Document and Entity Information
Document and Entity Information - USD ($) | 12 Months Ended | ||
Dec. 31, 2016 | Feb. 21, 2017 | Jun. 30, 2016 | |
Document And Entity Information | |||
Entity Registrant Name | TherapeuticsMD, Inc. | ||
Entity Central Index Key | 25,743 | ||
Document Type | 10-K | ||
Trading Symbol | TXMD | ||
Document Period End Date | Dec. 31, 2016 | ||
Amendment Flag | false | ||
Current Fiscal Year End Date | --12-31 | ||
Entity a Well-known Seasoned Issuer | Yes | ||
Entity a Voluntary Filer | No | ||
Entity's Reporting Status Current | Yes | ||
Entity Filer Category | Large Accelerated Filer | ||
Entity Public Float | $ 1,376,117,097 | ||
Entity Common Stock, Held by non-affiliates | 161,896,129 | ||
Entity Common Stock, Shares Outstanding | 197,523,925 | ||
Document Fiscal Period Focus | FY | ||
Document Fiscal Year Focus | 2,016 |
CONSOLIDATED BALANCE SHEETS
CONSOLIDATED BALANCE SHEETS - USD ($) | Dec. 31, 2016 | Dec. 31, 2015 |
Current Assets: | ||
Cash | $ 131,534,101 | $ 64,706,355 |
Accounts receivable, net of allowance for doubtful accounts of $376,374 and $81,910, respectively | 4,500,699 | 3,049,715 |
Inventory | 1,076,321 | 690,153 |
Other current assets | 2,299,052 | 2,233,897 |
Total current assets | 139,410,173 | 70,680,120 |
Fixed assets, net | 516,839 | 198,592 |
Other Assets: | ||
Intangible assets, net | 2,405,972 | 1,615,251 |
Security deposit | 139,036 | 125,000 |
Prepaid expense | 1,109,883 | |
Total other assets | 2,545,008 | 2,850,134 |
Total assets | 142,472,020 | 73,728,846 |
Current Liabilities: | ||
Accounts payable | 7,358,514 | 3,126,174 |
Other current liabilities | 7,624,085 | 7,539,526 |
Total current liabilities | 14,982,599 | 10,665,700 |
Stockholders' Equity: | ||
Preferred stock - par value $0.001; 10,000,000 shares authorized; no shares issued and outstanding | ||
Common stock - par value $0.001; 350,000,000 shares authorized: 196,688,222 and 177,928,041 issued and outstanding, respectively | 196,688 | 177,928 |
Additional paid-in capital | 436,995,052 | 282,712,078 |
Accumulated deficit | (309,702,319) | (219,826,860) |
Total stockholders' equity | 127,489,421 | 63,063,146 |
Total liabilities and stockholders' equity | $ 142,472,020 | $ 73,728,846 |
CONSOLIDATED BALANCE SHEETS (Pa
CONSOLIDATED BALANCE SHEETS (Parenthetical) - USD ($) | Dec. 31, 2016 | Dec. 31, 2015 |
Statement of Financial Position [Abstract] | ||
Allowance for doubtful accounts | $ 376,374 | $ 81,910 |
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 | 350,000,000 |
Common stock, shares issued | 196,688,222 | 177,928,041 |
Common stock, shares outstanding | 196,688,222 | 177,928,041 |
CONSOLIDATED STATEMENTS OF OPER
CONSOLIDATED STATEMENTS OF OPERATIONS - USD ($) | 12 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Income Statement [Abstract] | |||
Revenues, net | $ 19,356,450 | $ 20,142,898 | $ 15,026,219 |
Cost of goods sold | 4,185,708 | 4,506,673 | 3,671,803 |
Gross profit | 15,170,742 | 15,636,225 | 11,354,416 |
Operating expenses: | |||
Sales, general, and administrative | 51,348,414 | 28,721,236 | 22,124,072 |
Research and development | 53,943,477 | 72,042,774 | 43,218,938 |
Depreciation and amortization | 132,451 | 62,400 | 52,467 |
Total operating expenses | 105,424,342 | 100,826,410 | 65,395,477 |
Operating loss | (90,253,600) | (85,190,185) | (54,041,061) |
Other income and (expense) | |||
Miscellaneous income | 367,317 | 95,719 | 46,569 |
Accreted interest | 10,824 | 17,442 | 37,309 |
Financing costs | (260,027) | ||
Total other income (expense) | 378,141 | 113,161 | (176,149) |
Loss before income taxes | (89,875,459) | (85,077,024) | (54,217,210) |
Net loss | $ (89,875,459) | $ (85,077,024) | $ (54,217,210) |
Loss per share, basic and diluted: | |||
Net loss per share, basic and diluted | $ (0.46) | $ (0.49) | $ (0.36) |
Weighted average number of common shares outstanding, basic and diluted | 196,088,196 | 173,174,229 | 149,727,228 |
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, 2013 | $ 144,977 | $ 135,086,056 | $ (80,532,626) | $ 54,698,407 |
Beginning balance (in shares) at Dec. 31, 2013 | 144,976,757 | |||
Increase (Decrease) in Stockholders' Deficiency [Roll Forward] | ||||
Shares issued in offerings, net of cost | $ 9,850 | 42,761,503 | 42,771,353 | |
Shares issued in offerings, net of cost (in shares) | 9,850,106 | |||
Shares issued for exercise of options, net | $ 855 | 344,891 | 345,746 | |
Shares issued for exercise of options, net (in shares) | 854,573 | |||
Shares issued for exercise of warrants, net | $ 365 | 180,635 | 181,000 | |
Shares issued for exercise of warrants, net (in shares) | 365,583 | |||
Shares issued for exercise of restricted stock units | $ 50 | (50) | ||
Shares issued for exercise of restricted stock units (in 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 (in shares) at Dec. 31, 2014 | 156,097,019 | |||
Increase (Decrease) in Stockholders' Deficiency [Roll Forward] | ||||
Shares issued in offerings, net of cost | $ 20,040 | 91,354,609 | 91,374,649 | |
Shares issued in offerings, net of cost (in shares) | 20,040,359 | |||
Shares issued for exercise of options, net | $ 613 | 1,231,966 | 1,232,579 | |
Shares issued for exercise of options, net (in shares) | 612,981 | |||
Shares issued for exercise of warrants, net | $ 1,178 | 364,822 | 366,000 | |
Shares issued for exercise of warrants, net (in 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 (in shares) at Dec. 31, 2015 | 177,928,041 | 177,928,041 | ||
Increase (Decrease) in Stockholders' Deficiency [Roll Forward] | ||||
Shares issued in offerings, net of cost | $ 17,424 | 134,846,051 | $ 134,863,475 | |
Shares issued in offerings, net of cost (in shares) | 17,424,242 | |||
Shares issued for exercise of options, net | $ 613 | 988,447 | 989,060 | |
Shares issued for exercise of options, net (in shares) | 613,195 | |||
Shares issued for exercise of warrants, net | $ 723 | 1,372,277 | 1,373,000 | |
Shares issued for exercise of warrants, net (in shares) | 722,744 | |||
Share-based compensation | 17,076,199 | 17,076,199 | ||
Net loss | (89,875,459) | (89,875,459) | ||
Ending balance at Dec. 31, 2016 | $ 196,688 | $ 436,995,052 | $ (309,702,319) | $ 127,489,421 |
Ending balance (in shares) at Dec. 31, 2016 | 196,688,222 | 196,688,222 |
CONSOLIDATED STATEMENTS OF CASH
CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) | 12 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
CASH FLOWS FROM OPERATING ACTIVITIES | |||
Net loss | $ (89,875,459) | $ (85,077,024) | $ (54,217,210) |
Adjustments to reconcile net loss to net cash used in operating activities: | |||
Depreciation | 77,906 | 29,959 | 28,987 |
Amortization of intangible assets | 54,545 | 32,441 | 23,480 |
Provision for (recovery of) doubtful accounts | 2,524,909 | 22,157 | (5,436) |
Share-based compensation | 17,411,021 | 7,189,699 | 4,970,312 |
Amortization of deferred financing costs | 260,027 | ||
Changes in operating assets and liabilities: | |||
Accounts receivable | (3,975,893) | (917,656) | (458,028) |
Inventory | (386,168) | 491,960 | (138,495) |
Other current assets | 709,907 | (773,532) | 680,281 |
Other assets | (17,442) | (37,309) | |
Accounts payable | 4,232,340 | (3,200,955) | 4,212,912 |
Deferred revenue | (522,613) | (1,079,967) | |
Other current liabilities | 84,559 | 3,698,887 | 239,450 |
Net cash used in operating activities | (69,142,333) | (79,044,119) | (45,520,996) |
CASH FLOWS FROM INVESTING ACTIVITIES | |||
Patent costs | (845,266) | (419,104) | (586,480) |
Purchase of fixed assets | (396,154) | (165,257) | (30,962) |
(Payment) refund of security deposit | (14,036) | 10,686 | |
Net cash used in investing activities | (1,255,456) | (584,361) | (606,756) |
CASH FLOWS FROM FINANCING ACTIVITIES | |||
Proceeds from sale of common stock, net of costs | 134,863,475 | 91,374,649 | 42,771,353 |
Proceeds from exercise of options | 989,060 | 1,232,579 | 345,746 |
Proceeds from exercise of warrants | 1,373,000 | 366,000 | 181,000 |
Net cash provided by financing activities | 137,225,535 | 92,973,228 | 43,298,099 |
Increase (decrease) in cash | 66,827,746 | 13,344,748 | (2,829,653) |
Cash, beginning of period | 64,706,355 | 51,361,607 | 54,191,260 |
Cash, end of period | $ 131,534,101 | $ 64,706,355 | $ 51,361,607 |
THE COMPANY
THE COMPANY | 12 Months Ended |
Dec. 31, 2016 | |
Company | |
THE COMPANY | NOTE 1 – THE COMPANY TherapeuticsMD, Inc., a Nevada corporation, or TherapeuticsMD or the Company, has three wholly owned subsidiaries, vitaMedMD, LLC, a Delaware limited liability company, or VitaMed; BocaGreenMD, Inc., a Nevada corporation, or BocaGreen; and VitaCare Prescription Services, Inc., a Florida corporation, or VitaCare. Unless the context otherwise requires, TherapeuticsMD, VitaMed, BocaGreen, and VitaCare collectively are sometimes referred to as “our company,” “we,” “our,” or “us.” Nature of Business We are a women’s health care company focused on creating and commercializing products targeted exclusively for women. Currently, we are focused on pursuing the regulatory approvals and pre-commercialization activities necessary for commercialization of our advanced hormone therapy pharmaceutical products. Our drug candidates that have completed 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 clinical efficacy at lower doses, thereby enabling an enhanced side effect profile compared with competing products. With our SYMBODA™ technology, we are developing advanced hormone therapy pharmaceutical products to enable delivery of bio-identical hormones through a variety of dosage forms and administration routes. In addition, we manufacture and distribute branded and generic prescription prenatal vitamins, as well as over-the-counter, or OTC, iron supplements. |
SUMMARY OF SIGNIFICANT ACCOUNTI
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | 12 Months Ended |
Dec. 31, 2016 | |
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 During the third quarter of 2016, we wrote-off accounts receivable balances of $2.2 million related to two retail pharmacy distributors. Both pharmacies are relatively small owner-managed pharmacies and share a similar amount of collection risk. Among the factors that contributed to our decision to write-off these balances were our inability to collect the outstanding balances and the lack of a continuing communication and business relationship with these parties following the centralization of the distribution channel for both our retail pharmacy distributors and wholesale distributors, effective September 1, 2016. Inventories Inventories represent packaged vitamins, nutritional products and supplements and raw materials, which are valued at the lower of cost or net realizable value using the average-cost method. Any costs of manufacturing the prescription products associated with the deferred revenue (as discussed in Revenue Recognition) prior to January 1, 2015, were recorded as deferred costs and included in inventory, until such time as the related deferred revenue was recognized. We review our inventory for excess or obsolete inventory and write-down obsolete or otherwise unmarketable inventory to its estimated net realizable value. Obsolescence may occur due to product expiring or product improvements rendering previous versions obsolete. Pre-Launch Inventory Inventory costs associated with product candidates that have not yet received regulatory approval are capitalized if we believe there is probable future commercial use and future economic benefit. If the probability of future commercial use and future economic benefit cannot be reasonably determined, then pre-launch inventory costs associated with such product candidates are expensed as research and development expenses during the period the costs are incurred. We have not capitalized any pre-launch inventory to date. Fixed Assets We state fixed assets at cost, net of accumulated depreciation. We charge maintenance costs, which do not significantly extend the useful lives of the respective assets, and repair costs to operating expenses as incurred. We compute depreciation using the straight-line method over the estimated useful lives of the related assets, which range from three to seven years. Leasehold improvements are depreciated over the shorter of their useful life or the term of the lease. We capitalize software and software development costs incurred to create and acquire computer software for internal use, principally related to software coding and application development. We begin to capitalize software development costs when both the preliminary project stage is completed and it is probable that the software will be used as intended. Capitalized software costs include only external direct costs and services utilized in developing or obtaining computer software. Capitalized software costs are amortized on a straight-line basis when placed into service over the estimated useful life, generally five to seven years. Intangible Assets Patents and Trademarks We have adopted the provisions of Financial Accounting Standards Board, or FASB, Accounting Standards Codification, or ASC, 350, Intangibles - Goodwill and Other 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, 2016, 2015, and 2014. 