x
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ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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For the fiscal year ended December 31, 2015
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OR
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o
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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For the transition period from to
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Commission File No. 001-336180
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Nevada
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41-2118656
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(State or other jurisdiction of incorporation or organization)
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(I.R.S. Employer Identification No.)
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4452 Beltway Drive
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||
Addison, Texas
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75001
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(Address of principal executive offices)
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(Zip Code)
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Large accelerated filer o
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Accelerated filer o
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Non-accelerated filer o
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Smaller reporting company x
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ULURU Inc.
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FORM 10-K
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||
FOR THE YEAR ENDED DECEMBER 31, 2015
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Item
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Page
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|
ITEM 1.
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BUSINESS
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§
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Establish a market leadership position in wound management by developing and commercializing a customer focused portfolio of innovative wound care products based on our Nanoflex® technology to treat the various phases of wound healing; and
|
§
|
Develop our oral mucoadhesive film technology (OraDiscTM) for systemic drug delivery and for delivery of actives to the oral cavity.
|
§
|
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 in September 2008, the product is indicated for both exuding acute wounds such as partial thickness burns, donor sites, non-healing surgical wounds, and trauma and for chronic wounds such as venous leg ulcers, diabetic foot ulcers, and pressure ulcers;
|
§
|
Aphthasol® is a drug approved by the FDA for the treatment of canker sores; and
|
§
|
OraDisc™ A was developed as an improved drug delivery system for the treatment of canker sores.
|
§
|
We have embarked on a plan to consolidate operations of disparate affiliates to remove inefficiency and align interests;
|
§
|
We completed the acquisition of the European, Middle East and Australian marketing and distribution rights for Altrazeal® from Altrazeal Trading GmbH and IPMD GmbH;
|
§
|
We have determined that creating a product roadmap with line extensions is necessary to respond to market interest in Altrazeal®;
|
§
|
We have implemented a plan to restructure our operations to improve efficiency and reduce cost, including production, distribution, and administration costs;
|
§
|
We are undertaking efforts to stimulate sales and enhance marketing; and
|
§
|
We have developed a new plan to streamline regulatory activity to expedite new market entry.
|
§
|
Nanoflex® Powder
|
§
|
Nanoflex® Injectable Liquid
|
Altrazeal®
|
|||
ULURU and various sub-distribution agreements acquired from Altrazeal Trading GmbH
|
§
|
European Union, Australia, New Zealand, Middle East (excluding Jordan and Syria), North Africa, Albania, Bosnia, Croatia, Kosovo, Macedonia, Montenegro, and Serbia
|
|
Altrazeal AG
|
§
|
Africa (markets not already licensed), Latin America, Georgia, Ukraine, Turkmenistan, the Commonwealth of Independent States, Jordan, Syria, Afghanistan, Russia, Asia and the Pacific (excluding China, Hong Kong, Macau, Taiwan, South Korea, Japan, Australia, and New Zealand)
|
|
Jiangxi Aiqilin Pharmaceuticals Group
|
§
|
China, Hong Kong, Macau, and Taiwan
|
Nanoflex® technology - Veterinary
|
|||
Novartis Animal Health
|
§
|
Worldwide
|
Amlexanox 5% paste and OraDisc™ A
|
|||
ORADISC GmbH
|
§
|
Worldwide (excluding territories held by Meda AB, KunWha Pharmaceutical, Laboratories del Dr. Esteve SA, Orient Europharma, Co., Ltd., and Pharmascience Inc.)
|
|
Meda AB
|
§
|
United Kingdom, Ireland, Belgium, France, Germany, Italy, Luxembourg, Netherlands, Switzerland, Austria, Bulgaria, Cyprus, Czech Republic, Hungary, Malta, Poland, Romania, Slovenia, Slovakia, Turkey, Denmark, Sweden, Norway, Finland, Estonia, Lithuania, Latvia, Russia, and nine other CIS markets
|
|
KunWha Pharmaceutical
|
§
|
South Korea
|
|
Laboratories del Dr. Esteve SA
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§
|
Spain, Portugal, Greece, and Andorra
|
|
Orient Europharma, Co., Ltd.
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§
|
Taiwan and Hong-Kong
|
|
Pharmascience Inc.
|
§
|
Canada
|
OraDisc™ B
|
|||
ORADISC GmbH
|
§
|
Worldwide
|
Nanoflex® technology
|
Year of Expiration
|
||
§
|
Hydrogel – Shape retentive hydrogel particle aggregate
|
2022
|
|
§
|
Altrazeal® Injectable
|
2024
|
|
§
|
Altrazeal® wound dressing and biomaterials
|
2026
|
|
OraDisc™ technology
|
|||
§
|
Mucoadhesive erodible drug delivery device
|
2021
|
Customers
|
Product
|
2015
|
2014
|
||||||
Customer A
|
Altrazeal®
|
58 | % | 80 | % | ||||
Customer B
|
Altrazeal®
|
18 | % | 11 | % | ||||
Total
|
76 | % | 91 | % |
§
|
Altrazeal® is been cleared or approved for sale in the U.S., the European Union (together with countries that recognize the CE mark), Australia, New Zealand, and a number of additional international markets;
|
§
|
Other Altrazeal® products are currently in development phases;
|
§
|
5% amlexanox paste is a product approved for sale in the U.S. (Aphthasol®), Canada and a number of EU countries, but not yet sold;
|
§
|
OraDisc™ A is a product approved for sale in the U.S.;
|
§
|
OraDisc™ B is a product under the classification as an OTC monograph product which is approved for sale in the U.S., and
|
§
|
Our other OraDisc™ products are currently in the development phase.
|
ITEM 1A.
|
RISK FACTORS
|
§
|
our commercial partners and licensees may not place the same priority on sales of our products as we do, may fail to honor contractual commitments, may not have the expertise, financial strength, marketing ability or other characteristics necessary to effectively market our products, may dedicate only limited resources to, and/or may abandon, marketing of a product for reasons, including reasons such as a shift in corporate focus, unrelated to our products’ merits;
|
§
|
our commercial partners may be in the early stages of development and may not have sufficient liquidity to effectively obtain approvals for and market our products consistent with contractual commitments or our expectations;
|
§
|
we may have disputes with our commercial partners, which may inhibit development, lead to an abandonment of our arrangements, lead to a protracted dispute or have other negative consequences;
|
§
|
our commercial partners may fail to honor the terms of our agreements with them, with respect to payment, compliance with law or other terms, which may lead to liquidity issues, reputational harm with end customers and other issues; and
|
§
|
even if the commercialization and marketing of products is successful, our revenue share may be limited and may not exceed our associated development and operating costs.
|
§
|
Third-party payers’ increasing challenges to the prices charged for medical products and services;
|
§
|
The trend toward managed health care in the Unites States and the concurrent growth of HMOs and similar organizations that can control or significantly influence the purchase of healthcare services and products;
|
§
|
The existence of government-managed health care or insurance programs in Europe and other nations, in which government agencies or committees have broad powers to approve or disapprove reimbursement and leverage to influence pricing; and
|
§
|
The Affordable Care Act and other proposals to reform healthcare or reduce government insurance programs.
|
§
|
some or all of our product candidates may be found to be unsafe or ineffective or otherwise fail to meet applicable regulatory standards or receive necessary regulatory clearances;
|
§
|
our product candidates, if safe and effective, may be too difficult to develop into commercially viable products;
|
§
|
it may be difficult to manufacture or market our product candidates on a large scale;
|
§
|
given our limited market presence, we may be unable, directly or indirectly through licensees, to effectively market and distribute our products or establish a strong brand;
|
§
|
proprietary rights of third parties may preclude us from marketing our product candidates; and
|
§
|
third parties may market superior or equivalent products.
|
§
|
Is priced under five dollars;
|
§
|
Is not traded on a national stock exchange, such as NASDAQ or the NYSE;
|
§
|
Is issued by a company that has less than $5 million in net tangible assets (if it has been in business less than three years) or has less than $2 million in net tangible assets (if it has been in business for at least three years); and
|
§
|
Is issued by a company that has average revenues of less than $6 million for the past three years.
|
§
|
Certain broker-dealers who recommend penny stock to persons other than established customers and accredited investors must make a special written suitability determination for the purchaser and receive the purchaser’s written agreement to a transaction prior to sale.
|
§
|
Prior to executing any transaction involving a penny stock, certain broker-dealers must deliver to certain purchasers a disclosure schedule explaining the risks involved in owning penny stock, the broker-dealer’s duties to the customer, a toll-free telephone number for inquiries about the broker-dealer’s disciplinary history and the customer’s rights and remedies in case of fraud or abuse in the sale.
|
§
|
In connection with the execution of any transaction involving a penny stock, certain broker-dealers must deliver to certain purchasers the following:
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· bid and offer price quotes and volume information;
|
|
· the broker-dealer’s compensation for the trade;
|
|
· the compensation received by certain salespersons for the trade;
|
|
· monthly accounts statements; and
|
|
§ a written statement of the customer’s financial situation and investment goals.
|
ITEM 1B.
|
UNRESOLVED STAFF COMMENTS
|
ITEM 2.
|
PROPERTIES
|
ITEM 3.
|
LEGAL PROCEEDINGS
|
ITEM 4.
|
MINE SAFETY DISCLOSURES
|
ITEM 5.
|
MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES
|
Year Ended December 31, 2015
|
High
|
Low
|
||||||
First Quarter
|
$ | 0.90 | $ | 0.70 | ||||
Second Quarter
|
$ | 0.75 | $ | 0.38 | ||||
Third Quarter
|
$ | 0.63 | $ | 0.27 | ||||
Fourth Quarter
|
$ | 0.38 | $ | 0.10 | ||||
Year Ended December 31, 2014
|
||||||||
First Quarter
|
$ | 1.80 | $ | 0.80 | ||||
Second Quarter
|
$ | 1.60 | $ | 0.89 | ||||
Third Quarter
|
$ | 1.35 | $ | 1.03 | ||||
Fourth Quarter
|
$ | 1.17 | $ | 0.81 | ||||
Plan Category
|
Number of securities to
be issued upon exercise
of outstanding options,
warrants and rights
|
Weighted-average
exercise price of
outstanding options,
warrants and rights
|
Number of securities
remaining available for
future issuance under
equity compensation
plans (excluding
securities reflected in
column (a))
|
|||||||||
(a)
|
(b)
|
(c)
|
||||||||||
Equity compensation plans approved by security holders
|
||||||||||||
2006 Equity Incentive Plan
|
1,664,573 | $ | 1.73 | 1,065,981 | ||||||||
Equity compensation plans not approved by security holders
|
-0- | n/a | -0- | |||||||||
Total
|
1,664,573 | $ | 1.73 | 1,065,981 |
ITEM 6.
|
SELECTED FINANCIAL DATA
|
ITEM 7.
|
MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
|
§
|
Establish a market leadership position in wound management by developing and commercializing a customer focused portfolio of innovative wound care products based on our Nanoflex® technology to treat the various phases of wound healing; and
|
§
|
Develop our oral mucoadhesive film technology (OraDiscTM) for systemic drug delivery and for delivery of actives to the oral cavity.
|
§
|
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 in September 2008, the product is indicated for both exuding acute wounds such as partial thickness burns, donor sites, non-healing surgical wounds, and trauma and for chronic wounds such as venous leg ulcers, diabetic foot ulcers, and pressure ulcers;
|
§
|
Aphthasol® is a drug approved by the FDA for the treatment of canker sores; and
|
§
|
OraDisc™ A was developed as an improved drug delivery system for the treatment of canker sores.
