TherapeuticsMD (TXMD) 10-Q 8 Nov 18 2018 Q3 Quarterly report Financial data

Document and Entity Information

Document and Entity Information - shares	9 Months Ended
	Sep. 30, 2018	Nov. 01, 2018
Document And Entity Information
Entity Registrant Name	TherapeuticsMD, Inc.
Entity Central Index Key	25,743
Document Type	10-Q
Trading Symbol	TXMD
Document Period End Date	Sep. 30, 2018
Amendment Flag	false
Current Fiscal Year End Date	--12-31
Entity's Reporting Status Current	Yes
Entity Emerging Growth Company	false
Entity Small Business	false
Entity Filer Category	Large Accelerated Filer
Entity Common Stock, Shares Outstanding		237,881,189
Document Fiscal Period Focus	Q3
Document Fiscal Year Focus	2,018

CONSOLIDATED BALANCE SHEETS (Un

CONSOLIDATED BALANCE SHEETS (Unaudited) - USD ($)	Sep. 30, 2018	Dec. 31, 2017
Current Assets:
Cash	$ 189,999,293	$ 127,135,628
Accounts receivable, net of allowance for doubtful accounts of $612,056 and $380,580, respectively	12,802,652	4,328,802
Inventory	2,378,221	1,485,358
Other current assets	6,509,646	6,604,284
Total current assets	211,689,812	139,554,072
Fixed assets, net	381,928	437,055
Other Assets:
Intangible assets, net	3,771,530	3,099,747
License rights	20,000,000
Long term deferred financing fees	759,229
Security deposit	150,522	139,036
Total other assets	24,681,281	3,238,783
Total assets	236,753,021	143,229,910
Current Liabilities:
Accounts payable	11,382,093	4,097,600
Accrued expenses and other current liabilities	17,894,582	9,223,595
Total current liabilities	29,276,675	13,321,195
Long-term Liabilities:
Long-term debt	73,261,065
Total long-term liabilities	73,261,065
Total liabilities	102,537,740	13,321,195
Commitments and Contingencies - See Note 15
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: 236,464,789 and 216,429,642 issued and outstanding, respectively	236,465	216,430
Additional paid-in capital	613,864,115	516,351,405
Accumulated deficit	(479,885,299)	(386,659,120)
Total stockholders' equity	134,215,281	129,908,715
Total liabilities and stockholders' equity	$ 236,753,021	$ 143,229,910

CONSOLIDATED BALANCE SHEETS (_2

CONSOLIDATED BALANCE SHEETS (Unaudited) (Parenthetical) - USD ($)	Sep. 30, 2018	Dec. 31, 2017
Statement of Financial Position [Abstract]
Allowance for doubtful accounts	$ 612,056	$ 380,580
Preferred stock, par value (in dollars per share)	$ 0.001	$ 0.001
Preferred stock, authorized	10,000,000	10,000,000
Preferred stock, issued	0	0
Preferred stock, outstanding	0	0
Common stock, par value (in dollars per share)	$ 0.001	$ 0.001
Common stock, authorized	350,000,000	350,000,000
Common stock, issued	236,464,789	216,429,642
Common stock, outstanding	236,464,789	216,429,642

CONSOLIDATED STATEMENTS OF OPER

CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited) - USD ($)	3 Months Ended		9 Months Ended
	Sep. 30, 2018	Sep. 30, 2017	Sep. 30, 2018	Sep. 30, 2017
Income Statement [Abstract]
Revenues, net	$ 3,473,535	$ 4,417,598	$ 11,009,937	$ 12,653,495
Cost of goods sold	699,118	700,814	1,786,902	2,042,174
Gross profit	2,774,417	3,716,784	9,223,035	10,611,321
Operating expenses:
Sales, general, and administration	30,354,072	12,057,868	80,578,079	43,524,412
Research and development	6,708,271	6,436,802	20,545,948	22,878,037
Depreciation and amortization	73,321	54,055	198,545	156,943
Total operating expense	37,135,664	18,548,725	101,322,572	66,559,392
Operating loss	(34,361,247)	(14,831,941)	(92,099,537)	(55,948,071)
Other income (expense):
Miscellaneous income	809,022	167,300	1,457,817	442,322
Accreted interest				7,699
Interest expense	(2,053,077)		(2,584,459)
Total other (expense) income	(1,244,055)	167,300	(1,126,642)	450,021
Loss before taxes	(35,605,302)	(14,664,641)	(93,226,179)	(55,498,050)
Provision for income taxes
Net loss	$ (35,605,302)	$ (14,664,641)	$ (93,226,179)	$ (55,498,050)
Net loss per share, basic and diluted (in dollars per share)	$ (0.16)	$ (0.07)	$ (0.42)	$ (0.27)
Weighted average number of common shares outstanding	228,107,240	207,938,338	220,466,673	203,282,335

CONSOLIDATED STATEMENTS OF CASH

CONSOLIDATED STATEMENTS OF CASH FLOWS (Unaudited) - USD ($)	9 Months Ended
	Sep. 30, 2018	Sep. 30, 2017
CASH FLOWS FROM OPERATING ACTIVITIES
Net loss	$ (93,226,179)	$ (55,498,050)
Adjustments to reconcile net loss to net cash flows used in operating activities:
Depreciation of fixed assets	121,423	104,622
Amortization of intangible assets	77,123	52,321
Provision for doubtful accounts	231,475	1,555
Share-based compensation	6,388,635	5,037,783
Amortization of deferred financing costs	149,909
Changes in operating assets and liabilities:
Accounts receivable	(8,705,325)	106,509
Inventory	(892,863)	(217,196)
Other current assets	1,233,482	(831,623)
Accounts payable	7,284,493	(3,159,145)
Accrued interest	59,375
Accrued expenses and other current liabilities	8,611,611	(946,853)
Net cash used in operating activities	(78,666,841)	(55,350,077)
CASH FLOWS FROM INVESTING ACTIVITIES
Payment for intellectual property license	(20,000,000)
Patent costs	(748,906)	(439,770)
Purchase of fixed assets	(66,295)	(35,849)
Payment of security deposit	(11,485)
Net cash used in investing activities	(20,826,686)	(475,619)
CASH FLOWS FROM FINANCING ACTIVITIES
Proceeds from sale of common stock, net of costs	89,907,797	68,572,635
Proceeds from term loan	75,000,000
Payment of deferred financing fees	(3,786,918)
Proceeds from exercise of options	1,236,313	212,615
Proceeds from exercise of warrants		3,798,999
Net cash provided by financing activities	162,357,192	72,584,249
Increase in cash	62,863,665	16,758,553
Cash, beginning of period	127,135,628	131,534,101
Cash, end of period	189,999,293	$ 148,292,654
Supplemental disclosure of cash flow information
Interest paid	$ 1,759,316

THE COMPANY

THE COMPANY	9 Months Ended
	Sep. 30, 2018
Organization, Consolidation and Presentation of Financial Statements [Abstract]
THE COMPANY	NOTE 1 – THE COMPANY TherapeuticsMD, Inc., a Nevada corporation, or TherapeuticsMD or the Company, has three wholly owned subsidiaries, vitaMedMD, LLC, a Delaware limited liability company, or VitaMed; BocaGreenMD, Inc., a Nevada corporation, or BocaGreen; and VitaCare Prescription Services, Inc., a Florida corporation, or VitaCare. Unless the context otherwise requires, TherapeuticsMD, VitaMed, BocaGreen, and VitaCare collectively are sometimes referred to as “our company,” “we,” “our,” or “us.” Nature of Business We are a women’s health care company focused on creating and commercializing products targeted exclusively for women. In July 2018, we launched our recently U.S. Food and Drug Administration, or FDA, approved product, IMVEXXY™ (estradiol vaginal inserts) for the treatment of moderate-to-severe dyspareunia (vaginal pain associated with sexual activity), a symptom of vulvar and vaginal atrophy, or VVA, due to menopause. We are also focused on commercialization activities necessary for commercialization of TX-001HR, or BIJUVA ™ ™ ™

BASIS OF PRESENTATION AND RECEN

BASIS OF PRESENTATION AND RECENTLY ISSUED ACCOUNTING PRONOUNCEMENTS	9 Months Ended
	Sep. 30, 2018
Basis of Presentation and Recently Issued Accounting Pronouncements [Abstract]
BASIS OF PRESENTATION AND RECENTLY ISSUED ACCOUNTING PRONOUNCEMENTS	NOTE 2 – BASIS OF PRESENTATION AND RECENTLY ISSUED ACCOUNTING PRONOUNCEMENTS Interim Financial Statements The accompanying unaudited interim consolidated financial statements of TherapeuticsMD, Inc., which include our wholly owned subsidiaries, should be read in conjunction with the audited consolidated financial statements and notes thereto included in our Annual Report on Form 10-K for the year ended December 31, 2017, as filed with the Securities and Exchange Commission, or the SEC, from which we derived the accompanying consolidated balance sheet as of December 31, 2017. The accompanying unaudited interim consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America, or GAAP , for interim financial information and with the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, since they are interim statements, the accompanying unaudited interim consolidated financial statements do not include all of the information and notes required by GAAP for complete financial statements. The accompanying unaudited interim consolidated financial statements reflect all adjustments, consisting of normal recurring adjustments, that are, in the opinion of our management, necessary to a fair statement of the results for the interim periods presented. Interim results are not necessarily indicative of results for a full year or any other interim period in the future. Recently Issued Accounting Pronouncements In August 2018, the Financial Accounting Standards Board, or FASB, issued Accounting Standards Update, or ASU, 2018-13 that eliminates certain disclosure requirements for fair value measurements for all entities, requires public entities to disclose certain new information and modifies some disclosure requirements. The FASB developed the amendments to Accounting Standards Codification 820 as part of its broader disclosure framework project, which aims to improve the effectiveness of disclosures in the notes to financial statements by focusing on requirements that clearly communicate the most important information to users of the financial statements. The new guidance is effective for all entities for fiscal years beginning after December 15, 2019 and for interim periods within those fiscal years. An entity is permitted to early adopt either the entire standard or only the provisions that eliminate or modify requirements. We are currently evaluating the effect of this guidance on our disclosures. In June 2018, FASB issued ASU 2018-07 to simplify the accounting for share-based payments to nonemployees by aligning it with the accounting for share-based payments to employees, with certain exceptions. The new guidance expands the scope of Accounting Standards Codification, or ASC, 718 to include share-based payments granted to nonemployees in exchange for goods or services used or consumed in an entity’s own operations and supersedes the guidance in ASC 505-50. The guidance is effective for public business entities in annual periods beginning after December 15, 2018, and interim periods within those annual periods. Early adoption is permitted, including in an interim period for which financial statements have not been issued, but not before an entity adopts ASC 606. We are currently evaluating the effect of this guidance on our consolidated financial statements and disclosures. In February 2016, the FASB issued ASU 2016-02, Leases. This guidance requires lessees to record most leases on their balance sheets but recognize expenses on their income statements in a manner similar to current accounting. The guidance also eliminates current real estate-specific provisions for all entities. For lessors, the guidance modifies the classification criteria and the accounting for sales-type and direct financing leases. The standard is effective for public business entities for annual periods beginning after December 15, 2018, and interim periods within those years. Early adoption is permitted for all entities. We are in the process of analyzing the quantitative impact of this guidance on our results of operations and financial position. In July 2018, FASB amended the new leases standard by issuing ASU 2018-10, Codification improvements to Topic 842, Leases as well as ASU 2018-11, Leases, (Topic 842): Targeted improvements. ASU 2018-11 gives entities another option for transition and to provide lessors with a practical expedient. We plan to adopt ASU 2016-02 on January 1, 2019 utilizing the alternative transition method allowed for under ASU 2018-11. We continue to assess all potential impacts of the standard and we currently believe the impact of this standard will be primarily related to the accounting for our current operating lease and a new operating lease entered into in the third quarter of 2018. In May 2014, the FASB issued ASU No. 2014-09, Revenue from Contracts with Customers (Topic 606). The standard’s core principle is that a company will recognize revenue when it transfers promised goods or services to customers in an amount that reflects the consideration to which the company expects to be entitled in exchange for those goods or services. In doing so, companies will need to use more judgment and make more estimates than under previous guidance. This may include identifying performance obligations in the contract, estimating the amount of variable consideration to include in the transaction price and allocating the transaction price to each separate performance obligation. In July 2015, the FASB approved the proposal to defer the effective date of ASU 2014-09 standard by one year. Early adoption is permitted after December 15, 2016, and the standard is effective for public entities for annual reporting periods beginning after December 15, 2017 and interim periods therein. In 2016, the FASB issued final amendments to clarify the implementation guidance for principal versus agent considerations (ASU 2016-08), accounting for licenses of intellectual property and identifying performance obligations (ASU 2016- 10), narrow-scope improvements and practical expedients (ASU 2016-12) and technical corrections and improvements to topic 606 (ASU 2016-20) in its new revenue standard. We adopted this standard under the modified retrospective method to all contracts not completed as of January 1, 2018 and the adoption did not have a material effect on our financial statements but we expanded our disclosures related to contracts with customers in Note 3.

