TherapeuticsMD (TXMD) 10-Q 8 May 19 2019 Q1 Quarterly report Financial data

Document and Entity Information

Document and Entity Information - shares	3 Months Ended
	Mar. 31, 2019	May 01, 2019
Schedule of assumptions used in the Black-Scholes Model of warrants
Entity Registrant Name	TherapeuticsMD, Inc.
Entity Central Index Key	0000025743
Document Type	10-Q
Trading Symbol	TXMD
Document Period End Date	Mar. 31, 2019
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		241,221,840
Document Fiscal Period Focus	Q1
Document Fiscal Year Focus	2019

CONSOLIDATED BALANCE SHEETS (Un

CONSOLIDATED BALANCE SHEETS (Unaudited) - USD ($)	Mar. 31, 2019	Dec. 31, 2018
Current Assets:
Cash	$ 122,883,852	$ 161,613,077
Accounts receivable, net of allowance for doubtful accounts of $678,886 and $596,602, respectively	14,944,750	11,063,821
Inventory	4,955,715	3,267,670
Other current assets	9,846,899	10,834,693
Total current assets	152,631,216	186,779,261
Fixed assets, net	668,607	472,683
Other Assets:
License rights	20,000,000	20,000,000
Intangible assets, net	4,455,730	4,092,679
Other assets	3,821,566	324,855
Security deposit	314,446	314,446
Total other assets	28,591,742	24,731,980
Total assets	181,891,565	211,983,924
Current Liabilities:
Accounts payable	25,365,243	22,743,841
Other current liabilities	19,607,439	18,334,948
Total current liabilities	44,972,682	41,078,789
Long-Term Liabilities:
Long-term debt	73,501,160	73,381,014
Operating lease liability	2,724,501
Total liabilities	121,198,343	114,459,803
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: 241,221,840 and 240,462,439 issued and outstanding, respectively	241,222	240,463
Additional paid-in capital	619,234,655	616,559,938
Accumulated deficit	(558,782,655)	(519,276,280)
Total stockholders' equity	60,693,222	97,524,121
Total liabilities and stockholders' equity	$ 181,891,565	$ 211,983,924

CONSOLIDATED BALANCE SHEETS (Pa

CONSOLIDATED BALANCE SHEETS (Parenthetical) - USD ($)	Mar. 31, 2019	Dec. 31, 2018
Statement of Financial Position [Abstract]
Allowance for doubtful accounts	$ 678,886	$ 596,602
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	241,221,840	240,462,439
Common stock, outstanding	241,221,840	240,462,439

CONSOLIDATED STATEMENTS OF OPER

CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited) - USD ($)	3 Months Ended
	Mar. 31, 2019	Mar. 31, 2018
Income Statement [Abstract]
Revenues, net	$ 3,946,651	$ 3,773,392
Cost of goods sold	762,827	633,623
Gross profit	3,183,824	3,139,769
Operating expenses:
Sales, general, and administrative	34,864,082	20,757,237
Research and development	6,317,882	7,039,297
Depreciation and amortization	106,938	59,621
Total operating expenses	41,288,902	27,856,155
Operating loss	(38,105,078)	(24,716,386)
Other (expense) income
Miscellaneous income	688,721	314,557
Interest expense	(2,090,018)
Total other (expense) income	(1,401,297)	314,557
Loss before income taxes	(39,506,375)	(24,401,829)
Provision for income taxes
Net loss	$ (39,506,375)	$ (24,401,829)
Loss per share, basic and diluted:
Net loss per share, basic and diluted (in dollars per share)	$ (0.16)	$ (0.11)
Weighted average number of common shares outstanding, basic and diluted (in shares)	241,006,032	216,525,316

CONSOLIDATED STATEMENTS OF CASH

CONSOLIDATED STATEMENTS OF CASH FLOWS (Unaudited) - USD ($)	3 Months Ended
	Mar. 31, 2019	Mar. 31, 2018
CASH FLOWS FROM OPERATING ACTIVITIES
Net loss	$ (39,506,375)	$ (24,401,829)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation of fixed assets	66,494	38,424
Amortization of intangible assets	40,444	21,197
Non-cash operating lease expense	219,765
Provision for doubtful accounts	82,284	22,955
Share-based compensation	2,586,948	1,751,358
Amortization of deferred financing costs	120,146
Changes in operating assets and liabilities:
Accounts receivable	(3,963,214)	(790,885)
Inventory	(1,688,045)	(135,514)
Other current assets	987,794	1,506,152
Accounts payable	2,621,402	2,186,224
Accrued expenses and other liabilities	268,939	152,223
Net cash used in operating activities	(38,163,418)	(19,649,695)
CASH FLOWS FROM INVESTING ACTIVITIES
Patent costs	(403,496)	(142,136)
Purchase of fixed assets	(262,418)	(26,908)
Payment of security deposit		(11,486)
Net cash used in investing activities	(665,914)	(180,530)
CASH FLOWS FROM FINANCING ACTIVITIES
Proceeds from exercise of options	100,107	44,057
Net cash provided by financing activities	100,107	44,057
Decrease in cash	(38,729,225)	(19,786,168)
Cash, beginning of period	161,613,077	127,135,628
Cash, end of period	122,883,852	$ 107,349,460
Supplemental disclosure of cash flow information
Interest paid	$ 1,913,956

CONSOLIDATED STATEMENTS OF STOC

CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY (Unaudited) - USD ($)	Common Stock [Member]	Additional Paid in Capital [Member]	Accumulated Deficit [Member]	Total
Beginning balance at Dec. 31, 2017	$ 216,430	$ 516,351,405	$ (386,659,120)	$ 129,908,715
Beginning balance (in shares) at Dec. 31, 2017	216,429,642
Shares issued for exercise of options, net	$ 154	43,902		44,056
Shares issued for exercise of options, net (in shares)	154,632
Share-based compensation		1,751,358		1,751,358
Net loss			(24,401,829)	(24,401,829)
Ending balance at Mar. 31, 2018	$ 216,584	518,146,665	(411,060,949)	107,302,300
Ending balance (in shares) at Mar. 31, 2018	216,584,274
Beginning balance at Dec. 31, 2018	$ 240,463	616,559,938	(519,276,280)	$ 97,524,121
Beginning balance (in shares) at Dec. 31, 2018	240,462,439			240,462,439
Shares issued for exercise of options, net	$ 759	99,348		$ 100,107
Shares issued for exercise of options, net (in shares)	759,401
Share-based compensation		2,575,369		2,575,369
Net loss			(39,506,375)	(39,506,375)
Ending balance at Mar. 31, 2019	$ 241,222	$ 619,234,655	$ (558,782,655)	$ 60,693,222
Ending balance (in shares) at Mar. 31, 2019	241,221,840			241,221,840

THE COMPANY

THE COMPANY	3 Months Ended
	Mar. 31, 2019
Organization, Consolidation and Presentation of Financial Statements [Abstract]
THE COMPANY	NOTE 1 – THE COMPANY TherapeuticsMD, Inc., a Nevada corporation, or TherapeuticsMD or the Company, has three wholly owned subsidiaries, vitaMedMD, LLC, a Delaware limited liability company, or VitaMed; BocaGreenMD, Inc., a Nevada corporation, or BocaGreen; and VitaCare Prescription Services, Inc., a Florida corporation, or VitaCare. Unless the context otherwise requires, TherapeuticsMD, VitaMed, BocaGreen, and VitaCare collectively are sometimes referred to as “our company,” “we,” “our,” or “us.” Nature of Business We are a women’s healthcare company focused on creating and commercializing innovative products to support the lifespan of women and championing awareness of women’s healthcare issues, specifically, for pregnancy prevention, pregnancy, childbirth, nursing, pre-menopause, and menopause. At TherapeuticsMD, we combine entrepreneurial spirit, clinical expertise, and business leadership to develop and commercialize health solutions that enable new standards of care for women. Our solutions range from advanced hormone therapy pharmaceutical products to patient-controlled, long-acting contraceptive. We also manufacture and distribute branded and generic prescription prenatal vitamins under the vitaMedMD ® ® With our SYMBODA™ technology, we are developing and commercializing advanced hormone therapy pharmaceutical products to enable delivery of bio-identical hormones through a variety of dosage forms and administration routes. Our track record of commercialization allows us to efficiently leverage and grow our marketing and sales organization to commercialize our recently approved products. During 2018, U.S. Food and Drug Administration, or FDA, approval of our drugs has transitioned our company from predominately focused on conducting research and development to one focused on commercializing our drugs. In July 2018, we launched our FDA-approved product, IMVEXXY ® ®

BASIS OF PRESENTATION AND RECEN

BASIS OF PRESENTATION AND RECENTLY ISSUED ACCOUNTING PRONOUNCEMENTS	3 Months Ended
	Mar. 31, 2019
Basis Of Presentation And Recently Issued Accounting Pronouncements
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, 2018, as filed with the Securities and Exchange Commission, or the SEC, from which we derived the accompanying consolidated balance sheet as of December 31, 2018. 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 the FASB, issued Accounting Standards Update, or ASU, 2018-13 which eliminates certain disclosure requirements for fair value measurements for all entities, requires public entities to disclose certain new information and modifies some disclosure requirements. The FASB developed the amendments to ASC 820 as part of its broader disclosure framework project, which aims to improve the effectiveness of disclosures in the notes to financial statements by focusing on requirements that clearly communicate the most important information to users of the financial statements. The new guidance is effective for all entities for fiscal years beginning after December 15, 2019 and for interim periods within those fiscal years. An entity is permitted to early adopt either the entire standard or only the provisions that eliminate or modify requirements. We are currently evaluating the effect of this guidance on our disclosures. In June 2018, the FASB issued ASU 2018-07 to simplify the accounting for share-based payments to nonemployees by aligning it with the accounting for share-based payments to employees, with certain exceptions. The new guidance expands the scope of ASC 718 to include share-based payments granted to nonemployees in exchange for goods or services used or consumed in an entity’s own operations and supersedes the guidance in ASC 505-50. The guidance is effective for public business entities in annual periods beginning after December 15, 2018, and interim periods within those annual periods. Early adoption is permitted, including in an interim period for which financial statements have not been issued, but not before an entity adopts ASC 606. We adopted this standard on January 1, 2019 and the adoption of this standard did not have a material effect on our consolidated financial statements. In February 2016, the FASB issued ASU 2016-02, Leases. This guidance requires lessees to record most leases on their balance sheets while recognizing expenses on their income statements in a manner similar to current accounting. The guidance also eliminates current real estate-specific provisions for all entities. For lessors, the guidance modifies the classification criteria and the accounting for sales-type and direct financing leases. The standard is effective for public business entities for annual periods beginning after December 15, 2018, and interim periods within those years. Early adoption is permitted for all entities. In July 2018, the FASB amended the new leases standard and issued ASU 2018-11, Leases, (Topic 842): Targeted Improvements to give entities another option for transition and to provide lessors with a practical expedient. We adopted ASU 2016-02 on January 1, 2019 utilizing the alternative transition method allowed for under ASU 2018-11 and we recorded a $3.8 million right of use asset and a $4.1 million liability related to adoption of this standard. Comparative financial information was not adjusted and will continue to be reported under ASC 840. We also elected the transition relief package of practical expedients and as a result we did not assess (1) whether existing or expired contracts contain leases, (2) lease classification for any existing or expired leases, and (3) whether lease origination costs qualified as initial direct costs. We elected the short-term lease practical expedient by establishing an accounting policy to exclude leases with a term of 12 months or less. We elected not to separate lease components from non-lease components for our specified asset classes. Additionally, the adoption of the new standard resulted in increased disclosure requirements in our quarterly and annual filings. Other recent accounting pronouncements issued by the FASB (including its Emerging Issues Task Force), the American Institute of Certified Public Accountants and the SEC did not, and are not expected to, have a material effect on our results of operations or financial position.

