Document and Entity Information
Document and Entity Information - USD ($) | 12 Months Ended | ||
Dec. 31, 2016 | Apr. 17, 2017 | Jun. 30, 2016 | |
Entity Information [Line Items] | |||
Entity Registrant Name | ULURU Inc. | ||
Entity Central Index Key | 1,168,220 | ||
Current Fiscal Year End Date | --12-31 | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
Entity Current Reporting Status | Yes | ||
Entity Filer Category | Smaller Reporting Company | ||
Entity Public Float | $ 2,843,000 | ||
Document Fiscal Year Focus | 2,016 | ||
Document Fiscal Period Focus | FY | ||
Document Type | 10-K | ||
Amendment Flag | false | ||
Document Period End Date | Dec. 31, 2016 | ||
Common Stock [Member] | |||
Entity Information [Line Items] | |||
Entity Common Stock, Shares Outstanding | 76,349,431 | ||
Series A Preferred Stock [Member] | |||
Entity Information [Line Items] | |||
Entity Common Stock, Shares Outstanding | 0 | ||
Series B Preferred Stock [Member] | |||
Entity Information [Line Items] | |||
Entity Common Stock, Shares Outstanding | 1,250 |
CONSOLIDATED BALANCE SHEETS
CONSOLIDATED BALANCE SHEETS - USD ($) | Dec. 31, 2016 | Dec. 31, 2015 |
Current Assets | ||
Cash and cash equivalents | $ 36,615 | $ 180,000 |
Accounts receivable, net | 61,788 | 89,378 |
Accounts receivable - related party, net | 0 | 2,805 |
Inventory | 559,600 | 531,421 |
Prepaid expenses and deferred charges | 135,394 | 123,201 |
Total Current Assets | 793,397 | 926,805 |
Property, Equipment and Leasehold Improvements, net | 126,741 | 257,417 |
Other Assets | ||
Intangible asset - patents, net | 216,781 | 2,720,541 |
Intangible asset - licensing rights, net | 3,181,087 | 3,506,235 |
Deposits | 18,069 | 18,069 |
Total Other Assets | 3,415,937 | 6,244,845 |
TOTAL ASSETS | 4,336,075 | 7,429,067 |
Current Liabilities | ||
Accounts payable | 2,026,671 | 1,780,197 |
Accrued liabilities | 315,300 | 402,214 |
Accrued interest | 53 | 0 |
Promissory note payable, current portion | 20,000 | 0 |
Promissory note payable, net of unamortized debt discount and debt issuance costs, current portion | 0 | 315,058 |
Deferred revenue, current portion | 45,764 | 42,934 |
Total Current Liabilities | 2,407,788 | 2,540,403 |
Long Term Liabilities | ||
Deferred revenue, net of current portion | 358,462 | 685,287 |
Total Long Term Liabilities | 358,462 | 685,287 |
TOTAL LIABILITIES | 2,766,250 | 3,225,690 |
COMMITMENTS AND CONTINGENCIES | ||
STOCKHOLDERS' EQUITY | ||
Preferred stock - $0.001 par value; 20,000 shares authorized; Preferred Stock Series A, 1,000 shares designated; no shares issued and outstanding at December 31, 2016 and December 31, 2015, respectively | 0 | 0 |
Common Stock - $0.001 par value; 200,000,000 shares authorized; 62,974,431 and 36,834,933 shares issued and outstanding at December 31, 2016 and December 31, 2015, respectively | 62,974 | 36,835 |
Additional paid-in capital | 62,220,850 | 60,426,915 |
Accumulated (deficit) | (60,713,999) | (56,260,373) |
TOTAL STOCKHOLDERS' EQUITY | 1,569,825 | 4,203,377 |
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY | $ 4,336,075 | $ 7,429,067 |
CONSOLIDATED BALANCE SHEETS (Pa
CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares | Dec. 31, 2016 | Dec. 31, 2015 |
STOCKHOLDERS' EQUITY | ||
Preferred stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized (in shares) | 20,000 | 20,000 |
Common stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Common stock, shares authorized (in shares) | 200,000,000 | 200,000,000 |
Common stock, shares issued (in shares) | 62,974,431 | 36,834,933 |
Common stock, shares outstanding (in shares) | 62,974,431 | 36,834,933 |
Series A Preferred Stock [Member] | ||
STOCKHOLDERS' EQUITY | ||
Shares designated to Series A (in shares) | 1,000 | 1,000 |
Preferred stock, shares issued (in shares) | 0 | 0 |
Preferred stock, shares outstanding (in shares) | 0 | 0 |
CONSOLIDATED STATEMENTS OF OPER
CONSOLIDATED STATEMENTS OF OPERATIONS - USD ($) | 12 Months Ended | |
Dec. 31, 2016 | Dec. 31, 2015 | |
Revenues | ||
License fees | $ 363,995 | $ 207,832 |
Royalty income | 0 | 12,046 |
Product sales, net | 78,570 | 715,861 |
Total Revenues | 442,565 | 935,739 |
Costs and Expenses | ||
Cost of product sold | 27,668 | 271,310 |
Research and development | 445,404 | 763,547 |
Selling, general and administrative | 1,308,759 | 1,680,650 |
Amortization | 801,598 | 481,419 |
Depreciation | 132,841 | 180,480 |
Impairment of intangible asset - patent | 2,027,310 | 0 |
Total Costs and Expenses | 4,743,580 | 3,377,406 |
Operating (Loss) | (4,301,015) | (2,441,667) |
Other Income (Expense) | ||
Interest and miscellaneous income | 836 | 281 |
Interest expense | (136,851) | (178,914) |
Foreign currency transaction gain (loss) | 4,279 | (79,654) |
Gain on sale of equipment | 4,125 | 0 |
Accommodation fee on promissory note | (25,000) | 0 |
(Loss) Before Income Taxes | (4,453,626) | (2,699,954) |
Income taxes | 0 | 0 |
Net (Loss) | $ (4,453,626) | $ (2,699,954) |
Basic and diluted net (loss) per common share (in dollars per share) | $ (0.08) | $ (0.10) |
Weighted average number of common shares outstanding (in shares) | 56,680,140 | 25,899,240 |
CONSOLIDATED STATEMENTS OF STOC
CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY - USD ($) | Common Stock [Member] | Additional Paid-in Capital [Member] | Accumulated (Deficit) [Member] | Total |
Balance (in shares) at Dec. 31, 2014 | 24,458,018 | |||
Balance at Dec. 31, 2014 | $ 24,458 | $ 56,289,882 | $ (53,560,419) | $ 2,753,921 |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||
Issuance of common stock in a private placement; net of fund raising costs ($198,423) (in shares) | 3,830,131 | |||
Issuance of common stock in a private placement; net of fund raising costs ($198,423) | $ 3,830 | 1,253,197 | 0 | 1,257,027 |
Issuance of common stock and warrants for acquisition of licensing rights, net of offering costs ($32,000) (in shares) | 6,536,847 | |||
Issuance of common stock and warrants for acquisition of licensing rights, net of offering costs ($32,000) | $ 6,537 | 2,452,217 | 0 | 2,458,754 |
Issuance of common stock for principle and interest due on promissory note (in shares) | 1,648,421 | |||
Issuance of common stock for principle and interest due on promissory note | $ 1,648 | 216,845 | 0 | 218,493 |
Issuance of common stock for exercise of warrant - 361,516 shares for cashless exercise of warrant shares (392,857) (in shares) | 361,516 | |||
Issuance of common stock for exercise of warrant - 361,516 shares for cashless exercise of warrant shares (392,857) | $ 362 | (362) | 0 | 0 |
Issuance of stock warrant in connection with promissory note, net of fund raising costs ($17,493) | 0 | 51,643 | 0 | 51,643 |
Offering costs adjustment - Series A preferred stock sale in 2011 | 0 | 10,509 | 0 | 10,509 |
Share-based compensation of employees | 0 | 50,277 | 0 | 50,277 |
Share-based compensation of non-employees | 0 | 102,707 | 0 | 102,707 |
Net (loss) | $ 0 | 0 | (2,699,954) | (2,699,954) |
Balance (in shares) at Dec. 31, 2015 | 36,834,933 | |||
Balance at Dec. 31, 2015 | $ 36,835 | 60,426,915 | (56,260,373) | 4,203,377 |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||
Issuance of common stock for principle and interest due on promissory note (in shares) | 694,056 | |||
Issuance of common stock for principle and interest due on promissory note | $ 694 | 53,019 | 0 | 53,713 |
Offering costs adjustment - Series A preferred stock sale in 2011 | 0 | |||
Offering costs associated with issuance of common stock and warrants | $ 0 | (21,950) | 0 | (21,950) |
Issuance of common stock and warrants in a private placement, net of fund raising costs ($67,663) (in shares) | 25,245,442 | |||
Issuance of common stock and warrants in a private placement, net of fund raising costs ($67,663) | $ 25,245 | 1,707,092 | 0 | 1,732,337 |
Issuance of common stock for services (in shares) | 200,000 | |||
Issuance of common stock for services | $ 200 | 35,800 | 0 | 36,000 |
Share-based compensation of employees | 0 | 19,974 | 0 | 19,974 |
Share-based compensation of non-employees | 0 | 0 | 0 | 0 |
Net (loss) | $ 0 | 0 | (4,453,626) | (4,453,626) |
Balance (in shares) at Dec. 31, 2016 | 62,974,431 | |||
Balance at Dec. 31, 2016 | $ 62,974 | $ 62,220,850 | $ (60,713,999) | $ 1,569,825 |
CONSOLIDATED STATEMENTS OF STO6
CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY (Parenthetical) - USD ($) | 12 Months Ended | |
Dec. 31, 2016 | Dec. 31, 2015 | |
CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY [Abstract] | ||
Issuance of stock in a private placement, fund raising costs | $ (67,663) | $ (198,423) |
Offering costs associated with issuing of common stock and warrants for acquisition of licensing rights | $ (32,000) | |
Cashless exercise of warrants (in shares) | 361,516 | |
Issuance of common stock (in shares) | (392,857) | |
Issuance of stock warrant in connection with promissory note, fundraising costs | $ (17,493) |
CONSOLIDATED STATEMENTS OF CASH
CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) | 12 Months Ended | |
Dec. 31, 2016 | Dec. 31, 2015 | |
OPERATING ACTIVITIES : | ||
Net (loss) | $ (4,453,626) | $ (2,699,954) |
Adjustments to reconcile net (loss) to net cash used in operating activities: | ||
Amortization of intangible assets | 801,598 | 481,419 |
Depreciation | 132,841 | 180,480 |
Share-based compensation for stock and options issued to employees | 19,974 | 50,277 |
Share-based compensation for options issued to non-employees | 0 | 102,707 |
Amortization of debt discount on promissory note | 32,015 | 37,120 |
Amortization of debt issuance costs | 22,927 | 27,073 |
Common stock issued for interest due on promissory note | 0 | 38,493 |
Gain on sale of equipment | (4,125) | 0 |
Impairment of intangible asset - patents | 2,027,310 | 0 |
Change in operating assets and liabilities: | ||
Accounts receivable | 30,395 | (506,335) |
Inventory | (28,179) | (205,764) |
Prepaid expenses and deferred charges | (12,193) | 14,657 |
Accounts payable | 246,474 | 438,011 |
Accrued liabilities | (50,914) | 129,013 |
Accrued interest | 2,292 | 0 |
Deferred revenue | (323,995) | (169,912) |
Total | 2,896,420 | 617,239 |
Net Cash Used in Operating Activities | (1,557,206) | (2,082,715) |
INVESTING ACTIVITIES : | ||
Purchase of property and equipment | (2,165) | (5,787) |
Proceeds from sale of equipment | 4,125 | 0 |
Net Cash Provided by / Used in Investing Activities | 1,960 | (5,787) |
FINANCING ACTIVITIES : | ||
Proceeds from sale of common stock and warrants, net | 1,732,337 | 0 |
Proceeds from sale of common stock, net | 0 | 1,257,027 |
Proceeds from issuance of promissory note | 20,000 | 0 |
Proceeds from issuance of promissory note and warrant, net | 0 | 482,508 |
Repayment of principle due on promissory note | (318,526) | 0 |
Temporary working capital advance from related party | 0 | 220,000 |
Repayment of temporary working capital advance from related party | 0 | (220,000) |
Offering costs associated with issuing of common stock and warrants | (21,950) | (32,000) |
Offering cost adjustment - preferred stock sale in 2011 | 0 | 10,509 |
Net Cash Provided by Financing Activities | 1,411,861 | 1,718,044 |
Net (Decrease) in Cash | (143,385) | (370,458) |
Cash, beginning of period | 180,000 | 550,458 |
Cash, end of period | 36,615 | 180,000 |
SUPPLEMENTAL CASH FLOW DISCLOSURE: | ||
Cash paid for interest | 16,099 | 5,447 |
Non-cash investing and financing activities: | ||
Issuance of common stock for principle due on promissory note | 51,474 | 180,000 |
Issuance of common stock for interest due on promissory note | 2,239 | 0 |
Issuance of common stock for services | 36,000 | 0 |
Application of accounts receivable and accounts payable for acquisition of licensing rights in 2015 | 0 | 1,021,752 |
Issuance of common stock for acquisition of licensing rights in 2015 | $ 0 | $ 2,490,754 |
COMPANY OVERVIEW AND BASIS OF P
COMPANY OVERVIEW AND BASIS OF PRESENTATION | 12 Months Ended |
Dec. 31, 2016 | |
COMPANY OVERVIEW AND BASIS OF PRESENTATION [Abstract] | |
COMPANY OVERVIEW AND BASIS OF PRESENTATION | NOTE 1. COMPANY OVERVIEW AND BASIS OF PRESENTATION Company Overview ULURU Inc. (hereinafter “we”, “our”, “us”, “ULURU”, or the “Company”) is a Nevada corporation. We are a specialty medical technology company committed to developing and commercializing a range of innovative wound care and mucoadhesive film products based on our patented Nanoflex® and OraDisc TM Basis of Presentation The accompanying consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United State of America (“U.S. GAAP”) and include the accounts of ULURU Inc., a Nevada corporation, and its wholly-owned subsidiary, ULURU Delaware Inc., a Delaware corporation. Both companies have a December 31 fiscal year end. The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, as well as disclosure of contingent assets and liabilities at the date of the financial statements, and the reported amounts of revenues and expenses during the reporting periods. Actual results may differ from those estimates and assumptions. These differences are usually minor and are included in our consolidated financial statements as soon as they are known. Our estimates, judgments, and assumptions are continually evaluated based on available information and experience. Because of the use of estimates inherent in the financial reporting process, actual results could differ from those estimates. All intercompany transactions and balances have been eliminated in consolidation. |
SUMMARY OF SIGNIFICANT ACCOUNTI
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | 12 Months Ended |
Dec. 31, 2016 | |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES [Abstract] | |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | NOTE 2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES The following is a summary of significant accounting policies used in the preparation of these consolidated financial statements: Cash and Cash Equivalents Cash and cash equivalents include highly liquid investments with original maturities of three months or less. The carrying value of these cash equivalents approximates fair value. We invest cash in excess of immediate requirements in money market accounts, certificates of deposit, corporate commercial paper with high quality ratings, and U.S. government securities taking into consideration the need for liquidity and capital preservation. These investments are not held for trading or other speculative purposes. Accounts Receivable and Allowance for Doubtful Accounts Accounts receivable are recorded at the invoiced amount and do not bear interest. We estimate the collectability of our accounts receivable. In order to assess the collectability of these receivables, we monitor the current creditworthiness of each customer and analyze the balances aged beyond the customer's credit terms. Theses evaluations may indicate a situation in which a certain customer cannot meet its financial obligations due to deterioration of its financial viability, credit ratings or bankruptcy. The allowance requirements are based on current facts and are reevaluated and adjusted as additional information is received. Accounts receivable are subject to an allowance for collection when it is probable that the balance will not be collected. As of December 31, 2016 and 2015, the allowance for doubtful accounts was $2,679 and $100,672, respectively. For the years ended December 31, 2016 and 2015, the accounts written off as uncollectible were $72,644 and $14,347, respectively. Inventory Inventories are stated at the lower of cost or market value. Raw material inventory cost is determined on the first-in, first-out method. Costs of finished goods are determined by an actual cost method. We regularly review inventories on hand and write down the carrying value of our inventories for excess and potentially obsolete inventories based on historical usage and estimated future usage. In assessing the ultimate realization of our inventories, we are required to make judgments as to future demand requirements. As actual future demand or market conditions may vary from those projected by us, adjustment to inventories may be required. Prepaid Expenses and Deferred Charges As of December 31, 2016 and 2015, prepaid expenses were composed primarily of insurance policy costs. We amortize our insurance costs ratably over the term of each policy. Typically, our insurance policies are subject to renewal in July and October of each year. Property, Equipment and Leasehold Improvements Property, equipment, and leasehold improvements are recorded at cost. Depreciation is provided over the estimated useful lives of the related assets using the straight-line method. Estimated useful lives for property, equipment, and leasehold improvements categories are as follows: Laboratory and manufacturing equipment 7 years Computers, office equipment, and furniture 5 years Computer software 3 years Leasehold improvements Lease term Intangible Assets We expense internal patent and application costs as incurred because, even though we believe the patents and underlying processes have continuing value, the amount of future benefits to be derived from them are uncertain. Purchased patents are capitalized and amortized over the life of the patent. Licensing Rights Purchased licensing rights are capitalized and amortized over the life of the patent associated with the licensed product. Impairment of Assets In accordance with the provisions of Accounting Standards Codification (“ASC”) Topic 350-30, Intangibles Other than Goodwill, Debt Issuance Costs We defer debt issuance costs associated with the issuance of our promissory note payable and amortize those costs over the period of the promissory note obligation using the effective interest method. In 2016, we did not incur any new debt issuance costs related to our promissory note payable with Velocitas Healthcare. In 2015, we incurred $50,000 of debt issuance costs related to our promissory note payable with Inter-Mountain Capital Corp. During 2016 and 2015, we recorded amortization of approximately $23,000 and $27,000, respectively, of debt issuance costs. Unamortized debt issuance costs at December 31, 2016 and 2015 were approximately nil and $23,000, respectively. Shipping and Handling Costs Shipping and handling costs incurred for product shipments are included in cost of goods sold. Income Taxes We use the liability method of accounting for income taxes pursuant to ASC Topic 740, Income Taxes Revenue Recognition and Deferred Revenue License Fees We recognize revenue from license payments not tied to achieving a specific performance milestone ratably during the period over which we are obligated to perform services. The period over which we are obligated to perform services is estimated based on available facts and circumstances. Determination of any alteration of the performance period normally indicated by the terms of such agreements involves judgment on management's part. License revenues with no specific performance criteria are recognized when received from our foreign licensee and their various foreign sub-licensees as there is no control by us over the various foreign sub-licensees and no performance criteria to which we are subject. We recognize revenue from performance payments ratably, when such performance is substantially in our control and when we believe that completion of such performance is reasonably probable, over the period during which we estimate that we will complete such performance obligations. In circumstances where the arrangement includes a refund provision, we defer revenue recognition until the refund condition is no longer applicable unless, in our judgment, the refund circumstances are within our operating control and are unlikely to occur. Substantive at-risk milestone payments, which are based on achieving a specific performance milestone when performance of such milestone is contingent on performance by others or for which achievement cannot be reasonably estimated or assured, are recognized as revenue when the milestone is achieved and the related payment is due, provided that there is no substantial future service obligation associated with the milestone. For the year ended December 31, 2016, we recognized approximately $343,000 in licensing fees due to the one-time recognition of unamortized licensing fees related to the cancellation of distribution agreements with three distributors. For the year ended December 31, 2015, we recognized approximately $145,000 in licensing fees due to the one-time recognition of unamortized licensing fees related to the cancellation of distribution agreements with one distributor. The recognition of unamortized licensing fees is based upon the cancellation of each distribution agreements and that there are no further performance obligations that are required by the Company under each distribution agreement. Royalty Income We receive royalty revenues under license agreements with a number of third parties that sell products based on technology we have developed or to which we have rights. The license agreements provide for the payment of royalties to us based on sales of the licensed products. We record these revenues based on estimates of the sales that occurred during the relevant period. The relevant period estimates of sales are based on interim data provided by licensees and analysis of historical royalties we have been paid (adjusted for any changes in facts and circumstances, as appropriate). We maintain regular communication with our licensees in order to gauge the reasonableness of our estimates. Differences between actual royalty revenues and estimated royalty revenues are reconciled and adjusted for in the period in which they become known, typically the following quarter. Historically, adjustments have not been material based on actual amounts paid by licensees. As it relates to royalty income, there are no future performance obligations