Document and Entity Information
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Jun. 30, 2015
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Aug. 03, 2015
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Document And Entity Information | ||
Entity Registrant Name | TherapeuticsMD, Inc. | |
Entity Central Index Key | 0000025743 | |
Document Type | 10-Q | |
Document Period End Date | Jun. 30, 2015 | |
Amendment Flag | false | |
Current Fiscal Year End Date | --12-31 | |
Entity a Well-known Seasoned Issuer | No | |
Entity a Voluntary Filer | No | |
Entity's Reporting Status Current | Yes | |
Entity Filer Category | Accelerated Filer | |
Entity Common Stock, Shares Outstanding | 177,500,730 | |
Document Fiscal Period Focus | Q2 | |
Document Fiscal Year Focus | 2015 |
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CONSOLIDATED BALANCE SHEETS (Unaudited) (Parenthetical) (USD $)
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Jun. 30, 2015
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Dec. 31, 2014
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Statement of Financial Position [Abstract] | ||
Allowance for doubtful accounts | $ 90,520 | $ 59,753 |
Preferred stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized | 10,000,000 | 10,000,000 |
Preferred stock, shares issued | 0 | 0 |
Preferred stock, shares outstanding | 0 | 0 |
Common stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 350,000,000 | 250,000,000 |
Common stock, shares issued | 173,037,653 | 156,097,019 |
Common stock, shares outstanding | 173,037,653 | 156,097,019 |
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CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited) (USD $)
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3 Months Ended | 6 Months Ended | ||
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Jun. 30, 2015
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Jun. 30, 2014
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Jun. 30, 2015
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Jun. 30, 2014
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Income Statement [Abstract] | ||||
Revenues, net | $ 4,847,934 | $ 3,751,778 | $ 9,322,983 | $ 6,582,311 |
Cost of goods sold | 1,033,089 | 892,956 | 2,076,730 | 1,723,663 |
Gross profit | 3,814,845 | 2,858,822 | 7,246,253 | 4,858,648 |
Operating expenses: | ||||
Sales, general, and administrative | 6,865,442 | 5,537,164 | 13,029,054 | 10,566,661 |
Research and development | 24,190,714 | 8,234,641 | 42,367,549 | 14,142,719 |
Depreciation and amortization | 14,280 | 14,094 | 27,852 | 27,162 |
Total operating expense | 31,070,436 | 13,785,899 | 55,424,455 | 24,736,542 |
Operating loss | (27,255,591) | (10,927,077) | (48,178,202) | (19,877,894) |
Other income and (expense) | ||||
Miscellaneous income | 25,585 | 18,579 | 44,098 | 37,151 |
Interest income | 2,560 | 9,238 | 12,402 | 18,392 |
Financing costs | (260,027) | |||
Total other income (expense) | 28,145 | 27,817 | 56,500 | (204,484) |
Loss before taxes | (27,227,446) | (10,899,260) | (48,121,702) | (20,082,378) |
Net loss | $ (27,227,446) | $ (10,899,260) | $ (48,121,702) | $ (20,082,378) |
Net loss per share, basic and diluted | $ (0.16) | $ (0.07) | $ (0.29) | $ (0.14) |
Weighted average number of common shares outstanding | 172,782,264 | 145,485,505 | 168,734,760 | 145,253,818 |
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THE COMPANY
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Jun. 30, 2015
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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 two wholly owned subsidiaries, vitaMedMD, LLC, a Delaware limited liability company, or VitaMed, and BocaGreenMD, Inc., a Nevada corporation, or BocaGreen. Unless the context otherwise requires, TherapeuticsMD, VitaMed, and BocaGreen collectively are sometimes referred to as our company, we, our, or us.
Nature of Business
We are a womens health care product company focused on creating and commercializing products targeted exclusively for women. As of the date of these consolidated financial statements, we are focused on conducting the clinical trials necessary for regulatory approval and commercialization of our advanced hormone therapy pharmaceutical products. The drug candidates used in our clinical trials are designed to alleviate the symptoms of and reduce the health risks resulting from menopause-related hormone deficiencies, including hot flashes, osteoporosis, and vaginal discomfort. We are developing these hormone therapy drug candidates, which contain estradiol and progesterone alone or in combination, with the aim of demonstrating equivalent clinical efficacy at lower doses, thereby enabling an enhanced side effect profile compared with competing products. Our drug candidates are created from a platform of hormone technology that enables the administration of hormones with high bioavailability alone or in combination. In addition, we manufacture and distribute branded and generic prescription prenatal vitamins, as well as over-the-counter, or OTC, vitamins. |
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BASIS OF PRESENTATION AND RECENTLY ISSUED ACCOUNTING PRONOUNCEMENTS
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Jun. 30, 2015
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Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
BASIS OF PRESENTATION AND RECENTLY ISSUED ACCOUNTING PRONOUNCEMENTS | NOTE 2 BASIS OF PRESENTATION AND RECENTLY ISSUED ACCOUNTING PRONOUNCEMENTS
Interim Financial Statements
The accompanying unaudited interim consolidated financial statements of TherapeuticsMD, Inc., which include our wholly owned subsidiaries, should be read in conjunction with the audited consolidated financial statements and notes thereto included in our Annual Report on Form 10-K for the year ended December 31, 2014, as filed with the Securities and Exchange Commission, or the SEC, from which we derived our balance sheet as of December 31, 2014. The accompanying unaudited interim consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America, or GAAP, for interim financial information and with the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, since they are interim statements, the accompanying unaudited interim consolidated financial statements do not include all of the information and notes required by GAAP for complete financial statements. The accompanying unaudited interim consolidated financial statements reflect all adjustments, consisting of normal recurring adjustments, that are, in the opinion of our management, necessary to a fair statement of the results for the interim periods presented. Interim results are not necessarily indicative of results for a full year.
Recently Issued Accounting Pronouncements
In June 2015, the Financial Accounting Standards Board, or FASB, issued Accounting Standards Update, or ASU, No. 2015-10, Technical Corrections and Improvements, to correct differences between original guidance and the Accounting Standards Codification, or ASC, clarify the guidance, correct references and make minor improvements affecting a variety of topics. Amendments that FASB deemed more substantive are effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2015. The other amendments are effective immediately. We do not expect the adoption of ASU 2015-10 to have a material effect on our consolidated financial statements and disclosures.
In August 2014, the FASB issued ASU No. 2014-15, Presentation of Financial Statements-Going Concern (Subtopic 205-40): Disclosure of Uncertainties about an Entitys Ability to Continue as a Going Concern. ASU 2014-15 requires management to evaluate whether there are conditions and events that raise substantial doubt about the entitys ability to continue as a going concern within one year after the financial statements are issued (or available to be issued when applicable) and, if so, disclose that fact. ASU 2014-15 is effective for annual periods ending after December 15, 2016 and interim periods within annual periods beginning after December 15, 2016. Early adoption is permitted for annual or interim reporting periods for which the financial statements have not previously been issued. We do not expect the adoption of ASU 2014-15 to have a material effect on our consolidated financial statements and disclosures.
In May 2014, the FASB and the International Accounting Standards Board (IASB) issued ASU No. 2014-09, Revenue from Contracts with Customers (Topic 606). The standards core principle is that a company will recognize revenue when it transfers promised goods or services to customers in an amount that reflects the consideration to which the company expects to be entitled in exchange for those goods or services. In doing so, companies will need to use more judgment and make more estimates than under previous guidance. These may include identifying performance obligations in the contract, estimating the amount of variable consideration to include in the transaction price and allocating the transaction price to each separate performance obligations. On July 9, 2015, FASB approved the proposal to defer the effective date of ASU 2014-09 standard by one year. Early adoption is permitted as of December 15, 2016, and the standard is effective for public entities for annual reporting periods beginning after December 15, 2017 and interim periods therein. We are currently evaluating the impact of ASU 2014-09 on our consolidated financial statements and disclosures.
