Document and Entity Information - USD ($)	12 Months Ended
Document and Entity Information - USD ($)	Dec. 31, 2018	Feb. 18, 2019	Jun. 30, 2018
Document And Entity Information
Entity Registrant Name	TherapeuticsMD, Inc.
Entity Central Index Key	0000025743
Document Type	10-K
Trading Symbol	TXMD
Document Period End Date	Dec. 31, 2018
Amendment Flag	false
Current Fiscal Year End Date	--12-31
Entity Well-known Seasoned Issuer	Yes
Entity a Voluntary Filer	No
Entity's Reporting Status Current	Yes
Entity Emerging Growth Company	false
Entity Small Business	false
Entity Shell Company	false
Entity Filer Category	Large Accelerated Filer
Entity Common Stock, Shares Outstanding		241,161,845
Entity Common Stock, Held by non-affiliates (shares)			182,622,092
Entity Public Float			$ 1,139,561,854
Document Fiscal Period Focus	FY
Document Fiscal Year Focus	2018

CONSOLIDATED BALANCE SHEETS - USD ($)	Dec. 31, 2018	Dec. 31, 2017
Current Assets:
Cash	$ 161,613,077	$ 127,135,628
Accounts receivable, net of allowance for doubtful accounts of $596,602 and $380,580, respectively	11,063,821	4,328,802
Inventory	3,267,670	1,485,358
Other current assets	10,834,693	6,604,284
Total current assets	186,779,261	139,554,072
Fixed assets, net	472,683	437,055
Other Assets:
License rights	20,000,000
Intangible assets, net	4,092,679	3,099,747
Other assets	324,855
Security deposit	314,446	139,036
Total other assets	24,731,980	3,238,783
Total assets	211,983,924	143,229,910
Current Liabilities:
Accounts payable	22,743,841	4,097,600
Accrued expenses and other current liabilities	18,334,948	9,223,595
Total current liabilities	41,078,789	13,321,195
Long-Term Liabilities:
Long-term debt	73,381,014
Total liabilities	114,459,803	13,321,195
Commitments and Contingencies - See Note 13
Stockholders' Equity:
Preferred stock - par value $0.001; 10,000,000 shares authorized; no shares issued and outstanding
Common stock - par value $0.001; 350,000,000 shares authorized: 240,462,439 and 216,429,642 issued and outstanding, respectively	240,463	216,430
Additional paid-in capital	616,559,938	516,351,405
Accumulated deficit	(519,276,280)	(386,659,120)
Total stockholders' equity	97,524,121	129,908,715
Total liabilities and stockholders' equity	$ 211,983,924	$ 143,229,910

CONSOLIDATED BALANCE SHEETS (Parenthetical) - USD ($)	Dec. 31, 2018	Dec. 31, 2017
Statement of Financial Position [Abstract]
Allowance for doubtful accounts	$ 596,602	$ 380,580
Preferred stock, par value (in dollars per share)	$ 0.001	$ 0.001
Preferred stock, authorized	10,000,000	10,000,000
Preferred stock, issued	0	0
Preferred stock, outstanding	0	0
Common stock, par value (in dollars per share)	$ 0.001	$ 0.001
Common stock, authorized	350,000,000	350,000,000
Common stock, issued	240,462,439	216,429,642
Common stock, outstanding	240,462,439	216,429,642

CONSOLIDATED STATEMENTS OF OPERATIONS - USD ($)	12 Months Ended
CONSOLIDATED STATEMENTS OF OPERATIONS - USD ($)	Dec. 31, 2018	Dec. 31, 2017	Dec. 31, 2016
Income Statement [Abstract]
Revenues, net	$ 16,099,460	$ 16,777,713	$ 19,356,450
Cost of goods sold	2,737,652	2,636,943	4,185,708
Gross profit	13,361,808	14,140,770	15,170,742
Operating expenses:
Sales, general, and administrative	115,988,954	57,703,370	51,348,414
Research and development	27,299,138	33,852,993	53,943,477
Depreciation and amortization	293,886	213,117	132,451
Total operating expenses	143,581,978	91,769,480	105,424,342
Operating loss	(130,220,170)	(77,628,710)	(90,253,600)
Other (expense) income
Miscellaneous income	2,280,844	695,631	367,317
Interest expense	(4,677,834)
Accreted interest		7,699	10,824
Total other (expense) income	(2,396,990)	703,330	378,141
Loss before income taxes	(132,617,160)	(76,925,380)	(89,875,459)
Provision for income taxes
Net loss	$ (132,617,160)	$ (76,925,380)	$ (89,875,459)
Loss per share, basic and diluted:
Net loss per share, basic and diluted (in dollars per share)	$ (0.59)	$ (0.37)	$ (0.46)
Weighted average number of common shares outstanding, basic and diluted (in shares)	225,026,300	205,523,288	196,088,196

CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY - USD ($)	Common Stock	Additional Paid in Capital	Accumulated Deficit	Total
Beginning balance at Dec. 31, 2015	$ 177,928	$ 282,712,078	$ (219,826,860)	$ 63,063,146
Beginning balance (in shares) at Dec. 31, 2015	177,928,041
Increase (Decrease) in Stockholders' Equity [Roll Forward]
Shares issued in offerings, net of cost	$ 17,424	134,846,051		134,863,475
Shares issued in offerings, net of cost (in shares)	17,424,242
Shares issued for exercise of options, net	$ 723	1,372,277		1,373,000
Shares issued for exercise of options, net (in shares)	722,744
Shares issued for exercise of warrants, net	$ 613	988,447		989,060
Shares issued for exercise of warrants, net (in shares)	613,195
Share-based compensation		17,076,199		17,076,199
Net loss			(89,875,459)	(89,875,459)
Ending balance at Dec. 31, 2016	$ 196,688	436,995,052	(309,702,319)	127,489,421
Ending balance (in shares) at Dec. 31, 2016	196,688,222
Increase (Decrease) in Stockholders' Equity [Roll Forward]
Shares issued in offerings, net of cost	$ 12,400	68,560,235		68,572,635
Shares issued in offerings, net of cost (in shares)	12,400,000
Shares issued for exercise of options, net	$ 103	212,512		212,615
Shares issued for exercise of options, net (in shares)	102,546
Shares issued for exercise of warrants, net	$ 7,239	3,791,760		3,798,999
Shares issued for exercise of warrants, net (in shares)	7,238,874
Share-based compensation		6,760,425		6,760,425
Adoption of ASU 2016-09 at Dec. 31, 2016		31,421	(31,421)
Increase (Decrease) in Stockholders' Equity [Roll Forward]
Net loss			(76,925,380)	(76,925,380)
Ending balance at Dec. 31, 2017	$ 216,430	516,351,405	(386,659,120)	$ 129,908,715
Ending balance (in shares) at Dec. 31, 2017	216,429,642			216,429,642
Increase (Decrease) in Stockholders' Equity [Roll Forward]
Shares issued in offerings, net of cost	$ 18,578	89,889,219		$ 89,907,797
Shares issued in offerings, net of cost (in shares)	18,578,430
Shares issued for exercise of options, net	$ 5,455	1,660,753		1,666,208
Shares issued for exercise of options, net (in shares)	5,454,367
Share-based compensation		8,658,561		8,658,561
Net loss			(132,617,160)	(132,617,160)
Ending balance at Dec. 31, 2018	$ 240,463	$ 616,559,938	$ (519,276,280)	$ 97,524,121
Ending balance (in shares) at Dec. 31, 2018	240,462,439			240,462,439

CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($)	12 Months Ended
CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($)	Dec. 31, 2018	Dec. 31, 2017	Dec. 31, 2016
CASH FLOWS FROM OPERATING ACTIVITIES
Net loss	$ (132,617,160)	$ (76,925,380)	$ (89,875,459)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation of fixed assets	181,412	141,601	77,906
Amortization of intangible assets	112,474	71,516	54,545
Provision for doubtful accounts	216,022	4,206	2,524,909
Share-based compensation	8,661,967	6,889,323	17,411,021
Amortization of deferred financing costs	269,859
Changes in operating assets and liabilities:
Accounts receivable	(6,951,041)	167,691	(3,975,893)
Inventory	(1,782,312)	(409,037)	(386,168)
Other current assets	(2,332,335)	(4,434,130)	709,907
Other assets	(324,855)
Accounts payable	18,646,241	(3,260,914)	4,232,340
Accrued expenses and other current liabilities	9,107,947	1,599,510	84,559
Net cash used in operating activities	(106,811,781)	(76,155,614)	(69,142,333)
CASH FLOWS FROM INVESTING ACTIVITIES
Payment for intellectual property license	(20,000,000)
Patent costs	(1,105,407)	(765,291)	(845,266)
Purchase of fixed assets	(217,040)	(61,817)	(396,154)
Payment of security deposit	(175,410)		(14,036)
Net cash used in investing activities	(21,497,857)	(827,108)	(1,255,456)
CASH FLOWS FROM FINANCING ACTIVITIES
Proceeds from sale of common stock, net of costs	89,907,797	68,572,635	134,863,475
Proceeds from term loan	75,000,000
Payment of deferred financing fees	(3,786,918)
Proceeds from exercise of options	1,666,208	212,615	989,060
Proceeds from exercise of warrants		3,798,999	1,373,000
Net cash provided by financing activities	162,787,087	72,584,249	137,225,535
Increase (decrease) in cash	34,477,449	(4,398,473)	66,827,746
Cash, beginning of period	127,135,628	131,534,101	64,706,355
Cash, end of period	161,613,077	$ 127,135,628	$ 131,534,101
Supplemental disclosure of cash flow information
Interest paid	$ 1,890,166

THE COMPANY

12 Months Ended

Dec. 31, 2018

Organization, Consolidation and Presentation of Financial Statements [Abstract]

THE COMPANY

NOTE 1 – THE COMPANY

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

Nature of Business

We are a women’s healthcare company focused on creating and commercializing innovative products to support the lifespan of women and championing awareness of women’s healthcare issues, specifically, for pregnancy prevention, pregnancy, childbirth, nursing, pre-menopause, and menopause. At TherapeuticsMD, we combine entrepreneurial spirit, clinical expertise, and business leadership to develop and commercialize health solutions that enable new standards of care for women. Our solutions range from advanced hormone therapy pharmaceutical products to patient-controlled, long-acting contraceptive. We also manufacture and distribute branded and generic prescription prenatal vitamins under the vitaMedMD® and BocaGreenMD® brands.

With our SYMBODA™ technology, we are developing and commercializing advanced hormone therapy pharmaceutical products to enable delivery of bio-identical hormones through a variety of dosage forms and administration routes. Our track record of commercialization allows us to efficiently leverage and grow our marketing and sales organization to commercialize our recently approved products.

During 2018, U.S. Food and Drug Administration, or FDA, approval of our drugs has transitioned our company from predominately focused on conducting research and development to one focused on commercializing our drugs. In July 2018, we launched our recently 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. We are also focused on commercialization activities necessary for launch of BIJUVA™ and ANNOVERA™. BIJUVA™ is 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, which was approved by the FDA on October 28, 2018. ANNOVERA™ (segesterone acetate/ethinyl estradiol vaginal system), is the first and only patient-controlled, procedure-free, reversible prescription contraceptive that can prevent unintended pregnancy for up to a full year, which was approved by the FDA on August 10, 2018. On July 30, 2018, we entered into a license and supply agreement with Knight Therapeutics Inc., or Knight, pursuant to which we granted Knight an exclusive license to commercialize IMVEXXY® and BIJUVA™ in Canada and Israel. In addition, on July 30, 2018, we entered into an exclusive license agreement, or the Council License Agreement, with the Population Council, Inc., or the Population Council, to commercialize ANNOVERA™ in the U.S.

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

12 Months Ended

Dec. 31, 2018

Accounting Policies [Abstract]

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

NOTE 2 – SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

Principles of Consolidation

The accompanying consolidated financial statements include the accounts of our company and our wholly owned subsidiaries, VitaMed, BocaGreen and VitaCare. All intercompany balances and transactions have been eliminated in consolidation.

Cash

We maintain cash at financial institutions that at times may exceed the Federal Deposit Insurance Corporation, or the FDIC, insured limits of $250,000 per bank. We have never experienced any losses related to these funds.

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 charge-backs and provide an allowance for doubtful accounts, which is based upon a review of outstanding receivables, historical collection information, and existing economic conditions. We consider trade accounts receivable past due for more than 90 days to be delinquent. We write off delinquent receivables against our allowance for doubtful accounts based on individual credit evaluations, the results of collection efforts, and specific circumstances of customers. We record recoveries of accounts previously written off when received as an increase in the allowance for doubtful accounts. To the extent data we use to calculate these estimates does not accurately reflect bad debts, adjustments to these reserves may be required. At December 31, 2018, three different customers represented 42%, 24% and 13% of our gross accounts receivable. At December 31, 2017, four different customers represented 27%, 23%, 22% and 11% of our gross accounts receivable.

Inventories

Inventories represent hormone therapy drugs, packaged vitamins, nutritional products and supplements and raw materials, which are valued at the lower of cost or net realizable value using the average-cost method. We review our inventory for excess or obsolete inventory and write-down obsolete or otherwise unmarketable inventory to its estimated net realizable value. Obsolescence may occur due to product expiring or product improvements rendering previous versions obsolete.

Pre-Launch Inventory

Inventory costs associated with product candidates that have not yet received regulatory approval are capitalized if we believe there is probable future commercial use and future economic benefit. If the probability of future commercial use and future economic benefit cannot be reasonably determined, then pre-launch inventory costs associated with such product candidates are expensed as research and development expenses during the period the costs are incurred. We have not capitalized any pre-launch inventory to date.

Fixed Assets

We state fixed assets at cost, net of accumulated depreciation. We charge maintenance costs, which do not significantly extend the useful lives of the respective assets, and repair costs to operating expenses as incurred. We compute depreciation using the straight-line method over the estimated useful lives of the related assets, which range from three to seven years. Leasehold improvements are depreciated over the shorter of their useful life or the term of the lease.

We capitalize software and software development costs incurred to create and acquire computer software for internal use, principally related to software coding and application development. We begin to capitalize software development costs when both the preliminary project stage is completed and it is probable that the software will be used as intended. Capitalized software costs include only external direct costs and services utilized in developing or obtaining computer software. Capitalized software costs are amortized on a straight-line basis when placed into service over the estimated useful life, generally five to seven years.

Intangible Assets

We have adopted the provisions of Financial Accounting Standards Board, or FASB, Accounting Standards Codification, or ASC, 350, Intangibles - Goodwill and Other, or ASC 350. Capitalized patent costs, net of accumulated amortization, include outside legal costs incurred for patent applications. In accordance with ASC 350, once a patent is granted, we amortize the capitalized patent costs over the remaining life of the patent using the straight-line method. If the patent is not granted, we write-off any capitalized patent costs at that time. As of December 31, 2018, we had 21 issued domestic, or U.S., patents and 24 issued foreign patents (See Note 6). We capitalize external costs, consisting primarily of legal costs, related to securing our trademarks. Trademarks are perpetual and are not amortized. We review intangible assets for impairment annually or when events or circumstances indicate that their carrying amount may not be recoverable.