on our part under these license agreements. To the extent we do not have sufficient ability to accurately estimate revenue; we record it on a cash basis. Product Sales We recognize revenue and related costs from the sale of our products at the time the products are shipped to the customer. Provisions for returns, rebates, and discounts are established in the same period the related product sales are recorded. We review the supply levels of our products sold to major wholesalers in the U.S., primarily by reviewing reports supplied by our major wholesalers and available volume information for our products, or alternative approaches. When we believe wholesaler purchasing patterns have caused an unusual increase or decrease in the sales of a major product compared with underlying demand, we disclose this in our product sales discussion if we believe the amount is material to the product sales trend; however, we are not always able to accurately quantify the amount of stocking or destocking. Wholesaler stocking and destocking activity historically has not caused any material changes in the rate of actual product returns. We establish sales return accruals for anticipated product returns. We record the return amounts as a deduction to arrive at our net product sales. Consistent with Revenue Recognition accounting guidance, we estimate a reserve when the sales occur for future product returns related to those sales. This estimate is primarily based on historical return rates as well as specifically identified anticipated returns due to known business conditions and product expiry dates. Actual product returns have been nil over the past two years. We establish sales rebate and discount accruals in the same period as the related sales. The rebate and discount amounts are recorded as a deduction to arrive at our net product sales. We base these accruals primarily upon our historical rebate and discount payments made to our customer segment groups and the provisions of current rebate and discount contracts. Foreign currency transaction gain (loss) Our functional currency and our reporting currency is the U.S. dollar and foreign currency transactions are primarily undertaken in Euros. Monetary assets and liabilities are translated using the foreign currency exchange rate prevailing at the balance sheet date. Revenues, non-monetary assets and liabilities denominated in foreign currencies are translated at rates of foreign currency exchange in effect at the date of the transaction. Expenses are translated at average foreign currency exchange rates for the period. Gains and losses arising on translation or settlement of foreign currency denominated transactions or balances are included in the determination of net income. Research and Development Expenses Pursuant to ASC Topic 730, Research and Development Basic and Diluted Net Loss Per Common Share In accordance with ASC Topic 260, Earnings per Share Concentrations of Credit Risk Concentration of credit risk with respect to financial instruments, consisting primarily of cash and cash equivalents, that potentially expose us to concentrations of credit risk due to the use of a limited number of banking institutions and due to maintaining cash balances in banks, which, at times, may exceed the limits of amounts insured by the Federal Deposit Insurance Corporation. During 2016 and 2015, we utilized Bank of America, N.A. as our banking institution. At December 31, 2016 and December 31, 2015 our cash and cash equivalents totaled approximately $37,000 and $180,000, respectively. We also invest cash in excess of immediate requirements in money market accounts, certificates of deposit, corporate commercial paper with high quality ratings, and U.S. government securities. These investments are not held for trading or other speculative purposes. We are exposed to credit risk in the event of default by these high quality corporations. Concentration of credit risk with respect to trade accounts receivable are customers with balances that exceed 5% of total consolidated trade accounts receivable at December 31, 2016 and at December 31, 2015. As of December 31, 2016, one customer, being one of our international distributors, exceeded the 5% threshold, with 95%. One customer, being one of our international distributors, exceeded the 5% threshold at December 31, 2015, with 92%. As a result, we believe that accounts receivable credit risk exposure is limited. We maintain an allowance for doubtful accounts, but historically have not experienced any significant losses related to an individual customer or group of customers. Concentrations of Foreign Currency Risk A portion of our revenues and all of our expenses are denominated in U.S. dollars. We are expecting an increase in revenues in international territories denominated in a foreign currency. Certain of our licensing and distribution agreements in international territories are denominated in Euros. Currently, we do not employ forward contracts or other financial instruments to mitigate foreign currency risk. As our international operations continue to grow, we may engage in hedging activities to hedge our exposure to foreign currency risk. Fair Value of Financial Instruments In accordance with portions of ASC Topic 820, Fair Value Measurements Our financial instruments, including cash, cash equivalents, accounts receivable, and accounts payable are carried at cost, which approximates their fair value because of the short-term maturity of these instruments. We believe that the carrying value of our other receivable, notes receivable and accrued interest, and convertible note payable balances approximates fair value based on a valuation methodology using the income approach and a discounted cash flow model. |
THE EFFECT OF RECENTLY ISSUED A
THE EFFECT OF RECENTLY ISSUED ACCOUNTING STANDARDS | 12 Months Ended |
Dec. 31, 2016 | |
THE EFFECT OF RECENTLY ISSUED ACCOUNTING STANDARDS [Abstract] | |
THE EFFECT OF RECENTLY ISSUED ACCOUNTING STANDARDS | NOTE 3. THE EFFECT OF RECENTLY ISSUED ACCOUNTING STANDARDS In February 2016, Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2016-02, “Leases (Topic 842)”, In July 2015, FASB issued Update No. 2015-11, "Simplifying the Measurement of Inventory." In April 2015, FASB issued Update No. 2015-03, Simplifying the Presentation of Debt Issuance Costs, In August 2014, FASB issued ASU No. 2014-15, “Presentation of Financial Statements – Going Concern” In May 2014, FASB issued ASU No. 2014-09, “ Revenue from Contracts with Customers There are no other new accounting pronouncements adopted or enacted during the year ended December 31, 2016 that had, or are expected to have, a material impact on our financial statements. |
SEGMENT INFORMATION
SEGMENT INFORMATION | 12 Months Ended |
Dec. 31, 2016 | |
SEGMENT INFORMATION [Abstract] | |
SEGMENT INFORMATION | NOTE 4. SEGMENT INFORMATION Our entire business is managed by a single management team, which reports to the Chief Executive Officer. Our corporate headquarters in the United States collects proceeds from product sales, licensing fees, royalties, and sponsored research revenues from our arrangements with external customers and licensees. Our revenues are currently derived primarily from licensees for international activities and our domestic sales activities for our products. Revenues per geographic area, along with relative percentages of total revenues, for the year ended December 31, are summarized as follows: Revenues 2016 % 2015 % Domestic $ 20,326 5 % $ 28,030 3 % International 422,239 95 % 907,709 97 % Total $ 442,565 100 % $ 935,739 100 % A significant portion of our revenues are derived from a few major customers. For the year ended December 31, 2016, three customers had greater than 10% of total revenues, and jointly represented 88% of total revenues. For the year ended December 31, 2015, two customers had greater than 10% of total revenues, and jointly represented 76% of total revenues. |
INVENTORY
INVENTORY | 12 Months Ended |
Dec. 31, 2016 | |
INVENTORY [Abstract] | |
INVENTORY | NOTE 5. INVENTORY As of December 31, 2016 and 2015, our inventory was comprised of Altrazeal® finished goods, manufacturing costs incurred in the production of Altrazeal®, and raw materials. Inventories are stated at the lower of cost (first in, first out method) or net realizable value. We regularly review inventories on hand and write down the carrying value of our inventories for excess and potentially obsolete inventories based on historical usage and estimated future usage. In assessing the ultimate realization of our inventories, we are required to make judgments as to future demand requirements. As actual future demand or market conditions may vary from those projected by us, adjustment to inventories may be required. For the years ended December 31, 2016 and 2015, we wrote off approximately nil and $1,600, respectively, in obsolete inventories. The components of inventory, at the different stages of production, consisted of the following at December 31: Inventory 2016 2015 Raw materials $ 35,800 $ 38,037 Work-in-progress 424,741 485,123 Finished goods 99,059 8,261 Total $ 559,600 $ 531,421 |
PROPERTY, EQUIPMENT AND LEASEHO
PROPERTY, EQUIPMENT AND LEASEHOLD IMPROVEMENTS | 12 Months Ended |
Dec. 31, 2016 | |
PROPERTY, EQUIPMENT AND LEASEHOLD IMPROVEMENTS [Abstract] | |
PROPERTY, EQUIPMENT AND LEASEHOLD IMPROVEMENTS | NOTE 6. PROPERTY, EQUIPMENT AND LEASEHOLD IMPROVEMENTS Property, equipment and leasehold improvements, net, consisted of the following at December 31: Property, equipment and leasehold improvements 2016 2015 Laboratory equipment $ 424,888 $ 424,888 Manufacturing equipment 1,604,894 1,604,894 Computers, office equipment, and furniture 151,280 153,865 Computer software 4,108 4,108 Leasehold improvements 95,841 95,841 2,281,011 2,283,596 Less: accumulated depreciation and amortization (2,154,270 ) (2,026,179 ) Property, equipment and leasehold improvements, net $ 126,741 $ 257,417 Depreciation expense on property, equipment, and leasehold improvements was $132,841 and $180,480 for the years ended December 31, 2016 and 2015, respectively. |
INTANGIBLE ASSETS
INTANGIBLE ASSETS | 12 Months Ended |
Dec. 31, 2016 | |
INTANGIBLE ASSETS [Abstract] | |
INTANGIBLE ASSETS | NOTE 7. INTANGIBLE ASSETS Patents Intangible patent assets are composed of patents acquired in October 2005. Intangible patent assets, net consisted of the following at December 31: Intangible assets - patents 2016 2015 Patent - Amlexanox (Aphthasol®) $ 2,090,000 $ 2,090,000 Patent - Amlexanox (OraDisc™ A) 6,873,080 6,873,080 Patent - OraDisc™ 73,000 73,000 Patent - Hydrogel nanoparticle aggregate 589,858 589,858 9,625,938 9,625,938 Less: accumulated amortization (7,381,847 ) (6,905,397 ) Less: reserve for impairment (2,027,310 ) --- Intangible assets, net $ 216,781 $ 2,720,541 We performed an evaluation of our intangible patent assets for purposes of determining possible impairment as of December 31, 2016. Based upon recent market conditions and comparable market transactions for similar intangible assets, we determined that an income approach using a discounted cash flow model was an appropriate valuation methodology to determine each intangible asset’s fair value. The income approach converts future amounts to a single present value amount (discounted cash flow model). Our discounted cash flow models are highly reliant on various assumptions, including estimates of future cash flow (including long-term growth rates), discount rate, and expectations about variations in the amount and timing of cash flows and the probability of achieving the estimated cash flows, all of which we consider level 3 inputs for determination of fair value. We believe we have appropriately reflected our best estimate of the assumptions that market participants would use in determining the fair value of our intangible assets at the measurement date. Upon completion of the evaluation, the fair value of our intangible patent assets exceeded the recorded remaining book value except for the valuation of two patents; “Amlexanox (OraDisc™ A)” and “OraDisc™”. We recognized an impairment charge of $2,027,310 for the year ended December 31, 2016. Amortization expense for intangible patent assets was $476,450 and $475,148 for the years ended December 31, 2016 and 2015, respectively. The future aggregate amortization expense for intangible patent assets, remaining as of December 31, 2016, is as follows: Calendar Years Future Amortization Expense 2017 $ 37,044 2018 37,044 2019 37,044 2020 37,145 2021 37,044 2022 & Beyond 31,460 Total $ 216,781 Licensing rights On December 24, 2015, we entered into and closed the transaction contemplated by a License Purchase and Termination Agreement (the “Altrazeal Termination Agreement”) with Altrazeal Trading GmbH (“Altrazeal Trading”) and IPMD GmbH (“IPMD”). The Altrazeal Termination Agreement relates to the License and Supply Agreement dated January 11, 2012 (the “Altrazeal License”), under which Altrazeal Trading and its affiliates were authorized by the Company to distribute our Altrazeal® wound care product in the European Union, Australia, New Zealand, Middle East (excluding Jordan and Syria), North Africa, Albania, Bosnia, Croatia, Kosovo, Macedonia, Montenegro, and Serbia. Under the Altrazeal Termination Agreement, the Altrazeal License was assigned to the Company, thereby effecting its termination, and the Company’s 25% ownership interest in Altrazeal Trading was cancelled. In addition, the Company agreed to assume from Altrazeal Trading and certain affiliated entities rights and future obligations under sub-distribution agreements in numerous territories within the scope of the Altrazeal License and related consulting agreements. Under the terms of the Altrazeal Termination Agreement, we agreed to pay to Altrazeal Trading a net transfer fee of €1,570,271 and to pay IPMD a transfer fee of €703,500. The net transfer fee to Altrazeal Trading includes adjustments for amounts owed by Altrazeal Trading to the Company. The Company paid the net transfer fee (a) to Altrazeal Trading by means of the issuance of 4,441,606 shares of Common Stock together with warrants to purchase 444,161 shares of Common Stock and (b) to IPMD by means of the issuance of 2,095,241 shares of Common Stock, together with warrants to purchase 209,525 shares of Common Stock. The warrants have an exercise price of $0.68 per share and a term of one-year and, as a result, have expired. Altrazeal Trading also agreed to return inventory of Altrazeal® blisters held in its possession in an amount up to €88,834 (“Inventory Payment”). To the extent Altrazeal Trading does not return the entire inventory, we may deduct from the Inventory Payment €4.20 per Altrazeal® blister not returned in usable condition. We are currently in the process of confirming with Altrazeal Trading the actual number of Altrazeal® blisters to be returned. Under the Altrazeal Termination Agreement, we also agreed to file within twenty (20) days of closing a registration statement registering the resale of 2,500,000 shares of Common Stock issued under the Altrazeal Termination Agreement and to use all commercially reasonable efforts to cause such registration Statement to become effective. In accordance with our obligations under the Altrazeal Termination Agreement, we filed with the SEC a registration statement that was declared effective on February 16, 2016. We are required to keep the registration statement effective at all times with respect to such 2,500,000 shares, other than permitted suspension periods, until the earliest of (i) June 24, 2016, (ii) the date when Altrazeal Trading and IPMD may sell all of the registered shares under Rule 144 under the Securities Act without volume limitations, or (iii) the date when Altrazeal Trading and IPMD no longer own any of the registered shares. As of the date of this filing, shares cannot be sold under the registration statement because the associated prospectus is not current. In connection with the Altrazeal Termination Agreement, we also entered into a Mutual Termination and Release Agreement, dated December 24, 2015, for the purpose of terminating the Binding Term Sheet dated May 12, 2015 with Altrazeal Trading and Firnron LTD (the “Term Sheet”). Under the Term Sheet, it was contemplated that the Company would acquire all of the remaining equity interests in Altrazeal Trading. Intangible licensing rights, net consisted of the following at December 31: Intangible assets - licensing rights 2016 2015 European Union, Australia, New Zealand, Middle East (excluding Jordan and Syria), North Africa, Albania, Bosnia, Croatia, Kosovo, Macedonia, Montenegro, and Serbia. $ 3,512,506 $ 3,512,506 Less: accumulated amortization (331,419 ) (6,271 ) Licensing rights, net $ 3,181,087 $ 3,506,235 We performed an evaluation of our intangible licensing rights assets for purposes of determining possible impairment as of December 31, 2016. Based upon recent market conditions and comparable market transactions for similar licensing rights, we determined that an income approach using a discounted cash flow model was an appropriate valuation methodology to determine each licensing rights asset fair value. The income approach converts future amounts to a single present value amount (discounted cash flow model). Our discounted cash flow models are highly reliant on various assumptions, including estimates of future cash flow (including long-term growth rates), discount rate, and expectations about variations in the amount and timing of cash flows and the probability of achieving the estimated cash flows, all of which we consider level 3 inputs for determination of fair value. We believe we have appropriately reflected our best estimate of the assumptions that market participants would use in determining the fair value of our intangible licensing rights assets at the measurement date. Upon completion of the evaluation, the fair value of our intangible licensing rights assets exceeded the recorded remaining book value. Amortization expense for intangible licensing rights assets was $325,148 and $6,271 for the years ended December 31, 2016 and 2015, respectively. The future aggregate amortization expense for intangible licensing rights assets, remaining as of December 31, 2016, is as follows: Calendar Years Future Amortization Expense 2017 $ 325,148 2018 325,148 2019 325,148 2020 325,148 2021 325,148 2022 & Beyond 1,555,347 Total $ 3,181,087 |
INVESTMENT IN UNCONSOLIDATED SU
INVESTMENT IN UNCONSOLIDATED SUBSIDIARY | 12 Months Ended |
Dec. 31, 2016 | |
INVESTMENT IN UNCONSOLIDATED SUBSIDIARY [Abstract] | |
INVESTMENT IN UNCONSOLIDATED SUBSIDIARY | NOTE 8. INVESTMENT IN UNCONSOLIDATED SUBSIDIARY We use the equity method of accounting for investments in other companies that are not controlled by us and in which our interest is generally between 20% and 50% of the voting shares or we have significant influence over the entity, or both. Altrazeal Trading GmbH On January 11, 2012, we executed a shareholders’ agreement for the establishment of Altrazeal Trading Ltd., a single purpose entity to be used for the exclusive marketing of Altrazeal® throughout the European Union, Australia, New Zealand, North Africa, and the Middle East. As a result of this transaction, we received a non-dilutable 25% ownership interest in Altrazeal Trading Ltd. On February 1, 2014, Altrazeal Trading Ltd. transferred all of their rights and obligations under the existing shareholders’ agreement to Altrazeal Trading GmbH (“Altrazeal Trading”). As a result of this transfer, we were entitled to receive a non-dilutable 25% ownership interest in Altrazeal Trading. On December 24, 2015, we completed the Altrazeal Termination Agreement with Altrazeal Trading and IPMD as more fully described in Note 7. Under the Altrazeal Termination Agreement, our ownership interest in Altrazeal Trading was cancelled. Altrazeal AG On February 1, 2014, we executed a shareholders’ agreement with Altrazeal AG, a single purpose entity for the marketing of Altrazeal® in several territories, including Africa (markets not already licensed), Latin America, Georgia, Turkmenistan, Ukraine, the Commonwealth of Independent States, Jordan, Syria, Asia and the Pacific (excluding China, Hong Kong, Macau, Taiwan, South Korea, Japan, Australia, and New Zealand). As a result of this transaction, we were entitled to receive a non-dilutable 25% ownership interest in Altrazeal AG. In late March 2016, we provided Altrazeal AG with a notice identifying certain breaches in the Exclusive License and Supply Agreement, dated September 30, 2013 with Altrazeal AG (as amended, the “AG Agreement”). On or about March 24, 2016, we learned that Altrazeal AG had commenced an insolvency proceeding in Switzerland and immediately sent an additional notice of termination referencing the insolvency. On or about April 18, 2016, we learned that the insolvency petition filed by Altrazeal AG in Switzerland has been accepted by the court and an administrator was appointed. As a result of the breaches by Altrazeal AG in the AG Agreement, the AG Agreement has been terminated in accordance with its terms. As a result of the accepted insolvency petition, we believe that our ownership interest in Altrazeal AG is deemed to be worthless and certain net accounts receivables with Altrazeal AG are uncollectible. ORADISC GmbH On October 19, 2012, we executed a shareholders’ agreement for the establishment of ORADISC GmbH, through which OraDisc™ erodible film technology products would be developed and marketed. We were entitled to receive a non-dilutable 25% ownership interest in ORADISC GmbH. In October 2012, we also executed a License and Supply Agreement with ORADISC GmbH for the marketing of applications of our OraDisc™ erodible film technology. On December 31, 2015 we informed ORADISC GmbH that their right to use the OraDisc™ erodible film technology had expired. In March 2016, we also provided ORADISC GmbH with a notice identifying certain breaches in the License and Supply Agreement with ORADISC GmbH. As a result of the breaches by ORADISC GmbH in the License and Supply Agreement, the License and Supply Agreement has been terminated in accordance with its terms and ORADISC GmbH has ceased to be a product distributor for the Company. As a result of the termination of the License and Supply Agreement, we believe that our ownership interest in ORADISC GmbH is deemed to be worthless. |