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, 2016, 2015, and 2014. 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, 2016 and 2015, 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, 2016, 2015, and 2014. 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, 2016 and 2015, 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 2013 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. We amortize such compensation amounts, if any, over the respective service periods of the award. We use the Black-Scholes-Merton option pricing model, or the Black-Scholes Model, an acceptable model in accordance with ASC 718, Compensation-Stock Compensation 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. Revenue Recognition We recognize revenue on arrangements in accordance with ASC 605, Revenue Recognition Our OTC and prescription prenatal vitamin products are generally variations of the same product with slight modifications in formulation and marketing. The primary difference between our OTC and prescription prenatal vitamin products is the source of payment. Purchasers of our OTC prenatal vitamin products pay for the product directly while purchasers of our prescription prenatal vitamin products pay for the product primarily via third-party payers. Both OTC and prescription prenatal vitamin products share the same marketing support team utilizing similar marketing techniques. As of January 1, 2017, we ceased manufacturing and distributing our OTC product lines, except for Iron 21/7, which have declined steadily over time resulting in immaterial sales. The revenue that is generated by us from major customers is all generated from sales of our prescription prenatal vitamin products which is disclosed in Note 13. There are no major customers for our OTC prenatal vitamin or other products. Over-the-Counter Products We generate OTC revenue from product sales primarily to retail consumers. We recognize revenue from product sales upon shipment, when the rights of ownership and risk of loss have passed to the consumer. We include outbound shipping and handling fees, if any, 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 and sales discounts. As of January 1, 2017, we ceased manufacturing and distributing our OTC product lines, except for Iron 21/7, which have declined steadily over time resulting in immaterial sales. Prescription Products We sell our name brand and generic prescription products primarily through wholesale distributors and retail pharmacy distributors. We recognize revenue from prescription product sales, net of sales discounts, chargebacks, wholesaler fees, customer rebates and estimated returns. Revenue related to prescription products sold through wholesale distributors is recognized when the prescription products are shipped to the distributors and the control of the products passes to each distributor. We accept returns of unsalable prescription products sold through wholesale distributors within a return period of six months prior to and up to 12 months following product expiration. Our prescription products currently have a shelf life of 24 months from the date of manufacture. Prior to January 1, 2015, we deferred the recognition of revenue on prescription products sold through wholesale distributors until the right of return no longer existed as, prior to that date, we could not reasonably estimate the amount of future returns. As of January 1, 2015, we began estimating and reserving for returns based on historical return rates, while recording actual product returns against this reserve as received. Prior to September 1, 2016, we recognized revenue related to prescription products sold through retail pharmacy distributors when the product was dispensed by the retail pharmacy distributor, at which point all revenue and discounts related to such product were known or determinable and there was no right of return with respect to such product. On September 1, 2016, we centralized the distribution channel for both our retail pharmacy distributors and wholesale distributors, in order to facilitate sales to a broader population of retail pharmacies and mitigate exposure to any one retail pharmacy. Beginning on September 1, 2016, all of our prescription products are distributed under the wholesale distributor model described above. 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. We record distributor fees based on amounts stated in contracts and estimate chargebacks based on the number of units sold each period. 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 $752,611, $792,574, and $698,871 during the years ended December 31, 2016, 2015, and 2014, 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 $228,933 at December 31, 2016, all of which was included in other current assets on the accompanying consolidated balance sheets. Advance payments to be expensed in future R&D activities 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. 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 As of December 31, 2016 2015 2014 Stock options 21,767,854 20,725,325 16,792,443 Warrants 12,060,071 12,722,431 13,927,916 33,827,925 33,447,756 30,720,359 Subsequent to December 31, 2016, certain individuals exercised warrants to purchase 1,800,000 shares of our Common Stock for approximately $2,436,000 in cash. See Note 15 - 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 pharmacy distributors. 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. Recently Issued Accounting Pronouncements In August 2016, the FASB issued Accounting Standards Update, or ASU, 2016-15, Statement of Cash Flows (Topic 230). ASU 2016-15 is intended to reduce the diversity in practice regarding how certain transactions are classified within the statement of cash flows. ASU 2016-15 is effective for public business entities for annual periods beginning after December 15, 2017, including interim periods within those fiscal years. Early adoption is permitted with retrospective application. We are currently evaluating the impact of this guidance on our consolidated financial statements and disclosures. In March 2016, the FASB issued ASU 2016-09, Compensation – Stock Compensation: Improvements to Employee Share-Based Payment Accounting. This guidance simplifies several aspects of the accounting for employee share-based payment transactions for both public and nonpublic entities, including the accounting for income taxes, forfeitures, and statutory tax withholding requirements, as well as classification in the statement of cash flows. 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 in any annual or interim period for which financial statements have not been issued or made available for issuance, but all of the guidance must be adopted in the same period. If an entity early adopts the guidance in an interim period, any adjustments must be reflected as of the beginning of the fiscal year that includes that interim period. We will adopt the various amendments in ASU 2016-09 in our consolidated financial statements for the quarterly period ending March 31, 2017 with an effective date of January 1, 2017. We do not expect the adoption of these amendments to have a material effect on our consolidated financial statements. In February 2016, the FASB issued ASU 2016-02, Leases. This guidance requires lessees to record most leases on their balance sheets but recognize expenses on their income statements in a manner similar to current accounting. The guidance also eliminates current real estate-specific provisions for all entities. For lessors, the guidance modifies the classification criteria and the accounting for sales-type and direct financing leases. The standard is effective for public business entities for annual periods beginning after December 15, 2018, and interim periods within those years. Early adoption is permitted for all entities. We are in the process of analyzing the quantitative impact of this guidance on our results of operations and financial position. While we are continuing to assess all potential impacts of the standard, we currently believe, the impact of this standard will be primarily related to the accounting for our operating lease. 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 adopted ASU 2015-11 in the fourth quarter of 2016. The adoption of this ASU 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 adopted ASU 2014-15 in the fourth quarter of 2016. The adoption of this ASU did not 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. In 2016, the FASB issued final amendments to clarify the implementation guidance for principal versus agent considerations (ASU 2016-08), accounting for licenses of intellectual property and identifying performance obligations (ASU 2016-10), narrow-scope improvements and practical expedients (ASU 2016-12) and technical corrections and improvements to topic 606 (ASU 2016-20) in its new revenue standard. |
INVENTORY
INVENTORY | 12 Months Ended |
Dec. 31, 2016 | |
Inventory Disclosure [Abstract] | |
INVENTORY | NOTE 3 – INVENTORY Inventory consists of the following: December 31, 2016 2015 Finished product $ 1,062,285 $ 661,167 Raw material 14,036 28,986 TOTAL INVENTORY $ 1,076,321 $ 690,153 |
OTHER CURRENT ASSETS
OTHER CURRENT ASSETS | 12 Months Ended |
Dec. 31, 2016 | |
Other Current Assets | |
OTHER CURRENT ASSETS | NOTE 4 – OTHER CURRENT ASSETS Other current assets consist of the following: December 31, 2016 2015 Prepaid insurance $ 628,039 $ 695,421 Prepaid manufacturing costs 991,809 — Prepaid consulting 128,898 334,822 Other prepaid costs 405,960 369,812 Prepaid vendor deposits 44,311 159,489 Prepaid research and development costs 100,035 674,353 TOTAL OTHER CURRENT ASSETS $ 2,299,052 $ 2,233,897 |
FIXED ASSETS, NET
FIXED ASSETS, NET | 12 Months Ended |
Dec. 31, 2016 | |
Property, Plant and Equipment [Abstract] | |
FIXED ASSETS | NOTE 5 – FIXED ASSETS, NET Fixed assets, net consist of the following: December 31, 2016 2015 Accounting system $ 301,096 $ 149,699 Equipment 215,182 132,150 Computer hardware 80,211 — Furniture and fixtures 113,079 69,454 Leasehold improvements 37,888 — 747,456 351,303 Accumulated depreciation (230,617 ) (152,711 ) TOTAL FIXED ASSETS, NET $ 516,839 $ 198,592 Depreciation expense for the years ended December 31, 2016, 2015, and 2014 was $77,906, $29,959, and $28,987, respectively. |
