TherapeuticsMD (TXMD) 10-K 4 Mar 21 2020 FY Annual report Financial data

Cover

Cover - USD ($)	12 Months Ended
	Dec. 31, 2020	Mar. 01, 2021	Jun. 30, 2020
Cover [Abstract]
Document Type	10-K
Amendment Flag	false
Document Annual Report	true
Document Transition Report	false
Document Period End Date	Dec. 31, 2020
Document Fiscal Period Focus	FY
Document Fiscal Year Focus	2020
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	Yes
Entity Voluntary Filers	No
Entity Current Reporting Status	Yes
Entity Interactive Data Current	Yes
Entity Filer Category	Non-accelerated Filer
Entity Small Business	true
Entity Emerging Growth Company	false
Entity Shell Company	false
Entity Public Float			$ 307,578,710
Entity Common Stock, Shares Outstanding		387,825,545
ICFR Auditor Attestation Flag	false
Entity Common Stock Held by Non-affiliates			246,062,968

CONSOLIDATED BALANCE SHEETS

CONSOLIDATED BALANCE SHEETS - USD ($)	Dec. 31, 2020	Dec. 31, 2019
Current Assets:
Cash	$ 80,485,784	$ 160,829,713
Accounts receivable, net of allowance for doubtful accounts of $1,117,854 and $904,040, respectively	32,381,701	24,395,958
Inventory	7,993,087	11,860,716
Other current assets	7,543,397	11,329,793
Total current assets	128,403,969	208,416,180
Fixed assets, net	1,942,224	2,507,775
Other Assets:
License rights, net	36,196,916	39,221,308
Intangible assets, net	5,247,723	5,258,211
Right of use assets	9,565,700	10,109,154
Other assets	253,121	473,009
Total other assets	51,263,460	55,061,682
Total assets	181,609,653	265,985,637
Current Liabilities:
Accounts payable	21,068,327	19,181,212
Other current liabilities	38,169,869	33,823,613
Total current liabilities	59,238,196	53,004,825
Long-Term Liabilities:
Long-term debt	237,697,531	194,634,643
Operating lease liability	8,675,477	9,145,049
Total long-term liabilities	246,373,008	203,779,692
Total liabilities	305,611,204	256,784,517
Stockholders’ (Deficit) Equity:
Preferred stock - par value $0.001; 10,000,000 shares authorized; no shares issued and outstanding
Common stock - par value $0.001; 600,000,000 and 350,000,000 shares authorized: 299,765,396 and 271,177,076 issued and outstanding, respectively	299,765	271,177
Additional paid-in capital	754,644,100	704,351,222
Accumulated deficit	(878,945,416)	(695,421,279)
Total stockholders’ (deficit) equity	(124,001,551)	9,201,120
Total liabilities and stockholders’ (deficit) equity	$ 181,609,653	$ 265,985,637

CONSOLIDATED BALANCE SHEETS (Pa

CONSOLIDATED BALANCE SHEETS (Parenthetical) - USD ($)	Dec. 31, 2020	Dec. 31, 2019
Statement of Financial Position [Abstract]
Allowance for doubtful accounts	$ 1,117,854	$ 904,040
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	600,000,000	350,000,000
Common Stock, Shares, Issued	299,765,396	271,177,076
Common Stock, Shares, Outstanding	299,765,396	271,177,076

CONSOLIDATED STATEMENTS OF OPER

CONSOLIDATED STATEMENTS OF OPERATIONS - USD ($)	12 Months Ended
	Dec. 31, 2020	Dec. 31, 2019	Dec. 31, 2018
Total revenue, net	$ 64,872,280	$ 49,646,937	$ 16,099,460
Cost of goods sold	15,974,977	6,334,585	2,737,652
Gross profit	48,897,303	43,312,352	13,361,808
Operating expenses:
Sales, general, and administrative	192,963,967	174,112,612	115,988,954
Research and development	10,431,907	19,792,212	27,299,138
Depreciation and amortization	1,042,170	612,786	293,886
Total operating expenses	204,438,044	194,517,610	143,581,978
Operating loss	(155,540,741)	(151,205,258)	(130,220,170)
Other (expense) income
Loss on extinguishment of debt		(10,057,632)
Miscellaneous income	597,647	2,500,106	2,280,844
Interest expense	(28,581,043)	(17,382,215)	(4,677,834)
Total other expense	(27,983,396)	(24,939,741)	(2,396,990)
Loss before income taxes	(183,524,137)	(176,144,999)	(132,617,160)
Provision for income taxes
Net loss	$ (183,524,137)	$ (176,144,999)	$ (132,617,160)
Loss per share, basic and diluted:
Net loss per share, basic and diluted	$ (0.67)	$ (0.72)	$ (0.59)
Weighted average number of common shares outstanding, basic and diluted	275,648,552	246,353,318	225,026,300
Product [Member]
Total revenue, net	$ 62,872,280	$ 34,140,537	$ 16,099,460
License [Member]
Total revenue, net	$ 2,000,000	$ 15,506,400

CONSOLIDATED STATEMENTS OF STOC

CONSOLIDATED STATEMENTS OF STOCKHOLDERS' (DEFICIT) EQUITY - USD ($)	Common Stock [Member]	Additional Paid-in Capital [Member]	Retained Earnings [Member]	Total
Beginning balance, value at Dec. 31, 2017	$ 216,430	$ 516,351,405	$ (386,659,120)	$ 129,908,715
Balance at beginning (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 and warrants, net	$ 5,455	1,660,753		1,666,208
Shares issued for exercise of options and warrants, 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
Balance at ending (in shares) at Dec. 31, 2018	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
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
Share-based compensation		10,682,084		10,682,084
Net loss			(176,144,999)	(176,144,999)
Ending balance, value at Dec. 31, 2019	$ 271,177	704,351,222	(695,421,279)	$ 9,201,120
Balance at ending (in shares) at Dec. 31, 2019	271,177,076			271,177,076
Shares issued in offerings, net of cost	$ 26,953	31,675,682		$ 31,702,635
Shares issued in offerings, net of cost (in shares)	26,953,125
Shares issued for exercise of options and warrants, net	$ 1,182	270,496		271,678
Shares issued for exercise of options and warrants, net (in shares)	1,182,195
Issuance of shares from release of restricted stock (in shares)	453,000
Issuance of shares from release of restricted stock	$ 453	(453)
Warrant granted in relation to Financing Agreement		7,668,161		7,668,161
Share-based compensation		10,678,992		10,678,992
Net loss			(183,524,137)	(183,524,137)
Ending balance, value at Dec. 31, 2020	$ 299,765	$ 754,644,100	$ (878,945,416)	$ (124,001,551)
Balance at ending (in shares) at Dec. 31, 2020	299,765,396			299,765,396

CONSOLIDATED STATEMENTS OF CASH

CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($)	12 Months Ended
	Dec. 31, 2020	Dec. 31, 2019	Dec. 31, 2018
CASH FLOWS FROM OPERATING ACTIVITIES
Net loss	$ (183,524,137)	$ (176,144,999)	$ (132,617,160)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation of fixed assets	772,624	415,193	181,412
Amortization of intangible assets	269,546	197,593	112,474
Write off of patent and trademark cost	1,131,776	78,864
Write off of deferred financing fees	275,379
Non-cash operating lease expense	1,405,443	1,062,318
Provision for doubtful accounts	213,814	307,438	216,022
Lease impairment	136,832
Inventory Write-down	7,204,818	0
Loss of extinguishment of debt		10,057,632
Share-based compensation	10,678,992	10,693,662	8,661,967
Amortization of intellectual property license fee	3,024,391	778,692
Amortization of deferred financing costs	2,256,429	856,302	269,859
Changes in operating assets and liabilities:
Accounts receivable	(8,199,558)	(13,639,575)	(6,951,041)
Inventory	(3,337,189)	(8,593,046)	(1,782,312)
Other assets	3,429,443	(1,880,048)	(2,657,190)
Accounts payable	1,887,115	(3,562,629)	18,646,241
Accrued expenses and other liabilities	2,903,947	13,675,008	9,107,947
Net cash used in operating activities	(159,470,335)	(165,697,595)	(106,811,781)
CASH FLOWS FROM INVESTING ACTIVITIES
Payment for intellectual property license		(20,000,000)	(20,000,000)
Patent costs	(1,390,834)	(1,441,989)	(1,105,407)
Purchase of fixed assets	(207,073)	(2,450,285)	(217,040)
Payment of security deposit		(20,420)	(175,410)
Net cash used in investing activities	(1,597,907)	(23,912,694)	(21,497,857)
CASH FLOWS FROM FINANCING ACTIVITIES
Proceeds from exercise of options and warrants	271,678	108,656	1,666,208
Proceeds from sale of common stock, net of costs	31,702,635	77,031,258	89,907,797
Proceeds from Financing Agreement	50,000,000	200,000,000
Proceeds from Credit Agreement			75,000,000
Payment of deferred financing fees	(1,250,000)	(6,652,270)	(3,786,918)
Repayment of Credit Agreement		(81,660,719)
Net cash provided by financing activities	80,724,313	188,826,925	162,787,087
(Decrease) increase in cash	(80,343,929)	(783,364)	34,477,449
Cash, beginning of period	160,829,713	161,613,077	127,135,628
Cash, end of period	80,485,784	160,829,713	161,613,077
Supplemental disclosure of cash flow information
Interest paid	25,849,236	17,787,903	1,890,166
Non-cash investing activity
Warrant granted in relation to Financing Agreement	$ 7,668,161

THE COMPANY

THE COMPANY	12 Months Ended
	Dec. 31, 2020
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 annual patient-controlled, procedure-free, reversible prescription contraceptive option for women. Although we expected to commence the full commercial launch of ANNOVERA in the first quarter of 2020, as a result of the uncertainty surrounding the COVID-19 pandemic, we paused the commercial launch of ANNOVERA and deferred sales and marketing initiatives into subsequent quarters as the pandemic began to negatively affect our revenue growth. We resumed the commercial launch of ANNOVERA on July 1, 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, with Knight Therapeutics Inc., or Knight, pursuant to which we granted Knight an exclusive license to commercialize IMVEXXY and BIJUVA in Canada and Israel. On June 6, 2019, we entered into an exclusive license and supply agreement, or the Theramex License Agreement, with Theramex HQ UK Limited, or Theramex, to commercialize BIJUVA and IMVEXXY outside of the U.S., excluding Canada and Israel, or the Theramex Territory.

SUMMARY OF SIGNIFICANT ACCOUNTI

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES	12 Months Ended
	Dec. 31, 2020
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. Risks and Uncertainties We continue to be subject to risks and uncertainties as a result of the COVID-19 pandemic. The extent of the future impact of the COVID-19 pandemic on our business continues to be highly uncertain and difficult to predict. We continue to provide an uninterrupted supply of our portfolio of products for patients. We have sufficient inventory of finished product to meet anticipated demand in the near future. Additionally, we currently do not foresee any interruption in our ability to continue to manufacture additional product to be used beyond this period and have sufficient active pharmaceutical ingredients on hand for the continued manufacture of our products. During the year ended December 31, 2020, we recorded an inventory charge of $ 7,204,818 Since the early phase of the COVID-19 pandemic, we have been using substantial virtual options to ensure business continuity. Our VitaCare Prescription Services patient model assists patients in obtaining easy and convenient access to their prescriptions for products at a retail pharmacy of their choice, including via home delivery retail pharmacy options. We have also partnered with independent community pharmacies and multiple third-party online pharmacies and telemedicine providers that focus on contraception or menopause to ensure patients have real-time access to both diagnosis and treatment. We continue to support prescribers’ needs with samples and product materials through our sales force. If access is restricted, we have mailing options in place for these materials. We also have business continuity plans and infrastructure in place that allows for live virtual e-detailing of our products. As part of our response to the COVID-19 pandemic, we implemented measures to reduce marketing expenses for 2020. We also implemented cost saving measures, which included negotiating lower fees or suspending services from third party vendors; implementing a company-wide hiring restriction; delaying or cancelling non-critical information technology projects; and eliminating non-essential travel, entertainment, meeting, and event expenses. The full impact of the COVID-19 pandemic continues to evolve. However, we remain committed to the execution of our corporate goals, despite the ongoing COVID-19 pandemic, as demonstrated in part by the increase in product revenue throughout 2020. As of the date of issuance of these consolidated financial statements, the future extent to which the COVID-19 pandemic may continue to materially impact our financial condition, liquidity, or results of operations remains uncertain. We are continuing to assess the effect the COVID-19 pandemic on our operations by monitoring the spread of COVID-19 and the various actions implemented to combat the pandemic throughout the world. Even after the COVID-19 pandemic has subsided, we may continue to experience adverse impacts to our business as a result of any economic recession or depression that has occurred or may occur in the future. While we currently believe that our COVID-19 contingency plan has the ability to mitigate the effect of the COVID-19 pandemic on our business, the severity of the impact of the COVID-19 pandemic on our business will depend on a number of factors, including, but not limited to, the duration and severity of the pandemic, the duration of “social distancing” orders, the ability of our sales force to access healthcare providers to promote our products, increases in unemployment, which could reduce access to commercial health insurance for our patients, thus limiting payer coverage for our products, and the impact of the pandemic on our global supply chain, all of which are uncertain. Our future results of operations and liquidity could be materially adversely affected by delays in payments of outstanding receivable amounts beyond normal payment terms, supply chain disruptions, uncertain demand, and the impact of any initiatives or programs that we may undertake to address financial and operations challenges that we may face. Liquidity As of the filing date of this Annual Report on Form 10-K, our cash balance was above the required balance by the Financing Agreement (as defined in Note 8 - Debt). On November 8, 2020, we and our subsidiaries entered into Amendment No. 6 to the Financing Agreement, or Amendment No. 6, with the Administrative Agent (as defined in Note 8 - Debt) and the lenders party thereto, pursuant to which we temporarily lowered the minimum required cash balance from $ 60 45 60 However, if we are unsuccessful with the commercialization of IMVEXXY, BIJUVA, or ANNOVERA, if commercialization is delayed, or if the continued impact of the COVID-19 pandemic on our business is worse than we anticipate, our existing cash reserves may be insufficient to maintain compliance with the Financing Agreement covenants or satisfy our liquidity requirements until we are able to successfully commercialize IMVEXXY, BIJUVA, and ANNOVERA. The Financing Agreement also requires us to maintain certain minimum quarterly product net revenue requirements and several other restrictive covenants. On March 1, 2021, we entered into Amendment No. 8 to the Financing Agreement, or Amendment No. 8, pursuant to which, among other amendments, the minimum consolidated net revenue requirements attributable to commercial sales of IMVEXXY, BIJUVA, and ANNOVERA were revised. See Note 8 – Debt – for a description of these covenants. These and other terms in the Financing Agreement have to be monitored closely for compliance and could restrict our ability to grow our business or enter into transactions that we believe would be beneficial to our business. If we are unable to maintain the minimum unrestricted cash balance, achieve any of the total minimum net revenue requirements, or otherwise comply with the covenants of the Financing Agreement, all or a portion of our obligations under the Financing Agreement may be declared immediately due and payable, which would have a material adverse effect on our business, results of operations and financial condition. 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, reasonable supportable forecasts, and existing economic conditions and we record an allowance that presents the net amount expected to be collected. We evaluate trade accounts receivable 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. Our exposure to credit losses may increase if our customers are adversely affected by changes in healthcare laws, coverage, and reimbursement, economic pressures or uncertainty associated with local or global economic recessions, disruption associated with the current COVID-19 pandemic, or other customer-specific factors. Although we have historically not experienced significant credit losses, it is possible that there could be a material adverse impact from potential adjustments of the carrying amount of trade receivables in the future. At December 31, 2020, four different customers represented 25 19 17 11 36 21 16 11 The opening balance of the allowance for doubtful accounts is reconciled to the closing balance for expected credit losses as follows: Allowance for Doubtful Accounts Balance - January 1, 2020 $ 904,040 Increase in allowance 422,137 Recoveries (181,514 ) Write-offs (26,809 ) Balance - December 31, 2020 $ 1,117,854 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, product improvements rendering previous versions obsolete, or decreases in demand for our products. 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. Inventory Write-Off We evaluate inventory quarterly for short dated and excess inventory. During the years ended December 31, 2020 and December 31, 2019, we recorded an inventory charge of $ 7,204,818 0 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. 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 years 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 years Intangible Assets We have adopted the provisions of Financial Accounting Standards Board, or FASB, Accounting Standards Codification, or ASC, 350, Intangibles - Goodwill and Other 38 39 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. 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. 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. 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 years ended December 31, 2020 and 2019, we wrote off $ 1,131,776 78,864 Fair Value of Financial Instruments Our financial instruments consist primarily of cash, accounts receivable, accounts payable, accrued expenses and long-term debt. The carrying amount of cash, accounts receivable, accounts payable and accrued expenses approximates their fair value because of the short-term maturity of such instruments, which are considered Level 1 assets under the fair value hierarchy. The carrying amount for long-term debt as of December 31, 2020 and 2019 (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, 2020 and 2019, we had no assets or liabilities that were valued at fair value on a recurring basis. 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, 2020 and 2019, 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 We grant restricted stock units and performance-based stock units for shares of common stock, par value $ 0.001 Revenue Recognition In accordance with ASC 606, Revenue from Contracts with Customers Prescription Products As of December 31, 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 product 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 product 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 product revenue would be subject to a significant reversal. We consider all the facts and circumstances associated with both the risk of a product revenue reversal arising from an uncertain future event and the magnitude of the reversal if that uncertain event were to occur. Actual amounts of consideration ultimately received may differ from our estimates. If actual results in the future vary from our original estimates, we will adjust these estimates, which would affect net product revenue and earnings in the period such changes in estimates become known. We accept returns of unsalable prescription products sold through wholesale distributors within a return period of six months prior to and up to 12 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 revenue at the time the product revenue is recognized. We record distributor fees based on amounts stated in contracts. Rebate and coupon estimates and distributor fees are recorded in 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 revenue at the time the product revenue is 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. 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 product 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. Disaggregation of revenue The following table provides information about disaggregated revenue, net by product mix for the years ended December 31, 2020, 2019, and 2018: For the Years Ended December 31, 2020 2019 2018 Prescription vitamins $ 9,767,644 $ 9,885,493 $ 15,041,259 IMVEXXY 27,139,387 16,252,045 1,058,201 BIJUVA 6,353,963 1,836,443 — ANNOVERA 19,611,286 6,166,556 — License revenue 2,000,000 15,506,400 — Net revenue $ 64,872,280 $ 49,646,937 $ 16,099,460 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 intellectual property is transferred to the customer. 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. We began selling ANNOVERA in a “test and learn” market introduction in the third quarter of 2019. As a result of the uncertainty surrounding the COVID-19 pandemic, we paused the commercial launch of ANNOVERA in the first quarter of 2020 and deferred sales and marketing initiatives into subsequent quarters. We resumed the commercial launch of ANNOVERA on July 1, 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 3,024,391 778,692 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 40 200 400 1 20,000,000 Unless earlier terminated, the Population Council License Agreement will remain in effect until the later of the expiration of the last-to-expire of the Population Council’s U.S. patents that are licensed to us, or the date following such expiration that follows a continuous period of six months during which we and our affiliates have not made a commercial sale of ANNOVERA in the U.S. The Population Council License Agreement may also be terminated for certain breach and bankruptcy-related events and by us on 180 days’ prior notice to the Population Council. License Agreement with Knight Therapeutics Inc. In July 2018, we entered into the Knight License Agreement 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 paid us $ 2,000,000 License Agreement with Theramex On June 6, 2019, we entered into the Theramex License Agreement with Theramex to commercialize BIJUVA and IMVEXXY in the Territory. Under the terms of the Theramex License Agreement, Theramex paid us EUR 14 15,506,400 2 million 27.5 million Territory ranging from EUR 25 100 5 Territory. Theramex is responsible for all regulatory and commercial activities for BIJUVA and IMVEXXY in the Territory. Theramex may sublicense its rights to commercialize BIJUVA and IMVEXXY in the Territory, except for certain specified markets. We may terminate the Theramex License Agreement if Theramex does not submit all regulatory applications, submissions and/or registrations required for regulatory approval to use and commercialize BIJUVA and IMVEXXY within certain specified time periods. We also may terminate the Theramex License Agreement if Theramex challenges our patents. Either party may terminate the Theramex 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. Segment Reporting We are managed and operated as one business, which is focused on creating and commercializing products targeted exclusively for women. Our business operations are managed by a single executive leadership team that is led by the Chief Executive Officer of our Company, who oversees all operations. We do not operate separate lines of business with respect to any of our products and we do not prepare discrete financial information with respect to separate products. All product sales are derived from sales in the United States. Accordingly, we view our business as one reportable operating segment. 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. Advertising Costs We expense advertising costs when incurred. Advertising costs were $ 35,799,313 9,045,571 1,682,746 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 Pe