SUMMARY OF SIGNIFICANT ACCOUNTI

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES	3 Months Ended
	Mar. 31, 2019
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, 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 March 31, 2019 and 2018, 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 the Company’s impairment test. There was no impairment of intangible assets or long-lived assets during the three months ended March 31, 2019 and 2018. The carrying amount for the long-term debt as of March 31, 2019 (as disclosed in Note 9), approximates fair value based on market activity for other debt instruments with similar characteristics and comparable risk (Level 2). 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. Revenue Recognition We adopted ASC 606 on January 1, 2018 using the modified retrospective method for all contracts not completed as of the date of adoption. ASC 606 states that a contract is considered “completed” if all (or substantially all) of the revenue was recognized in accordance with revenue guidance that was in effect before the date of initial application. Because all (or substantially all) of the revenue related to sales of our products has been recognized under ASC 605 prior to the date of initial application of the new standard, the contracts are considered completed under ASC 606. Based on our evaluation of ASC 606, we concluded that a cumulative adjustment was not necessary upon implementation of ASC 606 on January 1, 2018. In accordance with ASC 606, revenue is recognized when a customer obtains control of promised goods or services. The amount of revenue recognized reflects the consideration to which we expect to be entitled to receive in exchange for these goods or services. The provisions of ASC 606 include a five-step process by which we determine revenue recognition, depicting the transfer of goods or services to customers in amounts reflecting the payment to which we expect to be entitled in exchange for those goods or services. ASC 606 requires us to apply the following steps: (1) identify the contract with the customer; (2) identify the performance obligations in the contract; (3) determine the transaction price; (4) allocate the transaction price to the performance obligations in the contract; and (5) recognize revenue when, or as, we satisfy the performance obligation. Prescription Products As of March 31, 2019, our products consisted primarily of prescription vitamins and our recently approved product IMVEXXY®, which we began selling during the third quarter of 2018. We sell our name brand and generic prescription products primarily through wholesale distributors and retail pharmacy distributors. We have one performance obligation related to prescription products sold through wholesale distributors, which is to transfer promised goods to a customer and two performance obligations related to products sold through retail pharmacy distributors, which are to: (1) transfer promised goods and (2) provide customer service for an immaterial fee. We treat shipping as a fulfillment activity rather than as a separate obligation. We recognize prescription revenue only when we satisfy performance obligations by transferring a promised good or service to a customer. A good or service is considered to be transferred when the customer receives the goods or service or obtains control. Control refers to the customer’s ability to direct the use of, and obtain substantially all of the remaining benefits from, an asset. All of our performance obligations, and associated revenue, are transferred to customers at a point in time. Based on our contracts, we invoice customers once our performance obligations have been satisfied, at which point payment is unconditional. We disclose receivables from contracts with customers separately in the statement of financial position. Payment for goods or services sold by us is typically due between 30 and 60 days after an invoice is sent to the customer. The transaction price of a contract is the amount of consideration which we expect to be entitled to in exchange for transferring promised goods or services to a customer. Prescription products are sold at fixed wholesale acquisition cost, or WAC, determined based on our list price. However, the total transaction price is variable as it is calculated net of estimated product returns, chargebacks, rebates, coupons, discounts and wholesaler fees. These estimates are based on the amounts earned or to be claimed on the related sales and are classified as reductions of accounts receivable (if the amount is payable to the customer) or a current liability (if the amount is payable to a party other than a customer). In order to determine the transaction price, we estimate the amount of variable consideration at the outset of the contract either utilizing the expected value or most likely amount method, depending on the facts and circumstances relative to the contract or each variable consideration. The estimated amount of variable consideration is included in the transaction price only to the extent that it is probable that a significant reversal in the amount of cumulative revenue recognized will not occur when the uncertainty associated with the variable consideration is subsequently resolved. In determining amounts of variable consideration to include in a contract’s transaction price, we rely on our historical experience and other evidence that supports our qualitative assessment of whether revenue would be subject to a significant reversal. We consider all the facts and circumstances associated with both the risk of a revenue reversal arising from an uncertain future event and the magnitude of the reversal if that uncertain event were to occur. Actual amounts of consideration ultimately received may differ from our estimates. If actual results in the future vary from our original estimates, we will adjust these estimates, which would affect net product revenue and earnings in the period such changes in estimates become known. We accept returns of unsalable prescription products sold through wholesale distributors within a return period of six months prior to and up to 12 months following product expiration. Our prescription products currently have a shelf life of 24 months from the date of manufacture. We do not allow product returns for prescription products that have been dispensed to a patient. We estimate the amount of our product sales that may be returned by our customers and record this estimate as a reduction of revenue in the period the related product revenue is recognized. Where historical rates of return exist, we use history as a basis to establish a returns reserve for products shipped to wholesalers. For our newly launched products, for which the right of return exists but for which we currently do not have history of product returns, we estimate returns based on available industry data, our own sales information and our visibility into the inventory remaining in the distribution channel. At the end of each reporting period, we may decide to constrain revenue for product returns based on information from various sources, including channel inventory levels and dating and sell-through data, the expiration dates of products currently being shipped, price changes of competitive products and any introductions of generic products. We recognize the amount of expected returns as a refund liability, representing the obligation to return the customer’s consideration. Since our returns primarily consist of expired and short dated products that will not be resold, we do not record a return asset for the right to recover the goods returned by the customer at the time of the initial sale (when recognition of revenue is deferred due to the anticipated return). Return estimates are recorded in the accrued expenses and other current liabilities on the consolidated balance sheet. We offer various rebate and discount programs in an effort to maintain a competitive position in the marketplace and to promote sales and customer loyalty. We estimate the allowance for consumer rebates and coupons that we have offered based on our experience and industry averages, which is reviewed, and adjusted if necessary, on a quarterly basis. Estimates relating to these rebates and coupons are deducted from gross product revenues at the time the revenues are recognized. We record distributor fees based on amounts stated in contracts. Rebate and coupon estimates and distributor fees are recorded in accrued expenses and other current liabilities on the consolidated balance sheet. We estimate chargebacks based on number of units sold during the period taking into account prices stated in contracts and our historical experience. Estimates related to distributors fees, rebates, coupons and returns are disclosed in Note 8. We provide invoice discounts to our customers for prompt payment. Estimates relating to invoice discounts and chargebacks are deducted from gross product revenues at the time the revenues are recognized. As part of the commercial launch for IMVEXXY® during the third quarter of 2018, we introduced a co-pay assistance program where enrolled patients do not pay more than $35 for up to 12 IMVEXXY® prescription fills. This allows patients to access the product at a reasonable cost regardless of insurance coverage. We reimburse pharmacies for this discount through third-party vendors. We consider these payments as consideration paid to the customer and reflect such payments as a reduction of the transaction price as we do not receive a distinct good or service related to these payments. The variable consideration is estimated based on contract prices, the estimated percentage of patients that will utilize the copay assistance, the average assistance paid, the estimated levels of inventory in the distribution channel and the current level of prescriptions covered by patients’ insurance. Payers may change coverage levels for IMVEXXY® positively or negatively, at any time up to the time that we have formally contracted coverage with the payer. As such, the net transaction price of IMVEXXY® is susceptible to such changes in coverage levels, which are outside the influence of the Company. As a result, we constrain revenue recognized for IMVEXXY® to an amount that will not result in a significant revenue reversal in future periods. Our ability to estimate the net transaction price for IMVEXXY® is constrained by our estimates of the amount to be paid for the co-pay assistance program for IMVEXXY® which is directly related to the level of prescriptions paid for by insurance. As such, we record an accrual to reduce gross sales for the estimated co-pay and other patient assistance based on currently available third-party data and our internal analyses. We re-evaluate any constraint each reporting period. Disaggregation of revenue The following table provides information about disaggregated revenue by product mix for the three months ended March 31, 2019 and 2018: For the Three Months Ended 2019 2018 Prescription vitamins $ 1,935,971 $ 3,773,392 IMVEXXY ® 2,010,680 — Net revenue $ 3,946,651 $ 3,773,392 Share-Based Compensation We measure the compensation costs of share-based compensation arrangements based on the grant-date fair value and recognize the costs in the financial statements over the period during which employees are required to provide services. Share-based compensation arrangements include options, restricted stock, restricted stock units, performance-based awards, share appreciation rights, and employee share purchase plans. We amortize such compensation amounts, if any, over the respective service periods of the award. We use the Black-Scholes-Merton option pricing model, or the Black-Scholes Model, an acceptable model in accordance with ASC 718, Compensation-Stock Compensation, to value options. Option valuation models require the input of assumptions, including the expected life of the stock-based awards, the estimated stock price volatility, the risk-free interest rate, and the expected dividend yield. The risk-free interest rate assumption is based upon observed interest rates on zero coupon U.S. Treasury bonds whose maturity period is appropriate for the term of the instrument. Estimated volatility is a measure of the amount by which our stock price is expected to fluctuate each year during the term of the award. Prior to January 1, 2017, the expected volatility of share options was estimated based on a historical volatility analysis of peer entities whose stock prices were publicly available that were similar to the Company with respect to industry, stage of life cycle, market capitalization, and financial leverage. On January 1, 2017, we began using our own stock price in our volatility calculation along with the other peer entities whose stock prices were publicly available that were similar to our company and in 2019 we started using only our own stock price in the volatility calculation. Our calculation of estimated volatility is based on historical stock prices over a period equal to the expected term of the awards. The average expected life is based on the contractual terms of the stock option using the simplified method. We utilize a dividend yield of zero based on the fact that we have never paid cash dividends and have no current intention to pay cash dividends. Calculating share-based compensation expense requires the input of highly subjective judgment and assumptions, estimates of expected life of the share-based award, stock price volatility and risk-free interest rates. The assumptions used in calculating the fair value of share-based awards represent our best estimates, but these estimates involve inherent uncertainties and the application of management judgment. As a result, if factors change and we use different assumptions, our share-based compensation expense could be materially different in the future. We recognize the compensation expense for share-based compensation granted based on the grant date fair value estimated in accordance with ASC 718. We generally recognize the compensation expense on a straight-line basis over the employee’s requisite service period. Effective January 1, 2017, we account for forfeitures when they occur. On January 1, 2019, we adopted ASU 2018-07 which simplified the accounting for share-based payments to nonemployees by aligning it with the accounting for share-based payments to employees, with certain exceptions. The new guidance expanded the scope of ASC 718 to include share-based payments granted to nonemployees in exchange for goods or services used or consumed in an entity’s own operations and superseded the guidance in ASC 505-50. Prior to January 1, 2019, equity instruments issued to non-employees were recorded on a fair value basis, as required by ASC 505, Equity - Based Payments to Non-Employees. 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 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	3 Months Ended
	Mar. 31, 2019
Inventory Disclosure [Abstract]
INVENTORY	NOTE 4 – INVENTORY Inventory consists of the following: March 31, 2019 December 31, 2018 Finished product $ 3,217,706 $ 2,908,958 Work in process 808,694 339,312 Raw material 929,315 19,400 TOTAL INVENTORY $ 4,955,715 $ 3,267,670

OTHER CURRENT ASSETS

OTHER CURRENT ASSETS	3 Months Ended
	Mar. 31, 2019
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract]
OTHER CURRENT ASSETS	NOTE 5 – OTHER CURRENT ASSETS Other current assets consist of the following: March 31, 2019 December 31, 2018 Prepaid sales and marketing costs $ 3,774,437 $ 5,148,789 Debt financing fees (Note 9) 1,898,074 1,898,074 Prepaid insurance 455,929 790,465 Other prepaid costs 3,718,459 2,997,365 TOTAL OTHER CURRENT ASSETS $ 9,846,899 $ 10,834,693

FIXED ASSETS, NET

FIXED ASSETS, NET	3 Months Ended
	Mar. 31, 2019
Property, Plant and Equipment [Abstract]
FIXED ASSETS, NET	NOTE 6 – FIXED ASSETS, NET Fixed assets, net consist of the following: March 31, 2019 December 31, 2018 Accounting system $ 301,096 $ 301,096 Equipment 560,772 490,576 Furniture and fixtures 271,864 116,542 Computer hardware 80,211 80,211 Leasehold improvements 74,788 37,888 1,288,731 1,026,313 Accumulated depreciation (620,124 ) (553,630 ) TOTAL FIXED ASSETS, NET $ 668,607 $ 472,683 Depreciation expense for the three months ended March 31, 2019 and 2018 was $66,494 and $38,424, respectively.

