Document_and_Entity_Informatio
Document and Entity Information | 9 Months Ended | |
Sep. 30, 2014 | Nov. 04, 2014 | |
Document And Entity Information | ' | ' |
Entity Registrant Name | 'TherapeuticsMD, Inc. | ' |
Entity Central Index Key | '0000025743 | ' |
Document Type | '10-Q | ' |
Document Period End Date | 30-Sep-14 | ' |
Amendment Flag | 'false | ' |
Current Fiscal Year End Date | '--12-31 | ' |
Is Entity a Well-known Seasoned Issuer? | 'No | ' |
Is Entity a Voluntary Filer? | 'No | ' |
Is Entity's Reporting Status Current? | 'Yes | ' |
Entity Filer Category | 'Accelerated Filer | ' |
Entity Common Stock, Shares Outstanding | ' | 156,030,476 |
Document Fiscal Period Focus | 'Q3 | ' |
Document Fiscal Year Focus | '2014 | ' |
CONDENSED_CONSOLIDATED_BALANCE
CONDENSED CONSOLIDATED BALANCE SHEETS (Unaudited) (USD $) | Sep. 30, 2014 | Dec. 31, 2013 |
Current Assets: | ' | ' |
Cash | $66,999,114 | $54,191,260 |
Accounts receivable, net of allowance for doubtful accounts of $29,149 and $26,555, respectively | 2,148,724 | 1,690,753 |
Inventory | 1,011,945 | 1,043,618 |
Other current assets | 2,020,118 | 2,477,715 |
Total current assets | 72,179,901 | 59,403,346 |
Fixed assets, net | 69,567 | 61,318 |
Other Assets: | ' | ' |
Prepaid expense | 1,392,264 | 1,750,455 |
Intangible assets | 841,741 | 665,588 |
Security deposit | 125,000 | 135,686 |
Total other assets | 2,359,005 | 2,551,729 |
Total assets | 74,608,473 | 62,016,393 |
Current Liabilities: | ' | ' |
Accounts payable | 5,648,679 | 2,114,217 |
Deferred revenue | 848,149 | 1,602,580 |
Other current liabilities | 4,511,079 | 3,601,189 |
Total current liabilities | 11,007,907 | 7,317,986 |
Commitments and Contingencies | ' | ' |
Stockholders' Equity: | ' | ' |
Preferred stock - par value $0.001; 10,000,000 shares authorized; no shares issued and outstanding | ' | ' |
Common stock - par value $0.001; 250,000,000 shares authorized; 156,030,476 and 144,976,757 issued and outstanding, respectively | 156,030 | 144,977 |
Additional paid in capital | 181,891,791 | 135,086,056 |
Accumulated deficit | -118,447,255 | -80,532,626 |
Total stockholders' equity | 63,600,566 | 54,698,407 |
Total liabilities and stockholders' equity | $74,608,473 | $62,016,393 |
CONDENSED_CONSOLIDATED_BALANCE1
CONDENSED CONSOLIDATED BALANCE SHEETS (Unaudited) (Parenthetical) (USD $) | Sep. 30, 2014 | Dec. 31, 2013 |
Statement of Financial Position [Abstract] | ' | ' |
Allowance for doubtful accounts | $29,149 | $26,555 |
Preferred stock, par value | $0.00 | $0.00 |
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 | $0.00 | $0.00 |
Common stock, shares authorized | 250,000,000 | 250,000,000 |
Common stock, shares issued | 156,030,476 | 144,976,757 |
Common stock, shares outstanding | 156,030,476 | 144,976,757 |
CONDENSED_CONSOLIDATED_STATEME
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited) (USD $) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2014 | Sep. 30, 2013 | Sep. 30, 2014 | Sep. 30, 2013 | |
Income Statement [Abstract] | ' | ' | ' | ' |
Revenues, net | $4,186,261 | $2,294,720 | $10,768,572 | $5,912,800 |
Cost of goods sold | 1,068,605 | 648,403 | 2,792,268 | 1,492,355 |
Gross profit | 3,117,656 | 1,646,317 | 7,976,304 | 4,420,445 |
Operating expenses: | ' | ' | ' | ' |
Sales, general, and administrative | 6,043,354 | 4,752,062 | 16,610,015 | 14,455,839 |
Research and development | 14,909,430 | 4,098,903 | 29,052,149 | 7,710,546 |
Depreciation and amortization | 12,747 | 32,356 | 39,909 | 50,949 |
Total operating expense | 20,965,531 | 8,883,321 | 45,702,073 | 22,217,334 |
Operating loss | -17,847,875 | -7,237,004 | -37,725,769 | -17,796,889 |
Other income and (expense) | ' | ' | ' | ' |
Miscellaneous income | 6,260 | 11,965 | 43,411 | 15,444 |
Interest income | 9,364 | ' | 27,756 | 18,133 |
Interest expense | ' | ' | ' | -1,165,981 |
Financing costs | ' | -447,969 | -260,027 | -1,107,937 |
Loan guaranty costs | ' | ' | ' | -2,944 |
Total other expense | 15,624 | -436,004 | -188,860 | -2,243,285 |
Loss before taxes | -17,832,251 | -7,673,008 | -37,914,629 | -20,040,174 |
Net loss | ($17,832,251) | ($7,673,008) | ($37,914,629) | ($20,040,174) |
Net loss per share, basic and diluted | ($0.12) | ($0.06) | ($0.26) | ($0.16) |
Weighted average number of shares outstanding | 152,200,455 | 131,212,706 | 147,594,810 | 121,701,292 |
CONDENSED_CONSOLIDATED_STATEME1
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (Unaudited) (USD $) | 9 Months Ended | |
Sep. 30, 2014 | Sep. 30, 2013 | |
CASH FLOWS FROM OPERATING ACTIVITIES | ' | ' |
Net loss | ($37,914,629) | ($20,040,174) |
Adjustments to reconcile net loss to net cash flows used in operating activities: | ' | ' |
Depreciation | 22,713 | 41,186 |
Amortization of intangible assets | 17,196 | 9,764 |
Provision for doubtful accounts | 2,594 | 48,355 |
Stock based compensation | 3,226,241 | 1,926,992 |
Stock based expense for services | 708,595 | 804,878 |
Amortization of deferred financing costs | 260,027 | 1,055,948 |
Amortization of debt discount | ' | 1,102,680 |
Loan guaranty costs | ' | 2,944 |
Changes in operating assets and liabilities: | ' | ' |
Accounts receivable | -460,565 | -1,235,433 |
Inventory | 31,673 | 467,624 |
Other current assets | 197,569 | -1,927,156 |
Other assets | -17,069 | -984,974 |
Accounts payable | 3,534,462 | 830,585 |
Deferred revenue | -754,431 | 707,520 |
Accrued expenses and other current liabilities | 909,890 | 1,190,178 |
Net cash flows used in operating activities | -30,235,734 | -15,999,083 |
CASH FLOWS FROM INVESTING ACTIVITIES | ' | ' |
Patent and trademark costs, net of abandoned costs | -193,349 | -257,633 |
Purchase of property and equipment | -30,962 | -23,755 |
Net cash flows used in investing activities | -224,311 | -281,388 |
CASH FLOWS FROM FINANCING ACTIVITIES | ' | ' |
Proceeds from sale of common stock, net | 42,771,353 | 78,984,960 |
Proceeds from exercise of options | 315,546 | 6,231 |
Proceeds from exercise of warrants | 181,000 | ' |
Proceeds from line of credit | ' | 500,000 |
Repayment of line of credit | ' | -500,000 |
Repayment of notes payable | ' | -4,691,847 |
Net cash flows provided by financing activities | 43,267,899 | 74,299,344 |
Increase in cash | 12,807,854 | 58,018,873 |
Cash, beginning of period | 54,191,260 | 1,553,474 |
Cash, end of period | 66,999,114 | 59,572,347 |
SUPPLEMENTAL DISCLOSURES OF CASH FLOW INFORMATION: | ' | ' |
Cash paid for interest | ' | 212,853 |
SUPPLEMENTAL SCHEDULE OF NON-CASH FINANCING ACTIVITIES: | ' | ' |
Warrants issued for financing | ' | 1,711,956 |
Warrants issued for services | ' | $462,196 |
THE_COMPANY
THE COMPANY | 9 Months Ended |
Sep. 30, 2014 | |
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 organized on May 13, 2008, or VitaMed, and BocaGreenMD, Inc., a Nevada corporation incorporated on January 10, 2012, 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 women’s health care product company focused on creating and commercializing products targeted exclusively for women. Currently, we are focused on conducting the clinical trials necessary for regulatory approval and commercialization of our advanced hormone therapy pharmaceutical products. The current drug candidates used in our clinical trials to alleviate the symptoms of and reduce the health risks resulting from menopause-related hormone deficiencies, including hot flashes, osteoporosis, and vaginal dryness. 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 a 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 and cosmetics. |
BASIS_OF_PRESENTATION_AND_RECE
BASIS OF PRESENTATION AND RECENTLY ISSUED ACCOUNTING PRONOUNCEMENTS | 9 Months Ended |
Sep. 30, 2014 | |
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 condensed 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, 2013, as filed with the Securities and Exchange Commission, or the SEC, from which we derived our balance sheet as of December 31, 2013. The accompanying financial statements have been prepared in accordance with U.S. generally accepted accounting principles, 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 financial statements do not include all of the information and notes required by GAAP for complete financial statements. The accompanying 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 and Newly Adopted Accounting Pronouncements | |
