Document and Entity Information
Document and Entity Information - shares | 6 Months Ended | |
Jun. 30, 2015 | Aug. 14, 2015 | |
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 | |
Document Fiscal Year Focus | 2,015 | |
Document Fiscal Period Focus | Q2 | |
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Jun. 30, 2015 | |
Common Stock [Member] | ||
Entity Information [Line Items] | ||
Entity Common Stock, Shares Outstanding | 24,819,534 | |
Series A Preferred Stock [Member] | ||
Entity Information [Line Items] | ||
Entity Common Stock, Shares Outstanding | 0 |
CONDENSED CONSOLIDATED BALANCE
CONDENSED CONSOLIDATED BALANCE SHEETS (Unaudited) - USD ($) | Jun. 30, 2015 | Dec. 31, 2014 |
Current Assets | ||
Cash and cash equivalents | $ 19,296 | $ 550,458 |
Accounts receivable, net | 2,381 | 3,879 |
Accounts receivable - related party, net | 1,249,683 | 798,147 |
Inventory | 538,187 | 325,657 |
Prepaid expenses and deferred charges | 60,713 | 137,858 |
Total Current Assets | 1,870,260 | 1,815,999 |
Property, Equipment and Leasehold Improvements, net | 328,370 | 432,110 |
Other Assets | ||
Intangible assets, net | 2,960,067 | 3,195,689 |
Investment in unconsolidated subsidiary | 0 | 0 |
Deposits | 18,069 | 18,069 |
Total Other Assets | 2,978,136 | 3,213,758 |
TOTAL ASSETS | 5,176,766 | 5,461,867 |
Current Liabilities | ||
Accounts payable | 1,986,356 | 1,536,612 |
Accrued liabilities | 327,001 | 273,201 |
Accrued interest | 11,764 | 0 |
Promissory notes payable, net of unamortized debt discount and debt issuance costs, current portion | 405,275 | 0 |
Deferred revenue, current portion | 64,100 | 58,959 |
Total Current Liabilities | 2,794,496 | 1,868,772 |
Long Term Liabilities | ||
Promissory notes payable, net of unamortized debt discount, debt issuance costs, and current portion | 44,728 | 0 |
Deferred revenue, net of current portion | 841,435 | 839,174 |
Total Long Term Liabilities | 886,163 | 839,174 |
TOTAL LIABILITIES | $ 3,680,659 | $ 2,707,946 |
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 June 30, 2015 and December 31, 2014, respectively | $ 0 | $ 0 |
Common Stock - $0.001 par value; 200,000,000 shares authorized; 24,819,534 and 24,458,018 shares issued and outstanding at June 30, 2015 and December 31, 2014, respectively | 24,820 | 24,458 |
Additional paid-in capital | 56,499,358 | 56,289,882 |
Accumulated (deficit) | (55,028,071) | (53,560,419) |
TOTAL STOCKHOLDERS' EQUITY | 1,496,107 | 2,753,921 |
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY | $ 5,176,766 | $ 5,461,867 |
CONDENSED CONSOLIDATED BALANCE3
CONDENSED CONSOLIDATED BALANCE SHEETS (Unaudited) (Parenthetical) - $ / shares | Jun. 30, 2015 | Dec. 31, 2014 |
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) | 24,819,534 | 24,458,018 |
Common Stock, shares outstanding (in shares) | 24,819,534 | 24,458,018 |
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 |
CONDENSED CONSOLIDATED STATEMEN
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2015 | Jun. 30, 2014 | Jun. 30, 2015 | Jun. 30, 2014 | |
Revenues | ||||
License fees | $ 15,979 | $ 14,698 | $ 30,518 | $ 29,237 |
Royalty income | 0 | 17,012 | 0 | 17,012 |
Product sales, net | 243,018 | 177,584 | 523,127 | 265,026 |
Total Revenues | 258,997 | 209,294 | 553,645 | 311,275 |
Costs and Expenses | ||||
Cost of product sold | 81,286 | 113,090 | 182,816 | 154,132 |
Research and development | 219,335 | 184,423 | 423,494 | 372,019 |
Selling, general and administrative | 495,034 | 411,279 | 941,191 | 880,352 |
Amortization of intangible assets | 118,461 | 118,461 | 235,622 | 235,622 |
Depreciation | 46,218 | 59,553 | 104,527 | 120,107 |
Total Costs and Expenses | 960,334 | 886,806 | 1,887,650 | 1,762,232 |
Operating (Loss) | (701,337) | (677,512) | (1,334,005) | (1,450,957) |
Other Income (Expense) | ||||
Interest and miscellaneous income | 69 | 519 | 211 | 5,060 |
Interest (expense) income | (63,185) | (32,722) | (76,154) | 2,969 |
Equity in earnings (loss) of unconsolidated subsidiary | 0 | 0 | 0 | 0 |
Foreign currency transaction gain (loss) | 35,074 | 0 | (57,704) | 0 |
Loss on early extinguishment of convertible note | 0 | 0 | 0 | (135,078) |
(Loss) Before Income Taxes | (729,379) | (709,715) | (1,467,652) | (1,578,006) |
Income taxes | 0 | 0 | 0 | 0 |
Net (Loss) | $ (729,379) | $ (709,715) | $ (1,467,652) | $ (1,578,006) |
Basic and diluted net (loss) per common share (in dollars per share) | $ (0.03) | $ (0.03) | $ (0.06) | $ (0.07) |
Weighted average number of common shares outstanding (in shares) | 24,767,889 | 24,122,176 | 24,613,809 | 22,776,695 |
CONDENSED CONSOLIDATED STATEME5
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (Unaudited) - USD ($) | 6 Months Ended | |
Jun. 30, 2015 | Jun. 30, 2014 | |
OPERATING ACTIVITIES : | ||
Net loss | $ (1,467,652) | $ (1,578,006) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Amortization of intangible assets | 235,622 | 235,622 |
Depreciation | 104,527 | 120,107 |
Share-based compensation for stock and options issued to employees | 24,933 | 9,276 |
Share-based compensation for options issued to non-employees | 120,253 | 37,647 |
Equity in earnings (loss) of unconsolidated subsidiary | 0 | 0 |
Amortization of debt discount on convertible note | 0 | (78,630) |
Amortization of debt discount on promissory note | 11,035 | 0 |
Amortization of debt issuance costs | 8,103 | 7,309 |
Warrants issued (cancelled) for services | 0 | 72,771 |
Common stock issued for services | 0 | 42,600 |
Common stock issued for interest due on convertible note | 0 | 2,063 |
Loss on early extinguishment of convertible note | 0 | 135,078 |
Change in operating assets and liabilities: | ||
Accounts receivable | (450,038) | (243,915) |
Inventory | (212,530) | 46,912 |
Prepaid expenses and deferred charges | 77,145 | 36,063 |
Notes receivable and accrued interest | 0 | 777,710 |
Accounts payable | 449,744 | (343,456) |
Accrued liabilities | 53,800 | (150,742) |
Accrued interest | 11,764 | (859) |
Deferred revenue | 7,402 | (29,237) |
Total | 441,760 | 676,319 |
Net Cash Used in Operating Activities | (1,025,892) | (901,687) |
INVESTING ACTIVITIES : | ||
Purchase of property and equipment | (787) | (16,233) |
Net Cash Used in Investing Activities | (787) | (16,233) |
FINANCING ACTIVITIES : | ||
Proceeds from sale of common stock and warrants, net | 0 | 610,000 |
Proceeds from exercise of common stock warrants | 0 | 1,800,000 |
Proceeds from issuance of convertible note and warrant, net | 485,008 | 0 |
Offering cost adjustment - preferred stock sale in 2011 | 10,509 | 0 |
Repayment of principle due on convertible note | 0 | (776,609) |
Net Cash Provided by Financing Activities | 495,517 | 1,633,391 |
Net Increase (Decrease) in Cash | (531,162) | 715,471 |
Cash, beginning of period | 550,458 | 5,119 |
Cash, end of period | 19,296 | 720,590 |
SUPPLEMENTAL CASH FLOW DISCLOSURE: | ||
Cash paid for interest | 1,601 | 14,516 |
Non-cash investing and financing activities: | ||
Issuance of common stock for principle due on convertible note | $ 0 | $ 597,029 |
COMPANY OVERVIEW AND BASIS OF P
COMPANY OVERVIEW AND BASIS OF PRESENTATION | 6 Months Ended |
Jun. 30, 2015 | |
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 diversified specialty pharmaceutical company committed to developing and commercializing a broad range of innovative wound care and muco-adhesive film products based on our patented Nanoflex® and OraDisc TM Basis of Presentation In the opinion of management, the accompanying unaudited condensed consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the United States of America (“U.S. GAAP”) for interim financial information and with the instructions to Form 10-Q and include the accounts of ULURU Inc., a Nevada corporation, and its wholly-owned subsidiary, Uluru Delaware Inc., a Delaware corporation. They do not include all of the information and footnotes required by generally accepted accounting principles for complete financial statements. In the opinion of management, all adjustments (consisting of normal recurring accruals) considered necessary for a fair presentation of the Company’s financial position as of June 30, 2015 and the results of its operations for the three and six months ended June 30, 2015 and 2014 and cash flows for the six months ended June 30, 2015 and 2014 have been made. 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. Operating results for the three and six months ended June 30, 2015 are not necessarily indicative of the results that may be expected for the year ending December 31, 2015. These condensed consolidated financial statements should be read in conjunction with the financial statements and notes thereto contained in the Company’s Annual Report on Form 10-K for the year ended December 31, 2014, as filed with the Securities and Exchange Commission on April 1, 2015, including the risk factors set forth therein. Liquidity and Going Concern The report of our independent registered public accounting firm for the fiscal year ended December 31, 2014, contained an explanatory paragraph to reflect its significant doubt about our ability to continue as a going concern as a result of our history of losses and our liquidity position, as discussed herein and in this Form 10-Q. Based on our existing liquidity, the expected level of operating expenses, projected sales of our existing products combined with other revenues and financing transactions we are exploring, we believe that we do not have sufficient working capital to meet our working capital and capital expenditure requirements through the third quarter of 2015. In the long run we cannot be sure that our anticipated revenue growth will be realized or that we will generate significant positive cash flow from operations. Moreover, we may not be able to raise sufficient additional capital on acceptable returns, or at all, to continue operations and may not be able to execute any strategic transactions. Therefore, we are unable to assert that our financial position is sufficient to fund operations beyond the third quarter of 2015, and as a result, there is substantial doubt about our ability to continue as a going concern beyond the third quarter of 2015. |
SIGNIFICANT ACCOUNTING POLICIES
SIGNIFICANT ACCOUNTING POLICIES | 6 Months Ended |
Jun. 30, 2015 | |
SIGNIFICANT ACCOUNTING POLICIES [Abstract] | |
SIGNIFICANT ACCOUNTING POLICIES | NOTE 2. SIGNIFICANT ACCOUNTING POLICIES The significant accounting policies used in preparation of these condensed consolidated financial statements for the three and six months ended June 30, 2015 are consistent with those discussed in Note 2 to the consolidated financial statements in our Annual Report on Form 10-K for the year ended December 31, 2014, as filed with the Securities and Exchange Commission on April 1, 2015. |
THE EFFECT OF RECENTLY ISSUED A
THE EFFECT OF RECENTLY ISSUED ACCOUNTING STANDARDS | 6 Months Ended |
Jun. 30, 2015 | |
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 April 2015, the Financial Accounting Standards Board issued Update No. 2015-03, Simplifying the Presentation of Debt Issuance Costs, There were no other new accounting pronouncements adopted or enacted during the periods presented that had, or are expected to have, a material impact on our financial statements. |