PREPAID EXPENSE
PREPAID EXPENSE | 12 Months Ended |
Dec. 31, 2016 | |
Prepaid Expense | |
PREPAID EXPENSE | NOTE 6 –PREPAID EXPENSE Prepaid expense consists of the following: December 31, 2016 2015 Prepaid manufacturing costs $ — $ 980,985 Prepaid research and development costs 128,898 TOTAL PREPAID EXPENSE $ — $ 1,109,883 |
INTANGIBLE ASSETS, NET
INTANGIBLE ASSETS, NET | 12 Months Ended |
Dec. 31, 2016 | |
Intangible Assets, Net (Excluding Goodwill) [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, 2016 and 2015: December 31, 2016 Gross Carrying Amount Accumulated Amortization Net Weighted- Average Amortizing intangible assets: OPERA ® $ 31,951 $ (6,490 ) $ 25,461 12.75 Development costs of corporate website 91,743 (91,743 ) — n/a Approved hormone therapy drug candidate patents 1,093,452 (102,393 ) 991,059 16 Hormone therapy drug candidate patents (pending) 1,203,987 — 1,203,987 n/a Non-amortizing intangible assets: Multiple trademarks 185,465 — 185,465 indefinite TOTAL $ 2,606,598 $ (200,626 ) $ 2,405,972 December 31, 2015 Gross Carrying Amount Accumulated Amortization Net Weighted- Average Amortizing 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 (pending) 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 We capitalize external costs, consisting primarily of legal costs, related to securing our patents and trademarks. Once a patent is granted, we amortize the approved hormone therapy drug candidate patents using the straight-line method over the estimated useful life of approximately 20 years, which is the life of intellectual property patents. If the patent is not granted, we write-off any capitalized patent costs at that time. Trademarks are perpetual and are not amortized. During the years ended December 31, 2016 and 2015, there was no impairment recognized related to intangible assets. In addition to numerous pending patent applications, as of December 31, 2016, we had 17 issued patents, including: ● 13 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; ● two utility patents that relate to TX-004HR, our applicator-free vaginal estradiol softgel product candidate, which establish an important intellectual property foundation for TX-004HR, which are owned by us and are U.S. jurisdiction patents with expiration dates in 2033 and 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 a pipeline transdermal patch technology, which is owned by us and is a U.S. jurisdiction patent with an expiration date in 2032. We have pending patent applications with respect to this technology in Australia, Brazil, Canada, Europe, Mexico, Japan, and South Africa; and ● one utility patent that relates to our OPERA ® Amortization expense was $54,545, $32,441 and $23,480 for the years ended December 31, 2016, 2015, and 2014, respectively. Estimated amortization expense, based on current patent cost being amortized, for the next five years is as follows: Year Ending Estimated 2017 $ 63,938 2018 $ 63,938 2019 $ 63,938 2020 $ 63,938 2021 $ 63,938 Thereafter $ 696,830 |
OTHER CURRENT LIABILITIES
OTHER CURRENT LIABILITIES | 12 Months Ended |
Dec. 31, 2016 | |
Other Liabilities Disclosure [Abstract] | |
OTHER CURRENT LIABILITIES | NOTE 8 – OTHER CURRENT LIABILITIES Other current liabilities consist of the following: December 31, 2016 2015 Accrued clinical trial costs $ 1,281,080 $ 3,725,377 Accrued payroll, bonuses and commission costs 3,531,440 2,108,143 Accrued compensated absences 665,561 562,096 Accrued legal and accounting expense 176,518 210,309 Accrued sales and marketing costs 665,773 — Other accrued expenses 224,865 546,264 Allowance for wholesale distributor fees 76,510 32,659 Accrued royalties 26,507 46,851 Allowance for coupons and returns 794,816 224,300 Accrued rent 181,015 83,527 TOTAL OTHER CURRENT LIABILITIES $ 7,624,085 $ 7,539,526 |
STOCKHOLDERS' EQUITY
STOCKHOLDERS' EQUITY | 12 Months Ended |
Dec. 31, 2016 | |
Stockholders' Equity: | |
STOCKHOLDERS' EQUITY | NOTE 9 – STOCKHOLDERS’ EQUITY Preferred Stock At December 31, 2016, 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, 2016, we had 350,000,000 shares of Common Stock authorized for issuance, of which 196,688,222 shares of our Common Stock were issued and outstanding. Issuances During 2016 On January 6, 2016, we entered into an underwriting agreement with Goldman Sachs & Co. 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 to us 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 and we issued 17,424,242 shares of our Common Stock. During the year ended December 31, 2016, certain individuals exercised stock options to purchase 525,362 shares of Common Stock for $989,060 in cash. Also during the same period, stock options to purchase 127,109 shares of Common Stock were exercised pursuant to the options’ cashless exercise provisions, wherein 87,833 shares of Common Stock were issued. 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. 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. Warrants to Purchase Common Stock As of December 31, 2016, we had warrants outstanding to purchase an aggregate of 12,060,071 shares of our Common Stock with a weighted-average contractual remaining life of 1.0 years, and exercise prices ranging from $0.24 to $8.20 per share, resulting in a weighted average exercise price of $2.08 per share. The valuation methodology used to determine the fair value of our warrants is the Black-Scholes Model. The Black-Scholes Model requires the use of a number of assumptions, including volatility of the stock price, the risk-free interest rate, dividend yield and the term of the warrant. During the year ended December 31, 2016, we granted warrants to purchase 245,000 shares of Common Stock to outside consultants at the weighted average price of $7.90 per share. These warrants vest and have expiration dates as follows: warrants to purchase 75,000 shares of Common Stock vested on April 21, 2016 and have an expiration date of April 21, 2021, warrants to purchase 50,000 shares of Common Stock vest ratably over a 24-month period and have an expiration date of April 21, 2021, and warrants to purchase 120,000 shares of Common Stock vest ratable over a 12-month period and have an expiration date of January 21, 2021. 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. We recorded share-based compensation expense related to warrants previously issued of $936,974, $139,142 and $36,284 for the years ended December 31, 2016, 2015, and 2014, respectively, in the accompanying consolidated financial statements. Summary of our Warrant activity during the year ended December 31, 2016: Number of Shares Under Warrants Weighted Average Exercise Price Weighted Aggregate Balance at December 31, 2015 12,722,431 $ 1.93 1.7 $ 107,344,752 Granted 245,000 $ 7.90 Exercised (722,744 ) $ 1.90 $ 3,988,343 Expired (184,616 ) $ 0.41 Cancelled/Forfeited — Balance at December 31, 2016 12,060,071 $ 2.08 1.0 $ 45,063,867 Vested and Exercisable at December 31, 2016 11,733,410 $ 2.06 1.0 $ 43,998,535 Unvested at December 31, 2016 326,661 $ 2.81 1.7 $ 1,065,332 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, 2016, 2015 and 2014 are set forth in the table below. 2016 2015 2014 Weighted average price $7.90 $6.35 n/a Weighted average grant date fair value $4.78 $3.27 n/a Risk-free interest rate 1.04-1.28% 1.02% n/a Volatility 74.10-74.15% 60.59% n/a Term (in years) 5 5 n/a Dividend yield 0.00% 0.00% n/a 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 instrument. The 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 instrument as we have insufficient historical information regarding our stock options to provide a basis for estimate. The expected volatility of warrants was estimated based on a historical volatility analysis of peers that were similar to the Company with respect to industry, stage of life cycle, market capitalization, and financial leverage. In January 2013, we issued warrants to purchase 1,250,000 shares of our Common Stock in connection with the issuance of a Multiple Advance Revolving Credit Note to Plato and Associates, LLC, or the Plato Warrant. The Plato Warrant has an exercise price of $3.20 per share. The Plato Warrant vested on October 31, 2013 and may be exercised prior to its expiration on January 31, 2019. The Plato Warrant, with a fair value of 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, 2016, 2015, 2014, and 2013, $0, $0, and $260,027, respectively, was recorded as financing costs in connection with the issuance of the Plato Warrant on the accompanying consolidated financial statements. In May 2013, we entered into a consulting agreement with Sancilio and Company, Inc., or 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 2016, 2015, and 2014, we recorded $77,026, $154,068, and $154,068, respectively, as non-cash compensation in the accompanying consolidated financial statements related to this warrant. As of December 31, 2016 this warrant was fully amortized; 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 May 2017. 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. The warrants vested upon issuance. Services provided are to include (a) services in support of our drug development efforts, including services in support our ongoing and future drug development and commercialization efforts, regulatory approval efforts, third-party investment and financing efforts, marketing efforts, chemistry, manufacturing and controls efforts, drug launch and post-approval activities, and other intellectual property and know-how transfer associated therewith; (b) services in support of our efforts to successfully obtain New Drug Approval; and (c) other consulting services as mutually agreed upon from time to time in relation to new drug development opportunities. The warrants were valued at $1,532,228 on the date of the issuance using an exercise price of $2.57; a term of five years; a volatility of 44.71%; risk free rate of 0.74%; and a dividend yield of 0%. At December 31, 2016, we had $128,898 reported as prepaid expense-short term associated with these warrants. During the years ended December 31, 2016, 2015, and 2014, we recorded $257,796, $257,796, and $309,165, 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, 2016, unamortized costs associated with the SCI warrants issued in 2013 and 2012 totaled approximately $128,898 and will be recognized over a period of six months. Warrant exercises During the year ended December 31, 2016, certain individuals exercised warrants to purchase 722,744 shares of Common Stock for $1,373,000 in cash. 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. Subsequent to December 31, 2016, certain individuals exercised warrants to purchase 1,800,000 shares of our Common Stock for approximately $2,436,000 in cash. 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. As of December 31, 2016, there were non-qualified stock options to purchase 17,899,380 shares of Common Stock outstanding under the 2009 Plan. As of December 31, 2016, there were 2,952,128 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, 2016, there were non-qualified stock options to purchase 3,868,474 shares of Common Stock outstanding under the 2012 Plan. As of December 31, 2016, there were 6,050,000 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, 2016, 2015, and 2014 are set forth in the table below. 