NOTE 1.
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COMPANY OVERVIEW AND BASIS OF PRESENTATION
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Company Overview
ULURU Inc. (hereinafter “we”, “our”, “us”, “ULURU”, or the “Company”) is a Nevada corporation. We are a diversified specialty pharmaceutical company committed to developing and commercializing a broad range of innovative wound care and muco-adhesive film products based on our patented Nanoflex® and OraDisc
TM
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 June 30, 2014 and the results of its operations for the three and six months ended June 30, 2014 and 2013 and cash flows for the six months ended June 30, 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 and six months ended June 30, 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.
NOTE 2.
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SIGNIFICANT ACCOUNTING POLICIES
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The significant accounting policies used in preparation of these condensed consolidated financial statements for the three and six months ended June 30, 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.
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THE EFFECT OF RECENTLY ISSUED ACCOUNTING STANDARDS
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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.
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SEGMENT INFORMATION
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We operate in one business segment: the research, development and commercialization of pharmaceutical products. Our corporate headquarters in the United States collects product sales, licensing fees, royalties, and sponsored research revenues from our arrangements with external customers and licensees. Our entire business is managed by a single management team, which reports to the Chief Executive Officer.
Our revenues are currently derived primarily from seven licensees for international activities and our domestic sales activities of Altrazeal®.
Revenues per geographic area, along with relative percentages of total revenues, for the three and six months ended June 30 are summarized as follows:
|
|
Three Months Ended June 30,
|
|
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Six Months Ended June 30,
|
|
Revenues
|
|
2014
|
|
|
%
|
|
|
2013
|
|
|
%
|
|
|
2014
|
|
|
%
|
|
|
2013
|
|
|
%
|
|
Domestic
|
|
$
|
11,770
|
|
|
|
6
|
%
|
|
$
|
17,610
|
|
|
|
61
|
%
|
|
$
|
21,442
|
|
|
|
7
|
%
|
|
$
|
37,397
|
|
|
|
29
|
%
|
International
|
|
|
197,524
|
|
|
|
94
|
%
|
|
|
11,274
|
|
|
|
39
|
%
|
|
|
289,833
|
|
|
|
93
|
%
|
|
|
93,531
|
|
|
|
71
|
%
|
Total
|
|
$
|
209,294
|
|
|
|
100
|
%
|
|
$
|
28,884
|
|
|
|
100
|
%
|
|
$
|
311,275
|
|
|
|
100
|
%
|
|
$
|
130,928
|
|
|
|
100
|
%
|
A significant portion of our revenues are derived from a few major customers. Customers with greater than 10% of total sales, along with their relative percentage of all sales, for the three and six months ended June 30 are represented on the following table:
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|
|
Three Months Ended June 30,
|
|
|
Six Months Ended June 30,
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Customers
|
Product
|
|
2014
|
|
|
2013
|
|
|
2014
|
|
|
2013
|
|
Customer A
|
Altrazeal®
|
|
|
87
|
%
|
|
|
---
|
|
|
|
59
|
%
|
|
|
---
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|
Customer B
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Altrazeal®
|
|
|
3
|
%
|
|
|
---
|
|
|
|
28
|
%
|
|
|
57
|
%
|
Customer C
|
Altrazeal®
|
|
|
*
|
|
|
|
29
|
%
|
|
|
*
|
|
|
|
*
|
|
Total
|
|
|
|
90
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%
|
|
|
29
|
%
|
|
|
87
|
%
|
|
|
57
|
%
|
* Sales from this customer were less than 10% of total sales for the period reported.
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|
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 June 30, 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 June 30, 2014 and December 31, 2013:
Inventory
|
|
June 30, 2014
|
|
|
December 31, 2013
|
|
Finished goods
|
|
$
|
22,230
|
|
|
$
|
85,993
|
|
Work-in-progress
|
|
|
308,001
|
|
|
|
299,464
|
|
Raw materials
|
|
|
18,462
|
|
|
|
10,148
|
|
Total
|
|
$
|
348,693
|
|
|
$
|
395,605
|
|
NOTE 7.
