UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q/A
Amendment No. 1
[X] Quarterly Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934.
For the quarterly period ended: March 31, 2014
OR
[_] Transition Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934.
For the transition period from: ___ to ___.
Commission File Number: 001-336180
ULURU Inc.
(Exact Name of Registrant as Specified in its Charter)
Nevada | 41-2118656 |
(State or Other Jurisdiction of | (I.R.S. Employer Identification No.) |
Incorporation or Organization) | |
4452 Beltway Drive Addison, Texas | 75001 |
(Address of Principal Executive Offices) | (Zip Code) |
(214) 905-5145
Registrant's Telephone Number, including Area Code
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes þ No o
Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).
Yes þ No o
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See the definitions of “large accelerate filer”, “accelerated filer”, and “smaller reporting company” in Rule 12b-2 of the Exchange Act. (Check one):
Large accelerated filer o | Accelerated filer o | Non-accelerated filer o | Smaller reporting company þ |
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes o No þ
As of May 15, 2014, there were 24,338,110 shares of the registrant’s Common Stock, $0.001 par value per share (“Common Stock”), and no shares of Series A Preferred Stock, $0.001 par value per share, issued and outstanding.
Explanatory Note
We are filing this Amendment No. 1 on Form 10-Q/A (this “Amendment”) to our Quarterly Report on Form 10-Q for the period ended March 31, 2014 (the “Original Report”) as filed with the U.S. Securities and Exchange Commission on May 15, 2014 (a) to correct the Condensed Consolidated Financial Statements that were included in the Original Report, and (b) to modify other Items affected by the correction to the Condensed Consolidated Financial Statements.
Background for the Restatement
On June 27, 2012, we entered into a Securities Purchase Agreement related to our issuance of a $2,210,000 Secured Convertible Note (the “June 2012 Note”), with Inter-Mountain Capital Corp., a Delaware corporation (“Inter-Mountain”). As part of the June 2012 Note transaction, we received $1,500,000 in the form of six promissory notes in favor of the Company, each in the principal amount of $250,000 (the “Investor Notes”) and each of which became due as the outstanding balance under the June 2012 Note is reduced to certain levels. On January 22, 2014, we provided notice to Inter-Mountain of our election to exercise our rights under the June 2012 Note to offset amounts we owed to Inter-Mountain against amounts Inter-Mountain owed to us under the Investor Notes. As a result of this offset, the amount owed by Inter-Mountain to the Company under the Investor Notes was reduced to zero. As a result of this offset and a subsequent conversion by Inter-Mountain of the remaining balance of the June 2012 Note, the outstanding balance owed by the Company under the June 2012 Note was reduced to zero.
In connection with the preparation of our consolidated financial statements for the year ended December 31, 2014, we determined that entries recorded in the Original Report reflecting a gain of $142,703 on the early extinguishment of the June 2012 Note on January 22, 2014 (as reflected in the Condensed Consolidated Statements of Operations), a loss of $410,873 relating to the issuance of common stock for the final conversion of the June 2012 Note that occurred on March 7, 2014 (as reflected in the Condensed Consolidated Balance Sheets and included under the caption “Additional paid-in capital”) and amortization of debt discount of $970 (as reflected in the Condensed Consolidated Statements of Operations and included under the caption “Interest expense”) did not properly take into account the effect of certain allocations of unamortized debt discount. In this Amendment, the Company corrects this error and the financial statement herein reflect a loss of $135,078 on the early extinguishment of June 2012 Note (as reflected in the Condensed Consolidated Statements of Operations), a loss of $234,042 relating to the issuance of common stock for the final conversion of the June 2012 Note (as reflected in the Condensed Consolidated Balance Sheets and included under the caption “Additional paid-in capital”) and amortization of debt discount of $(99,980) (as reflected in the Condensed Consolidated Statements of Operations and included under the caption “Interest expense”). After restatement, total Stockholders’ Equity, as of March 31, 2014, remains unchanged at $3,050,086.
Because these revisions are treated as corrections of errors to our prior period financial results, the revisions are considered to be a “restatement” under U.S. generally accepted accounting principles. Accordingly, the revised financial information included in this Amendment has been identified as “restated”.
Items Amended in this Amendment
In this Amendment, the following Items have been revised in part:
· | Part I, Item I Financial Statements (including Note 1 - Organization and Basis of Presentation which contains tabular disclosure regarding the restatement). |
· | Part I, Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations. |
· | Part I, Item 4. Controls and Procedures. |
· | Part II, Item 6. Exhibits (including currently dated certifications required by Rule 13a-14(a) under the Exchange Act). |
Items in Original Report not identified above have not been modified in this Amendment. For convenience, this Amendment includes Items from the Original Report that have not been modified. Except as required for the restatement or as addressed in the Original Report, this Amendment is as of the period ended March 31, 2014 and the date of the Original Report and does not address subsequent events You should read this Amendment in connection with the Company’s other filings with the SEC subsequent to the Original Filing.
Restatement of Other Financial Statements
In addition to this Amendment, we are concurrently filing an amendment to our Quarterly Reports on Form 10-Q for the quarters ended June 30, 2014 and September 30, 2014. We are filing amendments to such reports to restate our unaudited condensed consolidated financial statements and related financial information for the periods contained in those reports and to amend certain other Items within those reports consistent with the amendments set forth herein.
Disclosure and Internal Control Considerations
Management has assessed the effect of the restatement on the Company's internal control over financial reporting and disclosure controls and procedures and reports its conclusions in Part I, Item 4 of this Amendment.
INDEX TO FORM 10-Q/A
For the Three Months Ended MARCH 31, 2014
CONDENSED CONSOLIDATED BALANCE SHEETS
| | March 31, 2014 | | | December 31, 2013 | |
| | (Unaudited) | | | (Audited) | |
| | (As restated, see Note 1) | | | | |
ASSETS | | | | | | |
Current Assets | | | | | | |
Cash and cash equivalents | | $ | 1,015,778 | | | $ | 5,119 | |
Accounts receivable, net | | | 256,563 | | | | 185,078 | |
Notes receivable and accrued interest, current portion | | | --- | | | | 777,710 | |
Inventory | | | 380,967 | | | | 395,605 | |
Prepaid expenses and deferred charges | | | 127,843 | | | | 123,812 | |
Total Current Assets | | | 1,781,151 | | | | 1,487,324 | |
| | | | | | | | |
Property, Equipment and Leasehold Improvements, net | | | 594,055 | | | | 638,614 | |
| | | | | | | | |
Other Assets | | | | | | | | |
Intangible assets, net | | | 3,553,676 | | | | 3,670,837 | |
Investment in unconsolidated subsidiary | | | --- | | | | --- | |
Deferred financing costs, net | | | --- | | | | 86,770 | |
Deposits | | | 18,069 | | | | 18,069 | |
Total Other Assets | | | 3,571,745 | | | | 3,775,676 | |
| | | | | | | | |
TOTAL ASSETS | | $ | 5,946,951 | | | $ | 5,901,614 | |
| | | | | | | | |
LIABILITIES AND STOCKHOLDERS' EQUITY | | | | | |
Current Liabilities | | | | | | | | |
Accounts payable | | $ | 1,423,807 | | | $ | 1,734,725 | |
Accrued liabilities | | | 248,817 | | | | 315,963 | |
Accrued interest | | | 19,895 | | | | 13,360 | |
Convertible notes payable, net of unamortized debt discount, current portion | | | 261,793 | | | | 1,147,057 | |
Deferred revenue, current portion | | | 58,959 | | | | 58,959 | |
Total Current Liabilities | | | 2,013,271 | | | | 3,270,064 | |
| | | | | | | | |
Long Term Liabilities | | | | | | | | |
Deferred revenue, net of current portion | | | 883,594 | | | | 898,133 | |
Total Long Term Liabilities | | | 883,594 | | | | 898,133 | |
| | | | | | | | |
TOTAL LIABILITIES | | | 2,896,865 | | | | 4,168,197 | |
| | | | | | | | |
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 March 31, 2014 and December 31, 2013, respectively | | | --- | | | | --- | |
| | | | | | | | |
Common Stock - $0.001 par value; 200,000,000 shares authorized; | | | | | | | | |
23,588,110 and 18,871,420 shares issued and outstanding at March 31, 2014 and December 31, 2013, respectively | | | 23,588 | | | | 18,872 | |
Additional paid-in capital | | | 55,516,371 | | | | 53,336,127 | |
Accumulated (deficit) | | | (52,489,873 | ) | | | (51,621,582 | ) |
TOTAL STOCKHOLDERS’ EQUITY | | | 3,050,086 | | | | 1,733,417 | |
| | | | | | | | |
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY | | $ | 5,946,951 | | | $ | 5,901,614 | |
| | | | | | | | |
The accompanying notes are an integral part of these condensed consolidated financial statements. | |
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
| | Three Months Ended March 31, | |
| | 2014 | | | 2013 | |
| | (As restated, see Note 1) | | | | |
Revenues | | | | | | |
License fees | | $ | 14,539 | | | $ | 11,153 | |
Product sales, net | | | 87,441 | | | | 90,891 | |
Total Revenues | | | 101,980 | | | | 102,044 | |
| | | | | | | | |
Costs and Expenses | | | | | | | | |
Cost of goods sold | | | 41,042 | | | | 40,889 | |
Research and development | | | 187,595 | | | | 165,285 | |
Selling, general and administrative | | | 469,073 | | | | 260,690 | |
Amortization of intangible assets | | | 117,161 | | | | 117,161 | |
Depreciation | | | 60,554 | | | | 65,388 | |
Total Costs and Expenses | | | 875,425 | | | | 649,413 | |
Operating (Loss) | | | (773,445 | ) | | | (547,369 | ) |
| | | | | | | | |
Other Income (Expense) | | | | | | | | |
Interest and miscellaneous income | | | 4,541 | | | | 22,465 | |
Interest expense | | | 35,691 | | | | (131,686 | ) |
Equity in earnings (loss) of unconsolidated subsidiary | | | --- | | | | --- | |
Loss on early extinguishment of convertible note | | | (135,078 | ) | | | --- | |
(Loss) Before Income Taxes | | | (868,291 | ) | | | (656,590 | ) |
| | | | | | | | |
Income taxes | | | --- | | | | --- | |
Net (Loss) | | $ | (868,291 | ) | | $ | (656,590 | ) |
| | | | | | | | |
Less preferred stock dividends | | | --- | | | | (12,021 | ) |
Net (Loss) Allocable to Common Stockholders | | $ | (868,291 | ) | | $ | (668,611 | ) |
| | | | | | | | |
| | | | | | | | |
Basic and diluted net (loss) per common share | | $ | (0.04 | ) | | $ | (0.06 | ) |
| | | | | | | | |
Weighted average number of common shares outstanding | | | 21,416,265 | | | | 11,657,123 | |
| | | | | | | | |
The accompanying notes are an integral part of these condensed consolidated financial statements. | |
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
| | Three Months Ended March 31, | |
| | 2014 | | | 2013 | |
| | (As restated, see Note 1) | | | | |
OPERATING ACTIVITIES : | | | | | | |
Net loss | | $ | (868,291 | ) | | $ | (656,590 | ) |
| | | | | | | | |
Adjustments to reconcile net loss to net cash used in operating activities: | | | | | | | | |
| | | | | | | | |
Amortization of intangible assets | | | 117,161 | | | | 117,161 | |
Depreciation | | | 60,554 | | | | 65,388 | |
Share-based compensation for stock and options issued to employees | | | 4,612 | | | | 1,554 | |
Share-based compensation for options issued to non-employees | | | 19,928 | | | | 8,418 | |
Equity in earnings (loss) of unconsolidated subsidiary | | | --- | | | | --- | |
Amortization of debt discount on convertible note | | | (81,285 | ) | | | 44,778 | |
Amortization of deferred financing costs | | | 7,309 | | | | 18,844 | |
Warrants issued (cancelled) for services | | | 72,771 | | | | (48,776 | ) |
Common stock issued for services | | | 42,600 | | | | --- | |
Common stock issued for interest due on convertible note | | | 2,063 | | | | 37,918 | |
Loss on early extinguishment of convertible note | | | 135,078 | | | | --- | |
| | | | | | | | |
Change in operating assets and liabilities: | | | | | | | | |
Accounts receivable | | | (71,485 | ) | | | 27,357 | |
Inventory | | | 14,638 | | | | 21,438 | |
Prepaid expenses and deferred charges | | | (4,031 | ) | | | 58,476 | |
Notes receivable and accrued interest | | | 777,710 | | | | 240,444 | |
Accounts payable | | | (310,918 | ) | | | (436,920 | ) |
Accrued liabilities | | | (67,146 | ) | | | 7,271 | |
Accrued interest | | | 6,535 | | | | 7,310 | |
Deferred revenue | | | (14,539 | ) | | | (11,153 | ) |
Total | | | 711,555 | | | | 159,508 | |
| | | | | | | | |
Net Cash Used in Operating Activities | | | (156,736 | ) | | | (497,082 | ) |
| | | | | | | | |
INVESTING ACTIVITIES : | | | | | | | | |
Purchase of property and equipment | | | (15,996 | ) | | | --- | |
Net Cash Used in Investing Activities | | | (15,996 | ) | | | --- | |
| | | | | | | | |
FINANCING ACTIVITIES : | | | | | | | | |
Proceeds from sale of common stock and warrants, net | | | 610,000 | | | | 481,446 | |
Proceeds from exercise of common stock warrants | | | 1,350,000 | | | | --- | |
Repayment of principle due on convertible note | | | (776,609 | ) | | | --- | |
Net Cash Provided by Financing Activities | | | 1,183,391 | | | | 481,446 | |
| | | | | | | | |
Net Increase (Decrease) in Cash | | | 1,010,659 | | | | (15,636 | ) |
| | | | | | | | |
Cash, beginning of period | | | 5,119 | | | | 21,549 | |
Cash, end of period | | $ | 1,015,778 | | | $ | 5,913 | |
| | | | | | | | |
SUPPLEMENTAL CASH FLOW DISCLOSURE: | | | | | | | | |
Cash paid for interest | | $ | 983 | | | $ | 1,264 | |
| | | | | | | | |
Non-cash investing and financing activities: | | | | | | | | |
Issuance of common stock for principle due on convertible note | | $ | 317,029 | | | $ | 212,081 | |
| | | | | | | | |
The accompanying notes are an integral part of these condensed consolidated financial statements. | |
NOTES TO
CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
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 OraDiscTM technologies, with the goal of improving outcomes for patients, health care professionals, and health care payers.
