0001387131-20-009695 | 10-Q | XBRL Viewer

Cover - shares	9 Months Ended
Cover - shares	Sep. 30, 2020	Nov. 02, 2020
Cover [Abstract]
Document Type	10-Q
Amendment Flag	false
Document Quarterly Report	true
Document Transition Report	false
Document Period End Date	Sep. 30, 2020
Document Fiscal Period Focus	Q3
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 Road
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 Current Reporting Status	Yes
Entity Interactive Data Current	Yes
Entity Filer Category	Large Accelerated Filer
Entity Small Business	false
Entity Emerging Growth Company	false
Entity Shell Company	false
Entity Common Stock, Shares Outstanding		272,812,271

CONSOLIDATED BALANCE SHEETS (Unaudited) - USD ($)	Sep. 30, 2020	Dec. 31, 2019
Current Assets:
Cash	$ 79,633,675	$ 160,829,713
Accounts receivable, net of allowance for doubtful accounts of $857,176 and $904,040, respectively	24,059,095	24,395,958
Inventory, net	9,932,304	11,860,716
Other current assets	8,819,239	11,329,793
Total current assets	122,444,313	208,416,180
Fixed assets, net	1,969,929	2,507,775
Other Assets:
License rights, net	36,959,305	39,221,308
Intangible assets, net	5,537,885	5,258,211
Right of use assets	9,975,725	10,109,154
Other assets	403,643	473,009
Total other assets	52,876,558	55,061,682
Total assets	177,290,800	265,985,637
Current Liabilities:
Accounts payable	16,109,638	19,181,212
Other current liabilities	31,220,484	33,823,613
Total current liabilities	47,330,122	53,004,825
Long-Term Liabilities:
Long-term debt	237,051,202	194,634,643
Operating lease liability	8,907,995	9,145,049
Other long-term liabilities	35,000
Total long-term liabilities	245,994,197	203,779,692
Total liabilities	293,324,319	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: 272,812,271 and 271,177,076 issued and outstanding, respectively	272,812	271,177
Additional paid-in capital	720,551,488	704,351,222
Accumulated deficit	(836,857,819)	(695,421,279)
Total stockholders' (deficit) equity	(116,033,519)	9,201,120
Total liabilities and stockholders' (deficit) equity	$ 177,290,800	$ 265,985,637

CONSOLIDATED BALANCE SHEETS (Unaudited) (Parenthetical) - USD ($)	Sep. 30, 2020	Dec. 31, 2019
Statement of Financial Position [Abstract]
Allowance for doubtful accounts	$ 857,176	$ 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	272,812,271	271,177,076
Common Stock, Shares, Outstanding	272,812,271	271,177,076

CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited) - USD ($)	3 Months Ended		9 Months Ended
	Sep. 30, 2020	Sep. 30, 2019	Sep. 30, 2020	Sep. 30, 2019
Total revenue, net	$ 19,342,805	$ 23,719,741	$ 42,294,495	$ 33,745,257
Cost of goods sold	3,278,609	1,444,308	10,394,145	3,455,995
Gross profit	16,064,196	22,275,433	31,900,350	30,289,262
Operating expenses:
Sales, general, and administrative	38,751,250	45,126,986	144,018,899	121,378,519
Research and development	2,027,195	4,077,738	8,038,056	15,359,988
Depreciation and amortization	258,787	141,959	777,338	363,956
Total operating expenses	41,037,232	49,346,683	152,834,293	137,102,463
Operating loss	(24,973,036)	(27,071,250)	(120,933,943)	(106,813,201)
Other (expense) income
Loss on extinguishment of debt				(10,057,632)
Miscellaneous income	41,405	703,662	465,745	1,878,980
Interest expense	(7,679,443)	(5,599,005)	(20,968,342)	(11,717,632)
Total other expense, net	(7,638,038)	(4,895,343)	(20,502,597)	(19,896,284)
Loss before income taxes	(32,611,074)	(31,966,593)	(141,436,540)	(126,709,485)
Provision for income taxes
Net loss	$ (32,611,074)	$ (31,966,593)	$ (141,436,540)	$ (126,709,485)
Loss per share, basic and diluted:
Net loss per share, basic and diluted	$ (0.12)	$ (0.13)	$ (0.52)	$ (0.53)
Weighted average number of common shares outstanding, basic and diluted	272,564,635	241,261,299	271,968,981	241,163,994
Product [Member]
Total revenue, net	$ 17,342,805	$ 8,213,341	$ 40,294,495	$ 18,238,857
License [Member]
Total revenue, net	$ 2,000,000	$ 15,506,400	$ 2,000,000	$ 15,506,400

CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY (DEFICIT) (Unaudited) - USD ($)	Common Stock [Member]	Additional Paid-in Capital [Member]	Retained Earnings [Member]	Total
Beginning balance, value at Dec. 31, 2018	$ 240,463	$ 616,559,938	$ (519,276,280)	$ 97,524,121
Beginning balance, shares at Dec. 31, 2018	240,462,439
Shares issued for exercise of options and warrants, net	$ 759	99,348		100,107
Shares issued for exercise of options and warrants, net (in shares)	759,401
Share-based compensation		2,575,369		2,575,369
Net loss			(39,506,375)	(39,506,375)
Ending balance, value at Mar. 31, 2019	$ 241,222	619,234,655	(558,782,655)	60,693,222
Ending balance, shares at Mar. 31, 2019	241,221,840
Beginning balance, value at Dec. 31, 2018	$ 240,463	616,559,938	(519,276,280)	97,524,121
Beginning balance, shares at Dec. 31, 2018	240,462,439
Net loss				(126,709,485)
Ending balance, value at Sep. 30, 2019	$ 241,277	624,515,559	(645,985,765)	(21,228,929)
Ending balance, shares at Sep. 30, 2019	241,277,076
Beginning balance, value at Mar. 31, 2019	$ 241,222	619,234,655	(558,782,655)	60,693,222
Beginning balance, shares at Mar. 31, 2019	241,221,840
Share-based compensation		2,637,264		2,637,264
Net loss			(55,236,517)	(55,236,517)
Ending balance, value at Jun. 30, 2019	$ 241,222	621,871,919	(614,019,172)	8,093,969
Ending balance, shares at Jun. 30, 2019	241,221,840
Shares issued for exercise of options and warrants, net	$ 55	8,494		8,549
Shares issued for exercise of options and warrants, net (in shares)	55,236
Share-based compensation		2,635,146		2,635,146
Net loss			(31,966,593)	(31,966,593)
Ending balance, value at Sep. 30, 2019	$ 241,277	624,515,559	(645,985,765)	(21,228,929)
Ending balance, shares at Sep. 30, 2019	241,277,076
Beginning balance, value at Dec. 31, 2019	$ 271,177	704,351,222	(695,421,279)	$ 9,201,120
Beginning balance, shares at Dec. 31, 2019	271,177,076			271,177,076
Shares issued for exercise of options and warrants, net	$ 351	71,758		$ 72,109
Shares issued for exercise of options and warrants, net (in shares)	350,666
Share-based compensation		2,366,453		2,366,453
Net loss			(56,848,802)	(56,848,802)
Ending balance, value at Mar. 31, 2020	$ 271,678	706,789,283	(752,270,081)	(45,209,120)
Ending balance, shares at Mar. 31, 2020	271,677,742
Issuance of shares from release of restricted stock	$ 150	(150)
Issuance of shares from release of restricted stock (in shares)	150,000
Beginning balance, value at Dec. 31, 2019	$ 271,177	704,351,222	(695,421,279)	$ 9,201,120
Beginning balance, shares at Dec. 31, 2019	271,177,076			271,177,076
Net loss				$ (141,436,540)
Ending balance, value at Sep. 30, 2020	$ 272,812	720,551,488	(836,857,819)	$ (116,033,519)
Ending balance, shares at Sep. 30, 2020	272,812,271			272,812,271
Beginning balance, value at Mar. 31, 2020	$ 271,678	706,789,283	(752,270,081)	$ (45,209,120)
Beginning balance, shares at Mar. 31, 2020	271,677,742
Shares issued for exercise of options and warrants, net	$ 313	93,762		94,075
Shares issued for exercise of options and warrants, net (in shares)	313,638
Share-based compensation		3,002,826		3,002,826
Net loss			(51,976,664)	(51,976,664)
Ending balance, value at Jun. 30, 2020	$ 272,294	709,885,568	(804,246,745)	(94,088,883)
Ending balance, shares at Jun. 30, 2020	272,294,380
Issuance of shares from release of restricted stock	$ 303	(303)
Issuance of shares from release of restricted stock (in shares)	303,000
Shares issued for exercise of options and warrants, net	$ 518	104,976		105,494
Shares issued for exercise of options and warrants, net (in shares)	517,891
Share-based compensation		3,132,765		3,132,765
Net loss			(32,611,074)	(32,611,074)
Ending balance, value at Sep. 30, 2020	$ 272,812	720,551,488	(836,857,819)	$ (116,033,519)
Ending balance, shares at Sep. 30, 2020	272,812,271			272,812,271
Warrant granted in relation to Financing Agreement		$ 7,428,179		$ 7,428,179

- Definition

The portion of profit or loss for the period, net of income taxes, which is attributable to the parent.

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+ Details

- Definition

Total of all stockholders' equity (deficit) items, net of receivables from officers, directors, owners, and affiliates of the entity which are attributable to the parent. The amount of the economic entity's stockholders' equity attributable to the parent excludes the amount of stockholders' equity which is allocable to that ownership interest in subsidiary equity which is not attributable to the parent (noncontrolling interest, minority interest). This excludes temporary equity and is sometimes called permanent equity.

+ References + Details

CONSOLIDATED STATEMENTS OF CASH FLOWS (Unaudited) - USD ($)	9 Months Ended
	Sep. 30, 2020	Sep. 30, 2019
CASH FLOWS FROM OPERATING ACTIVITIES
Net loss	$ (141,436,540)	$ (126,709,485)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation of fixed assets	576,459	223,750
Amortization of intangible assets	200,879	140,206
Write off of patent and trademark costs	584,509	78,864
Write off of deferred financing fees	275,379
Non-cash operating lease expense	1,050,940	711,836
(Recovery of) provision for doubtful accounts	(46,864)	95,097
Lease impairment	81,309
Inventory obsolesence reserve	5,744,464
Loss on extinguishment of debt		10,057,632
Share-based compensation	8,502,044	7,859,357
Amortization of intellectual property license fee	2,262,002	15,998
Amortization of deferred financing fees	1,370,118	582,829
Changes in operating assets and liabilities:
Accounts receivable	383,727	(4,354,890)
Inventory	(3,816,053)	(7,265,174)
Other assets	2,003,079	(1,128,515)
Accounts payable	(3,071,574)	1,389,665
Other current liabilities	(3,812,919)	3,402,511
Net cash used in operating activities	(129,149,041)	(114,900,319)
CASH FLOWS FROM INVESTING ACTIVITIES
Patent costs	(1,065,062)	(1,068,542)
Purchase of fixed assets	(38,613)	(2,089,413)
Security deposit	35,000	(20,420)
Net cash used in investing activities	(1,068,675)	(3,178,375)
CASH FLOWS FROM FINANCING ACTIVITIES
Proceeds from exercise of options and warrants	271,678	108,656
Repayment of the Credit Agreement		(81,660,719)
Proceeds from the Financing Agreement	50,000,000	200,000,000
Payment of deferred financing fees	(1,250,000)	(6,652,270)
Net cash provided by financing activities	49,021,678	111,795,667
Decrease in cash	(81,196,038)	(6,283,027)
Cash, beginning of period	160,829,713	161,613,077
Cash, end of period	79,633,675	155,330,050
Supplemental disclosure of noncash investing and financing activities
Warrant granted in relation to Financing Agreement	7,428,179
Amount accrued for intellectual property license		20,000,000
Supplemental disclosure of cash flow information
Interest paid	$ 19,172,847	$ 12,446,792

NOTE 1 – THE COMPANY

9 Months Ended

Sep. 30, 2020

Organization, Consolidation and Presentation of Financial Statements [Abstract]

NOTE 1 – THE COMPANY

NOTE 1 – THE COMPANY

TherapeuticsMD, Inc., a Nevada corporation, or TherapeuticsMD or the Company, has three wholly owned subsidiaries, vitaMedMD, LLC, a Delaware limited liability company, or VitaMed; BocaGreenMD, Inc., a Nevada corporation, or BocaGreen; and vitaCare Prescription Services, Inc., a Florida corporation, or vitaCare. Unless the context otherwise requires, TherapeuticsMD, VitaMed, BocaGreen, and vitaCare collectively are sometimes referred to as “our company,” “we,” “our,” or “us.” TherapeuticsMD^®, vitaMedMD^®, BocaGreenMD^®, IMVEXXY^®, BIJUVA^®and ANNOVERA^® are registered trademarks of our company.

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 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.