ACCRUED LIABILITIES
ACCRUED LIABILITIES | 12 Months Ended |
Dec. 31, 2016 | |
ACCRUED LIABILITIES [Abstract] | |
ACCRUED LIABILITIES | NOTE 9. ACCRUED LIABILITIES Accrued liabilities consisted of the following at December 31: Accrued Liabilities 2016 2015 Accrued compensation/benefits $ 274,874 $ 329,131 Accrued insurance payable 40,422 73,074 Product rebates/returns 4 9 Total accrued liabilities $ 315,300 $ 402,214 |
PROMISSORY NOTE PAYABLE
PROMISSORY NOTE PAYABLE | 12 Months Ended |
Dec. 31, 2016 | |
PROMISSORY NOTE PAYABLE [Abstract] | |
PROMISSORY NOTE PAYABLE | NOTE 10. PROMISSORY NOTE PAYABLE Debt Financing – December 2016 On December 15, 2016, we issued a Promissory Note (the “December 2016 Note”) to Velocitas Partners, LLC (“Velocitas”) with a purchase price of $20,000. The December 2016 Note bears interest at the rate of 6.0% per annum with payment of principal and interest due on the earlier of (i) 180 days from the date of issuance, (ii) the date of closing of any debt or equity financing transaction by and between Uluru and Velocitas, or (iii) the payment to Uluru of certain invoices due from selected Company’s distributors. The December 2016 Note is secured by a pledge of certain product inventory and there were no debt issuance costs incurred by the Company. Subsequent to December 31, 2016, the December 2016 Note was repaid in connection with the issuance of the Initial Note under the Purchase Agreement with Velocitas. Debt Financing – April 2015 On April 15, 2015, we entered into a Securities Purchase Agreement dated April 14, 2015 (the “Inter-Mountain Purchase Agreement”) with Inter-Mountain Capital Corp. (“Inter-Mountain”) related to our issuance of a $550,000 Promissory Note (the “April 2015 Note”). The purchase price for the April 2015 Note, which reflected a $50,000 original issue discount, was $500,000. The Inter-Mountain Purchase Agreement also included representations and warranties, restrictive covenants and indemnification provisions standard for similar transactions. On August 11, 2016, the Company remitted the final installment due under the April 2015 Note and brought the balance outstanding to zero. The April 2015 Note bore interest at the rate of 10.0% per annum, with monthly installment payments of $45,000 commencing on the date that was 120 calendar days after the issuance date of the April 2015 Note. At our option, subject to certain volume, price and other conditions, the monthly installments may have been paid in whole, or in part, in cash or in Common Stock. If the monthly installments were paid in Common Stock, such shares being issued being based on a price that is 80% of the average of the three lowest volume weighted average prices of the shares of Common Stock during the preceding twenty trading days. The percentage declines to 70% if the average of the three lowest volume weighted average prices of the shares of Common Stock during the preceding twenty trading days was less than $0.05 per share. At our option, the outstanding principal balance of the April 2015 Note, or a portion thereof, may have been prepaid in cash at 120% of the amount elected to be prepaid. The April 2015 Note was unsecured and was not subject to conversion at the discretion of Inter-Mountain. Events of default under the April 2015 Note included failure to make required payments, the entry of a $100,000 judgment not stayed within 30 days, breach of representations or covenants under the transaction documents, various events associated with insolvency or failure to pay debts, delisting of the Common Stock, a restatement of financial statements and a default under certain other agreements. In the event of default, the interest rate under the April 2015 Note would have increased to 18% and the April 2015 Note becomes callable at a premium. In addition, Inter-Mountain had all remedies under law and equity. As part of the debt financing, Inter-Mountain also received a warrant (the “Warrant”) to purchase up to an aggregate of 194,118 shares of Common Stock. The Warrant has an exercise price of $0.85 per share and expires on April 30, 2020. The Warrant includes a standard net cashless exercise provision and provisions requiring proportionate adjustments in connection with a recapitalization transaction. As part of the debt financing, we entered into a Registration Rights Agreement whereby we agreed to prepare and file with the Securities and Exchange Commission (the “SEC”) a registration statement no later than May 11, 2015 and to cause such registration statement to be declared effective no later than 120 after the closing date and to keep such registration statement effective for a period of no less than 180 days. In accordance with our obligations under the Registration Rights Agreement, we filed with the SEC a registration statement that was declared effective on June 4, 2015. Such registration statement ceased to be effective in April 2016. On January 11, 2016, we executed a Waiver Agreement with Inter-Mountain. The Waiver Agreement relates to the April 2015 Note and our failure to make the installment payment under the April 2015 Note due in November 2015 on a timely basis. Subsequent installment payments with respect to 2015 and 2016 were all made on a timely basis. Under the terms of the Waiver Agreement, we agreed to remit the November 2015 installment payment of $45,000 in cash and to pay Inter-Mountain an accommodation fee of $25,000, with the accommodation fee being added to the outstanding loan balance. Using specific guidelines in accordance with U.S. GAAP, we allocated the value of the proceeds received to the promissory note and to the warrant on a relative fair value basis. We calculated the fair value of the warrant issued with the debt instrument using the Black-Scholes valuation method, using the same assumptions used for valuing employee stock options, except the contractual life of the warrant was used. Using the effective interest method, the allocated fair value of the warrant was recorded as a debt discount and is being amortized over the expected term of the promissory note to interest expense. Information relating to the April 2015 Note is as follows: As of December 31, 2016 Transaction Initial Principal Amount Interest Rate Maturity Date Conversion Price (1) Principal Balance (2) Unamortized Debt Discount Unamortized Debt Issuance Costs Carrying Value April 2015 Note $ 550,000 10.0 % 08/12/2016 --- --- --- --- Total $ 550,000 --- --- --- --- (1) As part of the April 2015 Note, at our option, subject to certain volume, price and other conditions, the monthly installments of principle and interest due under the April 2015 Note may be paid in whole, or in part, in cash or in Common Stock. If the monthly installments are paid in Common Stock, such shares being issued will be based on a price that is 80% of the average of the three lowest volume weighted average prices of the shares of Common Stock during the preceding twenty trading days. The percentage declines to 70% if the average of the three lowest volume weighted average prices of the shares of Common Stock during the preceding twenty trading days is less than $0.05 per share. (2) On August 11, 2016, the Company issued the final installment payment due under the April 2015 Note. For the year ended December 31, 2016, we remitted six installment payments in cash totaling $343,526 and have remitted one installment payment by issuing 694,056 shares of Common Stock for principal and interest due under the April 2015 Note. For the year ended December 31, 2015, we issued 1,648,421 shares of Common Stock for four installment payments of principal and interest due under the April 2015 Note. The amount of interest cost recognized from our promissory note was $14,079 and $37,110 for the years ended December 31, 2016 and 2015, respectively. The amount of debt discount amortized from our promissory note was $32,015 and $37,120 for the years ended December 31, 2016 and 2015, respectively. The amount of debt issuance costs amortized from our promissory note was $22,927 and $27,073 for the years ended December 31, 2016 and 2015, respectively. |
EQUITY TRANSACTIONS
EQUITY TRANSACTIONS | 12 Months Ended |
Dec. 31, 2016 | |
EQUITY TRANSACTIONS [Abstract] | |
EQUITY TRANSACTIONS | NOTE 11. EQUITY TRANSACTIONS Common Stock Transactions March 2016 Offering On March 29, 2016, we entered into a Stock Purchase Agreement with fifteen investors for the offer and sale of 25,245,442 shares of Common Stock and warrants to purchase an additional 25,245,442 shares of Common Stock at a purchase price of $0.0713 per unit, with each unit consisting of one share and one warrant to purchase Common Stock, for an aggregate purchase price of $1,800,000 (the “March 2016 Offering). The issue price of the shares sold was based on a 10% discount to the average closing price between March 7, 2016 and March 11, 2016 and the warrant exercise price was based on a 10% premium to the same average closing price. The warrants have an exercise price of $0.0871 per share and a five-year term. The warrants also include cashless exercise provisions and a “full ratchet” anti-dilution provision under which the exercise price of such warrants resets to any lower sales price at which the Company offers or sells Common Stock or Common Stock equivalents for one year (subject to standard exceptions). The March 2016 Offering resulted in gross proceeds of $1,800,000, of which $1,439,000 was received in March 2016 and $361,000 was received in April 2016. As part of the offering expenses, we paid to a European placement agent a referral fee of $29,000 which is equal to 10% of the gross proceeds, provided that the investors referred by such placement agent were not U.S. Persons and were solicited outside the United States. Purchasers in the March 2016 Offering include Michael I. Sacks ($1,000,000), the father of Bradley J. Sacks, the Chairman of our Board of Directors, Centric Capital Ventures, LLC ($19,000), an investment entity controlled by Bradley J. Sacks, Terrance K. Wallberg ($50,000), our Vice President and Chief Financial Officer, and Daniel G. Moro ($10,000), our Vice President of Polymer Drug Delivery. October 2015 Offering On September 6, 2015, we entered into a Securities Purchase Agreement with several institutional investors from Europe (collectively, the “Investors”) relating to an equity investment of $1,588,225 by the Investors for 4,179,539 shares of our common stock, at a per-share purchase price of $0.38 (the “October 2015 Offering”). As of the date of this Report, the October 2015 Offering has resulted in net proceeds to the Company of approximately $1,257,000, of which approximately $1,050,000 was received in October 2015 and $207,000 was received in November 2015. As part of the offering expenses, we paid to a European placement agent a referral fee equal to 12% of the gross proceeds immediately following each closing, provided that the investors are not U.S. Persons and were solicited outside the United States. We also entered into a Registration Rights Agreement with the Investors under which we agreed to prepare and file with the Securities and Exchange Commission (the “SEC”) a registration statement with respect to the resale of the Shares no later than September 26, 2015 and thereafter use all commercially reasonable efforts to cause such registration statement to become effective. In accordance with our obligations under the Registration Rights Agreement, we filed with the SEC a registration statement that was declared effective on October 9, 2015. We are required to keep such registration statement effective until the earliest of (i) the date that is six months after the Closing Date under the SPA, (ii) the date when the respective Investor may sell all of the Shares under Rule 144 without volume limitations, or (iii) the date the Investor no longer owns any of the Shares. Such registration statement has ceased to be effective. |
STOCKHOLDERS' EQUITY
STOCKHOLDERS' EQUITY | 12 Months Ended |
Dec. 31, 2016 | |
STOCKHOLDERS' EQUITY [Abstract] | |
STOCKHOLDERS' EQUITY | NOTE 12. STOCKHOLDERS’ EQUITY Common Stock As of December 31, 2016, we had 62,974,431 shares of common stock issued and outstanding. For the year ended December 31, 2016, we issued 26,139,498 shares of Common Stock composed of 25,245,442 shares of Common Stock issued to investors pursuant to the March 2016 offering, 694,056 shares of Common Stock issued for installment payments due under the April 2015 Note with Inter-Mountain, and 200,000 shares issued for consulting services related to investor relations. Preferred Stock As of December 31, 2016, we had no shares of Series A Preferred Stock (the “Series A Shares”) issued and outstanding. For the year ended December 31, 2016, we did not issue any new Series A Shares. Warrants The following table summarizes the warrants outstanding and the number of shares of common stock subject to exercise as of December 31, 2016 and the changes therein during the two years then ended: Number of Shares of Common Stock Subject to Exercise Weighted – Average Exercise Price Balance as of December 31, 2014 1,676,401 $ 1.14 Warrants issued 847,804 0.72 Warrants exercised (392,857 ) 0.35 Warrants cancelled (357,155 ) 2.85 Balance as of December 31, 2015 1,774,193 $ 0.77 Warrants issued 25,245,442 $ 0.09 Warrants exercised --- --- Warrants cancelled (840,075 ) $ 0.84 Balance as of December 31, 2016 26,179,560 $ 0.11 For the year ended December 31, 2016, we issued warrants to purchase up to an aggregate of 25,245,442 shares of our Common Stock at an exercise price of $0.0871 per shares pursuant to the March 2016 Offering. Of the warrant shares subject to exercise as of December 31, 2016, expiration of the right to exercise is as follows: Date of Expiration Number of Warrant Shares of Common Stock Subject to Expiration March 14, 2018 660,000 January 15, 2019 80,000 April 30, 2020 194,118 March 30, 2021 25,245,442 Total 26,179,560 |
EARNINGS PER SHARE
EARNINGS PER SHARE | 12 Months Ended |
Dec. 31, 2016 | |
EARNINGS PER SHARE [Abstract] | |
EARNINGS PER SHARE | NOTE 13. EARNINGS PER SHARE Basic and Diluted Net Loss Per Share In accordance with FASB Accounting Standards Codification (“ASC”) Topic 260, Earnings per Share Shares used in calculating basic and diluted net loss per common share exclude these potential common shares as of December 31: 2016 2015 Warrants to purchase Common Stock 26,179,560 1,774,193 Stock options to purchase common stock 691,237 1,664,573 Common stock issuable upon the assumed conversion of payments due under our promissory note from April 2015 (1) --- 1,934,718 Total 26,870,797 5,373,484 (1) As part of the April 2015 Note, at our option, subject to certain volume, price and other conditions, the monthly installments of principle and interest due under the April 2015 Note have been paid in whole, or in part, in cash or in Common Stock. If the monthly installments were paid in Common Stock, such shares being issued were based on a price that is 80% of the average of the three lowest volume weighted average prices of the shares of Common Stock during the preceding twenty trading days. The percentage declines to 70% if the average of the three lowest volume weighted average prices of the shares of Common Stock during the preceding twenty trading days is less than $0.05 per share. For the purposes of this Table, we have assumed that all outstanding monthly installments of principal and interest were paid in Common Stock based on a price of $0.10 per share (80% of the average of the three lowest volume weighted average prices of the shares of Common Stock during the preceding twenty trading days prior to December 31, 2015), subject to certain ownership limitations. On August 11, 2016, the Company issued the final installment payment due under the April 2015 Note. |
SHARE BASED COMPENSATION
SHARE BASED COMPENSATION | 12 Months Ended |
Dec. 31, 2016 | |
SHARE BASED COMPENSATION [Abstract] | |
SHARE BASED COMPENSATION | NOTE 14. SHARE BASED COMPENSATION The Company’s share-based compensation plan, the 2006 Equity Incentive Plan (“Incentive Plan”), is administered by the compensation committee of the Board of Directors, which selects persons to receive awards and determines the number of shares subject to each award and the terms, conditions, performance measures and other provisions of the award. Our Board did not grant any incentive stock option awards to executives or employees or any nonstatutory stock option awards to directors or non-employees for the years ended December 31, 2016 and 2015, respectively. We account for share-based compensation under FASB ASC Topic 718, Stock Compensation Stock Options (Incentive and Nonstatutory) The following table summarizes share-based compensation related to stock options for the years ended December 31: 2016 2015 Research and development $ 7,614 $ 69,028 Selling, general and administrative 12,360 83,956 Total share-based compensation expense $ 19,974 $ 152,984 At December 31, 2016, the balance of unearned share-based compensation to be expensed in future periods related to unvested stock option awards, as adjusted for expected forfeitures, is approximately $13,000. The period over which the unearned share-based compensation is expected to be recognized is approximately nine months. The following table summarizes the stock options outstanding and the number of shares of common stock subject to exercise as of December 31, 2016 and the changes therein during the two years then ended: Stock Options Weighted Average Exercise Price per Share Outstanding as of December 31, 2014 1,699,907 $ 1.73 Granted --- --- Forfeited/cancelled (35,334 ) 1.77 Exercised --- --- Outstanding as of December 31, 2015 1,664,573 $ 1.73 Granted --- --- Forfeited/cancelled (973,336 ) 1.58 Exercised --- --- Outstanding as of December 31, 2016 691,237 $ 1.94 The following table presents the stock option grants outstanding and exercisable as of December 31, 2016: Options Outstanding Options Exercisable Stock Options Outstanding Weighted Average Exercise Price per Share Weighted Average Remaining Contractual Life in Years Stock Options Exercisable Weighted Average Exercise Price per Share 422,500 $ 0.33 6.2 422,500 $ 0.33 240,000 1.15 7.7 240,000 1.15 28,737 32.28 1.2 28,737 32.28 691,237 $ 1.94 6.5 691,237 $ 1.94 Restricted Stock Awards Restricted stock awards, which typically vest over a period of six months to five years, are issued to certain key employees and are subject to forfeiture until the end of an established restriction period. We utilize the market price on the date of grant as the fair market value of restricted stock awards and expense the fair value on a straight-line basis over the vesting period. For the years ended December 31, 2016 and 2015, we did not grant any restricted stock awards. At December 31, 2016, the balance of unearned share-based compensation to be expensed in future periods related to restricted stock awards, as adjusted for expected forfeitures, is nil. Summary of Plans 2006 Equity Incentive Plan In March 2006, our Board adopted and our stockholders approved our Equity Incentive Plan, which initially provided for the issuance of up to 133,333 shares of our Common Stock pursuant to stock option and other equity awards. At the annual meetings of the stockholders held on May 8, 2007, December 17, 2009, June 15, 2010, June 14, 2012, June 13, 2013, and on June 5, 2014, our stockholders approved amendments to the Equity Incentive Plan to increase the total number of shares of Common Stock issuable under the Equity Incentive Plan pursuant to stock options and other equity awards by 266,667 shares, 200,000 shares, 200,000 shares, 400,000 shares, 600,000 shares, and 1,000,000 shares, respectively, to a total of 2,800,000 shares. In December 2006, we began issuing stock options to employees, consultants, and directors. The stock options issued generally vest over a period of one to four years and have a maximum contractual term of ten years. In January 2007, we began issuing restricted stock awards to our employees. Restricted stock awards generally vest over a period of six months to five years after the date of grant. Prior to vesting, restricted stock awards do not have dividend equivalent rights, do not have voting rights and the shares underlying the restricted stock awards are not considered issued and outstanding. Shares of Common Stock are issued on the date the restricted stock awards vest. As of December 31, 2016, we had granted options to purchase 2,061,167 shares of Common Stock since the inception of the Equity Incentive Plan, of which 691,237 were outstanding at a weighted average exercise price of $1.94 per share, and we had granted awards for 68,616 shares of restricted stock since the inception of the Equity Incentive Plan, of which none were outstanding. As of December 31, 2016, there were 2,039,317 shares that remained available for future grants under our Equity Incentive Plan. |
EMPLOYMENT BENEFIT PLAN
EMPLOYMENT BENEFIT PLAN | 12 Months Ended |
Dec. 31, 2016 | |
EMPLOYMENT BENEFIT PLAN [Abstract] | |
