WDB1 1I"MVS!0S@DA2<9P#TH __]D! end XML 18 R1.htm IDEA: XBRL DOCUMENT

Document and Entity Information - USD ($)	12 Months Ended
Document and Entity Information - USD ($)	Dec. 31, 2015	Feb. 22, 2016	Jun. 30, 2015
Document And Entity Information
Entity Registrant Name	TherapeuticsMD, Inc.
Entity Central Index Key	0000025743
Document Type	10-K
Document Period End Date	Dec. 31, 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	Large Accelerated Filer
Entity Public Float			$ 738,931,545
Entity Common Stock, Shares held by Nonaffiliates			94,011,647
Entity Common Stock, Shares Outstanding		196,150,311
Document Fiscal Period Focus	FY
Document Fiscal Year Focus	2015

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CONSOLIDATED BALANCE SHEETS - USD ($)	Dec. 31, 2015	Dec. 31, 2014
Current Assets:
Cash	$ 64,706,355	$ 51,361,607
Accounts receivable, net of allowance for doubtful accounts of $81,910 and $96,916, respectively	3,049,715	2,154,217
Inventory	690,153	1,182,113
Other current assets	2,233,897	1,537,407
Total current assets	70,680,120	56,235,344
Fixed assets, net	198,592	63,293
Other Assets:
Intangible assets, net	1,615,251	1,228,588
Prepaid expense	1,109,883	1,427,263
Security deposit	125,000	125,000
Total other assets	2,850,134	2,780,851
Total assets	73,728,846	59,079,488
Current Liabilities:
Accounts payable	3,126,174	6,327,129
Other current liabilities	$ 7,539,526	3,840,639
Deferred revenue		522,613
Total current liabilities	$ 10,665,700	$ 10,690,381
Commitments and Contingencies - See Note 14
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; 177,928,041 and 156,097,019 issued and outstanding, respectively	$ 177,928	$ 156,097
Additional paid in capital	282,712,078	182,982,846
Accumulated deficit	(219,826,860)	(134,749,836)
Total stockholders' equity	63,063,146	48,389,107
Total liabilities and stockholders' equity	$ 73,728,846	$ 59,079,488

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CONSOLIDATED BALANCE SHEETS (Parenthetical) - USD ($)	Dec. 31, 2015	Dec. 31, 2014
Statement of Financial Position [Abstract]
Allowance for doubtful accounts	$ 81,910	$ 96,916
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	177,928,041	156,097,019
Common stock, shares outstanding	177,928,041	156,097,019

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CONSOLIDATED STATEMENTS OF OPERATIONS - USD ($)	12 Months Ended
CONSOLIDATED STATEMENTS OF OPERATIONS - USD ($)	Dec. 31, 2015	Dec. 31, 2014	Dec. 31, 2013
Income Statement [Abstract]
Revenues, net	$ 20,142,898	$ 15,026,219	$ 8,775,598
Cost of goods sold	4,506,673	3,671,803	1,959,597
Gross profit	15,636,225	11,354,416	6,816,001
Operating expenses:
Sales, general, and administrative	28,721,236	22,124,072	19,014,837
Research and development	72,042,774	43,218,938	13,551,263
Depreciation and amortization	62,400	52,467	58,145
Total operating expense	100,826,410	65,395,477	32,624,245
Operating loss	(85,190,185)	(54,041,061)	(25,808,244)
Other income (expense):
Miscellaneous income, net	95,719	46,569	34,544
Interest income	17,442	37,309	27,234
Financing costs		(260,027)	(1,503,922)
Interest expense			(1,165,981)
Loan guaranty costs			(2,944)
Total other income (expense)	113,161	(176,149)	(2,611,069)
Loss before income taxes	(85,077,024)	(54,217,210)	(28,419,313)
Net loss	$ (85,077,024)	$ (54,217,210)	$ (28,419,313)
Loss per share, basic and diluted:
Net loss per share, basic and diluted	$ (0.49)	$ (0.36)	$ (0.22)
Weighted average number of common shares outstanding, basic and diluted	173,174,229	149,727,228	127,569,731

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CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY - USD ($)	Common Stock [Member]	Additional Paid in Capital [Member]	Accumulated Deficit [Member]	Total
Beginning balance at Dec. 31, 2012	$ 99,785	$ 50,580,400	$ (52,113,313)	$ (1,433,128)
Beginning balance, shares at Dec. 31, 2012	99,784,982
Shares issued in offerings, net of cost	$ 45,117	78,605,236		78,650,353
Shares issued in offerings, net of cost, shares	45,116,352
Shares issued for exercise of options	$ 75	30,835		$ 30,910
Shares issued for exercise of options, shares	75,423			75,423
Share-based Compensation		3,254,083		$ 3,254,083
Warrants issued for financing costs		1,711,956		1,711,956
Warrants issued for services		867,262		867,262
Warrants issued as compensation-related party		36,284		36,284
Net loss			(28,419,313)	(28,419,313)
Ending balance at Dec. 31, 2013	$ 144,977	135,086,056	(80,532,626)	$ 54,698,407
Ending balance, shares at Dec. 31, 2013	144,976,757			144,976,757
Shares issued in offerings, net of cost	$ 9,850	42,761,503		$ 42,771,353
Shares issued in offerings, net of cost, shares	9,850,106
Shares issued for exercise of options	$ 855	344,891		345,746
Shares issued for exercise of options, shares	854,573
Shares issued in exercise of warrants	$ 365	180,635		181,000
Shares issued in exercise of warrants, shares	365,583
Shares issued for exercise of restricted stock units	$ 50	(50)
Shares issued for exercise of restricted stock units, shares	50,000
Share-based Compensation		4,609,811		4,609,811
Net loss			(54,217,210)	(54,217,210)
Ending balance at Dec. 31, 2014	$ 156,097	182,982,846	(134,749,836)	$ 48,389,107
Ending balance, shares at Dec. 31, 2014	156,097,019			156,097,019
Shares issued in offerings, net of cost	$ 20,040	91,354,609		$ 91,374,649
Shares issued in offerings, net of cost, shares	20,040,359
Shares issued for exercise of options	$ 613	1,231,966		1,232,579
Shares issued for exercise of options, shares	612,981
Shares issued in exercise of warrants	$ 1,178	364,822		366,000
Shares issued in exercise of warrants, shares	1,177,682
Share-based Compensation		6,777,835		6,777,835
Net loss			(85,077,024)	(85,077,024)
Ending balance at Dec. 31, 2015	$ 177,928	$ 282,712,078	$ (219,826,860)	$ 63,063,146
Ending balance, shares at Dec. 31, 2015	177,928,041			177,928,041

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CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($)	12 Months Ended
CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($)	Dec. 31, 2015	Dec. 31, 2014	Dec. 31, 2013
CASH FLOWS FROM OPERATING ACTIVITIES
Net loss	$ (85,077,024)	$ (54,217,210)	$ (28,419,313)
Adjustments to reconcile net loss to net cash flows used in operating activities:
Depreciation	29,959	28,987	47,883
Amortization of intangible assets	32,441	23,480	10,262
Provision for (recovery of) doubtful accounts	22,157	(5,436)	(15,493)
Amortization of debt discount			1,102,680
Stock based compensation	7,189,699	4,970,312	3,844,155
Amortization of deferred financing costs		260,027	1,451,934
Loan guaranty costs			2,944
Changes in operating assets and liabilities:
Accounts receivable	(917,656)	(458,028)	(1,068,619)
Inventory	491,960	(138,495)	571,592
Other current assets	(773,532)	680,281	(1,386,319)
Other assets	(17,442)	(37,309)	(565,706)
Accounts payable	(3,200,955)	4,212,912	472,851
Deferred revenue	(522,613)	(1,079,967)	457,828
Other current liabilities	3,698,887	239,450	2,875,320
Other liabilities			(150,068)
Net cash flows used in operating activities	(79,044,119)	(45,520,996)	(20,768,069)
CASH FLOWS FROM INVESTING ACTIVITIES
Patent costs	(419,104)	(586,480)	(439,034)
Purchase of fixed assets	(165,257)	(30,962)	(40,790)
Refund (payment) of security deposit		10,686	(103,737)
Net cash flows used in investing activities	(584,361)	(606,756)	(583,561)
CASH FLOWS FROM FINANCING ACTIVITIES
Proceeds from sale of common stock, net of costs	91,374,649	42,771,353	78,650,353
Proceeds from exercise of options	1,232,579	345,746	30,910
Proceeds from exercise of warrants	366,000	181,000
Proceeds bank line of credit			500,000
Repayment of bank line of credit			(500,000)
Repayment of notes payable			(4,691,847)
Net cash flows provided by financing activities	92,973,228	43,298,099	73,989,416
Increase (decrease) in cash	13,344,748	(2,829,653)	52,637,786
Cash, beginning of period	51,361,607	54,191,260	1,553,474
Cash, end of period	$ 64,706,355	$ 51,361,607	54,191,260
SUPPLEMENTAL DISCLOSURES OF CASH FLOW INFORMATION:
Cash paid for interest			212,853
SUPPLEMENTAL SCHEDULE OF NON-CASH FINANCING ACTIVITIES:
Warrants issued for financing			1,711,956
Warrants issued for services			$ 462,196

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THE COMPANY

12 Months Ended

Dec. 31, 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 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.

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SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

12 Months Ended

Dec. 31, 2015

Accounting Policies [Abstract]

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

NOTE 2 – SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

Principles of Consolidation

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

Cash

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

Trade Accounts Receivable and Allowance for Doubtful Accounts

Trade accounts receivable are customer obligations due under normal trade terms. We review accounts receivable for uncollectible accounts and credit card charge-backs and provide an allowance for doubtful accounts, which is based upon a review of outstanding receivables, historical collection information, and existing economic conditions. We consider trade accounts receivable past due for more than 90 days to be delinquent. We write off delinquent receivables against our allowance for doubtful accounts based on individual credit evaluations, the results of collection efforts, and specific circumstances of customers. We record recoveries of accounts previously written off when received as an increase in the allowance for doubtful accounts. To the extent data we use to calculate these estimates does not accurately reflect bad debts; adjustments to these reserves may be required.

Inventories

Inventories represent packaged vitamins, nutritional products and supplements and raw materials, which are valued at the lower of cost or market using the average-cost method. Any costs of manufacturing the prescription products associated with the deferred revenue (as discussed in Revenue Recognition) prior to January 1 , 2015, were recorded as deferred costs and included in inventory, until such time as the related deferred revenue was recognized. We review our inventory for excess or obsolete inventory and write-down obsolete or otherwise unmarketable inventory to its estimated net realizable value. Obsolescence may occur due to product expiring or product improvements rendering previous versions obsolete.

Pre-Launch Inventory

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

Fixed Assets

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

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

Intangible Assets

Patents and Trademarks

We have adopted the provisions of Financial Accounting Standards Board, or FASB, Accounting Standards Codification, or ASC, 350, Intangibles - Goodwill and Other, or ASC 350. Capitalized patent costs, net of accumulated amortization, include legal costs incurred for patent applications. In accordance with ASC 350, once a patent is granted, we amortize the capitalized patent costs over the remaining life of the patent using the straight-line method. If the patent is not granted, we write-off any capitalized patent costs at that time. As of December 31, 2015, we had 14 issued patents (See Note 7). We capitalize external costs, consisting primarily of legal costs, related to securing our trademarks. Trademarks are perpetual and are not amortized. We review intangible assets for impairment annually or when events or circumstances indicate that their carrying amount may not be recoverable.

Impairment of Long-Lived Assets

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

significant declines in an asset’s market price;

significant deterioration in an asset’s physical condition;

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

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

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

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

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

If impairment indicators are present, we determine whether an impairment loss should be recognized by testing the applicable asset or asset group’s carrying value for recoverability. This test requires long-lived assets to be grouped at the lowest level for which identifiable cash flows are largely independent of the cash flows of other assets and liabilities, the determination of which requires judgment. We estimate the undiscounted future cash flows expected to be generated from the use and eventual disposal of the assets and compare that estimate to the respective carrying values in order to determine if such carrying values are recoverable. This assessment requires the exercise of judgment in assessing the future use of and projected value to be derived from the eventual disposal of the assets to be held and used. In our assessments, we also consider changes in asset utilization, including, if applicable, the temporary idling of capacity and the expected timing for placing this capacity back into production. If the carrying value of the assets is not recoverable, then we record a loss for the difference between the assets’ fair value and respective carrying values. We determine the fair value of the assets using an “income approach” based upon a forecast of all the expected discounted future net cash flows associated with the subject assets. Some of the more significant estimates and assumptions include market size and growth, market share, projected selling prices, manufacturing cost, and discount rate. We base estimates upon historical experience, our commercial relationships, market conditions, and available external information about future trends. We believe our current assumptions and estimates are reasonable and appropriate. Unanticipated events and changes in market conditions, however, could affect such estimates, resulting in the need for an impairment charge in future periods. There was no impairment of long-lived assets to be held and used during the years ended December 31, 2015, 2014 and 2013.

We perform impairment tests for intangible assets with indefinite useful lives annually, or more frequently if events occur or circumstances change that would more likely than not reduce the fair value of an intangible asset below its carrying value. The impairment test for assets with indefinite lives consists of a comparison of the fair value of the asset with its carrying amount. If the carrying amount of an intangible asset exceeds its fair value, an impairment loss is recognized in an amount equal to that excess. There was no impairment of indefinite lived intangible assets during the years ended December 31, 2015, 2014 and 2013.

Fair Value of Financial Instruments

Our financial instruments consist primarily of cash, accounts receivable, accounts payable and accrued expenses. The carrying amount of cash, accounts receivable, accounts payable and accrued expenses approximates their fair value because of the short-term maturity of such instruments, which are considered Level 1 assets under the fair value hierarchy.