|
§
|
We have embarked on a plan to consolidate operations of disparate affiliates to remove inefficiency and align interests;
|
§
|
We completed the acquisition of the European, Middle East and Australian marketing and distribution rights for Altrazeal® from Altrazeal Trading GmbH and IPMD GmbH;
|
§
|
We have determined that creating a product roadmap with line extensions is necessary to respond to market interest in Altrazeal®;
|
§
|
We have implemented a plan to restructure our operations to improve efficiency and reduce cost, including production, distribution, and administration costs;
|
§
|
We are undertaking efforts to stimulate sales and enhance marketing; and
|
§
|
We have developed a new plan to streamline regulatory activity to expedite new market entry.
|
Year Ended December 31,
|
||||||||
Net Cash Provided by (Used in)
|
2015
|
2014
|
||||||
Operating activities
|
$ | (2,083,000 | ) | $ | (1,057,000 | ) | ||
Investing activities
|
(5,000 | ) | (31,000 | ) | ||||
Financing activities
|
1,718,000 | 1,633,000 | ||||||
Net increase in cash and cash equivalents
|
$ | 370,000 | $ | 545,000 |
§
|
our ability to successfully commercialize our wound management 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;
|
§
|
our ability to collect outstanding receivables;
|
§
|
the costs involved in filing, prosecuting and enforcing patent claims;
|
§
|
competing technological developments;
|
§
|
the trading volume and price of our capital stock;
|
§
|
the actions of parties whose consents, waivers or prompt responses are required for approval of a financing (such as parties with rights of first refusal or consent rights);
|
§
|
our general financial situation, including the amount of our indebtedness; and
|
§
|
the cost of manufacturing and production scale-up.
|
Payments Due By Period
|
||||||||||||||||||||
Contractual Obligations
|
Total
|
Less Than
1 Year
|
1-2
Years
|
3-5
Years
|
After 5
Years
|
|||||||||||||||
April 2015 Note
|
$ | 370,000 | $ | 370,000 | $ | --- | $ | --- | $ | --- | ||||||||||
Operating leases
|
$ | 268,538 | $ | 119,840 | $ | 148,698 | $ | --- | $ | --- | ||||||||||
Total contractual cash obligations
|
$ | 638,538 | $ | 489,840 | $ | 148,698 | $ | --- | $ | --- |
Year Ended December 31,
|
||||||||
Technology
|
2015
|
2014
|
||||||
Wound care & Nanoflex®
|
$ | 212,000 | $ | 276,000 | ||||
OraDisc™
|
15,000 | 15,000 | ||||||
Aphthasol® & other technologies
|
4,000 | 3,000 | ||||||
Total
|
$ | 231,000 | $ | 294,000 |
ITEM 7A.
|
QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
|
ITEM 8.
|
FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA
|
ITEM 9.
|
CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE
|
ITEM 9A.
|
CONTROLS AND PROCEDURES
|
§
|
Pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of our assets;
|
§
|
Provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with U.S. generally accepted accounting principles, and that our receipts and expenditures are being made only in accordance with authorizations of our management and directors; and
|
§
|
Provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use or disposition of our assets that could have a material effect on the financial statements.
|
ITEM 9B.
|
OTHER INFORMATION
|
ITEM 10.
|
DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE
|
Name
|
Age
|
Position
|
||
Bradley J. Sacks (1)(2)(3)(4)
|
48
|
Chairman
|
||
Robert F. Goldrich(2)(3)(4)
|
53
|
Director
|
||
Helmut Kerschbaumer (4)
|
54
|
Director, Interim President and Chief Executive Officer
|
||
Klaus Kuehne (3)
|
49
|
Director
|
||
Terrance K. Wallberg
|
61
|
Director, Vice President, Chief Financial Officer, Secretary, and, Treasurer
|
(1)
|
On November 19, 2015, Mr. Sacks was appointed to serve as the Company’s Chairman of the Board of Directors. Mr. Sacks has served as one of our Directors since July 2015.
|
(2)
|
Member of Audit Committee.
|
(3)
|
Member of Compensation Committee.
|
(4)
|
Member of Nominating and Governance Committee.
|
Director
|
Audit
Committee
|
Compensation
Committee
|
Nominating and Governance Committee
|
|||||
Bradley J. Sacks
|
Chair
|
XX
|
XX
|
|||||
Robert F. Goldrich
|
XX
|
Chair
|
Chair
|
|||||
Helmut Kerschbaumer
|
XX
|
|||||||
Klaus Kuehne
|
XX
|
ITEM 11.
|
EXECUTIVE COMPENSATION
|
Name and Principal Position
|
Fiscal
Year
|
Salary
($)
|
Bonus
($)
|
Stock Awards
($)
|
Option
Awards
($)(4)
|
Non Equity
Incentive Plan
Compensation
($)
|
All Other
Compensation
($)(5)
|
Total
($)
|
|||||||||||||||||||||
Helmut Kerschbaumer (1)
|
2015
|
--- | --- | --- | --- | --- | --- | --- | |||||||||||||||||||||
Interim President & Chief Executive Officer
|
2014
|
--- | --- | --- | 60,703 | --- | --- | 60,703 | |||||||||||||||||||||
Kerry P. Gray (2)
|
2015
|
319,606 | --- | --- | --- | --- | 1,028 | 320,634 | |||||||||||||||||||||
Former President & Chief Executive Officer
|
2014
|
335,000 | --- | --- | 202,344 | --- | 25,000 | 562,344 | |||||||||||||||||||||
Terrance K. Wallberg (3)
|
2015
|
200,000 | --- | --- | --- | --- | 7,870 | 207,870 | |||||||||||||||||||||
Vice President & Chief Financial Officer
|
2014
|
200,000 | --- | --- | 32,375 | --- | 10,328 | 242,703 |
(1)
|
On November 19, 2015, Mr. Kerschbaumer was appointed as the Company’s interim President and Chief Executive Officer and continues to serve as a director for the Company. Mr. Kerschbaumer is not party to an employment agreement regarding his service as an executive officer of the Company and is currently not compensated for such service.
|
|
(2)
|
On November 19, 2015, Mr. Gray resigned as the Company’s President and Chief Executive Officer and on February 18, 2016 resigned as a director for the Company. During 2015, Mr. Gray earned compensation of $319,606 which was composed of $133,523 for his duties as President and Chief Executive Officer and $186,083 for his duties as Chairman of the Executive Committee of the Company’s Board of Directors. As part of a plan to conserve the Company’s cash and financial resources during 2015, Mr. Gray temporarily deferred $275,153 of compensation which was composed of $51,770 earned as salary compensation for his duties as President and Chief Executive Officer, $186,083 for his duties as Chairman of the Executive Committee of the Company’s Board of Directors, and $37,300 as a temporary advance of working capital. During 2014, Mr. Gray earned compensation of $360,000 which was comprised of $25,000 pursuant to a Separation Agreement, $125,000 for his duties as President and Chief Executive Officer, and $210,000 for his duties as Chairman of the Executive Committee of the Company’s Board of Directors. As part of a plan to conserve the Company’s cash and financial resources during 2014, Mr. Gray temporarily deferred $150,000 of compensation which was composed of $62,500 earned as salary compensation for his duties as President and Chief Executive Officer and $87,500 for his duties as Chairman of the Executive Committee of the Company’s Board of Directors. During 2014, Mr. Gray was also repaid $269,986 of temporarily deferred compensation from prior years, of which $100,000 was used by Mr. Gray for funding required for certain equity purchases of our common stock.
|
|
(3)
|
|
During 2015, Mr. Wallberg earned salary compensation of $200,000 for his duties as Vice President and Chief Financial Officer. As part of a plan to conserve the Company’s cash and financial resources during 2015, Mr. Wallberg temporarily deferred $53,540 of salary compensation thereby receiving cash compensation of $146,460 for the year. During 2014, Mr. Wallberg earned salary compensation of $200,000 for his duties as Vice President and Chief Financial Officer. During 2014, Mr. Wallberg was also repaid $25,000 of temporarily deferred compensation from prior years, of which $10,000 was used by Mr. Wallberg for funding required for certain equity purchases of our common stock.
|
(4)
|
The amounts shown do not reflect compensation actually received by our named executive officers or the actual value that may be recognized by our named executive officers with respect to these awards in the future. Instead, the amounts in this column represent the Black-Scholes fair value on the date of grant for stock options awarded in 2015 and 2014. During 2015, we did not grant any stock option awards to our named executive officers. During 2014, we granted stock option awards to Messrs. Kerschbaumer, Gray, and Wallberg to purchase 75,000, 250,000, and 40,000 shares of common stock, respectively. The fair value on the date of grant for the stock option awards to Messrs. Kerschbaumer, Gray, and Wallberg was $60,703, $202,344, and $32,375, respectively. The stock option award to Mr. Kerschbaumer in 2014 was granted for his services as a director of the Company. For a description of the assumptions used to determine the grant date fair value of stock options granted in 2014, see Note 15 to the Company’s audited financial statements for the year ended December 31, 2014 included in this prospectus beginning on page F-1, except that, as required by SEC regulations, the amounts included herein do not reflect any assumed forfeitures.
|
|
(5)
|
All Other Compensation includes the following:
|
Name
|
Fiscal Year
|
401(k) Matching Contributions
|
Life and Disability Insurance
|
Separation
Agreement
|
Other
|
Total
|
|||||||||||||||
Helmut Kerschbaumer
|
2015
|
--- | --- | --- | --- | --- | |||||||||||||||
Kerry P. Gray
|
2015
|
--- | $ | 1,028 | --- | --- | $ | 1,028 | |||||||||||||
Terrance K. Wallberg
|
2015
|
$ | 5,858 | $ | 1,652 | --- | $ | 360 | $ | 7,870 | |||||||||||
Helmut Kerschbaumer
|
2014
|
--- | --- | --- | --- | --- | |||||||||||||||
Kerry P. Gray
|
2014
|
--- | --- | $ | 25,000 | --- | $ | 25,000 | |||||||||||||
Terrance K. Wallberg
|
2014
|
$ | 9,000 | $ | 968 | --- | $ | 360 | $ | 10,328 |
Estimated Future Payouts Under Non-Equity Incentive Plan Awards (1)
|
||||||||||||||||||||||||||||||||
Name
|
Grant Date
|
Threshold
($)
|
Target
($)
|
Maximum
($)
|
All Other Stock Awards: Number of Shares of Stock on Units (#)
|
All Other Option Awards: Number of Securities Underlying Options (#) (2)
|
Exercise or Base Price of Option Awards ($/Sh)
|
Grant Date Fair Value of Stock and Option Awards ($)(3)
|
||||||||||||||||||||||||
Helmut Kerschbaumer (4)
|
n/a | n/a | n/a | n/a | --- | --- | --- | --- | ||||||||||||||||||||||||
Kerry P. Gray (5)
|
n/a | n/a | n/a | n/a | --- | --- | --- | --- | ||||||||||||||||||||||||
Terrance K. Wallberg
|
n/a | $ | -0- | $ | 60,000 | $ | 120,000 | --- | --- | --- | --- |
(1)
|
|
The amounts shown reflect the range of possible bonuses payable in accordance with the Bonus Incentive Plan previously established by our Compensation Committee for our named executive officers. The amounts shown in the “threshold” column reflect the lowest amount payable under the plan in the event our Compensation Committee determined that no corporate or individual goals were met by the individual with respect to the year ended December 31, 2015. The amounts shown in each of the “target” and “maximum” columns reflect the amount payable under the plan with respect to each of the named executive officers for services rendered during the year ended December 31, 2015. For 2015, the “target” bonus percentage for Mr. Wallberg was 30% of base salary. The “maximum” bonus awards are capped at 200% of the “target” award opportunity.
|
(2)
|
|
During 2015, we did not grant any restricted stock awards to our named executive officers.
|
(3)
|
During 2015, we did not grant any stock option awards to our named executive officers.
