TherapeuticsMD (TXMD) 10-Q 5 Nov 15 2015 Q3 Quarterly report Financial data

Document and Entity Information

Document and Entity Information - shares	9 Months Ended
	Sep. 30, 2015	Nov. 02, 2015
Document And Entity Information
Entity Registrant Name	TherapeuticsMD, Inc.
Entity Central Index Key	25,743
Document Type	10-Q
Document Period End Date	Sep. 30, 2015
Amendment Flag	false
Current Fiscal Year End Date	--12-31
Entity a Well-known Seasoned Issuer	No
Entity a Voluntary Filer	No
Entity's Reporting Status Current	Yes
Entity Filer Category	Accelerated Filer
Entity Common Stock, Shares Outstanding		177,848,041
Document Fiscal Period Focus	Q3
Document Fiscal Year Focus	2,015

CONSOLIDATED BALANCE SHEETS (Un

CONSOLIDATED BALANCE SHEETS (Unaudited) - USD ($)	Sep. 30, 2015	Dec. 31, 2014
Current Assets:
Cash	$ 81,123,988	$ 51,361,607
Accounts receivable, net of allowance for doubtful accounts of $96,916 and $59,753, respectively	3,666,586	2,154,217
Inventory	870,059	1,182,113
Other current assets	2,120,805	1,537,407
Total current assets	87,781,438	56,235,344
Fixed assets, net	56,748	63,293
Other Assets:
Prepaid expense	1,172,051	1,427,263
Intangible assets, net	1,324,284	1,228,588
Security deposit	125,000	125,000
Total other assets	2,621,335	2,780,851
Total assets	90,459,521	59,079,488
Current Liabilities:
Accounts payable	5,301,625	6,327,129
Other current liabilities	$ 6,386,777	3,840,639
Deferred revenue		522,613
Total current liabilities	$ 11,688,402	$ 10,690,381
Long-Term Liabilities:
Accrued Expense	1,213,874
Total liabilities	$ 12,902,276	$ 10,690,381
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 and 250,000,000 shares authorized; 177,787,927 and 156,097,019 issued and outstanding, respectively	$ 177,788	$ 156,097
Additional paid in capital	279,723,640	182,982,846
Accumulated deficit	(202,344,183)	(134,749,836)
Total stockholders' equity	77,557,245	48,389,107
Total liabilities and stockholders' equity	$ 90,459,521	$ 59,079,488

CONSOLIDATED BALANCE SHEETS (U3

CONSOLIDATED BALANCE SHEETS (Unaudited) (Parenthetical) - USD ($)	Sep. 30, 2015	Dec. 31, 2014
Statement of Financial Position [Abstract]
Allowance for doubtful accounts	$ 96,916	$ 59,753
Preferred stock, par value (in dollars per share)	$ 0.001	$ 0.001
Preferred stock, shares authorized	10,000,000	10,000,000
Preferred stock, shares issued	0	0
Preferred stock, shares outstanding	0	0
Common stock, par value (in dollars per share)	$ 0.001	$ 0.001
Common stock, shares authorized	350,000,000	250,000,000
Common stock, shares issued	177,787,927	156,097,019
Common stock, shares outstanding	177,787,927	156,097,019

CONSOLIDATED STATEMENTS OF OPER

CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited) - USD ($)	3 Months Ended		9 Months Ended
	Sep. 30, 2015	Sep. 30, 2014	Sep. 30, 2015	Sep. 30, 2014
Income Statement [Abstract]
Revenues, net	$ 5,190,175	$ 4,186,261	$ 14,513,158	$ 10,768,572
Cost of goods sold	1,193,965	1,068,605	3,270,695	2,792,268
Gross profit	3,996,210	3,117,656	11,242,463	7,976,304
Operating expenses:
Sales, general, and administrative	7,060,944	6,043,354	20,089,998	16,610,015
Research and development	16,421,753	14,909,430	58,789,302	29,052,149
Depreciation and amortization	16,548	12,747	44,400	39,909
Total operating expense	23,499,245	20,965,531	78,923,700	45,702,073
Operating loss	(19,503,035)	(17,847,875)	(67,681,237)	(37,725,769)
Other income (expense):
Miscellaneous income	27,630	6,260	71,728	43,411
Interest income	2,760	9,364	15,162	27,756
Financing costs				(260,027)
Total other income (expense)	30,390	15,624	86,890	(188,860)
Loss before income taxes	(19,472,645)	(17,832,251)	(67,594,347)	(37,914,629)
Net loss	$ (19,472,645)	$ (17,832,251)	$ (67,594,347)	$ (37,914,629)
Loss per share, basic and diluted:
Net loss per share, basic and diluted	$ (0.11)	$ (0.12)	$ (0.39)	$ (0.26)
Weighted average number of common shares outstanding, basic and diluted	177,206,168	152,200,455	171,589,595	147,594,810

CONSOLIDATED STATEMENTS OF CASH

CONSOLIDATED STATEMENTS OF CASH FLOWS (Unaudited) - USD ($)	9 Months Ended
	Sep. 30, 2015	Sep. 30, 2014
CASH FLOWS FROM OPERATING ACTIVITIES
Net loss	$ (67,594,347)	$ (37,914,629)
Adjustments to reconcile net loss to net cash flows used in operating activities:
Depreciation	22,104	22,713
Amortization of intangible assets	22,296	17,196
Provision for doubtful accounts	37,163	2,594
Stock based compensation	4,740,906	3,934,836
Amortization of deferred financing costs		260,027
Changes in operating assets and liabilities:
Accounts receivable	(1,549,532)	(460,565)
Inventory	312,054	31,673
Other current assets	(621,923)	197,569
Other assets	(15,162)	(17,069)
Accounts payable	(1,025,504)	3,534,462
Deferred revenue	(522,613)	(754,431)
Other current liabilities	2,546,138	909,890
Long term accrued expenses	1,213,874
Net cash flows used in operating activities	(62,434,546)	(30,235,734)
CASH FLOWS FROM INVESTING ACTIVITIES
Patent costs	(117,992)	(193,349)
Purchase of property and equipment	(15,559)	(30,962)
Net cash flows used in investing activities	(133,551)	(224,311)
CASH FLOWS FROM FINANCING ACTIVITIES
Proceeds from sale of common stock, net of costs	91,374,649	42,771,353
Proceeds from exercise of options	589,829	315,546
Proceeds from exercise of warrants	366,000	181,000
Net cash flows provided by financing activities	92,330,478	43,267,899
Increase in cash	29,762,381	12,807,854
Cash, beginning of period	51,361,607	54,191,260
Cash, end of period	$ 81,123,988	$ 66,999,114

THE COMPANY

THE COMPANY	9 Months Ended
	Sep. 30, 2015
Organization, Consolidation and Presentation of Financial Statements [Abstract]
THE COMPANY	NOTE 1 – THE COMPANY TherapeuticsMD, Inc., a Nevada corporation, or TherapeuticsMD or the Company, has three wholly owned subsidiaries, vitaMedMD, LLC, a Delaware limited liability company, or VitaMed, BocaGreenMD, Inc., a Nevada corporation, or BocaGreen, and VitaCare Prescription Services, Inc., a Florida corporation, or VitaCare. Unless the context otherwise requires, TherapeuticsMD, VitaMed, BocaGreen, and VitaCare collectively are sometimes referred to as "our company," "we," "our," or "us." Nature of Business We are a women’s health care product company focused on creating and commercializing products targeted exclusively for women. As of the date of these unaudited consolidated financial statements, we are focused on conducting the clinical trials necessary for regulatory approval and commercialization of our advanced hormone therapy pharmaceutical products. The drug candidates used in our clinical trials are designed to alleviate the symptoms of and reduce the health risks resulting from menopause-related hormone deficiencies, including hot flashes, osteoporosis, and vaginal discomfort. We are developing these hormone therapy drug candidates, which contain estradiol and progesterone alone or in combination, with the aim of demonstrating equivalent clinical efficacy at lower doses, thereby enabling an enhanced side effect profile compared with competing products. Our drug candidates are created from a platform of hormone technology that enables the administration of hormones with high bioavailability alone or in combination. In addition, we manufacture and distribute branded and generic prescription prenatal vitamins, as well as over-the-counter, or OTC, vitamins.

