Document and Entity Information
Document and Entity Information - USD ($) | 12 Months Ended | ||
Dec. 31, 2017 | Feb. 20, 2018 | Jun. 30, 2017 | |
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, 2017 | ||
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 Common Stock, Held by non-affiliates (shares) | 169,430,175 | ||
Entity Public Float | $ 892,897,022 | ||
Entity Common Stock, Shares Outstanding | 216,439,483 | ||
Document Fiscal Period Focus | FY | ||
Document Fiscal Year Focus | 2,017 |
CONSOLIDATED BALANCE SHEETS
CONSOLIDATED BALANCE SHEETS - USD ($) | Dec. 31, 2017 | Dec. 31, 2016 |
Current Assets: | ||
Cash | $ 127,135,628 | $ 131,534,101 |
Accounts receivable, net of allowance for doubtful accounts of $380,580 and $376,374, respectively | 4,328,802 | 4,500,699 |
Inventory | 1,485,358 | 1,076,321 |
Other current assets | 6,604,284 | 2,299,052 |
Total current assets | 139,554,072 | 139,410,173 |
Fixed assets, net | 437,055 | 516,839 |
Other Assets: | ||
Intangible assets, net | 3,099,747 | 2,405,972 |
Security deposit | 139,036 | 139,036 |
Total other assets | 3,238,783 | 2,545,008 |
Total assets | 143,229,910 | 142,472,020 |
Current Liabilities: | ||
Accounts payable | 4,097,600 | 7,358,514 |
Other current liabilities | 9,223,595 | 7,624,085 |
Total current liabilities | 13,321,195 | 14,982,599 |
Commitments and Contingencies - See Note 12 | ||
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; 216,429,642 and 196,688,222 issued and outstanding, respectively | 216,430 | 196,688 |
Additional paid in capital | 516,351,405 | 436,995,052 |
Accumulated deficit | (386,659,120) | (309,702,319) |
Total stockholders' equity | 129,908,715 | 127,489,421 |
Total liabilities and stockholders' equity | $ 143,229,910 | $ 142,472,020 |
CONSOLIDATED BALANCE SHEETS (Pa
CONSOLIDATED BALANCE SHEETS (Parenthetical) - USD ($) | Dec. 31, 2017 | Dec. 31, 2016 |
Statement of Financial Position [Abstract] | ||
Allowance for doubtful accounts | $ 380,580 | $ 376,374 |
Preferred stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Preferred stock, authorized | 10,000,000 | 10,000,000 |
Preferred stock, issued | 0 | 0 |
Preferred stock, outstanding | 0 | 0 |
Common stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Common stock, authorized | 350,000,000 | 350,000,000 |
Common stock, issued | 216,429,642 | 196,688,222 |
Common stock, outstanding | 216,429,642 | 196,688,222 |
CONSOLIDATED STATEMENTS OF OPER
CONSOLIDATED STATEMENTS OF OPERATIONS - USD ($) | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Income Statement [Abstract] | |||
Revenues, net | $ 16,777,713 | $ 19,356,450 | $ 20,142,898 |
Cost of goods sold | 2,636,943 | 4,185,708 | 4,506,673 |
Gross profit | 14,140,770 | 15,170,742 | 15,636,225 |
Operating expenses: | |||
Sales, general, and administration | 57,703,370 | 51,348,414 | 28,721,236 |
Research and development | 33,852,993 | 53,943,477 | 72,042,774 |
Depreciation and amortization | 213,117 | 132,451 | 62,400 |
Total operating expense | 91,769,480 | 105,424,342 | 100,826,410 |
Operating loss | (77,628,710) | (90,253,600) | (85,190,185) |
Other income: | |||
Miscellaneous income | 695,631 | 367,317 | 95,719 |
Accreted interest | 7,699 | 10,824 | 17,442 |
Total other income | 703,330 | 378,141 | 113,161 |
Loss before taxes | (76,925,380) | (89,875,459) | (85,077,024) |
Net loss | $ (76,925,380) | $ (89,875,459) | $ (85,077,024) |
Net loss per share, basic and diluted (in dollars per share) | $ (0.37) | $ (0.46) | $ (0.49) |
Weighted average number of common shares outstanding (in shares) | 205,523,288 | 196,088,196 | 173,174,229 |
CONSOLIDATED STATEMENTS OF STOC
CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY - USD ($) | Common Stock | Additional Paid in Capital | Accumulated Deficit | Total |
Beginning balance at Dec. 31, 2014 | $ 156,097 | $ 182,982,846 | $ (134,749,836) | $ 48,389,107 |
Beginning balance (in shares) at Dec. 31, 2014 | 156,097,019 | |||
Shares issued in offerings, net of cost | $ 20,040 | 91,354,609 | 91,374,649 | |
Shares issued in offerings, net of cost (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 | |||
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 | ||
Adoption of ASU 2016-09 at Dec. 31, 2016 | 31,421 | (31,421) | ||
Shares issued in offerings, net of cost | $ 12,400 | 68,560,235 | $ 68,572,635 | |
Shares issued in offerings, net of cost (in shares) | 12,400,000 | |||
Shares issued for exercise of options, net | $ 103 | 212,512 | 212,615 | |
Shares issued for exercise of options, net (in shares) | 102,546 | |||
Shares issued for exercise of warrants, net | $ 7,239 | 3,791,760 | 3,798,999 | |
Shares issued for exercise of warrants, net (in shares) | 7,238,874 | |||
Share-based compensation | 6,760,425 | 6,760,425 | ||
Net loss | (76,925,380) | (76,925,380) | ||
Ending balance at Dec. 31, 2017 | $ 216,430 | $ 516,351,405 | $ (386,659,120) | $ 129,908,715 |
Ending balance (in shares) at Dec. 31, 2017 | 216,429,642 | 216,429,642 |
CONSOLIDATED STATEMENTS OF CASH
CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
CASH FLOWS FROM OPERATING ACTIVITIES | |||
Net loss | $ (76,925,380) | $ (89,875,459) | $ (85,077,024) |
Adjustments to reconcile net loss to net cash flows used in operating activities: | |||
Depreciation | 141,601 | 77,906 | 29,959 |
Amortization of intangible assets | 71,516 | 54,545 | 32,441 |
Provision for doubtful accounts | 4,206 | 2,524,909 | 22,157 |
Share-based compensation | 6,889,323 | 17,411,021 | 7,189,699 |
Changes in operating assets and liabilities: | |||
Accounts receivable | 167,691 | (3,975,893) | (917,656) |
Inventory | (409,037) | (386,168) | 491,960 |
Other current assets | (4,434,130) | 709,907 | (773,532) |
Other assets | (17,442) | ||
Accounts payable | (3,260,914) | 4,232,340 | (3,200,955) |
Deferred revenue | (522,613) | ||
Other current liabilities | 1,599,510 | 84,559 | 3,698,887 |
Net cash used in operating activities | (76,155,614) | (69,142,333) | (79,044,119) |
CASH FLOWS FROM INVESTING ACTIVITIES | |||
Patent costs | (765,291) | (845,266) | (419,104) |
Purchase of fixed assets | (61,817) | (396,154) | (165,257) |
Payment of security deposit | (14,036) | ||
Net cash used in investing activities | (827,108) | (1,255,456) | (584,361) |
CASH FLOWS FROM FINANCING ACTIVITIES | |||
Proceeds from sale of common stock, net of costs | 68,572,635 | 134,863,475 | 91,374,649 |
Proceeds from exercise of options | 212,615 | 989,060 | 1,232,579 |
Proceeds from exercise of warrants | 3,798,999 | 1,373,000 | 366,000 |
Net cash provided by financing activities | 72,584,249 | 137,225,535 | 92,973,228 |
(Decrease) increase in cash | (4,398,473) | 66,827,746 | 13,344,748 |
Cash, beginning of period | 131,534,101 | 64,706,355 | 51,361,607 |
Cash, end of period | $ 127,135,628 | $ 131,534,101 | $ 64,706,355 |
THE COMPANY
THE COMPANY | 12 Months Ended |
Dec. 31, 2017 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
THE COMPANY | NOTE 1 – THE COMPANY TherapeuticsMD, Inc., a Nevada corporation, or TherapeuticsMD or the Company, has three wholly owned subsidiaries, vitaMedMD, LLC, a Delaware limited liability company, or VitaMed; BocaGreenMD, Inc., a Nevada corporation, or BocaGreen; and VitaCare Prescription Services, Inc., a Florida corporation, or VitaCare. Unless the context otherwise requires, TherapeuticsMD, VitaMed, BocaGreen, and VitaCare collectively are sometimes referred to as “our company,” “we,” “our,” or “us.” Nature of Business We are a women’s health care 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, which we ceased manufacturing in October 2017. |
SUMMARY OF SIGNIFICANT ACCOUNTI
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | 12 Months Ended |
Dec. 31, 2017 | |
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 approximately $2,200,000 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. 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 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, 2017, 2016, and 2015. 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, 2017, 2016, and 2015. 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, 2017 and 2016, 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, 2017, 2016, and 2015. 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, 2017 and 2016, 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 we ceased manufacturing in October 2017. 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 11. 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 (Iron 21/7). 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 we ceased manufacturing in October 2017. 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, coupons 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 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. We estimate the allowance for consumer rebates and coupons that we have offered based on our experience and industry averages, which is reviewed, and adjusted if necessary, on a quarterly basis. 