Document and Entity Information
Document and Entity Information - USD ($) | 12 Months Ended | ||
Dec. 31, 2015 | Feb. 22, 2016 | Jun. 30, 2015 | |
Document And Entity Information | |||
Entity Registrant Name | TherapeuticsMD, Inc. | ||
Entity Central Index Key | 25,743 | ||
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 | 2,015 |
CONSOLIDATED BALANCE SHEETS
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 |
CONSOLIDATED BALANCE SHEETS (Pa
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 |
CONSOLIDATED STATEMENTS OF OPER
CONSOLIDATED STATEMENTS OF OPERATIONS - USD ($) | 12 Months Ended | ||
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 |
CONSOLIDATED STATEMENTS OF STOC
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 |
CONSOLIDATED STATEMENTS OF CASH
CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) | 12 Months Ended | ||
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 |
THE COMPANY
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 womens 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. |
SUMMARY OF SIGNIFICANT ACCOUNTI
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 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. 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 350, Intangibles - Goodwill and Other . Capitalized patent costs, net of accumulated amortization, include legal costs incurred for patent applications. 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. 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 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 . 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 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. |
INVENTORY
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 |
OTHER CURRENT ASSETS
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 |
FIXED ASSETS, NET
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. |
PREPAID EXPENSE
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 |
INTANGIBLE ASSETS
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 Accumulated Amortization Net Weighted- Amortizable intangible assets: OPERA ® $ 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 Accumulated Amortization Net Weighted- Amortizable intangible assets: OPERA ® $ 31,951 $ (2,496 ) $ 29,455 14.75 Development costs of corporate website 91,743 (91,743 ) — n/a Approved hormone therapy drug candidate patents 439,184 (19,401 ) 419,783 18 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 Estimated 2016 $ 40,580 2017 $ 40,580 2018 $ 40,580 2019 $ 40,580 2020 $ 40,580 |
OTHER CURRENT LIABILITIES
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 |
NOTES PAYABLE
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). |
STOCKHOLDERS' EQUITY
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: 1. 283,333 shares were earned on May 11, 2013 upon acceptance of an Investigational New Drug application by the FDA for an estradiol-based drug candidate in a softgel vaginal capsule for the treatment of VVA; however, pursuant to the terms of the consulting agreement, the shares did not vest until June 30, 2013. The fair value of $405,066 for the shares vested on June 30, 2013 was determined by using the Black-Scholes Model on the date of vesting using a term of 5 years; a volatility of 45.89%; risk free rate of 1.12%; and a dividend yield of 0%. We recorded the entire $405,066 as non-cash compensation as of June 30, 2013; 2. 283,333 shares vested on June 30, 2013. The fair value of $462,196 for these shares was determined by using the Black-Scholes Model on the date of vesting using a term of 5 years; a volatility of 45.84%; risk free rate of 1.41%; and a dividend yield of 0%. During the years ended December 31 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 3. 283,334 shares will vest upon the receipt by us of any final FDA approval of a drug candidate that SCI helped us design. It is anticipated that this event will not occur before December 2016. 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 Weighted Weighted Aggregate 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 Weighted Weighted Aggregate 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, . 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. |
INCOME TAXES
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. |
RELATED PARTIES
RELATED PARTIES | 12 Months Ended |
Dec. 31, 2015 | |
Related Party Transactions [Abstract] | |
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. |
BUSINESS CONCENTRATIONS
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. |
COMMITMENTS AND CONTINGENCIES
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. |
SELECTED QUARTERLY FINANCIAL DA
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 ) |
SUBSEQUENT EVENTS
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. |
SUMMARY OF SIGNIFICANT ACCOUN23
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies) | 12 Months Ended |
Dec. 31, 2015 | |
Accounting Policies [Abstract] | |
Principles of Consolidation | 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 | 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 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 |
Inventories | 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. 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 | 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 | Intangible Assets Patents and Trademarks We have adopted the provisions of 350, Intangibles - Goodwill and Other . Capitalized patent costs, net of accumulated amortization, include legal costs incurred for patent applications. 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 | 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 assets market price; · significant deterioration in an assets physical condition; · significant changes in the nature or extent of an assets use or operation; · significant adverse changes in the business climate that could impact an assets 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 assets 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 groups 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 | 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. 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 | 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 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 | 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 . 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 employees 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 | 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 | 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 | 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 | 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 | 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 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 | Earnings Per Share We calculate earnings per share, or EPS, in accordance with ASC 260, Earnings Per Share The table below presents the potentially dilutive securities that would have been included in our calculation of diluted net loss per share allocable to common stockholders if they were not antidilutive for the periods presented. As of 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 | 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 customers financial condition, and collateral is not required. |
Use of Estimates | 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 | Reclassifications Certain 2014 and 2013 amounts have been reclassified to conform to current year presentation. |