NOTE 2 – BASIS OF PRESENTATION AND RECENTLY ISSUED ACCOUNTING PRONOUNCEMENTS

9 Months Ended

Sep. 30, 2020

Organization, Consolidation and Presentation of Financial Statements [Abstract]

NOTE 2 – BASIS OF PRESENTATION AND RECENTLY ISSUED ACCOUNTING PRONOUNCEMENTS

NOTE 2 – BASIS OF PRESENTATION AND RECENTLY ISSUED ACCOUNTING PRONOUNCEMENTS

Interim Financial Statements

The accompanying unaudited interim consolidated financial statements of TherapeuticsMD, Inc., which include our wholly owned subsidiaries, should be read in conjunction with the audited consolidated financial statements and notes thereto included in our Annual Report on Form 10-K for the year ended December 31, 2019, as filed with the Securities and Exchange Commission, or the SEC, from which we derived the accompanying consolidated balance sheet as of December 31, 2019. The accompanying unaudited interim consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America, or GAAP, for interim financial information and with the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, since they are interim statements, the accompanying unaudited interim consolidated financial statements do not include all of the information and notes required by GAAP for complete financial statements. The accompanying unaudited interim consolidated financial statements reflect all adjustments, consisting of normal recurring adjustments, that are, in the opinion of our management, necessary to a fair statement of the results for the interim periods presented. Interim results are not necessarily indicative of results for a full year or any other interim period in the future.

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.

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 virtual detailing.

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 of our third quarter 2020 product revenues as compared to our second quarter 2020 product revenues. 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 virus 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 and Going Concern

As of the filing date of this Quarterly Report on Form 10-Q, our cash balance was above the $60 million balance as required by the Financing Agreement (as defined in Note 9 - 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 9 - Debt) and the lenders party thereto, pursuant to which we temporarily lowered the minimum required cash balance from $60 million to $45 million through December 31, 2020. After December 31, 2020, the minimum cash balance will revert to $60 million. Based on our current projections, we will need to raise additional capital to remain in compliance with this minimum cash balance covenant for the next twelve months from the issuance of these financial statements.

In order to address our projected capital needs, we are pursuing various equity financing and other alternatives including the sale of a controlling interest in vitaCare Prescription Services for which we commended a sale process and received initial indications of interest. The equity financing alternatives may include the private placement of equity, equity-linked, or other similar instruments or obligations with one or more investors, lenders, or other institutional counterparties or an underwritten public equity or equity-linked securities offering. Our ability to sell equity securities may be limited by market conditions. To the extent that we raise additional capital through the sale of such securities, the ownership interests of our existing stockholders will be diluted, and the terms of these new securities may include liquidation or other preferences that adversely affect the rights of our existing stockholders.

Along with considering additional financings, we have reviewed numerous potential scenarios in connection with the impact of COVID-19 on our business including the impact of the recent steps we have taken to reduce our operating expenses in response. Based on our analysis, we believe that our existing cash reserves along with potential proceeds from the sale of certain non-core assets of the Company and proceeds from potential future financings, if available to us, would be sufficient to meet our cash needs arising in the ordinary course of business for the next twelve months from the date of this Quarterly Report on Form 10-Q.

However, if we are unsuccessful with future financings and if the successful commercialization of IMVEXXY, BIJUVA, or ANNOVERA is delayed, or the continued impact of the COVID-19 pandemic on our business is worse than we anticipate, our existing cash reserves would 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 presence of these projected factors in conjunction with the uncertainty of the capital markets raises substantial doubt about the Company's ability to continue as a going concern for the next twelve months from the issuance of these financial statements.

The accompanying unaudited consolidated financial statements do not include any adjustments that might be necessary if the Company is unable to continue as a going concern.

Recently Issued Accounting Pronouncements

In August 2018, the Financial Accounting Standards Board, or the FASB, issued Accounting Standards Update, or ASU, 2018-13 which eliminates certain disclosure requirements for fair value measurements for all entities, requires public entities to disclose certain new information and modifies some disclosure requirements. The FASB developed the amendments to 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.

NOTE 3 – SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

9 Months Ended

Sep. 30, 2020

Accounting Policies [Abstract]

NOTE 3 – SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

NOTE 3 – SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

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.

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 September 30, 2020 (as disclosed in Note 9) approximates fair value based on market activity for other debt instruments with similar characteristics and comparable risk (Level 2).

We categorize our assets and liabilities that are valued at fair value on a recurring basis into a three-level fair value hierarchy as defined by ASC 820, Fair Value Measurements, or ASC 820. The fair value hierarchy gives the highest priority to quoted prices in active markets for identical assets and liabilities (Level 1) and lowest priority to unobservable inputs (Level 3). Assets and liabilities recorded in the consolidated balance sheet at fair value are categorized based on a hierarchy of inputs, as follows:

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 September 30, 2020 and 2019, we had no assets or liabilities that were valued at fair value on a recurring basis.

The fair value of indefinite-lived assets is measured on a non-recurring basis using significant unobservable inputs (Level 3) in connection with any required impairment test. During the nine months ended September 30, 2020 and 2019, we wrote off $584,509 and $78,864, respectively, in costs related to trademarks and patents.

Share-Based Compensation

We measure the compensation costs of share-based compensation arrangements based on the grant-date fair value and recognize the costs in the financial statements over the period during which employees are required to provide services. Share-based compensation arrangements include options, restricted stock, restricted stock units, performance-based awards, share appreciation rights, and employee share purchase plans. We amortize such compensation amounts, if any, over the respective service periods of the award. We use the Black-Scholes-Merton option pricing model, or the Black-Scholes Model, an acceptable model in accordance with ASC 718, Compensation-Stock Compensation, to value options. Option valuation models require the input of assumptions, including the expected life of the stock-based awards, the estimated stock price volatility, the risk-free interest rate, and the expected dividend yield. The risk-free interest rate assumption is based upon observed interest rates on zero coupon U.S. Treasury bonds whose maturity period is appropriate for the term of the instrument. Estimated volatility is a measure of the amount by which our stock price is expected to fluctuate each year during the term of the award. On January 1, 2017, we began using our own stock price in our volatility calculation along with the other peer entities whose stock prices were publicly available that were similar to our company and in 2019 we started using only our own stock price in the volatility calculation. Our calculation of estimated volatility is based on historical stock prices over a period equal to the expected term of the awards. On January 1, 2020, we began calculating the expected term of our stock-based awards, which represents the period that the stock-based awards are expected to be outstanding. Prior to January 1, 2020, the average expected life of options was based on the contractual terms of the stock option using the simplified method. We utilize a dividend yield of zero based on the fact that we have never paid cash dividends and have no current intention to pay cash dividends. The assumptions used in calculating the fair value of stock-based awards represent our best estimates, but these estimates involve inherent uncertainties and the application of management judgment. As a result, if factors change and we use different assumptions, our share-based compensation expense could be materially different in the future. We recognize the compensation expense for share-based compensation granted based on the grant date fair value estimated in accordance with ASC 718. We generally recognize the compensation expense on a straight-line basis over the employee’s requisite service period. Effective January 1, 2017, we account for forfeitures when they occur. On January 1, 2019, we adopted ASU 2018-07 which simplified the accounting for share-based payments to non-employees by aligning it with the accounting for share-based payments to employees, with certain exceptions. The new guidance expanded the scope of ASC 718 to include share-based payments granted to non-employees in exchange for goods or services used or consumed in an entity’s own operations and superseded the guidance in ASC 505-50. Prior to January 1, 2019, equity instruments issued to non-employees were recorded on a fair value basis, as required by ASC 505, Equity - Based Payments to Non-Employees.

We grant performance-based stock units and restricted stock units for shares of common stock, par value $0.001 per share, or Common Stock, to employees. We value our restricted stock units and our performance-based stock units by reference to our stock price on the date of grant. We recognize compensation expense for restricted stock units based on a straight-line basis over the requisite service period of the entire award. 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 number of target shares that vest are determined based on the level of attainment of the targets. If a minimum level of performance is attained for the awards, restricted stock is issued based on the level of attainment.

Revenue Recognition

In accordance with ASC 606, Revenue from Contracts with Customers, or ASC 606, revenue is recognized when a customer obtains control of promised goods or services. The amount of revenue recognized reflects the consideration to which we expect to be entitled to receive in exchange for these goods or services. The provisions of ASC 606 include a five-step process by which we determine revenue recognition, depicting the transfer of goods or services to customers in amounts reflecting the payment to which we expect to be entitled in exchange for those goods or services. ASC 606 requires us to apply the following steps: (1) identify the contract with the customer; (2) identify the performance obligations in the contract; (3) determine the transaction price; (4) allocate the transaction price to the performance obligations in the contract; and (5) recognize revenue when, or as, we satisfy the performance obligation.

Prescription Products

As of September 30, 2020, our products consisted primarily of prescription vitamins and our FDA-approved products: IMVEXXY, which we began selling during the third quarter of 2018, BIJUVA, which we began selling in the second quarter of 2019, and ANNOVERA, which we began selling 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 launch of ANNOVERA on July 1, 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 months following product expiration. Our vitamins and IMVEXXY currently have a shelf life of 24 months from the date of manufacture and BIJUVA and ANNOVERA currently have a shelf life of 18 months from the date of manufacture. We do not allow product returns for prescription products that have been dispensed to a patient. We estimate the amount of our product sales that may be returned by our customers and record this estimate as a reduction of product revenue in the period the related product revenue is recognized. Where historical rates of return exist, we use history as a basis to establish a returns reserve for products shipped to wholesalers. For our newly launched products, for which the right of return exists but for which we currently do not have history of product returns, we estimate returns based on available industry data, our own sales information and our visibility into the inventory remaining in the distribution channel. At the end of each reporting period, we may decide to constrain product revenue for product returns based on information from various sources, including channel inventory levels and dating and sell-through data, the expiration dates of products currently being shipped, price changes of competitive products and any introductions of generic products. We recognize the amount of expected returns as a refund liability, representing the obligation to return the customer’s consideration. Since our returns primarily consist of expired and short dated products that will not be resold, we do not record a return asset for the right to recover the goods returned by the customer at the time of the initial sale (when recognition of product revenue is deferred due to the anticipated return). Return estimates are recorded in other current liabilities on the consolidated balance sheet.

We offer various rebate and discount programs in an effort to maintain a competitive position in the marketplace and to promote sales and customer loyalty. We estimate the allowance for consumer rebates and coupons that we have offered based on our experience and industry averages, which is reviewed, and adjusted if necessary, on a quarterly basis. Estimates relating to these rebates and coupons are deducted from gross product revenues at the time the product revenues are 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 8. We provide invoice discounts to our customers for prompt payment. Estimates relating to invoice discounts and chargebacks are deducted from gross product revenues at the time the product revenues are recognized.

As part of commercial launches for our FDA-approved prescription products, we introduced a co-pay assistance program for eligible enrolled patients whose out of pocket costs are reduced to a more affordable price. This allows patients to access the product at a reasonable cost and is in line with our responsible pricing approach. We reimburse pharmacies for this discount through third-party vendors. 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.

License Revenue

License arrangements may consist of non-refundable upfront license fees, exclusive licensed rights to patented or patent pending technology, and various performance or sales milestones and future product royalty payments. Some of these arrangements may include multiple performance obligations. Non-refundable up-front fees that are not contingent on any future performance by us, and do not require continuing involvement on our part, are recognized as revenue when the right to use functional IP is transferred to the customer.

Disaggregation of revenue

The following table provides information about disaggregated revenue by product mix for the three and nine months ended September 30, 2020 and 2019:

	Three Months Ended September 30,				Nine Months Ended September 30,
	2020		2019		2020		2019
Prescription vitamins	$	2,435,903	$	2,550,330	$	7,337,976	$	7,309,174
IMVEXXY		6,841,592		4,772,354		18,319,382		9,904,744
BIJUVA		1,646,320		490,705		4,109,925		624,987
ANNOVERA		6,418,990		399,952		10,527,212		399,952
License revenue		2,000,000		15,506,400		2,000,000		15,506,400
Net revenue	$	19,342,805	$	23,719,741	$	42,294,495	$	33,745,257

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 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 within 30 days following the approval by the FDA of the new drug application, or NDA, for ANNOVERA and $20,000,000 within 30 days following the first commercial batch release of ANNOVERA. Both milestone payments of $20,000,000 were recorded as license rights in the consolidated balance sheets. We started amortizing license rights in the third quarter of 2019 once ANNOVERA became commercially available for use. The cost is amortized over the remaining useful life over which the license rights will contribute directly or indirectly to our cash flows, which is estimated to be the remaining patent life of the product, which expires in December 2032. The cost is amortized using the straight-line method as the pattern of economic benefit cannot be reliably determined. During the three and nine months ended September 30, 2020, we recorded $762,389 and $2,262,002, respectively, in amortization expense related to the license fee. During both the three and nine months ended September 30, 2019, we recorded $15,998 in amortization expense related to the license fee which was recorded as a component of cost of sales.