INTANGIBLE ASSETS

INTANGIBLE ASSETS	3 Months Ended
	Mar. 31, 2019
Intangible Assets, Net (Excluding Goodwill) [Abstract]
INTANGIBLE ASSETS	NOTE 7 – INTANGIBLE ASSETS The following table sets forth the gross carrying amount, accumulated amortization and net carrying amount of our intangible assets as of March 31, 2019 and December 31, 2018: March 31, 2019 Gross Carrying Amount Accumulated Amortization Net Amount Weighted-Average Remaining Amortization Period (yrs.) Amortizable intangible assets: OPERA ® $ 31,951 $ (10,983 ) $ 20,968 10.5 Approved hormone therapy drug candidate patents 2,519,316 (322,431 ) 2,196,885 13.75 Hormone therapy drug candidate patents (pending) 1,967,124 — 1,967,124 n/a Non-amortizable intangible assets: Multiple trademarks 270,753 — 270,753 indefinite Total $ 4,789,144 $ (333,414 ) $ 4,455,730 December 31, 2018 Gross Carrying Amount Accumulated Amortization Net Amount Weighted-Average Remaining Amortization Period (yrs.) Amortizable intangible assets: OPERA ® $ 31,951 $ (10,484 ) $ 21,467 10.75 Development costs of corporate website 91,743 (91,743 ) — n/a Approved hormone therapy drug candidate patents 2,234,129 (282,485 ) 1,951,644 14 Hormone therapy drug candidate patents (pending) 1,855,279 — 1,855,279 n/a Non-amortizable intangible assets: Multiple trademarks 264,289 — 264,289 indefinite Total $ 4,477,391 $ (384,712 ) $ 4,092,679 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 months ended March 31, 2019 and year ended December 31, 2018, there was no impairment recognized related to intangible assets. As of March 31, 2019, we had 22 issued domestic, or U.S., patents and 27 issued foreign patents, including: ● 12 domestic patents and five foreign patents that relate to BIJUVA™ as well as three domestic patents that relate to non-approved doses of BIJUVA™. These patents establish an important intellectual property foundation for BIJUVA™ and are owned by us. The domestic patents will expire in 2032. The foreign patents will expire no earlier than 2032. In addition, we have pending patent applications relating to BIJUVA™ in the U.S., Argentina, Australia, Brazil, Canada, Europe, Israel, Japan, Mexico, Russia, South Africa, and South Korea; ● Four foreign patents that relate to our progesterone-only candidate, which are owned by us. The foreign patents will expire no earlier than 2033. In addition, we have pending patent applications with respect to our progesterone-only candidate in the U.S., Argentina, Australia, Brazil, Canada, Europe, Israel, Japan, Mexico, Russia, South Africa, and South Korea; ● Three domestic patents (two utility and one design) and 13 foreign patents (three utility and ten design) that relate to IMVEXXY®. These patents establish an important intellectual property foundation for IMVEXXY® and are owned by us. The domestic patents will expire in 2032 or 2033. The foreign utility patents will expire no earlier than 2033. The foreign design patents provide protection expiring no earlier than 2025. In certain jurisdictions, the foreign design patents provide protection through at least 2037. In addition, we have pending patent applications related to IMVEXXY® in the U.S., Argentina, Australia, Brazil, Canada, Europe, Israel, Japan, Mexico, New Zealand, Russia, South Africa, and South Korea; ● One domestic utility patent that relates to our topical-cream candidates, which is owned by us. The domestic patent will expire in 2035. We have pending patent applications with respect to our topical-cream candidates in the U.S., Argentina, Australia, Brazil, Canada, Europe, Israel, Japan, Mexico, Russia, South Africa, and South Korea; ● One domestic utility patent and five foreign patents that relate to our transdermal-patch candidates, which are owned by us. The domestic utility patent will expire in 2032. The foreign patents will expire no earlier than 2033. We have pending patent applications with respect to our transdermal-patch candidates in the U.S., Australia, Brazil, Canada, Europe, Mexico, Japan, and South Africa; ● One domestic utility patent that relates to our OPERA® information-technology platform, which is owned by us and will expire in 2031; and ● One domestic utility patent that relates to TX-009HR, a progesterone and estradiol product candidate, which is owned by us and will expire in 2037. We have pending patent applications with respect to TX-009HR in the U.S., Argentina, Australia, Brazil, Canada, Europe, Israel, Japan, Mexico, New Zealand, Russia, South Africa, and South Korea. Amortization expense was $40,444 and $21,197 for the three months ended March 31, 2019 and 2018, respectively. Estimated amortization expense for the next five years for the patent costs currently being amortized is as follows: Year Ending December 31, Estimated Amortization 2019 (9 months) $ 121,333 2020 $ 161,777 2021 $ 161,777 2022 $ 161,777 2023 $ 161,777 License Agreement with the Population Council On July 30, 2018, we entered into the Council License Agreement to commercialize in the U.S. ANNOVERA™. We currently estimate that ANNOVERA™ will be commercially available as early as the third quarter of 2019 with a planned full commercial launch by the first quarter of 2020. Under the terms of the Council License Agreement, we paid the Population Council a milestone payment of $20,000,000 within 30 days following approval by the FDA of the NDA for ANNOVERA™ and will be required to pay the Population Council $20,000,000 within 30 days following the release of the first commercial batch of ANNOVERA™. The Population Council is also eligible to receive milestone payments and royalties from commercial sales of ANNOVERA™. We will assume responsibility for marketing expenses related to the commercialization of ANNOVERA™. The milestone payment of $20,000,000 upon the FDA’s approval of ANNOVERA™ in the third quarter of 2018 was recorded as a finite-lived intangible asset in the consolidated balance sheet and will be amortized on a straight-line basis once it becomes available for use which is expected to be upon release of first commercial batch of ANNOVERA™. In addition, we are required to pay the Population Council, on a quarterly basis, step-based royalty payments based on annual net sales of ANNOVERA™ in the U.S. by the Company and its affiliates and permitted licensees as follows: (i) if annual net sales are less than or equal to $50,000,000, a royalty of 5% of net sales; (ii) for annual net sales greater than $50,000,000 and less than or equal to $150,000,000, a royalty of 10% of such net sales; and (iii) for net sales greater than $150,000,000, a royalty of 15% of such net sales. The annual royalty rate will be reduced to 50% of the initial rate during the six-month period beginning on the date of the first arms-length commercial sale of a generic equivalent of the one-year vaginal contraceptive system that is launched by a third party in the U.S., and thereafter will be reduced to 20% of the initial rate. The Population Council has agreed to perform and pay the costs and expenses associated with four post-approval studies required by the FDA for ANNOVERA™ and we have agreed to perform and pay the costs and expenses associated with a post approval study required by the FDA to measure risk for venous thromboembolism, provided that if the costs and expenses associated with such post-approval study exceed $20,000,000, half of such excess will be offset against royalties or other payments owed by us to the Population Council under the Council License Agreement. We and the Population Council have agreed to form a joint product committee responsible for overseeing activities under the Council License Agreement. We will be responsible for all aspects of promotion, product positioning, pricing, education programs, publications, sales messages and any additional desired clinical studies for the one-year vaginal contraceptive system, subject to oversight and decisions made by the joint product committee. The Council License Agreement includes exclusive rights for us to negotiate co-development of two other investigational vaginal contraceptive systems in development by the Population Council. We assess our intangible assets for impairment if indicators are present or changes in circumstance suggest that impairment may exist. If impairment indicators are present or changes in circumstance suggest that impairment may exist, we perform a recoverability test by comparing the sum of the estimated undiscounted cash flows of each intangible asset to its carrying value on the consolidated balance sheet. If the undiscounted cash flows used in the recoverability test are less than the carrying value, we would determine the fair value of the intangible asset and recognize an impairment loss if the carrying value of the intangible asset exceeds its fair value. We also evaluate the remaining useful life of intangible assets subject to amortization on a periodic basis to determine whether events and circumstances would indicate impairment or warrant a revision to the remaining useful life. If the estimate of an intangible asset’s remaining useful life is changed, we will amortize the remaining carrying value of the intangible asset prospectively over the revised remaining useful life. License Agreement with Knight Therapeutics Inc. On July 30, 2018, we entered into a license and supply agreement, or the Knight License Agreement, with Knight pursuant to which we granted Knight an exclusive license to commercialize IMVEXXY ® TM ® ® ® ® ®

ACCRUED EXPENSES AND OTHER CURR

ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES	3 Months Ended
	Mar. 31, 2019
Payables and Accruals [Abstract]
ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES	NOTE 8 – ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES Other current liabilities consist of the following: March 31, December 31, Accrued payroll, bonuses and commission costs $ 5,200,009 $ 6,854,002 Allowance for coupons and returns 5,995,027 5,294,120 Accrued sales and marketing costs 1,590,746 2,288,028 Accrued compensated absences 1,390,396 1,178,110 Allowance for wholesale distributor fees 1,115,689 792,891 Operating lease liability - short term 1,158,286 — Accrued legal and accounting expense 690,346 385,824 Accrued research and development 869,188 388,675 Accrued rent — 365,155 Accrued rebates 929,022 412,570 Other accrued expenses 668,730 375,573 TOTAL OTHER CURRENT LIABILITIES $ 19,607,439 $ 18,334,948

DEBT

DEBT	3 Months Ended
	Mar. 31, 2019
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), as amended. The Credit Agreement provided a secured term loan facility in an aggregate principal amount of up to $200,000,000, or the Term Loan. Under the terms of the Credit Agreement, the Term Loan was available to be made in three separate tranches, with each tranche to be made available to us, at our option, upon our achievement of certain milestones. Amounts borrowed under the Term Loan bore interest at a rate equal to the sum of (i) one-month LIBOR (subject to a LIBOR floor of 1.50%) plus (ii) 7.75% per annum. Interest on amounts borrowed under the Term Loan was due and payable monthly in arrears. Interest expense related to the Term Loan for the three months ending March 31, 2019 was $1,969,872. As of March 31, 2019, 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 were deferred as assets until the Tranche 2 and Tranche 3 milestones have been met. As of March 31, 2019, deferred financing fees related to Tranche 2 and Tranche 3 were included in other current assets in the accompanying consolidated financial statements. During the three months ended March 31, 2019, we amortized $120,146 of debt issuance costs related to Tranche 1 as interest expense in the accompanying unaudited consolidated financial statements. The overall effective interest rate was approximately 11% as of March 31, 2019. As of March 31, 2019, the carrying value of debt consisted of the following: March 31, December 31, Term Loan $ 75,000,000 $ 75,000,000 Debt discount and financing fees (1,498,840 ) (1,618,986 ) TOTAL LONG-TERM DEBT $ 73,501,160 $ 73,381,014 On April 24, 2019, we entered into a Financing Agreement, or the Financing Agreement, with TPG Specialty Lending, Inc., as administrative agent, or Administration Agent, various lenders from time to time party thereto, and certain of our subsidiaries party thereto from time to time as guarantors, which provides a $300,000,000 first lien secured term loan credit facility, or the Facility, to the Company. See Note 16 - Subsequent Events. On April 24, 2019, we terminated the Credit Agreement. A portion of the initial tranche of borrowing under the Facility in the amount of approximately $81,661,000 was used to repay all amounts outstanding under the Credit Agreement, which included a prepayment fee of 4%, a repayment fee of 4% and other fees and expenses payable to the lenders under the Credit Agreement.