We categorize our assets and liabilities that are valued at fair value on a recurring basis into a three-level fair value hierarchy as defined by ASC 820, Fair Value Measurements. The fair value hierarchy gives the highest priority to quoted prices in active markets for identical assets and liabilities (Level 1) and lowest priority to unobservable inputs (Level 3). Assets and liabilities recorded in the consolidated balance sheet at fair value are categorized based on a hierarchy of inputs, as follows:

Level 1

unadjusted quoted prices in active markets for identical assets or liabilities;

Level 2

quoted prices for similar assets or liabilities in active markets or inputs that are observable for the asset or liability, either directly or indirectly through market corroboration, for substantially the full term of the financial instrument; and

Level 3

unobservable inputs for the asset or liability.

At December 31, 2015 and 2014, we had no assets or liabilities that were valued at fair value on a recurring basis.

The fair value of indefinite-lived assets is measured on a non-recurring basis using significant unobservable inputs (Level 3) in connection with any required impairment test. There was no impairment of intangible assets during the years ended December 31, 2015, 2014 and 2013.

Income Taxes

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

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

We recognize both interest and penalties related to uncertain tax positions as part of the income tax provision. At December 31, 2015 and 2014, we had no tax positions relating to open tax returns that were considered to be uncertain.

Our tax returns are subject to review by the Internal Revenue Service three years after they are filed. Currently, years filed after 2012 are subject to review.

Share-Based Compensation

We measure the compensation costs of share-based compensation arrangements based on the grant-date fair value and recognize the costs in the financial statements over the period during which employees are required to provide services. Share-based compensation arrangements include options, restricted stock, restricted stock units, performance-based awards, share appreciation rights, and employee share purchase plans. As such, compensation cost is measured on the date of grant at fair value. 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 to value options. Calculating share-based compensation expense requires the input of highly subjective judgment and assumptions, including forfeiture rates, estimates of expected life of the share-based award, stock price volatility and risk-free interest rates. The assumptions used in calculating the fair value of share-based awards represent our best estimates, but these estimates involve inherent uncertainties and the application of management judgment. As a result, if factors change and we use different assumptions, our share-based compensation expense could be materially different in the future.

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

We recognize the compensation expense for all share-based compensation granted, net of estimated forfeitures, based on the grant date fair value estimated in accordance with ASC 718. We generally recognize the compensation expense on a straight-line basis over the employee’s requisite service period. We estimate the forfeiture rate based on our historical experience of forfeitures. If our actual forfeiture rate is materially different from our estimate, share-based compensation expense could be significantly different from what we have recorded in the current period.

Debt Discounts

Costs incurred from parties that are providing long-term financing, which include warrants issued in connection with the underlying debt, are reflected as a debt discount based on the relative fair value of the debt and warrants to the total proceeds. We amortize discounts over the life of the related debt using the effective interest rate method.

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 over-the-counter (OTC) and prescription prenatal vitamin products are generally variations of the same product with slight modifications in formulation and marketing. The primary difference between our OTC and prescription prenatal vitamin products is the source of payment. Purchasers of our OTC prenatal vitamin products pay for the product directly while purchasers of our prescription prenatal vitamin products pay for the product primarily via third-party payers. Both OTC and prescription prenatal vitamin products share the same marketing support team utilizing similar marketing techniques. The revenue that is generated by us from major external customers is all generated from sales of our prescription prenatal vitamin products which is disclosed in Note 13. There are no major external customers for our OTC prenatal vitamin or other products.

OTC 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 OTC customers pay for our products with credit cards, and we usually receive the cash settlement in two to three banking days. Credit card sales minimize accounts receivable balances relative to OTC sales. We provide an unconditional 30-day money-back return policy under which we accept product returns from our retail and eCommerce OTC customers. We recognize revenue from OTC sales, net of estimated returns, 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 prescription products 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 prescription products until the right of return no longer existed as prior to that date, we could not reasonably estimate the amount of future returns.

We offer 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 that we have offered based on our experience and industry averages, which is reviewed, and adjusted if necessary, on a quarterly basis.

Segment Reporting

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

Shipping and Handling Costs

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

Advertising Costs

We expense advertising costs when incurred. Advertising costs were $792,574, $698,871 and $11,739 during the years ended December 31, 2015, 2014 and 2013, respectively.

Research and Development Expenses

Research and development, or R&D, expenses include internal R&D activities, services of external contract research organizations, or CROs, costs of their clinical research sites, manufacturing, scale-up and validation costs, and other activities. Internal R&D activity expenses include laboratory supplies, salaries, benefits, and non-cash share-based compensation expenses. Advance payments to be expensed in future research and development activities are capitalized, and were $1,138,073 at December 31, 2015, of which $1,009,175 was included in other current assets and $128,898 was included in long term prepaid expense on the accompanying consolidated balance sheets. Advance payments to be expensed in future R&D 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 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 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 R&D, patents and regulatory matters. These consulting and legal expenses were direct costs associated with preparing, reviewing, and undertaking work for our clinical trials and investigative drugs. We charge internal R&D activities and other activity expenses to operations as incurred. We make payments to CROs based on agreed-upon terms, which may include payments in advance of a study starting date. We expense nonrefundable advance payments for goods and services that will be used in future R&D activities when the activity has been performed or when the goods have been received rather than when the payment is made. We review and accrue CRO expenses and clinical trial study expenses based on services performed and rely on estimates of those costs applicable to the completion stage of a study as provided by CROs. Estimated accrued CRO costs are subject to revisions as such studies progress to completion. We charge revisions expense in the period in which the facts that give rise to the revision become known.

Earnings Per Share

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

The table below presents 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 December 31,
	2015		2014		2013
Stock options		20,725,325		16,792,443		15,632,742
Warrants		12,722,431		13,927,916		14,293,499
		33,447,756		30,720,359		29,926,241

Subsequent to December 31, 2015, we issued 17,424,242 shares of our Common Stock at a public offering price of $8.25 per share. In January 2016, certain individuals exercised stock options to purchase 281,657 shares of our Common Stock for approximately $758,000 in cash. In addition, warrants to purchase 500,000 shares of our Common Stock were exercised for approximately $1,285,000 in cash. See Note 16 - Subsequent Events for more details.

Concentration of Credit Risk and other Risks and Uncertainties

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

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

Use of Estimates

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

Reclassifications

Certain 2014 and 2013 amounts have been reclassified to conform to current year presentation.

Recently Issued Accounting Pronouncements

In November 2015, the FASB issued Accounting Standards Update, or ASU, No. 2015-17, Income Taxes (Topic 740), Balance Sheet Classification of Deferred Taxes. This guidance requires companies to classify all deferred tax assets and liabilities as noncurrent on the balance sheet instead of separating deferred taxes into current and noncurrent amounts. Also, companies will no longer allocate valuation allowances between current and noncurrent deferred tax assets because those allowances also will be classified as noncurrent. For public business entities, the guidance is effective for financial statements issued for annual periods beginning December 15, 2016, and interim periods within those annual periods. Companies can adopt the guidance either prospectively or retrospectively. We adopted this guidance in the fourth quarter of 2015. The adoption of this guidance did not have a material impact on our consolidated financial statements or disclosures.

In July 2015, the FASB issued ASU 2015-11, Inventory (Topic 330), simplifying the Measurement of Inventory. This guidance 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, if any, on our consolidated financial statements and disclosures.

In June 2015, the FASB issued ASU No. 2015-10, Technical Corrections and Improvements, to correct differences between original guidance and the 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 adoption of ASU 2015-10 did not 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.

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INVENTORY

12 Months Ended

Dec. 31, 2015

Inventory Disclosure [Abstract]

INVENTORY

NOTE 3 – INVENTORY

Inventory consists of the following:

	December 31,
	2015		2014
Finished product	$	661,167	$	874,294
Raw material		28,986		155,341
Deferred costs		—		152,478
TOTAL INVENTORY	$	690,153	$	1,182,113

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OTHER CURRENT ASSETS

12 Months Ended

Dec. 31, 2015

Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract]

OTHER CURRENT ASSETS

NOTE 4 – OTHER CURRENT ASSETS

Other current assets consist of the following:

	December 31,
	2015		2014
Prepaid insurance	$	695,421	$	394,878
Prepaid research and development costs		674,353		299,498
Other prepaid costs		369,812		181,186
Prepaid consulting		334,822		411,864
Prepaid vendor deposits		159,489		—
Other receivables-related party (Note 12)		—		249,981
TOTAL OTHER CURRENT ASSETS	$	2,233,897	$	1,537,407

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FIXED ASSETS, NET

12 Months Ended

Dec. 31, 2015

Property, Plant and Equipment [Abstract]

FIXED ASSETS

NOTE 5 – FIXED ASSETS, NET

Fixed assets, net consist of the following:

	December 31,
	2015			2014
Equipment	$	132,150		$	132,150
Accounting system in process		149,699			—
Furniture and fixtures		69,454			53,895
		351,303			186,045
Accumulated depreciation		(152,711	)		(122,752	)
TOTAL FIXED ASSETS, NET	$	198,592		$	63,293

Depreciation expense for the years ended December 31, 2015, 2014, and 2013 was $29,959, $28,987 and $47,883, respectively.

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PREPAID EXPENSE

12 Months Ended

Dec. 31, 2015

Prepaid Expense and Other Assets [Abstract]

PREPAID EXPENSE

NOTE 6 –PREPAID EXPENSE

Prepaid expense (long-term) consists of the following:

	December 31,
	2015		2014
Prepaid manufacturing costs	$	980,985	$	963,543
Prepaid research and development costs		128,898		463,720
TOTAL PREPAID EXPENSE	$	1,109,883	$	1,427,263

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INTANGIBLE ASSETS

12 Months Ended

Dec. 31, 2015

Goodwill and Intangible Assets Disclosure [Abstract]

INTANGIBLE ASSETS

NOTE 7 – INTANGIBLE ASSETS, NET

The following table sets forth the gross carrying amount, accumulated amortization and net carrying amount of our intangible assets as of December 31, 2015 and 2014:

	December 31, 2015
	Gross Carrying Amount		Accumulated Amortization			Net Amount		Weighted- Average Remaining Amortization Period (yrs.)
Amortizable intangible assets:
OPERA^® software patent	$	31,951	$	(4,493	)	$	27,458		13.75
Development costs of corporate website		91,743		(91,743	)		—		n/a
Approved hormone therapy drug candidate patents		705,752		(49,845	)		655,907		17
Hormone therapy drug candidate patents (in process)		774,165		—			774,165		n/a
Non-amortizable intangible assets:
Multiple trademarks for vitamins/supplements		157,721		—			157,721		indefinite
Total	$	1,761,332	$	(146,081	)	$	1,615,251

	December 31, 2014
	Gross Carrying Amount		Accumulated Amortization			Net Amount		Weighted- Average Remaining Amortization Period (yrs.)
Amortizable intangible assets:
OPERA^® software patent	$	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
Hormone therapy drug candidate patents (in process)		675,982		—			675,982		n/a
Non-amortizable intangible assets:
Multiple trademarks for vitamins/supplements		103,368		—			103,368		indefinite
Total	$	1,342,228	$	(113,640	)	$	1,228,588

We amortize the approved hormone therapy drug candidate patents using straight-line method over the estimated useful life of approximately 20 years, which is the life of intellectual property patents.. As of December 31, 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 years ended December 31, 2015 and 2014, there was no impairment recognized related to intangible assets.

In addition to numerous pending patent applications, as of December 31, 2015, we had fourteen issued patents, including:

· 12 utility patents that relate to our combination progesterone and estradiol product candidates, 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, Brazil, Canada, Europe, Israel, Japan, Mexico, Russia, South Africa and South Korea.

· one utility patent that relates to TX-004HR, our applicator-free vaginal estradiol softgel product candidate, which establishes an important intellectual property foundation for TX-004HR, is owned by us and is a U.S. jurisdiction patent with an expiration date in 2033. We have pending patent applications with respect to this patent in Argentina, Australia, Brazil, Canada, Europe, Israel, Japan, Mexico, Russia, South Africa, and South Korea.

· one utility 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.

Amortization expense was $32,441, $23,480, and $10,262 for the years ended December 31, 2015, 2014, and 2013, respectively. Estimated amortization expense for the next five years is as follows:

Year Ending December 31,		Estimated Amortization
	2016	$	40,580
	2017	$	40,580
	2018	$	40,580
	2019	$	40,580
	2020	$	40,580

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OTHER CURRENT LIABILITIES

12 Months Ended

Dec. 31, 2015

Other Liabilities Disclosure [Abstract]

OTHER CURRENT LIABILITIES

NOTE 8 – OTHER CURRENT LIABILITIES

Other current liabilities consist of the following:

	December 31,
	2015		2014
Accrued clinical trial costs	$	3,725,377	$	1,706,542
Accrued payroll, bonuses and commission costs		2,108,143		814,205
Accrued compensated absences		562,096		442,430
Other accrued expenses		546,264		185,965
Allowance for coupons and returns		224,300		90,446
Accrued legal and accounting expense		210,309		276,470
Accrued rent		83,527		91,368
Accrued royalties		46,851		72,710
Allowance for wholesale distributor fees		32,659		160,503
TOTAL OTHER CURRENT LIABILITIES	$	7,539,526	$	3,840,639

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NOTES PAYABLE

12 Months Ended

Dec. 31, 2015

Debt Disclosure [Abstract]

NOTES PAYABLE

NOTE 9 – NOTES PAYABLE

Issuance and Payment of Multiple Advance Revolving Credit Note

On January 31, 2013, we entered into a business loan agreement with Plato and Associates, LLC, or Plato, for a Multiple Advance Revolving Credit Note, or the Revolving Credit Note. The Revolving Credit Note allowed us to draw down funding up to a $10,000,000 maximum principal amount, at a stated interest rate of 6% per annum. Plato was able to make advances to us from time to time under the Revolving Credit Note at our request, which advances were of a revolving nature and were able to be made, repaid, and made from time to time. Interest payments were due and payable on the tenth day following the end of each calendar quarter in which any interest was accrued and unpaid, commencing on April 10, 2013, and the principal balance outstanding under the Revolving Credit Note, together with all accrued interest and other amounts payable under the Revolving Credit Note, if any, was due and payable on February 24, 2014. The Revolving Credit Note was secured by substantially all of our assets. On each of February 25 and March 13, 2013, $200,000 was drawn against the Revolving Credit Note. On March 21, 2013, we repaid $401,085, which included accrued interest, and there was no balance outstanding under the Revolving Credit Note as of December 31, 2013 and February 24, 2014 when it expired. As additional consideration for the Revolving Credit Note, we granted to Plato a warrant to purchase 1,250,000 shares of our Common Stock at an exercise price of $3.20 per share (See Note 10).