SUMMARY OF SIGNIFICANT ACCOUNTI

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES	9 Months Ended
	Sep. 30, 2018
Accounting Policies [Abstract]
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES	NOTE 3 – SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES Fair Value of Financial Instruments Our financial instruments consist primarily of cash, accounts receivable, accounts payable and accrued expenses and long-term debt. The carrying amount of cash, accounts receivable, accounts payable and accrued expenses approximates their fair value because of the short-term maturity of such instruments, which are considered Level 1 assets under the fair value hierarchy. We categorize our assets and liabilities that are valued at fair value on a recurring basis into a three-level fair value hierarchy as defined by Accounting Standards Codification, or ASC, 820, Fair Value Measurements. Level 1 unadjusted quoted prices in active markets for identical assets or liabilities; Level 2 quoted prices for similar assets or liabilities in active markets or inputs that are observable for the asset or liability, either directly or indirectly through market corroboration, for substantially the full term of the financial instrument; and Level 3 unobservable inputs for the asset or liability. At September 30, 2018 and 2017, we had no assets or liabilities that were valued at fair value on a recurring basis. The fair value of indefinite-lived assets or long-lived assets is measured on a non-recurring basis using significant unobservable inputs (Level 3) in connection with our impairment test. There was no impairment of intangible assets or long-lived assets during the three and nine months ended September 30, 2018 and 2017. The carrying amounts for the Term Loan (as discussed in Note 9) approximates fair value based on market activity for other debt instruments with similar characteristics and comparable risk . 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. Inventories Inventories are valued at the lower of cost or net realizable value. Inventories related to packaged vitamins, nutritional products and supplements and raw materials are valued using the average-cost method and inventories related to our progesterone and estradiol products are valued using first in first out 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 had no capitalized pre-launch inventory as of September 30, 2018 or 2017. Revenue Recognition We adopted Accounting Standards Codification, or ASC, 606 on January 1, 2018 using the modified retrospective method for all contracts not completed as of the date of adoption. ASC 606 states that a contract is considered “completed” if all (or substantially all) of the revenue was recognized in accordance with revenue guidance that was in effect before the date of initial application. Because all (or substantially all) of the revenue related to sales of our products has been recognized under ASC 605 prior to the date of initial application of the new standard, the contracts are considered completed under ASC 606. Based on our evaluation of ASC 606, we concluded that a cumulative adjustment was not necessary upon implementation of ASC 606 on January 1, 2018. In accordance with ASC 606, revenue is recognized when a customer obtains control of promised goods or services. The amount of revenue recognized reflects the consideration to which we expect to be entitled to receive in exchange for these goods or services. The provisions of ASC 606 include a five-step process by which we determine revenue recognition, depicting the transfer of goods or services to customers in amounts reflecting the payment to which we expect to be entitled in exchange for those goods or services. ASC 606 requires us to apply the following steps: (1) identify the contract with the customer; (2) identify the performance obligations in the contract; (3) determine the transaction price; (4) allocate the transaction price to the performance obligations in the contract; and (5) recognize revenue when, or as, we satisfy the performance obligation. Prescription Products Our products consist primarily of prescription vitamins and our recently approved product IMVEXXY ™ The transaction price of a contract is the amount of consideration which we expect to be entitled to in exchange for transferring promised goods or services to a customer. Prescription products are sold at fixed wholesale acquisition cost, or WAC, determined based on our list price. However, the total transaction price is variable as it is calculated net of estimated product returns, chargebacks, rebates, coupons, discounts and wholesaler fees. These estimates are based on the amounts earned or to be claimed on the related sales and are classified as reductions of accounts receivable (if the amount is payable to the customer) or a current liability (if the amount is payable to a party other than a customer). In order to determine the transaction price, we estimate the amount of variable consideration at the outset of the contract either utilizing the expected value or most likely amount method, depending on the facts and circumstances relative to the contract or each variable consideration. The estimated amount of variable consideration is included in the transaction price only to the extent that it is probable that a significant reversal in the amount of cumulative revenue recognized will not occur when the uncertainty associated with the variable consideration is subsequently resolved. In determining amounts of variable consideration to include in a contract’s transaction price, we rely on our historical experience and other evidence that supports our qualitative assessment of whether revenue would be subject to a significant reversal. We consider all the facts and circumstances associated with both the risk of a revenue reversal arising from an uncertain future event and the magnitude of the reversal if that uncertain event were to occur. Actual amounts of consideration ultimately received may differ from our estimates. If actual results in the future vary from our original estimates, we will adjust these estimates, which would affect net product revenue and earnings in the period such changes in estimates become known. We accept returns of unsalable prescription products sold through wholesale distributors within a return period of six months prior to and up to 12 months following product expiration. Our prescription products currently have a shelf life of 24 months from the date of manufacture. We do not allow product returns for prescription products that have been dispensed to a patient. We estimate the amount of our product sales that may be returned by our customers and record this estimate as a reduction of revenue in the period the related product revenue is recognized. Where historical rates of return exist, we use history as a basis to establish a returns reserve for products shipped to wholesalers. For our newly launched products, for which the right of return exists but for which we currently do not have history of product returns, we estimate returns based on available industry data, our own sales information and our visibility into the inventory remaining in the distribution channel. At the end of each reporting period, we may decide to constrain revenue for product returns based on information from various sources, including channel inventory levels and dating and sell-through data, the expiration dates of products currently being shipped, price changes of competitive products and any introductions of generic products. We recognize the amount of expected returns as a refund liability, representing the obligation to return the customer’s consideration. Since our returns primarily consist of expired and short dated products that will not be resold, we do not record a return asset for the right to recover the goods returned by the customer at the time of the initial sale. Return estimates are recorded in the other current liabilities on the consolidated balance sheet. We offer various rebate and discount programs in an effort to maintain a competitive position in the marketplace and to promote sales and customer loyalty. We estimate the allowance for consumer rebates and coupons that we have offered based on our experience and industry averages, which is reviewed, and adjusted if necessary, on a quarterly basis. Estimates relating to these rebates and coupons are deducted from gross product revenues at the time the revenues are recognized. We record distributor fees based on amounts stated in contracts. Rebates estimates are recorded in accrued expenses and coupon estimates and distributor fees are recorded in the other current liabilities on the consolidated balance sheet. We estimate chargebacks based on number of units sold during the period taking into account prices stated in contracts and our historical experience. We provide invoice discounts to our customers for prompt payment. Estimates relating to invoice discounts and chargebacks are deducted from gross product revenues at the time the revenues are recognized. Estimates related to distributors fees, rebates, coupons and returns are disclosed in Note 8. As part of the commercial launch for IMVEXXY ™ OTC Products Our over the counter, or OTC, and prescription prenatal vitamin products are generally variations of the same product with slight modifications in formulation and marketing. As of January 1, 2017, we decided to focus on selling our prescription vitamins and ceased manufacturing and distributing our OTC product lines, except for Iron 21/7 which we ceased manufacturing in October 2017. We generated OTC revenue from product sales primarily to retail consumers. We recognized revenue from product sales upon shipment, when the rights of ownership and risk of loss have passed to the consumer. We included outbound shipping and handling fees, if any, in revenues, net, and bill them upon shipment. We included shipping expenses in cost of goods sold. A majority of our OTC customers paid for our products with credit cards, and we usually received the cash settlement in two to three banking days. Credit card sales minimized accounts receivable balances relative to OTC sales. We provided an unconditional 30-day money-back return policy under which we accept product returns from our retail and eCommerce OTC customers. We recognized revenue from OTC sales, net of estimated returns and sales discounts. Disaggregation of revenue The following table provides information about disaggregated revenue by product mix for the three and nine months ended September 30, 2018 and 2017: Three Months Ended Nine Months Ended 2018 2017 2018 2017 Prescription vitamins $ 3,261,459 $ 4,407,464 $ 10,797,861 $ 12,623,152 IMVEXXY ™ 212,076 — 212,076 — OTC products — 10,134 — 30,343 Net revenue $ 3,473,535 $ 4,417,598 $ 11,009,937 $ 12,653,495 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 may 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 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 account for forfeitures when they occur. Research and Development Expenses Research and development, or R&D, expenses include internal R&D activities, services of external contract research organizations, or CROs, costs of their clinical research sites, manufacturing, scale-up and validation costs, and other activities. Internal R&D activity expenses include laboratory supplies, salaries, benefits, and non-cash share-based compensation expenses. CRO activity expenses include preclinical laboratory experiments and clinical trial studies. Other activity expenses include regulatory consulting and legal fees and costs. The activities undertaken by our regulatory consultants that were classified as R&D expenses include assisting, consulting with, and advising our in-house staff with respect to various FDA submission processes, clinical trial processes, and scientific writing matters, including preparing protocols and FDA submissions. Legal activities that were classified as R&D expenses include professional research and advice regarding R&D, patents and regulatory matters. These consulting and legal expenses were direct costs associated with preparing, reviewing, and undertaking work for our clinical trials and investigative drugs. We charge internal R&D activities and other activity expenses to operations as incurred. We make payments to CROs based on agreed-upon terms, which may include payments in advance of a study starting date. We expense nonrefundable advance payments for goods and services that will be used in future R&D activities when the activity has been performed or when the goods have been received rather than when the payment is made. We review and accrue CRO expenses and clinical trial study expenses based on services performed and rely on estimates of those costs applicable to the completion stage of a study as provided by CROs. Estimated accrued CRO costs are subject to revisions as such studies progress to completion. We charge revisions to expense in the period in which the facts that give rise to the revision become known. 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.

INVENTORY

INVENTORY	9 Months Ended
	Sep. 30, 2018
Inventory Disclosure [Abstract]
INVENTORY	NOTE 4 – INVENTORY Inventory consists of the following: September 30, December 31, Finished product $ 2,254,822 $ 1,485,358 Work in process 83,911 — Raw materials 39,488 — TOTAL INVENTORY $ 2,378,221 $ 1,485,358

OTHER CURRENT ASSETS

OTHER CURRENT ASSETS	9 Months Ended
	Sep. 30, 2018
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract]
OTHER CURRENT ASSETS	NOTE 5 – OTHER CURRENT ASSETS Other current assets consist of the following: September 30, December 31, Prepaid sales and marketing costs $ 1,341,899 $ 5,335,936 Debt financing fees 1,138,844 — Prepaid insurance 1,127,416 680,243 Other prepaid costs 2,682,952 523,694 Prepaid vendor deposits 218,535 64,411 TOTAL OTHER CURRENT ASSETS $ 6,509,646 $ 6,604,284

FIXED ASSETS, NET

FIXED ASSETS, NET	9 Months Ended
	Sep. 30, 2018
Property, Plant and Equipment [Abstract]
FIXED ASSETS, NET	NOTE 6 – FIXED ASSETS, NET Fixed assets, net consist of the following: September 30, December 31, Accounting system $ 301,096 $ 301,096 Equipment 339,832 273,536 Furniture and fixtures 116,542 116,542 Computer hardware 80,211 80,211 Leasehold improvements 37,888 37,888 TOTAL 875,569 809,273 Accumulated depreciation (493,641 ) (372,218 ) TOTAL FIXED ASSETS, NET $ 381,928 $ 437,055 Depreciation expense for the three months ended September 30, 2018 and 2017 was $42,221 and $35,622, respectively, and $121,423 and $104,622 for the nine months ended September 30, 2018 and 2017, respectively.