Impairment of Long-Lived Assets

We review the carrying values of fixed assets and long-lived intangible assets to be held and used for impairment whenever events or changes in circumstances indicate that their carrying values may not be recoverable. Such events or circumstances may include, among others, the following:

●

significant declines in an asset’s market price;

●

significant deterioration in an asset’s physical condition;

●

significant changes in the nature or extent of an asset’s use or operation;

●

significant adverse changes in the business climate that could impact an asset’s value, including adverse actions or assessments by regulators;

●

accumulation of costs significantly in excess of original expectations related to the acquisition or construction of an asset;

●

current-period operating or cash flow losses combined with a history of such losses or a forecast that demonstrates continuing losses associated with an asset’s use; and

●

expectations that it is more likely than not that an asset will be sold or otherwise disposed of significantly before the end of its previously estimated useful life.

If impairment indicators are present, we determine whether an impairment loss should be recognized by testing the applicable asset or asset group’s carrying value for recoverability. This test requires long-lived assets to be grouped at the lowest level for which identifiable cash flows are largely independent of the cash flows of other assets and liabilities, the determination of which requires judgment. We estimate the undiscounted future cash flows expected to be generated from the use and eventual disposal of the assets and compare that estimate to the respective carrying values in order to determine if such carrying values are recoverable. This assessment requires the exercise of judgment in assessing the future use of and projected value to be derived from the eventual disposal of the assets to be held and used. In our assessments, we also consider changes in asset utilization, including, if applicable, the temporary idling of capacity and the expected timing for placing this capacity back into production. If the carrying value of the assets is not recoverable, then we record a loss for the difference between the assets’ fair value and respective carrying values. We determine the fair value of the assets using an “income approach” based upon a forecast of all the expected discounted future net cash flows associated with the subject assets. Some of the more significant estimates and assumptions include market size and growth, market share, projected selling prices, manufacturing cost, and discount rate. We base estimates upon historical experience, our commercial relationships, market conditions, and available external information about future trends. We believe our current assumptions and estimates are reasonable and appropriate. Unanticipated events and changes in market conditions, however, could affect such estimates, resulting in the need for an impairment charge in future periods. There was no impairment of long-lived assets to be held and used during the years ended December 31, 2018, 2017, and 2016.

We perform impairment tests for intangible assets with indefinite useful lives annually, or more frequently if events occur or circumstances change that would more likely than not reduce the fair value of an intangible asset below its carrying value. The impairment test for assets with indefinite lives consists of a comparison of the fair value of the asset with its carrying amount. If the carrying amount of an intangible asset exceeds its fair value, an impairment loss is recognized in an amount equal to that excess. There was no impairment of indefinite lived intangible assets during the years ended December 31, 2018, 2017, and 2016.

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.

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. 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 asset or liability.

At December 31, 2018 and 2017, 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. There was no impairment of intangible assets during the years ended December 31, 2018, 2017, and 2016.

The carrying amount for the long term debt as of December 31, 2018 (as discussed in Note 8) approximates fair value based on market activity for other debt instruments with similar characteristics and comparable risk (Level 2).

Income Taxes

We account for income taxes under the asset and liability method. We recognize deferred tax assets and liabilities for the estimated future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax basis. We measure deferred tax assets and liabilities using enacted tax rates expected to apply to taxable income in the years in which the related temporary differences are expected to be recovered or settled. We recognize the effect on deferred tax assets and liabilities of a change in tax rates when the rate change is enacted. Valuation allowances are recorded to reduce deferred tax assets to the amount that will more likely than not be realized.

In accordance with ASC 740, Income Taxes, we recognize the effect of uncertain income tax positions only if the positions are more likely than not of being sustained in an audit, based on the technical merits of the position. We measure recognized uncertain income tax positions using the largest amount that has a likelihood of being realized that is greater than 50%. Changes in recognition or measurement are reflected in the period in which those changes in judgment occur.

We recognize both interest and penalties related to uncertain tax positions as part of the income tax provision. At December 31, 2018 and 2017, we had no tax positions relating to open tax returns that were considered to be uncertain.

Our U.S. federal and state tax returns since 2011, which was the first year we generated net operating losses, remain open to examination.

Share-Based Compensation

We measure the compensation costs of share-based compensation arrangements based on the grant-date fair value and recognize the costs in the financial statements over the period during which employees are required to provide services. Share-based compensation arrangements include options, restricted stock, restricted stock units, performance-based awards, share appreciation rights, and employee share purchase plans. We amortize such compensation amounts, if any, over the respective service periods of the award. We use the Black-Scholes-Merton option pricing model, or the Black-Scholes Model, an acceptable model in accordance with ASC 718, Compensation-Stock Compensation, to value options. Option valuation models require the input of assumptions, including the expected life of the stock-based awards, the estimated stock price volatility, the risk-free interest rate, and the expected dividend yield. The risk-free interest rate assumption is based upon observed interest rates on zero coupon U.S. Treasury bonds whose maturity period is appropriate for the term of the instrument. Estimated volatility is a measure of the amount by which our stock price is expected to fluctuate each year during the term of the award. Prior to January 1, 2017, the expected volatility of share options was estimated based on a historical volatility analysis of peer entities whose stock prices were publicly available that were similar to the Company with respect to industry, stage of life cycle, market capitalization, and financial leverage. On January 1, 2017, we began using our own stock price in our volatility calculation along with the other peer entities whose stock prices were publicly available that were similar to our company. Our calculation of estimated volatility is based on historical stock prices over a period equal to the expected term of the awards. The average expected life is based on the contractual terms of the stock option using the simplified method. We utilize a dividend yield of zero based on the fact that we have never paid cash dividends and have no current intention to pay cash dividends. Calculating share-based compensation expense requires the input of highly subjective judgment and assumptions: estimates of expected life of the share-based award, stock price volatility and risk-free interest rates. The assumptions used in calculating the fair value of share-based awards represent our best estimates, but these estimates involve inherent uncertainties and the application of management judgment. As a result, if factors change and we use different assumptions, our share-based compensation expense could be materially different in the future.

Equity instruments (“instruments”) issued to non-employees are recorded on the basis of the fair value of the instruments, as required by ASC 505, Equity - Based Payments to Non-Employees, or ASC 505. ASC 505 defines the measurement date and recognition period for such instruments. In general, the measurement date is when either (a) a performance commitment, as defined, is reached or (b) the earlier of (i) the non-employee performance is complete or (ii) the instruments are vested. The estimated expense is recognized each period based on the current fair value of the award. As a result, the amount of expense related to awards to non-employees can fluctuate significantly during the period from the date of the grant through the final measurement date. The measured value related to the instruments is recognized over a period based on the facts and circumstances of each particular grant as defined in ASC 505.

We recognize the compensation expense for all share-based compensation granted to employees 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. We estimate the forfeiture rate based on our historical experience of forfeitures. If our actual forfeiture rate is materially different from our estimate, share-based compensation expense could be significantly different from what we have recorded in the current period.

Revenue Recognition

We adopted ASC 606 on January 1, 2018 using the modified retrospective method for all contracts not completed as of the date of adoption. ASC 606 states that a contract is considered “completed” if all (or substantially all) of the revenue was recognized in accordance with revenue guidance that was in effect before the date of initial application. Because all (or substantially all) of the revenue related to sales of our products has been recognized under ASC 605 prior to the date of initial application of the new standard, the contracts are considered completed under ASC 606. Based on our evaluation of ASC 606, we concluded that a cumulative adjustment was not necessary upon implementation of ASC 606 on January 1, 2018.

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

Prescription Products

Our products consist primarily of prescription vitamins and our recently approved product IMVEXXY®, which we began selling during the third quarter of 2018. We sell our name brand and generic prescription products primarily through wholesale distributors and retail pharmacy distributors. 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 pharmacy distributors, which are to: (1) transfer promised goods and (2) provide customer service for an immaterial fee. We treat shipping as a fulfillment activity rather than as a separate obligation. We recognize prescription revenue only when we satisfy performance obligations by transferring a promised good or service to a customer. A good or service is considered to be transferred when the customer receives the goods or service or obtains control. Control refers to the customer’s ability to direct the use of, and obtain substantially all of the remaining benefits from, an asset. All of our performance obligations, and associated revenue, are transferred to customers at a point in time. Based on our contracts, we invoice customers once our performance obligations have been satisfied, at which point payment is unconditional. We disclose receivables from contracts with customers separately in the statement of financial position. Payment for goods or services sold by us is typically due between 30 and 60 days after an invoice is sent to the customer.

The transaction price of a contract is the amount of consideration which we expect to be entitled to in exchange for transferring promised goods or services to a customer. Prescription products are sold at fixed wholesale acquisition cost, or WAC, determined based on our list price. However, the total transaction price is variable as it is calculated net of estimated product returns, chargebacks, rebates, coupons, discounts and wholesaler fees. These estimates are based on the amounts earned or to be claimed on the related sales and are classified as reductions of accounts receivable (if the amount is payable to the customer) or a current liability (if the amount is payable to a party other than a customer). In order to determine the transaction price, we estimate the amount of variable consideration at the outset of the contract either utilizing the expected value or most likely amount method, depending on the facts and circumstances relative to the contract or each variable consideration. The estimated amount of variable consideration is included in the transaction price only to the extent that it is probable that a significant reversal in the amount of cumulative revenue recognized will not occur when the uncertainty associated with the variable consideration is subsequently resolved. In determining amounts of variable consideration to include in a contract’s transaction price, we rely on our historical experience and other evidence that supports our qualitative assessment of whether revenue would be subject to a significant reversal. We consider all the facts and circumstances associated with both the risk of a revenue reversal arising from an uncertain future event and the magnitude of the reversal if that uncertain event were to occur. Actual amounts of consideration ultimately received may differ from our estimates. If actual results in the future vary from our original estimates, we will adjust these estimates, which would affect net product revenue and earnings in the period such changes in estimates become known.

We accept returns of unsalable prescription products sold through wholesale distributors within a return period of six months prior to and up to 12 months following product expiration. Our prescription products currently have a shelf life of 24 months from the date of manufacture. We do not allow product returns for prescription products that have been dispensed to a patient. We estimate the amount of our product sales that may be returned by our customers and record this estimate as a reduction of revenue in the period the related product revenue is recognized. Where historical rates of return exist, we use history as a basis to establish a returns reserve for products shipped to wholesalers. For our newly launched products, for which the right of return exists but for which we currently do not have history of product returns, we estimate returns based on available industry data, our own sales information and our visibility into the inventory remaining in the distribution channel. At the end of each reporting period, we may decide to constrain revenue for product returns based on information from various sources, including channel inventory levels and dating and sell-through data, the expiration dates of products currently being shipped, price changes of competitive products and any introductions of generic products. We recognize the amount of expected returns as a refund liability, representing the obligation to return the customer’s consideration. Since our returns primarily consist of expired and short dated products that will not be resold, we do not record a return asset for the right to recover the goods returned by the customer at the time of the initial sale (when recognition of revenue is deferred due to the anticipated return). Return estimates are recorded in the accrued expenses and other current liabilities on the consolidated balance sheet.

We offer various rebate and discount programs in an effort to maintain a competitive position in the marketplace and to promote sales and customer loyalty. We estimate the allowance for consumer rebates and coupons that we have offered based on our experience and industry averages, which is reviewed, and adjusted if necessary, on a quarterly basis. Estimates relating to these rebates and coupons are deducted from gross product revenues at the time the revenues are recognized. We record distributor fees based on amounts stated in contracts. Rebate and coupon estimates and distributor fees are recorded in accrued expenses and other current liabilities on the consolidated balance sheet. We estimate chargebacks based on number of units sold during the period taking into account prices stated in contracts and our historical experience. Estimates related to distributors fees, rebates, coupons and returns are disclosed in Note 7. We provide invoice discounts to our customers for prompt payment. Estimates relating to invoice discounts and chargebacks are deducted from gross product revenues at the time the revenues are recognized.

As part of the commercial launch for IMVEXXY® during the third quarter of 2018, we introduced a co-pay assistance program where enrolled patients do not pay more than $35 for up to 12 IMVEXXY® prescription fills. This allows patients to access the product at a reasonable cost regardless of insurance coverage. We reimburse pharmacies for this discount through third-party vendors. We consider these payments as consideration paid to the customer and reflect such payments as a reduction of the transaction price as we do not receive a distinct good or service related to these payments. The variable consideration is estimated based on contract prices, the estimated percentage of patients that will utilize the copay assistance, the average assistance paid, the estimated levels of inventory in the distribution channel and the current level of prescriptions covered by patients’ insurance. Payers may change coverage levels for IMVEXXY® positively or negatively, at any time up to the time that we have formally contracted coverage with the payer. As such, the net transaction price of IMVEXXY® is susceptible to such changes in coverage levels, which are outside the influence of the Company. As a result, we constrain revenue recognized for IMVEXXY® to an amount that will not result in a significant revenue reversal in future periods. Our ability to estimate the net transaction price for IMVEXXY® is constrained by our estimates of the amount to be paid for the co-pay assistance program for IMVEXXY® which is directly related to the level of prescriptions paid for by insurance. As such, we record an accrual to reduce gross sales for the estimated co-pay and other patient assistance based on currently available third-party data and our internal analyses. We re-evaluate any constraint each reporting period.

OTC Products

Our over the counter, or OTC, and prescription prenatal vitamin products are generally variations of the same product with slight modifications in formulation and marketing. As of January 1, 2017, we decided to focus on selling our prescription vitamins and ceased manufacturing and distributing our OTC product lines, except for Iron 21/7 which we ceased manufacturing in October 2017. We generated OTC revenue from product sales primarily to retail consumers. We recognized revenue from product sales upon shipment, when the rights of ownership and risk of loss have passed to the consumer. We included outbound shipping and handling fees, if any, in revenues, net, and bill them upon shipment. We included shipping expenses in cost of goods sold. A majority of our OTC customers paid for our products with credit cards, and we usually received the cash settlement in two to three banking days. Credit card sales minimized accounts receivable balances relative to OTC sales. We provided an unconditional 30-day money-back return policy under which we accept product returns from our retail and eCommerce OTC customers. We recognized revenue from OTC sales, net of estimated returns and sales discounts.

Disaggregation of revenue

The following table provides information about disaggregated revenue by product mix for the years ended December 31, 2018, 2017, and 2016:

	For the Years Ended December 31,
	2018		2017		2016
Prescription vitamins	$	15,041,259	$	16,744,831	$	18,854,984
IMVEXXY®		1,058,201		—		—
OTC products		—		32,882		501,466
Net revenue	$	16,099,460	$	16,777,713	$	19,356,450

Segment Reporting

We are managed and operated as one business, which is focused on creating and commercializing products targeted exclusively for women. Our business operations are managed by a single management team that reports to the President of our company. We do not operate separate lines of business with respect to any of our products and we do not prepare discrete financial information with respect to separate products. All product sales are derived from sales in the United States. Accordingly, we view our business as one reportable operating segment.

Shipping and Handling Costs

We expense all shipping and handling costs as incurred. We include these costs in cost of goods sold on the accompanying consolidated financial statements.

Advertising Costs

We expense advertising costs when incurred. Advertising costs were $1,682,746, $448,288, and $752,611 during the years ended December 31, 2018, 2017, and 2016, respectively.