BASIS OF PRESENTATION AND RECEN

BASIS OF PRESENTATION AND RECENTLY ISSUED ACCOUNTING PRONOUNCEMENTS	9 Months Ended
	Sep. 30, 2015
Organization, Consolidation and Presentation of Financial Statements [Abstract]
BASIS OF PRESENTATION AND RECENTLY ISSUED ACCOUNTING PRONOUNCEMENTS	NOTE 2 – BASIS OF PRESENTATION AND RECENTLY ISSUED ACCOUNTING PRONOUNCEMENTS Interim Financial Statements The accompanying unaudited interim consolidated financial statements of TherapeuticsMD, Inc., which include our wholly owned subsidiaries, should be read in conjunction with the audited consolidated financial statements and notes thereto included in our Annual Report on Form 10-K for the year ended December 31, 2014, as filed with the Securities and Exchange Commission, or the SEC, from which we derived the accompanying consolidated balance sheet as of December 31, 2014. 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. Recently Issued Accounting Pronouncements In July 2015, the Financial Accounting Standards Board, or FASB, issued final guidance that requires entities to measure inventory at the lower of cost or net realizable value rather than at the lower of cost or market (LOCOM). The guidance applies only to inventories for which cost is determined by methods other than last-in first-out (LIFO) or the retail inventory method (RIM). Entities that use LIFO or RIM will continue to use existing impairment models. The new guidance does not change the calculation of net realizable value that entities are required to calculate when applying existing LOCOM guidance. Net realizable value is the estimated selling price in the ordinary course of business, less reasonably predictable costs of completion, disposal and transportation. Under the new guidance, however, entities will no longer need to calculate other measures of “market.” The guidance is effective for public business entities for fiscal years beginning after December 15, 2016, and interim periods within those fiscal years. Early adoption is permitted. We are currently evaluating the impact of this guidance on our consolidated financial statements and disclosures. In June 2015, the FASB issued Accounting Standards Update, or ASU, No. 2015-10, Technical Corrections and Improvements, to correct differences between original guidance and the Accounting Standards Codification, or ASC, clarify the guidance, correct references and make minor improvements affecting a variety of topics. Amendments that the FASB deemed more substantive are effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2015. The other amendments are effective immediately. We do not expect the adoption of ASU 2015-10 to have a material effect on our consolidated financial statements and disclosures. In August 2014, the FASB issued ASU No. 2014-15, Presentation of Financial Statements-Going Concern (Subtopic 205-40): Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern. ASU 2014-15 requires management to evaluate whether there are conditions and events that raise substantial doubt about the entity’s ability to continue as a going concern within one year after the financial statements are issued (or available to be issued when applicable) and, if so, disclose that fact. ASU 2014-15 is effective for annual periods ending after December 15, 2016 and interim periods within annual periods beginning after December 15, 2016. Early adoption is permitted for annual or interim reporting periods for which the financial statements have not previously been issued. We do not expect the adoption of ASU 2014-15 to have a material effect on our consolidated financial statements and disclosures. In May 2014, the FASB and the International Accounting Standards Board (IASB) issued ASU No. 2014-09, Revenue from Contracts with Customers (Topic 606). The standard’s core principle is that a company will recognize revenue when it transfers promised goods or services to customers in an amount that reflects the consideration to which the company expects to be entitled in exchange for those goods or services. In doing so, companies will need to use more judgment and make more estimates than under previous guidance. These may include identifying performance obligations in the contract, estimating the amount of variable consideration to include in the transaction price and allocating the transaction price to each separate performance obligations. In July 2015, the FASB approved the proposal to defer the effective date of ASU 2014-09 standard by one year. Early adoption is permitted after December 15, 2016, and the standard is effective for public entities for annual reporting periods beginning after December 15, 2017 and interim periods therein. We are currently evaluating the impact of ASU 2014-09 on our consolidated financial statements and disclosures. We do not believe there would have been a material effect on the accompanying consolidated financial statements had any other recently issued, but not yet effective, accounting standards been adopted in the current period.

SUMMARY OF SIGNIFICANT ACCOUNTI

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES	9 Months Ended
	Sep. 30, 2015
Accounting Policies [Abstract]
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES	NOTE 3 – SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES Impairment of Long-Lived Assets We review the carrying values of property and equipment and long-lived intangible assets for impairment whenever events or changes in circumstances indicate that their carrying values may not be recoverable. There was no impairment of any long-lived assets during the three and nine months ended September 30, 2015 and 2014. Fair Value of Financial Instruments Our financial instruments consist primarily of accounts receivable, accounts payable and accrued expenses. The carrying amount of accounts receivable, accounts payable and accrued expenses approximates their fair value because of the short-term maturity of such instruments. We categorize our assets and liabilities that are valued at fair value on a recurring basis into a three-level fair value hierarchy as defined by ASC 820, Fair Value Measurements. Level 1 unadjusted quoted prices in active markets for identical assets or liabilities; Level 2 quoted prices for similar assets or liabilities in active markets or inputs that are observable for the asset or liability, either directly or indirectly through market corroboration, for substantially the full term of the financial instrument; and Level 3 unobservable inputs for the asset or liability. At September 30, 2015 and December 31, 2014, 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 any required impairment test. Revenue Recognition We recognize revenue on arrangements in accordance with ASC 605, Revenue Recognition. We recognize revenue only when the price is fixed or determinable, persuasive evidence of an arrangement exists, the service is performed, and collectability is reasonably assured. Our OTC and prescription prenatal vitamin products are generally variations of the same product with slight modifications in formulation and marketing. The primary difference between our OTC and prescription prenatal vitamin products is the source of payment. Purchasers of our OTC prenatal vitamin products pay for the product directly while purchasers of our prescription prenatal vitamin products pay for the product via third-party payers. Both OTC and prescription prenatal vitamin products share the same marketing support team utilizing similar marketing techniques. Over-the-Counter Products We generate OTC revenue from product sales primarily to retail consumers. We recognize revenue from product sales upon shipment, when the rights of ownership and risk of loss have passed to the consumer. We include outbound shipping and handling fees in revenues, net, and bill them upon shipment. We include shipping expenses in cost of goods sold. A majority of our customers pay for our products with credit cards, and we usually receive the cash settlement in two to three banking days. Credit card sales minimize accounts receivable balances relative to sales. We provide an unconditional 30-day money-back return policy under which we accept product returns from our retail and eCommerce customers. We recognize our revenue from OTC sales, net of estimated returns, sales discounts, and eCommerce fees. Prescription Products We sell our name brand and generic prescription products primarily through drug wholesalers and retail pharmacies. We recognize revenue from prescription product sales, net of sales discounts, chargebacks, and customer rebates. We accept returns of unsalable product from customers 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. As of January 1, 2015, we started estimating returns based on historical return rates and recorded actual product returns against this reserve as received. Prior to January 1, 2015, we deferred the recognition of revenue on certain arrangements until the right of return no longer existed. We maintain various rebate programs in an effort to maintain a competitive position in the marketplace and to promote sales and customer loyalty. The consumer rebate program is designed to enable the end user to submit a coupon to us. If the coupon qualifies, we send a rebate check to the end user. We estimate the allowance for consumer rebates based on our experience and industry averages, which is reviewed, and adjusted if necessary, on a quarterly basis. Research and Development Expenses Research and development, or R&D, expenses include internal R&D activities, services of external contract research organizations, or CROs, costs of their clinical research sites, manufacturing, scale-up and validation costs, and other activities. Internal R&D activity expenses include laboratory supplies, salaries, benefits, and non-cash share-based compensation expenses. Advance payments to be expensed in future research and development activities were $948,499 at September 30, 2015, of which $755,152 was included in Other current assets and $193,347 was included in long term Prepaid expense on the accompanying consolidated balance sheets. Advance payments to be expensed in future research and development activities were $1,175,082 at December 31, 2014, of which $711,362 was included in Other current assets and $463,720 was included in long term Prepaid expense on the accompanying consolidated balance sheets. CRO activity expenses include preclinical laboratory experiments and clinical trial studies. Other activity expenses include regulatory consulting and legal fees and costs. The activities undertaken by our regulatory consultants that were classified as research and development 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 research and development expenses related to designing experiments to generate data for patents and to further the formulation development process for our pipeline technologies. Outside legal counsel also provided professional research and advice regarding research and development, 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. As of September 30, 2015, we classified $1,213,874 of the accrued clinical study costs as long term Accrued Expenses related to the costs that will be paid at the completion of one of our clinical trials. 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	9 Months Ended
	Sep. 30, 2015
Inventory Disclosure [Abstract]
INVENTORY	NOTE 4 – INVENTORY Inventory consists of the following: September 30, 2015 December 31, 2014 Finished product $ 787,232 $ 874,294 Raw material 82,827 155,341 Deferred costs — 152,478 TOTAL INVENTORY $ 870,059 $ 1,182,113