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STOCKHOLDERS' EQUITY

12 Months Ended

Dec. 31, 2015

Stockholders' Equity:

STOCKHOLDERS' EQUITY

NOTE 10 – STOCKHOLDERS’ EQUITY

Preferred Stock

At December 31, 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 December 31, 2015, we had 350,000,000 shares of Common Stock authorized for issuance, of which 177,928,041 shares of our Common Stock were issued and outstanding. During the year ended December 31, 2015, our stockholders’ approved an amendment to our articles of incorporation to increase the number of authorized shares of Common Stock from 250,000,000 to 350,000,000.

Issuances During 2015

On July 9, 2015, we entered into an underwriting agreement with Stifel, Nicolaus & Company, Incorporated and Guggenheim Securities, LLC, as the representatives of the several underwriters, or the Stifel Underwriters, relating to an underwritten public offering of 3,846,154 shares of Common Stock at a public offering price of $7.80 per share. Under the terms of the underwriting agreement, we granted the Stifel Underwriters a 30-day option to purchase up to an aggregate of 576,923 additional shares of Common Stock, which option was exercised in full. The net proceeds to us from the offering were approximately $32.2 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.

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

Subsequent to December 31, 2015, we issued 17,424,242 shares of our Common Stock in an underwritten public offering at a public offering price of $8.25 per share. In January 2016, certain individuals exercised stock options to purchase 281,657 shares of our Common Stock for approximately $758,000 in cash. In addition, warrants to purchase 500,000 shares of our Common Stock were exercised for approximately $1,285,000 in cash. See Note 16 - Subsequent Events for more details.

Issuances During 2014

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.

During the year ended December 31, 2014, certain individuals exercised stock options to purchase 860,800 shares of our Common Stock. Stock options to purchase shares of our Common Stock were exercised as follows: (i) 724,193 options for $345,746 in cash and (ii) 136,607 options, pursuant to the stock options’ cashless provision, wherein 130,380 shares of Common Stock were issued. In addition, during 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.

Issuances During 2013

On March 14, 2013, we entered into an underwriting agreement with Jefferies LLC as the representative of the underwriters named therein, or the Jefferies Underwriters, relating to the issuance and sale of 29,411,765 shares of our Common Stock. The price to the public in the offering was $1.70 per share. In addition, under the terms of the underwriting agreement, we granted the Jefferies Underwriters a 30-day option to purchase up to an additional 4,411,765 shares of our Common Stock. The offering closed on March 20, 2013. On April 12, 2013, the Jefferies Underwriters exercised their option to purchase an additional 1,954,587 shares of our Common Stock, which were issued on April 18, 2013. The net proceeds to us from this offering were approximately $48.5 million, after deducting underwriting discounts and commissions and other offering expenses payable by us.

On September 25, 2013, we entered into an underwriting agreement with Stifel, Nicolaus & Company, Incorporated, as the representative of the underwriters named therein, relating to the issuance and sale of 13,750,000 shares of our Common Stock. The price to the public in the offering was $2.40 per share. The net proceeds to us from this offering were approximately $30.2 million, after deducting underwriting discounts and commissions and other offering expenses payable by us. The offering closed on September 30, 2013.

During the year ended December 31, 2013, certain individuals exercised options to purchase an aggregate of 75,423 shares of our Common Stock for approximately $31,000.

Warrants to Purchase Common Stock

As of December 31, 2015, we had warrants outstanding to purchase an aggregate of 12,722,431 shares of our Common Stock with a weighted-average contractual remaining life of 1.7 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 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.

During the year ended December 31, 2015, we granted warrants to purchase 50,000 shares of Common Stock to an outside consultant at an exercise price of $6.35, vesting ratably over a 12 month period, with an expiration date of April 6, 2020. The grant date fair value of this warrant was $3.27. During the year ended December 31, 2015, we recorded $139,142 as non-cash compensation in the accompanying consolidated financial statements related to this warrant.

In January 2013, we issued warrants to purchase 1,250,000 shares of our Common Stock in connection with the issuance of the Revolving Credit Note, or the Plato Warrant (see NOTE 9 above for more details). 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 approximately $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%. During the years ended December 31, 2015, 2014 and 2013, $0, $260,027 and $1,451,934, 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 SCI, to develop drug platforms to be used in our hormone replacement drug candidates. These services include support of our efforts to successfully obtain U.S. Food and Drug Administration, or the FDA, approval for our drug candidates, including a vaginal capsule for the treatment of vulvar and vaginal atrophy, or VVA. In connection with the agreement, SCI agreed to forfeit its rights to receive warrants to purchase 833,000 shares of our Common Stock that were to be granted pursuant to the terms of a prior consulting agreement dated May 17, 2012. As consideration under the agreement, we agreed to issue to SCI a warrant to purchase 850,000 shares of our Common Stock at $2.01 per share that has vested or will vest, as applicable, as follows:

283,333 shares were earned on May 11, 2013 upon acceptance of an Investigational New Drug application by the FDA for an estradiol-based drug candidate in a softgel vaginal capsule for the treatment of VVA; however, pursuant to the terms of the consulting agreement, the shares did not vest until June 30, 2013. The fair value of $405,066 for the shares vested on June 30, 2013 was determined by using the Black-Scholes Model on the date of vesting using a term of 5 years; a volatility of 45.89%; risk free rate of 1.12%; and a dividend yield of 0%. We recorded the entire $405,066 as non-cash compensation as of June 30, 2013;

283,333 shares vested on June 30, 2013. The fair value of $462,196 for these shares was determined by using the Black-Scholes Model on the date of vesting using a term of 5 years; a volatility of 45.84%; risk free rate of 1.41%; and a dividend yield of 0%. During the years ended December 31 2015, 2014 and 2013, we recorded $154,068, $154,068 and $77,034, respectively, as non-cash compensation in the accompanying consolidated financial statements related to this warrant. As of December 31, 2015, there was a remaining balance of $77,026 related to this warrant which was included in other current assets in the accompanying consolidated financial statements; and

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.

In May 2012, we issued warrants to purchase an aggregate of 1,300,000 shares of Common Stock to an unaffiliated entity for services to be rendered over approximately five years beginning in May 2012. Services provided are to include (a) services in support of our drug development efforts, including services in support our ongoing and future drug development and commercialization efforts, regulatory approval efforts, third-party investment and financing efforts, marketing efforts, chemistry, manufacturing and controls efforts, drug launch and post-approval activities, and other intellectual property and know-how transfer associated therewith; (b) services in support of our efforts to successfully obtain New Drug Approval; and (c) other consulting services as mutually agreed upon from time to time in relation to new drug development opportunities. The warrants were valued at $1,532,228 on the date of the issuance using an exercise price of $2.57; a term of five years; a volatility of 44.71%; risk free rate of 0.74%; and a dividend yield of 0%. At December 31, 2015, we had $257,796 reported as prepaid expense-short term and $128,898 recorded as prepaid expense-long term associated with these warrants. During the years ended December 31, 2015, 2014 and 2013, we recorded $257,796, $309,165 and $360,528, respectively as non-cash compensation with respect to these warrants in the accompanying consolidated financial statements. The contract will expire upon the commercial manufacture of a drug product. We have determined that the process will take approximately five years.

As of December 31, 2015, unamortized costs associated with the SCI warrants issued in 2013 and 2012 totaled approximately $464,000 and will be recognized over a period of eighteen months.

Warrant exercises

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

During the year ended December 31, 2014, certain individuals exercised warrants to purchase 365,583 shares of Common Stock for $181,000 in cash.

Summary of our Warrant activity during the year ended December 31, 2015:

	Number of Shares Under Warrants			Weighted Average Exercise Price		Weighted Average Remaining Contractual Life in Years		Aggregate Intrinsic Value
Balance at December 31, 2014		13,927,916		$	1.82		3.0	$	36,623,875
Granted		50,000		$	6.35
Exercised		(1,255,485	)	$	0.79			$	7,282,404
Expired		—
Cancelled/Forfeited		—
Balance at December 31, 2015		12,722,431		$	1.93		1.7	$	107,344,752
Vested and Exercisable at December 31, 2015		12,422,432		$	1.92		1.6	$	104,909,091

The weighted average fair value per share of warrants issued and the assumptions used in the Black-Scholes Model during the years ended December 31, 2015, 2014 and 2013 are set forth in the table below.

	2015	2014	2013
Weighted average fair value	$6.35	n/a	$2.83
Risk-free interest rate	1.02%	n/a	0.88-1.12%
Volatility	60.59%	n/a	44.29-45.89%
Term (in years)	5	n/a	5-6
Dividend yield	0.00%	n/a	0.00%

The risk-free interest rate assumption is based upon observed interest rates on zero coupon U.S. Treasury bonds whose maturity period is appropriate for the term.

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. 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 have used the historical volatility of peer entities due to the lack of sufficient historical data of our stock price during 2011-2015.

Options to Purchase Common Stock of the Company

In 2009, we adopted the 2009 Long Term Incentive Compensation Plan, or the 2009 Plan, to provide financial incentives to employees, directors, advisers, and consultants of our company who are able to contribute towards the creation of or who have created stockholder value by providing them stock options and other stock and cash incentives, or the Awards. The Awards available under the 2009 Plan consist of stock options, stock appreciation rights, restricted stock, restricted stock units, performance stock, performance units, and other stock or cash awards as described in the 2009 Plan. There are 25,000,000 shares authorized for issuance thereunder. Generally, the options vest annually over four years or as determined by our board of directors, upon each option grant. Options may be exercised by paying the price for shares or on a cashless exercise basis after they have vested and prior to the specified expiration date provided and applicable exercise conditions are met, if any. The expiration date is generally ten years from the date the option is issued. Prior to the merger with VitaMed, no Awards had been issued under the 2009 Plan. As of December 31, 2015, there were non-qualified stock options to purchase 17,856,851 shares of Common Stock outstanding under the 2009 Plan. As of December 31, 2015, there were 3,607,852 shares available to be issued under 2009 Plan.

In 2012, we adopted the 2012 Stock Incentive Plan, or the 2012 Plan, a non-qualified plan that was amended in August 2013. The 2012 Plan was designed to serve as an incentive for retaining qualified and competent key employees, officers, directors, and certain consultants and advisors of our company. The Awards available under the 2012 Plan consist of stock options, stock appreciation rights, restricted stock, restricted stock units, performance stock, performance units, and other stock or cash awards as described in the 2012 Plan. Generally, the options vest annually over four years or as determined by our board of directors, upon each option grant. Options may be exercised by paying the price for shares or on a cashless exercise basis after they have vested and prior to the specified expiration date provided and applicable exercise conditions are met, if any. The expiration date is generally ten years from the date the option is issued. There are 10,000,000 shares of Common Stock authorized for issuance thereunder. As of December 31, 2015, there were non-qualified stock options to purchase 2,868,474 shares of Common Stock outstanding under the 2012 Plan. As of December 31, 2015, there were 7,050,000 shares available to be issued under 2012 Plan.

The valuation methodology used to determine the fair value of stock options is the Black-Scholes Model. The Black-Scholes Model requires the use of a number of assumptions including volatility of the stock price, the risk-free interest rate, and the expected life of the stock options. The ranges of assumptions used in the Black-Scholes Model during the years ended December 31, 2015, 2014 and 2013 are set forth in the table below.

	2015	2014	2013
Risk-free interest rate	1.47-1.67%	0.07-1.77%	0.65-1.71%
Volatility	58.78-62.94%	68.05-82.29%	33.35-45.76%
Term (in years)	5.27-6.25	5-6.25	5-6.25
Dividend yield	0.00%	0.00%	0.00%

The risk-free interest rate assumption is based upon observed interest rates on zero coupon U.S. Treasury bonds whose maturity period is appropriate for the expected term. Estimated volatility is a measure of the amount by which the 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 during the year ended December 31, 2015 is as follows:

	Number of Shares Under Options			Weighted Average Exercise Price		Weighted Average Remaining Contractual Life in Years		Aggregate Intrinsic Value
Balance at December 31, 2014		16,792,443		$	1.88		6.9	$	43,996,311
Granted		4,685,000		$	8.14
Exercised		(613,284	)	$	2.01
Expired		(102,500	)	$	2.68
Cancelled/Forfeited		(36,334	)	$	4.02
Balance at December 31, 2015		20,725,325		$	3.28		6.5	$	146,864,184
Vested and Exercisable at December 31, 2015		15,461,986		$	1.86		5.5	$	131,523,505
Unvested at December 31, 2015		5,263,339		$	7.46		9.4	$	15,340,679

At December 31, 2015, our outstanding 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 during the year ended December 31, 2015 was $4.45. The total intrinsic value of options exercised during the year ended December 31, 2015 was $3,186,371.

Share-based compensation expense related to options recognized in our results of operations for the years ended December 31, 2015, 2014 and 2013 was $6,621,658, $4,393,455 and $3,200,655, respectively, and it is based on awards vested. We estimate forfeitures at the time of grant and revise the forfeiture rate in subsequent periods if actual forfeitures differ from the estimates. At December 31, 2015, total unrecognized estimated compensation expense related to unvested options was approximately $19.8 million, which may be adjusted for future changes in forfeitures. This cost is expected to be recognized over a weighted-average period of 1.7 years. No tax benefit was realized due to a continued pattern of operating losses.

In December 2013, we granted a restricted stock unit, or the RSU, under our 2012 Plan to an employee for 50,000 shares of our Common Stock having a fair value of $233,500. During the years ended December 31, 2014 and 2013, we recorded $53,428 and $180,072, respectively, of non-cash compensation related to the RSU on the accompanying consolidated financial statements. The RSU was issued in June 2014.