Research and Development Expenses

Research and development, or R&D, expenses include internal R&D activities, services of external contract research organizations, or CROs, costs of their clinical research sites, manufacturing, scale-up and validation costs, and other activities. Internal R&D activity expenses include laboratory supplies, salaries, benefits, and non-cash share-based compensation expenses. CRO activity expenses include preclinical laboratory experiments and clinical trial studies. Other activity expenses include regulatory consulting and legal fees and costs. The activities undertaken by our regulatory consultants that were classified as R&D expenses include assisting, consulting with, and advising our in-house staff with respect to various FDA submission processes, clinical trial processes, and scientific writing matters, including preparing protocols and FDA submissions. Legal activities that were classified as R&D expenses include professional research and advice regarding R&D, patents and regulatory matters. These consulting and legal expenses were direct costs associated with preparing, reviewing, and undertaking work for our clinical trials and investigative drugs. We charge internal R&D activities and other activity expenses to operations as incurred. We make payments to CROs based on agreed-upon terms, which may include payments in advance of a study starting date. We expense nonrefundable advance payments for goods and services that will be used in future R&D activities when the activity has been performed or when the goods have been received rather than when the payment is made. We review and accrue CRO expenses and clinical trial study expenses based on services performed and rely on estimates of those costs applicable to the completion stage of a study as provided by CROs. Estimated accrued CRO costs are subject to revisions as such studies progress to completion. We charge revisions to expense in the period in which the facts that give rise to the revision become known.

Earnings Per Share

We calculate earnings per share, or EPS, in accordance with ASC 260, Earnings Per Share, which requires the computation and disclosure of two EPS amounts: basic and diluted. We compute basic EPS based on the weighted-average number of shares of common stock, par value $0.001 per share, or Common Stock, outstanding during the period. We compute diluted EPS based on the weighted-average number of shares of our Common Stock outstanding plus all potentially dilutive shares of our Common Stock outstanding during the period. Such potentially dilutive shares of our Common Stock consist of options, warrants and restricted stock awards and were excluded from the calculation of diluted earnings per share because their effect would have been 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.

	As of December 31,
	2018		2017		2016
Stock options		20,872,824		23,365,225		21,767,854
Warrants		3,007,571		3,115,905		12,060,071
Restricted stock awards		1,040,000		—		—
		24,920,395		26,481,130		33,827,925

Concentration of Credit Risk and other Risks and Uncertainties

Financial instruments that potentially expose us to concentrations of credit risk consist primarily of cash and trade accounts receivable. Cash is on deposit with financial institutions in the United States and these deposits generally exceed the amount of insurance provided by the FDIC. We have not experienced any historical losses on its deposits of cash.

Concentration of credit risk with respect to our trade accounts receivable from our customers is primarily limited to drug wholesalers and retail pharmacy distributors. Credit is extended to our customers based on an evaluation of a customer’s financial condition, and collateral is not required.

Use of Estimates

Our consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America, or GAAP. The preparation of these financial statements requires us to make significant estimates and judgments that affect the reported amounts of assets, liabilities, revenue, expenses, and related disclosure of contingent assets and liabilities. We evaluate our estimates, including those related to contingencies, on an ongoing basis. We base our estimates on historical experience and on various other assumptions that we believe to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ, at times in material amounts, from these estimates under different assumptions or conditions.

Recently Issued Accounting Pronouncements

In August 2018, the FASB issued Accounting Standards Update, or ASU, 2018-13 which eliminates certain disclosure requirements for fair value measurements for all entities, requires public entities to disclose certain new information and modifies some disclosure requirements. The FASB developed the amendments to ASC 820 as part of its broader disclosure framework project, which aims to improve the effectiveness of disclosures in the notes to financial statements by focusing on requirements that clearly communicate the most important information to users of the financial statements. The new guidance is effective for all entities for fiscal years beginning after December 15, 2019 and for interim periods within those fiscal years. An entity is permitted to early adopt either the entire standard or only the provisions that eliminate or modify requirements. We are currently evaluating the effect of this guidance on our disclosures.

In June 2018, the FASB issued ASU 2018-07 to simplify the accounting for share-based payments to nonemployees by aligning it with the accounting for share-based payments to employees, with certain exceptions. The new guidance expands the scope of ASC 718 to include share-based payments granted to nonemployees in exchange for goods or services used or consumed in an entity’s own operations and supersedes the guidance in ASC 505-50. The guidance is effective for public business entities in annual periods beginning after December 15, 2018, and interim periods within those annual periods. Early adoption is permitted, including in an interim period for which financial statements have not been issued, but not before an entity adopts ASC 606. We do not expect that the adoption of this standard will have a material effect on our consolidated financial statements and disclosures.

In February 2016, the FASB issued ASU 2016-02, Leases. This guidance requires lessees to record most leases on their balance sheets but recognize expenses on their income statements in a manner similar to current accounting. The guidance also eliminates current real estate-specific provisions for all entities. For lessors, the guidance modifies the classification criteria and the accounting for sales-type and direct financing leases. The standard is effective for public business entities for annual periods beginning after December 15, 2018, and interim periods within those years. Early adoption is permitted for all entities. In July 2018, the FASB amended the new leases standard and issued ASU 2018-11, Leases, (Topic 842): Targeted Improvements to give entities another option for transition and to provide lessors with a practical expedient. We plan to adopt ASU 2016-02 on January 1, 2019 utilizing the alternative transition method allowed for under ASU 2018-11. While we are still finalizing the quantitative and qualitative impact of adopting this new standard and the subsequent amendments, the most significant impact is expected to be the recognition of a right of use asset and lease liability on our statement of financial position related to the operating leases for our new and existing office space. We elected the optional transition method of recognizing a cumulative-effect adjustment to the opening balance of retained earnings on January 1, 2019. Therefore, comparative financial information will not be adjusted and will continue to be reported under ASC 840. We also elected the transition relief package of practical expedients and as a result we will not assess 1) whether existing or expired contracts contain leases, 2) lease classification for any existing or expired leases, and 3) whether lease origination costs qualified as initial direct costs. We elected the short-term lease practical expedient by establishing an accounting policy to exclude leases with a term of 12 months or less. We will not separate lease components from non-lease components for our specified asset classes. Based on our preliminary calculations, we currently expect to recognize right-of-use asset and corresponding lease liability between $4 million to $5 million on our Consolidated Balance Sheet based on the present value of future minimum lease payments under operating leases in effect on January 1, 2019. Additionally, the adoption of the new standard will result in increased disclosure requirements in our quarterly and annual filings.

In May 2014, the FASB issued ASU No. 2014-09, Revenue from Contracts with Customers (Topic 606). The standard’s core principle is that a company will recognize revenue when it transfers promised goods or services to customers in an amount that reflects the consideration to which the company expects to be entitled in exchange for those goods or services. In doing so, companies will need to use more judgment and make more estimates than under previous guidance. This may include identifying performance obligations in the contract, estimating the amount of variable consideration to include in the transaction price and allocating the transaction price to each separate performance obligation. In July 2015, the FASB approved the proposal to defer the effective date of ASU 2014-09 standard by one year. Early adoption is permitted after December 15, 2016, and the standard is effective for public entities for annual reporting periods beginning after December 15, 2017 and interim periods therein. In 2016, the FASB issued final amendments to clarify the implementation guidance for principal versus agent considerations (ASU 2016-08), accounting for licenses of intellectual property and identifying performance obligations (ASU 2016-10), narrow-scope improvements and practical expedients (ASU 2016-12) and technical corrections and improvements to topic 606 (ASU 2016-20) in its new revenue standard. We adopted this standard under the modified retrospective method to all contracts not completed as of January 1, 2018 and the adoption did not have a material effect on our financial statements but we expanded our disclosures related to contracts with customers.

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.

INTANGIBLE ASSETS, NET

12 Months Ended

Dec. 31, 2018

Intangible Assets, Net (Excluding Goodwill) [Abstract]

INTANGIBLE ASSETS, NET

NOTE 6 – INTANGIBLE ASSETS, NET

The following table sets forth the gross carrying amount, accumulated amortization and net carrying amount of our intangible assets as of December 31, 2018 and 2017:

	December 31, 2018
	Gross Carrying Amount		Accumulated Amortization			Net Amount		Weighted- Average Remaining Amortization Period (yrs.)
Amortizable intangible assets:
OPERA^®software patent	$	31,951	$	(10,484	)	$	21,467		10.75
Development costs of corporate website		91,743		(91,743	)		—		n/a
Approved hormone therapy drug candidate patents		2,234,129		(282,485	)		1,951,644		14
Hormone therapy drug candidate patents (pending)		1,855,279		—			1,855,279		n/a
Non-amortizable intangible assets:
Multiple trademarks		264,289		—			264,289		indefinite
TOTAL	$	4,477,391	$	(384,712	)	$	4,092,679

	December 31, 2017
	Gross Carrying Amount		Accumulated Amortization			Net Amount		Weighted- Average Remaining Amortization Period (yrs.)
Amortizable intangible assets:
OPERA^®software patent	$	31,951	$	(8,487	)	$	23,464		11.75
Development costs of corporate website		91,743		(91,743	)		—		n/a
Approved hormone therapy drug candidate patents		1,293,614		(171,911	)		1,121,703		15
Hormone therapy drug candidate patents (pending)		1,721,305		—			1,721,305		n/a
Non-amortizable intangible assets:
Multiple trademarks		233,275		—			233,275		indefinite
TOTAL	$	3,371,888	$	(272,141	)	$	3,099,747

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 years ended December 31, 2018 and 2017, there was no impairment recognized related to intangible assets.

As of December 31, 2018, we had 21 issued domestic or U.S. patents and 24 issued foreign patents, including:

●	11 domestic patents and five foreign patents that relate to BIJUVA™ as well as 3 domestic patents that relate to non-approved doses of BIJUVA™. These patents establish an important intellectual property foundation for BIJUVA™ 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, Europe, Israel, Japan, Mexico, Russia, South Africa, and South Korea;
●	Three foreign patents that relate to our progesterone-only candidate, which are owned by us. The foreign patent will expire no earlier than 2033. In addition, we have pending patent applications with respect to our progesterone-only candidate in the U.S., Argentina, Australia, Brazil, Canada, Europe, Israel, Japan, Mexico, Russia, South Africa, and South Korea;
●	Three domestic patents (two utility and one design) and 12 foreign patents (three utility and nine design) that relate to IMVEXXY®. These patents establish an important intellectual property foundation for IMVEXXY® and are owned by us. These 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 jurisdictions, 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, 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. We have pending patent applications with respect to our topical-cream candidates in the U.S., Argentina, Australia, Brazil, Canada, Europe, Israel, Japan, Mexico, Russia, South Africa, and South Korea;
●	One domestic utility patent and four 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., Australia, Brazil, Canada, Europe, Mexico, Japan, and South Africa;
●	One domestic utility patent that relates to our OPERA® information-technology platform, which is owned by us and will expire in 2029; and

●	One domestic utility patent that relates to TX-009HR, a progesterone and estradiol product candidate, which is owned by us and will expire in 2037. We have pending patent applications with respect to TX-009HR in the U.S., Argentina, Australia, Brazil, Canada, Europe, Israel, Japan, Mexico, New Zealand, Russia, South Africa, and South Korea.

Amortization expense was $112,474, $71,516, and $54,545 for the years ended December 31, 2018, 2017, and 2016, 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
	2019	$	139,410
	2020	$	139,410
	2021	$	139,410
	2022	$	139,410
	2023	$	139,410
	Thereafter	$	1,276,061

License Agreement with the Population Council

On July 30, 2018, we entered into the Council License Agreement, with the Population Council to commercialize in the U.S. ANNOVERA™. We currently estimate that ANNOVERA™ will be commercially available as early as the third quarter of 2019 with a planned full commercial launch by the first quarter of 2020.

Under the terms of the Council License Agreement, we paid the Population Council a milestone payment of $20,000,000 within 30 days following approval by the FDA of the NDA for ANNOVERA™ and will be required to pay the Population Council $20,000,000 within 30 days following the release of the first commercial batch of ANNOVERA™. The Population Council is also eligible to receive milestone payments and royalties from commercial sales of ANNOVERA™. We will assume responsibility for marketing expenses related to the commercialization of ANNOVERA™. The milestone payment of $20,000,000 upon the FDA’s approval of ANNOVERA™ in the third quarter of 2018 was recorded as a finite-lived intangible asset in the consolidated balance sheet and will be amortized on a straight-line basis once it becomes available for use which is expected to be upon release of first commercial batch of ANNOVERA^TM. In addition, we are required to pay the Population Council, on a quarterly basis, step-based royalty payments based on annual net sales of ANNOVERA™ in the U.S. by the Company and its affiliates and permitted licensees as follows: (i) if annual net sales are less than or equal to $50,000,000, a royalty of 5% of net sales; (ii) for annual net sales greater than $50,000,000 and less than or equal to $150,000,000, a royalty of 10% of such net sales; and (iii) for net sales greater than $150,000,000, a royalty of 15% of such net sales. The annual royalty rate will be reduced to 50% of the initial rate during the six-month period beginning on the date of the first arms-length commercial sale of a generic equivalent of the one-year vaginal contraceptive system that is launched by a third party in the U.S., and thereafter will be reduced to 20% of the initial rate. The Population Council has agreed to perform and pay the costs and expenses associated with four post-approval studies required by the FDA for ANNOVERA™ and we have agreed to perform and pay the costs and expenses associated with a post approval study required by the FDA to measure risk for venous thromboembolism, provided that if the costs and expenses associated with such post-approval study exceed $20,000,000, half of such excess will be offset against royalties or other payments owed by us to the Population Council under the Council License Agreement. We and the Population Council have agreed to form a joint product committee responsible for overseeing activities under the Council License Agreement. We will be responsible for all aspects of promotion, product positioning, pricing, education programs, publications, sales messages and any additional desired clinical studies for the one-year vaginal contraceptive system, subject to oversight and decisions made by the joint product committee. The Council License Agreement includes exclusive rights for us to negotiate co-development of two other investigational vaginal contraceptive systems in development by the Population Council.

We assess our intangible assets for impairment if indicators are present or changes in circumstance suggest that impairment may exist. If impairment indicators are present or changes in circumstance suggest that impairment may exist, we perform a recoverability test by comparing the sum of the estimated undiscounted cash flows of each intangible asset to its carrying value on the consolidated balance sheet. If the undiscounted cash flows used in the recoverability test are less than the carrying value, we would determine the fair value of the intangible asset and recognize an impairment loss if the carrying value of the intangible asset exceeds its fair value. We also evaluate the remaining useful life of intangible assets subject to amortization on a periodic basis to determine whether events and circumstances would indicate impairment or warrant a revision to the remaining useful life. If the estimate of an intangible asset’s remaining useful life is changed, we will amortize the remaining carrying value of the intangible asset prospectively over the revised remaining useful life.

License Agreement with Knight Therapeutics Inc.

On July 30, 2018, we entered into a license and supply agreement, or the Knight License Agreement, with Knight pursuant to which we granted Knight an exclusive license to commercialize IMVEXXY® and BIJUVA^TM in Canada and Israel. Pursuant to the terms of the Knight License Agreement, Knight will pay us a milestone fee upon first regulatory approval in Canada of each of IMVEXXY® and BIJUVA^TM, sales milestone fees based upon certain aggregate annual sales in Canada and Israel of each of IMVEXXY® and BIJUVA^TM and royalties based on aggregate annual sales of each of IMVEXXY® and BIJUVA^TMin Canada and Israel. Knight will be responsible for all regulatory and commercial activities in Canada and Israel related to IMVEXXY® and BIJUVA^TM. 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^TMin Canada and Israel within certain specified time periods. We also may terminate the Knight License Agreement if Knight challenges our patents. Either party may terminate the Knight License Agreement for any material breach by the other party that is not cured within certain specified time periods or if the other party files for bankruptcy or other related matters. In connection with the Knight License Agreement, Knight entered into a subscription agreement with us, pursuant to which Knight purchased 3,921,568 of shares of our Common Stock concurrently with the closing of the underwritten public offering of Common Stock at a price of $5.10, for proceeds of $20,000,000, on August 6, 2018.

DEBT

12 Months Ended

Dec. 31, 2018

Debt Disclosure [Abstract]

DEBT

NOTE 8 – DEBT

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).