OTHER CURRENT ASSETS

OTHER CURRENT ASSETS	9 Months Ended
	Sep. 30, 2015
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract]
OTHER CURRENT ASSETS	NOTE 5 – OTHER CURRENT ASSETS Other current assets consist of the following: September 30, 2015 December 31, 2014 Prepaid insurance $ 870,949 $ 394,878 Prepaid research and development costs 381,813 299,498 Prepaid consulting 373,339 411,864 Other receivables-related party (Note 13) 249,981 249,981 Other prepaid costs 219,086 181,186 Prepaid vendor deposits 25,637 — TOTAL OTHER CURRENT ASSETS $ 2,120,805 $ 1,537,407

FIXED ASSETS, NET

FIXED ASSETS, NET	9 Months Ended
	Sep. 30, 2015
Property, Plant and Equipment [Abstract]
FIXED ASSETS	NOTE 6 – FIXED ASSETS, NET Fixed assets, net consist of the following: September 30, 2015 December 31, 2014 Equipment $ 132,150 $ 132,150 Furniture and fixtures 69,454 53,895 201,604 186,045 Accumulated depreciation (144,856 ) (122,752 ) TOTAL FIXED ASSETS, NET $ 56,748 $ 63,293 Depreciation expense for the three months ended September 30, 2015 and 2014 was $7,856 and $7,122, respectively, and $22,104 and $22,713 for the nine months ended September 30, 2015 and 2014, respectively.

PREPAID EXPENSE

PREPAID EXPENSE	9 Months Ended
	Sep. 30, 2015
Prepaid Expense and Other Assets [Abstract]
PREPAID EXPENSE	NOTE 7 – PREPAID EXPENSE Prepaid expense (long-term) consists of the following: September 30, 2015 December 31, 2014 Prepaid manufacturing costs $ 978,704 $ 963,543 Prepaid research and development costs 193,347 463,720 TOTAL PREPAID EXPENSE $ 1,172,051 $ 1,427,263

INTANGIBLE ASSETS

INTANGIBLE ASSETS	9 Months Ended
	Sep. 30, 2015
Goodwill and Intangible Assets Disclosure [Abstract]
INTANGIBLE ASSETS	NOTE 8 – INTANGIBLE ASSETS, NET The following table sets forth the gross carrying amount, accumulated amortization and net carrying amount of our intangible assets as of September 30, 2015 and December 31, 2014: September 30, 2015 Gross Carrying Amount Accumulated Amortization Net Amount Weighted- Average Amortization Period (yrs.) Amortizing intangible assets: OPERA ® $ 31,951 $ (3,994 ) $ 27,957 14 Development costs of corporate website 91,743 (91,743 ) — n/a Approved hormone therapy drug candidate patents 605,502 (40,199 ) 565,303 17.25 Non-amortizing intangible assets: Hormone therapy drug candidate patents (pending) 585,241 — 585,241 n/a Multiple trademarks for vitamins/supplements 145,783 — 145,783 indefinite Total $ 1,460,220 $ (135,936 ) $ 1,324,284 December 31, 2014 Gross Carrying Amount Accumulated Amortization Net Amount Weighted- Average Amortization Period (yrs.) Amortizing intangible assets: OPERA ® $ 31,951 $ (2,496 ) $ 29,455 14.75 Development costs of corporate website 91,743 (91,743 ) — n/a Approved hormone therapy drug candidate patents 439,184 (19,401 ) 419,783 18 Non-amortizing intangible assets: Hormone therapy drug candidate patents (pending) 675,982 — 675,982 n/a Multiple trademarks for vitamins/supplements 103,368 — 103,368 indefinite Total $ 1,342,228 $ (113,640 ) $ 1,228,588 We capitalize external costs, consisting primarily of legal costs, related to securing our patents and trademarks. Once a patent is granted, we amortize the capitalized patent costs over the remaining life of the patent using the straight-line method. If the patent is not granted, we write-off any capitalized patent costs at that time. Trademarks are perpetual and are not amortized. As of September 30, 2015, the remaining life related to OPERA® patent was approximately 14 years and the remaining life related to the approved hormone therapy drug candidate patents was approximately 17 years. During the three and nine months ended September 30, 2015 and 2014, there was no impairment recognized. In addition to numerous pending patent applications, as of September 30, 2015, we had 13 issued patents, including: · one method patent that relates to our OPERA® information technology platform, which is owned by us and is a U.S. jurisdiction patent with an expiration date in 2029; · twelve utility patents that relate to our combination progesterone and estradiol formulations, which are owned by us and are U.S. jurisdiction patents with expiration dates in 2032. We have pending patent applications with respect to certain of these patents in Argentina, Australia, Canada, the European Union, Israel, Mexico, Brazil, Japan, Russia, South Africa and South Korea. Amortization expense was $8,692 and $5,625 for the three months ended September 30, 2015 and 2014, respectively and $22,296 and $17,196 for the nine months ended September 30, 2015 and 2014, respectively. Estimated amortization expense for the next five years is as follows: Year Ending December 31, Estimated Amortization 2015 (3 months) $ 8,692 2016 $ 34,768 2017 $ 34,768 2018 $ 34,768 2019 $ 34,768

OTHER CURRENT LIABILITIES

OTHER CURRENT LIABILITIES	9 Months Ended
	Sep. 30, 2015
Other Liabilities Disclosure [Abstract]
OTHER CURRENT LIABILITIES	NOTE 9 – OTHER CURRENT LIABILITIES Other current liabilities consist of the following: September 30, 2015 December 31, 2014 Accrued clinical trial costs $ 3,528,061 $ 1,706,542 Accrued payroll, bonuses and commission costs 930,913 814,205 Accrued legal and accounting expense 615,946 276,470 Accrued compensated absences 490,170 442,430 Other accrued expenses 388,268 185,965 Allowance for coupons and returns 208,361 90,446 Allowance for wholesale distributor fees 96,440 160,503 Accrued rent 86,998 91,368 Accrued royalties 41,620 72,710 TOTAL OTHER CURRENT LIABILITIES $ 6,386,777 $ 3,840,639

NET LOSS PER SHARE

NET LOSS PER SHARE	9 Months Ended
	Sep. 30, 2015
Net Loss Per Share
NET LOSS PER SHARE	NOTE 10 – NET LOSS PER SHARE We calculate basic and diluted net loss per share allocable to common stockholders using the weighted-average number of shares of common stock, par value $0.001 per share, or Common Stock outstanding during the period, less any shares subject to repurchase or forfeiture. There were no shares of our Common Stock outstanding subject to repurchase or forfeiture for the three and nine months ended September 30, 2015 and 2014. Since we are in a net loss position, we have excluded outstanding stock options, all of which are subject to forfeiture, as well as warrants for the purchase of our Common Stock from our calculation of diluted net loss per share. The table below presents the potentially dilutive securities that would have been included in our calculation of diluted net loss per share allocable to common stockholders if they were not antidilutive for the periods presented. As of September 30, 2015 2014 Stock options 17,414,242 16,851,943 Warrants 12,722,431 13,927,916 30,136,673 30,779,859