INTANGIBLE ASSETS

INTANGIBLE ASSETS	9 Months Ended
	Sep. 30, 2018
Intangible Assets, Net (Excluding Goodwill) [Abstract]
INTANGIBLE ASSETS	NOTE 7 – INTANGIBLE ASSETS The following tables sets forth the gross carrying amount, accumulated amortization and net carrying amount of our intangible assets, (excluding licenses) as of September 30, 2018 and December 31, 2017: September 30, 2018 Gross Carrying Accumulated Net Weighted- Average Amortizable intangible assets: OPERA ® $ 31,951 $ (9,985 ) $ 21,966 11 Development costs of corporate website 91,743 (91,743 ) — n/a Approved hormone therapy drug candidate patents 1,991,790 (247,536 ) 1,744,254 14.25 Hormone therapy drug candidate patents (pending) 1,749,561 — 1,749,561 n/a Non-amortizable intangible assets: Multiple trademarks 255,749 — 255,749 indefinite Total $ 4,120,794 $ (349,264 ) $ 3,771,530 December 31, 2017 Gross Accumulated Net Weighted- Average Amortizable intangible assets: OPERA ® $ 31,951 $ (8,487 ) $ 23,464 11.75 Development costs of corporate website 91,743 (91,743 ) — n/a Approved hormone therapy drug candidate patents 1,293,614 (171,911 ) 1,121,703 15 Hormone therapy drug candidate patents (pending) 1,721,305 — 1,721,305 n/a Non-amortizable intangible assets: Multiple trademarks 233,275 — 233,275 indefinite Total $ 3,371,888 $ (272,141 ) $ 3,099,747 We capitalize external costs, consisting primarily of legal costs, related to securing our patents and trademarks. Once a patent is granted, we amortize the approved hormone therapy drug candidate patents using the straight-line method over the estimated useful life of approximately 20 years, which is the life of intellectual property patents. If the patent is not granted, we write-off any capitalized patent costs at that time. Trademarks are perpetual and are not amortized. During the three and nine months ended September 30, 2018 and year ended December 31, 2017, there was no impairment recognized related to intangible assets. We have numerous pending foreign and domestic patent applications. As of September 30, 2018, we had 22 issued foreign patents and 20 issued domestic, or U.S., patents including: ● 14 domestic utility patents that relate to our combination progesterone and estradiol product candidates, which are owned by us. These 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 patents that relate to IMVEXXY ™ ™ ™ ● One domestic utility patent that relates to our pipeline transdermal patch technology, which is owned by us. The domestic utility patent 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; ● One domestic utility patent that relates to our OPERA® information-technology platform, which is owned by us and will expire in 2029; and ● One domestic utility patent that relates to TX-009HR, our progesterone and estradiol product candidate, which is owned by us and will expire in 2037. Amortization expense was $31,100 and $18,433 for the three months ended September 30, 2018 and 2017, respectively and $77,123 and $52,321 for the nine months ended September 30, 2018 and 2017, respectively. Estimated amortization expense for the next five years for the patent cost currently being amortized is as follows: Year Ending December 31, Estimated Amortization 2018 (3 months) $ 31,100 2019 $ 124,400 2020 $ 124,400 2021 $ 124,400 2022 $ 124,400 Thereafter $ 1,237,520 License Agreement with the Population Council On July 30, 2018, we entered into an exclusive license agreement, or the Council License Agreement, with the Population Council to commercialize in the U.S. ANNOVERA™. We currently estimate that the ANNOVERA™ will be commercially available as early as the third quarter of 2019 with a planned commercial launch in the fourth quarter of 2019. Under the terms of the Council License Agreement, we paid the Population Council a milestone payment of $20,000,000 within 30 days following approval by the FDA of the New Drug Application, or NDA, for ANNOVERA™ and will be required to pay the Population Council $20,000,000 within 30 days following the release of the first commercial batch of ANNOVERA™. The Population Council is also eligible to receive milestone payments and royalties from commercial sales of ANNOVERA™. We will assume responsibility for marketing expenses related to the commercialization of ANNOVERA™. The milestone payment of $20,000,000 upon the FDA’s approval of ANNOVERA™ in the third quarter of 2018 was recorded as a finite-lived intangible asset in the consolidated balance sheet and will be amortized on a straight-line basis once it becomes available for use which is expected to be upon release of first commercial batch of ANNOVERA ™ The Council License Agreement includes exclusive rights for us to negotiate co-development of two other investigational vaginal contraceptive systems in development by the Population Council. In addition, we are required to pay the Population Council, on a quarterly basis, step-based royalty payments based on annual net sales of ANNOVERA™ in the U.S. by the Company and its affiliates and permitted licensees as follows: (i) if annual net sales are less than or equal to $50,000,000, a royalty of 5% of net sales; (ii) for annual net sales greater than $50,000,000 and less than or equal to $150,000,000, a royalty of 10% of such net sales; and (iii) for net sales greater than $150,000,000, a royalty of 15% of such net sales. The annual royalty rate will be reduced to 50% of the initial rate during the six-month period beginning on the date of the first arms-length commercial sale of a generic equivalent of the one-year vaginal contraceptive system that is launched by a third party in the U.S., and thereafter will be reduced to 20% of the initial rate. The Population Council has agreed to perform and pay the costs and expenses associated with four post-approval studies required by the FDA for ANNOVERA™ and we have agreed to perform and pay the costs and expenses associated with a post approval study required by the FDA to measure risk for venous thromboembolism, provided that if the costs and expenses associated with such post-approval study exceed $20,000,000, half of such excess will be offset against royalties or other payments owed by us to the Population Council under the Council License Agreement. We and the Population Council have agreed to form a joint product committee responsible for overseeing activities under the Council License Agreement. We will be responsible for all aspects of promotion, product positioning, pricing, education programs, publications, sales messages and any additional desired clinical studies for the one-year vaginal contraceptive system, subject to oversight and decisions made by the joint product committee. We assess our intangible assets for impairment if indicators are present or changes in circumstance suggest that impairment may exist. If impairment indicators are present or changes in circumstance suggest that impairment may exist, we perform a recoverability test by comparing the sum of the estimated undiscounted cash flows of each intangible asset to its carrying value on the consolidated balance sheet. If the undiscounted cash flows used in the recoverability test are less than the carrying value, we would determine the fair value of the intangible asset and recognize an impairment loss if the carrying value of the intangible asset exceeds its fair value. We also evaluate the remaining useful life of intangible assets subject to amortization on a periodic basis to determine whether events and circumstances would indicate impairment or warrant a revision to the remaining useful life. If the estimate of an intangible asset’s remaining useful life is changed, we will amortize the remaining carrying value of the intangible asset prospectively over the revised remaining useful life. License Agreement with Knight Therapeutics Inc. On July 30, 2018, we entered into a license and supply agreement, or the Knight License Agreement, with Knight pursuant to which we granted Knight an exclusive license to commercialize IMVEXXY™ and BIJUVA ™ ™ ™ ™ ™ ™

OTHER CURRENT LIABILITIES

OTHER CURRENT LIABILITIES	9 Months Ended
	Sep. 30, 2018
Other Liabilities Disclosure [Abstract]
OTHER CURRENT LIABILITIES	NOTE 8 – OTHER CURRENT LIABILITIES Other current liabilities consist of the following: September 30, December 31, Accrued payroll, bonuses and commission costs $ 3,683,863 $ 4,240,379 Accrued patient assistance program 4,389,948 — Allowance for coupons and returns 1,817,112 1,432,846 Accrued sales and marketing costs 1,982,872 420,162 Accrued compensated absences 1,115,615 945,457 Accrued legal and accounting expense 576,522 600,350 Other accrued expenses 2,450,022 525,999 Accrued research and development 587,220 366,933 Accrued interest 59,375 — Accrued rent 354,490 327,099 SAR liability 36,392 — Accrued rebates 44,297 76,917 Allowance for wholesale distributor fees 796,854 172,973 Accrued royalties — 114,480 TOTAL OTHER CURRENT LIABILITIES $ 17,894,582 $ 9,223,595

DEBT

DEBT	9 Months Ended
	Sep. 30, 2018
Debt Disclosure [Abstract]
DEBT	NOTE 9 – DEBT On May 1, 2018, we entered into a Credit and Security Agreement, or the Credit Agreement, with MidCap Financial Trust, or MidCap, as agent, or Agent, and as lender, and the additional lenders party thereto from time to time (together with MidCap as a lender, the Lenders). On July 30, 2018, we entered into Amendment No. 1 to the Credit Agreement in order to permit our entry into the Council License Agreement. Pursuant to the amendment, we were required to receive aggregate net cash proceeds of at least $75,000,000 from the issuance of our equity securities within thirty days of entering into the Council License Agreement, which we did in connection with the August 2018 underwritten public offering described in Note 11. The Credit Agreement provides a secured term loan facility in an aggregate principal amount of up to $200,000,000, or the Term Loan. Under the terms of the Credit Agreement, the Term Loan will be made in three separate tranches, each, a Tranche, with each Tranche to be made available to us, at our option, upon our achievement of certain milestones. The first Tranche of $75,000,000, or Tranche 1, was drawn by us on June 7, 2018, following approval by the FDA of the NDA for IMVEXXY ™ ™ ™ ™ ™ Amounts borrowed under the Term Loan bear interest at a rate equal to the sum of (i) one-month LIBOR (subject to a LIBOR floor of 1.50%) plus (ii) 7.75% per annum. Interest on amounts borrowed under the Term Loan is due and payable monthly in arrears. Principal on each Tranche is payable in 36 equal monthly installments beginning May 1, 2020 until paid in full on May 1, 2023, or the Maturity Date. However, if we generate at least $95,000,000 of consolidated net revenue attributable to commercial sales of BIJUVA ™ ™ The Term Loan may be prepaid, in whole or in part, subject to a prepayment fee on the amount being prepaid (or required to be prepaid, if such amount is greater) of (i) 4.0% for the first year following the Tranche 1 funding date, (ii) 3.0% for the second year following the Tranche 1 funding date and (iii) 2.0% thereafter. Upon repayment of the Term Loan at the Maturity Date or prepayment on any earlier date, we will be required to pay a termination payment based on the principal amount paid or prepaid. In connection with the execution of the Credit Agreement, we paid the Agent, for the benefit of all Lenders, an origination fee equal to 1.00% of the maximum potential amount of the Term Loan. We are also required to pay the Agent an annual administration fee of 0.25% based on the amounts borrowed under the Term Loan, in addition to other fees and expenses. Our obligations under the Credit Agreement are secured, subject to customary permitted liens and other agreed upon exceptions, by a first priority perfected security interest in all of our existing and after-acquired assets. Our obligations under the Credit Agreement are guaranteed by each of our future direct and indirect subsidiaries (other than certain non-U.S. subsidiaries of ours and certain U.S. subsidiaries substantially all of whose assets consist of equity interests in non-U.S. subsidiaries, subject to certain exceptions). The Credit Agreement contains customary restrictions and covenants. Among other requirements, we must (i) maintain a minimum cash balance of $50,000,000 and (ii) achieve certain minimum consolidated net revenue amounts attributable to commercial sales of our products. As of September 30, 2018, we were in compliance with the covenants under the Credit Agreement. The Credit Agreement also contains customary covenants that limit, among other things, our ability to (i) incur indebtedness, (ii) incur liens on our property, (iii) pay dividends or make other distributions, (iv) sell our assets, (v) make certain loans or investments, (vi) merge or consolidate, (vii) voluntarily repay or prepay certain permitted indebtedness and (viii) enter into transactions with affiliates, in each case subject to certain exceptions. The Credit Agreement contains customary representations and warranties and events of default relating to, among other things, payment defaults, breaches of covenants, the occurrence of any fact, event or circumstance that could reasonably be expected to result in a Material Adverse Effect (as defined in the Credit Agreement), delisting of our common stock, par value $0.001 per share, or Common Stock, bankruptcy and insolvency, cross defaults with certain material indebtedness and certain material contracts, judgments and inaccuracies of representations and warranties. Upon or after an event of default, the agent and the Lenders may declare all or a portion of our obligations under the Credit Agreement to be immediately due and payable and exercise other rights and remedies provided for under the Credit Agreement. As of September 30, 2018, we had $75,000,000 in borrowings outstanding under the Term Loan, which are classified as long-term debt in the accompanying unaudited consolidated financial statements. We incurred $3,786,918 in debt issuance costs related to the Term Loan. Debt financing fees related to the entire Term Loan have been allocated pro rata between the funded and unfunded portions of each tranche. Allocated debt financing fees related to Tranche 1 of $1,888,844 have been reclassified to debt discount and are accreted to interest expense using the effective interest method. Debt financing fees associated with unfunded tranches are deferred as assets until Tranche 2 and Tranche 3 milestones have been met. Deferred financing fees related to Tranche 2 are included in Other current assets and deferred financing fees related to Tranche 3 are included in Total other assets in the accompanying unaudited consolidated financial statements. During the three and nine months ended September 30, 2018, we amortized $119,753 and $149,909, respectively, of debt issuance costs related to Tranche 1 as interest expense in our accompanying unaudited consolidated financial statements. The overall effective interest rate was 10.9% as of September 30, 2018. As of September 30, 2018, the carrying value of debt consists of the following: September 30, 2018 Term Loan $ 75,000,000 Debt discount and financing fees (1,738,935 ) Total long-term debt $ 73,261,065