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PROPERTY, EQUIPMENT and LEASEHOLD IMPROVEMENTS
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Property, equipment and leasehold improvements, net, consisted of the following at June 30, 2014 and December 31, 2013:
Property, equipment and leasehold improvements
|
|
June 30, 2014
|
|
|
December 31, 2013
|
|
Laboratory equipment
|
|
$
|
424,888
|
|
|
$
|
424,888
|
|
Manufacturing equipment
|
|
|
1,597,961
|
|
|
|
1,581,728
|
|
Computers, office equipment, and furniture
|
|
|
140,360
|
|
|
|
140,360
|
|
Computer software
|
|
|
4,108
|
|
|
|
4,108
|
|
Leasehold improvements
|
|
|
95,841
|
|
|
|
95,841
|
|
|
|
|
2,263,158
|
|
|
|
2,246,925
|
|
Less: accumulated depreciation and amortization
|
|
|
( 1,728,418
|
)
|
|
|
(1,608,311
|
)
|
Property, equipment and leasehold improvements, net
|
|
$
|
534,740
|
|
|
$
|
638,614
|
|
Depreciation expense on property, equipment and leasehold improvements was $59,553 and $60,460 for the three months ended June 30, 2014 and 2013, respectively, and was $120,107 and $125,848 for the six months ended June 30, 2014 and 2013, respectively.
NOTE 8.
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INTANGIBLE ASSETS
|
Intangible assets are comprised of patents acquired in October, 2005. Intangible assets, net consisted of the following at June 30, 2014 and December 31, 2013:
Intangible assets
|
|
June 30, 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
|
|
|
( 6,190,723
|
)
|
|
|
(5,955,101
|
)
|
Intangible assets, net
|
|
$
|
3,435,215
|
|
|
$
|
3,670,837
|
|
Amortization expense for intangible assets was $118,461 and $118,461 for the three months ended June 30, 2014 and 2013, respectively, and was $235,622 and $235,622 for the six months ended June 30, 2014 and 2013, respectively.
The future aggregate amortization expense for intangible assets, remaining as of June 30, 2014, is as follows:
Calendar Years
|
|
Future Amortization
Expense
|
|
2014 (Six months)
|
|
$
|
239,526
|
|
2015
|
|
|
475,148
|
|
2016
|
|
|
476,450
|
|
2017
|
|
|
475,148
|
|
2018
|
|
|
475,148
|
|
2019 & Beyond
|
|
|
1,293,795
|
|
Total
|
|
$
|
3,435,215
|
|
NOTE 9.
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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 and six months ended June 30, 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 and six months ended June 30, 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 updated unaudited financial statements received in May 2014, our unrecorded share of Altrazeal Trading Ltd. losses for the year ended December 31, 2012 totaled $129,207.
Summarized financial information for our investment in Altrazeal Trading Ltd. assuming 100% ownership is as follows:
Altrazeal Trading Ltd.
|
|
December 31, 2012
|
|
Balance sheet
|
|
|
|
Total assets
|
|
$
|
136,661
|
|
Total liabilities
|
|
$
|
660,006
|
|
Total stockholders’ equity
|
|
$
|
(523,345
|
)
|
Statement of operations
|
|
|
|
|
Revenues
|
|
$
|
61,028
|
|
Net (loss)
|
|
$
|
(516,829
|
)
|
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 June 30, 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 and six months ended June 30, 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 and six months ended June 30, 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 and six months ended June 30, 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.
NOTE 10.
|
ACCRUED LIABILITIES
|
Accrued liabilities consisted of the following at June 30, 2014 and December 31, 2013:
Accrued Liabilities
|
|
June 30, 2014
|
|
|
December 31, 2013
|
|
Accrued taxes – payroll
|
|
$
|
106,299
|
|
|
$
|
106,299
|
|
Accrued compensation/benefits
|
|
|
49,972
|
|
|
|
148,683
|
|
Accrued insurance payable
|
|
|
---
|
|
|
|
60,113
|
|
Accrued property taxes
|
|
|
8,100
|
|
|
|
---
|
|
Product rebates/returns
|
|
|
14
|
|
|
|
32
|
|
Other
|
|
|
836
|
|
|
|
836
|
|
Total accrued liabilities
|
|
$
|
165,221
|
|
|
$
|
315,963
|
|
NOTE 11.
|
CONVERTIBLE DEBT
|
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 June 30, 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. Such issuance of shares of Common Stock following the cashless exercise of three warrants by Inter-Mountain during 2013 was based upon an agreement in December 2013 with Inter-Mountain modifying the formula in the Warrants for determining the number of shares to be issued upon a cashless exercise. As of June 30, 2014, there is one warrant that remains vested but unexercised for 392,857 shares of Common Stock. Inter-Mountain delivered a notice of a cashless exercise with respect to this warrant on or about May 1, 2014 purporting to exercise it with respect to the delivery of 782,284 shares of Common Stock. We believe that, as a result of the December 2013 agreement, the warrant is exercisable, on a cashless basis, with respect to only 261,516 shares of Common Stock as of May 1, 2014 and, as a result, have not honored such warrant exercise.
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, which registration statement expired by rule on April 30, 2013.
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.