NET LOSS PER SHARE

NET LOSS PER SHARE	3 Months Ended
	Mar. 31, 2019
Loss per share, basic and diluted:
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, par value $0.001 per share, or Common Stock, outstanding during the period. We compute diluted EPS based on the weighted-average number of shares of our Common Stock outstanding plus all potentially dilutive shares of our Common Stock outstanding during the period. Such potentially dilutive shares of our Common Stock consist of options, warrants and restricted stock awards and were excluded from the calculation of diluted earnings per share because their effect would have been antidilutive 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 months ended March 31, March 31, Stock options 21,447,719 25,196,684 Warrants 1,832,571 3,290,905 Restricted stock awards 1,040,000 — 24,320,290 28,487,589

STOCKHOLDERS' EQUITY

STOCKHOLDERS' EQUITY	3 Months Ended
	Mar. 31, 2019
Stockholders' Equity:
STOCKHOLDERS' EQUITY	NOTE 11 – STOCKHOLDERS’ EQUITY Preferred Stock At March 31, 2019, 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 March 31, 2019, we had 350,000,000 shares of Common Stock authorized for issuance, of which 241,221,840 shares of Common Stock were issued and outstanding. Issuances During the Three Months Ended March 31, 2019 During the three months ended March 31, 2019, certain individuals exercised stock options to purchase 276,383 shares of Common Stock for $100,107 in cash. Also, during the same period, stock options to purchase 12,097 shares of Common Stock were exercised pursuant to the options’ cashless exercise provisions, wherein 11,834 shares of Common Stock were issued. Issuances During the Three Months Ended March 31, 2018 During the three months ended March 31, 2018, certain individuals exercised stock options to purchase 144,791 shares of Common Stock for $44,057 in cash. Also, during the same period, 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. Warrants to Purchase Common Stock As of March 31, 2019, we had warrants outstanding to purchase an aggregate of 1,832,571 shares of Common Stock with a weighted-average contractual remaining life of approximately 2.70 years, and exercise prices ranging from $0.24 to $8.20 per share, resulting in a weighted average exercise price of $2.62 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 three months ended March 31, 2019, we granted warrants to purchase 75,000 shares of Common Stock to outside consultants at an exercise price of $5.63. The fair value for these warrants was determined by using the Black-Scholes Model on the date of the grant using a term of 5 years; volatility of 60.8%; risk free rate of 2.52%; and dividend yield of 0%. The grant date fair value of the warrants was $3.00 per share. The warrants are vesting ratably over a 12-month period and have an expiration date of February 12, 2024. During the three months ended March 31, 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 are vesting ratably over a 12-month period and have an expiration date of March 15, 2023. During the three months ended March 31, 2019 and 2018, we recorded $85,716 and $91,475, respectively, as share-based compensation expense in the accompanying consolidated financial statements related to warrants. As of March 31, 2019, total unrecognized estimated compensation expense related to the unvested portion of these warrants was approximately $196,000, which is expected to be recognized over a weighted-average period of 0.9 years. During the three months ended March 31, 2019, warrants to purchase 1,250,000 shares of Common Stock were exercised pursuant to the options’ cashless exercise provisions, wherein 471,184 shares of Common Stock were issued. During the three months ended March 31, 2018, no warrants were exercised. 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 March 31, 2019, there were non-qualified stock options to purchase 15,128,745 shares of Common Stock outstanding under the 2009 Plan. As of March 31, 2019, there were 44,300 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 March 31, 2019, there were non-qualified stock options to purchase 6,318,974 shares of Common Stock outstanding and 1,040,000 restricted stock awards under the 2012 Plan. As of March 31, 2019, there were 2,392,833 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 three months ended March 31, 2019 and 2018 are set forth in the table below. Three Months Three Months Risk-free interest rate 2.54 % 2.38-2.60 % Volatility 61.85 % 63.59-64.04 % Term (in years) 6.25 6-6.25 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 Weighted Aggregate Intrinsic Value Balance at December 31, 2018 20,872,824 $ 4.93 5.94 $ 12,239,876 Granted 907,000 $ 5.63 Exercised (288,480 ) $ 0.35 $ 1,315,238 Expired/Forfeited (43,625 ) $ 5.69 Balance at March 31, 2019 21,447,719 $ 5.02 5.93 $ 19,747,182 Vested and Exercisable at March 31, 2019 16,995,263 $ 4.78 5.16 $ 19,747,182 Unvested at March 31, 2019 4,452,456 $ 5.93 8.83 $ 0 At March 31, 2019, 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 $3.35 and $3.11 during the three months ended March 31, 2019 and 2018, respectively. Share-based compensation expense for options recognized in our results of operations for the three months ended March 31, 2019 and 2018 ($2,143,239 and $1,659,883, respectively) is based on vested awards. At March 31, 2019, total unrecognized estimated compensation expense related to unvested options granted prior to that date was approximately $12,942,820 which may be adjusted for future changes in forfeitures. This cost is expected to be recognized over a weighted-average period of 2.30 years. No tax benefit was realized due to a continued pattern of operating losses. Restricted Stock Restricted stock awards granted under our 2009 and 2012 Plans entitle the holder to receive, at the end of vesting period, a specified number of shares of our Common Stock. Share-based compensation expense is measured by the market value of our Common Stock on the day of the grant. The shares vest ratably over the period specified in the grant. There is no partial vesting and any unvested portion is forfeited. On December 13, 2018, we granted 1,040,000 restricted stock units to certain executive employees which will vest at the end of the third year. The grant date fair value was $4.06 per unit. During the three months ended March 31, 2019 we recorded $346,414 in share-based compensation expense related to restricted stock units. At March 31, 2019, total unrecognized estimated compensation expense related to unvested restricted stock units was approximately $3,800,000, which may be adjusted for future changes in forfeitures. This cost is expected to be recognized over a weighted-average period of 2.7 years. At March 31, 2019, 1,040,000 restricted stock awards remained outstanding. Cash-Settled Stock Appreciation Rights (SARs) On July 1, 2018, we issued cash-settled SARs to certain consultants and employees. The SARs plan year begins on July 1 and ends on or immediately following June 30, 2019. SARs are granted with a grant price equal to the market value of a share of our Common Stock on the date of grant. Cash-settled SARs provide for the cash payment of the excess of the fair market value of our Common Stock on June 30, 2019 over the grant price. Cash-settled SARs have no effect on dilutive shares or shares outstanding as any appreciation of our Common Stock over the grant price is paid in cash and not in Common Stock. Cash settled SARs are recorded in our consolidated balance sheets as a liability until the date of exercise. The fair value of each SAR award is estimated using the Black-Scholes valuation model. In accordance with ASC Topic 718, “Stock Compensation,” the fair value of each SAR award is recalculated at the end of each reporting period and the liability and expense adjusted based on the new fair value and the percent vested. At March 31, 2019, we had 97,000 SARs outstanding and the liability related to SAR calculation was approximately $11,579.

INCOME TAXES

INCOME TAXES	3 Months Ended
	Mar. 31, 2019
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 2019 as a result of (i) the losses recorded during the three months ended March 31, 2019, (ii) additional losses expected for the remainder of 2019, 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 March 31, 2019, 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	3 Months Ended
	Mar. 31, 2019
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 March 31, 2019 and 2018, we were billed by Catalent approximately $1,397,000 and $338,000, respectively, for manufacturing activities related to our clinical trials, scale-up, registration batches, stability and validation testing. As of March 31, 2019 and December 31, 2018, there were amounts due to Catalent of approximately $937,000 and $88,000, respectively.

BUSINESS CONCENTRATIONS

BUSINESS CONCENTRATIONS	3 Months Ended
	Mar. 31, 2019
Risks and Uncertainties [Abstract]
BUSINESS CONCENTRATIONS	NOTE 14 – BUSINESS CONCENTRATIONS We purchase our prescription products from several suppliers with approximately 33%, 29%, 27% and 11% of our purchases were supplied by four vendors each, respectively, during the three months ended March 31, 2019 and 100% of our purchases were supplied by one vendor for the three months ended March 31, 2018. We sell our prescription products to wholesale distributors, specialty pharmacies, specialty distributors, and chain drug stores that generally sell products to retail pharmacies, hospitals, and other institutional customers. During the three months ended March 31, 2019, five customers each generated more than 10% of our net revenues. During the three months ended March 31, 2018, five customers each generated more than 10% of our net revenues. Revenue generated from the five customers combined accounted for approximately 83% of our net revenue for the three months ended March 31, 2019 and revenue generated from five customers combined accounted for approximately 80% of our net revenue for the three months ended March 31, 2018. During the three months ended March 31, 2019, PI Services accounted for approximately $967,000 of our net revenue, Pillpack, Inc. accounted for approximately $534,000 of our net revenue, AmerisourceBergen accounted for approximately $787,000 of our net revenue, Cardinal Health accounted for approximately $525,000 of our net revenue and McKesson Corporation accounted for approximately $457,000 of our net revenues. During the three months ended March 31, 2018, PI Services generated approximately $557,000 of our revenue, Pillpack, Inc. generated approximately $905,000 of our revenue, AmerisourceBergen generated approximately $668,000 of our revenue, Cardinal Health generated approximately $493,000 of our revenue and McKesson Corporation generated approximately $385,000 of our revenue.

COMMITMENTS AND CONTINGENCIES

COMMITMENTS AND CONTINGENCIES	3 Months Ended
	Mar. 31, 2019
Commitments and Contingencies Disclosure [Abstract]
COMMITMENTS AND CONTINGENCIES	NOTE 15 – COMMITMENTS AND CONTINGENCIES We adopted ASC 842 effective January 1, 2019. Substantially all our operating lease right-of-use assets and operating lease liabilities represent leases for office space used to conduct our business. Upon adoption, we have recognized a right-of-use asset and a lease liability for all leases that have commenced as of January 1, 2019. The right-of-use assets represent the right to use the leased asset for the lease term. The lease liabilities represent the present value of the lease payments under the lease. The right-of-use asset is initially measured at cost, which primarily comprises the initial amount of the lease liability, plus any initial direct costs incurred, less any lease incentives received. All right-of-use assets are reviewed for impairment. The lease liability is initially measured at the present value of the lease payments, discounted using our secured incremental borrowing rate for the same term as the underlying lease because the rates are not implicit in the leases. Some of our leases contain variable lease payments, including payments based on an index or rate. Variable lease payments based on an index or rate are initially measured using the index or rate in effect at lease commencement. Additional payments based on the change in an index or rate, or payments based on a change in our portion of the operating expenses are recorded as a period expense when incurred. Lease modifications result in remeasurement of the lease liability. Included in lease expense are any variable lease payments incurred in the period that were not included in the initial lease liability. We lease administrative office space in Boca Raton, Florida pursuant to a non-cancelable operating lease that commenced on July 1, 2013 and originally provided for a 63-month term. On February 18, 2015, we entered into an agreement with the same lessors to lease additional administrative office space in the same location, pursuant to an addendum to such lease. In addition, on April 26, 2016, we entered into an agreement with the same lessors to lease additional administrative office space in the same location. This agreement was effective beginning May 1, 2016 and extended the original expiration of the lease term to October 31, 2021. On October 4, 2016, we entered into an agreement with the same lessors to lease additional administrative office space in the same location, pursuant to an addendum to such lease. This addendum is effective beginning November 1, 2016. In October 2018, we entered into a lease for new corporate offices in Boca Raton, Florida. The lease includes 56,212 rentable square feet, or the full premises, of which lease on 7,561 square feet has commenced in 2018 and the lease on the remaining 48,651 square feet will commence no earlier than June 1, 2019, or the full premises commencement date. The lease will expire 11 years after full premises commencement date, unless terminated earlier in accordance with the terms of the lease. We have the option to extend the term of the lease for two additional consecutive periods of five years. The extension option is not included in the determination of the lease term as it is not reasonably certain to be exercised. The term of the lease includes escalating rent and free rent periods. We are also responsible for certain other operating costs under the lease, including electricity and utility expenses. In addition, we will be entitled to reimbursement from the landlord of up to $1,800,000 for tenant improvements. Supplemental lease information at March 31, 2019: Right of use asset $ 3,540,407 Short-term operating lease liability $ 1,158,286 Long-term operating lease liability $ 2,724,501 Weighted average remaining term 5.3 years Weighted average discount rate 8.25 % Supplemental cash flow information: Cash paid for amounts included in the measurement of lease liabilities for operating lease $ 279,742 Right-of-use assets obtained in exchange for lease obligation $ 3,760,171 The following table reconciles the undiscounted cash flows for all operating leases at March 31, 2019 to the operating lease liabilities recorded on the balance sheet: Years Ending December 31, 2019 (9 months) $ 879,998 2020 1,292,914 2021 1,135,467 2022 172,651 2023 176,968 Thereafter 1,228,504 Total undiscounted lease payments 4,886,502 Less: Imputed interest (1,003,715 ) Present value of lease payments $ 3,882,787 As of March 31, 2019, we estimated fixed future minimum rental commitments of approximately $11.6 million and estimated variable future minimum rental commitments of approximately $5.7 million over the term of the lease related to the operating lease for the new corporate office that we entered into in October 2018 that had not commenced yet, as disclosed above. During the three months ended March 31, 2019, operating lease expense was $295,109 and variable lease expense was $11,786 related to our real estate leases. Rent expense totaled $257,301 during the three months ended March 31, 2018.