NET LOSS PER SHARE

NET LOSS PER SHARE	9 Months Ended
	Sep. 30, 2018
Earnings Per Share [Abstract]
NET LOSS PER SHARE	NOTE 10 – NET LOSS PER SHARE We calculate earnings per share, or EPS, in accordance with ASC 260, Earnings Per Share, which requires the computation and disclosure of two EPS amounts: basic and diluted. We compute basic EPS based on the weighted-average number of shares of Common Stock outstanding during the period. We compute diluted EPS based on the weighted-average number of shares of our Common Stock outstanding plus all potentially dilutive shares of our Common Stock outstanding during the period. Such potentially dilutive shares of our Common Stock consist of options 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. Three and Nine months ended September 30, 2018 2017 Stock options 24,837,349 23,383,100 Warrants 3,007,571 3,115,905 27,844,920 26,499,005

STOCKHOLDERS' EQUITY

STOCKHOLDERS' EQUITY	9 Months Ended
	Sep. 30, 2018
Stockholders' Equity:
STOCKHOLDERS' EQUITY	NOTE 11 – STOCKHOLDERS’ EQUITY Preferred Stock At September 30, 2018, we had 10,000,000 shares of preferred stock, par value $0.001, authorized for issuance, of which no shares of preferred stock were issued or outstanding. Common Stock At September 30, 2018, we had 350,000,000 shares of Common Stock authorized for issuance, of which 236,464,789 shares of Common Stock were issued and outstanding. On August 1, 2018, we entered into an underwriting agreement with Goldman Sachs & Co. LLC, as representative of the underwriters, relating to an underwritten public offering of 12,745,098 shares of our Common Stock at a price of $5.10 per share. We granted the underwriters an option, exercisable for a period of 30 days, to purchase up to 1,911,764 additional shares of Common Stock. On August 2, 2018, the underwriters exercised the option in full. The net proceeds from the offering, including the exercise of the option to purchase additional shares, were approximately $69,908,000, after deducting the underwriting discount and offering expenses payable by us. The offering closed on August 6, 2018. In connection with the Knight License Agreement, Knight entered into a subscription agreement with us, pursuant to which Knight purchased $20,000,000 of shares of our Common Stock concurrently with the closing of the underwritten public offering of Common Stock on August 6, 2018. Issuances During the Three and Nine Months Ended September 30, 2018 During the three months ended September 30, 2018, certain individuals exercised stock options to purchase 1,052,300 shares of Common Stock for $107,318 in cash. During the nine months ended September 30, 2018, certain individuals exercised stock options to purchase 1,446,876 shares of Common Stock for $1,236,313 in cash. Also, during the nine months ended September 30, 2018, stock options to purchase 10,000 shares of Common Stock were exercised pursuant to the options’ cashless exercise provisions, wherein 9,841 shares of Common Stock were issued. Issuances During the Three and Nine Months Ended September 30, 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 three months ended September 30, 2017, certain individuals exercised stock options to purchase 2,500 shares of Common Stock for $255 in cash. During the nine months ended September 30, 2017, certain individuals exercised stock options to purchase 102,546 shares of Common Stock for $212,615 in cash. Warrants to Purchase Common Stock As of September 30, 2018, we had warrants outstanding to purchase an aggregate of 3,007,571 shares of Common Stock with a weighted-average contractual remaining life of approximately 1.8 years, and exercise prices ranging from $0.24 to $8.20 per share, resulting in a weighted average exercise price of $2.78 per share. The valuation methodology used to determine the fair value of our warrants is the Black-Scholes Model. The Black-Scholes Model requires the use of a number of assumptions, including volatility of the stock price, the risk-free interest rate, dividend rate and the term of the warrant. During the nine months ended September 30, 2018, we granted warrants to purchase 175,000 shares of Common Stock to outside consultants at an exercise price of $5.16. The fair value for these warrants was determined by using the Black-Scholes Model on the date of the grant using a term of 5 years; volatility of 62.1%; risk free rate of 2.36%; and dividend yield of 0%. The grant date fair value of the warrants was $2.79 per share. The warrants vest ratably over a 12-month period and have an expiration date of March 15, 2023. During the nine months ended September 30, 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 three months ended September 30, 2018 and 2017, we recorded $150,977 and $101,376, respectively, and during the nine months ended September 30, 2018 and 2017, we recorded $407,292 and $217,150, respectively, as share based compensation expense in the accompanying consolidated financial statements related to warrants. As of September 30, 2018, total unrecognized estimated compensation expense related to the unvested portion of these warrants was approximately $218,000 which is expected to be recognized over a weighted-average period of 0.5 years. In May 2012, we issued warrants to purchase an aggregate of 1,300,000 shares of Common Stock to Sancilio and Company, Inc. 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 three months ended September 30, 2018 and 2017, we did not record any expenses with respect to these warrants, and during the nine months ended September 30, 2018 and 2017, we recorded $0 and $128,898, respectively, as non-cash compensation with respect to these warrants in the accompanying consolidated financial statements. This warrant was fully exercised, of which 800,000 shares were exercised in 2017 and 500,000 shares were exercised in 2016. During both the three months ended September 30, 2018 and 2017, no warrants were exercised. During the nine months ended September 30, 2018, no warrants were exercised. During the nine months ended September 30, 2017, certain individuals exercised warrants to purchase 2,476,666 shares of Common Stock for $3,798,999 in cash. In addition, during the nine months ended September 30, 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. Options to Purchase Common Stock In 2009, we adopted the 2009 Long Term Incentive Compensation Plan, or the 2009 Plan, to provide financial incentives to employees, directors, advisers, and consultants of our company who are able to contribute towards the creation of or who have created stockholder value by providing them stock options and other stock and cash incentives, or the Awards. 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 of Common Stock 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 September 30, 2018, there were non-qualified stock options to purchase 18,558,875 shares of Common Stock outstanding under the 2009 Plan. As of September 30, 2018, there were 900,037 shares of Common Stock 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 September 30, 2018, there were non-qualified stock options to purchase 6,278,474 shares of Common Stock outstanding under the 2012 Plan. As of September 30, 2018, there were 3,473,333 shares of Common Stock 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 assumptions used in the Black-Scholes Model for options granted during the nine months ended September 30, 2018 and 2017 are set forth in the table below. Nine Months Ended 2018 2017 Risk-free interest rate 2.78-2.82% 1.84-2.01% Volatility 61.80-63.34% 61.56-63.95% Term (in years) 5.5-6.25 5.5-6.25 Dividend yield 0.00 % 0.00 % A summary of activity under the 2009 and 2012 Plans and related information follows: Number of Shares Underlying Stock Options Weighted Average Exercise Price Weighted Aggregate Intrinsic Value Balance at December 31, 2017 23,365,225 $ 3.78 5.1 $ 64,664,821 Granted 3,006,500 $ 5.50 Exercised (1,456,876 ) $ 0.85 $ 8,025,055 Expired/Forfeited (77,500 ) $ 7.41 Balance at September 30, 2018 24,837,349 $ 4.15 5.2 $ 68,682,857 Vested and Exercisable at September 30, 2018 19,661,975 $ 3.65 4.3 $ 64,794,996 Unvested at September 30, 2018 5,175,374 $ 6.04 8.9 $ 3,887,861 At September 30, 2018, our outstanding stock options had exercise prices ranging from $0.10 to $8.92 per share. The weighted average grant date fair value per share of options granted was $3.27 and $3.82 during the nine months ended September 30, 2018 and 2017, respectively. Share-based compensation expense for options recognized in our results of operations for the three months ended September 30, 2018 and 2017 ($2,109,218 and $1,885,050, respectively) and for the nine months ended September 30, 2018 and 2017 ($5,981,343 and $4,691,735, respectively) is based on vested awards. At September 30, 2018, total unrecognized estimated compensation expense related to unvested options granted prior to that date was approximately $14,203,000 which may be adjusted for future forfeitures. This cost is expected to be recognized over a weighted-average period of 2.2 years. No tax benefit was realized due to a continued pattern of operating losses. Cash-Settled Stock Appreciation Rights (SARs) On July 1, 2018, we issued cash-settled SARs to certain consultants and employees. The SARs plan year begins on July 1 and ends on or immediately following June 30, 2019. SARs are granted with a grant price equal to the market value of a share of our Common Stock on the date of grant. Cash-settled SARs provide for the cash payment of the excess of the fair market value of our Common Stock on June 30, 2019 over the grant price. Cash-settled SARs have no effect on dilutive shares or shares outstanding as any appreciation of our Common Stock over the grant price is paid in cash and not in Common Stock. Cash settled SARs are recorded in our consolidated balance sheets as a liability until the date of exercise. The fair value of each SAR award is estimated using the Black-Scholes valuation model. In accordance with ASC Topic 718, “Stock Compensation,” the fair value of each SAR award is recalculated at the end of each reporting period and the liability and expense adjusted based on the new fair value and the percent vested. At September 30, 2018, we had 106,000 SARs outstanding and the liability related to SAR calculation was $36,392. The assumptions used to determine the fair value of the cash settled SAR awards at September 30, 2018 were expected life of 1 year, 52.2% volatility, 2.45% risk-free rate, and zero annual dividends. As of September 30, 2018, the fair value of SARs outstanding was $1.36 per award.