- Definition

The entire disclosure for shareholders' equity comprised of portions attributable to the parent entity and noncontrolling interest, including other comprehensive income. Includes, but is not limited to, balances of common stock, preferred stock, additional paid-in capital, other capital and retained earnings, accumulated balance for each classification of other comprehensive income and amount of comprehensive income.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef
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-Name Accounting Standards Codification
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-Subparagraph (SX 210.4-08.(d),(e))
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-Publisher FASB
-Name Accounting Standards Codification
-Glossary Preferred Stock
-URI http://asc.fasb.org/extlink&oid=6521494

Reference 12: http://www.xbrl.org/2003/role/presentationRef
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Reference 14: http://www.xbrl.org/2003/role/presentationRef
-Publisher SEC
-Name Staff Accounting Bulletin (SAB)
-Number Topic 4
-Section E

Reference 15: http://www.xbrl.org/2003/role/presentationRef
-Publisher SEC
-Name Staff Accounting Bulletin (SAB)
-Number Topic 4
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+ Details

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INCOME TAXES

12 Months Ended

Dec. 31, 2015

Income Tax Disclosure [Abstract]

INCOME TAXES

NOTE 11 – INCOME TAXES

For the years ended December 31, 2015, 2014 and 2013, there was no provision for income taxes, current or deferred. All product sales are derived from sales in the United States.

At December 31, 2015, we had a federal net operating loss carry forward of $192,601,415 available to offset future taxable income through 2035. The federal carryforwards will begin to expire in 2021.

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

	2015			2014			2013
Federal statutory tax rate		34.0	%		34.0	%		35.0	%
State tax rate, net of federal tax benefit		4.73	%		5.8	%		5.8	%
Adjustment in valuation allowances		(38.97	)%		(50.9)	%		(32.4	)%
Permanent and other differences		0.24	%		11.1	%		(8.4	)%
Provision (benefit) for income taxes		—	%		—	%		—	%

Deferred income taxes result from temporary differences between the amount of assets and liabilities recognized for financial reporting and tax purposes. The components of the net deferred income tax asset as of December 31, 2015, 2014, and 2013 are as follows:

	2015			2014			2013
Deferred Income Tax Assets:
Net operating losses	$	79,499,633		$	43,091,437		$	14,773,537
R&D Credit		186,347			—			547,511
Total deferred income tax asset		79,685,980			43,091,437			15,321,048
Valuation allowance		(79,685,980	)		(43,091,437	)		(15,321,048	)
Deferred income tax assets, net	$	—		$	—		$	—

We believe that it is more likely than not that we will not generate sufficient future taxable income to realize the tax benefits related to the deferred tax assets on our balance sheet and as such, a valuation allowance has been established against the deferred tax assets for the period ended December 31, 2015.

Unrecognized Tax Benefits

As of the period ended December 31, 2015, we have no unrecognized tax benefits.

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RELATED PARTIES

12 Months Ended

Dec. 31, 2015

RELATED PARTIES

NOTE 12 – RELATED PARTIES

Agreements with Pernix Therapeutics, LLC

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 years ended December 31, 2015, 2014 and 2013, we did not engage in any transactions with Pernix. As of December 31, 2014 and 2013, there were amounts due to 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 as of the years ended December 31, 2014 and 2013. During the year ended December 31, 2015, we entered into a settlement agreement with Pernix according to which Pernix paid us $175,000 in cash, resulting in the elimination of the approximately $46,000 outstanding payable and $250,000 outstanding receivable disclosed above and the recording of approximately $29,000 in settlement fees on the accompanying consolidated financial statements.

- Definition

The entire disclosure for related party transactions. Examples of related party transactions include transactions between (a) a parent company and its subsidiary; (b) subsidiaries of a common parent; (c) and entity and its principal owners; and (d) affiliates.

+ References + Details

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BUSINESS CONCENTRATIONS

12 Months Ended

Dec. 31, 2015

Risks and Uncertainties [Abstract]

BUSINESS CONCENTRATIONS

NOTE 13 - BUSINESS CONCENTRATIONS

We purchase our products from several suppliers with approximately 60%, 82% and 98% of our purchases supplied by one vendor for the years ended December 31, 2015, 2014 and 2013, respectively.

We sell our prescription prenatal vitamin products to wholesale distributors, specialty pharmacies, specialty distributors, and chain drug stores that generally sell products to retail pharmacies, hospitals, and other institutional customers. During the year ended December 31, 2015, two customers each generated more than 10% of our total revenues and during the years ended December 31, 2014 and 2013, four customers each generated more than 10% of our total revenues. Revenue generated from two major customers combined accounted for approximately 67% of total revenue during the year ended December 31, 2015. Revenue generated from four major customers combined accounted for approximately 75% and 79% of our recognized revenue during the years ended December 31, 2014 and 2013, respectively.

Customers that generated more than 10% of our sales are designated as customers “A”, “B”, “C” and “D”. During the year ended December 31, 2015, customer A generated $8,848,243 in revenues and customer B generated approximately $4,843,463 in revenues. During the year ended December 31, 2014 customers A, B, C and D generated $1,609,950, $1,586,903, $1,804,018 and $4,053,838 in sales, respectively. During the year ended December 31, 2013, customers A, B, C and D generated $1,221,212, $1,711,417, $2,588,626 and $1,312,192 in sales, respectively.

Prior to January 1, 2015, we deferred the recognition of revenue on prescription products until the right of return no longer existed as prior to that date, we could not reasonably estimate the amount of future returns. Revenue generated by major customers accounted for approximately 97% of deferred revenue for both periods ended December 31, 2014 and 2013. As of January 1, 2015, we started estimating returns based on historical return rates and recorded actual product returns against this reserve as received. As a result no deferred revenue was recorded for the year ended December 31, 2015.

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COMMITMENTS AND CONTINGENCIES

12 Months Ended

Dec. 31, 2015

Commitments and Contingencies Disclosure [Abstract]

COMMITMENTS AND CONTINGENCIES

NOTE 14 – COMMITMENTS AND CONTINGENCIES

Operating Lease

We lease administrative office space in Boca Raton, Florida pursuant to a 63 month non-cancelable operating lease that commenced on July 1, 2013. The lease expires on September 30, 2018 and we have an option to extend the lease term for a period of five years. 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. This addendum was effective beginning April 1, 2015 and will expire with the original lease term on September 30, 2018.

The rental expense related to our current lease during the years ended December 31, 2015 and 2014 was $446,099 and $361,793, respectively. The rental expense during the year ended December 31, 2013 consisted of $180,894 expense related to our current lease and $60,168 expense related to our prior lease which expired June 30, 2013. The rental expense during the years ended December 31, 2014 and 2013 was partially offset by the rent income of $41,613 and $32,963, respectively. We did not sublet any space during the year ended December 31, 2015.

As of December 31, 2015, future minimum rental payments on non-cancelable operating leases are as follows:

Years Ending December 31,
	2016	$	493,790
	2017		507,087
	2018		388,976
	2019		—
	Total minimum lease payments	$	1,389,853

Legal Proceedings

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

Off-Balance Sheet Arrangements

As of December 31, 2015, 2014 and 2013, we had no off-balance sheet arrangements that have had or are reasonably likely to have current or future effect on our financial condition, changes in financial condition, revenues or expenses, results of operations, liquidity, capital expenditures or capital resources that are material to investors.

Employment Agreements

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

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SELECTED QUARTERLY FINANCIAL DATA (UNAUDITED)

12 Months Ended

Dec. 31, 2015

Quarterly Financial Information Disclosure [Abstract]

SELECTED QUARTERLY FINANCIAL DATA (UNAUDITED)

NOTE 15 – SELECTED QUARTERLY FINANCIAL DATA (UNAUDITED)

Summarized quarterly financial data for fiscal years 2015 and 2014 is as follows:

	2015 Quarters
(In thousands, except per share)		1^st			2^nd			3^rd			4^th
Revenues	$	4,475		$	4,848		$	5,190		$	5,630
Gross profit	$	3,431		$	3,815		$	3,996		$	4,395
Net loss	$	(20,895	)	$	(27,227	)	$	(19,472	)	$	(17,483	)

Loss per common share, basic and diluted	$	(0.13	)	$	(0.16	)	$	(0.11	)	$	(0.10	)

	2014 Quarters
(In thousands, except per share)		1^st			2^nd			3^rd			4^th
Revenues	$	2,831		$	3,752		$	4,186		$	4,257
Gross profit	$	2,000		$	2,859		$	3,118		$	3,377
Net loss	$	(9,183	)	$	(10,899	)	$	(17,832	)	$	(16,303	)

Loss per common share, basic and diluted	$	(0.06	)	$	(0.07	)	$	(0.12	)	$	(0.10	)

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SUBSEQUENT EVENTS

12 Months Ended

Dec. 31, 2015

Subsequent Events [Abstract]

SUBSEQUENT EVENTS

NOTE 16 – SUBSEQUENT EVENTS

On January 6, 2016, we entered into an underwriting agreement with Goldman Sachs and Cowen and Company, LLC, as the representatives of the several underwriters, or the Underwriters, relating to an underwritten public offering of 15,151,515 shares of our Common Stock at a public offering price of $8.25 per share. Under the terms of the underwriting agreement, we granted the Underwriters a 30-day option to purchase up to an aggregate of 2,272,727 additional shares of Common Stock, which option was exercised in full. The net proceeds from the offering were approximately $134.9 million, after deducting underwriting discounts and commissions and other estimated offering expenses payable by us. The offering closed on January 12, 2016.

In January 2016, certain individuals exercised stock options to purchase 281,657 shares of our Common Stock for approximately $758,000 in cash and warrants to purchase 500,000 shares of our Common Stock were exercised for approximately $1,285,000 in cash.

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SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies)

12 Months Ended

Dec. 31, 2015

Accounting Policies [Abstract]

Principles of Consolidation

Cash

Trade Accounts Receivable and Allowance for Doubtful Accounts

Inventories

Pre-Launch Inventory

Fixed Assets

Intangible Assets

Patents and Trademarks

Impairment of Long-Lived Assets

significant declines in an asset’s market price;

significant deterioration in an asset’s physical condition;

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

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

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

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

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

Fair Value of Financial Instruments

Level 1

unadjusted quoted prices in active markets for identical assets or liabilities;

Level 2

Level 3

unobservable inputs for the asset or liability.

At December 31, 2015 and 2014, we had no assets or liabilities that were valued at fair value on a recurring basis.

Income Taxes

Our tax returns are subject to review by the Internal Revenue Service three years after they are filed. Currently, years filed after 2012 are subject to review.

Share-Based Compensation

Debt Discounts

Revenue Recognition

OTC Products

Prescription Products

Segment Reporting

Shipping and Handling Costs

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

Advertising Costs

We expense advertising costs when incurred. Advertising costs were $792,574, $698,871 and $11,739 during the years ended December 31, 2015, 2014 and 2013, respectively.

Research and Development

Research and Development Expenses

Earnings Per Share

	As of December 31,
	2015		2014		2013
Stock options		20,725,325		16,792,443		15,632,742
Warrants		12,722,431		13,927,916		14,293,499
		33,447,756		30,720,359		29,926,241

Subsequent to December 31, 2015, we issued 17,424,242 shares of our Common Stock at a public offering price of $8.25 per share. In January 2016, certain individuals exercised stock options to purchase 281,657 shares of our Common Stock for approximately $758,000 in cash. In addition, warrants to purchase 500,000 shares of our Common Stock were exercised for $1,285,000 in cash. See Note 16 - Subsequent Events for more details.

Concentration of Credit Risk and other Risks and Uncertainties

Use of Estimates

Reclassifications

Certain 2014 and 2013 amounts have been reclassified to conform to current year presentation.

Recently Issued Accounting Pronouncements

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SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Tables)

12 Months Ended

Dec. 31, 2015

Accounting Policies [Abstract]

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

	As of December 31,
	2015		2014		2013
Stock options		20,725,325		16,792,443		15,632,742
Warrants		12,722,431		13,927,916		14,293,499
		33,447,756		30,720,359		29,926,241

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INVENTORY (Tables)

12 Months Ended

Dec. 31, 2015

Inventory Disclosure [Abstract]

Schedule of Inventory

Inventory consists of the following:

	December 31,
	2015		2014
Finished product	$	661,167	$	874,294
Raw material		28,986		155,341
Deferred costs		—		152,478
TOTAL INVENTORY	$	690,153	$	1,182,113

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OTHER CURRENT ASSETS (Tables)

12 Months Ended

Dec. 31, 2015

Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract]

Schedule of other current assets

Other current assets consist of the following:

	December 31,
	2015		2014
Prepaid insurance	$	695,421	$	394,878
Prepaid research and development costs		674,353		299,498
Other prepaid costs		369,812		181,186
Prepaid consulting		334,822		411,864
Prepaid vendor deposits		159,489		—
Other receivables-related party (Note 12)		—		249,981
TOTAL OTHER CURRENT ASSETS	$	2,233,897	$	1,537,407

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FIXED ASSETS, NET (Tables)

12 Months Ended

Dec. 31, 2015

Property, Plant and Equipment [Abstract]

Schedule of fixed assets

Fixed assets, net consist of the following:

	December 31,
	2015			2014
Equipment	$	132,150		$	132,150
Accounting system in process		149,699			—
Furniture and fixtures		69,454			53,895
		351,303			186,045
Accumulated depreciation		(152,711	)		(122,752	)
TOTAL FIXED ASSETS, NET	$	198,592		$	63,293

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PREPAID EXPENSE (Tables)

12 Months Ended

Dec. 31, 2015

Prepaid Expense and Other Assets [Abstract]

Schedule of prepaid expense

Prepaid expense (long-term) consists of the following:

	December 31,
	2015		2014
Prepaid manufacturing costs	$	980,985	$	963,543
Prepaid research and development costs		128,898		463,720
TOTAL PREPAID EXPENSE	$	1,109,883	$	1,427,263