We do not believe there would have been a material effect on the accompanying consolidated financial statements had any other recently issued, but not yet effective, accounting standards been adopted in the current period. |
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SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
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Jun. 30, 2015
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Accounting Policies [Abstract] | |||||||||||||||||||||||||||||||
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | NOTE 3 SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Impairment of Long-Lived Assets
We review the carrying values of property and equipment and long-lived intangible assets for impairment whenever events or changes in circumstances indicate that their carrying values may not be recoverable. Such events or circumstances include the following:
If impairment indicators are present, we determine whether an impairment loss should be recognized by testing the applicable asset or asset groups carrying value for recoverability. This test requires long-lived assets to be grouped at the lowest level for which identifiable cash flows are largely independent of the cash flows of other assets and liabilities, the determination of which requires judgment. We estimate the undiscounted future cash flows expected to be generated from the use and eventual disposal of the assets and compare that estimate to the respective carrying values in order to determine if such carrying values are recoverable. This assessment requires the exercise of judgment in assessing the future use of and projected value to be derived from the eventual disposal of the assets to be held and used. In our assessments, we also consider changes in asset utilization, including 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 intangibles or long-lived assets during the three and six months ended June 30, 2015 and 2014.
Fair Value of Financial Instruments
Our financial instruments consist primarily of accounts receivable, accounts payable and accrued expenses. The carrying amount of accounts receivable, accounts payable and accrued expenses approximates their fair value because of the short-term maturity of such instruments.
We categorize our assets and liabilities that are valued at fair value on a recurring basis into a three-level fair value hierarchy as defined by ASC 820, Fair Value Measurements. The fair value hierarchy gives the highest priority to quoted prices in active markets for identical assets and liabilities (Level 1) and lowest priority to unobservable inputs (Level 3). Assets and liabilities recorded in the consolidated balance sheet at fair value are categorized based on a hierarchy of inputs, as follows:
At June 30, 2015 and December 31, 2014, we had no assets or liabilities that were valued at fair value on a recurring basis.
The fair value of indefinite-lived assets or long-lived assets is measured on a non-recurring basis using significant unobservable inputs (Level 3) in connection with our impairment test. There was no impairment of intangible assets or long-lived assets during the three and six months ended June 30, 2015 and 2014.
Revenue Recognition
We recognize revenue on arrangements in accordance with ASC 605, Revenue Recognition. We recognize revenue only when the price is fixed or determinable, persuasive evidence of an arrangement exists, the service is performed, and collectability is reasonably assured.
Our OTC and prescription prenatal vitamin products are generally variations of the same product with slight modifications in formulation and marketing. The primary difference between our OTC and prescription prenatal vitamin products is the source of payment. Purchasers of our OTC prenatal vitamin products pay for the product directly while purchasers of our prescription prenatal vitamin products pay for the product via third-party payers. Both OTC and prescription prenatal vitamin products share the same marketing support team utilizing similar marketing techniques.
Over-the-Counter Products
We generate OTC revenue from product sales primarily to retail consumers. We recognize revenue from product sales upon shipment, when the rights of ownership and risk of loss have passed to the consumer. We include outbound shipping and handling fees in sales and bill them upon shipment. We include shipping expenses in cost of sales. A majority of our customers pay for our products with credit cards, and we usually receive the cash settlement in two to three banking days. Credit card sales minimize accounts receivable balances relative to sales. We provide an unconditional 30-day money-back return policy under which we accept product returns from our retail and eCommerce customers. We recognize our revenue from OTC sales, net of returns, sales discounts, and eCommerce fees.
Prescription Products
We sell our name brand and generic prescription products primarily through drug wholesalers and retail pharmacies. We recognize revenue from prescription product sales, net of sales discounts, chargebacks, and rebates.
We accept returns of unsalable product from customers within a return period of six months prior to and up to 12 months following product expiration. Our prescription products currently have a shelf life of 24 months from the date of manufacture. As of January 1, 2015, we started estimating returns based on historical return rates and record actual product returns against this reserve as received.
We maintain various rebate programs in an effort to maintain a competitive position in the marketplace and to promote sales and customer loyalty. The consumer rebate program is designed to enable the end user to return a coupon to us. If the coupon qualifies, we send a rebate check to the end user. We estimate the allowance for consumer rebates based on our experience and industry averages, which is reviewed, and adjusted if necessary, on a quarterly basis.
Research and Development Expenses
Research and development, or R&D, expenses include internal R&D activities, services of external contract research organizations, or CROs, costs of their clinical research sites, and other activities. Internal R&D activity expenses include laboratory supplies, salaries, benefits, and non-cash share-based compensation expenses. Advance payments to be expensed in future research and development activities were $679,700 and $1,175,082, at June 30, 2015 and December 31, 2014, respectively. CRO activity expenses include preclinical laboratory experiments and clinical trial studies. Other activity expenses include regulatory consulting and legal counsel. The activities undertaken by our regulatory consultants that were classified as research and development expenses include assisting, consulting with, and advising our in-house staff with respect to various FDA submission processes, clinical trial processes, and scientific writing matters, including preparing protocols and FDA submissions. Legal activities that were classified as research and development expenses related to designing experiments to generate data for patents and to further the formulation development process for our pipeline technologies. Outside legal counsel also provided professional research regarding the legal landscape of potential patents. These consulting and legal expenses were direct costs associated with preparing, reviewing, and undertaking work for our clinical trials and investigative drugs. We charge internal R&D activities and other activity expenses to operations as incurred. We make payments to CROs based on agreed-upon terms, which may include payments in advance of a study starting date. We expense nonrefundable advance payments for goods and services that will be used in future R&D activities when the activity has been performed or when the goods have been received rather than when the payment is made. We review and accrue CRO expenses and clinical trial study expenses based on services performed and rely on estimates of those costs applicable to the completion stage of a study as provided by CROs. As of June 30, 2015, we classified $967,286 of the accrued clinical study costs as long term Accrued Expense related to the costs that will be paid at the completion of one of our clinical trials. Accrued CRO costs are subject to revisions as such studies progress to completion. We charge revisions expense in the period in which the facts that give rise to the revision become known.
Segment Reporting
We are managed and operated as one business, which is focused on creating and commercializing products targeted exclusively for women. Our business operations are managed by a single management team that reports to the President of our Company. We do not operate separate lines of business with respect to any of our products and we do not prepare discrete financial information with respect to separate products. All product sales are derived from sales in the United States. Accordingly, we view our business as one reportable operating segment. |
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INVENTORY
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INVENTORY | NOTE 4 INVENTORY
Inventory consists of the following:
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OTHER CURRENT ASSETS
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OTHER CURRENT ASSETS | NOTE 5 OTHER CURRENT ASSETS
Other current assets consist of the following:
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FIXED ASSETS
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FIXED ASSETS | NOTE 6 FIXED ASSETS
Fixed assets consist of the following:
Depreciation expense for the three months ended June 30, 2015 and 2014 was $7,367 and $8,469, respectively, and $14,248 and $15,591 for the six months ended June 30, 2015 and 2014, respectively.
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PREPAID EXPENSE
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PREPAID EXPENSE | NOTE 7 PREPAID EXPENSE
Prepaid expense consists of the following:
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Disclosure of prepaid expenses. No definition available.
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INTANGIBLE ASSETS
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INTANGIBLE ASSETS | NOTE 8 INTANGIBLE ASSETS
The following table sets forth the gross carrying amount and accumulated amortization of our intangible assets as of June 30, 2015 and December 31, 2014:
We amortize the intangible asset related to development costs for corporate website over 36 months, which is the prescribed life for software and website development costs. We amortize the intangible asset related to OPERA® using the straight-line method over the estimated remaining useful life of approximately 15 years, which is the life of the intellectual property patents. We amortize the approved hormone therapy drug candidate patents using straight-line method over the estimated remaining useful life of approximately 18 years. During the three and six months ended June 30, 2015 and 2014, there was no impairment recognized.