Recently Issued Accounting Pronouncements | 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 Entitys 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 entitys 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 standards core principle is that a company will recognize revenue when it transfers promised goods or services to customers in an amount that reflects the consideration to which the company expects to be entitled in exchange for those goods or services. In doing so, companies will need to use more judgment and make more estimates than under previous guidance. These may include identifying performance obligations in the contract, estimating the amount of variable consideration to include in the transaction price and allocating the transaction price to each separate performance obligations. In July 2015, the FASB approved the proposal to defer the effective date of ASU 2014-09 standard by one year. Early adoption is permitted after December 15, 2016, and the standard is effective for public entities for annual reporting periods beginning after December 15, 2017 and interim periods therein. We are currently evaluating the impact of ASU 2014-09 on our consolidated financial statements and disclosures. We do not believe there would have been a material effect on the accompanying consolidated financial statements had any other recently issued, but not yet effective, accounting standards been adopted in the current period. |
SUMMARY OF SIGNIFICANT ACCOUN24
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 | 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 |
INVENTORY (Tables)
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 |
OTHER CURRENT ASSETS (Tables)
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 |
FIXED ASSETS, NET (Tables)
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 |
PREPAID EXPENSE (Tables)
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 |
INTANGIBLE ASSETS (Tables)
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 Accumulated Amortization Net Weighted- Amortizable intangible assets: OPERA ® $ 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 Accumulated Amortization Net Weighted- Amortizable intangible assets: OPERA ® $ 31,951 $ (2,496 ) $ 29,455 14.75 Development costs of corporate website 91,743 (91,743 ) — n/a Approved hormone therapy drug candidate patents 439,184 (19,401 ) 419,783 18 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 Estimated 2016 $ 40,580 2017 $ 40,580 2018 $ 40,580 2019 $ 40,580 2020 $ 40,580 |
OTHER CURRENT LIABILITIES (Tabl
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 |
STOCKHOLDERS' EQUITY (Tables)
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 Weighted Weighted Aggregate 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 | 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% |
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 Weighted Weighted Aggregate 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 |
INCOME TAXES (Tables)
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 | 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 $ — $ — $ — |
COMMITMENTS AND CONTINGENCIES (
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 |
SELECTED QUARTERLY FINANCIAL 34
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 ) |
SUMMARY OF SIGNIFICANT ACCOUN35
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details Narrative) | Jan. 12, 2016shares | Feb. 17, 2016shares | Dec. 31, 2015USD ($) | Dec. 31, 2014USD ($) | Dec. 31, 2013USD ($) |
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 |
SUMMARY OF SIGNIFICANT ACCOUN36
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 |
INVENTORY (Details)
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 |
OTHER CURRENT ASSETS (Details)
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 |
FIXED ASSETS, NET (Details Narr
FIXED ASSETS, NET (Details Narrative) - USD ($) | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Property, Plant and Equipment [Abstract] | |||
Depreciation Expense | $ 29,959 | $ 28,987 | $ 47,883 |
FIXED ASSETS, NET (Details)
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 |
PREPAID EXPENSE (Details)
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 |
INTANGIBLE ASSETS (Details Narr
INTANGIBLE ASSETS (Details Narrative) | 12 Months Ended | ||
Dec. 31, 2015USD ($) | Dec. 31, 2014USD ($) | Dec. 31, 2013USD ($) | |
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 |
INTANGIBLE ASSETS (Details )
INTANGIBLE ASSETS (Details ) - USD ($) | 12 Months Ended | |
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 |
INTANGIBLE ASSETS (Details 1)
INTANGIBLE ASSETS (Details 1) | Dec. 31, 2015USD ($) |
Estimated amortization expense for the year: | |
2,016 | $ 40,580 |
2,017 | 40,580 |
2,018 | 40,580 |
2,019 | 40,580 |
2,020 | $ 40,580 |
OTHER CURRENT LIABILITIES (Deta
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 |
NOTES PAYABLE (Details Narrativ
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 |
STOCKHOLDERS' EQUITY (Details N
STOCKHOLDERS' EQUITY (Details Narrative) - USD ($) | Jul. 15, 2015 | Jul. 09, 2015 | Feb. 17, 2015 | Feb. 10, 2015 | Aug. 04, 2014 | Jul. 29, 2014 | 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 |
STOCKHOLDERS' EQUITY (Details48
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 |
STOCKHOLDERS' EQUITY (Details49
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. 6, 2020 |
STOCKHOLDERS' EQUITY (Details50
STOCKHOLDERS' EQUITY (Details Narrative 3) - USD ($) | 1 Months Ended | 12 Months Ended | ||
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 |
STOCKHOLDERS' EQUITY (Details51
STOCKHOLDERS' EQUITY (Details Narrative 4) - USD ($) | 1 Months Ended | 12 Months Ended | ||
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 |
STOCKHOLDERS' EQUITY (Details)
STOCKHOLDERS' EQUITY (Details) - Warrants [Member] | 12 Months Ended |
Dec. 31, 2015USD ($)$ / sharesshares | |
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 |
STOCKHOLDERS' EQUITY (Details 1
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 |
STOCKHOLDERS' EQUITY (Details 2
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 |
STOCKHOLDERS' EQUITY (Details 3
STOCKHOLDERS' EQUITY (Details 3) - USD ($) | 12 Months Ended | ||
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 |
INCOME TAXES (Details Narrative
INCOME TAXES (Details Narrative) | Dec. 31, 2015USD ($) |
Federal [Member] | |
Net operating loss carryforwards | $ 192,601,415 |
INCOME TAXES (Details)
INCOME TAXES (Details) | 12 Months Ended | ||
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 |
INCOME TAXES (Details 1)
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 |
RELATED PARTIES (Details Narrat
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 |
BUSINESS CONCENTRATIONS (Detail
BUSINESS CONCENTRATIONS (Details Narrative) - USD ($) | 3 Months Ended | 12 Months Ended | |||||||||
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 |
COMMITMENTS AND CONTINGENCIES61
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 |
COMMITMENTS AND CONTINGENCIES62
COMMITMENTS AND CONTINGENCIES (Details) | Dec. 31, 2015USD ($) |
Future minimum rental payments, year ending December 31, | |
2,016 | $ 493,790 |
2,017 | 507,087 |
2,018 | 388,976 |
Minimum lease payments | $ 1,389,853 |
SELECTED QUARTERLY FINANCIAL 63
SELECTED QUARTERLY FINANCIAL DATA (Details) - USD ($) | 3 Months Ended | 12 Months Ended | |||||||||
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) |
SUBSEQUENT EVENTS (Details Nara
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 |