On July 30, 2018, we entered into Amendment No. 1 to the Credit Agreement in order to permit our entry into the Council License Agreement. Pursuant to the amendment, we were required to receive aggregate net cash proceeds of at least $75,000,000 from the issuance of our equity securities within thirty days of entering into the Council License Agreement, which we did in connection with the August 2018 underwritten public offering.

The Credit Agreement provides 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 will be made in three separate tranches, with each tranche to be made available to us, at our option, upon our achievement of certain milestones. The first tranche of $75,000,000, or Tranche 1, was drawn by us on June 7, 2018, following approval by the FDA of the NDA for IMVEXXY®. The second tranche of $75,000,000, or Tranche 2, may be drawn by us on or before May 31, 2019, provided that we satisfy certain conditions described in the Credit Agreement, including (i) that Tranche 1 has been drawn, (ii) the approval by the FDA of the NDA for BIJUVA^TMand (iii) we have consummated our first commercial sale in the United States of BIJUVA^TM. The third tranche of $50,000,000, or Tranche 3, may be drawn by us on or before December 31, 2019, provided that we satisfy certain conditions described in the Credit Agreement, including that (i) Tranche 2 has been drawn and (ii) we have generated at least $75,000,000 of consolidated net revenue attributable to commercial sales of BIJUVA^TM and IMVEXXY® during the twelve-month period ending immediately prior to the funding of Tranche 3.

Amounts borrowed under the Term Loan bear 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. Interest on amounts borrowed under the Term Loan is due and payable monthly in arrears. Principal on each Tranche is payable in 36 equal monthly installments beginning May 1, 2020 until paid in full on May 1, 2023, or the Maturity Date. However, if we generate at least $95,000,000 of consolidated net revenue attributable to commercial sales of BIJUVA^TMand IMVEXXY® by December 31, 2019, we may extend the interest-only period by an additional 12 months to May 1, 2021. Interest expense related to this Term Loan for the year ended December 31, 2018 was $4,407,975.

The Term Loan may be prepaid, in whole or in part, subject to a prepayment fee on the amount being prepaid (or required to be prepaid, if such amount is greater) of (i) 4.0% for the first year following the Tranche 1 funding date, (ii) 3.0% for the second year following the Tranche 1 funding date and (iii) 2.0% thereafter. Upon repayment of the Term Loan at the Maturity Date or prepayment on any earlier date, we will be required to pay a termination payment based on the principal amount paid or prepaid. In connection with the execution of the Credit Agreement, we paid the Agent, for the benefit of all Lenders, an origination fee equal to 1.00% of the maximum potential amount of the Term Loan. We are also required to pay the Agent an annual administration fee of 0.25% based on the amounts borrowed under the Term Loan, in addition to other fees and expenses.

Our obligations under the Credit Agreement are secured, subject to customary permitted liens and other agreed upon exceptions, by a first priority perfected security interest in all of our existing and after-acquired assets. Our obligations under the Credit Agreement are guaranteed by each of our future direct and indirect subsidiaries (other than certain non-U.S. subsidiaries of ours and certain U.S. subsidiaries substantially all of whose assets consist of equity interests in non-U.S. subsidiaries, subject to certain exceptions). The Credit Agreement contains customary restrictions and covenants. Among other requirements, we must (i) maintain a minimum cash balance of $50,000,000 and (ii) achieve certain minimum consolidated net revenue amounts attributable to commercial sales of our products. As of December 31, 2018, we were in compliance with the covenants under the Credit Agreement.

The Credit Agreement also contains customary covenants that limit, among other things, our ability to (i) incur indebtedness, (ii) incur liens on our property, (iii) pay dividends or make other distributions, (iv) sell our assets, (v) make certain loans or investments, (vi) merge or consolidate, (vii) voluntarily repay or prepay certain permitted indebtedness and (viii) enter into transactions with affiliates, in each case subject to certain exceptions. The Credit Agreement contains customary representations and warranties and events of default relating to, among other things, payment defaults, breaches of covenants, the occurrence of any fact, event or circumstance that could reasonably be expected to result in a Material Adverse Effect (as defined in the Credit Agreement), delisting of our common stock, par value $0.001 per share, or Common Stock, bankruptcy and insolvency, cross defaults with certain material indebtedness and certain material contracts, judgments and inaccuracies of representations and warranties. Upon or after an event of default, the agent and the Lenders may declare all or a portion of our obligations under the Credit Agreement to be immediately due and payable and exercise other rights and remedies provided for under the Credit Agreement.

As of December 31, 2018, we had $75,000,000 in borrowings outstanding under the Term Loan, which are classified as long-term debt in the accompanying consolidated financial statements. We incurred $3,786,918 in debt issuance costs related to the Term Loan. Debt financing fees related to the entire Term Loan have been allocated pro rata between the funded and unfunded portions of each tranche. Allocated debt financing fees related to Tranche 1 of $1,888,844 have been reclassified to debt discount and are accreted to interest expense using the effective interest method. Debt financing fees associated with unfunded tranches are deferred as assets until Tranche 2 and Tranche 3 milestones have been met. As of December 31, 2018, deferred financing fees related to Tranche 2 and Tranche 3 are included in other current assets in the accompanying consolidated financial statements. During the year ended December 31, 2018, we amortized $269,859, of debt issuance costs related to Tranche 1 as interest expense in our accompanying consolidated financial statements. The overall effective interest rate was approximately 11% as of December 31, 2018. As of December 31, 2018, the carrying value of debt consists of the following:

	December 31, 2018
Term Loan	$	75,000,000
Debt discount and financing fees		(1,618,986	)
TOTAL LONG-TERM DEBT	$	73,381,014

STOCKHOLDERS' EQUITY

12 Months Ended

Dec. 31, 2018

Stockholders' Equity:

STOCKHOLDERS' EQUITY

NOTE 9 – STOCKHOLDERS’ EQUITY

Preferred Stock

At December 31, 2018, we had 10,000,000 shares of preferred stock, par value $0.001, authorized for issuance, of which no shares of preferred stock were issued or outstanding.

Common Stock

At December 31, 2018, we had 350,000,000 shares of Common Stock authorized for issuance, of which 240,462,439 shares of our Common Stock were issued and outstanding.

On August 1, 2018, we entered into an underwriting agreement with Goldman Sachs & Co. LLC, as representative of the underwriters, relating to an underwritten public offering of 12,745,098 shares of our Common Stock at a price of $5.10 per share. We granted the underwriters an option, exercisable for a period of 30 days, to purchase up to 1,911,764 additional shares of Common Stock. On August 2, 2018, the underwriters exercised the option in full. The net proceeds from the offering, including the exercise of the option to purchase additional shares, were approximately $69,908,000, after deducting the underwriting discount and offering expenses payable by us. The offering closed on August 6, 2018.

In connection with the Knight License Agreement, on August 6, 2018, Knight entered into a subscription agreement with us, pursuant to which Knight purchased 3,921,568 of shares of our Common Stock concurrently with the closing of the underwritten public offering of Common Stock at a price of $5.10, for proceeds of $20,000,000.

Issuances During 2018

During the year ended December 31, 2018, certain individuals exercised stock options to purchase 5,444,526 shares of Common Stock for $1,666,208 in cash. Also, during the year ended December 31, 2018, stock options to purchase 10,000 shares of Common Stock were exercised pursuant to the options’ cashless exercise provisions, wherein 9,841 shares of Common Stock were issued.

Issuances During 2017

On September 25, 2017, we entered into an underwriting agreement with J.P. Morgan Securities LLC relating to an underwritten public offering of 12,400,000 shares of our Common Stock at a price of $5.55 per share. The net proceeds to us from the offering were approximately $68,573,000, after deducting estimated offering expenses payable by us. The offering closed on September 28, 2017 and we issued 12,400,000 shares of Common Stock.

During the year ended December 31, 2017, certain individuals exercised stock options to purchase 102,546 shares of Common Stock for $212,615 in cash.

Issuances During 2016

On January 6, 2016, we entered into an underwriting agreement with Goldman Sachs & Co. and Cowen and Company, LLC, as the representatives of the several underwriters relating to an underwritten public offering of 15,151,515 shares of our Common Stock at a public offering price of $8.25 per share. Under the terms of the underwriting agreement, we granted the Underwriters a 30-day option to purchase up to an aggregate of 2,272,727 additional shares of Common Stock, which the option was exercised in full. The net proceeds to us from the offering were approximately $134,864,000, after deducting underwriting discounts and commissions and other expenses payable by us. The offering closed on January 12, 2016 and we issued 17,424,242 shares of our Common Stock.

During the year ended December 31, 2016, certain individuals exercised stock options to purchase 525,362 shares of Common Stock for $989,060 in cash. Also, during the same period, stock options to purchase 127,109 shares of Common Stock were exercised pursuant to the options’ashless exercise provisions, wherein 87,833 shares of Common Stock were issued.

Warrants to Purchase Common Stock

As of December 31, 2018, we had warrants outstanding to purchase an aggregate of 3,007,571 shares of Common Stock with a weighted-average contractual remaining life of approximately 1.6 years, and exercise prices ranging from $0.24 to $8.20 per share, resulting in a weighted average exercise price of $2.78 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.

During the year ended December 31, 2018, we granted warrants to purchase 175,000 shares of Common Stock to outside consultants at an exercise price of $5.16 per share. 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 62.1%; risk free rate of 2.36%; and dividend yield of 0%. The grant date fair value of the warrants was $2.79 per share. The warrants vest ratably over a 12-month period and have an expiration date of March 15, 2023.

During the year ended December 31, 2017, we granted warrants to purchase 125,000 shares of Common Stock to outside consultants at an exercise price of $6.83 per share. 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 63.24%; risk free rate of 1.47%; and dividend yield of 0%. The grant date fair value of the warrants was $3.67 per share. The warrants vest ratably over a 12-month period and have an expiration date of March 15, 2022.

During the year ended December 31, 2016, we granted warrants to purchase 245,000 shares of Common Stock to outside consultants at the weighted average price of $7.90 per share. These warrants vest and have expiration dates as follows: warrants to purchase 75,000 shares of Common Stock vested on April 21, 2016 and have an expiration date of April 21, 2021, warrants to purchase 50,000 shares of Common Stock vest ratably over a 24-month period and have an expiration date of April 21, 2021, and warrants to purchase 120,000 shares of Common Stock vest ratable over a 12-month period and have an expiration date of January 21, 2021. We recorded share-based compensation expense related to warrants previously issued of $494,136, $313,271 and $936,974 for the years ended December 31, 2018, 2017 and 2016, respectively, in the accompanying consolidated financial statements. At December 31, 2018, total unrecognized estimated compensation expense related to unvested warrants was approximately $106,000 which is expected to be recognized over weighted-average period of 0.2 years.

Summary of our Warrant activity during the year ended December 31, 2018:

	Number of Shares Under Warrants			Weighted Average Exercise Price		Weighted Average Remaining Contractual Life in Years		Aggregate Intrinsic Value
Balance at December 31, 2017		3,115,905		$	2.58		1.8	$	11,348,273
Granted		175,000		$	5.16
Exercised		—
Expired		(283,334	)	$	2.01
Cancelled/Forfeited		—
Balance at December 31, 2018		3,007,571		$	2.78		1.58	$	4,826,403
Vested and Exercisable at December 31, 2018		2,963,818		$	2.75		1.54	$	4,826,403
Unvested at December 31, 2018		43,753		$	5.16		4.21	$	0

The weighted average fair value per share of warrants issued and the assumptions used in the Black-Scholes Model during the years ended December 31, 2018, 2017, and 2016 are set forth in the table below.

	2018			2017			2016
Weighted average exercise price	$	5.16		$	6.83		$	7.90
Weighted average grant date fair value	$	2.79		$	3.67		$	4.78
Risk-free interest rate		2.36	%		1.47	%		1.04-1.28	%
Volatility		62.12	%		63.24	%		74.10-74.15	%
Term (in years)		5			5			5
Dividend yield		0.00	%		0.00	%		0.00	%

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 the stock price is expected to fluctuate each year during the term of the instrument. Our calculation of estimated volatility is based on historical stock prices over a period equal to the term of the instrument. The expected volatility of warrants was estimated based on a historical volatility analysis of our Company as well as peers that were similar to the Company with respect to industry, stage of life cycle, market capitalization, and financial leverage.

In May 2013, we entered into a consulting agreement with Sancilio and Company, Inc., or SCI, to develop drug platforms to be used in our hormone replacement drug candidates. These services include support of our efforts to successfully obtain FDA approval for our drug candidates, including a vaginal capsule for the treatment of VVA. In connection with the agreement, SCI agreed to forfeit its rights to receive warrants to purchase 833,000 shares of our Common Stock that were to be granted pursuant to the terms of a prior consulting agreement dated May 17, 2012. As consideration under the agreement, we agreed to issue to SCI a warrant to purchase 850,000 shares of our Common Stock at $2.01 per share that has vested or will vest, as applicable, as follows:

283,333 shares were earned on May 11, 2013 upon acceptance of an Investigational New Drug application by the FDA for an estradiol-based drug candidate in a softgel vaginal capsule for the treatment of VVA; however, pursuant to the terms of the consulting agreement, the shares did not vest until June 30, 2013. The fair value of $405,066 for the shares vested on June 30, 2013 was determined by using the Black-Scholes Model on the date of vesting using a term of five years; a volatility of 45.89%; risk free rate of 1.12%; and a dividend yield of 0%. We recorded the entire $405,066 as non-cash compensation as of June 30, 2013. These shares were exercised in 2017 and are included in the warrant exercise details below;

283,333 shares vested on June 30, 2013. The fair value of $462,196 for these shares was determined by using the Black-Scholes Model on the date of vesting using a term of five years; a volatility of 45.84%; risk free rate of 1.41%; and a dividend yield of 0%. During the years ended December 31, 2017, 2016, and 2015, we recorded $0, $0, and $77,026, respectively, as non-cash compensation in the accompanying consolidated financial statements related to this warrant. As of December 31, 2017 this warrant was fully amortized. These shares were exercised in 2017 and are included in the warrant exercise details below; and

283,334 shares were going to vest upon the receipt by us, prior to the warrant expiration date of April 30, 2018, of any final FDA approval of a drug candidate that SCI helped us design. Since the receipt of such approval did not occur before warrant’s expiration date, the warrant expired on April 30, 2018.

In May 2012, we issued warrants to purchase an aggregate of 1,300,000 shares of Common Stock to SCI for services to be rendered over approximately five years beginning in May 2012. The warrants vested upon issuance. Services provided are to include (a) services in support of our drug development efforts, including services in support our ongoing and future drug development and commercialization efforts, regulatory approval efforts, third-party investment and financing efforts, marketing efforts, chemistry, manufacturing and controls efforts, drug launch and post-approval activities, and other intellectual property and know-how transfer associated therewith; (b) services in support of our efforts to successfully obtain new drug approval; and (c) other consulting services as mutually agreed upon from time to time in relation to new drug development opportunities. The warrants were valued at $1,532,228 on the date of the issuance using an exercise price of $2.57; a term of five years; a volatility of 44.71%; risk free rate of 0.74%; and a dividend yield of 0%. During the years ended December 31, 2018, 2017, and 2016, we recorded $0, $128,898, and $257,796, respectively as non-cash compensation with respect to these warrants in the accompanying consolidated financial statements. As of December 31, 2017, the SCI warrants issued in 2013 and 2012 were fully amortized. This warrant was fully exercised, of which 800,000 shares were exercised in 2017 and 500,000 shares were exercised in 2016.