2016 2015 2014 Risk-free interest rate 1.13-1.90% 1.47-1.67% 0.07-1.77% Volatility 70.26-73.34% 58.78-62.94% 68.05-82.29% Term (in years) 5.5-6.25 5.27-6.25 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 as we have insufficient historical information regarding our stock options to provide a basis for estimate. The expected volatility of share options was estimated based on a historical volatility analysis of peers that were similar to us with respect to industry, stage of life cycle, market capitalization, and financial leverage. The average expected life is based on the contractual terms of the stock option using the simplified method. We utilize a dividend yield of zero based on the fact that we have never paid cash dividends and have no current intention to pay cash dividends. Future stock-based compensation may significantly differ based on changes in the fair value of our common stock and our estimates of expected volatility and the other relevant assumptions. A summary of activity under the 2009 and 2012 Plans and related information during the year ended December 31, 2016 is as follows: Number of Shares Under Options Weighted Average Exercise Price Weighted Aggregate Balance at December 31, 2015 20,725,325 $ 3.28 6.5 $ 146,864,184 Granted 1,732,500 $ 6.22 Exercised (652,471 ) $ 1.91 $ 3,828,358 Expired (5,750 ) $ 4.76 Cancelled/Forfeited (31,750 ) $ 6.38 Balance at December 31, 2016 21,767,854 $ 3.56 5.8 $ 60,495,730 Vested and Exercisable at December 31, 2016 18,633,479 $ 3.09 5.3 $ 59,382,849 Unvested at December 31, 2016 3,134,375 $ 6.29 9.0 $ 1,112,881 At December 31, 2016, our outstanding options had exercise prices ranging from $0.10 to $8.92 per share. The weighted average grant date fair value of options granted during the year ended December 31, 2016 was $3.94 per share. Share-based compensation expense related to options recognized in our results of operations for the years ended December 31, 2016, 2015, and 2014 was approximately $16,139,225, $6,621,658, and $4,393,455, 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, 2016, total unrecognized estimated compensation expense related to unvested options was approximately $10,669,000, which may be adjusted for future changes in forfeitures. This cost is expected to be recognized over a weighted-average period of 2.6 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 year ended December 31, 2014 we recorded $180,072 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, 2016 | |
Income Tax Disclosure [Abstract] | |
INCOME TAXES | NOTE 10 – INCOME TAXES For the years ended December 31, 2016, 2015, and 2014, there was no provision for income taxes, current or deferred. At December 31, 2016, we had a federal net operating loss carry forward of $268,199,351 available to offset future taxable income through 2036. The federal carryforwards will begin to expire in 2031. A reconciliation between taxes computed at the federal statutory rate and the consolidated effective tax rate is as follows: 2016 2015 2014 Federal statutory tax rate 34.0 % 34.0 % 34.0 % State tax rate, net of federal tax benefit 5.4 % 4.73 % 5.8 % Adjustment in valuation allowances (40.3 )% (38.97 )% (50.9 )% Permanent and other differences 0.9 % 0.24 % 11.1 % 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, 2016, 2015, and 2014 are as follows: 2016 2015 2014 Deferred Income Tax Assets: Net operating losses $ 111,730,450 $ 79,499,633 $ 43,091,437 R&D Credit 186,347 186,347 — Total deferred income tax asset 111,916,797 79,685,980 43,091,437 Valuation allowance (111,916,797 ) (79,685,980 ) (43,091,437 ) 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, 2016. Unrecognized Tax Benefits As of the period ended December 31, 2016, we have no unrecognized tax benefits. |
RELATED PARTIES
RELATED PARTIES | 12 Months Ended |
Dec. 31, 2016 | |
Related Party Transactions [Abstract] | |
RELATED PARTIES | NOTE 11 – RELATED PARTIES In July 2015, J. Martin Carroll, a director of our Company, was appointed to the board of directors of Catalent, Inc. From time to time, we have entered into agreements with Catalent, Inc. and its affiliates, or Catalent, in the normal course of business. Agreements with Catalent have been reviewed by independent directors of our Company or a committee consisting of independent directors of our Company since July 2015. During the years ended December 31, 2016 and 2015, the amounts billed by Catalent were approximately $3,647,000 and $1,266,000, respectively, for manufacturing activities related to our clinical trials, scale-up, registration batches, stability and validation testing. As of December 31, 2016 and 2015 there were amounts due to Catalent of approximately $57,000 and $4,600, respectively. 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 year ended December 31, 2015, we entered into a settlement agreement with Pernix according to which Pernix paid us $175,000 in cash for legal fee reimbursement relating to a litigation matter stemming from a license and supply agreement, resulting in the elimination of an approximately $46,000 outstanding payable and $250,000 outstanding receivable 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, 2016 | |
Risks and Uncertainties [Abstract] | |
BUSINESS CONCENTRATIONS | NOTE 12 - BUSINESS CONCENTRATIONS We purchase our products from several suppliers with approximately 98%, 60% and 82% of our purchases supplied by one vendor for the years ended December 31, 2016, 2015 and 2014, respectively. We sell our prescription prenatal vitamin products to wholesale distributors, specialty pharmacies, specialty distributors, and chain drug stores that generally sell products to retail pharmacies, hospitals, and other institutional customers. During the years ended December 31, 2016, 2015 and 2014; three, two and four customers each, respectively, generated more than 10% of our revenues. Revenue generated from three major customers combined accounted for approximately 41% of our revenue during the year ended December 31, 2016. Revenue generated from two major customers combined accounted for approximately 67% of our revenue during the year ended December 31, 2015. Revenue generated from four major customers combined accounted for approximately 75% of our recognized revenue during the year ended December 31, 2014. During the year ended December 31, 2016, Woodstock Pharmaceutical and Compounding generated approximately $2,247,000 of our revenue; Medical Center Pharmacy generated approximately $3,700,000 of our revenue and Pharmacy Innovations PA generated approximately $2,040,000 of our revenue. During the year ended December 31, 2015, Woodstock Pharmaceutical and Compounding generated approximately $8,848,000 of our revenue and Due West Pharmacy generated approximately $4,843,000 of our revenue. During the year ended December 31, 2014, AmerisourceBergen generated approximately $1,610,000, McKesson generated approximately $1,587,000, Cardinal generated approximately $1,804,000 and Woodstock Pharmaceutical and Compounding generated approximately $4,054,000 in sales, respectively. As a result of developments in the pharmaceutical industry that negatively affected independent pharmacies, including such pharmacies’ reliance on third party payors, in 2016, we identified that payment periods for our retail pharmacy distributors were becoming longer than in prior years. As a result, during the third quarter of 2016, we centralized the distribution channel for both our retail pharmacy distributors and wholesale distributors, in order to facilitate sales to a broader population of retail pharmacies and minimize business risk exposure to any one retail pharmacy. During the third quarter of 2016, we entered into new distribution agreements with our retail pharmacy distributors to effectuate this centralization which were effective September 1, 2016. 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 the year ended December 31, 2014. 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 years ended December 31, 2016 and 2015. |
COMMITMENTS AND CONTINGENCIES
COMMITMENTS AND CONTINGENCIES | 12 Months Ended |
Dec. 31, 2016 | |
Commitments and Contingencies Disclosure [Abstract] | |
COMMITMENTS AND CONTINGENCIES | NOTE 13 – COMMITMENTS AND CONTINGENCIES Operating Lease We lease administrative office space in Boca Raton, Florida pursuant to a non-cancelable operating lease that commenced on July 1, 2013 and originally provided for a 63-month term. On February 18, 2015, we entered into an agreement with the same lessors to lease additional administrative office space in the same location, pursuant to an addendum to such lease. In addition, on April 26, 2016, we entered into an agreement with the same lessors to lease additional administrative office space in the same location. This agreement was effective beginning May 1, 2016 and extended the original expiration of the lease term to October 31, 2021. On October 4, 2016, we entered into an agreement with the same lessors to lease additional administrative office space in the same location, pursuant to an addendum to such lease. This addendum is effective beginning November 1, 2016. The rental expense related to our current lease during the years ended December 31, 2016, 2015 and 2014 was $709,483, $446,099 and $361,793, respectively. The rental expense during the year ended December 31, 2014 was partially offset by rent income of $41,613. We did not sublet any space during the years ended December 31, 2016 and 2015. As of December 31, 2016, future minimum rental payments on non-cancelable operating leases are as follows: Years Ending December 31, 2017 $ 864,827 2018 942,305 2019 1,083,890 2020 1,102,667 2021 934,313 Total minimum lease payments $ 4,928,002 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, 2016, 2015, and 2014, 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, 2016 | |
Quarterly Financial Information Disclosure [Abstract] | |
SELECTED QUARTERLY FINANCIAL DATA (UNAUDITED) | NOTE 14 – SELECTED QUARTERLY FINANCIAL DATA (UNAUDITED) Summarized quarterly financial data for fiscal years 2016 and 2015 is as follows: 2016 Quarters (In thousands, except per share) 1 st 2 nd 3 rd 4th Revenues $ 4,930 $ 4,403 $ 5,536 $ 4,487 Gross profit $ 3,822 $ 3,273 $ 4,298 $ 3,778 Net loss $ (20,929 ) $ (21,094 ) $ (25,016 ) $ (22,836 ) Loss per common share, basic and diluted $ (0.11 ) $ (0.11 ) $ (0.13 ) $ (0.12 ) 2015 Quarters (In thousands, except per share) 1 st 2 nd 3 rd 4th 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 ) |
SUBSEQUENT EVENTS
SUBSEQUENT EVENTS | 12 Months Ended |
Dec. 31, 2016 | |
Subsequent Events [Abstract] | |
SUBSEQUENT EVENTS | NOTE 15 – SUBSEQUENT EVENTS Subsequent to December 31, 2016, certain individuals exercised warrants to purchase 1,800,000 shares of Common Stock for approximately $2,436,000 in cash. |
SUMMARY OF SIGNIFICANT ACCOUN22
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies) | 12 Months Ended |
Dec. 31, 2016 | |
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 During the third quarter of 2016, we wrote-off accounts receivable balances of $2.2 million related to two retail pharmacy distributors. Both pharmacies are relatively small owner-managed pharmacies and share a similar amount of collection risk. Among the factors that contributed to our decision to write-off these balances were our inability to collect the outstanding balances and the lack of a continuing communication and business relationship with these parties following the centralization of the distribution channel for both our retail pharmacy distributors and wholesale distributors, effective September 1, 2016. |
Inventories | Inventories Inventories represent packaged vitamins, nutritional products and supplements and raw materials, which are valued at the lower of cost or net realizable value using the average-cost method. Any costs of manufacturing the prescription products associated with the deferred revenue (as discussed in Revenue Recognition) prior to January 1, 2015, were recorded as deferred costs and included in inventory, until such time as the related deferred revenue was recognized. We review our inventory for excess or obsolete inventory and write-down obsolete or otherwise unmarketable inventory to its estimated net realizable value. Obsolescence may occur due to product expiring or product improvements rendering previous versions obsolete. |