In August 2014, the Financial Accounting Standards Board, or FASB, issued Accounting Standards Update, or ASU, No. 2014-15, Presentation of Financial Statements-Going Concern (Subtopic 205-40): Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern. ASU 2014-15 requires management to evaluate whether there are conditions and events that raise substantial doubt about the entity’s ability to continue as a going concern within one year after the financial statements are issued (or available to be issued when applicable) and, if so, disclose that fact. ASU 2014-15 is effective for annual periods ending after December 15, 2016 and interim periods within annual periods beginning after December 15, 2016. Early adoption is permitted for annual or interim reporting periods for which the financial statements have not previously been issued. We do not expect the adoption of the ASU 2014-15 to have a material effect on our condensed consolidated financial statements and disclosures. | |
In May 2014, the FASB and the International Accounting Standards Board (IASB) issued ASU No. 2014-09, Revenue from Contracts with Customers (Topic 606). The standard’s core principle is that a company will recognize revenue when it transfers promised goods or services to customers in an amount that reflects the consideration to which the company expects to be entitled in exchange for those goods or services. In doing so, companies will need to use more judgment and make more estimates than under today’s 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. ASU 2014-09 is effective for public business entities, certain not-for-profit entities and certain employee benefit plans, for annual periods beginning after December 15, 2016, including interim periods within that period. Early adoption is not permitted under GAAP. We are currently evaluating the impact of ASU 2014-09 on our condensed consolidated financial statements and disclosures. | |
In July 2013, the FASB issued ASU 2013-11, Income Taxes (Topic 740): Presentation of an Unrecognized Tax Benefit when a Net Operating Loss Carryforward, a Similar Tax Loss, or a Tax Credit Carryforward Exists (a consensus of the FASB Emerging Issues Task Force), or ASU 2013-11. The amendments in ASU 2013-11 provide guidance on the financial statement presentation of an unrecognized tax benefit when a net operating loss carryforward, a similar tax loss, or a tax credit carryforward exists. An unrecognized tax benefit should be presented in the financial statements as a reduction to a deferred tax asset for a net operating loss carryforward, a similar tax loss, or a tax credit carryforward with certain exceptions, in which case such an unrecognized tax benefit should be presented in the financial statements as a liability. The amendments in ASU No. 2013-11 do not require new recurring disclosures. The amendments in ASU 2013-11 are effective for fiscal years, and interim periods within those years, beginning after December 15, 2013. The amendments in ASU No. 2013-11 did not have a material impact on our condensed consolidated financial statements. | |
In December 2011, the FASB issued ASU No. 2011-11, Balance Sheet (Topic 210): Disclosures about Offsetting Assets and Liabilities, or ASU 2011-11. ASU 2011-11 enhances current disclosures about financial instruments and derivative instruments that are either offset on the statement of financial position or subject to an enforceable master netting arrangement or similar agreement, irrespective of whether they are offset on the statement of financial position. Entities are required to provide both net and gross information for these assets and liabilities in order to facilitate comparability between financial statements prepared in conformity with GAAP and financial statements prepared on the basis of International Financial Reporting Standards. ASU 2011-11 is effective for annual reporting periods beginning on or after January 1, 2013, and interim periods within those years. ASU 2011-11 did not have a material impact on our financial position or results of operations. | |
We do not believe there would have been a material effect on the accompanying condensed consolidated financial statements had any other recently issued, but not yet effective, accounting standards been adopted in the current period. | |
Reclassifications | |
Certain 2013 amounts have been reclassified to conform to current year presentation. |
SUMMARY_OF_SIGNIFICANT_ACCOUNT
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | 9 Months Ended | ||
Sep. 30, 2014 | |||
Accounting Policies [Abstract] | ' | ||
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | ' | ||
NOTE 3 – SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | |||
There have been no material changes to our significant accounting policies as summarized in NOTE 2 of our Annual Report on Form 10-K for the year ended December 31, 2013. | |||
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: | |||
· | 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 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 or nine months ended September 30, 2014 and 2013. | |||
Fair Value of Financial Instruments | |||
Our financial instruments consist primarily of accounts receivable, accounts payable, accrued expenses, and short-term debt. The carrying amount of 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 Accounting Standards Codification, or ASC, 820, Fair Value Measurements. The fair value hierarchy gives the highest priority to quoted prices in active markets for identical assets and liabilities (Level 1) and lowest priority to unobservable inputs (Level 3). Assets and liabilities recorded in the consolidated balance sheet at fair value are categorized based on a hierarchy of inputs, as follows: | |||
Level 1 | unadjusted quoted prices in active markets for identical assets or liabilities; | ||
Level 2 | quoted prices for similar assets or liabilities in active markets or inputs that are observable for the asset or liability, either directly or indirectly through market corroboration, for substantially the full term of the financial instrument; and | ||
Level 3 | unobservable inputs for the asset or liability. | ||
At September 30, 2014 and December 31, 2013, we had no assets or liabilities that were valued at fair value on a recurring basis. | |||
INVENTORY
INVENTORY | 9 Months Ended | ||||||||
Sep. 30, 2014 | |||||||||
Inventory Disclosure [Abstract] | ' | ||||||||
INVENTORY | ' | ||||||||
NOTE 4 – INVENTORY | |||||||||
Inventory consists of the following: | |||||||||
September 30, | December 31, | ||||||||
2014 | 2013 | ||||||||
Finished product | $ | 670,276 | $ | 621,679 | |||||
Raw material | 178,426 | 250,943 | |||||||
Deferred costs | 163,243 | 170,996 | |||||||
TOTAL INVENTORY | $ | 1,011,945 | $ | 1,043,618 | |||||
OTHER_CURRENT_ASSETS
OTHER CURRENT ASSETS | 9 Months Ended | ||||||||
Sep. 30, 2014 | |||||||||
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] | ' | ||||||||
OTHER CURRENT ASSETS | ' | ||||||||
NOTE 5 – OTHER CURRENT ASSETS | |||||||||
Other current assets consist of the following: | |||||||||
September 30, | December 31, | ||||||||
2014 | 2013 | ||||||||
Prepaid consulting | $ | 514,596 | $ | 530,596 | |||||
Prepaid insurance | 503,064 | 145,722 | |||||||
Prepaid research and development costs | 457,458 | 1,267,588 | |||||||
Other receivables-related party (Note 14) | 249,981 | 249,981 | |||||||
Other prepaid costs | 195,019 | 23,806 | |||||||
Other current assets | 100,000 | — | |||||||
Deferred financing costs | — | 260,022 | |||||||
TOTAL OTHER CURRENT ASSETS | $ | 2,020,118 | $ | 2,477,715 | |||||
FIXED_ASSETS
FIXED ASSETS | 9 Months Ended | ||||||||
Sep. 30, 2014 | |||||||||
Property, Plant and Equipment [Abstract] | ' | ||||||||
FIXED ASSETS | ' | ||||||||
NOTE 6 – FIXED ASSETS | |||||||||
Fixed assets consist of the following: | |||||||||
September 30, | December 31, | ||||||||
2014 | 2013 | ||||||||
Equipment | $ | 132,150 | $ | 108,458 | |||||
Furniture and fixtures | 53,895 | 46,625 | |||||||
186,045 | 155,083 | ||||||||
Accumulated depreciation | (116,478 | ) | (93,765 | ) | |||||
TOTAL FIXED ASSETS | $ | 69,567 | $ | 61,318 | |||||
Depreciation expense for the three months ended September 30, 2014 and 2013 was $7,122 and $29,103, respectively. Depreciation expense for the nine months ended September 30, 2014 and 2013 was $22,713 and $41,186, respectively. |