INVENTORY

INVENTORY	12 Months Ended
	Dec. 31, 2020
Inventory Disclosure [Abstract]
INVENTORY	NOTE 3 – INVENTORY Inventory consists of the following: December 31, 2020 2019 Finished products $ 3,350,580 $ 4,976,910 Work in process 219,918 1,182,059 Raw materials 4,422,589 5,701,747 TOTAL INVENTORY $ 7,993,087 $ 11,860,716

OTHER CURRENT ASSETS

OTHER CURRENT ASSETS	12 Months Ended
	Dec. 31, 2020
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, 2020 2019 Prepaid sales and marketing costs $ 4,308 $ 1,583,698 Debt financing fees on undrawn tranches (Note 8) — 550,757 Prepaid insurance 2,568,269 1,812,135 Prepaid manufacturing 1,331,100 2,595,721 Other prepaid costs 3,639,720 4,787,482 TOTAL OTHER CURRENT ASSETS $ 7,543,397 $ 11,329,793

FIXED ASSETS, NET

FIXED ASSETS, NET	12 Months Ended
	Dec. 31, 2020
Property, Plant and Equipment [Abstract]
FIXED ASSETS, NET	NOTE 5 – FIXED ASSETS, NET Fixed assets, net consist of the following: December 31, 2020 2019 Accounting system $ 411,550 $ 301,096 Equipment 1,704,931 1,619,646 Furniture and fixtures 1,406,858 1,406,858 Computer hardware 80,211 80,211 Leasehold improvements 80,121 68,788 TOTAL FIXED ASSETS 3,683,671 3,476,599 Accumulated depreciation (1,741,447 ) (968,824 ) TOTAL FIXED ASSETS, NET $ 1,942,224 $ 2,507,775 Depreciation expense for the years ended December 31, 2020, 2019, and 2018 was $ 772,624 415,193 181,412

INTANGIBLE ASSETS, NET

INTANGIBLE ASSETS, NET	12 Months Ended
	Dec. 31, 2020
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, 2020 and 2019: December 31, 2020 Gross Accumulated Net Weighted- Average Amortization Period (yrs.) Amortizable intangible assets: Approved hormone therapy drug candidate patents $ 4,044,552 $ (748,627 ) $ 3,295,925 12 Hormone therapy drug candidate patents (pending) 1,628,457 — 1,628,457 n/a Non-amortizable intangible assets: Multiple trademarks 323,341 — 323,341 indefinite TOTAL $ 5,996,350 $ (748,627 ) $ 5,247,723 December 31, 2019 Gross Accumulated Net Weighted- Average Amortization Period (yrs.) 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 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 wrote off $ 1,131,776 78,864 As of December 31, 2020, we had 38 39 ● 15 nine three ● 12 ten two 18 eight ten ● One ● One eight ● Three ● Two four ● One Amortization expense was $ 269,546 197,593 112,474 Estimated amortization expense, based on current patent cost being amortized, for the next five years is as follows: Year Ending December 31, Estimated Amortization 2021 $ 274,669 2022 $ 274,669 2023 $ 274,669 2024 $ 274,669 2025 $ 274,669

OTHER CURRENT LIABILITIES

OTHER CURRENT LIABILITIES	12 Months Ended
	Dec. 31, 2020
Payables and Accruals [Abstract]
OTHER CURRENT LIABILITIES	NOTE 7– OTHER CURRENT LIABILITIES Other current liabilities December 31, 2020 2019 Accrued payroll, bonuses and commission costs $ 8,758,073 $ 8,040,278 Allowance for coupons and returns 6,770,206 10,316,298 Accrued sales and marketing costs 227,500 3,285,662 Accrued compensated absences 2,353,996 1,463,878 Allowance for wholesale distributor fees 2,632,432 2,347,122 Accrued legal and accounting expense 898,568 422,336 Accrued research and development 925,314 1,049,603 Operating lease liability 2,253,994 1,501,539 Accrued rebates 11,010,588 3,916,672 Other accrued expenses 2,339,198 1,480,225 TOTAL OTHER CURRENT LIABILITIES $ 38,169,869 $ 33,823,613

DEBT

DEBT	12 Months Ended
	Dec. 31, 2020
Debt Disclosure [Abstract]
DEBT	NOTE 8 – DEBT On April 24, 2019, we entered into a Financing Agreement, as amended, or the Financing Agreement, with Sixth Street 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 provided us with up to a $ 300,000,000 200,000,000 50,000,000 11,000,000 $50,000,000 50,000,000 3-month LIBOR 7.75 2.70 prime rate 6.75 5.2 four 15 5.0 35 5.0 5 10 41.25 30.0 5 5.0 5.0 3.0 2.5 60,000,000 17 20 23 26.5 30 35 40 45 50 55 60 65.5 70 45 On August 5, 2020, we entered into Amendment No. 5 to the Financing Agreement, or Amendment No. 5. Amendment No. 5 adjusted the covenant in the Financing Agreement regarding our achievement of minimum consolidated net revenue attributable to commercial sales of our IMVEXXY, BIJUVA, and ANNOVERA products to reflect the impact of COVID-19 on our business. The covenant was effective beginning with the fiscal quarter ending December 31, 2020. In connection with Amendment No. 5 and in lieu of a cash amendment fee, we issued to the Administrative Agent and the lenders under the Financing Agreement warrants to purchase an aggregate of 4,752,116 1.58 On November 8, 2020, in connection with entering into Amendment No. 6 to the Financing Agreement, or Amendment No. 6, we amended the Lender Warrants to provide for an adjustment to the exercise price if we conduct certain dilutive issuances prior to December 31, 2020, or if the volume-weighted average price of our Common Stock for the fifteen trading days ending December 31, 2020 is lower than the then-current exercise price. Pursuant to Amendment No. 6, the issuance of Common Stock by the Company in the underwritten public offering at a price per share equal to $ 1.1856 1.58 1.1856 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 7.7 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 4,407,975 120,146 269,859 As of December 31, 2020, we 250,000,000 7,902,270 7,626,891 7,428,178 239,983 During the third quarter of 2020, we concluded that the undrawn $ 50,000,000 275,379 During the years ended December 31, 2020 and 2019, we amortized $ 2,256,428 736,156 26,049,236 14,709,166 12.5 As of December 31, 2020 and 2019, the carrying value of our debt consisted of the following: As of December 31, 2020 2019 Financing Agreement $ 250,000,000 $ 200,000,000 Debt discount and financing fees (12,302,469 ) (5,365,357 ) TOTAL LONG-TERM DEBT $ 237,697,531 $ 194,634,643 The following table reflects our aggregate future principal payments under the Financing Agreement for the next five years, as amended by Amendment No. 8: Year Ending December 31, 2021 $ 50,000,000 2022 $ 25,000,000 2023 $ 133,750,000 2024 $ 41,250,000 2025 $ —

STOCKHOLDERS_ EQUITY

STOCKHOLDERS’ EQUITY	12 Months Ended
	Dec. 31, 2020
Equity [Abstract]
STOCKHOLDERS’ EQUITY	NOTE 9 – STOCKHOLDERS’ EQUITY Preferred Stock At December 31, 2020, we had 10,000,000 0.001 no Common Stock At December 31, 2020, we had 600,000,000 299,765,396 Issuances During 2020 During the year ended December 31, 2020, stock options to purchase an aggregate of 1,182,195 271,678 On November 10, 2020, we entered into an underwriting agreement with Cantor Fitzgerald & Co., or Cantor Fitzgerald, as underwriter, relating to an underwritten public offering of 23,437,500 1.1856 30 days 3,515,625 31,703,000 23,437,500 3,515,625 In November 2020, we entered into a Controlled Equity Offering SM 50 million 3.0 50 million 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 Warrants to Purchase Common Stock As of December 31, 2020, we had warrants outstanding to purchase an aggregate of 6,534,687 7.25 0.24 8.20 1.55 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. In connection with Amendment No. 5 and in lieu of a cash amendment fee, we issued to the Administrative Agent and the lenders under the Financing Agreement the Lender Warrants. The fair value for the Lender Warrants was determined by using the Black-Scholes Model on the date of the grant using a term of ten years 68.8 0.34 0 1.56 On November 8, 2020, in connection with entering into Amendment No. 6, we amended the Lender Warrants to provide for an adjustment to the exercise price if we conducted certain dilutive issuances prior to December 31, 2020, or if the volume-weighted average price of our Common Stock for the fifteen trading days ending December 31, 2020 was lower than the then-current exercise price. Pursuant to Amendment No. 6, the issuance of the shares of Common Stock in the November 2020 underwritten public offering triggered the automatic reduction in the exercise price of the Warrants from $ 1.58 1.1856 239,983 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 We recorded share-based compensation expense related to warrants previously issued of $ 26,446 254,970 494,136 Summary of our Warrant activity during the year ended December 31, 2020: Number of Shares Under Warrants Weighted Average Exercise Price Weighted Average Remaining Contractual Life in Years Aggregate Intrinsic Value Balance at December 31, 2019 1,832,571 $ 2.62 1.95 $ 2,447,929 Granted 4,752,116 $ 1.19 Exercised — — — Expired — — Cancelled/Forfeited (50,000 ) $ 6.35 Balance at December 31, 2020 6,534,687 $ 1.55 7.25 $ 1,041,219 Vested and Exercisable at December 31, 2020 6,534,687 $ 1.55 7.25 $ 1,041,219 Unvested at December 31, 2020 — — — — 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, 2020, 2019, and 2018 are set forth in the table below. 2020 2019 2018 Weighted average exercise price $ 1.19 $ 5.63 $ 5.16 Weighted average grant date fair value $ 1.56 $ 3.00 $ 2.79 Risk-free interest rate 0.34 % 2.52 % 2.36 % Volatility 68.8 % 60.8 % 62.12 % Term (in years) 10 5 5 Dividend yield 0.00 % 0.00 % 0.00 % Warrant exercises During the year ended December 31, 2020, no During the year ended December 31, 2019, warrants to purchase an aggregate of 1,250,000 471,184 During the year ended December 31, 2018, no 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, 2020, there were non-qualified stock options to purchase an aggregate of 13,285,205 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, 2020, there were non-qualified stock options to purchase an aggregate of 6,305,974 890,000 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 ten years As of December 31, 2020, there were 2,583,565 4,190,751 6,171,024 2,403,951 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, 2020, 2019, and 2018 are set forth in the table below. 2020 2019 2018 Weighted average exercise price $ 1.58 $ 3.10 $ 5.45 Weighted average grant date fair value $ 0.95 $ 1.82 $ 3.24 Risk-free interest rate 0.34 1.68 1.64 2.54 2.38 2.89 Volatility 63.53 67.92 61.25 64.49 59.45 64.04 Term (in years) 6 6.8 5.5 6.5 5.1 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, 2020 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, 2019 25,030,234 $ 4.65 5.84 $ 3,668,171 Granted 736,500 $ 1.58 Exercised (1,182,195 ) $ 0.23 $ 1,738,740 Expired (386,609 ) $ 3.76 Cancelled/Forfeited (416,000 ) $ 3.80 Balance at December 31, 2020 23,781,930 $ 4.80 5.20 $ 152,253 Vested and Exercisable at December 31, 2020 19,862,681 $ 5.06 4.59 $ 117,443 Unvested at December 31, 2020 3,919,249 $ 3.53 8.29 $ 34,810 At December 31, 2020, our outstanding options had exercise prices ranging from $ 0.38 8.92 5,235,585 8,798,707 8,091,294 5,238,000 1.9 Restricted Stock Restricted stock units 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. Performance stock units will vest if certain performance targets are achieved. If minimum performance thresholds are achieved, each award will convert into Common Stock at a defined ratio depending on the degree of achievement of the performance target designated by each individual award. If minimum performance thresholds are not achieved, then no shares will be issued. We recognize performance-based restricted stock as compensation expense based on the most likely probability of attaining the prescribed performance and over the requisite service period beginning at its grant date and through the date the restricted stock vests. The expected levels of achievement are reassessed over the requisite service periods and, to the extent that the expected levels of achievement change, stock-based compensation is adjusted and recorded on the consolidated statements of income and the remaining unrecognized stock-based compensation is recognized over the remaining requisite service period. During the years ended December 31, 2020, 2019 and 2018 we recorded $ 5,399,472 1,628,407 73,132 9,989,000 1.6 Schedule of restricted stock units and performance stock units Restricted Stock Units Performance Stock Units Number of Shares Weighted Average Grant Date Fair Value Number of Shares Weighted Average Grant Date Fair Value Balance at December 31, 2019 1,240,000 $ 3.56 — $ — Granted 6,152,818 $ 1.39 2,585,745 $ 1.08 Vested/Released (301,500 ) $ 1.78 (151,500 ) $ 1.14 Forfeited (30,294 ) $ 1.07 (30,294 ) $ 1.07 Balance at December 31, 2020 7,061,024 $ 1.76 2,403,951 * $ 1.08 * The number of performance stock units (PSUs) represents the base number of PSUs that may vest. The actual number of PSUs that will vest will be between zero and two times the base number of PSUs depending on the Company’s achievement of break-even quarterly EBITDA. Employee Stock Purchase Plan On June 18, 2020, our stockholders approved the TherapeuticsMD, Inc. 2020 Employee Stock Purchase Plan, or the ESPP, which reserved 5,400,000 85 17,489