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 March 31, 2014 and the results of its operations for the three months ended March 31, 2014 and 2013 and cash flows for the three months ended March 31, 2014 and 2013 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 months ended March 31, 2014 are not necessarily indicative of the results that may be expected for the year ending December 31, 2014.
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, 2013, as filed with the Securities and Exchange Commission on March 31, 2014, including the risk factors set forth therein
Restatement of Prior Period Financial Statements
In connection with the preparation of our consolidated financial statements for the year ended December 31, 2014, we determined that entries recorded in the Original Report reflecting a gain of $142,703 on the early extinguishment of the June 2012 Note on January 22, 2014 (as reflected in the Condensed Consolidated Statements of Operations), a loss of $410,873 relating to the issuance of common stock for the final conversion of the June 2012 Note that occurred on March 7, 2014 (as reflected in the Condensed Consolidated Balance Sheets and included under the caption “Additional paid-in capital”) and amortization of debt discount of $970 (as reflected in the Condensed Consolidated Statements of Operations and included under the caption “Interest expense”) did not properly take into account the effect of certain allocations of unamortized debt discount. In this Amendment, the Company corrects this error and the financial statement herein reflect a loss of $135,078 on the early extinguishment of June 2012 Note (as reflected in the Condensed Consolidated Statements of Operations), a loss of $234,042 relating to the issuance of common stock for the final conversion of the June 2012 Note (as reflected in the Condensed Consolidated Balance Sheets and included under the caption “Additional paid-in capital”) and amortization of debt discount of $(99,980) (as reflected in the Condensed Consolidated Statements of Operations and included under the caption “Interest expense”). After restatement, total Stockholders’ Equity, as of March 31, 2014, remains unchanged at $3,050,086.
The following tables present the effects of the restatement on the previously issued financial statements presented herein.
Condensed Consolidated Statements of Operations (Unaudited) | | Three Months Ended March 31, 2014 | |
| | As previously reported | | | As restated | | | Adjustment | |
Operating (Loss) | | | (773,445 | ) | | | (773,445 | ) | | | --- | |
Interest and miscellaneous income | | | 4,541 | | | | 4,541 | | | | --- | |
Interest expense | | | (65,259 | ) | | | 35,691 | | | | 100,950 | |
Equity in earnings (loss) of unconsolidated subsidiary | | | --- | | | | --- | | | | --- | |
Gain (loss) on early extinguishment of convertible note | | | 142,703 | | | | (135,078 | ) | | | (277,781 | ) |
(Loss) Before Income Taxes | | | (691,460 | ) | | | (868,291 | ) | | | (176,831 | ) |
Income taxes | | | --- | | | | --- | | | | --- | |
Net (Loss) | | $ | (691,460 | ) | | $ | (868,291 | ) | | $ | (176,831 | ) |
Less preferred stock dividends | | | --- | | | | --- | | | | --- | |
Net (Loss) Allocable to Common Stockholders | | $ | (691,460 | ) | | $ | (868,291 | ) | | $ | (176,831 | ) |
| | | | | | | | | | | | |
Basic and diluted net (loss) per common share | | $ | (0.03 | ) | | $ | (0.04 | ) | | $ | (0.01 | ) |
Condensed Consolidated Balance Sheet (Unaudited) | | As of March 31, 2014 | |
| | As previously reported | | | As restated | | | Adjustment | |
Common stock | | | 23,588 | | | | 23,588 | | | | --- | |
Additional paid-in capital | | | 55,339,540 | | | | 55,516,371 | | | | 176,831 | |
Accumulated (deficit) | | | (52,313,042 | ) | | | (52,489,873 | ) | | | (176,831 | ) |
| | | | | | | | | | | | |
Total Stockholders’ Equity | | | 3,050,086 | | | | 3,050,086 | | | | --- | |
Condensed Consolidated Statements of Cash Flows (Unaudited) | | Three Months Ended March 31, 2014 | |
| | As previously reported | | | As restated | | | Adjustment | |
Net (Loss) | | $ | (691,460 | ) | | $ | (868,291 | ) | | $ | (176,831 | ) |
| | | | | | | | | | | | |
Amortization of debt discount on convertible note | | | 19,665 | | | | (81,285 | ) | | | (100,950 | ) |
Gain (loss) on early extinguishment of convertible note | | | (142,703 | ) | | | 135,078 | | | | 277,781 | |
| | | | | | | | | | | | |
Changes in operating assets and liabilities: Total | | | 534,724 | | | | 711,555 | | | | 176,831 | |
Net Cash Used in Operating Activities | | | (156,736 | ) | | | (156,736 | ) | | | --- | |
NOTE 2. | SIGNIFICANT ACCOUNTING POLICIES |
The significant accounting policies used in preparation of these condensed consolidated financial statements for the three months ended March 31, 2014 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, 2013, as filed with the Securities and Exchange Commission on March 31, 2014.
NOTE 3. | THE EFFECT OF RECENTLY ISSUED ACCOUNTING STANDARDS |
There were no new accounting pronouncements adopted or enacted during the periods presented that had, or are expected to have, a material impact on our financial statements.
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 for the three months ended March 31 are summarized as follows:
Revenues | | 2014 | | | % | | | 2013 | | | % | |
Domestic | | $ | 9,672 | | | | 9 | % | | $ | 19,787 | | | | 19 | % |
International | | | 92,308 | | | | 91 | % | | | 82,257 | | | | 81 | % |
Total | | $ | 101,980 | | | | 100 | % | | $ | 102,044 | | | | 100 | % |
A significant portion of our revenues are derived from a few major customers. Customers with greater than 10% of total sales for the three months ended March 31 are represented on the following table:
Customers | Product | | 2014 | | | 2013 | |
Customer A | Altrazeal® | | | 76 | % | | | --- | |
Customer B | Altrazeal® | | | * | | | | 75 | % |
Total | | | | 76 | % | | | 75 | % |
| | | | | | | | | |
* Sales from this customer were less than 10% of total sales for the period reported. | |
On June 27, 2012, we entered into a Securities Purchase Agreement related to our issuance of a $2,210,000 Secured Convertible Note (the “June 2012 Note”), with Inter-Mountain Capital Corp., a Delaware corporation (“Inter-Mountain”). As part of the June 2012 Note transaction, we received $1,500,000 in the form of six promissory notes in favor of the Company, each in the principal amount of $250,000 (the “Investor Notes”) and each of which becomes due as the outstanding balance under the June 2012 Note is reduced to certain levels. As of December 31, 2013, we had $777,710 in notes receivable which is comprised of $687,500 for three Investor Notes and $90,210 for accrued interest thereon.
On January 22, 2014, we provided notice to Inter-Mountain of our election to exercise our rights under the June 2012 Note and to offset amounts we owed to Inter-Mountain against amounts it owed to us under the Investor Notes. Our notice provided that such deduction and offset occurred on January 22, 2014, that we will not incur the 120% prepayment premium with respect to amounts paid under the June 2012 Note as a result of the deduction and offset, that no warrants will become exercisable as a result of the offset, and that any warrants unvested as of January 22, 2014 shall immediately and automatically terminate. As a result of the deduction and offset, the outstanding amount owed to us under the Investor Notes was reduced to zero.
Please refer to Note 11. for a more detailed description of the June 2012 Note transaction.
As of March 31, 2014, our inventory was comprised of Altrazeal® finished goods, manufacturing costs incurred in the production of Altrazeal®, and raw materials. Inventories are stated at the lower of cost (first in, first out method) or 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 March 31, 2014 and December 31, 2013:
Inventory | | March 31, 2014 | | | December 31, 2013 | |
Finished goods | | $ | 24,261 | | | $ | 85,993 | |
Work-in-progress | | | 346,347 | | | | 299,464 | |
Raw materials | | | 10,359 | | | | 10,148 | |
Total | | $ | 380,967 | | | $ | 395,605 | |
NOTE 7. | PROPERTY, EQUIPMENT and LEASEHOLD IMPROVEMENTS |
Property, equipment and leasehold improvements, net, consisted of the following at March 31, 2014 and December 31, 2013:
Property, equipment and leasehold improvements | | March 31, 2014 | | | December 31, 2013 | |
Laboratory equipment | | $ | 424,888 | | | $ | 424,888 | |
Manufacturing equipment | | | 1,597,723 | | | | 1,581,728 | |
Computers, office equipment, and furniture | | | 140,360 | | | | 140,360 | |
Computer software | | | 4,108 | | | | 4,108 | |
Leasehold improvements | | | 95,841 | | | | 95,841 | |
| | | 2,262,920 | | | | 2,246,925 | |
Less: accumulated depreciation and amortization | | | ( 1,668,865 | ) | | | (1,608,311 | ) |
Property, equipment and leasehold improvements, net | | $ | 594,055 | | | $ | 638,614 | |
Depreciation expense on property, equipment and leasehold improvements was $60,554 and $65,388 for the three months ended March 31, 2014 and 2013, respectively.