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, a royalty of 5% of net sales; (ii) for annual net sales greater than $50,000,000 and less than or equal to $150,000,000, a royalty of 10% of such net sales; and (iii) for net sales greater than $150,000,000, a royalty of 15% of such net sales. The annual royalty rate will be reduced to 50% of the initial rate during the six-month period beginning on the date of the first arms-length commercial sale of a generic equivalent of the one-year vaginal contraceptive system that is launched by a third party in the U.S., and thereafter will be reduced to 20% of the initial rate. We are required to pay the Population Council milestone payments of $40 million upon cumulative net sales of ANNOVERA in the U.S. by us and our affiliates and permitted sublicensees of each of $200 million, $400 million and $1 billion. The Population Council has agreed to perform and pay the costs and expenses associated with four post-approval studies required by the FDA for ANNOVERA and we have agreed to perform and pay the costs and expenses associated with a post approval study required by the FDA to measure risk for venous thromboembolism, provided that if the costs and expenses associated with such post-approval study exceed $20,000,000, half of such excess will be offset against royalties or other payments owed by us to the Population Council under the Population Council License Agreement. We and the Population Council have agreed to form a joint product committee responsible for overseeing activities under the Population Council License Agreement. We will be responsible for all aspects of promotion, product positioning, pricing, education programs, publications, sales messages and any additional desired clinical studies for the one-year vaginal contraceptive system, subject to oversight and decisions made by the joint product committee. The Population Council License Agreement includes exclusive rights for us to negotiate co-development of two other investigational vaginal contraceptive systems in development by the Population Council.

License Agreement with Knight

In July 2018, we entered into a license and supply agreement, or the Knight License Agreement, with Knight pursuant to which we granted Knight an exclusive license to commercialize IMVEXXY and BIJUVA in Canada and Israel. Pursuant to the terms of the Knight License Agreement, Knight paid us $2,000,000 in milestone fees upon the first regulatory approval in Canada for IMVEXXY and BIJUVA in the third quarter of 2020, and is also required to pay us sales milestone fees based upon certain aggregate annual sales in Canada and Israel of each of IMVEXXY and BIJUVA and royalties based on aggregate annual sales of each of IMVEXXY and BIJUVA in Canada and Israel. We may terminate the Knight License Agreement if Knight does not submit all regulatory applications, submissions and/or registrations required for regulatory approval to use and commercialize IMVEXXY and BIJUVA in Canada within certain specified time periods. We also may terminate the Knight License Agreement if Knight challenges our patents. Either party may terminate the Knight License Agreement for any material breach by the other party that is not cured within certain specified time periods or if the other party files for bankruptcy or other related matters. As part of the Knight License Agreement, Knight is prohibited from exporting IMVEXXY and BIJUVA to the United States.

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.

Inventory Obsolescence Reserve

We evaluate inventory quarterly and record an allowance for obsolescence primarily associated with materials that are not currently or likely to be used in production in the near future. As of September 30, 2020 and December 31, 2019, we recorded an inventory obsolescence reserve of $5,744,464 and $0, respectively. The reserve recorded as of September 30, 2020 was primarily related to BIJUVA and resulted from the impact of the COVID-19 pandemic on our business, which decreased demand for our products.

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 chaired 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.

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.

NOTE 4 – INVENTORY, NET

9 Months Ended

Sep. 30, 2020

Inventory Disclosure [Abstract]

NOTE 4 – INVENTORY, NET

NOTE 4 – INVENTORY, NET

Inventory, net consists of the following:

	September 30, 2020		December 31, 2019
Finished products	$	4,794,132	$	4,976,910
Work in process		440,149		1,182,059
Raw materials		4,698,023		5,701,747
TOTAL INVENTORY, NET	$	9,932,304	$	11,860,716

NOTE 5 – OTHER CURRENT ASSETS

9 Months Ended

Sep. 30, 2020

Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract]

NOTE 5 – OTHER CURRENT ASSETS

NOTE 5 – OTHER CURRENT ASSETS

Other current assets consist of the following:

	September 30, 2020		December 31, 2019
Prepaid sales and marketing costs	$	686,346	$	1,583,698
Debt financing fees on undrawn tranches (Note 9)		—		550,757
Prepaid insurance		3,599,906		1,812,135
Prepaid manufacturing		543,050		2,595,721
Other prepaid costs		3,989,937		4,787,482
TOTAL OTHER CURRENT ASSETS	$	8,819,239	$	11,329,793

NOTE 6 – FIXED ASSETS, NET

9 Months Ended

Sep. 30, 2020

Property, Plant and Equipment [Abstract]

NOTE 6 – FIXED ASSETS, NET

NOTE 6 – FIXED ASSETS, NET

Fixed assets, net consist of the following:

	September 30, 2020			December 31, 2019
Accounting system	$	301,096		$	301,096
Equipment		1,658,258			1,619,646
Furniture and fixtures		1,406,858			1,406,858
Computer hardware		80,211			80,211
Leasehold improvements		68,788			68,788
TOTAL FIXED ASSETS		3,515,211			3,476,599
Accumulated depreciation		(1,545,282	)		(968,824	)
TOTAL FIXED ASSETS, NET	$	1,969,929		$	2,507,775

Depreciation expense for the three months ended September 30, 2020 and 2019 was $188,810 and $90,700, respectively, and for the nine months ended September 30, 2020 and 2019 was $576,459 and $223,750, respectively.

NOTE 7 – INTANGIBLE ASSETS, NET

9 Months Ended

Sep. 30, 2020

Goodwill and Intangible Assets Disclosure [Abstract]

NOTE 7 – INTANGIBLE ASSETS, NET

NOTE 7 – INTANGIBLE ASSETS, NET

The following table sets forth the gross carrying amount, accumulated amortization and net carrying amount of our intangible assets as of September 30, 2020 and December 31, 2019:

	September 30, 2020
	Gross Carrying Amount		Accumulated Amortization			Net Amount		Weighted- Average Remaining Amortization Period (yrs.)
Amortizable intangible assets:
Approved hormone therapy drug candidate patents	$	4,108,745	$	(679,959	)	$	3,428,786		12.25
Hormone therapy drug candidate patents (pending)		1,760,923		—			1,760,923		n/a
Non-amortizable intangible assets:
Multiple trademarks		348,176		—			348,176		indefinite
TOTAL	$	6,217,844	$	(679,959	)	$	5,537,885

	December 31, 2019
	Gross Carrying Amount		Accumulated Amortization			Net Amount		Weighted- Average Remaining 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 years, which is the life of intellectual property patents. If the patent is not granted, we write-off any capitalized patent costs at that time. Trademarks are perpetual and are not amortized. During the nine months ended September 30, 2020 and 2019, we wrote off $584,509 and $78,864, respectively, in costs related to trademarks and patents.

As of September 30, 2020, we had 35 issued domestic patents and 35 issued foreign patents, including:

•

14 domestic patents and seven foreign patents that relate to BIJUVA as well as three domestic patents that relate to estradiol and progesterone product candidates. These patents establish an important intellectual property foundation and are owned by us. The domestic patents will expire in 2032. The foreign patents will expire no earlier than 2032. In addition, we have pending patent applications relating to BIJUVA in the U.S., Argentina, Australia, Brazil, Canada, China, Europe, Hong Kong, Israel, Japan, Mexico, New Zealand, Russia, South Africa, and South Korea.

•

Ten domestic patents (eight utility and two design) and 16 foreign patents (six utility and ten design) that relate to IMVEXXY. These patents establish an important intellectual property foundation for IMVEXXY and are owned by us. The domestic patents will expire in 2032 or 2033. The foreign utility patents will expire no earlier than 2033. The foreign design patents provide protection expiring no earlier than 2025. In certain countries, the foreign design patents provide protection through at least 2037. In addition, we have pending patent applications related to IMVEXXY in the U.S., Argentina, Australia, Brazil, Canada, Europe, Hong Kong, Israel, Japan, Mexico, New Zealand, Russia, South Africa, and South Korea.

•

One domestic utility patent that relates to our topical-cream candidates, which is owned by us. The domestic patent will expire in 2035.

•

One domestic utility patent and eight foreign patents that relate to our transdermal-patch candidates, which are owned by us. The domestic utility patent will expire in 2032. The foreign patents will expire no earlier than 2033. We have pending patent applications with respect to our transdermal-patch candidates in the U.S., Brazil, Canada, Mexico, and South Africa.

•

Three domestic utility patents that relate to TX-009HR, a progesterone and estradiol product candidate, which are owned by us and will expire in 2037.

•

Two domestic and four foreign patents that relate to formulations containing progesterone, which are owned by us. The domestic patents will expire between 2032 and 2036. The foreign patents will expire no earlier than 2033.

•

One domestic utility patent that relates to our OPERA information-technology platform, which is owned by us and will expire in 2031.

Amortization expense was $69,977 and $51,259 for the three months ended September 30, 2020 and 2019, respectively, and $200,879 and $140,206 for the nine months ended September 30, 2020 and 2019, respectively. Estimated amortization expense, based on current patent cost being amortized, for the next five years is as follows:

Year Ending December 31,		Estimated Amortization
	2020 (3 months)	$	69,977
	2021	$	279,909
	2022	$	279,909
	2023	$	279,909
	2024	$	279,909

NOTE 8– OTHER CURRENT LIABILITIES

9 Months Ended

Sep. 30, 2020

Payables and Accruals [Abstract]

NOTE 8– OTHER CURRENT LIABILITIES

NOTE 8– OTHER CURRENT LIABILITIES

Other current liabilities consist of the following:

	September 30, 2020		December 31, 2019
Accrued payroll, bonuses and commission costs	$	4,381,729	$	8,040,278
Allowance for coupons and returns		8,353,403		10,316,298
Accrued sales and marketing costs		1,578,971		3,285,662
Accrued compensated absences		2,558,055		1,463,878
Allowance for wholesale distributor fees		2,130,230		2,347,122
Accrued legal and accounting expense		1,052,935		422,336
Accrued research and development		1,059,077		1,049,603
Operating lease liability		2,404,286		1,501,539
Accrued rebates		6,629,732		3,916,672
Other accrued expenses		1,072,066		1,480,225
TOTAL OTHER CURRENT LIABILITIES	$	31,220,484	$	33,823,613

NOTE 9 – DEBT

9 Months Ended

Sep. 30, 2020

Debt Disclosure [Abstract]

NOTE 9 – DEBT

NOTE 9 – DEBT

On April 24, 2019, we entered into a Financing Agreement, as amended, or the Financing Agreement, with TPG Specialty Lending, Inc., as administrative agent, or the Administrative Agent, various lenders from time to time party thereto, and certain of our subsidiaries party thereto from time to time as guarantors, which provides us with up to a $300,000,000 first lien secured term loan credit facility, or the Facility. The Facility provides for availability to us in three tranches: (i) $200,000,000 was drawn upon entering into the Financing Agreement; (ii) $50,000,000 was drawn on February 18, 2020 following our achievement of more than $11,000,000 in net revenues from IMVEXXY, BIJUVA and ANNOVERA for the fourth quarter of 2019 and (iii) $50,000,000 was previously available to us in the Administrative Agent’s sole and absolute discretion either contemporaneously with the delivery of our financial statements for the quarter ended June 30, 2020 or at such earlier date as the Administrative Agent may have consented to. Due to the pause in the successful full launch of ANNOVERA caused by the COVID-19 pandemic, the undrawn $50,000,000 tranche under the Financing Agreement is no longer available. Borrowings under the Facility accrue interest at either (i) 3-month LIBOR plus 7.75%, subject to a LIBOR floor of 2.70% or (ii) the prime rate plus 6.75%, subject to a prime rate floor of 5.2% as selected by us. Interest on amounts borrowed under the Facility is payable quarterly. The outstanding principal amount of the Facility is payable in four equal quarterly installments beginning on June 30, 2023, with the Facility maturing on March 31, 2024. We have the right to prepay borrowings under the Facility in whole or in part at any time, subject to a prepayment fee on the principal amount being prepaid of (i) 30.0% for the first two years following the initial funding date of the applicable borrowing, (ii) 5.0% for the third year following the initial funding date of the applicable borrowing, (iii) 3.0% for the fourth year following the initial funding date of the applicable borrowing and (iv) 1.0% for the fifth year following the initial funding date of the applicable borrowing but prior to March 31, 2024. In connection with the initial borrowing under the Facility, we paid, for the benefit of the lenders, a facility fee equal to 2.5% of the initial amount borrowed and will be required to pay such a facility fee in connection with any subsequent borrowings under the Facility. We are also required to pay the Administrative Agent and the lenders an annual administrative fee in addition to other fees and expenses. The Financing Agreement contains customary mandatory prepayments, restrictions and covenants applicable to us that are customary for financings of this type. Among other requirements, we are required to (i) maintain a minimum unrestricted cash balance of $60,000,000, and (ii) achieve certain minimum consolidated net revenue amounts attributable to commercial sales of our IMVEXXY, BIJUVA and ANNOVERA products beginning with the fiscal quarter ending December 31, 2020. Pursuant to Amendment No. 6, the minimum required cash balance was lowered to $45 million through December 31, 2020. As of September 30, 2020, we were in compliance with all covenants under the Financing Agreement. The Financing Agreement also includes other representations, warranties, indemnities and events of default that are customary for financings of this type, including an event of default relating to a change of control of the Company. Upon or after an event of default, the Administrative Agent and the lenders may declare all or a portion of our obligations under the Financing Agreement to be immediately due and payable and exercise other rights and remedies provided for under the Financing Agreement. The obligations of our company and its subsidiaries under the Financing Agreement are secured, subject to customary permitted liens and other agreed upon exceptions, by a first priority perfected security interest in all existing and after acquired assets of our company and its subsidiaries. The obligations under the Financing Agreement will be guaranteed by each of our future direct and indirect subsidiaries, subject to certain exceptions.