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INTANGIBLE ASSETS (Tables)

12 Months Ended

Dec. 31, 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 December 31, 2015 and 2014:

	December 31, 2015
	Gross Carrying Amount		Accumulated Amortization			Net Amount		Weighted- Average Remaining Amortization Period (yrs.)
Amortizable intangible assets:
OPERA^® software patent	$	31,951	$	(4,493	)	$	27,458		13.75
Development costs of corporate website		91,743		(91,743	)		—		n/a
Approved hormone therapy drug candidate patents		705,752		(49,845	)		655,907		17
Hormone therapy drug candidate patents (in process)		774,165		—			774,165		n/a
Non-amortizable intangible assets:
Multiple trademarks for vitamins/supplements		157,721		—			157,721		indefinite
Total	$	1,761,332	$	(146,081	)	$	1,615,251

	December 31, 2014
	Gross Carrying Amount		Accumulated Amortization			Net Amount		Weighted- Average Remaining Amortization Period (yrs.)
Amortizable intangible assets:
OPERA^® software patent	$	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
Hormone therapy drug candidate patents (in process)		675,982		—			675,982		n/a
Non-amortizable intangible assets:
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
	2016	$	40,580
	2017	$	40,580
	2018	$	40,580
	2019	$	40,580
	2020	$	40,580

XML 47 R30.htm IDEA: XBRL DOCUMENT

OTHER CURRENT LIABILITIES (Tables)

12 Months Ended

Dec. 31, 2015

Other Liabilities Disclosure [Abstract]

Schedule of other current liabilities

Other current liabilities consist of the following:

	December 31,
	2015		2014
Accrued clinical trial costs	$	3,725,377	$	1,706,542
Accrued payroll, bonuses and commission costs		2,108,143		814,205
Accrued compensated absences		562,096		442,430
Other accrued expenses		546,264		185,965
Allowance for coupons and returns		224,300		90,446
Accrued legal and accounting expense		210,309		276,470
Accrued rent		83,527		91,368
Accrued royalties		46,851		72,710
Allowance for wholesale distributor fees		32,659		160,503
TOTAL OTHER CURRENT LIABILITIES	$	7,539,526	$	3,840,639

XML 48 R31.htm IDEA: XBRL DOCUMENT

STOCKHOLDERS' EQUITY (Tables)

12 Months Ended

Dec. 31, 2015

Stockholders' Equity Note [Abstract]

Schedule of warrant activity

Summary of our Warrant activity during the year ended December 31, 2015:

	Number of Shares Under Warrants			Weighted Average Exercise Price		Weighted Average Remaining Contractual Life in Years		Aggregate Intrinsic Value
Balance at December 31, 2014		13,927,916		$	1.82		3.0	$	36,623,875
Granted		50,000		$	6.35
Exercised		(1,255,485	)	$	0.79			$	7,282,404
Expired		—
Cancelled/Forfeited		—
Balance at December 31, 2015		12,722,431		$	1.93		1.7	$	107,344,752
Vested and Exercisable at December 31, 2015		12,422,432		$	1.92		1.6	$	104,909,091

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

	2015	2014	2013
Weighted average fair value	$6.35	n/a	$2.83
Risk-free interest rate	1.02%	n/a	0.88-1.12%
Volatility	60.59%	n/a	44.29-45.89%
Term (in years)	5	n/a	5-6
Dividend yield	0.00%	n/a	0.00%

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

The ranges of assumptions used in the Black-Scholes Model during the years ended December 31, 2015, 2014 and 2013 are set forth in the table below.

	2015	2014	2013
Risk-free interest rate	1.47-1.67%	0.07-1.77%	0.65-1.71%
Volatility	58.78-62.94%	68.05-82.29%	33.35-45.76%
Term (in years)	5.27-6.25	5-6.25	5-6.25
Dividend yield	0.00%	0.00%	0.00%

Schedule of plan activity

A summary of activity under the 2009 and 2012 Plans and related information during the year ended December 31, 2015 is as follows:

	Number of Shares Under Options			Weighted Average Exercise Price		Weighted Average Remaining Contractual Life in Years		Aggregate Intrinsic Value
Balance at December 31, 2014		16,792,443		$	1.88		6.9	$	43,996,311
Granted		4,685,000		$	8.14
Exercised		(613,284	)	$	2.01
Expired		(102,500	)	$	2.68
Cancelled/Forfeited		(36,334	)	$	4.02
Balance at December 31, 2015		20,725,325		$	3.28		6.5	$	146,864,184
Vested and Exercisable at December 31, 2015		15,461,986		$	1.86		5.5	$	131,523,505
Unvested at December 31, 2015		5,263,339		$	7.46		9.4	$	15,340,679

XML 49 R32.htm IDEA: XBRL DOCUMENT

INCOME TAXES (Tables)

12 Months Ended

Dec. 31, 2015

Income Tax Disclosure [Abstract]

Schedule of tax rate reconciliation

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

	2015			2014			2013
Federal statutory tax rate		34.0	%		34.0	%		35.0	%
State tax rate, net of federal tax benefit		4.73	%		5.8	%		5.8	%
Adjustment in valuation allowances		(38.97	)%		(50.9)	%		(32.4	)%
Permanent and other differences		0.24	%		11.1	%		(8.4	)%
Provision (benefit) for income taxes		—	%		—	%		—	%

Schedule of deferred tax assets and liabilities

	2015			2014			2013
Deferred Income Tax Assets:
Net operating losses	$	79,499,633		$	43,091,437		$	14,773,537
R&D Credit		186,347			—			547,511
Total deferred income tax asset		79,685,980			43,091,437			15,321,048
Valuation allowance		(79,685,980	)		(43,091,437	)		(15,321,048	)
Deferred income tax assets, net	$	—		$	—		$	—

XML 50 R33.htm IDEA: XBRL DOCUMENT

COMMITMENTS AND CONTINGENCIES (Tables)

12 Months Ended

Dec. 31, 2015

Commitments And Contingencies Tables

Schedule of future minimum rental payments

As of December 31, 2015, future minimum rental payments on non-cancelable operating leases are as follows:

Years Ending December 31,
	2016	$	493,790
	2017		507,087
	2018		388,976
	2019		—
	Total minimum lease payments	$	1,389,853

XML 51 R34.htm IDEA: XBRL DOCUMENT

SELECTED QUARTERLY FINANCIAL DATA (Tables)

12 Months Ended

Dec. 31, 2015

Quarterly Financial Information Disclosure [Abstract]

Schedule of quarterly unaudited summary information

Summarized quarterly financial data for fiscal years 2015 and 2014 is as follows:

	2015 Quarters
(In thousands, except per share)		1^st			2^nd			3^rd			4^th
Revenues	$	4,475		$	4,848		$	5,190		$	5,630
Gross profit	$	3,431		$	3,815		$	3,996		$	4,395
Net loss	$	(20,895	)	$	(27,227	)	$	(19,472	)	$	(17,483	)

Loss per common share, basic and diluted	$	(0.13	)	$	(0.16	)	$	(0.11	)	$	(0.10	)

	2014 Quarters
(In thousands, except per share)		1^st			2^nd			3^rd			4^th
Revenues	$	2,831		$	3,752		$	4,186		$	4,257
Gross profit	$	2,000		$	2,859		$	3,118		$	3,377
Net loss	$	(9,183	)	$	(10,899	)	$	(17,832	)	$	(16,303	)

Loss per common share, basic and diluted	$	(0.06	)	$	(0.07	)	$	(0.12	)	$	(0.10	)

XML 52 R35.htm IDEA: XBRL DOCUMENT

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details Narrative)		2 Months Ended	12 Months Ended
	Jan. 12, 2016 shares	Feb. 17, 2016 shares	Dec. 31, 2015 USD ($)	Dec. 31, 2014 USD ($)	Dec. 31, 2013 USD ($)
Advertising costs			$ 792,574	$ 698,871	$ 11,739
Federal insurance limits			$ 250,000
Number of issued patents			14
Shelf life of prescription products			24 months
Related to Research and Development Activities [Member]
Advance payments - total			$ 1,138,073	1,175,082
Advance payments - other assets current			1,009,175	711,362
Advance payments - long term prepaid expense			$ 128,898	$ 463,720
Subsequent Event- Underwriting Agreement [Member]
Shares issued in offerings, net of cost, shares \| shares	15,151,515	17,424,242
Minimum [Member]
Return period of unsalable prescription products			6 months
Maximum [Member]
Return period of unsalable prescription products			24 months

XML 53 R36.htm IDEA: XBRL DOCUMENT

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details) - shares	12 Months Ended
	Dec. 31, 2015	Dec. 31, 2014	Dec. 31, 2013
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Anti-dilutive shares excluded from earnings per share calculation	33,447,756	30,720,359	29,926,241
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	14,293,499
Stock Option [Member]
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Anti-dilutive shares excluded from earnings per share calculation	20,725,325	16,792,443	15,632,742

XML 54 R37.htm IDEA: XBRL DOCUMENT

INVENTORY (Details) - USD ($)	Dec. 31, 2015	Dec. 31, 2014
Inventory
Finished product	$ 661,167	$ 874,294
Raw material	28,986	155,341
Deferred costs		152,478
TOTAL INVENTORY	$ 690,153	$ 1,182,113

XML 55 R38.htm IDEA: XBRL DOCUMENT

OTHER CURRENT ASSETS (Details) - USD ($)	Dec. 31, 2015	Dec. 31, 2014
Other Current Assets
Prepaid insurance	$ 695,421	$ 394,878
Prepaid research and development costs	674,353	299,498
Other prepaid costs	369,812	181,186
Prepaid consulting	334,822	411,864
Prepaid vendor deposits	159,489
Other receivables-related party (Note 12)		249,981
TOTAL OTHER CURRENT ASSETS	$ 2,233,897	$ 1,537,407

XML 56 R39.htm IDEA: XBRL DOCUMENT

FIXED ASSETS, NET (Details Narrative) - USD ($)	12 Months Ended
FIXED ASSETS, NET (Details Narrative) - USD ($)	Dec. 31, 2015	Dec. 31, 2014	Dec. 31, 2013
Property, Plant and Equipment [Abstract]
Depreciation Expense	$ 29,959	$ 28,987	$ 47,883

XML 57 R40.htm IDEA: XBRL DOCUMENT

FIXED ASSETS, NET (Details) - USD ($)	Dec. 31, 2015	Dec. 31, 2014
Fixed assets, gross	$ 351,303	$ 186,045
Accumulated depreciation	(152,711)	(122,752)
TOTAL FIXED ASSETS	198,592	63,293
Equipment [Member]
Fixed assets, gross	132,150	132,150
Accounting System in Process [Member]
Fixed assets, gross	149,699
Furniture and Fixtures [Member]
Fixed assets, gross	$ 69,454	$ 53,895

XML 58 R41.htm IDEA: XBRL DOCUMENT

PREPAID EXPENSE (Details) - USD ($)	Dec. 31, 2015	Dec. 31, 2014
Prepaid Expense and Other Assets [Abstract]
Prepaid manufacturing costs	$ 980,985	$ 963,543
Prepaid research and development costs	128,898	463,720
TOTAL PREPAID EXPENSE	$ 1,109,883	$ 1,427,263

XML 59 R42.htm IDEA: XBRL DOCUMENT

INTANGIBLE ASSETS (Details Narrative)	12 Months Ended
INTANGIBLE ASSETS (Details Narrative)	Dec. 31, 2015 USD ($)	Dec. 31, 2014 USD ($)	Dec. 31, 2013 USD ($)
Amortization expense	$ 32,441	$ 23,480	$ 10,262
Number of issued patents	14
OPERA software patent [Member]
Number of issued patents	1
Approved Hormone Therapy Drug Candidate Patents [Member]
Useful Life	20 years
Utility Patent Progesterone and Estradiol Products [Member]
Number of issued patents	12
Utility Patent TX-004HR [Member]
Number of issued patents	1

XML 60 R43.htm IDEA: XBRL DOCUMENT

INTANGIBLE ASSETS (Details ) - USD ($)	12 Months Ended
INTANGIBLE ASSETS (Details ) - USD ($)	Dec. 31, 2015	Dec. 31, 2014
Finite-Lived Intangible Assets
Accumulated Amortization	$ (146,081)	$ (113,640)
Indefinite-Lived Intangible Assets
Gross Carrying Amount	1,761,332	1,342,228
Net Amount	1,615,251	1,228,588
Hormone therapy drug candidate patents - In Process [Member]
Indefinite-Lived Intangible Assets
Gross Carrying Amount	774,165	675,982
Net Amount	774,165	675,982
Multiple trademarks for vitamins/supplements [Member]
Indefinite-Lived Intangible Assets
Gross Carrying Amount	157,721	103,368
Net Amount	157,721	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 remaining amortization period	13 years 9 months	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	$ 705,752	$ 439,184
Accumulated Amortization	(49,845)	(19,401)
Net Amount	$ 655,907	$ 419,783
Weighted average remaining amortization period	17 years	18 years

XML 61 R44.htm IDEA: XBRL DOCUMENT

INTANGIBLE ASSETS (Details 1)	Dec. 31, 2015 USD ($)
Estimated amortization expense for the year:
2016	$ 40,580
2017	40,580
2018	40,580
2019	40,580
2020	$ 40,580

XML 62 R45.htm IDEA: XBRL DOCUMENT

OTHER CURRENT LIABILITIES (Details) - USD ($)	Dec. 31, 2015	Dec. 31, 2014
Other Liabilities Disclosure [Abstract]
Accrued clinical trial costs	$ 3,725,377	$ 1,706,542
Accrued payroll, bonuses and commission costs	2,108,143	814,205
Accrued compensated absences	562,096	442,430
Other accrued expenses	546,264	185,965
Allowance for coupons and returns	224,300	90,446
Accrued legal and accounting expense	210,309	276,470
Accrued rent	83,527	91,368
Accrued royalties	46,851	72,710
Allowance for wholesale distributor fees	32,659	160,503
TOTAL OTHER CURRENT LIABILITIES	$ 7,539,526	$ 3,840,639

