Document and Entity Information - USD ($)	12 Months Ended
Document and Entity Information - USD ($)	Dec. 31, 2017	Feb. 20, 2018	Jun. 30, 2017
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, 2017
Amendment Flag	false
Current Fiscal Year End Date	--12-31
Entity a Well-known Seasoned Issuer	Yes
Entity a Voluntary Filer	No
Entity's Reporting Status Current	Yes
Entity Filer Category	Large Accelerated Filer
Entity Common Stock, Held by non-affiliates (shares)			169,430,175
Entity Public Float			$ 892,897,022
Entity Common Stock, Shares Outstanding		216,439,483
Document Fiscal Period Focus	FY
Document Fiscal Year Focus	2017

CONSOLIDATED BALANCE SHEETS - USD ($)	Dec. 31, 2017	Dec. 31, 2016
Current Assets:
Cash	$ 127,135,628	$ 131,534,101
Accounts receivable, net of allowance for doubtful accounts of $380,580 and $376,374, respectively	4,328,802	4,500,699
Inventory	1,485,358	1,076,321
Other current assets	6,604,284	2,299,052
Total current assets	139,554,072	139,410,173
Fixed assets, net	437,055	516,839
Other Assets:
Intangible assets, net	3,099,747	2,405,972
Security deposit	139,036	139,036
Total other assets	3,238,783	2,545,008
Total assets	143,229,910	142,472,020
Current Liabilities:
Accounts payable	4,097,600	7,358,514
Other current liabilities	9,223,595	7,624,085
Total current liabilities	13,321,195	14,982,599
Commitments and Contingencies - See Note 12
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; 216,429,642 and 196,688,222 issued and outstanding, respectively	216,430	196,688
Additional paid in capital	516,351,405	436,995,052
Accumulated deficit	(386,659,120)	(309,702,319)
Total stockholders' equity	129,908,715	127,489,421
Total liabilities and stockholders' equity	$ 143,229,910	$ 142,472,020

CONSOLIDATED BALANCE SHEETS (Parenthetical) - USD ($)	Dec. 31, 2017	Dec. 31, 2016
Statement of Financial Position [Abstract]
Allowance for doubtful accounts	$ 380,580	$ 376,374
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	216,429,642	196,688,222
Common stock, outstanding	216,429,642	196,688,222

CONSOLIDATED STATEMENTS OF OPERATIONS - USD ($)	12 Months Ended
CONSOLIDATED STATEMENTS OF OPERATIONS - USD ($)	Dec. 31, 2017	Dec. 31, 2016	Dec. 31, 2015
Income Statement [Abstract]
Revenues, net	$ 16,777,713	$ 19,356,450	$ 20,142,898
Cost of goods sold	2,636,943	4,185,708	4,506,673
Gross profit	14,140,770	15,170,742	15,636,225
Operating expenses:
Sales, general, and administration	57,703,370	51,348,414	28,721,236
Research and development	33,852,993	53,943,477	72,042,774
Depreciation and amortization	213,117	132,451	62,400
Total operating expense	91,769,480	105,424,342	100,826,410
Operating loss	(77,628,710)	(90,253,600)	(85,190,185)
Other income:
Miscellaneous income	695,631	367,317	95,719
Accreted interest	7,699	10,824	17,442
Total other income	703,330	378,141	113,161
Loss before taxes	(76,925,380)	(89,875,459)	(85,077,024)
Net loss	$ (76,925,380)	$ (89,875,459)	$ (85,077,024)
Net loss per share, basic and diluted (in dollars per share)	$ (0.37)	$ (0.46)	$ (0.49)
Weighted average number of common shares outstanding (in shares)	205,523,288	196,088,196	173,174,229

CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY - USD ($)	Common Stock	Additional Paid in Capital	Accumulated Deficit	Total
Beginning balance at Dec. 31, 2014	$ 156,097	$ 182,982,846	$ (134,749,836)	$ 48,389,107
Beginning balance (in shares) at Dec. 31, 2014	156,097,019
Shares issued in offerings, net of cost	$ 20,040	91,354,609		91,374,649
Shares issued in offerings, net of cost (in shares)	20,040,359
Shares issued for exercise of options, net	$ 613	1,231,966		1,232,579
Shares issued for exercise of options, net (in shares)	612,981
Shares issued for exercise of warrants, net	$ 1,178	364,822		366,000
Shares issued for exercise of warrants, net (in shares)	1,177,682
Share-based compensation		6,777,835		6,777,835
Net loss			(85,077,024)	(85,077,024)
Ending balance at Dec. 31, 2015	$ 177,928	282,712,078	(219,826,860)	63,063,146
Ending balance (in shares) at Dec. 31, 2015	177,928,041
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	$ 613	988,447		989,060
Shares issued for exercise of options, net (in shares)	613,195
Shares issued for exercise of warrants, net	$ 723	1,372,277		1,373,000
Shares issued for exercise of warrants, net (in shares)	722,744
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			196,688,222
Adoption of ASU 2016-09 at Dec. 31, 2016		31,421	(31,421)
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
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

CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($)	12 Months Ended
CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($)	Dec. 31, 2017	Dec. 31, 2016	Dec. 31, 2015
CASH FLOWS FROM OPERATING ACTIVITIES
Net loss	$ (76,925,380)	$ (89,875,459)	$ (85,077,024)
Adjustments to reconcile net loss to net cash flows used in operating activities:
Depreciation	141,601	77,906	29,959
Amortization of intangible assets	71,516	54,545	32,441
Provision for doubtful accounts	4,206	2,524,909	22,157
Share-based compensation	6,889,323	17,411,021	7,189,699
Changes in operating assets and liabilities:
Accounts receivable	167,691	(3,975,893)	(917,656)
Inventory	(409,037)	(386,168)	491,960
Other current assets	(4,434,130)	709,907	(773,532)
Other assets			(17,442)
Accounts payable	(3,260,914)	4,232,340	(3,200,955)
Deferred revenue			(522,613)
Other current liabilities	1,599,510	84,559	3,698,887
Net cash used in operating activities	(76,155,614)	(69,142,333)	(79,044,119)
CASH FLOWS FROM INVESTING ACTIVITIES
Patent costs	(765,291)	(845,266)	(419,104)
Purchase of fixed assets	(61,817)	(396,154)	(165,257)
Payment of security deposit		(14,036)
Net cash used in investing activities	(827,108)	(1,255,456)	(584,361)
CASH FLOWS FROM FINANCING ACTIVITIES
Proceeds from sale of common stock, net of costs	68,572,635	134,863,475	91,374,649
Proceeds from exercise of options	212,615	989,060	1,232,579
Proceeds from exercise of warrants	3,798,999	1,373,000	366,000
Net cash provided by financing activities	72,584,249	137,225,535	92,973,228
(Decrease) increase in cash	(4,398,473)	66,827,746	13,344,748
Cash, beginning of period	131,534,101	64,706,355	51,361,607
Cash, end of period	$ 127,135,628	$ 131,534,101	$ 64,706,355

THE COMPANY

12 Months Ended

Dec. 31, 2017

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 health care company focused on creating and commercializing products targeted exclusively for women. Currently, we are focused on pursuing the regulatory approvals and pre-commercialization activities necessary for commercialization of our advanced hormone therapy pharmaceutical products. Our drug candidates that have completed clinical trials are designed to alleviate the symptoms of and reduce the health risks resulting from menopause-related hormone deficiencies, including hot flashes, osteoporosis and vaginal discomfort. We are developing these hormone therapy drug candidates, which contain estradiol and progesterone alone or in combination, with the aim of demonstrating clinical efficacy at lower doses, thereby enabling an enhanced side effect profile compared with competing products. With our SYMBODA™ technology, we are developing advanced hormone therapy pharmaceutical products to enable delivery of bio-identical hormones through a variety of dosage forms and administration routes. In addition, we manufacture and distribute branded and generic prescription prenatal vitamins, as well as over-the-counter, or OTC, iron supplements, which we ceased manufacturing in October 2017.

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

12 Months Ended

Dec. 31, 2017

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 (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, 2017, four different customers represented 27%, 23%, 22% and 11%, respectively, of our gross accounts receivable. At December 31, 2016, two different customers represented 28% and 20%, respectively, of our gross accounts receivable.

During the third quarter of 2016, we wrote-off accounts receivable balances of approximately $2,200,000 related to two retail pharmacy distributors. Both pharmacies are relatively small owner-managed pharmacies and share a similar amount of collection risk. Among the factors that contributed to our decision to write-off these balances were our inability to collect the outstanding balances and the lack of a continuing communication and business relationship with these parties following the centralization of the distribution channel for both our retail pharmacy distributors and wholesale distributors, effective September 1, 2016.

Inventories

Inventories represent 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, 2017, we had 18 issued 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, 2017, 2016, and 2015.

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, 2017, 2016, and 2015.

Fair Value of Financial Instruments

Our financial instruments consist primarily of cash, accounts receivable, accounts payable and accrued expenses. 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, 2017 and 2016, 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, 2017, 2016, and 2015.