SEGMENT INFORMATION
SEGMENT INFORMATION | 6 Months Ended |
Jun. 30, 2015 | |
SEGMENT INFORMATION [Abstract] | |
SEGMENT INFORMATION | NOTE 4. SEGMENT INFORMATION We operate in one business segment: the research, development and commercialization of pharmaceutical products. Our corporate headquarters in the United States collects product sales, licensing fees, royalties, and sponsored research revenues from our arrangements with external customers and licensees. Our entire business is managed by a single management team, which reports to the Chief Executive Officer. Our revenues are currently derived primarily from seven licensees for international activities and our domestic sales activities of Altrazeal®. Revenues per geographic area, along with relative percentages of total revenues, for the three and six months ended June 30 are summarized as follows: Three Months Ended June 30, Six Months Ended June 30, Revenues 2015 % 2014 % 2015 % 2014 % Domestic $ 7,085 3 % $ 11,770 6 % $ 13,887 3 % $ 21,442 7 % International 251,912 97 % 197,524 94 % 539,758 97 % 289,833 93 % Total $ 258,997 100 % $ 209,294 100 % $ 553,645 100 % $ 311,275 100 % A significant portion of our revenues are derived from a few major customers. Customers with greater than 10% of total sales, along with their relative percentage of all sales, for the three and six months ended June 30 are represented on the following table: Three Months Ended June 30, Six Months Ended June 30, Customers Product 2015 2014 2015 2014 Customer A Altrazeal® 91 % 87 % 92 % 59 % Customer B Altrazeal® 2 % 3 % 2 % 28 % Total 93 % 90 % 94 % 87 % |
INVENTORY
INVENTORY | 6 Months Ended |
Jun. 30, 2015 | |
INVENTORY [Abstract] | |
INVENTORY | NOTE 5. INVENTORY As of June 30, 2015, our inventory was composed 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 market. 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. The components of inventory, at the different stages of production, consisted of the following at June 30, 2015 and December 31, 2014: Inventory June 30, 2015 December 31, 2014 Raw materials $ 48,393 $ 41,648 Work-in-progress 468,573 271,571 Finished goods 21,221 12,438 Total $ 538,187 $ 325,657 |
PROPERTY, EQUIPMENT and LEASEHO
PROPERTY, EQUIPMENT and LEASEHOLD IMPROVEMENTS | 6 Months Ended |
Jun. 30, 2015 | |
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 June 30, 2015 and December 31, 2014: Property, equipment and leasehold improvements June 30, 2015 December 31, 2014 Laboratory equipment $ 424,888 $ 424,888 Manufacturing equipment 1,599,894 1,599,894 Computers, office equipment, and furniture 153,865 153,078 Computer software 4,108 4,108 Leasehold improvements 95,841 95,841 2,278,596 2,277,809 Less: accumulated depreciation and amortization (1,950,226 ) (1,845,699 ) Property, equipment and leasehold improvements, net $ 328,370 $ 432,110 Depreciation expense on property, equipment and leasehold improvements was $46,218 and $59,553 for the three months ended June 30, 2015 and 2014, respectively, and was $104,527 and $120,107 for the six months ended June 30, 2015 and 2014, respectively. |
INTANGIBLE ASSETS
INTANGIBLE ASSETS | 6 Months Ended |
Jun. 30, 2015 | |
INTANGIBLE ASSETS [Abstract] | |
INTANGIBLE ASSETS | NOTE 7. INTANGIBLE ASSETS Intangible assets are composed of patents acquired in October, 2005. Intangible assets, net consisted of the following at June 30, 2015 and December 31, 2014: Intangible assets June 30, 2015 December 31, 2014 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 ( 6,665,871 ) (6,430,249 ) Intangible assets, net $ 2,960,067 $ 3,195,689 Amortization expense for intangible assets was $118,461 and $118,461 for the three months ended June 30, 2015 and 2014, respectively, and was $235,622 and $235,622 for the six months ended June 30, 2015 and 2014, respectively. The future aggregate amortization expense for intangible assets, remaining as of June 30, 2015, is as follows: Calendar Years Future Amortization Expense 2015 (Six months) $ 239,526 2016 476,450 2017 475,148 2018 475,148 2019 475,148 2020 & Beyond 818,647 Total $ 2,960,067 |
INVESTMENTS IN UNCONSOLIDATED E
INVESTMENTS IN UNCONSOLIDATED ENTITIES | 6 Months Ended |
Jun. 30, 2015 | |
INVESTMENTS IN UNCONSOLIDATED ENTITIES [Abstract] | |
INVESTMENTS IN UNCONSOLIDATED ENTITIES | NOTE 8. INVESTMENTS IN UNCONSOLIDATED ENTITIES 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 Ltd. 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. Audited financial statements of Altrazeal Trading Ltd. for the years ended December 31, 2013 and 2014 and unaudited financial statements for the three and six months ended June 30, 2015 have not been released to us and, therefore, we have not included the effect of the financial activities of Altrazeal Trading Ltd. in our financial statements for each reporting period. We believe that our share of the cumulative losses of Altrazeal Trading Ltd. for the six months ended June 30, 2015 and for the years ended December 31, 2014, 2013, and 2012 would exceed the carrying value of our investment, therefore the equity method of accounting would be suspended for such reporting periods and no additional losses would be charged to operations. Based upon audited financial statements received in May 2014, our unrecorded share of Altrazeal Trading Ltd. losses for the year ended December 31, 2012 totaled $129,207. Summarized financial information for our investment in Altrazeal Trading Ltd. assuming 100% ownership is as follows: Altrazeal Trading Ltd. December 31, 2012 Balance sheet Total assets $ 136,661 Total liabilities $ 660,006 Total stockholders’ (deficit) $ (523,345 ) Statement of operations Revenues $ 61,028 Net (loss) $ (516,829 ) Altrazeal Trading GmbH 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 received a non-dilutable 25% ownership interest in Altrazeal Trading. Audited financial statements of Altrazeal Trading for the years ended December 31, 2013 and 2014 and unaudited financial statements for the three and six months ended June 30, 2015 have not been released to us and, therefore, we have not included the effect of the financial activities of Altrazeal Trading in our financial statements for each reporting period. We believe that our share of the cumulative losses of Altrazeal Trading for the six months ended June 30, 2015 and for the years ended December 31, 2014 and 2013 would exceed the carrying value of our investment, therefore the equity method of accounting would be suspended for such reporting periods and no additional losses would be charged to operations. Based upon the unaudited financial statements for the year ended December 31, 2014, our unrecorded share of Altrazeal Trading cumulative losses as of December 31, 2014 totaled $295,477. Summarized financial information for our investment in Altrazeal Trading assuming 100% ownership is as follows: Altrazeal Trading GmbH December 31, 2014 (Unaudited) December 31, 2013 (Unaudited) Balance sheet Total assets $ 1,039,343 $ 757,784 Total liabilities $ 2,178,865 $ 1,563,046 Total stockholders’ (deficit) $ (1,139,522 ) $ (805,262 ) Statement of operations Revenues $ 882,583 $ --- Net (loss) $ (465,580 ) $ (798,009 ) Purchase of Altrazeal Trading GmbH – May 2015 On May 12, 2015, we entered into a Binding Term Sheet (the “Term Sheet”) with IPMD GmbH, an Austrian limited liability company, and Firnron Ltd., a Cypriot limited liability company (collectively, the “Seller”) related to our purchase of 75% of the share capital of Altrazeal Trading. We currently own the remaining 25% of share capital of Altrazeal Trading. Altrazeal Trading is the distributor of Altrazeal® transforming powder dressing in European Union, Australia, New Zealand, Middle East (excluding Jordan and Syria), North Africa, Albania, Bosnia, Croatia, Kosovo, Macedonia, Montenegro, and Serbia. Pursuant to the terms and conditions in the Term Sheet, the purchase price will be composed of 3,150,000 Euro for the purchase of the share capital of Altrazeal Trading and 88,834 Euro for the purchase of product inventory. The purchase of the share capital of Altrazeal Trading will be paid in installments, with 1,147,200 Euro due at closing (of which 646,500 Euro will be paid with an offset of accounts receivable) and five installment payments of 500,700 Euro due by no later than June 30, 2015, August 31, 2015, October 31, 2015, and December 31, 2015. The sale is structured as an “installment sale”, with 15% of equity in Altrazeal Trading being transferred upon the payment of each installment by us. The installments are payable in either cash or in shares of our common stock at our option. If installment payments are made in common stock, the calculation of shares to be issued will be 110% of the average closing price for the last 10 trading days prior to the installment payment date and include a warrant for 10% of the shares issued with a premium of $0.30 per share to the market price. The purchase of the product inventory for 88,834 Euro will be paid on September 30, 2015. To the extent we issue shares of common stock to pay the purchase price, we have agreed to register the resale of such shares to the extent possible. The Term Sheet anticipates the negotiation and execution of a purchase agreement containing all terms of the Term Sheet and other standard terms for such a transaction within 60 days. Such 60 day period expired on July 21, 2015 but both parties are continuing in their efforts to finalize the negotiation and execution of a purchase agreement by no later than November 15, 2015. ORADISC GmbH On October 19, 2012, we executed a shareholders’ agreement for the establishment of ORADISC GmbH, a single purpose entity to be used for the exclusive development and marketing of OraDisc™ erodible film technology products. We received a non-dilutable 25% ownership interest in ORADISC GmbH. Audited financial statements of ORADISC GmbH for the years ended December 31, 2013 and 2014 and unaudited financial statements for the three and six months ended June 30, 2015 have not been released to us and, therefore, we have not included the effect of the financial activities of ORADISC GmbH. in our financial statements for each reporting period. We believe that our share of the cumulative losses of ORADISC GmbH for the six months ended June 30, 2015 and for the years ended December 31, 2014 and 2013 would exceed the carrying value of our investment, therefore the equity method of accounting would be suspended for such reporting periods and no additional losses would be charged to operations. Based upon the unaudited financial statements for the year ended December 31, 2013, our unrecorded share of ORADISC GmbH cumulative losses as of December 31, 2013 totaled $11,430. Summarized financial information for our investment in ORADISC GmbH assuming 100% ownership is as follows: ORADISC GmbH December 31, 2013 (Unaudited) Balance sheet Total assets $ 305,069 Total liabilities $ 302,572 Total stockholders’ equity $ 2,497 Statement of operations Revenues $ --- Net (loss) $ (34,671 ) 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 received a non-dilutable 25% ownership interest in Altrazeal AG. Audited or unaudited financial statements of Altrazeal AG for the three and six months ended June 30, 2015 and for the year ended December 31, 2014 have not been released to us and, therefore, we have not included the effect of the financial activities of Altrazeal AG in our financial statements for such reporting period. We believe that our share of the cumulative losses of Altrazeal AG for the six months ended June 30, 2015 and for the year ended December 31, 2014 would exceed the carrying value of our investment, therefore the equity method of accounting would be suspended for such reporting periods and no additional losses would be charged to operations. |