In addition to numerous pending patent applications, as of June 30, 2015, we had 11 issued patents, including:
Amortization expense was $6,913 and $5,625 for the three months ended June 30, 2015 and 2014, respectively and $13,604 and $11,570 for the six months ended June 30, 2015 and 2014, respectively. Estimated amortization expense for the next five years is as follows:
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OTHER CURRENT LIABILITIES
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Other Liabilities Disclosure [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
OTHER CURRENT LIABILITIES | NOTE 9 OTHER CURRENT LIABILITIES
Other current liabilities consist of the following:
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NET LOSS PER SHARE
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NET LOSS PER SHARE | NOTE 10 NET LOSS PER SHARE
We calculate basic and diluted net loss per share allocable to common stockholders using the weighted-average number of shares of common stock, par value $0.001 per share, or Common Stock outstanding during the period, less any shares subject to repurchase or forfeiture. There were no shares of our Common Stock outstanding subject to repurchase or forfeiture for the three and six months ended June 30, 2015 and 2014.
Since we are in a net loss position, we have excluded outstanding stock options, all of which are subject to forfeiture, as well as warrants for the purchase of our Common Stock from our calculation of diluted net loss per share.
The table below presents the potentially dilutive securities that would have been included in our calculation of diluted net loss per share allocable to common stockholders if they were not antidilutive for the periods presented.
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STOCKHOLDERS' EQUITY
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STOCKHOLDERS' EQUITY | NOTE 11 STOCKHOLDERS EQUITY
Preferred Stock
At June 30, 2015, we had 10,000,000 shares of Preferred Stock, par value $0.001, authorized for issuance, of which no shares of Preferred Stock were issued or outstanding.
Common Stock
At June 30, 2015, we had 350,000,000 shares of Common Stock authorized, of which 173,037,653 shares of Common Stock were issued and outstanding.
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 $59,100,000, after deducting underwriting discounts and commissions and other estimated offering expenses payable by us. The offering closed on February 17, 2015.
Exercises During 2015
During the three months ended June 30, 2015, certain individuals exercised stock options to purchase 366,617 shares of Common Stock for $484,143 in cash. During the six months ended June 30, 2015, certain individuals exercised stock options to purchase 377,867 shares of Common Stock for $491,351 in cash.
Exercises During 2014
During the six months ended June 30, 2014, certain individuals exercised stock options to purchase 728,844 shares of Common Stock. Stock options to purchase shares of our Common Stock were exercised as follows: (i) 615,007 options for $287,288 in cash and (ii) 119,607 options, pursuant to the stock options cashless provision, wherein 113,837 shares of Common Stock were issued. Also, during the six months ended June 30, 2014, we granted 50,000 shares of Common Stock to an employee upon the vesting of restricted stock units that were granted in December 2013.
Warrants to Purchase Common Stock
As of June 30, 2015, we had warrants outstanding to purchase an aggregate of 13,032,431 shares of Common Stock with a weighted-average contractual remaining life of 2.2 years, and exercise prices ranging from $0.24 to $6.35 per share, resulting in a weighted average exercise price of $1.94 per share.
The valuation methodology used to determine the fair value of our warrants is the Black-Scholes-Merton valuation model, or the Black-Scholes Model. The Black-Scholes Model requires the use of a number of assumptions, including volatility of the stock price, the risk-free interest rate and the term of the warrant.
In January 2013, we granted warrants to purchase 1,250,000 shares of Common Stock in connection with the issuance of a Revolving Credit Note to Plato and Associates, LLC, or the Plato Warrant. The Plato Warrant has an exercise price of $3.20 per share. The Plato Warrant vested on October 31, 2013 and may be exercised prior to its expiration on January 31, 2019. The Plato Warrant, with a fair value of $1,711,956, was valued on the date of the grant using a term of six years; a volatility of 44.29%; risk free rate of 0.88%; and a dividend yield of 0%. For the six months ended June 30, 2015 and 2014, $0 and $260,027, respectively, was recorded as financing costs in connection with the issuance of the Plato Warrant on the accompanying consolidated financial statements.
In May 2013, we entered into a consulting agreement with Sancilio & Company, Inc., or SCI, to develop drug technology to be used in our hormone replacement drug candidates. These services include support of our efforts to successfully obtain U.S. Food and Drug Administration, or the FDA, approval for our drug candidates, including a vaginal capsule for the treatment of vulvar and vaginal atrophy, or VVA. In connection with the agreement, SCI agreed to forfeit its rights to receive warrants to purchase 833,000 shares of Common Stock that were to be granted pursuant to the terms of a prior consulting agreement dated May 17, 2012. As consideration under the agreement, we agreed to grant to SCI a warrant to purchase 850,000 shares of Common Stock at $2.01 per share that has vested or will vest, as applicable, as follows:
As of June 30, 2015, unamortized costs associated with the SCI warrants issued in 2013 and 2012 totaled approximately $670,000.
During the three and six months ended June 30, 2015, we granted warrants to purchase 50,000 shares of Common Stock at an exercise price of $6.35 to an outside consultant.
Warrant exercises
During the three months ended June 30, 2015, certain individuals exercised warrants to purchase 20,000 shares of our Common Stock for $7,600 in cash and during the six months ended June 30, 2015, certain individuals exercised warrants to purchase 945,485 shares of our Common Stock for $366,000 in cash. During the three and six months ended June 30, 2014, certain individuals exercised warrants to purchase 171,372 shares of Common Stock for $87,000 in cash.
Options to Purchase Common Stock
In 2009, we adopted the 2009 Long Term Incentive Compensation Plan, or the 2009 Plan, to provide financial incentives to employees, directors, advisers, and consultants of our company who are able to contribute towards the creation of or who have created stockholder value by providing them stock options and other stock and cash incentives, or the Awards. The Awards available under the 2009 Plan consist of stock options, stock appreciation rights, restricted stock, restricted stock units, performance stock, performance units, and other stock or cash awards as described in the 2009 Plan. There are 25,000,000 shares authorized for issuance thereunder. During the six months ended June 30, 2015, we granted 1,231,000 non-qualified stock options under 2009 Plan. As of June 30, 2015, there were non-qualified stock options to purchase 15,556,726 shares of Common Stock outstanding under the 2009 Plan.
In 2012, we adopted the 2012 Stock Incentive Plan, or the 2012 Plan, a non-qualified plan that was amended in August 2013. The 2012 Plan was designed to serve as an incentive for retaining qualified and competent key employees, officers, directors, and certain consultants and advisors of our company. There are 10,000,000 shares of Common Stock authorized for issuance thereunder. As of June 30, 2015, there were non-qualified stock options to purchase 1,968,474 shares of Common Stock outstanding under the 2012 Plan.
The valuation methodology used to determine the fair value of stock options is the Black-Scholes Model. The Black-Scholes Model requires the use of a number of assumptions including volatility of the stock price, the risk-free interest rate, and the expected life of the stock options. The assumptions used in the Black-Scholes Model during the six months ended June 30, 2015 and 2014 are set forth in the table below.
The risk-free interest rate assumption is based upon observed interest rates on zero coupon U.S. Treasury bonds whose maturity period is appropriate for the expected term. Estimated volatility is a measure of the amount by which the price of our Common Stock is expected to fluctuate each year during the term of an award. Our estimated volatility is an average of the historical volatility of the stock prices of our peer entities whose stock prices were publicly available. Our calculation of estimated volatility is based on historical stock prices over a period equal to the term of the awards. We used the historical volatility of our peer entities due to the lack of sufficient historical data on our stock price. The average expected life is based on the contractual terms of the stock option using the simplified method.
A summary of activity under the 2009 and 2012 Plans and related information follows:
At June 30, 2015, our outstanding stock options had exercise prices ranging from $0.10 to $7.72 per share.