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 $448,288, $752,611, and $792,574 during the years ended December 31, 2017, 2016, and 2015, 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 $0 and $228,933 at December 31, 2017 and 2016, respectively, all of which was included in other current assets 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 U.S. Food and Drug Administration, or the FDA, submission processes, clinical trial processes, and scientific writing matters, including preparing protocols and FDA submissions. Legal activities that were classified as R&D expenses include professional research and advice regarding R&D, patents and regulatory matters. These consulting and legal expenses were direct costs associated with preparing, reviewing, and undertaking work for our clinical trials and investigative drugs. We charge internal R&D activities and other activity expenses to operations as incurred. We make payments to CROs based on agreed-upon terms, which may include payments in advance of a study starting date. We expense nonrefundable advance payments for goods and services that will be used in future R&D activities when the activity has been performed or when the goods have been received rather than when the payment is made. We review and accrue CRO expenses and clinical trial study expenses based on services performed and rely on estimates of those costs applicable to the completion stage of a study as provided by CROs. Estimated accrued CRO costs are subject to revisions as such studies progress to completion. We charge revisions expense in the period in which the facts that give rise to the revision become known. Earnings Per Share We calculate earnings per share, or EPS, in accordance with ASC 260, Earnings Per Share As of December 31, 2017 2016 2015 Stock options 23,365,225 21,767,854 20,725,325 Warrants 3,115,905 12,060,071 12,722,431 26,481,130 33,827,925 33,447,756 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 May 2017, the FASB issued ASU 2017-09, which clarifies when changes to the terms or conditions of a share-based payment award must be accounted for as modifications. The new guidance will reduce diversity in practice and result in fewer changes to the terms of an award being accounted for as modifications. The new guidance will allow companies to make certain changes to awards without accounting for them as modifications. This guidance does not change the accounting for modifications. The guidance will be applied prospectively to awards modified on or after the adoption date and is effective for annual periods, and interim periods within those annual periods, beginning after December 15, 2017. Early adoption is permitted, including in an interim period. We adopted this guidance and it did not have an impact on our consolidated financial statements. In August 2016, the FASB issued 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 adopted this guidance and it did not have an impact on our consolidated financial statements. 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. We adopted ASU 2016-09 effective January 1, 2017, electing to account for forfeitures when they occur. The impact from adoption of the provisions related to forfeiture rates was reflected in our consolidated financial statements on a modified retrospective basis, resulting in an adjustment of approximately $31,000 to retained earnings. The impact from adoption of the provisions related to excess tax benefits or deficiencies in the provision for income taxes rather than paid-in capital was adopted on a modified retrospective basis. Since we have a full valuation allowance on our net deferred tax assets, an amount equal to the cumulative adjustment made to retained earnings to recognize the previously unrecognized net operating losses from prior periods was made to the valuation allowance through retained earnings for the first quarter financial statements. Adoption of all other changes did not have an impact 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 May 2014, the FASB 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. This 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 obligation. 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. We have performed a review of the requirements of the new revenue standard and are monitoring the activity of the FASB and the transition resource group as it relates to specific interpretive guidance. We have reviewed customer contracts and applied the five-step model of the new standard to our contracts as well as compared the results to our current accounting practices. We are currently in the process of drafting disclosures required by the new standard. At this point of our analysis, we do not believe that the adoption of this standard will have a material effect on our financial statements but will potentially expand our disclosures related to contracts with customers. |
INVENTORY
INVENTORY | 12 Months Ended |
Dec. 31, 2017 | |
Inventory Disclosure [Abstract] | |
INVENTORY | NOTE 3 – INVENTORY Inventory consists of the following: December 31, 2017 2016 Finished product $ 1,485,358 $ 1,062,285 Raw material — 14,036 TOTAL INVENTORY $ 1,485,358 $ 1,076,321 |
OTHER CURRENT ASSETS
OTHER CURRENT ASSETS | 12 Months Ended |
Dec. 31, 2017 | |
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] | |
OTHER CURRENT ASSETS | NOTE 4 – OTHER CURRENT ASSETS Other current assets consist of the following: December 31, 2017 2016 Prepaid sales and marketing costs $ 5,335,936 $ — Prepaid insurance 680,243 628,039 Prepaid manufacturing costs — 991,809 Prepaid consulting — 128,898 Other prepaid costs 523,694 405,960 Prepaid vendor deposits 64,411 44,311 Prepaid research and development costs — 100,035 TOTAL OTHER CURRENT ASSETS $ 6,604,284 $ 2,299,052 |
FIXED ASSETS
FIXED ASSETS | 12 Months Ended |
Dec. 31, 2017 | |
Property, Plant and Equipment [Abstract] | |
FIXED ASSETS | NOTE 5 – FIXED ASSETS, NET Fixed assets, net consist of the following: December 31, 2017 2016 Accounting system $ 301,096 $ 301,096 Equipment 273,536 215,182 Computer hardware 80,211 80,211 Furniture and fixtures 116,542 113,079 Leasehold improvements 37,888 37,888 TOTAL 809,273 747,456 Accumulated depreciation (372,218 ) (230,617 ) TOTAL FIXED ASSETS, NET $ 437,055 $ 516,839 Depreciation expense for the years ended December 31, 2017, 2016, and 2015 was $141,601, $77,906, and $29,959, respectively. |
INTANGIBLE ASSETS
INTANGIBLE ASSETS | 12 Months Ended |
Dec. 31, 2017 | |
Intangible Assets, Net (Excluding Goodwill) [Abstract] | |
INTANGIBLE ASSETS | NOTE 6 – 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, 2017 and 2016: December 31, 2017 Gross Accumulated Net Weighted- Amortizable intangible assets: OPERA ® $ 31,951 $ (8,487 ) $ 23,464 11.75 Development costs of corporate website 91,743 (91,743 ) — n/a Approved hormone therapy drug candidate patents 1,293,614 (171,911 ) 1,121,703 15 Hormone therapy drug candidate patents (pending) 1,721,305 — 1,721,305 n/a Non-amortizable intangible assets: Multiple trademarks 233,275 — 233,275 indefinite TOTAL $ 3,371,888 $ (272,141 ) $ 3,099,747 December 31, 2016 Gross Accumulated Net Weighted- Amortizable 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-amortizable intangible assets: Multiple trademarks for vitamins/supplements 185,465 — 185,465 indefinite Total $ 2,606,598 $ (200,626 ) $ 2,405,972 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, 2017 and 2016, there was no impairment recognized related to intangible assets. We have numerous pending foreign and domestic patent applications. As of December 31, 2017, we had 18 issued domestic, or U.S., patents and 13 issued foreign patents, including: ● 13 domestic and three foreign utility patents that relate to our combination progesterone and estradiol product candidates, which are owned by us. The domestic utility patents will expire in 2032. In addition, we have pending patent applications with respect to our combination progesterone and estradiol product candidates in the U.S., Argentina, Australia, Brazil, Canada, Europe, Israel, Japan, Mexico, Russia, South Africa, and South Korea; ● three domestic and 10 foreign patents that relate to TX-004HR, our applicator-free vaginal estradiol softgel product candidate. These patents establish an important intellectual property foundation for TX-004HR and are owned by us. These domestic patents will expire in 2033 or 2032. In addition, we have pending patent applications related to our applicator-free vaginal estradiol softgel product candidate in the U.S., Argentina, Australia, Brazil, Canada, Europe, Israel, Japan, Mexico, Russia, South Africa, and South Korea; ● one domestic utility patent that relates to a pipeline transdermal patch technology, which is owned by us and will expire in 2032. We have pending patent applications with respect to this technology in the U.S., Australia, Brazil, Canada, Europe, Mexico, Japan, and South Africa; and ● one utility patent that relates to our OPERA ® Amortization expense was $71,516, $54,545, and $32,441 for the years ended December 31, 2017, 2016, and 2015, respectively. Estimated amortization expense, based on current patent cost being amortized, for the next five years is as follows: Year Ending Estimated 2018 $ 76,777 2019 $ 76,777 2020 $ 76,777 2021 $ 76,777 2022 $ 76,777 Thereafter $ 761,282 |
OTHER CURRENT LIABILITIES
OTHER CURRENT LIABILITIES | 12 Months Ended |
Dec. 31, 2017 | |
Other Liabilities Disclosure [Abstract] | |