EMPLOYEE BENEFIT PLAN

EMPLOYEE BENEFIT PLAN	12 Months Ended
	Dec. 31, 2020
Retirement Benefits [Abstract]
EMPLOYEE BENEFIT PLAN	NOTE 10 – EMPLOYEE BENEFIT PLAN The Company maintains a voluntary defined contribution 401(k) plan covering all eligible employees as defined in the plan documents. The plan provides for discretionary matching contribution, which is equal to up to four 2,000 five years 487,000 403,000

INCOME TAXES

INCOME TAXES	12 Months Ended
	Dec. 31, 2020
Income Tax Disclosure [Abstract]
INCOME TAXES	NOTE 11 – INCOME TAXES For financial reporting purposes, (loss) income before taxes includes the following components: 2020 2019 2018 United States $ (183,524,137 ) $ (176,144,999 ) $ (132,617,160 ) Total $ (183,524,137 ) $ (177,144,999 ) $ (132,617,160 ) For the years ended December 31, 2020, 2019, and 2018, there was no provision for income taxes, current or deferred. 761,701,546 338,775,332 20 2031 422,926,214 A reconciliation between taxes computed at the federal statutory rate and the consolidated effective tax rate is as follows: 2020 2019 2018 Federal statutory tax rate 21.0 % 21.0 % 21.0 % State tax rate, net of federal tax benefit 5.1 % 4.0 % 5.2 % Adjustment in valuation allowances (27.0 )% (22.5 )% (31.2 )% Excess stock benefits 0.1 % 0.2 % 5.3 % Federal income tax rate change 0 % 0 % - % Permanent and other differences 0.8 % (2.7 )% (0.3 )% 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, 2020, 2019, and 2018 are as follows: 2020 2019 2018 Deferred Income Tax Assets: Net operating losses $ 195,008,131 $ 157,555,975 $ 126,419,113 Share based compensation 17,251,900 13,913,568 11,640,464 Interest expense limitation 12,991,716 5,389,129 1,173,614 Other, net 4,818,935 3,662,037 1,658,573 R&D credit 186,347 186,347 186,347 Total deferred income tax asset 230,257,029 180,707,056 141,078,111 Valuation allowance (230,257,029 ) (180,707,056 ) (141,078,111 ) 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, 2020. The change in valuation allowance was $ 49,549,973 $39,628,945 $41,295,443 Unrecognized Tax Benefits As of December 31, 2020 and 2019, we have no unrecognized tax benefits.

RELATED PARTIES

RELATED PARTIES	12 Months Ended
	Dec. 31, 2020
Related Party Transactions [Abstract]
RELATED PARTIES	NOTE 12 – 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, 2020, 2019 and 2018, we were billed by Catalent approximately $ 3,036,000 6,101,000 4,111,000 0 35,000 In April 2020, Karen L. Ling, Executive Vice President and Chief Human Resources Officer of American International Group, Inc., or AIG, was appointed to our board of directors. From time to time, we have entered into agreements with AIG in the normal course of business. Agreements with AIG have been reviewed by independent directors of our Company, or a committee consisting of independent directors of our Company, since April 2020. During the year ended December 31, 2020, we were billed by AIG approximately $ 209,000

BUSINESS CONCENTRATIONS

BUSINESS CONCENTRATIONS	12 Months Ended
	Dec. 31, 2020
Risks and Uncertainties [Abstract]
BUSINESS CONCENTRATIONS	NOTE 13 - BUSINESS CONCENTRATIONS We purchase our prescription products from several suppliers with approximately 36 30 25 24 27 35 43 33 24 three 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 the year ended December 31, 2020, three 10 four 10 three 63 four 73 76 During the year ended December 31, 2020, Cardinal Health accounted for approximately $ 17,489,000 13,228,000 9,862,000 12,676,000 4,551,000 3,927,000 3,911,000 5,075,000 3,246,000 2,308,000 1,610,000

COMMITMENTS AND CONTINGENCIES

COMMITMENTS AND CONTINGENCIES	12 Months Ended
	Dec. 31, 2020
Commitments and Contingencies Disclosure [Abstract]
COMMITMENTS AND CONTINGENCIES	NOTE 14 – COMMITMENTS AND CONTINGENCIES Operating Leases We adopted ASC 842, Leases, 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 pursuant to an addendum to such lease, which commenced in May 2020. Supplemental lease information as of: December 31, 2020 December 31, 2019 Right-of-use asset $ 9,565,700 $ 10,109,154 Short-term operating lease liability (included in Other current liabilities $ 2,253,994 $ 1,501,539 Long-term operating lease liability $ 8,675,477 $ 9,145,049 Weighted average remaining term 8.9 9 Weighted average discount rate 8.30 % 8.25 % Supplemental cash flow information for the year ended: December 31, December 31, 2019 Cash paid for amounts included in the measurement of lease liabilities for operating lease $ 1,617,645 $ 1,164,234 Right-of-use assets obtained in exchange for lease obligation $ 998,821 $ 11,171,471 The following table reconciles the undiscounted cash flows for all operating leases at December 31, 2020 to the operating lease liabilities recorded on the balance sheet: Years Ending December 31, 2021 $ 2,334,582 2022 1,413,289 2023 1,443,143 2024 1,476,534 2025 1,513,458 Thereafter 7,434,412 Total undiscounted lease payments 15,615,418 Less: imputed interest (4,685,947 ) Present value of lease payments $ 10,929,471 During the year ended December 31, 2020, operating lease expense related to our real estate leases was $ 2,325,844 423,578 1,558,794 1,068,275 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 2, Summary of Significant Accounting Policies 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 3,458,000 2,150,000 2,991,000 3,347,000 3,786,000 1,526,000 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, 2020, 2019, and 2018, 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, 2020
Quarterly Financial Information Disclosure [Abstract]
SELECTED QUARTERLY FINANCIAL DATA (UNAUDITED)	NOTE 15 – SELECTED QUARTERLY FINANCIAL DATA (UNAUDITED) Summarized quarterly financial data for fiscal years 2020 and 2019 is as follows 2020 (In thousands, except per share) First Second Third Quarter (1)(2)(3)(4) Fourth (5) Revenues $ 12,251 $ 10,701 $ 19,343 $ 22,577 Gross profit $ 9,536 $ 6,301 $ 16,064 $ 16,996 Net loss $ (56,849 ) $ (51,976 ) $ (32,611 ) $ (42,088 ) Loss per common share, basic and diluted $ (0.21 ) $ (0.19 ) $ (0.12 ) $ (0.15 ) 2019 (In thousands, except per share) First Second (6) Third Quarter (7) Fourth 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 ) (1) During the third quarter of 2020, we recorded $ 2 million (2) During the third quarter of 2020, we recorded the fair value of the Lender Warrants based on Amendment No. 5 of approximately $ 7.4 million (3) During the third quarter of 2020, we wrote off approximately $ 0.6 million (4) During the third quarter of 2020, we recorded approximately $ 5.7 million (5) During the fourth quarter of 2020, we wrote off approximately $ 0.5 million (6) During the second quarter of 2019, we recorded approximately $ 10.1 million (7) During the third quarter of 2019, we recorded approximately $ 15. 5 million (1) During the third quarter of 2020, we recorded $2 million in license revenue related to the Knight License Agreement. Refer to discussion in Note 2-Summary of Significant Accounting Policies. (2) During the third quarter of 2020, we recorded the fair value of the Lender Warrants based on Amendment No. 5 of approximately $7.4 million as a debt discount, which is being amortized to interest expense using the effective interest method over the term of the Financing Agreement. Refer to discussion in Note 8-Debt. (3) During the third quarter of 2020, we wrote off approximately $0.6 million in costs related to trademarks and patents. Refer to discussion in Note 6-Intangible Assets, Net. (4) During the third quarter of 2020, we recorded approximately $5.7 million in inventory charge, primarily related to BIJUVA. Refer to discussion in Note 2-Summary of Significant Accounting Policies. (5) During the fourth quarter of 2020, we wrote off approximately $0.5 million in costs related to trademarks and patents. Refer to discussion in Note 6-Intangible Assets, Net. (6) During the second quarter of 2019, we recorded approximately $10.1 million in loss on extinguishment of debt related to the repayment of the Credit Agreement. Refer to discussion in Note 8-Debt. (7) During the third quarter of 2019, we recorded approximately $15.5 million in license revenue related to the Theramex License Agreement. Refer to discussion in Note 2-Summary of Significant Accounting Policies.

SUBSEQUENT EVENTS

SUBSEQUENT EVENTS	12 Months Ended
	Dec. 31, 2020
Subsequent Events [Abstract]
SUBSEQUENT EVENTS	NOTE 16 – SUBSEQUENT EVENTS During the period from January 1, 2021 through February 8, 2021 in accordance with the terms of the sales agreement described in Note 9- Stockholders’ Equity, we sold 28,600,689 47.3 million On January 13, 2021, we entered into Amendment No. 7 to the Financing Agreement, or Amendment No. 7, pursuant to which, among other amendments, the minimum consolidated net revenue requirements attributable to commercial sales of IMVEXXY, BIJUVA, and ANNOVERA for the fiscal quarters ending March 31, 2021 and June 30, 2021 were reduced to $ 18 22 On March 1, 2021, we entered into Amendment No. 8, pursuant to which, among other amendments, the minimum consolidated net revenue requirements attributable to commercial sales of IMVEXXY, BIJUVA, and ANNOVERA. See Note 8 – Debt for information regarding Amendment No. 8. On February 11, 2021, we entered into an underwriting agreement with Cantor Fitzgerald, as underwriter, relating to an underwritten public offering of 59,459,460 30 days 8,918,919 97.1 million