On July 28, 2014, we issued 115,741 shares of Common Stock to Mr. Gray for the conversion and final payment of $125,000 due under the July 2011 Note and remitted to Mr. Gray the annual interest due on July 28, 2014 of $13,457.
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.
On June 13, 2014, we issued 116,667 shares of Common Stock to Mr. Gray for the conversion and final payment of $140,000 due under the June 2011 Note and remitted to Mr. Gray the annual interest due on June 13, 2014 of $13,346.
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 June 30, 2014
|
|
Transaction
|
|
Initial
Principal
Amount
|
|
|
Interest
Rate
|
|
Maturity
Date
|
|
Conversion Price (1)
|
|
|
Principal
Balance
|
|
|
Unamortized
Debt
Discount
|
|
|
Carrying
Value
|
|
July 2011 Note
|
|
$
|
125,000
|
|
|
|
10.0
|
%
|
07/28/2014
|
|
$
|
1.08
|
|
|
$
|
125,000
|
|
|
$
|
552
|
|
|
$
|
124,448
|
|
Total
|
|
$
|
125,000
|
|
|
|
|
|
|
|
|
|
|
|
$
|
125,000
|
|
|
$
|
552
|
|
|
$
|
124,448
|
|
(1)
|
On July 28, 2014, Mr. Gray elected to convert the outstanding principal balance ($125,000) of the July 2011 Note and we issued 115,741 shares of Common Stock for such conversion.
|
The amount of interest cost recognized from our convertible notes payable was $5,952 and $41,417 for the three months ended June 30, 2014 and 2013, respectively, and was $19,897 and $86,645 for the six months ended June 30, 2014 and 2013, respectively.
The amount of debt discount amortized from our convertible notes payable was $2,655 and $44,683 for the three months ended June 30, 2014 and 2013, respectively, and was $22,320 and $89,461 for the six months ended June 30, 2014 and 2013, respectively.
The future minimum payments relating to our convertible notes payable, as of June 30, 2014, are as follows:
|
|
Payments Due By Period
|
|
Transaction
|
|
Total
|
|
|
2014
(Six Months)
|
|
|
2015
|
|
|
2016
|
|
|
2017
|
|
|
2018
|
|
July 2011 Note
|
|
$
|
125,000
|
|
|
$
|
125,000
|
|
|
$
|
---
|
|
|
$
|
---
|
|
|
$
|
---
|
|
|
$
|
---
|
|
Total
|
|
$
|
125,000
|
|
|
$
|
125,000
|
|
|
$
|
---
|
|
|
$
|
---
|
|
|
$
|
---
|
|
|
$
|
---
|
|
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 June 30, 2014, we had 24,454,777 shares of Common Stock issued and outstanding. We issued 116,667 shares of Common Stock for the three months ended June 30, 2014 comprised of 116,667 shares of Common Stock issued for the conversion and final payment of the June 2011 Note held by Kerry Gray.
Preferred Stock
As of June 30, 2014, we had no shares of Series A Preferred Stock (the “Series A Shares”). For the three months ended June 30, 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 June 30, 2014 and the changes therein during the six months then ended:
|
|
Number of Shares of Common Stock Subject to Exercise
|
|
|
Weighted – Average
Exercise Price
|
|
Balance as of December 31, 2013
|
|
|
4,665,451
|
|
|
$
|
0.82
|
|
Warrants issued
|
|
|
80,000
|
|
|
$
|
1.20
|
|
Warrants exercised
|
|
|
(3,000,000
|
)
|
|
$
|
0.60
|
|
Warrants cancelled
|
|
|
---
|
|
|
|
---
|
|
Balance as of June 30, 2014
(1)
|
|
|
1,745,451
|
|
|
$
|
1.22
|
|
(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. Such issuance of shares of Common Stock following the cashless exercise of three warrants by Inter-Mountain during 2013 was based upon an agreement in December 2013 with Inter-Mountain modifying the formula in the Warrants for determining the number of shares to be issued upon a cashless exercise. 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 six months ended June 30, 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 June 30, 2014, expiration of the right to exercise is as follows:
Date of Expiration
|
|
Number of Warrant Shares of Common Stock Subject to Expiration
|
|
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
|
|
|
1,745,451
|
|
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 June 30, 2014 and December 31, 2013:
|
|
June 30, 2014
|
|
|
December 31, 2013
|
|
Warrants to purchase Common Stock
|
|
|
1,745,451
|
|
|
|
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 note payable from June 2011 (2)
|
|
|
---
|
|
|
|
127,712
|
|
Common stock issuable upon the assumed conversion of our convertible note payable from July 2011 (2)
|
|
|
115,741
|
|
|
|
125,603
|
|
Total
|
|
|
2,876,099
|
|
|
|
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)
|
On June 13, 2014, Mr. Gray elected to convert the outstanding principal balance ($140,000) of the June 2011 Note and we issued 116,667 shares of Common Stock for such conversion. On July 28, 2014, Mr. Gray elected to convert the outstanding principal balance ($125,000) of the July 2011 Note and we issued 115,741 shares of Common Stock for such conversion.