STOCKHOLDERS' EQUITY

STOCKHOLDERS' EQUITY	9 Months Ended
	Sep. 30, 2015
Stockholders' Equity:
STOCKHOLDERS' EQUITY	NOTE 11 – STOCKHOLDERS’ EQUITY Preferred Stock At September 30, 2015, we had 10,000,000 shares of Preferred Stock, par value $0.001, authorized for issuance, of which no shares of Preferred Stock were issued or outstanding. Common Stock At September 30, 2015, we had 350,000,000 shares of Common Stock authorized, of which 177,787,927 shares of Common Stock were issued and outstanding. On July 9, 2015, we entered into an underwriting agreement with Stifel, Nicolaus & Company, Incorporated and Guggenheim Securities, LLC, as the representatives of the several underwriters, or the Stifel Underwriters, relating to an underwritten public offering of 3,846,154 shares of Common Stock at a public offering price of $7.80 per share. Under the terms of the underwriting agreement, we granted the Stifel Underwriters a 30-day option to purchase up to an aggregate of 576,923 additional shares of Common Stock, which option was exercised in full. The net proceeds to us from the offering were approximately $32.2 million, after deducting underwriting discounts and commissions and other estimated offering expenses payable by us. The offering closed on July 15, 2015 and we issued 4,423,077 shares of our Common Stock. On February 10, 2015, we entered into an underwriting agreement, or the Cowen Agreement, with Cowen and Company, LLC, as the representative of the several underwriters, or the Cowen Underwriters, relating to an underwritten public offering of 13,580,246 shares of Common Stock, at a public offering price of $4.05 per share. Under the terms of the Cowen Agreement, we granted the Cowen Underwriters a 30-day option to purchase up to an aggregate of 2,037,036 additional shares of Common Stock, which option was exercised in full. The net proceeds from the offering were approximately $59.1 million, after deducting underwriting discounts and commissions and other estimated offering expenses payable by us. The offering closed on February 17, 2015 and we issued 15,617,282 shares of our Common Stock. On July 29, 2014, we entered into an underwriting agreement with Goldman Sachs & Co, or Goldman Sachs, as the representative of the underwriters named therein, or the Goldman Sachs Underwriters, relating to an underwritten public offering of 8,565,310 shares of Common Stock. The price to the public in the offering was $4.67 per share. Under the terms of the underwriting agreement, we granted the Goldman Sachs Underwriters a 30-day option to purchase up to an additional 1,284,796 shares of Common Stock. On July 30, 2014, the Goldman Sachs Underwriters exercised their option to purchase the additional 1,284,796 shares of Common Stock. Net proceeds from this offering were approximately $42.8 million, after deducting underwriting discounts and commissions and other offering expenses. The offering closed on August 4, 2014 and we issued 9,850,106 shares of our Common Stock. Exercises During 2015 During the three months ended September 30, 2015, certain individuals exercised stock options to purchase 95,000 shares of Common Stock for $98,478 in cash. During the nine months ended September 30, 2015, certain individuals exercised stock options to purchase 472,867 shares of Common Stock for $589,829 in cash. Exercises During 2014 During the nine months ended September 30, 2014, certain individuals exercised stock options to purchase 793,800 shares of Common Stock. Stock options to purchase shares of Common Stock were exercised as follows: (i) 674,193 options for $315,546 in cash and (ii) 119,607 options, pursuant to the stock options’ cashless provision, wherein 113,837 shares of Common Stock were issued. Also during the nine months ended September 30, 2014, we issued 50,000 shares of Common Stock to an employee upon the vesting of restricted stock units that were granted in December 2013. Warrants to Purchase Common Stock As of September 30, 2015, we had warrants outstanding to purchase an aggregate of 12,772,431 shares of Common Stock with a weighted-average contractual remaining life of 1.92 years, and exercise prices ranging from $0.24 to $6.35 per share, resulting in a weighted average exercise price of $1.93 per share. The valuation methodology used to determine the fair value of our warrants is the Black-Scholes-Merton valuation model, or 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 term of the warrant. In January 2013, we granted warrants to purchase 1,250,000 shares of Common Stock in connection with the issuance of a Revolving Credit Note to Plato and Associates, LLC, or the Plato Warrant. The Plato Warrant has an exercise price of $3.20 per share. The Plato Warrant vested on October 31, 2013 and may be exercised prior to its expiration on January 31, 2019. The Plato Warrant, with a fair value of $1,711,956, was valued on the date of the grant using a term of six years; a volatility of 44.29%; risk free rate of 0.88%; and a dividend yield of 0%. For the nine months ended September 30, 2015 and 2014, $0 and $260,027, respectively, was recorded as financing costs in connection with the issuance of the Plato Warrant on the accompanying consolidated financial statements. In May 2013, we entered into a consulting agreement with Sancilio & Company, Inc., or SCI, to develop drug technology to be used in our hormone replacement drug candidates. These services include support of our efforts to successfully obtain U.S. Food and Drug Administration, or the FDA, approval for our drug candidates, including a vaginal capsule for the treatment of vulvar and vaginal atrophy, or VVA. In connection with the agreement, SCI agreed to forfeit its rights to receive warrants to purchase 833,000 shares of Common Stock that were to be granted pursuant to the terms of a prior consulting agreement dated May 17, 2012. As consideration under the agreement, we agreed to grant to SCI a warrant to purchase 850,000 shares of Common Stock at $2.01 per share that has vested or will vest, as applicable, as follows: 1. 283,333 shares were earned on May 11, 2013 upon acceptance of an Investigational New Drug application by the FDA for an estradiol-based drug candidate in a softgel vaginal capsule for the treatment of VVA; however, pursuant to the terms of the consulting agreement, the shares did not vest until June 30, 2013. The fair value of $405,066 for the shares vested on June 30, 2013 was determined by using the Black-Scholes Model on the date of vesting using a term of five years; a volatility of 45.89%; risk free rate of 1.12%; and a dividend yield of 0%. We recorded the entire $405,066 as non-cash compensation as of June 30, 2013; 2. 283,333 shares vested on June 30, 2013. The fair value of $462,196 for these shares was determined by using the Black-Scholes Model on the date of the vesting using a term of five years; a volatility of 45.84%; risk free rate of 1.41%; and a dividend yield of 0%. As of September 30, 2015, we recorded $115,543 in other current assets in the accompanying consolidated financial statements with respect to such shares. During the three and nine month periods ended September 30, 2015 and 2014, we recorded $38,517 and $115,551, respectively, as non-cash compensation in the accompanying consolidated financial statements with respect to such shares; and 3. 283,334 shares will vest upon the receipt by us of any final FDA approval of a drug candidate that SCI helped us design. It is anticipated that this event will not occur before December 2016. As of September 30, 2015, unamortized costs associated with the SCI warrants issued in 2013 and 2012 totaled approximately $567,000 and will be recognized over a period of 1.75 years. During the nine months ended September 30, 2015, we granted warrants to purchase 50,000 shares of Common Stock to an outside consultant at an exercise price of $6.35 and the expiration date of April 6, 2020. The total non-cash compensation expense related to this warrant was $42,266 and $86,008, respectively, for the three and nine months ended September 30, 2015. Warrant exercises During the three months ended September 30, 2015, certain individuals and an entity exercised warrants to purchase 310,000 shares of Common Stock pursuant to the warrants’ cashless exercise provisions, wherein 232,197 shares of Common Stock were issued. shares of Common Stock were exercised pursuant to the warrants’ cashless exercise provisions, wherein 232,197 shares of Common Stock were issued. During the nine months ended September 30, 2014, certain individuals exercised warrants to purchase 365,583 shares of Common Stock for $181,000 in cash. 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 authorized for issuance thereunder. During the nine months ended September 30, 2015, we granted 1,231,000 non-qualified stock options under the 2009 Plan. As of September 30, 2015, there were non-qualified stock options to purchase 15,445,768 shares of Common Stock outstanding under the 2009 Plan. In 2012, we adopted the 2012 Stock Incentive Plan, or the 2012 Plan, a non-qualified plan that was amended in August 2013. The 2012 Plan was designed to serve as an incentive for retaining qualified and competent key employees, officers, directors, and certain consultants and advisors of our company. There are 10,000,000 shares of Common Stock authorized for issuance thereunder. As of September 30, 2015, there were non-qualified stock options to purchase 1,968,474 shares of Common Stock outstanding under the 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 estimated 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 during the nine months ended September 30, 2015 and 2014 are set forth in the table below. Nine Months Ended September 30, 2015 2014 Risk-free interest rate 1.47-1.54 % 1.68-1.77 % Volatility 58.77-62.94 % 69.15-70.93 % Term (in years) 5.27-6.25 5-6.25 Dividend yield 0.00 % 0.00 % The risk-free interest rate assumption is based upon observed interest rates on zero coupon U.S. Treasury bonds whose maturity period is appropriate for the expected term. Estimated volatility is a measure of the amount by which the price of our Common Stock is expected to fluctuate each year during the term of an award. Our estimated volatility is an average of the historical volatility of the stock prices of our peer entities whose stock prices were publicly available. Our calculation of estimated volatility is based on historical stock prices over a period equal to the term of the awards. We used the historical volatility of our peer entities due to the lack of sufficient historical data on our stock price. The average expected life is based on the contractual terms of the stock option using the simplified method. A summary of activity under the 2009 and 2012 Plans and related information follows: Number of Shares Underlying Stock Options Weighted Average Exercise Price Weighted Average Remaining Contractual Life in Years Aggregate Intrinsic Value Balance at December 31, 2014 16,792,443 $ 1.88 6.92 $ 43,996,311 Granted 1,231,000 $ 6.38 Exercised (472,867 ) $ 1.25 Expired/Forfeited (136,334 ) $ 3.01 Balance at September 30, 2015 17,414,242 $ 2.21 6.09 $ 64,265,785 Vested and Exercisable at September 30, 2015 13,848,923 $ 1.59 5.49 $ 59,095,453 At September 30, 2015, our outstanding stock options had exercise prices ranging from $0.10 to $7.72 per share. Share-based compensation expense for options recognized in our results of operations (based on vested awards) for the three and nine months ended September 30, 2015 were $1,626,862 and $4,328,964, respectively, and $1,047,493 and $3,341,604, respectively, for the same periods in 2014. ASC 718-10 requires forfeitures to be estimated at the time of grant and revised in subsequent periods if actual forfeitures differ from the estimates. At September 30, 2015, total unrecognized estimated compensation expense related to unvested options granted prior to that date was approximately $5,593,000 which may be adjusted for future changes in forfeitures. This cost is expected to be recognized over a weighted-average period of 2.3 years. No tax benefit was realized due to a continued pattern of operating losses.