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, 2017 and 2016, we had no tax positions relating to open tax returns that were considered to be uncertain.

Our tax returns are subject to review by the Internal Revenue Service three years after they are filed. Currently, years filed after 2013 are subject to review.

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, including forfeiture rates, 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, net of estimated forfeitures, 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 recognize revenue on arrangements in accordance with ASC 605, Revenue Recognition. We recognize revenue only when the price is fixed or determinable, persuasive evidence of an arrangement exists, the service is performed, and collectability is reasonably assured.

Our OTC and prescription prenatal vitamin products are generally variations of the same product with slight modifications in formulation and marketing. The primary difference between our OTC and prescription prenatal vitamin products is the source of payment. Purchasers of our OTC prenatal vitamin products pay for the product directly while purchasers of our prescription prenatal vitamin products pay for the product primarily via third-party payers. Both OTC and prescription prenatal vitamin products share the same marketing support team utilizing similar marketing techniques. As of January 1, 2017, we ceased manufacturing and distributing our OTC product lines, except for Iron 21/7, which we ceased manufacturing in October 2017. The revenue that is generated by us from major customers is all generated from sales of our prescription prenatal vitamin products, which is disclosed in Note 11. There are no major customers for our OTC prenatal vitamin or other products.

Over-the-Counter Products

We generate OTC revenue from product sales primarily to retail consumers. We recognize revenue from product sales upon shipment, when the rights of ownership and risk of loss have passed to the consumer. We include outbound shipping and handling fees, if any, in revenues, net, and bill them upon shipment. We include shipping expenses in cost of goods sold. A majority of our OTC customers pay for our products with credit cards, and we usually receive the cash settlement in two to three banking days. Credit card sales minimize accounts receivable balances relative to OTC sales (Iron 21/7). We provide an unconditional 30-day money-back return policy under which we accept product returns from our retail and eCommerce OTC customers. We recognize revenue from OTC sales, net of estimated returns and sales discounts. As of January 1, 2017, we ceased manufacturing and distributing our OTC product lines, except for Iron 21/7, which we ceased manufacturing in October 2017.

Prescription Products

We sell our name brand and generic prescription products primarily through wholesale distributors and retail pharmacy distributors. We recognize revenue from prescription product sales, net of sales discounts, chargebacks, wholesaler fees, customer rebates, coupons and estimated returns.

Revenue related to prescription products sold through wholesale distributors is recognized when the prescription products are shipped to the distributors and the control of the products passes to each distributor. 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.

Prior to September 1, 2016, we recognized revenue related to prescription products sold through retail pharmacy distributors when the product was dispensed by the retail pharmacy distributor, at which point all revenue and discounts related to such product were known or determinable and there was no right of return with respect to such product. On September 1, 2016, we centralized the distribution channel for both our retail pharmacy distributors and wholesale distributors, in order to facilitate sales to a broader population of retail pharmacies and mitigate exposure to any one retail pharmacy. Beginning on September 1, 2016, all of our prescription products are distributed under the wholesale distributor model described above.

We offer various rebate 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. We record distributor fees based on amounts stated in contracts and estimate chargebacks based on the number of units sold each period.

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 $448,288, $752,611, and $792,574 during the years ended December 31, 2017, 2016, and 2015, 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. Advance payments to be expensed in future research and development activities are capitalized, and were $0 and $228,933 at December 31, 2017 and 2016, respectively, all of which was included in other current assets on the accompanying consolidated balance sheets. 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 U.S. Food and Drug Administration, or the FDA, submission processes, clinical trial processes, and scientific writing matters, including preparing protocols and FDA submissions. Legal activities that were classified as R&D expenses include professional research and advice regarding R&D, patents and regulatory matters. These consulting and legal expenses were direct costs associated with preparing, reviewing, and undertaking work for our clinical trials and investigative drugs. We charge internal R&D activities and other activity expenses to operations as incurred. We make payments to CROs based on agreed-upon terms, which may include payments in advance of a study starting date. We expense nonrefundable advance payments for goods and services that will be used in future R&D activities when the activity has been performed or when the goods have been received rather than when the payment is made. We review and accrue CRO expenses and clinical trial study expenses based on services performed and rely on estimates of those costs applicable to the completion stage of a study as provided by CROs. Estimated accrued CRO costs are subject to revisions as such studies progress to completion. We charge revisions expense in the period in which the facts that give rise to the revision become known.

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 and warrants 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,
	2017		2016		2015
Stock options		23,365,225		21,767,854		20,725,325
Warrants		3,115,905		12,060,071		12,722,431
		26,481,130		33,827,925		33,447,756

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. The Company has 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 May 2017, the FASB issued ASU 2017-09, which clarifies when changes to the terms or conditions of a share-based payment award must be accounted for as modifications. The new guidance will reduce diversity in practice and result in fewer changes to the terms of an award being accounted for as modifications. The new guidance will allow companies to make certain changes to awards without accounting for them as modifications. This guidance does not change the accounting for modifications. The guidance will be applied prospectively to awards modified on or after the adoption date and is effective for annual periods, and interim periods within those annual periods, beginning after December 15, 2017. Early adoption is permitted, including in an interim period. We adopted this guidance and it did not have an impact on our consolidated financial statements.

In August 2016, the FASB issued ASU 2016-15, Statement of Cash Flows (Topic 230). ASU 2016-15 is intended to reduce the diversity in practice regarding how certain transactions are classified within the statement of cash flows. ASU 2016-15 is effective for public business entities for annual periods beginning after December 15, 2017, including interim periods within those fiscal years. Early adoption is permitted with retrospective application. We adopted this guidance and it did not have an impact on our consolidated financial statements.

In March 2016, the FASB issued ASU 2016-09, Compensation – Stock Compensation: Improvements to Employee Share-Based Payment Accounting. This guidance simplifies several aspects of the accounting for employee share-based payment transactions for both public and nonpublic entities, including the accounting for income taxes, forfeitures, and statutory tax withholding requirements, as well as classification in the statement of cash flows. The guidance is effective for public business entities for fiscal years beginning after December 15, 2016, and interim periods within those fiscal years. We adopted ASU 2016-09 effective January 1, 2017, electing to account for forfeitures when they occur. The impact from adoption of the provisions related to forfeiture rates was reflected in our consolidated financial statements on a modified retrospective basis, resulting in an adjustment of approximately $31,000 to retained earnings. The impact from adoption of the provisions related to excess tax benefits or deficiencies in the provision for income taxes rather than paid-in capital was adopted on a modified retrospective basis. Since we have a full valuation allowance on our net deferred tax assets, an amount equal to the cumulative adjustment made to retained earnings to recognize the previously unrecognized net operating losses from prior periods was made to the valuation allowance through retained earnings for the first quarter financial statements. Adoption of all other changes did not have an impact on our consolidated financial statements.

In February 2016, the FASB issued ASU 2016-02, Leases. This guidance requires lessees to record most leases on their balance sheets 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. We are in the process of analyzing the quantitative impact of this guidance on our results of operations and financial position. While we are continuing to assess all potential impacts of the standard, we currently believe the impact of this standard will be primarily related to the accounting for our operating lease.

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 have performed a review of the requirements of the new revenue standard and are monitoring the activity of the FASB and the transition resource group as it relates to specific interpretive guidance. We have reviewed customer contracts and applied the five-step model of the new standard to our contracts as well as compared the results to our current accounting practices. We are currently in the process of drafting disclosures required by the new standard. At this point of our analysis, we do not believe that the adoption of this standard will have a material effect on our financial statements but will potentially expand our disclosures related to contracts with customers.

FIXED ASSETS

12 Months Ended

Dec. 31, 2017

Property, Plant and Equipment [Abstract]

FIXED ASSETS

NOTE 5 – FIXED ASSETS, NET

Fixed assets, net consist of the following:

	December 31,
	2017			2016
Accounting system	$	301,096		$	301,096
Equipment		273,536			215,182
Computer hardware		80,211			80,211
Furniture and fixtures		116,542			113,079
Leasehold improvements		37,888			37,888
TOTAL		809,273			747,456
Accumulated depreciation		(372,218	)		(230,617	)
TOTAL FIXED ASSETS, NET	$	437,055		$	516,839

Depreciation expense for the years ended December 31, 2017, 2016, and 2015 was $141,601, $77,906, and $29,959, respectively.

INTANGIBLE ASSETS

12 Months Ended

Dec. 31, 2017

Intangible Assets, Net (Excluding Goodwill) [Abstract]

INTANGIBLE ASSETS

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, 2017 and 2016:

	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

	December 31, 2016
	Gross Carrying Amount		Accumulated Amortization			Net Amount		Weighted- Average Remaining Amortization Period (yrs.)
Amortizable intangible assets:
OPERA^® software patent	$	31,951	$	(6,490	)	$	25,461		12.75
Development costs of corporate website		91,743		(91,743	)		—		n/a
Approved hormone therapy drug candidate patents		1,093,452		(102,393	)		991,059		16
Hormone therapy drug candidate patents (pending)		1,203,987		—			1,203,987		n/a
Non-amortizable intangible assets:
Multiple trademarks for vitamins/supplements		185,465		—			185,465		indefinite
Total	$	2,606,598	$	(200,626	)	$	2,405,972

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, 2017 and 2016, there was no impairment recognized related to intangible assets.