Pre-Launch Inventory | 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. Leasehold improvements are depreciated over the shorter of their useful life or the term of the lease. 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 Financial Accounting Standards Board, or FASB, Accounting Standards Codification, or ASC, 350, Intangibles - Goodwill and Other |
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 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, 2016, 2015, and 2014. 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, 2016, 2015, and 2014. |
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, 2016 and 2015, 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, 2016, 2015, and 2014. |
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, 2016 and 2015, 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 2013 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. We amortize such compensation amounts, if any, over the respective service periods of the award. We use the Black-Scholes-Merton option pricing model, or the Black-Scholes Model, an acceptable model in accordance with ASC 718, Compensation-Stock Compensation 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. |
Revenue Recognition | Revenue Recognition We recognize revenue on arrangements in accordance with ASC 605, Revenue Recognition Our OTC and prescription prenatal vitamin products are generally variations of the same product with slight modifications in formulation and marketing. The primary difference between our OTC and prescription prenatal vitamin products is the source of payment. Purchasers of our OTC prenatal vitamin products pay for the product directly while purchasers of our prescription prenatal vitamin products pay for the product primarily via third-party payers. Both OTC and prescription prenatal vitamin products share the same marketing support team utilizing similar marketing techniques. As of January 1, 2017, we ceased manufacturing and distributing our OTC product lines, except for Iron 21/7, which have declined steadily over time resulting in immaterial sales. The revenue that is generated by us from major customers is all generated from sales of our prescription prenatal vitamin products which is disclosed in Note 13. There are no major customers for our OTC prenatal vitamin or other products. |
Over-the-Counter Products | Over-the-Counter Products We generate OTC revenue from product sales primarily to retail consumers. We recognize revenue from product sales upon shipment, when the rights of ownership and risk of loss have passed to the consumer. We include outbound shipping and handling fees, if any, 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 and sales discounts. As of January 1, 2017, we ceased manufacturing and distributing our OTC product lines, except for Iron 21/7, which have declined steadily over time resulting in immaterial sales. |
Prescription Products | Prescription Products We sell our name brand and generic prescription products primarily through wholesale distributors and retail pharmacy distributors. We recognize revenue from prescription product sales, net of sales discounts, chargebacks, wholesaler fees, customer rebates and estimated returns. Revenue related to prescription products sold through wholesale distributors is recognized when the prescription products are shipped to the distributors and the control of the products passes to each distributor. We accept returns of unsalable prescription products sold through wholesale distributors within a return period of six months prior to and up to 12 months following product expiration. Our prescription products currently have a shelf life of 24 months from the date of manufacture. Prior to January 1, 2015, we deferred the recognition of revenue on prescription products sold through wholesale distributors until the right of return no longer existed as, prior to that date, we could not reasonably estimate the amount of future returns. As of January 1, 2015, we began estimating and reserving for returns based on historical return rates, while recording actual product returns against this reserve as received. Prior to September 1, 2016, we recognized revenue related to prescription products sold through retail pharmacy distributors when the product was dispensed by the retail pharmacy distributor, at which point all revenue and discounts related to such product were known or determinable and there was no right of return with respect to such product. On September 1, 2016, we centralized the distribution channel for both our retail pharmacy distributors and wholesale distributors, in order to facilitate sales to a broader population of retail pharmacies and mitigate exposure to any one retail pharmacy. Beginning on September 1, 2016, all of our prescription products are distributed under the wholesale distributor model described above. 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. We record distributor fees based on amounts stated in contracts and estimate chargebacks based on the number of units sold each period. |
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 $752,611, $792,574, and $698,871 during the years ended December 31, 2016, 2015, and 2014, 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 $228,933 at December 31, 2016, all of which was included in other current assets on the accompanying consolidated balance sheets. Advance payments to be expensed in future R&D activities 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. 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 As of December 31, 2016 2015 2014 Stock options 21,767,854 20,725,325 16,792,443 Warrants 12,060,071 12,722,431 13,927,916 33,827,925 33,447,756 30,720,359 Subsequent to December 31, 2016, certain individuals exercised warrants to purchase 1,800,000 shares of our Common Stock for approximately $2,436,000 in cash. See Note 15 - Subsequent Events for more details. |
Concentration of Credit Risk and other Risks and Uncertainties | Concentration of Credit Risk and other Risks and Uncertainties Concentration of credit risk with respect to our trade accounts receivable from our customers is primarily limited to drug wholesalers and retail pharmacy distributors. Credit is extended to our customers based on an evaluation of a customer’s 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. |
Recently Issued Accounting Pronouncements | Recently Issued Accounting Pronouncements In August 2016, the FASB issued Accounting Standards Update, or ASU, 2016-15, Statement of Cash Flows (Topic 230). ASU 2016-15 is intended to reduce the diversity in practice regarding how certain transactions are classified within the statement of cash flows. ASU 2016-15 is effective for public business entities for annual periods beginning after December 15, 2017, including interim periods within those fiscal years. Early adoption is permitted with retrospective application. We are currently evaluating the impact of this guidance on our consolidated financial statements and disclosures. In March 2016, the FASB issued ASU 2016-09, Compensation – Stock Compensation: Improvements to Employee Share-Based Payment Accounting. This guidance simplifies several aspects of the accounting for employee share-based payment transactions for both public and nonpublic entities, including the accounting for income taxes, forfeitures, and statutory tax withholding requirements, as well as classification in the statement of cash flows. 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 in any annual or interim period for which financial statements have not been issued or made available for issuance, but all of the guidance must be adopted in the same period. If an entity early adopts the guidance in an interim period, any adjustments must be reflected as of the beginning of the fiscal year that includes that interim period. We will adopt the various amendments in ASU 2016-09 in our consolidated financial statements for the quarterly period ending March 31, 2017 with an effective date of January 1, 2017. We do not expect the adoption of these amendments to have a material effect on our consolidated financial statements. In February 2016, the FASB issued ASU 2016-02, Leases. This guidance requires lessees to record most leases on their balance sheets but recognize expenses on their income statements in a manner similar to current accounting. The guidance also eliminates current real estate-specific provisions for all entities. For lessors, the guidance modifies the classification criteria and the accounting for sales-type and direct financing leases. The standard is effective for public business entities for annual periods beginning after December 15, 2018, and interim periods within those years. Early adoption is permitted for all entities. We are in the process of analyzing the quantitative impact of this guidance on our results of operations and financial position. While we are continuing to assess all potential impacts of the standard, we currently believe, the impact of this standard will be primarily related to the accounting for our operating lease. 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 adopted ASU 2015-11 in the fourth quarter of 2016. The adoption of this ASU 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 adopted ASU 2014-15 in the fourth quarter of 2016. The adoption of this ASU did not 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. In 2016, the FASB issued final amendments to clarify the implementation guidance for principal versus agent considerations (ASU 2016-08), accounting for licenses of intellectual property and identifying performance obligations (ASU 2016-10), narrow-scope improvements and practical expedients (ASU 2016-12) and technical corrections and improvements to topic 606 (ASU 2016-20) in its new revenue standard. |
SUMMARY OF SIGNIFICANT ACCOUN23
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
Accounting Policies [Abstract] | |
Schedule of potentially dilutive securities in calculation of diluted net loss per share allocable to common stockholders | The table below presents potentially dilutive securities that could affect our calculation of diluted net loss per share allocable to common stockholders for the periods presented. As of December 31, 2016 2015 2014 Stock options 21,767,854 20,725,325 16,792,443 Warrants 12,060,071 12,722,431 13,927,916 33,827,925 33,447,756 30,720,359 |
INVENTORY (Tables)
INVENTORY (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
Inventory Disclosure [Abstract] | |
Schedule of Inventory | Inventory consists of the following: December 31, 2016 2015 Finished product $ 1,062,285 $ 661,167 Raw material 14,036 28,986 TOTAL INVENTORY $ 1,076,321 $ 690,153 |
OTHER CURRENT ASSETS (Tables)
OTHER CURRENT ASSETS (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
Other Current Assets Tables | |
Schedule of other current assets | Other current assets consist of the following: December 31, 2016 2015 Prepaid insurance $ 628,039 $ 695,421 Prepaid manufacturing costs 991,809 — Prepaid consulting 128,898 334,822 Other prepaid costs 405,960 369,812 Prepaid vendor deposits 44,311 159,489 Prepaid research and development costs 100,035 674,353 TOTAL OTHER CURRENT ASSETS $ 2,299,052 $ 2,233,897 |
FIXED ASSETS, NET (Tables)
FIXED ASSETS, NET (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
Property, Plant and Equipment [Abstract] | |