SUBSEQUENT EVENTS

SUBSEQUENT EVENTS	3 Months Ended
	Mar. 31, 2019
Subsequent Events [Abstract]
SUBSEQUENT EVENTS	NOTE 16 – SUBSEQUENT EVENTS In April 2019, we launched BIJUVA™, our hormone therapy combination of bio-identical 17ß-estradiol and bio-identical progesterone in a single, oral softgel capsule, for the treatment of VMS due to menopause in women with a uterus, which was approved by the FDA on October 28, 2018. BIJUVA™ will follow a similar commercialization model to IMVEXXY®. On April 24, 2019, we entered into the Financing Agreement with the Administrative Agent, various lenders from time to time party thereto, and certain of our Company’s subsidiaries party thereto from time to time as guarantors. The Facility provides for availability to us in three tranches: (i) $200,000,000 was drawn upon entering into the Financing Agreement; (ii) $50,000,000 will be available to us upon the designation of our ANNOVERA TM TM TM Borrowings under the Facility will accrue interest at either (i) 3-month LIBOR plus 7.75%, subject to a LIBOR floor of 2.70% or (ii) the prime rate plus 6.75%, subject to a prime rate floor of 5.20%. Interest on amounts borrowed under the Facility will be payable quarterly. The outstanding principal amount of the Facility will be payable in four equal quarterly installments beginning on June 30, 2023, with the Facility maturing on March 31, 2024. We will have the right to prepay borrowings under the Facility in whole or in part at any time, subject to a prepayment fee on the principal amount being prepaid of (i) 30.0% for the first two years following the initial funding date of the applicable borrowing, (ii) 5.0% for the third year following the initial funding date of the applicable borrowing, (iii) 3.0% for the fourth year following the initial funding date of the applicable borrowing and (iv) 1.0% for the fifth year following the initial funding date of the applicable borrowing but prior to March 31, 2024. In connection with the initial borrowing under the Facility, we paid, for the benefit of the lenders, a facility fee equal to 2.5% of the initial amount borrowed and will be required to pay such a facility fee in connection with any subsequent borrowings under the Facility. We will also be required to pay the Administrative Agent and the lenders an annual administrative fee in addition to other fees and expenses. The Financing Agreement contains customary mandatory prepayments, restrictions and covenants applicable to us that are customary for financings of this type. Among other requirements, we will be required to (i) maintain a minimum unrestricted cash balance of $50,000,000, which will increase to $60,000,000 if we draw either the second or third tranche of the Facility, and (ii) achieve certain minimum consolidated net revenue amounts attributable to commercial sales of our IMVEXXY®, BIJUVA TM TM The obligations of our company and its subsidiaries under the Financing Agreement are secured, subject to customary permitted liens and other agreed upon exceptions, by a first priority perfected security interest in all existing and after-acquired assets of our company and its subsidiaries. The obligations under the Financing Agreement will be guaranteed by each of our future direct and indirect subsidiaries, subject to certain exceptions.

SUMMARY OF SIGNIFICANT ACCOUN_2

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies)	3 Months Ended
	Mar. 31, 2019
Accounting Policies [Abstract]
Fair Value of Financial Instruments	Fair Value of Financial Instruments Our financial instruments consist primarily of cash, accounts receivable, accounts payable, accrued expenses and long-term debt. The carrying amount of cash, accounts receivable, accounts payable and accrued expenses approximates their fair value because of the short-term maturity of such instruments, which are considered Level 1 assets under the fair value hierarchy. 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 March 31, 2019 and 2018, 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 the Company’s impairment test. There was no impairment of intangible assets or long-lived assets during the three months ended March 31, 2019 and 2018. The carrying amount for the long-term debt as of March 31, 2019 (as disclosed in Note 9), approximates fair value based on market activity for other debt instruments with similar characteristics and comparable risk (Level 2).
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.
Revenue Recognition	Revenue Recognition We adopted ASC 606 on January 1, 2018 using the modified retrospective method for all contracts not completed as of the date of adoption. ASC 606 states that a contract is considered “completed” if all (or substantially all) of the revenue was recognized in accordance with revenue guidance that was in effect before the date of initial application. Because all (or substantially all) of the revenue related to sales of our products has been recognized under ASC 605 prior to the date of initial application of the new standard, the contracts are considered completed under ASC 606. Based on our evaluation of ASC 606, we concluded that a cumulative adjustment was not necessary upon implementation of ASC 606 on January 1, 2018. In accordance with ASC 606, revenue is recognized when a customer obtains control of promised goods or services. The amount of revenue recognized reflects the consideration to which we expect to be entitled to receive in exchange for these goods or services. The provisions of ASC 606 include a five-step process by which we determine revenue recognition, depicting the transfer of goods or services to customers in amounts reflecting the payment to which we expect to be entitled in exchange for those goods or services. ASC 606 requires us to apply the following steps: (1) identify the contract with the customer; (2) identify the performance obligations in the contract; (3) determine the transaction price; (4) allocate the transaction price to the performance obligations in the contract; and (5) recognize revenue when, or as, we satisfy the performance obligation. Prescription Products As of March 31, 2019, our products consisted primarily of prescription vitamins and our recently approved product IMVEXXY®, which we began selling during the third quarter of 2018. We sell our name brand and generic prescription products primarily through wholesale distributors and retail pharmacy distributors. We have one performance obligation related to prescription products sold through wholesale distributors, which is to transfer promised goods to a customer and two performance obligations related to products sold through retail pharmacy distributors, which are to: (1) transfer promised goods and (2) provide customer service for an immaterial fee. We treat shipping as a fulfillment activity rather than as a separate obligation. We recognize prescription revenue only when we satisfy performance obligations by transferring a promised good or service to a customer. A good or service is considered to be transferred when the customer receives the goods or service or obtains control. Control refers to the customer’s ability to direct the use of, and obtain substantially all of the remaining benefits from, an asset. All of our performance obligations, and associated revenue, are transferred to customers at a point in time. Based on our contracts, we invoice customers once our performance obligations have been satisfied, at which point payment is unconditional. We disclose receivables from contracts with customers separately in the statement of financial position. Payment for goods or services sold by us is typically due between 30 and 60 days after an invoice is sent to the customer. The transaction price of a contract is the amount of consideration which we expect to be entitled to in exchange for transferring promised goods or services to a customer. Prescription products are sold at fixed wholesale acquisition cost, or WAC, determined based on our list price. However, the total transaction price is variable as it is calculated net of estimated product returns, chargebacks, rebates, coupons, discounts and wholesaler fees. These estimates are based on the amounts earned or to be claimed on the related sales and are classified as reductions of accounts receivable (if the amount is payable to the customer) or a current liability (if the amount is payable to a party other than a customer). In order to determine the transaction price, we estimate the amount of variable consideration at the outset of the contract either utilizing the expected value or most likely amount method, depending on the facts and circumstances relative to the contract or each variable consideration. The estimated amount of variable consideration is included in the transaction price only to the extent that it is probable that a significant reversal in the amount of cumulative revenue recognized will not occur when the uncertainty associated with the variable consideration is subsequently resolved. In determining amounts of variable consideration to include in a contract’s transaction price, we rely on our historical experience and other evidence that supports our qualitative assessment of whether revenue would be subject to a significant reversal. We consider all the facts and circumstances associated with both the risk of a revenue reversal arising from an uncertain future event and the magnitude of the reversal if that uncertain event were to occur. Actual amounts of consideration ultimately received may differ from our estimates. If actual results in the future vary from our original estimates, we will adjust these estimates, which would affect net product revenue and earnings in the period such changes in estimates become known. We accept returns of unsalable prescription products sold through wholesale distributors within a return period of six months prior to and up to 12 months following product expiration. Our prescription products currently have a shelf life of 24 months from the date of manufacture. We do not allow product returns for prescription products that have been dispensed to a patient. We estimate the amount of our product sales that may be returned by our customers and record this estimate as a reduction of revenue in the period the related product revenue is recognized. Where historical rates of return exist, we use history as a basis to establish a returns reserve for products shipped to wholesalers. For our newly launched products, for which the right of return exists but for which we currently do not have history of product returns, we estimate returns based on available industry data, our own sales information and our visibility into the inventory remaining in the distribution channel. At the end of each reporting period, we may decide to constrain revenue for product returns based on information from various sources, including channel inventory levels and dating and sell-through data, the expiration dates of products currently being shipped, price changes of competitive products and any introductions of generic products. We recognize the amount of expected returns as a refund liability, representing the obligation to return the customer’s consideration. Since our returns primarily consist of expired and short dated products that will not be resold, we do not record a return asset for the right to recover the goods returned by the customer at the time of the initial sale (when recognition of revenue is deferred due to the anticipated return). Return estimates are recorded in the accrued expenses and other current liabilities on the consolidated balance sheet. We offer various rebate and discount programs in an effort to maintain a competitive position in the marketplace and to promote sales and customer loyalty. We estimate the allowance for consumer rebates and coupons that we have offered based on our experience and industry averages, which is reviewed, and adjusted if necessary, on a quarterly basis. Estimates relating to these rebates and coupons are deducted from gross product revenues at the time the revenues are recognized. We record distributor fees based on amounts stated in contracts. Rebate and coupon estimates and distributor fees are recorded in accrued expenses and other current liabilities on the consolidated balance sheet. We estimate chargebacks based on number of units sold during the period taking into account prices stated in contracts and our historical experience. Estimates related to distributors fees, rebates, coupons and returns are disclosed in Note 8. We provide invoice discounts to our customers for prompt payment. Estimates relating to invoice discounts and chargebacks are deducted from gross product revenues at the time the revenues are recognized. As part of the commercial launch for IMVEXXY® during the third quarter of 2018, we introduced a co-pay assistance program where enrolled patients do not pay more than $35 for up to 12 IMVEXXY® prescription fills. This allows patients to access the product at a reasonable cost regardless of insurance coverage. We reimburse pharmacies for this discount through third-party vendors. We consider these payments as consideration paid to the customer and reflect such payments as a reduction of the transaction price as we do not receive a distinct good or service related to these payments. The variable consideration is estimated based on contract prices, the estimated percentage of patients that will utilize the copay assistance, the average assistance paid, the estimated levels of inventory in the distribution channel and the current level of prescriptions covered by patients’ insurance. Payers may change coverage levels for IMVEXXY® positively or negatively, at any time up to the time that we have formally contracted coverage with the payer. As such, the net transaction price of IMVEXXY® is susceptible to such changes in coverage levels, which are outside the influence of the Company. As a result, we constrain revenue recognized for IMVEXXY® to an amount that will not result in a significant revenue reversal in future periods. Our ability to estimate the net transaction price for IMVEXXY® is constrained by our estimates of the amount to be paid for the co-pay assistance program for IMVEXXY® which is directly related to the level of prescriptions paid for by insurance. As such, we record an accrual to reduce gross sales for the estimated co-pay and other patient assistance based on currently available third-party data and our internal analyses. We re-evaluate any constraint each reporting period. Disaggregation of revenue The following table provides information about disaggregated revenue by product mix for the three months ended March 31, 2019 and 2018: For the Three Months Ended 2019 2018 Prescription vitamins $ 1,935,971 $ 3,773,392 IMVEXXY ® 2,010,680 — Net revenue $ 3,946,651 $ 3,773,392
Share-Based Compensation	Share-Based Compensation We measure the compensation costs of share-based compensation arrangements based on the grant-date fair value and recognize the costs in the financial statements over the period during which employees are required to provide services. Share-based compensation arrangements include options, restricted stock, restricted stock units, performance-based awards, share appreciation rights, and employee share purchase plans. We amortize such compensation amounts, if any, over the respective service periods of the award. We use the Black-Scholes-Merton option pricing model, or the Black-Scholes Model, an acceptable model in accordance with ASC 718, Compensation-Stock Compensation, 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 and in 2019 we started using only our own stock price in the volatility calculation. Our calculation of estimated volatility is based on historical stock prices over a period equal to the expected term of the awards. The average expected life is based on the contractual terms of the stock option using the simplified method. We utilize a dividend yield of zero based on the fact that we have never paid cash dividends and have no current intention to pay cash dividends. Calculating share-based compensation expense requires the input of highly subjective judgment and assumptions, estimates of expected life of the share-based award, stock price volatility and risk-free interest rates. The assumptions used in calculating the fair value of share-based awards represent our best estimates, but these estimates involve inherent uncertainties and the application of management judgment. As a result, if factors change and we use different assumptions, our share-based compensation expense could be materially different in the future. We recognize the compensation expense for share-based compensation granted based on the grant date fair value estimated in accordance with ASC 718. We generally recognize the compensation expense on a straight-line basis over the employee’s requisite service period. Effective January 1, 2017, we account for forfeitures when they occur. On January 1, 2019, we adopted ASU 2018-07 which simplified the accounting for share-based payments to nonemployees by aligning it with the accounting for share-based payments to employees, with certain exceptions. The new guidance expanded the scope of ASC 718 to include share-based payments granted to nonemployees in exchange for goods or services used or consumed in an entity’s own operations and superseded the guidance in ASC 505-50. Prior to January 1, 2019, equity instruments issued to non-employees were recorded on a fair value basis, as required by ASC 505, Equity - Based Payments to Non-Employees.
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 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)	3 Months Ended
	Mar. 31, 2019
Accounting Policies [Abstract]
Schedule of disaggregated revenue	The following table provides information about disaggregated revenue by product mix for the three months ended March 31, 2019 and 2018: For the Three Months Ended 2019 2018 Prescription vitamins $ 1,935,971 $ 3,773,392 IMVEXXY ® 2,010,680 — Net revenue $ 3,946,651 $ 3,773,392