Intangible assets are comprised of patents acquired in October, 2005. Intangible assets, net consisted of the following at March 31, 2014 and December 31, 2013:
Intangible assets | | March 31, 2014 | | | December 31, 2013 | |
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 | | | ( 6,072,262 | ) | | | (5,955,101 | ) |
Intangible assets, net | | $ | 3,553,676 | | | $ | 3,670,837 | |
Amortization expense for intangible assets was $117,161 and $117,161 for the three months ended March 31, 2014 and 2013, respectively.
The future aggregate amortization expense for intangible assets, remaining as of March 31, 2014, is as follows:
Calendar Years | | Future Amortization Expense | |
2014 (Nine months) | | $ | 357,987 | |
2015 | | | 475,148 | |
2016 | | | 476,450 | |
2017 | | | 475,148 | |
2018 | | | 475,148 | |
2019 & Beyond | | | 1,293,795 | |
Total | | $ | 3,553,676 | |
NOTE 9. | 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, 2012 and 2013 and unaudited financial statements for the three months ended March 31, 2014 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 years ended December 31, 2012 and 2013 and for the three months ended March 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.
Based upon unaudited financial statements provided by Altrazeal Trading Ltd. for the year ended December 31, 2012, our share of Altrazeal Trading Ltd. losses exceeded the carrying value of our investment, therefore the equity method of accounting was suspended and no additional losses were charged to our operations. Our unrecorded share of Altrazeal Trading Ltd. losses for the year ended December 31, 2012 totaled $82,740.
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 | | $ | 415,248 | |
Total liabilities | | $ | 205,991 | |
Total stockholders’ equity | | $ | 209,257 | |
Statement of operations | | | | |
Revenues | | $ | 131,869 | |
Net (loss) | | $ | (330,961 | ) |
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.
As of March 31, 2014, ORADISC GmbH had not begun operations and accordingly the net book value of the investee assets had not been determined and there were no equity method investee gains or losses for the three months ended March 31, 2014.
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.
Financial statements of Altrazeal AG for the three months ended March 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 three months ended March 31, 2014 would exceed the carrying value of our investment, therefore the equity method of accounting would be suspended for such reporting period and no additional losses would be charged to operations.
NOTE 10. | ACCRUED LIABILITIES |
Accrued liabilities consisted of the following at March 31, 2014 and December 31, 2013:
Accrued Liabilities | | March 31, 2014 | | | December 31, 2013 | |
Accrued taxes – payroll | | $ | 106,299 | | | $ | 106,299 | |
Accrued compensation/benefits | | | 118,194 | | | | 148,683 | |
Accrued insurance payable | | | 19,142 | | | | 60,113 | |
Accrued property taxes | | | 4,050 | | | | --- | |
Product rebates/returns | | | 17 | | | | 32 | |
Other | | | 1,115 | | | | 836 | |
Total accrued liabilities | | $ | 248,817 | | | $ | 315,963 | |
Convertible Note – June 2012
On June 27, 2012, we entered into a Securities Purchase Agreement (the “Purchase Agreement”), related to our issuance of the June 2012 Note, with Inter-Mountain. The purchase price for the June 2012 Note was paid $500,000 at closing in cash and $1,500,000 in the form of six Investor Notes in favor of the Company, each in the principal amount of $250,000 at an interest rate of 8.0% per annum, and each of which becomes due as the outstanding balance under the June 2012 Note is reduced to certain levels. The purchase price of the June 2012 Note also reflected a $200,000 original issue discount and $10,000 in attorney’s fees. The Purchase Agreement also includes representations and warranties, restrictive covenants, and indemnification provisions standard for similar transactions.
The June 2012 Note bears interest at the rate of 8.0% per annum, with monthly installment payments of $83,333 commencing on the date that is the earlier of (i) thirty calendar days after the effective date of a registration statement registering the re-sale of the shares issuable upon conversion under the June 2012 Note or (ii) December 24, 2012, but in no event sooner than September 25, 2012. At our option, subject to certain volume, price, and other conditions, the monthly installment payments on the June 2012 Note may be paid in whole, or in part, in cash or in our Common Stock. If the monthly installment is 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.
At the option of Inter-Mountain, the outstanding principal balance of the June 2012 Note may be converted into shares of our Common Stock at a conversion price of $0.35 per share, subject to certain pricing adjustments and ownership limitations. The initial tranche was $710,000 and the six subsequent tranches are each $250,000, plus interest. At our option, the outstanding principal balance of the June 2012 Note, or a portion thereof, may be prepaid in cash at 120% of the amount elected to be prepaid. The June 2012 Note is secured by a Security Agreement pursuant to which we granted to Inter-Mountain a first-priority security interest in the assets held by the Company.
Events of default under the June 2012 Note include failure to make required payments or to deliver shares upon conversion, 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 our Common Stock, a restatement of financial statements, and a default under certain other agreements. In the event of default, the interest rate under the June 2012 Note increases to 18% and the June 2012 Note becomes callable at a premium. In addition, the holder has all remedies under law and equity, including foreclosing on our assets under a Security Agreement with Inter-Mountain.
As part of the convertible debt financing, Inter-Mountain also received a total of seven warrants (the “Warrants”) to purchase, if they all vest, an aggregate of 3,142,857 shares of Common Stock, which number of shares could increase based upon the terms and conditions of the Warrants. The Warrants have an exercise price of $0.35 per share, subject to certain pricing adjustments, and are exercisable, subject to vesting provisions and ownership limitations, until June 27, 2017. Warrants for 785,714, 392,857, 392,857, and 392,857 shares of Common Stock vested on June 27, 2012, December 31, 2012, February 26, 2013, and July 15, 2013, respectively. Each of the three remaining Warrants has terminated, as described below. As of March 31, 2014, we have issued 725,274 shares of Common Stock to Inter-Mountain for the cashless exercise of three warrants that vested prior to February 26, 2013 to purchase 1,571,428 shares of Common Stock. At March 31, 2014, there is one warrant that remains vested but unexercised for 392,857 shares of Common Stock.
As part of the convertible debt financing, we entered into a Registration Rights Agreement whereby we agreed to prepare and file with the SEC a registration statement for the number of shares referred to therein no later than July 27, 2012 and to cause such registration statement to be declared effective no later than ninety days after such filing with the SEC and to keep such registration statement effective for a period of no less than one hundred and eighty days. The Registration Rights Agreement also grants Inter-Mountain piggy-back registration rights with respect to future offerings by the Company. In accordance with our obligations under the Registration Rights Agreement, we filed with the SEC a registration statement that was declared effective on July 31, 2012.
On October 5, 2012, we and Inter-Mountain entered into a First Amendment to Buyer Trust Deed Note #1 for the purpose of revising certain terms and conditions contained in the Buyer Trust Deed Note #1, to include an updated schedule for the timing of certain payment obligations by Inter-Mountain contained therein.
On January 22, 2014, we provided notice to Inter-Mountain of our election to exercise our rights under the June 2012 Note and to offset amounts we owed to Inter-Mountain against amounts it owed to us under the Investor Notes. Our notice provided that such deduction and offset occurred on January 22, 2014, that we will not incur the 120% prepayment premium with respect to amounts paid under the June 2012 Note as a result of the deduction and offset, that no warrants will become exercisable as a result of the offset, and that any warrants unvested as of January 22, 2014 shall immediately and automatically terminate. As a result of the deduction and offset, the outstanding amount owed under the June 2012 Note was reduced to approximately $317,000 as of January 22, 2014.
On February 27, 2014 and on March 3, 2014, we received conversion notices from Inter-Mountain whereby we issued an aggregate of 435,502 shares of Common Stock for the final payment of approximately $152,000 due under the June 2012 Note.
Convertible Note – July 2011
On July 28, 2011, we completed a convertible debt financing for $125,000 with Mr. Kerry P. Gray, the Company’s Chairman, President, and Chief Executive Officer (the “July 2011 Note”). The July 2011 Note bears interest at the rate of 10.0% per annum, with annual payments of interest commencing on July 1, 2012. The full amount of principal and any unpaid interest will be due on July 28, 2014. The outstanding principal balance of the July 2011 Note may be converted into shares of the Company’s Common Stock, at the option of the note holder and at any time, at a conversion price of $1.08 per share or 115,741 shares of Common Stock. We may force conversion of the July 2011 Note if our Common Stock trades for a defined period of time at a price greater than $2.16. The July 2011 Note is collateralized by the grant of a security interest in the inventory, accounts receivables and capital equipment held by the Company. The securities issuable on conversion have not been registered under the Securities Act of 1933 and may not be sold absent registration or an applicable exemption from the registration requirements. As part of the convertible debt financing, Mr. Gray also received a warrant to purchase up to 34,722 shares of the Company’s Common Stock. The warrant has an exercise price of $1.08 per share and is exercisable at any time until July 28, 2016.
On July 3, 2012, the Company and Mr. Gray entered into a Modification Agreement for the purpose of deferring the annual payment of interest due on July 1, 2012 of $11,542 until such time as Mr. Gray provides written notice to us with such notice being no less than 15 days prior to the relevant payment date. Moreover, the parties agreed that no Event of Default under the July 2011 Note occurred as a result of any failure by us to make the annual payment of interest due on July 1, 2012. Commencing on July 1, 2012, interest at the rate of 12.0% per annum accrued on the deferred interest payment of $11,542 until the relevant payment date. On September 5, 2013, we remitted to Mr. Gray the annual interest due on July 1, 2012 of $11,542 and accrued interest thereon of $1,643.
On July 1, 2013, the Company and Mr. Gray entered into a Modification Agreement for the purpose of deferring the annual payment of interest due on July 1, 2013 of $12,501 until such time as Mr. Gray provides written notice to us with such notice being no less than 15 days prior to the relevant payment date. Moreover, the parties agreed that no Event of Default under the July 2011 Note occurred as a result of any failure by us to make the annual payment of interest due on July 1, 2013. Commencing on July 1, 2013, interest at the rate of 12.0% per annum accrued on the deferred interest payment of $12,501 until the relevant payment date. On October 28, 2013, we remitted to Mr. Gray the annual interest due on July 1, 2013 of $12,501 and accrued interest thereon of $492.
Convertible Note – June 2011
On June 13, 2011, we completed a $140,000 convertible debt financing with Mr. Gray (the “June 2011 Note”). The June 2011 Note bears interest at the rate of 10% per annum, with annual payments of interest commencing on July 1, 2012. The full amount of principal and any unpaid interest will be due on June 13, 2014. The outstanding principal balance of the June 2011 Note may be converted into shares of the Company’s Common Stock, at the option of the note holder and at any time, at a conversion price of $1.20 per share or 116,667 shares of Common Stock. We may force conversion of the convertible note if our Common Stock trades for a defined period of time at a price greater than $1.80. The June 2011 Note is collateralized by the grant of a security interest in the inventory, accounts receivables, and capital equipment held by the Company. The securities issuable on conversion have not been registered under the Securities Act of 1933 and may not be sold absent registration or an applicable exemption from the registration requirements. As part of the convertible debt financing, Mr. Gray also received a warrant to purchase up to 35,000 shares of the Company’s Common Stock. The warrant has an exercise price of $1.20 per share and is exercisable at any time until June 13, 2016.
On July 3, 2012, the Company and Mr. Gray entered into a Modification Agreement for the purpose of deferring the annual payment of interest due on July 1, 2012 of $14,653 until such time as Mr. Gray provides written notice to us with such notice being no less than 15 days prior to the relevant payment date. Moreover, the parties agreed that no Event of Default under the June 2011 Note occurred as a result of any failure by us to make the annual payment of interest due on July 1, 2012. Commencing on July 1, 2012, interest at the rate of 12.0% per annum accrued on the deferred interest payment of $14,653 until the relevant payment date. On September 5, 2013, we remitted to Mr. Gray the annual interest due on July 1, 2012 of $14,653 and accrued interest thereon of $2,080.