Schedule of fixed assets | Fixed assets, net consist of the following: December 31, 2016 2015 Accounting system $ 301,096 $ 149,699 Equipment 215,182 132,150 Computer hardware 80,211 — Furniture and fixtures 113,079 69,454 Leasehold improvements 37,888 — 747,456 351,303 Accumulated depreciation (230,617 ) (152,711 ) TOTAL FIXED ASSETS, NET $ 516,839 $ 198,592 |
PREPAID EXPENSE (Tables)
PREPAID EXPENSE (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
Prepaid Expense Tables | |
Schedule of prepaid expense | Prepaid expense consists of the following: December 31, 2016 2015 Prepaid manufacturing costs $ — $ 980,985 Prepaid research and development costs 128,898 TOTAL PREPAID EXPENSE $ — $ 1,109,883 |
INTANGIBLE ASSETS, NET (Tables)
INTANGIBLE ASSETS, NET (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
Intangible Assets, Net (Excluding Goodwill) [Abstract] | |
Schedule of intangible assets | The following table sets forth the gross carrying amount, accumulated amortization and net carrying amount of our intangible assets as of December 31, 2016 and 2015: December 31, 2016 Gross Carrying Amount Accumulated Amortization Net Weighted- Average Amortizing intangible assets: OPERA ® $ 31,951 $ (6,490 ) $ 25,461 12.75 Development costs of corporate website 91,743 (91,743 ) — n/a Approved hormone therapy drug candidate patents 1,093,452 (102,393 ) 991,059 16 Hormone therapy drug candidate patents (pending) 1,203,987 — 1,203,987 n/a Non-amortizing intangible assets: Multiple trademarks 185,465 — 185,465 indefinite TOTAL $ 2,606,598 $ (200,626 ) $ 2,405,972 December 31, 2015 Gross Carrying Amount Accumulated Amortization Net Weighted- Average Amortizing 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 (pending) 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 |
Schedule of estimated amortization expense | Estimated amortization expense, based on current patent cost being amortized, for the next five years is as follows: Year Ending Estimated 2017 $ 63,938 2018 $ 63,938 2019 $ 63,938 2020 $ 63,938 2021 $ 63,938 Thereafter $ 696,830 |
OTHER CURRENT LIABILITIES (Tabl
OTHER CURRENT LIABILITIES (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
Other Liabilities Disclosure [Abstract] | |
Schedule of other current liabilities | Other current liabilities consist of the following: December 31, 2016 2015 Accrued clinical trial costs $ 1,281,080 $ 3,725,377 Accrued payroll, bonuses and commission costs 3,531,440 2,108,143 Accrued compensated absences 665,561 562,096 Accrued legal and accounting expense 176,518 210,309 Accrued sales and marketing costs 665,773 — Other accrued expenses 224,865 546,264 Allowance for wholesale distributor fees 76,510 32,659 Accrued royalties 26,507 46,851 Allowance for coupons and returns 794,816 224,300 Accrued rent 181,015 83,527 TOTAL OTHER CURRENT LIABILITIES $ 7,624,085 $ 7,539,526 |
STOCKHOLDERS' EQUITY (Tables)
STOCKHOLDERS' EQUITY (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
Stockholders' Equity Note [Abstract] | |
Schedule of warrant activity | Summary of our Warrant activity during the year ended December 31, 2016: Number of Shares Under Warrants Weighted Average Exercise Price Weighted Aggregate Balance at December 31, 2015 12,722,431 $ 1.93 1.7 $ 107,344,752 Granted 245,000 $ 7.90 Exercised (722,744 ) $ 1.90 $ 3,988,343 Expired (184,616 ) $ 0.41 Cancelled/Forfeited — Balance at December 31, 2016 12,060,071 $ 2.08 1.0 $ 45,063,867 Vested and Exercisable at December 31, 2016 11,733,410 $ 2.06 1.0 $ 43,998,535 Unvested at December 31, 2016 326,661 $ 2.81 1.7 $ 1,065,332 |
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, 2016, 2015 and 2014 are set forth in the table below. 2016 2015 2014 Weighted average price $7.90 $6.35 n/a Weighted average grant date fair value $4.78 $3.27 n/a Risk-free interest rate 1.04-1.28% 1.02% n/a Volatility 74.10-74.15% 60.59% n/a Term (in years) 5 5 n/a Dividend yield 0.00% 0.00% n/a |
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, 2016, 2015, and 2014 are set forth in the table below. 2016 2015 2014 Risk-free interest rate 1.13-1.90% 1.47-1.67% 0.07-1.77% Volatility 70.26-73.34% 58.78-62.94% 68.05-82.29% Term (in years) 5.5-6.25 5.27-6.25 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, 2016 is as follows: Number of Shares Under Options Weighted Average Exercise Price Weighted Aggregate Balance at December 31, 2015 20,725,325 $ 3.28 6.5 $ 146,864,184 Granted 1,732,500 $ 6.22 Exercised (652,471 ) $ 1.91 $ 3,828,358 Expired (5,750 ) $ 4.76 Cancelled/Forfeited (31,750 ) $ 6.38 Balance at December 31, 2016 21,767,854 $ 3.56 5.8 $ 60,495,730 Vested and Exercisable at December 31, 2016 18,633,479 $ 3.09 5.3 $ 59,382,849 Unvested at December 31, 2016 3,134,375 $ 6.29 9.0 $ 1,112,881 |
INCOME TAXES (Tables)
INCOME TAXES (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
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: 2016 2015 2014 Federal statutory tax rate 34.0 % 34.0 % 34.0 % State tax rate, net of federal tax benefit 5.4 % 4.73 % 5.8 % Adjustment in valuation allowances (40.3 )% (38.97 )% (50.9 )% Permanent and other differences 0.9 % 0.24 % 11.1 % 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, 2016, 2015, and 2014 are as follows: 2016 2015 2014 Deferred Income Tax Assets: Net operating losses $ 111,730,450 $ 79,499,633 $ 43,091,437 R&D Credit 186,347 186,347 — Total deferred income tax asset 111,916,797 79,685,980 43,091,437 Valuation allowance (111,916,797 ) (79,685,980 ) (43,091,437 ) Deferred income tax assets, net $ — $ — $ — |
COMMITMENTS AND CONTINGENCIES (
COMMITMENTS AND CONTINGENCIES (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
Commitments and Contingencies Disclosure [Abstract] | |
Schedule of future minimum rental payments | As of December 31, 2016, future minimum rental payments on non-cancelable operating leases are as follows: Years Ending December 31, 2017 $ 864,827 2018 942,305 2019 1,083,890 2020 1,102,667 2021 934,313 Total minimum lease payments $ 4,928,002 |
SELECTED QUARTERLY FINANCIAL 33
SELECTED QUARTERLY FINANCIAL DATA (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
Quarterly Financial Information Disclosure [Abstract] | |
Schedule of quarterly unaudited summary information | Summarized quarterly financial data for fiscal years 2016 and 2015 is as follows: 2016 Quarters (In thousands, except per share) 1 st 2 nd 3 rd 4th Revenues $ 4,930 $ 4,403 $ 5,536 $ 4,487 Gross profit $ 3,822 $ 3,273 $ 4,298 $ 3,778 Net loss $ (20,929 ) $ (21,094 ) $ (25,016 ) $ (22,836 ) Loss per common share, basic and diluted $ (0.11 ) $ (0.11 ) $ (0.13 ) $ (0.12 ) 2015 Quarters (In thousands, except per share) 1 st 2 nd 3 rd 4th 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 ) |
SUMMARY OF SIGNIFICANT ACCOUN34
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details Narrative) | 1 Months Ended | 9 Months Ended | 12 Months Ended | ||
Jan. 31, 2017USD ($)shares | Sep. 30, 2016USD ($) | Dec. 31, 2016USD ($)Numbershares | Dec. 31, 2015USD ($)shares | Dec. 31, 2014USD ($)shares | |
Federal insurance limits | $ 250,000 | ||||
Number of issued patents | Number | 17 | ||||
Advertising costs | $ 752,611 | $ 792,574 | $ 698,871 | ||
Shelf life of prescription products | 24 months | ||||
Number of operating segment | Number | 1 | ||||
Shares issued for exercise of warrants, net | $ 1,373,000 | $ 366,000 | $ 181,000 | ||
Warrants [Member] | |||||
Shares issued for exercise of warrants, net (in shares) | shares | 722,744 | 945,485 | 365,583 | ||
Shares issued for exercise of warrants, net | $ 1,373,000 | $ 366,000 | $ 181,000 | ||
Subsequent Event [Member] | Warrants [Member] | |||||
Shares issued for exercise of warrants, net (in shares) | shares | 1,800,000 | ||||
Shares issued for exercise of warrants, net | $ 2,436,000 | ||||
Two Customers [Member] | |||||
Wrote off accounts receivable | $ 2,200,000 | ||||
Customer A [Member] | Accounts Receivable [Member] | |||||
Concentration risk | 28.00% | 27.00% | |||
Customer B [Member] | Accounts Receivable [Member] | |||||
Concentration risk | 20.00% | 30.00% | |||
Customer C [Member] | Accounts Receivable [Member] | |||||
Concentration risk | 14.00% | ||||
Related to Research and Development Activities [Member] | |||||
Advance payments - total | $ 228,933 | $ 1,138,073 | |||
Advance payments - other assets current | 1,009,175 | ||||
Advance payments - long term prepaid expense | $ 128,898 | ||||
Minimum [Member] | |||||
Estimated useful lives | 3 years | ||||
Return period of unsalable prescription products | 6 months | ||||
Minimum [Member] | Software [Member] | |||||
Estimated useful lives | 5 years | ||||
Maximum [Member] | |||||
Estimated useful lives | 7 years | ||||
Return period of unsalable prescription products | 12 months | ||||
Maximum [Member] | Software [Member] | |||||
Estimated useful lives | 7 years |
SUMMARY OF SIGNIFICANT ACCOUN35
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details) - shares | 12 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Anti-dilutive shares excluded from earnings per share calculation | 33,827,925 | 33,447,756 | 30,720,359 |
Warrants [Member] | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Anti-dilutive shares excluded from earnings per share calculation | 12,060,071 | 12,722,431 | 13,927,916 |
Stock Options [Member] | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Anti-dilutive shares excluded from earnings per share calculation | 21,767,854 | 20,725,325 | 16,792,443 |
INVENTORY (Details)
INVENTORY (Details) - USD ($) | Dec. 31, 2016 | Dec. 31, 2015 |
Inventory | ||
Finished product | $ 1,062,285 | $ 661,167 |
Raw material | 14,036 | 28,986 |
TOTAL INVENTORY | $ 1,076,321 | $ 690,153 |
OTHER CURRENT ASSETS (Details)
OTHER CURRENT ASSETS (Details) - USD ($) | Dec. 31, 2016 | Dec. 31, 2015 |
Other Current Assets | ||
Prepaid insurance | $ 628,039 | $ 695,421 |
Prepaid manufacturing costs | 991,809 | |
Prepaid consulting | 128,898 | 334,822 |
Other prepaid costs | 405,960 | 369,812 |
Prepaid vendor deposits | 44,311 | 159,489 |
Prepaid research and development costs | 100,035 | 674,353 |
TOTAL OTHER CURRENT ASSETS | $ 2,299,052 | $ 2,233,897 |
FIXED ASSETS, NET (Details Narr
FIXED ASSETS, NET (Details Narrative) - USD ($) | 12 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Property, Plant and Equipment [Abstract] | |||
Depreciation Expense | $ 77,906 | $ 29,959 | $ 28,987 |
FIXED ASSETS, NET (Details)
FIXED ASSETS, NET (Details) - USD ($) | Dec. 31, 2016 | Dec. 31, 2015 |
Property, Plant and Equipment [Line Items] | ||
Fixed assets, gross | $ 747,456 | $ 351,303 |
Accumulated depreciation | (230,617) | (152,711) |
TOTAL FIXED ASSETS, NET | 516,839 | 198,592 |
Software [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Fixed assets, gross | 301,096 | 149,699 |
Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Fixed assets, gross | 215,182 | 132,150 |
Computer Hardware [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Fixed assets, gross | 80,211 | |
Furniture and Fixtures [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Fixed assets, gross | 113,079 | 69,454 |
Leasehold improvements [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Fixed assets, gross | $ 37,888 |
PREPAID EXPENSE (Details)
PREPAID EXPENSE (Details) | Dec. 31, 2015USD ($) |
Prepaid Expense Details | |
Prepaid manufacturing costs | $ 980,985 |
Prepaid research and development costs | 128,898 |
TOTAL PREPAID EXPENSE | $ 1,109,883 |
INTANGIBLE ASSETS, NET (Details
INTANGIBLE ASSETS, NET (Details Narrative) | 12 Months Ended | ||
Dec. 31, 2016USD ($)Number | Dec. 31, 2015USD ($) | Dec. 31, 2014USD ($) | |
Finite-Lived Intangible Assets [Line Items] | |||
Amortization expense | $ | $ 54,545 | $ 32,441 | $ 23,480 |
Number of issued patents | 17 | ||
Approved Hormone Therapy Drug Candidate Patents [Member] | |||