|
NOTE 15.
|
SHARE BASED COMPENSATION
|
The Company’s share-based compensation plan, the 2006 Equity Incentive Plan (“Equity Incentive Plan”), is administered by the compensation committee of the Board of Directors (“Board”), which selects persons to receive awards and determines the number of shares subject to each award and the terms, conditions, performance measures and other provisions of the award.
Our Board granted the following incentive stock option awards to executives or employees and nonstatutory stock option awards to directors or non-employees for the three and six months ended June 30:
|
|
Three Months Ended
June 30,
|
|
|
Six Months Ended
June 30,
|
|
|
|
2014
|
|
|
2013
|
|
|
2014
|
|
|
2013
|
|
Incentive Stock Options
(1)
|
|
|
|
|
|
|
|
|
|
|
|
|
Quantity
|
|
|
---
|
|
|
|
---
|
|
|
|
---
|
|
|
|
232,500
|
|
Weighted average fair value per share
|
|
|
---
|
|
|
|
---
|
|
|
|
---
|
|
|
$
|
0.24
|
|
Fair value
|
|
|
---
|
|
|
|
---
|
|
|
|
---
|
|
|
$
|
56,112
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nonstatutory Stock Options
(2)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Quantity
|
|
|
---
|
|
|
|
---
|
|
|
|
---
|
|
|
|
735,000
|
|
Weighted average fair value per share
|
|
|
---
|
|
|
|
---
|
|
|
|
---
|
|
|
$
|
0.24
|
|
Fair value
|
|
|
---
|
|
|
|
---
|
|
|
|
---
|
|
|
$
|
177,388
|
|
|
(1)
|
The Company did not award any incentive stock options for the three months ended June 30, 2014 and 2013, respectively.
|
|
(2)
|
The Company did not award any nonstatutory stock options for the three months ended June 30, 2014 and 2013, respectively.
|
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:
|
|
Six Months Ended June 30,
|
|
|
|
2014
|
|
|
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.
|
Stock Options (Incentive and Nonstatutory)
The following table summarizes share-based compensation related to stock options for the three and six months ended June 30:
|
|
Three Months Ended
June 30,
|
|
|
Six Months Ended
June 30,
|
|
|
|
2014
|
|
|
2013
|
|
|
2014
|
|
|
2013
|
|
Research and development
|
|
$
|
5,365
|
|
|
$
|
5,365
|
|
|
$
|
10,672
|
|
|
$
|
6,013
|
|
Selling, general and administrative
|
|
|
17,018
|
|
|
|
16,419
|
|
|
|
36,251
|
|
|
|
24,752
|
|
Total share-based compensation expense
|
|
$
|
22,383
|
|
|
$
|
21,784
|
|
|
$
|
46,923
|
|
|
$
|
30,765
|
|
At June 30, 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 $105,520. The period over which the unearned share-based compensation is expected to be recognized is approximately twenty one months.
The following table summarizes the stock options outstanding and the number of shares of Common Stock subject to exercise as of June 30, 2014 and the changes therein during the six 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 June 30, 2014
|
|
|
1,014,907
|
|
|
$
|
2.12
|
|
The following table presents the stock option grants outstanding and exercisable as of June 30, 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
|
|
|
|
8.7
|
|
|
|
272,500
|
|
|
$
|
0.33
|
|
|
53,334
|
|
|
|
2.38
|
|
|
|
4.0
|
|
|
|
53,334
|
|
|
|
2.38
|
|
|
30,002
|
|
|
|
14.40
|
|
|
|
2.8
|
|
|
|
30,002
|
|
|
|
14.40
|
|
|
39,071
|
|
|
|
33.35
|
|
|
|
3.3
|
|
|
|
39,071
|
|
|
|
33.35
|
|
|
1,014,907
|
|
|
$
|
2.12
|
|
|
|
8.1
|
|
|
|
394,907
|
|
|
$
|
4.94
|
|
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 and six months ended June 30:
|
|
Three Months Ended
June 30,
|
|
|
Six Months Ended
June 30,
|
|
|
|
2014
|
|
|
2013
|
|
|
2014
|
|
|
2013
|
|
Research and development
|
|
$
|
---
|
|
|
$
|
---
|
|
|
$
|
---
|
|
|
$
|
444
|
|
Selling, general and administrative
|
|
|
---
|
|
|
|
---
|
|
|
|
---
|
|
|
|
547
|
|
Total share-based compensation expense
|
|
$
|
---
|
|
|
$
|
---
|
|
|
$
|
---
|
|
|
$
|
991
|
|
At June 30, 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 June 30, 2014 and the changes therein during the six 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 June 30, 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, June 13, 2013, and on June 5, 2014, our stockholders approved amendments to the Equity Incentive Plan to increase the total number of shares of Common Stock issuable under the Equity Incentive Plan pursuant to stock options and other equity awards by 266,667 shares, 200,000 shares, 200,000 shares, 400,000 shares, 600,000 shares, and 1,000,000 shares, respectively, to a total of 2,800,000 shares.