On July 1, 2013, the Company and Mr. Gray entered into a Modification Agreement for the purpose of deferring the annual payment of interest due on July 1, 2013 of $14,001 until such time as Mr. Gray provides written notice to us with such notice being no less than 15 days prior to the relevant payment date. Moreover, the parties agreed that no Event of Default under the June 2011 Note occurred as a result of any failure by us to make the annual payment of interest due on July 1, 2013. Commencing on July 1, 2013, interest at the rate of 12.0% per annum accrued on the deferred interest payment of $14,001 until the relevant payment date. On October 28, 2013, we remitted to Mr. Gray the annual interest due on July 1, 2013 of $14,001 and accrued interest thereon of $553.
We account for convertible debt using specific guidelines in accordance with U.S. GAAP. We allocated the value of the proceeds received to the convertible instrument and to the warrant on a relative fair value basis. We calculated the fair value of the warrant issued with the convertible 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 was recorded as a debt discount and is being amortized over the expected term of the convertible debt to interest expense.
On the date of issuance of the June 2011 Note, the July 2011 Note, and the June 2012 Note, no portion of the proceeds were attributable to a beneficial conversion feature since the conversion price of the June 2011 Note, the July 2011 Note, and the June 2012 Note exceeded the market price of the Company’s Common Stock.
Information relating to our convertible notes payable is as follows:
| | | | | | | | | | | | As of March 31, 2014 | |
Transaction | | Initial Principal Amount | | | Interest Rate | | Maturity Date | | Conversion Price (1) | | | Principal Balance | | | Unamortized Debt Discount | | | Carrying Value | |
June 2011 Note | | $ | 140,000 | | | | 10.0 | % | 06/13/2014 | | $ | 1.20 | | | $ | 140,000 | | | $ | 810 | | | $ | 139,190 | |
July 2011 Note | | | 125,000 | | | | 10.0 | % | 07/28/2014 | | $ | 1.08 | | | | 125,000 | | | | 2,397 | | | | 122,603 | |
Total | | $ | 265,000 | | | | | | | | | | | | $ | 265,000 | | | $ | 3,207 | | | $ | 261,793 | |
(1) | The outstanding principal balance of the June 2011 Note and the July 2011 Note may be converted, at the option of Mr. Gray, into shares of Common Stock at a fixed conversion price of $1.20 per share and $1.08 per shares, respectively. |
The amount of interest cost recognized from our convertible notes payable was $13,945 and $45,228 for the three months ended March 31, 2014 and 2013, respectively. The amount of debt discount amortized from our convertible notes payable was $(81,285) and $44,778 for the three months ended March 31, 2014 and 2013, respectively.
The future minimum payments relating to our convertible notes payable, as of March 31, 2014, are as follows:
| | Payments Due By Period | |
Transaction | | Total | | | 2014 (Nine Months) | | | 2015 | | | 2016 | | | 2017 | | | 2018 | |
June 2011 Note | | $ | 140,000 | | | $ | 140,000 | | | $ | --- | | | $ | --- | | | $ | --- | | | $ | --- | |
July 2011 Note | | | 125,000 | | | | 125,000 | | | | --- | | | | --- | | | | --- | | | | --- | |
Total | | $ | 265,000 | | | $ | 265,000 | | | $ | --- | | | $ | --- | | | $ | --- | | | $ | --- | |
NOTE 12. | EQUITY TRANSACTIONS |
Common Stock Transactions
March 2013 Offering
On March 14, 2013, we entered into a Securities Purchase Agreement (the “March SPA”) with Kerry P. Gray, the Company’s Chairman, President, and Chief Executive Officer and Terrance K. Wallberg, the Company’s Vice President and Chief Financial Officer (collectively, the “Investors”) relating to an equity investment of $440,000 by the Investors for 1,100,000 shares of our Common Stock (the “March Shares”) and warrants to purchase up to 660,000 shares of our Common Stock (the “March Warrants”) (the “March 2013 Offering”). Under the March SPA, the purchase and sale of the March Shares and March Warrants took place at four closings over twelve months, with $88,000 being funded at the initial closing under the March SPA, $110,000 being funded on the four-month anniversary of the initial closing, $132,000 being funded on the eight-month anniversary of the initial closing, and $110,000 being funded on the one-year anniversary of the initial closing. The March Warrants have a fixed exercise price of $0.60 per share, become exercisable in tranches on each of the four funding dates, and expire on the five-year anniversary of the initial closing. On March 14, 2013, we closed the March 2013 Offering and received the initial funding tranche of $88,000 for the purchase of 220,000 shares of our Common Stock. We received subsequent funding tranches of $110,000, $132,000, and $110,000 for the purchase of 275,000, 330,000, and 275,000 shares of our Common Stock on July 15, 2013, November 14, 2013, and March 14, 2014, respectively.
January 2013 Offering
On December 21, 2012, we entered into a Securities Purchase Agreement (the “SPA”) with IPMD GmbH (“IPMD”) relating to an equity investment of $2,000,000 by IPMD for 5,000,000 shares of our Common Stock (the “Shares”) and warrants to purchase up to 3,000,000 shares of our Common Stock (the “Warrants”) (the “January 2013 Offering”). Under the SPA, the purchase and sale of the Shares and Warrants took place at four closings over twelve months, with $400,000 being funded at the initial closing under the SPA, $500,000 being funded on the four-month anniversary of the initial closing, $600,000 being funded on the eight-month anniversary of the initial closing, and $500,000 being funded on the one-year anniversary of the initial closing. The Warrants have a fixed exercise price of $0.60 per share, become exercisable in tranches on each of the four funding dates, and expire on the one-year anniversary of the initial closing. On January 3, 2013, we closed the January 2013 Offering and received the initial funding tranche of $400,000 for the purchase of 1,000,000 shares of our Common Stock. We received subsequent funding tranches of $500,000, $300,000, $300,000, and $500,000 for the purchase of 1,250,000, 750,000, 750,000, and 1,250,000 shares of our Common Stock on May 7, 2013, September 6, 2013, October 24, 2013, and January 6, 2014 respectively.
In the SPA, we also agree to appoint up to two directors nominated by IPMD to serve on our Board of Directors. 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. Messrs. Kerschbaumer and Kuehne are the designees of IPMD to serve on the Company’s Board of Directors pursuant to covenants in the SPA with IPMD.
On January 3, 2014, the Warrants vested with respect to 3,000,000 shares of our Common Stock and were exercised by IPMD on that date pursuant to a Notice of Exercise, accepted by the Company, that provided for the issuance of 750,000 shares of Common Stock on each of January 31, 2014, February 28, 2014, March 31, 2014, and April 30, 2014 in exchange for the payment of $450,000 on each such date.
On January 31, 2014, IPMD entered into an Assignment Agreement (the “Assignment Agreement”) with The Punch Trust (“TPT”) and Michael I. Sacks (“Sacks”) pursuant to which IPMD assigned to TPT and Sacks its rights and interests to purchase up to 3,000,000 shares of our Common Stock as detailed in the Warrants and the Notice of Exercise. Neither TPT nor Sacks paid any monetary consideration to IPMD in connection with the assignments under the Assignment Agreement.
Concurrent with the assignment under the Assignment Agreement described above, ULURU, TPT, Sacks, and IPMD entered into an Implementation Agreement (the “Implementation Agreement”) pursuant to which we consented and agreed to the assignment of the Warrants to TPT and Sacks. We also agreed to issue and facilitate the delivery of the shares of Common Stock under the Warrants to TPT and Sacks upon their payment of the corresponding purchase price due under the Warrants. Under the terms of the Warrants, Sacks made payments of $450,000 on each of January 31, 2014 and February 28, 2014 and $150,000 on each of March 31, 2014 and April 30, 2014. The Company issued 750,000 shares of Common Stock to Sacks on each of January 31, 2014 and February 28, 2014 and 250,000 shares of Common Stock on each of March 31, 2014 and April 30, 2014. Under the terms of the Warrants, TPT made payments of $300,000 on each of March 31, 2014 and April 30, 2014 and the Company issued 500,000 shares of Common Stock to TPT on each date, respectively.
On January 31, 2014, we also entered into a Registration Rights Agreement with TPT and Sacks whereby we agreed to prepare and file with the SEC a registration statement for the number of shares referred to therein within sixty days after request and to use commercially reasonable efforts to cause such registration statement to be declared effective with the SEC and to keep such registration statement effective for a period of eighty days and, if necessary, such eighty day period being extended for up to sixty additional days.
NOTE 13. | STOCKHOLDERS’ EQUITY |
Common Stock
As of March 31, 2014, we had 23,588,110 shares of Common Stock issued and outstanding. We issued 4,716,690 shares of Common Stock for the three months ended March 31, 2014 comprised of 1,250,000 shares of Common Stock issued to IPMD pursuant to the January 2013 Offering, 275,000 shares of Common Stock issued to Messrs. Gray and Wallberg pursuant to the March 2013 Offering, 911,690 shares of Common Stock issued for installment payments and note conversion on the June 2012 Note with Inter-Mountain, 2,250,000 shares of Common Stock issued for the exercise of warrants held by Sacks and TPT, and 30,000 shares of Common Stock issued for consulting services.
Preferred Stock
As of March 31, 2014, we had no shares of Series A Preferred Stock (the “Series A Shares”). For the three months ended March 31, 2014, 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 March 31, 2014 and the changes therein during the three months then ended:
| | Number of Shares of Common Stock Subject to Exercise | | | Weighted – Average Exercise Price | |
Balance as of December 31, 2013 | | | 4,665,451 | | | $ | 0.82 | |
Warrants issued | | | 80,000 | | | $ | 1.20 | |
Warrants exercised | | | (2,250,000 | ) | | $ | 0.60 | |
Warrants cancelled | | | --- | | | | --- | |
Balance as of March 31, 2014 (1) | | | 2,495,451 | | | $ | 1.03 | |
(1) | As part of the June 2012 Note, Inter-Mountain received a total of seven warrants to purchase, if they all had vested, an aggregate of 3,142,857 shares of Common Stock, which number of shares could increase based upon the terms and conditions of the warrants. The warrants have an exercise price of $0.35 per share, subject to certain pricing adjustments, and are exercisable, subject to vesting provisions and ownership limitations, until June 27, 2017. Warrants for 785,714, 392,857, 392,857, and 392,857 shares of Common Stock vested on June 27, 2012, December 31, 2012, February 26, 2013, and July 15, 2013, respectively, and three warrants for 1,571,428 shares of Common Stock were exercised in 2013. On January 22, 2014, we elected to offset and deduct the three remaining Investor Notes from the principle amount due to Inter-Mountain under the June 2012 Note and as a result of the offset and deduction the three remaining warrants terminated. For the purposes of this Table, only such net vested shares of Common Stock from one unexercised warrant (392,857 shares) have been included, based upon an exercise price of $0.35 per share of Common Stock. |
For the three months ended March 31, 2014, we issued a warrant to Torrey Hills Capital, Inc., to purchase up to an aggregate of 80,000 shares of our Common Stock at an exercise price of $1.20 per share, for consulting services.