On May 1, 2018, we entered into a Credit and Security Agreement, or the Credit Agreement, with MidCap Financial Trust, or MidCap, as agent, or Agent, and as lender, and the additional lenders party thereto from time to time (together with MidCap as a lender, the Lenders), as amended. The Credit Agreement provided a secured term loan facility in an aggregate principal amount of up to $200,000,000, or the Term Loan. Under the terms of the Credit Agreement, the Term Loan was available to be made in three separate tranches, with each tranche to be made available to us, at our option, upon our achievement of certain milestones. Amounts borrowed under the Term Loan bore interest at a rate equal to the sum of (i) one-month LIBOR (subject to a LIBOR floor of 1.50%) plus (ii) 7.75% per annum.

On April 24, 2019, we terminated the Credit Agreement. A portion of the initial tranche of borrowing under the Financing Agreement in the amount of approximately $81,661,000 was used to repay all amounts outstanding under the Credit Agreement, which included a prepayment fee of 4%, a repayment fee of 4% and other fees and expenses payable to the lenders under the Credit Agreement. As a result of the termination of the Credit Agreement, we recorded $10,057,632 in loss on extinguishment of debt in the second quarter of 2019. Interest expense for the nine months ending September 30, 2019 related to the Credit Agreement was $1,816,747. During the nine months ended September 30, 2019, and prior to the repayment of the Credit Agreement, we amortized $120,146 of deferred financing fees as interest expense in the accompanying unaudited consolidated financial statements.

On August 5, 2020, we entered into Amendment No. 5 to the Financing Agreement, or Amendment No. 5. Amendment No. 5 adjusts 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 is 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 shares of Common Stock with an exercise price of $1.58 per share and a ten-year term, or the Lender Warrants. The Lender Warrants were issued pursuant to an exemption from registration under the Securities Act of 1933, as amended, and no registration rights were issued. The Company concluded that the modification accounting model is applicable to this transaction and recognized the fair value of the warrants as a debt discount.

As of September 30, 2020, we had $250,000,000 in borrowings outstanding under the Financing Agreement, which are classified as long-term debt in the accompanying consolidated financial statements. We incurred $7,902,270 in deferred financing fees related to the Financing Agreement. Deferred financing fees related to the entire Financing Agreement have been allocated pro rata between the funded and unfunded tranches. Allocated deferred financing fees related to the two tranches of borrowings that we received of $7,626,891 have been reflected as a debt discount upon each draw and are amortized to interest expense using the effective interest method. In addition, during the three months ended September 30, 2020, we recorded the fair value of the Lender Warrants of $7,428,179 as a debt discount, which is being amortized to interest expense using the effective interest method over the term of the Financing Agreement. During the three months ended September 30, 2020, we concluded that the undrawn $50,000,000 tranche under the Financing Agreement is no longer available to us. As such, we wrote off $275,379 of deferred financing fees associated with the unfunded tranche, which were previously deferred as assets until such tranche had been drawn.

During the three and nine months ended September 30, 2020, we amortized $677,676 and $1,370,118, respectively, of deferred financing fees related to the Financing Agreement as interest expense in the accompanying consolidated financial statements. During the three and nine months ended September 30, 2019, we amortized $265,949 and $462,683, respectively, of deferred financing fees related to the Financing Agreement as interest expense in the accompanying consolidated financial statements. Interest on amounts borrowed under the Financing Agreement is due and payable quarterly in arrears. Interest expense for the three and nine months ended September 30, 2020 was $6,726,389 and $19,322,847, respectively. Interest expense for the three and nine months ended September 30, 2019 was $5,333,056 and $9,318,056, respectively. The overall effective interest rate under the Financing Agreement was approximately 12.5% as of September 30, 2020.

As of September 30, 2020 and December 31, 2019, the carrying value of our debt consisted of the following:

	September 30, 2020			December 31, 2019
Financing Agreement	$	250,000,000		$	200,000,000
Debt discount and financing fees		(12,948,798	)		(5,365,357	)
TOTAL LONG-TERM DEBT	$	237,051,202		$	194,634,643

On April 27, 2020, we received a loan pursuant to the Paycheck Protection Program under the Coronavirus Aid, Relief, and Economic Security Act (the “CARES Act”), as administered by the U.S. Small Business Administration. The loan in the principal amount of $6,477,094 (the “PPP Loan”) was disbursed by Bank of America, NA, a national banking association, pursuant to a promissory note issued by the Company. Although we believed, in good faith, we were qualified for the PPP Loan under the available regulations, as a result of newly-issued guidance, particularly with respect to publicly traded companies receiving funding under the CARES Act, we voluntarily returned the PPP Loan proceeds on May 14, 2020.

NOTE 10 – NET LOSS PER SHARE

9 Months Ended

Sep. 30, 2020

Loss per share, basic and diluted:

NOTE 10 – NET LOSS PER SHARE

NOTE 10 – NET LOSS PER SHARE

We calculate earnings per share, or EPS, in accordance with ASC 260, Earnings Per Share, which requires the computation and disclosure of two EPS amounts: basic and diluted. We compute basic EPS based on the weighted-average number of shares of Common Stock outstanding during the period. We compute diluted EPS based on the weighted-average number of shares of our Common Stock outstanding plus all potentially dilutive shares of our Common Stock outstanding during the period. Such potentially dilutive shares of our Common Stock consist of options, warrants and restricted stock units and were excluded from the calculation of diluted earnings per share because their effect would have been anti-dilutive due to the net loss reported by us. The table below presents potentially dilutive securities that could affect our calculation of diluted net loss per share allocable to common stockholders for the periods presented.

	September 30, 2020		September 30, 2019
Stock options		23,893,180		24,849,984
Warrants		6,534,687		1,832,571
Performance stock units		2,422,885		—
Restricted stock units		6,029,957		1,240,000
		38,880,709		27,922,555

NOTE 11 – STOCKHOLDERS’ EQUITY

9 Months Ended

Sep. 30, 2020

Equity [Abstract]

NOTE 11 – STOCKHOLDERS’ EQUITY

NOTE 11 – STOCKHOLDERS’ EQUITY

Preferred Stock

At September 30, 2020, we had 10,000,000 shares of preferred stock, par value $0.001 per share, authorized for issuance, of which no shares were issued or outstanding.

Common Stock

At September 30, 2020, we had 600,000,000 shares of Common Stock authorized for issuance, of which 272,812,271 shares of Common Stock were issued and outstanding.

Issuances During the Three and Nine Months ended September 30, 2020

During the three months ended September 30, 2020, stock options to purchase an aggregate of 517,891 shares of Common Stock were exercised for $105,494 in cash. During the nine months ended September 30, 2020, stock options to purchase an aggregate of 1,182,195 shares of Common Stock were exercised for $271,678 in cash.

Issuances During the Three and Nine Months ended September 30, 2019

During the three months ended September 30, 2019, certain individuals exercised stock options to purchase an aggregate of 55,236 shares of Common Stock for $8,549 in cash. During the nine months ended September 30, 2019, certain individuals exercised stock options to purchase an aggregate of 331,619 shares of Common Stock for $108,656 in cash. Also, during the same period, stock options to purchase an aggregate of 12,097 shares of Common Stock were exercised pursuant to the options’ cashless exercise provisions, wherein an aggregate of 11,834 shares of Common Stock were issued.

Warrants to Purchase Common Stock

As of September 30, 2020, we had warrants outstanding to purchase an aggregate of 6,534,687 shares of Common Stock with a weighted-average contractual remaining life of approximately 7.5 years, and exercise prices ranging from $0.24 to $8.20 per share, resulting in a weighted average exercise price of $1.83 per share.

The valuation methodology used to determine the fair value of our warrants is the Black-Scholes Model. The Black-Scholes Model requires the use of a number of assumptions, including volatility of the stock price, the risk-free interest rate, dividend 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, volatility of 68.8%, risk-free interest rate of 0.34% and dividend yield of 0%. The grant date fair value of the warrants was $1.56 per share. The warrants vested upon issuance. We concluded that the modification accounting model is applicable to this warrant issuance and recognized the fair value of the warrants as a debt discount. As a result, the fair value of the Lender Warrants is being amortized to interest expense over the term of the Financing Agreement.

We recorded share-based compensation expense related to warrants previously issued of $0 and $56,418 for the three months ended September 30, 2020 and 2019, respectively, and $26,446 and $198,306 for the nine months ended September 30, 2020 and 2019, respectively, in the accompanying consolidated financial statements. At September 30, 2020, there was no unrecognized compensation expense remaining related to unvested warrants.

During the nine months ended September 30, 2019, we granted warrants to purchase an aggregate of 75,000 shares of Common Stock to outside consultants at an exercise price of $5.63. The fair value for these warrants was determined by using the Black-Scholes Model on the date of the grant using a term of five years, volatility of 60.8%, risk-free interest rate of 2.52%, and dividend yield of 0%. The grant date fair value of the warrants was $3.00 per share. The warrants are vesting ratably over a 12-month period and have an expiration date of February 12, 2024.

During the nine months ended September 30, 2020, no warrants were exercised. During the nine months ended September 30, 2019, warrants to purchase an aggregate of 1,250,000 shares of Common Stock were exercised pursuant to the warrants’ cashless exercise provisions, wherein an aggregate of 471,184 shares of Common Stock were issued.

Options to Purchase Common Stock

In 2009, we adopted the 2009 Long Term Incentive Compensation Plan, or the 2009 Plan, to provide financial incentives to employees, directors, advisers, and consultants of our company who are able to contribute towards the creation of or who have created stockholder value by providing them stock options and other stock and cash incentives, or the Awards. As of September 30, 2020, there were non-qualified stock options to purchase an aggregate of 13,346,455 shares of Common Stock outstanding under the 2009 Plan. Effective upon our adoption of the TherapeuticsMD, Inc. 2019 Stock Incentive Plan, or the 2019 Plan, on June 20, 2019, no future awards may be made under the 2009 Plan.

In 2012, we adopted the 2012 Stock Incentive Plan, or the 2012 Plan, a non-qualified plan that was amended in August 2013. The 2012 Plan was designed to serve as an incentive for retaining qualified and competent key employees, officers, directors, and certain consultants and advisors of our company. As of September 30, 2020, there were non-qualified stock options to purchase an aggregate of 6,305,974 shares of Common Stock outstanding and an aggregate of 890,000 restricted stock units under the 2012 Plan. Effective upon our adoption of the 2019 Plan, no future awards may be made under the 2012 Plan.

On June 20, 2019, we adopted the 2019 Plan to serve as an incentive for retaining qualified and competent key employees, officers, directors, and certain consultants and advisors of our company. The Awards available under the 2019 Plan consist of stock options, stock appreciation rights, restricted stock, restricted stock units, performance stock, performance units, and other stock or cash awards as described in the 2019 Plan. Generally, the options vest annually over four years or as determined by our board of directors, upon each option grant. Options may be exercised by paying the price for shares or on a cashless exercise basis after they have vested and prior to the specified expiration date provided and applicable exercise conditions are met, if any. The expiration date is generally ten years from the date the option is issued.

As of September 30, 2020, there were 3,465,514 shares of Common Stock available for issuance under the 2019 Plan, consisting of (i) 470,522 new shares, (ii) 2,405,833 unallocated shares previously available for issuance under the 2012 Plan that were not then subject to outstanding “Awards” (as defined in the 2012 Plan), and (iii) 589,159 unallocated shares previously available for issuance under the 2009 Plan that were not then subject to outstanding “Awards” (as defined in the 2009 Plan). Any shares subject to outstanding options or other equity “Awards” under the 2019 Plan, the 2012 Plan and the 2009 Plan that are forfeited, expire or otherwise terminate without issuance of the underlying shares, or if any such Award is settled for cash or otherwise does not result in the issuance of all or a portion of the shares subject to such Award (other than shares tendered or withheld in connection with the exercise of an Award or the satisfaction of withholding tax liabilities), the shares to which those Awards were subject, shall, to the extent of such forfeiture, expiration, termination, cash settlement or non-issuance, again be available for delivery with respect to Awards under the 2019 Plan. As of September 30, 2020, there were non-qualified stock options to purchase an aggregate of 4,240,751 shares of Common Stock outstanding under the 2019 Plan and an aggregate of 5,139,957 restricted stock units and 2,422,885 performance stock units outstanding under the 2019 Plan.

The valuation methodology used to determine the fair value of stock options is the Black-Scholes Model. The Black-Scholes Model requires the use of a number of assumptions including volatility of the stock price, the risk-free interest rate, and the expected life of the stock options. The ranges of assumptions used in the Black-Scholes Model during the nine months ended September 30, 2020 and 2019 are set forth in the table below.