We have numerous pending foreign and domestic patent applications. As of December 31, 2017, we had 18 issued domestic, or U.S., patents and 13 issued foreign patents, including:

●

13 domestic and three foreign utility patents that relate to our combination progesterone and estradiol product candidates, which are owned by us. The domestic utility patents will expire in 2032. In addition, we have pending patent applications with respect to our combination progesterone and estradiol product candidates in the U.S., Argentina, Australia, Brazil, Canada, Europe, Israel, Japan, Mexico, Russia, South Africa, and South Korea;

●

three domestic and 10 foreign patents that relate to TX-004HR, our applicator-free vaginal estradiol softgel product candidate. These patents establish an important intellectual property foundation for TX-004HR and are owned by us. These domestic patents will expire in 2033 or 2032. In addition, we have pending patent applications related to our applicator-free vaginal estradiol softgel product candidate in the U.S., Argentina, Australia, Brazil, Canada, Europe, Israel, Japan, Mexico, Russia, South Africa, and South Korea;

●

one domestic utility patent that relates to a pipeline transdermal patch technology, which is owned by us and will expire in 2032. We have pending patent applications with respect to this technology in the U.S., Australia, Brazil, Canada, Europe, Mexico, Japan, and South Africa; and

●

one utility patent that relates to our OPERA^® information-technology platform, which is owned by us and is a domestic patent that will expire in 2029.

Amortization expense was $71,516, $54,545, and $32,441 for the years ended December 31, 2017, 2016, and 2015, 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
	2018	$	76,777
	2019	$	76,777
	2020	$	76,777
	2021	$	76,777
	2022	$	76,777
	Thereafter	$	761,282

STOCKHOLDERS' EQUITY

12 Months Ended

Dec. 31, 2017

Stockholders' Equity:

STOCKHOLDERS' EQUITY

NOTE 8 – STOCKHOLDERS’ EQUITY

Preferred Stock

At December 31, 2017, 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, 2017, we had 350,000,000 shares of Common Stock authorized for issuance, of which 216,429,642 shares of our Common Stock were issued and outstanding.

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, or the 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 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 estimated offering 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’ cashless exercise provisions, wherein 87,833 shares of Common Stock were issued.

Issuances During 2015

On July 9, 2015, we entered into an underwriting agreement with Stifel, Nicolaus & Company, Incorporated and Guggenheim Securities, LLC, as the representatives of the several underwriters, or the Stifel Underwriters, relating to an underwritten public offering of 3,846,154 shares of Common Stock at a public offering price of $7.80 per share. Under the terms of the underwriting agreement, we granted the Stifel Underwriters a 30-day option to purchase up to an aggregate of 576,923 additional shares of Common Stock, which option was exercised in full. The net proceeds to us from the offering were approximately $32,257,000, after deducting underwriting discounts and commissions and other estimated offering expenses payable by us. The offering closed on July 15, 2015 and we issued 4,423,077 shares of our Common Stock.

On February 10, 2015, we entered into an underwriting agreement, or the Cowen Agreement, with Cowen and Company, LLC, as the representative of the several underwriters, or the Cowen Underwriters, relating to an underwritten public offering of 13,580,246 shares of Common Stock, at a public offering price of $4.05 per share. Under the terms of the Cowen Agreement, we granted the Cowen Underwriters a 30-day option to purchase up to an aggregate of 2,037,036 additional shares of Common Stock, which option was exercised in full. The net proceeds from the offering were approximately $59,118,000, after deducting underwriting discounts and commissions and other estimated offering expenses payable by us. The offering closed on February 17, 2015 and we issued 15,617,282 shares of our Common Stock.

During the year ended December 31, 2015, certain individuals exercised stock options to purchase 612,867 shares of Common Stock for $1,232,579 in cash. Also during the same period, stock options to purchase 417 shares of Common Stock were exercised pursuant to the options’ cashless exercise provisions, wherein 114 shares of Common Stock were issued.

Warrants to Purchase Common Stock

As of December 31, 2017, we had warrants outstanding to purchase an aggregate of 3,115,905 shares of our Common Stock with a weighted-average contractual remaining life of 1.8 years, and exercise prices ranging from $0.24 to $8.20 per share, resulting in a weighted average exercise price of $2.58 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, 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.

During the year ended December 31, 2015, we granted warrants to purchase 50,000 shares of Common Stock to an outside consultant at an exercise price of $6.35 vesting ratably over a 12-month period, with an expiration date of April 6, 2020. We recorded share-based compensation expense related to warrants previously issued of $313,271, $936,974 and $139,142 for the years ended December 31, 2017, 2016, and 2015, respectively, in the accompanying consolidated financial statements. At December 31, 2017, total unrecognized estimated compensation expense related to the unvested portion of these warrants was approximately $128,000 which is expected to be recognized over a weighted-average period of 0.2 years.

Summary of our Warrant activity during the year ended December 31, 2017:

	Number of Shares Under Warrants			Weighted Average Exercise Price		Weighted Average Remaining Contractual Life in Years		Aggregate Intrinsic Value
Balance at December 31, 2016		12,060,071		$	2.08		1.0	$	45,063,867
Granted		125,000		$	6.83
Exercised		(9,066,666	)	$	1.98			$	48,535,969
Expired		(2,500	)	$	2.64
Cancelled/Forfeited		—		$	—
Balance at December 31, 2017		3,115,905		$	2.58		1.8	$	11,348,273
Vested and Exercisable at December 31, 2017		2,792,983		$	2.64		0.8	$	1,141,836
Unvested at December 31, 2017		322,922		$	2.57		2.0	$	10,206,436

The aggregate intrinsic value of warrants exercised during 2016 and 2015, was $3,988,343 and $7,282,404, respectively. 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, 2017, 2016 and 2015 are set forth in the table below.

	2017			2016			2015
Weighted average exercise price	$	6.83		$	7.90		$	6.35
Weighted average grant date fair value	$	3.67		$	4.78		$	3.27
Risk-free interest rate		1.47	%		1.04-1.28	%		1.02	%
Volatility		63.24	%		74.10-74.15	%		60.59	%
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 our stock price is expected to fluctuate each year during the term of the instrument. The estimated volatility is an average of the historical volatility of the stock prices of our peer entities whose stock prices were publicly available. Our calculation of estimated volatility is based on historical stock prices over a period equal to the term of the instrument as we have insufficient historical information regarding our stock options to provide a basis for estimate. The expected volatility of warrants was estimated based on a historical volatility analysis of 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 U.S. Food and Drug Administration, or the FDA, approval for our drug candidates, including a vaginal capsule for the treatment of vulvar and vaginal atrophy, or 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:

	1.	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 5 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;

	2.	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 5 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, $77,026, and $154,068, 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 will 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. It is anticipated that receipt of such an approval may occur in the near future.

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, 2017, 2016, and 2015, we recorded $128,898, $257,796, 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, 2017, certain individuals exercised warrants to purchase 2,476,666 shares of Common Stock for $3,798,999 in cash. 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.

During the year ended December 31, 2015, certain individuals and an entity exercised warrants to purchase 1,255,485 shares of Common Stock as follows: (i) 945,485 shares of Common Stock were issued for $366,000 in cash and (ii) warrants to purchase 310,000 shares of Common Stock were exercised pursuant to the warrants’ cashless exercise provisions, wherein 232,197 shares of Common Stock were issued.

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, 2017, there were non-qualified stock options to purchase 18,575,084 shares of Common Stock outstanding under the 2009 Plan. As of December 31, 2017, there were 2,173,878 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, 2017, there were non-qualified stock options to purchase 4,790,141 shares of Common Stock outstanding under the 2012 Plan. As of December 31, 2017, there were 5,128,333 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, 2017, 2016, and 2015 are set forth in the table below.