EMPLOYMENT BENEFIT PLAN | NOTE 15. EMPLOYMENT BENEFIT PLAN We maintain a defined contribution or 401(k) Plan for our qualified employees. Participants may contribute a percentage of their compensation on a pre-tax basis, subject to a maximum annual contribution imposed by the Internal Revenue Code. We may make discretionary matching contributions as well as discretionary profit-sharing contributions to the 401(k) Plan. Our contributions to the 401(k) Plan are made in cash and vest immediately. The Company’s common stock is not an investment option available to participants in the 401(k) Plan. We contributed $17,396 and $18,861 to the 401(k) Plan during the years ended December 31, 2016 and 2015, respectively. |
FAIR VALUE MEASUREMENTS
FAIR VALUE MEASUREMENTS | 12 Months Ended |
Dec. 31, 2016 | |
FAIR VALUE MEASUREMENTS [Abstract] | |
FAIR VALUE MEASUREMENTS | NOTE 16. FAIR VALUE MEASUREMENTS In accordance with ASC Topic 820, Fair Value Measurements Observable inputs are based on market data obtained from independent sources, while unobservable inputs are based on our market assumptions. Unobservable inputs require significant management judgment or estimation. In some cases, the inputs used to measure an asset or liability may fall into different levels of the fair value hierarchy. In those instances, the fair value measurement is required to be classified using the lowest level of input that is significant to the fair value measurement. Such determination requires significant management judgment. The three-tier value hierarchy, which prioritizes the inputs used in the valuation methodologies, is as follows: Level 1 — Valuations based on quoted prices (unadjusted) for identical assets or liabilities in active markets. Level 2 — Valuations based on observable inputs other than quoted prices in Level 1, such as quoted prices for similar assets or liabilities in active markets, quoted prices for identical or similar assets and liabilities in markets that are not active, and other inputs that are observable or can be corroborated by observable market data. Level 3 — Valuations based on unobservable inputs reflecting the Company’s own assumptions, consistent with reasonably available assumptions made by other market participants. Assets and liabilities are classified in their entirety based on the lowest level of input that is significant to the fair value measurements. We review the fair value hierarchy classification on a quarterly basis. Changes in the observability of valuation inputs may result in a reclassification of levels for certain securities within the fair value hierarchy. Our financial instruments, including cash, cash equivalents, accounts receivable, and accounts payable are carried at cost, which approximates their fair value because of the short-term maturity of these instruments. We believe that the carrying value of our notes receivable and accrued interest and convertible note payable balances approximates fair value based on a valuation methodology using the income approach and a discounted cash flow model. The fair value of our financial instruments consisted of the following at December 31: Description 2016 2015 Liabilities: Promissory note – December 2016 $ 20,000 --- Promissory note – April 2015 (1) --- $ 370,000 (1) On August 11, 2016, the Company issued the final installment payment due under the April 2015 Note. |
INCOME TAXES
INCOME TAXES | 12 Months Ended |
Dec. 31, 2016 | |
INCOME TAXES [Abstract] | |
INCOME TAXES | NOTE 17. INCOME TAXES There was no current federal tax provision or benefit recorded for any period since inception, nor were there any recorded deferred income tax assets, as such amounts were completely offset by valuation allowances. Deferred tax assets as of December 31, 2016, of $21,437,140 were reduced to zero, after considering the valuation allowance of $21,437,140, since there is no assurance of future taxable income. As of December 31, 2016 we have consolidated net operating loss carryforwards (“NOL”) and research credit carryforwards for income tax purposes of approximately $56,451,877 and $555,177, respectively. The following are the consolidated operating loss carryforwards and research credit carryforwards that will begin expiring as follows: Calendar Years Consolidated Operating Loss Carryforwards Research Activities Carryforwards 2021 $ 34,248 $ --- 2023 95,666 --- 2024 910,800 13,584 2025 1,687,528 21,563 2026 11,950,281 60,797 2027 3,431,365 85,052 2028 8,824,940 139,753 2029 6,889,761 81,940 2030 5,113,583 41,096 2031 3,728,626 43,592 2032 3,695,792 8,690 2033 3,187,559 15,882 2034 1,797,031 19,491 2035 2,594,151 21,113 2036 2,510,546 2,624 Total $ 56,451,877 $ 555,177 The Tax Reform Act of 1986 contains provisions, which limit the amount of NOL and tax credit carryforwards that companies may utilize in any one year in the event of cumulative changes in ownership over a three-year period in excess of 50%. Since the effective date of the Tax Reform Act of 1986, the Company has completed significant share issuances in 2003 and 2006 which may significantly limit our ability to utilize our NOL and tax credit carryforwards against taxable earnings in future periods. Ownership changes in future periods may place additional limits on our ability to utilize NOLs and tax credit carryforwards. An analysis of the tax effects of temporary differences that give rise to significant portions of the deferred tax assets and deferred tax liabilities at December 31, 2016 and 2015 are as follows: 2016 2015 Deferred tax assets: Net operating loss carryforwards $ 20,056,077 $ 19,179,724 Intangible assets 816,389 132,836 Other 575,065 605,231 Total gross deferred tax assets 21,447,531 19,917,791 Deferred tax liabilities: Property and equipment 10,391 12,541 Total gross deferred tax liabilities 10,391 12,541 Net total of deferred assets and liabilities 21,437,140 19,905,250 Valuation allowance (21,437,140 ) (19,905,250 ) Net deferred tax assets $ --- $ --- The valuation allowance increased by $1,531,890 and $915,874 in 2016 and 2015, respectively. The following is a reconciliation of the expected statutory federal income tax rate to our actual income tax rate for the years ended December 31: 2016 2015 Expected income tax (benefit) at federal statutory tax rate -35% $ ( 1,558,549 ) $ ( 961,543 ) Permanent differences 7,739 53,653 Research tax credits (2,624 ) (21,113 ) Amortization of deferred start up costs --- --- Valuation allowance 1,553,434 929,003 Income tax expense $ --- $ --- Effective January 1, 2007, we adopted ASC Topic 740, Accounting for Uncertainty in Income Taxes Federal income tax returns for fiscal years 2013 through 2016 remain open and subject to examination by the Internal Revenue Service. We file and remit state income taxes in various states where we have determined it is required to file state income taxes. Our filings with those states remain open for audit for the fiscal years 2013 through 2016. We do not believe there will be any material changes in our unrecognized tax positions over the next 12 months. Our policy is that we recognize interest and penalties accrued on any unrecognized tax benefits as a component of income tax expense. As of the date of adoption of ASC 740, we did not have any accrued interest or penalties associated with any unrecognized tax benefits nor were any interest expense recognized during the period. The liability for unrecognized tax benefits is zero at December 31, 2016 and 2015. |
COMMITMENTS AND CONTINGENCIES
COMMITMENTS AND CONTINGENCIES | 12 Months Ended |
Dec. 31, 2016 | |
COMMITMENTS AND CONTINGENCIES [Abstract] | |
COMMITMENTS AND CONTINGENCIES | NOTE 18. COMMITMENTS AND CONTINGENCIES Operating Leases On January 31, 2006 we entered into a lease agreement for office and laboratory space in Addison, Texas. The lease commenced on April 1, 2006 and originally continued until April 1, 2013. The lease required a minimum monthly lease obligation of $9,330, which was inclusive of monthly operating expenses, until April 1, 2011 and at such time increased to $9,776, which was inclusive of monthly operating expenses. On February 22, 2013, we executed an Amendment to Lease Agreement (the “Lease Amendment”) that renewed and extended our lease until March 31, 2015. The Lease Amendment required a minimum monthly lease obligation of $9,193, which was inclusive of monthly operating expenses, until March 31, 2014 and at such time, increased to $9,379, which was inclusive of monthly operating expenses. On March 17, 2015, we executed a Second Amendment to Lease Agreement (the “Second Amendment”) that renewed and extended our lease until March 31, 2018. The Second Amendment requires a minimum monthly lease obligation of $9,436, which is inclusive of monthly operating expenses. On December 10, 2010 we entered into a lease agreement for certain office equipment that commenced on February 1, 2011 and continued until February 1, 2015 and required a minimum lease obligation of $744 per month. On January 16, 2015 we entered into a new lease agreement for certain office equipment. The new office equipment lease, that commenced on February 1, 2015 and continues until February 1, 2018, requires a minimum lease obligation of $551 per month. The future minimum lease payments under the 2013 office lease and the 2015 equipment lease are as follows as of December 31, 2016: Calendar Years Future Lease Expense 2017 $ 120,041 2018 28,908 2019 --- 2020 --- Total $ 148,949 Rent expense for our operating leases amounted to $130,098 and $121,623 for the years ended December 31, 2016 and 2015, respectively. Indemnification In accordance with our restated articles of incorporation and our amended and restated bylaws, we have indemnification obligations to our officers and directors for certain events or occurrences, subject to certain limits, while they are serving at our request in their respective capacities. We have a director and officer insurance policy that enables us to recover a portion of any amounts paid for future potential claims. We have also entered into contractual indemnification agreements with each of our officers and directors. Related Party Transactions and Concentration On January 17, 2013, the Board of Directors of the Company appointed Helmut Kerschbaumer and Klaus Kuehne to each serve as a director of the Company. In November 2015, Helmut Kerschbaumer was appointed to serve as the interim President and Chief Executive Officer of the Company. During 2015, Mr. Kerschbaumer served as a director of Altrazeal Trading GmbH, Altrazeal AG, and Melmed Holding AG (collectively, the “Altrazeal Distributors”) and Mr. Kuehne served as a director of Altrazeal AG. In such capacities, Mr. Kerschbaumer may have been considered, either singularly or collectively, to have had control of, and make investment and business decisions on behalf of, the Altrazeal Distributors and Mr. Kuehne may have been considered, either singularly of collectively, to have had control of, and make investment and business decisions on behalf of, Altrazeal AG. As a result of the Altrazeal Termination Agreement in December 2015, Altrazeal Trading GmbH and Melmed Holding AG ceased to be product distributors for the Company. As a result of the breaches in March and April 2016 by Altrazeal AG in the AG Agreement, we believe that the AG Agreement has been cancelled and Altrazeal AG has ceased to be a product distributor for the Company. Each of Mr. Kerschbaumer and Mr. Kuehne were managing directors of ORADISC GmbH and in such capacities may be considered, either singularly or collectively, to had control of, and made investment and business decisions on behalf of the ORADISC GmbH. In April 2016, Mr. Kerschbaumer and Mr. Kuehne each resigned as a managing director of ORADISC GmbH. In October 2012, we also executed a License and Supply Agreement with ORADISC GmbH for the marketing of applications of our OraDisc™ erodible film technology. On December 31, 2015 we informed ORADISC GmbH that their right to use the OraDisc™ erodible film technology had expired. In March 2016, we also provided ORADISC GmbH with a notice identifying certain breaches in the License and Supply Agreement with ORADISC GmbH. As a result of the breaches by ORADISC GmbH in the License and Supply Agreement, the License and Supply Agreement has been terminated in accordance with its terms and ORADISC GmbH has ceased to be a product distributor for the Company. For the years ended December 31, 2016 and 2015, the Company recorded revenues, in approximate numbers, of nil and $795,000, respectively, with the various Altrazeal Distributors, which represented 0% and 85% of our total revenues. As of December 31, 2016 and 2015, Altrazeal Distributors had an outstanding net accounts receivable, in approximate numbers, of nil and $3,000, respectively, which represented 0% and 3% of our net outstanding accounts receivables. License Purchase and Termination Agreement Refer to a description in greater detail of the License Purchase and Termination Agreement in Note 7. Intangible Assets – Licensing Rights. Temporary Advances Mr. Kerschbaumer is an officer and an indirect shareholder of IPMD and Mr. Kuehne is an indirect shareholder of IPMD and may each be considered, either singularly or collectively, to have control of, and make investment and business decisions on behalf of IPMD. The Company received temporary working capital advances from IPMD of $180,000 in July 2015 and $40,000 in September 2015. The Company repaid $220,000 to IPMD in October 2015. The Company did not receive any working capital advances from IPMD in 2016. The Company received temporary working capital advances from Mr. Gray of $18,000 in April 2015, $30,000 in June 2015, and $10,300 in August 2015. The Company repaid $18,000 and $3,000 to Mr. Gray in April 2015 and September 2015, respectively. The Company did not receive any working capital advances from Mr. Gray in 2016. The Company received temporary working capital advances from Terrance K. Wallberg, the Company’s Vice President and Chief Financial Officer, of $10,000 in April 2015 and $3,000 in September 2015. The Company repaid $10,000 and $3,000 to Mr. Wallberg in April 2015 and September 2015, respectively. The Company did not receive any working capital advances from Mr. Wallberg in 2016. Related Party Obligations Since 2011, our named executive officers and certain key executives have temporarily deferred portions of their compensation as part of a plan to conserve and manage the Company’s cash and financial resources. As of December 31, 2016, the following table summarizes the amounts recognized in the Company’s financial statements related to obligations for compensation temporarily deferred by our employees. Name 2016 2015 2014 – 2011 Total Kerry P. Gray (1) (2) (3) (4) $ --- $ 275,153 $ 150,000 $ 425,153 Terrance K. Wallberg (5,207 ) 53,540 --- 48,333 Other employees (54,871 ) 54,871 --- --- Total $ (60,078 ) $ 383,564 $ 150,000 $ 473,486 (1) On November 19, 2015, Mr. Gray resigned as the Company’s President and Chief Executive Officer and on February 18, 2016 resigned as a director for the Company. (2) The Company is asserting in a dispute with Mr. Gray that amounts recorded as being owed to Mr. Gray are not in fact owed to Mr. Gray or are offset by amounts Mr. Gray owes to the Company. (3) During 2015, Mr. Gray temporarily deferred compensation of $275,153 which consisted of $51,770 earned as salary compensation for his duties as President of the Company, $186,083 for his duties as Chairman of the Executive Committee of the Company’s Board of Directors, and $37,300 as a temporary advance of working capital. (4) During 2014, Mr. Gray temporarily deferred compensation of $150,000 which consisted of $62,500 earned as salary compensation for his duties as President of the Company and $87,500 for his duties as Chairman of the Executive Committee of the Company’s Board of Directors. During 2014, Mr. Gray was also repaid $269,986 of temporarily deferred compensation, of which $100,000 was used by Mr. Gray for funding required pursuant to a Securities Purchase Agreement, dated March 14, 2013 (the “March 2013 Offering”). Prior to 2014, over a three year period Mr. Gray temporarily deferred, at various times, aggregate compensation of $582,486 and during the same time period was also repaid $312,500 of temporarily deferred compensation, of which $300,000 was used by Mr. Gray for funding required pursuant to the March 2013 Offering. As of December 31, 2016, the Company has recognized an obligation for temporarily deferred compensation of $473,486 of which $199,903 was included in accrued liabilities and $273,583 was included in accounts payable, respectively. As of December 31, 2015, the Company has recognized an obligation for temporarily deferred compensation of $533,564 of which $259,981 was included in accrued liabilities and $273,583 was included in accounts payable, respectively. Contingent Milestone Obligations We are subject to paying Access Pharmaceuticals, Inc. (“Access”) for certain milestones based on our achievement of certain annual net sales, cumulative net sales, and/or our having reached certain defined technology milestones including licensing agreements and advancing products to clinical development. As of December 31, 2016, the future milestone obligations that we are subject to paying Access, if the milestones related thereto are achieved, total $4,750,000. Such milestones are based on total annual sales of 20 and 40 million dollars of certain products, annual sales of 20 million dollars of any one certain product, and cumulative sales of such products of 50 and 100 million dollars. On March 7, 2008, we terminated the license agreement with ProStrakan Ltd. for Amlexanox-related products in the United Kingdom and Ireland. As part of the termination, we agreed to pay ProStrakan Ltd. a royalty of 30% on any future payments received by us from a new licensee in the United Kingdom and Ireland territories, up to a maximum of $1,400,000. On November 17, 2008, we entered into a licensing agreement for Amlexanox-related product rights to the United Kingdom and Ireland territories with MEDA AB. Prescription Drug User Fee Obligation The Company was assessed prescription drug user fees (“PDUFA”) of approximately $535,000 by the United States Department of Health and Human Services (the “DHHS”) for the sale and manufacture of Aphthasol® from 2009 to 2012. The Company has contested the assessments as we believe such fees should be waived because the Company should qualify for abatement of the PDUFA fees. However, the Company’s challenge has been denied by the DHHS. As of December 31, 2016, the Company has accrued potential penalties and interest of approximately $492,000 related to the unpaid PDUFA fees. The PDUFA fees remain unpaid as of this Report. Since the Company has not yet reached a settlement with the DHHS, it is possible that the Company may be subject to additional collection costs. |
LEGAL PROCEEDINGS
LEGAL PROCEEDINGS | 12 Months Ended |
Dec. 31, 2016 | |
LEGAL PROCEEDINGS [Abstract] | |
LEGAL PROCEEDINGS | NOTE 19. LEGAL PROCEEDINGS From time to time, we may be involved in litigation relating to claims arising out of our operations in the normal course of business. We are not currently a party to any legal proceedings, the adverse outcome of which, in management’s opinion, individually or in the aggregate, would have a material adverse effect on the results of our operations or financial position. There are no material proceedings to which any director, officer or any of our affiliates, any owner of record or beneficially of more than five percent of any class of our voting securities, or any associate of any such director, officer, our affiliates, or security holder, is a party adverse to us or our consolidated subsidiary or has a material interest adverse thereto; however, one or more events may lead to a formal dispute or proceeding in the future. |
SUBSEQUENT EVENTS
SUBSEQUENT EVENTS | 12 Months Ended |
Dec. 31, 2016 | |
SUBSEQUENT EVENTS [Abstract] | |