SUMMARY OF SIGNIFICANT ACCOUN_2

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies)	12 Months Ended
	Dec. 31, 2020
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.
Risks and Uncertainties	Risks and Uncertainties We continue to be subject to risks and uncertainties as a result of the COVID-19 pandemic. The extent of the future impact of the COVID-19 pandemic on our business continues to be highly uncertain and difficult to predict. We continue to provide an uninterrupted supply of our portfolio of products for patients. We have sufficient inventory of finished product to meet anticipated demand in the near future. Additionally, we currently do not foresee any interruption in our ability to continue to manufacture additional product to be used beyond this period and have sufficient active pharmaceutical ingredients on hand for the continued manufacture of our products. During the year ended December 31, 2020, we recorded an inventory charge of $ 7,204,818 Since the early phase of the COVID-19 pandemic, we have been using substantial virtual options to ensure business continuity. Our VitaCare Prescription Services patient model assists patients in obtaining easy and convenient access to their prescriptions for products at a retail pharmacy of their choice, including via home delivery retail pharmacy options. We have also partnered with independent community pharmacies and multiple third-party online pharmacies and telemedicine providers that focus on contraception or menopause to ensure patients have real-time access to both diagnosis and treatment. We continue to support prescribers’ needs with samples and product materials through our sales force. If access is restricted, we have mailing options in place for these materials. We also have business continuity plans and infrastructure in place that allows for live virtual e-detailing of our products. As part of our response to the COVID-19 pandemic, we implemented measures to reduce marketing expenses for 2020. We also implemented cost saving measures, which included negotiating lower fees or suspending services from third party vendors; implementing a company-wide hiring restriction; delaying or cancelling non-critical information technology projects; and eliminating non-essential travel, entertainment, meeting, and event expenses. The full impact of the COVID-19 pandemic continues to evolve. However, we remain committed to the execution of our corporate goals, despite the ongoing COVID-19 pandemic, as demonstrated in part by the increase in product revenue throughout 2020. As of the date of issuance of these consolidated financial statements, the future extent to which the COVID-19 pandemic may continue to materially impact our financial condition, liquidity, or results of operations remains uncertain. We are continuing to assess the effect the COVID-19 pandemic on our operations by monitoring the spread of COVID-19 and the various actions implemented to combat the pandemic throughout the world. Even after the COVID-19 pandemic has subsided, we may continue to experience adverse impacts to our business as a result of any economic recession or depression that has occurred or may occur in the future. While we currently believe that our COVID-19 contingency plan has the ability to mitigate the effect of the COVID-19 pandemic on our business, the severity of the impact of the COVID-19 pandemic on our business will depend on a number of factors, including, but not limited to, the duration and severity of the pandemic, the duration of “social distancing” orders, the ability of our sales force to access healthcare providers to promote our products, increases in unemployment, which could reduce access to commercial health insurance for our patients, thus limiting payer coverage for our products, and the impact of the pandemic on our global supply chain, all of which are uncertain. Our future results of operations and liquidity could be materially adversely affected by delays in payments of outstanding receivable amounts beyond normal payment terms, supply chain disruptions, uncertain demand, and the impact of any initiatives or programs that we may undertake to address financial and operations challenges that we may face.
Liquidity	Liquidity As of the filing date of this Annual Report on Form 10-K, our cash balance was above the required balance by the Financing Agreement (as defined in Note 8 - Debt). On November 8, 2020, we and our subsidiaries entered into Amendment No. 6 to the Financing Agreement, or Amendment No. 6, with the Administrative Agent (as defined in Note 8 - Debt) and the lenders party thereto, pursuant to which we temporarily lowered the minimum required cash balance from $ 60 45 60 However, if we are unsuccessful with the commercialization of IMVEXXY, BIJUVA, or ANNOVERA, if commercialization is delayed, or if the continued impact of the COVID-19 pandemic on our business is worse than we anticipate, our existing cash reserves may be insufficient to maintain compliance with the Financing Agreement covenants or satisfy our liquidity requirements until we are able to successfully commercialize IMVEXXY, BIJUVA, and ANNOVERA. The Financing Agreement also requires us to maintain certain minimum quarterly product net revenue requirements and several other restrictive covenants. On March 1, 2021, we entered into Amendment No. 8 to the Financing Agreement, or Amendment No. 8, pursuant to which, among other amendments, the minimum consolidated net revenue requirements attributable to commercial sales of IMVEXXY, BIJUVA, and ANNOVERA were revised. See Note 8 – Debt – for a description of these covenants. These and other terms in the Financing Agreement have to be monitored closely for compliance and could restrict our ability to grow our business or enter into transactions that we believe would be beneficial to our business. If we are unable to maintain the minimum unrestricted cash balance, achieve any of the total minimum net revenue requirements, or otherwise comply with the covenants of the Financing Agreement, all or a portion of our obligations under the Financing Agreement may be declared immediately due and payable, which would have a material adverse effect on our business, results of operations and financial condition.
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, reasonable supportable forecasts, and existing economic conditions and we record an allowance that presents the net amount expected to be collected. We evaluate trade accounts receivable 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. Our exposure to credit losses may increase if our customers are adversely affected by changes in healthcare laws, coverage, and reimbursement, economic pressures or uncertainty associated with local or global economic recessions, disruption associated with the current COVID-19 pandemic, or other customer-specific factors. Although we have historically not experienced significant credit losses, it is possible that there could be a material adverse impact from potential adjustments of the carrying amount of trade receivables in the future. At December 31, 2020, four different customers represented 25 19 17 11 36 21 16 11 The opening balance of the allowance for doubtful accounts is reconciled to the closing balance for expected credit losses as follows: Allowance for Doubtful Accounts Balance - January 1, 2020 $ 904,040 Increase in allowance 422,137 Recoveries (181,514 ) Write-offs (26,809 ) Balance - December 31, 2020 $ 1,117,854
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, product improvements rendering previous versions obsolete, or decreases in demand for our products. 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. Inventory Write-Off We evaluate inventory quarterly for short dated and excess inventory. During the years ended December 31, 2020 and December 31, 2019, we recorded an inventory charge of $ 7,204,818 0
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.
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 years 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 years
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 38 39
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. 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. 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. 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 years ended December 31, 2020 and 2019, we wrote off $ 1,131,776 78,864
Fair Value of Financial Instruments	Fair Value of Financial Instruments Our financial instruments consist primarily of cash, accounts receivable, accounts payable, accrued expenses and long-term debt. The carrying amount of cash, accounts receivable, accounts payable and accrued expenses approximates their fair value because of the short-term maturity of such instruments, which are considered Level 1 assets under the fair value hierarchy. The carrying amount for long-term debt as of December 31, 2020 and 2019 (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, 2020 and 2019, we had no assets or liabilities that were valued at fair value on a recurring basis.
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, 2020 and 2019, 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 We grant restricted stock units and performance-based stock units for shares of common stock, par value $ 0.001
Revenue Recognition	Revenue Recognition In accordance with ASC 606, Revenue from Contracts with Customers Prescription Products As of December 31, 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 product 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 product 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 product revenue would be subject to a significant reversal. We consider all the facts and circumstances associated with both the risk of a product revenue reversal arising from an uncertain future event and the magnitude of the reversal if that uncertain event were to occur. Actual amounts of consideration ultimately received may differ from our estimates. If actual results in the future vary from our original estimates, we will adjust these estimates, which would affect net product revenue and earnings in the period such changes in estimates become known. We accept returns of unsalable prescription products sold through wholesale distributors within a return period of six months prior to and up to 12 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 revenue at the time the product revenue is recognized. We record distributor fees based on amounts stated in contracts. Rebate and coupon estimates and distributor fees are recorded in 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 revenue at the time the product revenue is 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. 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 product 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. Disaggregation of revenue The following table provides information about disaggregated revenue, net by product mix for the years ended December 31, 2020, 2019, and 2018: For the Years Ended December 31, 2020 2019 2018 Prescription vitamins $ 9,767,644 $ 9,885,493 $ 15,041,259 IMVEXXY 27,139,387 16,252,045 1,058,201 BIJUVA 6,353,963 1,836,443 — ANNOVERA 19,611,286 6,166,556 — License revenue 2,000,000 15,506,400 — Net revenue $ 64,872,280 $ 49,646,937 $ 16,099,460 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 intellectual property is transferred to the customer. 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. We began selling ANNOVERA in a “test and learn” market introduction in the third quarter of 2019. As a result of the uncertainty surrounding the COVID-19 pandemic, we paused the commercial launch of ANNOVERA in the first quarter of 2020 and deferred sales and marketing initiatives into subsequent quarters. We resumed the commercial launch of ANNOVERA on July 1, 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 3,024,391 778,692 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 40 200 400 1 20,000,000 Unless earlier terminated, the Population Council License Agreement will remain in effect until the later of the expiration of the last-to-expire of the Population Council’s U.S. patents that are licensed to us, or the date following such expiration that follows a continuous period of six months during which we and our affiliates have not made a commercial sale of ANNOVERA in the U.S. The Population Council License Agreement may also be terminated for certain breach and bankruptcy-related events and by us on 180 days’ prior notice to the Population Council. License Agreement with Knight Therapeutics Inc. In July 2018, we entered into the Knight License Agreement 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 paid us $ 2,000,000 License Agreement with Theramex On June 6, 2019, we entered into the Theramex License Agreement with Theramex to commercialize BIJUVA and IMVEXXY in the Territory. Under the terms of the Theramex License Agreement, Theramex paid us EUR 14 15,506,400 2 million 27.5 million Territory ranging from EUR 25 100 5 Territory. Theramex is responsible for all regulatory and commercial activities for BIJUVA and IMVEXXY in the Territory. Theramex may sublicense its rights to commercialize BIJUVA and IMVEXXY in the Territory, except for certain specified markets. We may terminate the Theramex License Agreement if Theramex does not submit all regulatory applications, submissions and/or registrations required for regulatory approval to use and commercialize BIJUVA and IMVEXXY within certain specified time periods. We also may terminate the Theramex License Agreement if Theramex challenges our patents. Either party may terminate the Theramex 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.
Segment Reporting	Segment Reporting We are managed and operated as one business, which is focused on creating and commercializing products targeted exclusively for women. Our business operations are managed by a single executive leadership team that is led by the Chief Executive Officer of our Company, who oversees all operations. We do not operate separate lines of business with respect to any of our products and we do not prepare discrete financial information with respect to separate products. All product sales are derived from sales in the United States. Accordingly, we view our business as one reportable operating segment.
Shipping and Handling Costs	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.
Advertising Costs	Advertising Costs We expense advertising costs when incurred. Advertising costs were $ 35,799,313 9,045,571 1,682,746
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 As of December 31, 2020 2019 2018 Stock options 23,781,930 25,030,234 20,872,824 Warrants 6,534,687 1,832,571 3,007,571 Performance stock units 2,403,951 — — Restricted stock units 7,061,024 1,240,000 1,040,000 39,781,592 28,102,805 24,920,395
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 March 2020, the FASB issued Accounting Standards Update, or ASU, 2020-04: Reference Rate Reform (Topic 848) Facilitation of the Effects of Reference Rate Reform on Financial Reporting. This update provides optional guidance for a limited period of time to ease potential accounting impacts associated with transitioning away from reference rates that are expected to be discontinued, such as London Interbank Offered Rate (LIBOR). This ASU includes practical expedients for contract modifications due to reference rate reform. Generally, contract modifications related to reference rate reform may be considered an event that does not require remeasurement or reassessment of a previous accounting determination at the modification date. This ASU is effective March 12, 2020 through December 31, 2022. Our debt agreements currently include the use of alternate rates when LIBOR is not available. We do not expect the change from LIBOR to an alternate rate will have a material impact to our financial statements and, to the extent we enter into modifications of agreements that are impacted by the LIBOR phase-out, we will apply such guidance to those contract modifications. In August 2018, the FASB issued 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 Accounting Standards Codification, or 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 adopted this standard on January 1, 2020, and the adoption did not have a material effect on our disclosures. In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments - Credit Losses (Topic 326), Measurement of Credit Losses on Financial Instruments. The amendments in this update require a financial asset (or a group of financial assets) measured at amortized cost basis to be presented at the net amount expected to be collected based on historical experience, current conditions, and reasonable supportable forecasts. The amendments in this update are effective for public business entities for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2019, with early adoption permitted no sooner than the first quarter of 2019. A modified retrospective approach is required for all investments, except debt securities for which an other-than-temporary impairment had been recognized prior to the effective date, which will require a prospective transition approach and should be applied either prospectively or retrospectively depending on the nature of the disclosure. The adoption of ASU 2016-13 requires expanded quantitative and qualitative disclosures about the Company’s expected credit losses. Effective January 1, 2020, we adopted ASU 2016-13 under a modified retrospective approach for all financial assets measured at amortized cost. There was no adjustment recorded for the cumulative effect of adopting ASU 2016-13. The adoption expanded disclosures about our credit losses. 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, 2020
Accounting Policies [Abstract]
The opening balance of the allowance for doubtful accounts is reconciled to the closing balance for expected credit losses as follows:	The opening balance of the allowance for doubtful accounts is reconciled to the closing balance for expected credit losses as follows: Allowance for Doubtful Accounts Balance - January 1, 2020 $ 904,040 Increase in allowance 422,137 Recoveries (181,514 ) Write-offs (26,809 ) Balance - December 31, 2020 $ 1,117,854
The following table provides information about disaggregated revenue, net by product mix for the years ended December 31, 2020, 2019, and 2018:	The following table provides information about disaggregated revenue, net by product mix for the years ended December 31, 2020, 2019, and 2018: For the Years Ended December 31, 2020 2019 2018 Prescription vitamins $ 9,767,644 $ 9,885,493 $ 15,041,259 IMVEXXY 27,139,387 16,252,045 1,058,201 BIJUVA 6,353,963 1,836,443 — ANNOVERA 19,611,286 6,166,556 — License revenue 2,000,000 15,506,400 — Net revenue $ 64,872,280 $ 49,646,937 $ 16,099,460
Schedule of calculation of diluted net loss per share allocable to common stockholders	As of December 31, 2020 2019 2018 Stock options 23,781,930 25,030,234 20,872,824 Warrants 6,534,687 1,832,571 3,007,571 Performance stock units 2,403,951 — — Restricted stock units 7,061,024 1,240,000 1,040,000 39,781,592 28,102,805 24,920,395

INVENTORY (Tables)

INVENTORY (Tables)	12 Months Ended
	Dec. 31, 2020
Inventory Disclosure [Abstract]
Inventory consists of the following:	Inventory consists of the following: December 31, 2020 2019 Finished products $ 3,350,580 $ 4,976,910 Work in process 219,918 1,182,059 Raw materials 4,422,589 5,701,747 TOTAL INVENTORY $ 7,993,087 $ 11,860,716

OTHER CURRENT ASSETS (Tables)

OTHER CURRENT ASSETS (Tables)	12 Months Ended
	Dec. 31, 2020
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, 2020 2019 Prepaid sales and marketing costs $ 4,308 $ 1,583,698 Debt financing fees on undrawn tranches (Note 8) — 550,757 Prepaid insurance 2,568,269 1,812,135 Prepaid manufacturing 1,331,100 2,595,721 Other prepaid costs 3,639,720 4,787,482 TOTAL OTHER CURRENT ASSETS $ 7,543,397 $ 11,329,793

FIXED ASSETS, NET (Tables)

FIXED ASSETS, NET (Tables)	12 Months Ended
	Dec. 31, 2020
Property, Plant and Equipment [Abstract]
Fixed assets, net consist of the following:	Fixed assets, net consist of the following: December 31, 2020 2019 Accounting system $ 411,550 $ 301,096 Equipment 1,704,931 1,619,646 Furniture and fixtures 1,406,858 1,406,858 Computer hardware 80,211 80,211 Leasehold improvements 80,121 68,788 TOTAL FIXED ASSETS 3,683,671 3,476,599 Accumulated depreciation (1,741,447 ) (968,824 ) TOTAL FIXED ASSETS, NET $ 1,942,224 $ 2,507,775

INTANGIBLE ASSETS, NET (Tables)

INTANGIBLE ASSETS, NET (Tables)	12 Months Ended
	Dec. 31, 2020
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, 2020 and 2019:	The following table sets forth the gross carrying amount, accumulated amortization and net carrying amount of our intangible assets as of December 31, 2020 and 2019: December 31, 2020 Gross Accumulated Net Weighted- Average Amortization Period (yrs.) Amortizable intangible assets: Approved hormone therapy drug candidate patents $ 4,044,552 $ (748,627 ) $ 3,295,925 12 Hormone therapy drug candidate patents (pending) 1,628,457 — 1,628,457 n/a Non-amortizable intangible assets: Multiple trademarks 323,341 — 323,341 indefinite TOTAL $ 5,996,350 $ (748,627 ) $ 5,247,723 December 31, 2019 Gross Accumulated Net Weighted- Average Amortization Period (yrs.) 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
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 December 31, Estimated Amortization 2021 $ 274,669 2022 $ 274,669 2023 $ 274,669 2024 $ 274,669 2025 $ 274,669

OTHER CURRENT LIABILITIES (Tabl

OTHER CURRENT LIABILITIES (Tables)	12 Months Ended
	Dec. 31, 2020
Payables and Accruals [Abstract]
Other current liabilities	Other current liabilities December 31, 2020 2019 Accrued payroll, bonuses and commission costs $ 8,758,073 $ 8,040,278 Allowance for coupons and returns 6,770,206 10,316,298 Accrued sales and marketing costs 227,500 3,285,662 Accrued compensated absences 2,353,996 1,463,878 Allowance for wholesale distributor fees 2,632,432 2,347,122 Accrued legal and accounting expense 898,568 422,336 Accrued research and development 925,314 1,049,603 Operating lease liability 2,253,994 1,501,539 Accrued rebates 11,010,588 3,916,672 Other accrued expenses 2,339,198 1,480,225 TOTAL OTHER CURRENT LIABILITIES $ 38,169,869 $ 33,823,613

DEBT (Tables)

DEBT (Tables)	12 Months Ended
	Dec. 31, 2020
Debt Disclosure [Abstract]
As of December 31, 2020 and 2019, the carrying value of our debt consisted of the following:	As of December 31, 2020 and 2019, the carrying value of our debt consisted of the following: As of December 31, 2020 2019 Financing Agreement $ 250,000,000 $ 200,000,000 Debt discount and financing fees (12,302,469 ) (5,365,357 ) TOTAL LONG-TERM DEBT $ 237,697,531 $ 194,634,643
The following table reflects our aggregate future principal payments under the Financing Agreement for the next five years, as amended by Amendment No. 8:	The following table reflects our aggregate future principal payments under the Financing Agreement for the next five years, as amended by Amendment No. 8: Year Ending December 31, 2021 $ 50,000,000 2022 $ 25,000,000 2023 $ 133,750,000 2024 $ 41,250,000 2025 $ —

STOCKHOLDERS_ EQUITY (Tables)