Finite-Lived Intangible Assets [Line Items] | |||
Useful Life | 20 years | ||
Utility Patent Progesterone and Estradiol Products [Member] | |||
Finite-Lived Intangible Assets [Line Items] | |||
Number of issued patents | 13 | ||
Utility Patent TX-004HR [Member] | |||
Finite-Lived Intangible Assets [Line Items] | |||
Number of issued patents | 2 | ||
Opera Software Patent [Member] | |||
Finite-Lived Intangible Assets [Line Items] | |||
Number of issued patents | 1 | ||
Utility Patent Pipeline Transdermal Patch Technology [Member] | |||
Finite-Lived Intangible Assets [Line Items] | |||
Number of issued patents | 1 |
INTANGIBLE ASSETS, NET (Detai42
INTANGIBLE ASSETS, NET (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2016 | Dec. 31, 2015 | |
Finite-Lived Intangible Assets | ||
Accumulated Amortization | $ (200,626) | $ (146,081) |
Indefinite-Lived Intangible Assets | ||
Gross Carrying Amount | 2,606,598 | 1,761,332 |
Net Amount | 2,405,972 | 1,615,251 |
Hormone Therapy Drug Candidate Patents - (Pending) [Member] | ||
Finite-Lived Intangible Assets | ||
Gross Carrying Amount | 1,203,987 | 774,165 |
Net Amount | 1,203,987 | 774,165 |
Multiple Trademarks For Vitamins/Supplements [Member] | ||
Indefinite-Lived Intangible Assets | ||
Gross Carrying Amount | 185,465 | 157,721 |
Net Amount | 185,465 | 157,721 |
Opera Software Patent [Member] | ||
Finite-Lived Intangible Assets | ||
Gross Carrying Amount | 31,951 | 31,951 |
Accumulated Amortization | (6,490) | (4,493) |
Net Amount | $ 25,461 | $ 27,458 |
Weighted average remaining amortization period | 12 years 9 months | 13 years 9 months |
Development Costs Of Corporate Website [Member] | ||
Finite-Lived Intangible Assets | ||
Gross Carrying Amount | $ 91,743 | $ 91,743 |
Accumulated Amortization | (91,743) | (91,743) |
Approved Hormone Therapy Drug Candidate Patents [Member] | ||
Finite-Lived Intangible Assets | ||
Gross Carrying Amount | 1,093,452 | 705,752 |
Accumulated Amortization | (102,393) | (49,845) |
Net Amount | $ 991,059 | $ 655,907 |
Weighted average remaining amortization period | 16 years | 17 years |
INTANGIBLE ASSETS, NET (Detai43
INTANGIBLE ASSETS, NET (Details 1) | Dec. 31, 2016USD ($) |
Estimated amortization expense for the year: | |
2,017 | $ 63,938 |
2,018 | 63,938 |
2,019 | 63,938 |
2,020 | 63,938 |
2,021 | 63,938 |
Thereafter | $ 696,830 |
OTHER CURRENT LIABILITIES (Deta
OTHER CURRENT LIABILITIES (Details) - USD ($) | Dec. 31, 2016 | Dec. 31, 2015 |
Other Liabilities Disclosure [Abstract] | ||
Accrued clinical trial costs | $ 1,281,080 | $ 3,725,377 |
Accrued payroll, bonuses and commission costs | 3,531,440 | 2,108,143 |
Accrued compensated absences | 665,561 | 562,096 |
Accrued legal and accounting expense | 176,518 | 210,309 |
Accrued sales and marketing costs | 665,773 | |
Other accrued expenses | 224,865 | 546,264 |
Allowance for wholesale distributor fees | 76,510 | 32,659 |
Accrued royalties | 26,507 | 46,851 |
Allowance for coupons and returns | 794,816 | 224,300 |
Accrued rent | 181,015 | 83,527 |
TOTAL OTHER CURRENT LIABILITIES | $ 7,624,085 | $ 7,539,526 |
STOCKHOLDERS' EQUITY (Details N
STOCKHOLDERS' EQUITY (Details Narrative) - USD ($) | Jan. 12, 2016 | Jan. 06, 2016 | Jul. 15, 2015 | Jul. 09, 2015 | Feb. 17, 2015 | Feb. 10, 2015 | Aug. 04, 2014 | Jul. 29, 2014 | Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 |
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, shares authorized | 350,000,000 | 350,000,000 | |||||||||
Common stock, shares issued | 196,688,222 | 177,928,041 | |||||||||
Common stock, shares outstanding | 196,688,222 | 177,928,041 | |||||||||
Common stock issued during the period | $ 134,863,475 | $ 91,374,649 | $ 42,771,353 | ||||||||
Value of common stock issued during period for stock options exercised | 989,060 | 1,232,579 | 345,746 | ||||||||
Shares issued for exercise of warrants, net | $ 1,373,000 | 366,000 | 181,000 | ||||||||
Stock Options [Member] | |||||||||||
Value of common stock issued during period for stock options exercised | $ 1,232,579 | $ 345,746 | |||||||||
Number of common stock issued during period for stock options exercised (shares) | 652,471 | 612,867 | 724,193 | ||||||||
Number of stock options exercised (shares) | 417 | 860,800 | |||||||||
Number of stock options exercised in cashless exercise | 136,307 | ||||||||||
Number of common stock issued during period for stock options exercised in cashless exercise (shares) | 114 | 130,380 | |||||||||
Individuals [Member] | |||||||||||
Value of common stock issued during period for stock options exercised | $ 989,060 | ||||||||||
Number of common stock issued during period for stock options exercised (shares) | 525,362 | ||||||||||
Number of stock options exercised (shares) | 127,109 | ||||||||||
Number of common stock issued during period for stock options exercised in cashless exercise (shares) | 87,833 | ||||||||||
Goldman Sachs Underwriters [Member] | |||||||||||
Number of shares issued during the period | 9,850,106 | 8,565,310 | |||||||||
Share price (in dollars per share) | $ 4.67 | ||||||||||
Common stock issued during the period | $ 42,800,000 | ||||||||||
Additional common stock issued under offering | 1,284,796 | ||||||||||
Number of days of the option to purchase shares | 30 days | ||||||||||
Goldman Sachs Underwriters [Member] | |||||||||||
Number of shares issued during the period | 17,424,242 | 15,151,515 | |||||||||
Share price (in dollars per share) | $ 8.25 | ||||||||||
Common stock issued during the period | $ 134,900,000 | ||||||||||
Additional common stock issued under offering | 2,272,727 | ||||||||||
Number of days of the option to purchase shares | 30 days | ||||||||||
Stifel Underwriters [Member] | |||||||||||
Number of shares issued during the period | 4,423,077 | 3,846,154 | |||||||||
Share price (in dollars per share) | $ 7.80 | ||||||||||
Common stock issued during the period | $ 32,200,000 | ||||||||||
Additional common stock issued under offering | 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 | 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 | 2,037,036 | ||||||||||
Number of days of the option to purchase shares | 30 days |
STOCKHOLDERS' EQUITY (Details46
STOCKHOLDERS' EQUITY (Details Narrative 1) - USD ($) | 12 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Warrants: | |||
Warrants outstanding | $ 12,060,071 | ||
Weighted-average contractual remaining life | 1 year | ||
Weighted average exercise price of warrants (in dollars per share) | $ 2.08 | ||
Warrants granted (in shares) | 245,000 | ||
Warrants granted (in dollars per share) | $ 7.09 | ||
Share based compensation expense | $ 17,411,021 | $ 7,189,699 | $ 4,970,312 |
Outside Consultant Warrants #2 [Member] | Tranche One [Member] | |||
Warrants: | |||
Warrants granted (in shares) | 75,000 | ||
Expiration date of warrants | Apr. 21, 2021 | ||
Vesting date of warrants | Apr. 21, 2016 | ||
Outside Consultant Warrants #2 [Member] | Tranche Two [Member] | |||
Warrants: | |||
Warrants granted (in shares) | 50,000 | ||
Expiration date of warrants | Apr. 21, 2021 | ||
Vesting period of warrants | 24 months | ||
Outside Consultant Warrants #2 [Member] | Tranche Three [Member] | |||
Warrants: | |||
Warrants granted (in shares) | 120,000 | ||
Expiration date of warrants | Jan. 21, 2021 | ||
Vesting period of warrants | 12 months | ||
Outside Consultant Warrants #3 [Member] | |||
Warrants: | |||
Exercise price of warrants (in dollars per share) | $ 6.35 | ||
Warrants granted (in shares) | 50,000 | ||
Expiration date of warrants | Apr. 6, 2020 | ||
Vesting period of warrants | 12 months | ||
Outside Consultant Warrants [Member] | |||
Warrants: | |||
Share based compensation expense | $ 936,974 | $ 139,142 | $ 36,284 |
Warrants [Member] | Minimum [Member] | |||
Warrants: | |||
Exercise price of warrants (in dollars per share) | $ 0.24 | ||
Warrants [Member] | Maximum [Member] | |||
Warrants: | |||
Exercise price of warrants (in dollars per share) | $ 8.20 |
STOCKHOLDERS' EQUITY (Details47
STOCKHOLDERS' EQUITY (Details Narrative 2) - USD ($) | Jun. 30, 2013 | May 11, 2013 | May 31, 2013 | Jan. 31, 2013 | May 31, 2012 | Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 |
Prepaid expenses - current | $ 405,960 | $ 369,812 | ||||||
Recognition period of unamortized costs | 2 years 7 months 6 days | |||||||
Financing costs | $ 260,027 | |||||||
SCI - Warrants [Member] | ||||||||
Exercise price of warrants (in dollars per share) | $ 2.01 | |||||||
Warrants granted to purchase common stock (shares) | 850,000 | |||||||
Non-cash compensation | $ 77,026 | 154,068 | 154,068 | |||||
Unamortized costs of warrants | $ 128,898 | |||||||
Vesting date of warrants | Jun. 30, 2013 | |||||||
Expected term | 5 years | |||||||
Volatility rate | 45.89% | |||||||
Risk free rate | 1.12% | |||||||
Dividend yield | 0.00% | |||||||
Forfeited warrants granted to purchase common stock (shares) | 833,000 | |||||||
Vested warrants granted to purchase common stock (shares) | 283,333 | |||||||
Recognition period of unamortized costs | 6 months | |||||||
SCI - Warrants [Member] | Tranche One [Member] | ||||||||
Fair value of grant | $ 405,066 | |||||||
Non-cash compensation | 405,066 | |||||||
SCI - Warrants [Member] | Tranche Two [Member] | ||||||||
Fair value of grant | $ 462,196 | |||||||
Expected term | 5 years | |||||||
Volatility rate | 45.84% | |||||||
Risk free rate | 1.41% | |||||||
Dividend yield | 0.00% | |||||||
Vested warrants granted to purchase common stock (shares) | 283,333 | |||||||
Warrants - Unaffiliated Entity [Member] [Member] | ||||||||
Exercise price of warrants (in dollars per share) | $ 2.57 | |||||||
Fair value of grant | $ 1,532,228 | |||||||
Warrants granted to purchase common stock (shares) | 1,300,000 | |||||||
Prepaid expenses - current | $ 128,898 | |||||||
Non-cash compensation | 257,796 | 257,796 | 309,165 | |||||
Expected term | 5 years | |||||||
Volatility rate | 44.71% | |||||||
Risk free rate | 0.74% | |||||||
Dividend yield | 0.00% | |||||||
Multiple Advance Revolving Credit Note (Plato Warrant) [Member] | ||||||||
Exercise price of warrants (in dollars per share) | $ 3.20 | |||||||
Fair value of grant | $ 1,711,956 | |||||||
Common stock for warrants issued (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 | $ 0 | $ 260,027 |
STOCKHOLDERS' EQUITY (Details48
STOCKHOLDERS' EQUITY (Details Narrative 3) - USD ($) | 1 Months Ended | 12 Months Ended | |||
Jan. 31, 2017 | Dec. 31, 2013 | Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Share-based compensation expense | $ 16,139,225 | $ 6,621,658 | $ 4,393,455 | ||
Total unrecognized estimated compensation expense | $ 10,669,000 | ||||
Recognized weighted-average period | 2 years 7 months 6 days | ||||
Shares issued for exercise of warrants, net | $ 1,373,000 | $ 366,000 | 181,000 | ||
Weighted average grant date fair value (per share) | $ 3.94 | ||||
2012 Stock Incentive Plan [Member] | |||||
Number of shares authorized for issuance | 10,000,000 | ||||
Options outstanding, ending | 3,868,474 | ||||
Number of shares available for issuance | 6,050,000 | ||||
Grant - restricted stock unit (shares) | 50,000 | ||||
Fair value of grant | $ 233,500 | ||||
Restricted stock expense | 180,072 | ||||
2009 Long Term Incentive Compensation Plan [Member] | |||||
Number of shares authorized for issuance | 25,000,000 | ||||
Options outstanding, ending | 17,899,380 | ||||
Number of shares available for issuance | 2,952,128 | ||||
Stock Options [Member] | |||||
Options outstanding, ending | 21,767,854 | 20,725,325 | |||
Option exercise prices (in dollars per shares) | $ 3.56 | $ 3.28 | |||
Stock Options [Member] | Minimum [Member] | |||||
Option exercise prices (in dollars per shares) | 0.10 | ||||
Stock Options [Member] | Maximum [Member] | |||||