INCOME TAXES

INCOME TAXES	9 Months Ended
	Sep. 30, 2018
Income Tax Disclosure [Abstract]
INCOME TAXES	NOTE 12 – INCOME TAXES Deferred income tax assets and liabilities are determined based upon differences between the financial reporting and tax basis of assets and liabilities and are measured using the enacted tax rates and laws that will be in effect when the differences are expected to reverse. We do not expect to pay any significant federal or state income tax for 2018 as a result of (i) the losses recorded during the nine months ended September 30, 2018, (ii) additional losses expected for the remainder of 2018, and/or (iii) net operating loss carry forwards from prior years. Accounting standards require the consideration of a valuation allowance for deferred tax assets if it is “more likely than not” that some component or all of the benefits of deferred tax assets will not be realized. As of September 30, 2018, we maintain a full valuation allowance for all deferred tax assets. Based on these requirements, no provision or benefit for income taxes has been recorded. There were no recorded unrecognized tax benefits at the end of the reporting period.

RELATED PARTIES

RELATED PARTIES	9 Months Ended
	Sep. 30, 2018
Related Party Transactions [Abstract]
RELATED PARTIES	NOTE 13 – RELATED PARTIES In July 2015, J. Martin Carroll, a director of our company, was appointed to the board of directors of Catalent, Inc. From time to time, we have entered into agreements with Catalent, Inc. and its affiliates, or Catalent, in the normal course of business. Agreements with Catalent have been reviewed by independent directors of our company or a committee consisting of independent directors of our company since July 2015. During the three months ended September 30, 2018 and 2017, we were billed by Catalent approximately $830,000 and $186,000, respectively, for manufacturing activities related to our clinical trials, scale-up, registration batches, stability and validation testing. During the nine months ended September 30, 2018 and 2017, we were billed by Catalent approximately $2,774,000 and $2,460,000, respectively, for manufacturing activities related to our clinical trials, scale-up, registration batches, stability and validation testing. As of September 30, 2018 and December 31, 2017, there were amounts due to Catalent of approximately $4,000 and $523,000, respectively. In addition, we have minimum purchase requirements in place with Catalent as disclosed in Note 15, Commitments and Contingencies.

BUSINESS CONCENTRATIONS

BUSINESS CONCENTRATIONS	9 Months Ended
	Sep. 30, 2018
Risks and Uncertainties [Abstract]
BUSINESS CONCENTRATIONS	NOTE 14 – BUSINESS CONCENTRATIONS Approximately 100% of our products were manufactured by one vendor related to each prenatal vitamins and IMVEXXY ™ 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 both the nine months ended September 30, 2018 and 2017, four customers each generated more than 10% of our total revenues. Revenue generated from the four customers combined accounted for approximately 71% of our recognized revenue for the nine months ended September 30, 2018 and approximately 60% of our recognized revenue for the nine months ended September 30, 2017. During the nine months ended September 30, 2018, PI Services accounted for approximately $1,559,000 of our net revenue, Pillpack, Inc. accounted for approximately $3,057,000 of our net revenue, AmerisourceBergen accounted for approximately $1,834,000 of our net revenue and Cardinal Health accounted for approximately $1,399,000 of our net revenue. During the nine months ended September 30, 2017, Pharmacy Innovations PA accounted for approximately $2,715,000 of our net revenue, AmerisourceBergen accounted for approximately $1,716,000 of our net revenue, Cardinal Health accounted for approximately $1,764,000 of our net revenue and McKesson Corporation accounted for approximately $1,458,000 of our net revenue.

COMMITMENTS AND CONTINGENCIES

COMMITMENTS AND CONTINGENCIES	9 Months Ended
	Sep. 30, 2018
Commitments and Contingencies Disclosure [Abstract]
COMMITMENTS AND CONTINGENCIES	NOTE 15 – 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 both the three months ended September 30, 2018 and 2017 was approximately $257,000 and the rental expense related to our current lease during both the nine months ended September 30, 2018 and 2017 was approximately $772,000. As of September 30, 2018, future minimum rental payments on non-cancelable operating leases are as follows: Years Ending December 31, 2018 (3 months) $ 270,073 2019 1,094,116 2020 1,113,069 2021 943,127 2022 — Total minimum lease payments $ 3,420,385 Intellectual Property Licenses We have license agreements with third parties that provide for minimum royalty, license, and exclusivity payments to be paid by us for access to certain technologies. In addition, we pay royalties as a percent of revenue as described in Note 7, Intangible Assets, to these consolidated financial statements. Purchase commitments We have a manufacturing and supply agreement whereby we are required to purchase from Catalent a minimum of number of softgels during the first contract year and a higher number or softgels after the first contract year. If the minimum order quantities of specific products are not met, we are required to pay Catalent 50% of the difference between the total amount we would have paid to Catalent if the minimum requirement had been fulfilled and the sum of all purchases of our products from Catalent during the contract year.

SUBSEQUENT EVENTS

SUBSEQUENT EVENTS	9 Months Ended
	Sep. 30, 2018
Subsequent Events [Abstract]
SUBSEQUENT EVENTS	NOTE 16 – SUBSEQUENT EVENTS In October 2018, we entered into a lease for new corporate offices in Boca Raton, Florida, pursuant to an eleven-year lease. The lease provides for total future minimum payments over the life of the lease of approximately $19.6 million, inclusive of estimated operating expenses and sales tax. October 28, 2018, the FDA approved BIJUVA™ (estradiol and progesterone) capsules, 1 mg/100 mg, the first and only FDA-approved bio-identical hormone therapy combination of estradiol and progesterone in a single, oral capsule for the treatment of moderate to severe vasomotor symptoms (commonly known as hot flashes or flushes) due to menopause in women with a uterus.

SUMMARY OF SIGNIFICANT ACCOUN_2

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies)	9 Months Ended
	Sep. 30, 2018
Accounting Policies [Abstract]
Fair Value of Financial Instruments	Fair Value of Financial Instruments Our financial instruments consist primarily of cash, accounts receivable, accounts payable and accrued expenses and long-term debt. The carrying amount of cash, accounts receivable, accounts payable and accrued expenses approximates their fair value because of the short-term maturity of such instruments, which are considered Level 1 assets under the fair value hierarchy. We categorize our assets and liabilities that are valued at fair value on a recurring basis into a three-level fair value hierarchy as defined by Accounting Standards Codification, or ASC, 820, Fair Value Measurements. Level 1 unadjusted quoted prices in active markets for identical assets or liabilities; Level 2 quoted prices for similar assets or liabilities in active markets or inputs that are observable for the asset or liability, either directly or indirectly through market corroboration, for substantially the full term of the financial instrument; and Level 3 unobservable inputs for the asset or liability. At September 30, 2018 and 2017, we had no assets or liabilities that were valued at fair value on a recurring basis. The fair value of indefinite-lived assets or long-lived assets is measured on a non-recurring basis using significant unobservable inputs (Level 3) in connection with our impairment test. There was no impairment of intangible assets or long-lived assets during the three and nine months ended September 30, 2018 and 2017. The carrying amounts for the Term Loan (as discussed in Note 9) approximates fair value based on market activity for other debt instruments with similar characteristics and comparable risk.
Trade Accounts Receivable and Allowance for Doubtful Accounts	Trade Accounts Receivable and Allowance for Doubtful Accounts Trade accounts receivable are customer obligations due under normal trade terms. We review accounts receivable for uncollectible accounts and credit card 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.
Inventories	Inventories Inventories are valued at the lower of cost or net realizable value. Inventories related to packaged vitamins, nutritional products and supplements and raw materials are valued using the average-cost method and inventories related to our progesterone and estradiol products are valued using first in first out 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 had no capitalized pre-launch inventory as of September 30, 2018 or 2017.
Revenue Recognition	Revenue Recognition We adopted Accounting Standards Codification, or ASC, 606 on January 1, 2018 using the modified retrospective method for all contracts not completed as of the date of adoption. ASC 606 states that a contract is considered “completed” if all (or substantially all) of the revenue was recognized in accordance with revenue guidance that was in effect before the date of initial application. Because all (or substantially all) of the revenue related to sales of our products has been recognized under ASC 605 prior to the date of initial application of the new standard, the contracts are considered completed under ASC 606. Based on our evaluation of ASC 606, we concluded that a cumulative adjustment was not necessary upon implementation of ASC 606 on January 1, 2018. In accordance with ASC 606, revenue is recognized when a customer obtains control of promised goods or services. The amount of revenue recognized reflects the consideration to which we expect to be entitled to receive in exchange for these goods or services. The provisions of ASC 606 include a five-step process by which we determine revenue recognition, depicting the transfer of goods or services to customers in amounts reflecting the payment to which we expect to be entitled in exchange for those goods or services. ASC 606 requires us to apply the following steps: (1) identify the contract with the customer; (2) identify the performance obligations in the contract; (3) determine the transaction price; (4) allocate the transaction price to the performance obligations in the contract; and (5) recognize revenue when, or as, we satisfy the performance obligation. Prescription Products Our products consist primarily of prescription vitamins and our recently approved product IMVEXXY ™ The transaction price of a contract is the amount of consideration which we expect to be entitled to in exchange for transferring promised goods or services to a customer. Prescription products are sold at fixed wholesale acquisition cost, or WAC, determined based on our list price. However, the total transaction price is variable as it is calculated net of estimated product returns, chargebacks, rebates, coupons, discounts and wholesaler fees. These estimates are based on the amounts earned or to be claimed on the related sales and are classified as reductions of accounts receivable (if the amount is payable to the customer) or a current liability (if the amount is payable to a party other than a customer). In order to determine the transaction price, we estimate the amount of variable consideration at the outset of the contract either utilizing the expected value or most likely amount method, depending on the facts and circumstances relative to the contract or each variable consideration. The estimated amount of variable consideration is included in the transaction price only to the extent that it is probable that a significant reversal in the amount of cumulative revenue recognized will not occur when the uncertainty associated with the variable consideration is subsequently resolved. In determining amounts of variable consideration to include in a contract’s transaction price, we rely on our historical experience and other evidence that supports our qualitative assessment of whether revenue would be subject to a significant reversal. We consider all the facts and circumstances associated with both the risk of a revenue reversal arising from an uncertain future event and the magnitude of the reversal if that uncertain event were to occur. Actual amounts of consideration ultimately received may differ from our estimates. If actual results in the future vary from our original estimates, we will adjust these estimates, which would affect net product revenue and earnings in the period such changes in estimates become known. We accept returns of unsalable prescription products sold through wholesale distributors within a return period of six months prior to and up to 12 months following product expiration. Our prescription products currently have a shelf life of 24 months from the date of manufacture. We do not allow product returns for prescription products that have been dispensed to a patient. We estimate the amount of our product sales that may be returned by our customers and record this estimate as a reduction of revenue in the period the related product revenue is recognized. Where historical rates of return exist, we use history as a basis to establish a returns reserve for products shipped to wholesalers. For our newly launched products, for which the right of return exists but for which we currently do not have history of product returns, we estimate returns based on available industry data, our own sales information and our visibility into the inventory remaining in the distribution channel. At the end of each reporting period, we may decide to constrain revenue for product returns based on information from various sources, including channel inventory levels and dating and sell-through data, the expiration dates of products currently being shipped, price changes of competitive products and any introductions of generic products. We recognize the amount of expected returns as a refund liability, representing the obligation to return the customer’s consideration. Since our returns primarily consist of expired and short dated products that will not be resold, we do not record a return asset for the right to recover the goods returned by the customer at the time of the initial sale. Return estimates are recorded in the other current liabilities on the consolidated balance sheet. We offer various rebate and discount programs in an effort to maintain a competitive position in the marketplace and to promote sales and customer loyalty. We estimate the allowance for consumer rebates and coupons that we have offered based on our experience and industry averages, which is reviewed, and adjusted if necessary, on a quarterly basis. Estimates relating to these rebates and coupons are deducted from gross product revenues at the time the revenues are recognized. We record distributor fees based on amounts stated in contracts. Rebates estimates are recorded in accrued expenses and coupon estimates and distributor fees are recorded in the other current liabilities on the consolidated balance sheet. We estimate chargebacks based on number of units sold during the period taking into account prices stated in contracts and our historical experience. We provide invoice discounts to our customers for prompt payment. Estimates relating to invoice discounts and chargebacks are deducted from gross product revenues at the time the revenues are recognized. Estimates related to distributors fees, rebates, coupons and returns are disclosed in Note 8. As part of the commercial launch for IMVEXXY ™ OTC Products Our over the counter, or OTC, and prescription prenatal vitamin products are generally variations of the same product with slight modifications in formulation and marketing. As of January 1, 2017, we decided to focus on selling our prescription vitamins and ceased manufacturing and distributing our OTC product lines, except for Iron 21/7 which we ceased manufacturing in October 2017. We generated OTC revenue from product sales primarily to retail consumers. We recognized revenue from product sales upon shipment, when the rights of ownership and risk of loss have passed to the consumer. We included outbound shipping and handling fees, if any, in revenues, net, and bill them upon shipment. We included shipping expenses in cost of goods sold. A majority of our OTC customers paid for our products with credit cards, and we usually received the cash settlement in two to three banking days. Credit card sales minimized accounts receivable balances relative to OTC sales. We provided an unconditional 30-day money-back return policy under which we accept product returns from our retail and eCommerce OTC customers. We recognized revenue from OTC sales, net of estimated returns and sales discounts. Disaggregation of revenue The following table provides information about disaggregated revenue by product mix for the three and nine months ended September 30, 2018 and 2017: Three Months Ended Nine Months Ended 2018 2017 2018 2017 Prescription vitamins $ 3,261,459 $ 4,407,464 $ 10,797,861 $ 12,623,152 IMVEXXY ™ 212,076 — 212,076 — OTC products — 10,134 — 30,343 Net revenue $ 3,473,535 $ 4,417,598 $ 11,009,937 $ 12,653,495
Share-Based Compensation	Share-Based Compensation We measure the compensation costs of share-based compensation arrangements based on the grant-date fair value and recognize the costs in the financial statements over the period during which employees are required to provide services. Share-based compensation arrangements may 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 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 account for forfeitures when they occur.
Research and Development Expenses	Research and Development Expenses Research and development, or R&D, expenses include internal R&D activities, services of external contract research organizations, or CROs, costs of their clinical research sites, manufacturing, scale-up and validation costs, and other activities. Internal R&D activity expenses include laboratory supplies, salaries, benefits, and non-cash share-based compensation expenses. CRO activity expenses include preclinical laboratory experiments and clinical trial studies. Other activity expenses include regulatory consulting and legal fees and costs. The activities undertaken by our regulatory consultants that were classified as R&D expenses include assisting, consulting with, and advising our in-house staff with respect to various FDA submission processes, clinical trial processes, and scientific writing matters, including preparing protocols and FDA submissions. Legal activities that were classified as R&D expenses include professional research and advice regarding R&D, patents and regulatory matters. These consulting and legal expenses were direct costs associated with preparing, reviewing, and undertaking work for our clinical trials and investigative drugs. We charge internal R&D activities and other activity expenses to operations as incurred. We make payments to CROs based on agreed-upon terms, which may include payments in advance of a study starting date. We expense nonrefundable advance payments for goods and services that will be used in future R&D activities when the activity has been performed or when the goods have been received rather than when the payment is made. We review and accrue CRO expenses and clinical trial study expenses based on services performed and rely on estimates of those costs applicable to the completion stage of a study as provided by CROs. Estimated accrued CRO costs are subject to revisions as such studies progress to completion. We charge revisions to expense in the period in which the facts that give rise to the revision become known.
Segment Reporting	Segment Reporting We are managed and operated as one business, which is focused on creating and commercializing products targeted exclusively for women. Our business operations are managed by a single 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.