	2017			2016			2015
Weighted average exercise price	$	6.60		$	6.22		$	8.14
Weighted average grant date fair value	$	3.82		$	3.94		$	4.45
Risk-free interest rate		1.84-2.05	%		1.13-1.90	%		1.47-1.67	%
Volatility		61.56-64.25	%		70.26-73.34	%		58.78-62.94	%
Term (in years)		5.5-6.25			5.5-6.25			5.27-6.25
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 price of our Common Stock is expected to fluctuate each year during the term of an award. Our estimated volatility is an average of the historical volatility of the stock prices of our peer entities whose stock prices were publicly available. Our calculation of estimated volatility is based on historical stock prices over a period equal to the term of the awards as we have insufficient historical information regarding our stock options to provide a basis for estimate. The expected volatility of share options was estimated based on a historical volatility analysis of 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, 2017 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, 2016		21,767,854		$	3.56		5.8	$	60,495,730
Granted		2,271,500		$	6.60
Exercised		(102,546	)	$	2.07			$	452,287
Expired		(108,375	)	$	7.64
Cancelled/Forfeited		(463,208	)	$	6.28
Balance at December 31, 2017		23,365,225		$	3.78		5.13	$	64,664,821
Vested and Exercisable at December 31, 2017		19,770,142		$	3.27		4.47	$	63,895,512
Unvested at December 31, 2017		3,595,083		$	6.60		8.79	$	769,309

At December 31, 2017, our outstanding options had exercise prices ranging from $0.10 to $8.92 per share. The aggregate intrinsic value of options exercised during 2016 and 2015, was $3,828,358 and $3,186,371, respectively. Share-based compensation expense related to options recognized in our results of operations for the years ended December 31, 2017, 2016, and 2015 was approximately $6,447,154, $16,139,225, and $6,621,658, respectively, and it is based on awards vested. At December 31, 2017, total unrecognized estimated compensation expense related to unvested options was approximately $10,596,000, which may be adjusted for future changes in forfeitures. This cost is expected to be recognized over a weighted-average period of 2.1 years. No tax benefit was realized due to a continued pattern of operating losses.

INCOME TAXES

12 Months Ended

Dec. 31, 2017

Income Tax Disclosure [Abstract]

INCOME TAXES

NOTE 9 – INCOME TAXES

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

	2017			2016			2015
United States	$	(76,925,380	)	$	(89,875,459	)	$	(85,077,024	)
Total	$	(76,925,380	)	$	(89,875,459	)	$	(85,077,024	)

For the years ended December 31, 2017, 2016, and 2015, there was no provision for income taxes, current or deferred. At December 31, 2017, we had a federal net operating loss carry forward of approximately $338,613,987 available to offset future taxable income through 2037. The federal carryforwards will begin to expire in 2031.

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

	2017			2016			2015
Federal statutory tax rate		34.0	%		34.0	%		34.0	%
State tax rate, net of federal tax benefit		5.0	%		5.4	%		4.73	%
Adjustment in valuation allowances		22.6	%		(40.3	)%		(38.97	)%
Federal income tax rate change		(60.8	)%		—	%		—	%
Permanent and other differences		(0.8	)%		0.9	%		0.24	%
(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, 2017, 2016, and 2015 are as follows:

	2017			2016			2015
Deferred Income Tax Assets:
Net operating losses	$	99,596,321		$	111,730,450		$	79,499,633
R&D Credit		186,347			186,347			186,347
Total deferred income tax asset		99,782,668			111,916,797			79,685,980
Valuation allowance		(99,782,668	)		(111,916,797	)		(79,685,980	)
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 the Company’s Balance Sheet and as such, a valuation allowance has been established against the deferred tax assets for the period ended December 31, 2017.

Unrecognized Tax Benefits

As of the period ended December 31, 2017, 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. Consequently, we have recorded a decrease related to deferred tax assets and deferred tax liabilities of approximately $49,500,000 and approximately $2,800,000, respectively, with a corresponding net adjustment to the valuation allowance of approximately $46,700,000 for the year ended December 31, 2017.

The Tax Act modifies Section 162(m) of the Internal Revenue Code of 1986, as amended, or the IRC, by (1) expanding which employees are considered covered employees by including the chief financial officer, (2) providing that if an individual is a covered employee for a taxable year beginning after December 31, 2016, the individual remains a covered employee for all future years, and (3) removing the exceptions for compensation stemming from contracts entered into on or before November 2, 2017, unless such contracts were materially modified on or after the date. Compensation agreements entered into and share-based payment awards granted after this date will be subject to the revised terms of IRC Section 162(m). In December 2017, the SEC staff issued Staff Accounting Bulletin No. 118, Income Tax Accounting Implications of the Tax Cuts and Jobs Act (SAB 118), which allows us to record provisional amounts during a measurement period not to extend beyond one year of the enactment date. Since the Tax Act was passed late in the fourth quarter of 2017, and ongoing guidance and accounting interpretation are expected over the next 12 months, we consider the accounting for share-based compensation arrangements under the Tax Act to be incomplete due to the forthcoming guidance and our ongoing analysis of final year-end data and tax positions.

We must assess whether our valuation allowance analyses are affected by various aspects of the Tax Act. Since, as discussed herein, we have recorded provisional amounts related to certain portions of the Tax Act, any corresponding determination of the need for or change in a valuation allowance is also provisional.

RELATED PARTIES

12 Months Ended

Dec. 31, 2017

RELATED PARTIES

NOTE 10 – RELATED PARTIES

In July 2015, J. Martin Carroll, a director of our company, was appointed to the board of directors of Catalent, Inc. From time to time, we have entered into agreements with Catalent, Inc. and its affiliates, or Catalent, in the normal course of business. Agreements with Catalent have been reviewed by independent directors of our company or a committee consisting of independent directors of our company since July 2015. During the years ended December 31, 2017, 2016 and 2015, we were billed by Catalent approximately $3,646,000, $3,647,000 and $1,266,000, respectively, for manufacturing activities related to our clinical trials, scale-up, registration batches, stability and validation testing. As of December 31, 2017 and December 31, 2016, there were amounts due to Catalent of approximately $523,000 and $57,000, respectively.

BUSINESS CONCENTRATIONS

12 Months Ended

Dec. 31, 2017

Risks and Uncertainties [Abstract]

BUSINESS CONCENTRATIONS

NOTE 11 - BUSINESS CONCENTRATIONS

We purchase our products from several suppliers with approximately 100%, 98%, and 60% of our purchases supplied by one vendor for the years ended December 31, 2017, 2016 and 2015, respectively.

We sell our prescription prenatal vitamin products to wholesale distributors, specialty pharmacies, specialty distributors, and chain drug stores that generally sell products to retail pharmacies, hospitals, and other institutional customers. During the years ended December 31, 2017, 2016 and 2015; four, three, and two customers each, respectively, generated more than 10% of our revenues. Revenue generated from four major customers combined accounted for approximately 59% of our revenue during the year ended December 31, 2017. Revenue generated from three major customers combined accounted for approximately 41% of our revenue during the year ended December 31, 2016. Revenue generated from two major customers combined accounted for approximately 67% of our recognized revenue during the year ended December 31, 2015.

During the year ended December 31, 2017, AmerisourceBergen generated approximately $2,667,000 of our revenue; McKesson Corporation generated approximately $1,959,000 of our revenue; Cardinal Health generated approximately $2,559,000 of our revenue and Pharmacy Innovations PA generated approximately $2,715,000 of our revenue. During the year ended December 31, 2016, Woodstock Pharmaceutical and Compounding generated approximately $2,247,000 of our revenue; Medical Center Pharmacy generated approximately $3,700,000 of our revenue and Pharmacy Innovations PA generated approximately $2,040,000 of our revenue. During the year ended December 31, 2015, Woodstock Pharmaceutical and Compounding generated approximately $8,848,000 of our revenue and Due West Pharmacy generated approximately $4,843,000 of our revenue.

As a result of developments in the pharmaceutical industry that negatively affected independent pharmacies, including such pharmacies’ reliance on third party payors, in 2016, we identified that payment periods for our retail pharmacy distributors were becoming longer than in prior years. As a result, during the third quarter of 2016, we centralized the distribution channel for both our retail pharmacy distributors and wholesale distributors, in order to facilitate sales to a broader population of retail pharmacies and minimize business risk exposure to any one retail pharmacy. During the third quarter of 2016, we entered into new distribution agreements with our retail pharmacy distributors to effectuate this centralization which were effective September 1, 2016.

COMMITMENTS AND CONTINGENCIES

12 Months Ended

Dec. 31, 2017

Commitments and Contingencies Disclosure [Abstract]

COMMITMENTS AND CONTINGENCIES

NOTE 12 – COMMITMENTS AND CONTINGENCIES

Operating Lease

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.

The rental expense related to our current lease during the years ended December 31, 2017, 2016 and 2015 was $1,029,205, $709,483, and $446,099, respectively.

As of December 31, 2017, future minimum rental payments on non-cancelable operating leases are as follows:

Years Ending December 31,
	2018	$	951,194
	2019		1,094,116
	2020		1,113,069
	2021		943,127
	2022		—
	Total minimum lease payments	$	4,101,506

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, 2017, 2016, and 2015, we had no off-balance sheet arrangements that have had or are reasonably likely to have current or future effect on our financial condition, changes in financial condition, revenues or expenses, results of operations, liquidity, capital expenditures or capital resources that are material to investors.

Employment Agreements

We have entered into employment agreements with certain of our executives that provide for compensation and certain other benefits. Under certain circumstances, including a change in control, some of these agreements provide for severance or other payments, if those circumstances occur during the term of the employment agreement.