Share-based compensation expense for options recognized in our results of operations (based on vested awards) for the three and six months ended June 30, 2015 were $1,973,675 and $2,702,102, respectively, and $1,288,086 and $2,294,111, respectively, for the same periods in 2014. ASC 718-10 requires forfeitures to be estimated at the time of grant and revised in subsequent periods if actual forfeitures differ from the estimates. At June 30, 2015, total unrecognized estimated compensation expense related to unvested options granted prior to that date was approximately $7,110,000 which may be adjusted for future changes in forfeitures. This cost is expected to be recognized over a weighted-average period of 2.3 years. No tax benefit was realized due to a continued pattern of operating losses. |
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INCOME TAXES
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Income Tax Disclosure [Abstract] | |
INCOME TAXES | NOTE 12 INCOME TAXES
Deferred income tax assets and liabilities are determined based upon differences between the financial reporting and tax basis of assets and liabilities and are measured using the enacted tax rates and laws that will be in effect when the differences are expected to reverse. We do not expect to pay any significant federal or state income tax for 2015 as a result of (i) the losses recorded during the six months ended June 30, 2015, (ii) additional losses expected for the remainder of 2015, and/or (iii) net operating loss carry forwards from prior years. Accounting standards require the consideration of a valuation allowance for deferred tax assets if it is more likely than not that some component or all of the benefits of deferred tax assets will not be realized. As of June 30, 2015, we maintain a full valuation allowance for all deferred tax assets. Based on these requirements, no provision or benefit for income taxes has been recorded. There were no recorded unrecognized tax benefits at the end of the reporting period. |
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RELATED PARTIES
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Related Party Transactions [Abstract] | |
RELATED PARTIES | NOTE 13 RELATED PARTIES
On February 29, 2012, Cooper C. Collins, who was then president and largest shareholder of Pernix Therapeutics, LLC, or Pernix, was elected to serve on our board of directors. From time to time, we have entered into agreements with Pernix in the normal course of business. All such agreements are reviewed by independent directors of our company or a committee consisting of independent directors of our company. During the six months ended June 30, 2015 and 2014, we did not engage in any transactions with Pernix. At June 30, 2015 and December 31, 2014, there were amounts due Pernix of approximately $46,000.
Additionally, there were amounts due to us from Pernix for legal fee reimbursement relating to a litigation matter stemming from a license and supply agreement in the amounts of approximately $250,000 at both June 30, 2015 and December 31, 2014. |
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BUSINESS CONCENTRATIONS
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Risks and Uncertainties [Abstract] | |
BUSINESS CONCENTRATIONS | NOTE 14 - BUSINESS CONCENTRATIONS
We purchase our products from several suppliers with approximately 98% and 71% of our purchases supplied from one vendor for the six months ended June 30, 2015 and 2014, respectively.
We sell our prescription prenatal vitamin products to wholesale distributors, specialty pharmacies, specialty distributors, and chain drug stores that generally sell products to retail pharmacies, hospitals, and other institutional customers. Revenue generated from four major customers accounted for approximately 91% and 97% of our recognized revenue for the six months ended June 30, 2015 and 2014, respectively.
Customers that generated more than 10% of our sales are designated as customers A, B, C and D. During the six months ended June 30, 2015, two customers generated more than 10% of revenues and during the six months ended June 30, 2014, four customers generated more than 10% of revenues. During the six months ended June 30, 2015, customer A generated approximately $4,474,000 in revenues and customer B generated approximately $1,832,000 in revenues. During the six months ended June 30, 2014, customers A, B, C and D generated approximately $2,465,000, $1,227,000, $1,089,000 and $1,053,000 in sales, respectively. |
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COMMITMENTS AND CONTINGENCIES
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COMMITMENTS AND CONTINGENCIES | NOTE 15 COMMITMENTS AND CONTINGENCIES
We lease administrative office space in Boca Raton, Florida pursuant to a 63 month non-cancelable operating lease that commenced on July 1, 2013 and expires on September 30, 2018. On February 18, 2015, we entered into an agreement to lease additional administrative office space in Boca Raton, Florida, pursuant to an addendum to such lease. This addendum is effective beginning April 1, 2015 and will expire with the original lease term on September 30, 2018.
The straight line rental expense related to our current lease totaled approximately $119,000 and $90,000 for the three months ended June 30, 2015 and 2014, respectively, and approximately $209,000 and $181,000 for the six months ended June 30, 2015 and 2014, respectively. The 2014 amounts were partially offset by the rent income of approximately $18,000 and $36,000, respectively, for sublet space. We did not sublet any space during the six months ended June 30, 2015.
As of June 30, 2015, future minimum rental payments are as follows:
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SUBSEQUENT EVENTS
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Subsequent Events [Abstract] | |
SUBSEQUENT EVENTS | NOTE 16 SUBSEQUENT EVENTS
On July 9, 2015, we entered into an underwriting agreement with Stifel, Nicolaus & Company, Incorporated and Guggenheim Securities, LLC, as the representatives of the several underwriters, or the Stifel Underwriters, relating to an underwritten public offering of 3,846,154 shares of Common Stock at a public offering price of $7.80 per share. Under the terms of the underwriting agreement, we granted the Stifel Underwriters a 30-day option to purchase up to an aggregate of 576,923 additional shares of Common Stock, which option was exercised in full. The net proceeds to us from the offering were approximately $32.2 million, after deducting underwriting discounts and commissions and other estimated offering expenses payable by us. The offering closed on July 15, 2015 and we issued 4,423,077 shares of our Common Stock.
Subsequent to June 30, 2015, we received our first patent application allowance related to our phase 3 drug candidate for the treatment of VVA.
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SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies)
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Impairment of Long-Lived Assets | Impairment of Long-Lived Assets
We review the carrying values of property and equipment and long-lived intangible assets for impairment whenever events or changes in circumstances indicate that their carrying values may not be recoverable. Such events or circumstances include the following:
If impairment indicators are present, we determine whether an impairment loss should be recognized by testing the applicable asset or asset groups carrying value for recoverability. This test requires long-lived assets to be grouped at the lowest level for which identifiable cash flows are largely independent of the cash flows of other assets and liabilities, the determination of which requires judgment. We estimate the undiscounted future cash flows expected to be generated from the use and eventual disposal of the assets and compare that estimate to the respective carrying values in order to determine if such carrying values are recoverable. This assessment requires the exercise of judgment in assessing the future use of and projected value to be derived from the eventual disposal of the assets to be held and used. In our assessments, we also consider changes in asset utilization, including 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 intangibles or long-lived assets during the three and six months ended June 30, 2015 and 2014. |
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Fair Value of Financial Instruments | Fair Value of Financial Instruments
Our financial instruments consist primarily of accounts receivable, accounts payable and accrued expenses. The carrying amount of accounts receivable, accounts payable and accrued expenses approximates their fair value because of the short-term maturity of such instruments.
We categorize our assets and liabilities that are valued at fair value on a recurring basis into a three-level fair value hierarchy as defined by ASC 820, Fair Value Measurements. The fair value hierarchy gives the highest priority to quoted prices in active markets for identical assets and liabilities (Level 1) and lowest priority to unobservable inputs (Level 3). Assets and liabilities recorded in the consolidated balance sheet at fair value are categorized based on a hierarchy of inputs, as follows:
At June 30, 2015 and December 31, 2014, we had no assets or liabilities that were valued at fair value on a recurring basis.
The fair value of indefinite-lived assets or long-lived assets is measured on a non-recurring basis using significant unobservable inputs (Level 3) in connection with our impairment test. There was no impairment of intangible assets or long-lived assets during the three and six months ended June 30, 2015 and 2014. |
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Revenue Recognition | Revenue Recognition
We recognize revenue on arrangements in accordance with ASC 605, Revenue Recognition. We recognize revenue only when the price is fixed or determinable, persuasive evidence of an arrangement exists, the service is performed, and collectability is reasonably assured.