SUBSEQUENT EVENTS | NOTE 20. SUBSEQUENT EVENTS On January 18, 2017 and on February 16, 2017, we issued promissory notes to Velocitas Partners, LLC (“Velocitas”) with a purchase price of $65,000 and $30,000, respectively. Each promissory note bears interest at the rate of 6.0% per annum with payment of principal and interest due on the earlier of (i) 180 days from the date of issuance, (ii) the date of closing of any debt or equity financing transaction by and between Uluru and Velocitas, or (iii) the payment to Uluru of certain invoices due from selected Company’s distributors. Each promissory note is secured by a pledge of certain product inventory and there were no debt issuance costs incurred by the Company. On February 27, 2017, each outstanding promissory note to Velocitas was repaid in connection with the issuance of the Initial Note under the Purchase Agreement with Velocitas. On February 21, 2017, we issued a promissory note to Kirkwood Investors, Inc. (“Kirkwood”) with a purchase price of $25,000. The promissory note bears interest at the rate of 6.0% per annum with payment of principal and interest due on the earlier of (i) 60 days from the date of issuance, (ii) the date of closing of any debt or equity financing transaction by Uluru, or (iii) no later than two days after receiving written request by Kirkwood. The promissory note is secured by a pledge of certain product inventory and accounts receivables and there were no debt issuance costs incurred by the Company. On February 27, 2017, the outstanding promissory note to Kirkwood was repaid in connection with the issuance of the Initial Note under the Purchase Agreement with Velocitas. On February 27, 2017, the Company entered into a Note, Warrant and Preferred Stock Purchase Agreement (the “Purchase Agreement”) with Velocitas Partners, LLC and an affiliated entity (“Velocitas") under which the Company received gross proceeds of $6,000,000, in two closing with the initial closing occurring on February 27, 2017 and the second closing occurring on March 31, 2017 (the “March 2017 Offering”). The first closing, which occurred on February 27, 2017, included the purchase by Velocitas at face value of the $500,000 Initial Note, with the Initial Note accruing interest at 12.5% per annum and having a term of two years (subject to acceleration under certain circumstances). The Initial Note is convertible into shares of common stock at a conversion price of $0.04 per share, subject to equitable adjustments. The Initial Note is secured by all of the assets of the Company and its subsidiaries pursuant to a Security Agreement executed at the initial closing. The second closing, which occurred on March 31, 2017, included the purchase by Velocitas at face value the additional $500,000 Second Note, and one or more affiliates of Velocitas purchasing Series B Convertible Preferred Stock of the Company for gross proceeds of of $5,000,000, at an as-converted-to-common stock purchase price of $0.04 per share. The Series B Convertible Preferred Stock that was issued in connection with the second closing, (a) votes together with the common stock as a single class (subject to standard protective provisions for the Series B Convertible Preferred Stock), (b) has the same dividend rights as the Common Stock, (c) has a liquidation preference equal to the greater of its purchase price and its as converted-to-common stock value, (d) automatically converts into common stock if the number of authorized shares of common stock is increased within 190 days of the second closing as necessary to permit all outstanding convertible or exercisable securities (including the Series B Convertible Preferred Stock) to convert to common stock, and (e) may is convertible into Common Stock at the discretion of the holder, subject to the availability of authorized shares. As a condition of the March 2017 Offering, the Company issued to Velocitas at the second closing a warrant to purchase up to 57,055,057 shares of common stock (the “Warrant”). The Warrant has an exercise price of $0.04 per share, a 10-year term and is subject to cashless exercise. In addition, at the second closing, the Company acquired the Altrazeal distributor agreements Velocitas had with its sub-distributors in exchange for the issuance of 13,375,000 shares of common stock (the “Assignment Shares”). If the gross proceeds from the Equity Offering were less than $4,000,000 (with such deficit being referred to as the “Proceeds Gap”), the Company would have been obligated to seek capital, in an amount at least equal to the Proceeds Gap, from third parties in a private placement over the 180 days following the second closing. Velocitas negotiated with the Company to establish the $0.04 per share price for the shares of Common Stock underlying the Series B Convertible Preferred Stock. After this price negotiation was completed, Bradley J. Sacks, Chairman of the Board of Directors, was requested to provide a backstop for the Equity Offering to ensure that the Company raised sufficient capital to effect its current business plan. If the Company was unable to raise additional capital at least equal to the Proceeds Gap from third parties, pursuant to a Backstop Agreement, Mr. Sacks agreed that he or his affiliates would purchase a number of shares of common stock, at a price of $0.04 per share (equal to the price being paid by Velocitas for the shares underlying the Series B Convertible Preferred Stock), with a purchase price equal to the Proceeds Gap. As a result of the issuance of $5,000,000 of Series B Convertible Preferred Stock at the second closing, the conditions under the Backstop Agreement where Mr. Sacks would have been obligated to purchase up to $2,000,000 in common stock were not satisfied and any purchase obligations thereunder have expired and are now terminated. In addition, the Company, Velocitas and certain affiliates signed a Voting Agreement (the “Voting Agreement”) pursuant to which the parties agreed to set the size of the Board of Directors at six directors, and agreed to vote for the election to the Board of Directors of four persons designated by Velocitas (initially to be Anish Shah, Oksana Tiedt, Vaidehi Shah and Arindam Bose), one director designated by Bradley J. Sacks and one additional director designated by a major investor or by the Board of Directors. In addition, the parties to the Voting Agreement have agreed to vote in favor of a proposal to amend the Company’s articles of incorporation to increase the authorized shares as required to permit the conversion of the Series B Convertible Preferred Stock. In addition, the Company, Velocitas and certain affiliates entered into an Investor Rights Agreement (the “Investor Rights Agreement”) that provides the parties thereto with demand, demand Form S-3 and piggy back registration rights, Rule 144 information rights, and right of first offer (or preemptive rights) in connection with future sales of securities by the Company (subject to standard exceptions). The Investor Rights Agreement includes indemnification obligations associated with the registration rights. Michael I. Sacks and Bradley Sacks and affiliates are parties to the Investor Rights Agreement, in part in exchange for the termination by certain of such persons and The Punch Trust of a Registration Rights Agreement dated as of January 31, 2014. As required by the Purchase Agreement, at the initial closing, the Company appointed Ms. Vaidehi Shah to serve as the Company’s Chief Executive Officer and to also serve as a member of the Company’s Board of Directors. Concurrent with the initial closing and as a condition of the March 2017 Offering, the Company received resignation notices from Helmut Kerschbaumer, the Company’s Interim President, Chief Executive and Director, and Klaus Kuehne, a member of the Company’s Board of Directors. As required by the Purchase Agreement, at the second closing, the Company appointed Mr. Anish Shah and Ms. Oksana Tiedt to join the Company and to serve as part of the Company’s executive management team and together with Mr. Arindam Bose to join the Company’s Board of Directors. Concurrent with the second closing and as a condition of the Financing, the Company received resignation notices from Robert F. Goldrich and Terrance K. Wallberg, each being a member of the Company’s Board of Directors. Mr. Wallberg will continue to serve as the Company’s Vice President, Chief Financial Officer, Secretary, and Treasurer. Also occurring at the second closing, Mr. Bradley J. Sacks stepped down as Chairman of the Board of Directors and Ms. Vaidehi Shah, the Company’s Chief Executive Officer and Director, assumed such duties. Mr. Sacks will continue to serve as a Director of the Company. |
COMPANY OVERVIEW AND BASIS OF28
COMPANY OVERVIEW AND BASIS OF PRESENTATION (Policies) | 12 Months Ended |
Dec. 31, 2016 | |
COMPANY OVERVIEW AND BASIS OF PRESENTATION [Abstract] | |
Basis of Presentation | Basis of Presentation The accompanying consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United State of America (“U.S. GAAP”) and include the accounts of ULURU Inc., a Nevada corporation, and its wholly-owned subsidiary, ULURU Delaware Inc., a Delaware corporation. Both companies have a December 31 fiscal year end. The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, as well as disclosure of contingent assets and liabilities at the date of the financial statements, and the reported amounts of revenues and expenses during the reporting periods. Actual results may differ from those estimates and assumptions. These differences are usually minor and are included in our consolidated financial statements as soon as they are known. Our estimates, judgments, and assumptions are continually evaluated based on available information and experience. Because of the use of estimates inherent in the financial reporting process, actual results could differ from those estimates. All intercompany transactions and balances have been eliminated in consolidation. |
SUMMARY OF SIGNIFICANT ACCOUN29
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies) | 12 Months Ended |
Dec. 31, 2016 | |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES [Abstract] | |
Cash and Cash Equivalents | Cash and Cash Equivalents Cash and cash equivalents include highly liquid investments with original maturities of three months or less. The carrying value of these cash equivalents approximates fair value. We invest cash in excess of immediate requirements in money market accounts, certificates of deposit, corporate commercial paper with high quality ratings, and U.S. government securities taking into consideration the need for liquidity and capital preservation. These investments are not held for trading or other speculative purposes. |
Accounts Receivable and Allowance for Doubtful Accounts | Accounts Receivable and Allowance for Doubtful Accounts Accounts receivable are recorded at the invoiced amount and do not bear interest. We estimate the collectability of our accounts receivable. In order to assess the collectability of these receivables, we monitor the current creditworthiness of each customer and analyze the balances aged beyond the customer's credit terms. Theses evaluations may indicate a situation in which a certain customer cannot meet its financial obligations due to deterioration of its financial viability, credit ratings or bankruptcy. The allowance requirements are based on current facts and are reevaluated and adjusted as additional information is received. Accounts receivable are subject to an allowance for collection when it is probable that the balance will not be collected. As of December 31, 2016 and 2015, the allowance for doubtful accounts was $2,679 and $100,672, respectively. For the years ended December 31, 2016 and 2015, the accounts written off as uncollectible were $72,644 and $14,347, respectively. |
Inventory | Inventory Inventories are stated at the lower of cost or market value. Raw material inventory cost is determined on the first-in, first-out method. Costs of finished goods are determined by an actual cost method. We regularly review inventories on hand and write down the carrying value of our inventories for excess and potentially obsolete inventories based on historical usage and estimated future usage. In assessing the ultimate realization of our inventories, we are required to make judgments as to future demand requirements. As actual future demand or market conditions may vary from those projected by us, adjustment to inventories may be required. |
Prepaid Expenses and Deferred Charges | Prepaid Expenses and Deferred Charges As of December 31, 2016 and 2015, prepaid expenses were composed primarily of insurance policy costs. We amortize our insurance costs ratably over the term of each policy. Typically, our insurance policies are subject to renewal in July and October of each year. |
Property, Equipment and Leasehold Improvements | Property, Equipment and Leasehold Improvements Property, equipment, and leasehold improvements are recorded at cost. Depreciation is provided over the estimated useful lives of the related assets using the straight-line method. Estimated useful lives for property, equipment, and leasehold improvements categories are as follows: Laboratory and manufacturing equipment 7 years Computers, office equipment, and furniture 5 years Computer software 3 years Leasehold improvements Lease term |
Intangible Assets | Intangible Assets We expense internal patent and application costs as incurred because, even though we believe the patents and underlying processes have continuing value, the amount of future benefits to be derived from them are uncertain. Purchased patents are capitalized and amortized over the life of the patent. |
Licensing Rights | Licensing Rights Purchased licensing rights are capitalized and amortized over the life of the patent associated with the licensed product. |
Impairment of Assets | Impairment of Assets In accordance with the provisions of Accounting Standards Codification (“ASC”) Topic 350-30, Intangibles Other than Goodwill, |
Debt Issuance Costs | Debt Issuance Costs We defer debt issuance costs associated with the issuance of our promissory note payable and amortize those costs over the period of the promissory note obligation using the effective interest method. In 2016, we did not incur any new debt issuance costs related to our promissory note payable with Velocitas Healthcare. In 2015, we incurred $50,000 of debt issuance costs related to our promissory note payable with Inter-Mountain Capital Corp. During 2016 and 2015, we recorded amortization of approximately $23,000 and $27,000, respectively, of debt issuance costs. Unamortized debt issuance costs at December 31, 2016 and 2015 were approximately nil and $23,000, respectively. |
Shipping and Handling Costs | Shipping and Handling Costs Shipping and handling costs incurred for product shipments are included in cost of goods sold. |
Income Taxes | Income Taxes We use the liability method of accounting for income taxes pursuant to ASC Topic 740, Income Taxes |
Revenue Recognition and Deferred Revenue | Revenue Recognition and Deferred Revenue License Fees We recognize revenue from license payments not tied to achieving a specific performance milestone ratably during the period over which we are obligated to perform services. The period over which we are obligated to perform services is estimated based on available facts and circumstances. Determination of any alteration of the performance period normally indicated by the terms of such agreements involves judgment on management's part. License revenues with no specific performance criteria are recognized when received from our foreign licensee and their various foreign sub-licensees as there is no control by us over the various foreign sub-licensees and no performance criteria to which we are subject. We recognize revenue from performance payments ratably, when such performance is substantially in our control and when we believe that completion of such performance is reasonably probable, over the period during which we estimate that we will complete such performance obligations. In circumstances where the arrangement includes a refund provision, we defer revenue recognition until the refund condition is no longer applicable unless, in our judgment, the refund circumstances are within our operating control and are unlikely to occur. Substantive at-risk milestone payments, which are based on achieving a specific performance milestone when performance of such milestone is contingent on performance by others or for which achievement cannot be reasonably estimated or assured, are recognized as revenue when the milestone is achieved and the related payment is due, provided that there is no substantial future service obligation associated with the milestone. For the year ended December 31, 2016, we recognized approximately $343,000 in licensing fees due to the one-time recognition of unamortized licensing fees related to the cancellation of distribution agreements with three distributors. For the year ended December 31, 2015, we recognized approximately $145,000 in licensing fees due to the one-time recognition of unamortized licensing fees related to the cancellation of distribution agreements with one distributor. The recognition of unamortized licensing fees is based upon the cancellation of each distribution agreements and that there are no further performance obligations that are required by the Company under each distribution agreement. Royalty Income We receive royalty revenues under license agreements with a number of third parties that sell products based on technology we have developed or to which we have rights. The license agreements provide for the payment of royalties to us based on sales of the licensed products. We record these revenues based on estimates of the sales that occurred during the relevant period. The relevant period estimates of sales are based on interim data provided by licensees and analysis of historical royalties we have been paid (adjusted for any changes in facts and circumstances, as appropriate). We maintain regular communication with our licensees in order to gauge the reasonableness of our estimates. Differences between actual royalty revenues and estimated royalty revenues are reconciled and adjusted for in the period in which they become known, typically the following quarter. Historically, adjustments have not been material based on actual amounts paid by licensees. As it relates to royalty income, there are no future performance obligations on our part under these license agreements. To the extent we do not have sufficient ability to accurately estimate revenue; we record it on a cash basis. Product Sales We recognize revenue and related costs from the sale of our products at the time the products are shipped to the customer. Provisions for returns, rebates, and discounts are established in the same period the related product sales are recorded. We review the supply levels of our products sold to major wholesalers in the U.S., primarily by reviewing reports supplied by our major wholesalers and available volume information for our products, or alternative approaches. When we believe wholesaler purchasing patterns have caused an unusual increase or decrease in the sales of a major product compared with underlying demand, we disclose this in our product sales discussion if we believe the amount is material to the product sales trend; however, we are not always able to accurately quantify the amount of stocking or destocking. Wholesaler stocking and destocking activity historically has not caused any material changes in the rate of actual product returns. We establish sales return accruals for anticipated product returns. We record the return amounts as a deduction to arrive at our net product sales. Consistent with Revenue Recognition accounting guidance, we estimate a reserve when the sales occur for future product returns related to those sales. This estimate is primarily based on historical return rates as well as specifically identified anticipated returns due to known business conditions and product expiry dates. Actual product returns have been nil over the past two years. We establish sales rebate and discount accruals in the same period as the related sales. The rebate and discount amounts are recorded as a deduction to arrive at our net product sales. We base these accruals primarily upon our historical rebate and discount payments made to our customer segment groups and the provisions of current rebate and discount contracts. |
Foreign currency transaction gain (loss) | Foreign currency transaction gain (loss) Our functional currency and our reporting currency is the U.S. dollar and foreign currency transactions are primarily undertaken in Euros. Monetary assets and liabilities are translated using the foreign currency exchange rate prevailing at the balance sheet date. Revenues, non-monetary assets and liabilities denominated in foreign currencies are translated at rates of foreign currency exchange in effect at the date of the transaction. Expenses are translated at average foreign currency exchange rates for the period. Gains and losses arising on translation or settlement of foreign currency denominated transactions or balances are included in the determination of net income. |
Research and Development Expenses | Research and Development Expenses Pursuant to ASC Topic 730, Research and Development |
Basic and Diluted Net Loss Per Common Share | Basic and Diluted Net Loss Per Common Share In accordance with ASC Topic 260, Earnings per Share |
Concentrations of Credit Risk | Concentrations of Credit Risk Concentration of credit risk with respect to financial instruments, consisting primarily of cash and cash equivalents, that potentially expose us to concentrations of credit risk due to the use of a limited number of banking institutions and due to maintaining cash balances in banks, which, at times, may exceed the limits of amounts insured by the Federal Deposit Insurance Corporation. During 2016 and 2015, we utilized Bank of America, N.A. as our banking institution. At December 31, 2016 and December 31, 2015 our cash and cash equivalents totaled approximately $37,000 and $180,000, respectively. We also invest cash in excess of immediate requirements in money market accounts, certificates of deposit, corporate commercial paper with high quality ratings, and U.S. government securities. These investments are not held for trading or other speculative purposes. We are exposed to credit risk in the event of default by these high quality corporations. Concentration of credit risk with respect to trade accounts receivable are customers with balances that exceed 5% of total consolidated trade accounts receivable at December 31, 2016 and at December 31, 2015. As of December 31, 2016, one customer, being one of our international distributors, exceeded the 5% threshold, with 95%. One customer, being one of our international distributors, exceeded the 5% threshold at December 31, 2015, with 92%. As a result, we believe that accounts receivable credit risk exposure is limited. We maintain an allowance for doubtful accounts, but historically have not experienced any significant losses related to an individual customer or group of customers. |
Concentrations of Foreign Currency Risk | Concentrations of Foreign Currency Risk A portion of our revenues and all of our expenses are denominated in U.S. dollars. We are expecting an increase in revenues in international territories denominated in a foreign currency. Certain of our licensing and distribution agreements in international territories are denominated in Euros. Currently, we do not employ forward contracts or other financial instruments to mitigate foreign currency risk. As our international operations continue to grow, we may engage in hedging activities to hedge our exposure to foreign currency risk. |