ACCRUED LIABILITIES
ACCRUED LIABILITIES | 6 Months Ended |
Jun. 30, 2015 | |
ACCRUED LIABILITIES [Abstract] | |
ACCRUED LIABILITIES | NOTE 9. ACCRUED LIABILITIES Accrued liabilities consisted of the following at June 30, 2015 and December 31, 2014: Accrued Liabilities June 30, 2015 December 31, 2014 Accrued taxes – payroll $ 106,299 $ 106,299 Accrued compensation/benefits 208,678 96,795 Accrued insurance payable 6,616 69,815 Accrued property taxes 5,400 --- Product rebates/returns 8 13 Other --- 279 Total accrued liabilities $ 327,001 $ 273,201 |
PROMISSORY NOTE PAYABLE
PROMISSORY NOTE PAYABLE | 6 Months Ended |
Jun. 30, 2015 | |
PROMISSORY NOTE PAYABLE [Abstract] | |
PROMISSORY NOTE PAYABLE | NOTE 10. PROMISSORY NOTE PAYABLE Debt Financing – April 2015 On April 15, 2015, we entered into a Securities Purchase Agreement dated April 14, 2015 (the “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 reflects a $50,000 original issue discount, was $500,000. The Purchase Agreement also included representations and warranties, restrictive covenants and indemnification provisions standard for similar transactions. The April 2015 Note bears interest at the rate of 10.0% per annum, with monthly installment payments of $45,000 commencing on the date that is 120 calendar days after the issuance date of the Note. At our option, subject to certain volume, price and other conditions, the monthly installments 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. The April 2015 Note is not subject to conversion at the discretion of Inter-Mountain. At our option, the outstanding principal balance of the April 2015 Note, or a portion thereof, may be prepaid in cash at 120% of the amount elected to be prepaid. The April 2015 Note is unsecured. Events of default under the April 2015 Note include 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 increases to 18% and the April 2015 Note becomes callable at a premium. In addition, Inter-Mountain has 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. 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 our promissory note payable is as follows: As of June 30, 2015 Transaction Initial Principal Amount Interest Rate Maturity Date Conversion Price (1) Principal Balance Unamortized Debt Discount Unamortized Debt Issuance Costs Carrying Value April 2015 Note $ 550,000 10.0 % 08/12/2016 $ 550,000 $ 58,100 $ 41,897 $ 450,003 Total $ 550,000 $ 550,000 $ 58,100 $ 41,897 $ 450,003 (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. The amount of interest cost recognized from our promissory note and convertible notes payable was $11,764 and $5,952 for the three months ended June 30, 2015 and 2014, respectively, and was $11,764 and $19,897 for the six months ended June 30, 2015 and 2014, respectively. The amount of debt discount amortized from our promissory note and convertible notes payable was $11,035 and $2,655 for the three months ended June 30, 2015 and 2014, respectively, and was $11,035 and $(78,630) for the six months ended June 30, 2015 and 2014, respectively. The future minimum payments relating to our promissory note payable, as of June 30, 2015, are as follows: Payments Due By Period Transaction Total 2014 (Six Months) 2015 2016 2017 2018 April 2015 Note $ 550,000 $ 225,000 $ 325,000 $ --- $ --- $ --- Total $ 550,000 $ 225,000 $ 325,000 $ --- $ --- $ --- |
STOCKHOLDERS' EQUITY
STOCKHOLDERS' EQUITY | 6 Months Ended |
Jun. 30, 2015 | |
STOCKHOLDERS' EQUITY [Abstract] | |
STOCKHOLDERS' EQUITY | NOTE 11. STOCKHOLDERS’ EQUITY Common Stock As of June 30, 2015, we had 24,819,534 shares of Common Stock issued and outstanding. For the three months ended June 30, 2015, we issued 361,516 shares of Common Stock issued for the cashless exercise of a warrant held by Inter-Mountain Capital Corp. Preferred Stock As of June 30, 2015, we had no shares of Series A Preferred Stock (the “Series A Shares”) issued and outstanding. For the three months ended June 30, 2015, we did not issue or redeem any Series A Shares. Warrants The following table summarizes the warrants outstanding and the number of shares of Common Stock subject to exercise as of June 30, 2015 and the changes therein during the six months 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 194,118 $ 0.85 Warrants exercised (392,857 ) $ 0.35 Warrants cancelled (357,155 ) $ 2.85 Balance as of June 30, 2015 1,120,507 $ 0.82 For the three months ended June 30, 2015, we issued a warrant to Inter-Mountain 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. Of the warrant shares subject to exercise as of June 30, 2015, expiration of the right to exercise is as follows: Date of Expiration Number of Warrant Shares of Common Stock Subject to Expiration June 13, 2016 35,000 July 16, 2016 116,667 July 28, 2016 34,722 March 14, 2018 660,000 January 15, 2019 80,000 April 30, 2020 194,118 Total 1,120,507 |
EARNINGS PER SHARE
EARNINGS PER SHARE | 6 Months Ended |
Jun. 30, 2015 | |
EARNINGS PER SHARE [Abstract] | |
EARNINGS PER SHARE | NOTE 12. EARNINGS PER SHARE Basic and Diluted Net Loss Per Share In accordance with the Financial Accounting Standards Board (“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 June 30, 2015 and December 31, 2014: June 30, 2015 December 31, 2014 Warrants to purchase Common Stock 1,120,507 1,676,401 Stock options to purchase common stock 1,664,573 1,699,907 Common stock issuable upon the assumed conversion of payments due under our promissory note from April 2015 (1) 1,189,050 --- Total 3,974,130 3,376,308 (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. For the purposes of this Table, we have assumed that all outstanding monthly installments of principal and interest will be paid in Common Stock based on a price of $0.50 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 June 30, 2015). |
SHARE BASED COMPENSATION
SHARE BASED COMPENSATION | 6 Months Ended |
Jun. 30, 2015 | |
SHARE BASED COMPENSATION [Abstract] | |
SHARE BASED COMPENSATION | NOTE 13. SHARE BASED COMPENSATION The Company’s share-based compensation plan, the 2006 Equity Incentive Plan, as amended (“Equity Incentive Plan”), is administered by the compensation committee of the Board of Directors (“Board”), 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 granted the following incentive stock option awards to executives or employees and nonstatutory stock option awards to directors or non-employees for the three and six months ended June 30: Three Months Ended June 30, Six Months Ended June 30, 2015 2014 2015 2014 Incentive Stock Options (1) Quantity --- --- --- --- Weighted average fair value per share --- --- --- --- Fair value --- --- --- --- Nonstatutory Stock Options (2) Quantity --- --- --- --- Weighted average fair value per share --- --- --- --- Fair value --- --- --- --- (1) The Company did not award any incentive stock options for the three and six months ended June 30, 2015 and 2014, respectively. (2) The Company did not award any nonstatutory stock options for the three and six months ended June 30, 2015 and 2014, 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 three and six months ended June 30: Three Months Ended June 30, Six Months Ended June 30, 2015 2014 2015 2014 Research and development $ 18,819 $ 5,365 $ 37,431 $ 10,672 Selling, general and administrative 51,019 17,018 107,755 36,251 Total share-based compensation expense $ 69,838 $ 22,383 $ 145,186 $ 46,923 At June 30, 2015, 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 $408,000. The period over which the unearned share-based compensation is expected to be recognized is approximately twenty seven months. The following table summarizes the stock options outstanding and the number of shares of Common Stock subject to exercise as of June 30, 2015 and the changes therein during the six months 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 June 30, 2015 1,664,573 $ 1.73 The following table presents the stock option grants outstanding and exercisable as of June 30, 2015: 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 882,500 $ 0.33 7.7 640,000 $ 0.33 680,000 1.15 7.4 77,500 1.15 33,334 2.55 4.8 33,334 2.55 68,739 25.07 2.1 68,739 25.07 1,664,573 $ 1.73 7.3 819,573 $ 2.57 Restricted Stock Awards Restricted stock awards, which typically vest over a period of two 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 three and six months ended June 30, 2015 and 2014, we did not grant any restricted stock awards. At June 30, 2015, the balance of unearned share-based compensation to be expensed in future periods related to restricted stock awards, as adjusted for expected forfeitures, is zero. 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 June 30, 2015, we had granted options to purchase 2,061,167 shares of Common Stock since the inception of the Equity Incentive Plan, of which 1,664,573 were outstanding at a weighted average exercise price of $1.73 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 June 30, 2015, there were 1,065,981 shares that remained available for future grants under our Equity Incentive Plan. |
FAIR VALUE MEASUREMENTS
FAIR VALUE MEASUREMENTS | 6 Months Ended |
Jun. 30, 2015 | |
FAIR VALUE MEASUREMENTS [Abstract] | |
FAIR VALUE MEASUREMENTS | NOTE 14. FAIR VALUE MEASUREMENTS In accordance with FASB 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 other receivable and convertible note payable balances approximates fair value based on a valuation methodology using the income approach and a discounted cash flow model. The following table summarizes the fair value of our financial instruments at June 30, 2015 and December 31, 2014. Description June 30, 2015 December 31, 2014 Liabilities: Promissory note – April 2015 $ 550,000 --- |
INCOME TAXES
INCOME TAXES | 6 Months Ended |
Jun. 30, 2015 | |
INCOME TAXES [Abstract] | |
INCOME TAXES | NOTE 15. 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. |
COMMITMENTS AND CONTINGENCIES
COMMITMENTS AND CONTINGENCIES | 6 Months Ended |
Jun. 30, 2015 | |
COMMITMENTS AND CONTINGENCIES [Abstract] | |