|
|
(4)
|
On November 19, 2015, Mr. Kerschbaumer was appointed as the Company’s interim President and Chief Executive Officer and continues to serve as a director for the Company. During 2015, Mr. Kerschbaumer did not participate in the Company’s Incentive Bonus Plan.
|
|
(5)
|
On November 19, 2015, Mr. Gray resigned as the Company’s President and Chief Executive Officer and on February 18, 2016 resigned as a director for the Company. During 2015, Mr. Gray did not participate in the Company’s Incentive Bonus Plan.
|
Option Awards
|
Stock Awards
|
|||||||||||||||||||||
Name
|
Grant Date
|
Number of
Securities
Underlying
Unexercised
Options (#)
Exercisable
|
Number of
Securities
Underlying
Unexercised
Options (#)
Unexercisable (1)
|
Option Exercise Price per Share ($)
|
Option Expiration Date
|
Number of Shares or Units of Stock That Have Not Vested (#)
|
Market Value of Shares or Units of Stock That Have Not Vested ($)
|
|||||||||||||||
Helmut Kerschbaumer
|
03/20/13
|
100,000 | --- | $ | 0.33 |
03/20/2023
|
||||||||||||||||
09/25/14
|
37,500 | 37,500 | $ | 1.15 |
09/25/2024
|
|||||||||||||||||
Kerry P. Gray (2)
|
03/20/13
|
175,000 | 75,000 | $ | 0.33 |
03/20/2018
|
--- | --- | ||||||||||||||
09/25/14
|
--- | 250,000 | $ | 1.15 |
09/25/2019
|
--- | --- | |||||||||||||||
Terrance K. Wallberg
|
12/06/06
|
13,334 | --- | $ | 14.25 |
12/06/2016
|
--- | --- | ||||||||||||||
02/12/08
|
5,334 | --- | $ | 34.65 |
02/12/2018
|
--- | --- | |||||||||||||||
03/20/13
|
52,500 | 37,500 | $ | 0.33 |
03/20/2023
|
--- | --- | |||||||||||||||
09/25/14
|
--- | 40,000 | $ | 1.15 |
09/25/2024
|
--- | --- |
(1)
|
|
The unvested portion of stock option awards granted in 2014 and 2013 will become exercisable over a three year period with the vesting being determined upon a review and evaluation by the Company’s Compensation Committee of each employee’s contribution to the progress of the Company’s business plan. The stock option award for Mr. Gray expires five years from the date of grant and the stock option awards for Mr. Wallberg expire ten years from the date of grant. All other options are fully vested. The stock option award to Mr. Kerschbaumer in 2014 was granted for his services as a director of the Company and expires ten years from the date of grant.
|
(2)
|
On November 19, 2015, Mr. Gray resigned as the Company’s President and Chief Executive Officer and on February 18, 2016 resigned as a director for the Company. Due to Mr. Gray’s resignation, all of his stock option awards will be forfeited on May 11, 2016 unless exercised prior to such date.
|
§
|
annual compensation of $150,000 as President and Chief Executive Officer;
|
§
|
annual compensation of $210,000 as Chairman of the Executive Committee of the Board; and
|
§
|
stock options and restricted stock at the discretion of our Board.
|
§
|
a bonus payable in cash and common stock, with a target bonus of 30% of his base salary and a maximum bonus of 60% of his base salary, related to the attainment of reasonable performance goals specified by our Board (provided that since the Board has not specified performance goals, such bonus will be granted, or not granted, on a discretionary basis); and
|
§
|
stock options and restricted stock at the discretion of our Board.
|
Name
|
Severance Payment
Upon Termination (1)
|
Deferred Compensation
|
Vested Paid Time Off Benefits (2)
|
Total
|
||||||||||||
Helmut Kerschbaumer (3)
|
$ | --- | $ | --- | $ | --- | $ | --- | ||||||||
Kerry P. Gray (4)
|
$ | 12,500 | $ | 425,153 | $ | 15,865 | $ | 453,518 | ||||||||
Terrance K. Wallberg (5)
|
$ | 16,667 | $ | 53,540 | $ | 21,923 | $ | 92,130 |
(1)
|
|
Represents one month salary based on base salary as of December 31, 2015.
|
(2)
|
The Company maintains a paid-time-off benefit plan in lieu of vacation/holiday/sick benefits. The Table includes vested and unpaid benefits as of December 31, 2015.
|
|
(3)
|
|
On November 19, 2015, Mr. Kerschbaumer was appointed as the Company’s interim President and Chief Executive Officer and continues to serve as a director for the Company. Mr. Kerschbaumer is not party to an employment agreement regarding his service as an executive officer of the Company and is currently not compensated for such service.
|
(4)
|
On November 19, 2015, Mr. Gray resigned as the Company’s President and Chief Executive Officer and on February 18, 2016 resigned as a director for the Company. Mr. Gray is owed $114,270 from the temporary deferral of earned salary compensation, $273,583 of unpaid fees from his duties as Chairman of the Executive Committee of the Company’s Board of Directors, and $37,300 as a temporary advance of working capital.
|
|
(5)
|
During the year of 2015, Mr. Wallberg temporarily deferred certain portions of his compensation. As of December 31, 2015, Mr. Wallberg is owed $53,540.
|
Plan Category
|
Number of securities to
be issued upon exercise
of outstanding options,
warrants and rights
|
Weighted-average
exercise price of
outstanding options,
warrants and rights
|
Number of securities
remaining available for
future issuance under
equity compensation
plans (excluding
securities reflected in
column (a))
|
|||||||||
(a)
|
(b)
|
(c)
|
||||||||||
Equity compensation plans approved by security holders
|
||||||||||||
2006 Equity Incentive Plan
|
1,664,573 | $ | 1.73 | 1,065,981 | ||||||||
Equity compensation plans not approved by security holders
|
-0- | n/a | -0- | |||||||||
Total
|
1,664,573 | $ | 1.73 | 1,065,981 |
Name
|
Fee Earned or Paid in Cash
($)
|
Stock Awards
($)
|
Option
Awards
($)(1)
|
Non-Equity
Incentive Plan
Compensation
($)
|
All
Other
Compensation
($)
|
Total
|
||||||||||||||||||
Jeffrey B. Davis (2)
|
--- | --- | $ | --- | --- | --- | $ | --- | ||||||||||||||||
Robert F. Goldrich (3)
|
--- | --- | $ | --- | --- | --- | $ | --- | ||||||||||||||||
Klaus Kuehne
|
--- | --- | $ | --- | --- | --- | $ | --- | ||||||||||||||||
Bradley J. Sacks (4)
|
--- | --- | $ | --- | --- | --- | $ | --- |
(1)
|
|
The Board did not grant any stock option awards to the directors for their services during 2015.
|
|
(2)
|
|
Mr. Davis resigned as a director of the Company effective December 1, 2015.
|
|
(3)
|
|
Mr. Goldrich was appointed as a director of the Company on September 25, 2015.
|
|
(4)
|
|
Mr. Sacks was appointed as a director of the Company on July 20, 2015.
|
Option Awards
|
||||||||||||||||
Name
|
Number of
Securities
Underlying
Unexercised
Options (#)
Exercisable
|
Number of
Securities
Underlying
Unexercised
Options (#)
Unexercisable
|
Option
Exercise
Price
($)
|
Option
Expiration
Date
|
||||||||||||
Jeffrey B. Davis (1)
|
10,000 | --- | $ | 24.75 |
12/13/2016
|
|||||||||||
1,667 | --- | $ | 74.24 |
05/08/2017
|
||||||||||||
3,334 | --- | $ | 20.70 |
05/15/2018
|
||||||||||||
1,667 | --- | $ | 13.80 |
06/19/2018
|
||||||||||||
33,334 | --- | $ | 2.55 |
04/26/2020
|
||||||||||||
75,000 | --- | $ | 0.33 |
03/20/2023
|
||||||||||||
50,000 | 50,000 | $ | 1.15 |
09/25/2024
|
||||||||||||
Robert F. Goldrich
|
--- | --- | --- | --- | ||||||||||||
Klaus Kuehne
|
100,000 | --- | $ | 0.33 |
03/20/2023
|
|||||||||||
37,500 | 37,500 | $ | 1.15 |
09/25/2024
|
||||||||||||
Bradley J. Sacks
|
--- | --- | --- | --- |
(1)
|
|
Mr. Davis resigned as a director of the Company effective December 1, 2015. Due to Mr. Davis’s resignation, all of his stock option awards were forfeited on February 28, 2016.
|
ITEM 12.
|
SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS
|
Name and Address of Beneficial Owner
|
Number of Shares
Beneficially Owned
|
% of Class
|
||||||
5% or Greater Stockholders:
|
||||||||
IPMD Affiliate Group(1)(2)(6)
|
10,724,803 | 28.6 | % | |||||
Kerry P. Gray (3)(4)
|
2,444,641 | 6.5 | % | |||||
Michael I. Sacks (5)(6)
|
2,000,000 | 5.4 | % | |||||
Directors and Named Executive Officers:
|
||||||||
Robert F. Goldrich (7)
|
--- | --- | ||||||
Helmut Kerschbaumer (8)
|
156,250 | * | ||||||
Klaus Kuehne (9)
|
156,250 | * | ||||||
Bradley J. Sacks (10)
|
20,000 | * | ||||||
Terrance K. Wallberg, Chief Financial Officer, Vice President (11)
|
332,925 | * | ||||||
Directors and Executive Officers as a Group (5 persons) (12)
|
665,425 | 1.8 | % | |||||
* Less than 1% of the total outstanding common stock.
|
(1)
|
The IPMD Affiliate Group includes IPMD and Altrazeal Trading. The address for the IPMD Affiliate Group is Schreyvogelgasse 3/5, 1010 Wien, Vienna, Austria. IPMD has represented that voting and investment decisions are made by majority vote of a board or committee consisting of three persons. Altrazeal Trading GmbH has represented that voting and investment decisions are made by each of Helmut Kerschbaumer and Martin Egger, either of whom has voting and investment authority with respect to such shares.
|
(2)
|
Includes up to 520,438 shares of common stock issuable on exercise of warrants held directly by IPMD (209,525 shares) and indirectly by Altrazeal Trading (310,913 shares) that are currently exercisable or will become exercisable within 60 days of March 10, 2016.
|
(3)
|
Includes 669,722 shares of common stock issuable on exercise of warrants and 175,000 shares of common stock issuable on exercise of stock options that are currently exercisable or will become exercisable within 60 days of March 10, 2016.
|
(4)
|
Includes 50,000 shares held by Kerry P. Gray, Trustee for benefit of Michael J. Gray and 50,000 shares held by Kerry P. Gray, Trustee for benefit of Lindsay K. Gray. Mr. Gray disclaims beneficial ownership of such shares.
|
(5)
|
The address for M Sacks is 11th Floor, Sandton City Office Towers, Sandhurst, Ext 3, Sandton, 2196, South Africa. M Sacks is the father of Bradley J. Sacks (“B Sacks”). As disclosed in the Schedule 13D/A, filed by M Sacks with the Securities and Exchange Commission on July 29, 2015, M Sacks, B Sacks and Centric Capital Ventures LLC (“Centric”) may be deemed to be a “group” within the meaning of Rule 13d-5(b) under the Exchange Act, however, M Sacks disclaims any beneficial ownership in the shares of common stock beneficially owned by B Sacks and Centric. B Sacks and Centric disclaim any beneficial ownership in the shares of common stock beneficially owned by M Sacks.
|
(6)
|
IPMD is party to an Equalization Agreement, dated January 31, 2014, with M Sacks and The Punch Trust. Pursuant to the Equalization Agreement, IPMD is required to transfer a certain number of shares of Company common stock to M Sacks and The Punch Trust that IPMD related entities receive from certain strategic transactions involving such entities and the Company. Currently, the parties to the Equalization Agreement are evaluating their obligations thereunder, and any effect on beneficial ownership has not been reflected in the Table.