INVENTORY (Tables)

INVENTORY (Tables)	3 Months Ended
	Mar. 31, 2019
Inventory Disclosure [Abstract]
Schedule of inventory	Inventory consists of the following: March 31, December 31, Finished product $ 3,217,706 $ 2,908,958 Work in process 808,694 339,312 Raw material 929,315 19,400 TOTAL INVENTORY $ 4,955,715 $ 3,267,670

OTHER CURRENT ASSETS (Tables)

OTHER CURRENT ASSETS (Tables)	3 Months Ended
	Mar. 31, 2019
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract]
Schedule of other current assets	Other current assets consist of the following: March 31, December 31, Prepaid sales and marketing costs $ 3,774,437 $ 5,148,789 Debt financing fees (Note 9) 1,898,074 1,898,074 Prepaid insurance 455,929 790,465 Other prepaid costs 3,718,459 2,997,365 TOTAL OTHER CURRENT ASSETS $ 9,846,899 $ 10,834,693

FIXED ASSETS, NET (Tables)

FIXED ASSETS, NET (Tables)	3 Months Ended
	Mar. 31, 2019
Property, Plant and Equipment [Abstract]
Schedule of fixed assets	Fixed assets, net consist of the following: March 31, December 31, Accounting system $ 301,096 $ 301,096 Equipment 560,772 490,576 Furniture and fixtures 271,864 116,542 Computer hardware 80,211 80,211 Leasehold improvements 74,788 37,888 1,288,731 1,026,313 Accumulated depreciation (620,124 ) (553,630 ) TOTAL FIXED ASSETS, NET $ 668,607 $ 472,683

INTANGIBLE ASSETS (Tables)

INTANGIBLE ASSETS (Tables)	3 Months Ended
	Mar. 31, 2019
Intangible Assets, Net (Excluding Goodwill) [Abstract]
Schedule of intangible assets	The following table sets forth the gross carrying amount, accumulated amortization and net carrying amount of our intangible assets as of March 31, 2019 and December 31, 2018: March 31, 2019 Gross Accumulated Net Weighted-Average Amortizable intangible assets: OPERA ® $ 31,951 $ (10,983 ) $ 20,968 10.5 Approved hormone therapy drug candidate patents 2,519,316 (322,431 ) 2,196,885 13.75 Hormone therapy drug candidate patents (pending) 1,967,124 — 1,967,124 n/a Non-amortizable intangible assets: Multiple trademarks 270,753 — 270,753 indefinite Total $ 4,789,144 $ (333,414 ) $ 4,455,730 December 31, 2018 Gross Accumulated Net Weighted-Average Amortizable intangible assets: OPERA ® $ 31,951 $ (10,484 ) $ 21,467 10.75 Development costs of corporate website 91,743 (91,743 ) — n/a Approved hormone therapy drug candidate patents 2,234,129 (282,485 ) 1,951,644 14 Hormone therapy drug candidate patents (pending) 1,855,279 — 1,855,279 n/a Non-amortizable intangible assets: Multiple trademarks 264,289 — 264,289 indefinite Total $ 4,477,391 $ (384,712 ) $ 4,092,679
Schedule of estimated amortization expense	Estimated amortization expense for the next five years for the patent costs currently being amortized is as follows: Year Ending Estimated 2019 (9 months) $ 121,333 2020 $ 161,777 2021 $ 161,777 2022 $ 161,777 2023 $ 161,777

ACCRUED EXPENSES AND OTHER CU_2

ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES (Tables)	3 Months Ended
	Mar. 31, 2019
Payables and Accruals [Abstract]
Schedule of accrued expenses and current liabilities	Other current liabilities consist of the following: March 31, December 31, Accrued payroll, bonuses and commission costs $ 5,200,009 $ 6,854,002 Allowance for coupons and returns 5,995,027 5,294,120 Accrued sales and marketing costs 1,590,746 2,288,028 Accrued compensated absences 1,390,396 1,178,110 Allowance for wholesale distributor fees 1,115,689 792,891 Operating lease liability - short term 1,158,286 — Accrued legal and accounting expense 690,346 385,824 Accrued research and development 869,188 388,675 Accrued rent — 365,155 Accrued rebates 929,022 412,570 Other accrued expenses 668,730 375,573 TOTAL OTHER CURRENT LIABILITIES $ 19,607,439 $ 18,334,948

DEBT (Tables)

DEBT (Tables)	3 Months Ended
	Mar. 31, 2019
Debt Disclosure [Abstract]
Schedule of debt	As of March 31, 2019, the carrying value of debt consisted of the following: March 31, December 31, Term Loan $ 75,000,000 $ 75,000,000 Debt discount and financing fees (1,498,840 ) (1,618,986 ) TOTAL LONG-TERM DEBT $ 73,501,160 $ 73,381,014

NET LOSS PER SHARE (Tables)

NET LOSS PER SHARE (Tables)	3 Months Ended
	Mar. 31, 2019
Loss per share, basic and diluted:
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 months ended March 31, March 31, Stock options 21,447,719 25,196,684 Warrants 1,832,571 3,290,905 Restricted stock awards 1,040,000 — 24,320,290 28,487,589

STOCKHOLDERS' EQUITY (Tables)

STOCKHOLDERS' EQUITY (Tables)	3 Months Ended
	Mar. 31, 2019
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 three months ended March 31, 2019 and 2018 are set forth in the table below. Three Months Three Months Risk-free interest rate 2.54 % 2.38-2.60 % Volatility 61.85 % 63.59-64.04 % Term (in years) 6.25 6-6.25 Dividend yield 0.00 % 0.00 %
Schedule of activity of 2009 and 2012 Plans	A summary of activity under the 2009 and 2012 Plans and related information follows: Number of Shares Underlying Stock Options Weighted Weighted Aggregate Intrinsic Value Balance at December 31, 2018 20,872,824 $ 4.93 5.94 $ 12,239,876 Granted 907,000 $ 5.63 Exercised (288,480 ) $ 0.35 $ 1,315,238 Expired/Forfeited (43,625 ) $ 5.69 Balance at March 31, 2019 21,447,719 $ 5.02 5.93 $ 19,747,182 Vested and Exercisable at March 31, 2019 16,995,263 $ 4.78 5.16 $ 19,747,182 Unvested at March 31, 2019 4,452,456 $ 5.93 8.83 $ 0

COMMITMENTS AND CONTINGENCIES (

COMMITMENTS AND CONTINGENCIES (Tables)	3 Months Ended
	Mar. 31, 2019
Commitments and Contingencies Disclosure [Abstract]
Schedule of supplemental lease information and cash flow information	Supplemental lease information at March 31, 2019: Right of use asset $ 3,540,407 Short-term operating lease liability $ 1,158,286 Long-term operating lease liability $ 2,724,501 Weighted average remaining term 5.3 years Weighted average discount rate 8.25 % Supplemental cash flow information: Cash paid for amounts included in the measurement of lease liabilities for operating lease $ 279,742 Right-of-use assets obtained in exchange for lease obligation $ 3,760,171
Reconciliation of undiscounted cash flows for all operating leases to the operating lease liabilities	The following table reconciles the undiscounted cash flows for all operating leases at March 31, 2019 to the operating lease liabilities recorded on the balance sheet: Years Ending December 31, 2019 (9 months) $ 879,998 2020 1,292,914 2021 1,135,467 2022 172,651 2023 176,968 Thereafter 1,228,504 Total undiscounted lease payments 4,886,502 Less: Imputed interest (1,003,715 ) Present value of lease payments $ 3,882,787

BASIS OF PRESENTATION AND REC_2

BASIS OF PRESENTATION AND RECENTLY ISSUED ACCOUNTING PRONOUNCEMENTS (Details Narrative) - USD ($)	Mar. 31, 2019	Jan. 02, 2019
Right of use asset	$ 3,540,407
Lease liability	$ 3,882,787
ASU 2018-11, Leases [Member]
Right of use asset		$ 3,800,000
Lease liability		$ 4,100,000

SUMMARY OF SIGNIFICANT ACCOUN_4

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details) - USD ($)	3 Months Ended
	Mar. 31, 2019	Mar. 31, 2018
Revenues, net	$ 3,946,651	$ 3,773,392
Prescription Vitamins [Member]
Revenues, net	1,935,971	$ 3,773,392
IMVEXXY [Member]
Revenues, net	$ 2,010,680

SUMMARY OF SIGNIFICANT ACCOUN_5

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details Narrative)	3 Months Ended
	Mar. 31, 2019USD ($)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 [Member]
Enrolled patients | $	$ 35

INVENTORY (Details)

