
Long-term operating lease liability | $ 9,145,049 | ||
Weighted average remaining term | 9 years | ||
Weighted average discount rate | 8.25% | ||
Cash paid for amounts included in the measurement of lease liabilities for operating lease | $ 1,164,234 | ||
Right-of-use assets obtained in exchange for lease obligation | $ 11,171,471 |
The following table reconciles
The following table reconciles the undiscounted cash flows for all operating leases at December 31, 2019 to the operating lease liabilities recorded on the balance sheet: (Details) - USD ($) | Dec. 31, 2019 | Aug. 31, 2019 |
Commitments and Contingencies Disclosure [Abstract] | ||
2020 | $ 1,566,617 | |
2021 | 2,198,541 | |
2022 | 1,262,302 | |
2023 | 1,293,859 | |
2024 | 1,326,206 | |
Thereafter | 8,036,931 | |
Total undiscounted lease payments | 15,684,456 | |
Less: imputed interest | (5,037,868) | |
Present value of lease payments | $ 10,646,588 | $ 7,200,000 |
COMMITMENTS AND CONTINGENCIES_2
COMMITMENTS AND CONTINGENCIES (Details Narrative) | Jul. 01, 2013 | Dec. 31, 2019USD ($) | Dec. 31, 2018USD ($) | Dec. 31, 2017USD ($) | Aug. 01, 2019ft² | Jun. 01, 2019ft² | Oct. 02, 2018ft² |
Recorded Unconditional Purchase Obligation [Line Items] | |||||||
Non-cancelable operating lease term | 63 months | ||||||
Net rentable area | ft² | 56,212 | ||||||
Rented area lease | ft² | 7,561 | ||||||
Additional area of lease occupied | ft² | 48,651 | ||||||
Lessee, Operating Lease, Term of Contract | 11 years | ||||||
Number of options to extend lease | 2 | ||||||
Lease renewal term | 5 years | ||||||
Lease not yet commenced (area) | ft² | 6,536 | ||||||
Operating lease expense | $ 1,558,794 | ||||||
Rental expense | $ 1,068,275 | $ 1,029,205 | |||||
Significant supply commitment percentage payable | 50.00% | ||||||
Catalent [Member] | |||||||
Recorded Unconditional Purchase Obligation [Line Items] | |||||||
Minimum purchase commitment, 2020 | $ 5,650,853 | ||||||
Minimum purchase commitment, 2021 | 4,000,035 | ||||||
Minimum purchase commitment, 2022 | 5,643,291 | ||||||
Minimum purchase commitment, 2023 | 6,445,301 | ||||||
Minimum purchase commitment, 2024 | 6,758,945 | ||||||
ANNOVERA [Member] | |||||||
Recorded Unconditional Purchase Obligation [Line Items] | |||||||
Minimum purchase commitment, 2020 | $ 1,049,750 |
Summarized quarterly financial
Summarized quarterly financial data for fiscal years 2019 and 2018 is as follows: (Details) - USD ($) | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2019 | Sep. 30, 2019 | Jun. 30, 2019 | Mar. 31, 2019 | Dec. 31, 2018 | Sep. 30, 2018 | Jun. 30, 2018 | Mar. 31, 2018 | Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||
Revenues | $ 15,902,000 | $ 23,719,000 | $ 6,079,000 | $ 3,947,000 | $ 5,089,000 | $ 3,474,000 | $ 3,763,000 | $ 3,773,000 | $ 49,646,937 | $ 16,099,460 | $ 16,777,713 |
Gross profit | 13,023,000 | 22,275,000 | 4,830,000 | 3,184,000 | 4,139,000 | 2,775,000 | 3,309,000 | 3,139,000 | 43,312,352 | 13,361,808 | 14,140,770 |
Net loss | $ (49,435,000) | $ (31,967,000) | $ (55,237,000) | $ (39,506,000) | $ (39,391,000) | $ (35,605,000) | $ (33,219,000) | $ (24,402,000) | $ (176,144,999) | $ (132,617,160) | $ (76,925,380) |
Loss per common share, basic and diluted | $ (0.19) | $ (0.13) | $ (0.23) | $ (0.16) | $ (0.17) | $ (0.16) | $ (0.15) | $ (0.11) | $ (0.72) | $ (0.59) | $ (0.37) |
Loss on extinguishment of debt | $ 10,100,000 | $ 10,057,632 | |||||||||
License Agreement Theramex | |||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||
Revenues | $ 15,500,000 |
SUBSEQUENT EVENTS (Details Narr
SUBSEQUENT EVENTS (Details Narrative) - USD ($) | Feb. 18, 2020 | Dec. 31, 2019 | Sep. 30, 2019 | Jun. 30, 2019 | Mar. 31, 2019 | Dec. 31, 2018 | Sep. 30, 2018 | Jun. 30, 2018 | Mar. 31, 2018 | Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 |
Subsequent Event [Line Items] | ||||||||||||
Proceeds from Financing Agreement | $ 200,000,000 | |||||||||||
Net revenue | $ 15,902,000 | $ 23,719,000 | $ 6,079,000 | $ 3,947,000 | $ 5,089,000 | $ 3,474,000 | $ 3,763,000 | $ 3,773,000 | $ 49,646,937 | $ 16,099,460 | $ 16,777,713 | |
IMVEXXY, BIJUVA and ANNOVERA [Member] | Minimum [Member] | ||||||||||||
Subsequent Event [Line Items] | ||||||||||||
Net revenue | $ 11,000,000 | |||||||||||
Financing Agreement [Member] | Subsequent Event [Member] | ||||||||||||
Subsequent Event [Line Items] | ||||||||||||
Proceeds from Financing Agreement | $ 50,000,000 |