XML 63 R46.htm IDEA: XBRL DOCUMENT

NOTES PAYABLE (Details Narrative) - Multiple Advance Revolving Credit Note (Plato Warrant) [Member] - USD ($)	Mar. 21, 2013	Mar. 13, 2013	Feb. 25, 2013	Jan. 31, 2013
Debt Instrument [Line Items]
Maximum borrowing amount				$ 10,000,000
Interest rate				6.00%
Proceeds from revolving credit note		$ 200,000	$ 200,000
Repayment of revolving credit note	$ 401,085
Number of shares upon warrant exercise (shares)				1,250,000
Exercise price of warrants (in dollars per unit)				$ 3.20

XML 64 R47.htm IDEA: XBRL DOCUMENT

STOCKHOLDERS' EQUITY (Details Narrative) - USD ($)							12 Months Ended
STOCKHOLDERS' EQUITY (Details Narrative) - USD ($)	Jul. 15, 2015	Jul. 09, 2015	Feb. 17, 2015	Feb. 10, 2015	Aug. 04, 2014	Jul. 29, 2014	Dec. 31, 2015	Dec. 31, 2014	Dec. 31, 2013
Common stock issued during the period							$ 91,374,649	$ 42,771,353	$ 78,650,353
Number of common stock issued during period for stock options exercised (shares)									75,423
Value of common stock issued during period for stock options exercised							$ 1,232,579	$ 345,746	$ 30,910
Options exercised [Member]
Number of common stock issued during period for stock options exercised (shares)							612,867	860,800	75,423
Value of common stock issued during period for stock options exercised							$ 1,232,579		$ 31,000
Number of stock options exercised							417	136,607
Number of stock options exercised in cashless exercise							114	130,380
Options exercised 1 [Member]
Number of common stock issued during period for stock options exercised (shares)								724,193
Value of common stock issued during period for stock options exercised								$ 345,746
Stifel Underwriters [Member]
Number of shares issued during the period (shares)	4,423,077	3,846,154
Share price (in dollars per share)		$ 7.80
Common stock issued during the period		$ 32,000,000
Additional common stock issued under offering (shares)		576,923
Number of days of the option to purchase shares		30 days
Cowen and Company, LLC (Underwriters) [Member]
Number of shares issued during the period (shares)			15,617,282	13,580,246
Share price (in dollars per share)				$ 4.05
Common stock issued during the period				$ 59,100,000
Additional common stock issued under offering (shares)				2,037,036
Number of days of the option to purchase shares				30 days
Goldman Sachs Underwriters [Member]
Number of shares issued during the period (shares)					9,850,106	8,565,310
Share price (in dollars per share)						$ 4.67
Common stock issued during the period						$ 42,800,000
Additional common stock issued under offering (shares)						1,284,796
Number of days of the option to purchase shares						30 days

XML 65 R48.htm IDEA: XBRL DOCUMENT

STOCKHOLDERS' EQUITY (Details Narrative 1) - USD ($)					12 Months Ended
STOCKHOLDERS' EQUITY (Details Narrative 1) - USD ($)	Sep. 25, 2013	Apr. 18, 2013	Mar. 20, 2013	Mar. 14, 2013	Dec. 31, 2015	Dec. 31, 2014	Dec. 31, 2013
Common stock issued during the period					$ 91,374,649	$ 42,771,353	$ 78,650,353
Number of common stock issued during period for stock options exercised (shares)							75,423
Value of common stock issued during period for stock options exercised					$ 1,232,579	$ 345,746	$ 30,910
Options exercised [Member]
Number of common stock issued during period for stock options exercised (shares)					612,867	860,800	75,423
Value of common stock issued during period for stock options exercised					$ 1,232,579		$ 31,000
Jefferies LLC (Underwriters) [Member]
Number of shares issued during the period (shares)				29,411,765
Share price (in dollars per share)				$ 1.70
Common stock issued during the period		$ 48,500,000
Number of days of the option to purchase shares				30 days
Total Additional common stock to be issued under offering (shares)			4,411,765
Additional common stock issued under offering (shares)		1,954,587
Stifel, Nicolaus & Company (Underwriters) [Member]
Number of shares issued during the period (shares)	13,750,000
Share price (in dollars per share)	$ 2.40
Common stock issued during the period	$ 30,200,000

XML 66 R49.htm IDEA: XBRL DOCUMENT

STOCKHOLDERS' EQUITY (Details Narrative 2) - USD ($)			1 Months Ended		12 Months Ended
STOCKHOLDERS' EQUITY (Details Narrative 2) - USD ($)	Jun. 30, 2013	May. 11, 2013	May. 31, 2013	Jan. 31, 2013	Dec. 31, 2015	Dec. 31, 2014	Dec. 31, 2013
Warrants:
Warrants outstanding					$ 12,772,431
Recognition period of unamortized costs					1 year 8 months 12 days
Financing costs						$ 260,027	$ 1,503,922
Multiple Advance Revolving Credit Note (Plato Warrant) [Member]
Warrants:
Exercise price of warrants (in dollars per share)				$ 3.20
Fair value of grant				$ 1,711,956
Number of shares upon warrant exercise (shares)				1,250,000
Expiration date of warrants				Jan. 31, 2019
Vesting date of warrants				Oct. 31, 2013
Expected term				6 years
Volatility rate				44.29%
Risk free rate				0.88%
Dividend yield				0.00%
Financing costs					$ 0	260,027	1,451,934
Warrants [Member] \| Minimum [Member]
Warrants:
Exercise price of warrants (in dollars per share)					$ .24
Warrants [Member] \| Maximum [Member]
Warrants:
Exercise price of warrants (in dollars per share)					$ 6.35
SCI - Warrants [Member]
Warrants:
Exercise price of warrants (in dollars per share)			$ 2.01
Fair value of grant	$ 462,196	$ 405,066
Warrants granted to purchase common stock (shares)			850,000
Non-cash compensation	$ 462,196	$ 405,066			$ 154,068	$ 154,068	$ 77,034
Unamortized costs of warrants					$ 464,000
Vesting date of warrants		Jun. 30, 2013
Expected term	5 years	5 years
Volatility rate	45.84%	45.89%
Risk free rate	1.41%	1.12%
Dividend yield	0.00%	0.00%
Forfeited warrants granted to purchase common stock (shares)			833,000
Vested warrants granted to purchase common stock (shares)	283,333	283,333
Warrants granted to purchase common stock expected to vest (shares)					283,333
Unamortized noncash compensation associated with warrants					$ 77,026
Recognition period of unamortized costs					18 years
Outside Consultant Warrants [Member]
Warrants:
Exercise price of warrants (in dollars per share)					$ 6.35
Warrants granted to purchase common stock (shares)					50,000
Non-cash compensation					$ 139,142
Grant date fair value (per share)					$ 3.27
Expiration date of warrants					Apr. 06, 2020

XML 67 R50.htm IDEA: XBRL DOCUMENT

STOCKHOLDERS' EQUITY (Details Narrative 3) - USD ($)	1 Months Ended	12 Months Ended
STOCKHOLDERS' EQUITY (Details Narrative 3) - USD ($)	May. 31, 2012	Dec. 31, 2015	Dec. 31, 2014	Dec. 31, 2013
Warrants:
Prepaid expenses - current		$ 369,812	$ 181,186
Warrants - Unaffiliated Entity [Member] [Member]
Warrants:
Exercise price of warrants (in dollars per share)	$ 2.57
Fair value of grant	$ 1,532,228
Warrants granted to purchase common stock (shares)	1,300,000
Non-cash compensation		257,796	$ 309,165	$ 360,528
Expected term	5 years
Volatility rate	44.71%
Risk free rate	0.74%
Dividend yield	0.00%
Prepaid expenses - current		257,796
Prepaid expenses - noncurrent		$ 128,898

XML 68 R51.htm IDEA: XBRL DOCUMENT

STOCKHOLDERS' EQUITY (Details Narrative 4) - USD ($)	1 Months Ended	12 Months Ended
STOCKHOLDERS' EQUITY (Details Narrative 4) - USD ($)	Dec. 31, 2013	Dec. 31, 2015	Dec. 31, 2014	Dec. 31, 2013
Share-based compensation expense		$ 6,621,658	$ 4,393,455	$ 3,200,655
Total unrecognized estimated compensation expense		$ 19,800,000
Recognized weighted-average period		1 year 8 months 12 days
Shares issued in exercise of warrants		$ 366,000	181,000
Weighted average grant date fair value (per share)		$ 4.45
Intrinsic value of options exercised		$ 3,186,371
Warrants [Member]
Shares issued in exercise of warrants		$ 366,000	$ 181,000
Shares issued in exercise of warrants, shares		945,485	365,583
Warrants exercised		(1,255,485)
Warrants - Issued [Member]
Shares issued in exercise of warrants, shares		232,197
Warrants exercised		(310,000)
Stock Option [Member] \| Minimum [Member]
Option exercise prices (in dollars per shares)		$ 0.10
Stock Option [Member] \| Maximum [Member]
Option exercise prices (in dollars per shares)		$ 8.92
2009 Long Term Incentive Compensation Plan [Member]
Number of shares authorized for issuance		25,000,000
Options outstanding, ending		17,856,851
Number of shares available for issuance		3,607,852
2012 Stock Incentive Plan [Member]
Number of shares authorized for issuance		10,000,000
Options outstanding, ending		2,868,474
Number of shares available for issuance		7,050,000
Grant - restricted stock unit (shares)	50,000
Fair value of grant	$ 233,500
Restricted stock expense			$ 53,428	$ 180,072

XML 69 R52.htm IDEA: XBRL DOCUMENT

STOCKHOLDERS' EQUITY (Details) - Warrants [Member]	12 Months Ended
STOCKHOLDERS' EQUITY (Details) - Warrants [Member]	Dec. 31, 2015 USD ($) $ / shares shares
Number of shares under warrant
Warrants outstanding, beginning \| shares	13,927,916
Warrants exercised \| shares	(1,255,485)
Warrants outstanding, ending \| shares	12,722,431
Vested and Exercisable \| shares	12,422,432
Weighted Average Exercise Price
Warrants outstanding, beginning	$ 1.82
Warrants granted	6.35
Warrants exercised	0.79
Warrants outstanding, ending	1.93
Vested and Exercisable	$ 1.92
Weighted Average Remaining Contractual Life
Warrants outstanding, beginning	3 years
Warrants outstanding, ending	1 year 8 months 12 days
Vested and Exercisable	1 year 7 months 6 days
Aggregate Intrinsic Value
Warrants outstanding, beginning \| $	$ 36,623,875
Warrants exercised \| $	7,282,404
Warrants outstanding, ending \| $	107,344,752
Vested and Exercisable \| $	$ 104,909,091

XML 70 R53.htm IDEA: XBRL DOCUMENT

STOCKHOLDERS' EQUITY (Details 1) - Warrants [Member] - $ / shares	12 Months Ended
	Dec. 31, 2015	Dec. 31, 2013
Class of Warrant or Right [Line Items]
Weighted average fair value	$ 6.35	$ 2.83
Risk-free interest rate	1.02%
Volatility	60.59%
Term (in years)	5 years
Dividend yield	0.00%	0.00%
Minimum [Member]
Class of Warrant or Right [Line Items]
Risk-free interest rate		0.88%
Volatility		44.29%
Term (in years)		5 years
Maximum [Member]
Class of Warrant or Right [Line Items]
Risk-free interest rate		1.12%
Volatility		45.89%
Term (in years)		6 years

XML 71 R54.htm IDEA: XBRL DOCUMENT

STOCKHOLDERS' EQUITY (Details 2) - Stock Options [Member]	12 Months Ended
	Dec. 31, 2015	Dec. 31, 2014	Dec. 31, 2013
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Dividend yield	0.00%	0.00%	0.00%
Minimum [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Risk-free interest rate	1.47%	0.07%	0.65%
Volatility	58.78%	68.05%	33.35%
Term	5 years 3 months 8 days	5 months	5 years
Maximum [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Risk-free interest rate	1.67%	1.77%	1.71%
Volatility	62.94%	82.29%	45.76%
Term	6 years 2 months 30 days	6 years 3 months	6 years 3 months

XML 72 R55.htm IDEA: XBRL DOCUMENT

STOCKHOLDERS' EQUITY (Details 3) - USD ($)	12 Months Ended
STOCKHOLDERS' EQUITY (Details 3) - USD ($)	Dec. 31, 2015	Dec. 31, 2014	Dec. 31, 2013
Number Options
Options Exercised			(75,423)
Stock Options [Member]
Number Options
Options outstanding, beginning	16,792,443
Options Granted	4,685,000
Options Exercised	(613,284)
Options Expired	(102,500)
Options Cancelled/Forfeited	(36,334)
Options outstanding, ending	20,725,325	16,792,443
Vested and exercisable	15,461,986
Unvested	5,263,339
Weighted Average Exercise Price
Options outstanding, beginning	$ 1.88
Granted	8.14
Exercised	2.01
Expired	2.68
Cancelled	4.02
Options outstanding, ending	3.28	$ 1.88
Vested and exercisable	1.86
Unvested	$ 7.46
Weighted Average Remaining Contractual Life
Options outstanding, ending	6 years 6 months	6 years 10 months 25 days
Vested and exercisable	5 years 6 months
Unvested	9 years 4 months 24 days
Aggregate Intrinsic Value
Options outstanding, beginning	$ 43,996,311
Options outstanding, ending	146,864,184	$ 43,996,311
Vested and exercisable	131,523,505
Unvested	$ 15,340,679

XML 73 R56.htm IDEA: XBRL DOCUMENT

INCOME TAXES (Details Narrative)	Dec. 31, 2015 USD ($)
Federal [Member]
Net operating loss carryforwards	$ 192,601,415