INVENTORY (Details) - USD ($)	Mar. 31, 2019	Dec. 31, 2018
Inventory
Finished product	$ 3,217,706	$ 2,908,958
Work in process	808,694	339,312
Raw material	929,315	19,400
TOTAL INVENTORY	$ 4,955,715	$ 3,267,670

OTHER CURRENT ASSETS (Details)

OTHER CURRENT ASSETS (Details) - USD ($)	Mar. 31, 2019	Dec. 31, 2018
Other Current Assets
Prepaid sales and marketing costs	$ 3,774,437	$ 5,148,789
Debt financing fees (Note 9)	1,898,074	1,898,074
Prepaid insurance	455,929	790,465
Other prepaid costs	3,718,459	2,997,365
TOTAL OTHER CURRENT ASSETS	$ 9,846,899	$ 10,834,693

FIXED ASSETS, NET (Details)

FIXED ASSETS, NET (Details) - USD ($)	Mar. 31, 2019	Dec. 31, 2018
Property, Plant and Equipment [Line Items]
TOTAL FIXED ASSETS, GROSS	$ 1,288,731	$ 1,026,313
Accumulated depreciation	(620,124)	(553,630)
TOTAL FIXED ASSETS, NET	668,607	472,683
Acounting System [Member]
Property, Plant and Equipment [Line Items]
TOTAL FIXED ASSETS, GROSS	301,096	301,096
Equipment [Member]
Property, Plant and Equipment [Line Items]
TOTAL FIXED ASSETS, GROSS	560,772	490,576
Furniture And Fixtures [Member]
Property, Plant and Equipment [Line Items]
TOTAL FIXED ASSETS, GROSS	271,864	116,542
Computer hardware [Member]
Property, Plant and Equipment [Line Items]
TOTAL FIXED ASSETS, GROSS	80,211	80,211
Leasehold improvements [Member]
Property, Plant and Equipment [Line Items]
TOTAL FIXED ASSETS, GROSS	$ 74,788	$ 37,888

FIXED ASSETS, NET (Details Narr

FIXED ASSETS, NET (Details Narrative) - USD ($)	3 Months Ended
	Mar. 31, 2019	Mar. 31, 2018
Property, Plant and Equipment [Abstract]
Depreciation expense	$ 66,494	$ 38,424

INTANGIBLE ASSETS (Details)

INTANGIBLE ASSETS (Details) - USD ($)	3 Months Ended	12 Months Ended
	Mar. 31, 2019	Dec. 31, 2018
Finite-Lived Intangible Assets
Accumulated Amortization	$ (333,414)	$ (384,712)
Indefinite-Lived Intangible Assets
Gross Carrying Amount	4,789,144	4,477,391
Net Amount	4,455,730	4,092,679
Hormone Therapy Drug Candidate Patents - (Pending) [Member]
Finite-Lived Intangible Assets
Gross Carrying Amount	1,967,124	1,855,279
Net Amount	1,967,124	1,855,279
Multiple Trademarks [Member]
Indefinite-Lived Intangible Assets
Gross Carrying Amount	270,753	264,289
Net Amount	270,753	264,289
Domestic Utilty Patent - Opera Software [Member]
Finite-Lived Intangible Assets
Gross Carrying Amount	31,951	31,951
Accumulated Amortization	(10,983)	(10,484)
Net Amount	$ 20,968	$ 21,467
Weighted average remaining amortization period	10 years 6 months	10 years 9 months
Approved Hormone Therapy Drug Candidate Patents [Member]
Finite-Lived Intangible Assets
Gross Carrying Amount	$ 2,519,316	$ 2,234,129
Accumulated Amortization	(322,431)	(282,485)
Net Amount	$ 2,196,885	$ 1,951,644
Weighted average remaining amortization period	13 years 9 months	14 years
Development Costs Of Corporate Website [Member]
Finite-Lived Intangible Assets
Gross Carrying Amount		$ 91,743
Accumulated Amortization		$ (91,743)

INTANGIBLE ASSETS (Details 1)

INTANGIBLE ASSETS (Details 1)	Dec. 31, 2018USD ($)
Year Ending December 31,
2019 (9 months)	$ 121,333
2020	161,777
2021	161,777
2022	161,777
2023	$ 161,777

INTANGIBLE ASSETS (Details Narr

INTANGIBLE ASSETS (Details Narrative)	Aug. 06, 2018USD ($)$ / sharesshares	Jul. 30, 2018USD ($)	Mar. 31, 2019USD ($)Number	Mar. 31, 2018USD ($)
Finite-Lived Intangible Assets [Line Items]
Amortization expense | $			$ 40,444	$ 21,197
Subscription Agreement [Member] | Knight Therapeutics Inc. [Member]
Finite-Lived Intangible Assets [Line Items]
Issue of common stock shares (in shares) | shares	3,921,568
Common stock sale price (in dollars per share) | $ / shares	$ 5.10
Gross proceeds | $	$ 20,000,000
Approved Hormone Therapy Drug Candidate Patents [Member]
Finite-Lived Intangible Assets [Line Items]
Useful Life			20 years
Domestic U.S. Patents [Member]
Finite-Lived Intangible Assets [Line Items]
Number of issued patents			22
Foreign Patents [Member]
Finite-Lived Intangible Assets [Line Items]
Number of issued patents			27
Domestic Utility Patents [Member]
Finite-Lived Intangible Assets [Line Items]
Number of issued patents			12
Foreign Utility Patents [Member]
Finite-Lived Intangible Assets [Line Items]
Number of issued patents			5
Domestic Patents - TX-004HR [Member]
Finite-Lived Intangible Assets [Line Items]
Number of issued patents			3
Foreign Patents - TX-004HR [Member]
Finite-Lived Intangible Assets [Line Items]
Number of issued patents			13
Domestic Utility Patent - Transdermal Patch Candidates [Member]
Finite-Lived Intangible Assets [Line Items]
Number of issued patents			1
Foreign Utility Patent - Transdermal Patch Candidates [Member]
Finite-Lived Intangible Assets [Line Items]
Number of issued patents			5
Domestic Utilty Patent - Opera Software [Member]
Finite-Lived Intangible Assets [Line Items]
Number of issued patents			1
Domestic Utility Patents Topical - Cream Candidates [Member]
Finite-Lived Intangible Assets [Line Items]
Number of issued patents			1
Domestic Patents - TX-009HR [Member]
Finite-Lived Intangible Assets [Line Items]
Number of issued patents			1
Foreign Patents Progesterone - Only Candidate [Member]
Finite-Lived Intangible Assets [Line Items]
Number of issued patents			5
Domestic Patents - TX-009HR [Member]
Finite-Lived Intangible Assets [Line Items]
Number of issued patents			1
Foreign Patents Progesterone - Only Candidate [Member]
Finite-Lived Intangible Assets [Line Items]
Number of issued patents			4
Council License Agreement [Member]
Finite-Lived Intangible Assets [Line Items]
Payment of milestone recorded as finite-lived intangible asset | $		$ 20,000,000
Council License Agreement [Member] | ANNOVERA [Member]
Finite-Lived Intangible Assets [Line Items]
Milestone payments upon FDA approval | $			$ 20,000,000
Milestone payments (payment after release of first commercial batch) | $			$ 20,000,000
Annual royalty rate reduction of initial rate during the six-month period from commercial sale of a generic equivalent			50.00%
Annual royalty rate reduction of initial rate after the six-month period from commercial sale of a generic equivalent			20.00%
Maximum costs and expenses for post approval study to be paid by the Company | $			$ 20,000,000
Council License Agreement [Member] | ANNOVERA [Member] | Step-based Royalty Payment One [Member]
Finite-Lived Intangible Assets [Line Items]
Royalty (percent)			5.00%
Council License Agreement [Member] | ANNOVERA [Member] | Step-based Royalty Payment One [Member] | Maximum [Member]
Finite-Lived Intangible Assets [Line Items]
Net sales amount per step-based royalty | $			$ 50,000,000
Council License Agreement [Member] | ANNOVERA [Member] | Step-based Royalty Payment Three [Member]
Finite-Lived Intangible Assets [Line Items]
Royalty (percent)			15.00%
Council License Agreement [Member] | ANNOVERA [Member] | Step-based Royalty Payment Three [Member] | Minimum [Member]
Finite-Lived Intangible Assets [Line Items]
Net sales amount per step-based royalty | $			$ 150,000,000
Council License Agreement [Member] | ANNOVERA [Member] | Step-based Royalty Payment Two [Member]
Finite-Lived Intangible Assets [Line Items]
Royalty (percent)			10.00%
Council License Agreement [Member] | ANNOVERA [Member] | Step-based Royalty Payment Two [Member] | Minimum [Member]
Finite-Lived Intangible Assets [Line Items]
Net sales amount per step-based royalty | $			$ 50,000,000
Council License Agreement [Member] | ANNOVERA [Member] | Step-based Royalty Payment Two [Member] | Maximum [Member]
Finite-Lived Intangible Assets [Line Items]
Net sales amount per step-based royalty | $			$ 150,000,000

ACCRUED EXPENSES AND OTHER CU_3

ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES (Details) - USD ($)	Mar. 31, 2019	Dec. 31, 2018
Payables and Accruals [Abstract]
Accrued payroll, bonuses and commission costs	$ 5,200,009	$ 6,854,002
Allowance for coupons and returns	5,995,027	5,294,120
Accrued sales and marketing costs	1,590,746	2,288,028
Accrued compensated absences	1,390,396	1,178,110
Allowance for wholesale distributor fees	1,115,689	792,891
Operating lease liability - short term	1,158,286
Accrued legal and accounting expense	690,346	385,824
Accrued research and development	869,188	388,675
Accrued rent		365,155
Accrued rebates	929,022	412,570
Other accrued expenses	668,730	375,573
TOTAL OTHER CURRENT LIABILITIES	$ 19,607,439	$ 18,334,948

DEBT (Details)

DEBT (Details) - USD ($)	Mar. 31, 2019	Dec. 31, 2018
Debt Disclosure [Abstract]
Term Loan	$ 75,000,000	$ 75,000,000
Debt discount and financing fees	(1,498,840)	(1,618,986)
TOTAL LONG-TERM DEBT	$ 73,501,160	$ 73,381,014

DEBT (Details Narrative)

DEBT (Details Narrative)	Apr. 24, 2019USD ($)	May 01, 2018USD ($)	Mar. 31, 2019USD ($)
Amortization of debt issuance costs			$ 120,146
Term Loan [Member]
Borrowing capacity under loan facility		$ 200,000,000
Number of tranches under term loan facility		3
Description of Interest Rate		One-month LIBOR (subject to a LIBOR floor of 1.50%) plus (ii) 7.75% per annum.
Basis spread of loan		7.75%
LIBOR floor		1.50%
Interest expense - debt			1,969,872
Term Loan [Member] | Tranche 1 [Member]
Borrowings outstanding			75,000,000
Proceeds from term loan			75,000,000
Amortization of debt issuance costs			120,146
Debt issuance costs			3,786,918
Debt discount			$ 1,888,844
Credit Agreement [Member] | Subsequent Event [Member]
Repayment fee (percent)	4.00%
Prepayment fee (percent)	4.00%
Repayment of debt with new credit facility	$ 81,661,000
Financing Agreement [Member] | Subsequent Event [Member] | TSPP Facility [Member]
Borrowing capacity under loan facility	$ 300,000,000
Number of tranches under term loan facility	3
Description of Interest Rate	3 month Libor
Basis spread of loan	7.75%
Financing Agreement [Member] | Subsequent Event [Member] | TSPP Facility [Member] | Tranche 1 [Member]
Borrowings outstanding	$ 200,000,000

NET LOSS PER SHARE (Details)