Fair Value of Financial Instruments | Fair Value of Financial Instruments In accordance with portions of ASC Topic 820, Fair Value Measurements Our financial instruments, including cash, cash equivalents, accounts receivable, and accounts payable are carried at cost, which approximates their fair value because of the short-term maturity of these instruments. We believe that the carrying value of our other receivable, notes receivable and accrued interest, and convertible note payable balances approximates fair value based on a valuation methodology using the income approach and a discounted cash flow model. |
SUMMARY OF SIGNIFICANT ACCOUN30
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES [Abstract] | |
Estimated useful lives for property and equipment | Estimated useful lives for property, equipment, and leasehold improvements categories are as follows: Laboratory and manufacturing equipment 7 years Computers, office equipment, and furniture 5 years Computer software 3 years Leasehold improvements Lease term |
SEGMENT INFORMATION (Tables)
SEGMENT INFORMATION (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
SEGMENT INFORMATION [Abstract] | |
Revenues per geographic area | Revenues per geographic area, along with relative percentages of total revenues, for the year ended December 31, are summarized as follows: Revenues 2016 % 2015 % Domestic $ 20,326 5 % $ 28,030 3 % International 422,239 95 % 907,709 97 % Total $ 442,565 100 % $ 935,739 100 % |
INVENTORY (Tables)
INVENTORY (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
INVENTORY [Abstract] | |
Inventory | The components of inventory, at the different stages of production, consisted of the following at December 31: Inventory 2016 2015 Raw materials $ 35,800 $ 38,037 Work-in-progress 424,741 485,123 Finished goods 99,059 8,261 Total $ 559,600 $ 531,421 |
PROPERTY, EQUIPMENT AND LEASE33
PROPERTY, EQUIPMENT AND LEASEHOLD IMPROVEMENTS (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
PROPERTY, EQUIPMENT AND LEASEHOLD IMPROVEMENTS [Abstract] | |
Property, equipment and leasehold improvements | Property, equipment and leasehold improvements, net, consisted of the following at December 31: Property, equipment and leasehold improvements 2016 2015 Laboratory equipment $ 424,888 $ 424,888 Manufacturing equipment 1,604,894 1,604,894 Computers, office equipment, and furniture 151,280 153,865 Computer software 4,108 4,108 Leasehold improvements 95,841 95,841 2,281,011 2,283,596 Less: accumulated depreciation and amortization (2,154,270 ) (2,026,179 ) Property, equipment and leasehold improvements, net $ 126,741 $ 257,417 |
INTANGIBLE ASSETS (Tables)
INTANGIBLE ASSETS (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
Patents [Member] | |
Finite-Lived Intangible Assets [Line Items] | |
Intangible assets | Intangible patent assets, net consisted of the following at December 31: Intangible assets - patents 2016 2015 Patent - Amlexanox (Aphthasol®) $ 2,090,000 $ 2,090,000 Patent - Amlexanox (OraDisc™ A) 6,873,080 6,873,080 Patent - OraDisc™ 73,000 73,000 Patent - Hydrogel nanoparticle aggregate 589,858 589,858 9,625,938 9,625,938 Less: accumulated amortization (7,381,847 ) (6,905,397 ) Less: reserve for impairment (2,027,310 ) --- Intangible assets, net $ 216,781 $ 2,720,541 |
Future aggregate amortization expense for intangible assets | The future aggregate amortization expense for intangible patent assets, remaining as of December 31, 2016, is as follows: Calendar Years Future Amortization Expense 2017 $ 37,044 2018 37,044 2019 37,044 2020 37,145 2021 37,044 2022 & Beyond 31,460 Total $ 216,781 |
Licensing Rights [Member] | |
Finite-Lived Intangible Assets [Line Items] | |
Intangible assets | Intangible licensing rights, net consisted of the following at December 31: Intangible assets - licensing rights 2016 2015 European Union, Australia, New Zealand, Middle East (excluding Jordan and Syria), North Africa, Albania, Bosnia, Croatia, Kosovo, Macedonia, Montenegro, and Serbia. $ 3,512,506 $ 3,512,506 Less: accumulated amortization (331,419 ) (6,271 ) Licensing rights, net $ 3,181,087 $ 3,506,235 |
Future aggregate amortization expense for intangible assets | The future aggregate amortization expense for intangible licensing rights assets, remaining as of December 31, 2016, is as follows: Calendar Years Future Amortization Expense 2017 $ 325,148 2018 325,148 2019 325,148 2020 325,148 2021 325,148 2022 & Beyond 1,555,347 Total $ 3,181,087 |
ACCRUED LIABILITIES (Tables)
ACCRUED LIABILITIES (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
ACCRUED LIABILITIES [Abstract] | |
Accrued liabilities | Accrued liabilities consisted of the following at December 31: Accrued Liabilities 2016 2015 Accrued compensation/benefits $ 274,874 $ 329,131 Accrued insurance payable 40,422 73,074 Product rebates/returns 4 9 Total accrued liabilities $ 315,300 $ 402,214 |
PROMISSORY NOTE PAYABLE (Tables
PROMISSORY NOTE PAYABLE (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
PROMISSORY NOTE PAYABLE [Abstract] | |
Information relating to promissory notes payable | Information relating to the April 2015 Note is as follows: As of December 31, 2016 Transaction Initial Principal Amount Interest Rate Maturity Date Conversion Price (1) Principal Balance (2) Unamortized Debt Discount Unamortized Debt Issuance Costs Carrying Value April 2015 Note $ 550,000 10.0 % 08/12/2016 --- --- --- --- Total $ 550,000 --- --- --- --- (1) As part of the April 2015 Note, at our option, subject to certain volume, price and other conditions, the monthly installments of principle and interest due under the April 2015 Note may be paid in whole, or in part, in cash or in Common Stock. If the monthly installments are paid in Common Stock, such shares being issued will be based on a price that is 80% of the average of the three lowest volume weighted average prices of the shares of Common Stock during the preceding twenty trading days. The percentage declines to 70% if the average of the three lowest volume weighted average prices of the shares of Common Stock during the preceding twenty trading days is less than $0.05 per share. (2) On August 11, 2016, the Company issued the final installment payment due under the April 2015 Note. |
STOCKHOLDERS' EQUITY (Tables)
STOCKHOLDERS' EQUITY (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
STOCKHOLDERS' EQUITY [Abstract] | |
Warrants outstanding and number of shares of common stock subject to exercise | The following table summarizes the warrants outstanding and the number of shares of common stock subject to exercise as of December 31, 2016 and the changes therein during the two years then ended: Number of Shares of Common Stock Subject to Exercise Weighted – Average Exercise Price Balance as of December 31, 2014 1,676,401 $ 1.14 Warrants issued 847,804 0.72 Warrants exercised (392,857 ) 0.35 Warrants cancelled (357,155 ) 2.85 Balance as of December 31, 2015 1,774,193 $ 0.77 Warrants issued 25,245,442 $ 0.09 Warrants exercised --- --- Warrants cancelled (840,075 ) $ 0.84 Balance as of December 31, 2016 26,179,560 $ 0.11 |
Expiration dates for warrants subject to exercise | Of the warrant shares subject to exercise as of December 31, 2016, expiration of the right to exercise is as follows: Date of Expiration Number of Warrant Shares of Common Stock Subject to Expiration March 14, 2018 660,000 January 15, 2019 80,000 April 30, 2020 194,118 March 30, 2021 25,245,442 Total 26,179,560 |
EARNINGS PER SHARE (Tables)
EARNINGS PER SHARE (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
EARNINGS PER SHARE [Abstract] | |
Common shares excluded from calculating basic and diluted net loss per common share | Shares used in calculating basic and diluted net loss per common share exclude these potential common shares as of December 31: 2016 2015 Warrants to purchase Common Stock 26,179,560 1,774,193 Stock options to purchase common stock 691,237 1,664,573 Common stock issuable upon the assumed conversion of payments due under our promissory note from April 2015 (1) --- 1,934,718 Total 26,870,797 5,373,484 (1) As part of the April 2015 Note, at our option, subject to certain volume, price and other conditions, the monthly installments of principle and interest due under the April 2015 Note have been paid in whole, or in part, in cash or in Common Stock. If the monthly installments were paid in Common Stock, such shares being issued were based on a price that is 80% of the average of the three lowest volume weighted average prices of the shares of Common Stock during the preceding twenty trading days. The percentage declines to 70% if the average of the three lowest volume weighted average prices of the shares of Common Stock during the preceding twenty trading days is less than $0.05 per share. For the purposes of this Table, we have assumed that all outstanding monthly installments of principal and interest were paid in Common Stock based on a price of $0.10 per share (80% of the average of the three lowest volume weighted average prices of the shares of Common Stock during the preceding twenty trading days prior to December 31, 2015), subject to certain ownership limitations. On August 11, 2016, the Company issued the final installment payment due under the April 2015 Note. |
SHARE BASED COMPENSATION (Table
SHARE BASED COMPENSATION (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
SHARE BASED COMPENSATION [Abstract] | |
Allocated share-based compensation expense | The following table summarizes share-based compensation related to stock options for the years ended December 31: 2016 2015 Research and development $ 7,614 $ 69,028 Selling, general and administrative 12,360 83,956 Total share-based compensation expense $ 19,974 $ 152,984 |
Stock option activity | The following table summarizes the stock options outstanding and the number of shares of common stock subject to exercise as of December 31, 2016 and the changes therein during the two years then ended: Stock Options Weighted Average Exercise Price per Share Outstanding as of December 31, 2014 1,699,907 $ 1.73 Granted --- --- Forfeited/cancelled (35,334 ) 1.77 Exercised --- --- Outstanding as of December 31, 2015 1,664,573 $ 1.73 Granted --- --- Forfeited/cancelled (973,336 ) 1.58 Exercised --- --- Outstanding as of December 31, 2016 691,237 $ 1.94 |
Stock option grants outstanding and exercisable | The following table presents the stock option grants outstanding and exercisable as of December 31, 2016: Options Outstanding Options Exercisable Stock Options Outstanding Weighted Average Exercise Price per Share Weighted Average Remaining Contractual Life in Years Stock Options Exercisable Weighted Average Exercise Price per Share 422,500 $ 0.33 6.2 422,500 $ 0.33 240,000 1.15 7.7 240,000 1.15 28,737 32.28 1.2 28,737 32.28 691,237 $ 1.94 6.5 691,237 $ 1.94 |
FAIR VALUE MEASUREMENTS (Tables
FAIR VALUE MEASUREMENTS (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
FAIR VALUE MEASUREMENTS [Abstract] | |
Fair value of our financial instruments | The fair value of our financial instruments consisted of the following at December 31: Description 2016 2015 Liabilities: Promissory note – December 2016 $ 20,000 --- Promissory note – April 2015 (1) --- $ 370,000 (1) On August 11, 2016, the Company issued the final installment payment due under the April 2015 Note. |
INCOME TAXES (Tables)
INCOME TAXES (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
INCOME TAXES [Abstract] | |
Expiration of consolidated operating loss carryforwards and research credit carryforwards | The following are the consolidated operating loss carryforwards and research credit carryforwards that will begin expiring as follows: Calendar Years Consolidated Operating Loss Carryforwards Research Activities Carryforwards 2021 $ 34,248 $ --- 2023 95,666 --- 2024 910,800 13,584 2025 1,687,528 21,563 2026 11,950,281 60,797 2027 3,431,365 85,052 2028 8,824,940 139,753 2029 6,889,761 81,940 2030 5,113,583 41,096 2031 3,728,626 43,592 2032 3,695,792 8,690 2033 3,187,559 15,882 2034 1,797,031 19,491 2035 2,594,151 21,113 2036 2,510,546 2,624 Total $ 56,451,877 $ 555,177 |
Deferred tax assets and deferred tax liabilities | An analysis of the tax effects of temporary differences that give rise to significant portions of the deferred tax assets and deferred tax liabilities at December 31, 2016 and 2015 are as follows: 2016 2015 Deferred tax assets: Net operating loss carryforwards $ 20,056,077 $ 19,179,724 Intangible assets 816,389 132,836 Other 575,065 605,231 Total gross deferred tax assets 21,447,531 19,917,791 Deferred tax liabilities: Property and equipment 10,391 12,541 Total gross deferred tax liabilities 10,391 12,541 Net total of deferred assets and liabilities 21,437,140 19,905,250 Valuation allowance (21,437,140 ) (19,905,250 ) Net deferred tax assets $ --- $ --- |
Reconciliation of expected statutory federal income tax rate to actual income tax rate | The following is a reconciliation of the expected statutory federal income tax rate to our actual income tax rate for the years ended December 31: 2016 2015 Expected income tax (benefit) at federal statutory tax rate -35% $ ( 1,558,549 ) $ ( 961,543 ) Permanent differences 7,739 53,653 Research tax credits (2,624 ) (21,113 ) Amortization of deferred start up costs --- --- Valuation allowance 1,553,434 929,003 Income tax expense $ --- $ --- |
COMMITMENTS AND CONTINGENCIES (
COMMITMENTS AND CONTINGENCIES (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
COMMITMENTS AND CONTINGENCIES [Abstract] | |
Future minimum lease payments | The future minimum lease payments under the 2013 office lease and the 2015 equipment lease are as follows as of December 31, 2016: Calendar Years Future Lease Expense 2017 $ 120,041 2018 28,908 2019 --- 2020 --- Total $ 148,949 |
Summary of compensation earned, compensation paid in cash, and compensation temporarily deferred | As of December 31, 2016, the following table summarizes the amounts recognized in the Company’s financial statements related to obligations for compensation temporarily deferred by our employees. Name 2016 2015 2014 – 2011 Total Kerry P. Gray (1) (2) (3) (4) $ --- $ 275,153 $ 150,000 $ 425,153 Terrance K. Wallberg (5,207 ) 53,540 --- 48,333 Other employees (54,871 ) 54,871 --- --- Total $ (60,078 ) $ 383,564 $ 150,000 $ 473,486 (1) On November 19, 2015, Mr. Gray resigned as the Company’s President and Chief Executive Officer and on February 18, 2016 resigned as a director for the Company. (2) The Company is asserting in a dispute with Mr. Gray that amounts recorded as being owed to Mr. Gray are not in fact owed to Mr. Gray or are offset by amounts Mr. Gray owes to the Company. (3) During 2015, Mr. Gray temporarily deferred compensation of $275,153 which consisted of $51,770 earned as salary compensation for his duties as President of the Company, $186,083 for his duties as Chairman of the Executive Committee of the Company’s Board of Directors, and $37,300 as a temporary advance of working capital. (4) During 2014, Mr. Gray temporarily deferred compensation of $150,000 which consisted of $62,500 earned as salary compensation for his duties as President of the Company and $87,500 for his duties as Chairman of the Executive Committee of the Company’s Board of Directors. During 2014, Mr. Gray was also repaid $269,986 of temporarily deferred compensation, of which $100,000 was used by Mr. Gray for funding required pursuant to a Securities Purchase Agreement, dated March 14, 2013 (the “March 2013 Offering”). Prior to 2014, over a three year period Mr. Gray temporarily deferred, at various times, aggregate compensation of $582,486 and during the same time period was also repaid $312,500 of temporarily deferred compensation, of which $300,000 was used by Mr. Gray for funding required pursuant to the March 2013 Offering. |
SUMMARY OF SIGNIFICANT ACCOUN43
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details) | 12 Months Ended | ||
Dec. 31, 2016USD ($)Customer | Dec. 31, 2015USD ($)Customer | Dec. 31, 2014USD ($) | |
Accounts Receivable and Allowance for Doubtful Accounts [Abstract] | |||
Allowance for doubtful accounts | $ 2,679 | $ 100,672 | |
Accounts written off as uncollectible | 72,644 | 14,347 | |
Debt Instrument [Line Items] | |||
Debt issuance costs related to promissory note payable | 0 | ||
Amortization of deferred financing costs | 22,927 | 27,073 | |
Unamortized debt issuance costs | 0 | 23,000 | |
Revenue Recognition and Deferred Revenue [Abstract] | |||
License costs | $ 343,000 | 145,000 | |
Product Sales [Abstract] | |||
Period over which no actual product returns occurred | 2 years | ||
Concentrations of Credit Risk [Abstract] | |||
Cash and cash equivalents | $ 36,615 | $ 180,000 | $ 550,458 |
Concentrations of Credit Risk [Line Items] | |||
Minimum threshold limit of trade accounts receivable | 5.00% | 5.00% | |
Number of customers exceeds threshold limit of 5% | Customer | 1 | 1 | |
Concentration risk, percentage | 100.00% | 100.00% | |
Inter-Mountain [Member] | |||
Debt Instrument [Line Items] | |||
Debt issuance costs related to promissory note payable | $ 50,000 | ||
Velocitas Partners, LLC [Member] | |||
Debt Instrument [Line Items] | |||
Debt issuance costs related to promissory note payable | $ 0 | ||
Laboratory and Manufacturing Equipment [Member] | |||
Property, Equipment and Leasehold Improvements [Line Items] | |||
Estimated useful life of property and equipment | 7 years | ||
Computers, Office Equipment, and Furniture [Member] | |||
Property, Equipment and Leasehold Improvements [Line Items] | |||
Estimated useful life of property and equipment | 5 years | ||
Computer Software [Member] | |||
Property, Equipment and Leasehold Improvements [Line Items] | |||
Estimated useful life of property and equipment | 3 years | ||
Leasehold Improvements [Member] | |||
Property, Equipment and Leasehold Improvements [Line Items] | |||
Estimated useful life of property and equipment, description | Lease term | ||
Accounts Receivable [Member] | Credit Concentration Risk [Member] | |||
Concentrations of Credit Risk [Line Items] | |||
Concentration risk, percentage | 95.00% | 92.00% |
SEGMENT INFORMATION (Details)
SEGMENT INFORMATION (Details) | 12 Months Ended | |
Dec. 31, 2016USD ($)Customer | Dec. 31, 2015USD ($)Customer | |
Revenues from External Customers and Long-Lived Assets [Line Items] | ||
Total Revenues | $ 442,565 | $ 935,739 |
Total Revenue, percentage | 100.00% | 100.00% |
Revenue [Member] | Customer Concentration Risk [Member] | ||
Revenues from External Customers and Long-Lived Assets [Line Items] | ||
Total Revenue, percentage | 88.00% | 76.00% |
Number of major customers | Customer | 3 | 2 |
Reportable Geographical Components [Member] | Domestic [Member] | ||
Revenues from External Customers and Long-Lived Assets [Line Items] | ||
Total Revenues | $ 20,326 | $ 28,030 |
Total Revenue, percentage | 5.00% | 3.00% |
Reportable Geographical Components [Member] | International [Member] | ||
Revenues from External Customers and Long-Lived Assets [Line Items] | ||
Total Revenues | $ 422,239 | $ 907,709 |
Total Revenue, percentage | 95.00% | 97.00% |
INVENTORY (Details)
INVENTORY (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2016 | Dec. 31, 2015 | |
INVENTORY [Abstract] | ||
Obsolete finished goods | $ 0 | $ 1,600 |
Components of inventory [Abstract] | ||
Raw materials | 35,800 | 38,037 |
Work-in-progress | 424,741 | 485,123 |
Finished goods | 99,059 | 8,261 |
Total | $ 559,600 | $ 531,421 |
PROPERTY, EQUIPMENT AND LEASE46
PROPERTY, EQUIPMENT AND LEASEHOLD IMPROVEMENTS (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2016 | Dec. 31, 2015 | |
Property, equipment and leasehold improvements, net [Abstract] | ||
Property, equipment and leasehold improvements, gross | $ 2,281,011 | $ 2,283,596 |
Less: accumulated depreciation and amortization | (2,154,270) | (2,026,179) |
Property, equipment and leasehold improvements, net | 126,741 | 257,417 |
Depreciation expense | 132,841 | 180,480 |
Laboratory Equipment [Member] | ||
Property, equipment and leasehold improvements, net [Abstract] | ||
Property, equipment and leasehold improvements, gross | 424,888 | 424,888 |
Manufacturing Equipment [Member] | ||
Property, equipment and leasehold improvements, net [Abstract] | ||
Property, equipment and leasehold improvements, gross | 1,604,894 | 1,604,894 |
Computers, Office Equipment, and Furniture [Member] | ||
Property, equipment and leasehold improvements, net [Abstract] | ||
Property, equipment and leasehold improvements, gross | 151,280 | 153,865 |
Computer Software [Member] | ||
Property, equipment and leasehold improvements, net [Abstract] | ||
Property, equipment and leasehold improvements, gross | 4,108 | 4,108 |
Leasehold Improvements [Member] | ||
Property, equipment and leasehold improvements, net [Abstract] | ||
Property, equipment and leasehold improvements, gross | $ 95,841 | $ 95,841 |
INTANGIBLE ASSETS, Patents (Det
INTANGIBLE ASSETS, Patents (Details) | 12 Months Ended | |
Dec. 31, 2016USD ($)Patent | Dec. 31, 2015USD ($) | |
Finite-Lived Intangible Assets [Line Items] | ||
Total | $ 216,781 | $ 2,720,541 |
Number of patents | Patent | 2 | |
Amortization expense | $ 801,598 | 481,419 |
Future aggregate amortization expense for intangible assets [Abstract] | ||
Total | 216,781 | 2,720,541 |
Patents [Member] | ||
Finite-Lived Intangible Assets [Line Items] | ||
Intangible assets, gross | 9,625,938 | 9,625,938 |
Less: accumulated amortization | (7,381,847) | (6,905,397) |
Less: reserve for impairment | (2,027,310) | 0 |
Total | 216,781 | 2,720,541 |
Amortization expense | 476,450 | 475,148 |
Future aggregate amortization expense for intangible assets [Abstract] | ||
2,017 | 37,044 | |
2,018 | 37,044 | |
2,019 | 37,044 | |
2,020 | 37,145 | |
2,021 | 37,044 | |
2022 & Beyond | 31,460 | |
Total | 216,781 | 2,720,541 |
Patents [Member] | Amlexanox (Aphthasol) [Member] | ||
Finite-Lived Intangible Assets [Line Items] | ||
Intangible assets, gross | 2,090,000 | 2,090,000 |