OTHER CURRENT LIABILITIES | NOTE 7– OTHER CURRENT LIABILITIES Other current liabilities consist of the following: December 31, 2017 2016 Accrued clinical trial costs $ 366,933 $ 1,281,080 Accrued payroll, bonuses and commission costs 4,240,379 3,531,440 Accrued compensated absences 945,457 665,561 Accrued legal and accounting expense 600,350 176,518 Accrued sales and marketing costs 420,162 665,773 Other accrued expenses 602,916 224,865 Allowance for wholesale distributor fees 172,973 76,510 Accrued royalties 114,480 26,507 Allowance for coupons and returns 1,432,846 794,816 Accrued rent 327,099 181,015 TOTAL OTHER CURRENT LIABILITIES $ 9,223,595 $ 7,624,085 |
STOCKHOLDERS' EQUITY
STOCKHOLDERS' EQUITY | 12 Months Ended |
Dec. 31, 2017 | |
Stockholders' Equity: | |
STOCKHOLDERS' EQUITY | NOTE 8 – STOCKHOLDERS’ EQUITY Preferred Stock At December 31, 2017, 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, 2017, we had 350,000,000 shares of Common Stock authorized for issuance, of which 216,429,642 shares of our Common Stock were issued and outstanding. Issuances During 2017 On September 25, 2017, we entered into an underwriting agreement with J.P. Morgan Securities LLC relating to an underwritten public offering of 12,400,000 shares of our Common Stock at a price of $5.55 per share. The net proceeds to us from the offering were approximately $68,573,000, after deducting estimated offering expenses payable by us. The offering closed on September 28, 2017 and we issued 12,400,000 shares of Common Stock. During the year ended December 31, 2017, certain individuals exercised stock options to purchase 102,546 shares of Common Stock for $212,615 in cash. 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 $134,864,000, 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 $32,257,000, 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 $59,118,000, 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. Warrants to Purchase Common Stock As of December 31, 2017, we had warrants outstanding to purchase an aggregate of 3,115,905 shares of our Common Stock with a weighted-average contractual remaining life of 1.8 years, and exercise prices ranging from $0.24 to $8.20 per share, resulting in a weighted average exercise price of $2.58 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, 2017, we granted warrants to purchase 125,000 shares of Common Stock to outside consultants at an exercise price of $6.83 per share. The fair value for these warrants was determined by using the Black-Scholes Model on the date of the grant using a term of five years; volatility of 63.24%; risk free rate of 1.47%; and dividend yield of 0%. The grant date fair value of the warrants was $3.67 per share. The warrants vest ratably over a 12-month period and have an expiration date of March 15, 2022. 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 $313,271, $936,974 and $139,142 for the years ended December 31, 2017, 2016, and 2015, respectively, in the accompanying consolidated financial statements. At December 31, 2017, total unrecognized estimated compensation expense related to the unvested portion of these warrants was approximately $128,000 which is expected to be recognized over a weighted-average period of 0.2 years. Summary of our Warrant activity during the year ended December 31, 2017: Number of Weighted Weighted Aggregate Balance at December 31, 2016 12,060,071 $ 2.08 1.0 $ 45,063,867 Granted 125,000 $ 6.83 Exercised (9,066,666 ) $ 1.98 $ 48,535,969 Expired (2,500 ) $ 2.64 Cancelled/Forfeited — $ — Balance at December 31, 2017 3,115,905 $ 2.58 1.8 $ 11,348,273 Vested and Exercisable at December 31, 2017 2,792,983 $ 2.64 0.8 $ 1,141,836 Unvested at December 31, 2017 322,922 $ 2.57 2.0 $ 10,206,436 The aggregate intrinsic value of warrants exercised during 2016 and 2015, was $3,988,343 and $7,282,404, respectively. 2017 2016 2015 Weighted average exercise price $ 6.83 $ 7.90 $ 6.35 Weighted average grant date fair value $ 3.67 $ 4.78 $ 3.27 Risk-free interest rate 1.47 % 1.04-1.28 % 1.02 % Volatility 63.24 % 74.10-74.15 % 60.59 % Term (in years) 5 5 5 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 term of the instrument. Estimated volatility is a measure of the amount by which our stock price is expected to fluctuate each year during the term of the 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 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. These shares were exercised in 2017 and are included in the warrant exercise details below; 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, 2017, 2016, and 2015, we recorded $0, $77,026, and $154,068, respectively, as non-cash compensation in the accompanying consolidated financial statements related to this warrant. As of December 31, 2017 this warrant was fully amortized. These shares were exercised in 2017 and are included in the warrant exercise details below; and 3. 283,334 shares will vest upon the receipt by us, prior to the warrant expiration date of April 30,2018, of any final FDA approval of a drug candidate that SCI helped us design. It is anticipated that receipt of such an approval may occur in the near future. In May 2012, we issued warrants to purchase an aggregate of 1,300,000 shares of Common Stock to SCI 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%. During the years ended December 31, 2017, 2016, and 2015, we recorded $128,898, $257,796, and $257,796, respectively as non-cash compensation with respect to these warrants in the accompanying consolidated financial statements. As of December 31, 2017, the SCI warrants issued in 2013 and 2012 were fully amortized. This warrant was fully exercised, of which 800,000 shares were exercised in 2017 and 500,000 shares were exercised in 2016. Warrant exercises During the year ended December 31, 2017, certain individuals exercised warrants to purchase 2,476,666 shares of Common Stock for $3,798,999 in cash. In addition, during the year ended December 31, 2017, certain individuals exercised warrants to purchase 6,590,000 shares of Common Stock pursuant to the warrants’ cashless exercise provisions, wherein 4,762,208 shares of Common Stock were issued. 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. 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, 2017, there were non-qualified stock options to purchase 18,575,084 shares of Common Stock outstanding under the 2009 Plan. As of December 31, 2017, there were 2,173,878 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, 2017, there were non-qualified stock options to purchase 4,790,141 shares of Common Stock outstanding under the 2012 Plan. As of December 31, 2017, there were 5,128,333 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, 2017, 2016, and 2015 are set forth in the table below. 2017 2016 2015 Weighted average exercise price $ 6.60 $ 6.22 $ 8.14 Weighted average grant date fair value $ 3.82 $ 3.94 $ 4.45 Risk-free interest rate 1.84-2.05 % 1.13-1.90 % 1.47-1.67 % Volatility 61.56-64.25 % 70.26-73.34 % 58.78-62.94 % Term (in years) 5.5-6.25 5.5-6.25 5.27-6.25 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, 2017 is as follows: Number of Weighted Weighted Aggregate Balance at December 31, 2016 21,767,854 $ 3.56 5.8 $ 60,495,730 Granted 2,271,500 $ 6.60 Exercised (102,546 ) $ 2.07 $ 452,287 Expired (108,375 ) $ 7.64 Cancelled/Forfeited (463,208 ) $ 6.28 Balance at December 31, 2017 23,365,225 $ 3.78 5.13 $ 64,664,821 Vested and Exercisable at December 31, 2017 19,770,142 $ 3.27 4.47 $ 63,895,512 Unvested at December 31, 2017 3,595,083 $ 6.60 8.79 $ 769,309 At December 31, 2017, our outstanding options had exercise prices ranging from $0.10 to $8.92 per share. The aggregate intrinsic value of options exercised during 2016 and 2015, was $3,828,358 and $3,186,371, respectively. Share-based compensation expense related to options recognized in our results of operations for the years ended December 31, 2017, 2016, and 2015 was approximately $6,447,154, $16,139,225, and $6,621,658, respectively, and it is based on awards vested. At December 31, 2017, total unrecognized estimated compensation expense related to unvested options was approximately $10,596,000, which may be adjusted for future changes in forfeitures. This cost is expected to be recognized over a weighted-average period of 2.1 years. No tax benefit was realized due to a continued pattern of operating losses. |
INCOME TAXES
INCOME TAXES | 12 Months Ended |
Dec. 31, 2017 | |
Income Tax Disclosure [Abstract] | |
