Document_and_Entity_Informatio
Document and Entity Information | 3 Months Ended | |
Mar. 31, 2015 | 4-May-15 | |
Document And Entity Information | ||
Entity Registrant Name | TherapeuticsMD, Inc. | |
Entity Central Index Key | 25743 | |
Document Type | 10-Q | |
Document Period End Date | 31-Mar-15 | |
Amendment Flag | FALSE | |
Current Fiscal Year End Date | -19 | |
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 | 172,656,036 | |
Document Fiscal Period Focus | Q1 | |
Document Fiscal Year Focus | 2015 |
CONSOLIDATED_BALANCE_SHEETS_Un
CONSOLIDATED BALANCE SHEETS (Unaudited) (USD $) | Mar. 31, 2015 | Dec. 31, 2014 |
Current Assets: | ||
Cash | $91,658,453 | $51,361,607 |
Accounts receivable, net of allowance for doubtful accounts of $72,757 and $59,753, respectively | 2,644,049 | 2,154,217 |
Inventory | 959,188 | 1,182,113 |
Other current assets | 1,445,995 | 1,537,407 |
Total current assets | 96,707,685 | 56,235,344 |
Fixed assets, net | 56,412 | 63,293 |
Other Assets: | ||
Prepaid expense | 1,334,139 | 1,427,263 |
Intangible assets | 1,258,750 | 1,228,588 |
Security deposit | 125,000 | 125,000 |
Total other assets | 2,717,889 | 2,780,851 |
Total assets | 99,481,986 | 59,079,488 |
Current Liabilities: | ||
Accounts payable | 6,235,183 | 6,327,129 |
Other current liabilities | 4,879,452 | 3,840,639 |
Deferred revenue | 522,613 | |
Total current liabilities | 11,114,635 | 10,690,381 |
Long-Term Liabilities: | ||
Accrued Expense | 651,567 | |
Total liabilities | 11,766,202 | 10,690,381 |
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; 172,651,036 and 156,097,019 issued and outstanding, respectively | 172,651 | 156,097 |
Additional paid in capital | 243,187,225 | 182,982,846 |
Accumulated deficit | -155,644,092 | -134,749,836 |
Total stockholders' equity | 87,715,784 | 48,389,107 |
Total liabilities and stockholders' equity | $99,481,986 | $59,079,488 |
CONSOLIDATED_BALANCE_SHEETS_Un1
CONSOLIDATED BALANCE SHEETS (Unaudited) (Parenthetical) (USD $) | Mar. 31, 2015 | Dec. 31, 2014 |
Statement of Financial Position [Abstract] | ||
Allowance for doubtful accounts | $72,757 | $59,753 |
Preferred stock, par value (in dollars per share) | $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 (in dollars per share) | $0.00 | $0.00 |
Common stock, shares authorized | 250,000,000 | 250,000,000 |
Common stock, shares issued | 172,651,036 | 156,097,019 |
Common stock, shares outstanding | 172,651,036 | 156,097,019 |
CONSOLIDATED_STATEMENTS_OF_OPE
CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited) (USD $) | 3 Months Ended | |
Mar. 31, 2015 | Mar. 31, 2014 | |
Income Statement [Abstract] | ||
Revenues, net | $4,475,049 | $2,830,533 |
Cost of goods sold | 1,043,641 | 830,707 |
Gross profit | 3,431,408 | 1,999,826 |
Operating expenses: | ||
Sales, general, and administrative | 6,163,612 | 5,029,497 |
Research and development | 18,176,835 | 5,908,078 |
Depreciation and amortization | 13,572 | 13,068 |
Total operating expense | 24,354,019 | 10,950,643 |
Operating loss | -20,922,611 | -8,950,817 |
Other income and (expense) | ||
Miscellaneous income | 18,513 | 18,572 |
Interest income | 9,842 | 9,154 |
Financing costs | -260,027 | |
Total other income (expense) | 28,355 | -232,301 |
Loss before taxes | -20,894,256 | -9,183,118 |
Provision for income taxes | ||
Net loss | ($20,894,256) | ($9,183,118) |
Net loss per share, basic and diluted (in dollars per share) | ($0.13) | ($0.06) |
Weighted average number of common shares outstanding-basic and diluted (in shares) | 163,448,130 | 145,019,561 |
CONSOLIDATED_STATEMENTS_OF_CAS
CONSOLIDATED STATEMENTS OF CASH FLOWS (Unaudited) (USD $) | 3 Months Ended | |
Mar. 31, 2015 | Mar. 31, 2014 | |
CASH FLOWS FROM OPERATING ACTIVITIES | ||
Net loss | ($20,894,256) | ($9,183,118) |
Adjustments to reconcile net loss to net cash flows used in operating activities: | ||
Depreciation | 6,881 | 7,122 |
Amortization of intangible assets | 6,691 | 5,946 |
Provision for doubtful accounts | 13,004 | 6,046 |
Stock based compensation | 704,872 | 1,009,526 |
Amortization of deferred financing costs | 260,027 | |
Stock based expense for services | 135,592 | 314,291 |
Changes in operating assets and liabilities: | ||
Accounts receivable | -502,836 | -654,748 |
Inventory | 222,925 | 122,933 |
Other current assets | 91,412 | -85,834 |
Other assets | -9,842 | -9,154 |
Accounts payable | -91,946 | 954,513 |
Deferred revenue | -522,613 | -124,271 |
Accrued expenses and other current liabilities | 1,038,813 | -1,329,216 |
Other long-term liabilities | 651,567 | |
Net cash flows used in operating activities | -19,149,736 | -8,705,937 |
CASH FLOWS FROM INVESTING ACTIVITIES | ||
Patent costs | -36,853 | -97,284 |
Purchase of property and equipment | -23,692 | |
Net cash flows used in investing activities | -36,853 | -120,976 |
CASH FLOWS FROM FINANCING ACTIVITIES | ||
Proceeds from sale of common stock, net of costs | 59,117,827 | |
Proceeds from exercise of options | 7,208 | 40,055 |
Proceeds from exercise of warrants | 358,400 | |
Net cash flows provided by financing activities | 59,483,435 | 40,055 |
Increase (decrease) in cash | 40,296,846 | -8,786,858 |
Cash, beginning of period | 51,361,607 | 54,191,260 |
Cash, end of period | $91,658,453 | $45,404,402 |
THE_COMPANY
THE COMPANY | 3 Months Ended |
Mar. 31, 2015 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
THE COMPANY | NOTE 1 – THE COMPANY |
TherapeuticsMD, Inc., a Nevada corporation, or TherapeuticsMD or the Company, has 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 women’s 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. | |
BASIS_OF_PRESENTATION_AND_RECE
BASIS OF PRESENTATION AND RECENTLY ISSUED ACCOUNTING PRONOUNCEMENTS | 3 Months Ended |
Mar. 31, 2015 | |
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. | |
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 consolidated financial statements and disclosures. | |