Of the warrant shares subject to exercise as of March 31, 2014, expiration of the right to exercise is as follows:
Date of Expiration | | Number of Warrant Shares of Common Stock Subject to Expiration | |
April 30, 2014 | | | 750,000 | |
July 23, 2014 | | | 69,050 | |
May 15, 2015 | | | 357,155 | |
June 13, 2016 | | | 35,000 | |
July 16, 2016 | | | 116,667 | |
July 28, 2016 | | | 34,722 | |
June 27, 2017 | | | 392,857 | |
March 14, 2018 | | | 660,000 | |
January 15, 2019 | | | 80,000 | |
Total | | | 2,495,451 | |
NOTE 14. | 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, basic earnings (loss) per common share is computed by dividing net income (loss) by the weighted average number of common shares outstanding for the period. Diluted earnings (loss) per common share is computed by dividing net income (loss) by the weighted average number of common shares outstanding during the period, increased to include potential dilutive common shares. The effect of outstanding stock options, restricted vesting Common Stock, convertible debt, convertible preferred stock, and warrants, when dilutive, is reflected in diluted earnings (loss) per common share by application of the treasury stock method. We have excluded all outstanding stock options, restricted vesting Common Stock, convertible debt, convertible preferred stock, and warrants from the calculation of diluted net loss per common share because all such securities are antidilutive for all periods presented.
Shares used in calculating basic and diluted net loss per common share exclude these potential common shares as of March 31, 2014 and December 31, 2013:
| | March 31, 2014 | | | December 31, 2013 | |
Warrants to purchase Common Stock | | | 2,495,451 | | | | 4,665,451 | |
Stock options to purchase common stock | | | 1,014,907 | | | | 1,014,907 | |
Unvested restricted common stock | | | --- | | | | --- | |
Common stock issuable upon the assumed conversion of our convertible note payable from June 2012 (1) | | | --- | | | | 3,124,680 | |
Common stock issuable upon the assumed conversion of our convertible notes payable from June 2011 and July 2011 (2) | | | 241,386 | | | | 253,315 | |
Total | | | 3,751,744 | | | | 9,058,353 | |
(1) | The outstanding principal balance and the accrued and unpaid interest of the June 2012 Note may be converted, at the option of Inter-Mountain, into shares of Common Stock at a conversion price of $0.35 per share, subject to certain pricing adjustments and ownership limitations. For the purposes of this Table, we have assumed a conversion price of $0.35 per share and no ownership limitations. On February 27, 2014 and on March 3, 2014, we received conversion notices from Inter-Mountain whereby we issued an aggregate of 435,502 shares of Common Stock for the final payment of approximately $152,000 due under the June 2012 Note. |
(2) | The outstanding principal balance of the June 2011 Note and the July 2011 Note may be converted, at the option of Mr. Gray, into shares of Common Stock at a fixed conversion price of $1.20 per share and $1.08 per share, respectively. The accrued and unpaid interest for each convertible note payable may be converted, at the option of Mr. Gray, into shares of Common Stock at a conversion price based upon the average of the five trading days prior to the payment date, which for the purposes of this Table we have assumed to be March 31, 2014. |
NOTE 15. | 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 months ended March 31:
| | Three Months Ended March 31, | |
| | 2014 (1) | | | 2013 | |
Incentive Stock Options | | | | | | |
Quantity | | | --- | | | | 232,500 | |
Weighted average fair value per share | | | --- | | | $ | 0.24 | |
Fair value | | | --- | | | $ | 56,112 | |
| | | | | | | | |
Nonstatutory Stock Options | | | | | | | | |
Quantity | | | --- | | | | 735,000 | |
Weighted average fair value per share | | | --- | | | $ | 0.24 | |
Fair value | | | --- | | | $ | 177,388 | |
(1) | The Company did not award any shared-based compensation for the three months ended March 31, 2014. |
We account for share-based compensation under FASB ASC Topic 718, Stock Compensation, which requires the measurement and recognition of compensation expense for all share-based payment awards made to employees, consultants, and directors based on estimated fair values of the award on the grant date. We use the Black-Scholes option-pricing model to estimate the fair value of share-based awards with the following weighted average assumptions for the three months ended March 31:
| | Three Months Ended March 31, | |
| | 2014 (4) | | | 2013 | |
Incentive Stock Options | | | | | | |
Expected volatility (1) | | | --- | | | | 103.55 | % |
Risk-free interest rate % (2) | | | --- | | | | 0.81 | % |
Expected term (in years) | | | --- | | | | 5.0 | |
Dividend yield (3) | | | --- | | | | --- | |
Forfeiture rate | | | --- | | | | --- | |
| | | | | | | | |
Nonstatutory Stock Options | | | | | | | | |
Expected volatility (1) | | | --- | | | | 103.55 | % |
Risk-free interest rate % (2) | | | --- | | | | 0.81 | % |
Expected term (in years) | | | --- | | | | 5.0 | |
Dividend yield (3) | | | --- | | | | --- | |
Forfeiture rate | | | --- | | | | --- | |
(1) | Expected volatility assumption was based upon a combination of historical stock price volatility measured on a daily basis and an estimate of expected future stock price volatility |
(2) | Risk-free interest rate assumption is based upon U.S. Treasury bond interest rates appropriate for the term of the stock options. |
(3) | The Company does not currently intend to pay cash dividends, thus has assumed a 0% dividend yield. |
(4) | The Company did not award any shared-based compensation for the three months ended March 31, 2014. |
Stock Options (Incentive and Nonstatutory)
The following table summarizes share-based compensation related to stock options for the three months ended March 31:
| | Three Months Ended March 31, | |
| | 2014 | | | 2013 | |
Research and development | | $ | 5,307 | | | $ | 648 | |
Selling, general and administrative | | | 19,233 | | | | 8,333 | |
Total share-based compensation expense | | $ | 24,540 | | | $ | 8,981 | |
At March 31, 2014, 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 $127,903. The period over which the unearned share-based compensation is expected to be recognized is approximately two years.
The following table summarizes the stock options outstanding and the number of shares of Common Stock subject to exercise as of March 31, 2014 and the changes therein during the three months then ended:
| | Stock Options | | | Weighted Average Exercise Price per Share | |
Outstanding as of December 31, 2013 | | | 1,014,907 | | | $ | 2.12 | |
Granted | | | --- | | | | --- | |
Forfeited/cancelled | | | --- | | | | --- | |
Exercised | | | --- | | | | --- | |
Outstanding as of March 31, 2014 | | | 1,014,907 | | | $ | 2.12 | |
The following table presents the stock option grants outstanding and exercisable as of March 31, 2014:
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 | |
| 892,500 | | | $ | 0.33 | | | | 9.0 | | | | 272,500 | | | $ | 0.33 | |
| 53,334 | | | | 2.38 | | | | 4.2 | | | | 46,668 | | | | 2.36 | |
| 30,002 | | | | 14.40 | | | | 3.0 | | | | 30,002 | | | | 14.40 | |
| 39,071 | | | | 33.35 | | | | 3.6 | | | | 39,071 | | | | 33.35 | |
| 1,014,907 | | | $ | 2.12 | | | | 8.3 | | | | 388,241 | | | $ | 4.98 | |
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.
The following table summarizes share-based compensation related to restricted stock awards for the three months ended March 31:
| | Three Months Ended March 31, | |
| | 2014 | | | 2013 | |
Research and development | | | --- | | | $ | 444 | |
Selling, general and administrative | | | --- | | | | 547 | |
Total share-based compensation expense | | | --- | | | $ | 991 | |
At March 31, 2014, 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.
The following table summarizes the non-vested restricted stock awards outstanding and the number of shares of Common Stock subject to potential issue as of March 31, 2014 and the changes therein during the three months then ended:
| | Restricted stock | | | Weighted Average Grant Date Fair Value | |
Outstanding as of December 31, 2013 | | | --- | | | | --- | |
Shares granted | | | --- | | | | --- | |
Shares forfeited/cancelled | | | --- | | | | --- | |
Shares exercised/issued | | | --- | | | | --- | |
Outstanding as of March 31, 2014 | | | --- | | | | --- | |
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, and on June 13, 2013, 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, and 600,000 shares, respectively, to a total of 1,800,000 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 March 31, 2014, we had granted options to purchase 1,376,167 shares of Common Stock since the inception of the Equity Incentive Plan, of which 1,014,907 were outstanding at a weighted average exercise price of $2.12 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 March 31, 2014, there were 715,647 shares that remained available for future grants under our Equity Incentive Plan.
NOTE 16. | FAIR VALUE MEASUREMENTS |
In accordance with FASB ASC Topic 820, Fair Value Measurements, (“ASC Topic 820”) certain assets and liabilities of the Company are required to be recorded at fair value. Fair value is determined based on the exchange price that would be received for an asset or paid to transfer a liability in an orderly transaction between market participants. The guidance in ASC Topic 820 also establishes a hierarchy for inputs used in measuring fair value that maximizes the use of observable inputs and minimized the use of unobservable inputs by requiring that the most observable inputs be used when available.
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 March 31, 2014 and December 31, 2013.
Description | | March 31, 2014 | | | December 31, 2013 | |
Assets: | | | | | | |
Notes receivable and accrued interest | | | --- | | | $ | 777,710 | |
| | | | | | | | |
Liabilities: | | | | | | | | |
Convertible note – June 2011 | | $ | 139,190 | | | $ | 138,220 | |
Convertible note – July 2011 | | $ | 122,603 | | | $ | 120,738 | |
Convertible note – June 2012 | | | --- | | | $ | 888,099 | |
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.
NOTE 18. | COMMITMENTS AND CONTINGENCIES |
Operating Leases
On January 31, 2006 we entered into a lease agreement for office and laboratory space in Addison, Texas. The lease commenced on April 1, 2006 and originally continued until April 1, 2013. The lease required a minimum monthly lease obligation of $9,330, which was inclusive of monthly operating expenses, until April 1, 2011 and at such time increased to $9,776, which was inclusive of monthly operating expenses. On February 22, 2013, we executed an Amendment to Lease Agreement (the “Lease Amendment”) that renewed and extended our lease until March 31, 2015. The Lease Amendment requires a minimum monthly lease obligation of $9,193, which is inclusive of monthly operating expenses, until March 31, 2014 and at such time, will increase to $9,379, which is inclusive of monthly operating expenses.
On December 10, 2010 we entered into a lease agreement for certain office equipment. The lease, which commenced on February 1, 2011 and continues until February 1, 2015, requires a minimum lease obligation of $744 per month.
The future minimum lease payments under the 2013 office lease and the 2010 equipment lease are as follows as of March 31, 2014:
Calendar Years | | Future Lease Expense | |
2014 (Nine months) | | $ | 91,106 | |
2015 | | | 28,881 | |
2016 | | | --- | |
2017 | | | --- | |
2018 | | | --- | |
Total | | $ | 119,987 | |
Rent expense for our operating leases amounted to $30,380 and $25,028 for the three months ended March 31, 2014 and 2013, 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 IPMD, 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 of collectively, to have control of, and make investment and business decisions on behalf of Altrazeal AG.
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. On December 21, 2012, we entered into a Securities Purchase Agreement with IPMD as described in more detail in Note 12.
For the three months ended March 31, 2014 and 2013, the Company recorded product sales, in approximate numbers, of $78,000 and $71,000, respectively, with the various Altrazeal Distributors, which represented 76% and 70% of our total revenues. As of March 31, 2014 and December 31, 2013, Altrazeal Distributors had an outstanding accounts receivable, in approximate numbers, of $252,000 and $174,000, respectively, which represented 97% and 97% of our total outstanding accounts receivables.