SELECTED QUARTERLY FINANCIAL DATA (UNAUDITED)

12 Months Ended

Dec. 31, 2017

Quarterly Financial Information Disclosure [Abstract]

SELECTED QUARTERLY FINANCIAL DATA (UNAUDITED)

NOTE 13 – SELECTED QUARTERLY FINANCIAL DATA (UNAUDITED)

Summarized quarterly financial data for fiscal years 2017 and 2016 is as follows:

	2017 Quarters
(In thousands, except per share)	1^st			2^nd			3^rd			4th
Revenues	$	3,985		$	4,250		$	4,418		$	4,125
Gross profit	$	3,326		$	3,568		$	3,717		$	3,530
Net loss	$	(21,156	)	$	(19,677	)	$	(14,665	)	$	(21,427	)

Loss per common share, basic and diluted	$	(0.11	)	$	(0.10	)	$	(0.07	)	$	(0.10	)

	2016 Quarters
(In thousands, except per share)	1^st			2^nd			3^rd			4th
Revenues	$	4,930		$	4,403		$	5,536		$	4,487
Gross profit	$	3,822		$	3,273		$	4,298		$	3,778
Net loss	$	(20,929	)	$	(21,094	)	$	(25,016	)	$	(22,836	)

Loss per common share, basic and diluted	$	(0.11	)	$	(0.11	)	$	(0.13	)	$	(0.12	)

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies)

12 Months Ended

Dec. 31, 2017

Accounting Policies [Abstract]

Principles of Consolidation

Cash

Trade Accounts Receivable and Allowance for Doubtful Accounts

Inventories

Pre-Launch Inventory

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, 2017 and 2016, we had no assets or liabilities that were valued at fair value on a recurring basis.

Income Taxes

Our tax returns are subject to review by the Internal Revenue Service three years after they are filed. Currently, years filed after 2013 are subject to review.

Share-Based Compensation

Revenue Recognition

Over-the-Counter Products

Over-the-Counter Products

Prescription Products

Prescription Products

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 $448,288, $752,611, and $792,574 during the years ended December 31, 2017, 2016, and 2015, respectively.

Research and Development

Research and Development Expenses

Earnings Per Share

	As of December 31,
	2017		2016		2015
Stock options		23,365,225		21,767,854		20,725,325
Warrants		3,115,905		12,060,071		12,722,431
		26,481,130		33,827,925		33,447,756

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, 2017

Accounting Policies [Abstract]

Schedule of potentially dilutive securities in calculation of diluted net loss per share allocable to common stockholders

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,
	2017		2016		2015
Stock options		23,365,225		21,767,854		20,725,325
Warrants		3,115,905		12,060,071		12,722,431
		26,481,130		33,827,925		33,447,756

INVENTORY (Tables)

12 Months Ended

Dec. 31, 2017

Inventory Disclosure [Abstract]

Schedule of inventory

Inventory consists of the following:

	December 31,
	2017		2016
Finished product	$	1,485,358	$	1,062,285
Raw material		—		14,036
TOTAL INVENTORY	$	1,485,358	$	1,076,321

INTANGIBLE ASSETS (Tables)

12 Months Ended

Dec. 31, 2017

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, 2017 and 2016:

	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

	December 31, 2016
	Gross Carrying Amount		Accumulated Amortization			Net Amount		Weighted- Average Remaining Amortization Period (yrs.)
Amortizable intangible assets:
OPERA^® software patent	$	31,951	$	(6,490	)	$	25,461		12.75
Development costs of corporate website		91,743		(91,743	)		—		n/a
Approved hormone therapy drug candidate patents		1,093,452		(102,393	)		991,059		16
Hormone therapy drug candidate patents (pending)		1,203,987		—			1,203,987		n/a
Non-amortizable intangible assets:
Multiple trademarks for vitamins/supplements		185,465		—			185,465		indefinite
Total	$	2,606,598	$	(200,626	)	$	2,405,972

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
	2018	$	76,777
	2019	$	76,777
	2020	$	76,777
	2021	$	76,777
	2022	$	76,777
	Thereafter	$	761,282

STOCKHOLDERS' EQUITY (Tables)

12 Months Ended

Dec. 31, 2017

Stockholders' Equity:

Schedule of warrant activity

Summary of our Warrant activity during the year ended December 31, 2017:

	Number of Shares Under Warrants			Weighted Average Exercise Price		Weighted Average Remaining Contractual Life in Years		Aggregate Intrinsic Value
Balance at December 31, 2016		12,060,071		$	2.08		1.0	$	45,063,867
Granted		125,000		$	6.83
Exercised		(9,066,666	)	$	1.98			$	48,535,969
Expired		(2,500	)	$	2.64
Cancelled/Forfeited		—		$	—
Balance at December 31, 2017		3,115,905		$	2.58		1.8	$	11,348,273
Vested and Exercisable at December 31, 2017		2,792,983		$	2.64		0.8	$	1,141,836
Unvested at December 31, 2017		322,922		$	2.57		2.0	$	10,206,436

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

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, 2017, 2016 and 2015 are set forth in the table below.

	2017			2016			2015
Weighted average exercise price	$	6.83		$	7.90		$	6.35
Weighted average grant date fair value	$	3.67		$	4.78		$	3.27
Risk-free interest rate		1.47	%		1.04-1.28	%		1.02	%
Volatility		63.24	%		74.10-74.15	%		60.59	%
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, 2017, 2016, and 2015 are set forth in the table below.

	2017			2016			2015
Weighted average exercise price	$	6.60		$	6.22		$	8.14
Weighted average grant date fair value	$	3.82		$	3.94		$	4.45
Risk-free interest rate		1.84-2.05	%		1.13-1.90	%		1.47-1.67	%
Volatility		61.56-64.25	%		70.26-73.34	%		58.78-62.94	%
Term (in years)		5.5-6.25			5.5-6.25			5.27-6.25
Dividend yield		0.00	%		0.00	%		0.00	%

Schedule of 2009 and 2012 Plans activity

A summary of activity under the 2009 and 2012 Plans and related information during the year ended December 31, 2017 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, 2016		21,767,854		$	3.56		5.8	$	60,495,730
Granted		2,271,500		$	6.60
Exercised		(102,546	)	$	2.07			$	452,287
Expired		(108,375	)	$	7.64
Cancelled/Forfeited		(463,208	)	$	6.28
Balance at December 31, 2017		23,365,225		$	3.78		5.13	$	64,664,821
Vested and Exercisable at December 31, 2017		19,770,142		$	3.27		4.47	$	63,895,512
Unvested at December 31, 2017		3,595,083		$	6.60		8.79	$	769,309

INCOME TAXES (Tables)

12 Months Ended

Dec. 31, 2017

Income Tax Disclosure [Abstract]

Schedule of components of income before taxes

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

	2017			2016			2015
United States	$	(76,925,380	)	$	(89,875,459	)	$	(85,077,024	)
Total	$	(76,925,380	)	$	(89,875,459	)	$	(85,077,024	)

Schedule of tax rate reconciliation

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

	2017			2016			2015
Federal statutory tax rate		34.0	%		34.0	%		34.0	%
State tax rate, net of federal tax benefit		5.0	%		5.4	%		4.73	%
Adjustment in valuation allowances		22.6	%		(40.3	)%		(38.97	)%
Federal income tax rate change		(60.8	)%		—	%		—	%
Permanent and other differences		(0.8	)%		0.9	%		0.24	%
(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, 2017, 2016, and 2015 are as follows:

	2017			2016			2015
Deferred Income Tax Assets:
Net operating losses	$	99,596,321		$	111,730,450		$	79,499,633
R&D Credit		186,347			186,347			186,347
Total deferred income tax asset		99,782,668			111,916,797			79,685,980
Valuation allowance		(99,782,668	)		(111,916,797	)		(79,685,980	)
Deferred income tax assets, net	$	—		$	—		$	—

SELECTED QUARTERLY FINANCIAL DATA (Tables)

12 Months Ended

Dec. 31, 2017

Quarterly Financial Information Disclosure [Abstract]

Schedule of summarized quarterly financial data

Summarized quarterly financial data for fiscal years 2017 and 2016 is as follows:

	2017 Quarters
(In thousands, except per share)	1^st			2^nd			3^rd			4th
Revenues	$	3,985		$	4,250		$	4,418		$	4,125
Gross profit	$	3,326		$	3,568		$	3,717		$	3,530
Net loss	$	(21,156	)	$	(19,677	)	$	(14,665	)	$	(21,427	)

Loss per common share, basic and diluted	$	(0.11	)	$	(0.10	)	$	(0.07	)	$	(0.10	)

	2016 Quarters
(In thousands, except per share)	1^st			2^nd			3^rd			4th
Revenues	$	4,930		$	4,403		$	5,536		$	4,487
Gross profit	$	3,822		$	3,273		$	4,298		$	3,778
Net loss	$	(20,929	)	$	(21,094	)	$	(25,016	)	$	(22,836	)

Loss per common share, basic and diluted	$	(0.11	)	$	(0.11	)	$	(0.13	)	$	(0.12	)