|
(7)
|
Includes nil shares of common stock issuable on exercise of stock options that are currently exercisable or will become exercisable within 60 days of March 10, 2016.
|
(8)
|
Includes 156,250 shares of common stock issuable on exercise of stock options that are currently exercisable or will become exercisable within 60 days of March 10, 2016.
|
(9)
|
Includes 156,250 shares of common stock issuable on exercise of stock options that are currently exercisable or will become exercisable within 60 days of March 10, 2016.
|
(10)
|
The address for Centric and B Sacks is 590 Madison Avenue, Floor 18, New York, NY 10022. B Sacks is the Managing Member of Centric and has sole voting and investment power with respect with to the common stock held by Centric. Includes nil shares of common stock issuable on exercise of stock options that are currently exercisable or will become exercisable within 60 days of March 10, 2016.
|
(11)
|
Includes 60,000 shares of common stock issuable on exercise of warrants and 148,668 shares of common stock issuable on exercise of stock options that are currently exercisable or will become exercisable within 60 days of March 10, 2016.
|
(12)
|
Includes 60,000 shares of common stock issuable on exercise of warrants, and 461,168 shares of common stock issuable on exercise of stock options that are currently exercisable or will become exercisable within 60 days of March 10, 2016.
|
ITEM 13.
|
CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS AND DIRECTOR INDEPENDENCE
|
Name
|
2015
|
2014
|
2013
|
2012
|
2011
|
Total
|
||||||||||||||||||
Kerry P. Gray (1) (2) (3)
|
$ | 275,153 | $ | (119,986 | ) | $ | (91,000 | ) | $ | 220,673 | $ | 140,313 | $ | 425,153 | ||||||||||
Terrance K. Wallberg
|
53,540 | (25,000 | ) | (35,769 | ) | 24,230 | 36,539 | 53,540 | ||||||||||||||||
Other employees
|
54,871 | --- | --- | --- | --- | 54,871 | ||||||||||||||||||
Total
|
$ | 383,564 | $ | (144,986 | ) | $ | (126,769 | ) | $ | 244,903 | $ | 176,852 | $ | 533,564 |
(1)
|
During 2015, Mr. Gray temporarily deferred compensation of $275,153 which consisted of $51,770 earned as salary compensation for his duties as President of the Company, $186,083 for his duties as Chairman of the Executive Committee of the Company’s Board of Directors, and $37,300 as a temporary advance of working capital.
|
(2)
|
During 2014, Mr. Gray temporarily deferred compensation of $150,000 which consisted of $62,500 earned as salary compensation for his duties as President of the Company and $87,500 for his duties as Chairman of the Executive Committee of the Company’s Board of Directors. During 2014, Mr. Gray was also repaid $269,986 of temporarily deferred compensation, of which $100,000 was used by Mr. Gray for funding required pursuant to the March 2013 Offering.
|
(3)
|
During 2013, Mr. Gray temporarily deferred compensation of $221,500 which consisted of $11,500 earned pursuant to a Separation Agreement and $210,000 for his duties as Chairman of the Executive Committee of the Company’s Board of Directors. During 2013, Mr. Gray was also repaid $312,500 of temporarily deferred compensation, of which $300,000 was used by Mr. Gray for funding required pursuant to the March 2013 Offering.
|
ITEM 14.
|
PRINCIPAL ACCOUNTANT FEES AND SERVICES
|
Years Ended December 31,
|
||||||||
Nature of Service
|
2015
|
2014
|
||||||
Audit fees (1)
|
$ | 51,000 | $ | 50,588 | ||||
Audit related fees (2)
|
$ | 22,993 | $ | 20,832 | ||||
Tax fees (3)
|
$ | --- | $ | --- | ||||
All other fees (4)
|
$ | 16,671 | $ | 2,803 |
(1)
|
Consists of fees billed for the audit of our annual financial statements, review of our Form 10-K, and services that are normally provided by the accountant in connection with year-end statutory and regulatory filings or engagements.
|
(2)
|
Consists of fees billed for the review of our quarterly financial statements, review of our Forms 10-Q and 8-K and services that are normally provided by the accountant in connection with non year end statutory and regulatory filings and engagements.
|
(3)
|
Consists of fees and professional services for tax compliance, tax advice, and tax planning. The Company does not use its principal accountants to provide tax services. McGuiness and Hodavance, CPA billed $1,500 and $1,500 for tax return preparation for 2015 and 2014, respectively.
|
(4)
|
The services provided by our principal accountants within this category consisted of advice and other services relating to SEC matters, registration statement review, internal controls, accounting issues and client conferences. The Company does not use its principal accountants to provide internal controls consulting. Saville, Dodgen and Company, PLLC billed $5,000 and $10,000 for internal controls consulting for 2015 and 2014, respectively.
|
ITEM 15.
|
EXHIBITS AND FINANCIAL STATEMENT SCHEDULES
|
(a)
|
The following documents are filed as part of this report:
|
||||
1.
|
Financial Statements
|
||||
Report of Independent Registered Public Accounting Firm
|
51
|
||||
Consolidated Balance Sheets as of December 31, 2015 and 2014
|
52
|
||||
Consolidated Statements of Operations for the years ended December 31, 2015 and 2014
|
53
|
||||
Consolidated Statements of Stockholders’ Equity for the years ended December 31, 2015 and 2014
|
54
|
||||
Consolidated Statements of Cash Flows for the years ended December 31, 2015 and 2014
|
55
|
||||
Notes to Consolidated Financial Statements
|
56
|
||||
2.
|
Financial Statement Schedules
|
||||
All other schedules are omitted because they are not applicable or because the required information is shown in the consolidated financial statements or the notes thereto.
|
|||||
3.
|
List of Exhibits
|
||||
The exhibits which are filed with this report or which are incorporated herein by reference are set forth in the Exhibit Index hereto.
In reviewing the agreements included as exhibits to this annual report on Form 10-K, please remember they are included to provide you with information regarding their terms and are not intended to provide any other factual or disclosure information about the Company or the other parties to the agreements. The agreements contain representations and warranties by each of the parties to the applicable agreement. These representations and warranties have been made solely for the benefit of the other parties to the applicable agreement and:
|
|||||
§
|
should not in all instances be treated as categorical statements of fact, but rather as a way of allocating the risk to one of the parties if those statements prove to be inaccurate;
|
||||
§
|
have been qualified by disclosures that were made to the other party in connection with the negotiation of the applicable agreement, which disclosures are not necessarily reflected in the agreement;
|
||||
§
|
may apply standards of materiality in a way that is different from what may be viewed as material to you or other investors; and
|
||||
§
|
were made only as of the date of the applicable agreement or such other date or dates as may be specified in the agreement and are subject to more recent developments. Accordingly, these representations and warranties may not describe the actual state of affairs as of the date they were made or at any other time.
|
||||
SIGNATURES
|
|||
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
|
|||
ULURU Inc.
|
|||
|
|
|
|
Date: March 30, 2016
|
By
|
/s/ Helmut Kerschbaumer
|
|
Helmut Kerschbaumer
|
|||
Interim Chief Executive Officer
|
|||
Principal Executive Officer
|
|||
Date: March 30, 2016
|
By
|
/s/ Terrance K. Wallberg
|
|
Terrance K. Wallberg
|
|||
Chief Financial Officer
|
|||
Principal Accounting Officer
|
|||
Date: March 30, 2016
|
/s/ Bradley J. Sacks
|
|
Bradley J. Sacks, Director
|
||
Date: March 30, 2016
|
/s/ Robert F. Goldrich
|
|
Robert F. Goldrich, Director
|
||
Date: March 30, 2016
|
/s/ Helmut Kerschbaumer
|
|
Helmut Kerschbaumer, Director
|
||
Date: March 30, 2016
|
/s/ Klaus Kuehne
|
|
Klaus Kuehne, Director
|
||
Date: March 30, 2016
|
/s/ Terrance K. Wallberg
|
|
Terrance K. Wallberg, Director
|
Exhibit
Number
|
Description of Document
|
||
2.1
|
Agreement and Plan of Merger and Reorganization dated October 12, 2005 by and among the Registrant, ULURU Acquisition Corp., and ULURU Delaware Inc. (1)
|
||
2.2.1
|
Asset Sale Agreement dated October 12, 2005 by and between ULURU Delaware Inc. and Access Pharmaceuticals, Inc. (3)
|
||
2.2.2
|
Amendment to Asset Sale Agreement dated December 8, 2006 by and between ULURU Delaware Inc. and Access Pharmaceuticals, Inc. (4)
|
||
3.1
|
Restated Articles of Incorporation dated November 5, 2007. (6)
|
||
3.2
|
Amended and Restated Bylaws dated December 5, 2008. (7)
|
||
3.3
|
Certificate of Designations of Series A Preferred Stock. (16)
|
||
4.1
|
Common Stock Purchase Warrants dated January 6, 2011 by and between ULURU Inc. and the purchasers’ party thereto. (14)
|
||
4.2
|
Common Stock Purchase Warrant dated June 13, 2011 by and between ULURU Inc. and Kerry P. Gray. (15)
|
||
4.3
|
Common Stock Purchase Warrant dated July 28, 2011 by and between ULURU Inc. and Kerry P. Gray. (16)
|
||
4.4
|
Common Stock Purchase Warrant dated June 27, 2012 by and between ULURU Inc. and Inter-Mountain Capital Corp. (19)
|
||
4.5
|
Common Stock Purchase Warrant dated December 21, 2012 by and between ULURU Inc. and IPMD GmbH (21)
|
||
4.6
|
Common Stock Purchase Warrant dated March 14, 2013 by and between ULURU Inc. and Kerry P. Gray. (22)
|
||
4.7
|
Common Stock Purchase Warrant dated March 14, 2013 by and between ULURU Inc. and Terrance K. Wallberg. (22)
|
||
4.8
|
Common Stock Purchase Warrant dated March 6, 2014 by and between ULURU Inc. and San Diego Torrey Hills Capital, Inc. (27)
|
||
4.9
|
Warrant to Purchase Shares of Common Stock dated April 14, 2015 by and between ULURU Inc. and Inter-Mountain Capital Corp. (30)
|
||
4.10
|
Common Stock Purchase Warrant dated December 24, 2015 by and between ULURU Inc. and Altrazeal Trading GmbH. (37)