INCOME TAXES | NOTE 9 – INCOME TAXES For financial reporting purposes, income before taxes includes the following components: 2017 2016 2015 United States $ (76,925,380 ) $ (89,875,459 ) $ (85,077,024 ) Total $ (76,925,380 ) $ (89,875,459 ) $ (85,077,024 ) For the years ended December 31, 2017, 2016, and 2015, there was no provision for income taxes, current or deferred. At December 31, 2017, we had a federal net operating loss carry forward of approximately $338,613,987 available to offset future taxable income through 2037. 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: 2017 2016 2015 Federal statutory tax rate 34.0 % 34.0 % 34.0 % State tax rate, net of federal tax benefit 5.0 % 5.4 % 4.73 % Adjustment in valuation allowances 22.6 % (40.3 )% (38.97 )% Federal income tax rate change (60.8 )% — % — % Permanent and other differences (0.8 )% 0.9 % 0.24 % (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, 2017, 2016, and 2015 are as follows: 2017 2016 2015 Deferred Income Tax Assets: Net operating losses $ 99,596,321 $ 111,730,450 $ 79,499,633 R&D Credit 186,347 186,347 186,347 Total deferred income tax asset 99,782,668 111,916,797 79,685,980 Valuation allowance (99,782,668 ) (111,916,797 ) (79,685,980 ) 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 the Company’s Balance Sheet and as such, a valuation allowance has been established against the deferred tax assets for the period ended December 31, 2017. Unrecognized Tax Benefits As of the period ended December 31, 2017, we have no unrecognized tax benefits. On December 22, 2017, the U.S. federal government enacted comprehensive tax legislation commonly referred to as the Tax Cuts and Jobs Act, or the Tax Act. The Tax Act makes broad and complex changes to the U.S. federal tax code, including, but not limited to reducing the U.S. federal corporate tax rate from 34 percent to 21 percent, effective January 1, 2018. Consequently, we have recorded a decrease related to deferred tax assets and deferred tax liabilities of approximately $49,500,000 and approximately $2,800,000, respectively, with a corresponding net adjustment to the valuation allowance of approximately $46,700,000 for the year ended December 31, 2017. The Tax Act modifies Section 162(m) of the Internal Revenue Code of 1986, as amended, or the IRC, by (1) expanding which employees are considered covered employees by including the chief financial officer, (2) providing that if an individual is a covered employee for a taxable year beginning after December 31, 2016, the individual remains a covered employee for all future years, and (3) removing the exceptions for compensation stemming from contracts entered into on or before November 2, 2017, unless such contracts were materially modified on or after the date. Compensation agreements entered into and share-based payment awards granted after this date will be subject to the revised terms of IRC Section 162(m). In December 2017, the SEC staff issued Staff Accounting Bulletin No. 118, Income Tax Accounting Implications of the Tax Cuts and Jobs Act We must assess whether our valuation allowance analyses are affected by various aspects of the Tax Act. Since, as discussed herein, we have recorded provisional amounts related to certain portions of the Tax Act, any corresponding determination of the need for or change in a valuation allowance is also provisional. |
RELATED PARTIES
RELATED PARTIES | 12 Months Ended |
Dec. 31, 2017 | |
Related Party Transactions [Abstract] | |
RELATED PARTIES | NOTE 10 – 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, 2017, 2016 and 2015, we were billed by Catalent approximately $3,646,000, $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, 2017 and December 31, 2016, there were amounts due to Catalent of approximately $523,000 and $57,000, respectively. |
BUSINESS CONCENTRATIONS
BUSINESS CONCENTRATIONS | 12 Months Ended |
Dec. 31, 2017 | |
Risks and Uncertainties [Abstract] | |
BUSINESS CONCENTRATIONS | NOTE 11 - BUSINESS CONCENTRATIONS We purchase our products from several suppliers with approximately 100%, 98%, and 60% of our purchases supplied by one vendor for the years ended December 31, 2017, 2016 and 2015, 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, 2017, 2016 and 2015; four, three, and two customers each, respectively, generated more than 10% of our revenues. Revenue generated from four major customers combined accounted for approximately 59% of our revenue during the year ended December 31, 2017. 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 recognized revenue during the year ended December 31, 2015. During the year ended December 31, 2017, AmerisourceBergen generated approximately $2,667,000 of our revenue; McKesson Corporation generated approximately $1,959,000 of our revenue; Cardinal Health generated approximately $2,559,000 of our revenue and Pharmacy Innovations PA generated approximately $2,715,000 of our revenue. 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. 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. |
COMMITMENTS AND CONTINGENCIES
COMMITMENTS AND CONTINGENCIES | 12 Months Ended |
Dec. 31, 2017 | |
Commitments and Contingencies Disclosure [Abstract] | |
COMMITMENTS AND CONTINGENCIES | NOTE 12 – 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, 2017, 2016 and 2015 was $1,029,205, $709,483, and $446,099, respectively. As of December 31, 2017, future minimum rental payments on non-cancelable operating leases are as follows: Years Ending December 31, 2018 $ 951,194 2019 1,094,116 2020 1,113,069 2021 943,127 2022 — Total minimum lease payments $ 4,101,506 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, 2017, 2016, and 2015, 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, 2017 | |
Quarterly Financial Information Disclosure [Abstract] | |
SELECTED QUARTERLY FINANCIAL DATA (UNAUDITED) | NOTE 13 – SELECTED QUARTERLY FINANCIAL DATA (UNAUDITED) Summarized quarterly financial data for fiscal years 2017 and 2016 is as follows: 2017 Quarters (In thousands, except per share) 1 st 2 nd 3 rd 4th Revenues $ 3,985 $ 4,250 $ 4,418 $ 4,125 Gross profit $ 3,326 $ 3,568 $ 3,717 $ 3,530 Net loss $ (21,156 ) $ (19,677 ) $ (14,665 ) $ (21,427 ) Loss per common share, basic and diluted $ (0.11 ) $ (0.10 ) $ (0.07 ) $ (0.10 ) 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 ) |
SUMMARY OF SIGNIFICANT ACCOUN20
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies) | 12 Months Ended |
Dec. 31, 2017 | |
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 approximately $2,200,000 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. 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 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, 2017, 2016, and 2015. 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, 2017, 2016, and 2015. |
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, 2017 and 2016, 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, 2017, 2016, and 2015. |
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, 2017 and 2016, 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 we ceased manufacturing in October 2017. 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 11. 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 (Iron 21/7). 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 we ceased manufacturing in October 2017. |
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, coupons 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 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. We estimate the allowance for consumer rebates and coupons that we have offered based on our experience and industry averages, which is reviewed, and adjusted if necessary, on a quarterly basis. 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 $448,288, $752,611, and $792,574 during the years ended December 31, 2017, 2016, and 2015, 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 $0 and $228,933 at December 31, 2017 and 2016, respectively, all of which was included in other current assets 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 U.S. Food and Drug Administration, or the FDA, submission processes, clinical trial processes, and scientific writing matters, including preparing protocols and FDA submissions. Legal activities that were classified as R&D expenses include professional research and advice regarding R&D, patents and regulatory matters. These consulting and legal expenses were direct costs associated with preparing, reviewing, and undertaking work for our clinical trials and investigative drugs. We charge internal R&D activities and other activity expenses to operations as incurred. We make payments to CROs based on agreed-upon terms, which may include payments in advance of a study starting date. We expense nonrefundable advance payments for goods and services that will be used in future R&D activities when the activity has been performed or when the goods have been received rather than when the payment is made. We review and accrue CRO expenses and clinical trial study expenses based on services performed and rely on estimates of those costs applicable to the completion stage of a study as provided by CROs. Estimated accrued CRO costs are subject to revisions as such studies progress to completion. We charge revisions expense in the period in which the facts that give rise to the revision become known. |
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, 2017 2016 2015 Stock options 23,365,225 21,767,854 20,725,325 Warrants 3,115,905 12,060,071 12,722,431 26,481,130 33,827,925 33,447,756 |