COMMITMENTS AND CONTINGENCIES | NOTE 16. 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 2015 office lease and the 2015 equipment lease are as follows as of June 30, 2015: Calendar Years Future Lease Expense 2015 (Six months) $ 59,920 2016 119,840 2017 119,840 2018 28,858 2019 --- Total $ 328,458 Rent expense for our operating leases amounted to $29,837 and $30,446 for the three months ended June 30, 2015 and 2014, respectively, and $61,002 and $60,826 for the six months ended June 30, 2015 and 2014, respectively. Indemnification In the normal course of business, we enter into contracts and agreements that contain a variety of representations and warranties and provide for general indemnifications. Our exposure under these agreements is unknown because it involves claims that may be made against us in the future, but have not yet been made. To date, we have not paid any claims or been required to defend any action related to our indemnification obligations. However, we may record charges in the future as a result of these indemnification obligations. 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. There have been no claims to date and 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. Mr. Kerschbaumer currently serves as a director of Altrazeal Trading GmbH, Altrazeal AG, and Melmed Holding AG (collectively, the “Altrazeal Distributors”) and Mr. Kuehne currently serves as a director of Altrazeal AG. In such capacities, Mr. Kerschbaumer may be considered, either singularly or collectively, to have control of, and make investment and business decisions on behalf of the Altrazeal Distributors and Mr. Kuehne may be considered, either singularly or collectively, to have control of, and make investment and business decisions on behalf of Altrazeal AG. Each of Mr. Kerschbaumer and Mr. Kuehne are shareholders of ORADISC GmbH and may be considered, either singularly or collectively, to have control of, and make investment and business decisions on behalf of the ORADISC GmbH. Currently, we are party to License and Supply Agreements with Altrazeal Trading GmbH, Altrazeal AG, and Melmed Holding AG for the marketing and distribution of Altrazeal in various international territories. We are also party to a License and Supply Agreement with ORADISC GmbH for the marketing of all applications of our OraDisc™ erodible film technology for dental applications including benzocaine (OraDisc™ B), re-mineralization dental strips, fluoride dental strips, long-acting breath freshener, amlexanox (OraDisc™ A) in certain territories, anti-psychotics, neurologic products, and actives for the treatment of erectile dysfunction. For the six months ended June 30, 2015 and 2014, the Company recorded revenues, in approximate numbers, of $527,000 and $278,000, respectively, with the various Altrazeal Distributors, which represented 95% and 89% of our total revenues. As of June 30, 2015 and December 31, 2014, Altrazeal Distributors had an outstanding net accounts receivable, in approximate numbers, of $1,250,000 and $798,000, respectively, which represented 99.8% and 99.5% of our total outstanding accounts receivables. Purchase of Altrazeal Trading GmbH – May 2015 On May 12, 2015, we entered into a Binding Term Sheet (the “Term Sheet”) with IPMD GmbH, an Austrian limited liability company, and Firnron Ltd., a Cypriot limited liability company (collectively, the “Seller”) related to our purchase of 75% of the share capital of Altrazeal Trading. We currently own the remaining 25% of share capital of Altrazeal Trading. Altrazeal Trading is the distributor of Altrazeal® transforming powder dressing in European Union, Australia, New Zealand, Middle East (excluding Jordan and Syria), North Africa, Albania, Bosnia, Croatia, Kosovo, Macedonia, Montenegro, and Serbia. Pursuant to the terms and conditions in the Term Sheet, the purchase price will be composed of 3,150,000 Euro for the purchase of the share capital of Altrazeal Trading and 88,834 Euro for the purchase of product inventory. The purchase of the share capital of Altrazeal Trading will be paid in installments, with 1,147,200 Euro due at closing (of which 646,500 Euro will be paid with an offset of accounts receivable) and five installment payments of 500,700 Euro due by no later than June 30, 2015, August 31, 2015, October 31, 2015, and December 31, 2015. The sale is structured as an “installment sale”, with 15% of equity in Altrazeal Trading being transferred upon the payment of each installment by us. The installments are payable in either cash or in shares of our common stock at our option. If installment payments are made in common stock, the calculation of shares to be issued will be 110% of the average closing price for the last 10 trading days prior to the installment payment date and include a warrant for 10% of the shares issued with a premium of $0.30 per share to the market price. The purchase of the product inventory for 88,834 Euro will be paid on September 30, 2015. To the extent we issue shares of common stock to pay the purchase price, we have agreed to register the resale of such shares to the extent possible. The Term Sheet anticipates the negotiation and execution of a purchase agreement containing all terms of the Term Sheet and other standard terms for such a transaction within 60 days. Such 60 day period expired on July 21, 2015 but both parties are continuing in their efforts to finalize the negotiation and execution of a purchase agreement by no later than November 15, 2015. 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 the Company’s cash and financial resources. As of June 30, 2015, the following table summarizes the compensation temporarily deferred and subsequent repayments: Name 2015 2014 2013 2012 2011 Total Kerry P. Gray (1) (2) (3) $ 151,806 $ (119,986 ) $ (91,000 ) $ 220,673 $ 140,313 $ 301,806 Terrance K. Wallberg 14,966 (25,000 ) (35,769 ) 24,230 36,539 14,996 Total $ 166,772 $ (144,986 ) $ (126,769 ) $ 244,903 $ 176,852 $ 316,772 (1) During 2015, Mr. Gray temporarily deferred compensation of $151,806 which consisted of $46,806 earned as salary compensation for his duties as President of the Company and $105,000 for his duties as Chairman of the Executive Committee of the Company’s Board of Directors. (2) 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 the March 2013 Offering. (3) During 2013, Mr. Gray temporarily deferred compensation of $221,500 which consisted of $11,500 earned pursuant to a Separation Agreement and $210,000 for his duties as Chairman of the Executive Committee of the Company’s Board of Directors. During 2013, Mr. Gray 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 June 30, 2015, the Company’s obligation for temporarily deferred compensation was $316,772 of which $124,272 was included in accrued liabilities and $192,500 was included in accounts payable, respectively. As of December 31, 2014, the Company’s obligation for temporarily deferred compensation was $150,000 of which $62,500 was included in accrued liabilities and $87,500 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 June 30, 2015, 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. |
LEGAL PROCEEDINGS
LEGAL PROCEEDINGS | 6 Months Ended |
Jun. 30, 2015 | |
LEGAL PROCEEDINGS [Abstract] | |
LEGAL PROCEEDINGS | NOTE 17. LEGAL PROCEEDINGS On or about August 22, 2014, Inter-Mountain Capital Corp. (“Inter-Mountain”) filed a Complaint against ULURU in the U.S. Federal Court for the District of Utah, Central Division. The Complaint relates to Inter-Mountain’s delivery of a notice of a cashless exercise with respect to its last remaining warrant to purchase Common Stock on or about May 1, 2014 purporting to exercise it with respect to the delivery of 782,284 shares of Common Stock under the non-standard cashless exercise or conversion provisions in the warrant. The Company declined to honor the exercise on the basis that, as a result of an amendment to the warrant agreed to in December 2013, the warrant was exercisable, on a cashless basis, with respect to only 261,516 shares of Common Stock as of May 1, 2014. Inter-Mountain alleged that the Company’s refusal to honor the exercise constituted a breach of the warrant, breach of implied covenant of good faith and fair dealing, unjust enrichment, a violation of securities laws and common law fraud and sought actual damages, consequential damages, treble damages, specific performance, attorneys’ fees and costs and other relief. Answers and counterclaims were filed. On April 15, 2015, the Company and Inter-Mountain entered into a Settlement Agreement (the “Settlement Agreement”) for the purpose of settling the pending litigation between the Company and Inter-Mountain. Under the Settlement Agreement and related documents, the Company and Inter-Mountain agreed that Inter-Mountain would exercise the warrant and receive 361,516 shares of Common Stock. The Settlement Agreement also included standard releases and anticipated the prompt filing of dismissal documents. As part of the settlement, the Company and Inter-Mountain signed and closed under the Securities Purchase Agreement described in Note 10. 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. |
SUBSEQUENT EVENTS
SUBSEQUENT EVENTS | 6 Months Ended |
Jun. 30, 2015 | |
SUBSEQUENT EVENTS [Abstract] | |
SUBSEQUENT EVENTS | NOTE 18. SUBSEQUENT EVENTS None. |
COMPANY OVERVIEW AND BASIS OF24
COMPANY OVERVIEW AND BASIS OF PRESENTATION (Policies) | 6 Months Ended |
Jun. 30, 2015 | |
COMPANY OVERVIEW AND BASIS OF PRESENTATION [Abstract] | |
Basis of Presentation | Basis of Presentation In the opinion of management, the accompanying unaudited condensed consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the United States of America (“U.S. GAAP”) for interim financial information and with the instructions to Form 10-Q and include the accounts of ULURU Inc., a Nevada corporation, and its wholly-owned subsidiary, Uluru Delaware Inc., a Delaware corporation. They do not include all of the information and footnotes required by generally accepted accounting principles for complete financial statements. In the opinion of management, all adjustments (consisting of normal recurring accruals) considered necessary for a fair presentation of the Company’s financial position as of June 30, 2015 and the results of its operations for the three and six months ended June 30, 2015 and 2014 and cash flows for the six months ended June 30, 2015 and 2014 have been made. 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. Operating results for the three and six months ended June 30, 2015 are not necessarily indicative of the results that may be expected for the year ending December 31, 2015. These condensed consolidated financial statements should be read in conjunction with the financial statements and notes thereto contained in the Company’s Annual Report on Form 10-K for the year ended December 31, 2014, as filed with the Securities and Exchange Commission on April 1, 2015, including the risk factors set forth therein. |
Liquidity and Going Concern | Liquidity and Going Concern The report of our independent registered public accounting firm for the fiscal year ended December 31, 2014, contained an explanatory paragraph to reflect its significant doubt about our ability to continue as a going concern as a result of our history of losses and our liquidity position, as discussed herein and in this Form 10-Q. Based on our existing liquidity, the expected level of operating expenses, projected sales of our existing products combined with other revenues and financing transactions we are exploring, we believe that we do not have sufficient working capital to meet our working capital and capital expenditure requirements through the third quarter of 2015. In the long run we cannot be sure that our anticipated revenue growth will be realized or that we will generate significant positive cash flow from operations. Moreover, we may not be able to raise sufficient additional capital on acceptable returns, or at all, to continue operations and may not be able to execute any strategic transactions. Therefore, we are unable to assert that our financial position is sufficient to fund operations beyond the third quarter of 2015, and as a result, there is substantial doubt about our ability to continue as a going concern beyond the third quarter of 2015. |