In May 2014, the FASB and the International Accounting Standards Board (IASB) issued ASU, No. 2014-09, Revenue from Contracts with Customers (Topic 606). The standard’s core principle is that a company will recognize revenue when it transfers promised goods or services to customers in an amount that reflects the consideration to which the company expects to be entitled in exchange for those goods or services. In doing so, companies will need to use more judgment and make more estimates than under previous guidance. These may include identifying performance obligations in the contract, estimating the amount of variable consideration to include in the transaction price and allocating the transaction price to each separate performance obligations. 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 consolidated financial statements and disclosures. | |
We do not believe there would have been a material effect on the accompanying consolidated financial statements had any other recently issued, but not yet effective, accounting standards been adopted in the current period. |
SUMMARY_OF_SIGNIFICANT_ACCOUNT
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | 3 Months Ended | ||
Mar. 31, 2015 | |||
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: | |||
· | 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 months ended March 31, 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 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 March 31, 2015 and 2014, we had no assets or liabilities that were valued at fair value on a recurring basis. | |||
The fair value of indefinite-lived assets or long-lived assets is measured on a non-recurring basis using significant unobservable inputs (Level 3) in connection with the Company’s impairment test. There was no impairment of intangible assets or long-lived assets during the three months ended March 31, 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 $995,144 and $1,175,082, at March 31, 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 March 31, 2015, we classified $651,567 of the accrued clinical study costs as 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. |
INVENTORY
INVENTORY | 3 Months Ended | ||||||||
Mar. 31, 2015 | |||||||||
Inventory Disclosure [Abstract] | |||||||||
INVENTORY | NOTE 4 – INVENTORY | ||||||||
Inventory consists of the following: | |||||||||
March 31, 2015 | December 31, 2014 | ||||||||
Finished product | $ | 789,174 | $ | 874,294 | |||||
Raw material | 170,014 | 155,341 | |||||||
Deferred costs | — | 152,478 | |||||||
TOTAL INVENTORY | $ | 959,188 | $ | 1,182,113 |
OTHER_CURRENT_ASSETS
OTHER CURRENT ASSETS | 3 Months Ended | ||||||||
Mar. 31, 2015 | |||||||||
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] | |||||||||
OTHER CURRENT ASSETS | NOTE 5 – OTHER CURRENT ASSETS | ||||||||
Other current assets consist of the following: | |||||||||
March 31, 2015 | December 31, 2014 | ||||||||
Prepaid consulting | $ | 411,864 | $ | 411,864 | |||||
Other receivables-related party (Note 13) | 249,981 | 249,981 | |||||||
Prepaid insurance | 237,867 | 394,878 | |||||||
Prepaid research and development costs | 222,526 | 299,498 | |||||||
Prepaid vendor deposits | 171,374 | — | |||||||
Other prepaid costs | 152,383 | 181,186 | |||||||
TOTAL OTHER CURRENT ASSETS | $ | 1,445,995 | $ | 1,537,407 |
FIXED_ASSETS
FIXED ASSETS | 3 Months Ended | ||||||||
Mar. 31, 2015 | |||||||||
Property, Plant and Equipment [Abstract] | |||||||||
FIXED ASSETS | NOTE 6 – FIXED ASSETS | ||||||||
Fixed assets consist of the following: | |||||||||
March 31, 2015 | 31-Dec-14 | ||||||||
Equipment | $ | 132,150 | $ | 132,150 | |||||
Furniture and fixtures | 53,895 | 53,895 | |||||||
186,045 | 186,045 | ||||||||
Accumulated depreciation | (129,633 | ) | (122,752 | ) | |||||
TOTAL FIXED ASSETS | $ | 56,412 | $ | 63,293 | |||||
Depreciation expense for the three months ended March 31, 2015 and 2014 was $6,881 and $7,122 respectively. |
PREPAID_EXPENSE
PREPAID EXPENSE | 3 Months Ended | ||||||||
Mar. 31, 2015 | |||||||||
Prepaid Expense and Other Assets [Abstract] | |||||||||
PREPAID EXPENSE | NOTE 7 – PREPAID EXPENSE | ||||||||
Prepaid expense consists of the following: | |||||||||
March 31, 2015 | 31-Dec-14 | ||||||||
Prepaid manufacturing costs | $ | 899,000 | $ | 899,000 | |||||
Prepaid research and development costs | 360,754 | 463,720 | |||||||
Accreted prepaid costs | 74,385 | 64,543 | |||||||
TOTAL PREPAID EXPENSE | $ | 1,334,139 | $ | 1,427,263 |
INTANGIBLE_ASSETS
INTANGIBLE ASSETS | 3 Months Ended | ||||||||||||||||
Mar. 31, 2015 | |||||||||||||||||
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 March 31, 2015 and December 31, 2014: | |||||||||||||||||
31-Mar-15 | |||||||||||||||||
Gross Carrying Amount | Accumulated Amortization | Net | Weighted- Average Amortization Period (yrs.) | ||||||||||||||
Amount | |||||||||||||||||
Amortizing intangible assets: | |||||||||||||||||
OPERA® software patent | $ | 31,951 | $ | (2,995 | ) | $ | 28,956 | 14.5 | |||||||||
Development costs of corporate website | 91,743 | (91,743 | ) | — | n/a | ||||||||||||
Approved hormone therapy drug candidate patents | 439,184 | (25,593 | ) | 413,591 | 17.75 | ||||||||||||
Non-amortizing intangible assets: | |||||||||||||||||
Hormone therapy drug candidate patents (pending) | 691,465 | — | 691,465 | n/a | |||||||||||||
Multiple trademarks for vitamins/supplements | 124,738 | — | 124,738 | n/a | |||||||||||||
Total | $ | 1,379,081 | $ | (120,331 | ) | $ | 1,258,750 | ||||||||||
31-Dec-14 | |||||||||||||||||
Gross Carrying Amount | Accumulated Amortization | Net | Weighted- Average Amortization Period (yrs.) | ||||||||||||||
Amount | |||||||||||||||||
Amortizing intangible assets: | |||||||||||||||||
OPERA® software patent | $ | 31,951 | $ | (2,496 | ) | $ | 29,455 | 14.75 | |||||||||