STOCKHOLDERS’ EQUITY (Tables)	12 Months Ended
	Dec. 31, 2020
Equity [Abstract]
Summary of our Warrant activity during the year ended December 31, 2020:	Summary of our Warrant activity during the year ended December 31, 2020: Number of Shares Under Warrants Weighted Average Exercise Price Weighted Average Remaining Contractual Life in Years Aggregate Intrinsic Value Balance at December 31, 2019 1,832,571 $ 2.62 1.95 $ 2,447,929 Granted 4,752,116 $ 1.19 Exercised — — — Expired — — Cancelled/Forfeited (50,000 ) $ 6.35 Balance at December 31, 2020 6,534,687 $ 1.55 7.25 $ 1,041,219 Vested and Exercisable at December 31, 2020 6,534,687 $ 1.55 7.25 $ 1,041,219 Unvested at December 31, 2020 — — — —
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, 2020, 2019, and 2018 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, 2020, 2019, and 2018 are set forth in the table below. 2020 2019 2018 Weighted average exercise price $ 1.19 $ 5.63 $ 5.16 Weighted average grant date fair value $ 1.56 $ 3.00 $ 2.79 Risk-free interest rate 0.34 % 2.52 % 2.36 % Volatility 68.8 % 60.8 % 62.12 % Term (in years) 10 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, 2020, 2019, and 2018 are set forth in the table below.	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, 2020, 2019, and 2018 are set forth in the table below. 2020 2019 2018 Weighted average exercise price $ 1.58 $ 3.10 $ 5.45 Weighted average grant date fair value $ 0.95 $ 1.82 $ 3.24 Risk-free interest rate 0.34 1.68 1.64 2.54 2.38 2.89 Volatility 63.53 67.92 61.25 64.49 59.45 64.04 Term (in years) 6 6.8 5.5 6.5 5.1 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, 2020 is as follows:	A summary of activity under the 2009, 2012 and 2019 Plans and related information during the year ended December 31, 2020 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, 2019 25,030,234 $ 4.65 5.84 $ 3,668,171 Granted 736,500 $ 1.58 Exercised (1,182,195 ) $ 0.23 $ 1,738,740 Expired (386,609 ) $ 3.76 Cancelled/Forfeited (416,000 ) $ 3.80 Balance at December 31, 2020 23,781,930 $ 4.80 5.20 $ 152,253 Vested and Exercisable at December 31, 2020 19,862,681 $ 5.06 4.59 $ 117,443 Unvested at December 31, 2020 3,919,249 $ 3.53 8.29 $ 34,810
Schedule of restricted stock units and performance stock units	Schedule of restricted stock units and performance stock units Restricted Stock Units Performance Stock Units Number of Shares Weighted Average Grant Date Fair Value Number of Shares Weighted Average Grant Date Fair Value Balance at December 31, 2019 1,240,000 $ 3.56 — $ — Granted 6,152,818 $ 1.39 2,585,745 $ 1.08 Vested/Released (301,500 ) $ 1.78 (151,500 ) $ 1.14 Forfeited (30,294 ) $ 1.07 (30,294 ) $ 1.07 Balance at December 31, 2020 7,061,024 $ 1.76 2,403,951 * $ 1.08 * The number of performance stock units (PSUs) represents the base number of PSUs that may vest. The actual number of PSUs that will vest will be between zero and two times the base number of PSUs depending on the Company’s achievement of break-even quarterly EBITDA.

INCOME TAXES (Tables)

INCOME TAXES (Tables)	12 Months Ended
	Dec. 31, 2020
Income Tax Disclosure [Abstract]
For financial reporting purposes, (loss) income before taxes includes the following components:	For financial reporting purposes, (loss) income before taxes includes the following components: 2020 2019 2018 United States $ (183,524,137 ) $ (176,144,999 ) $ (132,617,160 ) Total $ (183,524,137 ) $ (177,144,999 ) $ (132,617,160 )
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: 2020 2019 2018 Federal statutory tax rate 21.0 % 21.0 % 21.0 % State tax rate, net of federal tax benefit 5.1 % 4.0 % 5.2 % Adjustment in valuation allowances (27.0 )% (22.5 )% (31.2 )% Excess stock benefits 0.1 % 0.2 % 5.3 % Federal income tax rate change 0 % 0 % - % Permanent and other differences 0.8 % (2.7 )% (0.3 )% Provision (benefit) for income taxes — — —
The components of the net deferred income tax asset as of December 31, 2020, 2019, and 2018 are as follows:	The components of the net deferred income tax asset as of December 31, 2020, 2019, and 2018 are as follows: 2020 2019 2018 Deferred Income Tax Assets: Net operating losses $ 195,008,131 $ 157,555,975 $ 126,419,113 Share based compensation 17,251,900 13,913,568 11,640,464 Interest expense limitation 12,991,716 5,389,129 1,173,614 Other, net 4,818,935 3,662,037 1,658,573 R&D credit 186,347 186,347 186,347 Total deferred income tax asset 230,257,029 180,707,056 141,078,111 Valuation allowance (230,257,029 ) (180,707,056 ) (141,078,111 ) Deferred income tax assets, net $ — $ — $ —

COMMITMENTS AND CONTINGENCIES (

COMMITMENTS AND CONTINGENCIES (Tables)	12 Months Ended
	Dec. 31, 2020
Commitments and Contingencies Disclosure [Abstract]
Supplemental lease information	Supplemental lease information as of: December 31, 2020 December 31, 2019 Right-of-use asset $ 9,565,700 $ 10,109,154 Short-term operating lease liability (included in Other current liabilities $ 2,253,994 $ 1,501,539 Long-term operating lease liability $ 8,675,477 $ 9,145,049 Weighted average remaining term 8.9 9 Weighted average discount rate 8.30 % 8.25 % Supplemental cash flow information for the year ended: December 31, December 31, 2019 Cash paid for amounts included in the measurement of lease liabilities for operating lease $ 1,617,645 $ 1,164,234 Right-of-use assets obtained in exchange for lease obligation $ 998,821 $ 11,171,471
The following table reconciles the undiscounted cash flows for all operating leases at December 31, 2020 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, 2020 to the operating lease liabilities recorded on the balance sheet: Years Ending December 31, 2021 $ 2,334,582 2022 1,413,289 2023 1,443,143 2024 1,476,534 2025 1,513,458 Thereafter 7,434,412 Total undiscounted lease payments 15,615,418 Less: imputed interest (4,685,947 ) Present value of lease payments $ 10,929,471

SELECTED QUARTERLY FINANCIAL _2

SELECTED QUARTERLY FINANCIAL DATA (UNAUDITED) (Tables)	12 Months Ended
	Dec. 31, 2020
Quarterly Financial Information Disclosure [Abstract]
Summarized quarterly financial data for fiscal years 2020 and 2019 is as follows	Summarized quarterly financial data for fiscal years 2020 and 2019 is as follows 2020 (In thousands, except per share) First Second Third Quarter (1)(2)(3)(4) Fourth (5) Revenues $ 12,251 $ 10,701 $ 19,343 $ 22,577 Gross profit $ 9,536 $ 6,301 $ 16,064 $ 16,996 Net loss $ (56,849 ) $ (51,976 ) $ (32,611 ) $ (42,088 ) Loss per common share, basic and diluted $ (0.21 ) $ (0.19 ) $ (0.12 ) $ (0.15 ) 2019 (In thousands, except per share) First Second (6) Third Quarter (7) Fourth 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 ) (1) During the third quarter of 2020, we recorded $ 2 million (2) During the third quarter of 2020, we recorded the fair value of the Lender Warrants based on Amendment No. 5 of approximately $ 7.4 million (3) During the third quarter of 2020, we wrote off approximately $ 0.6 million (4) During the third quarter of 2020, we recorded approximately $ 5.7 million (5) During the fourth quarter of 2020, we wrote off approximately $ 0.5 million (6) During the second quarter of 2019, we recorded approximately $ 10.1 million (7) During the third quarter of 2019, we recorded approximately $ 15. 5 million (1) During the third quarter of 2020, we recorded $2 million in license revenue related to the Knight License Agreement. Refer to discussion in Note 2-Summary of Significant Accounting Policies. (2) During the third quarter of 2020, we recorded the fair value of the Lender Warrants based on Amendment No. 5 of approximately $7.4 million as a debt discount, which is being amortized to interest expense using the effective interest method over the term of the Financing Agreement. Refer to discussion in Note 8-Debt. (3) During the third quarter of 2020, we wrote off approximately $0.6 million in costs related to trademarks and patents. Refer to discussion in Note 6-Intangible Assets, Net. (4) During the third quarter of 2020, we recorded approximately $5.7 million in inventory charge, primarily related to BIJUVA. Refer to discussion in Note 2-Summary of Significant Accounting Policies. (5) During the fourth quarter of 2020, we wrote off approximately $0.5 million in costs related to trademarks and patents. Refer to discussion in Note 6-Intangible Assets, Net. (6) During the second quarter of 2019, we recorded approximately $10.1 million in loss on extinguishment of debt related to the repayment of the Credit Agreement. Refer to discussion in Note 8-Debt. (7) During the third quarter of 2019, we recorded approximately $15.5 million in license revenue related to the Theramex License Agreement. Refer to discussion in Note 2-Summary of Significant Accounting Policies.

THE COMPANY (Details Narrative)

THE COMPANY (Details Narrative)	Dec. 31, 2020Number
Organization, Consolidation and Presentation of Financial Statements [Abstract]
Number of subsidiaries	3

The opening balance of the allo

The opening balance of the allowance for doubtful accounts is reconciled to the closing balance for expected credit losses as follows: (Details)	12 Months Ended
	Dec. 31, 2020USD ($)
Accounting Policies [Abstract]
Balance at beginning	$ 904,040
Increase in allowance	422,137
Recoveries	(181,514)
Write-offs	(26,809)
Ending balance	$ 1,117,854

The following table provides in

The following table provides information about disaggregated revenue, net by product mix for the years ended December 31, 2020, 2019, and 2018: (Details) - USD ($)

3 Months Ended

12 Months Ended

Dec. 31, 2020

[1]

Sep. 30, 2020

[2],[3],[4],[5]

Jun. 30, 2020

Mar. 31, 2020

Dec. 31, 2019

Sep. 30, 2019

[6]

Jun. 30, 2019

[7]

Mar. 31, 2019

Dec. 31, 2020

Dec. 31, 2019

Dec. 31, 2018

Product Information [Line Items]

Net revenue

$ 22,577,000

$ 19,343,000

$ 10,701,000

$ 12,251,000

$ 15,902,000

$ 23,719,000

$ 6,079,000

$ 3,947,000

$ 64,872,280

$ 49,646,937

$ 16,099,460

Prescription Vitamins [Member]

Product Information [Line Items]

Net revenue

9,767,644

9,885,493

15,041,259

Imvexxy [Member]

Product Information [Line Items]

Net revenue

27,139,387

16,252,045

1,058,201

BIJUVA [Member]

Product Information [Line Items]

Net revenue

6,353,963

1,836,443

ANNOVERA [Member]

Product Information [Line Items]

Net revenue

19,611,286

6,166,556

License [Member]

Product Information [Line Items]

Net revenue

$ 2,000,000

$ 15,506,400

[1]

During the fourth quarter of 2020, we wrote off approximately $0.5 million in costs related to trademarks and patents. Refer to discussion in Note 6-Intangible Assets, Net.

[2]

During the third quarter of 2020, we recorded $2 million in license revenue related to the Knight License Agreement. Refer to discussion in Note 2-Summary of Significant Accounting Policies.

[3]

During the third quarter of 2020, we recorded approximately $5.7 million in inventory charge, primarily related to BIJUVA. Refer to discussion in Note 2-Summary of Significant Accounting Policies.

[4]

During the third quarter of 2020, we recorded the fair value of the Lender Warrants based on Amendment No. 5 of approximately $7.4 million as a debt discount, which is being amortized to interest expense using the effective interest method over the term of the Financing Agreement. Refer to discussion in Note 8-Debt.

[5]

During the third quarter of 2020, we wrote off approximately $0.6 million in costs related to trademarks and patents. Refer to discussion in Note 6-Intangible Assets, Net.

[6]

During the third quarter of 2019, we recorded approximately $15.5 million in license revenue related to the Theramex License Agreement. Refer to discussion in Note 2-Summary of Significant Accounting Policies.

[7]

During the second quarter of 2019, we recorded approximately $10.1 million in loss on extinguishment of debt related to the repayment of the Credit Agreement. Refer to discussion in Note 8-Debt.

Schedule of calculation of dilu

Schedule of calculation of diluted net loss per share allocable to common stockholders (Details) - shares	12 Months Ended
	Dec. 31, 2020	Dec. 31, 2019	Dec. 31, 2018
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount	39,781,592	28,102,805	24,920,395
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	23,781,930	25,030,234	20,872,824
Warrant [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount	6,534,687	1,832,571	3,007,571
Performance Stock Units [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount	2,403,951
Restricted Stock [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount	7,061,024	1,240,000	1,040,000

SUMMARY OF SIGNIFICANT ACCOUN_4

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details Narrative)	Aug. 05, 2019EUR (€)	Aug. 05, 2019USD ($)	Jun. 06, 2019EUR (€)	Jun. 06, 2019EUR (€)	Dec. 31, 2020USD ($)Number$ / shares	Sep. 30, 2020USD ($)	Dec. 31, 2020USD ($)Number$ / shares	Dec. 31, 2019USD ($)$ / shares	Dec. 31, 2018USD ($)	Nov. 08, 2020USD ($)
Product Information [Line Items]
Inventory charge						$ 5,700,000	$ 7,204,818	$ 0
Minimum cash balance requirement under credit agreement					$ 60,000,000		60,000,000
Cash FDIC insured amount					$ 250,000		$ 250,000
Number of issued patents domestic. | Number					38		38
Number of issued patents foreign | Number					39		39
Write off of patent and trademark cost					$ 500,000	$ 600,000	$ 1,131,776	$ 78,864
Common Stock, Par or Stated Value Per Share | $ / shares					$ 0.001		$ 0.001	$ 0.001
Amortization of intellectual property license fee							$ 3,024,391	$ 778,692
Advertising expense							$ 35,799,313	$ 9,045,571	$ 1,682,746
Council License Agreement [Member]
Product Information [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 six-month period from commercial sale of a generic equivalent							20.00%
Maximum costs and expenses for post approval							$ 20,000,000
Council License Agreement Step 1
Product Information [Line Items]
Royalty (percent)							5.00%
Council License Agreement Step 2
Product Information [Line Items]
Royalty (percent)							10.00%
Council License Agreement Step 3
Product Information [Line Items]
Royalty (percent)							15.00%
License Agreement Theramex [Member]
Product Information [Line Items]
Cash upfront payment received	€ 14,000,000	$ 15,506,400
Minimum [Member] | Council License Agreement Step 2
Product Information [Line Items]
Net sales amount per step-based royalty							$ 500,000
Minimum [Member] | Council License Agreement Step 3
Product Information [Line Items]
Net sales amount per step-based royalty							$ 1,500,000
Minimum [Member] | License Agreement Theramex [Member]
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] | Council License Agreement Step 1
Product Information [Line Items]
Net sales amount per step-based royalty							$ 500,000
Maximum [Member] | Council License Agreement Step 2
Product Information [Line Items]
Net sales amount per step-based royalty							$ 1,500,000
Maximum [Member] | License Agreement Theramex [Member]
Product Information [Line Items]
Regulatory milestone payments | €			2,000,000	€ 2,000,000
Sales milestone payment | €			27,500,000	€ 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
Customer A [Member] | Accounts Receivable [Member]
Product Information [Line Items]
Concentration risk percentage							25.00%	36.00%
Customer B [Member] | Accounts Receivable [Member]
Product Information [Line Items]
Concentration risk percentage							19.00%	21.00%
Customer C [Member] | Accounts Receivable [Member]
Product Information [Line Items]
Concentration risk percentage							17.00%	16.00%
Customer D [Member] | Accounts Receivable [Member]
Product Information [Line Items]
Concentration risk percentage							11.00%	11.00%
Financing Agreement Amendment No. 6 [Member]
Product Information [Line Items]
Minimum cash balance requirement under credit agreement before adjustment										$ 60,000,000
Minimum cash balance requirement under credit agreement										$ 45,000,000
BIJUVA [Member]
Product Information [Line Items]
Inventory charge							$ 7,204,818
ANNOVERA [Member]
Product Information [Line Items]
Return period of unsalable prescription products							12 months
ANNOVERA [Member] | Council License Agreement [Member]
Product Information [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
Milestone payments upon specified levels of cumulative net sales							40,000,000
Specified level one of cumulative net sales for milestone payments							200,000,000
Specified level two of cumulative net sales for milestone payments							400,000,000
Specified level three of cumulative net sales for milestone payments							$ 1,000,000,000
Vitamins, IMVEXXY and BIJUVA [Member]
Product Information [Line Items]
Shelf life of prescription products							24 months
BIJUVA and ANNOVERA [Member]
Product Information [Line Items]
Shelf life of prescription products							18 months
BIJUVA and ANNOVERA [Member] | Knight License Agreement [Member]
Product Information [Line Items]
Milestone payment received upon regulatory approval							$ 2,000,000
BIJUVA and ANNOVERA [Member] | License Agreement Theramex [Member]
Product Information [Line Items]
Quarterly royalty payments percentage				5.00%