Concentration of Credit Risk and other Risks and Uncertainties | Concentration of Credit Risk and other Risks and Uncertainties Financial instruments that potentially expose us to concentrations of credit risk consist primarily of cash and trade accounts receivable. Cash is on deposit with financial institutions in the United States and these deposits generally exceed the amount of insurance provided by the FDIC. The Company has not experienced any historical losses on its deposits of cash. Concentration of credit risk with respect to our trade accounts receivable from our customers is primarily limited to drug wholesalers and retail 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 May 2017, the FASB issued ASU 2017-09, which clarifies when changes to the terms or conditions of a share-based payment award must be accounted for as modifications. The new guidance will reduce diversity in practice and result in fewer changes to the terms of an award being accounted for as modifications. The new guidance will allow companies to make certain changes to awards without accounting for them as modifications. This guidance does not change the accounting for modifications. The guidance will be applied prospectively to awards modified on or after the adoption date and is effective for annual periods, and interim periods within those annual periods, beginning after December 15, 2017. Early adoption is permitted, including in an interim period. We adopted this guidance and it did not have an impact on our consolidated financial statements. In August 2016, the FASB issued 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 adopted this guidance and it did not have an impact on our consolidated financial statements. 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. We adopted ASU 2016-09 effective January 1, 2017, electing to account for forfeitures when they occur. The impact from adoption of the provisions related to forfeiture rates was reflected in our consolidated financial statements on a modified retrospective basis, resulting in an adjustment of approximately $31,000 to retained earnings. The impact from adoption of the provisions related to excess tax benefits or deficiencies in the provision for income taxes rather than paid-in capital was adopted on a modified retrospective basis. Since we have a full valuation allowance on our net deferred tax assets, an amount equal to the cumulative adjustment made to retained earnings to recognize the previously unrecognized net operating losses from prior periods was made to the valuation allowance through retained earnings for the first quarter financial statements. Adoption of all other changes did not have an impact 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 May 2014, the FASB 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. This 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 obligation. 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. We have performed a review of the requirements of the new revenue standard and are monitoring the activity of the FASB and the transition resource group as it relates to specific interpretive guidance. We have reviewed customer contracts and applied the five-step model of the new standard to our contracts as well as compared the results to our current accounting practices. We are currently in the process of drafting disclosures required by the new standard. At this point of our analysis, we do not believe that the adoption of this standard will have a material effect on our financial statements but will potentially expand our disclosures related to contracts with customers. |
SUMMARY OF SIGNIFICANT ACCOUN21
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
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, 2017 2016 2015 Stock options 23,365,225 21,767,854 20,725,325 Warrants 3,115,905 12,060,071 12,722,431 26,481,130 33,827,925 33,447,756 |
INVENTORY (Tables)
INVENTORY (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Inventory Disclosure [Abstract] | |
Schedule of inventory | Inventory consists of the following: December 31, 2017 2016 Finished product $ 1,485,358 $ 1,062,285 Raw material — 14,036 TOTAL INVENTORY $ 1,485,358 $ 1,076,321 |
OTHER CURRENT ASSETS (Tables)
OTHER CURRENT ASSETS (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] | |
Schedule of other current assets | Other current assets consist of the following: December 31, 2017 2016 Prepaid sales and marketing costs $ 5,335,936 $ — Prepaid insurance 680,243 628,039 Prepaid manufacturing costs — 991,809 Prepaid consulting — 128,898 Other prepaid costs 523,694 405,960 Prepaid vendor deposits 64,411 44,311 Prepaid research and development costs — 100,035 TOTAL OTHER CURRENT ASSETS $ 6,604,284 $ 2,299,052 |
FIXED ASSETS (Tables)
FIXED ASSETS (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Property, Plant and Equipment [Abstract] | |
Schedule of fixed assets | Fixed assets, net consist of the following: December 31, 2017 2016 Accounting system $ 301,096 $ 301,096 Equipment 273,536 215,182 Computer hardware 80,211 80,211 Furniture and fixtures 116,542 113,079 Leasehold improvements 37,888 37,888 TOTAL 809,273 747,456 Accumulated depreciation (372,218 ) (230,617 ) TOTAL FIXED ASSETS, NET $ 437,055 $ 516,839 |
INTANGIBLE ASSETS (Tables)
INTANGIBLE ASSETS (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
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, 2017 and 2016: December 31, 2017 Gross Accumulated Net Weighted- Amortizable intangible assets: OPERA ® $ 31,951 $ (8,487 ) $ 23,464 11.75 Development costs of corporate website 91,743 (91,743 ) — n/a Approved hormone therapy drug candidate patents 1,293,614 (171,911 ) 1,121,703 15 Hormone therapy drug candidate patents (pending) 1,721,305 — 1,721,305 n/a Non-amortizable intangible assets: Multiple trademarks 233,275 — 233,275 indefinite TOTAL $ 3,371,888 $ (272,141 ) $ 3,099,747 December 31, 2016 Gross Accumulated Net Weighted- Amortizable 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-amortizable intangible assets: Multiple trademarks for vitamins/supplements 185,465 — 185,465 indefinite Total $ 2,606,598 $ (200,626 ) $ 2,405,972 |
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 2018 $ 76,777 2019 $ 76,777 2020 $ 76,777 2021 $ 76,777 2022 $ 76,777 Thereafter $ 761,282 |
OTHER CURRENT LIABILITIES (Tabl
OTHER CURRENT LIABILITIES (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Other Liabilities Disclosure [Abstract] | |
Schedule of other current liabilities | Other current liabilities consist of the following: December 31, 2017 2016 Accrued clinical trial costs $ 366,933 $ 1,281,080 Accrued payroll, bonuses and commission costs 4,240,379 3,531,440 Accrued compensated absences 945,457 665,561 Accrued legal and accounting expense 600,350 176,518 Accrued sales and marketing costs 420,162 665,773 Other accrued expenses 602,916 224,865 Allowance for wholesale distributor fees 172,973 76,510 Accrued royalties 114,480 26,507 Allowance for coupons and returns 1,432,846 794,816 Accrued rent 327,099 181,015 TOTAL OTHER CURRENT LIABILITIES $ 9,223,595 $ 7,624,085 |
STOCKHOLDERS' EQUITY (Tables)
STOCKHOLDERS' EQUITY (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Stockholders' Equity: | |
Schedule of warrant activity | Summary of our Warrant activity during the year ended December 31, 2017: Number of Weighted Weighted Aggregate Balance at December 31, 2016 12,060,071 $ 2.08 1.0 $ 45,063,867 Granted 125,000 $ 6.83 Exercised (9,066,666 ) $ 1.98 $ 48,535,969 Expired (2,500 ) $ 2.64 Cancelled/Forfeited — $ — Balance at December 31, 2017 3,115,905 $ 2.58 1.8 $ 11,348,273 Vested and Exercisable at December 31, 2017 2,792,983 $ 2.64 0.8 $ 1,141,836 Unvested at December 31, 2017 322,922 $ 2.57 2.0 $ 10,206,436 |
Schedule of assumptions used in the Black-Scholes Model of warrants issued | 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, 2017, 2016 and 2015 are set forth in the table below. 2017 2016 2015 Weighted average exercise price $ 6.83 $ 7.90 $ 6.35 Weighted average grant date fair value $ 3.67 $ 4.78 $ 3.27 Risk-free interest rate 1.47 % 1.04-1.28 % 1.02 % Volatility 63.24 % 74.10-74.15 % 60.59 % Term (in years) 5 5 5 Dividend yield 0.00 % 0.00 % 0.00 % |
Schedule of assumptions used in the Black-Scholes Model of stock options | The ranges of assumptions used in the Black-Scholes Model during the years ended December 31, 2017, 2016, and 2015 are set forth in the table below. 2017 2016 2015 Weighted average exercise price $ 6.60 $ 6.22 $ 8.14 Weighted average grant date fair value $ 3.82 $ 3.94 $ 4.45 Risk-free interest rate 1.84-2.05 % 1.13-1.90 % 1.47-1.67 % Volatility 61.56-64.25 % 70.26-73.34 % 58.78-62.94 % Term (in years) 5.5-6.25 5.5-6.25 5.27-6.25 Dividend yield 0.00 % 0.00 % 0.00 % |
Schedule of 2009 and 2012 Plans activity | A summary of activity under the 2009 and 2012 Plans and related information during the year ended December 31, 2017 is as follows: Number of Weighted Weighted Aggregate Balance at December 31, 2016 21,767,854 $ 3.56 5.8 $ 60,495,730 Granted 2,271,500 $ 6.60 Exercised (102,546 ) $ 2.07 $ 452,287 Expired (108,375 ) $ 7.64 Cancelled/Forfeited (463,208 ) $ 6.28 Balance at December 31, 2017 23,365,225 $ 3.78 5.13 $ 64,664,821 Vested and Exercisable at December 31, 2017 19,770,142 $ 3.27 4.47 $ 63,895,512 Unvested at December 31, 2017 3,595,083 $ 6.60 8.79 $ 769,309 |
INCOME TAXES (Tables)
INCOME TAXES (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Income Tax Disclosure [Abstract] | |
Schedule of components of income before taxes | For financial reporting purposes, income before taxes includes the following components: 2017 2016 2015 United States $ (76,925,380 ) $ (89,875,459 ) $ (85,077,024 ) Total $ (76,925,380 ) $ (89,875,459 ) $ (85,077,024 ) |