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 March 31, 2014, the following table summarizes the compensation temporarily deferred and subsequent repayments:
Name | | 2014 | | | 2013 | | | 2012 | | | 2011 | | | Total | |
Kerry P. Gray (1) (2) | | $ | (97,500 | ) | | $ | (91,000 | ) | | $ | 220,673 | | | $ | 140,313 | | | $ | 172,486 | |
Terrance K. Wallberg | | | --- | | | | (35,769 | ) | | $ | 24,230 | | | $ | 36,539 | | | $ | 25,000 | |
Key executives | | | (17,188 | ) | | | (20,000 | ) | | $ | 27,253 | | | $ | 20,986 | | | $ | 11,051 | |
Total | | $ | (114,688 | ) | | $ | (146,769 | ) | | $ | 272,156 | | | $ | 197,838 | | | $ | 208,537 | |
| (1) | During 2014, Mr. Gray temporarily deferred compensation of $15,000 earned for his duties as Chairman of the Executive Committee of the Company’s Board of Directors. During 2014, Mr. Gray was also repaid $112,500 of temporarily deferred compensation, of which $100,000 was used by Mr. Gray for funding required pursuant to the March 2013 Offering. |
| (2) | 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 March 31, 2014 and December 31, 2013, the Company’s obligation for temporarily deferred compensation was $208,537, of which $122,500 was included in accounts payable and $86,037 was included in accrued liabilities, and $323,225 of which $207,500 was included in accounts payable and $115,725 was included in accrued liabilities, 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 March 31, 2014, 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.
NOTE 19. | LEGAL PROCEEDINGS |
From time to time, we may be involved in litigation relating to claims arising out of our operations in the normal course of business. We are not currently a party to any legal proceedings, the adverse outcome of which, in management’s opinion, individually or in the aggregate, would have a material adverse effect on the results of our operations or financial position. There are no material proceedings to which any director, officer or any of our affiliates, any owner of record or beneficially of more than five percent of any class of our voting securities, or any associate of any such director, officer, our affiliates, or security holder, is a party adverse to us or our consolidated subsidiary or has a material interest adverse thereto.
NOTE 20. | SUBSEQUENT EVENTS |
Under the terms of the warrants held by Sacks and TPT, on April 30, 2014 we received payments of $150,000 and $300,000 from Sacks and TPT, respectively, and we issued 250,000 and 500,000 shares of Common Stock to Sacks and TPT, respectively.
You should read the following discussion and analysis together with all financial and non-financial information appearing elsewhere in this Amendment and with our consolidated financial statements and related notes included in our 2013 Annual Report on Form 10-K, referred to as our 2013 Form 10-K, which has been previously filed with the Securities and Exchange Commission on March 31, 2014, including the risk factors set forth therein. In addition to historical information, the following discussion and other parts of this Amendment contain forward-looking information that involve risks and uncertainties, including the statement that our cash and cash equivalents are sufficient to fund our operations and capital expenditures through 2014 and beyond. Our actual results could differ materially from those anticipated by such forward-looking information due to competitive factors and other risks discussed in our 2013 Form 10-K under “Risks Associated with our Business”.
Management’s Discussion and Analysis of Financial Condition and Results of Operations has been revised for the effects of the restatement. See Note 1 – Organization and Basis of Presentation.
Business 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 OraDiscTM technologies, with the goal of improving outcomes for patients, health care professionals, and health care payers.
Our strategy is twofold:
§ | Establish the foundation for a market leadership position in wound management by developing and commercializing a customer focused portfolio of innovative wound care products based on the Nanoflex® technology to treat the various phases of wound healing; and |
§ | Develop our oral-transmucosal technology (OraDiscTM) and generate revenues through multiple licensing agreements. |
Utilizing our technologies, three of our products have been approved for marketing in various global markets. In addition, numerous additional products are under development utilizing our patented Nanoflex® and OraDiscTM technologies.
Altrazeal® Transforming Powder Dressing, based on our Nanoflex® technology, has the potential to change the way health care providers approach their treatment of wounds. Launched domestically in September 2008 and internationally in July 2012, the product is indicated for exuding wounds such as partial thickness burns, donor sites, abrasions, surgical, acute and chronic wounds.
Aphthasol®, our Amlexanox 5% paste product, is the first drug approved by the FDA for the treatment of canker sores.
OraDisc™ A was initially developed as a drug delivery system to treat canker sores with the same active ingredient (amlexanox) that is used in Aphthasol® paste. We anticipate that higher amlexanox concentrations will be achieved at the disease site, increasing the effectiveness of the product. OraDisc™ A was approved by the FDA in September 2004.
Recent Developments (as of March 31, 2014)
Common Stock Transaction – January 2013 Offering
On December 21, 2012, we entered into a Securities Purchase Agreement (the “SPA”) with IPMD GmbH (“IPMD”) relating to an equity investment of $2,000,000 by IPMD for 5,000,000 shares of our common stock (the “Shares”) and warrants to purchase up to 3,000,000 shares of our common stock (the “Warrants”) (the “January 2013 Offering”). Under the SPA, the purchase and sale of the Shares and Warrants took place at four closings over twelve months, with $400,000 being funded at the initial closing under the SPA, $500,000 being funded on the four-month anniversary of the initial closing, $600,000 being funded on the eight-month anniversary of the initial closing, and $500,000 being funded on the one-year anniversary of the initial closing. The Warrants have a fixed exercise price of $0.60 per share, become exercisable in tranches on each of the four funding dates, and expire on the one-year anniversary of the initial closing. On January 3, 2013, we closed the January 2013 Offering and received the initial funding tranche of $400,000 for the purchase of 1,000,000 shares of our common stock. We received subsequent funding tranches of $500,000, $300,000, $300,000, and $500,000 for the purchase of 1,250,000, 750,000, 750,000, and 1,250,000 shares of our common stock on May 7, 2013, September 6, 2013, October 24, 2013, and January 6, 2014 respectively.
On January 3, 2014, the Warrants vested with respect to 3,000,000 shares of our common stock and were exercised by an assignee of IPMD on that date pursuant to a Notice of Exercise, accepted by the Company, that provided for the issuance of 750,000 shares of common stock on each of January 31, 2014, February 28, 2014, March 31, 2014, and April 30, 2014 in exchange for the payment of $450,000 on each such date.
On January 31, 2014, IPMD documented the assignment by completing an Assignment Agreement (the “Assignment Agreement”) with The Punch Trust (“TPT”) and Michael I. Sacks (“Sacks”) pursuant to which IPMD completed the assignment to TPT and Sacks its rights and interests to purchase up to 3,000,000 shares of our common stock as detailed in the Warrants and the Notice of Exercise. Neither TPT nor Sacks paid any monetary consideration to IPMD in connection with the assignments under the Assignment Agreement.
Concurrent with the assignment under the Assignment Agreement described above, ULURU, TPT, Sacks, and IPMD entered into an Implementation Agreement (the “Implementation Agreement”) pursuant to which we consented and agreed to the assignment of the Warrants to TPT and Sacks. We also agreed to issue and facilitate the delivery of the shares of common stock under the Warrants to TPT and Sacks upon their payment of the corresponding purchase price due under the Warrants. Under the terms of the Warrants, Sacks made payments of $450,000 on each of January 31, 2014 and February 28, 2014 and $150,000 on each of March 31, 2014 and April 30, 2014. The Company issued 750,000 shares of common stock to Sacks on each of January 31, 2014 and February 28, 2014 and 250,000 share of common stock on each of March 31, 2014 and April 30, 2014. Under the terms of the Warrants, TPT made payments of $300,000 on each of March 31, 2014 and April 30, 2014 and the Company issued 500,000 shares of common stock to TPT on each date, respectively.
On January 31, 2014, we also entered into a Registration Rights Agreement with TPT and Sacks whereby we agreed to prepare and file with the SEC a registration statement for the number of shares referred to therein within sixty days after request and to use commercially reasonable efforts to cause such registration statement to be declared effective with the SEC and to keep such registration statement effective for a period of eighty days and, if necessary, such eighty day period being extended for up to sixty additional days.
Convertible Note – June 2012
On January 22, 2014, we provided notice to Inter-Mountain Capital Corp. (“Inter-Mountain”) of our election to exercise our rights under the $2,210,000 Secured Convertible Note issued to Inter-Mountain (the “June 2012 Note”) and to offset amounts we owed to Inter-Mountain against amounts it owed to us under certain Investor Notes. Our notice provided that such deduction and offset occurred on January 22, 2014, that we will not incur the 120% prepayment premium with respect to the June 2012 Note as a result of the deduction and offset, that no warrants will become exercisable as a result of the offset, and that any warrants unvested as of January 22, 2014 shall immediately and automatically terminate. As a result, the outstanding amount owed under the June 2012 Note was reduced to approximately $317,000 as of January 22, 2014.
On February 27, 2014 and on March 3, 2014, we received conversion notices from Inter-Mountain whereby we issued an aggregate of 435,502 shares of common stock for the final payment of approximately $152,000 due under the June 2012 Note.
Altrazeal® marketing and licensing activities
On September 30, 2013, we executed an Exclusive License and Supply Agreement with Altrazeal AG (the “AG Agreement”) to market Altrazeal® in several territories, including Africa (markets not already licensed), Latin America, Georgia, Turkmenistan, Ukraine, and the Commonwealth of Independent States. Under the terms of the AG Agreement, we received an up-front licensing payment, will receive certain royalties on product sales within the territories, and will supply Altrazeal® at an agreed upon price. On February 1, 2014, we executed a shareholders’ agreement with Altrazeal AG and received a non-dilutable 25% ownership interest in Altrazeal AG.
In October 2013 and February 2014, we executed amendments to the AG Agreement for the purpose of expanding the territories to include Asia and the Pacific (excluding China, Hong Kong, Macau, Taiwan, South Korea, Japan, Australia, and New Zealand), Jordan, and Syria. It is anticipated that Altrazeal® will be launched in a number of these markets in 2014.
In February 2014, we executed an amendment to the Melmed Agreement for the purpose of expanding the territories to include Albania, Bosnia, Croatia, Kosovo, Macedonia, Montenegro, and Serbia. It is anticipated that Altrazeal® will be launched in a number of these markets in 2014. Currently, such marketing efforts are being performed by Altrazeal Trading GmbH, an affiliate of Melmed Holding AG.
RESULTS OF OPERATIONS
Fluctuations in Operating Results
Our results of operations have fluctuated significantly from period to period in the past and are likely to continue to do so in the future. We anticipate that our quarterly and annual results of operations will be impacted for the foreseeable future by several factors, including the timing and amount of payments received pursuant to our current and future collaborations, and the progress and timing of expenditures related to our development and commercialization efforts. Due to these fluctuations, we believe that the period-to-period comparisons of our operating results may not be a good indication of our future performance.
Comparison of the three months ended March 31, 2014 and 2013
Total Revenues
Revenues were approximately $102,000 for the three months ended March 31, 2014, as compared to revenues of approximately $102,000 for the three months ended March 31, 2013, and were comprised of licensing fees of approximately $15,000 from Altrazeal® and OraDisc™ licensing agreements and product sales of approximately $87,000 for Altrazeal®.
Although the first quarter 2014 revenue totals were comparable to the first quarter 2013 revenue totals, there was an increase of $3,000 in Altrazeal® licensing fees and a decrease of $3,000 in domestic Altrazeal® product sales.
Costs and Expenses
Cost of Goods Sold
Cost of goods sold for the three months ended March 31, 2014 and 2013 were approximately $41,000 and $41,000, respectively, and were comprised entirely of costs associated with Altrazeal®.
Research and Development
Research and development expenses totaled approximately $187,000 for the three months ended March 31, 2014, including $5,000 in share-based compensation, compared to approximately $165,000 for the three months ended March 31, 2013, which included $1,000 in share-based compensation. The increase of approximately $22,000 in research and development expenses was primarily due to, in approximate numbers, an increase of $29,000 in scientific compensation related to share-based compensation and a higher head count and an increase of $20,000 in clinical costs related to Altrazeal®. These expense increases were partially offset by a decrease of $18,000 in regulatory costs and a decrease of $9,000 in direct research costs primarily related to Altrazeal®.