INCOME TAXES

INCOME TAXES	9 Months Ended
	Sep. 30, 2015
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 2015 as a result of (i) the losses recorded during the nine months ended September 30, 2015, (ii) additional losses expected for the remainder of 2015, and/or (iii) net operating loss carry forwards from prior years. Accounting standards require the consideration of a valuation allowance for deferred tax assets if it is "more likely than not" that some component or all of the benefits of deferred tax assets will not be realized. As of September 30, 2015, we maintain a full valuation allowance for all deferred tax assets. Based on these requirements, no provision or benefit for income taxes has been recorded. There were no recorded unrecognized tax benefits at the end of the reporting period.

RELATED PARTIES

RELATED PARTIES	9 Months Ended
	Sep. 30, 2015
Related Party Transactions [Abstract]
RELATED PARTIES	NOTE 13 – RELATED PARTIES On February 29, 2012, Cooper C. Collins, who was then president and largest shareholder of Pernix Therapeutics, LLC, or Pernix, was elected to serve on our board of directors. From time to time, we have entered into agreements with Pernix in the normal course of business. All such agreements are reviewed by independent directors of our company or a committee consisting of independent directors of our company. During the nine months ended September 30, 2015 and 2014, we did not engage in any transactions with Pernix. At September 30, 2015 and December 31, 2014, there were amounts due Pernix of approximately $46,000. Additionally, there were amounts due to us from Pernix for legal fee reimbursement relating to a litigation matter stemming from a license and supply agreement in the amounts of approximately $250,000 at both September 30, 2015 and December 31, 2014.

BUSINESS CONCENTRATIONS

BUSINESS CONCENTRATIONS	9 Months Ended
	Sep. 30, 2015
Risks and Uncertainties [Abstract]
BUSINESS CONCENTRATIONS	NOTE 14 - BUSINESS CONCENTRATIONS We purchase our products from several suppliers with approximately 54% and 77% of our purchases supplied from one vendor for the nine months ended September 30, 2015 and 2014, respectively. We sell our prescription prenatal vitamin products to wholesale distributors, specialty pharmacies, specialty distributors, and chain drug stores that generally sell products to retail pharmacies, hospitals, and other institutional customers. Revenue generated from four major customers accounted for approximately 90% and 95% of our recognized revenue for the nine months ended September 30, 2015 and 2014, respectively. Customers that generated more than 10% of our sales are designated as customers “A”, “B”, “C” and “D”. During the nine months ended September 30, 2015, two customers generated more than 10% of revenues and during the nine months ended September 30, 2014, four customers generated more than 10% of revenues. During the nine months ended September 30, 2015, customer A generated approximately $6,930,000 in revenues and customer B generated approximately $3,005,000 in revenues. During the nine months ended September 30, 2014, customers A, B, C and D generated approximately $3,930,000, $1,846,000, $1,590,000 and $1,555,000 in sales, respectively.

COMMITMENTS AND CONTINGENCIES

COMMITMENTS AND CONTINGENCIES	9 Months Ended
	Sep. 30, 2015
Commitments and Contingencies Disclosure [Abstract]
COMMITMENTS AND CONTINGENCIES	NOTE 15 – COMMITMENTS AND CONTINGENCIES We lease administrative office space in Boca Raton, Florida pursuant to a 63 month non-cancelable operating lease that commenced on July 1, 2013 and expires on September 30, 2018. On February 18, 2015, we entered into an agreement to lease additional administrative office space in Boca Raton, Florida, pursuant to an addendum to such lease. This addendum was effective beginning April 1, 2015 and will expire with the original lease term on September 30, 2018. The straight line rental expense related to our current lease totaled approximately $119,000 and $90,000 for the three months ended September 30, 2015 and 2014, respectively, and approximately $328,000 and $271,000 for the nine months ended September 30, 2015 and 2014, respectively. The 2014 amounts were partially offset by the rent income of approximately $6,000 and $42,000, respectively, for sublet space. We did not sublet any space during the nine months ended September 30, 2015. As of September 30, 2015, future minimum rental payments are as follows: Years Ending December 31, 2015 (3 months) $ 121,698 2016 493,790 2017 507,087 2018 388,976 Minimum lease payments $ 1,511,551

SUBSEQUENT EVENTS

SUBSEQUENT EVENTS	9 Months Ended
	Sep. 30, 2015
Subsequent Events [Abstract]
SUBSEQUENT EVENTS	NOTE 16 – SUBSEQUENT EVENTS In October 2015, we completed enrollment in the REPLENISH trial, a phase 3 study of TX-001HR in postmenopausal women with an intact uterus. The trial was designed to enroll approximately 1,750 patients at approximately 100 sites.

SUMMARY OF SIGNIFICANT ACCOUN22

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies)	9 Months Ended
	Sep. 30, 2015
Accounting Policies [Abstract]
Impairment of Long-Lived Assets	Impairment of Long-Lived Assets We review the carrying values of property and equipment and long-lived intangible assets for impairment whenever events or changes in circumstances indicate that their carrying values may not be recoverable. There was no impairment of any long-lived assets during the three and nine months ended September 30, 2015 and 2014.
Fair Value of Financial Instruments	Fair Value of Financial Instruments Our financial instruments consist primarily of accounts receivable, accounts payable and accrued expenses. The carrying amount of accounts receivable, accounts payable and accrued expenses approximates their fair value because of the short-term maturity of such instruments. We categorize our assets and liabilities that are valued at fair value on a recurring basis into a three-level fair value hierarchy as defined by ASC 820, Fair Value Measurements. Level 1 unadjusted quoted prices in active markets for identical assets or liabilities; Level 2 quoted prices for similar assets or liabilities in active markets or inputs that are observable for the asset or liability, either directly or indirectly through market corroboration, for substantially the full term of the financial instrument; and Level 3 unobservable inputs for the asset or liability. At September 30, 2015 and December 31, 2014, 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 any required impairment test.
Revenue Recognition	Revenue Recognition We recognize revenue on arrangements in accordance with ASC 605, Revenue Recognition. We recognize revenue only when the price is fixed or determinable, persuasive evidence of an arrangement exists, the service is performed, and collectability is reasonably assured. Our OTC and prescription prenatal vitamin products are generally variations of the same product with slight modifications in formulation and marketing. The primary difference between our OTC and prescription prenatal vitamin products is the source of payment. Purchasers of our OTC prenatal vitamin products pay for the product directly while purchasers of our prescription prenatal vitamin products pay for the product via third-party payers. Both OTC and prescription prenatal vitamin products share the same marketing support team utilizing similar marketing techniques. Over-the-Counter Products We generate OTC revenue from product sales primarily to retail consumers. We recognize revenue from product sales upon shipment, when the rights of ownership and risk of loss have passed to the consumer. We include outbound shipping and handling fees in revenues, net, and bill them upon shipment. We include shipping expenses in cost of goods sold. A majority of our customers pay for our products with credit cards, and we usually receive the cash settlement in two to three banking days. Credit card sales minimize accounts receivable balances relative to sales. We provide an unconditional 30-day money-back return policy under which we accept product returns from our retail and eCommerce customers. We recognize our revenue from OTC sales, net of estimated returns, sales discounts, and eCommerce fees. Prescription Products We sell our name brand and generic prescription products primarily through drug wholesalers and retail pharmacies. We recognize revenue from prescription product sales, net of sales discounts, chargebacks, and customer rebates. We accept returns of unsalable product from customers 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. As of January 1, 2015, we started estimating returns based on historical return rates and recorded actual product returns against this reserve as received. Prior to January 1, 2015, we deferred the recognition of revenue on certain arrangements until the right of return no longer existed. We maintain various rebate programs in an effort to maintain a competitive position in the marketplace and to promote sales and customer loyalty. The consumer rebate program is designed to enable the end user to submit a coupon to us. If the coupon qualifies, we send a rebate check to the end user. We estimate the allowance for consumer rebates based on our experience and industry averages, which is reviewed, and adjusted if necessary, on a quarterly basis.
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. Advance payments to be expensed in future research and development activities were $948,499 at September 30, 2015, of which $755,152 was included in Other current assets and $193,347 was included in long term Prepaid expense on the accompanying consolidated balance sheets. Advance payments to be expensed in future research and development activities were $1,175,082 at December 31, 2014, of which $711,362 was included in Other current assets and $463,720 was included in long term Prepaid expense on the accompanying consolidated balance sheets. CRO activity expenses include preclinical laboratory experiments and clinical trial studies. Other activity expenses include regulatory consulting and legal fees and costs. The activities undertaken by our regulatory consultants that were classified as research and development 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 research and development expenses related to designing experiments to generate data for patents and to further the formulation development process for our pipeline technologies. Outside legal counsel also provided professional research and advice regarding research and development, 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. As of September 30, 2015, we classified $1,213,874 of the accrued clinical study costs as long term Accrued Expenses related to the costs that will be paid at the completion of one of our clinical trials. 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.