Schedule of tax rate reconciliation | A reconciliation between taxes computed at the federal statutory rate and the consolidated effective tax rate is as follows: 2017 2016 2015 Federal statutory tax rate 34.0 % 34.0 % 34.0 % State tax rate, net of federal tax benefit 5.0 % 5.4 % 4.73 % Adjustment in valuation allowances 22.6 % (40.3 )% (38.97 )% Federal income tax rate change (60.8 )% — % — % Permanent and other differences (0.8 )% 0.9 % 0.24 % (Provision) benefit for income taxes — % — % — % |
Schedule of components of the net deferred income tax asset | The components of the net deferred income tax asset as of December 31, 2017, 2016, and 2015 are as follows: 2017 2016 2015 Deferred Income Tax Assets: Net operating losses $ 99,596,321 $ 111,730,450 $ 79,499,633 R&D Credit 186,347 186,347 186,347 Total deferred income tax asset 99,782,668 111,916,797 79,685,980 Valuation allowance (99,782,668 ) (111,916,797 ) (79,685,980 ) Deferred income tax assets, net $ — $ — $ — |
COMMITMENTS AND CONTINGENCIES (
COMMITMENTS AND CONTINGENCIES (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Commitments and Contingencies Disclosure [Abstract] | |
Schedule of future minimum rental payments on non-cancelable operating leases | As of December 31, 2017, future minimum rental payments on non-cancelable operating leases are as follows: Years Ending December 31, 2018 $ 951,194 2019 1,094,116 2020 1,113,069 2021 943,127 2022 — Total minimum lease payments $ 4,101,506 |
SELECTED QUARTERLY FINANCIAL 30
SELECTED QUARTERLY FINANCIAL DATA (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Quarterly Financial Information Disclosure [Abstract] | |
Schedule of summarized quarterly financial data | Summarized quarterly financial data for fiscal years 2017 and 2016 is as follows: 2017 Quarters (In thousands, except per share) 1 st 2 nd 3 rd 4th Revenues $ 3,985 $ 4,250 $ 4,418 $ 4,125 Gross profit $ 3,326 $ 3,568 $ 3,717 $ 3,530 Net loss $ (21,156 ) $ (19,677 ) $ (14,665 ) $ (21,427 ) Loss per common share, basic and diluted $ (0.11 ) $ (0.10 ) $ (0.07 ) $ (0.10 ) 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 ) |
SUMMARY OF SIGNIFICANT ACCOUN31
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details) - shares | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Anti-dilutive shares excluded from earnings per share calculation | 26,481,130 | 33,827,925 | 33,447,756 |
Warrants [Member] | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Anti-dilutive shares excluded from earnings per share calculation | 3,115,905 | 12,060,071 | 12,722,431 |
Stock Options [Member] | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Anti-dilutive shares excluded from earnings per share calculation | 23,365,225 | 21,767,854 | 20,725,325 |
SUMMARY OF SIGNIFICANT ACCOUN32
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details Narrative) | 3 Months Ended | 12 Months Ended | ||
Sep. 30, 2016USD ($) | Dec. 31, 2017USD ($)Number | Dec. 31, 2016USD ($) | Dec. 31, 2015USD ($) | |
Federal insurance limits | $ 250,000 | |||
Write-off accounts receivable | $ 2,200,000 | |||
Number of issued patents | Number | 18 | |||
Advertising costs | $ 448,288 | $ 752,611 | $ 792,574 | |
Shelf life of prescription products following product expiration | 24 months | |||
Number of operating segment | Number | 1 | |||
Impact from modified retrospective basis adoption of accounting standard | $ 31,000 | |||
Customer A [Member] | Accounts Receivable [Member] | ||||
Concentration risk | 27.00% | 28.00% | ||
Customer B [Member] | Accounts Receivable [Member] | ||||
Concentration risk | 23.00% | 20.00% | ||
Customer C [Member] | Accounts Receivable [Member] | ||||
Concentration risk | 22.00% | |||
Customer D [Member] | Accounts Receivable [Member] | ||||
Concentration risk | 11.00% | |||
Minimum [Member] | ||||
Return period of unsalable prescription products | 6 months | |||
Minimum [Member] | Software [Member] | ||||
Estimated useful lives | 5 years | |||
Maximum [Member] | ||||
Return period of unsalable prescription products | 12 months | |||
Maximum [Member] | Software [Member] | ||||
Estimated useful lives | 7 years | |||
Related to Research and Development Activities [Member] | ||||
Advance payments - total | $ 0 | $ 228,933 |
INVENTORY (Details)
INVENTORY (Details) - USD ($) | Dec. 31, 2017 | Dec. 31, 2016 |
Inventory | ||
Finished product | $ 1,485,358 | $ 1,062,285 |
Raw material | 14,036 | |
TOTAL INVENTORY | $ 1,485,358 | $ 1,076,321 |
OTHER CURRENT ASSETS (Details)
OTHER CURRENT ASSETS (Details) - USD ($) | Dec. 31, 2017 | Dec. 31, 2016 |
Other Current Assets | ||
Prepaid sales and marketing costs | $ 5,335,936 | |
Prepaid insurance | 680,243 | $ 628,039 |
Prepaid manufacturing costs | 991,809 | |
Prepaid consulting | 128,898 | |
Other prepaid costs | 523,694 | 405,960 |
Prepaid vendor deposits | 64,411 | 44,311 |
Prepaid research and development costs | 100,035 | |
TOTAL OTHER CURRENT ASSETS | $ 6,604,284 | $ 2,299,052 |
FIXED ASSETS (Details)
FIXED ASSETS (Details) - USD ($) | Dec. 31, 2017 | Dec. 31, 2016 |
Property, Plant and Equipment [Line Items] | ||
Fixed assets, gross | $ 809,273 | $ 747,456 |
Accumulated depreciation | (372,218) | (230,617) |
TOTAL FIXED ASSETS | 437,055 | 516,839 |
Software [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Fixed assets, gross | 301,096 | 301,096 |
Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Fixed assets, gross | 273,536 | 215,182 |
Computer hardware [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Fixed assets, gross | 80,211 | 80,211 |
Furniture and fixtures [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Fixed assets, gross | 116,542 | 113,079 |
Leasehold improvements [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Fixed assets, gross | $ 37,888 | $ 37,888 |
FIXED ASSETS (Details Narrative
FIXED ASSETS (Details Narrative) - USD ($) | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Property, Plant and Equipment [Abstract] | |||
Depreciation expense | $ 141,601 | $ 77,906 | $ 29,959 |
INTANGIBLE ASSETS (Details)
INTANGIBLE ASSETS (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2017 | Dec. 31, 2016 | |
Gross Carrying Amount | $ 3,371,888 | $ 2,606,598 |
Net Amount | 3,099,747 | 2,405,972 |
Finite-Lived Intangible Assets | ||
Accumulated Amortization | (272,141) | (200,626) |
Hormone Therapy Drug Candidate Patents - (Pending) [Member] | ||
Finite-Lived Intangible Assets | ||
Gross Carrying Amount | 1,721,305 | 1,203,987 |
Net Amount | 1,721,305 | 1,203,987 |
Multiple Trademarks [Member] | ||
Indefinite-Lived Intangible Assets | ||
Gross Carrying Amount | 233,275 | 185,465 |
Net Amount | 233,275 | 185,465 |
Opera Software Patent [Member] | ||
Finite-Lived Intangible Assets | ||
Gross Carrying Amount | 31,951 | 31,951 |
Accumulated Amortization | (8,487) | (6,490) |
Net Amount | $ 23,464 | $ 25,461 |
Weighted average remaining amortization period | 11 years 9 months | 12 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 | 1,293,614 | 1,093,452 |
Accumulated Amortization | (171,911) | (102,393) |
Net Amount | $ 1,121,703 | $ 991,059 |
Weighted average remaining amortization period | 15 years | 16 years |
INTANGIBLE ASSETS (Details 1)
INTANGIBLE ASSETS (Details 1) | Dec. 31, 2016USD ($) |
Year Ending December 31, | |
2,018 | $ 76,777 |
2,019 | 76,777 |
2,020 | 76,777 |
2,021 | 76,777 |
2,022 | 76,777 |
Thereafter | $ 761,282 |
INTANGIBLE ASSETS (Details Narr
INTANGIBLE ASSETS (Details Narrative) | 12 Months Ended | ||
Dec. 31, 2017USD ($)Number | Dec. 31, 2016USD ($) | Dec. 31, 2015USD ($) | |
Finite-Lived Intangible Assets [Line Items] | |||
Amortization expense | $ | $ 71,516 | $ 54,545 | $ 32,441 |
Number of issued patents | 18 | ||
Approved Hormone Therapy Drug Candidate Patents [Member] | |||
Finite-Lived Intangible Assets [Line Items] | |||
Useful Life | 20 years | ||
Domestic Utility Patents [Member] | |||
Finite-Lived Intangible Assets [Line Items] | |||
Number of issued patents | 13 | ||
Foreign Utility Patents [Member] | |||
Finite-Lived Intangible Assets [Line Items] | |||
Number of issued patents | 3 | ||
Utility Patent Domestic TX-004HR [Member] | |||
Finite-Lived Intangible Assets [Line Items] | |||
Number of issued patents | 3 | ||
Utility Patent Foreign TX-004HR [Member] | |||
Finite-Lived Intangible Assets [Line Items] | |||
Number of issued patents | 10 | ||
Utility Patent Pipeline Transdermal Patch Technology [Member] | |||
Finite-Lived Intangible Assets [Line Items] | |||
Number of issued patents | 1 | ||
Opera Software Patent [Member] | |||
Finite-Lived Intangible Assets [Line Items] | |||
Number of issued patents | 1 |
OTHER CURRENT LIABILITIES (Deta
OTHER CURRENT LIABILITIES (Details) - USD ($) | Dec. 31, 2017 | Dec. 31, 2016 |
Other Liabilities Disclosure [Abstract] | ||
Accrued clinical trial costs | $ 366,933 | $ 1,281,080 |
Accrued payroll, bonuses and commission costs | 4,240,379 | 3,531,440 |
Accrued compensated absences | 945,457 | 665,561 |
Accrued legal and accounting expense | 600,350 | 176,518 |
Accrued sales and marketing costs | 420,162 | 665,773 |
Other accrued expenses | 602,916 | 224,865 |