|
||
4.11
|
Common Stock Purchase Warrant dated December 24, 2015 by and between ULURU Inc. and IPMD GmbH. (37)
|
||
10.1
|
Patent Assignment Agreement dated October 12, 2005 by and between ULURU Delaware Inc. and Access Pharmaceuticals, Inc. (3)
|
||
10.2
|
License Agreement dated October 12, 2005 by and between ULURU Delaware Inc. and Access Pharmaceuticals, Inc. (3)
|
||
10.3.1
|
Lease Agreement dated January 31, 2006 by and between ULURU Delaware Inc. and Addison Park Ltd. (3)
|
||
10.3.2
|
Amendment to Lease Agreement dated February 22, 2013 by and ULURU Delaware Inc. and Addison Park Ltd. (26)
|
||
10.3.3
|
Second Amendment to Lease Agreement dated March 17, 2015 by and ULURU Delaware Inc. and Addison Park Ltd. (29)
|
||
10.4
|
License Agreement dated August 14, 1998 by and between ULURU Delaware Inc. and Strakan Ltd. (3)
|
||
10.5
|
*
|
ULURU Inc. 2006 Equity Incentive Plan. (2)
|
|
10.5.1
|
*
|
First Amendment to the ULURU Inc. 2006 Equity Incentive Plan dated May 8, 2007. (5)
|
|
10.5.2
|
*
|
Second Amendment to the ULURU Inc. 2006 Equity Incentive Plan dated December 17, 2009. (11)
|
|
10.5.3
|
*
|
Third Amendment to the ULURU Inc. 2006 Equity Incentive Plan dated June 10, 2010. (12)
|
|
10.5.4
|
*
|
Fourth Amendment to the ULURU Inc. 2006 Equity Incentive Plan dated June 14, 2012. (18)
|
|
10.5.5
|
*
|
Fifth Amendment to the ULURU Inc. 2006 Equity Incentive Plan dated June 13, 2013. (24)
|
|
10.5.6
|
*
|
Sixth Amendment to the ULURU Inc. 2006 Equity Incentive Plan dated June 5, 2014. (28)
|
|
10.6
|
License and Supply Agreement dated November 17, 2008 by and between ULURU Inc. and Meda AB. (8)
|
||
10.7
|
*
|
Indemnification Agreement dated July 10, 2009 by and between ULURU Inc. and Kerry P. Gray (9)
|
|
10.8
|
*
|
Indemnification Agreement dated July 13, 2009 by and between ULURU Inc. and Terrance K. Wallberg. (10)
|
|
10.9
|
Acquisition and Licensing Agreement dated June 25, 2010 by and between ULURU Inc., Strakan International Limited and Zindaclin Limited. (13)
|
||
10.10.1
|
Shareholders’ Agreement dated January 11, 2012 by and between ULURU Inc. and Melmed Holding AG. (17)
|
||
10.10.2
|
Amendment to Shareholders’ Agreement dated February 1, 2014 by and between ULURU Inc. and Melmed Holding AG. (26)
|
||
10.11.1
|
License and Supply Agreement dated January 11, 2012 by and between ULURU Inc. and Melmed Holding AG. (17)
|
||
10.11.2
|
Amendment No. 1 to License and Supply Agreement dated December 21, 2012 by and between ULURU Inc. and Melmed Holding AG. (23)
|
||
10.11.3
|
Amendment No. 2 to License and Supply Agreement dated December 21, 2012 by and between ULURU Inc. and Melmed Holding AG. (26)
|
||
10.11.4
|
Amendment No. 3 to License and Supply Agreement dated February 2, 2014 by and between ULURU Inc. and Melmed Holding AG. (26)
|
||
10.12
|
Binding Term Sheet dated September 20, 2012 by and between ULURU Inc. and Regenertec Invest GmbH. (20)
|
||
10.13
|
Shareholders’ Agreement dated October 19, 2012 by and between ULURU Inc. and ORADISC GmbH. (23)
|
||
10.14
|
License and Supply Agreement dated October 19, 2012 by and between ULURU Inc. and ORADISC GmbH. (23)
|
||
10.15
|
Securities Purchase Agreement dated December 21, 2012 by and between ULURU Inc. and IPMD GmbH. (21)
|
||
10.16
|
Securities Purchase Agreement dated March 14, 2013 by and between ULURU Inc. and the purchasers’ party thereto. (22)
|
||
10.17.1
|
Exclusive License and Supply Agreement dated September 30, 2013 by and between ULURU Inc. and Altrazeal AG. (25)
|
||
10.17.2
|
Amendment No. 1 to Exclusive License and Supply Agreement dated February 1, 2014 by and between ULURU Inc. and Altrazeal AG. (26)
|
||
10.18
|
Registration Rights Agreement dated January 31, 2014 by and between ULURU Inc. and the investors’ party thereto. (26)
|
||
10.19
|
Shareholders’ Agreement dated February 1, 2014 by and between ULURU Inc. and Altrazeal AG. (26)
|
||
10.20.1
|
Promissory Note dated April 14, 2015 by and between ULURU Inc. and Inter-Mountain Capital Corp. (30)
|
||
10.20.2
|
Waiver Agreement dated January 11, 2016 by and between ULURU Inc. and Inter-Mountain Capital Corp. (38)
|
||
10.21
|
Securities Purchase Agreement dated April 14, 2015 by and between ULURU Inc. and Inter-Mountain Capital Corp. (30)
|
||
10.22
|
Registration Rights Agreement dated April 14, 2015 by and between ULURU Inc. and Inter-Mountain Capital Corp. (30)
|
||
10.23.1
|
Binding Term Sheet dated May 12, 2015 by and between ULURU Inc., IPMD GmbH, and Firnron Ltd. (31)
|
||
10.23.2
|
Amendment to the Binding Term Sheet dated July 13, 2015 by and between ULURU Inc. and IPMD GmbH. (35)
|
||
10.24
|
Indemnification Agreement dated July 27, 2015 by and between ULURU Inc. and Bradley J. Sacks. (32)
|
||
10.25
|
Securities Purchase Agreement dated August 31, 2015 and executed on September 6, 2015 by and between ULURU Inc. and the purchasers’ party thereto. (34)
|
||
10.26
|
Registration Rights Agreement dated August 31, 2015 and executed on September 6, 2015 by and between ULURU Inc. and the parties thereto. (33)
|
||
10.27
|
*
|
Indemnification Agreement dated September 25, 2015 by and between ULURU Inc. and Robert F. Goldrich. (36)
|
|
10.28
|
*
|
Indemnification Agreement dated January 17, 2013 by and between ULURU Inc. and Helmut Kerschbaumer. (36)
|
|
10.29
|
*
|
Indemnification Agreement dated January 17, 2013 by and between ULURU Inc. and Klaus Kuehne. (36)
|
|
10.30
|
License Purchase and Termination Agreement, dated December 24, 2015, by and between ULURU Inc., Altrazeal Trading GmbH, and IPMD GmbH. (37)
|
||
101
|
***
|
The following financial statements are from ULURU Inc.’s Annual Report on Form 10-K for the year ended December 31, 2015, formatted in XBRL (eXtensible Business Reporting Language): (i) Consolidated Balance Sheets; (ii) Consolidated Statements of Operations; (iii) Consolidated Statements of Cash Flows; and (iv) Notes to Consolidated Financial Statements.
|
|
-----------------------------------------
|
|||
(1)
|
Incorporated by reference to the Company’s Current Report on Form 8-K filed on October 18, 2005.
|
||
(2)
|
Incorporated by reference to the Company’s Definitive Schedule 14C filed on March 1, 2006.
|
||
(3)
|
Incorporated by reference to the Company’s Form 8-K filed on March 31, 2006.
|
||
(4)
|
Incorporated by reference to the Company’s Form SB-2 Registration Statement filed on December 15, 2006.
|
||
(5)
|
Incorporated by reference to the Company’s Form S-8 Registration Statement filed on May 30, 2007.
|
||
(6)
|
Incorporated by reference to the Company’s Form 8-K filed on November 6, 2007.
|
||
(7)
|
Incorporated by reference to the Company’s Form 8-K filed on December 11, 2008.
|
||
(8)
|
Incorporated by reference to the Company’s Form 10-K filed on March 30, 2009.
|
||
(9)
|
Incorporated by reference to the Company’s Form 8-K filed on July 10, 2009.
|
||
(10)
|
Incorporated by reference to the Company’s Form 8-K filed on July 14, 2009.
|
||
(11)
|
Incorporated by reference to the Company’s Form S-8 Registration Statement filed on January 28, 2010.
|
||
(12)
|
Incorporated by reference to the Company’s Form S-8 Registration Statement filed on July 16, 2010.
|
||
(13)
|
Incorporated by reference to the Company’s Form 10-Q filed on August 16, 2010.
|
||
(14)
|
Incorporated by reference to the Company’s Form 8-K filed on January 4, 2011.
|
||
(15)
|
Incorporated by reference to the Company’s Form 8-K filed on June 14, 2011.
|
||
(16)
|
Incorporated by reference to the Company’s Form 8-K filed on August 1, 2011.
|
||
(17)
|
Incorporated by reference to the Company’s Form 10-K filed on March 30, 2012.
|
||
(18)
|
Incorporated by reference to the Company’s Form S-8 Registration Statement filed on June 28, 2012.
|
||
(19)
|
Incorporated by reference to the Company’s Form 8-K filed on July 3, 2012.
|
||
(20)
|
Incorporated by reference to the Company’s Form 10-Q filed on November 14, 2012.
|
||
(21)
|
Incorporated by reference to the Company’s Form 8-K filed on December 27, 2012.
|
||
(22)
|
Incorporated by reference to the Company’s Form 8-K filed on March 15, 2013.
|
||
(23)
|
Incorporated by reference to the Company’s Form 10-K filed on March 29, 2013.
|
||
(24)
|
Incorporated by reference to the Company’s Form S-8 Registration Statement filed on June 28, 2013.
|
||
(25)
|
Incorporated by reference to the Company’s Form 10-Q filed on November 14, 2013.
|
||
(26)
|
Incorporated by reference to the Company’s Form 10-K filed on March 31, 2014.
|
||
(27)
|
Incorporated by reference to the Company’s Form 10-Q filed on May 15, 2014.
|
||
(28)
|
Incorporated by reference to the Company’s Form S-8 Registration Statement filed on June 16, 2014.
|
||
(29)
|
Incorporated by reference to the Company’s Form 10-K filed on April 1, 2015.
|
||
(30)
|
Incorporated by reference to the Company’s Form 8-K filed on April 17, 2015.
|
||
(31)
|
Incorporated by reference to the Company’s Form S-1 Registration Statement filed on May 13, 2015.
|
||
(32)
|
Incorporated by reference to the Company’s Form 10-Q filed on August 14, 2015.
|
||
(33)
|
Incorporated by reference to the Company’s Form 8-K filed on September 11, 2015.
|
||
(34)
|
Incorporated by reference to the Company’s Form 8-K/A filed on September 25, 2015.
|
||
(35)
|
Incorporated by reference to the Company’s Form S-1 Registration Statement filed on September 25, 2015.
|
||
(36)
|
Incorporated by reference to the Company’s Form 10-Q filed on November 16, 2015.
|
||
(37)
|
Incorporated by reference to the Company’s Form 8-K filed on December 28, 2015.
|
||
(38)
|
Incorporated by reference to the Company’s Form 8-K filed on January 12, 2016.
|
||
*
|
Management contract or compensation plan arrangements.
|
||
**
|
Filed herewith.
|
||
***
|
Pursuant to Rule 406T of Regulation S-T, the XBRL-related information in Exhibit 101 to this Annual Report on Form 10-K 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.