PREPAID_EXPENSE
PREPAID EXPENSE | 9 Months Ended | ||||||||
Sep. 30, 2014 | |||||||||
Prepaid Expense and Other Assets [Abstract] | ' | ||||||||
PREPAID EXPENSE | ' | ||||||||
NOTE 7 – PREPAID EXPENSE | |||||||||
Prepaid expense consisted of the following: | |||||||||
September 30, | December 31, | ||||||||
2014 | 2013 | ||||||||
Prepaid manufacturing costs | $ | 899,000 | $ | 899,000 | |||||
Prepaid research and development costs | 438,274 | 824,221 | |||||||
Accreted prepaid costs | 54,990 | 27,234 | |||||||
TOTAL PREPAID EXPENSE | $ | 1,392,264 | $ | 1,750,455 | |||||
INTANGIBLE_ASSETS
INTANGIBLE ASSETS | 9 Months Ended | ||||||||||||||||
Sep. 30, 2014 | |||||||||||||||||
Goodwill and Intangible Assets Disclosure [Abstract] | ' | ||||||||||||||||
INTANGIBLE ASSETS | ' | ||||||||||||||||
NOTE 8 – INTANGIBLE ASSETS | |||||||||||||||||
The following table sets forth the gross carrying amount and accumulated amortization of our intangible assets as of September 30, 2014 and December 31, 2013: | |||||||||||||||||
30-Sep-14 | |||||||||||||||||
Gross | Accumulated | Net | Weighted- | ||||||||||||||
Carrying | Amortization | Amount | Average | ||||||||||||||
Amount | Remaining | ||||||||||||||||
Amortization | |||||||||||||||||
Period (yrs.) | |||||||||||||||||
Amortizing intangible assets: | |||||||||||||||||
OPERA® software patent | $ | 31,951 | $ | (1,997 | ) | $ | 29,954 | 15 | |||||||||
Development costs of | |||||||||||||||||
corporate website | 91,743 | (91,743 | ) | — | n/a | ||||||||||||
Approved hormone | |||||||||||||||||
therapy drug | |||||||||||||||||
candidate patents | 387,806 | (13,616 | ) | 374,190 | 18.25 | ||||||||||||
Non-amortizing intangible | |||||||||||||||||
assets: | |||||||||||||||||
Hormone therapy drug | |||||||||||||||||
candidate patents | 340,059 | — | 340,059 | n/a | |||||||||||||
(pending) | |||||||||||||||||
Multiple trademarks for | |||||||||||||||||
vitamins/supplements | 97,538 | — | 97,538 | n/a | |||||||||||||
Total | $ | 949,097 | $ | (107,356 | ) | $ | 841,741 | ||||||||||
31-Dec-13 | |||||||||||||||||
Gross | Accumulated | Net | Weighted- | ||||||||||||||
Carrying | Amortization | Amount | Average | ||||||||||||||
Amount | Remaining | ||||||||||||||||
Amortization | |||||||||||||||||
Period (yrs.) | |||||||||||||||||
Amortizing intangible assets: | |||||||||||||||||
OPERA® software patent | $ | 31,951 | $ | (499 | ) | $ | 31,452 | 15.8 | |||||||||
Development costs of | |||||||||||||||||
corporate website | 91,743 | (89,661 | ) | 2,082 | 0.3 | ||||||||||||
Non-amortizing intangible | |||||||||||||||||
assets: | |||||||||||||||||
Hormone therapy drug | |||||||||||||||||
candidate patents | 572,726 | — | 572,726 | n/a | |||||||||||||
(pending) | |||||||||||||||||
Multiple trademarks for | |||||||||||||||||
vitamins/supplements | 59,328 | — | 59,328 | n/a | |||||||||||||
Total | $ | 755,748 | $ | (90,160 | ) | $ | 665,588 | ||||||||||
We amortized 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 useful life of approximately 20 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 useful life of approximately 20 years. During the three and nine months ended September 30, 2014 and 2013, there was no impairment recognized. | |||||||||||||||||
Amortization expense was $5,625 and $3,255 for the three months ended September 30, 2014 and 2013, respectively and $17,196 and $9,764 for the nine months ended September 30, 2014 and 2013, respectively. Estimated amortization expense for the next five years is as follows: | |||||||||||||||||
Year Ending | Estimated | ||||||||||||||||
December 31, | Amortization | ||||||||||||||||
2014 (3 months) | $5,625 | ||||||||||||||||
2015 | $22,500 | ||||||||||||||||
2016 | $22,500 | ||||||||||||||||
2017 | $22,500 | ||||||||||||||||
2018 | $22,500 | ||||||||||||||||
OTHER_CURRENT_LIABILITIES
OTHER CURRENT LIABILITIES | 9 Months Ended | ||||||||
Sep. 30, 2014 | |||||||||
Other Liabilities Disclosure [Abstract] | ' | ||||||||
OTHER CURRENT LIABILITIES | ' | ||||||||
NOTE 9 – OTHER CURRENT LIABILITIES | |||||||||
Other current liabilities consist of the following: | |||||||||
September 30, | December 31, | ||||||||
2014 | 2013 | ||||||||
Accrued clinical trial costs | $ | 2,385,094 | $ | 665,782 | |||||
Accrued payroll and commission costs | 603,525 | 941,313 | |||||||
Accrued vacation costs | 434,614 | 256,920 | |||||||
Other accrued expenses(1) | 266,576 | 177,900 | |||||||
Allowance for wholesale distributor fees | 245,232 | 306,303 | |||||||
Accrued legal and accounting expense | 220,526 | 224,550 | |||||||
Accrued royalties | 164,707 | 52,188 | |||||||
Allowance for coupons and returns | 97,890 | 126,233 | |||||||
Accrued rent | 92,915 | — | |||||||
Accrued financing costs | — | 850,000 | |||||||
TOTAL OTHER CURRENT LIABILITIES | $ | 4,511,079 | $ | 3,601,189 | |||||
____________ | |||||||||
(1) In June 2008, we declared and paid a special dividend of $0.40 per share of our common stock to all stockholders of record as of June 10, 2008, of which $41,359 remained unclaimed by certain shareholders at September 30, 2014 and December 31, 2013. | |||||||||
NOTES_PAYABLE
NOTES PAYABLE | 9 Months Ended |
Sep. 30, 2014 | |
Debt Disclosure [Abstract] | ' |
NOTES PAYABLE | ' |
NOTE 10 – NOTES PAYABLE | |
Issuance and Payment of Multiple Advance Revolving Credit Note | |
On January 31, 2013, we entered into a business loan agreement with Plato and Associates, LLC, or Plato, for a Multiple Advance Revolving Credit Note, or the Revolving Credit Note. The Revolving Credit Note allowed us to draw down funding up to a $10,000,000 maximum principal amount, at a stated interest rate of 6% per annum. Plato was able to make advances to us from time to time under the Revolving Credit Note at our request, which advances were of a revolving nature and were able to be made, repaid, and made from time to time. Interest payments were due and payable on the tenth day following the end of each calendar quarter in which any interest was accrued and unpaid, commencing on April 10, 2013, and the principal balance outstanding under the Revolving Credit Note, together with all accrued interest and other amounts payable under the Revolving Credit Note, if any, was due and payable on February 24, 2014. The Revolving Credit Note was secured by substantially all of our assets. On each of February 25 and March 13, 2013, $200,000 was drawn against the Revolving Credit Note. On March 21, 2013, we repaid $401,085, which included accrued interest, and there was no balance outstanding under the Revolving Credit Note as of December 31, 2013 and February 24, 2014 when it expired. As additional consideration for the Revolving Credit Note, we granted to Plato a warrant to purchase 1,250,000 shares of our common stock at an exercise price of $3.20 per share (See Note 12). |
NET_LOSS_PER_SHARE
NET LOSS PER SHARE | 9 Months Ended | ||||||||
Sep. 30, 2014 | |||||||||
Earnings Per Share [Abstract] | ' | ||||||||
NET LOSS PER SHARE | ' | ||||||||
NOTE 11 – 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 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 or nine months ended September 30, 2014 and 2013. | |||||||||
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. | |||||||||
As of | |||||||||
September 30, | |||||||||
2014 | 2013 | ||||||||
Stock options | 16,851,943 | 14,780,793 | |||||||
Warrants | 13,927,916 | 14,293,499 | |||||||
30,779,859 | 29,074,292 | ||||||||
STOCKHOLDERS_EQUITY
STOCKHOLDERS' EQUITY | 9 Months Ended | ||||||||||||||||
Sep. 30, 2014 | |||||||||||||||||
Stockholders' Equity Note [Abstract] | ' | ||||||||||||||||
STOCKHOLDERS' EQUITY | ' | ||||||||||||||||
NOTE 12 – STOCKHOLDERS’ EQUITY | |||||||||||||||||
Preferred Stock | |||||||||||||||||
At September 30, 2014, 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 September 30, 2014, we had 250,000,000 shares of common stock, $0.001 par value per share, authorized, of which 156,030,476 shares of common stock were issued and outstanding. | |||||||||||||||||
Issuances During the Nine Months Ended September 30, 2014 | |||||||||||||||||