Our OTC and prescription prenatal vitamin products are generally variations of the same product with slight modifications in formulation and marketing. The primary difference between our OTC and prescription prenatal vitamin products is the source of payment. Purchasers of our OTC prenatal vitamin products pay for the product directly while purchasers of our prescription prenatal vitamin products pay for the product via third-party payers. Both OTC and prescription prenatal vitamin products share the same marketing support team utilizing similar marketing techniques.
Over-the-Counter Products
We generate OTC revenue from product sales primarily to retail consumers. We recognize revenue from product sales upon shipment, when the rights of ownership and risk of loss have passed to the consumer. We include outbound shipping and handling fees in sales and bill them upon shipment. We include shipping expenses in cost of sales. A majority of our customers pay for our products with credit cards, and we usually receive the cash settlement in two to three banking days. Credit card sales minimize accounts receivable balances relative to sales. We provide an unconditional 30-day money-back return policy under which we accept product returns from our retail and eCommerce customers. We recognize our revenue from OTC sales, net of returns, sales discounts, and eCommerce fees.
Prescription Products
We sell our name brand and generic prescription products primarily through drug wholesalers and retail pharmacies. We recognize revenue from prescription product sales, net of sales discounts, chargebacks, and rebates.
We accept returns of unsalable product from customers within a return period of six months prior to and up to 12 months following product expiration. Our prescription products currently have a shelf life of 24 months from the date of manufacture. As of January 1, 2015, we started estimating returns based on historical return rates and record actual product returns against this reserve as received.
We maintain various rebate programs in an effort to maintain a competitive position in the marketplace and to promote sales and customer loyalty. The consumer rebate program is designed to enable the end user to return a coupon to us. If the coupon qualifies, we send a rebate check to the end user. We estimate the allowance for consumer rebates based on our experience and industry averages, which is reviewed, and adjusted if necessary, on a quarterly basis.
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Research and Development Expenses | Research and Development Expenses
Research and development, or R&D, expenses include internal R&D activities, services of external contract research organizations, or CROs, costs of their clinical research sites, and other activities. Internal R&D activity expenses include laboratory supplies, salaries, benefits, and non-cash share-based compensation expenses. Advance payments to be expensed in future research and development activities were $679,700 and $1,175,082, at June 30, 2015 and December 31, 2014, respectively. CRO activity expenses include preclinical laboratory experiments and clinical trial studies. Other activity expenses include regulatory consulting and legal counsel. The activities undertaken by our regulatory consultants that were classified as research and development expenses include assisting, consulting with, and advising our in-house staff with respect to various FDA submission processes, clinical trial processes, and scientific writing matters, including preparing protocols and FDA submissions. Legal activities that were classified as research and development expenses related to designing experiments to generate data for patents and to further the formulation development process for our pipeline technologies. Outside legal counsel also provided professional research regarding the legal landscape of potential patents. These consulting and legal expenses were direct costs associated with preparing, reviewing, and undertaking work for our clinical trials and investigative drugs. We charge internal R&D activities and other activity expenses to operations as incurred. We make payments to CROs based on agreed-upon terms, which may include payments in advance of a study starting date. We expense nonrefundable advance payments for goods and services that will be used in future R&D activities when the activity has been performed or when the goods have been received rather than when the payment is made. We review and accrue CRO expenses and clinical trial study expenses based on services performed and rely on estimates of those costs applicable to the completion stage of a study as provided by CROs. As of June 30, 2015, we classified $967,286 of the accrued clinical study costs as long term Accrued Expense related to the costs that will be paid at the completion of one of our clinical trials. 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. |
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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. |
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INVENTORY (Tables)
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Jun. 30, 2015
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Inventory Disclosure [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Inventory | Inventory consists of the following:
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No authoritative reference available. No definition available.
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OTHER CURRENT ASSETS (Tables)
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6 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Jun. 30, 2015
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Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of other current assets | Other current assets consist of the following:
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No authoritative reference available. No definition available.
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FIXED ASSETS (Tables)
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6 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Jun. 30, 2015
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Property, Plant and Equipment [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of fixed assets | Fixed assets consist of the following:
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No authoritative reference available. No definition available.
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PREPAID EXPENSE (Tables)
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Jun. 30, 2015
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Prepaid Expense and Other Assets [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||
Schedule of prepaid expense | Prepaid expense consists of the following:
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No authoritative reference available. No definition available.
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INTANGIBLE ASSETS (Tables)
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6 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Jun. 30, 2015
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Goodwill and Intangible Assets Disclosure [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of intangible assets | The following table sets forth the gross carrying amount and accumulated amortization of our intangible assets as of June 30, 2015 and December 31, 2014:
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Schedule of estimated amortization expense | Estimated amortization expense for the next five years is as follows:
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- Definition
No authoritative reference available. No definition available.
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- Definition
No authoritative reference available. No definition available.
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OTHER CURRENT LIABILITIES (Tables)
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6 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Jun. 30, 2015
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Other Liabilities Disclosure [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of other current liabilities | Other current liabilities consist of the following:
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- Definition
No authoritative reference available. No definition available.
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- Details
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NET LOSS PER SHARE (Tables)
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Jun. 30, 2015
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Net Loss Per Share Tables | ||||||||||||||||||||||||||||||||||||||||||||||
Schedule of potentially dilutive securities | The table below presents the potentially dilutive securities that would have been included in our calculation of diluted net loss per share allocable to common stockholders if they were not antidilutive for the periods presented.
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- Definition
No authoritative reference available. No definition available.
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STOCKHOLDERS' EQUITY (Tables)
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6 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Jun. 30, 2015
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Stockholders' Equity Note [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of assumptions used in the Black-Scholes Model of stock options | The assumptions used in the Black-Scholes Model during the six months ended June 30, 2015 and 2014 are set forth in the table below.
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Schedule of option activity | A summary of activity under the 2009 and 2012 Plans and related information follows:
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- Definition
No authoritative reference available. No definition available.
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X | ||||||||||
- Definition
No authoritative reference available. No definition available.
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COMMITMENTS AND CONTINGENCIES (Tables)
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Jun. 30, 2015
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Commitments And Contingencies Tables | ||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of future minimum rental payments | As of June 30, 2015, future minimum rental payments are as follows:
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- Details
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X | ||||||||||
- Definition
No authoritative reference available. No definition available.
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SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details Narrative) (USD $)
|
Jun. 30, 2015
|
Dec. 31, 2014
|
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Accounting Policies [Abstract] | ||
Advance payments for future research and development activities | $ 679,700 | $ 1,175,082 |
Accrued Expense-LT | $ 967,286 |
X | ||||||||||
- Definition
Carrying amount of advance payments made for future research and development activiites to be expensed. No definition available.
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X | ||||||||||
- Details
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X | ||||||||||
- Definition
No authoritative reference available. No definition available.
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INVENTORY (Details) (USD $)
|
Jun. 30, 2015
|
Dec. 31, 2014
|
---|---|---|
Inventory | ||
Finished product | $ 1,094,169 | $ 874,294 |
Raw material | 154,550 | 155,341 |
Deferred costs | 152,478 | |
TOTAL INVENTORY | $ 1,248,719 | $ 1,182,113 |
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
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X | ||||||||||
- Definition
No authoritative reference available. No definition available.
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X | ||||||||||
- Definition
No authoritative reference available. No definition available.
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X | ||||||||||
- Details
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X | ||||||||||
- Definition
No authoritative reference available. No definition available.
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OTHER CURRENT ASSETS (Details) (USD $)
|
Jun. 30, 2015
|
Dec. 31, 2014
|
---|---|---|
Other Current Assets | ||
Prepaid consulting | $ 411,856 | $ 411,864 |
Other receivables-related party (Note 13) | 249,981 | 249,981 |
Prepaid insurance | 246,823 | 394,878 |
Prepaid vendor deposits | 100,566 | |
Prepaid research and development costs | 10,048 | 299,498 |
Other prepaid costs | 134,939 | 181,186 |
TOTAL OTHER CURRENT ASSETS | $ 1,154,213 | $ 1,537,407 |
X | ||||||||||
- Details
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X | ||||||||||
- Definition
Carrying amount as of the balance sheet date of unamortized costs of consulting contracts, which will be charged against earnings ratably over the period in which contractually agreed upon services will be provided; such periods expire within one year or the normal operating cycle, if longer. Current portion. No definition available.