Option exercise prices (in dollars per shares) | $ 8.92 | ||||
Warrants [Member] | |||||
Shares issued for exercise of warrants, net | $ 1,373,000 | $ 366,000 | $ 181,000 | ||
Shares issued for exercise of warrants, net (in shares) | 722,744 | 945,485 | 365,583 | ||
Warrants exercised | 722,744 | 1,255,485 | |||
Warrants [Member] | Subsequent Event [Member] | |||||
Shares issued for exercise of warrants, net | $ 2,436,000 | ||||
Shares issued for exercise of warrants, net (in shares) | 1,800,000 | ||||
Warrants - Cashless Exercise [Member] | |||||
Shares issued for exercise of warrants, net (in shares) | 232,197 | ||||
Warrants exercised | 310,000 |
STOCKHOLDERS' EQUITY (Details)
STOCKHOLDERS' EQUITY (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2016 | Dec. 31, 2015 | |
Number of shares under warrant | ||
Warrants granted | 245,000 | |
Weighted Average Exercise Price | ||
Warrants Unvested | $ 2.08 | |
Warrants [Member] | ||
Number of shares under warrant | ||
Warrants outstanding, beginning | 12,722,431 | |
Warrants granted | 245,000 | |
Warrants exercised | (722,744) | (1,255,485) |
Warrants expired | (184,616) | |
Warrants outstanding, ending | 12,060,071 | 12,722,431 |
Vested and Exercisable | 11,733,410 | |
Unvested | 326,661 | |
Weighted Average Exercise Price | ||
Warrants outstanding, beginning | $ 1.93 | |
Warrants granted | 7.90 | |
Warrants exercised | 1.90 | |
Warrants expired | 0.41 | |
Warrants outstanding, ending | 2.08 | $ 1.93 |
Vested and Exercisable | 2.06 | |
Warrants Unvested | $ 2.81 | |
Weighted Average Remaining Contractual Life | ||
Warrants outstanding | 1 year | 1 year 8 months 12 days |
Warrants Vested and Exercisable | 1 year | |
Warrants Unvested | 1 year 8 months 12 days | |
Aggregate Intrinsic Value | ||
Warrants outstanding, beginning | $ 107,344,752 | |
Warrants exercised | 3,988,343 | |
Warrants outstanding, ending | 45,063,867 | $ 107,344,752 |
Vested and Exercisable | 43,998,535 | |
Unvested | $ 1,065,332 |
STOCKHOLDERS' EQUITY (Details 1
STOCKHOLDERS' EQUITY (Details 1) - Warrants [Member] - $ / shares | 12 Months Ended | |
Dec. 31, 2016 | Dec. 31, 2015 | |
Class of Warrant or Right [Line Items] | ||
Weighted average price | $ 7.90 | $ 6.35 |
Weighted average grant date fair value | $ 4.78 | $ 3.27 |
Risk-free interest rate | 1.02% | |
Volatility | 60.59% | |
Term (in years) | 5 years | 5 years |
Dividend yield | 0.00% | 0.00% |
Minimum [Member] | ||
Class of Warrant or Right [Line Items] | ||
Risk-free interest rate | 1.04% | |
Volatility | 74.10% | |
Maximum [Member] | ||
Class of Warrant or Right [Line Items] | ||
Risk-free interest rate | 1.28% | |
Volatility | 74.15% |
STOCKHOLDERS' EQUITY (Details 2
STOCKHOLDERS' EQUITY (Details 2) - Stock Options [Member] | 12 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
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 | 1.13% | 1.47% | 0.07% |
Volatility | 70.26% | 58.78% | 68.05% |
Term | 5 years 6 months | 5 years 3 months 7 days | 5 months |
Maximum [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Risk-free interest rate | 1.90% | 1.67% | 1.77% |
Volatility | 73.34% | 62.94% | 82.29% |
Term | 6 years 3 months | 6 years 3 months | 6 years 3 months |
STOCKHOLDERS' EQUITY (Details 3
STOCKHOLDERS' EQUITY (Details 3) - Stock Options [Member] - USD ($) | 12 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Options, Outstanding | |||
Options outstanding, beginning | 20,725,325 | ||
Options Granted | 1,732,500 | ||
Options Exercised | (652,471) | (612,867) | (724,193) |
Options Expired | (5,750) | ||
Options Cancelled/Forfeited | (31,750) | ||
Options outstanding, ending | 21,767,854 | 20,725,325 | |
Vested and exercisable | 18,633,479 | ||
Unvested | 3,134,375 | ||
Options, Weighted Average Exercise Price | |||
Options outstanding, beginning | $ 3.28 | ||
Granted | 6.22 | ||
Exercised | 1.91 | ||
Expired | 4.76 | ||
Cancelled/Forfeited | 6.38 | ||
Options outstanding, ending | 3.56 | $ 3.28 | |
Vested and exercisable | 3.09 | ||
Unvested | $ 6.29 | ||
Options, Weighted Average Remaining Contractual Life | |||
Options outstanding | 5 years 9 months 18 days | 6 years 6 months | |
Vested and exercisable | 5 years 3 months 18 days | ||
Unvested | 9 years | ||
Options, Aggregate Intrinsic Value | |||
Options outstanding, beginning | $ 146,864,184 | ||
Options exercised | 3,828,358 | ||
Options outstanding, ending | 60,495,730 | $ 146,864,184 | |
Vested and exercisable | 59,382,849 | ||
Unvested | $ 1,112,881 |
INCOME TAXES (Details Narrative
INCOME TAXES (Details Narrative) | Dec. 31, 2016USD ($) |
Federal [Member] | |
Operating Loss Carryforwards [Line Items] | |
Net operating loss carryforwards | $ 268,199,351 |
INCOME TAXES (Details)
INCOME TAXES (Details) | 12 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Income Tax Disclosure [Abstract] | |||
Federal statutory tax rate | 34.00% | 34.00% | 34.00% |
State tax rate, net of federal tax benefit | 5.40% | 4.73% | 5.80% |
Adjustment in valuation allowances | (40.30%) | (38.97%) | (50.90%) |
Permanent and other differences | 0.90% | 0.24% | 11.10% |
INCOME TAXES (Details 1)
INCOME TAXES (Details 1) - USD ($) | Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 |
Deferred Income Tax Assets: | |||
Net operating losses | $ 111,730,450 | $ 79,499,633 | $ 43,091,437 |
R&D Credit | 186,347 | 186,347 | |
Total deferred income tax asset | 111,916,797 | 79,685,980 | 43,091,437 |
Valuation allowance | $ (111,916,797) | $ (79,685,980) | $ (43,091,437) |
RELATED PARTIES (Details Narrat
RELATED PARTIES (Details Narrative) - USD ($) | 12 Months Ended | |
Dec. 31, 2016 | Dec. 31, 2015 | |
Catalent Inc.[Member] | ||
Related Party Transaction [Line Items] | ||
Payable - related party | $ 57,000 | $ 4,600 |
Manufacturing activities billed from related party | $ 3,647,000 | 1,266,000 |
Pernix Therapeutics LLC [Member] | ||
Related Party Transaction [Line Items] | ||
Payable - related party | $ 46,000 | |
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 | |
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, 2016 | Sep. 30, 2016 | Jun. 30, 2016 | Mar. 31, 2016 | Dec. 31, 2015 | Sep. 30, 2015 | Jun. 30, 2015 | Mar. 31, 2015 | Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Concentration Risk [Line Items] | |||||||||||
Revenues | $ 4,487,000 | $ 5,536,000 | $ 4,403,000 | $ 4,930,000 | $ 5,630,000 | $ 5,190,000 | $ 4,848,000 | $ 4,475,000 | $ 19,356,450 | $ 20,142,898 | $ 15,026,219 |
Deferred Revenue [Member] | |||||||||||
Concentration Risk [Line Items] | |||||||||||
Concentration Risk | 97.00% | ||||||||||
Supplier Concentration Risk [Member] | |||||||||||
Concentration Risk [Line Items] | |||||||||||
Concentration Risk | 98.00% | 60.00% | 82.00% | ||||||||
Customer Concentration Risk [Member] | Sales Revenue [Member] | Woodstock Pharmaceutical and Compounding [Member] | |||||||||||
Concentration Risk [Line Items] | |||||||||||
Revenues | $ 2,247,000 | $ 8,848,000 | $ 4,054,000 | ||||||||
Customer Concentration Risk [Member] | Sales Revenue [Member] | Medical Center Pharmacy [Member] | |||||||||||
Concentration Risk [Line Items] | |||||||||||
Revenues | 3,700,000 | ||||||||||
Customer Concentration Risk [Member] | Sales Revenue [Member] | Pharmacy Innovations [Member] | |||||||||||
Concentration Risk [Line Items] | |||||||||||
Revenues | $ 2,040,000 | ||||||||||
Customer Concentration Risk [Member] | Sales Revenue [Member] | Due West Pharmacy [Member] | |||||||||||
Concentration Risk [Line Items] | |||||||||||
Revenues | $ 4,843,000 | ||||||||||
Customer Concentration Risk [Member] | Sales Revenue [Member] | AmerisourceBergen [Member] | |||||||||||
Concentration Risk [Line Items] | |||||||||||
Revenues | 1,610,000 | ||||||||||
Customer Concentration Risk [Member] | Sales Revenue [Member] | McKesson [Member] | |||||||||||
Concentration Risk [Line Items] | |||||||||||
Revenues | 1,587,000 | ||||||||||
Customer Concentration Risk [Member] | Sales Revenue [Member] | Cardinal [Member] | |||||||||||
Concentration Risk [Line Items] | |||||||||||
Revenues | $ 1,804,000 | ||||||||||
Customer Concentration Risk [Member] | Sales Revenue [Member] | Three Customers [Member] | |||||||||||
Concentration Risk [Line Items] | |||||||||||
Concentration Risk | 41.00% | ||||||||||
Customer Concentration Risk [Member] | Sales Revenue [Member] | Three Customers [Member] | Minimum [Member] | |||||||||||
Concentration Risk [Line Items] | |||||||||||
Concentration Risk | 10.00% | ||||||||||
Customer Concentration Risk [Member] | Sales Revenue [Member] | Two Customers [Member] | |||||||||||
Concentration Risk [Line Items] | |||||||||||
Concentration Risk | 67.00% | ||||||||||
Customer Concentration Risk [Member] | Sales Revenue [Member] | Two Customers [Member] | Minimum [Member] | |||||||||||
Concentration Risk [Line Items] | |||||||||||
Concentration Risk | 10.00% | ||||||||||
Customer Concentration Risk [Member] | Sales Revenue [Member] | Four Customers [Member] | |||||||||||
Concentration Risk [Line Items] | |||||||||||
Concentration Risk | 75.00% | ||||||||||
Customer Concentration Risk [Member] | Sales Revenue [Member] | Four Customers [Member] | Minimum [Member] | |||||||||||
Concentration Risk [Line Items] | |||||||||||
Concentration Risk | 10.00% |
COMMITMENTS AND CONTINGENCIES58
COMMITMENTS AND CONTINGENCIES (Details Narrative) - USD ($) | May 01, 2016 | Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 |
Commitments and Contingencies Disclosure [Abstract] | ||||
Non-cancelable operating lease term | 63 months | |||
Rental expense | $ 709,483 | $ 446,099 | $ 361,793 | |
Epiration date | Oct. 31, 2021 | |||
Rental income | $ 41,613 |
COMMITMENTS AND CONTINGENCIES59
COMMITMENTS AND CONTINGENCIES (Details) | Dec. 31, 2016USD ($) |
Future minimum rental payments, year ending December 31, | |
2,017 | $ 864,827 |
2,018 | 942,305 |
2,019 | 1,083,890 |
2,020 | 1,102,667 |
2,021 | 934,313 |
Total minimum lease payments | $ 4,928,002 |
SELECTED QUARTERLY FINANCIAL 60
SELECTED QUARTERLY FINANCIAL DATA (Details) - USD ($) | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2016 | Sep. 30, 2016 | Jun. 30, 2016 | Mar. 31, 2016 | Dec. 31, 2015 | Sep. 30, 2015 | Jun. 30, 2015 | Mar. 31, 2015 | Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Quarterly Financial Information Disclosure [Abstract] | |||||||||||
Revenues | $ 4,487,000 | $ 5,536,000 | $ 4,403,000 | $ 4,930,000 | $ 5,630,000 | $ 5,190,000 | $ 4,848,000 | $ 4,475,000 | $ 19,356,450 | $ 20,142,898 | $ 15,026,219 |
Gross profit | 3,778,000 | 4,298,000 | 3,273,000 | 3,822,000 | 4,395,000 | 3,996,000 | 3,815,000 | 3,431,000 | 15,170,742 | 15,636,225 | 11,354,416 |
Net loss | $ (22,836,000) | $ (25,016,000) | $ (21,094,000) | $ (20,929,000) | $ (17,483,000) | $ (19,472,000) | $ (27,227,000) | $ (20,895,000) | $ (89,875,459) | $ (85,077,024) | $ (54,217,210) |
Loss per common share, basic and diluted (in dollars per shares) | $ (0.12) | $ (0.13) | $ (0.11) | $ (0.11) | $ (0.10) | $ (0.11) | $ (0.16) | $ (0.13) | $ (0.46) | $ (0.49) | $ (0.36) |
SUBSEQUENT EVENTS (Details Narr
SUBSEQUENT EVENTS (Details Narrative) - USD ($) | 1 Months Ended | 12 Months Ended | ||
Jan. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Class of Warrant or Right [Line Items] | ||||
Shares issued for exercise of warrants, net | $ 1,373,000 | $ 366,000 | $ 181,000 | |
Warrants [Member] | ||||
Class of Warrant or Right [Line Items] | ||||
Shares issued for exercise of warrants, net (in shares) | 722,744 | 945,485 | 365,583 | |
Shares issued for exercise of warrants, net | $ 1,373,000 | $ 366,000 | $ 181,000 | |
Subsequent Event [Member] | Warrants [Member] | ||||
Class of Warrant or Right [Line Items] | ||||
Shares issued for exercise of warrants, net (in shares) | 1,800,000 | |||
Shares issued for exercise of warrants, net | $ 2,436,000 |