On July 29, 2014, we entered into an underwriting agreement with Goldman Sachs & Co, or Goldman Sachs, as the representative of the underwriters named therein, or the Goldman Sachs Underwriters, relating to an underwritten public offering of 8,565,310 shares of our common stock. The price to the public in the offering was $4.67 per share. Under the terms of the underwriting agreement, we granted the Goldman Sachs Underwriters a 30-day option to purchase up to an additional 1,284,796 shares of our common stock. On July 30, 2014, the Goldman Sachs Underwriters exercised their option to purchase the additional 1,284,796 shares of our common stock. Net proceeds from this offering were approximately $42.8 million, after deducting underwriting discounts and commissions and other offering expenses. The offering closed on August 4, 2014. | |||||||||||||||||
During the nine months ended September 30, 2014, certain individuals exercised stock options to purchase 793,800 shares of our common stock. Stock options to purchase shares of our common stock were exercised as follows: (i) 674,193 options for $315,546 in cash and (ii) 119,607 options, pursuant to the stock options’ cashless provision, wherein 113,837 common shares were issued. The Company granted 50,000 common shares to an employee upon the vesting of restricted stock units which were granted in December 2013. | |||||||||||||||||
During the nine months ended September 30, 2014, certain individuals exercised warrants to purchase 365,583 shares of our common stock for $181,000 in cash. | |||||||||||||||||
Issuances During the Year Ended December 31, 2013 | |||||||||||||||||
On March 14, 2013, we entered into an underwriting agreement with Jefferies LLC, or Jefferies, as the representative of the underwriters named therein, or the Jefferies Underwriters, relating to the issuance and sale of 29,411,765 shares of our common stock. The price to the public in the offering was $1.70 per share, and the Jefferies Underwriters agreed to purchase the shares of our common stock from us pursuant to the underwriting agreement at a price of $1.58 per share. The net proceeds to us from this offering were approximately $45.4 million, after deducting underwriting discounts and commissions and other offering expenses payable by us. In addition, under the terms of the underwriting agreement, we granted the Jefferies Underwriters a 30-day option to purchase up to an additional 4,411,765 shares of our common stock. The offering closed on March 20, 2013. On April 12, 2013, the Jefferies Underwriters exercised their option to purchase an additional 1,954,587 shares of our common stock. We issued these shares to the Jefferies Underwriters on April 18, 2013 and received proceeds of approximately $3.1 million, net of expenses. | |||||||||||||||||
On September 25, 2013, we entered into an underwriting agreement with Stifel, Nicolaus & Company, Incorporated, as the representative of the underwriters named therein, or the Stifel Underwriters, relating to the issuance and sale of 13,750,000 shares of our common stock. The price to the public in the offering was $2.40 per share, and the Stifel Underwriters agreed to purchase the shares of our common stock from us pursuant to the underwriting agreement at a price of $2.23 per share. The net proceeds to us from this offering were approximately $30.2 million, after deducting underwriting discounts and commissions and other offering expenses payable by us. The offering closed on September 30, 2013. | |||||||||||||||||
During 2013 certain individuals exercised their right to purchase shares of our common stock. Stock options to purchase an aggregate of 75,423 shares of our common stock were exercised for approximately $31,000. | |||||||||||||||||
Warrants to Purchase Common Stock of the Company | |||||||||||||||||
As of September 30, 2014, we had warrants outstanding to purchase an aggregate of 13,927,916 shares of our common stock with a weighted-average contractual remaining life of 3.2 years, and exercise prices ranging from $0.24 to $3.20 per share, resulting in a weighted average exercise price of $1.82 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. | |||||||||||||||||
Warrant Activity During the Nine Months Ended September 30, 2014 | |||||||||||||||||
During the nine months ended September 30, 2014, we did not grant any warrants. | |||||||||||||||||
Warrant Activity During the Year Ended December 31, 2013 | |||||||||||||||||
In January 2013, we granted warrants to purchase 1,250,000 shares of our common stock in connection with the issuance of the Revolving Credit Note, or the Plato Warrant (see NOTE 10 above for more details). The Plato Warrant has an exercise price of $3.20 per share. The Plato Warrant vested on October 31, 2013 and may be exercised prior to its expiration on January 31, 2019. The Plato Warrant, with a fair value of approximately $1,711,956, was valued on the date of the grant using a term of six years; a volatility of 44.29%; risk free rate of 0.88%; and a dividend yield of 0%. For the nine months ended September 30, 2014, $260,027 was recorded as financing costs in connection with the issuance of the Plato Warrant on the accompanying condensed consolidated financial statements. For the three and nine months ended September 30, 2013, $395,980 and $1,055,948, respectively, was recorded as financing costs on the accompanying condensed consolidated financial statements. | |||||||||||||||||
In May 2013, we entered into a consulting agreement with Sancilio & 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 grant to SCI a warrant to purchase 850,000 shares of our common stock at $2.01 per share that has vested or will vest, as applicable, as follows: | |||||||||||||||||
1 | 283,333 shares were earned on May 11, 2013 upon acceptance of an Investigational New Drug application by the FDA for an estradiol-based drug candidate in a softgel vaginal capsule for the treatment of VVA; however, pursuant to the terms of the consulting agreement, the shares did not vest until June 30, 2013. The fair value of $405,066 for the shares vested on June 30, 2013 was determined by using the Black-Scholes Model on the date of vesting using a term of 5 years; a volatility of 45.89%; risk free rate of 1.12%; and a dividend yield of 0%. We recorded the entire $405,066 as non-cash compensation as of June 30, 2013; | ||||||||||||||||
2 | 283,333 shares vested on June 30, 2013. The fair value of $462,196 for these shares was determined by using the Black-Scholes Model on the date of the vesting using a term of 5 years; a volatility of 45.84%; risk free rate of 1.41%; and a dividend yield of 0%. As of September 30, 2014, we recorded $154,068 as prepaid expense-short term and $115,543 as prepaid expense-long term in the accompanying condensed consolidated financial statements. During the three and nine months ended September 30, 2014, we recorded $38,517 and $115,551 as non-cash compensation in the accompanying condensed consolidated financial statements; and | ||||||||||||||||
3 | 283,334 shares will vest upon the receipt by us of any final FDA approval of a drug candidate that SCI helped us design. It is anticipated that this event will not occur before December 2015. | ||||||||||||||||
As of September 30, 2014, unamortized costs associated with the SCI warrants totaled approximately $950,000. | |||||||||||||||||
Stock Options to Purchase Common Stock of the Company | |||||||||||||||||
On September 25, 2009, our board of directors approved the 2009 Long Term Incentive Compensation Plan, or the LTIP, to provide financial incentives to our employees, members of the board of directors, and our advisers and consultants who are able to contribute towards the creation of or who have created stockholder value by providing them stock options and other equity and cash incentives, or the Awards. | |||||||||||||||||
The Awards available under the LTIP consist of stock options, stock appreciation rights, restricted stock, restricted stock units, performance stock, performance units, EVA awards, and other stock or cash awards as described in the LTIP. There are 25,000,000 shares authorized for issuance under the LTIP. Under the LTIP, non-qualified stock options for the purchase of an aggregate of 14,883,469 shares of our common stock were outstanding at September 30, 2014. | |||||||||||||||||