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details) - shares	12 Months Ended
	Dec. 31, 2017	Dec. 31, 2016	Dec. 31, 2015
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Anti-dilutive shares excluded from earnings per share calculation	26,481,130	33,827,925	33,447,756
Warrants [Member]
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Anti-dilutive shares excluded from earnings per share calculation	3,115,905	12,060,071	12,722,431
Stock Options [Member]
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Anti-dilutive shares excluded from earnings per share calculation	23,365,225	21,767,854	20,725,325

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details Narrative)	3 Months Ended	12 Months Ended
	Sep. 30, 2016 USD ($)	Dec. 31, 2017 USD ($) Number	Dec. 31, 2016 USD ($)	Dec. 31, 2015 USD ($)
Federal insurance limits		$ 250,000
Write-off accounts receivable	$ 2,200,000
Number of issued patents \| Number		18
Advertising costs		$ 448,288	$ 752,611	$ 792,574
Shelf life of prescription products following product expiration		24 months
Number of operating segment \| Number		1
Impact from modified retrospective basis adoption of accounting standard		$ 31,000
Customer A [Member] \| Accounts Receivable [Member]
Concentration risk		27.00%	28.00%
Customer B [Member] \| Accounts Receivable [Member]
Concentration risk		23.00%	20.00%
Customer C [Member] \| Accounts Receivable [Member]
Concentration risk		22.00%
Customer D [Member] \| Accounts Receivable [Member]
Concentration risk		11.00%
Minimum [Member]
Return period of unsalable prescription products		6 months
Minimum [Member] \| Software [Member]
Estimated useful lives		5 years
Maximum [Member]
Return period of unsalable prescription products		12 months
Maximum [Member] \| Software [Member]
Estimated useful lives		7 years
Related to Research and Development Activities [Member]
Advance payments - total		$ 0	$ 228,933

INVENTORY (Details) - USD ($)	Dec. 31, 2017	Dec. 31, 2016
Inventory
Finished product	$ 1,485,358	$ 1,062,285
Raw material		14,036
TOTAL INVENTORY	$ 1,485,358	$ 1,076,321

OTHER CURRENT ASSETS (Details) - USD ($)	Dec. 31, 2017	Dec. 31, 2016
Other Current Assets
Prepaid sales and marketing costs	$ 5,335,936
Prepaid insurance	680,243	$ 628,039
Prepaid manufacturing costs		991,809
Prepaid consulting		128,898
Other prepaid costs	523,694	405,960
Prepaid vendor deposits	64,411	44,311
Prepaid research and development costs		100,035
TOTAL OTHER CURRENT ASSETS	$ 6,604,284	$ 2,299,052

FIXED ASSETS (Details) - USD ($)	Dec. 31, 2017	Dec. 31, 2016
Property, Plant and Equipment [Line Items]
Fixed assets, gross	$ 809,273	$ 747,456
Accumulated depreciation	(372,218)	(230,617)
TOTAL FIXED ASSETS	437,055	516,839
Software [Member]
Property, Plant and Equipment [Line Items]
Fixed assets, gross	301,096	301,096
Equipment [Member]
Property, Plant and Equipment [Line Items]
Fixed assets, gross	273,536	215,182
Computer hardware [Member]
Property, Plant and Equipment [Line Items]
Fixed assets, gross	80,211	80,211
Furniture and fixtures [Member]
Property, Plant and Equipment [Line Items]
Fixed assets, gross	116,542	113,079
Leasehold improvements [Member]
Property, Plant and Equipment [Line Items]
Fixed assets, gross	$ 37,888	$ 37,888

INTANGIBLE ASSETS (Details) - USD ($)	12 Months Ended
INTANGIBLE ASSETS (Details) - USD ($)	Dec. 31, 2017	Dec. 31, 2016
Gross Carrying Amount	$ 3,371,888	$ 2,606,598
Net Amount	3,099,747	2,405,972
Finite-Lived Intangible Assets
Accumulated Amortization	(272,141)	(200,626)
Hormone Therapy Drug Candidate Patents - (Pending) [Member]
Finite-Lived Intangible Assets
Gross Carrying Amount	1,721,305	1,203,987
Net Amount	1,721,305	1,203,987
Multiple Trademarks [Member]
Indefinite-Lived Intangible Assets
Gross Carrying Amount	233,275	185,465
Net Amount	233,275	185,465
Opera Software Patent [Member]
Finite-Lived Intangible Assets
Gross Carrying Amount	31,951	31,951
Accumulated Amortization	(8,487)	(6,490)
Net Amount	$ 23,464	$ 25,461
Weighted average remaining amortization period	11 years 9 months	12 years 9 months
Development Costs Of Corporate Website [Member]
Finite-Lived Intangible Assets
Gross Carrying Amount	$ 91,743	$ 91,743
Accumulated Amortization	(91,743)	(91,743)
Approved Hormone Therapy Drug Candidate Patents [Member]
Finite-Lived Intangible Assets
Gross Carrying Amount	1,293,614	1,093,452
Accumulated Amortization	(171,911)	(102,393)
Net Amount	$ 1,121,703	$ 991,059
Weighted average remaining amortization period	15 years	16 years

INTANGIBLE ASSETS (Details 1)	Dec. 31, 2016 USD ($)
Year Ending December 31,
2018	$ 76,777
2019	76,777
2020	76,777
2021	76,777
2022	76,777
Thereafter	$ 761,282

INTANGIBLE ASSETS (Details Narrative)	12 Months Ended
INTANGIBLE ASSETS (Details Narrative)	Dec. 31, 2017 USD ($) Number	Dec. 31, 2016 USD ($)	Dec. 31, 2015 USD ($)
Finite-Lived Intangible Assets [Line Items]
Amortization expense \| $	$ 71,516	$ 54,545	$ 32,441
Number of issued patents	18
Approved Hormone Therapy Drug Candidate Patents [Member]
Finite-Lived Intangible Assets [Line Items]
Useful Life	20 years
Domestic Utility Patents [Member]
Finite-Lived Intangible Assets [Line Items]
Number of issued patents	13
Foreign Utility Patents [Member]
Finite-Lived Intangible Assets [Line Items]
Number of issued patents	3
Utility Patent Domestic TX-004HR [Member]
Finite-Lived Intangible Assets [Line Items]
Number of issued patents	3
Utility Patent Foreign TX-004HR [Member]
Finite-Lived Intangible Assets [Line Items]
Number of issued patents	10
Utility Patent Pipeline Transdermal Patch Technology [Member]
Finite-Lived Intangible Assets [Line Items]
Number of issued patents	1
Opera Software Patent [Member]
Finite-Lived Intangible Assets [Line Items]
Number of issued patents	1

OTHER CURRENT LIABILITIES (Details) - USD ($)	Dec. 31, 2017	Dec. 31, 2016
Other Liabilities Disclosure [Abstract]
Accrued clinical trial costs	$ 366,933	$ 1,281,080
Accrued payroll, bonuses and commission costs	4,240,379	3,531,440
Accrued compensated absences	945,457	665,561
Accrued legal and accounting expense	600,350	176,518
Accrued sales and marketing costs	420,162	665,773
Other accrued expenses	602,916	224,865
Allowance for wholesale distributor fees	172,973	76,510
Accrued royalties	114,480	26,507
Allowance for coupons and returns	1,432,846	794,816
Accrued rent	327,099	181,015
TOTAL OTHER CURRENT LIABILITIES	$ 9,223,595	$ 7,624,085

STOCKHOLDERS' EQUITY (Details) - Warrants [Member] - USD ($)	12 Months Ended
	Dec. 31, 2017	Dec. 31, 2016	Dec. 31, 2015
Number of shares Warrants
Warrants outstanding at December 31, 2016	12,060,071
Warrants granted	125,000
Warrants exercised	(9,066,666)		(1,255,485)
Warrants expired	(2,500)
Warrants outstanding at December 31, 2017	3,115,905	12,060,071
Vested and Exercisable at December 31, 2017	2,792,983
Unvested at December 31, 2017	322,922
Weighted Average Exercise Price
Warrants outstanding at December 31, 2016	$ 2.08
Warrants granted	6.83
Warrants exercised	1.98
Warrants expired	2.64
Warrants outstanding at December 31, 2017	2.58	$ 2.08
Vested and Exercisable at December 31, 2017	2.64
Warrants Unvested at December 31, 2017	$ 2.57
Weighted Average Remaining Contractual Life
Warrants outstanding	1 year 9 months 18 days	1 year
Warrants Vested and Exercisable	9 months 18 days
Warrants Unvested	2 years
Aggregate Intrinsic Value
Warrants outstanding at December 31, 2016	$ 45,063,867
Warrants exercised	48,535,969	$ 3,988,343	$ 7,282,404
Warrants outstanding at December 31, 2017	11,348,273	$ 45,063,867
Vested and Exercisable at December 31, 2017	1,141,836
Unvested at December 31, 2017	$ 10,206,436