INVENTORY (Tables)

INVENTORY (Tables)	9 Months Ended
	Sep. 30, 2015
Inventory Disclosure [Abstract]
Schedule of Inventory	Inventory consists of the following: September 30, 2015 December 31, 2014 Finished product $ 787,232 $ 874,294 Raw material 82,827 155,341 Deferred costs — 152,478 TOTAL INVENTORY $ 870,059 $ 1,182,113

OTHER CURRENT ASSETS (Tables)

OTHER CURRENT ASSETS (Tables)	9 Months Ended
	Sep. 30, 2015
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract]
Schedule of other current assets	Other current assets consist of the following: September 30, 2015 December 31, 2014 Prepaid insurance $ 870,949 $ 394,878 Prepaid research and development costs 381,813 299,498 Prepaid consulting 373,339 411,864 Other receivables-related party (Note 13) 249,981 249,981 Other prepaid costs 219,086 181,186 Prepaid vendor deposits 25,637 — TOTAL OTHER CURRENT ASSETS $ 2,120,805 $ 1,537,407

FIXED ASSETS, NET (Tables)

FIXED ASSETS, NET (Tables)	9 Months Ended
	Sep. 30, 2015
Property, Plant and Equipment [Abstract]
Schedule of fixed assets	Fixed assets, net consist of the following: September 30, 2015 December 31, 2014 Equipment $ 132,150 $ 132,150 Furniture and fixtures 69,454 53,895 201,604 186,045 Accumulated depreciation (144,856 ) (122,752 ) TOTAL FIXED ASSETS, NET $ 56,748 $ 63,293

PREPAID EXPENSE (Tables)

PREPAID EXPENSE (Tables)	9 Months Ended
	Sep. 30, 2015
Prepaid Expense and Other Assets [Abstract]
Schedule of prepaid expense	Prepaid expense (long-term) consists of the following: September 30, 2015 December 31, 2014 Prepaid manufacturing costs $ 978,704 $ 963,543 Prepaid research and development costs 193,347 463,720 TOTAL PREPAID EXPENSE $ 1,172,051 $ 1,427,263

INTANGIBLE ASSETS (Tables)

INTANGIBLE ASSETS (Tables)	9 Months Ended
	Sep. 30, 2015
Goodwill and Intangible Assets Disclosure [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 September 30, 2015 and December 31, 2014: September 30, 2015 Gross Carrying Amount Accumulated Amortization Net Amount Weighted- Average Amortization Period (yrs.) Amortizing intangible assets: OPERA ® $ 31,951 $ (3,994 ) $ 27,957 14 Development costs of corporate website 91,743 (91,743 ) — n/a Approved hormone therapy drug candidate patents 605,502 (40,199 ) 565,303 17.25 Non-amortizing intangible assets: Hormone therapy drug candidate patents (pending) 585,241 — 585,241 n/a Multiple trademarks for vitamins/supplements 145,783 — 145,783 indefinite Total $ 1,460,220 $ (135,936 ) $ 1,324,284 December 31, 2014 Gross Carrying Amount Accumulated Amortization Net Amount Weighted- Average Amortization Period (yrs.) Amortizing intangible assets: OPERA ® $ 31,951 $ (2,496 ) $ 29,455 14.75 Development costs of corporate website 91,743 (91,743 ) — n/a Approved hormone therapy drug candidate patents 439,184 (19,401 ) 419,783 18 Non-amortizing intangible assets: Hormone therapy drug candidate patents (pending) 675,982 — 675,982 n/a Multiple trademarks for vitamins/supplements 103,368 — 103,368 indefinite Total $ 1,342,228 $ (113,640 ) $ 1,228,588
Schedule of estimated amortization expense	Estimated amortization expense for the next five years is as follows: Year Ending December 31, Estimated Amortization 2015 (3 months) $ 8,692 2016 $ 34,768 2017 $ 34,768 2018 $ 34,768 2019 $ 34,768

OTHER CURRENT LIABILITIES (Tabl

OTHER CURRENT LIABILITIES (Tables)	9 Months Ended
	Sep. 30, 2015
Other Liabilities Disclosure [Abstract]
Schedule of other current liabilities	Other current liabilities consist of the following: September 30, 2015 December 31, 2014 Accrued clinical trial costs $ 3,528,061 $ 1,706,542 Accrued payroll, bonuses and commission costs 930,913 814,205 Accrued legal and accounting expense 615,946 276,470 Accrued compensated absences 490,170 442,430 Other accrued expenses 388,268 185,965 Allowance for coupons and returns 208,361 90,446 Allowance for wholesale distributor fees 96,440 160,503 Accrued rent 86,998 91,368 Accrued royalties 41,620 72,710 TOTAL OTHER CURRENT LIABILITIES $ 6,386,777 $ 3,840,639

NET LOSS PER SHARE (Tables)

NET LOSS PER SHARE (Tables)	9 Months Ended
	Sep. 30, 2015
Net Loss Per Share Tables
Schedule of potentially dilutive securities	The table below presents the potentially dilutive securities that would have been included in our calculation of diluted net loss per share allocable to common stockholders if they were not antidilutive for the periods presented. As of September 30, 2015 2014 Stock options 17,414,242 16,851,943 Warrants 12,722,431 13,927,916 30,136,673 30,779,859

STOCKHOLDERS' EQUITY (Tables)

STOCKHOLDERS' EQUITY (Tables)	9 Months Ended
	Sep. 30, 2015
Stockholders' Equity Note [Abstract]
Schedule of assumptions used in the Black-Scholes Model of stock options	The assumptions used in the Black-Scholes Model during the nine months ended September 30, 2015 and 2014 are set forth in the table below. Nine Months Ended September 30, 2015 2014 Risk-free interest rate 1.47-1.54 % 1.68-1.77 % Volatility 58.77-62.94 % 69.15-70.93 % Term (in years) 5.27-6.25 5-6.25 Dividend yield 0.00 % 0.00 %
Schedule of option activity	A summary of activity under the 2009 and 2012 Plans and related information follows: Number of Shares Underlying Stock Options Weighted Average Exercise Price Weighted Average Remaining Contractual Life in Years Aggregate Intrinsic Value Balance at December 31, 2014 16,792,443 $ 1.88 6.92 $ 43,996,311 Granted 1,231,000 $ 6.38 Exercised (472,867 ) $ 1.25 Expired/Forfeited (136,334 ) $ 3.01 Balance at September 30, 2015 17,414,242 $ 2.21 6.09 $ 64,265,785 Vested and Exercisable at September 30, 2015 13,848,923 $ 1.59 5.49 $ 59,095,453

COMMITMENTS AND CONTINGENCIES (

COMMITMENTS AND CONTINGENCIES (Tables)	9 Months Ended
	Sep. 30, 2015
Commitments And Contingencies Tables
Schedule of future minimum rental payments	As of September 30, 2015, future minimum rental payments are as follows: Years Ending December 31, 2015 (3 months) $ 121,698 2016 493,790 2017 507,087 2018 388,976 Minimum lease payments $ 1,511,551

SUMMARY OF SIGNIFICANT ACCOUN32

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details Narrative) - USD ($)	Sep. 30, 2015	Dec. 31, 2014
Accounting Policies [Abstract]
Advance payments for future research and development activities	$ 948,499	$ 1,175,082
Accrued Expense	1,213,874
Other assets current	755,152
Long term prepaid expense	$ 193,347	$ 463,720

INVENTORY (Details)