On February 23, 2012, our board of directors approved the 2012 Stock Incentive Plan, and on June 10, 2013, approved the Amended and Restated 2012 Stock Incentive Plan, or the 2012 SOP. The 2012 SOP was designed to serve as an incentive for retaining qualified and competent key employees, officers and directors, and certain consultants and advisors. There are 10,000,000 shares authorized for issuance under the 2012 SOP. Non-qualified stock options for the purchase of an aggregate of 1,968,474 shares of our common stock were outstanding at September 30, 2014. | |||||||||||||||||
The valuation methodology used to determine the fair value of the 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 nine months ended September 30, 2014 and 2013 are set forth in the table below. | |||||||||||||||||
Nine Months | Nine Months | ||||||||||||||||
Ended | Ended | ||||||||||||||||
September 30, | September 30, | ||||||||||||||||
2014 | 2013 | ||||||||||||||||
Risk-free interest rate | 1.68-1.77% | 0.65-1.71% | |||||||||||||||
Volatility | 69.15-70.93% | 33.35-45.76% | |||||||||||||||
Term (in years) | 5-6.25 | 5-6.25 | |||||||||||||||
Dividend yield | 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 life. Estimated volatility is a measure of the amount by which our stock price 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 term of the stock option using the simplified method. | |||||||||||||||||
A summary of activity under the LTIP and 2012 SOP and related information follows: | |||||||||||||||||
Number of | Weighted | Weighted | Aggregate | ||||||||||||||
Shares | Average | Average | Intrinsic | ||||||||||||||
Underlying | Exercise | Remaining | Value | ||||||||||||||
Stock | Price | Contractual | |||||||||||||||
Options | Life in Years | ||||||||||||||||
Balance at December 31, 2013 | 15,632,742 | $ | 1.44 | 7.2 | $ | 58,878,132 | |||||||||||
Granted | 2,013,500 | $ | 4.85 | ||||||||||||||
Exercised | (788,030 | ) | |||||||||||||||
Expired | (167 | ) | |||||||||||||||
Cancelled | (6,102 | ) | |||||||||||||||
Balance at September 30, 2014 | 16,851,943 | $ | 1.9 | 7.1 | $ | 46,835,281 | |||||||||||
Vested and Exercisable at | |||||||||||||||||
September 30, 2014 | 12,075,621 | $ | 1.19 | 5.8 | $ | 41,687,931 | |||||||||||
The Black-Scholes Model is used to calculate the fair value of individual stock option grants on their issue date. The weighted-average issue date fair value of stock options issued during the nine months ended September 30, 2014 was $3.03. Stock options issued under our plans have exercise prices ranging from $0.10 to $5.21 per share. Stock-based compensation expense for stock options recognized in our results of operations for the three and nine months ended September 30, 2014 were $1,047,493 and $3,341,604 respectively, and $793,426 and $1,962,673, respectively, for the same periods in 2013 (all based on awards vested and estimated without forfeitures). 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 September 30, 2014, total unrecognized estimated compensation expense related to unvested stock options previously issued was approximately $6,826,000, which is expected to be recognized over a weighted-average period of 2.8 years. No tax benefit was realized due to a continued pattern of operating losses. |
INCOME_TAXES
INCOME TAXES | 9 Months Ended |
Sep. 30, 2014 | |
Income Tax Disclosure [Abstract] | ' |
INCOME TAXES | ' |
NOTE 13 – 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 2014 as a result of (i) the losses recorded during the nine months ended September 30, 2014, (ii) additional losses expected for the remainder of 2014, 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 September 30, 2014, 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. | |
RELATED_PARTIES
RELATED PARTIES | 9 Months Ended |
Sep. 30, 2014 | |
Related Party Transactions [Abstract] | ' |
RELATED PARTIES | ' |
NOTE 14 – RELATED PARTIES | |
On February 29, 2012, Cooper C. Collins, who was then the largest shareholder of Pernix Therapeutics, LLC, or Pernix, was elected to serve on our board of directors. On October 5, 2011, we closed a stock purchase agreement with Pernix. 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 or a committee consisting of independent directors. During the nine months ended September 30, 2014 and 2013, we did not engage in any transactions with Pernix. At September 30, 2014 and December 31, 2013, 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 $249,981 at both September 30, 2014 and December 31, 2013. |
BUSINESS_CONCENTRATIONS
BUSINESS CONCENTRATIONS | 9 Months Ended |
Sep. 30, 2014 | |
Risks and Uncertainties [Abstract] | ' |
BUSINESS CONCENTRATIONS | ' |
NOTE 15 - BUSINESS CONCENTRATIONS | |
We purchase our products from several suppliers with approximately 77% and 98% of our purchases supplied from one vendor for the nine months ended September 30, 2014 and 2013, respectively. | |
We sell our prescription dietary supplement 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 95% and 98% of our recognized revenue for the nine months ended September 30, 2014 and 2013, respectively. | |
For the nine months ended September 30, 2014 and 2013, approximately 79% and 78%, respectively, of our recognized revenue and 96% and 98%, respectively, of our deferred revenue was generated from sales to four major customers. |
COMMITMENTS_AND_CONTINGENCIES
COMMITMENTS AND CONTINGENCIES | 9 Months Ended | ||||
Sep. 30, 2014 | |||||
Commitments and Contingencies Disclosure [Abstract] | ' | ||||
COMMITMENTS AND CONTINGENCIES | ' | ||||
NOTE 16 – 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. The lease stipulates, among other things, average base monthly rents of $30,149 (inclusive of estimated operating expenses) and sales tax, for total future minimum payments over the life of the lease of $1,899,414. The straight line rental expense related to our office lease totaled $90,448 for the three months ended September 30, 2014, partially offset by rent income of $5,993. The straight line rental expense related to our office lease totaled $271,345 for the nine months ended September 30, 2014, partially offset by rent income of $41,953. The rental expense for the nine months ended September 30, 2013 was approximately $150,000. | |||||
As of September 30, 2014, future minimum rental payments for our office lease are as follows: | |||||
Years Ending December 31, | |||||
2014 (3 months) | $ | 91,438 | |||
2015 | 371,240 | ||||
2016 | 382,377 | ||||
2017 | 393,848 | ||||
2018 | 302,748 | ||||
Total minimum lease payments | $ | 1,541,651 | |||
SUMMARY_OF_SIGNIFICANT_ACCOUNT1
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies) | 9 Months Ended | ||
Sep. 30, 2014 | |||
Accounting Policies [Abstract] | ' | ||
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: | |||
· | 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 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 or nine months ended September 30, 2014 and 2013. | |||
Fair Value of Financial Instruments | ' | ||
Fair Value of Financial Instruments | |||
Our financial instruments consist primarily of accounts receivable, accounts payable, accrued expenses, and short-term debt. The carrying amount of 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 Accounting Standards Codification, or ASC, 820, Fair Value Measurements. The fair value hierarchy gives the highest priority to quoted prices in active markets for identical assets and liabilities (Level 1) and lowest priority to unobservable inputs (Level 3). Assets and liabilities recorded in the consolidated balance sheet at fair value are categorized based on a hierarchy of inputs, as follows: | |||
Level 1 | unadjusted quoted prices in active markets for identical assets or liabilities; | ||
Level 2 | quoted prices for similar assets or liabilities in active markets or inputs that are observable for the asset or liability, either directly or indirectly through market corroboration, for substantially the full term of the financial instrument; and | ||
Level 3 | unobservable inputs for the asset or liability. | ||
At September 30, 2014 and December 31, 2013, we had no assets or liabilities that were valued at fair value on a recurring basis. | |||
INVENTORY_Tables
INVENTORY (Tables) | 9 Months Ended | ||||||||
Sep. 30, 2014 | |||||||||
Inventory Disclosure [Abstract] | ' | ||||||||
Schedule of Inventory | ' | ||||||||
Inventory consists of the following: | |||||||||