SEGMENT INFORMATION (Tables)
SEGMENT INFORMATION (Tables) | 6 Months Ended |
Jun. 30, 2015 | |
SEGMENT INFORMATION [Abstract] | |
Revenues per geographic area | Revenues per geographic area, along with relative percentages of total revenues, for the three and six months ended June 30 are summarized as follows: Three Months Ended June 30, Six Months Ended June 30, Revenues 2015 % 2014 % 2015 % 2014 % Domestic $ 7,085 3 % $ 11,770 6 % $ 13,887 3 % $ 21,442 7 % International 251,912 97 % 197,524 94 % 539,758 97 % 289,833 93 % Total $ 258,997 100 % $ 209,294 100 % $ 553,645 100 % $ 311,275 100 % |
Customers with greater than 10% of total sales | A significant portion of our revenues are derived from a few major customers. Customers with greater than 10% of total sales, along with their relative percentage of all sales, for the three and six months ended June 30 are represented on the following table: Three Months Ended June 30, Six Months Ended June 30, Customers Product 2015 2014 2015 2014 Customer A Altrazeal® 91 % 87 % 92 % 59 % Customer B Altrazeal® 2 % 3 % 2 % 28 % Total 93 % 90 % 94 % 87 % |
INVENTORY (Tables)
INVENTORY (Tables) | 6 Months Ended |
Jun. 30, 2015 | |
INVENTORY [Abstract] | |
Components of inventory | The components of inventory, at the different stages of production, consisted of the following at June 30, 2015 and December 31, 2014: Inventory June 30, 2015 December 31, 2014 Raw materials $ 48,393 $ 41,648 Work-in-progress 468,573 271,571 Finished goods 21,221 12,438 Total $ 538,187 $ 325,657 |
PROPERTY, EQUIPMENT and LEASE27
PROPERTY, EQUIPMENT and LEASEHOLD IMPROVEMENTS (Tables) | 6 Months Ended |
Jun. 30, 2015 | |
PROPERTY, EQUIPMENT and LEASEHOLD IMPROVEMENTS [Abstract] | |
Property, equipment and leasehold improvements | Property, equipment and leasehold improvements, net, consisted of the following at June 30, 2015 and December 31, 2014: Property, equipment and leasehold improvements June 30, 2015 December 31, 2014 Laboratory equipment $ 424,888 $ 424,888 Manufacturing equipment 1,599,894 1,599,894 Computers, office equipment, and furniture 153,865 153,078 Computer software 4,108 4,108 Leasehold improvements 95,841 95,841 2,278,596 2,277,809 Less: accumulated depreciation and amortization (1,950,226 ) (1,845,699 ) Property, equipment and leasehold improvements, net $ 328,370 $ 432,110 |
INTANGIBLE ASSETS (Tables)
INTANGIBLE ASSETS (Tables) | 6 Months Ended |
Jun. 30, 2015 | |
INTANGIBLE ASSETS [Abstract] | |
Intangible assets | Intangible assets are composed of patents acquired in October, 2005. Intangible assets, net consisted of the following at June 30, 2015 and December 31, 2014: Intangible assets June 30, 2015 December 31, 2014 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 ( 6,665,871 ) (6,430,249 ) Intangible assets, net $ 2,960,067 $ 3,195,689 |
Future aggregate amortization expense for intangible assets | The future aggregate amortization expense for intangible assets, remaining as of June 30, 2015, is as follows: Calendar Years Future Amortization Expense 2015 (Six months) $ 239,526 2016 476,450 2017 475,148 2018 475,148 2019 475,148 2020 & Beyond 818,647 Total $ 2,960,067 |
INVESTMENTS IN UNCONSOLIDATED29
INVESTMENTS IN UNCONSOLIDATED ENTITIES (Tables) | 6 Months Ended |
Jun. 30, 2015 | |
Altrazeal Trading Ltd. [Member] | |
Schedule of Equity Method Investments [Line Items] | |
Summarized financial information for investment | Summarized financial information for our investment in Altrazeal Trading Ltd. assuming 100% ownership is as follows: Altrazeal Trading Ltd. December 31, 2012 Balance sheet Total assets $ 136,661 Total liabilities $ 660,006 Total stockholders’ (deficit) $ (523,345 ) Statement of operations Revenues $ 61,028 Net (loss) $ (516,829 ) |
Altrazeal Trading GmbH [Member] | |
Schedule of Equity Method Investments [Line Items] | |
Summarized financial information for investment | Summarized financial information for our investment in Altrazeal Trading assuming 100% ownership is as follows: Altrazeal Trading GmbH December 31, 2014 (Unaudited) December 31, 2013 (Unaudited) Balance sheet Total assets $ 1,039,343 $ 757,784 Total liabilities $ 2,178,865 $ 1,563,046 Total stockholders’ (deficit) $ (1,139,522 ) $ (805,262 ) Statement of operations Revenues $ 882,583 $ --- Net (loss) $ (465,580 ) $ (798,009 ) |
ORADISC GmbH [Member] | |
Schedule of Equity Method Investments [Line Items] | |
Summarized financial information for investment | Summarized financial information for our investment in ORADISC GmbH assuming 100% ownership is as follows: ORADISC GmbH December 31, 2013 (Unaudited) Balance sheet Total assets $ 305,069 Total liabilities $ 302,572 Total stockholders’ equity $ 2,497 Statement of operations Revenues $ --- Net (loss) $ (34,671 ) |
ACCRUED LIABILITIES (Tables)
ACCRUED LIABILITIES (Tables) | 6 Months Ended |
Jun. 30, 2015 | |
ACCRUED LIABILITIES [Abstract] | |
Accrued liabilities | Accrued liabilities consisted of the following at June 30, 2015 and December 31, 2014: Accrued Liabilities June 30, 2015 December 31, 2014 Accrued taxes – payroll $ 106,299 $ 106,299 Accrued compensation/benefits 208,678 96,795 Accrued insurance payable 6,616 69,815 Accrued property taxes 5,400 --- Product rebates/returns 8 13 Other --- 279 Total accrued liabilities $ 327,001 $ 273,201 |
PROMISSORY NOTE PAYABLE (Tables
PROMISSORY NOTE PAYABLE (Tables) | 6 Months Ended |
Jun. 30, 2015 | |
PROMISSORY NOTE PAYABLE [Abstract] | |
Promissory Notes Payable | Information relating to our promissory note payable is as follows: As of June 30, 2015 Transaction Initial Principal Amount Interest Rate Maturity Date Conversion Price (1) Principal Balance Unamortized Debt Discount Unamortized Debt Issuance Costs Carrying Value April 2015 Note $ 550,000 10.0 % 08/12/2016 $ 550,000 $ 58,100 $ 41,897 $ 450,003 Total $ 550,000 $ 550,000 $ 58,100 $ 41,897 $ 450,003 (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. |
Future Minimum Payments of Promissory Note | The future minimum payments relating to our promissory note payable, as of June 30, 2015, are as follows: Payments Due By Period Transaction Total 2014 (Six Months) 2015 2016 2017 2018 April 2015 Note $ 550,000 $ 225,000 $ 325,000 $ --- $ --- $ --- Total $ 550,000 $ 225,000 $ 325,000 $ --- $ --- $ --- |
STOCKHOLDERS' EQUITY (Tables)
STOCKHOLDERS' EQUITY (Tables) | 6 Months Ended |
Jun. 30, 2015 | |
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 June 30, 2015 and the changes therein during the six months 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 194,118 $ 0.85 Warrants exercised (392,857 ) $ 0.35 Warrants cancelled (357,155 ) $ 2.85 Balance as of June 30, 2015 1,120,507 $ 0.82 |
Expiration dates for warrants subject to exercise | Of the warrant shares subject to exercise as of June 30, 2015, expiration of the right to exercise is as follows: Date of Expiration Number of Warrant Shares of Common Stock Subject to Expiration June 13, 2016 35,000 July 16, 2016 116,667 July 28, 2016 34,722 March 14, 2018 660,000 January 15, 2019 80,000 April 30, 2020 194,118 Total 1,120,507 |
EARNINGS PER SHARE (Tables)
EARNINGS PER SHARE (Tables) | 6 Months Ended |
Jun. 30, 2015 | |
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 June 30, 2015 and December 31, 2014: June 30, 2015 December 31, 2014 Warrants to purchase Common Stock 1,120,507 1,676,401 Stock options to purchase common stock 1,664,573 1,699,907 Common stock issuable upon the assumed conversion of payments due under our promissory note from April 2015 (1) 1,189,050 --- Total 3,974,130 3,376,308 (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. For the purposes of this Table, we have assumed that all outstanding monthly installments of principal and interest will be paid in Common Stock based on a price of $0.50 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 June 30, 2015). |
SHARE BASED COMPENSATION (Table
SHARE BASED COMPENSATION (Tables) | 6 Months Ended |
Jun. 30, 2015 | |
SHARE BASED COMPENSATION [Abstract] | |
Stock option awards granted | Our Board granted the following incentive stock option awards to executives or employees and nonstatutory stock option awards to directors or non-employees for the three and six months ended June 30: Three Months Ended June 30, Six Months Ended June 30, 2015 2014 2015 2014 Incentive Stock Options (1) Quantity --- --- --- --- Weighted average fair value per share --- --- --- --- Fair value --- --- --- --- Nonstatutory Stock Options (2) Quantity --- --- --- --- Weighted average fair value per share --- --- --- --- Fair value --- --- --- --- (1) The Company did not award any incentive stock options for the three and six months ended June 30, 2015 and 2014, respectively. (2) The Company did not award any nonstatutory stock options for the three and six months ended June 30, 2015 and 2014, respectively. |
Allocated share-based compensation expense | The following table summarizes share-based compensation related to stock options for the three and six months ended June 30: Three Months Ended June 30, Six Months Ended June 30, 2015 2014 2015 2014 Research and development $ 18,819 $ 5,365 $ 37,431 $ 10,672 Selling, general and administrative 51,019 17,018 107,755 36,251 Total share-based compensation expense $ 69,838 $ 22,383 $ 145,186 $ 46,923 |
Stock option activity | The following table summarizes the stock options outstanding and the number of shares of Common Stock subject to exercise as of June 30, 2015 and the changes therein during the six months 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 June 30, 2015 1,664,573 $ 1.73 |
Stock option grants outstanding and exercisable | The following table presents the stock option grants outstanding and exercisable as of June 30, 2015: 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 882,500 $ 0.33 7.7 640,000 $ 0.33 680,000 1.15 7.4 77,500 1.15 33,334 2.55 4.8 33,334 2.55 68,739 25.07 2.1 68,739 25.07 1,664,573 $ 1.73 7.3 819,573 $ 2.57 |
FAIR VALUE MEASUREMENTS (Tables
FAIR VALUE MEASUREMENTS (Tables) | 6 Months Ended |
Jun. 30, 2015 | |
FAIR VALUE MEASUREMENTS [Abstract] | |
Fair value of our financial instruments | The following table summarizes the fair value of our financial instruments at June 30, 2015 and December 31, 2014. Description June 30, 2015 December 31, 2014 Liabilities: Promissory note – April 2015 $ 550,000 --- |
COMMITMENTS AND CONTINGENCIES (
COMMITMENTS AND CONTINGENCIES (Tables) | 6 Months Ended |
Jun. 30, 2015 | |
COMMITMENTS AND CONTINGENCIES [Abstract] | |
Future minimum lease payments | The future minimum lease payments under the 2015 office lease and the 2015 equipment lease are as follows as of June 30, 2015: Calendar Years Future Lease Expense 2015 (Six months) $ 59,920 2016 119,840 2017 119,840 2018 28,858 2019 --- Total $ 328,458 |