INVENTORY (Details) - USD ($)	Sep. 30, 2015	Dec. 31, 2014
Inventory
Finished product	$ 787,232	$ 874,294
Raw material	$ 82,827	155,341
Deferred costs		152,478
TOTAL INVENTORY	$ 870,059	$ 1,182,113

OTHER CURRENT ASSETS (Details)

OTHER CURRENT ASSETS (Details) - USD ($)	Sep. 30, 2015	Dec. 31, 2014
Other Current Assets
Prepaid insurance	$ 870,949	$ 394,878
Prepaid research and development costs	381,813	299,498
Prepaid consulting	373,339	411,864
Other receivables-related party (Note 13)	249,981	249,981
Other prepaid costs	219,086	181,186
Prepaid vendor deposits	25,637
TOTAL OTHER CURRENT ASSETS	$ 2,120,805	$ 1,537,407

FIXED ASSETS, NET (Details Narr

FIXED ASSETS, NET (Details Narrative) - USD ($)	3 Months Ended		9 Months Ended
	Sep. 30, 2015	Sep. 30, 2014	Sep. 30, 2015	Sep. 30, 2014
Property, Plant and Equipment [Abstract]
Depreciation Expense	$ 7,856	$ 7,122	$ 22,104	$ 22,713

FIXED ASSETS, NET (Details)

FIXED ASSETS, NET (Details) - USD ($)	Sep. 30, 2015	Dec. 31, 2014
Fixed assets, gross	$ 201,604	$ 186,045
Accumulated depreciation	(144,856)	(122,752)
TOTAL FIXED ASSETS	56,748	63,293
Equipment [Member]
Fixed assets, gross	132,150	132,150
Furniture and Fixtures [Member]
Fixed assets, gross	$ 69,454	$ 53,895

PREPAID EXPENSE (Details)

PREPAID EXPENSE (Details) - USD ($)	Sep. 30, 2015	Dec. 31, 2014
Prepaid Expense and Other Assets [Abstract]
Prepaid manufacturing costs	$ 978,704	$ 963,543
Prepaid research and development costs	193,347	463,720
TOTAL PREPAID EXPENSE	$ 1,172,051	$ 1,427,263

INTANGIBLE ASSETS (Details Narr

INTANGIBLE ASSETS (Details Narrative)	3 Months Ended		9 Months Ended
	Sep. 30, 2015USD ($)	Sep. 30, 2014USD ($)	Sep. 30, 2015USD ($)	Sep. 30, 2014USD ($)
Goodwill and Intangible Assets Disclosure [Abstract]
Amortization expense	$ 8,692	$ 5,625	$ 22,296	$ 17,196
Number of patents	13		13

INTANGIBLE ASSETS (Details )

INTANGIBLE ASSETS (Details ) - USD ($)	9 Months Ended	12 Months Ended
	Sep. 30, 2015	Dec. 31, 2014
Finite-Lived Intangible Assets
Accumulated Amortization	$ (135,936)	$ (113,640)
Indefinite-Lived Intangible Assets
Gross Carrying Amount	1,460,220	1,342,228
Net Amount	1,324,284	1,228,588
Hormone therapy drug candidate patents - Pending [Member]
Indefinite-Lived Intangible Assets
Gross Carrying Amount	585,241	675,982
Net Amount	585,241	675,982
Multiple trademarks for vitamins/supplements [Member]
Indefinite-Lived Intangible Assets
Gross Carrying Amount	145,783	103,368
Net Amount	145,783	103,368
OPERA software patent [Member]
Finite-Lived Intangible Assets
Gross Carrying Amount	31,951	31,951
Accumulated Amortization	(3,994)	(2,496)
Net Amount	$ 27,957	$ 29,455
Weighted Average Amortization Period	14 years	14 years 9 months
Development costs for corporate website [Member]
Finite-Lived Intangible Assets
Gross Carrying Amount	$ 91,743	$ 91,743
Accumulated Amortization	$ (91,743)	$ (91,743)
Net Amount
Approved Hormone Therapy Drug Candidate Patents [Member]
Finite-Lived Intangible Assets
Gross Carrying Amount	$ 605,502	$ 439,184
Accumulated Amortization	(40,199)	(19,401)
Net Amount	$ 565,303	$ 419,783
Weighted Average Amortization Period		18 years
Non-Amortizing Intangible Assets [Member]
Finite-Lived Intangible Assets
Weighted Average Amortization Period	17 years 2 months 30 days

INTANGIBLE ASSETS (Details 1)

INTANGIBLE ASSETS (Details 1)	Sep. 30, 2015USD ($)
Estimated amortization expense for the year:
2015 (3 months)	$ 8,692
2,016	34,768
2,017	34,768
2,018	34,768
2,019	$ 34,768

OTHER CURRENT LIABILITIES (Deta

OTHER CURRENT LIABILITIES (Details) - USD ($)		Sep. 30, 2015	Dec. 31, 2014
Other Liabilities Disclosure [Abstract]
Accrued clinical trial costs		$ 3,528,061	$ 1,706,542
Accrued payroll, bonuses and commission costs		930,913	814,205
Accrued legal and accounting expense		615,946	276,470
Accrued compensated absences		490,170	442,430
Other accrued expenses	[1]	388,268	185,965
Allowance for coupons and returns		208,361	90,446
Allowance for wholesale distributor fees		96,440	160,503
Accrued rent		86,998	91,368
Accrued royalties		41,620	72,710
TOTAL OTHER CURRENT LIABILITIES		$ 6,386,777	$ 3,840,639
[1]	In June 2008, we declared and paid a special dividend of $0.40 per share of our Common Stock to all stockholders of record as of June 10, 2008, of which $41,359 remained unclaimed by certain shareholders at March 31, 2015 and December 31, 2014.

NET LOSS PER SHARE (Details)

NET LOSS PER SHARE (Details) - shares	9 Months Ended
	Sep. 30, 2015	Sep. 30, 2014
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Anti-dilutive shares excluded from earnings per share calculation	30,136,673	30,779,859
Stock Option [Member]
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Anti-dilutive shares excluded from earnings per share calculation	17,414,242	16,851,943
Warrants [Member]
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Anti-dilutive shares excluded from earnings per share calculation	12,722,431	13,927,916

STOCKHOLDERS' EQUITY (Details N

STOCKHOLDERS' EQUITY (Details Narrative) - USD ($)	Jul. 15, 2015	Jul. 09, 2015	Feb. 17, 2015	Feb. 10, 2015	Aug. 04, 2014	Jul. 29, 2014	Sep. 30, 2015	Sep. 30, 2015	Sep. 30, 2014	Dec. 31, 2014
Preferred stock, shares authorized							10,000,000	10,000,000		10,000,000
Preferred stock, par value (in dollars per share)							$ 0.001	$ 0.001		$ 0.001
Common stock, shares authorized							350,000,000	350,000,000		250,000,000
Common stock, shares issued							177,787,927	177,787,927		156,097,019
Common stock, shares outstanding							177,787,927	177,787,927		156,097,019
Number of common stock issued during period for stock options exercised							95,000	472,867	793,800
Value of common stock issued during period for stock options exercised							$ 98,478	$ 589,867
Share based compensation options grants in period								1,231,000	50,000
Options exercised 1 [Member]
Number of common stock issued during period for stock options exercised									674,800
Value of common stock issued during period for stock options exercised									$ 315,546
Options exercised 2 [Member]
Common stock, shares issued									113,837
Number of common stock issued during period for stock options exercised									119,607
Stifel Underwriters [Member]
Number of shares issued during the period	4,423,077	3,846,154
Share price (in dollars per share)		$ 7.80
Number of shares issued during the period,value		$ 3,200,000
Number of common stock issued during period for stock options exercised		576,923
Cowen and Company, LLC (Underwriters) [Member]
Number of shares issued during the period			15,617,282	13,580,246
Share price (in dollars per share)				$ 4.05
Number of shares issued during the period,value				$ 59,100,000
Number of common stock issued during period for stock options exercised				2,037,036
Goldman Sachs Underwriters [Member]
Number of shares issued during the period					9,850,106	8,565,310
Share price (in dollars per share)						$ 4.67
Number of shares issued during the period,value						$ 42,800,000
Number of common stock issued during period for stock options exercised						1,284,796