September 30, | December 31, | ||||||||
2014 | 2013 | ||||||||
Finished product | $ | 670,276 | $ | 621,679 | |||||
Raw material | 178,426 | 250,943 | |||||||
Deferred costs | 163,243 | 170,996 | |||||||
TOTAL INVENTORY | $ | 1,011,945 | $ | 1,043,618 | |||||
OTHER_CURRENT_ASSETS_Tables
OTHER CURRENT ASSETS (Tables) | 9 Months Ended | ||||||||
Sep. 30, 2014 | |||||||||
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] | ' | ||||||||
Schedule of other current assets | ' | ||||||||
Other current assets consist of the following: | |||||||||
September 30, | December 31, | ||||||||
2014 | 2013 | ||||||||
Prepaid consulting | $ | 514,596 | $ | 530,596 | |||||
Prepaid insurance | 503,064 | 145,722 | |||||||
Prepaid research and development costs | 457,458 | 1,267,588 | |||||||
Other receivables-related party (Note 14) | 249,981 | 249,981 | |||||||
Other prepaid costs | 195,019 | 23,806 | |||||||
Other current assets | 100,000 | — | |||||||
Deferred financing costs | — | 260,022 | |||||||
TOTAL OTHER CURRENT ASSETS | $ | 2,020,118 | $ | 2,477,715 |
FIXED_ASSETS_Tables
FIXED ASSETS (Tables) | 9 Months Ended | ||||||||
Sep. 30, 2014 | |||||||||
Property, Plant and Equipment [Abstract] | ' | ||||||||
Schedule of fixed assets | ' | ||||||||
Fixed assets consist of the following: | |||||||||
September 30, | December 31, | ||||||||
2014 | 2013 | ||||||||
Equipment | $ | 132,150 | $ | 108,458 | |||||
Furniture and fixtures | 53,895 | 46,625 | |||||||
186,045 | 155,083 | ||||||||
Accumulated depreciation | (116,478 | ) | (93,765 | ) | |||||
TOTAL FIXED ASSETS | $ | 69,567 | $ | 61,318 |
PREPAID_EXPENSE_Tables
PREPAID EXPENSE (Tables) | 9 Months Ended | ||||||||
Sep. 30, 2014 | |||||||||
Prepaid Expense and Other Assets [Abstract] | ' | ||||||||
Schedule of prepaid expense | ' | ||||||||
Prepaid expense consisted of the following: | |||||||||
September 30, | December 31, | ||||||||
2014 | 2013 | ||||||||
Prepaid manufacturing costs | $ | 899,000 | $ | 899,000 | |||||
Prepaid research and development costs | 438,274 | 824,221 | |||||||
Accreted prepaid costs | 54,990 | 27,234 | |||||||
TOTAL PREPAID EXPENSE | $ | 1,392,264 | $ | 1,750,455 | |||||
INTANGIBLE_ASSETS_Tables
INTANGIBLE ASSETS (Tables) | 9 Months Ended | ||||||||||||||||
Sep. 30, 2014 | |||||||||||||||||
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 September 30, 2014 and December 31, 2013: | |||||||||||||||||
30-Sep-14 | |||||||||||||||||
Gross | Accumulated | Net | Weighted- | ||||||||||||||
Carrying | Amortization | Amount | Average | ||||||||||||||
Amount | Remaining | ||||||||||||||||
Amortization | |||||||||||||||||
Period (yrs.) | |||||||||||||||||
Amortizing intangible assets: | |||||||||||||||||
OPERA® software patent | $ | 31,951 | $ | (1,997 | ) | $ | 29,954 | 15 | |||||||||
Development costs of | |||||||||||||||||
corporate website | 91,743 | (91,743 | ) | — | n/a | ||||||||||||
Approved hormone | |||||||||||||||||
therapy drug | |||||||||||||||||
candidate patents | 387,806 | (13,616 | ) | 374,190 | 18.25 | ||||||||||||
Non-amortizing intangible | |||||||||||||||||
assets: | |||||||||||||||||
Hormone therapy drug | |||||||||||||||||
candidate patents | 340,059 | — | 340,059 | n/a | |||||||||||||
(pending) | |||||||||||||||||
Multiple trademarks for | |||||||||||||||||
vitamins/supplements | 97,538 | — | 97,538 | n/a | |||||||||||||
Total | $ | 949,097 | $ | (107,356 | ) | $ | 841,741 | ||||||||||
31-Dec-13 | |||||||||||||||||
Gross | Accumulated | Net | Weighted- | ||||||||||||||
Carrying | Amortization | Amount | Average | ||||||||||||||
Amount | Remaining | ||||||||||||||||
Amortization | |||||||||||||||||
Period (yrs.) | |||||||||||||||||
Amortizing intangible assets: | |||||||||||||||||
OPERA® software patent | $ | 31,951 | $ | (499 | ) | $ | 31,452 | 15.8 | |||||||||
Development costs of | |||||||||||||||||
corporate website | 91,743 | (89,661 | ) | 2,082 | 0.3 | ||||||||||||
Non-amortizing intangible | |||||||||||||||||
assets: | |||||||||||||||||
Hormone therapy drug | |||||||||||||||||
candidate patents | 572,726 | — | 572,726 | n/a | |||||||||||||
(pending) | |||||||||||||||||
Multiple trademarks for | |||||||||||||||||
vitamins/supplements | 59,328 | — | 59,328 | n/a | |||||||||||||
Total | $ | 755,748 | $ | (90,160 | ) | $ | 665,588 | ||||||||||
Schedule of estimated amortization expense | ' | ||||||||||||||||
Amortization expense was $5,625 and $3,255 for the three months ended September 30, 2014 and 2013, respectively and $17,196 and $9,764 for the nine months ended September 30, 2014 and 2013, respectively. Estimated amortization expense for the next five years is as follows: | |||||||||||||||||
Year Ending | Estimated | ||||||||||||||||
December 31, | Amortization | ||||||||||||||||
2014 (3 months) | $5,625 | ||||||||||||||||
2015 | $22,500 | ||||||||||||||||
2016 | $22,500 | ||||||||||||||||
2017 | $22,500 | ||||||||||||||||
2018 | $22,500 | ||||||||||||||||
OTHER_CURRENT_LIABILITIES_Tabl
OTHER CURRENT LIABILITIES (Tables) | 9 Months Ended | ||||||||
Sep. 30, 2014 | |||||||||
Other Liabilities Disclosure [Abstract] | ' | ||||||||
Schedule of other current liabilities | ' | ||||||||
Other current liabilities consist of the following: | |||||||||
September 30, | December 31, | ||||||||
2014 | 2013 | ||||||||
Accrued clinical trial costs | $ | 2,385,094 | $ | 665,782 | |||||
Accrued payroll and commission costs | 603,525 | 941,313 | |||||||
Accrued vacation costs | 434,614 | 256,920 | |||||||
Other accrued expenses(1) | 266,576 | 177,900 | |||||||
Allowance for wholesale distributor fees | 245,232 | 306,303 | |||||||
Accrued legal and accounting expense | 220,526 | 224,550 | |||||||
Accrued royalties | 164,707 | 52,188 | |||||||
Allowance for coupons and returns | 97,890 | 126,233 | |||||||
Accrued rent | 92,915 | — | |||||||
Accrued financing costs | — | 850,000 | |||||||
TOTAL OTHER CURRENT LIABILITIES | $ | 4,511,079 | $ | 3,601,189 | |||||
____________ | |||||||||
(1) In June 2008, we declared and paid a special dividend of $0.40 per share of our common stock to all stockholders of record as of June 10, 2008, of which $41,359 remained unclaimed by certain shareholders at September 30, 2014 and December 31, 2013. | |||||||||
NET_LOSS_PER_SHARE_Tables
NET LOSS PER SHARE (Tables) | 9 Months Ended | ||||||||
Sep. 30, 2014 | |||||||||
Earnings Per Share [Abstract] | ' | ||||||||
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. | |||||||||
As of | |||||||||
September 30, | |||||||||
2014 | 2013 | ||||||||
Stock options | 16,851,943 | 14,780,793 | |||||||
Warrants | 13,927,916 | 14,293,499 | |||||||
30,779,859 | 29,074,292 | ||||||||
STOCKHOLDERS_EQUITY_Tables
STOCKHOLDERS' EQUITY (Tables) | 9 Months Ended | ||||||||||||||||
Sep. 30, 2014 | |||||||||||||||||
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 nine months ended September 30, 2014 and 2013 are set forth in the table below. | |||||||||||||||||
Nine Months | Nine Months | ||||||||||||||||
Ended | Ended | ||||||||||||||||
September 30, | September 30, | ||||||||||||||||
2014 | 2013 | ||||||||||||||||
Risk-free interest rate | 1.68-1.77% | 0.65-1.71% | |||||||||||||||
Volatility | 69.15-70.93% | 33.35-45.76% | |||||||||||||||
Term (in years) | 5-6.25 | 5-6.25 | |||||||||||||||
Dividend yield | 0.00% | 0.00% | |||||||||||||||
Schedule of option activity | ' | ||||||||||||||||
A summary of activity under the LTIP and 2012 SOP and related information follows: | |||||||||||||||||
Number of | Weighted | Weighted | Aggregate | ||||||||||||||
Shares | Average | Average | Intrinsic | ||||||||||||||
Underlying | Exercise | Remaining | Value | ||||||||||||||
Stock | Price | Contractual | |||||||||||||||
Options | Life in Years | ||||||||||||||||
Balance at December 31, 2013 | 15,632,742 | $ | 1.44 | 7.2 | $ | 58,878,132 | |||||||||||
Granted | 2,013,500 | $ | 4.85 | ||||||||||||||
Exercised | (788,030 | ) | |||||||||||||||
Expired | (167 | ) | |||||||||||||||
Cancelled | (6,102 | ) | |||||||||||||||
Balance at September 30, 2014 | 16,851,943 | $ | 1.9 | 7.1 | $ | 46,835,281 | |||||||||||
Vested and Exercisable at | |||||||||||||||||
September 30, 2014 | 12,075,621 | $ | 1.19 | 5.8 | $ | 41,687,931 | |||||||||||
COMMITMENTS_AND_CONTINGENCIES_
COMMITMENTS AND CONTINGENCIES (Tables) | 9 Months Ended | ||||
Sep. 30, 2014 | |||||