SUMMARY OF SIGNIFICANT ACCOUN_3

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Tables)	9 Months Ended
	Sep. 30, 2018
Accounting Policies [Abstract]
Schedule of disaggregated revenue	The following table provides information about disaggregated revenue by product mix for the three and nine months ended September 30, 2018 and 2017: Three Months Ended Nine Months Ended 2018 2017 2018 2017 Prescription vitamins $ 3,261,459 $ 4,407,464 $ 10,797,861 $ 12,623,152 IMVEXXY ™ 212,076 — 212,076 — OTC products — 10,134 — 30,343 Net revenue $ 3,473,535 $ 4,417,598 $ 11,009,937 $ 12,653,495

INVENTORY (Tables)

INVENTORY (Tables)	9 Months Ended
	Sep. 30, 2018
Inventory Disclosure [Abstract]
Schedule of inventory	Inventory consists of the following: September 30, December 31, Finished product $ 2,254,822 $ 1,485,358 Work in process 83,911 — Raw materials 39,488 — TOTAL INVENTORY $ 2,378,221 $ 1,485,358

OTHER CURRENT ASSETS (Tables)

OTHER CURRENT ASSETS (Tables)	9 Months Ended
	Sep. 30, 2018
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract]
Schedule of other current assets	Other current assets consist of the following: September 30, December 31, Prepaid sales and marketing costs $ 1,341,899 $ 5,335,936 Debt financing fees 1,138,844 — Prepaid insurance 1,127,416 680,243 Other prepaid costs 2,682,952 523,694 Prepaid vendor deposits 218,535 64,411 TOTAL OTHER CURRENT ASSETS $ 6,509,646 $ 6,604,284

FIXED ASSETS, NET (Tables)

FIXED ASSETS, NET (Tables)	9 Months Ended
	Sep. 30, 2018
Property, Plant and Equipment [Abstract]
Schedule of fixed assets	Fixed assets, net consist of the following: September 30, December 31, Accounting system $ 301,096 $ 301,096 Equipment 339,832 273,536 Furniture and fixtures 116,542 116,542 Computer hardware 80,211 80,211 Leasehold improvements 37,888 37,888 TOTAL 875,569 809,273 Accumulated depreciation (493,641 ) (372,218 ) TOTAL FIXED ASSETS, NET $ 381,928 $ 437,055

INTANGIBLE ASSETS (Tables)

INTANGIBLE ASSETS (Tables)	9 Months Ended
	Sep. 30, 2018
Intangible Assets, Net (Excluding Goodwill) [Abstract]
Schedule of intangible assets, excluding licenses	The following tables sets forth the gross carrying amount, accumulated amortization and net carrying amount of our intangible assets, (excluding licenses) as of September 30, 2018 and December 31, 2017: September 30, 2018 Gross Carrying Accumulated Net Weighted- Average Amortizable intangible assets: OPERA ® $ 31,951 $ (9,985 ) $ 21,966 11 Development costs of corporate website 91,743 (91,743 ) — n/a Approved hormone therapy drug candidate patents 1,991,790 (247,536 ) 1,744,254 14.25 Hormone therapy drug candidate patents (pending) 1,749,561 — 1,749,561 n/a Non-amortizable intangible assets: Multiple trademarks 255,749 — 255,749 indefinite Total $ 4,120,794 $ (349,264 ) $ 3,771,530 December 31, 2017 Gross Accumulated Net Weighted- Average Amortizable intangible assets: OPERA ® $ 31,951 $ (8,487 ) $ 23,464 11.75 Development costs of corporate website 91,743 (91,743 ) — n/a Approved hormone therapy drug candidate patents 1,293,614 (171,911 ) 1,121,703 15 Hormone therapy drug candidate patents (pending) 1,721,305 — 1,721,305 n/a Non-amortizable intangible assets: Multiple trademarks 233,275 — 233,275 indefinite Total $ 3,371,888 $ (272,141 ) $ 3,099,747
Schedule of estimated amortization expense	Estimated amortization expense for the next five years for the patent cost currently being amortized is as follows: Year Ending December 31, Estimated Amortization 2018 (3 months) $ 31,100 2019 $ 124,400 2020 $ 124,400 2021 $ 124,400 2022 $ 124,400 Thereafter $ 1,237,520

OTHER CURRENT LIABILITIES (Tabl

OTHER CURRENT LIABILITIES (Tables)	9 Months Ended
	Sep. 30, 2018
Other Liabilities Disclosure [Abstract]
Schedule of other current liabilities	Other current liabilities consist of the following: September 30, December 31, Accrued payroll, bonuses and commission costs $ 3,683,863 $ 4,240,379 Accrued patient assistance program 4,389,948 — Allowance for coupons and returns 1,817,112 1,432,846 Accrued sales and marketing costs 1,982,872 420,162 Accrued compensated absences 1,115,615 945,457 Accrued legal and accounting expense 576,522 600,350 Other accrued expenses 2,450,022 525,999 Accrued research and development 587,220 366,933 Accrued interest 59,375 — Accrued rent 354,490 327,099 SAR liability 36,392 — Accrued rebates 44,297 76,917 Allowance for wholesale distributor fees 796,854 172,973 Accrued royalties — 114,480 TOTAL OTHER CURRENT LIABILITIES $ 17,894,582 $ 9,223,595

DEBT (Tables)

DEBT (Tables)	9 Months Ended
	Sep. 30, 2018
Debt Disclosure [Abstract]
Schedule of debt	As of September 30, 2018, the carrying value of debt consists of the following: September 30, 2018 Term Loan $ 75,000,000 Debt discount and financing fees (1,738,935 ) Total long-term debt $ 73,261,065

NET LOSS PER SHARE (Tables)

NET LOSS PER SHARE (Tables)	9 Months Ended
	Sep. 30, 2018
Earnings Per Share [Abstract]
Schedule of potentially dilutive securities	The table below presents potentially dilutive securities that could affect our calculation of diluted net loss per share allocable to common stockholders for the periods presented. Three and Nine months ended September 30, 2018 2017 Stock options 24,837,349 23,383,100 Warrants 3,007,571 3,115,905 27,844,920 26,499,005

STOCKHOLDERS' EQUITY (Tables)

STOCKHOLDERS' EQUITY (Tables)	9 Months Ended
	Sep. 30, 2018
Stockholders' Equity:
Schedule of assumptions used in the Black-Scholes Model of stock options	The assumptions used in the Black-Scholes Model for options granted during the nine months ended September 30, 2018 and 2017 are set forth in the table below. Nine Months Ended 2018 2017 Risk-free interest rate 2.78-2.82% 1.84-2.01% Volatility 61.80-63.34% 61.56-63.95% Term (in years) 5.5-6.25 5.5-6.25 Dividend yield 0.00 % 0.00 %
Schedule of 2009 and 2012 Plans activity	A summary of activity under the 2009 and 2012 Plans and related information follows: Number of Shares Underlying Stock Options Weighted Average Exercise Price Weighted Aggregate Intrinsic Value Balance at December 31, 2017 23,365,225 $ 3.78 5.1 $ 64,664,821 Granted 3,006,500 $ 5.50 Exercised (1,456,876 ) $ 0.85 $ 8,025,055 Expired/Forfeited (77,500 ) $ 7.41 Balance at September 30, 2018 24,837,349 $ 4.15 5.2 $ 68,682,857 Vested and Exercisable at September 30, 2018 19,661,975 $ 3.65 4.3 $ 64,794,996 Unvested at September 30, 2018 5,175,374 $ 6.04 8.9 $ 3,887,861

COMMITMENTS AND CONTINGENCIES (

COMMITMENTS AND CONTINGENCIES (Tables)	9 Months Ended
	Sep. 30, 2018
Commitments and Contingencies Disclosure [Abstract]
Schedule of future minimum rental payments on non-cancelable operating leases	As of September 30, 2018, future minimum rental payments on non-cancelable operating leases are as follows: Years Ending December 31, 2018 (3 months) $ 270,073 2019 1,094,116 2020 1,113,069 2021 943,127 2022 — Total minimum lease payments $ 3,420,385

SUMMARY OF SIGNIFICANT ACCOUN_4

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details) - USD ($)	3 Months Ended		9 Months Ended
	Sep. 30, 2018	Sep. 30, 2017	Sep. 30, 2018	Sep. 30, 2017
Revenues, net	$ 3,473,535	$ 4,417,598	$ 11,009,937	$ 12,653,495
Prescription Vitamins [Member]
Revenues, net	3,261,459	4,407,464	10,797,861	12,623,152
IMVEXXY TM [Member]
Revenues, net	$ 212,076		$ 212,076
OTC Products [Member]
Revenues, net		$ 10,134		$ 30,343