	September 30, 2020		September 30, 2019
Weighted average grant date fair value	$	0.95	$	1.84
Risk-free interest rate		0.34-1.68%		1.83-2.54%
Volatility		63.53-67.92%		61.25-64.49%
Term (in years)		6-6.8		5.5-6.5
Dividend yield		0.00%		0.00%

A summary of option activity under the 2009, 2012 and 2019 Plans and related information during the nine months ended September 30, 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		(361,109	)	$	3.66
Cancelled/Forfeited		(330,250	)	$	3.69
Balance at September 30, 2020		23,893,180		$	4.80		5.46	$	379,535
Vested and Exercisable at September 30, 2020		19,827,306		$	5.06		4.83	$	218,370
Unvested at September 30, 2020		4,065,874		$	3.55		8.53	$	161,165

At September 30, 2020, our outstanding options had exercise prices ranging from $0.38 to $8.92 per share. Share-based compensation expense related to options recognized in our results of operations for the three months ended September 30, 2020 and 2019 was $1,143,920 and $2,194,667, respectively, and for the nine months ended September 30, 2020 and 2019 was $4,141,061 and $6,568,736, respectively, and it is based on awards vested. At September 30, 2020, total unrecognized estimated compensation expense related to unvested options was approximately $6,500,000, which may be adjusted for future changes in forfeitures. This cost is expected to be recognized over a weighted-average period of 2.0 years. No tax benefit was realized due to a continued pattern of operating losses.

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 three and nine months ended September 30, 2020 we recorded $1,988,844 and $4,334,537, respectively, and during the three and nine months ended September 30, 2019 we recorded $84,061 and $1,080,738, respectively, in share-based compensation expense related to restricted stock units and performance stock units. As of September 30, 2020, we recognized performance-based compensation expense using our assessment of the most likely probability of attaining EBITDA break-even which would result in vesting two times the base number of performance stock units. At September 30, 2020, total unrecognized estimated compensation expense related to unvested restricted stock units and performance stock units was approximately $11,000,000, which may be adjusted if certain performance targets are achieved or for future changes in forfeitures. This cost is expected to be recognized over a weighted-average period of 1.6 years.

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		5,102,817		$	1.40		2,585,745		$	1.08
Vested/Released		(301,500	)	$	1.78		(151,500	)	$	1.14
Forfeited		(11,360	)	$	1.07		(11,360	)	$	1.07
Balance at September 30, 2020		6,029,957		$	1.83		2,422,885	^*	$	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 (the “ESPP”), which reserved 5,400,000 shares of Common Stock for purchase. The ESPP permits eligible employee participants to purchase Common Stock at a price per share which is equal to 85% of the lesser of (a) the fair market value of the shares on the offering date of the offering period or (b) the fair market value of the shares on the purchase date.

NOTE 12 – INCOME TAXES

9 Months Ended

Sep. 30, 2020

Income Tax Disclosure [Abstract]

NOTE 12 – INCOME TAXES

NOTE 12 – INCOME TAXES

Deferred income tax assets and liabilities are determined based upon differences between the financial reporting and tax basis of assets and liabilities and are measured using the enacted tax rates and laws that will be in effect when the differences are expected to reverse. We do not expect to pay any significant federal or state income tax for 2020 as a result of (i) the losses recorded during the nine months ended September 30, 2020, (ii) additional losses expected for the remainder of 2020, and/or (iii) net operating loss carry forwards from prior years. Accounting standards require the consideration of a valuation allowance for deferred tax assets if it is “more likely than not” that some component or all of the benefits of deferred tax assets will not be realized. As of September 30, 2020, we maintain a full valuation allowance for all deferred tax assets. Based on these requirements, no provision or benefit for income taxes has been recorded. There were no recorded unrecognized tax benefits at the end of the reporting period.

- Definition

The entire disclosure for income taxes. Disclosures may include net deferred tax liability or asset recognized in an enterprise's statement of financial position, net change during the year in the total valuation allowance, approximate tax effect of each type of temporary difference and carryforward that gives rise to a significant portion of deferred tax liabilities and deferred tax assets, utilization of a tax carryback, and tax uncertainties information.

+ References + Details

NOTE 13 – RELATED PARTIES

9 Months Ended

Sep. 30, 2020

NOTE 13 – RELATED PARTIES

NOTE 13 – RELATED PARTIES

In July 2015, J. Martin Carroll, a director of our company, was appointed to the board of directors of Catalent, Inc. From time to time, we have entered into agreements with Catalent, Inc. and its affiliates, or Catalent, in the normal course of business. Agreements with Catalent have been reviewed by independent directors of our Company, or a committee consisting of independent directors of our company, since July 2015. During the three months ended September 30, 2020 and 2019, we were billed by Catalent approximately $520,000 and $2,196,000, respectively, for manufacturing activities related to our clinical trials, scale-up, registration batches, stability and validation testing. During the nine months ended September 30, 2020 and 2019, we were billed by Catalent approximately $2,563,000 and $4,118,000, respectively, for manufacturing activities related to our clinical trials, scale-up, registration batches, stability and validation testing. As of September 30, 2020 and December 31, 2019, there were amounts due to Catalent of approximately $147,000 and $35,000, respectively. In addition, we have minimum purchase requirements in place with Catalent as disclosed in Note 15, Commitments and Contingencies.

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 three and nine months ended September 30, 2020, we were billed by AIG approximately $52,000 and $195,000, respectively, for various insurance coverage for our Company.

NOTE 14 - BUSINESS CONCENTRATIONS

9 Months Ended

Sep. 30, 2020

Risks and Uncertainties [Abstract]

NOTE 14 - BUSINESS CONCENTRATIONS

NOTE 14 - BUSINESS CONCENTRATIONS

We purchase our prescription products from several suppliers with approximately 42%, 25% and 24% of our purchases supplied by three vendors each, respectively, during the nine months ended September 30, 2020, and 36%, 28%, and 26% of our purchases supplied by three vendors each, respectively, during the nine months ended September 30, 2019.

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 nine months ended September 30, 2020, three customers each accounted for more than 10% of our total product revenues. Product revenue from the three customers combined accounted for approximately 56% of our product revenue for the nine months ended September 30, 2020. During the nine months ended September 30, 2019, four customers each generated more than 10% of our product revenues. Revenue generated from the four customers combined accounted for approximately 68% of our product revenue for the nine months ended September 30, 2019.

During the nine months ended September 30, 2020, Pillpack, Inc. accounted for approximately $9,319,000 of our product revenue, Cardinal Health accounted for approximately $7,415,000 of our product revenue, and McKesson Corporation accounted for approximately $6,009,000 of our product revenue. During the nine months ended September 30, 2019, Pillpack, Inc. accounted for approximately $6,397,000 of our product revenue, AmerisourceBergen accounted for approximately $2,226,000 of our product revenue, PI Services accounted for approximately $1,935,000 of our product revenue and Cardinal Health accounted for approximately $1,863,000 of our product revenue.

NOTE 15 – COMMITMENTS AND CONTINGENCIES

9 Months Ended

Sep. 30, 2020

Commitments and Contingencies Disclosure [Abstract]

NOTE 15 – COMMITMENTS AND CONTINGENCIES

NOTE 15 – 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-month term. On February 18, 2015, we entered into an agreement with the same lessors to lease additional administrative office space in the same location, pursuant to an addendum to such lease. In addition, on April 26, 2016, we entered into an agreement with the same lessors to lease additional administrative office space in the same location. This agreement was effective beginning May 1, 2016 and extended the original expiration of the lease term to October 31, 2021. On October 4, 2016, we entered into an agreement with the same lessors to lease additional administrative office space in the same location, pursuant to an addendum to such lease. This addendum became effective beginning November 1, 2016.

In October 2018, we entered into a lease for new corporate offices in Boca Raton, Florida. The lease includes 56,212 rentable square feet, or the full premises, of which the lease on 7,561 square feet commenced in 2018 and the lease on the remaining 48,651 square feet commenced in August 2019, or the full premises commencement date. The lease will expire 11 years after the full premises commencement date, unless terminated earlier in accordance with the terms of the lease. We have the option to extend the term of the lease for two additional consecutive periods of five years. The extension option is not included in the determination of the lease term as it is not reasonably certain to be exercised. The term of the lease includes escalating rent and free rent periods. We are also responsible for certain other operating costs under the lease, including electricity and utility expenses. In June 2019, we entered into an agreement with the same lessors to lease additional 6,536 square feet of administrative office space in the same location, pursuant to an addendum to such lease, which commenced in May 2020.

Supplemental lease information:	September 30, 2020		December 31, 2019
Right-of-use asset	$	9,975,725	$	10,109,154
Short-term operating lease liability (included in Other current liabilities)	$	2,404,286	$	1,501,539
Long-term operating lease liability	$	8,907,995	$	9,145,049
Weighted average remaining term		8.8 years		9 years
Weighted average discount rate		8.3%		8.25%

Supplemental cash flow information for the nine months ended	September 30, 2020		September 30, 2019
Cash paid for amounts included in the measurement of lease liabilities for operating lease	$	1,006,970	$	849,440
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 September 30, 2020 to the operating lease liabilities recorded on the balance sheet:

Years Ended December 31,
2020 (3 months)	$	610,675
2021		2,334,582
2022		1,413,289
2023		1,443,143
2024		1,476,534
Thereafter		8,947,869
Total undiscounted lease payments		16,226,092
Less: imputed interest		(4,913,811	)
Present value of lease payments	$	11,312,281

During the three and nine months ended September 30, 2020, operating lease expense related to our real estate leases was approximately $590,000 and $1,749,000, respectively, and variable lease expense was approximately $148,000 and $226,000, respectively, for the same periods. During the three and nine months ended September 30, 2019, operating lease expense related to our real estate leases was approximately $458,000 and $1,062,000, respectively, and variable lease expense was insignificant for the same periods.

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 product revenue as described in Note 7, Intangible Assets, to these consolidated financial statements.

Purchase Commitments

We have manufacturing and supply agreements whereby we are required to purchase from Catalent a minimum number of softgels during the first contract year and a higher number of softgels after the first contract year. If the minimum order quantities of specific products are not met, we are required to pay Catalent 50% of the difference between the total amount we would have paid to Catalent if the minimum requirement had been fulfilled and the sum of all purchases of our products from Catalent during the contract year. The updated minimum purchase commitments for Catalent for the next five years are as follows: 2020 - $3,719,000, 2021 - $2,150,000, 2022 - $2,991,000, 2023 - $3,347,000, and 2024 - $3,786,000. In addition, we have a manufacturing and supply agreement whereby we are required to purchase a minimum number of units of ANNOVERA during a contract year. As of September 30, 2020, we have met our contract year purchase commitments.

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 September 30, 2020 and 2019, 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.

NOTE 16 – SUBSEQUENT EVENTS

9 Months Ended

Sep. 30, 2020

Subsequent Events [Abstract]

NOTE 16 – SUBSEQUENT EVENTS

NOTE 16 – SUBSEQUENT EVENTS

On November 8, 2020, we entered into Amendment No. 6 which temporarily lowered the minimum required cash balance under the Financing Agreement from $60 million to $45 million through December 31, 2020. After December 31, 2020, the minimum required cash balance will revert to $60 million. On November 8, 2020, in connection with entering into Amendment No. 6 to the Financing Agreement, 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.

NOTE 3 – SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies)

9 Months Ended

Sep. 30, 2020

Accounting Policies [Abstract]

Trade Accounts Receivable and Allowance for Doubtful Accounts

Fair Value of Financial Instruments

Level 1

unadjusted quoted prices in active markets for identical assets or liabilities;

Level 2

Level 3

unobservable inputs for the assets or liabilities.

At September 30, 2020 and 2019, we had no assets or liabilities that were valued at fair value on a recurring basis.