Warrant exercises

During the year ended December 31, 2018, no warrants were exercised.

During the year ended December 31, 2017, certain individuals exercised warrants to purchase 2,476,666 shares of Common Stock for $3,798,999 in cash, which included SCI warrants issued in 2012 and 2013. In addition, during the year ended December 31, 2017, certain individuals exercised warrants to purchase 6,590,000 shares of Common Stock pursuant to the warrants’ cashless exercise provisions, wherein 4,762,208 shares of Common Stock were issued.

During the year ended December 31, 2016, certain individuals exercised warrants to purchase 722,744 shares of Common Stock for $1,373,000 in cash, of which 500,000 shares related to SCI warrant issued in 2012.

Options to Purchase Common Stock of the Company

In 2009, we adopted the 2009 Long Term Incentive Compensation Plan, or the 2009 Plan, to provide financial incentives to employees, directors, advisers, and consultants of our company who are able to contribute towards the creation of or who have created stockholder value by providing them stock options and other stock and cash incentives, or the Awards. The Awards available under the 2009 Plan consist of stock options, stock appreciation rights, restricted stock, restricted stock units, performance stock, performance units, and other stock or cash awards as described in the 2009 Plan. There are 25,000,000 shares authorized for issuance thereunder. Generally, the options vest annually over four years or as determined by our board of directors, upon each option grant. Options may be exercised by paying the price for shares or on a cashless exercise basis after they have vested and prior to the specified expiration date provided and applicable exercise conditions are met, if any. The expiration date is generally ten years from the date the option is issued. As of December 31, 2018, there were non-qualified stock options to purchase 14,594,350 shares of Common Stock outstanding under the 2009 Plan. As of December 31, 2018, there were 866,912 shares available to be issued under 2009 Plan.

In 2012, we adopted the 2012 Stock Incentive Plan, or the 2012 Plan, a non-qualified plan that was amended in August 2013. The 2012 Plan was designed to serve as an incentive for retaining qualified and competent key employees, officers, directors, and certain consultants and advisors of our company. The Awards available under the 2012 Plan consist of stock options, stock appreciation rights, restricted stock, restricted stock units, performance stock, performance units, and other stock or cash awards as described in the 2012 Plan. Generally, the options vest annually over four years or as determined by our board of directors, upon each option grant. Options may be exercised by paying the price for shares or on a cashless exercise basis after they have vested and prior to the specified expiration date provided and applicable exercise conditions are met, if any. The expiration date is generally ten years from the date the option is issued. There are 10,000,000 shares of Common Stock authorized for issuance thereunder. As of December 31, 2018, there were non-qualified stock options to purchase 6,278,474 shares of Common Stock outstanding and 1,040,000 restricted stock units outstanding under the 2009 Plan. As of December 31, 2018, there were 2,433,333 shares available to be issued under 2012 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 years ended December 31, 2018, 2017, and 2016 are set forth in the table below.

	2018			2017			2016
Weighted average exercise price	$	5.45		$	6.60		$	6.22
Weighted average grant date fair value	$	3.24		$	3.82		$	3.94
Risk-free interest rate		2.38-2.89	%		1.84-2.05	%		1.13-1.90	%
Volatility		59.45-64.04	%		61.56-64.25	%		70.26-73.34	%
Term (in years)		5.1-6.25			5.5-6.25			5.5-6.25
Dividend yield		0.00	%		0.00	%		0.00	%

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 expected term. Estimated volatility is a measure of the amount by which the stock price is expected to fluctuate each year during the term of an award. Our calculation of estimated volatility is based on historical stock prices over a period equal to the term of the awards. The expected volatility of share options was estimated based on a historical volatility analysis of our Company as well as peers that were similar to us with respect to industry, stage of life cycle, market capitalization, and financial leverage. The average expected life is based on the contractual terms of the stock option using the simplified method. We utilize a dividend yield of zero based on the fact that we have never paid cash dividends and have no current intention to pay cash dividends. Future stock-based compensation may significantly differ based on changes in the fair value of our Common Stock and our estimates of expected volatility and the other relevant assumptions.

A summary of activity under the 2009 and 2012 Plans and related information during the year ended December 31, 2018 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, 2017		23,365,225		$	3.78		5.13	$	64,664,821
Granted		3,264,500		$	5.45
Exercised		(5,454,526	)	$	0.31			$	27,534,623
Expired		(25,000	)	$	7.76
Cancelled/Forfeited		(277,375	)	$	5.47
Balance at December 31, 2018		20,872,824		$	4.93		5.94	$	12,239,876
Vested and Exercisable at December 31, 2018		16,068,991		$	4.61		5.09	$	12,239,876
Unvested at December 31, 2018		4,803,833		$	5.99		8.8	$	0

At December 31, 2018, our outstanding options had exercise prices ranging from $0.10 to $8.92 per share. Share-based compensation expense related to options recognized in our results of operations for the years ended December 31, 2018, 2017, and 2016 was approximately $8,091,294, $6,447,154, and $16,139,225, respectively, and it is based on awards vested. At December 31, 2018, total unrecognized estimated compensation expense related to unvested options was approximately $12,175,000, which may be adjusted for future changes in forfeitures. This cost is expected to be recognized over a weighted-average period of 2.01 years. No tax benefit was realized due to a continued pattern of operating losses.

Restricted Stock

Restricted stock awards granted under our 2009 and 2012 Plans entitle the holder to receive, at the end of vesting period, a specified number of shares of our Common Stock. Share-based compensation expense is measured by the market value of our Common Stock on the day of the grant. The shares vest ratably over the period specified in the grant. There is no partial vesting and any unvested portion is forfeited.

On December 13, 2018, we granted 1,040,000 restricted stock units to certain executive employees which will vest at the end of the third year. The grant date fair value was $4.06 per unit. During the year ended December 31, 2018, we recorded $73,132 in share-based compensation expense related to restricted stock units. At December 31, 2018, total unrecognized estimated compensation expense related to unvested restricted stock units was approximately $4,149,000, which may be adjusted for future changes in forfeitures. This cost is expected to be recognized over a weighted-average period of 2.95 years. At December 31, 2018, 1,040,000 restricted stock awards remained outstanding.

Cash-Settled Stock Appreciation Rights (SARs)

On July 1, 2018, we issued cash-settled SARs to certain consultants and employees. The SARs plan year begins on July 1 and ends on or immediately following June 30, 2019. SARs are granted with a grant price equal to the market value of a share of our Common Stock on the date of grant. Cash-settled SARs provide for the cash payment of the excess of the fair market value of our Common Stock on June 30, 2019 over the grant price. Cash-settled SARs have no effect on dilutive shares or shares outstanding as any appreciation of our Common Stock over the grant price is paid in cash and not in Common Stock.

Cash settled SARs are recorded in our consolidated balance sheets as a liability until the date of exercise. The fair value of each SAR award is estimated using the Black-Scholes valuation model. In accordance with ASC Topic 718, “Stock Compensation,” the fair value of each SAR award is recalculated at the end of each reporting period and the liability and expense adjusted based on the new fair value and the percent vested. At December 31, 2018, we had 103,000 SARs outstanding and the liability related to SAR calculation was $3,406. The assumptions used to determine the fair value of the cash settled SAR awards at December 31, 2018 were life of 6 months, 49.7% volatility, 2.7% risk-free rate, and zero annual dividends. As of December 31, 2018, the fair value of SARs outstanding was $0.07 per award.

INCOME TAXES

12 Months Ended

Dec. 31, 2018

Income Tax Disclosure [Abstract]

INCOME TAXES

NOTE 10 – INCOME TAXES

For financial reporting purposes, income before taxes includes the following components:

	2018			2017			2016
United States		(132,617,160	)		(76,925,380	)		(89,875,459	)
Total		(132,617,160	)		(76,925,380	)		(89,875,459	)

For the years ended December 31, 2018, 2017, and 2016, there was no provision for income taxes, current or deferred. At December 31, 2018, we had a federal net operating loss carry forward of approximately $481,365,550. Approximately $338,668,076 of the federal net operating loss carry forward can be carried forward for 20 years and will begin to expire in 2031. The remaining $142,697,474 can be carried forward indefinitely.

A reconciliation between taxes computed at the federal statutory rate and the consolidated effective tax rate is as follows:

	2018			2017			2016
Federal statutory tax rate		21.0	%		34.0	%		34.0	%
State tax rate, net of federal tax benefit		5.2	%		5.0	%		5.4	%
Adjustment in valuation allowances		(31.2	)%		22.6	%		(40.3	)%
Excess stock benefit		5.3	%		0.0	%		0.0	%
Federal income tax rate change		0.0	%		(60.8	)%		—	%
Permanent and other differences		(0.3	)%		(0.8	)%		0.9	%
Provision (benefit) for income taxes		—			—			—

Deferred income taxes result from temporary differences between the amount of assets and liabilities recognized for financial reporting and tax purposes. The components of the net deferred income tax asset as of December 31, 2018, 2017, and 2016 are as follows:

	2018			2017			2016
Deferred Income Tax Assets:
Net operating losses	$	140,891,764		$	99,596,321		$	111,730,450
R&D Credit		186,347			186,347			186,347
Total deferred income tax asset		141,078,111			99,782,668			111,916,797
Valuation allowance		(141,078,111	)		(99,782,668	)		(111,916,797	)
Deferred income tax assets, net	$	—		$	—		$	—

We believe that it is more likely than not that we will not generate sufficient future taxable income to realize the tax benefits related to the deferred tax assets on our balance sheet and as such, a valuation allowance has been established against the deferred tax assets for the period ended December 31, 2018.

Unrecognized Tax Benefits

As of the period ended December 31, 2018, we have no unrecognized tax benefits.

On December 22, 2017, the U.S. federal government enacted comprehensive tax legislation commonly referred to as the Tax Cuts and Jobs Act, or the Tax Act. The Tax Act makes broad and complex changes to the U.S. federal tax code, including, but not limited to reducing the U.S. federal corporate tax rate from 34 percent to 21 percent, effective January 1, 2018. As the result of our initial analysis of the impact of the Tax Act, we recorded a provisional amount of net tax expense of $46.7 million in 2017 related to the remeasurement of our deferred tax balances and other effects. We completed our accounting for the income tax effects of the Tax Act in 2018, and no material adjustments were required to the provisional amounts initially recorded.

BUSINESS CONCENTRATIONS

12 Months Ended

Dec. 31, 2018

Risks and Uncertainties [Abstract]

BUSINESS CONCENTRATIONS

NOTE 12 - BUSINESS CONCENTRATIONS

We purchase our prescription products from several suppliers with approximately 43%, 33% and 24% of our purchases were supplied by three vendors each, respectively, during the year ended December 31, 2018, and 100% and 98% of our purchases were supplied by one vendor each for the years ended December 31, 2017 and 2016, respectively.

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 years ended December 31, 2018, 2017 and 2016, four, four and three customers each, respectively, accounted for more than 10% of our total net revenues. Net revenue from the four customers combined accounted for approximately 76% of our net recognized revenue for the year ended December 31, 2018 and approximately 59% of our recognized revenue for the year ended December 31, 2017. Net revenue from three customers combined accounted for approximately 41% of our net revenue during the year ended December 31, 2016.

During the year ended December 31, 2018, McKesson Corporation accounted for approximately $1,610,000 of our revenue, Pillpack, Inc. accounted for approximately $5,075,000 of our revenue, AmerisourceBergen accounted for approximately $3,246,000 of our revenue and Cardinal Health accounted for approximately $2,308,000 of our revenue. During the year ended December 31, 2017, AmerisourceBergen accounted for approximately $2,667,000 of our revenue; McKesson Corporation accounted for approximately $1,959,000 of our revenue; Cardinal Health accounted for approximately $2,559,000 of our revenue and Pharmacy Innovations PA accounted for approximately $2,715,000 of our revenue. During the year ended December 31, 2016, Woodstock Pharmaceutical and Compounding accounted for approximately $2,247,000 of our revenue; Medical Center Pharmacy accounted for approximately $3,700,000 of our revenue and Pharmacy Innovations PA accounted for approximately $2,040,000 of our revenue.

COMMITMENTS AND CONTINGENCIES

12 Months Ended

Dec. 31, 2018

Commitments and Contingencies Disclosure [Abstract]

COMMITMENTS AND CONTINGENCIES

NOTE 13 – COMMITMENTS AND CONTINGENCIES

Operating Leases

We lease administrative office space in Boca Raton, Florida pursuant to a non-cancelable operating lease that commenced on July 1, 2013 and originally provided for a 63-month term. On February 18, 2015, we entered into an agreement with the same lessors to lease additional administrative office space in the same location, pursuant to an addendum to such lease. In addition, on April 26, 2016, we entered into an agreement with the same lessors to lease additional administrative office space in the same location. This agreement was effective beginning May 1, 2016 and extended the original expiration of the lease term to October 31, 2021. On October 4, 2016, we entered into an agreement with the same lessors to lease additional administrative office space in the same location, pursuant to an addendum to such lease. This addendum is effective beginning November 1, 2016. As of December 31, 2018, future minimum rental payments on non-cancelable operating leases are as follows:

Years Ending December 31,
2019	$	1,094,116
2020		1,113,069
2021		943,127
Thereafter		—
Total minimum lease payments	$	3,150,312

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 full premises, of which lease on 7,561 square feet has commenced in 2018 and the lease on the remaining 48,651 square feet will commence no earlier than June 1, 2019, or full premises commencement date. The lease will expire 11 years after full premises commencement date, unless terminated earlier in accordance with the terms of the lease. We have the option to extend the term of the lease for two additional consecutive periods of five years. The term of the lease includes escalating rent and free rent periods. We are also responsible for certain other operating costs under the lease, including electricity and utility expenses. In addition, we will be entitled to reimbursement from the landlord of up to $1,800,000 for tenant improvements. As of December 31, 2018, future minimum rental payments on full premises related to the new operating leases are as follows, of which approximately $2.7 million relates to the lease on the suite that has commenced in 2018:

Years Ending December 31,
2019	$	48,288
2020		984,756
2021		1,779,384
2022		1,808,312
2023		1,837,963
Thereafter		12,390,298
Total minimum lease payments	$	18,849,001

The rental expense during the years ended December 31, 2018, 2017 and 2016 was approximately $1,068,275, $1,029,205 and $709,483, respectively.

Intellectual Property Licenses

We have license agreements with third parties that provide for minimum royalty, license, and exclusivity payments to be paid by us for access to certain technologies. In addition, we pay royalties as a percent of revenue as described in Note 6, Intangible Assets, to these consolidated financial statements.

Purchase Commitments

We have a manufacturing and supply agreement whereby we are required to purchase from Catalent a minimum of number of softgels during the first contract year and a higher number or 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. At December 31, 2018, we had minimum purchase obligations related to this agreement of approximately $2,600,000 over the next five years. This amount represents our estimate of the minimum required payments under the agreement.

Legal Proceedings

From time to time, we are involved in litigation and proceedings in the ordinary course of business. We are not currently involved in any legal proceeding that we believe would have a material effect on our consolidated financial condition, results of operations, or cash flows.

Off-Balance Sheet Arrangements

As of December 31, 2018, 2017, and 2016, 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.