Inventory consists of the follo

Inventory consists of the following: (Details) - USD ($)	Dec. 31, 2020	Dec. 31, 2019
Inventory Disclosure [Abstract]
Finished products	$ 3,350,580	$ 4,976,910
Work in process	219,918	1,182,059
Raw materials	4,422,589	5,701,747
TOTAL INVENTORY	$ 7,993,087	$ 11,860,716

Other current assets consist of

Other current assets consist of the following: (Details) - USD ($)	Dec. 31, 2020	Dec. 31, 2019
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract]
Prepaid sales and marketing costs	$ 4,308	$ 1,583,698
Debt financing fees on undrawn tranches (Note 8)		550,757
Prepaid insurance	2,568,269	1,812,135
Prepaid manufacturing	1,331,100	2,595,721
Other prepaid costs	3,639,720	4,787,482
TOTAL OTHER CURRENT ASSETS	$ 7,543,397	$ 11,329,793

Fixed assets, net consist of th

Fixed assets, net consist of the following: (Details) - USD ($)	Dec. 31, 2020	Dec. 31, 2019
Property, Plant and Equipment [Line Items]
TOTAL FIXED ASSETS	$ 3,683,671	$ 3,476,599
Accumulated depreciation	(1,741,447)	(968,824)
TOTAL FIXED ASSETS, NET	1,942,224	2,507,775
Software and Software Development Costs [Member]
Property, Plant and Equipment [Line Items]
TOTAL FIXED ASSETS	411,550	301,096
Equipment [Member]
Property, Plant and Equipment [Line Items]
TOTAL FIXED ASSETS	1,704,931	1,619,646
Furniture and Fixtures [Member]
Property, Plant and Equipment [Line Items]
TOTAL FIXED ASSETS	1,406,858	1,406,858
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	$ 80,121	$ 68,788

FIXED ASSETS, NET (Details Narr

FIXED ASSETS, NET (Details Narrative) - USD ($)	12 Months Ended
	Dec. 31, 2020	Dec. 31, 2019	Dec. 31, 2018
Property, Plant and Equipment [Abstract]
Depreciation	$ 772,624	$ 415,193	$ 181,412

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, 2020 and 2019: (Details) - USD ($)	12 Months Ended
	Dec. 31, 2020	Dec. 31, 2019
Finite-Lived Intangible Assets [Line Items]
Finite-Lived Intangible Assets, Accumulated Amortization	$ (748,627)	$ (478,983)
Intangible Assets, Gross (Excluding Goodwill)	5,996,350	5,737,194
Intangible assets, net	5,247,723	5,258,211
Multiple Trademarks [Member]
Finite-Lived Intangible Assets [Line Items]
Indefinite-Lived Trademarks	323,341	294,813
Indefinite-lived Intangible Assets (Excluding Goodwill)	323,341	294,813
Approved Hormone Therapy Drug Candidate Patents [Member]
Finite-Lived Intangible Assets [Line Items]
Finite-Lived Intangible Assets, Gross	4,044,552	3,463,082
Finite-Lived Intangible Assets, Accumulated Amortization	(748,627)	(478,983)
Finite-Lived Intangible Assets, Net	$ 3,295,925	$ 2,984,099
Finite-Lived Intangible Assets, Remaining Amortization Period	12 years	13 years
Hormone Therapy Drug Candidate Patents - (Pending) [Member]
Finite-Lived Intangible Assets [Line Items]
Finite-Lived Intangible Assets, Gross	$ 1,628,457	$ 1,979,299
Finite-Lived Intangible Assets, Net	$ 1,628,457	$ 1,979,299

Estimated amortization expense,

Estimated amortization expense, based on current patent cost being amortized, for the next five years is as follows: (Details)	Dec. 31, 2020USD ($)
Goodwill and Intangible Assets Disclosure [Abstract]
2021	$ 274,669
2022	274,669
2023	274,669
2024	274,669
2025	$ 274,669

INTANGIBLE ASSETS, NET (Details

INTANGIBLE ASSETS, NET (Details Narrative)	3 Months Ended		12 Months Ended
	Dec. 31, 2020USD ($)Number	Sep. 30, 2020USD ($)	Dec. 31, 2020USD ($)Number	Dec. 31, 2019USD ($)	Dec. 31, 2018USD ($)
Finite-Lived Intangible Assets [Line Items]
Impairment of Intangible Assets (Excluding Goodwill) | $	$ 500,000	$ 600,000	$ 1,131,776	$ 78,864
Amortization of Intangible Assets | $			$ 269,546	$ 197,593	$ 112,474
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	38		38
Foreign Patents Member
Finite-Lived Intangible Assets [Line Items]
Number of issued patents	39		39
Domestic Patents BIJUVA
Finite-Lived Intangible Assets [Line Items]
Number of issued patents	15		15
Foreign Patents BIJUVA
Finite-Lived Intangible Assets [Line Items]
Number of issued patents	9		9
Domestic Patents Non-Approved Bijuva [Member]
Finite-Lived Intangible Assets [Line Items]
Number of issued patents	3		3
Domestic US Patents IMVEXXY
Finite-Lived Intangible Assets [Line Items]
Number of issued patents	12		12
Domestic US Utility Patents IMVEXXY
Finite-Lived Intangible Assets [Line Items]
Number of issued patents	10		10
Domestic US Design Patents IMVEXXY
Finite-Lived Intangible Assets [Line Items]
Number of issued patents	2		2
Foreign Patents IMVEXXY
Finite-Lived Intangible Assets [Line Items]
Number of issued patents	18		18
Foreign Utility Patents IMVEXXY
Finite-Lived Intangible Assets [Line Items]
Number of issued patents	8		8
Foreign Design Patents IMVEXXY
Finite-Lived Intangible Assets [Line Items]
Number of issued patents	10		10
Domestic Utility Patent Topical Cream Candidates [Member]
Finite-Lived Intangible Assets [Line Items]
Number of issued patents	1		1
Domestic Utility Patent Transdermal Patch
Finite-Lived Intangible Assets [Line Items]
Number of issued patents	1		1
Foreign Utility Patent Transdermal Patch
Finite-Lived Intangible Assets [Line Items]
Number of issued patents	8		8
Domestic Utility Patent TX009HR
Finite-Lived Intangible Assets [Line Items]
Number of issued patents	3		3
Domestic Patents Progesterone Formulations
Finite-Lived Intangible Assets [Line Items]
Number of issued patents	2		2
Foreign Patents Progesterone Formulations
Finite-Lived Intangible Assets [Line Items]
Number of issued patents	4		4
Domestic Utility Patent Opera
Finite-Lived Intangible Assets [Line Items]
Number of issued patents	1		1

Other current liabilities (Deta

Other current liabilities (Details) - USD ($)	Dec. 31, 2020	Dec. 31, 2019
Payables and Accruals [Abstract]
Accrued payroll, bonuses and commission costs	$ 8,758,073	$ 8,040,278
Allowance for coupons and returns	6,770,206	10,316,298
Accrued sales and marketing costs	227,500	3,285,662
Accrued compensated absences	2,353,996	1,463,878
Allowance for wholesale distributor fees	2,632,432	2,347,122
Accrued legal and accounting expense	898,568	422,336
Accrued research and development	925,314	1,049,603
Operating lease liability	2,253,994	1,501,539
Accrued rebates	11,010,588	3,916,672
Other accrued expenses	2,339,198	1,480,225
TOTAL OTHER CURRENT LIABILITIES	$ 38,169,869	$ 33,823,613

As of December 31, 2020 and 201

As of December 31, 2020 and 2019, the carrying value of our debt consisted of the following: (Details) - USD ($)	Dec. 31, 2020	Dec. 31, 2019
Debt Instrument [Line Items]
Debt Instrument, Unamortized Discount (Premium) and Debt Issuance Costs, Net	$ (12,302,469)	$ (5,365,357)
TOTAL LONG-TERM DEBT	237,697,531	194,634,643
Financing Agreement [Member]
Debt Instrument [Line Items]
Long-term Debt, Gross	$ 250,000,000	$ 200,000,000

The following table reflects ou

The following table reflects our aggregate future principal payments under the Financing Agreement for the next five years, as amended by Amendment No. 8: (Details)	Dec. 31, 2020USD ($)
Debt Disclosure [Abstract]
2021	$ 50,000,000
2022	25,000,000
2023	133,750,000
2024	41,250,000
2025	$ 0

DEBT (Details Narrative)

DEBT (Details Narrative)

Mar. 01, 2021USD ($)

Apr. 24, 2019USD ($)Number

May 01, 2018USD ($)Number

Dec. 31, 2020USD ($)shares

Sep. 30, 2020USD ($)

Jun. 30, 2020USD ($)

Mar. 31, 2020USD ($)

Dec. 31, 2019USD ($)

Sep. 30, 2019USD ($)

[6]

Jun. 30, 2019USD ($)

Mar. 31, 2019USD ($)

Dec. 31, 2020USD ($)shares

Dec. 31, 2019USD ($)

Dec. 31, 2018USD ($)

Nov. 08, 2021$ / shares

Nov. 08, 2020USD ($)$ / shares

Aug. 05, 2020USD ($)$ / sharesshares

Debt Instrument [Line Items]

Revenues

$ 22,577,000

[1]

$ 19,343,000

[2],[3],[4],[5]

$ 10,701,000

$ 12,251,000

$ 15,902,000

$ 23,719,000

$ 6,079,000

[7]

$ 3,947,000

$ 64,872,280

$ 49,646,937

$ 16,099,460

Repayments of Lines of Credit

81,660,719

Minimum cash balance requirement under credit agreement

$ 60,000,000

$ 60,000,000

Number of warrants issued | shares

6,534,687

6,534,687

Shares Issued, Price Per Share | $ / shares

$ 1.1856

Gain (Loss) on Extinguishment of Debt

$ (10,100,000)

(10,057,632)

Amortization of deferred financing costs

2,256,429

856,302

269,859

Write off of deferred financing fees

275,379

Lender Warrants [Member]

Debt Instrument [Line Items]

Number of warrants issued | shares

4,752,116

Warrants exercise price | $ / shares

$ 1.58

Fair value of warrants

7,400,000

$ 7,428,178

Financing Agreement Amendment No. 6 [Member]

Debt Instrument [Line Items]

Minimum cash balance requirement under credit agreement

$ 45,000,000

Debt discount

$ 239,983

Financing Agreement Amendment No. 6 [Member] | Lender Warrants [Member]

Debt Instrument [Line Items]

Warrants exercise price | $ / shares

$ 1.1856

Financing Agreement [Member]

Debt Instrument [Line Items]

Amortization of deferred financing costs

2,256,428

736,156

Long-term Debt, Gross

$ 250,000,000

200,000,000

250,000,000

200,000,000

Debt Issuance Costs, Gross

$ 7,902,270

7,902,270

Interest Expense, Borrowings

$ 26,049,236

14,709,166

Debt Instrument, Interest Rate, Effective Percentage

12.50%

12.50%

IMVEXXY, BIJUVA and ANNOVERA [Member] | Subsequent Event [Member] | Financing Agreement Amendment No. 8 - First quarter of 2021 [Member]

Debt Instrument [Line Items]

Minimum revenue requirement under credit agreement

$ 17,000,000

IMVEXXY, BIJUVA and ANNOVERA [Member] | Subsequent Event [Member] | Financing Agreement Amendment No. 8 - Second quarter of 2021 [Member]

Debt Instrument [Line Items]

Minimum revenue requirement under credit agreement

20,000,000

IMVEXXY, BIJUVA and ANNOVERA [Member] | Subsequent Event [Member] | Financing Agreement Amendment No. 8 - Third quarter of 2021 [Member]

Debt Instrument [Line Items]

Minimum revenue requirement under credit agreement

23,000,000

IMVEXXY, BIJUVA and ANNOVERA [Member] | Subsequent Event [Member] | Financing Agreement Amendment No. 8 - Fourth quarter of 2021 [Member]

Debt Instrument [Line Items]

Minimum revenue requirement under credit agreement

26,500,000

IMVEXXY, BIJUVA and ANNOVERA [Member] | Subsequent Event [Member] | Financing Agreement Amendment No. 8 - First quarter of 2022 [Member]

Debt Instrument [Line Items]

Minimum revenue requirement under credit agreement

30,000,000

IMVEXXY, BIJUVA and ANNOVERA [Member] | Subsequent Event [Member] | Financing Agreement Amendment No. 8 - Second quarter of 2022 [Member]

Debt Instrument [Line Items]

Minimum revenue requirement under credit agreement

35,000,000

IMVEXXY, BIJUVA and ANNOVERA [Member] | Subsequent Event [Member] | Financing Agreement Amendment No. 8 - Third quarter of 2022 [Member]

Debt Instrument [Line Items]

Minimum revenue requirement under credit agreement

40,000,000

IMVEXXY, BIJUVA and ANNOVERA [Member] | Subsequent Event [Member] | Financing Agreement Amendment No. 8 - Fourth quarter of 2022 [Member]

Debt Instrument [Line Items]

Minimum revenue requirement under credit agreement

45,000,000

IMVEXXY, BIJUVA and ANNOVERA [Member] | Subsequent Event [Member] | Financing Agreement Amendment No. 8 - First quarter of 2023 [Member]

Debt Instrument [Line Items]

Minimum revenue requirement under credit agreement

50,000,000

IMVEXXY, BIJUVA and ANNOVERA [Member] | Subsequent Event [Member] | Financing Agreement Amendment No. 8 - Second quarter of 2023 [Member]

Debt Instrument [Line Items]

Minimum revenue requirement under credit agreement

55,000,000

IMVEXXY, BIJUVA and ANNOVERA [Member] | Subsequent Event [Member] | Financing Agreement Amendment No. 8 - Third quarter of 2023 [Member]

Debt Instrument [Line Items]

Minimum revenue requirement under credit agreement

60,000,000

IMVEXXY, BIJUVA and ANNOVERA [Member] | Subsequent Event [Member] | Financing Agreement Amendment No. 8 - Fourth quarter of 2023 [Member]

Debt Instrument [Line Items]

Minimum revenue requirement under credit agreement

65,500,000

IMVEXXY, BIJUVA and ANNOVERA [Member] | Subsequent Event [Member] | Financing Agreement Amendment No. 8 - First quarter of 2024 [Member]

Debt Instrument [Line Items]

Minimum revenue requirement under credit agreement

70,000,000

IMVEXXY, BIJUVA and ANNOVERA [Member] | Minimum [Member]