Share-Based Compensation

Revenue Recognition

Prescription Products

License Revenue

Disaggregation of revenue

The following table provides information about disaggregated revenue by product mix for the three and nine months ended September 30, 2020 and 2019:

	Three Months Ended September 30,				Nine Months Ended September 30,
	2020		2019		2020		2019
Prescription vitamins	$	2,435,903	$	2,550,330	$	7,337,976	$	7,309,174
IMVEXXY		6,841,592		4,772,354		18,319,382		9,904,744
BIJUVA		1,646,320		490,705		4,109,925		624,987
ANNOVERA		6,418,990		399,952		10,527,212		399,952
License revenue		2,000,000		15,506,400		2,000,000		15,506,400
Net revenue	$	19,342,805	$	23,719,741	$	42,294,495	$	33,745,257

License Agreement with the Population Council

License Agreement with Knight

Cost of Sales

Inventory Obsolescence Reserve

Segment Reporting

Research and Development Expenses

NOTE 3 – SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Tables)

9 Months Ended

Sep. 30, 2020

Accounting Policies [Abstract]

The following table provides information about disaggregated revenue by product mix

The following table provides information about disaggregated revenue by product mix for the three and nine months ended September 30, 2020 and 2019:

	Three Months Ended September 30,				Nine Months Ended September 30,
	2020		2019		2020		2019
Prescription vitamins	$	2,435,903	$	2,550,330	$	7,337,976	$	7,309,174
IMVEXXY		6,841,592		4,772,354		18,319,382		9,904,744
BIJUVA		1,646,320		490,705		4,109,925		624,987
ANNOVERA		6,418,990		399,952		10,527,212		399,952
License revenue		2,000,000		15,506,400		2,000,000		15,506,400
Net revenue	$	19,342,805	$	23,719,741	$	42,294,495	$	33,745,257

NOTE 4 – INVENTORY, NET (Tables)

9 Months Ended

Sep. 30, 2020

Inventory Disclosure [Abstract]

Inventory, net consists of the following:

	September 30, 2020		December 31, 2019
Finished products	$	4,794,132	$	4,976,910
Work in process		440,149		1,182,059
Raw materials		4,698,023		5,701,747
TOTAL INVENTORY, NET	$	9,932,304	$	11,860,716

NOTE 5 – OTHER CURRENT ASSETS (Tables)

9 Months Ended

Sep. 30, 2020

Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract]

Other current assets consist of the following:

	September 30, 2020		December 31, 2019
Prepaid sales and marketing costs	$	686,346	$	1,583,698
Debt financing fees on undrawn tranches (Note 9)		—		550,757
Prepaid insurance		3,599,906		1,812,135
Prepaid manufacturing		543,050		2,595,721
Other prepaid costs		3,989,937		4,787,482
TOTAL OTHER CURRENT ASSETS	$	8,819,239	$	11,329,793

NOTE 6 – FIXED ASSETS, NET (Tables)

9 Months Ended

Sep. 30, 2020

Property, Plant and Equipment [Abstract]

Fixed assets, net consist of the following:

	September 30, 2020			December 31, 2019
Accounting system	$	301,096		$	301,096
Equipment		1,658,258			1,619,646
Furniture and fixtures		1,406,858			1,406,858
Computer hardware		80,211			80,211
Leasehold improvements		68,788			68,788
TOTAL FIXED ASSETS		3,515,211			3,476,599
Accumulated depreciation		(1,545,282	)		(968,824	)
TOTAL FIXED ASSETS, NET	$	1,969,929		$	2,507,775

NOTE 7 – INTANGIBLE ASSETS, NET (Tables)

9 Months Ended

Sep. 30, 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 September 30, 2020 and December 31, 2019:

	September 30, 2020
	Gross Carrying Amount		Accumulated Amortization			Net Amount		Weighted- Average Remaining Amortization Period (yrs.)
Amortizable intangible assets:
Approved hormone therapy drug candidate patents	$	4,108,745	$	(679,959	)	$	3,428,786		12.25
Hormone therapy drug candidate patents (pending)		1,760,923		—			1,760,923		n/a
Non-amortizable intangible assets:
Multiple trademarks		348,176		—			348,176		indefinite
TOTAL	$	6,217,844	$	(679,959	)	$	5,537,885

	December 31, 2019
	Gross Carrying Amount		Accumulated Amortization			Net Amount		Weighted- Average Remaining 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:

Year Ending December 31,		Estimated Amortization
	2020 (3 months)	$	69,977
	2021	$	279,909
	2022	$	279,909
	2023	$	279,909
	2024	$	279,909

NOTE 8– OTHER CURRENT LIABILITIES (Tables)

9 Months Ended

Sep. 30, 2020

Payables and Accruals [Abstract]

Other current liabilities consist of the following:

	September 30, 2020		December 31, 2019
Accrued payroll, bonuses and commission costs	$	4,381,729	$	8,040,278
Allowance for coupons and returns		8,353,403		10,316,298
Accrued sales and marketing costs		1,578,971		3,285,662
Accrued compensated absences		2,558,055		1,463,878
Allowance for wholesale distributor fees		2,130,230		2,347,122
Accrued legal and accounting expense		1,052,935		422,336
Accrued research and development		1,059,077		1,049,603
Operating lease liability		2,404,286		1,501,539
Accrued rebates		6,629,732		3,916,672
Other accrued expenses		1,072,066		1,480,225
TOTAL OTHER CURRENT LIABILITIES	$	31,220,484	$	33,823,613

NOTE 9 – DEBT (Tables)

9 Months Ended

Sep. 30, 2020

Debt Disclosure [Abstract]

As of September 30, 2020 and December 31, 2019, the carrying value of our debt consisted of the following:

	September 30, 2020			December 31, 2019
Financing Agreement	$	250,000,000		$	200,000,000
Debt discount and financing fees		(12,948,798	)		(5,365,357	)
TOTAL LONG-TERM DEBT	$	237,051,202		$	194,634,643

NOTE 10 – NET LOSS PER SHARE (Tables)

9 Months Ended

Sep. 30, 2020

Loss per share, basic and diluted:

Schedule of calculation of diluted net loss per share allocable to common stockholders

	September 30, 2020		September 30, 2019
Stock options		23,893,180		24,849,984
Warrants		6,534,687		1,832,571
Performance stock units		2,422,885		—
Restricted stock units		6,029,957		1,240,000
		38,880,709		27,922,555

NOTE 11 – STOCKHOLDERS’ EQUITY (Tables)

9 Months Ended

Sep. 30, 2020

Equity [Abstract]

The ranges of assumptions used in the Black-Scholes Model during the nine months ended September 30, 2020 and 2019 are set forth in the table below.

	September 30, 2020		September 30, 2019
Weighted average grant date fair value	$	0.95	$	1.84
Risk-free interest rate		0.34-1.68%		1.83-2.54%
Volatility		63.53-67.92%		61.25-64.49%
Term (in years)		6-6.8		5.5-6.5
Dividend yield		0.00%		0.00%

A summary of option activity under the 2009, 2012 and 2019 Plans and related information during the nine months ended September 30, 2020 is as follows

A summary of option activity under the 2009, 2012 and 2019 Plans and related information during the nine months ended September 30, 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		(361,109	)	$	3.66
Cancelled/Forfeited		(330,250	)	$	3.69
Balance at September 30, 2020		23,893,180		$	4.80		5.46	$	379,535
Vested and Exercisable at September 30, 2020		19,827,306		$	5.06		4.83	$	218,370
Unvested at September 30, 2020		4,065,874		$	3.55		8.53	$	161,165

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		5,102,817		$	1.40		2,585,745		$	1.08
Vested/Released		(301,500	)	$	1.78		(151,500	)	$	1.14
Forfeited		(11,360	)	$	1.07		(11,360	)	$	1.07
Balance at September 30, 2020		6,029,957		$	1.83		2,422,885	^*	$	1.08

NOTE 15 – COMMITMENTS AND CONTINGENCIES (Tables)

9 Months Ended

Sep. 30, 2020

Commitments and Contingencies Disclosure [Abstract]

Supplemental lease information

Supplemental lease information:	September 30, 2020		December 31, 2019
Right-of-use asset	$	9,975,725	$	10,109,154
Short-term operating lease liability (included in Other current liabilities)	$	2,404,286	$	1,501,539
Long-term operating lease liability	$	8,907,995	$	9,145,049
Weighted average remaining term		8.8 years		9 years
Weighted average discount rate		8.3%		8.25%

Supplemental cash flow information for the nine months ended	September 30, 2020		September 30, 2019
Cash paid for amounts included in the measurement of lease liabilities for operating lease	$	1,006,970	$	849,440
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 September 30, 2020 to the operating lease liabilities recorded on the balance sheet:

Years Ended December 31,
2020 (3 months)	$	610,675
2021		2,334,582
2022		1,413,289
2023		1,443,143
2024		1,476,534
Thereafter		8,947,869
Total undiscounted lease payments		16,226,092
Less: imputed interest		(4,913,811	)
Present value of lease payments	$	11,312,281

NOTE 1 – THE COMPANY (Details Narrative)	Sep. 30, 2020 Number
Organization, Consolidation and Presentation of Financial Statements [Abstract]
Number of subsidiaries	3

NOTE 2 – BASIS OF PRESENTATION AND RECENTLY ISSUED ACCOUNTING PRONOUNCEMENTS (Details Narrative) - Subsequent Event [Member] - USD ($)	Nov. 09, 2020	Nov. 08, 2020
Financing Agreement [Member]
Debt Instrument [Line Items]
Minimum cash balance required under credit agreement	$ 60,000,000
Financing Agreement Amendment No. 6 [Member]
Debt Instrument [Line Items]
Minimum cash balance requirement under credit agreement before adjustment		$ 60,000,000
Financing Agreement Amendment No. 6 - Through December 31, 2020 [Member]
Debt Instrument [Line Items]
Minimum cash balance required under credit agreement		45,000,000
Financing Agreement Amendment No. 6 - After December 31, 2020 [Member]
Debt Instrument [Line Items]
Minimum cash balance required under credit agreement		$ 60,000,000

The following table provides information about disaggregated revenue by product mix (Details) - USD ($)	3 Months Ended		9 Months Ended
	Sep. 30, 2020	Sep. 30, 2019	Sep. 30, 2020	Sep. 30, 2019
Product Information [Line Items]
Net revenue	$ 19,342,805	$ 23,719,741	$ 42,294,495	$ 33,745,257
Prescription Vitamins [Member]
Product Information [Line Items]
Net revenue	2,435,903	2,550,330	7,337,976	7,309,174
Imvexxy [Member]
Product Information [Line Items]
Net revenue	6,841,592	4,772,354	18,319,382	9,904,744
BIJUVA [Member]
Product Information [Line Items]
Net revenue	1,646,320	490,705	4,109,925	624,987
ANNOVERA [Member]
Product Information [Line Items]
Net revenue	6,418,990	399,952	10,527,212	399,952
License [Member]
Product Information [Line Items]
Net revenue	$ 2,000,000	$ 15,506,400	$ 2,000,000	$ 15,506,400

- Definition

Amount, excluding tax collected from customer, of revenue from satisfaction of performance obligation by transferring promised good or service to customer. Tax collected from customer is tax assessed by governmental authority that is both imposed on and concurrent with specific revenue-producing transaction, including, but not limited to, sales, use, value added and excise.

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
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Reference 2: http://www.xbrl.org/2003/role/disclosureRef
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Reference 3: http://www.xbrl.org/2003/role/disclosureRef
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Reference 9: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 280
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-URI http://asc.fasb.org/extlink&oid=120311839&loc=d3e9054-108599

Reference 10: http://www.xbrl.org/2003/role/disclosureRef
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-Name Accounting Standards Codification
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-URI http://asc.fasb.org/extlink&oid=121604090&loc=SL49130545-203045

Reference 11: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 924
-SubTopic 10
-Section S99
-Paragraph 1
-Subparagraph (SAB Topic 11.L)
-URI http://asc.fasb.org/extlink&oid=6472922&loc=d3e499488-122856

+ Details

NOTE 3 – SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details Narrative) - USD ($)	3 Months Ended		9 Months Ended
	Sep. 30, 2020	Sep. 30, 2019	Sep. 30, 2020	Sep. 30, 2019	Dec. 31, 2019
Property, Plant and Equipment [Line Items]
Impairment of intangible assets			$ 584,509	$ 78,864
Amortization of intellectual property license fee	$ 762,389	$ 15,998	2,262,002	15,998
Inventory valuation reserves	5,744,464		$ 5,744,464		$ 0
Council License Agreement [Member]
Property, Plant and Equipment [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
Property, Plant and Equipment [Line Items]
Royalty (percent)			5.00%
Council License Agreement Step 2
Property, Plant and Equipment [Line Items]
Royalty (percent)			10.00%
Council License Agreement Step 3
Property, Plant and Equipment [Line Items]
Royalty (percent)			15.00%
Vitamins and IMVEXXY [Member]
Property, Plant and Equipment [Line Items]
Shelf life of prescription products following product expiration			24 months
BIJUVA and ANNOVERA [Member]
Property, Plant and Equipment [Line Items]
Shelf life of prescription products following product expiration			18 months
BIJUVA and ANNOVERA [Member] \| Knight License Agreement [Member]
Property, Plant and Equipment [Line Items]
Milestone payment received upon regulatory approval	$ 2,000,000
ANNOVERA [Member] \| Council License Agreement [Member]
Property, Plant and Equipment [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
Minimum [Member]
Property, Plant and Equipment [Line Items]
Return period of unsalable prescription products			6 months
Minimum [Member] \| Council License Agreement Step 2
Property, Plant and Equipment [Line Items]
Net sales amount per step-based royalty			$ 50,000,000
Minimum [Member] \| Council License Agreement Step 3
Property, Plant and Equipment [Line Items]
Net sales amount per step-based royalty			$ 150,000,000
Maximum [Member]
Property, Plant and Equipment [Line Items]
Return period of unsalable prescription products			12 months
Maximum [Member] \| Council License Agreement Step 1
Property, Plant and Equipment [Line Items]
Net sales amount per step-based royalty			$ 50,000,000
Maximum [Member] \| Council License Agreement Step 2
Property, Plant and Equipment [Line Items]
Net sales amount per step-based royalty			$ 150,000,000
Performance Shares [Member]
Property, Plant and Equipment [Line Items]
Common stock, shares, issued (in dollars per share)	$ 0.001		$ 0.001
Restricted Stock [Member]
Property, Plant and Equipment [Line Items]
Common stock, shares, issued (in dollars per share)	$ 0.001		$ 0.001
Trademarks and Trade Names [Member]
Property, Plant and Equipment [Line Items]
Impairment of intangible assets			$ 584,509	78,864
Fair Value, Recurring [Member]
Property, Plant and Equipment [Line Items]
Assets or liabilities valued at fair value	$ 0	$ 0	$ 0	$ 0