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies)

12 Months Ended

Dec. 31, 2018

Accounting Policies [Abstract]

Principles of Consolidation

Cash

Trade Accounts Receivable and Allowance for Doubtful Accounts

Inventories

Pre-Launch Inventory

Fixed Assets

Intangible Assets

Impairment of Long-Lived Assets

●

significant declines in an asset’s market price;

●

significant deterioration in an asset’s physical condition;

●

significant changes in the nature or extent of an asset’s use or operation;

●

significant adverse changes in the business climate that could impact an asset’s value, including adverse actions or assessments by regulators;

●

accumulation of costs significantly in excess of original expectations related to the acquisition or construction of an asset;

●

current-period operating or cash flow losses combined with a history of such losses or a forecast that demonstrates continuing losses associated with an asset’s use; and

●

expectations that it is more likely than not that an asset will be sold or otherwise disposed of significantly before the end of its previously estimated useful life.

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 asset or liability.

At December 31, 2018 and 2017, we had no assets or liabilities that were valued at fair value on a recurring basis.

Income Taxes

Our U.S. federal and state tax returns since 2011, which was the first year we generated net operating losses, remain open to examination.

Share-Based Compensation

Revenue Recognition

Prescription Products

OTC Products

Disaggregation of revenue

The following table provides information about disaggregated revenue by product mix for the years ended December 31, 2018, 2017, and 2016:

	For the Years Ended December 31,
	2018		2017		2016
Prescription vitamins	$	15,041,259	$	16,744,831	$	18,854,984
IMVEXXY®		1,058,201		—		—
OTC products		—		32,882		501,466
Net revenue	$	16,099,460	$	16,777,713	$	19,356,450

Segment Reporting

Shipping and Handling Costs

We expense all shipping and handling costs as incurred. We include these costs in cost of goods sold on the accompanying consolidated financial statements.

Advertising Costs

We expense advertising costs when incurred. Advertising costs were $1,682,746, $448,288, and $752,611 during the years ended December 31, 2018, 2017, and 2016, respectively.

Research and Development Expenses

Earnings Per Share

	As of December 31,
	2018		2017		2016
Stock options		20,872,824		23,365,225		21,767,854
Warrants		3,007,571		3,115,905		12,060,071
Restricted stock awards		1,040,000		—		—
		24,920,395		26,481,130		33,827,925

Concentration of Credit Risk and other Risks and Uncertainties

Use of Estimates

Recently Issued Accounting Pronouncements

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Tables)

12 Months Ended

Dec. 31, 2018

Accounting Policies [Abstract]

Schedule of disaggregated revenue

The following table provides information about disaggregated revenue by product mix for the years ended December 31, 2018, 2017, and 2016:

	For the Years Ended December 31,
	2018		2017		2016
Prescription vitamins	$	15,041,259	$	16,744,831	$	18,854,984
IMVEXXY®		1,058,201		—		—
OTC products		—		32,882		501,466
Net revenue	$	16,099,460	$	16,777,713	$	19,356,450

Schedule of potentially dilutive securities

The table below presents potentially dilutive securities that could affect our calculation of diluted net loss per share allocable to common stockholders for the periods presented.

	As of December 31,
	2018		2017		2016
Stock options		20,872,824		23,365,225		21,767,854
Warrants		3,007,571		3,115,905		12,060,071
Restricted stock awards		1,040,000		—		—
		24,920,395		26,481,130		33,827,925

INTANGIBLE ASSETS, NET (Tables)

12 Months Ended

Dec. 31, 2018

Intangible Assets, Net (Excluding Goodwill) [Abstract]

Schedule of intangible assets

The following table sets forth the gross carrying amount, accumulated amortization and net carrying amount of our intangible assets as of December 31, 2018 and 2017:

	December 31, 2018
	Gross Carrying Amount		Accumulated Amortization			Net Amount		Weighted- Average Remaining Amortization Period (yrs.)
Amortizable intangible assets:
OPERA^®software patent	$	31,951	$	(10,484	)	$	21,467		10.75
Development costs of corporate website		91,743		(91,743	)		—		n/a
Approved hormone therapy drug candidate patents		2,234,129		(282,485	)		1,951,644		14
Hormone therapy drug candidate patents (pending)		1,855,279		—			1,855,279		n/a
Non-amortizable intangible assets:
Multiple trademarks		264,289		—			264,289		indefinite
TOTAL	$	4,477,391	$	(384,712	)	$	4,092,679

	December 31, 2017
	Gross Carrying Amount		Accumulated Amortization			Net Amount		Weighted- Average Remaining Amortization Period (yrs.)
Amortizable intangible assets:
OPERA^®software patent	$	31,951	$	(8,487	)	$	23,464		11.75
Development costs of corporate website		91,743		(91,743	)		—		n/a
Approved hormone therapy drug candidate patents		1,293,614		(171,911	)		1,121,703		15
Hormone therapy drug candidate patents (pending)		1,721,305		—			1,721,305		n/a
Non-amortizable intangible assets:
Multiple trademarks		233,275		—			233,275		indefinite
TOTAL	$	3,371,888	$	(272,141	)	$	3,099,747

Schedule of estimated amortization expense

Estimated amortization expense, based on current patent cost being amortized, for the next five years is as follows:

Year Ending December 31,		Estimated Amortization
	2019	$	139,410
	2020	$	139,410
	2021	$	139,410
	2022	$	139,410
	2023	$	139,410
	Thereafter	$	1,276,061

STOCKHOLDERS' EQUITY (Tables)

12 Months Ended

Dec. 31, 2018

Stockholders' Equity:

Schedule of warrant activity

Summary of our Warrant activity during the year ended December 31, 2018:

	Number of Shares Under Warrants			Weighted Average Exercise Price		Weighted Average Remaining Contractual Life in Years		Aggregate Intrinsic Value
Balance at December 31, 2017		3,115,905		$	2.58		1.8	$	11,348,273
Granted		175,000		$	5.16
Exercised		—
Expired		(283,334	)	$	2.01
Cancelled/Forfeited		—
Balance at December 31, 2018		3,007,571		$	2.78		1.58	$	4,826,403
Vested and Exercisable at December 31, 2018		2,963,818		$	2.75		1.54	$	4,826,403
Unvested at December 31, 2018		43,753		$	5.16		4.21	$	0

Schedule of assumptions used in the Black-Scholes Model of warrants issued

	2018			2017			2016
Weighted average exercise price	$	5.16		$	6.83		$	7.90
Weighted average grant date fair value	$	2.79		$	3.67		$	4.78
Risk-free interest rate		2.36	%		1.47	%		1.04-1.28	%
Volatility		62.12	%		63.24	%		74.10-74.15	%
Term (in years)		5			5			5
Dividend yield		0.00	%		0.00	%		0.00	%

Schedule of assumptions used in the Black-Scholes Model of stock options

The ranges of assumptions used in the Black-Scholes Model during the years ended December 31, 2018, 2017, and 2016 are set forth in the table below.

	2018			2017			2016
Weighted average exercise price	$	5.45		$	6.60		$	6.22
Weighted average grant date fair value	$	3.24		$	3.82		$	3.94
Risk-free interest rate		2.38-2.89	%		1.84-2.05	%		1.13-1.90	%
Volatility		59.45-64.04	%		61.56-64.25	%		70.26-73.34	%
Term (in years)		5.1-6.25			5.5-6.25			5.5-6.25
Dividend yield		0.00	%		0.00	%		0.00	%

Schedule of activity of 2009 and 2012 Plans

A summary of activity under the 2009 and 2012 Plans and related information during the year ended December 31, 2018 is as follows:

	Number of Shares Under Warrants			Weighted Average Exercise Price		Weighted Average Remaining Contractual Life in Years		Aggregate Intrinsic Value
Balance at December 31, 2017		23,365,225		$	3.78		5.13	$	64,664,821
Granted		3,264,500		$	5.45
Exercised		(5,454,526	)	$	0.31			$	27,534,623
Expired		(25,000	)	$	7.76
Cancelled/Forfeited		(277,375	)	$	5.47
Balance at December 31, 2018		20,872,824		$	4.93		5.94	$	12,239,876
Vested and Exercisable at December 31, 2018		16,068,991		$	4.61		5.09	$	12,239,876
Unvested at December 31, 2018		4,803,833		$	5.99		8.8	$	0

INCOME TAXES (Tables)

12 Months Ended

Dec. 31, 2018

Income Tax Disclosure [Abstract]

Schedule of components of income before taxes

For financial reporting purposes, income before taxes includes the following components:

	2018			2017			2016
United States		(132,617,160	)		(76,925,380	)		(89,875,459	)
Total		(132,617,160	)		(76,925,380	)		(89,875,459	)

Schedule of tax rate reconciliation

A reconciliation between taxes computed at the federal statutory rate and the consolidated effective tax rate is as follows:

	2018			2017			2016
Federal statutory tax rate		21.0	%		34.0	%		34.0	%
State tax rate, net of federal tax benefit		5.2	%		5.0	%		5.4	%
Adjustment in valuation allowances		(31.2	)%		22.6	%		(40.3	)%
Excess stock benefit		5.3	%		0.0	%		0.0	%
Federal income tax rate change		0.0	%		(60.8	)%		—	%
Permanent and other differences		(0.3	)%		(0.8	)%		0.9	%
Provision (benefit) for income taxes		—			—			—

Schedule of components of the net deferred income tax asset

The components of the net deferred income tax asset as of December 31, 2018, 2017, and 2016 are as follows:

	2018			2017			2016
Deferred Income Tax Assets:
Net operating losses	$	140,891,764		$	99,596,321		$	111,730,450
R&D Credit		186,347			186,347			186,347
Total deferred income tax asset		141,078,111			99,782,668			111,916,797
Valuation allowance		(141,078,111	)		(99,782,668	)		(111,916,797	)
Deferred income tax assets, net	$	—		$	—		$	—

COMMITMENTS AND CONTINGENCIES (Tables)

12 Months Ended

Dec. 31, 2018

Commitments and Contingencies Disclosure [Abstract]

Schedule of future minimum rental payments on operating leases

This addendum is effective beginning November 1, 2016. As of December 31, 2018, future minimum rental payments on non-cancelable operating leases are as follows:

Years Ending December 31,
2019	$	1,094,116
2020		1,113,069
2021		943,127
Thereafter		—
Total minimum lease payments	$	3,150,312

As of December 31, 2018, future minimum rental payments on full premises related to the new operating leases are as follows, of which approximately $2.7 million relates to the lease on the suite that has commenced in 2018:

Years Ending December 31,
2019	$	48,288
2020		984,756
2021		1,779,384
2022		1,808,312
2023		1,837,963
Thereafter		12,390,298
Total minimum lease payments	$	18,849,001

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details) - USD ($)	3 Months Ended								12 Months Ended
	Dec. 31, 2018	Sep. 30, 2018	Jun. 30, 2018	Mar. 31, 2018	Dec. 31, 2017	Sep. 30, 2017	Jun. 30, 2017	Mar. 31, 2017	Dec. 31, 2018	Dec. 31, 2017	Dec. 31, 2016
Revenues, net	$ 5,089,000	$ 3,474,000	$ 3,763,000	$ 3,773,000	$ 4,125,000	$ 4,418,000	$ 4,250,000	$ 3,985,000	$ 16,099,460	$ 16,777,713	$ 19,356,450
Prescription Vitamins [Member]
Revenues, net									15,041,259	16,744,831	18,854,984
IMVEXXY R [Member]
Revenues, net									$ 1,058,201
OTC Products [Member]
Revenues, net										$ 32,882	$ 501,466

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details 1) - shares	12 Months Ended
	Dec. 31, 2018	Dec. 31, 2017	Dec. 31, 2016
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Anti-dilutive shares excluded from earnings per share calculation	24,920,395	26,481,130	33,827,925
Warrants [Member]
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Anti-dilutive shares excluded from earnings per share calculation	3,007,571	3,115,905	12,060,071
Stock Options [Member]
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Anti-dilutive shares excluded from earnings per share calculation	20,872,824	23,365,225	21,767,854
Restricted Stock Awards [Member]
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Anti-dilutive shares excluded from earnings per share calculation	1,040,000

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details Narrative)	12 Months Ended
	Dec. 31, 2018 USD ($) Number	Dec. 31, 2017 USD ($)	Dec. 31, 2016 USD ($)	Jan. 01, 2019 USD ($)
Shelf life of prescription products following product expiration	24 months
Number of operating segments \| Number	1
Federal insurance limits	$ 250,000
Number of issued patents domestic \| Number	21
Number of issued patents foreign \| Number	24
Advertising costs	$ 1,682,746	$ 448,288	$ 752,611
Customer A [Member] \| Accounts Receivable [Member]
Concentration risk	42.00%	27.00%
Customer B [Member] \| Accounts Receivable [Member]
Concentration risk	24.00%	23.00%
Customer C [Member] \| Accounts Receivable [Member]
Concentration risk	13.00%	22.00%
Customer D [Member] \| Accounts Receivable [Member]
Concentration risk		11.00%
Minimum [Member]
Return period of unsalable prescription products	6 months
Minimum [Member] \| Fixed Assets [Member]
Useful life of assets	3 years
Minimum [Member] \| Software and Software Development Costs [Member]
Useful life of assets	5 years
Maximum [Member]
Return period of unsalable prescription products	12 months
Maximum [Member] \| Fixed Assets [Member]
Useful life of assets	7 years
Maximum [Member] \| Software and Software Development Costs [Member]
Useful life of assets	7 years
Maximum [Member] \| IMVEXXY R [Member]
Enrolled patients co-pay for a set number of prescription refills	$ 35
ASU 2018-11, Leases [Member] \| Minimum [Member]
Right of use asset				$ 4,000,000
Lease liability				4,000,000
ASU 2018-11, Leases [Member] \| Maximum [Member]
Right of use asset				5,000,000
Lease liability				$ 5,000,000

INVENTORY (Details) - USD ($)	Dec. 31, 2018	Dec. 31, 2017
Inventory
Finished products	$ 2,908,958	$ 1,485,358
Work in process	339,312
Raw materials	19,400
TOTAL INVENTORY	$ 3,267,670	$ 1,485,358

OTHER CURRENT ASSETS (Details) - USD ($)	Dec. 31, 2018	Dec. 31, 2017
Other Current Assets
Prepaid sales and marketing costs	$ 5,148,789	$ 5,335,936
Debt financing fees (Note 8)	1,898,074
Prepaid insurance	790,465	680,243
Other prepaid costs	2,997,365	588,105
TOTAL OTHER CURRENT ASSETS	$ 10,834,693	$ 6,604,284

FIXED ASSETS, NET (Details) - USD ($)	Dec. 31, 2018	Dec. 31, 2017
Property, Plant and Equipment [Line Items]
TOTAL FIXED ASSETS, GROSS	$ 1,026,313	$ 809,273
Accumulated depreciation	(553,630)	(372,218)
TOTAL FIXED ASSETS, NET	472,683	437,055
Acounting System [Member]
Property, Plant and Equipment [Line Items]
TOTAL FIXED ASSETS, GROSS	301,096	301,096
Equipment [Member]
Property, Plant and Equipment [Line Items]
TOTAL FIXED ASSETS, GROSS	490,576	273,536
Furniture And Fixtures [Member]
Property, Plant and Equipment [Line Items]
TOTAL FIXED ASSETS, GROSS	116,542	116,542
Computer hardware [Member]
Property, Plant and Equipment [Line Items]
TOTAL FIXED ASSETS, GROSS	80,211	80,211
Leasehold improvements [Member]
Property, Plant and Equipment [Line Items]
TOTAL FIXED ASSETS, GROSS	$ 37,888	$ 37,888