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X | ||||||||||
- Definition
Carrying amount as of the balance sheet date of unamortized costs of research and development contracts, which will be charged against earnings ratably over the period in which contractually agreed upon services will be provided; such periods expire within one year or the normal operating cycle, if longer. Current portion. No definition available.
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X | ||||||||||
- Definition
It represents as a prepaid vendor deposits. No definition available.
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X | ||||||||||
- Definition
No authoritative reference available. No definition available.
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X | ||||||||||
- Definition
No authoritative reference available. No definition available.
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X | ||||||||||
- Definition
No authoritative reference available. No definition available.
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X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
FIXED ASSETS (Details Narrative) (USD $)
|
3 Months Ended | 6 Months Ended | ||
---|---|---|---|---|
Jun. 30, 2015
|
Jun. 30, 2014
|
Jun. 30, 2015
|
Jun. 30, 2014
|
|
Property, Plant and Equipment [Abstract] | ||||
Depreciation Expense | $ 7,367 | $ 8,469 | $ 14,248 | $ 15,591 |
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
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X | ||||||||||
- Details
|
FIXED ASSETS (Details) (USD $)
|
Jun. 30, 2015
|
Dec. 31, 2014
|
---|---|---|
Fixed assets, gross | $ 201,604 | $ 186,045 |
Accumulated depreciation | (137,000) | (122,752) |
TOTAL FIXED ASSETS | 64,604 | 63,293 |
Equipment [Member]
|
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Fixed assets, gross | 132,150 | 132,150 |
Furniture and Fixtures [Member]
|
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Fixed assets, gross | $ 69,454 | $ 53,895 |
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
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X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
PREPAID EXPENSE (Details) (USD $)
|
Jun. 30, 2015
|
Dec. 31, 2014
|
---|---|---|
Other Assets | ||
Prepaid manufacturing costs | $ 899,000 | $ 899,000 |
Prepaid research and development costs | 257,796 | 463,720 |
Accreted prepaid costs | 76,944 | 64,543 |
TOTAL PREPAID EXPENSE | $ 1,233,740 | $ 1,427,263 |
X | ||||||||||
- Definition
Carrying amount as of the balance sheet date of unamortized costs of accredited contracts, which will be charged against earnings ratably over the period in which contractually agreed upon services will be provided; such periods expire within one year or the normal operating cycle, if longer. Noncurrent portion. No definition available.
|
X | ||||||||||
- Definition
Carrying amount as of the balance sheet date of unamortized costs of manufacturing contracts, which will be charged against earnings ratably over the period in which contractually agreed upon services will be provided; such periods expire within one year or the normal operating cycle, if longer. Noncurrent portion. No definition available.
|
X | ||||||||||
- Definition
Carrying amount as of the balance sheet date of unamortized costs of research and development contracts, which will be charged against earnings ratably over the period in which contractually agreed upon services will be provided; non-current portion. No definition available.
|
X | ||||||||||
- Details
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X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
INTANGIBLE ASSETS (Details Narrative) (USD $)
|
3 Months Ended | 6 Months Ended | ||
---|---|---|---|---|
Jun. 30, 2015
|
Jun. 30, 2014
|
Jun. 30, 2015
|
Jun. 30, 2014
|
|
Amortization expense | $ 6,913 | $ 5,625 | $ 13,604 | $ 11,570 |
Number of patents | 11 | 11 | ||
Development costs for corporate website [Member]
|
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Amortization period | 36 months | |||
OPERA software patent [Member]
|
||||
Amortization period | 15 years | |||
Approved Hormone Therapy Drug Candidate Patents [Member]
|
||||
Amortization period | 18 years |
X | ||||||||||
- Definition
Number of patents outstanding No definition available.
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
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X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
INTANGIBLE ASSETS (Details ) (USD $)
|
6 Months Ended | 12 Months Ended |
---|---|---|
Jun. 30, 2015
|
Dec. 31, 2014
|
|
Finite-Lived Intangible Assets | ||
Accumulated Amortization | $ (127,244) | $ (113,640) |
Indefinite-Lived Intangible Assets | ||
Gross Carrying Amount | 1,421,020 | 1,342,228 |
Net Amount | 1,293,776 | 1,228,588 |
Hormone therapy drug candidate patents - Pending [Member]
|
||
Indefinite-Lived Intangible Assets | ||
Gross Carrying Amount | 678,213 | 675,982 |
Net Amount | 678,213 | 675,982 |
Multiple trademarks for vitamins/supplements [Member]
|
||
Indefinite-Lived Intangible Assets | ||
Gross Carrying Amount | 135,152 | 103,368 |
Net Amount | 135,152 | 103,368 |
OPERA software patent [Member]
|
||
Finite-Lived Intangible Assets | ||
Gross Carrying Amount | 31,951 | 31,951 |
Accumulated Amortization | (3,495) | (2,496) |
Net Amount | 28,956 | 29,455 |
Weighted Average Amortization Period | 14 years 2 months 30 days | 14 years 9 months |
Development costs for corporate website [Member]
|
||
Finite-Lived Intangible Assets | ||
Gross Carrying Amount | 91,743 | 91,743 |
Accumulated Amortization | (91,743) | (91,743) |
Net Amount | ||
Approved Hormone Therapy Drug Candidate Patents [Member]
|
||
Finite-Lived Intangible Assets | ||
Gross Carrying Amount | 483,961 | 439,184 |
Accumulated Amortization | (32,006) | (19,401) |
Net Amount | $ 451,955 | $ 419,783 |
Weighted Average Amortization Period | 18 years | |
Non-Amortizing Intangible Assets [Member]
|
||
Finite-Lived Intangible Assets | ||
Weighted Average Amortization Period | 17 years 6 months |
X | ||||||||||
- Definition
Net amount of assets, excluding financial assets and goodwill, lacking physical substance and having a projected indefinite period of benefit. No definition available.
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
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X | ||||||||||
- Definition
No authoritative reference available. No definition available.
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X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
X | ||||||||||
- Details
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
X | ||||||||||
- Details
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
INTANGIBLE ASSETS (Details 1) (USD $)
|
Jun. 30, 2015
|
---|---|
Estimated amortization expense for the year: | |
2015 (6 months) | $ 13,553 |
2016 | 27,106 |
2017 | 27,106 |
2018 | 27,106 |
2019 | $ 27,106 |
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
X | ||||||||||
- Details
|
OTHER CURRENT LIABILITIES (Details) (USD $)
|
Jun. 30, 2015
|
Dec. 31, 2014
|
||||
---|---|---|---|---|---|---|
Other Liabilities Disclosure [Abstract] | ||||||
Accrued clinical trial costs | $ 3,053,838 | $ 1,706,542 | ||||
Accrued payroll, bonuses and commission costs | 1,118,157 | 814,205 | ||||
Accrued vacation costs | 470,123 | 442,430 | ||||
Accrued legal and accounting expense | 526,335 | 276,470 | ||||
Other accrued expenses | 280,364 | [1] | 185,965 | [1] | ||
Allowance for wholesale distributor fees | 122,568 | 160,503 | ||||
Accrued royalties | 48,645 | 72,710 | ||||
Allowance for coupons and returns | 177,296 | 90,446 | ||||
Accrued rent | 90,576 | 91,368 | ||||
TOTAL OTHER CURRENT LIABILITIES | $ 5,887,902 | $ 3,840,639 | ||||
|
X | ||||||||||
- Definition
Carrying value as of the balance sheet date of the obligations incurred through that date and payable for clinical trial costs. Used to reflect the current portion of the liabilities (due within one year or within the normal operating cycle if longer). No definition available.
|
X | ||||||||||
- Definition
Carrying value as of the balance sheet date of the obligations incurred through that date and payable for wholesale distributor fees. Used to reflect the current portion of the liabilities (due within one year or within the normal operating cycle if longer). No definition available.
|
X | ||||||||||
- Definition
Aggregate allowance consisting of: (i) sales discounts given by the entity, including, but not limited to, early payments of accounts due, (ii) the total deduction from sales during the period arising from goods returned by customers (other than under warranty provisions), and (iii) price reductions (allowance, price protection agreements) given by the entity. Discounts, returns and allowances are a deduction from gross revenue in arriving at net revenue. No definition available.