Inventory, net consists of the following: (Details) - USD ($)	Sep. 30, 2020	Dec. 31, 2019
Inventory Disclosure [Abstract]
Finished products	$ 4,794,132	$ 4,976,910
Work in process	440,149	1,182,059
Raw materials	4,698,023	5,701,747
TOTAL INVENTORY, NET	$ 9,932,304	$ 11,860,716

Other current assets consist of the following: (Details) - USD ($)	Sep. 30, 2020	Dec. 31, 2019
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract]
Prepaid sales and marketing costs	$ 686,346	$ 1,583,698
Debt financing fees on undrawn tranches (Note 9)		550,757
Prepaid insurance	3,599,906	1,812,135
Prepaid manufacturing	543,050	2,595,721
Other prepaid costs	3,989,937	4,787,482
TOTAL OTHER CURRENT ASSETS	$ 8,819,239	$ 11,329,793

Fixed assets, net consist of the following: (Details) - USD ($)	Sep. 30, 2020	Dec. 31, 2019
Property, Plant and Equipment [Line Items]
TOTAL FIXED ASSETS	$ 3,515,211	$ 3,476,599
Accumulated depreciation	(1,545,282)	(968,824)
TOTAL FIXED ASSETS, NET	1,969,929	2,507,775
Software and Software Development Costs [Member]
Property, Plant and Equipment [Line Items]
TOTAL FIXED ASSETS	301,096	301,096
Equipment [Member]
Property, Plant and Equipment [Line Items]
TOTAL FIXED ASSETS	1,658,258	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	$ 68,788	$ 68,788

NOTE 6 – FIXED ASSETS, NET (Details Narrative) - USD ($)	3 Months Ended		9 Months Ended
	Sep. 30, 2020	Sep. 30, 2019	Sep. 30, 2020	Sep. 30, 2019
Property, Plant and Equipment [Abstract]
Depreciation expense	$ 188,810	$ 90,700	$ 576,459	$ 223,750

The following table sets forth the gross carrying amount, accumulated amortization and net carrying amount of our intangible assets as of September 30, 2020 and December 31, 2019: (Details) - USD ($)	9 Months Ended	12 Months Ended
	Sep. 30, 2020	Dec. 31, 2019
Finite-Lived Intangible Assets [Line Items]
Finite-Lived Intangible Assets, Accumulated Amortization	$ (679,959)	$ (478,983)
Intangible Assets, Gross (Excluding Goodwill)	6,217,844	5,737,194
Intangible assets, net	5,537,885	5,258,211
Multiple Trademarks [Member]
Finite-Lived Intangible Assets [Line Items]
Indefinite-Lived Trademarks	348,176	294,813
Indefinite-lived Intangible Assets (Excluding Goodwill)	348,176	294,813
Approved Hormone Therapy Drug Candidate Patents [Member]
Finite-Lived Intangible Assets [Line Items]
Finite-Lived Intangible Assets, Gross	4,108,745	3,463,082
Finite-Lived Intangible Assets, Accumulated Amortization	(679,959)	(478,983)
Finite-Lived Intangible Assets, Net	$ 3,428,786	$ 2,984,099
Finite-Lived Intangible Assets, Remaining Amortization Period	12 years 3 months	13 years
Hormone Therapy Drug Candidate Patents - (Pending) [Member]
Finite-Lived Intangible Assets [Line Items]
Finite-Lived Intangible Assets, Gross	$ 1,760,923	$ 1,979,299
Finite-Lived Intangible Assets, Net	$ 1,760,923	$ 1,979,299

Estimated amortization expense, based on current patent cost being amortized, for the next five years is as follows: (Details)	Sep. 30, 2020 USD ($)
Goodwill and Intangible Assets Disclosure [Abstract]
2020 (3 months)	$ 69,977
2021	279,909
2022	279,909
2023	279,909
2024	$ 279,909

NOTE 7 – INTANGIBLE ASSETS, NET (Details Narrative)	9 Months Ended
NOTE 7 – INTANGIBLE ASSETS, NET (Details Narrative)	Sep. 30, 2020 USD ($) Number	Sep. 30, 2019 USD ($)
Finite-Lived Intangible Assets [Line Items]
Write off of patent and trademark costs \| $	$ 584,509	$ 78,864
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	35
Foreign Patents Member
Finite-Lived Intangible Assets [Line Items]
Number of issued patents	35
Domestic Patents BIJUVA
Finite-Lived Intangible Assets [Line Items]
Number of issued patents	14
Foreign Patents BIJUVA
Finite-Lived Intangible Assets [Line Items]
Number of issued patents	7
Domestic Patents Estradiol and Progesterone Candidates
Finite-Lived Intangible Assets [Line Items]
Number of issued patents	3
Domestic US Patents IMVEXXY
Finite-Lived Intangible Assets [Line Items]
Number of issued patents	10
Domestic US Utility Patents IMVEXXY
Finite-Lived Intangible Assets [Line Items]
Number of issued patents	8
Domestic US Design Patents IMVEXXY
Finite-Lived Intangible Assets [Line Items]
Number of issued patents	2
Foreign Patents IMVEXXY
Finite-Lived Intangible Assets [Line Items]
Number of issued patents	16
Foreign Utility Patents IMVEXXY
Finite-Lived Intangible Assets [Line Items]
Number of issued patents	6
Foreign Design Patents IMVEXXY
Finite-Lived Intangible Assets [Line Items]
Number of issued patents	10
Domestic Utility Patent Topical Cream Candidates [Member]
Finite-Lived Intangible Assets [Line Items]
Number of issued patents	1
Domestic Utility Patent Transdermal Patch
Finite-Lived Intangible Assets [Line Items]
Number of issued patents	1
Foreign Utility Patent Transdermal Patch
Finite-Lived Intangible Assets [Line Items]
Number of issued patents	8
Domestic Utility Patent TX009HR
Finite-Lived Intangible Assets [Line Items]
Number of issued patents	3
Domestic Patents Progesterone Formulations
Finite-Lived Intangible Assets [Line Items]
Number of issued patents	2
Foreign Patents Progesterone Formulations
Finite-Lived Intangible Assets [Line Items]
Number of issued patents	4
Domestic Utility Patent Opera
Finite-Lived Intangible Assets [Line Items]
Number of issued patents	1

Other current liabilities consist of the following: (Details) - USD ($)	Sep. 30, 2020	Dec. 31, 2019
Payables and Accruals [Abstract]
Accrued payroll, bonuses and commission costs	$ 4,381,729	$ 8,040,278
Allowance for coupons and returns	8,353,403	10,316,298
Accrued sales and marketing costs	1,578,971	3,285,662
Accrued compensated absences	2,558,055	1,463,878
Allowance for wholesale distributor fees	2,130,230	2,347,122
Accrued legal and accounting expense	1,052,935	422,336
Accrued research and development	1,059,077	1,049,603
Operating lease liability	2,404,286	1,501,539
Accrued rebates	6,629,732	3,916,672
Other accrued expenses	1,072,066	1,480,225
TOTAL OTHER CURRENT LIABILITIES	$ 31,220,484	$ 33,823,613

As of September 30, 2020 and December 31, 2019, the carrying value of our debt consisted of the following: (Details) - USD ($)	Sep. 30, 2020	Dec. 31, 2019
Debt Instrument [Line Items]
Debt discount and financing fees	$ (12,948,798)	$ (5,365,357)
TOTAL LONG-TERM DEBT	237,051,202	194,634,643
Financing Agreement [Member]
Debt Instrument [Line Items]
Long-term Debt, Gross	$ 250,000,000	$ 200,000,000

NOTE 9 – DEBT (Details Narrative)			3 Months Ended				9 Months Ended
NOTE 9 – DEBT (Details Narrative)	Apr. 24, 2019 USD ($) Number	May 01, 2018 USD ($) Number	Sep. 30, 2020 USD ($)	Dec. 31, 2019 USD ($)	Sep. 30, 2019 USD ($)	Jun. 30, 2019 USD ($)	Sep. 30, 2020 USD ($)	Sep. 30, 2019 USD ($)	Nov. 09, 2020 USD ($)	Nov. 08, 2020 USD ($)	Aug. 05, 2020 $ / shares shares	Jun. 30, 2020 USD ($)	Apr. 27, 2020 USD ($)
Debt Instrument [Line Items]
Revenue from Contract with Customer, Excluding Assessed Tax			$ 19,342,805		$ 23,719,741		$ 42,294,495	$ 33,745,257
Repayments of Lines of Credit								81,660,719
Loss on extinguishment of debt						$ (10,057,632)		(10,057,632)
Amortization of deferred financing fees							1,370,118	582,829
Fair value of warrants			$ 6,534,687				6,534,687
Write off of deferred financing fees							$ 275,379
Debt Instrument, Interest Rate, Effective Percentage			12.50%				12.50%
Paycheck Protection Program Loan [Member]
Debt Instrument [Line Items]
Principal amount													$ 6,477,094
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			$ 7,428,179				$ 7,428,179
Financing Agreement Amendment No. 6 - Through December 31, 2020 [Member] \| Subsequent Event [Member]
Debt Instrument [Line Items]
Minimum cash balance requirement under credit agreement										$ 45,000,000
Financing Agreement [Member]
Debt Instrument [Line Items]
Amortization of deferred financing fees			677,676		265,949		1,370,118	462,683
Long-term Debt, Gross			250,000,000	$ 200,000,000			250,000,000
Debt Issuance Costs, Gross			7,902,270				7,902,270
Interest Expense, Borrowings			6,726,389		$ 5,333,056		19,322,847	$ 9,318,056
Financing Agreement [Member] \| Subsequent Event [Member]
Debt Instrument [Line Items]
Minimum cash balance requirement under credit agreement									$ 60,000,000
IMVEXXY, BIJUVA and ANNOVERA [Member] \| Minimum [Member]
Debt Instrument [Line Items]
Revenue from Contract with Customer, Excluding Assessed Tax				$ 11,000,000
Two Tranches [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
Prepayment fee for first two years funding (percent)	30.00%
Prepayment fee third year funding (percent)	5.00%
Prepayment fee fourth year funding (percent)	3.00%
Prepayment fee fifth year funding (percent)	1.00%
Facility fee paid (percent)	2.50%
Minimum cash balance requirement under credit agreement	$ 60,000,000
Write off of deferred financing fees			275,379
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, Maximum Borrowing Capacity												$ 50,000,000
Line Of Credit Facility Undrawn Tranche No Longer Available			$ 50,000,000				50,000,000
Credit Agreement [Member]
Debt Instrument [Line Items]
Repayments of Lines of Credit	$ 81,661,000
Prepayment fee percentage	4.00%
Repayment fee percentage	4.00%
Interest Expense, Debt							1,816,747
Amortization of deferred financing fees							$ 120,146
Revolving Credit Facility [Member]
Debt Instrument [Line Items]
Debt Instrument, Basis Spread on Variable Rate		7.75%
Revolving Credit Facility [Member] \| Financing Agreement [Member]
Debt Instrument [Line Items]
Line of Credit Facility, Maximum Borrowing Capacity	$ 300,000,000
Secured Debt [Member]
Debt Instrument [Line Items]
Line of Credit Facility, Maximum Borrowing Capacity	$ 200,000,000	$ 200,000,000
Debt Instrument, Description of Variable Rate Basis		one-month LIBOR
LIBOR floor rate		1.50%
Number of tranches under term loan facility \| Number		3

Schedule of calculation of diluted net loss per share allocable to common stockholders (Details) - shares	9 Months Ended
	Sep. 30, 2020	Sep. 30, 2019
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount	38,880,709	27,922,555
Stock Options [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount	23,893,180	24,849,984
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
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	2,422,885
Restricted Stock [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount	6,029,957	1,240,000

The ranges of assumptions used in the Black-Scholes Model during the nine months ended September 30, 2020 and 2019 are set forth in the table below. (Details) - Share-based Payment Arrangement, Option [Member] - $ / shares	9 Months Ended
	Sep. 30, 2020	Sep. 30, 2019
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Weighted average grant date fair value	$ 0.95	$ 1.84
Risk-free interest rate, minimum	0.34%	1.83%
Risk-free interest rate, maximum	1.68%	2.54%
Volatility, minimum	63.53%	61.25%
Volatility, maximum	67.92%	64.49%
Dividend yield	0.00%	0.00%
Minimum [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Term	6 years	5 years 6 months
Maximum [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Term	6 years 9 months 18 days	6 years 6 months