Development costs of corporate website | 91,743 | (91,743 | ) | — | n/a | ||||||||||||
Approved hormone therapy drug candidate patents | 439,184 | (19,401 | ) | 419,783 | 18 | ||||||||||||
Non-amortizing intangible assets: | |||||||||||||||||
Hormone therapy drug candidate patents (pending) | 675,982 | — | 675,982 | n/a | |||||||||||||
Multiple trademarks for vitamins/supplements | 103,368 | — | 103,368 | n/a | |||||||||||||
Total | $ | 1,342,228 | $ | (113,640 | ) | $ | 1,228,588 | ||||||||||
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. The average enforceable life of patents is 20 years. We amortize the intangible asset related to OPERA® using the straight-line method over the estimated remaining useful life of approximately 15 years. 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 months ended March 31, 2015 and 2014, there was no impairment recognized. | |||||||||||||||||
In addition to numerous pending patent applications, as of March 31, 2015, we had nine issued patents, including: | |||||||||||||||||
• | one method patent that relates to our OPERA® information technology platform, which is owned by us and is a U.S. jurisdiction patent with an expiration date in 2029; | ||||||||||||||||
• | eight utility patents that relate to our combination progesterone and estradiol formulations, which are owned by us and are U.S. jurisdiction patents with expiration dates in 2032. We have pending patent applications with respect to certain of these patents in Argentina, Australia, Canada, the European Union, Israel, Mexico, Brazil, Japan, Russia, South Africa and South Korea. | ||||||||||||||||
Subsequent to March 31, 2015, two additional patents were issued related to our combination progesterone and estradiol formulations. | |||||||||||||||||
Amortization expense was $6,691 and $5,946 for the three months ended March 31, 2015 and 2014, respectively. Estimated amortization expense for the next five years is as follows: | |||||||||||||||||
Year Ending | Estimated | ||||||||||||||||
December 31, | Amortization | ||||||||||||||||
2015 (9 months) | $ | 20,074 | |||||||||||||||
2016 | $ | 26,765 | |||||||||||||||
2017 | $ | 26,765 | |||||||||||||||
2018 | $ | 26,765 | |||||||||||||||
2019 | $ | 26,765 | |||||||||||||||
OTHER_CURRENT_LIABILITIES
OTHER CURRENT LIABILITIES | 3 Months Ended | ||||||||
Mar. 31, 2015 | |||||||||
Other Liabilities Disclosure [Abstract] | |||||||||
OTHER CURRENT LIABILITIES | NOTE 9 – OTHER CURRENT LIABILITIES | ||||||||
Other current liabilities consist of the following: | |||||||||
March 31, 2015 | 31-Dec-14 | ||||||||
Accrued clinical trial costs | $ | 2,672,962 | $ | 1,706,542 | |||||
Accrued payroll, bonuses and commission costs | 900,662 | 814,205 | |||||||
Accrued vacation costs | 429,740 | 442,430 | |||||||
Accrued legal and accounting expense | 114,760 | 276,470 | |||||||
Other accrued expenses(1) | 312,181 | 185,965 | |||||||
Allowance for wholesale distributor fees | 121,469 | 160,503 | |||||||
Accrued royalties | 53,415 | 72,710 | |||||||
Allowance for coupons and returns | 184,521 | 90,446 | |||||||
Accrued rent | 89,742 | 91,368 | |||||||
TOTAL OTHER CURRENT LIABILITIES | $ | 4,879,452 | $ | 3,840,639 | |||||
____________ | |||||||||
-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 March 31, 2015 and December 31, 2014. |
NET_LOSS_PER_SHARE
NET LOSS PER SHARE | 3 Months Ended | ||||||||
Mar. 31, 2015 | |||||||||
Net Loss Per Share | |||||||||
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 months ended March 31, 2015 and 2014. | |||||||||
Since we are in a net loss position, we have excluded outstanding stock options and restricted stock units, 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. | |||||||||
Three months ended | |||||||||
31-Mar-15 | 31-Mar-14 | ||||||||
Stock options | 17,586,109 | 16,511,006 | |||||||
Warrants | 13,002,431 | 14,293,499 | |||||||
Restricted stock units | — | 50,000 | |||||||
30,588,540 | 30,854,505 |
STOCKHOLDERS_EQUITY
STOCKHOLDERS' EQUITY | 3 Months Ended | ||||||||||||||||
Mar. 31, 2015 | |||||||||||||||||
Stockholders' Equity: | |||||||||||||||||
STOCKHOLDERS' EQUITY | NOTE 11 – STOCKHOLDERS’ EQUITY | ||||||||||||||||
Preferred Stock | |||||||||||||||||
At March 31, 2015, we had 10,000,000 shares of Preferred Stock, par value $0.001, authorized for issuance, of which no shares of Preferred Stock were issued or outstanding. | |||||||||||||||||
Common Stock | |||||||||||||||||
At March 31, 2015, we had 250,000,000 shares of Common Stock authorized, of which 172,651,036 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. | |||||||||||||||||
During the three months ended March 31, 2015, a certain individual exercised stock options to purchase 11,250 shares of Common Stock for $7,208 in cash. During the three months ended March 31, 2015, an outside service provider exercised warrants to purchase 925,485 of our Common Stock for $358,400 in cash. | |||||||||||||||||
During the three months ended March 31, 2014, certain individuals exercised stock options to purchase 90,303 shares of Common Stock. Stock options to purchase shares of Common Stock were exercised as follows: (1) 88,736 shares for $40,055 in cash and (ii) 1,567 shares, pursuant to the stock options’ cashless provision, wherein 1,433 shares were cancelled. | |||||||||||||||||
Warrants to Purchase Common Stock | |||||||||||||||||
As of March 31, 2015, we had warrants outstanding to purchase an aggregate of 13,002,431 shares of Common Stock with a weighted-average contractual remaining life of 2.5 years, and exercise prices ranging from $0.24 to $3.20 per share, resulting in a weighted average exercise price of $1.92 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 three months ended March 31, 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 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 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: | |||||||||||||||||