|
INDEX TO FINANCIAL STATEMENTS
|
||
Page
|
||
Financial Statements
|
||
December 31,
|
||||||||
2015
|
2014
|
|||||||
ASSETS
|
||||||||
Current Assets
|
||||||||
Cash and cash equivalents
|
$ | 180,000 | $ | 550,458 | ||||
Accounts receivable, net
|
89,378 | 3,879 | ||||||
Accounts receivable – related party, net
|
2,805 | 798,147 | ||||||
Inventory
|
531,421 | 325,657 | ||||||
Prepaid expenses and deferred charges
|
123,201 | 137,858 | ||||||
Total Current Assets
|
926,805 | 1,815,999 | ||||||
Property, Equipment and Leasehold Improvements, net
|
257,417 | 432,110 | ||||||
Other Assets
|
||||||||
Intangible assets, net
|
2,720,541 | 3,195,689 | ||||||
Licensing rights, net
|
3,506,235 | --- | ||||||
Investment in unconsolidated subsidiary
|
--- | --- | ||||||
Deposits
|
18,069 | 18,069 | ||||||
Total Other Assets
|
6,244,845 | 3,213,758 | ||||||
TOTAL ASSETS
|
$ | 7,429,067 | $ | 5,461,867 | ||||
LIABILITIES AND STOCKHOLDERS' EQUITY
|
||||||||
Current Liabilities
|
||||||||
Accounts payable
|
$ | 1,780,197 | $ | 1,536,612 | ||||
Accrued liabilities
|
402,214 | 273,201 | ||||||
Promissory notes payable, net of unamortized debt discount and debt issuance costs, current portion
|
315,058 | --- | ||||||
Deferred revenue, current portion
|
42,934 | 58,959 | ||||||
Total Current Liabilities
|
2,540,403 | 1,868,772 | ||||||
Long Term Liabilities
|
||||||||
Deferred revenue, net of current portion
|
685,287 | 839,174 | ||||||
Total Long Term Liabilities
|
685,287 | 839,174 | ||||||
TOTAL LIABILITIES
|
3,225,690 | 2,707,946 | ||||||
COMMITMENTS AND CONTINGENCIES
|
--- | --- | ||||||
STOCKHOLDERS' EQUITY
|
||||||||
Preferred Stock – $0.001 par value; 20,000 shares authorized;
|
||||||||
Series A Preferred Stock, 1,000 shares designated; no shares issued and outstanding at December 31, 2015 and December 31, 2014, respectively
|
--- | --- | ||||||
Common Stock – $ 0.001 par value; 200,000,000 shares authorized;
|
||||||||
36,834,933 and 24,458,018 shares issued and outstanding at December 31, 2015 and December 31, 2014, respectively
|
36,835 | 24,458 | ||||||
Additional paid-in capital
|
60,426,915 | 56,289,882 | ||||||
Accumulated (deficit)
|
(56,260,373 | ) | (53,560,419 | ) | ||||
TOTAL STOCKHOLDERS’ EQUITY
|
4,203,377 | 2,753,921 | ||||||
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY
|
$ | 7,429,067 | $ | 5,461,867 | ||||
The accompanying notes are an integral part of these consolidated financial statements.
|
Years Ended December 31,
|
||||||||
2015
|
2014
|
|||||||
Revenues
|
||||||||
License fees
|
$ | 207,832 | $ | 58,959 | ||||
Royalty income
|
12,046 | 62,966 | ||||||
Product sales, net
|
715,861 | 741,932 | ||||||
Total Revenues
|
935,739 | 863,857 | ||||||
Costs and Expenses
|
||||||||
Cost of goods sold
|
271,310 | 511,943 | ||||||
Research and development
|
763,547 | 770,542 | ||||||
Selling, general and administrative
|
1,680,650 | 1,773,540 | ||||||
Amortization
|
481,419 | 475,148 | ||||||
Depreciation
|
180,480 | 237,388 | ||||||
Total Costs and Expenses
|
3,377,406 | 3,768,561 | ||||||
Operating (Loss)
|
(2,441,667 | ) | (2,904,704 | ) | ||||
Other Income (Expense)
|
||||||||
Interest and miscellaneous income
|
281 | 5,386 | ||||||
Interest expense
|
(178,914 | ) | (50,574 | ) | ||||
Equity in earnings (loss) of unconsolidated subsidiary
|
--- | --- | ||||||
Foreign currency transaction (loss)
|
(79,654 | ) | (53,867 | ) | ||||
Loss on early extinguishment of convertible note
|
--- | (135,078 | ) | |||||
Proceeds from litigation settlement
|
--- | 1,200,000 | ||||||
(Loss) Before Income Taxes
|
(2,699,954 | ) | (1,938,837 | ) | ||||
Income taxes
|
--- | --- | ||||||
Net (Loss)
|
$ | (2,699,954 | ) | $ | (1,938,837 | ) | ||
Basic and diluted net (loss) per common share
|
$ | (0.10 | ) | $ | (0.08 | ) | ||
Weighted average number of common shares outstanding
|
25,899,240 | 23,639,427 | ||||||
The accompanying notes are an integral part of these consolidated financial statements.
|
ULURU Inc.
|
||||||||||||||||||||
CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY
|
||||||||||||||||||||
Years Ended December 31, 2015 and 2014
|
||||||||||||||||||||
Common Stock
|
Additional Paid-in
|
Accumulated
|
Stockholders’
|
|||||||||||||||||
Shares Issued
|
Amount
|
Capital
|
(Deficit)
|
Equity
|
||||||||||||||||
Balance as of December 31, 2013
|
18,871,420 | $ | 18,872 | $ | 53,336,127 | $ | (51,621,582 | ) | $ | 1,733,417 | ||||||||||
Issuance of common stock and warrants in a private placement; net of funding raising costs
|
1,250,000 | 1,250 | 498,750 | --- | 500,000 | |||||||||||||||
Issuance of common stock and warrants in a private placement
|
275,000 | 275 | 109,725 | --- | 110,000 | |||||||||||||||
Issuance of common stock for principle and interest due on convertible note
|
911,690 | 912 | 318,180 | --- | 319,092 | |||||||||||||||
Loss on conversion of convertible note settled with common stock
|
--- | --- | (234,042 | ) | --- | (234,042 | ) | |||||||||||||
Issuance of common stock for principle due on convertible notes
|
232,408 | 232 | 264,768 | --- | 265,000 | |||||||||||||||
Issuance of common stock for services
|
67,500 | 67 | 64,283 | --- | 64,350 | |||||||||||||||
Cancellation of common stock issued for services
|
(150,000 | ) | (150 | ) | (86,850 | ) | --- | (87,000 | ) | |||||||||||
Issuance of common stock for exercise of warrant
|
3,000,000 | 3,000 | 1,797,000 | 1,800,000 | ||||||||||||||||
Warrants issued for services
|
--- | --- | 72,771 | --- | 72,771 | |||||||||||||||
Share-based compensation of employees
|
--- | --- | 27,667 | --- | 27,667 | |||||||||||||||
Share-based compensation of non-employees
|
--- | --- | 121,503 | --- | 121,503 | |||||||||||||||
Net (loss)
|
--- | --- | --- | (1,938,837 | ) | (1,938,837 | ) | |||||||||||||
Balance as of December 31, 2014
|
24,458,018 | $ | 24,458 | $ | 56,289,882 | $ | (53,560,419 | ) | $ | 2,753,921 | ||||||||||
Issuance of common stock in a private placement; net of fund raising costs ($198,423)
|
3,830,131 | 3,830 | 1,253,197 | --- | 1,257,027 | |||||||||||||||
Issuance of common stock and warrants for acquisition of licensing rights, net of offering costs ($32,000)
|
6,536,847 | 6,537 | 2,452,217 | --- | 2,458,754 | |||||||||||||||
Issuance of common stock for principle and interest due on promissory note
|
1,648,421 | 1,648 | 216,845 | --- | 218,493 | |||||||||||||||
Issuance of common stock for exercise of warrant – 361,516 shares for cashless exercise of warrant shares (392,857)principle and interest due on promissory note
|
361,516 | 362 | (362 | ) | --- | --- | ||||||||||||||
Issuance of stock warrant in connection with promissory note, net of fund raising costs ($17,493)
|
--- | --- | 51,643 | --- | 51,643 | |||||||||||||||
Offering costs adjustment – Series A preferred stock sale in 2011
|
--- | --- | 10,509 | --- | 10,509 | |||||||||||||||
Share-based compensation of employees
|
--- | --- | 50,277 | --- | 50,277 | |||||||||||||||
Share-based compensation of non-employees
|
--- | --- | 102,707 | --- | 102,707 | |||||||||||||||
Net (loss)
|
--- | --- | --- | (2,699,954 | ) | (2,699,954 | ) | |||||||||||||
Balance as of December 31, 2015
|
36,834,933 | $ | 36,835 | $ | 60,426,915 | $ | (56,260,373 | ) | $ | 4,203,377 | ||||||||||
The accompanying notes are an integral part of these consolidated financial statements.
|
Years Ended December 31,
|
||||||||
2015
|
2014
|
|||||||
OPERATING ACTIVITIES :
|
||||||||
Net (loss)
|
$ | (2,699,954 | ) | $ | (1,938,837 | ) | ||
Adjustments to reconcile net (loss) to net cash used in operating activities:
|
||||||||
Amortization of intangible assets
|
481,419 | 475,148 | ||||||
Depreciation
|
180,480 | 237,388 | ||||||
Share-based compensation for stock and options issued to employees
|
50,277 | 27,667 | ||||||
Share-based compensation for options issued to non-employees
|
102,707 | 121,503 | ||||||
Equity in earnings (loss) of unconsolidated subsidiary
|
--- | --- | ||||||
Amortization of debt discount on convertible notes
|
37,120 | (78,078 | ) | |||||
Amortization of deferred financing costs
|
27,073 | 7,309 | ||||||
Warrants issued (cancelled) for services
|
--- | 72,771 | ||||||
Common stock issued (cancelled) for services
|
--- | (22,650 | ) | |||||
Common stock issued for interest due on convertible note
|
38,493 | 2,063 | ||||||
Loss on early extinguishment of convertible note
|
--- | 135,078 | ||||||
Change in operating assets and liabilities:
|
||||||||
Accounts receivable
|
(506,335) | (616,948 | ) | |||||
Inventory
|
(205,764 | ) | 69,949 | |||||
Prepaid expenses and deferred charges
|
14,657 | (14,046 | ) | |||||
Notes receivable and accrued interest
|
--- | 777,710 | ||||||
Accounts payable
|
438,011 | (198,113 | ) | |||||
Accrued liabilities
|
129,013 | (42,762 | ) | |||||
Accrued interest
|
--- | (13,360 | ) | |||||
Deferred revenue
|
(169,912 | ) | (58,959 | ) | ||||
Total
|
617,239 | 881,670 | ||||||
Net Cash Used in Operating Activities
|
(2,082,715 | ) | (1,057,167 | ) | ||||
INVESTING ACTIVITIES :
|
||||||||
Purchase of property and equipment
|
(5,787 | ) | (30,884 | ) | ||||
Net Cash Used in Investing Activities
|
(5,787 | ) | (30,884 | ) | ||||
FINANCING ACTIVITIES :
|
||||||||
Proceeds from sale of common stock, net
|
1,257,027 | --- | ||||||
Proceeds from sale of common stock and warrants, net
|
--- | 610,000 | ||||||
Proceeds from exercise of warrant
|
--- | 1,800,000 | ||||||
Proceeds from issuance of promissory note and warrant, net
|
482,508 | --- | ||||||
Repayment of principle due on convertible notes
|
--- | (776,610 | ) | |||||
Temporary working capital advance from related party
|
220,000 | --- | ||||||
Repayment of temporary working capital advance from related party
|
(220,000 | ) | --- | |||||
Offering costs associated with acquisition of licensing rights
|
(32,000 | ) | ||||||
Offering cost adjustment – preferred stock sale in 2011
|
10,509 | --- | ||||||
Net Cash Provided by Financing Activities
|
1,718,044 | 1,633,390 | ||||||
Net Increase (Decrease) in Cash
|
(370,458 | ) | 545,339 | |||||
Cash, beginning of period
|
550,458 | 5,119 | ||||||
Cash, end of period
|
$ | 180,000 | $ | 550,458 | ||||
SUPPLEMENTAL CASH FLOW DISCLOSURE:
|
||||||||
Cash paid for interest
|
$ | 5,447 | $ | 30,775 | ||||
Non-cash investing and financing activities:
|
||||||||
Application of accounts receivable and accounts payable for the acquisition of licensing rights | $ | 1,021,752 | ||||||
Issuance of common stock for acquisition of licensing rights
|
$ | 2,490,754 | $ | --- | ||||
Issuance of common stock for principle due on promissory note
|
$ | 180,000 | $ | --- | ||||
Issuance of common stock for principle due on convertible notes
|
$ | --- | $ | 582,029 | ||||
The accompanying notes are an integral part of these consolidated financial statements.