Allowance for wholesale distributor fees | 172,973 | 76,510 |
Accrued royalties | 114,480 | 26,507 |
Allowance for coupons and returns | 1,432,846 | 794,816 |
Accrued rent | 327,099 | 181,015 |
TOTAL OTHER CURRENT LIABILITIES | $ 9,223,595 | $ 7,624,085 |
STOCKHOLDERS' EQUITY (Details)
STOCKHOLDERS' EQUITY (Details) - Warrants [Member] - USD ($) | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Number of shares Warrants | |||
Warrants outstanding at December 31, 2016 | 12,060,071 | ||
Warrants granted | 125,000 | ||
Warrants exercised | (9,066,666) | (1,255,485) | |
Warrants expired | (2,500) | ||
Warrants outstanding at December 31, 2017 | 3,115,905 | 12,060,071 | |
Vested and Exercisable at December 31, 2017 | 2,792,983 | ||
Unvested at December 31, 2017 | 322,922 | ||
Weighted Average Exercise Price | |||
Warrants outstanding at December 31, 2016 | $ 2.08 | ||
Warrants granted | 6.83 | ||
Warrants exercised | 1.98 | ||
Warrants expired | 2.64 | ||
Warrants outstanding at December 31, 2017 | 2.58 | $ 2.08 | |
Vested and Exercisable at December 31, 2017 | 2.64 | ||
Warrants Unvested at December 31, 2017 | $ 2.57 | ||
Weighted Average Remaining Contractual Life | |||
Warrants outstanding | 1 year 9 months 18 days | 1 year | |
Warrants Vested and Exercisable | 9 months 18 days | ||
Warrants Unvested | 2 years | ||
Aggregate Intrinsic Value | |||
Warrants outstanding at December 31, 2016 | $ 45,063,867 | ||
Warrants exercised | 48,535,969 | $ 3,988,343 | $ 7,282,404 |
Warrants outstanding at December 31, 2017 | 11,348,273 | $ 45,063,867 | |
Vested and Exercisable at December 31, 2017 | 1,141,836 | ||
Unvested at December 31, 2017 | $ 10,206,436 |
STOCKHOLDERS' EQUITY (Details 1
STOCKHOLDERS' EQUITY (Details 1) - Warrants [Member] - $ / shares | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Class of Warrant or Right [Line Items] | |||
Weighted average price | $ 6.83 | $ 7.90 | $ 6.35 |
Weighted average grant date fair value | $ 3.67 | $ 4.78 | $ 3.27 |
Risk-free interest rate | 1.47% | 1.02% | |
Volatility | 63.24% | 60.59% | |
Term (in years) | 5 years | 5 years | 5 years |
Dividend yield | 0.00% | 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] - $ / shares | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Weighted average exercise price | $ 6.60 | $ 6.22 | $ 8.14 |
Weighted grant date fair value | $ 3.82 | $ 3.94 | $ 4.45 |
Risk-free interest rate - minimum | 1.84% | 1.13% | 1.47% |
Risk-free interest rate - maximum | 2.05% | 1.90% | 1.67% |
Volatility - minimum | 61.56% | 70.26% | 58.78% |
Volatility - maximum | 64.25% | 73.34% | 62.94% |
Dividend yield | 0.00% | 0.00% | 0.00% |
Minimum [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Term | 5 years 6 months | 5 years 6 months | 5 years 3 months 7 days |
Maximum [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
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, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Options, Outstanding | |||
Options outstanding at December 31, 2016 | 21,767,854 | ||
Options Granted | 2,271,500 | ||
Options Exercised | (102,546) | ||
Options Expired | (108,375) | ||
Options Cancelled/Forfeited | (463,208) | ||
Options outstanding at December 31, 2017 | 23,365,225 | 21,767,854 | |
Vested and Exercisable at December 31, 2017 | 19,770,142 | ||
Unvested at December 31, 2017 | 3,595,083 | ||
Options, Weighted Average Exercise Price | |||
Options outstanding at December 31, 2016 | $ 3.56 | ||
Granted | 6.60 | ||
Exercised | 2.07 | ||
Expired | 7.64 | ||
Cancelled/Forfeited | 6.28 | ||
Options outstanding at December 31, 2017 | 3.78 | $ 3.56 | |
Vested and Exercisable at December 31, 2017 | 3.27 | ||
Unvested at December 31, 2017 | $ 6.60 | ||
Options, Weighted Average Remaining Contractual Life | |||
Options outstanding | 5 years 1 month 16 days | 5 years 9 months 18 days | |
Vested and Exercisable | 4 years 5 months 20 days | ||
Unvested | 8 years 9 months 14 days | ||
Options outstanding, Aggregate Intrinsic Value | |||
Options outstanding at December 31, 2016 | $ 60,495,730 | ||
Options exercised | 452,287 | $ 3,828,358 | $ 3,186,371 |
Options outstanding at December 31, 2017 | 64,664,821 | $ 60,495,730 | |
Vested and Exercisable at December 31, 2017 | 63,895,512 | ||
Unvested at December 31, 2017 | $ 769,309 |
STOCKHOLDERS' EQUITY (Details N
STOCKHOLDERS' EQUITY (Details Narrative) - USD ($) | Sep. 28, 2017 | Sep. 25, 2017 | Jan. 12, 2016 | Jan. 06, 2016 | Jul. 15, 2015 | Jul. 09, 2015 | Feb. 17, 2015 | Feb. 10, 2015 | Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 |
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 | 216,429,642 | 196,688,222 | |||||||||
Common stock, shares outstanding | 216,429,642 | 196,688,222 | |||||||||
Value of common stock issued during period for stock options exercised | $ 212,615 | $ 989,060 | $ 1,232,579 | ||||||||
Number of stock options exercised (in shares) | 102,546 | 523,362 | |||||||||
Proceeds from sale of common stock, net of costs | $ 68,572,635 | $ 134,863,475 | 91,374,649 | ||||||||
Number of stock options exercised in cashless exercise (in shares) | 127,109 | ||||||||||
Number of common stock issued during period for stock options exercised in cashless exercise (in shares) | 87,833 | ||||||||||
Stock Options [Member] | |||||||||||
Value of common stock issued during period for stock options exercised | $ 1,232,579 | ||||||||||
Number of stock options exercised (in shares) | 612,867 | ||||||||||
Number of stock options exercised in cashless exercise (in shares) | 417 | ||||||||||
Number of common stock issued during period for stock options exercised in cashless exercise (in shares) | 114 | ||||||||||
Underwriting Agreement - J.P. Morgan Securities LLC [Member] | |||||||||||
Number of shares offered in underwriting agreement | 12,400,000 | ||||||||||
Number of shares issued during the period | 12,400,000 | ||||||||||
Share price (in dollars per share) | $ 5.55 | ||||||||||
Proceeds from sale of common stock, net of costs | $ 68,573,000 | ||||||||||
Underwriting Agreement - Goldman and Cowen [Member] | |||||||||||
Number of shares offered in underwriting agreement | 15,151,515 | ||||||||||
Number of shares issued during the period | 17,424,242 | ||||||||||
Share price (in dollars per share) | $ 8.25 | ||||||||||
Proceeds from sale of common stock, net of costs | $ 134,864,000 | ||||||||||
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 offered in underwriting agreement | 3,846,154 | ||||||||||
Number of shares issued during the period | 4,423,077 | ||||||||||
Share price (in dollars per share) | $ 7.80 | ||||||||||
Proceeds from sale of common stock, net of costs | $ 32,257,000 | ||||||||||
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 offered in underwriting agreement | 13,580,246 | ||||||||||
Number of shares issued during the period | 15,617,282 | ||||||||||
Share price (in dollars per share) | $ 4.05 | ||||||||||
Proceeds from sale of common stock, net of costs | $ 59,118,000 | ||||||||||
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, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Warrants: | |||
Share based compensation expense | $ 6,889,323 | $ 17,411,021 | $ 7,189,699 |
Unrecognized estimated compensation expense period recognition | 2 years 1 month 6 days | ||
Minimum [Member] | |||
Warrants: | |||
Exercise price of warrants (in dollars per share) | $ 0.24 | ||
Maximum [Member] | |||
Warrants: | |||
Exercise price of warrants (in dollars per share) | $ 8.20 | ||
Warrants [Member] | |||
Warrants: | |||
Warrants outstanding | $ 3,115,905 | ||
Weighted-average contractual remaining life | 1 year 9 months 18 days | ||
Weighted average exercise price of warrants (in dollars per share) | $ 2.58 | $ 2.08 | |
Warrants granted (in shares) | 125,000 | ||
Grant date fair value (in dollars per share) | $ 3.67 | $ 4.78 | $ 3.27 |
Share based compensation expense | $ 313,271 | $ 936,974 | $ 139,142 |
Unrecognized estimated compensation expense | $ 128,000 | ||
Unrecognized estimated compensation expense period recognition | 2 months 12 days | ||
Aggregate intrinsic value of warrants exercised | $ 48,535,969 | $ 3,988,343 | $ 7,282,404 |
Outside Consultants Warrants [Member] | |||
Warrants: | |||
Exercise price of warrants (in dollars per share) | $ 6.83 | ||
Weighted average exercise price of warrants (in dollars per share) | $ 7.90 | ||
Warrants granted (in shares) | 125,000 | 245,000 | |
Grant date fair value (in dollars per share) | $ 3.67 | ||
Expiration date of warrants | Mar. 15, 2022 | Jan. 21, 2021 | |
Vesting period of warrants | 12 months | 12 months | |
Expected term | 5 years | ||
Volatility rate | 63.24% | ||
Risk free rate | 1.47% | ||
Dividend yield | 0.00% | ||
Outside Consultants Warrants [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 Consultants Warrants [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 Consultants Warrants [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 [Member] | |||
Warrants: | |||
Weighted average 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 |
STOCKHOLDERS' EQUITY (Details47
STOCKHOLDERS' EQUITY (Details Narrative 2) - USD ($) | Jun. 30, 2013 | May 11, 2013 | May 31, 2013 | May 31, 2012 | Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 |