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 five 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 five years; a volatility of 45.84%; risk free rate of 1.41%; and a dividend yield of 0%. We recorded $154,068 as prepaid expense-short term and $38,509 as prepaid expense-long term in the accompanying consolidated financial statements. During both three months ended March 31, 2015 and 2014, we recorded $38,517 as non-cash compensation in the accompanying consolidated financial statements; and | ||||||||||||||||
3 | 283,334 shares will vest upon the receipt by us of any final FDA approval of a drug candidate that SCI helped us design. It is anticipated that this event will not occur before December 2015. | ||||||||||||||||
During the three months ended March 31, 2015 and 2014, we did not grant any warrants. As of March 31, 2015, unamortized costs associated with the SCI warrants issued in 2013 and 2012 totaled approximately $773,000. | |||||||||||||||||
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. As of March 31, 2015, there were non-qualified stock options to purchase 15,617,635 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 March 31, 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 three months ended March 31, 2015 and 2014 are set forth in the table below. | |||||||||||||||||
Three Months | Three Months | ||||||||||||||||
Ended | Ended | ||||||||||||||||
March 31, | March 31, | ||||||||||||||||
2015 | 2014 | ||||||||||||||||
Risk-free interest rate | 1.47 | % | 1.70-1.75 | % | |||||||||||||
Volatility | 58.78-62.59 | % | 69.15-70.76 | % | |||||||||||||
Term (in years) | 5.27-6.25 | 5.5-6.25 | |||||||||||||||
Dividend yield | 0 | % | 0 | % | |||||||||||||
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: | |||||||||||||||||
Number of Shares Underlying Stock | Weighted Average Exercise Price | Weighted Average Remaining Contractual Life in Years | Aggregate Intrinsic Value | ||||||||||||||
Options | |||||||||||||||||
Balance at December 31, 2014 | 16,792,443 | $ | 1.88 | 6.92 | $ | 43,996,311 | |||||||||||
Granted | 919,500 | $ | 5.92 | ||||||||||||||
Exercised | (11,250 | ) | $ | 0.64 | |||||||||||||
Cancelled | (114,584 | ) | $ | 2.82 | |||||||||||||
Balance at March 31, 2015 | 17,586,109 | $ | 2.09 | 6.53 | $ | 69,714,593 | |||||||||||
Vested and Exercisable at | 13,701,873 | $ | 1.5 | 5.89 | $ | 62,312,047 | |||||||||||
31-Mar-15 | |||||||||||||||||
At March 31, 2015, our outstanding stock options had exercise prices ranging from $0.10 to $5.92 per share. | |||||||||||||||||
Share-based compensation expense for options recognized in our results for the three months ended March 31, 2015 and 2014 ($728,426 and $1,006,025, respectively) is based on vested awards. 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 March 31, 2015, total unrecognized estimated compensation expense related to unvested options granted prior to that date was approximately $7,209,000 which may be adjusted for future changes in forfeitures. This cost is expected to be recognized over a weighted-average period of 2.1 years. No tax benefit was realized due to a continued pattern of operating losses. |
INCOME_TAXES
INCOME TAXES | 3 Months Ended |
Mar. 31, 2015 | |
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 three months ended March 31, 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 March 31, 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. |
RELATED_PARTIES
RELATED PARTIES | 3 Months Ended |
Mar. 31, 2015 | |
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 three months ended March 31, 2015 and 2014, we did not engage in any transactions with Pernix. At March 31, 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 $249,981 at both March 31, 2015 and December 31, 2014. |
BUSINESS_CONCENTRATIONS
BUSINESS CONCENTRATIONS | 3 Months Ended |
Mar. 31, 2015 | |
Risks and Uncertainties [Abstract] | |
BUSINESS CONCENTRATIONS | NOTE 14 – BUSINESS CONCENTRATIONS |
We purchase our products from several suppliers with approximately 95% and 84% of our purchases supplied from one vendor for the three months ended March 31, 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 70.40% and 81.75% of our recognized revenue for the three months ended March 31, 2015 and 2014, respectively. | |
We had four customers that generated more than 10% of our sales for the three months ended March 31, 2015 and three customers that generated more than 10% of our sales for the three months ended March 31, 2014 – these customers are designated as customers “A”, “B”, “C” and “D”. Customers A, B, C and D generated $1,416,127, $626,731, $543,447 and $386,909 in sales, respectively for the three months ended March 31, 2015 and $918,018, $0, $585,376 and $562,484 in sales, respectively, for the three months ended March 31, 2014. |
COMMITMENTS_AND_CONTINGENCIES
COMMITMENTS AND CONTINGENCIES | 3 Months Ended | ||||||
Mar. 31, 2015 | |||||||
Commitments and Contingencies Disclosure [Abstract] | |||||||
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. The lease stipulates, among other things, average base monthly rents of $30,149 (inclusive of estimated operating expenses) and sales tax, for a total future minimum payments over the life of the lease of $1,899,414. | |||||||
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 lease addendum stipulates, among other things, average base monthly rents of $9,367 (inclusive of estimated operating expenses) and sales tax, for a total future minimum payments over the life of the lease of $393,429. | |||||||
The straight line rental expense related to our current lease totaled $90,448 for each of the three months ended March 31, 2015 and 2014, partially offset by the rent income of $0 and $17,980, respectively, for sublet space. | |||||||