Debt Instrument [Line Items]

Revenues

$ 11,000,000

Tranche Two [Member]

Debt Instrument [Line Items]

Debt Issuance Costs, Gross

$ 7,626,891

$ 7,626,891

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 | Number

4

Facility fee paid (percent)

2.50%

Minimum cash balance requirement under credit agreement

$ 60,000,000

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%

Prime rate floor

5.20%

Financing Agreement [Member] | Tranche Two [Member]

Debt Instrument [Line Items]

Line of Credit Facility, Maximum Borrowing Capacity

$ 50,000,000

Financing Agreement [Member] | Tranche Three [Member]

Debt Instrument [Line Items]

Line Of Credit Facility Undrawn Tranche No Longer Available

$ 50,000,000

$ 50,000,000

Financing Agreement Amendment No 8 [Member] | Subsequent Event [Member]

Debt Instrument [Line Items]

Repayments of Lines of Credit

$ 15,000,000

Prepayment fee percentage

5.00%

Financing Agreement Amendment No 8 [Member] | Subsequent Event [Member] | Repayment by March 31, 2021 [Member]

Debt Instrument [Line Items]

Prepayment fee percentage

5.00%

Principal repayment

$ 35,000,000

Financing Agreement Amendment No 8 [Member] | Subsequent Event [Member] | Repayments on March 31, 2022, June 30, 2022 and September 30, 2022 [Member]

Debt Instrument [Line Items]

Principal repayment

5,000,000

Financing Agreement Amendment No 8 [Member] | Subsequent Event [Member] | Repayments on December 31, 2022 and March 31, 2023 [Member]

Debt Instrument [Line Items]

Principal repayment

10,000,000

Financing Agreement Amendment No 8 [Member] | Subsequent Event [Member] | Repayments on June 30, 2023, September 30, 2023, December 31, 2023 and March 31, 2024 [Member]

Debt Instrument [Line Items]

Principal repayment

$ 41,250,000

Financing Agreement Amendment No 8 [Member] | Subsequent Event [Member] | Repayments through March 31, 2022 [Member]

Debt Instrument [Line Items]

Prepayment fee percentage

30.00%

Financing Agreement Amendment No 8 [Member] | Subsequent Event [Member] | Repayment on March 31, 2022 [Member]

Debt Instrument [Line Items]

Prepayment fee percentage

5.00%

Principal repayment

$ 5,000,000

Financing Agreement Amendment No 8 [Member] | Subsequent Event [Member] | Repayments from April 1, 2022 through March 31, 2023 [Member]

Debt Instrument [Line Items]

Prepayment fee percentage

5.00%

Financing Agreement Amendment No 8 [Member] | Subsequent Event [Member] | Repayments from April 1, 2023 through March 31, 2024 [Member]

Debt Instrument [Line Items]

Prepayment fee percentage

3.00%

Credit Agreement [Member]

Debt Instrument [Line Items]

Prepayment fee percentage

4.00%

Repayment of debt with new credit facility

$ 81,661,000

Repayment fee percentage

4.00%

Interest Expense, Debt

1,816,747

4,407,975

Amortization of deferred financing costs

$ 120,146

$ 269,859

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

$ 200,000,000

Debt Instrument, Description of Variable Rate Basis

one-month LIBOR

Debt Instrument, Basis Spread on Variable Rate

7.70%

LIBOR floor rate

1.50%

Number of tranches under term loan facility | Number

3

[1]

During the fourth quarter of 2020, we wrote off approximately $0.5 million in costs related to trademarks and patents. Refer to discussion in Note 6-Intangible Assets, Net.

[2]

During the third quarter of 2020, we recorded $2 million in license revenue related to the Knight License Agreement. Refer to discussion in Note 2-Summary of Significant Accounting Policies.

[3]

During the third quarter of 2020, we recorded approximately $5.7 million in inventory charge, primarily related to BIJUVA. Refer to discussion in Note 2-Summary of Significant Accounting Policies.

[4]

During the third quarter of 2020, we recorded the fair value of the Lender Warrants based on Amendment No. 5 of approximately $7.4 million as a debt discount, which is being amortized to interest expense using the effective interest method over the term of the Financing Agreement. Refer to discussion in Note 8-Debt.

[5]

During the third quarter of 2020, we wrote off approximately $0.6 million in costs related to trademarks and patents. Refer to discussion in Note 6-Intangible Assets, Net.

[6]

During the third quarter of 2019, we recorded approximately $15.5 million in license revenue related to the Theramex License Agreement. Refer to discussion in Note 2-Summary of Significant Accounting Policies.

[7]

During the second quarter of 2019, we recorded approximately $10.1 million in loss on extinguishment of debt related to the repayment of the Credit Agreement. Refer to discussion in Note 8-Debt.

Summary of our Warrant activity

Summary of our Warrant activity during the year ended December 31, 2020: (Details) - Warrant [Member]	12 Months Ended
	Dec. 31, 2020USD ($)$ / sharesshares
Class of Warrant or Right [Line Items]
Number of shares under warrants outstanding beginning | shares	1,832,571
Weighted average exercise price warrants outstanding beginning | $ / shares	$ 2.62
Weighted average remaining contractual life, warrants outstanding	1 year 11 months 12 days
Aggregate intrinsic value, warrants outstanding beginning | $	$ 2,447,929
Number of shares under warrants granted | shares	4,752,116
Weighted average exercise price warrants granted | $ / shares	$ 1.19
Cancelled/Forfeited | shares	(50,000)
Weighted average exercise price warrants cancelled/forfeited | $ / shares	$ 6.35
Number of shares under warrants outstanding ending | shares	6,534,687
Weighted average exercise price warrants outstanding ending | $ / shares	$ 1.55
Weighted average remaining contractual life, warrants outstanding	7 years 3 months
Aggregate intrinsic value, warrants outstanding ending | $	$ 1,041,219
Number of shares under warrants vested and exercisable ending | shares	6,534,687
Weighted average exercise price warrants unvested ending | $ / shares	$ 1.55
Weighted average remaining contractual life, vested and exercisable ending	7 years 3 months
Aggregate intrinsic value, vested and exercisable ending | $	$ 1,041,219

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, 2020, 2019, and 2018 are set forth in the table below. (Details) - Warrant [Member] - $ / shares	12 Months Ended
	Dec. 31, 2020	Dec. 31, 2019	Dec. 31, 2018
Class of Warrant or Right [Line Items]
Weighted average exercise price	$ 1.19	$ 5.63	$ 5.16
Weighted average grant date fair value	$ 1.56	$ 3	$ 2.79
Risk-free interest rate	0.34%	2.52%	2.36%
Volatility	68.80%	60.80%	62.12%
Term (in years)	10 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, 2020, 2019, and 2018 are set forth in the table below. (Details) - Share-based Payment Arrangement, Option [Member] - $ / shares	12 Months Ended
	Dec. 31, 2020	Dec. 31, 2019	Dec. 31, 2018
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Weighted average exercise price	$ 1.58	$ 3.10	$ 5.45
Weighted average grant date fair value	$ 0.95	$ 1.82	$ 3.24
Risk-free interest rate - minimum	0.34%	1.64%	2.38%
Risk-free interest rate - maximum	1.68%	2.54%	2.89%
Volatility - minimum	63.53%	61.25%	59.45%
Volatility - maximum	67.92%	64.49%	64.04%
Dividend yield	0.00%	0.00%	0.00%
Minimum [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Term	6 years	5 years 6 months	5 years 1 month 6 days
Maximum [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Term	6 years 9 months 18 days	6 years 6 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, 2020 is as follows: (Details)	12 Months Ended
	Dec. 31, 2020USD ($)$ / sharesshares
Equity [Abstract]
Number of shares under options, beginning | shares	25,030,234
Weighted average exercise price, beginning | $ / shares	$ 4.65
Weighted average remaining contractual life	5 years 10 months 2 days
Aggregate intrinsic value, beginning | $	$ 3,668,171
Number of shares under options, granted | shares	736,500
Weighted average exercise price, granted | $ / shares	$ 1.58
Number of shares under options, exercised | shares	(1,182,195)
Weighted average exercise price, exercised | $ / shares	$ 0.23
Aggregate intrinsic value, exercised | $	$ 1,738,740
Number of shares under options, expired | shares	(386,609)
Weighted average exercise price, expired | $ / shares	$ 3.76
Number of shares under options, cancelled forfeited | shares	(416,000)
Weighted average exercise price, cancelled forfeited | $ / shares	$ 3.80
Number of shares under options, ending | shares	23,781,930
Weighted average exercise price, ending | $ / shares	$ 4.80
Weighted average remaining contractual life	5 years 2 months 12 days
Aggregate intrinsic value, ending | $	$ 152,253
Number of shares under options, vested and exercisable ending | shares	19,862,681
Weighted average exercise price, vested and exercisable ending | $ / shares	$ 5.06
Weighted average remaining contractual life, vested and exercisable	4 years 7 months 2 days
Aggregate intrinsic value, vested and exercisable ending | $	$ 117,443
Number of shares under options, unvested ending | shares	3,919,249
Weighted average exercise price, unvested ending | $ / shares	$ 3.53
Weighted average remaining contractual life, unvested	8 years 3 months 14 days
Aggregate intrinsic value, unvested ending | $	$ 34,810

Schedule of restricted stock un

Schedule of restricted stock units and performance stock units (Details)	12 Months Ended
	Dec. 31, 2020$ / sharesshares
Restricted Stock [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Beginning balance, number of shares | shares	1,240,000
Beginning balance, weighted average grant date fair value | $ / shares	$ 3.56
Granted, number of shares | shares	6,152,818
Granted, weighted average grant date fair value | $ / shares	$ 1.39
Vested/Released, number of shares | shares	(301,500)
Vested/Released, weighted average grant date fair value | $ / shares	$ 1.78
Forfeited, number of shares | shares	(30,294)
Forfeited, weighted average grant date fair value | $ / shares	$ 1.07
Ending balance, number of shares | shares	7,061,024
Ending balance, weighted average grant date fair value | $ / shares	$ 1.76
Performance Shares [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Granted, number of shares | shares	2,585,745
Granted, weighted average grant date fair value | $ / shares	$ 1.08
Vested/Released, number of shares | shares	(151,500)
Vested/Released, weighted average grant date fair value | $ / shares	$ 1.14
Forfeited, number of shares | shares	(30,294)
Forfeited, weighted average grant date fair value | $ / shares	$ 1.07
Ending balance, number of shares | shares	2,403,951	[1]
Ending balance, weighted average grant date fair value | $ / shares	$ 1.08
[1]	The number of performance stock units (PSUs) represents the base number of PSUs that may vest. The actual number of PSUs that will vest will be between zero and two times the base number of PSUs depending on the Company’s achievement of break-even quarterly EBITDA.

STOCKHOLDERS_ EQUITY (Details N

STOCKHOLDERS’ EQUITY (Details Narrative) - USD ($)

Feb. 16, 2021

Nov. 20, 2020

Nov. 13, 2020

Nov. 10, 2020

Jun. 18, 2020

Oct. 29, 2019

Aug. 06, 2018

Aug. 06, 2018

Feb. 08, 2021

Nov. 30, 2020

Feb. 28, 2021

Nov. 30, 2020

Dec. 31, 2020

Dec. 31, 2019

Dec. 31, 2018

Nov. 08, 2021

Nov. 08, 2020

Aug. 05, 2020

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

600,000,000

350,000,000

Common Stock, Shares, Issued

299,765,396

271,177,076

Common Stock, Shares, Outstanding

299,765,396

271,177,076

Shares issued for exercise of options, net (in shares)

1,182,195

Shares Issued, Price Per Share

$ 1.1856

Proceeds from Issuance of Common Stock

$ 31,702,635

$ 77,031,258

$ 89,907,797

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

Shares issued in offerings, net of cost

$ 31,702,635

$ 77,031,258

$ 89,907,797

Warrants outstanding

6,534,687

Weighted-average contractual remaining life

7 years 3 months

Non cash compensation expense

$ 10,678,992

$ 10,693,662

8,661,967

Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Number

23,781,930

25,030,234

Share-based Payment Arrangement, Expense

$ 5,235,585

$ 8,798,707

8,091,294

Share-based Payment Arrangement, Nonvested Award, Option, Cost Not yet Recognized, Amount

5,238,000

Restricted Stock or Unit Expense

5,399,472

$ 1,628,407

$ 73,132

Share-based Payment Arrangement, Nonvested Award, Excluding Option, Cost Not yet Recognized, Amount

$ 9,989,000

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

13,285,205

2012 Stock Incentive Plan [Member]

Class of Warrant or Right [Line Items]

Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Number

6,305,974

Plan 2019 [Member]

Class of Warrant or Right [Line Items]

Award vesting period

4 years

Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Number

4,190,751

Award expiration period

10 years

Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Authorized

2,583,565

Employee Stock Purchase Plan [Member]

Class of Warrant or Right [Line Items]

Non cash compensation expense

$ 17,489

Common Stock, Capital Shares Reserved for Future Issuance

5,400,000

Share-based Compensation Arrangement by Share-based Payment Award, Purchase Price of Common Stock, Percent

85.00%

Financing Agreement Amendment No. 6 [Member]

Class of Warrant or Right [Line Items]

Debt Discount

$ 239,983

Warrant [Member]

Class of Warrant or Right [Line Items]

Weighted average exercise price of warrants (in dollars per share)

$ 1.55

$ 2.62

Weighted average grant date fair value, granted

$ 1.56

$ 3

$ 2.79

Number of shares under warrants granted

4,752,116

Warrants exercised

0

1,250,000

0

Number of stock issued in cashless exercise of warrants

471,184

Share-based Compensation Arrangement by Share-based Payment Award, Non-Option Equity Instruments, Outstanding, Number

6,534,687

1,832,571

Lender Warrants [Member]

Class of Warrant or Right [Line Items]

Warrants outstanding

4,752,116

Class of Warrant or Right, Exercise Price of Warrants or Rights

$ 1.58

Share-based Goods and Nonemployee Services Transaction, Valuation Method, Expected Term

10 years

Share-based Goods and Nonemployee Services Transaction, Valuation Method, Expected Volatility Rate

68.80%

Share-based Goods and Nonemployee Services Transaction, Valuation Method, Risk Free Interest Rate

0.34%

Share-based Goods and Nonemployee Services Transaction, Valuation Method, Expected Dividend Rate

0.00%

Weighted average grant date fair value, granted

$ 1.56

Lender Warrants [Member] | Financing Agreement Amendment No. 6 [Member]

Class of Warrant or Right [Line Items]

Class of Warrant or Right, Exercise Price of Warrants or Rights

$ 1.1856

Outside Consultants Warrants [Member]

Class of Warrant or Right [Line Items]

Number of shares under warrants granted

75,000

175,000

Award vesting period

12 months

12 months

Warrants expiration date

Feb. 13, 2024

Mar. 15, 2023

Warrants [Member]

Class of Warrant or Right [Line Items]

Non cash compensation expense

$ 26,446

$ 254,970

$ 494,136

Maximum [Member]

Class of Warrant or Right [Line Items]

Range - exercise price of options

$ 8.92

Maximum [Member] | Warrant [Member]

Class of Warrant or Right [Line Items]

Class of Warrant or Right, Exercise Price of Warrants or Rights

8.20

Minimum [Member]

Class of Warrant or Right [Line Items]

Range - exercise price of options

0.38

Minimum [Member] | Warrant [Member]

Class of Warrant or Right [Line Items]

Class of Warrant or Right, Exercise Price of Warrants or Rights

$ 0.24

Underwriting Agreement Cantor Fitzgerald [Member]

Class of Warrant or Right [Line Items]

Shares issued in offerings, net of cost (in shares)