Summary of compensation earned, compensation paid in cash, and compensation temporarily deferred | As of June 30, 2015, the following table summarizes the compensation temporarily deferred and subsequent repayments: Name 2015 2014 2013 2012 2011 Total Kerry P. Gray (1) (2) (3) $ 151,806 $ (119,986 ) $ (91,000 ) $ 220,673 $ 140,313 $ 301,806 Terrance K. Wallberg 14,966 (25,000 ) (35,769 ) 24,230 36,539 14,996 Total $ 166,772 $ (144,986 ) $ (126,769 ) $ 244,903 $ 176,852 $ 316,772 (1) During 2015, Mr. Gray temporarily deferred compensation of $151,806 which consisted of $46,806 earned as salary compensation for his duties as President of the Company and $105,000 for his duties as Chairman of the Executive Committee of the Company’s Board of Directors. (2) 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 the March 2013 Offering. (3) During 2013, Mr. Gray temporarily deferred compensation of $221,500 which consisted of $11,500 earned pursuant to a Separation Agreement and $210,000 for his duties as Chairman of the Executive Committee of the Company’s Board of Directors. During 2013, Mr. Gray was also repaid $312,500 of temporarily deferred compensation, of which $300,000 was used by Mr. Gray for funding required pursuant to the March 2013 Offering. |
SEGMENT INFORMATION (Details)
SEGMENT INFORMATION (Details) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2015USD ($) | Jun. 30, 2014USD ($) | Jun. 30, 2015USD ($)SegmentLicensee | Jun. 30, 2014USD ($) | |
SEGMENT INFORMATION [Abstract] | ||||
Number of business segments | Segment | 1 | |||
Number of international licensees | Licensee | 7 | |||
Revenues per geographic area [Abstract] | ||||
Total Revenues | $ 258,997 | $ 209,294 | $ 553,645 | $ 311,275 |
Total revenue, percentage (in hundredths) | 100.00% | 100.00% | 100.00% | 100.00% |
Revenue, Major Customer [Line Items] | ||||
Sales from major customer, percentage (in hundredths) | 93.00% | 90.00% | 94.00% | 87.00% |
Customer A [Member] | Altrazeal [Member] | ||||
Revenue, Major Customer [Line Items] | ||||
Sales from major customer, percentage (in hundredths) | 91.00% | 87.00% | 92.00% | 59.00% |
Customer B [Member] | Altrazeal [Member] | ||||
Revenue, Major Customer [Line Items] | ||||
Sales from major customer, percentage (in hundredths) | 2.00% | 3.00% | 2.00% | 28.00% |
Reportable Geographical Components [Member] | Domestic [Member] | ||||
Revenues per geographic area [Abstract] | ||||
Total Revenues | $ 7,085 | $ 11,770 | $ 13,887 | $ 21,442 |
Total revenue, percentage (in hundredths) | 3.00% | 6.00% | 3.00% | 7.00% |
Reportable Geographical Components [Member] | International [Member] | ||||
Revenues per geographic area [Abstract] | ||||
Total Revenues | $ 251,912 | $ 197,524 | $ 539,758 | $ 289,833 |
Total revenue, percentage (in hundredths) | 97.00% | 94.00% | 97.00% | 93.00% |
INVENTORY (Details)
INVENTORY (Details) - USD ($) | Jun. 30, 2015 | Dec. 31, 2014 |
Components of inventory [Abstract] | ||
Raw materials | $ 48,393 | $ 41,648 |
Work-in-progress | 468,573 | 271,571 |
Finished goods | 21,221 | 12,438 |
Total | $ 538,187 | $ 325,657 |
PROPERTY, EQUIPMENT and LEASE39
PROPERTY, EQUIPMENT and LEASEHOLD IMPROVEMENTS (Details) - USD ($) | 3 Months Ended | 6 Months Ended | |||
Jun. 30, 2015 | Jun. 30, 2014 | Jun. 30, 2015 | Jun. 30, 2014 | Dec. 31, 2014 | |
Property, equipment and leasehold improvements, net [Abstract] | |||||
Property, equipment and leasehold improvements, gross | $ 2,278,596 | $ 2,278,596 | $ 2,277,809 | ||
Less: accumulated depreciation and amortization | (1,950,226) | (1,950,226) | (1,845,699) | ||
Property, equipment and leasehold improvements, net | 328,370 | 328,370 | 432,110 | ||
Depreciation expense | 46,218 | $ 59,553 | 104,527 | $ 120,107 | |
Laboratory Equipment [Member] | |||||
Property, equipment and leasehold improvements, net [Abstract] | |||||
Property, equipment and leasehold improvements, gross | 424,888 | 424,888 | 424,888 | ||
Manufacturing Equipment [Member] | |||||
Property, equipment and leasehold improvements, net [Abstract] | |||||
Property, equipment and leasehold improvements, gross | 1,599,894 | 1,599,894 | 1,599,894 | ||
Computers, Office Equipment, and Furniture [Member] | |||||
Property, equipment and leasehold improvements, net [Abstract] | |||||
Property, equipment and leasehold improvements, gross | 153,865 | 153,865 | 153,078 | ||
Computer Software [Member] | |||||
Property, equipment and leasehold improvements, net [Abstract] | |||||
Property, equipment and leasehold improvements, gross | 4,108 | 4,108 | 4,108 | ||
Leasehold Improvements [Member] | |||||
Property, equipment and leasehold improvements, net [Abstract] | |||||
Property, equipment and leasehold improvements, gross | $ 95,841 | $ 95,841 | $ 95,841 |
INTANGIBLE ASSETS (Details)
INTANGIBLE ASSETS (Details) - USD ($) | 3 Months Ended | 6 Months Ended | |||
Jun. 30, 2015 | Jun. 30, 2014 | Jun. 30, 2015 | Jun. 30, 2014 | Dec. 31, 2014 | |
Finite-Lived Intangible Assets [Line Items] | |||||
Intangible assets, gross | $ 9,625,938 | $ 9,625,938 | $ 9,625,938 | ||
Less: accumulated amortization | (6,665,871) | (6,665,871) | (6,430,249) | ||
Intangible assets, net | 2,960,067 | 2,960,067 | 3,195,689 | ||
Amortization expense | 118,461 | $ 118,461 | 235,622 | $ 235,622 | |
Future aggregate amortization expense for intangible assets [Abstract] | |||||
2015 (Six months) | 239,526 | 239,526 | |||
2,016 | 476,450 | 476,450 | |||
2,017 | 475,148 | 475,148 | |||
2,018 | 475,148 | 475,148 | |||
2,019 | 475,148 | 475,148 | |||
2020 & Beyond | 818,647 | 818,647 | |||
Total | 2,960,067 | 2,960,067 | |||
Patents [Member] | Amlexanox (Aphthasol) [Member] | |||||
Finite-Lived Intangible Assets [Line Items] | |||||
Intangible assets, gross | 2,090,000 | 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 | 6,873,080 | ||
Patents [Member] | ORADISC [Member] | |||||
Finite-Lived Intangible Assets [Line Items] | |||||
Intangible assets, gross | 73,000 | 73,000 | 73,000 | ||
Patents [Member] | Hydrogel Nanoparticle Aggregate [Member] | |||||
Finite-Lived Intangible Assets [Line Items] | |||||
Intangible assets, gross | $ 589,858 | $ 589,858 | $ 589,858 |
INVESTMENTS IN UNCONSOLIDATED41
INVESTMENTS IN UNCONSOLIDATED ENTITIES (Details) | Dec. 31, 2015EUR (€) | Oct. 31, 2015EUR (€) | Aug. 31, 2015EUR (€) | Jun. 30, 2015EUR (€) | May. 12, 2015EUR (€)$ / shares | May. 12, 2015EUR (€)Installment | Jun. 30, 2015USD ($) | Jun. 30, 2014USD ($) | Jun. 30, 2015USD ($) | Jun. 30, 2014USD ($) | Dec. 31, 2014USD ($) | Dec. 31, 2013USD ($) | Dec. 31, 2012USD ($) | Sep. 30, 2015EUR (€) |
Statement of operations [Abstract] | ||||||||||||||
Gains losses on equity method investments | $ 0 | $ 0 | $ 0 | $ 0 | ||||||||||
Minimum [Member] | ||||||||||||||
Schedule of Equity Method Investments [Line Items] | ||||||||||||||
Percentage of noncontrolling interest (in hundredths) | 20.00% | 20.00% | 20.00% | |||||||||||
Maximum [Member] | ||||||||||||||
Schedule of Equity Method Investments [Line Items] | ||||||||||||||
Percentage of noncontrolling interest (in hundredths) | 50.00% | 50.00% | 50.00% | |||||||||||
Altrazeal Trading Ltd. [Member] | ||||||||||||||
Schedule of Equity Method Investments [Line Items] | ||||||||||||||
Non-dilutable ownership interest (in hundredths) | 25.00% | |||||||||||||
Unrecorded profit (loss) | $ 129,207 | |||||||||||||
Balance sheet [Abstract] | ||||||||||||||
Total assets | 136,661 | |||||||||||||
Total liabilities | 660,006 | |||||||||||||
Total stockholders' equity (deficit) | (523,345) | |||||||||||||
Statement of operations [Abstract] | ||||||||||||||
Revenues | 61,028 | |||||||||||||
Net (loss) | $ (516,829) | |||||||||||||
Percentage of voting interest acquired (in hundreds) | 25.00% | |||||||||||||
ORADISC GmbH [Member] | ||||||||||||||
Schedule of Equity Method Investments [Line Items] | ||||||||||||||
Non-dilutable ownership interest (in hundredths) | 25.00% | |||||||||||||
Unrecorded profit (loss) | $ 11,430 | |||||||||||||
Balance sheet [Abstract] | ||||||||||||||
Total assets | 305,069 | |||||||||||||
Total liabilities | 302,572 | |||||||||||||
Total stockholders' equity (deficit) | 2,497 | |||||||||||||
Statement of operations [Abstract] | ||||||||||||||
Revenues | 0 | |||||||||||||
Net (loss) | (34,671) | |||||||||||||
Gains losses on equity method investments | $ 0 | $ 0 | $ 0 | |||||||||||
Percentage of voting interest acquired (in hundreds) | 25.00% | |||||||||||||
Altrazeal Trading GmbH [Member] | ||||||||||||||
Schedule of Equity Method Investments [Line Items] | ||||||||||||||
Non-dilutable ownership interest (in hundredths) | 25.00% | 75.00% | 75.00% | 25.00% | 25.00% | 25.00% | ||||||||
Unrecorded profit (loss) | $ 295,477 | |||||||||||||
Balance sheet [Abstract] | ||||||||||||||
Total assets | 1,039,343 | $ 757,784 | ||||||||||||
Total liabilities | 2,178,865 | 1,563,046 | ||||||||||||
Total stockholders' equity (deficit) | (1,139,522) | (805,262) | ||||||||||||
Statement of operations [Abstract] | ||||||||||||||
Revenues | 882,583 | 0 | ||||||||||||
Net (loss) | $ (465,580) | $ (798,009) | ||||||||||||
Percentage of voting interest acquired (in hundreds) | 25.00% | 75.00% | 75.00% | 25.00% | 25.00% | 25.00% | ||||||||
Purchase price allocation, share capital | € | € 3,150,000 | € 3,150,000 | ||||||||||||
Purchase price allocation, product inventory | € | € 88,834 | 88,834 | ||||||||||||
Purchase price of acquisition, installment amount | € | 1,147,200 | |||||||||||||
Purchase price offset of accounts receivable amount | € | € 646,500 | |||||||||||||
Number of installments | Installment | 5 | |||||||||||||
Purchase price of share capital, installment amount | € | € 500,700 | |||||||||||||
Percentage of equity being transferred on each installment (in hundredths) | 15.00% | |||||||||||||
Percentage of average closing price of shares (in hundredths) | 110.00% | |||||||||||||
Number of trading days | 10 days | |||||||||||||
Percentage of warrants included in installment payment (in hundredths) | 10.00% | |||||||||||||
Premium per share included in installment payments (in dollars per share) | $ / shares | € 0.30 | |||||||||||||
Altrazeal Trading GmbH [Member] | Subsequent Event [Member] | ||||||||||||||
Statement of operations [Abstract] | ||||||||||||||
Purchase price of share capital, installment amount | € | € 500,700 | € 500,700 | € 500,700 | |||||||||||
Payment for inventory included in working capital | € | € 88,834 | |||||||||||||
Altrazeal Trading GmbH [Member] | Subsequent Event [Member] | Maximum [Member] | ||||||||||||||
Statement of operations [Abstract] | ||||||||||||||
Purchase agreement execution period | 60 days | |||||||||||||
Altrazeal AG [Member] | ||||||||||||||
Schedule of Equity Method Investments [Line Items] | ||||||||||||||
Non-dilutable ownership interest (in hundredths) | 25.00% | 25.00% | 25.00% | |||||||||||
Statement of operations [Abstract] | ||||||||||||||
Gains losses on equity method investments | $ 0 | |||||||||||||
Percentage of voting interest acquired (in hundreds) | 25.00% | 25.00% | 25.00% |
ACCRUED LIABILITIES (Details)
ACCRUED LIABILITIES (Details) - USD ($) | Jun. 30, 2015 | Dec. 31, 2014 |
Accrued liabilities [Abstract] | ||
Accrued taxes - payroll | $ 106,299 | $ 106,299 |