As of March 31, 2015, future minimum rental payments are as follows: | |||||||
Years Ending December 31, | |||||||
2015 (9 months) | $ | 362,350 | |||||
2016 | 493,790 | ||||||
2017 | 507,087 | ||||||
2018 | 388,976 | ||||||
Total minimum lease payments | 1,752,203 | ||||||
Non-cancellable sub-lease income | (—) | ||||||
Net minimum lease payments | $ | 1,752,203 |
SUMMARY_OF_SIGNIFICANT_ACCOUNT1
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies) | 3 Months Ended | ||
Mar. 31, 2015 | |||
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 months ended March 31, 2015 and 2014. | |||
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 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 March 31, 2015 and 2014, we had no assets or liabilities that were valued at fair value on a recurring basis. | |||
The fair value of indefinite-lived assets or long-lived assets is measured on a non-recurring basis using significant unobservable inputs (Level 3) in connection with the Company’s impairment test. There was no impairment of intangible assets or long-lived assets during the three months ended March 31, 2015 and 2014. | |||
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. | |||
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 $995,144 and $1,175,082, at March 31, 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 March 31, 2015, we classified $651,567 of the accrued clinical study costs as 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 | 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. |
INVENTORY_Tables
INVENTORY (Tables) | 3 Months Ended | ||||||||
Mar. 31, 2015 | |||||||||
Inventory Disclosure [Abstract] | |||||||||
Schedule of Inventory | Inventory consists of the following: | ||||||||
March 31, 2015 | December 31, 2014 | ||||||||
Finished product | $ | 789,174 | $ | 874,294 | |||||
Raw material | 170,014 | 155,341 | |||||||
Deferred costs | — | 152,478 | |||||||
TOTAL INVENTORY | $ | 959,188 | $ | 1,182,113 |
OTHER_CURRENT_ASSETS_Tables
OTHER CURRENT ASSETS (Tables) | 3 Months Ended | ||||||||
Mar. 31, 2015 | |||||||||
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] | |||||||||
Schedule of other current assets | Other current assets consist of the following: | ||||||||
March 31, 2015 | December 31, 2014 | ||||||||
Prepaid consulting | $ | 411,864 | $ | 411,864 | |||||
Other receivables-related party (Note 13) | 249,981 | 249,981 | |||||||
Prepaid insurance | 237,867 | 394,878 | |||||||
Prepaid research and development costs | 222,526 | 299,498 | |||||||
Prepaid vendor deposits | 171,374 | — | |||||||
Other prepaid costs | 152,383 | 181,186 | |||||||
TOTAL OTHER CURRENT ASSETS | $ | 1,445,995 | $ | 1,537,407 |
FIXED_ASSETS_Tables
FIXED ASSETS (Tables) | 3 Months Ended | ||||||||
Mar. 31, 2015 | |||||||||
Property, Plant and Equipment [Abstract] | |||||||||
Schedule of fixed assets | Fixed assets consist of the following: | ||||||||
March 31, 2015 | 31-Dec-14 | ||||||||
Equipment | $ | 132,150 | $ | 132,150 | |||||
Furniture and fixtures | 53,895 | 53,895 | |||||||
186,045 | 186,045 | ||||||||
Accumulated depreciation | (129,633 | ) | (122,752 | ) | |||||
TOTAL FIXED ASSETS | $ | 56,412 | $ | 63,293 |
PREPAID_EXPENSE_Tables
PREPAID EXPENSE (Tables) | 3 Months Ended | ||||||||
Mar. 31, 2015 | |||||||||
Prepaid Expense and Other Assets [Abstract] | |||||||||
Schedule of prepaid expense | Prepaid expense consists of the following: | ||||||||
March 31, 2015 | 31-Dec-14 | ||||||||
Prepaid manufacturing costs | $ | 899,000 | $ | 899,000 | |||||
Prepaid research and development costs | 360,754 | 463,720 | |||||||
Accreted prepaid costs | 74,385 | 64,543 | |||||||
TOTAL PREPAID EXPENSE | $ | 1,334,139 | $ | 1,427,263 |
INTANGIBLE_ASSETS_Tables
INTANGIBLE ASSETS (Tables) | 3 Months Ended | ||||||||||||||||
Mar. 31, 2015 | |||||||||||||||||
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 March 31, 2015 and December 31, 2014: | ||||||||||||||||
31-Mar-15 | |||||||||||||||||
Gross Carrying Amount | Accumulated Amortization | Net | Weighted- Average Amortization Period (yrs.) | ||||||||||||||
Amount | |||||||||||||||||
Amortizing intangible assets: | |||||||||||||||||
OPERA® software patent | $ | 31,951 | $ | (2,995 | ) | $ | 28,956 | 14.5 | |||||||||
Development costs of corporate website | 91,743 | (91,743 | ) | — | n/a | ||||||||||||
Approved hormone therapy drug candidate patents | 439,184 | (25,593 | ) | 413,591 | 17.75 | ||||||||||||
Non-amortizing intangible assets: | |||||||||||||||||
Hormone therapy drug candidate patents (pending) | 691,465 | — | 691,465 | n/a | |||||||||||||
Multiple trademarks for vitamins/supplements | 124,738 | — | 124,738 | n/a | |||||||||||||
Total | $ | 1,379,081 | $ | (120,331 | ) | $ | 1,258,750 | ||||||||||
31-Dec-14 | |||||||||||||||||
Gross Carrying Amount | Accumulated Amortization | Net | Weighted- Average Amortization Period (yrs.) | ||||||||||||||
Amount | |||||||||||||||||
Amortizing intangible assets: | |||||||||||||||||
OPERA® software patent | $ | 31,951 | $ | (2,496 | ) | $ | 29,455 | 14.75 | |||||||||
Development costs of corporate website | 91,743 | (91,743 | ) | — | n/a | ||||||||||||
Approved hormone therapy drug candidate patents | 439,184 | (19,401 | ) | 419,783 | 18 | ||||||||||||
Non-amortizing intangible assets: | |||||||||||||||||
Hormone therapy drug candidate patents (pending) | 675,982 | — | 675,982 | n/a | |||||||||||||
Multiple trademarks for vitamins/supplements | 103,368 | — | 103,368 | n/a | |||||||||||||
Total | $ | 1,342,228 | $ | (113,640 | ) | $ | 1,228,588 | ||||||||||
Schedule of estimated amortization expense | Estimated amortization expense for the next five years is as follows: | ||||||||||||||||
Year Ending | Estimated | ||||||||||||||||
December 31, | Amortization | ||||||||||||||||
2015 (9 months) | $ | 20,074 | |||||||||||||||
2016 | $ | 26,765 | |||||||||||||||