In December 2006, we began issuing stock options to employees, consultants, and directors. The stock options issued generally vest over a period of one to four years and have a maximum contractual term of ten years. In January 2007, we began issuing restricted stock awards to our employees. Restricted stock awards generally vest over a period of six months to five years after the date of grant. Prior to vesting, restricted stock awards do not have dividend equivalent rights, do not have voting rights and the shares underlying the restricted stock awards are not considered issued and outstanding. Shares of Common Stock are issued on the date the restricted stock awards vest.
As of June 30, 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 June 30, 2014, there were 1,715,647 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 June 30, 2014 and December 31, 2013.
Description
|
|
June 30, 2014
|
|
|
December 31, 2013
|
|
Assets:
|
|
|
|
|
|
|
Notes receivable and accrued interest
|
|
|
---
|
|
|
$
|
777,710
|
|
|
|
|
|
|
|
|
|
|
Liabilities:
|
|
|
|
|
|
|
|
|
Convertible note – June 2011
|
|
|
---
|
|
|
$
|
138,220
|
|
Convertible note – July 2011
|
|
$
|
124,448
|
|
|
$
|
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 required a minimum monthly lease obligation of $9,193, which was inclusive of monthly operating expenses, until March 31, 2014 and at such time, increased to $9,379, which 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 June 30, 2014:
Calendar Years
|
|
Future Lease Expense
|
|
2014 (Six months)
|
|
$
|
60,737
|
|
2015
|
|
|
28,881
|
|
2016
|
|
|
---
|
|
2017
|
|
|
---
|
|
2018
|
|
|
---
|
|
Total
|
|
$
|
89,618
|
|
Rent expense for our operating leases amounted to $30,446 and $30,014 for the three months ended June 30, 2014 and 2013, respectively, and $60,826 and $55,042 for the six months ended June 30, 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 six months ended June 30, 2014 and 2013, the Company recorded product sales, in approximate numbers, of $244,000 and $71,000, respectively, with the various Altrazeal Distributors, which represented approximately 78% and 54% of our total revenues.
As of June 30, 2014 and December 31, 2013, Altrazeal Distributors had an outstanding accounts receivable, in approximate numbers, of $424,000 and $174,000, respectively, which represented approximately 99% and 97% of our gross 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 June 30, 2014, the following table summarizes the compensation temporarily deferred and subsequent repayments:
Name
|
|
2014
|
|
|
2013
|
|
|
2012
|
|
|
2011
|
|
|
Total
|
|
Kerry P. Gray
(1) (2)
|
|
$
|
(257,500
|
)
|
|
$
|
(91,000
|
)
|
|
$
|
220,673
|
|
|
$
|
140,313
|
|
|
$
|
12,486
|
|
Terrance K. Wallberg
|
|
|
(25,000
|
)
|
|
|
(35,769
|
)
|
|
$
|
24,230
|
|
|
$
|
36,539
|
|
|
|
---
|
|
Key executives
|
|
|
(28,239
|
)
|
|
|
(20,000
|
)
|
|
$
|
27,253
|
|
|
$
|
20,986
|
|
|
|
---
|
|
Total
|
|
$
|
(310,739
|
)
|
|
$
|
(146,769
|
)
|
|
$
|
272,156
|
|
|
$
|
197,838
|
|
|
$
|
12,486
|
|
|
(1)
|
During 2014, Mr. Gray was repaid $257,500 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 June 30, 2014 and December 31, 2013, the Company’s obligation for temporarily deferred compensation was $12,486 which 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 June 30, 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
|
On July 28, 2014, we issued 115,741 shares of Common Stock to Mr. Gray for the conversion and final payment of $125,000 due under the July 2011 Note and remitted to Mr. Gray the annual interest due on July 28, 2014 of $13,457.