SUMMARY OF SIGNIFICANT ACCOUN_5

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details Narrative)	9 Months Ended
	Sep. 30, 2018USD ($)Number
Shelf life of prescription products following product expiration	24 months
Number of operating segments | Number	1
Minimum [Member]
Return period of unsalable prescription products	6 months
Maximum [Member]
Return period of unsalable prescription products	12 months
Maximum [Member] | IMVEXXY TM [Member]
Enrolled patients co-pay for a set number of prescription refills | $	$ 35

INVENTORY (Details)

INVENTORY (Details) - USD ($)	Sep. 30, 2018	Dec. 31, 2017
Inventory
Finished product	$ 2,254,822	$ 1,485,358
Work in process	83,911
Raw materials	39,488
TOTAL INVENTORY	$ 2,378,221	$ 1,485,358

OTHER CURRENT ASSETS (Details)

OTHER CURRENT ASSETS (Details) - USD ($)	Sep. 30, 2018	Dec. 31, 2017
Other Current Assets
Prepaid sales and marketing costs	$ 1,341,899	$ 5,335,936
Debt financing fees	1,138,844
Prepaid insurance	1,127,416	680,243
Other prepaid costs	2,682,952	523,694
Prepaid vendor deposits	218,535	64,411
TOTAL OTHER CURRENT ASSETS	$ 6,509,646	$ 6,604,284

FIXED ASSETS, NET (Details)

FIXED ASSETS, NET (Details) - USD ($)	Sep. 30, 2018	Dec. 31, 2017
Property, Plant and Equipment [Line Items]
Fixed assets, gross	$ 875,569	$ 809,273
Accumulated depreciation	(493,641)	(372,218)
TOTAL FIXED ASSETS, NET	381,928	437,055
Acounting System [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	339,832	273,536
Furniture And Fixtures [Member]
Property, Plant and Equipment [Line Items]
Fixed assets, gross	116,542	116,542
Computer hardware [Member]
Property, Plant and Equipment [Line Items]
Fixed assets, gross	80,211	80,211
Leasehold improvements [Member]
Property, Plant and Equipment [Line Items]
Fixed assets, gross	$ 37,888	$ 37,888

FIXED ASSETS, NET (Details Narr

FIXED ASSETS, NET (Details Narrative) - USD ($)	3 Months Ended		9 Months Ended
	Sep. 30, 2018	Sep. 30, 2017	Sep. 30, 2018	Sep. 30, 2017
Property, Plant and Equipment [Abstract]
Depreciation expense	$ 42,221	$ 35,622	$ 121,423	$ 104,622

INTANGIBLE ASSETS (Details)

INTANGIBLE ASSETS (Details) - USD ($)	9 Months Ended	12 Months Ended
	Sep. 30, 2018	Dec. 31, 2017
Finite-Lived Intangible Assets
Accumulated Amortization	$ (349,264)	$ (272,141)
Indefinite-Lived Intangible Assets
Gross Carrying Amount	4,120,794	3,371,888
Net Amount	3,771,530	3,099,747
Hormone Therapy Drug Candidate Patents - (Pending) [Member]
Finite-Lived Intangible Assets
Gross Carrying Amount	1,749,561	1,721,305
Net Amount	1,749,561	1,721,305
Multiple Trademarks [Member]
Indefinite-Lived Intangible Assets
Gross Carrying Amount	255,749	233,275
Net Amount	255,749	233,275
Domestic Utilty Patent - Opera Software [Member]
Finite-Lived Intangible Assets
Gross Carrying Amount	31,951	31,951
Accumulated Amortization	(9,985)	(8,487)
Net Amount	$ 21,966	$ 23,464
Weighted average remaining amortization period	11 years	11 years 9 months
Approved Hormone Therapy Drug Candidate Patents [Member]
Finite-Lived Intangible Assets
Gross Carrying Amount	$ 1,991,790	$ 1,293,614
Accumulated Amortization	(247,536)	(171,911)
Net Amount	$ 1,744,254	$ 1,121,703
Weighted average remaining amortization period	14 years 3 months	15 years
Development Costs Of Corporate Website [Member]
Finite-Lived Intangible Assets
Gross Carrying Amount	$ 91,743	$ 91,743
Accumulated Amortization	$ (91,743)	$ (91,743)

INTANGIBLE ASSETS (Details 1)

INTANGIBLE ASSETS (Details 1)	Sep. 30, 2018USD ($)
Year Ending December 31,
2018(3 months)	$ 31,100
2,019	124,400
2,020	124,400
2,021	124,400
2,022	124,400
Thereafter	$ 1,237,520

INTANGIBLE ASSETS (Details Narr

INTANGIBLE ASSETS (Details Narrative)	Jul. 31, 2018USD ($)	Sep. 30, 2018USD ($)Number	Sep. 30, 2017USD ($)	Sep. 30, 2018USD ($)Number	Sep. 30, 2017USD ($)
Finite-Lived Intangible Assets [Line Items]
Amortization expense | $		$ 31,100	$ 18,433	$ 77,123	$ 52,321
Council License Agreement [Member] | Population Council, Inc. [Member]
Finite-Lived Intangible Assets [Line Items]
Milestone payments | $				20,000,000
Milestone payments payment after release of first commercial batch | $				$ 20,000,000
Description of royalty payments				<font style="font: 10pt Times New Roman, Times, Serif">(i) if annual net sales are less than or equal to $50,000,000, a royalty of 5% of net sales; (ii) for annual net sales greater than $50,000,000 and less than or equal to $150,000,000, a royalty of 10% of such net sales; and (iii) for net sales greater than $150,000,000, a royalty of 15% of such net sales. The annual royalty rate will be reduced to 50% of the initial rate during the six-month period beginning on the date of the first arms-length commercial sale of a generic equivalent of the one-year vaginal contraceptive system that is launched by a third party in the U.S., and thereafter will be reduced to 20% of the initial rate.</font></p>" id="sjs-E8">&lt;p style="margin-top: 0pt; margin-bottom: 0pt">&lt;font style="font: 10pt Times New Roman, Times, Serif">(i) if annual net sales are less than or equal to $50,000,000, a royalty of 5% of net sales; (ii) for annual net sales greater than $50,000,000 and less than or equal to $150,000,000, a royalty of 10% of such net sales; and (iii) for net sales greater than $150,000,000, a royalty of 15% of such net sales. The annual royalty rate will be reduced to 50% of the initial rate during the six-month period beginning on the date of the first arms-length commercial sale of a generic equivalent of the one-year vaginal contraceptive system that is launched by a third party in the U.S., and thereafter will be reduced to 20% of the initial rate.&lt;/font>&lt;/p>
Council License Agreement [Member] | Knight Therapeutics Inc. [Member]
Finite-Lived Intangible Assets [Line Items]
Gross proceeds | $	$ 50,000,000
Council License Agreement [Member] | Knight Therapeutics Inc. [Member] | Minimum [Member]
Finite-Lived Intangible Assets [Line Items]
Issue of common stock value | $	$ 20,000,000
Approved Hormone Therapy Drug Candidate Patents [Member]
Finite-Lived Intangible Assets [Line Items]
Useful Life				20 years
Domestic U.S. Patents [Member]
Finite-Lived Intangible Assets [Line Items]
Number of issued patents		20		20
Foreign Patents [Member]
Finite-Lived Intangible Assets [Line Items]
Number of issued patents		22		22
Domestic Utility Patents [Member]
Finite-Lived Intangible Assets [Line Items]
Number of issued patents		14		14
Domestic Patents - TX-004HR [Member]
Finite-Lived Intangible Assets [Line Items]
Number of issued patents		3		3
Domestic Utility Patent - Pipeline Transdermal Patch Technology [Member]
Finite-Lived Intangible Assets [Line Items]
Number of issued patents		1		1
Domestic Utilty Patent - Opera Software [Member]
Finite-Lived Intangible Assets [Line Items]
Number of issued patents		1		1
Domestic Patents - TX-009HR [Member]
Finite-Lived Intangible Assets [Line Items]
Number of issued patents		1		1

OTHER CURRENT LIABILITIES (Deta

OTHER CURRENT LIABILITIES (Details) - USD ($)	Sep. 30, 2018	Dec. 31, 2017
Other Liabilities Disclosure [Abstract]
Accrued payroll, bonuses and commission costs	$ 3,683,863	$ 4,240,379
Accrued patient assistance program	4,389,948
Allowance for coupons and returns	1,817,112	1,432,846
Accrued sales and marketing costs	1,982,872	420,162
Accrued compensated absences	1,115,615	945,457
Accrued legal and accounting expense	576,522	600,350
Other accrued expenses	2,450,022	525,999
Accrued research and development	587,220	366,933
Accrued interest	59,375
Accrued rent	354,490	327,099
SAR liability	36,392
Accrued rebates	44,297	76,917
Allowance for wholesale distributor fees	796,854	172,973
Accrued royalties		114,480
TOTAL OTHER CURRENT LIABILITIES	$ 17,894,582	$ 9,223,595

DEBT (Details)

DEBT (Details)	Sep. 30, 2018USD ($)
Debt Disclosure [Abstract]
Term Loan	$ 75,000,000
Debt discount and financing fees	(1,738,935)
Total long-term debt	$ 73,261,065

DEBT (Details Narrative)

DEBT (Details Narrative)	Jul. 30, 2018USD ($)	Jun. 07, 2018USD ($)	May 01, 2018USD ($)Number	Sep. 30, 2018USD ($)	Sep. 30, 2018USD ($)
Proceeds from term loan					$ 75,000,000
Amortization of debt issuance costs				$ 119,753	149,909
First Year After Tranche 1 Funding Date [Member]
Prepayment fee (percent)			4.00%
Second Year After Tranche 1 Funding Date [Member]
Prepayment fee (percent)			3.00%
Third Year and Thereafter After Tranche 1 Funding Date [Member]
Prepayment fee (percent)			2.00%
Council License Agreement [Member]
Proceeds from term loan	$ 75,000,000
Term Loan [Member]
Borrowing capacity under loan facility			$ 200,000,000
Number of tranches under term loan facility			3
Revenue requirement to extend interest-only period			$ 95,000,000
Description of Interest Rate			<font style="font: 10pt Times New Roman, Times, Serif"> one-month LIBOR (subject to a LIBOR floor of 1.50%) plus (ii) 7.75% per annum</font></p>" id="sjs-D16">&lt;p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&lt;font style="font: 10pt Times New Roman, Times, Serif"> one-month LIBOR (subject to a LIBOR floor of 1.50%) plus (ii) 7.75% per annum&lt;/font>&lt;/p>
Basis spread of loan			7.75%
LIBOR floor			1.50%
Number of principal installment payments | Number			36
Maturity date			May 1, 2023
Interest-only period extension			12 months
Interest expense - debt				1,933,324	2,434,550
Minimum cash balance requirement under credit agreement			$ 50,000,000
Loan origination fee (percent)			1.00%
Annual administration fee (percent)			0.25%
Term Loan [Member] | Tranche 1 [Member]
Borrowings outstanding				75,000,000	75,000,000
Proceeds from term loan		$ 75,000,000
Debt issuance costs		$ 3,786,918
Debt discount				$ 1,888,844	$ 1,888,844
Effective interest rate				10.90%	10.90%
Term Loan [Member] | Tranche 2 [Member]
Borrowing capacity under loan facility			$ 75,000,000
Term Loan [Member] | Tranche 3 [Member]
Borrowing capacity under loan facility			50,000,000
Revenue requirement to draw on term loan tranche			$ 75,000,000

NET LOSS PER SHARE (Details)