STOCKHOLDERS' EQUITY (Details 1) - Warrants [Member] - $ / shares	12 Months Ended
	Dec. 31, 2017	Dec. 31, 2016	Dec. 31, 2015
Class of Warrant or Right [Line Items]
Weighted average price	$ 6.83	$ 7.90	$ 6.35
Weighted average grant date fair value	$ 3.67	$ 4.78	$ 3.27
Risk-free interest rate	1.47%		1.02%
Volatility	63.24%		60.59%
Term (in years)	5 years	5 years	5 years
Dividend yield	0.00%	0.00%	0.00%
Minimum [Member]
Class of Warrant or Right [Line Items]
Risk-free interest rate		1.04%
Volatility		74.10%
Maximum [Member]
Class of Warrant or Right [Line Items]
Risk-free interest rate		1.28%
Volatility		74.15%

STOCKHOLDERS' EQUITY (Details 2) - Stock Options [Member] - $ / shares	12 Months Ended
	Dec. 31, 2017	Dec. 31, 2016	Dec. 31, 2015
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Weighted average exercise price	$ 6.60	$ 6.22	$ 8.14
Weighted grant date fair value	$ 3.82	$ 3.94	$ 4.45
Risk-free interest rate - minimum	1.84%	1.13%	1.47%
Risk-free interest rate - maximum	2.05%	1.90%	1.67%
Volatility - minimum	61.56%	70.26%	58.78%
Volatility - maximum	64.25%	73.34%	62.94%
Dividend yield	0.00%	0.00%	0.00%
Minimum [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Term	5 years 6 months	5 years 6 months	5 years 3 months 7 days
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, 2017	Dec. 31, 2016	Dec. 31, 2015
Options, Outstanding
Options outstanding at December 31, 2016	21,767,854
Options Granted	2,271,500
Options Exercised	(102,546)
Options Expired	(108,375)
Options Cancelled/Forfeited	(463,208)
Options outstanding at December 31, 2017	23,365,225	21,767,854
Vested and Exercisable at December 31, 2017	19,770,142
Unvested at December 31, 2017	3,595,083
Options, Weighted Average Exercise Price
Options outstanding at December 31, 2016	$ 3.56
Granted	6.60
Exercised	2.07
Expired	7.64
Cancelled/Forfeited	6.28
Options outstanding at December 31, 2017	3.78	$ 3.56
Vested and Exercisable at December 31, 2017	3.27
Unvested at December 31, 2017	$ 6.60
Options, Weighted Average Remaining Contractual Life
Options outstanding	5 years 1 month 16 days	5 years 9 months 18 days
Vested and Exercisable	4 years 5 months 20 days
Unvested	8 years 9 months 14 days
Options outstanding, Aggregate Intrinsic Value
Options outstanding at December 31, 2016	$ 60,495,730
Options exercised	452,287	$ 3,828,358	$ 3,186,371
Options outstanding at December 31, 2017	64,664,821	$ 60,495,730
Vested and Exercisable at December 31, 2017	63,895,512
Unvested at December 31, 2017	$ 769,309

STOCKHOLDERS' EQUITY (Details Narrative) - USD ($)									12 Months Ended
STOCKHOLDERS' EQUITY (Details Narrative) - USD ($)	Sep. 28, 2017	Sep. 25, 2017	Jan. 12, 2016	Jan. 06, 2016	Jul. 15, 2015	Jul. 09, 2015	Feb. 17, 2015	Feb. 10, 2015	Dec. 31, 2017	Dec. 31, 2016	Dec. 31, 2015
Preferred stock, par value (in dollars per share)									$ 0.001	$ 0.001
Preferred stock, shares authorized									10,000,000	10,000,000
Preferred stock, shares issued									0	0
Preferred stock, shares outstanding									0	0
Common stock, shares authorized									350,000,000	350,000,000
Common stock, shares issued									216,429,642	196,688,222
Common stock, shares outstanding									216,429,642	196,688,222
Value of common stock issued during period for stock options exercised									$ 212,615	$ 989,060	$ 1,232,579
Number of stock options exercised (in shares)									102,546	523,362
Proceeds from sale of common stock, net of costs									$ 68,572,635	$ 134,863,475	91,374,649
Number of stock options exercised in cashless exercise (in shares)										127,109
Number of common stock issued during period for stock options exercised in cashless exercise (in shares)										87,833
Stock Options [Member]
Value of common stock issued during period for stock options exercised											$ 1,232,579
Number of stock options exercised (in shares)											612,867
Number of stock options exercised in cashless exercise (in shares)											417
Number of common stock issued during period for stock options exercised in cashless exercise (in shares)											114
Underwriting Agreement - J.P. Morgan Securities LLC [Member]
Number of shares offered in underwriting agreement		12,400,000
Number of shares issued during the period	12,400,000
Share price (in dollars per share)		$ 5.55
Proceeds from sale of common stock, net of costs		$ 68,573,000
Underwriting Agreement - Goldman and Cowen [Member]
Number of shares offered in underwriting agreement				15,151,515
Number of shares issued during the period			17,424,242
Share price (in dollars per share)				$ 8.25
Proceeds from sale of common stock, net of costs				$ 134,864,000
Additional common stock issued under offering				2,272,727
Number of days of the option to purchase shares				30 days
Stifel Underwriters [Member]
Number of shares offered in underwriting agreement						3,846,154
Number of shares issued during the period					4,423,077
Share price (in dollars per share)						$ 7.80
Proceeds from sale of common stock, net of costs						$ 32,257,000
Additional common stock issued under offering						576,923
Number of days of the option to purchase shares						30 days
Cowen and Company, LLC (Underwriters) [Member]
Number of shares offered in underwriting agreement								13,580,246
Number of shares issued during the period							15,617,282
Share price (in dollars per share)								$ 4.05
Proceeds from sale of common stock, net of costs								$ 59,118,000
Additional common stock issued under offering								2,037,036
Number of days of the option to purchase shares								30 days

STOCKHOLDERS' EQUITY (Details Narrative 1) - USD ($)	12 Months Ended
STOCKHOLDERS' EQUITY (Details Narrative 1) - USD ($)	Dec. 31, 2017	Dec. 31, 2016	Dec. 31, 2015
Warrants:
Share based compensation expense	$ 6,889,323	$ 17,411,021	$ 7,189,699
Unrecognized estimated compensation expense period recognition	2 years 1 month 6 days
Minimum [Member]
Warrants:
Exercise price of warrants (in dollars per share)	$ 0.24
Maximum [Member]
Warrants:
Exercise price of warrants (in dollars per share)	$ 8.20
Warrants [Member]
Warrants:
Warrants outstanding	$ 3,115,905
Weighted-average contractual remaining life	1 year 9 months 18 days
Weighted average exercise price of warrants (in dollars per share)	$ 2.58	$ 2.08
Warrants granted (in shares)	125,000
Grant date fair value (in dollars per share)	$ 3.67	$ 4.78	$ 3.27
Share based compensation expense	$ 313,271	$ 936,974	$ 139,142
Unrecognized estimated compensation expense	$ 128,000
Unrecognized estimated compensation expense period recognition	2 months 12 days
Aggregate intrinsic value of warrants exercised	$ 48,535,969	$ 3,988,343	$ 7,282,404
Outside Consultants Warrants [Member]
Warrants:
Exercise price of warrants (in dollars per share)	$ 6.83
Weighted average exercise price of warrants (in dollars per share)		$ 7.90
Warrants granted (in shares)	125,000	245,000
Grant date fair value (in dollars per share)	$ 3.67
Expiration date of warrants	Mar. 15, 2022	Jan. 21, 2021
Vesting period of warrants	12 months	12 months
Expected term	5 years
Volatility rate	63.24%
Risk free rate	1.47%
Dividend yield	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
Outside Consultant Warrants [Member]
Warrants:
Weighted average exercise price of warrants (in dollars per share)			$ 6.35
Warrants granted (in shares)			50,000
Expiration date of warrants			Apr. 06, 2020
Vesting period of warrants			12 months

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, 2017	Dec. 31, 2016	Dec. 31, 2015
Non-cash compensation expense					$ 6,889,323	$ 17,411,021	$ 7,189,699
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	77,026	154,068
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]
Unvested warrants	283,334
Warrants - Unaffiliated Entity [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
Non-cash compensation expense					$ 128,898	$ 257,796	$ 257,796
Expected term				5 years
Volatility rate				44.71%
Risk free rate				0.74%
Dividend yield				0.00%
Warrants exercised					(800,000)	(500,000)