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
X | ||||||||||
- Details
|
NET LOSS PER SHARE (Details)
|
6 Months Ended | |
---|---|---|
Jun. 30, 2015
|
Jun. 30, 2014
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Anti-dilutive shares excluded from earnings per share calculation | 30,557,631 | 30,645,255 |
Stock Option [Member]
|
||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Anti-dilutive shares excluded from earnings per share calculation | 17,525,200 | 16,523,128 |
Warrants [Member]
|
||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Anti-dilutive shares excluded from earnings per share calculation | 13,032,431 | 14,122,127 |
Restricted Stock Units [Member]
|
||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Anti-dilutive shares excluded from earnings per share calculation |
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
X | ||||||||||
- Details
|
STOCKHOLDERS' EQUITY (Details Narrative) (USD $)
|
3 Months Ended | 6 Months Ended | 6 Months Ended | 0 Months Ended | |||
---|---|---|---|---|---|---|---|
Jun. 30, 2015
|
Jun. 30, 2015
|
Jun. 30, 2014
|
Dec. 31, 2014
|
Jun. 30, 2015
Options exercised 1 [Member]
|
Jun. 30, 2015
Options exercised 2 [Member]
|
Feb. 10, 2015
Cowen and Company, LLC (Underwriters) [Member]
|
|
Preferred stock, shares authorized | 10,000,000 | 10,000,000 | 10,000,000 | ||||
Preferred stock, par value (in dollars per share) | $ 0.001 | $ 0.001 | $ 0.001 | ||||
Common stock, shares authorized | 350,000,000 | 350,000,000 | 250,000,000 | ||||
Common stock, shares issued | 173,037,653 | 173,037,653 | 156,097,019 | 113,837 | |||
Common stock, shares outstanding | 173,037,653 | 173,037,653 | 156,097,019 | ||||
Number of shares issued during the period | 13,580,246 | ||||||
Share price (in dollars per share) | $ 4.05 | ||||||
Number of shares issued during the period,value | $ 59,100,000 | ||||||
Number of common stock issued during period for stock options exercised | 366,617 | 377,867 | 728,844 | 615,007 | 119,607 | 2,037,036 | |
Value of common stock issued during period for stock options exercised | $ 484,143 | $ 491,351 | $ 287,288 | ||||
Share based compensation options grants in period | 1,231,000 | 50,000 |
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
STOCKHOLDERS' EQUITY (Details Narrative 1) (USD $)
|
6 Months Ended | 1 Months Ended | 6 Months Ended | 0 Months Ended | 3 Months Ended | 6 Months Ended | 1 Months Ended | 6 Months Ended | ||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Jun. 30, 2015
|
Dec. 31, 2014
|
May 31, 2013
Sancilio and Company Warrants [Member]
|
Jun. 30, 2015
Sancilio and Company Warrants [Member]
|
Jun. 30, 2013
Sancilio & Company Warrants 1st Installments [Member]
|
May 11, 2013
Sancilio & Company Warrants 1st Installments [Member]
|
Jun. 30, 2013
Sancilio and Company Warrants 2nd Installments [Member]
|
Jun. 30, 2015
Sancilio and Company Warrants 2nd Installments [Member]
|
Jun. 30, 2014
Sancilio and Company Warrants 2nd Installments [Member]
|
Jun. 30, 2015
Sancilio and Company Warrants 2nd Installments [Member]
|
Jun. 30, 2014
Sancilio and Company Warrants 2nd Installments [Member]
|
Jun. 30, 2015
Sancilio and Company Warrants 3rd Installments [Member]
|
Jan. 31, 2013
Multiple Advance Revolving Credit Note (Plato Warrant) [Member]
|
Jun. 30, 2015
Multiple Advance Revolving Credit Note (Plato Warrant) [Member]
|
Jun. 30, 2014
Multiple Advance Revolving Credit Note (Plato Warrant) [Member]
|
Jun. 30, 2015
Minimum [Member]
|
Jun. 30, 2015
Maximum [Member]
|
Jun. 30, 2015
Weighted Average [Member]
|
|
Warrants: | ||||||||||||||||||
Warrants outstanding | $ 13,002,431 | |||||||||||||||||
Weighted-average contractual remaining life | 2 years 2 months 12 days | |||||||||||||||||
Exercise price of warrants (in dollars per share) | $ 2.01 | $ 6.35 | $ 3.20 | $ 0.24 | $ 6.35 | $ 1.94 | ||||||||||||
Unamortized costs of warrants | 670,000 | |||||||||||||||||
Number of shares purchased | 50,000 | 850,000 | 283,333 | 283,333 | 283,334 | 1,250,000 | ||||||||||||
Expiration date of warrants | Jan. 31, 2019 | |||||||||||||||||
Vesting date of warrants | Jun. 30, 2013 | Oct. 31, 2013 | ||||||||||||||||
Fair value of warrants | 405,066 | 462,196 | 1,711,956 | |||||||||||||||
Expected term | 5 years | 5 years | 6 years | |||||||||||||||
Volatility rate | 45.89% | 45.84% | 44.29% | |||||||||||||||
Risk free rate | 1.12% | 1.41% | 0.88% | |||||||||||||||
Dividend yield | 0.00% | 0.00% | 0.00% | |||||||||||||||
Amortization deferred financing costs | 0 | 260,027 | ||||||||||||||||
Number of shares purchased forfeit | 833,000 | |||||||||||||||||
Valuation method of warrants | Black-Scholes Model | |||||||||||||||||
Non-cash compensation recongised | 405,066 | 38,517 | 38,517 | 77,034 | 77,034 | |||||||||||||
Prepaid expense-short term | 154,068 | 154,068 | ||||||||||||||||
Prepaid expense-long term | $ 1,233,740 | $ 1,427,263 |
X | ||||||||||
- Definition
Refers to non cash compensation expenses of warrants. No definition available.
|
X | ||||||||||
- Definition
Date the warrants or rights are expired in CCYY-MM-DD format. No definition available.
|
X | ||||||||||
- Definition
Refers to fair value of warrants or rights. No definition available.
|
X | ||||||||||
- Definition
Refer to numbers of shares forfeit during the period. No definition available.
|
X | ||||||||||
- Definition
Refers to valuation method of warrants or rights. No definition available.
|
X | ||||||||||
- Definition
Date the warrants or rights are vesting in CCYY-MM-DD format. No definition available.
|
X | ||||||||||
- Definition
Refers to unamortized costs associated with warrants. No definition available.
|
X | ||||||||||
- Details
|
X | ||||||||||
- Definition
This item provides the weighted-average contractual remaining life of warrants. No definition available.