The direct research and development expenses for the three months ended March 31, 2014 and 2013 were, in approximate numbers, as follows:
| | Three Months Ended March 31, | |
Technology | | 2014 | | | 2013 | |
Wound care & nanoparticle | | $ | 60,000 | | | $ | 70,000 | |
OraDisc™ | | | 3,000 | | | | 3,000 | |
Aphthasol® & other technologies | | | 1,000 | | | | --- | |
Total | | $ | 64,000 | | | $ | 73,000 | |
Selling, General and Administrative
Selling, general and administrative expenses totaled approximately $469,000 for the three months ended March 31, 2014, including $19,000 in share-based compensation, compared to approximately $261,000 for the three months ended March 31, 2013, which included $9,000 in share-based compensation.
The increase of approximately $208,000 in selling, general and administrative expenses was primarily due to, in approximate numbers, an increase of $81,000 in investor relations consulting due to issuance of share-based compensation, an increase of $49,000 in investor relations as the prior year included a credit for the cancellation of a warrant issued for consulting services, an increase of $39,000 in legal costs related to a licensing agreement dispute, an increase of $20,000 in sales and marketing expenses, an increase of $9,000 in costs for directors fees, an increase of $8,000 in shareholder meeting costs, an increase of $7,000 in legal fees related to our patents, an increase of $4,000 related to property tax accruals, an increase of $4,000 in corporate travel, an increase of $3,000 in occupancy costs, an increase of $3,000 in insurance costs, and a increase of $4,000 in operating costs. These expense increases were partially offset by, in approximate numbers, a decrease of $12,000 in compensation cost related to our Chief Executive Officer and a decrease of $11,000 in consulting costs related to licensing activities.
Amortization of Intangible Assets
Amortization of intangible assets expense totaled approximately $117,000 for the three months ended March 31, 2014 as compared to approximately $117,000 for the three months ended March 31, 2013. The expense for each period consists primarily of amortization associated with our acquired patents. There were no additional purchases of patents during the three months ended March 31, 2014 and 2013, respectively.
Depreciation
Depreciation expense totaled approximately $61,000 for the three months ended March 31, 2014 as compared to approximately $65,000 for the three months ended March 31, 2013. The decrease of approximately $4,000 is attributable to certain equipment being fully depreciated.
Interest and Miscellaneous Income
Interest and miscellaneous income totaled approximately $5,000 for the three months ended March 31, 2014 as compared to approximately $22,000 for the three months ended March 31, 2013. The decrease of approximately $17,000 is attributable to a decrease in interest income resulting from the deduction and offset in January 2014 of the outstanding notes receivable against the outstanding principle due on the convertible promissory note with Inter-Mountain.
Interest Expense
Interest expense totaled approximately $(36,000) for the three months ended March 31, 2014 as compared to approximately $132,000 for the three months ended March 31, 2013. Interest expense is comprised of financing costs for our insurance policies, interest costs related to regulatory fees, and interest costs and amortization of debt discount and financing costs related to our convertible debt.
The decrease of approximately $168,000 is primarily attributable to the deduction and offset in January 2014 of the outstanding notes receivable against the outstanding principle due on the convertible promissory note with Inter-Mountain and the final payoff in March 2014 of the convertible promissory note with Inter-Mountain.
LIQUIDITY AND CAPITAL RESOURCES
We have funded our operations primarily through the public and private sales of convertible debentures and common stock. Product sales, royalty payments, contract research, licensing fees and milestone payments from our corporate alliances have provided, and are expected in the future to provide, funding for operations. Our principal source of liquidity is cash and cash equivalents. As of March 31, 2014 our cash and cash equivalents were approximately $1,016,000 which is an increase of approximately $1,011,000 as compared to our cash and cash equivalents at December 31, 2013 of approximately $5,000. Our working capital (current assets less current liabilities) was approximately $(232,000) at March 31, 2014 as compared to our working capital at December 31, 2013 of approximately $(1,783,000).
Consolidated Cash Flow Data
| | Three Months Ended March 31, | |
Net Cash Provided by (Used in) | | 2014 | | | 2013 | |
Operating activities | | $ | (156,000 | ) | | $ | (497,000 | ) |
Investing activities | | | (16,000 | ) | | | --- | |
Financing activities | | | 1,183,000 | | | | 481,000 | |
Net increase (decrease) in cash and cash equivalents | | $ | 1,011,000 | | | $ | (16,000 | ) |
Operating Activities
For the three months ended March 31, 2014, net cash used in operating activities was approximately $156,000. The principal components of net cash used for the three months ended March 31, 2014 were, in approximate numbers, our net loss of $868,000, a decrease of $311,000 in accounts payable due to timing of vendor payments, a decrease of $67,000 in accrued liabilities related to compensation and insurance, a decrease of $15,000 in deferred revenues due to amortization of revenues, an increase of $72,000 in accounts receivable, and an increase of $4,000 in prepaid expenses related to investor relations consulting. Our net loss for the three months ended March 31, 2014 included substantial non-cash charges of approximately $381,000 in the form of share-based compensation, amortization of patents, depreciation, amortization of debt discount, amortization of deferred financings costs, interest due on convertible notes settled with common stock, common stock and warrants issued for services, and the loss on early extinguishment of a convertible note. The aforementioned net cash used for the three months ended March 31, 2014 was partially offset by, in approximate numbers, a decrease of $778,000 in notes receivable due to our offset in January 2014 of all outstanding Investor Notes issued by Inter-Mountain, a decrease of $15,000 in inventory, and an increase in accrued interest of $7,000 related to our two outstanding convertible notes.
For the three months ended March 31, 2013, net cash used in operating activities was approximately $497,000. The principal components of net cash used for the three months ended March 31, 2013 were, in approximate numbers, our net loss of $656,000, a decrease of $437,000 in accounts payable due to timing of vendor payments, a decrease in deferred revenues of $11,000 due to amortization of revenues, and the cancellation of a warrant issued for service for $49,000. Our net loss for the three months ended March 31, 2013 included substantial non-cash charges of approximately $294,000 in the form of share-based compensation, amortization of patents, depreciation, amortization of debt discount, amortization of deferred financings costs, and interest due on convertible notes settled with common stock. The aforementioned net cash used for the three months ended March 31, 2013 was partially offset by, in approximate numbers, a decrease in notes receivable of $241,000 due to remittance of an Investor Note by Inter-Mountain, a decrease in prepaid expenses of $59,000 due to amortization of expenses, a decrease in receivables of $27,000 due to collection activities, a decrease in inventory of $21,000 related to product sales, an increase in accrued interest of $7,000 related to our convertible debt, and an increase in accrued liabilities of $7,000.
Investing Activities
Net cash used in investing activities for the three months ended March 31, 2014 was approximately $16,000 and relates to the purchase of manufacturing equipment.
There were no investing activities for the three months ended March 31, 2013.
Financing Activities
Net cash provided by financing activities for the three month ended March 31, 2014 was approximately $1,183,000 and was comprised of, in approximate numbers, the final funding of $500,000 from the sale of common stock and warrants pursuant to the January 2013 Offering, the final funding $110,000 from the sale of common stock and warrants pursuant to the March 2013 Offering, the funding of $1,350,000 from the exercise of warrants to purchase 2,250,000 shares of common stock pursuant to the Implementation Agreement with Sacks and TPT, and the repayment of $777,000 of principle due on the convertible promissory note with Inter-Mountain attributable to the deduction and offset in January 2014 of the outstanding Investor Notes against the outstanding principle due on the convertible promissory note with Inter-Mountain.
Net cash provided by financing activities for the three month ended March 31, 2013 was approximately $481,000 and was comprised of approximately $395,000 from the sale of common stock and warrants pursuant to the January 2013 Offering and approximately $86,000 from the sale of common stock and warrants pursuant to the March 2013 Offering.
Liquidity
As of March 31, 2014, we had cash and cash equivalents of approximately $1,016,000. We expect to use our cash, cash equivalents, and investments on working capital, general corporate purposes, property and equipment, and the payment of contractual obligations. Our long-term liquidity will depend to a great extent on our ability to fully commercialize our Altrazeal® and OraDisc™ technologies; therefore we are continuing to look both domestically and internationally for opportunities that will enable us to expand our business. At this time, we cannot accurately predict the effect of certain developments on the rate of sales growth, if any, during 2014 and beyond, such as the speed and degree of market acceptance, patent protection and exclusivity of our products, the impact of competition, the effectiveness of our sales and marketing efforts and those of our licensees, and the outcome of our current efforts to develop, receive approval for, and successfully launch our near-term product candidates.
Based on our existing liquidity as of the date of the Original Report, the expected level of operating expenses, projected sales of our existing products combined with other revenues, and the funding of $450,000 received in April 2014 from the warrant exercise by Sacks and TPT, we believe these factors will provide us with adequate financial resources to continue to fund our business plan and meet our operating requirements through 2014 and beyond. We do not expect any material changes in our capital expenditures spending during 2014. However, we cannot be sure that revenues or other liquidity sources will reach anticipated levels.
As we continue to expend funds to advance our business plan, there can be no assurance that changes in our development plans, capital expenditures or other events affecting our operations will not result in the earlier depletion of our funds. In appropriate situations, we may seek funding from other sources, including contribution by others to joint ventures, or collaborative arrangements or licensing for the development, testing, manufacturing and marketing of products under development. Additionally, we may explore alternative financing sources for our business activities, including the possibility of loans and public and/or private offerings of debt and equity securities. Other than proceeds of $450,000 received in April 2014 from the warrant exercised by Sacks and TPT, we have no agreements as of the date of the Original Report with respect to our potential receipt of additional capital. We cannot be certain that necessary funding will be available on terms acceptable to us, or at all.
Our future capital requirements and adequacy of available funds will depend on many factors including:
§ | our ability to successfully commercialize our wound management and burn care products and the market acceptance of these products; |
§ | our ability to establish and maintain collaborative arrangements with corporate partners for the development and commercialization of certain product opportunities; |
§ | continued scientific progress in our development programs; |
§ | the costs involved in filing, prosecuting and enforcing patent claims; |
§ | competing technological developments; and |
§ | the cost of manufacturing and production scale-up. |
Contractual Obligations
The following table summarizes our outstanding contractual cash obligations as of March 31, 2014, which consists of a lease agreement for office and laboratory space in Addison, Texas, a lease agreement for office equipment, amounts unpaid under a separation agreement with our current chief executive officer, Kerry P. Gray, and the principal balance due for our two convertible note agreements. These obligations and commitments assume non-termination of agreements and represent expected payments based on current operating forecasts, which are subject to change:
| | Payments Due By Period | |
Contractual Obligations | | Total | | | Less Than 1 Year | | | 1-2 Years | | | 3-5 Years | | | After 5 Years | |
Operating leases | | $ | 119,987 | | | $ | 119,987 | | | $ | --- | | | $ | --- | | | $ | --- | |
Separation agreement | | | 49,986 | | | | 49,986 | | | | --- | | | | --- | | | | --- | |
Convertible notes | | | 291,803 | | | | 291,803 | | | | --- | | | | --- | | | | --- | |
Total contractual cash obligations | | $ | 461,776 | | | $ | 461,776 | | | $ | --- | | | $ | --- | | | $ | --- | |
Capital Expenditures
For the three months ended March 31, 2014 and 2013, our expenditures for property, equipment, and leasehold improvements were, in approximate numbers, $16,000, and nil, respectively. Such expenditures in 2014 relate primarily to the purchase of equipment for the manufacture of Altrazeal®. At this time, we believe that our capital expenditures for the remainder of 2014 will be approximately $54,000 and consist of equipment related to the manufacture of our products and equipment for our computer systems.