INTANGIBLE ASSETS, NET (Details) - USD ($)	12 Months Ended
INTANGIBLE ASSETS, NET (Details) - USD ($)	Dec. 31, 2018	Dec. 31, 2017
Finite-Lived Intangible Assets
Accumulated Amortization	$ (384,712)	$ (272,141)
Indefinite-Lived Intangible Assets
Gross Carrying Amount	4,477,391	3,371,888
Net Amount	4,092,679	3,099,747
Hormone Therapy Drug Candidate Patents - (Pending) [Member]
Finite-Lived Intangible Assets
Gross Carrying Amount	1,855,279	1,721,305
Net Amount	1,855,279	1,721,305
Multiple Trademarks [Member]
Indefinite-Lived Intangible Assets
Gross Carrying Amount	264,289	233,275
Net Amount	264,289	233,275
Domestic Utilty Patent - Opera Software [Member]
Finite-Lived Intangible Assets
Gross Carrying Amount	31,951	31,951
Accumulated Amortization	(10,484)	(8,487)
Net Amount	$ 21,467	$ 23,464
Weighted average remaining amortization period	10 years 9 months	11 years 9 months
Approved Hormone Therapy Drug Candidate Patents [Member]
Finite-Lived Intangible Assets
Gross Carrying Amount	$ 2,234,129	$ 1,293,614
Accumulated Amortization	(282,485)	(171,911)
Net Amount	$ 1,951,644	$ 1,121,703
Weighted average remaining amortization period	14 years	15 years
Development Costs Of Corporate Website [Member]
Finite-Lived Intangible Assets
Gross Carrying Amount	$ 91,743	$ 91,743
Accumulated Amortization	$ (91,743)	$ (91,743)

INTANGIBLE ASSETS, NET (Details 1)	Dec. 31, 2018 USD ($)
Year Ending December 31,
2019	$ 139,410
2020	139,410
2021	139,410
2022	139,410
2023	139,410
Thereafter	$ 1,276,061

INTANGIBLE ASSETS, NET (Details Narrative)		3 Months Ended	12 Months Ended
INTANGIBLE ASSETS, NET (Details Narrative)	Aug. 06, 2018 USD ($) $ / shares shares	Sep. 30, 2018 USD ($)	Dec. 31, 2018 USD ($) Number	Dec. 31, 2017 USD ($)	Dec. 31, 2016 USD ($)
Finite-Lived Intangible Assets [Line Items]
Amortization expense \| $			$ 112,474	$ 71,516	$ 54,545
Subscription Agreement [Member] \| Knight Therapeutics Inc. [Member]
Finite-Lived Intangible Assets [Line Items]
Issue of common stock shares (in shares) \| shares	3,921,568
Common stock sale price (in dollars per share) \| $ / shares	$ 5.10
Gross proceeds \| $	$ 20,000,000
Approved Hormone Therapy Drug Candidate Patents [Member]
Finite-Lived Intangible Assets [Line Items]
Useful Life			20 years
Domestic U.S. Patents [Member]
Finite-Lived Intangible Assets [Line Items]
Number of issued patents			21
Foreign Patents [Member]
Finite-Lived Intangible Assets [Line Items]
Number of issued patents			24
Domestic Utility Patents [Member]
Finite-Lived Intangible Assets [Line Items]
Number of issued patents			11
Foreign Utility Patents [Member]
Finite-Lived Intangible Assets [Line Items]
Number of issued patents			5
Domestic Patents - TX-004HR [Member]
Finite-Lived Intangible Assets [Line Items]
Number of issued patents			3
Foreign Patents - TX-004HR [Member]
Finite-Lived Intangible Assets [Line Items]
Number of issued patents			12
Domestic Utility Patent - Transdermal Patch Candidates [Member]
Finite-Lived Intangible Assets [Line Items]
Number of issued patents			1
Foreign Utility Patent - Transdermal Patch Candidates [Member]
Finite-Lived Intangible Assets [Line Items]
Number of issued patents			4
Domestic Utilty Patent - Opera Software [Member]
Finite-Lived Intangible Assets [Line Items]
Number of issued patents			1
Domestic Patents - TX-009HR [Member]
Finite-Lived Intangible Assets [Line Items]
Number of issued patents			1
Foreign Patents Progesterone - Only Candidate [Member]
Finite-Lived Intangible Assets [Line Items]
Number of issued patents			3
Domestic Utility Patents Topical - Cream Candidates [Member]
Finite-Lived Intangible Assets [Line Items]
Number of issued patents			1
Council License Agreement [Member]
Finite-Lived Intangible Assets [Line Items]
Payment of milestone recorded as finite-lived intangible asset \| $		$ 20,000,000
Council License Agreement [Member] \| ANNOVERA [Member]
Finite-Lived Intangible Assets [Line Items]
Milestone payments upon FDA approval \| $			$ 20,000,000
Milestone payments (payment after release of first commercial batch) \| $			$ 20,000,000
Annual royalty rate reduction of initial rate during the six-month period from commercial sale of a generic equivalent			50.00%
Annual royalty rate reduction of initial rate after the six-month period from commercial sale of a generic equivalent			20.00%
Maximum costs and expenses for post approval study to be paid by the Company \| $			$ 20,000,000
Council License Agreement [Member] \| ANNOVERA [Member] \| Step-based Royalty Payment One [Member]
Finite-Lived Intangible Assets [Line Items]
Royalty (percent)			5.00%
Council License Agreement [Member] \| ANNOVERA [Member] \| Step-based Royalty Payment One [Member] \| Maximum [Member]
Finite-Lived Intangible Assets [Line Items]
Net sales amount per step-based royalty \| $			$ 50,000,000
Council License Agreement [Member] \| ANNOVERA [Member] \| Step-based Royalty Payment Three [Member]
Finite-Lived Intangible Assets [Line Items]
Royalty (percent)			15.00%
Council License Agreement [Member] \| ANNOVERA [Member] \| Step-based Royalty Payment Three [Member] \| Minimum [Member]
Finite-Lived Intangible Assets [Line Items]
Net sales amount per step-based royalty \| $			$ 150,000,000
Council License Agreement [Member] \| ANNOVERA [Member] \| Step-based Royalty Payment Two [Member]
Finite-Lived Intangible Assets [Line Items]
Royalty (percent)			10.00%
Council License Agreement [Member] \| ANNOVERA [Member] \| Step-based Royalty Payment Two [Member] \| Minimum [Member]
Finite-Lived Intangible Assets [Line Items]
Net sales amount per step-based royalty \| $			$ 50,000,000
Council License Agreement [Member] \| ANNOVERA [Member] \| Step-based Royalty Payment Two [Member] \| Maximum [Member]
Finite-Lived Intangible Assets [Line Items]
Net sales amount per step-based royalty \| $			$ 150,000,000

ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES (Details) - USD ($)	Dec. 31, 2018	Dec. 31, 2017
Payables and Accruals [Abstract]
Accrued payroll, bonuses and commission costs	$ 6,854,002	$ 4,240,379
Allowance for coupons and returns	5,294,120	1,432,846
Accrued sales and marketing costs	2,288,028	420,162
Accrued compensated absences	1,178,110	945,457
Allowance for wholesale distributor fees	792,891	172,973
Accrued legal and accounting expense	385,824	600,350
Accrued research and development	388,675	366,933
Accrued rent	365,155	327,099
Accrued rebates	412,570	76,917
Accrued royalties		114,480
Other accrued expenses	375,573	525,999
TOTAL	$ 18,334,948	$ 9,223,595

DEBT (Details)	Dec. 31, 2018 USD ($)
Debt Disclosure [Abstract]
Term Loan	$ 75,000,000
Debt discount and financing fees	(1,618,986)
TOTAL LONG-TERM DEBT	$ 73,381,014

DEBT (Details Narrative)				12 Months Ended
DEBT (Details Narrative)	Jul. 30, 2018 USD ($)	Jun. 07, 2018 USD ($)	May 01, 2018 USD ($) Number	Dec. 31, 2018 USD ($)
Proceeds from term loan				$ 75,000,000
Amortization of debt issuance costs				269,859
First Year After Tranche 1 Funding Date [Member]
Prepayment fee (percent)			4.00%
Second Year After Tranche 1 Funding Date [Member]
Prepayment fee (percent)			3.00%
Third Year and Thereafter After Tranche 1 Funding Date [Member]
Prepayment fee (percent)			2.00%
Council License Agreement [Member]
Proceeds from term loan	$ 75,000,000
Term Loan [Member]
Borrowing capacity under loan facility			$ 200,000,000
Number of tranches under term loan facility			3
Revenue requirement to extend interest-only period			$ 95,000,000
Description of Interest Rate			one-month LIBOR (subject to a LIBOR floor of 1.50%) plus (ii) 7.75% per annum
Basis spread of loan			7.75%
LIBOR floor			1.50%
Number of principal installment payments \| Number			36
Maturity date			May 01, 2023
Interest-only period extension			12 months
Interest expense - debt				4,407,975
Minimum cash balance requirement under credit agreement			$ 50,000,000
Loan origination fee (percent)			1.00%
Annual administration fee (percent)			0.25%
Term Loan [Member] \| Tranche 1 [Member]
Borrowings outstanding				75,000,000
Proceeds from term loan		$ 75,000,000
Debt issuance costs		$ 3,786,918
Debt discount				$ 1,888,844
Effective interest rate				11.00%
Term Loan [Member] \| Tranche 2 [Member]
Borrowing capacity under loan facility			$ 75,000,000
Term Loan [Member] \| Tranche 3 [Member]
Borrowing capacity under loan facility			50,000,000
Revenue requirement to draw on term loan tranche			$ 75,000,000

STOCKHOLDERS' EQUITY (Details) - Warrants [Member] - USD ($)	12 Months Ended
	Dec. 31, 2018	Dec. 31, 2017
Number of shares Warrants
Warrants outstanding beginning	3,115,905
Warrants granted	175,000
Warrants expired	(283,334)
Warrants outstanding ending	3,007,571	3,115,905
Vested and Exercisable ending	2,963,818
Unvested ending	43,753
Weighted Average Exercise Price
Warrants outstanding beginning	2.58
Warrants granted	5.16
Warrants expired	2.01
Warrants outstanding ending	2.78	2.58
Vested and Exercisable ending	2.75
Warrants Unvested ending	5.16
Weighted Average Remaining Contractual Life
Warrants outstanding	1 year 6 months 29 days	1 year 9 months 18 days
Warrants Vested and Exercisable ending	1 year 6 months 14 days
Warrants Unvested ending	4 years 2 months 16 days
Aggregate Intrinsic Value
Warrants outstanding beginning	$ 11,348,273
Warrants outstanding ending	4,826,403	$ 11,348,273
Vested and Exercisable ending	4,826,403
Unvested ending	$ 0

STOCKHOLDERS' EQUITY (Details 1) - Warrants [Member] - $ / shares	12 Months Ended
	Dec. 31, 2018	Dec. 31, 2017	Dec. 31, 2016
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Weighted average exercise price	5.16	6.83	7.90
Weighted average grant date fair value	$ 2.79	$ 3.67	$ 4.78
Risk-free interest rate	2.36%	1.47%
Risk-free interest rate - minimum			1.04%
Risk-free interest rate - maximum			1.28%
Volatility	62.12%	63.24%
Volatility - minimum			74.10%
Volatility - maximum			74.15%
Term (in years)	5 years	5 years	5 years
Dividend yield	0.00%	0.00%	0.00%

STOCKHOLDERS' EQUITY (Details 2) - Stock Options [Member] - $ / shares	12 Months Ended
	Dec. 31, 2018	Dec. 31, 2017	Dec. 31, 2016
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Weighted average exercise price	$ 5.45	$ 6.60	$ 6.22
Weighted average grant date fair value	$ 3.24	$ 3.82	$ 3.94
Risk-free interest rate - minimum	2.38%	1.84%	1.13%
Risk-free interest rate - maximum	2.89%	2.05%	1.90%
Volatility - minimum	59.45%	61.56%	70.26%
Volatility - maximum	64.04%	64.25%	73.34%
Dividend yield	0.00%	0.00%	0.00%
Minimum [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Term	5 years 1 month 6 days	5 years 6 months	5 years 6 months
Maximum [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Term	6 years 3 months	6 years 3 months	6 years 3 months

STOCKHOLDERS' EQUITY (Details 3) - Stock Options [Member] - USD ($)	12 Months Ended
	Dec. 31, 2018	Dec. 31, 2017
Options, Outstanding
Options Outstanding beginning	23,365,225
Options Granted	3,264,500
Options Exercised	(5,454,526)
Options Expired	(25,000)
Options Cancelled/Forfeited	(277,375)
Options Outstanding ending	20,872,824	23,365,225
Vested and Exercisable ending	16,068,991
Unvested ending	4,803,833
Options, Weighted Average Exercise Price
Options Outstanding beginning	$ 3.78
Granted	5.45
Exercised	0.31
Expired	7.76
Cancelled/Forfeited	5.47
Options Outstanding ending	4.93	$ 3.78
Vested and Exercisable ending	4.61
Unvested ending	$ 5.99
Options, Weighted Average Remaining Contractual Life
Options Outstanding	5 years 11 months 8 days	5 years 1 month 17 days
Vested and Exercisable ending	5 years 1 month 2 days
Unvested ending	8 years 9 months 18 days
Options outstanding, Aggregate Intrinsic Value
Options Outstanding beginning	$ 64,664,821
Options exercised	27,534,623
Options Outstanding ending	12,239,876	$ 64,664,821
Vested and Exercisable ending	12,239,876
Unvested ending	$ 0

STOCKHOLDERS' EQUITY (Details Narrative) - USD ($)							12 Months Ended
STOCKHOLDERS' EQUITY (Details Narrative) - USD ($)	Aug. 06, 2018	Sep. 28, 2017	Sep. 25, 2017	Aug. 01, 2017	Jan. 12, 2016	Jan. 06, 2016	Dec. 31, 2018	Dec. 31, 2017	Dec. 31, 2016
Preferred stock, par value (in dollars per share)							$ 0.001	$ 0.001
Preferred stock, authorized							10,000,000	10,000,000
Common stock, authorized							350,000,000	350,000,000
Common stock, issued							240,462,439	216,429,642
Common stock, outstanding							240,462,439	216,429,642
Value of common stock issued during period for stock options exercised							$ 1,666,208	$ 212,615	$ 1,373,000
Proceeds from sale of common stock, net of costs							89,907,797	68,572,635	134,863,475
Underwriting Agreement [Member] \| Goldman Sachs & Co. LLC, [Member]
Issue of common stock (in shares)				12,745,098
Issue of common stock (in dollars per shares)				$ 5.10
Common stock exercisable shares				1,911,764
Stock exercisable period				30 days
Net Proceeds				$ 69,908,000
Underwriting Agreement [Member] \| J.P. Morgan Securities LLC [Member]
Issue of common stock (in shares)		12,400,000	12,400,000
Issue of common stock (in dollars per shares)			$ 5.55
Net Proceeds			$ 68,573,000
Knight License Agreement [Member] \| Knight Therapeutics Inc. [Member]
Issue of common stock (in shares)	3,921,568
Issue of common stock (in dollars per shares)	$ 5.10
Net Proceeds	$ 20,000,000
Underwriting Agreement - Goldman and Cowen [Member]
Number of shares offered in underwriting agreement						15,151,515
Share price (in dollars per share)						$ 8.25
Number of days of the option to purchase shares						30 days
Additional common stock issued under offering						2,272,727
Proceeds from sale of common stock, net of costs						$ 134,864,000
Number of shares issued during the period					17,424,242
Stock Options [Member]
Value of common stock issued during period for stock options exercised							$ 1,666,208	$ 212,615	$ 989,060
Number of stock options exercised (in shares)							5,444,526	102,546	525,362
Number of stock options exercised in cashless exercise (in shares)							10,000		127,109
Number of common stock issued during period for stock options exercised in cashless exercise (in shares)							9,841		87,833