|
NOTE 1.
|
COMPANY OVERVIEW AND BASIS OF PRESENTATION
|
•
|
the market price of our stock and the availability and cost of additional equity capital from existing and potential new investors;
|
•
|
general economic and industry conditions affecting the availability and cost of capital;
|
•
|
our financial condition, including its revenues, the amount of its indebtedness and its ability to control costs associated with its operations;
|
•
|
the costs of filing, prosecuting, defending and enforcing any patent claims and other intellectual property rights; and
|
•
|
the terms and conditions of our existing collaborative and licensing agreements.
|
NOTE 2.
|
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
|
Laboratory and manufacturing equipment
|
7 years
|
Computers, office equipment, and furniture
|
5 years
|
Computer software
|
3 years
|
Leasehold improvements
|
Lease term
|
NOTE 3.
|
THE EFFECT OF RECENTLY ISSUED ACCOUNTING STANDARDS
|
NOTE 4.
|
SEGMENT INFORMATION
|
Revenues
|
2015
|
%
|
2014
|
%
|
||||||||||||
Domestic
|
$ | 28,030 | 3 | % | $ | 37,465 | 4 | % | ||||||||
International
|
907,709 | 97 | % | 826,392 | 96 | % | ||||||||||
Total
|
$ | 935,739 | 100 | % | $ | 863,857 | 100 | % |
Customers
|
Product
|
2015
|
2014
|
||||||
Customer A
|
Altrazeal®
|
58 | % | 80 | % | ||||
Customer B
|
Altrazeal®
|
18 | % | 11 | % | ||||
Total
|
76 | % | 91 | % | |||||
NOTE 5.
|
INVENTORY
|
Inventory
|
2015
|
2014
|
||||||
Raw materials
|
$ | 38,037 | $ | 41,648 | ||||
Work-in-progress
|
485,123 | 271,571 | ||||||
Finished goods
|
8,261 | 12,438 | ||||||
Total
|
$ | 531,421 | $ | 325,657 |
NOTE 6.
|
PROPERTY, EQUIPMENT AND LEASEHOLD IMPROVEMENTS
|
Property, equipment and leasehold improvements
|
2015
|
2014
|
||||||
Laboratory equipment
|
$ | 424,888 | $ | 424,888 | ||||
Manufacturing equipment
|
1,604,894 | 1,599,894 | ||||||
Computers, office equipment, and furniture
|
153,865 | 153,078 | ||||||
Computer software
|
4,108 | 4,108 | ||||||
Leasehold improvements
|
95,841 | 95,841 | ||||||
2,283,596 | 2,277,809 | |||||||
Less: accumulated depreciation and amortization
|
(2,026,179 | ) | (1,845,699 | ) | ||||
Property, equipment and leasehold improvements, net
|
$ | 257,417 | $ | 432,110 |
NOTE 7.
|
INTANGIBLE ASSETS
|
Intangible assets
|
2015
|
2014
|
||||||
Patent - Amlexanox (Aphthasol®)
|
$ | 2,090,000 | $ | 2,090,000 | ||||
Patent - Amlexanox (OraDisc™ A)
|
6,873,080 | 6,873,080 | ||||||
Patent - OraDisc™
|
73,000 | 73,000 | ||||||
Patent - Hydrogel nanoparticle aggregate
|
589,858 | 589,858 | ||||||
9,625,938 | 9,625,938 | |||||||
Less: accumulated amortization
|
(6,905,397 | ) | (6,430,249 | ) | ||||
Intangible assets, net
|
$ | 2,720,541 | $ | 3,195,689 |
Calendar Years
|
Future Amortization
Expense
|
|||
2016
|
$ | 476,450 | ||
2017
|
475,148 | |||
2018
|
475,148 | |||
2019
|
475,148 | |||
2020
|
476,450 | |||
2021 & Beyond
|
342,197 | |||
Total
|
$ | 2,720,541 |
NOTE 8.
|
LICENSING RIGHTS
|
Licensing rights
|
2015
|
2014
|
||||||
European Union, Australia, New Zealand, Middle East (excluding Jordan and Syria), North Africa, Albania, Bosnia, Croatia, Kosovo, Macedonia, Montenegro, and Serbia.
|
$ | 3,512,506 | --- | |||||
Less: accumulated amortization
|
(6,271 | ) | --- | |||||
Licensing rights, net
|
$ | 3,506,235 | --- |
Calendar Years
|
Future Amortization
Expense
|
|||
2016
|
$ | 325,148 | ||
2017
|
325,148 | |||
2018
|
325,148 | |||
2019
|
325,148 | |||
2020
|
325,148 | |||
2021 & Beyond
|
1,880,495 | |||
Total
|
$ | 3,506,235 |
NOTE 9.
|
INVESTMENT IN UNCONSOLIDATED SUBSIDIARY
|
ORADISC GmbH
|
December 31, 2014
(Unaudited)
|
December 31, 2013
(Unaudited)
|
||||||
Balance sheet
|
||||||||
Total assets
|
$ | 237,726 | $ | 305,069 | ||||
Total liabilities
|
$ | 286,643 | $ | 302,572 | ||||
Total stockholders’ (deficit)/equity
|
$ | (48,917 | ) | $ | 2,497 | |||
Statement of operations
|
||||||||
Revenues
|
$ | --- | $ | --- | ||||
Net (loss)
|
$ | (47,450 | ) | $ | (34,671 | ) |
NOTE 10.
|
ACCRUED LIABILITIES
|
Accrued Liabilities
|
2015
|
2014
|
||||||
Accrued compensation/benefits
|
$ | 329,131 | $ | 96,795 | ||||
Accrued taxes – payroll
|
--- | 106,299 | ||||||
Accrued insurance payable
|
73,074 | 69,815 | ||||||
Product rebates/returns
|
9 | 13 | ||||||
Other
|
--- | 279 | ||||||
Total accrued liabilities
|
$ | 402,214 | $ | 273,201 |
NOTE 11.
|
CONVERTIBLE DEBT
|
As of December 31, 2015
|
||||||||||||||||||||||||||
Transaction
|
Initial
Principal
Amount
|
Interest
Rate
|
Maturity
Date
|
Conversion Price (1)
|
Principal
Balance (2)
|
Unamortized
Debt
Discount
|
Unamortized Debt Issuance Costs
|
Carrying
Value
|
||||||||||||||||||
April 2015 Note
|
$ | 550,000 | 10.0 | % |
08/12/2016
|
$ | 370,000 | $ | 32,015 | $ | 22,927 | $ | 315,058 | |||||||||||||
Total
|
$ | 550,000 | $ | 370,000 | $ | 32,015 | $ | 22,927 | $ | 315,058 |
(1)
|
As part of the April 2015 Note, at our option, subject to certain volume, price and other conditions, the monthly installments of principle and interest due under the April 2015 Note may be paid in whole, or in part, in cash or in Common Stock. If the monthly installments are paid in Common Stock, such shares being issued will be based on a price that is 80% of the average of the three lowest volume weighted average prices of the shares of Common Stock during the preceding twenty trading days. The percentage declines to 70% if the average of the three lowest volume weighted average prices of the shares of Common Stock during the preceding twenty trading days is less than $0.05 per share.
|
(2)
|
The principle balances due, as of December 31, 2015 does not include the $25,000 accommodation fee pursuant to the Waiver Agreement executed on January 11, 2016.
|
Payments Due By Period
|
||||||||||||||||||||||||
Transaction
|
Total
|
2016
|
2017
|
2018
|
2019
|
2020
|
||||||||||||||||||
April 2015 Note (1)
|
$ | 370,000 | $ | 370,000 | $ | --- | $ | --- | $ | --- | $ | --- | ||||||||||||
Total
|
$ | 370,000 | $ | 370,000 | $ | --- | $ | --- | $ | --- | $ | --- |
(1)
|
The payments due by period does not include the $25,000 accommodation fee pursuant to the Waiver Agreement executed on January 11, 2016.
|
NOTE 12.
|
EQUITY TRANSACTIONS
|
NOTE 13.
|
STOCKHOLDERS’ EQUITY
|
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
|
(69,050 | ) | 3.22 | |||||
Balance as of December 31, 2014
|
1,676,401 | $ | 1.14 | |||||
Warrants issued
|
847,804 | 0.72 | ||||||
Warrants exercised
|
(392,857 | ) | 0.35 | |||||
Warrants cancelled
|
(357,155 | ) | 2.85 | |||||
Balance as of December 31, 2015
|
1,774,193 | $ | 0.77 |
Date of Expiration
|
Number of Warrant Shares of Common Stock Subject to Expiration
|
|||
June 13, 2016
|
35,000 | |||
July 16, 2016
|
116,667 | |||
July 28, 2016
|
34,722 | |||
December 24, 2016
|
653,686 | |||
March 14, 2018
|
660,000 | |||
January 15, 2019
|
80,000 | |||
April 30, 2020
|
194,118 | |||
Total
|
1,774,193 |
NOTE 14.
|
EARNINGS PER SHARE
|
2015
|
2014
|
|||||||
Warrants to purchase Common Stock
|
1,774,193 | 1,676,401 | ||||||
Stock options to purchase common stock
|
1,664,573 | 1,699,907 | ||||||
Common stock issuable upon the assumed conversion of payments due under our promissory note from April 2015 (1)
|
1,934,718 | --- | ||||||
Total
|
5,373,484 | 3,376,308 |
(1)
|
As part of the April 2015 Note, at our option, subject to certain volume, price and other conditions, the monthly installments of principle and interest due under the April 2015 Note may be paid in whole, or in part, in cash or in Common Stock. If the monthly installments are paid in Common Stock, such shares being issued will be based on a price that is 80% of the average of the three lowest volume weighted average prices of the shares of Common Stock during the preceding twenty trading days. The percentage declines to 70% if the average of the three lowest volume weighted average prices of the shares of Common Stock during the preceding twenty trading days is less than $0.05 per share. For the purposes of this Table, we have assumed that all outstanding monthly installments of principal and interest will be paid in Common Stock based on a price of $0.10 per share (80% of the average of the three lowest volume weighted average prices of the shares of Common Stock during the preceding twenty trading days prior to December 31, 2015), subject to certain ownership limitations.
|
NOTE 15.
|
SHARE BASED COMPENSATION
|
2015
|
2014
|
|||||||
Incentive Stock Options (1)
|
||||||||
Quantity
|
--- | 125,000 | ||||||
Weighted average fair value per share
|
--- | $ | 0.81 | |||||
Fair value
|
--- | $ | 101,171 | |||||
Nonstatutory Stock Options (2)
|
||||||||
Quantity
|
--- | 560,000 | ||||||
Weighted average fair value per share
|
--- | $ | 0.81 | |||||
Fair value
|
--- | $ | 453,250 |
(1)
|
The Company did not award any incentive stock options for the year ended December 31, 2015.
|
(2)
|
The Company did not award any nonstatutory stock options for the year ended December 31, 2015.
|
2015
|
2014
|
|||||||
Incentive Stock Options
|
||||||||
Expected volatility (1)
|
--- | 107.66 | % | |||||
Risk-fee interest rate % (2)
|
--- | 1.75 | % | |||||
Expected term (in years)
|
--- | 5.0 | ||||||
Dividend yield (3)
|
--- | --- | ||||||
Nonstatutory Stock Options
|
||||||||
Expected volatility (1)
|
--- | 107.66 | % | |||||
Risk-fee interest rate % (2)
|
--- | 1.75 | % | |||||
Expected term (in years)
|
--- | 5.0 | ||||||
Dividend yield (3)
|
--- | --- |
(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.