A summary of option activity under the 2009, 2012 and 2019 Plans and related information during the nine months ended September 30, 2020 is as follows (Details) - USD ($)	3 Months Ended		9 Months Ended		12 Months Ended
	Sep. 30, 2020	Sep. 30, 2019	Sep. 30, 2020	Sep. 30, 2019	Dec. 31, 2019
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Number of shares under options, exercised	(517,891)	(55,236)	(1,182,195)	(331,619)
Share-based Payment Arrangement, Option [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Number of shares under options, beginning			25,030,234
Weighted average exercise price, beginning			$ 4.65
Weighted average remaining contractual life			5 years 5 months 15 days		5 years 10 months 2 days
Aggregate intrinsic value, beginning			$ 3,668,171
Number of shares under options, granted			736,500
Weighted average exercise price, granted			$ 1.58
Number of shares under options, exercised			(1,182,195)
Weighted average exercise price, exercised			$ 0.23
Aggregate intrinsic value, exercised			$ 1,738,740
Number of shares under options, expired			(361,109)
Weighted average exercise price, expired			$ 3.66
Number of shares under options, cancelled forfeited			(330,250)
Weighted average exercise price, cancelled forfeited			$ 3.69
Number of shares under options, ending	23,893,180		23,893,180		25,030,234
Weighted average exercise price, ending	$ 4.80		$ 4.80		$ 4.65
Aggregate intrinsic value, ending	$ 379,535		$ 379,535		$ 3,668,171
Number of shares under options, vested and exercisable ending	19,827,306		19,827,306
Weighted average exercise price, vested and exercisable ending	$ 5.06		$ 5.06
Weighted average remaining contractual life, vested and exercisable			4 years 9 months 29 days
Aggregate intrinsic value, vested and exercisable ending	$ 218,370		$ 218,370
Number of shares under options, unvested ending	4,065,874		4,065,874
Weighted average exercise price, unvested	$ 3.55		$ 3.55
Weighted average remaining contractual life in years, unvested			8 years 6 months 10 days
Aggregate intrinsic value, unvested	$ 161,165		$ 161,165

Schedule of restricted stock units and performance stock units (Details)

9 Months Ended

Sep. 30, 2020

$ / shares

Restricted Stock [Member]

Share-based Compensation Arrangement by Share-based Payment Award [Line Items]

Number of shares, beginning | shares

1,240,000

Weighted average grant date fair values, beginning | $ / shares

$ 3.56

Number of shares, granted | shares

5,102,817

Weighted average grant date fair value, granted | $ / shares

$ 1.40

Number of shares, vested/released | shares

(301,500)

Weighted average grant date fair value, vested/released | $ / shares

$ 1.78

Number of shares, forfeited | shares

(11,360)

Weighted average grant date fair value, forfeited | $ / shares

$ 1.07

Number of shares, ending | shares

6,029,957

Weighted average grant date fair value, ending | $ / shares

$ 1.83

Performance Shares [Member]

Share-based Compensation Arrangement by Share-based Payment Award [Line Items]

Number of shares, granted | shares

2,585,745

Weighted average grant date fair value, granted | $ / shares

$ 1.08

Number of shares, vested/released | shares

(151,500)

Weighted average grant date fair value, vested/released | $ / shares

$ 1.14

Number of shares, forfeited | shares

(11,360)

Weighted average grant date fair value, forfeited | $ / shares

$ 1.07

Number of shares, ending | shares

2,422,885

^[1]

Weighted average grant date fair value, ending | $ / 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.

NOTE 11 – STOCKHOLDERS’ EQUITY (Details Narrative) - USD ($)

3 Months Ended

9 Months Ended

Jun. 18, 2020

Sep. 30, 2020

Sep. 30, 2019

Sep. 30, 2020

Sep. 30, 2019

Aug. 05, 2020

Dec. 31, 2019

Class of Warrant or Right [Line Items]

Preferred Stock, Shares Authorized

10,000,000

Preferred Stock, Par or Stated Value Per Share

$ 0.001

Preferred Stock, Shares Issued

Common Stock, Shares Authorized

600,000,000

350,000,000

Common Stock, Shares, Issued

272,812,271

271,177,076

Common Stock, Shares, Outstanding

272,812,271

271,177,076

Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercises in Period

517,891

55,236

1,182,195

331,619

Stock Issued During Period, Value, Stock Options Exercised

$ 105,494

$ 8,549

$ 271,678

$ 108,656

Number of stock options exercised in cashless exercise

12,097

Number of common stock issued during period for stock options exercised in cashless exercise

11,834

Warrants and Rights Outstanding

$ 6,534,687

Weighted-average contractual remaining life

7 years 6 months

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

$ 1.83

Share-based Payment Arrangement, Noncash Expense

$ 8,502,044

$ 7,859,357

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

$ 6,500,000

6,500,000

Restricted Stock or Unit Expense

1,988,844

84,061

4,334,537

1,080,738

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

$ 11,000,000

Restricted Stock [Member]

Class of Warrant or Right [Line Items]

Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Grants in Period, Weighted Average Grant Date Fair Value

$ 1.40

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

6,029,957

1,240,000

Performance Shares [Member]

Class of Warrant or Right [Line Items]

Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Grants in Period, Weighted Average Grant Date Fair Value

$ 1.08

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

^[1]

2,422,885

Share-based Payment Arrangement, Option [Member]

Class of Warrant or Right [Line Items]

Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercises in Period

1,182,195

Share-based Payment Arrangement, Noncash Expense

$ 1,143,920

2,194,667

$ 4,141,061

6,568,736

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

23,893,180

25,030,234

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

2 years

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

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

13,346,455

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

589,159

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

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

2,405,833

2012 Stock Incentive Plan [Member] | Restricted Stock [Member]

Class of Warrant or Right [Line Items]

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

890,000

Plan 2019 [Member]

Class of Warrant or Right [Line Items]

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

4,240,751

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

3,465,514

Plan 2019 [Member] | Restricted Stock [Member]

Class of Warrant or Right [Line Items]

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

5,139,957

Plan 2019 [Member] | Performance Shares [Member]

Class of Warrant or Right [Line Items]

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

2,422,885

New Shares [Member]

Class of Warrant or Right [Line Items]

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

470,522

Employee Stock Purchase Plan [Member]

Class of Warrant or Right [Line Items]

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%

Minimum [Member]

Class of Warrant or Right [Line Items]

Range - exercise price of options

$ 0.38

Maximum [Member]

Class of Warrant or Right [Line Items]

Range - exercise price of options

$ 8.92

Warrants Member

Class of Warrant or Right [Line Items]

Share-based Payment Arrangement, Noncash Expense

$ 0

$ 56,418

$ 26,446

$ 198,306

Warrants Member | Minimum [Member]

Class of Warrant or Right [Line Items]

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

$ 0.24

Warrants Member | Maximum [Member]

Class of Warrant or Right [Line Items]

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

$ 8.20

Lender Warrants [Member]

Class of Warrant or Right [Line Items]

Warrants and Rights Outstanding

$ 7,428,179

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

$ 1.58

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%

Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Grants in Period, Weighted Average Grant Date Fair Value

$ 1.56

Outside Consultants Warrants [Member]

Class of Warrant or Right [Line Items]

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

$ 5.63

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

60.80%

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

2.52%

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

0.00%

Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Grants in Period, Weighted Average Grant Date Fair Value

$ 3.00

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

75,000

Share-based Compensation Arrangement by Share-based Payment Award, Award Vesting Period

12 months

Warrant [Member]

Class of Warrant or Right [Line Items]

Warrants exercised

1,250,000

Warrants - Cashless Exercise [Member]

Class of Warrant or Right [Line Items]

Number of stock issued in cashless exercise of warrants

471,184

[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.

NOTE 13 – RELATED PARTIES (Details Narrative) - USD ($)	3 Months Ended		9 Months Ended
NOTE 13 – RELATED PARTIES (Details Narrative) - USD ($)	Sep. 30, 2020	Sep. 30, 2019	Sep. 30, 2020	Sep. 30, 2019	Dec. 31, 2019
Catalent [Member]
Related Party Transaction [Line Items]
Amount billed	$ 520,000	$ 2,196,000	$ 2,563,000	$ 4,118,000
Amounts due to related party	147,000		147,000		$ 35,000
American International Group [Member]
Related Party Transaction [Line Items]
Amount billed	$ 52,000		$ 195,000

NOTE 14 - BUSINESS CONCENTRATIONS (Details Narrative)	9 Months Ended
NOTE 14 - BUSINESS CONCENTRATIONS (Details Narrative)	Sep. 30, 2020 USD ($) Number	Sep. 30, 2019 USD ($) Number
Supplier One Concentration Risk [Member]
Concentration Risk [Line Items]
Concentration risk	42.00%	36.00%
Supplier 2
Concentration Risk [Line Items]
Concentration risk	25.00%	28.00%
Supplier 3
Concentration Risk [Line Items]
Concentration risk	24.00%	26.00%
Customer Concentration Risk [Member] \| Revenue Benchmark [Member]
Concentration Risk [Line Items]
Concentration risk	10.00%	10.00%
Number of customers - revenue \| Number	3	4
Three Customers Concentration Risk \| Revenue Benchmark [Member]
Concentration Risk [Line Items]
Concentration risk	56.00%
Four Customers Concentration Risk \| Revenue Benchmark [Member]
Concentration Risk [Line Items]
Concentration risk		68.00%
PillPack - Major Customer \| Revenue Benchmark [Member]
Concentration Risk [Line Items]
Revenues	$ 9,319,000	$ 6,397,000
Cardinal Health - Major Customer \| Revenue Benchmark [Member]
Concentration Risk [Line Items]
Revenues	7,415,000	1,863,000
McKesson Corporation - Major Customer \| Revenue Benchmark [Member]
Concentration Risk [Line Items]
Revenues	$ 6,009,000
AmerisourceBergen - Major Customer \| Revenue Benchmark [Member]
Concentration Risk [Line Items]
Revenues		2,226,000
PI Services - Major Customer \| Revenue Benchmark [Member]
Concentration Risk [Line Items]
Revenues		$ 1,935,000

Supplemental lease information (Details) - USD ($)	9 Months Ended
Supplemental lease information (Details) - USD ($)	Sep. 30, 2020	Sep. 30, 2019	Dec. 31, 2019
Commitments and Contingencies Disclosure [Abstract]
Right-of-use asset	$ 9,975,725		$ 10,109,154
Short-term operating lease liability (included in Other current liabilities)	2,404,286		1,501,539
Long-term operating lease liability	$ 8,907,995		$ 9,145,049
Weighted average remaining term	8 years 9 months 18 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	$ 1,006,970	$ 849,440
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 September 30, 2020 to the operating lease liabilities recorded on the balance sheet: (Details)	Sep. 30, 2020 USD ($)
Commitments and Contingencies Disclosure [Abstract]
2020 (3 months)	$ 610,675
2021	2,334,582
2022	1,413,289
2023	1,443,143
2024	1,476,534
Thereafter	8,947,869
Total undiscounted lease payments	16,226,092
Less: imputed interest	(4,913,811)
Present value of lease payments	$ 11,312,281

NOTE 15 – COMMITMENTS AND CONTINGENCIES (Details Narrative)		3 Months Ended		9 Months Ended
	Jul. 01, 2013	Sep. 30, 2020 USD ($)	Sep. 30, 2019 USD ($)	Sep. 30, 2020 USD ($)	Sep. 30, 2019 USD ($)	Aug. 01, 2019 ft²	Jun. 01, 2019 ft²	Oct. 02, 2018 ft²
Recorded Unconditional Purchase Obligation [Line Items]
Non-cancelable operating lease term	63 months
Net rentable area \| ft²								56,212
Rented area lease \| ft²								7,561
Additional area of lease occupied \| ft²						48,651
Lessee, Operating Lease, Term of Contract						11 years
Lessee operating lease existence of option to extend number		2		2
Lessee, Operating Lease, Renewal Term		5 years		5 years
Lease not yet commenced (area) \| ft²							6,536
Operating lease expense		$ 590,000	$ 458,000	$ 1,749,000	$ 1,062,000
Variable lease expense		$ 148,000		$ 226,000
Significant supply commitment percentage payable		50.00%		50.00%
Catalent [Member]
Recorded Unconditional Purchase Obligation [Line Items]
Minimum purchase commitment, 2020		$ 3,719,000		$ 3,719,000
Minimum purchase commitment, 2021		2,150,000		2,150,000
Minimum purchase commitment, 2022		2,991,000		2,991,000
Minimum purchase commitment, 2023		3,347,000		3,347,000
Minimum purchase commitment, 2024		$ 3,786,000		$ 3,786,000

NOTE 16 – SUBSEQUENT EVENTS (Details Narrative) - Subsequent Event [Member]	Nov. 08, 2020 USD ($)
Financing Agreement Amendment No. 6 [Member]
Subsequent Event [Line Items]
Minimum cash balance requirement under credit agreement before adjustment	$ 60,000,000
Financing Agreement Amendment No. 6 - Through December 31, 2020 [Member]
Subsequent Event [Line Items]
Minimum cash balance requirement under credit agreement	45,000,000
Financing Agreement Amendment No. 6 - After December 31, 2020 [Member]
Subsequent Event [Line Items]
Minimum cash balance requirement under credit agreement	$ 60,000,000