Non-cash compensation expense | $ 6,889,323 | $ 17,411,021 | $ 7,189,699 | ||||
SCI - Warrants [Member] | |||||||
Exercise price of warrants (in dollars per share) | $ 2.01 | ||||||
Warrants granted to purchase common stock (shares) | 850,000 | ||||||
Forfeited warrants granted to purchase common stock (shares) | 833,000 | ||||||
SCI - Warrants [Member] | Tranche One [Member] | |||||||
Fair value of grant | $ 405,066 | ||||||
Non-cash compensation expense | 405,066 | ||||||
Vesting date of warrants | Jun. 30, 2013 | ||||||
Expected term | 5 years | ||||||
Volatility rate | 45.89% | ||||||
Risk free rate | 1.12% | ||||||
Dividend yield | 0.00% | ||||||
Vested warrants granted to purchase common stock (shares) | 283,333 | ||||||
SCI - Warrants [Member] | Tranche Two [Member] | |||||||
Fair value of grant | $ 462,196 | ||||||
Non-cash compensation expense | 0 | 77,026 | 154,068 | ||||
Vesting date of warrants | Jun. 30, 2013 | ||||||
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 | ||||||
SCI - Warrants [Member] | Tranche Three [Member] | |||||||
Unvested warrants | 283,334 | ||||||
Warrants - Unaffiliated Entity [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 | ||||||
Non-cash compensation expense | $ 128,898 | $ 257,796 | $ 257,796 | ||||
Expected term | 5 years | ||||||
Volatility rate | 44.71% | ||||||
Risk free rate | 0.74% | ||||||
Dividend yield | 0.00% | ||||||
Warrants exercised | (800,000) | (500,000) |
STOCKHOLDERS' EQUITY (Details48
STOCKHOLDERS' EQUITY (Details Narrative 3) - USD ($) | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Share-based compensation expense | $ 6,447,154 | $ 16,139,225 | $ 6,621,658 |
Total unrecognized estimated compensation expense | $ 10,596,000 | ||
Recognized weighted-average period | 2 years 1 month 6 days | ||
Shares issued for exercise of warrants, net | $ 3,798,999 | $ 1,373,000 | 366,000 |
Stock Options [Member] | |||
Options outstanding, ending | 23,365,225 | 21,767,854 | |
Aggregate intrinsic value of options exercised | $ 452,287 | $ 3,828,358 | $ 3,186,371 |
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 | ||
2009 Long Term Incentive Compensation Plan [Member] | |||
Number of shares authorized for issuance | 25,000,000 | ||
Options outstanding, ending | 18,575,084 | ||
Number of shares available for issuance | 2,173,878 | ||
Vesting period | 4 years | ||
Expiration period | 10 years | ||
2012 Stock Incentive Plan [Member] | |||
Number of shares authorized for issuance | 10,000,000 | ||
Options outstanding, ending | 4,790,141 | ||
Number of shares available for issuance | 5,128,333 | ||
Vesting period | 4 years | ||
Expiration period | 10 years | ||
Warrants Cashless Exercise [Member] | |||
Shares issued for exercise of warrants, net (in shares) | 4,762,208 | 232,197 | |
Warrants exercised | 6,590,000 | 310,000 | |
Warrants [Member] | |||
Recognized weighted-average period | 2 months 12 days | ||
Shares issued for exercise of warrants, net | $ 366,000 | ||
Shares issued for exercise of warrants, net (in shares) | 945,485 | ||
Warrants exercised | 9,066,666 | 1,255,485 | |
Warrants [Member] | Individuals [Member] | |||
Shares issued for exercise of warrants, net | $ 3,798,999 | $ 1,373,000 | |
Shares issued for exercise of warrants, net (in shares) | 2,476,666 | 722,744 |
INCOME TAXES (Details)
INCOME TAXES (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Income before taxes | $ (76,925,380) | $ (89,875,459) | $ (85,077,024) |
United States [Member] | |||
Income before taxes | $ (76,925,380) | $ (89,875,459) | $ (85,077,024) |
INCOME TAXES (Details 1)
INCOME TAXES (Details 1) | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Income Tax Disclosure [Abstract] | |||
Federal statutory tax rate | 34.00% | 34.00% | 34.00% |
State tax rate, net of federal tax benefit | 5.00% | 5.40% | 4.73% |
Adjustment in valuation allowances | 22.60% | (40.30%) | (38.97%) |
Federal income tax rate change | (60.80%) | ||
Permanent and other differences | (0.80%) | 0.90% | 0.24% |
Provision (benefit) for income taxes |
INCOME TAXES (Details 2)
INCOME TAXES (Details 2) - USD ($) | Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 |
Deferred Income Tax Assets: | |||
Net operating losses | $ 99,596,321 | $ 111,730,450 | $ 79,499,633 |
R&D Credit | 186,347 | 186,347 | 186,347 |
Total deferred income tax asset | 99,782,668 | 111,916,797 | 79,685,980 |
Valuation allowance | (99,782,668) | (111,916,797) | (79,685,980) |
Deferred income tax assets, net |
INCOME TAXES (Details Narrative
INCOME TAXES (Details Narrative) - USD ($) | 12 Months Ended | |||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
U.S. statutory federal rate | 34.00% | 34.00% | 34.00% | |
Change in valuation allowance | $ 46,700,000 | |||
Deferred Tax Assets [Member] | ||||
Change in valuation allowance | 49,500,000 | |||
Deferred Tax Liabilities [Member] | ||||
Change in valuation allowance | (2,800,000) | |||
Subsequent Fiscal Years [Member] | ||||
U.S. statutory federal rate | 21.00% | |||
Federal [Member] | ||||
Net operating loss carryforwards | $ 338,613,987 |
RELATED PARTIES (Details Narrat
RELATED PARTIES (Details Narrative) - Catalent Inc.[Member] - USD ($) | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Related Party Transaction [Line Items] | |||
Manufacturing activities billed from related party | $ 3,646,000 | $ 3,647,000 | $ 1,266,000 |
Payable - related party | $ 523,000 | $ 57,000 |
BUSINESS CONCENTRATIONS (Detail
BUSINESS CONCENTRATIONS (Details Narrative) - USD ($) | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2017 | Sep. 30, 2017 | Jun. 30, 2017 | Mar. 31, 2017 | Dec. 31, 2016 | Sep. 30, 2016 | Jun. 30, 2016 | Mar. 31, 2016 | Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Concentration Risk [Line Items] | |||||||||||
Revenues | $ 4,125,000 | $ 4,418,000 | $ 4,250,000 | $ 3,985,000 | $ 4,487,000 | $ 5,536,000 | $ 4,403,000 | $ 4,930,000 | $ 16,777,713 | $ 19,356,450 | $ 20,142,898 |
Supplier Concentration Risk [Member] | |||||||||||
Concentration Risk [Line Items] | |||||||||||
Concentration Risk | 100.00% | 98.00% | 60.00% | ||||||||
Customer Concentration Risk [Member] | Sales Revenue [Member] | AmerisourceBergen [Member] | |||||||||||
Concentration Risk [Line Items] | |||||||||||
Revenues | $ 2,667,000 | ||||||||||
Customer Concentration Risk [Member] | Sales Revenue [Member] | McKesson Corporation [Member] | |||||||||||
Concentration Risk [Line Items] | |||||||||||
Revenues | 1,959,000 | ||||||||||
Customer Concentration Risk [Member] | Sales Revenue [Member] | Cardinal Health [Member] | |||||||||||
Concentration Risk [Line Items] | |||||||||||
Revenues | 2,559,000 | ||||||||||
Customer Concentration Risk [Member] | Sales Revenue [Member] | Pharmacy Innovations PA [Member] | |||||||||||
Concentration Risk [Line Items] | |||||||||||
Revenues | $ 2,715,000 | $ 2,040,000 | |||||||||
Customer Concentration Risk [Member] | Sales Revenue [Member] | Woodstock Pharmaceutical and Compounding [Member] | |||||||||||
Concentration Risk [Line Items] | |||||||||||
Revenues | 2,247,000 | $ 8,848,000 | |||||||||
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] | Due West Pharmacy [Member] | |||||||||||
Concentration Risk [Line Items] | |||||||||||
Revenues | $ 4,843,000 | ||||||||||
Customer Concentration Risk [Member] | Sales Revenue [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 | 59.00% | ||||||||||
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] | Two Customers [Member] | |||||||||||
Concentration Risk [Line Items] | |||||||||||
Concentration Risk | 67.00% |
COMMITMENTS AND CONTINGENCIES55
COMMITMENTS AND CONTINGENCIES (Details) | Dec. 31, 2017USD ($) |
Future minimum rental payments, year ending December 31, | |
2,018 | $ 951,194 |
2,019 | 1,094,116 |
2,020 | 1,113,069 |
2,021 | 943,127 |
Total minimum lease payments | $ 4,101,506 |
COMMITMENTS AND CONTINGENCIES56
COMMITMENTS AND CONTINGENCIES (Details Narrative) - USD ($) | May 01, 2016 | Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 |
Commitments and Contingencies Disclosure [Abstract] | ||||
Non-cancelable operating lease term | 63 months | |||
Rental expense | $ 1,029,205 | $ 709,843 | $ 446,099 | |
Expiration date | Oct. 31, 2021 |
SELECTED QUARTERLY FINANCIAL 57
SELECTED QUARTERLY FINANCIAL DATA (Details) - USD ($) | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2017 | Sep. 30, 2017 | Jun. 30, 2017 | Mar. 31, 2017 | Dec. 31, 2016 | Sep. 30, 2016 | Jun. 30, 2016 | Mar. 31, 2016 | Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Quarterly Financial Information Disclosure [Abstract] | |||||||||||
Revenues | $ 4,125,000 | $ 4,418,000 | $ 4,250,000 | $ 3,985,000 | $ 4,487,000 | $ 5,536,000 | $ 4,403,000 | $ 4,930,000 | $ 16,777,713 | $ 19,356,450 | $ 20,142,898 |
Gross profit | 3,530,000 | 3,717,000 | 3,568,000 | 3,326,000 | 3,778,000 | 4,298,000 | 3,273,000 | 3,822,000 | 14,140,770 | 15,170,742 | 15,636,225 |
Net loss | $ (21,427,000) | $ (14,665,000) | $ (19,677,000) | $ (21,156,000) | $ (22,836,000) | $ (25,016,000) | $ (21,094,000) | $ (20,929,000) | $ (76,925,380) | $ (89,875,459) | $ (85,077,024) |
Loss per common share, basic and diluted (in dollars per shares) | $ (.10) | $ (.07) | $ (.10) | $ (0.11) | $ (0.12) | $ (0.13) | $ (0.11) | $ (0.11) | $ (0.37) | $ (0.46) | $ (0.49) |