STOCKHOLDERS' EQUITY (Details Narrative 3) - USD ($)	12 Months Ended
STOCKHOLDERS' EQUITY (Details Narrative 3) - USD ($)	Dec. 31, 2017	Dec. 31, 2016	Dec. 31, 2015
Share-based compensation expense	$ 6,447,154	$ 16,139,225	$ 6,621,658
Total unrecognized estimated compensation expense	$ 10,596,000
Recognized weighted-average period	2 years 1 month 6 days
Shares issued for exercise of warrants, net	$ 3,798,999	$ 1,373,000	366,000
Stock Options [Member]
Options outstanding, ending	23,365,225	21,767,854
Aggregate intrinsic value of options exercised	$ 452,287	$ 3,828,358	$ 3,186,371
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
2009 Long Term Incentive Compensation Plan [Member]
Number of shares authorized for issuance	25,000,000
Options outstanding, ending	18,575,084
Number of shares available for issuance	2,173,878
Vesting period	4 years
Expiration period	10 years
2012 Stock Incentive Plan [Member]
Number of shares authorized for issuance	10,000,000
Options outstanding, ending	4,790,141
Number of shares available for issuance	5,128,333
Vesting period	4 years
Expiration period	10 years
Warrants Cashless Exercise [Member]
Shares issued for exercise of warrants, net (in shares)	4,762,208		232,197
Warrants exercised	6,590,000		310,000
Warrants [Member]
Recognized weighted-average period	2 months 12 days
Shares issued for exercise of warrants, net			$ 366,000
Shares issued for exercise of warrants, net (in shares)			945,485
Warrants exercised	9,066,666		1,255,485
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

INCOME TAXES (Details 1)	12 Months Ended
INCOME TAXES (Details 1)	Dec. 31, 2017	Dec. 31, 2016	Dec. 31, 2015
Income Tax Disclosure [Abstract]
Federal statutory tax rate	34.00%	34.00%	34.00%
State tax rate, net of federal tax benefit	5.00%	5.40%	4.73%
Adjustment in valuation allowances	22.60%	(40.30%)	(38.97%)
Federal income tax rate change	(60.80%)
Permanent and other differences	(0.80%)	0.90%	0.24%
Provision (benefit) for income taxes

INCOME TAXES (Details 2) - USD ($)	Dec. 31, 2017	Dec. 31, 2016	Dec. 31, 2015
Deferred Income Tax Assets:
Net operating losses	$ 99,596,321	$ 111,730,450	$ 79,499,633
R&D Credit	186,347	186,347	186,347
Total deferred income tax asset	99,782,668	111,916,797	79,685,980
Valuation allowance	(99,782,668)	(111,916,797)	(79,685,980)
Deferred income tax assets, net

INCOME TAXES (Details Narrative) - USD ($)	12 Months Ended
INCOME TAXES (Details Narrative) - USD ($)	Dec. 31, 2018	Dec. 31, 2017	Dec. 31, 2016	Dec. 31, 2015
U.S. statutory federal rate		34.00%	34.00%	34.00%
Change in valuation allowance		$ 46,700,000
Deferred Tax Assets [Member]
Change in valuation allowance		49,500,000
Deferred Tax Liabilities [Member]
Change in valuation allowance		(2,800,000)
Subsequent Fiscal Years [Member]
U.S. statutory federal rate	21.00%
Federal [Member]
Net operating loss carryforwards		$ 338,613,987

RELATED PARTIES (Details Narrative) - Catalent Inc.[Member] - USD ($)	12 Months Ended
	Dec. 31, 2017	Dec. 31, 2016	Dec. 31, 2015
Related Party Transaction [Line Items]
Manufacturing activities billed from related party	$ 3,646,000	$ 3,647,000	$ 1,266,000
Payable - related party	$ 523,000	$ 57,000

BUSINESS CONCENTRATIONS (Details Narrative) - USD ($)	3 Months Ended								12 Months Ended
BUSINESS CONCENTRATIONS (Details Narrative) - USD ($)	Dec. 31, 2017	Sep. 30, 2017	Jun. 30, 2017	Mar. 31, 2017	Dec. 31, 2016	Sep. 30, 2016	Jun. 30, 2016	Mar. 31, 2016	Dec. 31, 2017	Dec. 31, 2016	Dec. 31, 2015
Concentration Risk [Line Items]
Revenues	$ 4,125,000	$ 4,418,000	$ 4,250,000	$ 3,985,000	$ 4,487,000	$ 5,536,000	$ 4,403,000	$ 4,930,000	$ 16,777,713	$ 19,356,450	$ 20,142,898
Supplier Concentration Risk [Member]
Concentration Risk [Line Items]
Concentration Risk									100.00%	98.00%	60.00%
Customer Concentration Risk [Member] \| Sales Revenue [Member] \| AmerisourceBergen [Member]
Concentration Risk [Line Items]
Revenues									$ 2,667,000
Customer Concentration Risk [Member] \| Sales Revenue [Member] \| McKesson Corporation [Member]
Concentration Risk [Line Items]
Revenues									1,959,000
Customer Concentration Risk [Member] \| Sales Revenue [Member] \| Cardinal Health [Member]
Concentration Risk [Line Items]
Revenues									2,559,000
Customer Concentration Risk [Member] \| Sales Revenue [Member] \| Pharmacy Innovations PA [Member]
Concentration Risk [Line Items]
Revenues									$ 2,715,000	$ 2,040,000
Customer Concentration Risk [Member] \| Sales Revenue [Member] \| Woodstock Pharmaceutical and Compounding [Member]
Concentration Risk [Line Items]
Revenues										2,247,000	$ 8,848,000
Customer Concentration Risk [Member] \| Sales Revenue [Member] \| Medical Center Pharmacy [Member]
Concentration Risk [Line Items]
Revenues										$ 3,700,000
Customer Concentration Risk [Member] \| Sales Revenue [Member] \| Due West Pharmacy [Member]
Concentration Risk [Line Items]
Revenues											$ 4,843,000
Customer Concentration Risk [Member] \| Sales Revenue [Member] \| Minimum [Member]
Concentration Risk [Line Items]
Concentration Risk									10.00%
Customer Concentration Risk [Member] \| Sales Revenue [Member] \| Four Customers [Member]
Concentration Risk [Line Items]
Concentration Risk									59.00%
Customer Concentration Risk [Member] \| Sales Revenue [Member] \| Three Customers [Member]
Concentration Risk [Line Items]
Concentration Risk										41.00%
Customer Concentration Risk [Member] \| Sales Revenue [Member] \| Two Customers [Member]
Concentration Risk [Line Items]
Concentration Risk											67.00%

COMMITMENTS AND CONTINGENCIES (Details)	Dec. 31, 2017 USD ($)
Future minimum rental payments, year ending December 31,
2018	$ 951,194
2019	1,094,116
2020	1,113,069
2021	943,127
Total minimum lease payments	$ 4,101,506

SELECTED QUARTERLY FINANCIAL DATA (Details) - USD ($)	3 Months Ended								12 Months Ended
SELECTED QUARTERLY FINANCIAL DATA (Details) - USD ($)	Dec. 31, 2017	Sep. 30, 2017	Jun. 30, 2017	Mar. 31, 2017	Dec. 31, 2016	Sep. 30, 2016	Jun. 30, 2016	Mar. 31, 2016	Dec. 31, 2017	Dec. 31, 2016	Dec. 31, 2015
Quarterly Financial Information Disclosure [Abstract]
Revenues	$ 4,125,000	$ 4,418,000	$ 4,250,000	$ 3,985,000	$ 4,487,000	$ 5,536,000	$ 4,403,000	$ 4,930,000	$ 16,777,713	$ 19,356,450	$ 20,142,898
Gross profit	3,530,000	3,717,000	3,568,000	3,326,000	3,778,000	4,298,000	3,273,000	3,822,000	14,140,770	15,170,742	15,636,225
Net loss	$ (21,427,000)	$ (14,665,000)	$ (19,677,000)	$ (21,156,000)	$ (22,836,000)	$ (25,016,000)	$ (21,094,000)	$ (20,929,000)	$ (76,925,380)	$ (89,875,459)	$ (85,077,024)
Loss per common share, basic and diluted (in dollars per shares)	$ (.10)	$ (.07)	$ (.10)	$ (0.11)	$ (0.12)	$ (0.13)	$ (0.11)	$ (0.11)	$ (0.37)	$ (0.46)	$ (0.49)

COMMITMENTS AND CONTINGENCIES (Details Narrative) - USD ($)		12 Months Ended
	May 01, 2016	Dec. 31, 2017	Dec. 31, 2016	Dec. 31, 2015
Commitments and Contingencies Disclosure [Abstract]
Non-cancelable operating lease term		63 months
Rental expense		$ 1,029,205	$ 709,843	$ 446,099
Expiration date	Oct. 31, 2021

FIXED ASSETS (Details Narrative) - USD ($)	12 Months Ended
FIXED ASSETS (Details Narrative) - USD ($)	Dec. 31, 2017	Dec. 31, 2016	Dec. 31, 2015
Property, Plant and Equipment [Abstract]
Depreciation expense	$ 141,601	$ 77,906	$ 29,959

INCOME TAXES (Details) - USD ($)	12 Months Ended
INCOME TAXES (Details) - USD ($)	Dec. 31, 2017	Dec. 31, 2016	Dec. 31, 2015
Income before taxes	$ (76,925,380)	$ (89,875,459)	$ (85,077,024)
United States [Member]
Income before taxes	$ (76,925,380)	$ (89,875,459)	$ (85,077,024)