2017 | $ | 26,765 | |||||||||||||||
2018 | $ | 26,765 | |||||||||||||||
2019 | $ | 26,765 |
OTHER_CURRENT_LIABILITIES_Tabl
OTHER CURRENT LIABILITIES (Tables) | 3 Months Ended | ||||||||
Mar. 31, 2015 | |||||||||
Other Liabilities Disclosure [Abstract] | |||||||||
Schedule of other current liabilities | Other current liabilities consist of the following: | ||||||||
March 31, 2015 | 31-Dec-14 | ||||||||
Accrued clinical trial costs | $ | 2,672,962 | $ | 1,706,542 | |||||
Accrued payroll, bonuses and commission costs | 900,662 | 814,205 | |||||||
Accrued vacation costs | 429,740 | 442,430 | |||||||
Accrued legal and accounting expense | 114,760 | 276,470 | |||||||
Other accrued expenses(1) | 312,181 | 185,965 | |||||||
Allowance for wholesale distributor fees | 121,469 | 160,503 | |||||||
Accrued royalties | 53,415 | 72,710 | |||||||
Allowance for coupons and returns | 184,521 | 90,446 | |||||||
Accrued rent | 89,742 | 91,368 | |||||||
TOTAL OTHER CURRENT LIABILITIES | $ | 4,879,452 | $ | 3,840,639 | |||||
____________ | |||||||||
-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 March 31, 2015 and December 31, 2014. |
NET_LOSS_PER_SHARE_Tables
NET LOSS PER SHARE (Tables) | 3 Months Ended | ||||||||
Mar. 31, 2015 | |||||||||
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. | ||||||||
Three months ended | |||||||||
31-Mar-15 | 31-Mar-14 | ||||||||
Stock options | 17,586,109 | 16,511,006 | |||||||
Warrants | 13,002,431 | 14,293,499 | |||||||
Restricted stock units | — | 50,000 | |||||||
30,588,540 | 30,854,505 |
STOCKHOLDERS_EQUITY_Tables
STOCKHOLDERS' EQUITY (Tables) | 3 Months Ended | ||||||||||||||||
Mar. 31, 2015 | |||||||||||||||||
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 three months ended March 31, 2015 and 2014 are set forth in the table below. | ||||||||||||||||
Three Months | Three Months | ||||||||||||||||
Ended | Ended | ||||||||||||||||
March 31, | March 31, | ||||||||||||||||
2015 | 2014 | ||||||||||||||||
Risk-free interest rate | 1.47 | % | 1.70-1.75 | % | |||||||||||||
Volatility | 58.78-62.59 | % | 69.15-70.76 | % | |||||||||||||
Term (in years) | 5.27-6.25 | 5.5-6.25 | |||||||||||||||
Dividend yield | 0 | % | 0 | % | |||||||||||||
Schedule of option activity | A summary of activity under the 2009 and 2012 Plans and related information follows: | ||||||||||||||||
Number of Shares Underlying Stock | Weighted Average Exercise Price | Weighted Average Remaining Contractual Life in Years | Aggregate Intrinsic Value | ||||||||||||||
Options | |||||||||||||||||
Balance at December 31, 2014 | 16,792,443 | $ | 1.88 | 6.92 | $ | 43,996,311 | |||||||||||
Granted | 919,500 | $ | 5.92 | ||||||||||||||
Exercised | (11,250 | ) | $ | 0.64 | |||||||||||||
Cancelled | (114,584 | ) | $ | 2.82 | |||||||||||||
Balance at March 31, 2015 | 17,586,109 | $ | 2.09 | 6.53 | $ | 69,714,593 | |||||||||||
Vested and Exercisable at | 13,701,873 | $ | 1.5 | 5.89 | $ | 62,312,047 | |||||||||||
31-Mar-15 | |||||||||||||||||
COMMITMENTS_AND_CONTINGENCIES_
COMMITMENTS AND CONTINGENCIES (Tables) | 3 Months Ended | ||||||
Mar. 31, 2015 | |||||||
Commitments And Contingencies Tables | |||||||
Schedule of future minimum rental payments | As of March 31, 2015, future minimum rental payments are as follows: | ||||||
Years Ending December 31, | |||||||
2015 (9 months) | $ | 362,350 | |||||
2016 | 493,790 | ||||||
2017 | 507,087 | ||||||
2018 | 388,976 | ||||||
Total minimum lease payments | 1,752,203 | ||||||
Non-cancellable sub-lease income | (—) | ||||||
Net minimum lease payments | $ | 1,752,203 |
SUMMARY_OF_SIGNIFICANT_ACCOUNT2
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details Narrative) (USD $) | Mar. 31, 2015 | Dec. 31, 2014 |
Accounting Policies [Abstract] | ||
Advance payments for future research and development activities | $995,144 | $1,175,082 |
Accrued Expense-LT | $651,567 |
INVENTORY_Details
INVENTORY (Details) (USD $) | Mar. 31, 2015 | Dec. 31, 2014 |
Inventory | ||
Finished product | $789,174 | $874,294 |
Raw material | 170,014 | 155,341 |
Deferred costs | 152,478 | |
TOTAL INVENTORY | $959,188 | $1,182,113 |
OTHER_CURRENT_ASSETS_Details
OTHER CURRENT ASSETS (Details) (USD $) | Mar. 31, 2015 | Dec. 31, 2014 |
Other Current Assets | ||
Prepaid consulting | $411,864 | $411,864 |
Other receivables-related party (Note 13) | 249,981 | 249,981 |
Prepaid insurance | 237,867 | 394,878 |
Prepaid research and development costs | 222,526 | 299,498 |
Prepaid vendor deposits | 171,374 | |
Other prepaid costs | 152,383 | 181,186 |
TOTAL OTHER CURRENT ASSETS | $1,445,995 | $1,537,407 |
FIXED_ASSETS_Details_Narrative
FIXED ASSETS (Details Narrative) (USD $) | 3 Months Ended | |
Mar. 31, 2015 | Mar. 31, 2014 | |
Property, Plant and Equipment [Abstract] | ||
Depreciation Expense | $6,881 | $7,122 |
FIXED_ASSETS_Details
FIXED ASSETS (Details) (USD $) | Mar. 31, 2015 | Dec. 31, 2014 |
Fixed assets, gross | $186,045 | $186,045 |
Accumulated depreciation | -129,633 | -122,752 |
TOTAL FIXED ASSETS | 56,412 | 63,293 |
Equipment [Member] | ||
Fixed assets, gross | 132,150 | 132,150 |
Furniture and Fixtures [Member] | ||
Fixed assets, gross | $53,895 | $53,895 |
PREPAID_EXPENSE_Details
PREPAID EXPENSE (Details) (USD $) | Mar. 31, 2015 | Dec. 31, 2014 |
Other Assets | ||
Prepaid manufacturing costs | $899,000 | $899,000 |
Prepaid research and development costs | 360,754 | 463,720 |
Accreted prepaid costs | 74,385 | 64,543 |
TOTAL PREPAID EXPENSE | $1,334,139 | $1,427,263 |
INTANGIBLE_ASSETS_Details_Narr
INTANGIBLE ASSETS (Details Narrative) (USD $) | 3 Months Ended | |
Mar. 31, 2015 | Mar. 31, 2014 | |
Amortization expense | $6,691 | $5,946 |
Development costs for corporate website [Member] | ||
Amortization period | 36 months | |
OPERA software patent [Member] | ||
Amortization period | 15 years | |
Average enforecable life | 20 years | |
Approved Hormone Therapy Drug Candidate Patents [Member] | ||