XML 74 R57.htm IDEA: XBRL DOCUMENT

INCOME TAXES (Details)	12 Months Ended
INCOME TAXES (Details)	Dec. 31, 2015	Dec. 31, 2014	Dec. 31, 2013
Income Tax Disclosure [Abstract]
Federal statutory tax rate	34.00%	34.00%	35.00%
State tax rate, net of federal tax benefit	4.73%	5.80%	5.80%
Adjustment in valuation allowances	(38.97%)	(50.90%)	(32.40%)
Permanent and other differences	0.24%	11.10%	(8.40%)
Provision (Benefit) for Income Taxes

XML 75 R58.htm IDEA: XBRL DOCUMENT

INCOME TAXES (Details 1) - USD ($)	Dec. 31, 2015	Dec. 31, 2014	Dec. 31, 2013
Deferred Income Tax Assets:
Net operating losses	$ 79,499,633	$ 43,091,437	$ 14,773,537
R&D Credit	186,347		547,511
Total deferred income tax asset	79,685,980	$ 43,091,437	15,321,048
Valuation allowance	$ (79,685,980)	$ (43,091,437)	$ (15,321,048)
Deferred Income Tax Assets, net

XML 76 R59.htm IDEA: XBRL DOCUMENT

RELATED PARTIES (Details Narrative) - Pernix Therapeutics LLC [Member] - USD ($)	12 Months Ended
	Dec. 31, 2015	Dec. 31, 2014	Dec. 31, 2013
Manner of Settlement	We entered into a settlement agreement with Pernix according to which Pernix paid us $175,000 in cash.
Receivables- legal fee reimbursement		$ 250,000	$ 250,000
Payable - related party		$ 46,000	$ 46,000
Settlement fees	$ 29,000
Proceeds from settlement agreement	$ 175,000

XML 77 R60.htm IDEA: XBRL DOCUMENT

BUSINESS CONCENTRATIONS (Details Narrative) - USD ($)	3 Months Ended								12 Months Ended
BUSINESS CONCENTRATIONS (Details Narrative) - USD ($)	Dec. 31, 2015	Sep. 30, 2015	Jun. 30, 2015	Mar. 31, 2015	Dec. 31, 2014	Sep. 30, 2014	Jun. 30, 2014	Mar. 31, 2014	Dec. 31, 2015	Dec. 31, 2014	Dec. 31, 2013
Concentration Risk [Line Items]
Revenues	$ 5,630,000	$ 5,190,000	$ 4,848,000	$ 4,475,000	$ 4,257,000	$ 4,186,000	$ 3,752,000	$ 2,831,000	$ 20,142,898	$ 15,026,219	$ 8,775,598
Deferred Revenue [Member]
Concentration Risk [Line Items]
Concentration Risk										97.00%	97.00%
Supplier Concentration Risk [Member]
Concentration Risk [Line Items]
Concentration Risk									60.00%	82.00%	98.00%
Customer Concentration Risk [Member] \| Sales Revenue [Member]
Concentration Risk [Line Items]
Concentration Risk									67.00%	75.00%	79.00%
Customer Concentration Risk [Member] \| Sales Revenue [Member] \| Minimum [Member]
Concentration Risk [Line Items]
Concentration Risk									10.00%	10.00%	10.00%
Customer A [Member] \| Sales Revenue [Member]
Concentration Risk [Line Items]
Revenues									$ 8,848,243	$ 1,609,950	$ 1,221,212
Customer B [Member] \| Sales Revenue [Member]
Concentration Risk [Line Items]
Revenues									$ 4,843,463	1,586,903	1,711,417
Customer C [Member] \| Sales Revenue [Member]
Concentration Risk [Line Items]
Revenues										1,804,018	2,588,626
Customer D [Member] \| Sales Revenue [Member]
Concentration Risk [Line Items]
Revenues										$ 4,053,838	$ 1,312,192

XML 78 R61.htm IDEA: XBRL DOCUMENT

COMMITMENTS AND CONTINGENCIES (Details Narrative) - USD ($)	6 Months Ended		12 Months Ended
	Dec. 31, 2013	Jun. 30, 2013	Dec. 31, 2015	Dec. 31, 2014
Commitments and Contingencies Disclosure [Abstract]
Non-cancelable operating lease term			63 months
Rental Expense	$ 180,894	$ 60,168	$ 446,099	$ 361,793
Rental income	$ 32,963			$ 41,613

XML 79 R62.htm IDEA: XBRL DOCUMENT

COMMITMENTS AND CONTINGENCIES (Details)	Dec. 31, 2015 USD ($)
Future minimum rental payments, year ending December 31,
2016	$ 493,790
2017	507,087
2018	388,976
Minimum lease payments	$ 1,389,853

XML 80 R63.htm IDEA: XBRL DOCUMENT

SELECTED QUARTERLY FINANCIAL DATA (Details) - USD ($)	3 Months Ended								12 Months Ended
SELECTED QUARTERLY FINANCIAL DATA (Details) - USD ($)	Dec. 31, 2015	Sep. 30, 2015	Jun. 30, 2015	Mar. 31, 2015	Dec. 31, 2014	Sep. 30, 2014	Jun. 30, 2014	Mar. 31, 2014	Dec. 31, 2015	Dec. 31, 2014	Dec. 31, 2013
Quarterly Financial Information Disclosure [Abstract]
Revenues	$ 5,630,000	$ 5,190,000	$ 4,848,000	$ 4,475,000	$ 4,257,000	$ 4,186,000	$ 3,752,000	$ 2,831,000	$ 20,142,898	$ 15,026,219	$ 8,775,598
Gross profit	4,395,000	3,996,000	3,815,000	3,431,000	3,377,000	3,118,000	2,859,000	2,000,000	15,636,225	11,354,416	6,816,001
Net loss	$ (17,843,000)	$ (19,472,000)	$ (27,227,000)	$ (20,895,000)	$ (16,303,000)	$ (17,832,000)	$ (10,899,000)	$ (9,183,000)	$ (85,077,024)	$ (54,217,210)	$ (28,419,313)
Loss per common share, basic and diluted (in dollars per shares)	$ (.10)	$ (.11)	$ (.16)	$ (.13)	$ (0.10)	$ (0.12)	$ (0.07)	$ (0.06)	$ (0.49)	$ (0.36)	$ (0.22)

- Definition

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

+ References + Details

XML 81 R64.htm IDEA: XBRL DOCUMENT

SUBSEQUENT EVENTS (Details Narative) - USD ($)		1 Months Ended	2 Months Ended	12 Months Ended
SUBSEQUENT EVENTS (Details Narative) - USD ($)	Jan. 12, 2016	Jan. 31, 2016	Feb. 17, 2016	Dec. 31, 2015	Dec. 31, 2014	Dec. 31, 2013
Shares issued in offerings, net of cost				$ 91,374,649	$ 42,771,353	$ 78,650,353
Shares issued for exercise of options				1,232,579	345,746	$ 30,910
Shares issued for exercise of options, shares						75,423
Shares issued in exercise of warrants				$ 366,000	$ 181,000
Subsequent Event- Underwriting Agreement [Member]
Shares issued in offerings, net of cost	$ 134,900,000
Shares issued in offerings, net of cost, shares	15,151,515		17,424,242
Share price (in dollars per share)	$ 8.25
Number of days of the option to purchase shares	30 days
Options Granted	2,272,727
Subsequent Event - Exercises [Member]
Shares issued for exercise of options		$ 758,000
Shares issued for exercise of options, shares		281,657
Shares issued in exercise of warrants		$ 1,285,000
Shares issued in exercise of warrants, shares		500,000

EXCEL 82 Financial_Report.xlsx IDEA: XBRL DOCUMENT begin 644 Financial_Report.xlsx M4$L#!!0 ( $Z$6DB;*Y3H$P( )DF 3 6T-O;G1E;G1?5'EP97-= M+GAM;,W:2V[;,! &X*L8VA86S9?Z0)Q-TVT;H+T *XTMPJ)(D(SCW+Z4G!2M MX19)&P/_QK(\Y,Q((WTK7WU[")06!S>,:5WU.8IM>"SUZ5"RI/+;NBK1 M]*P*IQO_UIEUT]#"N/UMQW3^C]=R

Nevada			87-0233535
(State or Other Jurisdiction of Incorporation or Organization)			(I.R.S. Employer Identification No.)

Large accelerated filer ☒	Accelerated filer ☐
Non-accelerated filer ☐	Smaller reporting company ☐
(Do not check if a smaller reporting company)


	PART I

Item 1.	Business	1
Item 1A.	Risk Factors	26
Item 1B.	Unresolved Staff Comments	47
Item 2.	Properties	47
Item 3.	Legal Proceedings	48
Item 4.	Mine Safety Disclosures	48

	PART II

Item 5.	Market for the Registrant’s Common Equity, Related Stockholder Matters, and Issuer Purchases of Equity Securities	49
Item 6.	Selected Financial Data	51
Item 7.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	52
Item 7A.	Quantitative and Qualitative Disclosures about Market Risk	66
Item 8.	Financial Statements and Supplementary Data	66
Item 9.	Changes in and Disagreements with Accountants on Accounting and Financial Disclosure	66
Item 9A.	Controls and Procedures	67
Item 9B.	Other Information	70

	PART III

Item 10.	Directors, Executive Officers, and Corporate Governance	70
Item 11.	Executive Compensation	70
Item 12.	Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters	70
Item 13.	Certain Relationships and Related Transactions, and Director Independence	70
Item 14.	Principal Accounting Fees and Services	70

	PART IV

Item 15.	Exhibits and Financial Statement Schedules	71

	25 mcg	10 mcg	4 mcg
Week 2	P = 0.0105	P = 0.0019	P = 0.026
Week 6	P < 0.0001	P = 0.0009	P = 0.0069
Week 8	P < 0.0001	P < 0.0001	P = 0.0003
Week 12	P < 0.0001	P < 0.0001	P = 0.0149

	25 mcg		10 mcg		4 mcg
Severity of Vaginal Dryness		P < 0.0001		P < 0.0001		P = 0.0014

	TherapeuticsMD, Inc.
	(Exact Name of Registrant as Specified in Its Charter)

		High		Low
2015
Fourth Quarter	$	11.26	$	5.18
Third Quarter	$	8.83	$	5.29
Second Quarter	$	8.60	$	5.63
First Quarter	$	6.75	$	4.00

2014
Fourth Quarter	$	4.95	$	3.44
Third Quarter	$	6.29	$	3.88
Second Quarter	$	6.35	$	3.42
First quarter	$	9.01	$	4.86

	Year Ended December 31,
	2015			2014			2013			2012			2011

Consolidated Statements of Operations Data:
Revenue, net	$	20,143		$	15,026		$	8,776		$	3,818		$	2,088
Cost of goods sold		4,506			3,672			1,960			1,348			947
Gross profit		15,637			11,354			6,816			2,470			1,141
Operating expenses:
Sales, general, and administration		28,721			22,124			19,015			14,070			6,406
Research and development		72,043			43,219			13,551			4,492			107
Depreciation and amortization		63			52			58			56			55
Total operating expense		100,827			65,395			32,624			18,618			6,568
Operating loss		(85,190	)		(54,041	)		(25,808	)		(16,148	)		(5,427	)
Other income (expense), net		113			(176	)		(2,611	)		(18,972	)		(7,486	)
Net loss	$	(85,077	)	$	(54,217	)	$	(28,419	)	$	(35,120	)	$	(12,913	)
Net loss per share, basic and diluted	$	(0.49	)	$	(0.36	)	$	(0.22	)	$	(0.38	)	$	(0.21	)
Weighted average number of common shares outstanding, basic and diluted		173,174			149,727			127,570			91,630			62,516

Consolidated Balance Sheet Data (at end of period)
Total assets	$	73,729		$	59,079		$	62,016		$	5,926		$	1,439
Total liabilities	$	10,666		$	10,690		$	7,318		$	7,359		$	3,151
Total stockholders’ equity (deficit)	$	63,063		$	48,389		$	54,698		$	(1,433	)	$	(1,712	)
Other Data:
Capital expenditures (for the period)	$	584		$	617		$	480		$	273		$	38
Working capital (deficit)(at the end of period)	$	60,014		$	45,545		$	52,085		$	1,015		$	(1,914	)

	Year Ended December 31,
	2015		2014		2013
		(000s)
TX-001HR	$	33,227	$	26,123	$	4,809
TX-002HR		23		1,443		1,059
TX-004HR		19,574		3,984		—
Other research and development		19,219		11,669		7,683
Total research and development	$	72,043	$	43,219	$	13,551

	Year Ended December 31,
	2015			2014
Human resource related costs		15	%		16	%
Sales and marketing costs, excluding human resource costs		6	%		9	%
Product research and development costs		71	%		66	%
Professional fees and consulting costs		4	%		4	%
Other operating expenses		4	%		5	%

		(000s)
Increase in product research and development costs	$	28,824
Increase in human resource related costs		4,096
Increase in sales and marketing, excluding human resource costs		203
Increase in professional and consulting costs		1,281
Increase in all other operating expenses		1,028
	$	35,432

		(000s)
Increase in product research and development costs	$	29,668
Increase in human resource related costs		509
Increase in sales and marketing, excluding human resource costs		702
Increase in professional and consulting costs		852
Increase in all other operating expenses		1,040
	$	32,771

				Payments Due By Period

		Total		Less than 1 Year		1-3 Years		4-5 Years
Operating Lease Obligations	$	1,389,853	$	493,790	$	896,063	$	—