Off-Balance Sheet Arrangements
As of March 31, 2014, we did not have any off balance sheet arrangements.
Impact of Inflation
We have experienced only moderate price increases over the last three fiscal years under our agreements with third-party manufacturers as a result of raw material and labor price increases. However, there can be no assurance that possible future inflation would not impact our operations.
Concentrations of Credit Risk
Concentration of credit risk with respect to financial instruments, consisting primarily of cash and cash equivalents, potentially expose us to concentrations of credit risk due to the use of a limited number of banking institutions and due to maintaining cash balances in banks, which, at times, may exceed the limits of amounts insured by the Federal Deposit Insurance Corporation. Currently, we utilized Bank of America, N.A. and Bank of America Investment Services, Inc. as our banking institutions. At March 31, 2014 and December 31, 2013 our cash and cash equivalents totaled approximately $1,016,000 and $5,000, respectively. We also invest cash in excess of immediate requirements in money market accounts, certificates of deposit, corporate commercial paper with high quality ratings, and U.S. government securities. These investments are not held for trading or other speculative purposes. We are exposed to credit risk in the event of default by these institutions.
Concentration of credit risk with respect to trade accounts receivable are customers with balances that exceed 5% of total consolidated trade accounts receivable at March 31, 2014 and at December 31, 2013. As of March 31, 2014, three customers exceeded the 5% threshold, with 60%, 30% and 7%, respectively. Two customers exceeded the 5% threshold at December 31, 2013, with 86% and 11%, respectively. To reduce risk, we routinely assess the financial strength of our most significant customers and monitor the amounts owed to us, taking appropriate action when necessary. As a result, we believe that accounts receivable credit risk exposure is limited. We maintain an allowance for doubtful accounts, but historically have not experienced any significant losses related to an individual customer or group of customers.
Concentrations of Foreign Currency Risk
Currently, a portion of our revenue and all of our expenses are denominated in U.S. dollars, although we are recently experiencing an increase in revenues in international territories denominated in a foreign currency. Certain of our licensing and distribution agreements in international territories are denominated in Euros. Currently, we do not employ forward contracts or other financial instruments to mitigate foreign currency risk. As our international operations continue to grow, we may engage in hedging activities to hedge our exposure to foreign currency risk.
CRITICAL ACCOUNTING POLICIES AND ESTIMATES
Management’s Discussion and Analysis of Financial Condition and Results of Operations addresses our financial statements, which have been prepared in accordance with accounting principles generally accepted in the United States (“GAAP”) for interim financial information. The preparation of our financial statements requires that we make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. On an on-going basis, we evaluate these estimates and judgments. We base our estimates and judgments on historical experience and on various other factors that are believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions. Our critical accounting policies are summarized in our Annual Report on Form 10-K for the year ended December 31, 2013 as filed with the Securities and Exchange Commission on March 31, 2014. We had no significant changes in our critical accounting policies since our last annual report.
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
This Amendment (including documents incorporated by reference) and other written and oral statements the Company makes from time to time contain certain “forward-looking” statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. You can identify these forward-looking statements by the fact they use words such as “should”, “expect”, “anticipate”, “estimate”, “will”, “target”, “may”, “project”, “guidance”, “intend”, “plan”, “believe” and other words and terms of similar meaning and expression in connection with any discussion of future operating or financial performance. One can also identify forward-looking statements by the fact that they do not relate strictly to historical or current facts. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes to differ materially from current expectations. These statements include, among other things, statements regarding the Company’s expected cash and cash equivalents and working capital being sufficient to fund our operations and capital expenditure requirements through 2014 and beyond, and other statements, including the Company’s goals, plans and projections regarding its financial position, results of operations, cash flows, market position, product development, product approvals, sales efforts, expenses, performance or results of current and anticipated products and the outcome of contingencies such as legal proceedings, and financial results, which are based on current expectations that involve inherent risks and uncertainties, including internal or external factors that could delay, divert or change any of them in the next several years.
In addition, as a result of the restatement of financial statements described in, and effected by, this Amendment, the Company is subject to additional risks associated with potential inquiries by the Securities and Exchange Commission, demands and lawsuits by shareholders and other possible legal or investigative actions. To the extent any such inquiry, demand or lawsuit occurs, it will harm the Company’s liquidity and divert management’s attention from the operation of the business. It may also harm customer relationships, the ability of the Company to raise capital as needed and other aspects of the Company’s business. The Company has included additional important factors in the cautionary statements included in its 2013 Annual Report on Form 10-K, particularly under “Risk Associated with our Business” that the Company believes could cause actual results to differ materially from any forward-looking statement.
Although the Company believes it has been prudent in its plans and assumptions, no assurance can be given that any goal or plan set forth in forward-looking statements can be achieved and readers are cautioned not to place undue reliance on such statements, which speak only as of the date made. The Company undertakes no obligation to release publicly any revisions to forward-looking statements as a result of new information, future events or otherwise.
This item is not applicable to smaller reporting companies.
Evaluation of Disclosure Controls and Procedures
Our chief executive officer and our chief financial officer, after evaluating the effectiveness of our “disclosure controls and procedures” (as defined in Rule 13a-15(e) and Rule 15d-15(e) of the Securities and Exchange Act of 1934, as amended (the “Exchange Act”)) as of the end of the period covered by this quarterly report, concluded that our disclosure controls and procedures (as distinguished from our internal controls over financial reporting) were (1) designed to ensure that material information relating to us, including our consolidated subsidiaries, is made known to our chief executive officer and chief financial officer by others within the Company, particularly during the period in which the Original Report was being prepared, and (2) effective, in that they provide reasonable assurance that information required to be disclosed by us in the reports that we file or submit under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the Securities and Exchange Commission’s rules and forms.
Change in Internal Control over Financial Reporting
There were no changes in our internal control over financial reporting that occurred during the three months ended March 31, 2014 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting; however, in connection with the preparation of our consolidated financial statements for the year ended December 31, 2014, we determined, as reported in Part I, Item 1, Note 1 of this Amendment, that the financial statements included in the Original Report included an error, which is corrected in this Amendment. As a result, we reevaluated our internal controls over financial reporting effective as of March 31, 2014 and identified a material weakness in the effectiveness of our internal control over financial reporting with respect to our accounting for the early extinguishment of the June 2012 Note and the issuance of common stock for the final conversion of the June 2012 Note. A material weakness is a deficiency, or combination of deficiencies, in internal control over financial reporting, such that there is a reasonable possibility that a material misstatement of the Company’s annual or interim financial statements will not be prevented or detected on a timely basis.
After identifying this material weakness, we implemented new procedures, including enhanced documentation, analysis and review of non-routine accounting matters. We have retrained those working in corporate finance, as to the importance of appropriate communication and review of non-routine accounting matters so that any such changes can be properly assessed under generally accepted accounting principles.
As of March 31, 2015, management believes our remediation efforts are effective with respect to our internal control over financial reporting and that the previous material weakness in our internal control over financial reporting has been remediated. Notwithstanding the beliefs of managers, we will continue to assess the effectiveness of our remediation efforts in connection with our evaluations of internal control over financial reporting. There remains a risk that the processes and procedures on which we currently rely will fail to be sufficiently effective, which could result in an error in our disclosure in the future. Moreover, because of the inherent limitations in all control systems, no evaluation of controls—even where we conclude the controls are operating effectively—can provide absolute assurance that all control issues have been detected. These inherent limitations include the realities that judgments in decision-making can be faulty, and breakdowns can occur because of simple error or mistake.
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.
This item is not applicable to smaller reporting companies. Information about certain risks associated with an investment in our common stock is found in Part I, Item 1A of our Annual Report on Form 10-K, as filed with the SEC on March 31, 2014.
Set forth below is a description of unregistered sales of equity securities during the quarter ended March 31, 2014, to the extent not previously reported on a Current Report on Form 8-K.
On or about February 27, 2014, we issued 30,000 shares of our common stock and a warrant to purchase 80,000 shares of common stock at an exercise price of $1.20 per share during a term expiring on January 15, 2019 (collectively, the “Feb Securities”) as payment for $42,600 in consulting services provided by San Diego Torrey Hills Capital, Inc. The warrant vested 50% on January 15, 2014 and will vest 50% on July 15, 2014 if the Investor is still providing services to us.
The Feb Securities are being issued in reliance upon the exemptions for sales of securities not involving a public offering, as set forth in Section 4(2) of the Securities Act of 1933, as amended (the “Securities Act”) and/or Regulation D promulgated under the Securities Act, based upon the following: (a) the investor confirmed that he had such background education and experience in financial and business matters as to be able to evaluate the merits and risks of an investment in the securities; (b) the investor confirmed that he was an “accredited investor” as defined in Rule 501(a) under the Securities Act; (c) there was no public offering or general solicitation with respect to the offering; (d) the Investor was provided with certain disclosure materials and all other information requested with respect to the Company; (e) the Investor acknowledged that the securities being purchased were “restricted securities” for purposes of the Securities Act and agreed to transfer the underlying securities only in a transaction registered under the Securities Act or exempt from registration under the Securities Act; (f) restrictive legends will be placed on the Feb Securities, including shares of common stock issuable upon exercise of the warrants; and (f) the Company filed a Form D with respect to the Feb 2014 Offering.
None.
Not applicable.
None.
Exhibit Number | | Description |
3.1 | | Restated Articles of Incorporation dated November 5, 2007. (1) |
3.2 | | Amended and Restated Bylaws dated December 5, 2008. (2) |
4.9 | | Common Stock Purchase Warrant dated March 6, 2014 by and between ULURU Inc. and San Diego Torrey Hills Capital, Inc. (3) |
| | |
| | |
| | |
| | |
101.INS | *** | XBRL Instance Document |
101.SCH | *** | XBRL Taxonomy Extension Schema Document |
101.CAL | *** | XBRL Taxonomy Extension Calculation Linkbase Document |
101.DEF | *** | XBRL Taxonomy Extension Definition Linkbase Document |
101.LAB | *** | XBRL Taxonomy Extension Label Linkbase Document |
101.PRE | *** | XBRL Taxonomy Extension Presentation Linkbase Document |
--------------------------------------------------- |
(1) | | Incorporated by reference to the Company’s Form 8-K filed on November 6, 2007. |
(2) | | Incorporated by reference to the Company’s Form 8-K filed on December 11, 2008. |
(3) | | Incorporated by referenced to the Company’s Form 10-Q filed on May 15, 2014. |
| * | Filed herewith. |
| ** | Filed herewith. This exhibit shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 or otherwise subject to the liabilities of that Section nor shall it be deemed incorporated by reference in any filings under the Securities Act of 1933 or the Securities and Exchange Act of 1934. |
| *** | Pursuant to Rule 406T of Regulation S-T, the XBRL-related information in Exhibit 101 to this Quarterly Report on Form 10-Q/A is deemed not filed or part of a registration statement or prospectus for purposes of Sections 11 or 12 of the Securities Act of 1933, is deemed not filed for purposes of Section 18 of the Securities and Exchange Act of 1934, and otherwise is not subject to liability under these sections. |
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this Amendment No. 1 on Form 10-Q/A to be signed on its behalf by the undersigned, thereunto duly authorized.
| ULURU Inc. |
| |
Date: April 1, 2015 | | By: | /s/ Kerry P. Gray | |
| | Kerry P. Gray |
| | Chief Executive Officer and President |
| | (Principal Executive Officer) |
| |
| |
Date: April 1, 2015 | | By: | /s/ Terrance K. Wallberg | |
| | Terrance K. Wallberg |
| | Chief Financial Officer and Vice President |
| | (Principal Financial and Accounting Officer) |