STOCKHOLDERS' EQUITY (Details Narrative 1) - USD ($)	12 Months Ended
STOCKHOLDERS' EQUITY (Details Narrative 1) - USD ($)	Dec. 31, 2018	Dec. 31, 2017	Dec. 31, 2016
Warrants:
Share based compensation expense	$ 8,661,967	$ 6,889,323	$ 17,411,021
Unrecognized estimated compensation expense period recognition	2 years 1 month 6 days
Outside Consultants Warrants [Member]
Warrants:
Exercise price of warrants (in dollars per share)	$ 5.16	$ 6.83
Warrants granted (in shares)	175,000	125,000	245,000
Grant date fair value (in dollars per share)	$ 2.79	$ 3.67	$ 7.90
Expiration date of warrants	Mar. 15, 2023	Mar. 15, 2022
Vesting period of warrants	12 months	12 months
Expected term	5 years	5 years
Volatility rate	62.10%	63.24%
Risk free rate	2.36%	1.47%
Dividend yield	0.00%	0.00%
Outside Consultants Warrants [Member] \| Tranche One [Member]
Warrants:
Warrants granted (in shares)			75,000
Expiration date of warrants			Apr. 21, 2021
Vesting date of warrants			Apr. 21, 2016
Outside Consultants Warrants [Member] \| Tranche Two [Member]
Warrants:
Warrants granted (in shares)			50,000
Expiration date of warrants			Apr. 21, 2021
Vesting period of warrants			24 months
Outside Consultants Warrants [Member] \| Tranche Three [Member]
Warrants:
Warrants granted (in shares)			120,000
Expiration date of warrants			Jan. 21, 2021
Vesting period of warrants			12 months
Warrants [Member]
Warrants:
Warrants outstanding	$ 3,007,571
Weighted-average contractual remaining life	1 year 7 months 6 days
Weighted average exercise price of warrants (in dollars per share)	2.78	2.58
Warrants granted (in shares)	175,000
Grant date fair value (in dollars per share)	$ 2.79	$ 3.67	$ 4.78
Share based compensation expense	$ 494,136	$ 313,271	$ 936,974
Unrecognized estimated compensation expense	$ 106,000
Unrecognized estimated compensation expense period recognition	2 months 12 days
Warrants [Member] \| Minimum [Member]
Warrants:
Exercise price of warrants (in dollars per share)	$ 0.24
Warrants [Member] \| Maximum [Member]
Warrants:
Exercise price of warrants (in dollars per share)	$ 8.20

STOCKHOLDERS' EQUITY (Details Narrative 2) - USD ($)			1 Months Ended		12 Months Ended
STOCKHOLDERS' EQUITY (Details Narrative 2) - USD ($)	Jun. 30, 2013	May 11, 2013	May 31, 2013	May 31, 2012	Dec. 31, 2018	Dec. 31, 2017	Dec. 31, 2016	Dec. 31, 2015
Non-cash compensation expense					$ 8,661,967	$ 6,889,323	$ 17,411,021
Shares issued for exercise of warrants, net						3,798,999	989,060
SCI Warrants for Services [Member]
Exercise price of warrants (in dollars per share)				$ 2.57
Fair value of grant				$ 1,532,228
Warrants granted to purchase common stock (shares)				1,300,000
Expected term				5 years
Volatility rate				44.71%
Risk free rate				0.74%
Dividend yield				0.00%
SCI - Warrants [Member]
Exercise price of warrants (in dollars per share)			$ 2.01
Warrants granted to purchase common stock (shares)			850,000
Forfeited warrants granted to purchase common stock (shares)			833,000
SCI - Warrants [Member] \| Tranche One [Member]
Fair value of grant	$ 405,066
Non-cash compensation expense	405,066
Vesting date of warrants		Jun. 30, 2013
Expected term		5 years
Volatility rate		45.89%
Risk free rate		1.12%
Dividend yield		0.00%
Vested warrants granted to purchase common stock (shares)		283,333
SCI - Warrants [Member] \| Tranche Two [Member]
Fair value of grant	$ 462,196
Non-cash compensation expense						$ 0	0	$ 77,026
Vesting date of warrants	Jun. 30, 2013
Expected term	5 years
Volatility rate	45.84%
Risk free rate	1.41%
Dividend yield	0.00%
Vested warrants granted to purchase common stock (shares)	283,333
SCI - Warrants [Member] \| Tranche Three [Member]
Vesting date of warrants	Apr. 30, 2018
Unvested warrants	283,334
Warrants - Cashless Exercise [Member] \| Individuals [Member]
Warrants exercised						(6,590,000)
Warrants - Unaffiliated Entity [Member]
Non-cash compensation expense					0	$ 128,898	$ 257,796
Warrants exercised						(800,000)	(500,000)
Warrants [Member]
Non-cash compensation expense					$ 494,136	$ 313,271	$ 936,974
Unvested warrants					43,753
Warrants [Member] \| Individuals [Member]
Shares issued for exercise of warrants, net						$ 3,798,999	$ 1,373,000
Shares issued for exercise of warrants, net (in shares)						2,476,666	722,744
Number of shares issued during the period						4,762,208	500,000

STOCKHOLDERS' EQUITY (Details Narrative 3) - USD ($)	12 Months Ended
STOCKHOLDERS' EQUITY (Details Narrative 3) - USD ($)	Dec. 31, 2018	Dec. 31, 2017	Dec. 31, 2016
Share-based compensation expense	$ 8,091,294	$ 6,447,154	$ 16,139,225
Total unrecognized estimated compensation expense	$ 12,175,000
Recognized weighted-average period	2 years 1 month 6 days
Shares issued for exercise of warrants, net		3,798,999	989,060
Proceeds from sale of common stock, net of costs	$ 89,907,797	68,572,635	134,863,475
Share based compensation expense	$ 8,661,967	$ 6,889,323	$ 17,411,021
Stock Options [Member]
Options outstanding, ending	20,872,824	23,365,225
Options outstanding	$ 4.93	$ 3.78
Options Granted	3,264,500
Stock Options [Member] \| Minimum [Member]
Option exercise prices (in dollars per shares)	$ 0.10
Stock Options [Member] \| Maximum [Member]
Option exercise prices (in dollars per shares)	$ 8.92
Cash-Settled Stock Appreciation Rights (SARs) [Member]
Options outstanding, ending	103,000
Options outstanding	$ 0.07
Expected term	6 months
Volatility rate	49.70%
Risk free rate	2.70%
Dividend yield	0.00%
Restricted Stock Units [Member]
Grant date fair value (in dollars per share)	$ 4.06
Share based compensation expense	$ 73,132
Expected term	2 years 11 months 12 days
Unrecognized estimated compensation expense	$ 4,149,000
Options Granted	1,040,000
2012 Stock Incentive Plan [Member]
Number of shares authorized for issuance	10,000,000
Options outstanding, ending	6,278,474
Number of shares available for issuance	2,433,333
2009 Long Term Incentive Compensation Plan [Member]
Number of shares authorized for issuance	25,000,000
Options outstanding, ending	14,594,350
Number of shares available for issuance	866,912
2009 Long Term Incentive Compensation Plan [Member] \| Restricted Stock Units [Member]
Options outstanding	$ 1,040,000

INCOME TAXES (Details 1)	12 Months Ended
INCOME TAXES (Details 1)	Dec. 31, 2018	Dec. 31, 2017	Dec. 31, 2016
Income Tax Disclosure [Abstract]
Federal statutory tax rate	21.00%	34.00%	34.00%
State tax rate, net of federal tax benefit	5.20%	5.00%	5.40%
Adjustment in valuation allowances	(31.20%)	22.60%	(40.30%)
Excess stock benefit	5.30%	0.00%	0.00%
Federal income tax rate change	0.00%	(60.80%)
Permanent and other differences	(0.30%)	(0.80%)	0.90%
Provision (benefit) for income taxes	0.00%	0.00%	0.00%

INCOME TAXES (Details 2) - USD ($)	Dec. 31, 2018	Dec. 31, 2017	Dec. 31, 2016
Deferred Income Tax Assets:
Net operating losses	$ 140,891,764	$ 99,596,321	$ 111,730,450
R&D Credit	186,347	186,347	186,347
Total deferred income tax asset	141,078,111	99,782,668	111,916,797
Valuation allowance	(141,078,111)	(99,782,668)	(111,916,797)
Deferred income tax assets, net	$ 0	$ 0	$ 0

INCOME TAXES (Details Narrative) - USD ($)	12 Months Ended
INCOME TAXES (Details Narrative) - USD ($)	Dec. 31, 2018	Dec. 31, 2017	Dec. 31, 2016
Federal statutory tax rate	21.00%	34.00%	34.00%
Federal [Member]
Net operating loss carry forward	$ 481,365,550
Net operating loss carry forward expiration date	Dec. 31, 2038
Federal [Member] \| Expiration Period - 20 Years [Member]
Net operating loss carry forward	$ 338,668,076
NOL carry forward period	20 years
Federal [Member] \| Expiration Period - Indefinite [Member]
Net operating loss carry forward	$ 142,697,474

RELATED PARTIES (Details Narrative) - Catalent Inc.[Member] - USD ($)	12 Months Ended
	Dec. 31, 2018	Dec. 31, 2017	Dec. 31, 2016
Related Party Transaction [Line Items]
Manufacturing activities billed from related party	$ 4,111,000	$ 3,646,000	$ 3,647,000
Payable - related party	$ 88,000	$ 523,000

BUSINESS CONCENTRATIONS (Details Narrative) - USD ($)	12 Months Ended
BUSINESS CONCENTRATIONS (Details Narrative) - USD ($)	Dec. 31, 2018	Dec. 31, 2017	Dec. 31, 2016
Concentration Risk [Line Items]
Minimum purchase commitments for softgels	$ 2,600,000
Payment for minimum purchase quantities of purchase commitments (percent)	50.00%
Customer Concentration [Member] \| Sales Revenue [Member] \| Four Major Customers [Member]
Concentration Risk [Line Items]
Concentration Risk	76.00%	59.00%
Customer Concentration [Member] \| Sales Revenue [Member] \| Four Major Customers [Member] \| Minimum [Member]
Concentration Risk [Line Items]
Concentration Risk	10.00%	10.00%
Customer Concentration [Member] \| Sales Revenue [Member] \| Three Major Customers [Member]
Concentration Risk [Line Items]
Concentration Risk			41.00%
Customer Concentration [Member] \| Sales Revenue [Member] \| Three Major Customers [Member] \| Minimum [Member]
Concentration Risk [Line Items]
Concentration Risk			10.00%
Customer Concentration - Pillpack [Member] \| Sales Revenue [Member]
Concentration Risk [Line Items]
Revenues	$ 5,075,000
Customer Concentration - AmerisourceBergen [Member] \| Sales Revenue [Member]
Concentration Risk [Line Items]
Revenues	3,246,000	$ 2,667,000
Customer Concentration - Cardinal Health [Member] \| Sales Revenue [Member]
Concentration Risk [Line Items]
Revenues	2,308,000	2,559,000
Customer Concentration - McKesson Corp [Member] \| Sales Revenue [Member]
Concentration Risk [Line Items]
Revenues	$ 1,610,000	1,959,000
Customer Concentration - Pharmacy Innovations, Pa [Member] \| Sales Revenue [Member]
Concentration Risk [Line Items]
Revenues		$ 2,715,000	$ 2,040,000
Customer Concentration - Woodstock Pharmaceutical and Compounding [Member] \| Sales Revenue [Member]
Concentration Risk [Line Items]
Revenues			2,247,000
Customer Concentration - Medical Center Pharmacy [Member] \| Sales Revenue [Member]
Concentration Risk [Line Items]
Revenues			$ 3,700,000
Products Supplier #1 [Member]
Concentration Risk [Line Items]
Concentration Risk	43.00%	100.00%	98.00%
Products Supplier #2 [Member]
Concentration Risk [Line Items]
Concentration Risk	33.00%
Products Supplier #3 [Member]
Concentration Risk [Line Items]
Concentration Risk	24.00%

COMMITMENTS AND CONTINGENCIES (Details)	Dec. 31, 2018 USD ($)
Non-Cancelable Operating Leases [Member]
Future minimum rental payments, years ending December 31,
2019	$ 1,094,116
2020	1,113,069
2021	943,127
Total minimum lease payments	3,150,312
New Operating Leases [Member]
Future minimum rental payments, years ending December 31,
2019	48,288
2020	984,756
2021	1,779,384
2022	1,808,312
2023	1,837,963
Thereafter	12,390,298
Total minimum lease payments	$ 18,849,001

COMMITMENTS AND CONTINGENCIES (Details Narrative) - USD ($)		12 Months Ended
	May 01, 2016	Dec. 31, 2018	Dec. 31, 2017	Dec. 31, 2016
Non-cancelable operating lease term		63 months
Rental expense		$ 1,068,275	$ 1,029,205	$ 709,483
Expiration date	Oct. 31, 2021
Lease term		11 years
Description of lease renewal term		The option to extend the term of the lease for/r two additional consecutive periods of five years
Lease renewal term		5 years
Reimbursement from landlord - tenant improvements		$ 1,800,000
New Operating Lease - Suite [Member]
Total future minimum payments		$ 2,700,000

SELECTED QUARTERLY FINANCIAL DATA (UNAUDITED) (Details) - USD ($)	3 Months Ended								12 Months Ended
	Dec. 31, 2018	Sep. 30, 2018	Jun. 30, 2018	Mar. 31, 2018	Dec. 31, 2017	Sep. 30, 2017	Jun. 30, 2017	Mar. 31, 2017	Dec. 31, 2018	Dec. 31, 2017	Dec. 31, 2016
Quarterly Financial Information Disclosure [Abstract]
Revenues	$ 5,089,000	$ 3,474,000	$ 3,763,000	$ 3,773,000	$ 4,125,000	$ 4,418,000	$ 4,250,000	$ 3,985,000	$ 16,099,460	$ 16,777,713	$ 19,356,450
Gross profit	4,139,000	2,775,000	3,309,000	3,139,000	3,530,000	3,717,000	3,568,000	3,326,000	13,361,808	14,140,770	15,170,742
Net loss	$ (39,391,000)	$ (35,605,000)	$ (33,219,000)	$ (24,402,000)	$ (21,427,000)	$ (14,665,000)	$ (19,677,000)	$ (21,156,000)	$ (132,617,160)	$ (76,925,380)	$ (89,875,459)
Loss per common share, basic and diluted (in dollars per shares)	$ (0.17)	$ (0.16)	$ (0.15)	$ (0.11)	$ (0.10)	$ (0.07)	$ (0.10)	$ (0.11)	$ (0.59)	$ (0.37)	$ (0.46)

- Definition

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

+ References + Details

FIXED ASSETS, NET (Details Narrative) - USD ($)	12 Months Ended
FIXED ASSETS, NET (Details Narrative) - USD ($)	Dec. 31, 2018	Dec. 31, 2017	Dec. 31, 2016
Property, Plant and Equipment [Abstract]
Depreciation expense	$ 181,412	$ 141,601	$ 77,906

INCOME TAXES (Details) - USD ($)	12 Months Ended
INCOME TAXES (Details) - USD ($)	Dec. 31, 2018	Dec. 31, 2017	Dec. 31, 2016
Income before taxes	$ (132,617,160)	$ (76,925,380)	$ (89,875,459)
United States [Member]
Income before taxes	$ (132,617,160)	$ (76,925,380)	$ (89,875,459)