Amortization period | 18 years |
INTANGIBLE_ASSETS_Details
INTANGIBLE ASSETS (Details ) (USD $) | 3 Months Ended | 12 Months Ended |
Mar. 31, 2015 | Dec. 31, 2014 | |
Finite-Lived Intangible Assets | ||
Accumulated Amortization | ($120,331) | ($113,640) |
Indefinite-Lived Intangible Assets | ||
Gross Carrying Amount | 1,379,081 | 1,342,228 |
Net Amount | 1,258,750 | 1,228,588 |
Hormone therapy drug candidate patents - Pending [Member] | ||
Indefinite-Lived Intangible Assets | ||
Gross Carrying Amount | 691,465 | 675,982 |
Net Amount | 691,465 | 675,982 |
Multiple trademarks for vitamins/supplements [Member] | ||
Indefinite-Lived Intangible Assets | ||
Gross Carrying Amount | 124,738 | 103,368 |
Net Amount | 124,738 | 103,368 |
OPERA software patent [Member] | ||
Finite-Lived Intangible Assets | ||
Gross Carrying Amount | 31,951 | 31,951 |
Accumulated Amortization | -2,995 | -2,496 |
Net Amount | 28,956 | 29,455 |
Weighted Average Amortization Period | 14 years 6 months | 14 years 9 months |
Development costs for corporate website [Member] | ||
Finite-Lived Intangible Assets | ||
Gross Carrying Amount | 91,743 | 91,743 |
Accumulated Amortization | -91,743 | -91,743 |
Net Amount | ||
Approved Hormone Therapy Drug Candidate Patents [Member] | ||
Finite-Lived Intangible Assets | ||
Gross Carrying Amount | 439,184 | 439,184 |
Accumulated Amortization | -25,593 | -19,401 |
Net Amount | $413,591 | $419,783 |
Weighted Average Amortization Period | 18 years | |
Non-Amortizing Intangible Assets [Member] | ||
Finite-Lived Intangible Assets | ||
Weighted Average Amortization Period | 17 years 9 months |
INTANGIBLE_ASSETS_Details_1
INTANGIBLE ASSETS (Details 1) (USD $) | Dec. 31, 2014 |
Estimated amortization expense for the year: | |
2015 (9 months) | $20,074 |
2016 | 26,765 |
2017 | 26,765 |
2018 | 26,765 |
2019 | $26,765 |
OTHER_CURRENT_LIABILITIES_Deta
OTHER CURRENT LIABILITIES (Details Narrative) (USD $) | Mar. 31, 2015 |
Other Liabilities Disclosure [Abstract] | |
Date dividend declared | 2008-06 |
Dividends Payable, amount per share | $0.40 |
Unclaimed dividends | $41,359 |
OTHER_CURRENT_LIABILITIES_Deta1
OTHER CURRENT LIABILITIES (Details) (USD $) | Mar. 31, 2015 | Dec. 31, 2014 | ||
Other Liabilities Disclosure [Abstract] | ||||
Accrued clinical trial costs | $2,672,962 | $1,706,542 | ||
Accrued payroll, bonuses and commission costs | 900,662 | 814,205 | ||
Accrued vacation costs | 429,740 | 442,430 | ||
Accrued legal and accounting expense | 114,760 | 276,470 | ||
Other accrued expenses | 312,181 | [1] | 185,965 | [1] |
Allowance for wholesale distributor fees | 121,469 | 160,503 | ||
Accrued royalties | 53,415 | 72,710 | ||
Allowance for coupons and returns | 184,521 | 90,446 | ||
Accrued rent | 89,742 | 91,368 | ||
TOTAL OTHER CURRENT LIABILITIES | $4,879,452 | $3,840,639 | ||
[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 March 31, 2015 and December 31, 2014. |
NET_LOSS_PER_SHARE_Details
NET LOSS PER SHARE (Details) | 3 Months Ended | |
Mar. 31, 2015 | Mar. 31, 2014 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Anti-dilutive shares excluded from earnings per share calculation | 30,588,540 | 30,854,505 |
Stock Option [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Anti-dilutive shares excluded from earnings per share calculation | 17,586,109 | 16,511,006 |
Warrants [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Anti-dilutive shares excluded from earnings per share calculation | 13,002,431 | 14,293,499 |
Restricted Stock Units [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Anti-dilutive shares excluded from earnings per share calculation | 50,000 |
STOCKHOLDERS_EQUITY_Details_Na
STOCKHOLDERS' EQUITY (Details Narrative) (USD $) | 3 Months Ended | 0 Months Ended | ||
Mar. 31, 2015 | Mar. 31, 2014 | Feb. 10, 2015 | Dec. 31, 2014 | |
Preferred stock, shares authorized | 10,000,000 | 10,000,000 | ||
Preferred stock, par value (in dollars per share) | $0.00 | $0.00 | ||
Common stock, shares authorized | 250,000,000 | 250,000,000 | ||
Common stock, shares issued | 172,651,036 | 156,097,019 | ||
Common stock, shares outstanding | 172,651,036 | 156,097,019 | ||
Numbers of options to purchase shares of common stock | 11,250 | 90,303 | ||
Numbers of portions shares issued for exercise of options, shares | 88,736 | |||
Options to purchase shares of common stock, value | $7,208 | $40,055 | ||
Numbers of options to purchase shares of common stock using cashless exercise feature | 1,567 | |||
Numbers of options to purchase shares of common stock cancelled using cashless exercise feature | 1,433 | |||
Number of shares issued in exercise of warrants | 925,485 | |||
Amount of shares issued in exercise of warrants | 358,400 | |||
Cowen and Company, LLC (Underwriters) [Member] | ||||
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 | |||
Numbers of options to purchase shares of common stock | 2,037,036 |
STOCKHOLDERS_EQUITY_Details_Na1
STOCKHOLDERS' EQUITY (Details Narrative 1) (USD $) | 3 Months Ended | 1 Months Ended | 0 Months Ended | 3 Months Ended | 1 Months Ended | ||
Mar. 31, 2015 | 31-May-13 | Jun. 30, 2013 | 11-May-13 | Mar. 31, 2014 | Jan. 31, 2013 | Dec. 31, 2014 | |
Warrants: | |||||||
Warrants outstanding | $13,002,431 | ||||||
Weighted-average contractual remaining life | 2 years 6 months | ||||||
Prepaid expense-long term | 1,334,139 | 1,427,263 | |||||
Sancilio and Company Warrants [Member] | |||||||
Warrants: | |||||||
Exercise price of warrants (in dollars per share) | $2.01 | ||||||
Unamortized costs of warrants | 773,000 | ||||||
Number of shares purchased | 850,000 | ||||||
Number of shares purchased forfeit | 833,000 | ||||||
Sancilio & Company Warrants 1st Installments [Member] | |||||||
Warrants: | |||||||
Number of shares purchased | 283,333 | ||||||
Vesting date of warrants | 30-Jun-13 | ||||||