Exhibit	Date	Description

2.1	July 6, 2009	Agreement and Plan of Reorganization among Croff Enterprises, Inc., AMHN Acquisition Corp., America’s Minority Health Network, Inc., and the Major Shareholders⁽¹⁾
2.2	June 11, 2010	Agreement and Plan of Reorganization among AMHN, Inc., SHN Acquisition Corp., Spectrum Health Network, Inc., and the Sole Shareholder of Spectrum Health Network, Inc.⁽²⁾
2.3	October 25, 2007	Croff Enterprises, Inc. Plan of Corporate Division and Reorganization⁽³⁾
2.4	July 18, 2011	Agreement and Plan of Merger among VitaMedMD, LLC, AMHN, Inc., and VitaMed Acquisition, LLC⁽⁴⁾
3.1	July 20, 2010	Articles of Conversion of AMHN, Inc. filed in the State of Nevada⁽⁵⁾
3.2	July 20, 2010	Articles of Incorporation of AMHN, Inc. filed in the State of Nevada⁽⁵⁾
3.3	n/a	Composite Amended and Restated Articles of Incorporation of the Company, as amended⁽⁶⁾
3.4	n/a	Bylaws of AMHN, Inc.⁽⁷⁾
3.5	December 17, 2015	First Amendment to Bylaws of the Company⁽⁸⁾
4.1	n/a	Form of Certificate of Common Stock⁽⁹⁾
10.1	n/a	Form of Common Stock Purchase Warrant⁽¹⁰⁾
10.2*	n/a	Form of Non-Qualified Stock Option Agreement⁽¹⁰⁾
10.3*	n/a	Amended and Restated 2012 Stock Incentive Plan⁽¹¹⁾
10.4*	n/a	2009 Long Term Incentive Compensation Plan, as amended⁽¹²⁾
10.5	October 23, 2011	Common Stock Purchase Warrant to Lang Naturals, Inc.⁽¹³⁾
10.6	November 3, 2011	Software License Agreement between vitaMedMD, LLC and Pernix Therapeutics, LLC⁽¹⁴⁾
10.7	February 24, 2012	Form of Common Stock Purchase Warrant⁽¹⁵⁾
10.8	April 17, 2012	Master Services Agreement between the Company and Sancilio and Company, Inc.⁽¹⁶⁾
10.9†	May 17, 2012	Consulting Agreement between the Company and Sancilio and Company, Inc.
10.10	September 26, 2012	Form of Securities Purchase Agreement⁽¹⁷⁾
10.11*	November 8, 2012	Form of Employment Agreement⁽¹⁸⁾
10.12	January 31, 2013	Multiple Advance Revolving Credit Note, issued to Plato & Associates, LLC⁽¹⁹⁾
10.13	January 31, 2013	Common Stock Purchase Warrant, issued to Plato & Associates, LLC⁽¹⁹⁾
10.14	May 7, 2013	Consulting Agreement between the Company and Sancilio and Company, Inc.⁽²⁰⁾
10.15*	May 8, 2013	Agreement to Forfeit Non-Qualified Stock Options between the Company and Robert G. Finizio⁽²⁰⁾
10.16	May 16, 2013	Lease between the Company and 6800 Broken Sound LLC⁽²¹⁾

*	Indicates a contract with management or compensatory plan or arrangement.
†	Filed herewith.
⁽¹⁾	Filed as an exhibit to Form 8-K filed with the Commission on July 10, 2009 and incorporated herein by reference (SEC File No. 000-16731).
⁽²⁾	Filed as an exhibit to Form 8-K filed with the Commission on June 14, 2010 and incorporated herein by reference (SEC File No. 000-16731).
⁽³⁾	Filed as an exhibit to Form 10-K for the year ended December 31, 2007 filed with the Commission on May 1, 2008 and incorporated herein by reference (SEC File No. 000-16731).
⁽⁴⁾	Filed as an exhibit to Form 8-K filed with the Commission on July 21, 2011 and incorporated herein by reference (SEC File No. 000-16731).
⁽⁵⁾	Filed as an exhibit to Form 10-Q for quarter ended June 30, 2010 filed with the Commission on August 3, 2010 and incorporated herein by reference (SEC File No. 000-16731).
⁽⁶⁾	Filed as an exhibit to Form 10-Q for quarter ended June 30, 2015 filed with the Commission on August 7, 2015 and incorporated herein by reference (SEC File No. 001-00100).
⁽⁷⁾	Filed as an exhibit to Definitive 14C Information Statement filed with the Commission on June 29, 2010 and incorporated herein by reference (SEC File No. 000-16731).
⁽⁸⁾	Filed as an exhibit to Form 8-K filed with the Commission on December 22, 2015 and incorporated herein by reference (SEC File No. 001-00100).
⁽⁹⁾	Filed as an exhibit to Form S-3 filed with the Commission on January 25, 2013 and incorporated hereby by reference (SEC File No. 333-186189).
⁽¹⁰⁾	Filed as an exhibit to Form 8-K filed with the Commission on October 11, 2011 and incorporated herein by reference (SEC File No. 000-16731).
⁽¹¹⁾	Filed as an exhibit to Form 8-K filed with the Commission on August 22, 2013 and incorporated herein by reference (SEC File No. 001-00100).
⁽¹²⁾	Filed as an exhibit to Registration Statement on Form S-8 filed with the Commission on October 15, 2013 and incorporated herein by reference (SEC File No. 333-191730).
⁽¹³⁾	Filed as an exhibit to Form 8-K filed with the Commission on October 24, 2011 and incorporated herein by reference (SEC File No. 000-16731).
⁽¹⁴⁾	Filed as an exhibit to Form 10-Q for quarter ended September 30, 2011 filed with the Commission on November 7, 2011 and incorporated herein by reference (SEC File No. 000-16731).
⁽¹⁵⁾	Filed as an exhibit to Form 8-K filed with the Commission on February 24, 2012 and incorporated herein by reference (SEC File No. 000-16731).
⁽¹⁶⁾	Filed as an exhibit to Form 10-Q for quarter ended June 30, 2012 filed with the Commission on August 9, 2012 and incorporated herein by reference (SEC File No. 000-16731).
⁽¹⁷⁾	Filed as an exhibit to Form 8-K filed with the Commission on October 2, 2012 and incorporated herein by reference (SEC File No. 000-16731).
⁽¹⁸⁾	Filed as an exhibit to Form 10-Q for quarter ended September 30, 2012 filed with the Commission on November 13, 2012 and incorporated herein by reference (SEC File No. 000-16731).
⁽¹⁹⁾	Filed as an exhibit to Form 8-K filed with the Commission on February 6, 2013 and incorporated herein by reference (SEC File No. 000-16731).
⁽²⁰⁾	Filed as an exhibit to Form 10-Q for quarter ended March 31, 2013 filed with the Commission on May 10, 2013 and incorporated herein by reference (SEC File No. 001-00100).
⁽²¹⁾	Filed as an exhibit to Form 10-Q for quarter ended June 30, 2013 filed with the Commission on August 7, 2013 and incorporated herein by reference (SEC File No. 001-00100).
⁽²²⁾	Filed as an exhibit to Form 10-K for the year ended December 31, 2014 filed with the Commission on March 12, 2015 and incorporated herein by reference (SEC File No. 001-00100).

Date: February 26, 2016	THERAPEUTICSMD, INC.

	/s/ Robert G. Finizio
	Robert G. Finizio
	Chief Executive Officer

	Signature		Capacity		Date

/s/ Robert G. Finizio		Chief Executive Officer, Director (Principal Executive Officer)		February 26, 2016
Robert G. Finizio

/s/ John C.K. Milligan, IV		President, Secretary, Director		February 26, 2016
John C.K. Milligan, IV

/s/ Daniel A. Cartwright		Chief Financial Officer, Treasurer (Principal Financial and Accounting Officer)		February 26, 2016
Daniel A. Cartwright

/s/ Tommy G. Thompson		Chairman		February 26, 2016
Tommy G. Thompson

/s/ Brian Bernick		Director		February 26, 2016
Brian Bernick

/s/ J. Martin Carroll		Director		February 26, 2016
J. Martin Carroll

/s/ Cooper C. Collins		Director		February 26, 2016
Cooper C. Collins

/s/ Robert V. LaPenta, Jr.		Director		February 26, 2016
Robert V. LaPenta, Jr

/s/ Jules Musing		Director		February 26, 2016
Jules Musing

/s/ Angus C. Russell		Director		February 26, 2016
Angus C. Russell

/s/ Nicholas Segal		Director		February 26, 2016
Nicholas Segal


		Page

Reports of Independent Registered Public Accounting Firms		F-2

Consolidated Balance Sheets as of December 31, 2015 and 2014		F-4

Consolidated Statements of Operations for the years ended December 31, 2015, 2014 and 2013		F-5

Consolidated Statements of Stockholders’ Equity for the years ended December 31, 2015, 2014 and 2013		F-6

Consolidated Statements of Cash Flows for the years ended December 31, 2015, 2014 and 2013		F-7

Notes to Consolidated Financial Statements		F-8


					Additional
	Common Stock				Paid in			Accumulated
	Shares		Amount		Capital			Deficit			Total

Balance, January 1, 2013		99,784,982		99,785		50,580,400			(52,113,313	)		(1,433,128	)

Shares issued in offerings, net of cost		45,116,352		45,117		78,605,236			—			78,650,353
Shares issued for exercise of options, net		75,423		75		30,835			—			30,910
Share-based compensation		—		—		3,254,083			—			3,254,083
Warrants issued for financing costs		—		—		1,711,956			—			1,711,956
Warrants issued for services		—		—		867,262			—			867,262
Warrants issued as compensation-related party		—		—		36,284			—			36,284
Net loss		—		—		—			(28,419,313	)		(28,419,313	)

Balance, December 31, 2013		144,976,757		144,977		135,086,056			(80,532,626	)		54,698,407

Shares issued in offerings, net of cost		9,850,106		9,850		42,761,503			—			42,771,353
Shares issued for exercise of options, net		854,573		855		344,891			—			345,746
Shares issued for exercise of warrants, net		365,583		365		180,635			—			181,000
Shares issued for exercise of restricted stock units		50,000		50		(50	)		—			—
Share-based compensation		—		—		4,609,811			—			4,609,811
Net loss		—		—		—			(54,217,210	)		(54,217,210	)

Balance, December 31, 2014		156,097,019		156,097		182,982,846			(134,749,836	)		48,389,107

Shares issued in offerings, net of cost		20,040,359		20,040		91,354,609			—			91,374,649
Shares issued for exercise of options, net		612,981		613		1,231,966			—			1,232,579
Shares issued for exercise of warrants, net		1,177,682		1,178		364,822			—			366,000
Share-based compensation		—		—		6,777,835			—			6,777,835
Net loss		—		—		—			(85,077,024	)		(85,077,024	)

Balance, December 31, 2015		177,928,041	$	177,928	$	282,712,078		$	(219,826,860	)	$	63,063,146


	Year Ended December, 31,
	2015			2014			2013

CASH FLOWS FROM OPERATING ACTIVITIES
Net loss	$	(85,077,024	)	$	(54,217,210	)	$	(28,419,313	)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation		29,959			28,987			47,883
Amortization of intangible assets		32,441			23,480			10,262
Provision for (recovery of) doubtful accounts		22,157			(5,436	)		(15,493	)
Amortization of debt discount		—			—			1,102,680
Share-based compensation		7,189,699			4,970,312			3,844,155
Amortization of deferred financing costs		—			260,027			1,451,934
Loan guaranty costs		—			—			2,944
Changes in operating assets and liabilities:
Accounts receivable		(917,656	)		(458,028	)		(1,068,619	)
Inventory		491,960			(138,495	)		571,592
Other current assets		(773,532	)		680,281			(1,386,319	)
Other assets		(17,442	)		(37,309	)		(565,706	)
Accounts payable		(3,200,955	)		4,212,912			472,851
Deferred revenue		(522,613	)		(1,079,967	)		457,828
Other current liabilities		3,698,887			239,450			2,875,320
Other liabilities		—			—			(150,068	)

Net cash used in operating activities		(79,044,119	)		(45,520,996	)		(20,768,069	)

CASH FLOWS FROM INVESTING ACTIVITIES
Patent costs		(419,104	)		(586,480	)		(439,034	)
Purchase of fixed assets		(165,257	)		(30,962	)		(40,790	)
Refund (payment) of security deposit		—			10,686			(103,737	)

Net cash used in investing activities		(584,361	)		(606,756	)		(583,561	)

CASH FLOWS FROM FINANCING ACTIVITIES
Proceeds from sale of common stock, net of costs		91,374,649			42,771,353			78,650,353
Proceeds from exercise of options		1,232,579			345,746			30,910
Proceeds from exercise of warrants		366,000			181,000			—
Proceeds bank line of credit		—			—			500,000
Repayment of bank line of credit		—			—			(500,000	)
Repayment of notes payable		—			—			(4,691,847	)

Net cash provided by financing activities		92,973,228			43,298,099			73,989,416

Increase (decrease) in cash		13,344,748			(2,829,653	)		52,637,786
Cash, beginning of period		51,361,607			54,191,260			1,553,474
Cash, end of period	$	64,706,355		$	51,361,607		$	54,191,260

SUPPLEMENTAL DISCLOSURES OF CASH FLOW INFORMATION:

Cash paid for interest	$	—		$	—		$	212,853
Cash paid for income taxes	$	—		$	—		$	—

SUPPLEMENTAL SCHEDULE OF NON-CASH FINANCING ACTIVITIES:

Warrants issued for financing	$	—		$	—		$	1,711,956
Warrants issued for services	$	—		$	—		$	462,196

	If to SCI:		Sancilio and Company, Inc.
			Attn: Fred Sancilio, President & CEO
			3874 Fiscal Court, Suite 200
			Riviera Beach, Florida 33404
			Facsimile No: (561) 847-2312

	If to Therapeutics:		TherapeuticsMD, Inc.
			Attn: Robert Finizio, CEO
			951 Broken Sound Parkway NW, Suite 320
			Boca Raton, FL 33487
			Facsimile No: (561) 431-3389

	Sancilio and Company, Inc.



	By:	/s/ Fred Sancilio
		Fred Sancilio
		President & CEO



	TherapeuticsMD, Inc.



	By:	/s/ Robert Finizio
		Robert Finizio
		Chief Executive Officer

Name	State or Jurisdiction of Incorporation or Organization
VitaMedMD, LLC	Delaware
BocagreenMD, Inc.	Nevada
VitaCare Prescription Services, Inc.	Florida

	(a)	Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
	(b)	Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
	(c)	Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
	(d)	Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

	(a)	All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
	(b)	Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.