Commitments And Contingencies Tables | ' | ||||
Schedule of future minimum rental payments | ' | ||||
As of September 30, 2014, future minimum rental payments for our office lease are as follows: | |||||
Years Ending December 31, | |||||
2014 (3 months) | $ | 91,438 | |||
2015 | 371,240 | ||||
2016 | 382,377 | ||||
2017 | 393,848 | ||||
2018 | 302,748 | ||||
Total minimum lease payments | $ | 1,541,651 | |||
INVENTORY_Details
INVENTORY (Details) (USD $) | Sep. 30, 2014 | Dec. 31, 2013 |
Inventory | ' | ' |
Finished product | $670,276 | $621,679 |
Raw material | 178,426 | 250,943 |
Deferred costs | 163,243 | 170,996 |
Inventory | $1,011,945 | $1,043,618 |
OTHER_CURRENT_ASSETS_Details
OTHER CURRENT ASSETS (Details) (USD $) | Sep. 30, 2014 | Dec. 31, 2013 |
Other Current Assets | ' | ' |
Prepaid consulting | $514,596 | $530,596 |
Prepaid insurance | 503,064 | 145,722 |
Prepaid research and development costs | 457,458 | 1,267,588 |
Other receivables-related party (Note 14) | 249,981 | 249,981 |
Other prepaid costs | 195,019 | 23,806 |
Other current assets | 100,000 | ' |
Deferred financing costs | ' | 260,022 |
TOTAL OTHER CURRENT ASSETS | $2,020,118 | $2,477,715 |
FIXED_ASSETS_Details_Narrative
FIXED ASSETS (Details Narrative) (USD $) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2014 | Sep. 30, 2013 | Sep. 30, 2014 | Sep. 30, 2013 | |
Property, Plant and Equipment [Abstract] | ' | ' | ' | ' |
Depreciation Expense | $7,122 | $29,103 | $22,713 | $41,186 |
FIXED_ASSETS_Details
FIXED ASSETS (Details) (USD $) | Sep. 30, 2014 | Dec. 31, 2013 |
Fixed assets, gross | $186,045 | $155,083 |
Accumulated depreciation | -116,478 | -93,765 |
Fixed Assets, net | 69,567 | 61,318 |
Equipment (Member) | ' | ' |
Fixed assets, gross | 132,150 | 108,458 |
Furniture and Fixtures (Member) | ' | ' |
Fixed assets, gross | $53,895 | $46,625 |
PREPAID_EXPENSE_Details
PREPAID EXPENSE (Details) (USD $) | Sep. 30, 2014 | Dec. 31, 2013 |
Other Assets | ' | ' |
Prepaid manufacturing costs | $899,000 | $899,000 |
Prepaid research and development costs | 438,274 | 824,221 |
Accreted prepaid costs | 54,990 | 27,234 |
TOTAL PREPAID EXPENSE | $1,392,264 | $1,750,455 |
INTANGIBLE_ASSETS_Details_Narr
INTANGIBLE ASSETS (Details Narrative) (USD $) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2014 | Sep. 30, 2013 | Sep. 30, 2014 | Sep. 30, 2013 | |
Amortization expense | $5,625 | $3,255 | $17,196 | $9,764 |
Development costs for corporate website (Member) | ' | ' | ' | ' |
Amortization period | ' | ' | '36 months | ' |
OPERA software patent (Member) | ' | ' | ' | ' |
Amortization period | ' | ' | '20 years | ' |
Approved Hormone Therapy Drug Candidate Patents (Member) | ' | ' | ' | ' |
Amortization period | ' | ' | '20 years | ' |
INTANGIBLE_ASSETS_Details
INTANGIBLE ASSETS (Details ) (USD $) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2014 | Dec. 31, 2013 | |
Finite-Lived Intangible Assets | ' | ' |
Accumulated Amortization | ($101,730) | ($90,160) |
Indefinite-Lived Intangible Assets | ' | ' |
Gross Carrying Amount | ' | 755,748 |
Net Amount | ' | 665,588 |
Gross Carrying Amount | 949,097 | 755,748 |
Net Amount | 841,741 | 665,588 |
Hormone therapy drug candidate patents - Pending (Member) | ' | ' |
Indefinite-Lived Intangible Assets | ' | ' |
Gross Carrying Amount | 340,059 | 572,726 |
Net Amount | 340,059 | 572,726 |
Multiple trademarks for vitamins/supplements (Member) | ' | ' |
Indefinite-Lived Intangible Assets | ' | ' |
Gross Carrying Amount | 97,538 | 59,328 |
Net Amount | 97,538 | 59,328 |
OPERA software patent (Member) | ' | ' |
Finite-Lived Intangible Assets | ' | ' |
Gross Carrying Amount | 31,951 | 31,951 |
Accumulated Amortization | -1,997 | -499 |
Net Amount | 29,954 | 31,452 |
Weighted Average Amortization Period | '15 years | '15 years 9 months 18 days |
Development costs for corporate website (Member) | ' | ' |
Finite-Lived Intangible Assets | ' | ' |
Gross Carrying Amount | 91,743 | 91,743 |
Accumulated Amortization | -91,743 | -89,661 |
Net Amount | ' | 2,082 |
Weighted Average Amortization Period | ' | '3 months 19 days |
Approved Hormone Therapy Drug Candidate Patents (Member) | ' | ' |
Finite-Lived Intangible Assets | ' | ' |
Gross Carrying Amount | 387,806 | ' |
Accumulated Amortization | -13,616 | ' |
Net Amount | $374,190 | ' |
Weighted Average Amortization Period | '18 years 2 months 30 days | ' |
INTANGIBLE_ASSETS_Details_1
INTANGIBLE ASSETS (Details 1) (USD $) | Sep. 30, 2014 |
Estimated amortization expense for the year: | ' |
2014 (6 months) | $5,625 |
2015 | 22,500 |
2016 | 22,500 |
2017 | 22,500 |
2018 | $22,500 |
OTHER_CURRENT_LIABILITIES_Deta
OTHER CURRENT LIABILITIES (Details Narrative) (USD $) | Sep. 30, 2014 | Dec. 31, 2013 |
Other Liabilities Disclosure [Abstract] | ' | ' |
Date dividend declared | '2008-06 | '2008-06 |
Dividends Payable, amount per share | $0.40 | $0.40 |
Unclaimed dividends | $41,359 | $41,359 |
OTHER_CURRENT_LIABILITIES_Deta1
OTHER CURRENT LIABILITIES (Details) (USD $) | Sep. 30, 2014 | Dec. 31, 2013 | ||
Other Liabilities Disclosure [Abstract] | ' | ' | ||
Accrued clinical trial costs | $2,385,094 | $665,782 | ||
Accrued payroll and commission costs | 603,525 | 941,313 | ||
Accrued vacation costs | 434,614 | 256,920 | ||
Other accrued expenses | 266,576 | [1] | 177,900 | [1] |
Allowance for wholesale distributor fees | 245,232 | 306,303 | ||
Accrued legal and accounting expense | 220,526 | 224,550 | ||
Accrued royalties | 164,707 | 52,188 | ||
Allowance for coupons and returns | 97,890 | 126,233 | ||
Accrued rent | 92,915 | ' | ||
Accrued financing costs | ' | 850,000 | ||
TOTAL OTHER CURRENT LIABILITIES | $4,511,079 | $3,601,189 | ||
[1] | In June 2008, we declared and paid a special dividend of $0.40 per share of our common stock to all stockholders of record as of June 10, 2008, of which $41,359 remained unclaimed by certain shareholders at September 30, 2014 and December 31, 2013. |
NOTES_PAYABLE_Details_Narrativ
NOTES PAYABLE (Details Narrative) (USD $) | 0 Months Ended | |||
Mar. 21, 2013 | Mar. 13, 2013 | Feb. 25, 2013 | Jan. 31, 2013 | |
Plato Warrant (Member) | ' | ' | ' | ' |
Maximum principal amount | ' | ' | ' | 10,000,000 |
Multiple Advance Revolving Credit Note (Plato Warrant) (Member) | ' | ' | ' | ' |
Stated interest rate | ' | ' | ' | 6.00% |
Description of interest payment | ' | ' | ' | 'Interest payments were due and payable on the tenth day following the end of each calendar quarter |
Proceeds from revolving credit note | ' | 200,000 | 200,000 | ' |
Repayment of revolving credit note | $401,085 | ' | ' | ' |
NET_LOSS_PER_SHARE_Details
NET LOSS PER SHARE (Details) | 9 Months Ended | |
Sep. 30, 2014 | Sep. 30, 2013 | |
Anti-dilutive shares excluded from earnings per share calculation | 30,779,859 | 29,074,292 |
Stock Option [Member] | ' | ' |
Anti-dilutive shares excluded from earnings per share calculation | 16,851,943 | 14,780,793 |
Warrant [Member] | ' | ' |
Anti-dilutive shares excluded from earnings per share calculation | 13,927,916 | 14,293,499 |
STOCKHOLDERS_EQUITY_Details_Na
STOCKHOLDERS' EQUITY (Details Narrative) (USD $) | 0 Months Ended | 9 Months Ended | 12 Months Ended | 0 Months Ended | |||||||
Aug. 04, 2014 | Sep. 30, 2013 | Mar. 20, 2013 | Sep. 30, 2014 | Sep. 30, 2013 | Dec. 31, 2013 | Jul. 29, 2014 | Sep. 25, 2013 | Aug. 04, 2014 | Apr. 18, 2013 | Apr. 12, 2013 | |
Underwritings 30 Day Option to Purchase Shares - Goldman Sachs [Member] | Underwritings 30 Day Option to Purchase Shares - Jeffries LLC [Member] | Underwritings 30 Day Option to Purchase Shares - Jeffries LLC [Member] | |||||||||
Value of shares issued in exercise of stock options | ' | ' | ' | $315,546 | ' | $31,000 | ' | ' | ' | ' | ' |
Common shares issued in exercise of stock options | ' | ' | ' | 674,193 | ' | 75,423 | ' | ' | ' | ' | ' |
Number of options exercised | ' | ' | ' | 793,800 | ' | ' | ' | ' | ' | ' | ' |
Options exercised under cashless exercise | ' | ' | ' | 119,607 | ' | ' | ' | ' | ' | ' | ' |
Shares issued under cashless exercise of options | ' | ' | ' | 113,837 | ' | ' | ' | ' | ' | ' | ' |
Stock issued upon vesting of restricted stock units | ' | ' | ' | 50,000 | ' | ' | ' | ' | ' | ' | ' |
Number of shares issued in exercise of warrants | ' | ' | ' | 365,583 | ' | ' | ' | ' | ' | ' | ' |
Value of shares issued in exercise of warrants | ' | ' | ' | 181,000 | ' | ' | ' | ' | ' | ' | ' |