Fair value of warrants | 405,066 | ||||||
Expected term | 5 years | ||||||
Volatility rate | 45.89% | ||||||
Risk free rate | 1.12% | ||||||
Dividend yield | 0.00% | ||||||
Valuation method of warrants | Black-Scholes Model | ||||||
Non-cash compensation recongised | 405,066 | ||||||
Sancilio and Company Warrants 2nd Installments [Member] | |||||||
Warrants: | |||||||
Number of shares purchased | 283,333 | ||||||
Fair value of warrants | 462,196 | ||||||
Expected term | 5 years | ||||||
Volatility rate | 45.84% | ||||||
Risk free rate | 1.41% | ||||||
Dividend yield | 0.00% | ||||||
Non-cash compensation recongised | 38,517 | 38,517 | |||||
Prepaid expense-short term | 154,068 | ||||||
Prepaid expense-long term | 38,509 | ||||||
Sancilio and Company Warrants 3rd Installments [Member] | |||||||
Warrants: | |||||||
Number of shares purchased | 283,334 | ||||||
Multiple Advance Revolving Credit Note (Plato Warrant) [Member] | |||||||
Warrants: | |||||||
Exercise price of warrants (in dollars per share) | $3.20 | ||||||
Number of shares purchased | 1,250,000 | ||||||
Expiration date of warrants | 31-Jan-19 | ||||||
Vesting date of warrants | 31-Oct-13 | ||||||
Fair value of warrants | 1,711,956 | ||||||
Expected term | 6 years | ||||||
Volatility rate | 44.29% | ||||||
Risk free rate | 0.88% | ||||||
Dividend yield | 0.00% | ||||||
Amortization deferred financing costs | $0 | $260,027 | |||||
Minimum [Member] | |||||||
Warrants: | |||||||
Exercise price of warrants (in dollars per share) | $0.24 | ||||||
Maximum [Member] | |||||||
Warrants: | |||||||
Exercise price of warrants (in dollars per share) | $3.20 | ||||||
Weighted Average [Member] | |||||||
Warrants: | |||||||
Exercise price of warrants (in dollars per share) | $1.92 |
STOCKHOLDERS_EQUITY_Details_Na2
STOCKHOLDERS' EQUITY (Details Narrative 2) (USD $) | 3 Months Ended | ||
Mar. 31, 2015 | Mar. 31, 2014 | Dec. 31, 2014 | |
Numbers of options oustanding | 17,586,109 | 16,792,443 | |
Option exercise prices (in dollars per shares) | $2.09 | $1.88 | |
Share-based compensation expense | $728,426 | $1,006,025 | |
Total unrecognized estimated compensation expense | $7,209,000 | ||
Recognized weighted-average period | 1 year 215 days | ||
Minimum [Member] | |||
Option exercise prices (in dollars per shares) | $0.10 | ||
Maximum [Member] | |||
Option exercise prices (in dollars per shares) | $5.92 | ||
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 | 15,617,635 | ||
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 |
STOCKHOLDERS_EQUITY_Details
STOCKHOLDERS' EQUITY (Details) (Stock Options [Member]) | 3 Months Ended | |
Mar. 31, 2015 | Mar. 31, 2014 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Risk-free interest rate | 1.47% | |
Minimum [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Risk-free interest rate | 1.70% | |
Expected Volatility | 58.78% | 69.15% |
Expected term | 5 years 3 months 7 days | 5 years 6 months |
Maximum [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Risk-free interest rate | 1.75% | |
Expected Volatility | 62.59% | 70.76% |
Expected term | 6 years 3 months | 6 years 3 months |
STOCKHOLDERS_EQUITY_Details_1
STOCKHOLDERS' EQUITY (Details 1) (USD $) | 3 Months Ended | |
Mar. 31, 2015 | Mar. 31, 2014 | |
Number Options | ||
Options outstanding, beginning | 16,792,443 | |
Options Granted | 919,500 | |
Options Exercised | -11,250 | -90,303 |
Options Cancelled | -114,584 | |
Options outstanding, ending | 17,586,109 | |
Vested and exercisable | 13,701,873 | |
Weighted Average Exercise Price | ||
Options outstanding, beginning | $1.88 | |
Granted | $5.92 | |
Exercised | $0.64 | |
Cancelled | $2.82 | |
Options outstanding, ending | $2.09 | |
Vested and exercisable | $1.50 | |
Weighted Average Remaining Contractual Life | ||
Options outstanding, beginning | 6 years 11 months 12 days | |
Options outstanding, ending | 6 years 6 months 10 days | |
Vested and exercisable | 5 years 10 months 20 days | |
Aggregate Intrinsic Value | ||
Options outstanding, beginning | $43,996,311 | |
Options outstanding, ending | 69,714,593 | |
Vested and exercisable | $62,312,047 |
RELATED_PARTIES_Details_Narrat
RELATED PARTIES (Details Narrative) (Pernix Therapeutics LLC [Member], USD $) | Mar. 30, 2015 | Dec. 31, 2014 |
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) (USD $) | 3 Months Ended | |
Mar. 31, 2015 | Mar. 31, 2014 | |
Concentration Risk [Line Items] | ||
Revenues | $4,475,049 | $2,830,533 |
Customer Concentration Risk [Member] | ||
Concentration Risk [Line Items] | ||
Concentration Risk | 95.00% | 84.00% |
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 | 70.40% | 81.75% |
Customer A [Member] | Sales Revenue [Member] | ||
Concentration Risk [Line Items] | ||
Revenues | 1,416,127 | 918,018 |
Customer B [Member] | Sales Revenue [Member] | ||
Concentration Risk [Line Items] | ||
Revenues | 626,731 | 0 |
Customer C [Member] | Sales Revenue [Member] | ||
Concentration Risk [Line Items] | ||
Revenues | 543,447 | 585,376 |
Customer D [Member] | Sales Revenue [Member] | ||
Concentration Risk [Line Items] | ||
Revenues | $386,909 | $562,484 |
COMMITMENTS_AND_CONTINGENCIES_1
COMMITMENTS AND CONTINGENCIES (Details Narrative) (USD $) | 3 Months Ended | |
Mar. 31, 2015 | Mar. 31, 2014 | |
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 | |
Rental Expense | 90,448 | 90,448 |
Rental income | 17,980 | |
Monthly Base rent of additional leases agreement | 9,367 | |
Future minimum lease payments over life of additional leases agreement | $393,429 |
COMMITMENTS_AND_CONTINGENCIES_2
COMMITMENTS AND CONTINGENCIES (Details) (USD $) | Mar. 31, 2015 |
Future minimum rental payments, year ending December 31, | |
2015 | $362,350 |
2016 | 493,790 |
2017 | 507,087 |
2018 | 388,976 |
Total minimum lease payments | 1,752,203 |
Non-cancellable sub-lease income | |
Net minimum lease payments | $1,752,203 |