Patents [Member] | Amlexanox (OraDiscA) [Member] | ||
Finite-Lived Intangible Assets [Line Items] | ||
Intangible assets, gross | 6,873,080 | 6,873,080 |
Patents [Member] | OraDisc [Member] | ||
Finite-Lived Intangible Assets [Line Items] | ||
Intangible assets, gross | 73,000 | 73,000 |
Patents [Member] | Hydrogel Nanoparticle Aggregate [Member] | ||
Finite-Lived Intangible Assets [Line Items] | ||
Intangible assets, gross | $ 589,858 | $ 589,858 |
INTANGIBLE ASSETS, Licensing Ri
INTANGIBLE ASSETS, Licensing Rights (Details) | Dec. 24, 2015EUR (€)€ / Inventoryshares | Dec. 31, 2016USD ($)$ / sharesshares | Dec. 31, 2015USD ($)shares | Dec. 24, 2015$ / shares | Dec. 24, 2015EUR (€)shares |
Finite-Lived Intangible Assets [Line Items] | |||||
Transfer fee | $ 343,000 | $ 145,000 | |||
Issuance of common stock (in shares) | shares | 62,974,431 | 36,834,933 | |||
Aggregate shares of common stock issued upon exercise of warrants (in shares) | shares | 25,245,442 | ||||
Exercise price of warrants (in dollars per share) | $ / shares | $ 0.0871 | ||||
Total | $ 216,781 | $ 2,720,541 | |||
Amortization expense | 801,598 | 481,419 | |||
Future aggregate amortization expense for intangible assets [Abstract] | |||||
Total | 216,781 | 2,720,541 | |||
Licensing Rights [Member] | |||||
Finite-Lived Intangible Assets [Line Items] | |||||
European Union, Australia, New Zealand, Middle East (excluding Jordan and Syria), North Africa, Albania, Bosnia, Croatia, Kosovo, Macedonia, Montenegro, and Serbia | 3,512,506 | 3,512,506 | |||
Less: accumulated amortization | (331,419) | (6,271) | |||
Total | 3,181,087 | 3,506,235 | |||
Amortization expense | 325,148 | 6,271 | |||
Future aggregate amortization expense for intangible assets [Abstract] | |||||
2,017 | 325,148 | ||||
2,018 | 325,148 | ||||
2,019 | 325,148 | ||||
2,020 | 325,148 | ||||
2,021 | 325,148 | ||||
2022 & Beyond | 1,555,347 | ||||
Total | $ 3,181,087 | $ 3,506,235 | |||
Altrazeal Trading GmbH [Member] | Licensing Rights [Member] | |||||
Finite-Lived Intangible Assets [Line Items] | |||||
Percentage of ownership interest | 25.00% | ||||
Transfer fee | € | € 1,570,271 | ||||
Issuance of common stock (in shares) | shares | 4,441,606 | ||||
Aggregate shares of common stock issued upon exercise of warrants (in shares) | shares | 444,161 | ||||
Exercise price of warrants (in dollars per share) | $ / shares | $ 0.68 | ||||
Term of warrants | 1 year | ||||
Deduction in inventory payment (in dollars per share) | € / Inventory | 4.20 | ||||
Number of days for closing registration statement | 20 days | ||||
Common stock reissued (in shares) | shares | 2,500,000 | ||||
Altrazeal Trading GmbH [Member] | Licensing Rights [Member] | Maximum [Member] | |||||
Finite-Lived Intangible Assets [Line Items] | |||||
Inventory payment | € | € 88,834 | ||||
IPMD GmbH [Member] | Licensing Rights [Member] | |||||
Finite-Lived Intangible Assets [Line Items] | |||||
Transfer fee | € | € 703,500 | ||||
Issuance of common stock (in shares) | shares | 2,095,241 | ||||
Aggregate shares of common stock issued upon exercise of warrants (in shares) | shares | 209,525 | ||||
Exercise price of warrants (in dollars per share) | $ / shares | $ 0.68 | ||||
Term of warrants | 1 year |
INVESTMENT IN UNCONSOLIDATED 49
INVESTMENT IN UNCONSOLIDATED SUBSIDIARY (Details) | Dec. 31, 2016 | Feb. 01, 2014 | Oct. 19, 2012 | Jan. 11, 2012 |
Minimum [Member] | ||||
Schedule of Equity Method Investments [Line Items] | ||||
Percentage of noncontrolling interest | 20.00% | |||
Maximum [Member] | ||||
Schedule of Equity Method Investments [Line Items] | ||||
Percentage of noncontrolling interest | 50.00% | |||
Altrazeal Trading Ltd. [Member] | ||||
Schedule of Equity Method Investments [Line Items] | ||||
Non-dilutable ownership interest | 25.00% | |||
Altrazeal Trading GmbH [Member] | ||||
Schedule of Equity Method Investments [Line Items] | ||||
Non-dilutable ownership interest | 25.00% | |||
Altrazeal AG [Member] | ||||
Schedule of Equity Method Investments [Line Items] | ||||
Non-dilutable ownership interest | 25.00% | |||
ORADISC GmbH [Member] | ||||
Schedule of Equity Method Investments [Line Items] | ||||
Non-dilutable ownership interest | 25.00% |
ACCRUED LIABILITIES (Details)
ACCRUED LIABILITIES (Details) - USD ($) | Dec. 31, 2016 | Dec. 31, 2015 |
Accrued Liabilities [Abstract] | ||
Accrued compensation/benefits | $ 274,874 | $ 329,131 |
Accrued insurance payable | 40,422 | 73,074 |
Product rebates/returns | 4 | 9 |
Total accrued liabilities | $ 315,300 | $ 402,214 |
PROMISSORY NOTE PAYABLE (Detail
PROMISSORY NOTE PAYABLE (Details) | Jan. 11, 2016USD ($) | Apr. 15, 2015USD ($)$ / sharesshares | Dec. 31, 2016USD ($)Installment$ / sharesshares | Dec. 31, 2015USD ($)Installmentshares | Dec. 15, 2016USD ($) | |
Debt Instrument [Line Items] | ||||||
Initial principal amount | $ 550,000 | |||||
Promissory note original issue discount | 0 | |||||
Information relating to convertible notes payable [Abstract] | ||||||
Principal Balance | [1] | 0 | ||||
Unamortized Discount | 0 | |||||
Unamortized Debt Issuance Costs | 0 | $ 23,000 | ||||
Carrying Value | 0 | |||||
Repayment of principle due on promissory note | $ 318,526 | 0 | ||||
Share issued for payment of principal (in shares) | shares | 26,139,498 | |||||
Conversion Price (in dollars per share) | $ / shares | [2] | $ 0 | ||||
Amortization of debt discount | $ 32,015 | 37,120 | ||||
Class of Warrant or Right [Abstract] | ||||||
Number of securities called by warrants (in shares) | shares | 25,245,442 | |||||
Exercise price of warrants (in dollars per share) | $ / shares | $ 0.0871 | |||||
April 2015 Note [Member] | ||||||
Debt Instrument [Line Items] | ||||||
Initial principal amount | $ 550,000 | |||||
Promissory note original issue discount | $ 0 | |||||
Interest rate | 10.00% | |||||
Information relating to convertible notes payable [Abstract] | ||||||
Principal Balance | [1] | $ 0 | ||||
Unamortized Discount | 0 | |||||
Unamortized Debt Issuance Costs | 0 | |||||
Carrying Value | $ 0 | |||||
Maturity Date | Aug. 12, 2016 | |||||
Conversion Price (in dollars per share) | $ / shares | [2] | $ 0 | ||||
Interest cost recognized | $ 14,079 | 37,110 | ||||
Amortization of debt discount | 32,015 | 37,120 | ||||
Amortization of debt issuance costs | $ 22,927 | $ 27,073 | ||||
Inter Mountain Capital Corp [Member] | April 2015 Note [Member] | ||||||
Debt Instrument [Line Items] | ||||||
Initial principal amount | $ 550,000 | |||||
Promissory note original issue discount | 50,000 | |||||
Purchase price for promissory note | $ 500,000 | |||||
Interest rate | 10.00% | |||||
Promissory note monthly installment payments | $ 45,000 | |||||
Monthly installment payments commencing period | 120 days | |||||
Notes prepayment percentage | 120.00% | |||||
Notes repayment default amount | $ 100,000 | |||||
Judgement stay period on note default | 30 days | |||||
Increase in interest rate | 18.00% | |||||
Warrants expiration date | Apr. 30, 2020 | |||||
Maximum number of days with in which registration statement should be declared | 120 days | |||||
Number of days for registration effective for a period | 180 days | |||||
Intalment payment remittance amount | $ 45,000 | |||||
Promissory note accommodation fee | $ 25,000 | |||||
Information relating to convertible notes payable [Abstract] | ||||||
Unamortized Discount | $ 50,000 | |||||
Repayment of principle due on promissory note | $ 343,526 | |||||
Share issued for payment of principal (in shares) | shares | 694,056 | 1,648,421 | ||||
Number of installments covered under the stock issuance | Installment | 6 | 4 | ||||
Number of installments remitted in cash | Installment | 1 | |||||
Inter Mountain Capital Corp [Member] | Conversion Condition One [Member] | April 2015 Note [Member] | ||||||
Debt Instrument [Line Items] | ||||||
Average percentage of three lowest volume weighted average price | 80.00% | |||||
Number of trading days in conversion | 20 days | |||||
Inter Mountain Capital Corp [Member] | Conversion Condition Two [Member] | April 2015 Note [Member] | ||||||
Debt Instrument [Line Items] | ||||||
Average percentage of three lowest volume weighted average price | 70.00% | |||||
Number of trading days in conversion | 20 days | |||||
Inter Mountain Capital Corp [Member] | Maximum [Member] | Conversion Condition Two [Member] | April 2015 Note [Member] | ||||||
Debt Instrument [Line Items] | ||||||
Weighted average price of common stock (in dollars per share) | $ / shares | $ 0.05 | |||||
Inter Mountain Capital Corp [Member] | Secured Convertible Note [Member] | April 2015 Note [Member] | ||||||
Class of Warrant or Right [Abstract] | ||||||
Number of securities called by warrants (in shares) | shares | 194,118 | |||||
Exercise price of warrants (in dollars per share) | $ / shares | $ 0.85 | |||||
Velocitas Partners, LLC [Member] | December 2016 Note [Member] | ||||||
Debt Instrument [Line Items] | ||||||
Initial principal amount | $ 20,000 | |||||
Interest rate | 6.00% | |||||
Monthly installment payments commencing period | 180 days | |||||
Debt issuance costs | $ 0 | |||||
[1] | On August 11, 2016, the Company issued the final installment payment due under the April 2015 Note. | |||||
[2] | As part of the April 2015 Note, at our option, subject to certain volume, price and other conditions, the monthly installments of principle and interest due under the April 2015 Note may be paid in whole, or in part, in cash or in Common Stock. If the monthly installments are paid in Common Stock, such shares being issued will be based on a price that is 80% of the average of the three lowest volume weighted average prices of the shares of Common Stock during the preceding twenty trading days. The percentage declines to 70% if the average of the three lowest volume weighted average prices of the shares of Common Stock during the preceding twenty trading days is less than $0.05 per share. |
EQUITY TRANSACTIONS (Details)
EQUITY TRANSACTIONS (Details) | Mar. 29, 2016USD ($)InvestorWarrant$ / sharesshares | Apr. 30, 2016USD ($) | Mar. 31, 2016USD ($) | Nov. 30, 2015USD ($) | Oct. 31, 2015USD ($) | Dec. 31, 2016USD ($)$ / sharesshares | Dec. 31, 2015USD ($)$ / sharesshares |
Class of Stock [Line Items] | |||||||
Common stock issued during period (in shares) | shares | 26,139,498 | ||||||
Aggregate shares of common stock issued upon exercise of warrants (in shares) | shares | 25,245,442 | ||||||
Exercise price of warrants (in dollars per share) | $ / shares | $ 0.0871 | ||||||
Proceeds from offering | $ 0 | $ 1,257,027 | |||||
March 2016 Offering [Member] | |||||||
Class of Stock [Line Items] | |||||||
Number of investors entered into stock purchase | Investor | 15 | ||||||
Common stock issued during period (in shares) | shares | 25,245,442 | ||||||
Aggregate shares of common stock issued upon exercise of warrants (in shares) | shares | 25,245,442 | ||||||
Number of common shares per unit | shares | 1 | ||||||
Number of warrants per unit | Warrant | 1 | ||||||
Proceeds from issuance or sale of equity | $ 1,800,000 | ||||||
Percentage of discount on average closing price for share issue price | 10.00% | ||||||
Percentage of premium on average closing price for warrant exercise price | 10.00% | ||||||
Exercise price of warrants (in dollars per share) | $ / shares | $ 0.0871 | ||||||
Term of warrants | 5 years | ||||||
Purchase price (in dollars per share) | $ / shares | $ 0.0713 | ||||||
Proceeds from offering | $ 361,000 | $ 1,439,000 | $ 1,800,000 | ||||
Referral fee paid to european placement agent | $ 29,000 | ||||||
Percentage of referral fee to european placement agent | 10.00% | ||||||
March 2016 Offering [Member] | Michael I. Sacks [Member] | |||||||
Class of Stock [Line Items] | |||||||
Proceeds from offering | $ 1,000,000 | ||||||
March 2016 Offering [Member] | Bradley J. Sacks [Member] | |||||||
Class of Stock [Line Items] | |||||||
Proceeds from offering | 19,000 | ||||||
March 2016 Offering [Member] | Terrance K. Wallberg [Member] | |||||||
Class of Stock [Line Items] | |||||||
Proceeds from offering | 50,000 | ||||||
March 2016 Offering [Member] | Daniel G. Moro [Member] | |||||||
Class of Stock [Line Items] | |||||||
Proceeds from offering | $ 10,000 | ||||||
October 2015 Offering [Member] | |||||||
Class of Stock [Line Items] | |||||||
Equity investment | $ 1,588,225 | ||||||
Issuance of shares of common stock under securities purchase agreement (in shares) | shares | 4,179,539 | ||||||
Purchase price (in dollars per share) | $ / shares | $ 0.38 | ||||||
Proceeds from offering | $ 207,000 | $ 1,050,000 | $ 1,257,000 | ||||
Percentage of referral fee to european placement agent | 12.00% |
STOCKHOLDERS' EQUITY (Details)
STOCKHOLDERS' EQUITY (Details) - shares | Mar. 29, 2016 | Dec. 31, 2016 | Dec. 31, 2015 |
Common Stock [Abstract] | |||
Common stock, shares issued (in shares) | 62,974,431 | 36,834,933 | |
Common stock, shares outstanding (in shares) | 62,974,431 | 36,834,933 | |
Common stock issued during period (in shares) | 26,139,498 | ||
Number of shares of common stock issued for investors (in shares) | 200,000 | ||
March 2016 Offering [Member] | |||
Common Stock [Abstract] | |||
Common stock issued during period (in shares) | 25,245,442 | ||
Stock issued in lieu of offering agreement (in shares) | 25,245,442 | ||
April 2015 Note [Member] | Inter-Mountain [Member] | |||
Common Stock [Abstract] | |||
Number shares of common stock issued for installment payments (in shares) | 694,056 | ||
Series A Preferred Stock [Member] | |||
Preferred Stock [Abstract] | |||
Preferred stock, shares issued (in shares) | 0 | 0 | |
Preferred stock, shares outstanding (in shares) | 0 | 0 |
STOCKHOLDERS' EQUITY, Warrants
STOCKHOLDERS' EQUITY, Warrants (Details) | 12 Months Ended | |
Dec. 31, 2016$ / sharesshares | Dec. 31, 2015$ / sharesshares | |
Warrants and Number of Shares of Common Stock Subject to Exercise [Roll Forward] | ||
Balance (in shares) | 1,774,193 | 1,676,401 |
Warrants issued (in shares) | 25,245,442 | 847,804 |
Warrants exercised (in shares) | 0 | (392,857) |
Warrants cancelled (in shares) | (840,075) | (357,155) |
Balance (in shares) | 26,179,560 | 1,774,193 |
Warrants, Weighted-Average Exercise Price [Abstract] | ||
Balance (in dollars per share) | $ / shares | 0.77 | 1.14 |
Warrants issued (in dollars per share) | $ / shares | 0.09 | 0.72 |
Warrants exercised (in dollars per share) | $ / shares | 0 | 0.35 |
Warrants cancelled (in dollars per share) | $ / shares | 0.84 | 2.85 |
Balance (in dollars per share) | $ / shares | 0.11 | 0.77 |
Warrant Shares Subject to Expiration [Abstract] | ||
Aggregate shares of common stock issued upon exercise of warrants (in shares) | 25,245,442 | |
Exercise price of warrants (in dollars per share) | $ / shares | $ 0.0871 | |
March 14, 2018 [Member] | ||
Warrants and Number of Shares of Common Stock Subject to Exercise [Roll Forward] | ||
Balance (in shares) | 660,000 | |
January 15, 2019 [Member] | ||
Warrants and Number of Shares of Common Stock Subject to Exercise [Roll Forward] | ||
Balance (in shares) | 80,000 | |
April 30, 2020 [Member] | ||
Warrants and Number of Shares of Common Stock Subject to Exercise [Roll Forward] | ||
Balance (in shares) | 194,118 | |
March 30, 2021 [Member] | ||
Warrants and Number of Shares of Common Stock Subject to Exercise [Roll Forward] | ||
Balance (in shares) | 25,245,442 |
EARNINGS PER SHARE (Details)
EARNINGS PER SHARE (Details) - $ / shares | 12 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2015 | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Antidilutive securities excluded from calculating basic and diluted net loss per common share (in shares) | 26,870,797 | 5,373,484 | |
Conversion price per share (in dollars per share) | [1] | $ 0 | |
Warrants to Purchase Common Stock [Member] | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Antidilutive securities excluded from calculating basic and diluted net loss per common share (in shares) | 26,179,560 | 1,774,193 | |
Stock Options to Purchase Common Stock [Member] | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Antidilutive securities excluded from calculating basic and diluted net loss per common share (in shares) | 691,237 | 1,664,573 | |
Common Stock Issuable upon the Assumed Conversion of Payments Due under our Promissory Note from April 2015 [Member] | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Antidilutive securities excluded from calculating basic and diluted net loss per common share (in shares) | [2] | 0 | 1,934,718 |
Percentage of weighted average prices of shares of common stock | 80.00% | ||
Preceding number of trading days to calculate weighted average common stock price | 20 days | ||
Declined percentage of weighted average prices of shares of common stock | 70.00% | ||
Weighted average price of shares of common stock, Maximum (in dollars per share) | $ 0.05 | ||
Conversion price per share (in dollars per share) | $ 0.10 | ||
[1] | As part of the April 2015 Note, at our option, subject to certain volume, price and other conditions, the monthly installments of principle and interest due under the April 2015 Note may be paid in whole, or in part, in cash or in Common Stock. If the monthly installments are paid in Common Stock, such shares being issued will be based on a price that is 80% of the average of the three lowest volume weighted average prices of the shares of Common Stock during the preceding twenty trading days. The percentage declines to 70% if the average of the three lowest volume weighted average prices of the shares of Common Stock during the preceding twenty trading days is less than $0.05 per share. | ||
[2] | As part of the April 2015 Note, at our option, subject to certain volume, price and other conditions, the monthly installments of principle and interest due under the April 2015 Note have been paid in whole, or in part, in cash or in Common Stock. If the monthly installments were paid in Common Stock, such shares being issued were based on a price that is 80% of the average of the three lowest volume weighted average prices of the shares of Common Stock during the preceding twenty trading days. The percentage declines to 70% if the average of the three lowest volume weighted average prices of the shares of Common Stock during the preceding twenty trading days is less than $0.05 per share. For the purposes of this Table, we have assumed that all outstanding monthly installments of principal and interest were paid in Common Stock based on a price of $0.10 per share (80% of the average of the three lowest volume weighted average prices of the shares of Common Stock during the preceding twenty trading days prior to December 31, 2015), subject to certain ownership limitations. On August 11, 2016, the Company issued the final installment payment due under the April 2015 Note. |
SHARE BASED COMPENSATION, Alloc
SHARE BASED COMPENSATION, Allocated compensation expense (Details) - Stock Options [Member] - USD ($) | 12 Months Ended | |
Dec. 31, 2016 | Dec. 31, 2015 | |
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||
Share-based compensation expense | $ 19,974 | $ 152,984 |
Research and Development [Member] | ||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||
Share-based compensation expense | 7,614 | 69,028 |
Selling, General and Administrative [Member] | ||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||
Share-based compensation expense | $ 12,360 | $ 83,956 |
SHARE BASED COMPENSATION, Stock
SHARE BASED COMPENSATION, Stock option, restricted stock and summary of plans (Details) - USD ($) | Jun. 05, 2014 | Jun. 13, 2013 | Jun. 14, 2012 | Jun. 15, 2010 | Dec. 17, 2009 | May 08, 2007 | Dec. 31, 2016 | Dec. 31, 2015 | Mar. 31, 2006 |
Stock Options [Member] | |||||||||
Options, Outstanding [Roll Forward] | |||||||||
Outstanding, beginning of period (in shares) | 1,664,573 | 1,699,907 | |||||||
Granted (in shares) | 0 | 0 | |||||||
Forfeited/cancelled (in shares) | (973,336) | (35,334) | |||||||
Exercised (in shares) | 0 | 0 | |||||||
Outstanding, end of period (in shares) | 691,237 | 1,664,573 | |||||||
Outstanding, Weighted Average Exercise Price [Roll Forward] | |||||||||
Outstanding, beginning of period (in dollars per share) | $ 1.73 | $ 1.73 | |||||||
Granted (in dollars per share) | 0 | 0 | |||||||
Forfeited/cancelled (in dollars per share) | 1.58 | 1.77 | |||||||
Exercised (in dollars per share) | 0 | 0 | |||||||
Outstanding, end of period (in dollars per share) | $ 1.94 | $ 1.73 | |||||||
Nonvested Awards, unearned share-based compensation [Abstract] | |||||||||
Unearned share-based compensation expense | $ 13,000 | ||||||||
Unearned share-based compensation, recognition period | 9 months | ||||||||
Stock Options [Member] | Maximum [Member] | |||||||||
Additional disclosures [Abstract] | |||||||||
Contractual term | 10 years | ||||||||
Restricted Stock [Member] | |||||||||
Nonvested Awards, unearned share-based compensation [Abstract] | |||||||||
Unearned share-based compensation expense | $ 0 | $ 0 | |||||||
Restricted Stock [Member] | Minimum [Member] | |||||||||
Additional disclosures [Abstract] | |||||||||
Vesting period | 6 months | ||||||||
Restricted Stock [Member] | Maximum [Member] | |||||||||
Additional disclosures [Abstract] | |||||||||
Vesting period | 5 years | ||||||||
2006 Equity Incentive Plan [Member] | |||||||||
Additional disclosures [Abstract] | |||||||||
Number of shares authorized (in shares) | 2,800,000 | 133,333 | |||||||
Number of additional shares authorized (in shares) | 1,000,000 | 600,000 | 400,000 | 200,000 | 200,000 | 266,667 | |||
Number of shares available for grant (in shares) | 2,039,317 | ||||||||
2006 Equity Incentive Plan [Member] | Stock Options [Member] | |||||||||
Additional disclosures [Abstract] | |||||||||
Number of options granted to date (in shares) | 2,061,167 | ||||||||
2006 Equity Incentive Plan [Member] | Stock Options [Member] | Minimum [Member] | |||||||||