Accrued compensation/benefits | 208,678 | 96,795 |
Accrued insurance payable | 6,616 | 69,815 |
Accrued property taxes | 5,400 | 0 |
Product rebates/returns | 8 | 13 |
Other | 0 | 279 |
Total accrued liabilities | $ 327,001 | $ 273,201 |
PROMISSORY NOTE PAYABLE (Detail
PROMISSORY NOTE PAYABLE (Details) - USD ($) | Apr. 15, 2015 | Jun. 30, 2015 | Jun. 30, 2014 | Jun. 30, 2015 | Jun. 30, 2014 | |
Debt Instrument [Line Items] | ||||||
Promissory note original issue discount | $ 58,100 | $ 58,100 | ||||
Warrant to purchase shares of common stock (in shares) | 361,516 | |||||
Warrants expiration date | Apr. 30, 2020 | |||||
Initial Principal Amount | $ 550,000 | $ 550,000 | ||||
Conversion Price | [1] | $ 0 | $ 0 | |||
Principal Balance | $ 550,000 | $ 550,000 | ||||
Unamortized Debt Discount | 58,100 | 58,100 | ||||
Unamortized Debt Issuance Costs | 41,897 | |||||
Carrying Value | 450,003 | 450,003 | ||||
Accrued interest from promissory note and convertible notes payable | 11,764 | $ 5,952 | 11,764 | $ 19,897 | ||
Amortization of debt discount on promissory note and convertible note | 11,035 | $ 2,655 | 11,035 | $ (78,630) | ||
2014 (Six Months) | 225,000 | 225,000 | ||||
2,015 | 325,000 | 325,000 | ||||
2,016 | 0 | 0 | ||||
2,017 | 0 | 0 | ||||
2,018 | 0 | 0 | ||||
April 2015 Note [Member] | ||||||
Debt Instrument [Line Items] | ||||||
Promissory note original issue discount | 58,100 | 58,100 | ||||
Initial Principal Amount | $ 550,000 | $ 550,000 | ||||
Interest Rate | 10.00% | 10.00% | ||||
Maturity Date | Aug. 12, 2016 | |||||
Conversion Price | [1] | $ 0 | $ 0 | |||
Principal Balance | $ 550,000 | $ 550,000 | ||||
Unamortized Debt Discount | 58,100 | 58,100 | ||||
Unamortized Debt Issuance Costs | 41,897 | |||||
Carrying Value | 450,003 | 450,003 | ||||
2014 (Six Months) | 225,000 | 225,000 | ||||
2,015 | 325,000 | 325,000 | ||||
2,016 | 0 | 0 | ||||
2,017 | 0 | 0 | ||||
2,018 | $ 0 | $ 0 | ||||
Inter Mountain Capital Corp [Member] | ||||||
Debt Instrument [Line Items] | ||||||
Promissory note original issue discount | $ 50,000 | |||||
Purchase price for promissory note | 500,000 | |||||
Promissory note monthly installment payments | $ 45,000 | |||||
Monthly installment payments commencing period | 120 days | |||||
Notes prepayment percentage (in hundredths) | 120.00% | |||||
Notes repayment default amount | $ 100,000 | |||||
Judgement stay period on note default | 30 days | |||||
Increase in interest rate (in hundredths) | 18.00% | |||||
Warrant to purchase shares of common stock (in shares) | 194,118 | |||||
Warrants exercise price (in dollars per share) | $ 0.85 | |||||
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 | |||||
Unamortized Debt Discount | $ 50,000 | |||||
Inter Mountain Capital Corp [Member] | Conversion Condition One [Member] | ||||||
Debt Instrument [Line Items] | ||||||
Average percentage of three lowest volume weighted average price (in hundredths) | 80.00% | |||||
Number of trading days in conversion | 20 days | |||||
Inter Mountain Capital Corp [Member] | Conversion Condition Two [Member] | ||||||
Debt Instrument [Line Items] | ||||||
Weighted average price of common stock (in dollars per share) | $ 0.05 | |||||
Average percentage of three lowest volume weighted average price (in hundredths) | 70.00% | |||||
Number of trading days in conversion | 20 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 $0.05 per share. |
STOCKHOLDERS' EQUITY (Details)
STOCKHOLDERS' EQUITY (Details) | 6 Months Ended | ||
Jun. 30, 2015$ / sharesshares | Jun. 30, 2015shares | Dec. 31, 2014shares | |
Common Stock [Abstract] | |||
Common Stock, shares issued (in shares) | 24,819,534 | 24,458,018 | |
Common Stock, shares outstanding (in shares) | 24,819,534 | 24,458,018 | |
Common stock issued during period (in shares) | 361,516 | ||
Warrants and Number of Shares of Common Stock Subject to Exercise [Roll Forward] | |||
Balance (in shares) | 1,676,401 | ||
Warrants issued (in shares) | 194,118 | ||
Warrants exercised (in shares) | (392,857) | ||
Warrants cancelled (in shares) | (357,155) | ||
Balance (in shares) | 1,120,507 | ||
Warrants, Weighted-Average Exercise Price [Abstract] | |||
Balance (in dollars per share) | $ / shares | 1.14 | ||
Warrants issued (in dollars per share) | $ / shares | 0.85 | ||
Warrants exercised (in dollars per share) | $ / shares | 0.35 | ||
Warrants cancelled (in dollars per share) | $ / shares | 2.85 | ||
Balance (in dollars per share) | $ / shares | 0.82 | ||
Warrant shares subject to expiration [Abstract] | |||
Number of Warrant Shares of Common Stock Subject to Expiration (in shares) | 1,676,401 | 1,120,507 | 1,676,401 |
Warrants expiration date | Apr. 30, 2020 | ||
June 13, 2016 [Member] | |||
Warrants and Number of Shares of Common Stock Subject to Exercise [Roll Forward] | |||
Balance (in shares) | 35,000 | ||
Warrant shares subject to expiration [Abstract] | |||
Number of Warrant Shares of Common Stock Subject to Expiration (in shares) | 35,000 | 35,000 | |
July 16, 2016 [Member] | |||
Warrants and Number of Shares of Common Stock Subject to Exercise [Roll Forward] | |||
Balance (in shares) | 116,667 | ||
Warrant shares subject to expiration [Abstract] | |||
Number of Warrant Shares of Common Stock Subject to Expiration (in shares) | 116,667 | 116,667 | |
July 28, 2016 [Member] | |||
Warrants and Number of Shares of Common Stock Subject to Exercise [Roll Forward] | |||
Balance (in shares) | 34,722 | ||
Warrant shares subject to expiration [Abstract] | |||
Number of Warrant Shares of Common Stock Subject to Expiration (in shares) | 34,722 | 34,722 | |
March 14, 2018 [Member] | |||
Warrants and Number of Shares of Common Stock Subject to Exercise [Roll Forward] | |||
Balance (in shares) | 660,000 | ||
Warrant shares subject to expiration [Abstract] | |||
Number of Warrant Shares of Common Stock Subject to Expiration (in shares) | 660,000 | 660,000 | |
January 15, 2019 [Member] | |||
Warrants and Number of Shares of Common Stock Subject to Exercise [Roll Forward] | |||
Balance (in shares) | 80,000 | ||
Warrant shares subject to expiration [Abstract] | |||
Number of Warrant Shares of Common Stock Subject to Expiration (in shares) | 80,000 | 80,000 | |
April 30, 2020 [Member] | |||
Warrants and Number of Shares of Common Stock Subject to Exercise [Roll Forward] | |||
Balance (in shares) | 194,118 | ||
Warrant shares subject to expiration [Abstract] | |||
Number of Warrant Shares of Common Stock Subject to Expiration (in shares) | 194,118 | 194,118 | |
Series A Preferred Stock [Member] | |||
Preferred Stock [Abstract] | |||
Preferred stock, shares issued (in shares) | 0 | ||
Preferred stock, shares outstanding (in shares) | 0 |
EARNINGS PER SHARE (Details)
EARNINGS PER SHARE (Details) - $ / shares | 6 Months Ended | 12 Months Ended | |
Jun. 30, 2015 | Dec. 31, 2014 | ||
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) | 3,974,130 | 3,376,308 | |
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) | 1,120,507 | 1,676,401 | |
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) | 1,664,573 | 1,699,907 | |
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] | 1,189,050 | 0 |
Percentage of weighted average prices of shares of common stock (in hundredths) | 80.00% | ||
Monthly installment payment terms | 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. | ||
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 (in hundredths) | 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) | $ 0.50 | ||
[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 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. For the purposes of this Table, we have assumed that all outstanding monthly installments of principal and interest will be paid in Common Stock based on a price of $0.50 per share (80% of the average of the three lowest volume weighted average prices of the shares of Common Stock during the preceding twenty trading days prior to June 30, 2015). |
SHARE BASED COMPENSATION (Detai
SHARE BASED COMPENSATION (Details) - USD ($) | Jun. 05, 2014 | Jun. 13, 2013 | Jun. 14, 2012 | Jun. 15, 2010 | Dec. 17, 2009 | May. 08, 2007 | Jun. 30, 2015 | Jun. 30, 2014 | Jun. 30, 2015 | Jun. 30, 2014 | Mar. 31, 2006 | |
Additional disclosures [Abstract] | ||||||||||||
Number of shares authorized (in shares) | 2,800,000 | 2,800,000 | ||||||||||
Number of additional shares authorized (in shares) | 1,000,000 | 600,000 | 400,000 | 200,000 | 200,000 | 266,667 | ||||||
Incentive Stock Options [Member] | ||||||||||||
Options Granted [Abstract] | ||||||||||||
Quantity (in shares) | [1] | 0 | 0 | 0 | 0 | |||||||
Weighted average fair value per share (in dollars per share) | [1] | $ 0 | $ 0 | $ 0 | $ 0 | |||||||
Fair value | [1] | $ 0 | $ 0 | $ 0 | $ 0 | |||||||
Options, Outstanding [Roll Forward] | ||||||||||||
Granted (in shares) | [1] | 0 | 0 | 0 | 0 | |||||||
Nonstatutory Stock Options [Member] | ||||||||||||
Options Granted [Abstract] | ||||||||||||
Quantity (in shares) | [2] | 0 | 0 | 0 | 0 | |||||||
Weighted average fair value per share (in dollars per share) | [2] | $ 0 | $ 0 | $ 0 | $ 0 | |||||||
Fair value | [2] | $ 0 | $ 0 | $ 0 | $ 0 | |||||||
Options, Outstanding [Roll Forward] | ||||||||||||
Granted (in shares) | [2] | 0 | 0 | 0 | 0 | |||||||
Stock Options [Member] | ||||||||||||
Options Granted [Abstract] | ||||||||||||
Quantity (in shares) | 0 | |||||||||||
Options, Outstanding [Roll Forward] | ||||||||||||
Outstanding, beginning of period (in shares) | 1,699,907 | |||||||||||
Granted (in shares) | 0 | |||||||||||
Forfeited/cancelled (in shares) | (35,334) | |||||||||||
Exercised (in shares) | 0 | |||||||||||
Outstanding, end of period (in shares) | 1,664,573 | 1,664,573 | ||||||||||
Outstanding, Weighted Average Exercise Price [Roll Forward] | ||||||||||||
Outstanding, beginning of period (in dollars per share) | $ 1.73 | |||||||||||
Granted (in dollars per share) | 0 | |||||||||||
Forfeited/cancelled (in dollars per share) | 1.77 | |||||||||||
Exercised (in dollars per share) | 0 | |||||||||||
Outstanding, end of period (in dollars per share) | $ 1.73 | $ 1.73 | ||||||||||
Nonvested Awards, unearned share-based compensation [Abstract] | ||||||||||||
Unearned share-based compensation expense | $ 408,000 | $ 408,000 | ||||||||||
Unearned share-based compensation, recognition period | 27 months | |||||||||||
Stock Options [Member] | Maximum [Member] | ||||||||||||
Additional disclosures [Abstract] | ||||||||||||
Contractual term | 10 years | |||||||||||
Restricted Stock [Member] | ||||||||||||
Additional disclosures [Abstract] | ||||||||||||
Granted (in shares) | 0 | 0 | 0 | 0 | ||||||||
Nonvested Awards, unearned share-based compensation [Abstract] | ||||||||||||
Unearned share-based compensation expense | $ 0 | $ 0 | ||||||||||
Restricted Stock [Member] | Minimum [Member] | ||||||||||||
Additional disclosures [Abstract] | ||||||||||||
Vesting period | 2 years | |||||||||||
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) | 133,333 | |||||||||||
Number of shares available for grant (in shares) | 1,065,981 | 1,065,981 | ||||||||||
2006 Equity Incentive Plan [Member] | Stock Options [Member] | ||||||||||||
Additional disclosures [Abstract] | ||||||||||||