NET LOSS PER SHARE (Details) - shares	3 Months Ended
	Mar. 31, 2019	Mar. 31, 2018
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Anti-dilutive shares excluded from earnings per share calculation	24,320,290	28,487,589
Warrants [Member]
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Anti-dilutive shares excluded from earnings per share calculation	1,832,571	3,290,905
Stock Options [Member]
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Anti-dilutive shares excluded from earnings per share calculation	21,447,719	25,196,684
Restricted Stock [Member]
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Anti-dilutive shares excluded from earnings per share calculation	1,040,000

STOCKHOLDERS' EQUITY (Details)

STOCKHOLDERS' EQUITY (Details) - Stock Options [Member]	3 Months Ended
	Mar. 31, 2019	Mar. 31, 2018
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Risk-free interest rate - minimum		2.38%
Risk-free interest rate - maximum		2.60%
Risk-free interest rate	2.54%
Volatility - minimum		63.59%
Volatility - maximum		64.04%
Volatility	61.85%
Term	6 years 3 months
Dividend yield	0.00%	0.00%
Minimum [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Term		6 years
Maximum [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Term		6 years 3 months

STOCKHOLDERS' EQUITY (Details 1

STOCKHOLDERS' EQUITY (Details 1) - USD ($)	3 Months Ended	12 Months Ended
	Mar. 31, 2019	Dec. 31, 2018
Options, Weighted Average Exercise Price
Options Outstanding ending	$ 11,579
Stock Options [Member]
Options, Outstanding
Options Outstanding beginning	20,872,824
Options Granted	907,000
Options Exercised	(288,480)
Options Expired	(43,625)
Options Outstanding ending	21,447,719	20,872,824
Vested and Exercisable ending	16,995,263
Unvested ending	4,452,456
Options, Weighted Average Exercise Price
Options Outstanding beginning	$ 4.93
Granted	5.63
Exercised	0.35
Expired	5.69
Cancelled/Forfeited	5.02
Options Outstanding ending	4.78	$ 4.93
Vested and Exercisable ending	$ 5.93
Options, Weighted Average Remaining Contractual Life
Options Outstanding	5 years 11 months 5 days	5 years 11 months 8 days
Vested and Exercisable ending	5 years 1 month 28 days
Unvested ending	8 years 9 months 28 days
Options outstanding, Aggregate Intrinsic Value
Options Outstanding beginning	$ 12,239,876
Options exercised	1,315,238
Options Outstanding ending	19,747,182	$ 12,239,876
Vested and Exercisable ending	19,747,182
Unvested ending	$ 0

STOCKHOLDERS' EQUITY (Details N

STOCKHOLDERS' EQUITY (Details Narrative) - USD ($)	3 Months Ended
	Mar. 31, 2019	Mar. 31, 2018	Dec. 31, 2018
Preferred stock, par value (in dollars per share)	$ 0.001		$ 0.001
Preferred stock, authorized	10,000,000		10,000,000
Common stock, authorized	350,000,000		350,000,000
Common stock, issued	241,221,840		240,462,439
Value of common stock issued during period for stock options exercised	$ 100,107	$ 44,056
Number of stock options exercised (in shares)	276,383
Stock Options [Member]
Value of common stock issued during period for stock options exercised	$ 44,057
Number of stock options exercised (in shares)	144,791
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
	Mar. 31, 2019	Mar. 31, 2018	Dec. 31, 2018
Warrants:
Share based compensation expense	$ 2,586,948	$ 1,751,358
Unrecognized estimated compensation expense period recognition	2 years 3 months 9 days
Outside Consultants Warrants [Member]
Warrants:
Exercise price of warrants (in dollars per share)	$ 5.63	$ 5.16
Warrants granted (in shares)	75,000	175,000
Grant date fair value (in dollars per share)	$ 3	$ 2.79
Expiration date of warrants	Feb. 12, 2024	Mar. 15, 2023
Vesting period of warrants		12 months
Expected term	5 years	5 years
Volatility rate	60.80%	62.10%
Risk free rate	2.52%	2.36%
Dividend yield	0.00%	0.00%
Warrants [Member]
Warrants:
Warrants outstanding	$ 1,832,571
Weighted-average contractual remaining life	2 years 8 months 12 days
Weighted average exercise price of warrants (in dollars per share)	2.60
Share based compensation expense	$ 85,716	$ 91,475
Unrecognized estimated compensation expense			$ 196,000
Unrecognized estimated compensation expense period recognition	9 months
Warrants [Member] | Minimum [Member]
Warrants:
Exercise price of warrants (in dollars per share)	$ 0.24
Warrants [Member] | Maximum [Member]
Warrants:
Exercise price of warrants (in dollars per share)	$ 8.20

STOCKHOLDERS' EQUITY (Details_3

STOCKHOLDERS' EQUITY (Details Narrative 2) - USD ($)	3 Months Ended
	Mar. 31, 2019	Mar. 31, 2018	Dec. 31, 2018
weighted average grant date (in dollars per shares)	$ 3.35	$ 3.11
Share-based compensation expense	$ 2,143,239	$ 1,659,883
Total unrecognized estimated compensation expense	$ 12,942,820
Recognized weighted-average period	2 years 3 months 9 days
Options outstanding	$ 11,579
Share based compensation expense	$ 2,586,948	$ 1,751,358
Stock Options [Member]
Options outstanding, ending	21,447,719		20,872,824
Options outstanding	$ 4.78		$ 4.93
Options Granted	907,000
Stock Options [Member] | Minimum [Member]
Option exercise prices (in dollars per shares)	$ 0.10
Stock Options [Member] | Maximum [Member]
Option exercise prices (in dollars per shares)	$ 8.92
Cash-Settled Stock Appreciation Rights (SARs) [Member]
Options outstanding, ending	97,000
Restricted Stock Units [Member]
Grant date fair value (in dollars per share)	$ 4.06
Share based compensation expense	$ 346,414
Expected term	2 years 8 months 12 days
Unrecognized estimated compensation expense	$ 3,800,000
Options Granted	1,040,000
2012 Stock Incentive Plan [Member]
Number of shares authorized for issuance	10,000,000
Options outstanding, ending	6,318,974
Number of shares available for issuance	2,392,833
2009 Long Term Incentive Compensation Plan [Member]
Number of shares authorized for issuance	25,000,000
Options outstanding, ending	15,128,745
Number of shares available for issuance	44,300
2009 Long Term Incentive Compensation Plan [Member] | Restricted Stock Units [Member]
Options outstanding	$ 1,040,000

RELATED PARTIES (Details Narrat

RELATED PARTIES (Details Narrative) - Catalent Inc.[Member] - USD ($)	3 Months Ended
	Mar. 31, 2019	Mar. 31, 2018	Dec. 31, 2018
Related Party Transaction [Line Items]
Manufacturing activities billed from related party	$ 1,397,000	$ 338,000
Payable - related party	$ 937,000		$ 88,000

BUSINESS CONCENTRATIONS (Detail

BUSINESS CONCENTRATIONS (Details Narrative) - USD ($)	3 Months Ended
	Mar. 31, 2019	Mar. 31, 2018
Products Supplier #1 [Member] | Four Major Customers [Member]
Concentration Risk [Line Items]
Concentration Risk	33.00%
Products Supplier #1 [Member] | One Major Customers [Member]
Concentration Risk [Line Items]
Concentration Risk	100.00%
Products Supplier #2 [Member] | Four Major Customers [Member]
Concentration Risk [Line Items]
Concentration Risk	29.00%
Products Supplier #3 [Member] | Four Major Customers [Member]
Concentration Risk [Line Items]
Concentration Risk	27.00%
Products Supplier #4 [Member] | Four Major Customers [Member]
Concentration Risk [Line Items]
Concentration Risk	11.00%
Customer Concentration [Member] | Sales Revenue [Member] | Minimum [Member]
Concentration Risk [Line Items]
Concentration Risk	10.00%	10.00%
Customer Concentration [Member] | Five Major Customers [Member] | Sales Revenue [Member]
Concentration Risk [Line Items]
Concentration Risk	83.00%	80.00%
Customer Concentration - PI Services [Member] | Sales Revenue [Member]
Concentration Risk [Line Items]
Revenues	$ 967,000	$ 557,000
Customer Concentration - Pillpack [Member] | Sales Revenue [Member]
Concentration Risk [Line Items]
Revenues	534,000	905,000
Customer Concentration - AmerisourceBergen [Member] | Sales Revenue [Member]
Concentration Risk [Line Items]
Revenues	787,000	668,000
Customer Concentration - Cardinal Health [Member] | Sales Revenue [Member]
Concentration Risk [Line Items]
Revenues	525,000	493,000
Customer Concentration - McKesson Corp [Member] | Sales Revenue [Member]
Concentration Risk [Line Items]
Revenues	$ 457,000	$ 385,000

COMMITMENTS AND CONTINGENCIES_2

COMMITMENTS AND CONTINGENCIES (Details)	3 Months Ended
	Mar. 31, 2019USD ($)
Commitments and Contingencies Disclosure [Abstract]
Right of use asset	$ 3,540,407
Short-term operating lease liability	1,158,286
Long-term operating lease liability	$ 2,724,501
Weighted average remaining term	5 years 6 months 18 days
Weighted average discount rate	8.25%
Cash paid for amounts included in the measurement of lease liabilities for operating lease	$ 279,742
Right-of-use assets obtained in exchange for lease obligation	$ 3,760,171

COMMITMENTS AND CONTINGENCIES_3

COMMITMENTS AND CONTINGENCIES (Details 1)	Mar. 31, 2019USD ($)
Years ending December 31,
2019	$ 879,998
2020	1,292,914
2021	1,135,467
2022	172,651
2023	176,968
Thereafter	1,228,504
Total undiscounted lease payments	4,886,502
Less: Imputed interest	(1,003,715)
Present value of lease payments	$ 3,882,787

COMMITMENTS AND CONTINGENCIES_4

COMMITMENTS AND CONTINGENCIES (Details Narrative) - USD ($)	May 01, 2016	Mar. 31, 2019	Mar. 31, 2018
Non-cancelable operating lease term		63 months
Rental expense			$ 257,301
Operating lease expense		$ 295,109
Variable lease expense		$ 11,786
Expiration date	Oct. 31, 2021
Lease term		11 years
Lease renewal term		5 years
Reimbursement from landlord - tenant improvements		$ 1,800,000
New Operating Leases [Member] | New Corporate Office [Member]
Estimated fixed future minimum rental commitment		11,600,000
Estimated variable future minimum rental commitment		$ 5,700,000

SUBSEQUENT EVENTS (Details Narr

SUBSEQUENT EVENTS (Details Narrative) - Subsequent Event [Member] - Financing Agreement [Member] - TSPP Facility [Member]	Apr. 24, 2019USD ($)Number
Subsequent Event [Line Items]
Borrowing capacity under loan facility	$ 300,000,000
Maturity date of facility	Mar. 31, 2024
Description of rate	3 month Libor
Basis spread of loan	7.75%
LIBOR floor rate	2.70%
Number of tranches under term credit facility	3
Number of quarterly principal installment payments | Number	4
Minimum cash balance requirement under credit agreement	$ 50,000,000
Prepayment fee for first two years funding (percent)	30.00%
Prepayment fee third year funding (percent)	5.00%
Prepayment fee fourth year funding (percent)	3.00%
Prepayment fee fifth year funding (percent)	1.00%
Facility fee paid (percent)	2.50%
Prime Rate [Member]
Subsequent Event [Line Items]
Description of rate	Prime Rate
Basis spread of loan	6.75%
LIBOR floor rate	5.20%
Tranche 3 [Member]
Subsequent Event [Line Items]
Borrowing capacity under loan facility	$ 50,000,000
Revenue requirement to draw on term loan tranche	11,000,000
Tranche 1 [Member]
Subsequent Event [Line Items]
Borrowings outstanding	200,000,000
Tranche 2 [Member]
Subsequent Event [Line Items]
Borrowing capacity under loan facility	50,000,000
Minimum cash balance requirement under credit agreement	$ 60,000,000