NET LOSS PER SHARE (Details) - shares	3 Months Ended		9 Months Ended
	Sep. 30, 2018	Sep. 30, 2017	Sep. 30, 2018	Sep. 30, 2017
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Anti-dilutive shares excluded from earnings per share calculation	27,844,920	26,499,005	27,844,920	26,499,005
Warrants [Member]
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Anti-dilutive shares excluded from earnings per share calculation	3,007,571	3,115,905	3,007,571	3,115,905
Stock Options [Member]
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Anti-dilutive shares excluded from earnings per share calculation	24,837,349	23,383,100	24,837,349	23,383,100

STOCKHOLDERS' EQUITY (Details)

STOCKHOLDERS' EQUITY (Details) - Stock Options [Member]	9 Months Ended
	Sep. 30, 2018	Sep. 30, 2017
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Risk-free interest rate - minimum	2.78%	1.84%
Risk-free interest rate - maximum	2.82%	2.01%
Volatility - minimum	61.80%	61.56%
Volatility - maximum	63.34%	63.95%
Dividend yield	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
Maximum [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Term	6 years 3 months	6 years 3 months

STOCKHOLDERS' EQUITY (Details 1

STOCKHOLDERS' EQUITY (Details 1) - Stock Options [Member] - USD ($)	9 Months Ended	12 Months Ended
	Sep. 30, 2018	Dec. 31, 2017
Options, Outstanding
Options outstanding beginning	23,365,225
Options Granted	3,006,500
Options Exercised	(1,456,876)
Expired/Forfeited	(77,500)
Options outstanding ending	24,837,349	23,365,225
Vested and Exercisable ending	19,661,975
Unvested ending	5,175,374
Options, Weighted Average Exercise Price
Options outstanding beginning	$ 3.78
Granted	5.50
Exercised	0.85
Expired/Forfeited	7.41
Options outstanding ending	4.15	$ 3.78
Vested and Exercisable ending	3.65
Unvested ending	$ 6.04
Options, Weighted Average Remaining Contractual Life
Options outstanding	5 years 2 months 12 days	5 years 1 month 6 days
Vested and Exercisable ending	4 years 3 months 18 days
Unvested ending	8 years 10 months 24 days
Options outstanding, Aggregate Intrinsic Value
Options outstanding beginning	$ 64,664,821
Options exercised	8,025,055
Options outstanding ending	68,682,857	$ 64,664,821
Vested and Exercisable ending	64,794,996
Unvested ending	$ 3,887,861

STOCKHOLDERS' EQUITY (Details N

STOCKHOLDERS' EQUITY (Details Narrative) - Stock Options [Member] - USD ($)	3 Months Ended		9 Months Ended
	Sep. 30, 2018	Sep. 30, 2017	Sep. 30, 2018	Sep. 30, 2017
Value of common stock issued during period for stock options exercised	$ 107,318	$ 255	$ 1,236,313	$ 212,615
Number of stock options exercised (in shares)	1,052,300	2,500	1,446,876	102,546
Number of stock options exercised in cashless exercise (in shares)			10,000
Number of common stock issued during period for stock options exercised in cashless exercise (in shares)			9,841

STOCKHOLDERS' EQUITY (Details_2

STOCKHOLDERS' EQUITY (Details Narrative 1) - USD ($)	3 Months Ended		9 Months Ended
	Sep. 30, 2018	Sep. 30, 2017	Sep. 30, 2018	Sep. 30, 2017
Warrants:
Share based compensation expense			$ 6,388,635	$ 5,037,783
Unrecognized estimated compensation expense period recognition			2 years 2 months 12 days
Outside Consultants Warrants [Member]
Warrants:
Exercise price of warrants (in dollars per share)	$ 5.16	$ 6.83	$ 5.16	$ 6.83
Warrants granted (in shares)			175,000	125,000
Grant date fair value (in dollars per share)			$ 2.79	$ 3.67
Expiration date of warrants			Mar. 15, 2023	Mar. 15, 2022
Vesting period of warrants			12 months	12 months
Expected term			5 years	5 years
Volatility rate			62.10%	63.24%
Risk free rate			2.36%	1.47%
Dividend yield			0.00%	0.00%
Warrants [Member]
Warrants:
Warrants outstanding	$ 3,007,571		$ 3,007,571
Weighted-average contractual remaining life			1 year 9 months 18 days
Weighted average exercise price of warrants (in dollars per share)	$ 2.78		$ 2.78
Share based compensation expense	$ 150,977	$ 101,376	$ 407,292	$ 217,150
Unrecognized estimated compensation expense	$ 218,000		$ 218,000
Unrecognized estimated compensation expense period recognition			6 months
Warrants [Member] | Minimum [Member]
Warrants:
Exercise price of warrants (in dollars per share)	$ 0.24		$ 0.24
Warrants [Member] | Maximum [Member]
Warrants:
Exercise price of warrants (in dollars per share)	$ 8.20		$ 8.20

STOCKHOLDERS' EQUITY (Details_3

STOCKHOLDERS' EQUITY (Details Narrative 2) - USD ($)	1 Months Ended	9 Months Ended		12 Months Ended
	May 31, 2012	Sep. 30, 2018	Sep. 30, 2017	Dec. 31, 2017	Dec. 31, 2016
Non-cash compensation expense		$ 6,388,635	$ 5,037,783
Cash-Settled Stock Appreciation Rights (SARs) [Member]
Expected term		1 year
Volatility rate		52.20%
Risk free rate		2.45%
Dividend yield		0.00%
SCI Warrants for Services [Member]
Exercise price of warrants (in dollars per share)	$ 2.57
Fair value of grant	$ 1,532,228
Warrants granted to purchase common stock (shares)	1,300,000
Non-cash compensation expense		$ 0	$ 128,898
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_4

STOCKHOLDERS' EQUITY (Details Narrative 3) - USD ($)	Sep. 28, 2017	Sep. 25, 2017	Aug. 06, 2017	Aug. 01, 2017	Sep. 30, 2018	Sep. 30, 2017	Sep. 30, 2018	Sep. 30, 2017	Dec. 31, 2017
Share-based compensation expense					$ 2,109,218	$ 1,885,050	$ 5,981,343	$ 4,691,735
Total unrecognized estimated compensation expense					$ 14,203,000		$ 14,203,000
Recognized weighted-average period							2 years 2 months 12 days
Underwriting Agreement [Member] | Goldman Sachs & Co. LLC, [Member]
Issue of common stock (in shares)				12,745,098
Issue of common stock (in dollars per shares)				$ 5.10
Common stock exercisable shares				1,911,764
Stock exercisable period				30 days
Net Proceeds				$ 69,908,000
Underwriting Agreement [Member] | J.P. Morgan Securities LLC [Member]
Issue of common stock (in shares)	12,400,000	12,400,000
Issue of common stock (in dollars per shares)		$ 5.55
Net Proceeds		$ 68,573,000
Knight License Agreement [Member] | Knight Therapeutics Inc. [Member]
Issue of common stock value			$ 20,000,000
Stock Options [Member]
Options outstanding, ending					24,837,349		24,837,349		23,365,225
Weighted average grant date fair value per share of options granted							$ 3.27	$ 3.82
Options outstanding					$ 4.15		4.15		$ 3.78
Stock Options [Member] | Minimum [Member]
Option exercise prices (in dollars per shares)					0.10		0.10
Stock Options [Member] | Maximum [Member]
Option exercise prices (in dollars per shares)					$ 8.92		$ 8.92
Cash-Settled Stock Appreciation Rights (SARs) [Member]
Options outstanding, ending					106,000		106,000
Options outstanding					$ 1.36		$ 1.36
2012 Stock Incentive Plan [Member]
Number of shares authorized for issuance					10,000,000		10,000,000
Number of shares available for issuance					3,473,333		3,473,333
2009 Long Term Incentive Compensation Plan [Member]
Number of shares authorized for issuance					25,000,000		25,000,000
Number of shares available for issuance					900,037		900,037
Warrants [Member]
Recognized weighted-average period							6 months
Warrants [Member] | Individuals [Member]
Shares issued for exercise of warrants, net								$ 3,798,999
Shares issued for exercise of warrants, net (in shares)								2,476,666

RELATED PARTIES (Details Narrat

RELATED PARTIES (Details Narrative) - Catalent Inc.[Member] - USD ($)	3 Months Ended		9 Months Ended
	Sep. 30, 2018	Sep. 30, 2017	Sep. 30, 2018	Sep. 30, 2017	Dec. 31, 2017
Related Party Transaction [Line Items]
Manufacturing activities billed from related party	$ 830,000	$ 186,000	$ 2,774,000	$ 2,460,000
Payable - related party	$ 4,000		$ 4,000		$ 523,000

BUSINESS CONCENTRATIONS (Detail

BUSINESS CONCENTRATIONS (Details Narrative) - USD ($)	9 Months Ended
	Sep. 30, 2018	Sep. 30, 2017
Manufactured by One Vendor [Member]
Concentration Risk [Line Items]
Concentration Risk	100.00%
Products Supplied by One Vendor [Member]
Concentration Risk [Line Items]
Concentration Risk		100.00%
Customer Concentration [Member] | Sales Revenue [Member] | Four Major Customers [Member]
Concentration Risk [Line Items]
Concentration Risk	71.00%
Customer Concentration [Member] | Sales Revenue [Member] | Four Major Customers [Member] | Minimum [Member]
Concentration Risk [Line Items]
Concentration Risk	10.00%
Customer Concentration [Member] | Sales Revenue [Member] | Five Major Customers [Member]
Concentration Risk [Line Items]
Concentration Risk		60.00%
Customer Concentration [Member] | Sales Revenue [Member] | Five Major Customers [Member] | Minimum [Member]
Concentration Risk [Line Items]
Concentration Risk		10.00%
Customer Concentration - Pi Services [Member] | Sales Revenue [Member]
Concentration Risk [Line Items]
Revenues	$ 1,559,000
Customer Concentration - Pillpack [Member] | Sales Revenue [Member]
Concentration Risk [Line Items]
Revenues	3,057,000
Customer Concentration - AmerisourceBergen [Member] | Sales Revenue [Member]
Concentration Risk [Line Items]
Revenues	1,834,000	$ 1,716,000
Customer Concentration - Cardinal Health [Member] | Sales Revenue [Member]
Concentration Risk [Line Items]
Revenues	$ 1,399,000	1,764,000
Customer Concentration - Pharmacy Innovations, Tx [Member] | Sales Revenue [Member]
Concentration Risk [Line Items]
Revenues		834,000
Customer Concentration - Pharmacy Innovations, Pa [Member] | Sales Revenue [Member]
Concentration Risk [Line Items]
Revenues		2,715,000
Customer Concentration - McKesson Corp [Member] | Sales Revenue [Member]
Concentration Risk [Line Items]
Revenues		$ 1,458,000

COMMITMENTS AND CONTINGENCIES_2

COMMITMENTS AND CONTINGENCIES (Details)	Sep. 30, 2018USD ($)
Future minimum rental payments, years ending December 31,
2018 (3 months)	$ 270,073
2,019	1,094,116
2,020	1,113,069
2,021	943,127
Total minimum lease payments	$ 3,420,385

COMMITMENTS AND CONTINGENCIES_3

COMMITMENTS AND CONTINGENCIES (Details Narrative) - USD ($)	May 01, 2016	Sep. 30, 2018	Sep. 30, 2017	Sep. 30, 2018	Sep. 30, 2017
Commitments and Contingencies Disclosure [Abstract]
Non-cancelable operating lease term				63 months
Rental expense		$ 257,000	$ 257,000	$ 772,000	$ 772,000
Expiration date	Oct. 31, 2021

SUBSEQUENT EVENTS (Details Narr

SUBSEQUENT EVENTS (Details Narrative) - USD ($)	Oct. 31, 2018	Sep. 30, 2018
Subsequent Event [Line Items]
Total future minimum payments		$ 3,420,385
Subsequent Event [Member]
Subsequent Event [Line Items]
Lease term	11 years
Total future minimum payments	$ 19,600,000