Number of shares granted under 30 day option | ' | ' | ' | ' | ' | ' | ' | ' | 1,284,796 | 4,411,765 | ' |
Number of shares issued during the period | 8,563,310 | 13,750,000 | 29,411,765 | ' | ' | ' | ' | ' | 1,284,796 | 1,954,587 | ' |
Shares issued during the period, per share price (in dollars per share) | ' | ' | ' | ' | ' | ' | $4.67 | $2.40 | ' | ' | $1.70 |
Shares issued during the period, per share price from underwriters (in dollars per share) | ' | ' | ' | ' | ' | ' | ' | $2.23 | ' | ' | $1.58 |
Proceeds from issuance of common stock | $42,800,000 | $30,200,000 | $45,400,000 | $42,771,353 | $78,984,960 | ' | ' | ' | ' | $3,100,000 | ' |
Additional period to purchase shares via option | ' | ' | ' | ' | ' | ' | ' | ' | '30 days | '30 days | ' |
STOCKHOLDERS_EQUITY_Details_Na1
STOCKHOLDERS' EQUITY (Details Narrative 1) (USD $) | 3 Months Ended | 9 Months Ended | 1 Months Ended | 0 Months Ended | 3 Months Ended | 9 Months Ended | ||||||||
Sep. 30, 2013 | Sep. 30, 2014 | Sep. 30, 2013 | Dec. 31, 2013 | Jan. 31, 2013 | 31-May-13 | Jun. 30, 2013 | 11-May-13 | Jun. 30, 2013 | Sep. 30, 2014 | Sep. 30, 2014 | Sep. 30, 2014 | Sep. 30, 2014 | Sep. 30, 2014 | |
Plato Warrant (Member) | Sancilio and Company Warrants (Member) | Sancilio & Company Warrants 1st Installments (Member) | Sancilio & Company Warrants 1st Installments (Member) | Sancilio and Company Warrants 2nd Installments (Member) | Sancilio and Company Warrants 2nd Installments (Member) | Sancilio and Company Warrants 2nd Installments (Member) | Sancilio and Company Warrants 3rd Installments (Member) | Minimum (Member) | Maximum (Member) | |||||
Warrants: | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Warrants outstanding | ' | $13,927,916 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Weighted-average contractual remaining life | ' | '3 years 2 months 12 days | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Weighted average exercise price | ' | 1.82 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Exercise price of warrants (in dollars per share) | ' | ' | ' | ' | $3.20 | $2.01 | ' | ' | ' | ' | ' | ' | $0.24 | $3.20 |
Number of shares issuable for warrants granted | ' | ' | ' | ' | 1,250,000 | 850,000 | ' | 283,333 | 283,333 | ' | ' | 283,334 | ' | ' |
Expiration date of warrants | ' | ' | ' | ' | 31-Jan-19 | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Vesting date of warrants | ' | ' | ' | ' | 31-Oct-13 | ' | ' | 30-Jun-13 | ' | ' | ' | ' | ' | ' |
Fair value of warrants | ' | ' | ' | ' | 1,711,956 | ' | 405,066 | ' | 462,196 | ' | ' | ' | ' | ' |
Expected term | ' | ' | ' | ' | '6 years | ' | '5 years | ' | '5 years | ' | ' | ' | ' | ' |
Volatility rate | ' | ' | ' | ' | 44.29% | ' | 1.12% | ' | 1.41% | ' | ' | ' | ' | ' |
Risk free rate | ' | ' | ' | ' | 0.88% | ' | 45.89% | ' | 45.84% | ' | ' | ' | ' | ' |
Dividend yield | ' | ' | ' | ' | 0.00% | ' | 0.00% | ' | 0.00% | ' | ' | ' | ' | ' |
Financing costs | 395,980 | 260,027 | 1,055,948 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Number of shares issuable for warrants forfeited | ' | ' | ' | ' | ' | 833,000 | ' | ' | ' | ' | ' | ' | ' | ' |
Valuation method of warrants | ' | ' | ' | ' | ' | ' | 'Black-Scholes Model | ' | ' | ' | ' | ' | ' | ' |
Non-cash compensation recognized | ' | ' | ' | ' | ' | ' | 405,066 | ' | ' | 38,517 | 115,551 | ' | ' | ' |
Prepaid expense-short term | ' | ' | ' | ' | ' | ' | ' | ' | ' | 154,068 | 154,068 | ' | ' | ' |
Prepaid expense-long term | ' | 1,392,264 | ' | 1,750,455 | ' | ' | ' | ' | ' | 115,543 | 115,543 | ' | ' | ' |
Unamortized warrant costs | ' | $950,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
STOCKHOLDERS_EQUITY_Details_Na2
STOCKHOLDERS' EQUITY (Details Narrative 2) (USD $) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2014 | Sep. 30, 2013 | Sep. 30, 2014 | Sep. 30, 2013 | |
Options purchase Common Stock of the Company: | ' | ' | ' | ' |
Weighted average issue date fair value | $3.03 | ' | $3.03 | ' |
Unrecognized stock based compensation | $6,826,000 | ' | $6,826,000 | ' |
Stock Options (Member) | ' | ' | ' | ' |
Options purchase Common Stock of the Company: | ' | ' | ' | ' |
Stock based compensation | $1,047,493 | $793,426 | $3,341,604 | $1,962,673 |
Exercise prices of outstanding options -lower price | ' | ' | $0.10 | ' |
Exercise prices of outstanding options -upper price | ' | ' | $5.21 | ' |
Weighted average period of unrecognized stock based compensation | ' | ' | '2 years 9 months 18 days | ' |
2009 Long Term Incentive Compensation Plan (Member) | ' | ' | ' | ' |
Options purchase Common Stock of the Company: | ' | ' | ' | ' |
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 | ' | 25,000,000 | ' |
Numbers of options oustanding | 14,883,469 | ' | 14,883,469 | ' |
2012 Stock Incentive Plan (Member) | ' | ' | ' | ' |
Options purchase Common Stock of the Company: | ' | ' | ' | ' |
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 | ' | 10,000,000 | ' |
Numbers of options oustanding | 1,968,474 | ' | 1,968,474 | ' |
STOCKHOLDERS_EQUITY_Details
STOCKHOLDERS' EQUITY (Details) (Stock Options (Member)) | 9 Months Ended | |
Sep. 30, 2014 | Sep. 30, 2013 | |
Expected dividend yield | 0.00% | 0.00% |
Minimum (Member) | ' | ' |
Risk-free interest rate | 1.68% | 0.65% |
Expected Volatility | 69.15% | 33.35% |
Expected term | '5 years | '5 years |
Maximum (Member) | ' | ' |
Risk-free interest rate | 1.77% | 1.71% |
Expected Volatility | 70.93% | 45.76% |
Expected term | '6 years 2 months 30 days | '6 years 2 months 30 days |
STOCKHOLDERS_EQUITY_Details_1
STOCKHOLDERS' EQUITY (Details 1) (USD $) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2014 | Dec. 31, 2013 | |
Number Options | ' | ' |
Options Exercised | 674,193 | 75,423 |
LTIP and 2012 SOP (Member) | ' | ' |
Number Options | ' | ' |
Options outstanding, beginning | 15,632,742 | ' |
Options Granted | 2,013,500 | ' |
Options Exercised | -788,030 | ' |
Options Expired | -167 | ' |
Options Cancelled | -6,102 | ' |
Options outstanding, ending | 16,851,943 | 15,632,742 |
Vested and exercisable | 12,075,621 | ' |
Weighted Average Exercise Price | ' | ' |
Options outstanding, beginning | 1.44 | ' |
Granted | 4.85 | ' |
Options outstanding, ending | 1.9 | 1.44 |
Vested and exercisable | 1.19 | ' |
Weighted Average Remaining Contractual Life | ' | ' |
Options outstanding | '7 years 1 month 6 days | '7 years 2 months 12 days |
Vested and exercisable | '5 years 9 months 18 days | ' |
Aggregate Intrinsic Value | ' | ' |
Options outstanding | 46,835,281 | 58,878,132 |
Vested and exercisable | 41,687,931 | ' |
RELATED_PARTIES_Details_Narrat
RELATED PARTIES (Details Narrative) (Pernix Therapeutics LLC (Member), USD $) | Sep. 30, 2014 | Dec. 31, 2013 |
Pernix Therapeutics LLC (Member) | ' | ' |
Receivables- legal fee reimbursement | $249,981 | $249,981 |
Payable - related party | $46,000 | $46,000 |
BUSINESS_CONCENTRATIONS_Detail
BUSINESS CONCENTRATIONS (Details Narrative) | 9 Months Ended | |
Sep. 30, 2014 | Sep. 30, 2013 | |
Supplier Concentration Risk (Member) | ' | ' |
Concentration Risk [Line Items] | ' | ' |
Concentration Risk | 77.00% | 98.00% |
Revenue - Prescription dietary (Member) | ' | ' |
Concentration Risk [Line Items] | ' | ' |
Concentration Risk | 95.00% | 98.00% |
Recognized Revenue (Member) | ' | ' |
Concentration Risk [Line Items] | ' | ' |
Concentration Risk | 79.00% | 78.00% |
Deferred revenue (Member) | ' | ' |
Concentration Risk [Line Items] | ' | ' |
Concentration Risk | 96.00% | 98.00% |
COMMITMENTS_AND_CONTINGENCIES_1
COMMITMENTS AND CONTINGENCIES (Details Narrative) (USD $) | 3 Months Ended | 9 Months Ended | |
Sep. 30, 2014 | Sep. 30, 2014 | Sep. 30, 2013 | |
Commitments and Contingencies Disclosure [Abstract] | ' | ' | ' |
Non-cancelable operating lease term | ' | '63 months | ' |
Monthly Base rent of leases | ' | $30,149 | ' |
Future minimum lease payments over life of lease | 1,899,414 | 1,899,414 | ' |
Rental Expense | 90,448 | 271,345 | 150,000 |
Rental income | $5,993 | $41,953 | ' |
COMMITMENTS_AND_CONTINGENCIES_2
COMMITMENTS AND CONTINGENCIES (Details) (USD $) | Sep. 30, 2014 |
Future minimum rental payments, year ending December 31, | ' |
2014 | $91,438 |
2015 | 371,240 |
2016 | 382,377 |
2017 | 393,848 |
2018 | 302,748 |
Total minimum lease payments | $1,541,651 |