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
STOCKHOLDERS' EQUITY (Details Narrative 2) (USD $)
|
3 Months Ended | 6 Months Ended | |||
---|---|---|---|---|---|
Jun. 30, 2015
|
Jun. 30, 2014
|
Jun. 30, 2015
|
Jun. 30, 2014
|
Dec. 31, 2014
|
|
Option exercise prices (in dollars per shares) | $ 2.20 | $ 2.20 | $ 1.88 | ||
Share-based compensation expense | $ 1,973,675 | $ 1,288,086 | $ 2,702,102 | $ 2,294,111 | |
Total unrecognized estimated compensation expense | 7,110,000 | 7,110,000 | |||
Recognized weighted-average period | 2 years 3 months 19 days | ||||
Options granted | 1,231,000 | 50,000 | |||
Stock issued for excercised warrants, shares | 20,000 | 171,372 | 945,485 | 171,372 | |
Stock issued for excercised warrants, value | $ 7,600 | $ 87,000 | $ 366,000 | $ 87,000 | |
Minimum [Member]
|
|||||
Option exercise prices (in dollars per shares) | $ 0.10 | $ 0.10 | |||
Maximum [Member]
|
|||||
Option exercise prices (in dollars per shares) | $ 7.72 | $ 7.72 | |||
2009 Long Term Incentive Compensation Plan [Member]
|
|||||
Description of plan | To provide financial incentives to employees, directors, advisers, and consultants of our company who are able to contribute towards the creation of or who have created shareholder value by providing them stock options and other stock and cash incentives, or the Awards. | ||||
Number of shares authorized for issuance | 25,000,000 | ||||
Number of shares issued | 15,556,726 | ||||
Options granted | 1,231,000 | ||||
2012 Stock Incentive Plan [Member]
|
|||||
Description of plan | Plan was designed to serve as an incentive for retaining qualified and competent key employees, officers, directors, and certain consultants and advisors of our company. | ||||
Number of shares authorized for issuance | 10,000,000 | ||||
Number of shares issued | 1,968,474 |
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
STOCKHOLDERS' EQUITY (Details) (Stock Options [Member])
|
6 Months Ended | |
---|---|---|
Jun. 30, 2015
|
Jun. 30, 2014
|
|
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Expected dividend yield | 0.00% | 0.00% |
Minimum [Member]
|
||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Risk-free interest rate | 1.47% | 1.70% |
Expected Volatility | 58.77% | 69.15% |
Expected term | 5 years 3 months 8 days | 5 years |
Maximum [Member]
|
||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Risk-free interest rate | 1.54% | 1.77% |
Expected Volatility | 62.94% | 70.93% |
Expected term | 6 years 2 months 30 days | 5 years 2 months 30 days |
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
X | ||||||||||
- Details
|
STOCKHOLDERS' EQUITY (Details 1) (USD $)
|
3 Months Ended | 6 Months Ended | |
---|---|---|---|
Jun. 30, 2015
|
Jun. 30, 2015
|
Jun. 30, 2014
|
|
Number Options | |||
Options outstanding, beginning | 16,792,443 | ||
Options Granted | 1,231,000 | 50,000 | |
Options Exercised | (366,617) | (377,867) | (728,844) |
Options Cancelled | (120,376) | ||
Options outstanding, ending | 17,525,200 | 17,525,200 | |
Vested and exercisable | 13,746,672 | 13,746,672 | |
Weighted Average Exercise Price | |||
Options outstanding, beginning | $ 1.88 | ||
Granted | $ 6.38 | ||
Exercised | $ 1.30 | ||
Cancelled | $ 2.87 | ||
Options outstanding, ending | $ 2.20 | $ 2.20 | |
Vested and exercisable | $ 1.56 | $ 1.56 | |
Weighted Average Remaining Contractual Life | |||
Options outstanding, beginning | 6 years 11 months 1 day | ||
Options outstanding, ending | 6 years 4 months 6 days | ||
Vested and exercisable | 5 years 8 months 16 days | ||
Aggregate Intrinsic Value | |||
Options outstanding, beginning | $ 43,996,311 | ||
Options outstanding, ending | 99,168,915 | 99,168,915 | |
Vested and exercisable | $ 86,604,012 | $ 86,604,012 |
X | ||||||||||
- Details
|
X | ||||||||||
- Details
|
X | ||||||||||
- Definition
Refers to share based compensation arrangement by share based payment award options outstanding weighted average remaining contractual terms. No definition available.
|
X | ||||||||||
- Definition
Refers to share based compensation arrangement by share based payment award options outstanding weighted average remaining contractual terms. No definition available.
|
X | ||||||||||
- Details
|
X | ||||||||||
- Details
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
RELATED PARTIES (Details Narrative) (Pernix Therapeutics LLC [Member], USD $)
|
Jun. 30, 2015
|
Dec. 31, 2014
|
---|---|---|
Pernix Therapeutics LLC [Member]
|
||
Receivables- legal fee reimbursement | $ 250,000 | $ 250,000 |
Payable - related party | $ 46,000 | $ 46,000 |
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
BUSINESS CONCENTRATIONS (Details Narrative) (USD $)
|
3 Months Ended | 6 Months Ended | ||
---|---|---|---|---|
Jun. 30, 2015
|
Jun. 30, 2014
|
Jun. 30, 2015
|
Jun. 30, 2014
|
|
Concentration Risk [Line Items] | ||||
Revenues | $ 4,847,934 | $ 3,751,778 | $ 9,322,983 | $ 6,582,311 |
Customer Concentration Risk [Member]
|
||||
Concentration Risk [Line Items] | ||||
Concentration Risk | 98.00% | 71.00% | ||
Customer Concentration Risk [Member] | Sales Revenue [Member]
|
||||
Concentration Risk [Line Items] | ||||
Concentration Risk | 10.00% | 10.00% | ||
Deferred revenue [Member]
|
||||
Concentration Risk [Line Items] | ||||
Concentration Risk | 91.00% | 97.00% | ||
Customer A [Member] | Sales Revenue [Member]
|
||||
Concentration Risk [Line Items] | ||||
Revenues | 4,474,000 | 2,456,000 | ||
Customer B [Member] | Sales Revenue [Member]
|
||||
Concentration Risk [Line Items] | ||||
Revenues | 1,832,000 | 1,227,000 | ||
Customer C [Member] | Sales Revenue [Member]
|
||||
Concentration Risk [Line Items] | ||||
Revenues | 1,089,000 | |||
Customer D [Member] | Sales Revenue [Member]
|
||||
Concentration Risk [Line Items] | ||||
Revenues | $ 1,053,000 |
X | ||||||||||
- Details
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
COMMITMENTS AND CONTINGENCIES (Details Narrative) (USD $)
|
3 Months Ended | 6 Months Ended | ||
---|---|---|---|---|
Jun. 30, 2015
|
Jun. 30, 2014
|
Jun. 30, 2015
|
Jun. 30, 2014
|
|
Commitments and Contingencies Disclosure [Abstract] | ||||
Non-cancelable operating lease term | 63 months | |||
Rental Expense | $ 119,000 | $ 90,000 | $ 209,000 | $ 181,000 |
Rental income | $ 18,000 | $ 36,000 |
X | ||||||||||
- Definition
The total term (in months) of the company's outstanding lease obligation. No definition available.
|
X | ||||||||||
- Details
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
COMMITMENTS AND CONTINGENCIES (Details) (USD $)
|
Jun. 30, 2015
|
---|---|
Future minimum rental payments, year ending December 31, | |
2015 (6 months) | $ 243,396 |
2016 | 493,790 |
2017 | 507,087 |
2018 | 388,976 |
Minimum lease payments | $ 1,633,249 |
X | ||||||||||
- Details
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
SUBSEQUENT EVENTS (Details Narative) (USD $)
|
6 Months Ended | 0 Months Ended | ||
---|---|---|---|---|
Jun. 30, 2015
|
Jul. 15, 2015
Subsequent Event [Member]
|
Jul. 09, 2015
Subsequent Event [Member]
Over-Allotment Option [Member]
|
Jul. 09, 2015
Subsequent Event [Member]
Underwriiten Public Offering [Member]
|
|
Shares issued in underwritten public offering | $ 4,423,077 | $ 576,923 | $ 3,846,154 | |
Offering, price per share | $ 7.80 | |||
Proceeds from issuance of stock in public offering | $ 59,117,827 | $ 32,200,000 |
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|