Additional disclosures [Abstract] | |||||||||
Vesting period | 1 year | ||||||||
2006 Equity Incentive Plan [Member] | Stock Options [Member] | Maximum [Member] | |||||||||
Additional disclosures [Abstract] | |||||||||
Vesting period | 4 years | ||||||||
2006 Equity Incentive Plan [Member] | Restricted Stock [Member] | |||||||||
Additional disclosures [Abstract] | |||||||||
Number of restricted shares granted to date (in shares) | 68,616 | ||||||||
2006 Equity Incentive Plan [Member] | Restricted Stock [Member] | Minimum [Member] | |||||||||
Additional disclosures [Abstract] | |||||||||
Vesting period | 6 months | ||||||||
2006 Equity Incentive Plan [Member] | Restricted Stock [Member] | Maximum [Member] | |||||||||
Additional disclosures [Abstract] | |||||||||
Vesting period | 5 years |
SHARE BASED COMPENSATION, Sto58
SHARE BASED COMPENSATION, Stock options grant outstanding and excercisable (Details) | 12 Months Ended |
Dec. 31, 2016$ / sharesshares | |
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items] | |
Stock Options Outstanding (in shares) | shares | 691,237 |
Options Outstanding, Weighted Average Exercise Price per Share (in dollars per share) | $ / shares | $ 1.94 |
Options Outstanding, Weighted Average Remaining Contractual Life in Years | 6 years 6 months |
Stock Options Exercisable (in shares) | shares | 691,237 |
Options Exercisable, Weighted Average Exercise Price per Share (in dollars per share) | $ / shares | $ 1.94 |
Exercise Price Range 1 [Member] | |
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items] | |
Stock Options Outstanding (in shares) | shares | 422,500 |
Options Outstanding, Weighted Average Exercise Price per Share (in dollars per share) | $ / shares | $ 0.33 |
Options Outstanding, Weighted Average Remaining Contractual Life in Years | 6 years 2 months 12 days |
Stock Options Exercisable (in shares) | shares | 422,500 |
Options Exercisable, Weighted Average Exercise Price per Share (in dollars per share) | $ / shares | $ 0.33 |
Exercise Price Range 2 [Member] | |
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items] | |
Stock Options Outstanding (in shares) | shares | 240,000 |
Options Outstanding, Weighted Average Exercise Price per Share (in dollars per share) | $ / shares | $ 1.15 |
Options Outstanding, Weighted Average Remaining Contractual Life in Years | 7 years 8 months 12 days |
Stock Options Exercisable (in shares) | shares | 240,000 |
Options Exercisable, Weighted Average Exercise Price per Share (in dollars per share) | $ / shares | $ 1.15 |
Exercise Price Range 3 [Member] | |
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items] | |
Stock Options Outstanding (in shares) | shares | 28,737 |
Options Outstanding, Weighted Average Exercise Price per Share (in dollars per share) | $ / shares | $ 32.28 |
Options Outstanding, Weighted Average Remaining Contractual Life in Years | 1 year 2 months 12 days |
Stock Options Exercisable (in shares) | shares | 28,737 |
Options Exercisable, Weighted Average Exercise Price per Share (in dollars per share) | $ / shares | $ 32.28 |
EMPLOYMENT BENEFIT PLAN (Detail
EMPLOYMENT BENEFIT PLAN (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2016 | Dec. 31, 2015 | |
EMPLOYMENT BENEFIT PLAN [Abstract] | ||
Contributions made to 401(k) plan | $ 17,396 | $ 18,861 |
FAIR VALUE MEASUREMENTS (Detail
FAIR VALUE MEASUREMENTS (Details) - USD ($) | Dec. 31, 2016 | Dec. 31, 2015 | |
Promissory Note December 2016 [Member] | |||
Liabilities [Abstract] | |||
Promissory note payable | $ 20,000 | $ 0 | |
Promissory Note April 2015 [Member] | |||
Liabilities [Abstract] | |||
Promissory note payable | [1] | $ 0 | $ 370,000 |
[1] | On August 11, 2016, the Company issued the final installment payment due under the April 2015 Note. |
INCOME TAXES (Details)
INCOME TAXES (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2016 | Dec. 31, 2015 | |
Expiration of Operating Loss Carryforwards and Research Credit Carryforwards [Line Items] | ||
Consolidated operating loss carryforwards | $ 56,451,877 | |
Research activities carryforwards | $ 555,177 | |
Period of cumulative changes in ownership considered for limit on operating loss and tax credit carryforwards | 3 years | |
Minimum percentage of cumulative changes in ownership considered for limit on operating loss and tax credit carryforwards | 50.00% | |
Deferred tax assets [Abstract] | ||
Net operating loss carryforwards | $ 20,056,077 | $ 19,179,724 |
Intangible assets | 816,389 | 132,836 |
Other | 575,065 | 605,231 |
Total gross deferred tax assets | 21,447,531 | 19,917,791 |
Deferred tax liabilities [Abstract] | ||
Property and equipment | 10,391 | 12,541 |
Total gross deferred tax liabilities | 10,391 | 12,541 |
Net total of deferred assets and liabilities | 21,437,140 | 19,905,250 |
Valuation allowance | (21,437,140) | (19,905,250) |
Net deferred tax assets | 0 | 0 |
Increase in valuation allowance | 1,531,890 | 915,874 |
Reconciliation of expected statutory federal income tax rate to actual income tax rate [Abstract] | ||
Expected income tax (benefit) at federal statutory tax rate -35% | (1,558,549) | (961,543) |
Permanent differences | 7,739 | 53,653 |
Research tax credits | (2,624) | (21,113) |
Amortization of deferred start up costs | 0 | 0 |
Valuation allowance | 1,553,434 | 929,003 |
Income tax expense | $ 0 | 0 |
Federal statutory tax rate | 35.00% | |
Liability for unrecognized tax benefits | $ 0 | $ 0 |
2021 [Member] | ||
Expiration of Operating Loss Carryforwards and Research Credit Carryforwards [Line Items] | ||
Consolidated operating loss carryforwards | 34,248 | |
Research activities carryforwards | 0 | |
2023 [Member] | ||
Expiration of Operating Loss Carryforwards and Research Credit Carryforwards [Line Items] | ||
Consolidated operating loss carryforwards | 95,666 | |
Research activities carryforwards | 0 | |
2024 [Member] | ||
Expiration of Operating Loss Carryforwards and Research Credit Carryforwards [Line Items] | ||
Consolidated operating loss carryforwards | 910,800 | |
Research activities carryforwards | 13,584 | |
2025 [Member] | ||
Expiration of Operating Loss Carryforwards and Research Credit Carryforwards [Line Items] | ||
Consolidated operating loss carryforwards | 1,687,528 | |
Research activities carryforwards | 21,563 | |
2026 [Member] | ||
Expiration of Operating Loss Carryforwards and Research Credit Carryforwards [Line Items] | ||
Consolidated operating loss carryforwards | 11,950,281 | |
Research activities carryforwards | 60,797 | |
2027 [Member] | ||
Expiration of Operating Loss Carryforwards and Research Credit Carryforwards [Line Items] | ||
Consolidated operating loss carryforwards | 3,431,365 | |
Research activities carryforwards | 85,052 | |
2028 [Member] | ||
Expiration of Operating Loss Carryforwards and Research Credit Carryforwards [Line Items] | ||
Consolidated operating loss carryforwards | 8,824,940 | |
Research activities carryforwards | 139,753 | |
2029 [Member] | ||
Expiration of Operating Loss Carryforwards and Research Credit Carryforwards [Line Items] | ||
Consolidated operating loss carryforwards | 6,889,761 | |
Research activities carryforwards | 81,940 | |
2030 [Member] | ||
Expiration of Operating Loss Carryforwards and Research Credit Carryforwards [Line Items] | ||
Consolidated operating loss carryforwards | 5,113,583 | |
Research activities carryforwards | 41,096 | |
2031 [Member] | ||
Expiration of Operating Loss Carryforwards and Research Credit Carryforwards [Line Items] | ||
Consolidated operating loss carryforwards | 3,728,626 | |
Research activities carryforwards | 43,592 | |
2032 [Member] | ||
Expiration of Operating Loss Carryforwards and Research Credit Carryforwards [Line Items] | ||
Consolidated operating loss carryforwards | 3,695,792 | |
Research activities carryforwards | 8,690 | |
2033 [Member] | ||
Expiration of Operating Loss Carryforwards and Research Credit Carryforwards [Line Items] | ||
Consolidated operating loss carryforwards | 3,187,559 | |
Research activities carryforwards | 15,882 | |
2034 [Member] | ||
Expiration of Operating Loss Carryforwards and Research Credit Carryforwards [Line Items] | ||
Consolidated operating loss carryforwards | 1,797,031 | |
Research activities carryforwards | 19,491 | |
2035 [Member] | ||
Expiration of Operating Loss Carryforwards and Research Credit Carryforwards [Line Items] | ||
Consolidated operating loss carryforwards | 2,594,151 | |
Research activities carryforwards | 21,113 | |
2036 [Member] | ||
Expiration of Operating Loss Carryforwards and Research Credit Carryforwards [Line Items] | ||
Consolidated operating loss carryforwards | 2,510,546 | |
Research activities carryforwards | $ 2,624 |
COMMITMENTS AND CONTINGENCIES62
COMMITMENTS AND CONTINGENCIES (Details) - USD ($) | 12 Months Ended | 13 Months Ended | 21 Months Ended | 23 Months Ended | 48 Months Ended | 60 Months Ended | |||
Dec. 31, 2016 | Dec. 31, 2015 | Mar. 16, 2015 | Mar. 31, 2014 | Dec. 31, 2016 | Dec. 31, 2016 | Feb. 22, 2013 | Feb. 01, 2015 | Mar. 31, 2011 | |
Future minimum lease payments [Abstract] | |||||||||
2,017 | $ 120,041 | $ 120,041 | $ 120,041 | ||||||
2,018 | 28,908 | 28,908 | 28,908 | ||||||
2,019 | 0 | 0 | 0 | ||||||
2,020 | 0 | 0 | 0 | ||||||
Total | 148,949 | 148,949 | 148,949 | ||||||
Rent expense for operating lease | $ 130,098 | $ 121,623 | |||||||
Office and Laboratory Space [Member] | |||||||||
Operating Leased Assets [Line Items] | |||||||||
Minimum monthly lease obligation | $ 9,379 | $ 9,193 | $ 9,436 | $ 9,776 | $ 9,330 | ||||
Office Equipment [Member] | |||||||||
Operating Leased Assets [Line Items] | |||||||||
Minimum monthly lease obligation | $ 551 | $ 744 |
COMMITMENTS AND CONTINGENCIES,
COMMITMENTS AND CONTINGENCIES, Related Party (Details) - USD ($) | Oct. 31, 2015 | Sep. 30, 2015 | Aug. 31, 2015 | Jul. 31, 2015 | Jun. 30, 2015 | Apr. 30, 2015 | Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 | Dec. 31, 2011 | |
Related Party Obligations [Abstract] | |||||||||||||
Outstanding accounts receivable | $ 0 | $ 2,805 | |||||||||||
Concentration risk, percentage | 100.00% | 100.00% | |||||||||||
Increase (decrease) in working capital advances | $ 0 | $ 220,000 | |||||||||||
Summary of compensation earned, compensation paid in cash, and compensation temporarily deferred [Abstract] | |||||||||||||
Deferred compensation liability | (60,078) | 383,564 | $ 150,000 | $ 150,000 | $ 150,000 | $ 150,000 | |||||||
Deferred compensation | 473,486 | 533,564 | |||||||||||
Proceeds from issuance of common stock under March 2013 offering | 0 | 1,257,027 | |||||||||||
Compensation accrued liabilities | 199,903 | 259,981 | |||||||||||
Compensation accounts payable | 273,583 | 273,583 | |||||||||||
Kerry P. Gray [Member] | |||||||||||||
Related Party Obligations [Abstract] | |||||||||||||
Increase (decrease) in working capital advances | $ 10,300 | $ 30,000 | $ 18,000 | 0 | |||||||||
Increase (decrease) in receivables | $ 3,000 | 18,000 | |||||||||||
Summary of compensation earned, compensation paid in cash, and compensation temporarily deferred [Abstract] | |||||||||||||
Deferred compensation liability | [1],[2],[3],[4] | 0 | 275,153 | 150,000 | 150,000 | 150,000 | 150,000 | ||||||
Deferred compensation | [1],[2],[3],[4] | 425,153 | |||||||||||
Repayment of temporarily deferred compensation | 269,986 | 312,500 | |||||||||||
Proceeds from issuance of common stock under March 2013 offering | 100,000 | 300,000 | |||||||||||
Temporary advance of working capital | 37,300 | ||||||||||||
Kerry P. Gray [Member] | Temporarily Deferred Compensation [Member] | |||||||||||||
Summary of compensation earned, compensation paid in cash, and compensation temporarily deferred [Abstract] | |||||||||||||
Deferred compensation | 275,153 | 150,000 | 582,486 | ||||||||||
Kerry P. Gray [Member] | President [Member] | |||||||||||||
Summary of compensation earned, compensation paid in cash, and compensation temporarily deferred [Abstract] | |||||||||||||
Deferred compensation | 51,770 | 62,500 | |||||||||||
Kerry P. Gray [Member] | Board of Directors Chairman [Member] | |||||||||||||
Summary of compensation earned, compensation paid in cash, and compensation temporarily deferred [Abstract] | |||||||||||||
Deferred compensation | 186,083 | 87,500 | |||||||||||
Terrance K. Wallberg [Member] | |||||||||||||
Related Party Obligations [Abstract] | |||||||||||||
Increase (decrease) in working capital advances | 3,000 | 10,000 | 0 | ||||||||||
Increase (decrease) in receivables | 3,000 | $ 10,000 | |||||||||||
Summary of compensation earned, compensation paid in cash, and compensation temporarily deferred [Abstract] | |||||||||||||
Deferred compensation liability | (5,207) | 53,540 | 0 | 0 | 0 | 0 | |||||||
Deferred compensation | 48,333 | ||||||||||||
Other employees [Member] | |||||||||||||
Summary of compensation earned, compensation paid in cash, and compensation temporarily deferred [Abstract] | |||||||||||||
Deferred compensation liability | (54,871) | 54,871 | $ 0 | $ 0 | $ 0 | $ 0 | |||||||
Deferred compensation | 0 | ||||||||||||
Altrazeal Distributors [Member] | Revenue [Member] | |||||||||||||
Related Party Obligations [Abstract] | |||||||||||||
Related party sales | $ 0 | $ 795,000 | |||||||||||
Concentration risk, percentage | 0.00% | 85.00% | |||||||||||
Altrazeal Distributors [Member] | Accounts Receivable [Member] | |||||||||||||
Related Party Obligations [Abstract] | |||||||||||||
Outstanding accounts receivable | $ 0 | $ 3,000 | |||||||||||
Concentration risk, percentage | 0.00% | 3.00% | |||||||||||
IPMD GmbH [Member] | |||||||||||||
Related Party Obligations [Abstract] | |||||||||||||
Increase (decrease) in working capital advances | $ 40,000 | $ 180,000 | $ 0 | ||||||||||
Increase (decrease) in receivables | $ 220,000 | ||||||||||||
[1] | During 2014, Mr. Gray temporarily deferred compensation of $150,000 which consisted of $62,500 earned as salary compensation for his duties as President of the Company and $87,500 for his duties as Chairman of the Executive Committee of the Company's Board of Directors. During 2014, Mr. Gray was also repaid $269,986 of temporarily deferred compensation, of which $100,000 was used by Mr. Gray for funding required pursuant to a Securities Purchase Agreement, dated March 14, 2013 (the "March 2013 Offering"). Prior to 2014, over a three year period Mr. Gray temporarily deferred, at various times, aggregate compensation of $582,486 and during the same time period was also repaid $312,500 of temporarily deferred compensation, of which $300,000 was used by Mr. Gray for funding required pursuant to the March 2013 Offering. | ||||||||||||
[2] | During 2015, Mr. Gray temporarily deferred compensation of $275,153 which consisted of $51,770 earned as salary compensation for his duties as President of the Company, $186,083 for his duties as Chairman of the Executive Committee of the Company's Board of Directors, and $37,300 as a temporary advance of working capital. | ||||||||||||
[3] | On November 19, 2015, Mr. Gray resigned as the Company's President and Chief Executive Officer and on February 18, 2016 resigned as a director for the Company. | ||||||||||||
[4] | The Company is asserting in a dispute with Mr. Gray that amounts recorded as being owed to Mr. Gray are not in fact owed to Mr. Gray or are offset by amounts Mr. Gray owes to the Company. |
COMMITMENTS AND CONTINGENCIES64
COMMITMENTS AND CONTINGENCIES, Contingent Milestone Obligations (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2016 | Mar. 07, 2008 | |
Milestone payments [Line Items] | ||
Future milestone obligations | $ 4,750,000 | |
Access Pharmaceuticals [Member] | Annual Sales, Certain Products [Member] | Minimum [Member] | ||
Milestone payments [Line Items] | ||
Milestone for payment | 20,000,000 | |
Access Pharmaceuticals [Member] | Annual Sales, Certain Products [Member] | Maximum [Member] | ||
Milestone payments [Line Items] | ||
Milestone for payment | 40,000,000 | |
Access Pharmaceuticals [Member] | Annual Sales, Any One Certain Product [Member] | ||
Milestone payments [Line Items] | ||
Milestone for payment | 20,000,000 | |
Access Pharmaceuticals [Member] | Cumulative Sales, Certain Products [Member] | Minimum [Member] | ||
Milestone payments [Line Items] | ||
Milestone for payment | 50,000,000 | |
Access Pharmaceuticals [Member] | Cumulative Sales, Certain Products [Member] | Maximum [Member] | ||
Milestone payments [Line Items] | ||
Milestone for payment | $ 100,000,000 | |
ProStrakan Ltd [Member] | ||
Milestone payments [Line Items] | ||
Royalty percentage | 30.00% | 30.00% |
ProStrakan Ltd [Member] | Maximum [Member] | ||
Milestone payments [Line Items] | ||
Future milestone obligations | $ 1,400,000 | $ 1,400,000 |
COMMITMENTS AND CONTINGENCIES65
COMMITMENTS AND CONTINGENCIES, Prescription Drug User Fee Obligation (Details) - Assessed Prescription Drug User Fee [Member] | Dec. 31, 2016USD ($) |
Loss Contingencies [Line Items] | |
Prescription drug user fees | $ 535,000 |
Accrued potential penalties and interest | $ 492,000 |
LEGAL PROCEEDINGS (Details)
LEGAL PROCEEDINGS (Details) | 12 Months Ended |
Dec. 31, 2016 | |
LEGAL PROCEEDINGS [Abstract] | |
Maximum percentage of material proceedings/interest | 5.00% |
SUBSEQUENT EVENTS (Details)
SUBSEQUENT EVENTS (Details) | Feb. 27, 2017USD ($)ClosingDirector$ / sharesshares | Mar. 30, 2017 | Mar. 30, 2017 | Mar. 30, 2017 | Mar. 30, 2017 | Dec. 31, 2016USD ($)$ / sharesshares | Dec. 31, 2015USD ($) | Feb. 21, 2017USD ($) | Feb. 16, 2017USD ($) | Jan. 18, 2017USD ($) | |
Subsequent Event [Line Items] | |||||||||||
Initial principal amount | $ 550,000 | ||||||||||
Debt instrument face value | $ 0 | ||||||||||
Debt instrument conversion price (in dollars per share) | $ / shares | [1] | $ 0 | |||||||||
Warrants to purchase shares of common stock (in shares) | shares | 25,245,442 | ||||||||||
Warrants exercise price (in dollars per share) | $ / shares | $ 0.0871 | ||||||||||
Proceeds from offering | $ 0 | $ 1,257,027 | |||||||||
Second Closing [Member] | Subsequent Event [Member] | |||||||||||
Subsequent Event [Line Items] | |||||||||||
Number of Board of Directors | Director | 6 | ||||||||||
Bradley J. Sacks [Member] | Second Closing [Member] | Subsequent Event [Member] | |||||||||||
Subsequent Event [Line Items] | |||||||||||
Purchase price (in dollars per share) | $ / shares | $ 0.04 | ||||||||||
Number of Board of Directors | Director | 1 | ||||||||||
Major Investor Or Board Of Directors [Member] | Second Closing [Member] | Subsequent Event [Member] | |||||||||||
Subsequent Event [Line Items] | |||||||||||
Number of Board of Directors | Director | 1 | ||||||||||
Velocitas Partners, LLC [Member] | Subsequent Event [Member] | |||||||||||
Subsequent Event [Line Items] | |||||||||||
Initial principal amount | $ 30,000 | $ 65,000 | |||||||||
Interest rate | 6.00% | 6.00% | |||||||||
Monthly installment payments commencing period | 180 days | 180 days | |||||||||
Expected gross proceeds | $ 6,000,000 | ||||||||||
Number of closings | Closing | 2 | ||||||||||
Velocitas Partners, LLC [Member] | First Closing [Member] | Subsequent Event [Member] | |||||||||||
Subsequent Event [Line Items] | |||||||||||
Interest rate | 12.50% | ||||||||||
Debt instrument face value | $ 500,000 | ||||||||||
Debt instrument term | 2 years | ||||||||||
Debt instrument conversion price (in dollars per share) | $ / shares | $ 0.04 | ||||||||||
Velocitas Partners, LLC [Member] | Second Closing [Member] | Subsequent Event [Member] | |||||||||||
Subsequent Event [Line Items] | |||||||||||
Debt instrument face value | $ 500,000 | ||||||||||
Debt instrument conversion price (in dollars per share) | $ / shares | $ 0.04 | ||||||||||
Proceeds from issuance of preferred stock | $ 5,000,000 | ||||||||||
Number of days taken to automatically convert to common stock | 190 days | ||||||||||
Warrants to purchase shares of common stock (in shares) | shares | 13,375,000 | ||||||||||
Warrants exercise price (in dollars per share) | $ / shares | $ 0.04 | ||||||||||
Term of warrants | 10 years | ||||||||||
Number of days to seek capital in private placement | 180 days | ||||||||||
Purchase price (in dollars per share) | $ / shares | $ 0.04 | ||||||||||
Amount of preferred shares issued at second closing (in shares) | shares | 5,000,000 | ||||||||||
Number of Board of Directors | Director | 4 | ||||||||||
Velocitas Partners, LLC [Member] | Maximum [Member] | Second Closing [Member] | Subsequent Event [Member] | |||||||||||
Subsequent Event [Line Items] | |||||||||||
Warrants to purchase shares of common stock (in shares) | shares | 57,055,057 | ||||||||||
Proceeds from offering | $ 4,000,000 | ||||||||||
Velocitas Partners, LLC [Member] | Bradley J. Sacks [Member] | Second Closing [Member] | Subsequent Event [Member] | |||||||||||
Subsequent Event [Line Items] | |||||||||||
Amount of shares obligated to be purchased as part of agreement (in shares) | shares | 2,000,000 | ||||||||||
Kirkwood Investors, Inc [Member] | Subsequent Event [Member] | |||||||||||
Subsequent Event [Line Items] | |||||||||||
Initial principal amount | $ 25,000 | ||||||||||
Interest rate | 6.00% | ||||||||||
Monthly installment payments commencing period | 60 days | ||||||||||
Number of days after receiving interest rate | 2 days | ||||||||||
[1] | As part of the April 2015 Note, at our option, subject to certain volume, price and other conditions, the monthly installments of principle and interest due under the April 2015 Note may be paid in whole, or in part, in cash or in Common Stock. If the monthly installments are paid in Common Stock, such shares being issued will be based on a price that is 80% of the average of the three lowest volume weighted average prices of the shares of Common Stock during the preceding twenty trading days. The percentage declines to 70% if the average of the three lowest volume weighted average prices of the shares of Common Stock during the preceding twenty trading days is less than $0.05 per share. |