23,437,500

Shares Issued, Price Per Share

$ 1.1856

Period exercisable underwriters option

30 days

Underwriters option granted in period shares

3,515,625

Proceeds from issuance public offering

$ 31,703,000

Maximum Common Stock Offering Price

$ 50,000,000

Fixed Commission Rate

3.00%

Underwriting Agreement Cantor Fitzgerald [Member] | Subsequent Event [Member]

Class of Warrant or Right [Line Items]

Shares issued in offerings, net of cost (in shares)

59,459,460

28,600,689

Period exercisable underwriters option

30 days

Underwriters option granted in period shares

8,918,919

Proceeds from Issuance of Common Stock

$ 97,100,000

$ 47,300,000

Underwriting Agreement Cantor Fitzgerald [Member] | Subsequent Event [Member] | Maximum [Member]

Class of Warrant or Right [Line Items]

Proceeds from Issuance of Common Stock

$ 50,000,000

Underwriting Agreement JP Morgan Chase [Member]

Class of Warrant or Right [Line Items]

Shares issued in offerings, net of cost (in shares)

26,000,000

Shares Issued, Price Per Share

$ 2.75

Period exercisable underwriters option

30 days

Underwriters option granted in period shares

3,900,000

Proceeds from issuance public offering

$ 77,031,000

Underwriting Agreement Goldman Sachs [Member]

Class of Warrant or Right [Line Items]

Shares issued in offerings, net of cost (in shares)

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]

Shares issued in offerings, net of cost (in shares)

3,921,568

Shares Issued, Price Per Share

$ 5.10

$ 5.10

Shares issued in offerings, net of cost

$ 20,000,000

Equity Option [Member]

Class of Warrant or Right [Line Items]

Shares issued for exercise of options, net (in shares)

1,182,195

331,619

5,444,526

Shares issued for exercise of options, net

$ 271,678

$ 108,656

$ 1,666,208

Restricted Stock [Member]

Class of Warrant or Right [Line Items]

Weighted average grant date fair value, granted

$ 1.39

Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Nonvested, Number

7,061,024

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

890,000

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

6,171,024

Performance Stock Units [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

2,403,951

Share-based Payment Arrangement, Option [Member]

Class of Warrant or Right [Line Items]

Share-based Payment Arrangement, Nonvested Award, Cost Not yet Recognized, Period for Recognition

1 year 10 months 24 days

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

1 year 7 months 6 days

EMPLOYEE BENEFIT PLAN (Details

EMPLOYEE BENEFIT PLAN (Details Narrative) - USD ($)	12 Months Ended
	Dec. 31, 2020	Dec. 31, 2019
Retirement Benefits [Abstract]
Matching contribution percentage	4.00%
Maximum matching contribution per year	$ 2,000
Defined contribution plan vesting service period	5 years
Contributions under plan	$ 487,000	$ 403,000

For financial reporting purpose

For financial reporting purposes, (loss) income before taxes includes the following components: (Details) - USD ($)	12 Months Ended
	Dec. 31, 2020	Dec. 31, 2019	Dec. 31, 2018
Operating Loss Carryforwards [Line Items]
Income (Loss) from Continuing Operations before Income Taxes, Domestic	$ (183,524,137)	$ (177,144,999)	$ (132,617,160)
Domestic Tax Authority [Member]
Operating Loss Carryforwards [Line Items]
Income (Loss) from Continuing Operations before Income Taxes, Domestic	$ (183,524,137)	$ (176,144,999)	$ (132,617,160)

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, 2020	Dec. 31, 2019	Dec. 31, 2018
Income Tax Disclosure [Abstract]
Federal statutory tax rate	21.00%	21.00%	21.00%
State tax rate, net of federal tax benefit	5.10%	4.00%	5.20%
Adjustment in valuation allowances	(27.00%)	(22.50%)	(31.20%)
Excess stock benefits	0.10%	0.20%	5.30%
Federal income tax rate change	0.00%	0.00%	(0.00%)
Permanent and other differences	0.80%	(2.70%)	(0.30%)
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, 2020, 2019, and 2018 are as follows: (Details) - USD ($)	Dec. 31, 2020	Dec. 31, 2019	Dec. 31, 2018
Deferred Income Tax Assets:
Net operating losses	$ 195,008,131	$ 157,555,975	$ 126,419,113
Share based compensation	17,251,900	13,913,568	11,640,464
Interest expense limitation	12,991,716	5,389,129	1,173,614
Other, net	4,818,935	3,662,037	1,658,573
R&D credit	186,347	186,347	186,347
Total deferred income tax asset	230,257,029	180,707,056	141,078,111
Valuation allowance	(230,257,029)	(180,707,056)	(141,078,111)
Deferred income tax assets, net	$ 0	$ 0	$ 0

INCOME TAXES (Details Narrative

INCOME TAXES (Details Narrative) - USD ($)	12 Months Ended
	Dec. 31, 2020	Dec. 31, 2019	Dec. 31, 2018
Operating Loss Carryforwards [Line Items]
Change in valuation allowance	$ 49,549,973	$ 39,628,945	$ 41,295,443
Internal Revenue Service (IRS) [Member]
Operating Loss Carryforwards [Line Items]
Net operating loss carry forward	761,701,546
Internal Revenue Service (IRS) [Member] | Expiration Period 20 Years [Member]
Operating Loss Carryforwards [Line Items]
Net operating loss carry forward	$ 338,775,332
NOL carryforward period	20 years
NOL carryforward expiration year	2031
Internal Revenue Service (IRS) [Member] | Expiration Period Indefinite [Member]
Operating Loss Carryforwards [Line Items]
Net operating loss carry forward	$ 422,926,214

RELATED PARTIES (Details Narrat

RELATED PARTIES (Details Narrative) - USD ($)	12 Months Ended
	Dec. 31, 2020	Dec. 31, 2019	Dec. 31, 2018
Catalent [Member]
Related Party Transaction [Line Items]
Amount billed	$ 3,036,000	$ 6,101,000	$ 4,111,000
Amounts due to related party	0	$ 35,000
American International Group [Member]
Related Party Transaction [Line Items]
Amount billed	$ 209,000

BUSINESS CONCENTRATIONS (Detail

BUSINESS CONCENTRATIONS (Details Narrative)	12 Months Ended
	Dec. 31, 2020USD ($)Number	Dec. 31, 2019USD ($)Number	Dec. 31, 2018USD ($)Number
Concentration Risk [Line Items]
Number of vendors - suppliers | Number			3
Supplier One Concentration Risk [Member]
Concentration Risk [Line Items]
Concentration Risk, Percentage	36.00%	24.00%	43.00%
Supplier 2
Concentration Risk [Line Items]
Concentration Risk, Percentage	30.00%	27.00%	33.00%
Supplier 3
Concentration Risk [Line Items]
Concentration Risk, Percentage	25.00%	35.00%	24.00%
Customer Concentration Risk [Member]
Concentration Risk [Line Items]
Concentration Risk, Percentage	10.00%	10.00%	10.00%
Number of customers - revenue | Number	3	4	4
Customer Concentration Risk [Member] | Revenue Benchmark [Member]
Concentration Risk [Line Items]
Concentration Risk, Percentage	63.00%	73.00%	76.00%
Number of customers - revenue | Number	3	4	4
Cardinal Health - Major Customer | Revenue Benchmark [Member]
Concentration Risk [Line Items]
Revenues	$ 17,489,000	$ 4,551,000	$ 2,308,000
PillPack - Major Customer | Revenue Benchmark [Member]
Concentration Risk [Line Items]
Revenues	13,228,000	12,676,000	5,075,000
McKesson Corporation - Major Customer | Revenue Benchmark [Member]
Concentration Risk [Line Items]
Revenues	$ 9,862,000	3,911,000	1,610,000
AmerisourceBergen - Major Customer | Revenue Benchmark [Member]
Concentration Risk [Line Items]
Revenues		$ 3,927,000	$ 3,246,000

Supplemental lease information

Supplemental lease information (Details) - USD ($)	12 Months Ended
	Dec. 31, 2020	Dec. 31, 2019
Commitments and Contingencies Disclosure [Abstract]
Right-of-use asset	$ 9,565,700	$ 10,109,154
Short-term operating lease liability (included in Other current liabilities)	$ 2,253,994	$ 1,501,539
Operating Lease, Liability, Current, Statement of Financial Position [Extensible List]	Other current liabilities	Other current liabilities
Long-term operating lease liability	$ 8,675,477	$ 9,145,049
Operating Lease, Weighted Average Remaining Lease Term	8 years 10 months 24 days	9 years
Weighted average discount rate	8.30%	8.25%
Cash paid for amounts included in the measurement of lease liabilities for operating lease	$ 1,617,645	$ 1,164,234
Right-of-use assets obtained in exchange for lease obligation	$ 998,821	$ 11,171,471

The following table reconciles

The following table reconciles the undiscounted cash flows for all operating leases at December 31, 2020 to the operating lease liabilities recorded on the balance sheet: (Details)	Dec. 31, 2020USD ($)
Commitments and Contingencies Disclosure [Abstract]
2021	$ 2,334,582
2022	1,413,289
2023	1,443,143
2024	1,476,534
2025	1,513,458
Thereafter	7,434,412
Total undiscounted lease payments	15,615,418
Less: imputed interest	(4,685,947)
Present value of lease payments	$ 10,929,471

COMMITMENTS AND CONTINGENCIES_2

COMMITMENTS AND CONTINGENCIES (Details Narrative)	12 Months Ended
	Dec. 31, 2020USD ($)	Dec. 31, 2019USD ($)	Dec. 31, 2018USD ($)	Aug. 01, 2019ft²	Jun. 01, 2019ft²	Oct. 02, 2018ft²	Jul. 01, 2013
Recorded Unconditional Purchase Obligation [Line Items]
Operating lease term				11 years			63 months
Net rentable area | ft²						56,212
Rented area lease | ft²						7,561
Additional rented area occupied under the lease | ft²				48,651
Number of options to extend lease	2
Lease renewal term	5 years
Lease not yet commenced (area) | ft²					6,536
Operating Lease, Expense	$ 2,325,844	$ 1,558,794
Variable lease payment	$ 423,578
Rental expense			$ 1,068,275
Significant supply commitment percentage payable	50.00%
Catalent [Member]
Recorded Unconditional Purchase Obligation [Line Items]
Minimum purchase commitment, 2021	$ 3,458,000
Minimum purchase commitment, 2022	2,150,000
Minimum purchase commitment, 2023	2,991,000
Minimum purchase commitment, 2024	3,347,000
Minimum purchase commitment, 2025	3,786,000
ANNOVERA [Member]
Recorded Unconditional Purchase Obligation [Line Items]
Minimum purchase commitment, 2021	$ 1,526,000

Summarized quarterly financial

Summarized quarterly financial data for fiscal years 2020 and 2019 is as follows (Details) - USD ($)	3 Months Ended												12 Months Ended
	Dec. 31, 2020		Sep. 30, 2020		Jun. 30, 2020	Mar. 31, 2020	Dec. 31, 2019	Sep. 30, 2019		Jun. 30, 2019		Mar. 31, 2019	Dec. 31, 2020	Dec. 31, 2019	Dec. 31, 2018	Aug. 05, 2020
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Revenues	$ 22,577,000	[1]	$ 19,343,000	[2],[3],[4],[5]	$ 10,701,000	$ 12,251,000	$ 15,902,000	$ 23,719,000	[6]	$ 6,079,000	[7]	$ 3,947,000	$ 64,872,280	$ 49,646,937	$ 16,099,460
Gross profit	16,996,000	[1]	16,064,000	[2],[3],[4],[5]	6,301,000	9,536,000	13,023,000	22,275,000	[6]	4,830,000	[7]	3,184,000	48,897,303	43,312,352	13,361,808
Net loss	$ (42,088,000)	[1]	$ (32,611,000)	[2],[3],[4],[5]	$ (51,976,000)	$ (56,849,000)	$ (49,435,000)	$ (31,967,000)	[6]	$ (55,237,000)	[7]	$ (39,506,000)	$ (183,524,137)	$ (176,144,999)	$ (132,617,160)
Loss per common share, basic and diluted	$ (0.15)	[1]	$ (0.12)	[2],[3],[4],[5]	$ (0.19)	$ (0.21)	$ (0.19)	$ (0.13)	[6]	$ (0.23)	[7]	$ (0.16)	$ (0.67)	$ (0.72)	$ (0.59)
Write off of patent and trademark cost	$ 500,000		$ 600,000										$ 1,131,776	$ 78,864
Inventory charge			5,700,000										7,204,818	0
Loss on extinguishment of debt										$ 10,100,000				$ 10,057,632
Lender Warrants [Member]
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Fair value of warrants			7,400,000													$ 7,428,178
Knight License Agreement [Member]
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Revenues			$ 2,000,000
License Agreement Theramex [Member]
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Revenues								$ 1,500,000
[1]	During the fourth quarter of 2020, we wrote off approximately $0.5 million in costs related to trademarks and patents. Refer to discussion in Note 6-Intangible Assets, Net.
[2]	During the third quarter of 2020, we recorded $2 million in license revenue related to the Knight License Agreement. Refer to discussion in Note 2-Summary of Significant Accounting Policies.
[3]	During the third quarter of 2020, we recorded approximately $5.7 million in inventory charge, primarily related to BIJUVA. Refer to discussion in Note 2-Summary of Significant Accounting Policies.
[4]	During the third quarter of 2020, we recorded the fair value of the Lender Warrants based on Amendment No. 5 of approximately $7.4 million as a debt discount, which is being amortized to interest expense using the effective interest method over the term of the Financing Agreement. Refer to discussion in Note 8-Debt.
[5]	During the third quarter of 2020, we wrote off approximately $0.6 million in costs related to trademarks and patents. Refer to discussion in Note 6-Intangible Assets, Net.
[6]	During the third quarter of 2019, we recorded approximately $15.5 million in license revenue related to the Theramex License Agreement. Refer to discussion in Note 2-Summary of Significant Accounting Policies.
[7]	During the second quarter of 2019, we recorded approximately $10.1 million in loss on extinguishment of debt related to the repayment of the Credit Agreement. Refer to discussion in Note 8-Debt.

SUBSEQUENT EVENTS (Details Narr

SUBSEQUENT EVENTS (Details Narrative) - USD ($)	Feb. 16, 2021	Nov. 20, 2020	Nov. 13, 2020	Nov. 10, 2020	Feb. 08, 2021	Dec. 31, 2020	Dec. 31, 2019	Dec. 31, 2018	Jan. 13, 2021
Subsequent Event [Line Items]
Proceeds from sale of common stock, net of costs						$ 31,702,635	$ 77,031,258	$ 89,907,797
Subsequent Event [Member] | Financing Agreement Amendment No. 7 - Fiscal Quarter Ending March 31, 2021 [Member] | IMVEXXY, BIJUVA and ANNOVERA [Member]
Subsequent Event [Line Items]
Minimum revenue requirement under credit agreement									$ 18,000,000
Subsequent Event [Member] | Financing Agreement Amendment No. 7 - Fiscal Quarter Ending June 30, 2021 [Member] | IMVEXXY, BIJUVA and ANNOVERA [Member]
Subsequent Event [Line Items]
Minimum revenue requirement under credit agreement									$ 22,000,000
Underwriting Agreement Cantor Fitzgerald [Member]
Subsequent Event [Line Items]
Shares issued in offerings, net of cost (in shares)			23,437,500
Period exercisable underwriters option				30 days
Underwriters option granted in period shares		3,515,625
Underwriting Agreement Cantor Fitzgerald [Member] | Subsequent Event [Member]
Subsequent Event [Line Items]
Shares issued in offerings, net of cost (in shares)	59,459,460				28,600,689
Proceeds from sale of common stock, net of costs	$ 97,100,000				$ 47,300,000
Period exercisable underwriters option	30 days
Underwriters option granted in period shares	8,918,919