Number of options granted to date (in shares) | 2,061,167 | 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 | 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 | |||||||||||
[1] | The Company did not award any incentive stock options for the three and six months ended June 30, 2015 and 2014, respectively. | |||||||||||
[2] | The Company did not award any nonstatutory stock options for the three and six months ended June 30, 2015 and 2014, respectively. |
SHARE BASED COMPENSATION, Alloc
SHARE BASED COMPENSATION, Allocated Compensation expense (Details) - Stock Options [Member] - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2015 | Jun. 30, 2014 | Jun. 30, 2015 | Jun. 30, 2014 | |
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||||
Share-based compensation expense | $ 69,838 | $ 22,383 | $ 145,186 | $ 46,923 |
Research and Development [Member] | ||||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||||
Share-based compensation expense | 18,819 | 5,365 | 37,431 | 10,672 |
Selling, General and Administrative [Member] | ||||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||||
Share-based compensation expense | $ 51,019 | $ 17,018 | $ 107,755 | $ 36,251 |
SHARE BASED COMPENSATION, Stock
SHARE BASED COMPENSATION, Stock options grant outstanding and exercisable (Details) - Jun. 30, 2015 - $ / shares | Total |
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items] | |
Stock Options Outstanding (in shares) | 1,664,573 |
Options Outstanding, Weighted Average Exercise Price per Share (in dollars per share) | $ 1.73 |
Options Outstanding, Weighted Average Remaining Contractual Life in Years | 7 years 3 months 18 days |
Stock Options Exercisable (in shares) | 819,573 |
Options Exercisable, Weighted Average Exercise Price per Share (in dollars per share) | $ 2.57 |
Exercise Price Range 1 [Member] | |
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items] | |
Stock Options Outstanding (in shares) | 882,500 |
Options Outstanding, Weighted Average Exercise Price per Share (in dollars per share) | $ 0.33 |
Options Outstanding, Weighted Average Remaining Contractual Life in Years | 7 years 8 months 12 days |
Stock Options Exercisable (in shares) | 640,000 |
Options Exercisable, Weighted Average Exercise Price per Share (in dollars per share) | $ 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) | 680,000 |
Options Outstanding, Weighted Average Exercise Price per Share (in dollars per share) | $ 1.15 |
Options Outstanding, Weighted Average Remaining Contractual Life in Years | 7 years 4 months 24 days |
Stock Options Exercisable (in shares) | 77,500 |
Options Exercisable, Weighted Average Exercise Price per Share (in dollars per share) | $ 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) | 33,334 |
Options Outstanding, Weighted Average Exercise Price per Share (in dollars per share) | $ 2.55 |
Options Outstanding, Weighted Average Remaining Contractual Life in Years | 4 years 9 months 18 days |
Stock Options Exercisable (in shares) | 33,334 |
Options Exercisable, Weighted Average Exercise Price per Share (in dollars per share) | $ 2.55 |
Exercise Price Range 4 [Member] | |
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items] | |
Stock Options Outstanding (in shares) | 68,739 |
Options Outstanding, Weighted Average Exercise Price per Share (in dollars per share) | $ 25.07 |
Options Outstanding, Weighted Average Remaining Contractual Life in Years | 2 years 1 month 6 days |
Stock Options Exercisable (in shares) | 68,739 |
Options Exercisable, Weighted Average Exercise Price per Share (in dollars per share) | $ 25.07 |
FAIR VALUE MEASUREMENTS (Detail
FAIR VALUE MEASUREMENTS (Details) - USD ($) | Jun. 30, 2015 | Dec. 31, 2014 |
Promissory Note April 2015 [Member] | ||
Liabilities [Abstract] | ||
Promissory note payable | $ 550,000 | $ 0 |
COMMITMENTS AND CONTINGENCIES50
COMMITMENTS AND CONTINGENCIES (Details) | May. 12, 2015EUR (€)$ / shares | May. 12, 2015EUR (€)Installment | Mar. 17, 2015USD ($) | Jun. 30, 2015USD ($) | Jun. 30, 2014USD ($) | Jun. 30, 2015USD ($) | Jun. 30, 2015EUR (€) | Jun. 30, 2014USD ($) | Jun. 30, 2013USD ($) | Jun. 30, 2012USD ($) | Jun. 30, 2011USD ($) | Dec. 31, 2014USD ($) | Mar. 31, 2013USD ($) | Feb. 01, 2018USD ($) | Mar. 31, 2011USD ($) | Sep. 30, 2015EUR (€) | Mar. 07, 2008USD ($) | |||
Future minimum lease payments [Abstract] | ||||||||||||||||||||
2015 (Six months) | $ 59,920 | $ 59,920 | ||||||||||||||||||
2,016 | 119,840 | 119,840 | ||||||||||||||||||
2,017 | 119,840 | 119,840 | ||||||||||||||||||
2,018 | 28,858 | 28,858 | ||||||||||||||||||
2,019 | 0 | 0 | ||||||||||||||||||
Total | 328,458 | 328,458 | ||||||||||||||||||
Rent expense for operating lease | 29,837 | $ 30,446 | 61,002 | $ 60,826 | ||||||||||||||||
Related Party Obligations [Abstract] | ||||||||||||||||||||
Outstanding accounts receivable | $ 1,249,683 | $ 1,249,683 | $ 798,147 | |||||||||||||||||
Concentration risk, percentage (in hundredths) | 100.00% | 100.00% | 100.00% | 100.00% | 100.00% | |||||||||||||||
Summary of compensation earned, compensation paid in cash, and compensation temporarily deferred [Abstract] | ||||||||||||||||||||
Deferred compensation liability | $ 166,772 | $ (144,986) | $ (126,769) | $ 244,903 | $ 176,852 | |||||||||||||||
Deferred compensation | $ 316,772 | 316,772 | 150,000 | |||||||||||||||||
Compensation accounts payable | 192,500 | 192,500 | 87,500 | |||||||||||||||||
Compensation accrued liabilities | 124,272 | 124,272 | 62,500 | |||||||||||||||||
Milestone payments [Line Items] | ||||||||||||||||||||
Future milestone obligations | 4,750,000 | 4,750,000 | ||||||||||||||||||
Kerry P. Gray [Member] | ||||||||||||||||||||
Summary of compensation earned, compensation paid in cash, and compensation temporarily deferred [Abstract] | ||||||||||||||||||||
Deferred compensation liability | [1],[2],[3] | 151,806 | (119,986) | (91,000) | 220,673 | 140,313 | ||||||||||||||
Deferred compensation | 301,806 | [1],[2],[3] | $ 150,000 | 301,806 | [1],[2],[3] | 150,000 | 221,500 | |||||||||||||
Deferred compensation liability pursuant to separation agreement | 11,500 | |||||||||||||||||||
Deferred compensation liability pursuant to duties as president | 46,806 | 62,500 | ||||||||||||||||||
Deferred compensation liability pursuant to duties as chairman | 105,000 | 87,500 | 210,000 | |||||||||||||||||
Repayment of temporarily deferred compensation | 269,986 | 312,500 | ||||||||||||||||||
Proceeds from issuance of common stock under March 2013 offering | 100,000 | 300,000 | ||||||||||||||||||
Terrance K. Wallberg [Member] | ||||||||||||||||||||
Summary of compensation earned, compensation paid in cash, and compensation temporarily deferred [Abstract] | ||||||||||||||||||||
Deferred compensation liability | 14,966 | (25,000) | $ (35,769) | $ 24,230 | $ 36,539 | |||||||||||||||
Deferred compensation | 14,996 | 14,996 | ||||||||||||||||||
Altrazeal Trading GmbH [Member] | ||||||||||||||||||||
Related Party Obligations [Abstract] | ||||||||||||||||||||
Related party sales | 527,000 | $ 278,000 | ||||||||||||||||||
Outstanding accounts receivable | $ 1,250,000 | $ 1,250,000 | $ 798,000 | |||||||||||||||||
Percentage of voting interest acquired (in hundredths) | 75.00% | 75.00% | 25.00% | 25.00% | ||||||||||||||||
Purchase price allocation, share capital | € | € 3,150,000 | € 3,150,000 | ||||||||||||||||||
Purchase price allocation, working capital | € | € 88,834 | 88,834 | ||||||||||||||||||
Purchase price of acquisition, installment amount | € | 1,147,200 | |||||||||||||||||||
Purchase price offset of accounts receivable amount | € | € 646,500 | |||||||||||||||||||
Number of installments | Installment | 5 | |||||||||||||||||||
Purchase price of share capital, installment amount | € | € 500,700 | |||||||||||||||||||
Percentage of equity being transferred on each installment (in hundredths) | 15.00% | |||||||||||||||||||
Percentage of average closing price of shares (in hundredths) | 110.00% | |||||||||||||||||||
Number of trading days | 10 days | |||||||||||||||||||
Percentage of warrants included in installment payment (in hundredths) | 10.00% | |||||||||||||||||||
Premium per share included in installment payments (in dollars per share) | $ / shares | € 0.30 | |||||||||||||||||||
Altrazeal Trading GmbH [Member] | Maximum [Member] | ||||||||||||||||||||
Related Party Obligations [Abstract] | ||||||||||||||||||||
Purchase agreement execution period | 60 days | |||||||||||||||||||
Altrazeal Trading GmbH [Member] | Subsequent Event [Member] | ||||||||||||||||||||
Related Party Obligations [Abstract] | ||||||||||||||||||||
Payment for inventory included in working capital | € | € 88,834 | |||||||||||||||||||
Altrazeal Trading GmbH [Member] | Sales Revenue, Goods, Net [Member] | ||||||||||||||||||||
Related Party Obligations [Abstract] | ||||||||||||||||||||
Concentration risk, percentage (in hundredths) | 95.00% | 95.00% | 89.00% | |||||||||||||||||
Altrazeal Trading GmbH [Member] | Accounts Receivable [Member] | ||||||||||||||||||||
Related Party Obligations [Abstract] | ||||||||||||||||||||
Concentration risk, percentage (in hundredths) | 99.80% | 99.80% | 99.50% | |||||||||||||||||
Office and Laboratory Space [Member] | ||||||||||||||||||||
Operating Leased Assets [Line Items] | ||||||||||||||||||||
Minimum monthly lease obligation | $ 9,436 | $ 9,193 | $ 9,776 | $ 9,330 | ||||||||||||||||
Future minimum monthly lease obligation after specified period | $ 9,379 | |||||||||||||||||||
Office Equipment [Member] | ||||||||||||||||||||
Operating Leased Assets [Line Items] | ||||||||||||||||||||
Minimum monthly lease obligation | 744 | |||||||||||||||||||
Office Equipment [Member] | Subsequent Event [Member] | ||||||||||||||||||||
Operating Leased Assets [Line Items] | ||||||||||||||||||||
Minimum monthly lease obligation | $ 551 | |||||||||||||||||||
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 (in hundredths) | 30.00% | |||||||||||||||||||
ProStrakan Ltd [Member] | Maximum [Member] | ||||||||||||||||||||
Milestone payments [Line Items] | ||||||||||||||||||||
Future milestone obligations | $ 1,400,000 | |||||||||||||||||||
[1] | During 2013, Mr. Gray temporarily deferred compensation of 221,500 which consisted of 11,500 earned pursuant to a Separation Agreement and $210,000 for his duties as Chairman of the Executive Committee of the Company's Board of Directors. During 2013, Mr. Gray 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 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 the March 2013 Offering. | |||||||||||||||||||
[3] | During 2015, Mr. Gray temporarily deferred compensation of 151,806 which consisted of $46,806 earned as salary compensation for his duties as President of the Company and $105,000 for his duties as Chairman of the Executive Committee of the Company's Board of Directors. |
LEGAL PROCEEDINGS (Details)
LEGAL PROCEEDINGS (Details) - shares | May. 01, 2014 | Jun. 30, 2015 | Apr. 15, 2015 |
LEGAL PROCEEDINGS [Abstract] | |||
Number of shares under non-standard cashless exercise (in shares) | 782,284 | ||
Number of shares exercisable on cashless basis (in shares) | 261,516 | ||
Number of common shares issued on exercise of warrants (in shares) | 361,516 | ||
Maximum percentage of material proceedings/interest (in hundredths) | 5.00% |