STOCKHOLDERS' EQUITY (Details44

STOCKHOLDERS' EQUITY (Details Narrative 1) - USD ($)	Jun. 30, 2013	May. 11, 2013	May. 31, 2013	Jan. 31, 2013	Sep. 30, 2015	Sep. 30, 2014	Sep. 30, 2015	Sep. 30, 2014
Warrants:
Warrants outstanding					$ 12,772,431		$ 12,772,431
Exercise price of warrants (in dollars per share)					$ 1.93		$ 1.93
Other current assets					$ 755,152		$ 755,152
Options Granted							1,231,000	50,000
Sancilio and Company Warrants [Member]
Warrants:
Weighted-average contractual remaining life							1 year 9 months
Exercise price of warrants (in dollars per share)			$ 2.01
Unamortized costs of warrants							$ 567,000
Number of shares purchased			850,000
Number of shares purchased forfeit			833,000
Sancilio & Company Warrants 1st Installments [Member]
Warrants:
Number of shares purchased		283,333
Vesting date of warrants		Jun. 30, 2013
Fair value of warrants	$ 405,066
Expected term	5 years
Volatility rate	45.89%
Risk free rate	1.12%
Dividend yield	0.00%
Valuation method of warrants	Black-Scholes Model
Non-cash compensation recognised	$ 405,066
Sancilio and Company Warrants 2nd Installments [Member]
Warrants:
Number of shares purchased	283,333
Fair value of warrants	$ 462,196
Expected term	5 years
Volatility rate	45.84%
Risk free rate	1.41%
Dividend yield	0.00%
Non-cash compensation recognised					38,517	$ 38,517	115,551	$ 115,551
Other current assets					$ 115,543		$ 115,543
Sancilio and Company Warrants 3rd Installments [Member]
Warrants:
Number of shares purchased					283,334		283,334
Outside Consultant Warrants [Member]
Warrants:
Weighted-average contractual remaining life							1 year 11 months 1 day
Exercise price of warrants (in dollars per share)					$ 6.35		$ 6.35
Expiration date of warrants							Apr. 6, 2020
Non-cash compensation recognised					$ 42,266		$ 86,008
Options Granted							50,000
Multiple Advance Revolving Credit Note (Plato Warrant) [Member]
Warrants:
Exercise price of warrants (in dollars per share)				$ 3.20
Number of shares purchased				1,250,000
Expiration date of warrants				Jan. 31, 2019
Vesting date of warrants				Oct. 31, 2013
Fair value of warrants				$ 1,711,956
Expected term				6 years
Volatility rate				44.29%
Risk free rate				0.88%
Dividend yield				0.00%
Amortization deferred financing costs							$ 0	$ 260,027

STOCKHOLDERS' EQUITY (Details45

STOCKHOLDERS' EQUITY (Details Narrative 2) - USD ($)	3 Months Ended		9 Months Ended
	Sep. 30, 2015	Sep. 30, 2014	Sep. 30, 2015	Sep. 30, 2014	Dec. 31, 2014
Option exercise prices (in dollars per shares)	$ 2.21		$ 2.21		$ 1.88
Share-based compensation expense	$ 1,626,862	$ 1,047,493	$ 4,328,964	$ 3,341,604
Total unrecognized estimated compensation expense	$ 5,593,000		$ 5,593,000
Recognized weighted-average period			2 years 3 months 19 days
Options granted			1,231,000	50,000
Stock issued for excercised warrants, shares				365,583
Stock issued for excercised warrants, value				$ 181,000
Warrant Exercised 1 [Member]
Stock issued for excercised warrants, shares			945,485
Stock issued for excercised warrants, value			$ 366,000
Warrant Exercised 2 [Member]
Number of shares issued	232,197		232,197
Stock issued for excercised warrants, shares	310,000		310,000
Minimum [Member]
Option exercise prices (in dollars per shares)	$ 0.10		$ 0.10
Maximum [Member]
Option exercise prices (in dollars per shares)	$ 7.72		$ 7.72
2009 Long Term Incentive Compensation Plan [Member]
Description of 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 shareholder value by providing them stock options and other stock and cash incentives, or the Awards.
Number of shares authorized for issuance					25,000,000
Number of shares issued			15,445,768
Options granted			1,231,000
2012 Stock Incentive Plan [Member]
Description of plan			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.
Number of shares authorized for issuance					10,000,000
Number of shares issued			1,968,474

STOCKHOLDERS' EQUITY (Details)

STOCKHOLDERS' EQUITY (Details) - Stock Options [Member]	9 Months Ended
	Sep. 30, 2015	Sep. 30, 2014
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Expected dividend yield	0.00%	0.00%
Minimum [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Risk-free interest rate	1.47%	1.68%
Expected Volatility	58.77%	69.15%
Expected term	5 years 3 months 8 days	5 years
Maximum [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Risk-free interest rate	1.54%	1.77%
Expected Volatility	62.94%	70.93%
Expected term	6 years 2 months 30 days	6 years 2 months 30 days

STOCKHOLDERS' EQUITY (Details 1

STOCKHOLDERS' EQUITY (Details 1) - USD ($)	3 Months Ended	9 Months Ended
	Sep. 30, 2015	Sep. 30, 2015	Sep. 30, 2014
Number Options
Options outstanding, beginning		16,792,443
Options Granted		1,231,000	50,000
Options Exercised	(95,000)	(472,867)	(793,800)
Options Cancelled		(136,334)
Options outstanding, ending	17,414,242	17,414,242
Vested and exercisable	13,848,923	13,848,923
Weighted Average Exercise Price
Options outstanding, beginning		$ 1.88
Granted		6.38
Exercised		1.25
Cancelled		3.01
Options outstanding, ending	$ 2.21	2.21
Vested and exercisable	$ 1.59	$ 1.59
Weighted Average Remaining Contractual Life
Options outstanding, beginning		6 years 11 months 1 day
Options outstanding, ending		6 years 1 month 2 days
Vested and exercisable		5 years 5 months 27 days
Aggregate Intrinsic Value
Options outstanding, beginning		$ 43,996,311
Options outstanding, ending	$ 64,265,785	64,265,785
Vested and exercisable	$ 59,095,453	$ 59,095,453

RELATED PARTIES (Details Narrat

RELATED PARTIES (Details Narrative) - Pernix Therapeutics LLC [Member] - USD ($)	Sep. 30, 2015	Dec. 31, 2014
Receivables- legal fee reimbursement	$ 250,000	$ 250,000
Payable - related party	$ 46,000	$ 46,000

BUSINESS CONCENTRATIONS (Detail

BUSINESS CONCENTRATIONS (Details Narrative) - USD ($)	3 Months Ended		9 Months Ended
	Sep. 30, 2015	Sep. 30, 2014	Sep. 30, 2015	Sep. 30, 2014
Concentration Risk [Line Items]
Revenues	$ 5,190,175	$ 4,186,261	$ 14,513,158	$ 10,768,572
Supplier Concentration Risk [Member]
Concentration Risk [Line Items]
Concentration Risk			54.00%	77.00%
Customer Concentration Risk [Member] | Sales Revenue [Member]
Concentration Risk [Line Items]
Concentration Risk			90.00%	95.00%
Customer Concentration Risk [Member] | Sales Revenue [Member] | Minimum [Member]
Concentration Risk [Line Items]
Concentration Risk			10.00%	10.00%
Customer A [Member] | Sales Revenue [Member]
Concentration Risk [Line Items]
Revenues			$ 6,930,000	$ 3,930,000
Customer B [Member] | Sales Revenue [Member]
Concentration Risk [Line Items]
Revenues			$ 3,005,000	1,846,000
Customer C [Member] | Sales Revenue [Member]
Concentration Risk [Line Items]
Revenues				1,590,000
Customer D [Member] | Sales Revenue [Member]
Concentration Risk [Line Items]
Revenues				$ 1,555,000

COMMITMENTS AND CONTINGENCIES50

COMMITMENTS AND CONTINGENCIES (Details Narrative) - USD ($)	3 Months Ended		9 Months Ended
	Sep. 30, 2015	Sep. 30, 2014	Sep. 30, 2015	Sep. 30, 2014
Commitments and Contingencies Disclosure [Abstract]
Non-cancelable operating lease term			63 months
Rental Expense	$ 119,000	$ 90,000	$ 328,000	$ 271,000
Rental income		$ 6,000		$ 42,000

COMMITMENTS AND CONTINGENCIES51

COMMITMENTS AND CONTINGENCIES (Details)	Sep. 30, 2015USD ($)
Future minimum rental payments, year ending December 31,
2015 (3 months)	$ 121,698
2,016	493,790
2,017	507,087
2,018	388,976
Minimum lease payments	$ 1,511,551

SUBSEQUENT EVENTS (Details Nara

SUBSEQUENT EVENTS (Details Narative)	Oct. 31, 2015	Sep. 30, 2015
Number of patents		13
Subsequent Event [Member]
Number of patents	1,750
Number of sites	100