|
2015
|
2014
|
|||||||
Research and development
|
$ | 69,028 | $ | 35,861 | ||||
Selling, general and administrative
|
83,956 | 113,309 | ||||||
Total share-based compensation expense
|
$ | 152,984 | $ | 149,170 |
Stock Options
|
Weighted Average Exercise Price per Share
|
|||||||
Outstanding as of December 31, 2013
|
1,014,907 | $ | 2.12 | |||||
Granted
|
685,000 | 1.15 | ||||||
Forfeited/cancelled
|
--- | --- | ||||||
Exercised
|
--- | --- | ||||||
Outstanding as of December 31, 2014
|
1,699,907 | $ | 1.73 | |||||
Granted
|
--- | --- | ||||||
Forfeited/cancelled
|
(35,334 | ) | 1.77 | |||||
Exercised
|
--- | --- | ||||||
Outstanding as of December 31, 2015
|
1,664,573 | $ | 1.73 |
Options Outstanding
|
Options Exercisable
|
|||||||||||||||||
Stock Options Outstanding
|
Weighted Average Exercise Price per Share
|
Weighted Average Remaining Contractual Life in Years
|
Stock Options Exercisable
|
Weighted Average Exercise Price per Share
|
||||||||||||||
882,500 | $ | 0.33 | 7.2 | 640,000 | $ | 0.33 | ||||||||||||
680,000 | 1.15 | 6.9 | 155,000 | 1.15 | ||||||||||||||
33,334 | 2.55 | 4.3 | 33,334 | 2.55 | ||||||||||||||
68,739 | 25.07 | 1.6 | 68,739 | 25.07 | ||||||||||||||
1,664,573 | $ | 1.73 | 6.8 | 897,073 | $ | 2.45 |
NOTE 16.
|
EMPLOYMENT BENEFIT PLAN
|
NOTE 17.
|
FAIR VALUE MEASUREMENTS
|
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.
|
Description
|
2015
|
2014
|
||||||
Liabilities:
|
||||||||
Promissory note – April 2015
|
$ | 370,000 | --- | |||||
NOTE 18.
|
INCOME TAXES
|
Calendar Years
|
Consolidated Operating Loss Carryforwards
|
Research Activities
Carryforwards
|
||||||
2021
|
$ | 34,248 | $ | --- | ||||
2023
|
95,666 | --- | ||||||
2024
|
910,800 | 13,584 | ||||||
2025
|
1,687,528 | 21,563 | ||||||
2026
|
11,950,281 | 60,797 | ||||||
2027
|
3,431,365 | 85,052 | ||||||
2028
|
8,824,940 | 139,753 | ||||||
2029
|
6,889,761 | 81,940 | ||||||
2030
|
5,113,583 | 41,096 | ||||||
2031
|
3,728,626 | 43,592 | ||||||
2032
|
3,695,792 | 8,690 | ||||||
2033
|
3,187,559 | 15,882 | ||||||
2034
|
1,797,031 | 19,491 | ||||||
2035
|
2,594,151 | 21,113 | ||||||
Total
|
$ | 53,941,331 | $ | 552,553 |
2015
|
2014
|
|||||||
Deferred tax assets:
|
||||||||
Net operating loss carryforwards
|
$ | 19,179,724 | $ | 18,279,724 | ||||
Intangible assets
|
132,836 | 188,944 | ||||||
Other
|
605,231 | 554,404 | ||||||
Total gross deferred tax assets
|
19,917,791 | 19,023,072 | ||||||
Deferred tax liabilities:
|
||||||||
Property and equipment
|
12,541 | 33,696 | ||||||
Total gross deferred tax liabilities
|
12,541 | 33,696 | ||||||
Net total of deferred assets and liabilities
|
19,905,250 | 18,989,376 | ||||||
Valuation allowance
|
(19,905,250 | ) | (18,989,376 | ) | ||||
Net deferred tax assets
|
$ | --- | $ | --- |
2015
|
2014
|
|||||||
Expected income tax (benefit) at federal statutory tax rate -35%
|
$ | ( 961,543 | ) | $ | ( 681,109 | ) | ||
Permanent differences
|
53,653 | 52,273 | ||||||
Research tax credits
|
(21,113 | ) | (19,491 | ) | ||||
Amortization of deferred start up costs
|
--- | --- | ||||||
Valuation allowance
|
929,003 | 648,327 | ||||||
Income tax expense
|
$ | --- | $ | --- |
NOTE 19.
|
COMMITMENTS AND CONTINGENCIES
|
Calendar Years
|
Future Lease Expense
|
|||
2016
|
$ | 119,840 | ||
2017
|
119,840 | |||
2018
|
28,858 | |||
2019
|
--- | |||
2020
|
--- | |||
Total
|
$ | 268,538 |
Name
|
2015
|
2014
|
2013
|
2012
|
2011
|
Total
|
||||||||||||||||||
Kerry P. Gray (1) (2) (3)
|
$ | 275,153 | $ | (119,986 | ) | $ | (91,000 | ) | $ | 220,673 | $ | 140,313 | $ | 425,153 | ||||||||||
Terrance K. Wallberg
|
53,540 | (25,000 | ) | (35,769 | ) | 24,230 | 36,539 | 53,540 | ||||||||||||||||
Other employees
|
54,871 | --- | --- | --- | --- | 54,871 | ||||||||||||||||||
Total
|
$ | 383,564 | $ | (144,986 | ) | $ | (126,769 | ) | $ | 244,903 | $ | 176,852 | $ | 533,564 |
(1)
|
During 2015, Mr. Gray temporarily deferred compensation of $275,153 which consisted of $51,770 earned as salary compensation for his duties as President of the Company, $186,083 for his duties as Chairman of the Executive Committee of the Company’s Board of Directors, and $37,300 as a temporary advance of working capital.
|
(2)
|
During 2014, Mr. Gray temporarily deferred compensation of $150,000 which consisted of $62,500 earned as salary compensation for his duties as President of the Company and $87,500 for his duties as Chairman of the Executive Committee of the Company’s Board of Directors. During 2014, Mr. Gray was also repaid $269,986 of temporarily deferred compensation, of which $100,000 was used by Mr. Gray for funding required pursuant to the March 2013 Offering.
|
(3)
|
During 2013, Mr. Gray temporarily deferred compensation of $221,500 which consisted of $11,500 earned pursuant to a Separation Agreement and $210,000 for his duties as Chairman of the Executive Committee of the Company’s Board of Directors. During 2013, Mr. Gray was also repaid $312,500 of temporarily deferred compensation, of which $300,000 was used by Mr. Gray for funding required pursuant to the March 2013 Offering.
|
NOTE 20.
|
LEGAL PROCEEDINGS
|
NOTE 21.
|
SUBSEQUENT EVENTS
|
Subsidiary
|
Jurisdiction of Incorporation
|
||
Cardinia Acquisition Corp.
|
Delaware
|
||
ULURU Delaware Inc.
|
Delaware
|
||
/s/ Lane Gorman Trubitt, PLLC
|
||
Lane Gorman Trubitt, PLLC
Dallas, Texas
March 31, 2016
|
1.
|
I have reviewed this Annual Report on Form 10-K of ULURU Inc.;
|
|
2.
|
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
|
|
3.
|
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
|
|
4.
|
The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f) for the registrant and have:
|
|
(a)
|
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
|
|
(b)
|
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
|
|
(c)
|
Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report, based on such evaluation; and
|
|
(d)
|
Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
|
|
5.
|
The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
|
|
(a)
|
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
|
|
(b)
|
Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
|
Date: March 30, 2016
|
/s/ Helmut Kerschbaumer
|
||
Helmut Kerschbaumer
|
|||
Interim President and Chief Executive Officer
|
|||
(Principal Executive Officer)
|
1.
|
I have reviewed this Annual Report on Form 10-K of ULURU Inc.;
|
|
2.
|
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
|
|
3.
|
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
|
|
4.
|
The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f) for the registrant and have:
|
|
(a)
|
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
|
|
(b)
|
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
|
|
(c)
|
Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report, based on such evaluation; and
|
|
(d)
|
Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
|
|
5.
|
The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
|
|
(a)
|
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
|
|
(b)
|
Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
|
Date: March 30, 2016
|
/s/ Terrance K. Wallberg
|
||
Terrance K. Wallberg
|
|||
Vice President and Chief Financial Officer
|
|||
(Principal Financial and Accounting Officer)
|
CERTIFICATION PURSUANT TO 18 U.S.C. SECTION 1350,
|
|
AS ADOPTED PURSUANT TO
|
|
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
|
|
This certification set forth below is hereby made solely for the purposes of satisfying the requirements of Section 906 of the Sarbanes-Oxley Act of 2002 and may not be relied upon or used for any other purposes.
A signed original of this written statement required by Section 906 has been provided to ULURU Inc. and will be retained by ULURU Inc. and furnished to the SEC or its staff upon its request.
Pursuant to Section 906 of the Public Company Accounting Reform and Investor Act of 2002 (18 U.S.C. 1350, as adopted, the “Sarbanes-Oxley Act”), Helmut Kerschbaumer, Interim President and Chief Executive Officer of ULURU Inc. (the “Company”), hereby certifies that to his knowledge the Annual Report on Form 10-K for the period ended December 31, 2015 of the Company filed with the Securities and Exchange Commission on the date hereof
|
|
1.
|
(the “Report”) fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934 and
|
2.
|
the information contained in the Report fairly presents, in all material respects, the financial condition and result of operations of the Company for the period specified
|
Date: March 30, 2016
|
By:
|
/s/ Helmut Kerschbaumer
|
|||
Name:
|
Helmut Kerschbaumer
|
||||
Title:
|
Interim President and Chief Executive Officer
|
CERTIFICATION PURSUANT TO 18 U.S.C. SECTION 1350,
|
|
AS ADOPTED PURSUANT TO
|
|
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
|
|
This certification set forth below is hereby made solely for the purposes of satisfying the requirements of Section 906 of the Sarbanes-Oxley Act of 2002 and may not be relied upon or used for any other purposes.
A signed original of this written statement required by Section 906 has been provided to ULURU Inc. and will be retained by ULURU Inc. and furnished to the SEC or its staff upon its request.
Pursuant to Section 906 of the Public Company Accounting Reform and Investor Act of 2002 (18 U.S.C. 1350, as adopted, the “Sarbanes-Oxley Act”),Terrance K. Wallberg, Vice President and Chief Financial Officer of ULURU Inc. (the “Company”), hereby certifies that to his knowledge the Annual Report on Form 10-K for the period ended December 31, 2015 of the Company filed with the Securities and Exchange Commission on the date hereof
|
|
1.
|
(the “Report”) fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934 and
|
2.
|
the information contained in the Report fairly presents, in all material respects, the financial condition and result of operations of the Company for the period specified
|
Date: March 30, 2016
|
By:
|
/s/ Terrance K. Wallberg
|
|||
Name:
|
Terrance K. Wallberg
|
||||
Title:
|
Vice President and Chief Financial Officer
|
Document and Entity Information - USD ($) |
12 Months Ended | ||
---|---|---|---|
Dec. 31, 2015 |
Mar. 30, 2016 |
Jun. 30, 2015 |
|
Entity Information [Line Items] | |||
Entity Registrant Name | ULURU Inc. | ||
Entity Central Index Key | 0001168220 | ||
Current Fiscal Year End Date | --12-31 | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
Entity Current Reporting Status | Yes | ||
Entity Filer Category | Smaller Reporting Company | ||
Entity Public Float | $ 5,659,000 | ||
Document Fiscal Year Focus | 2015 | ||
Document Fiscal Period Focus | FY | ||
Document Type | 10-K | ||
Amendment Flag | false | ||
Document Period End Date | Dec. 31, 2015 | ||
Common Stock [Member] | |||
Entity Information [Line Items] | |||
Entity Common Stock, Shares Outstanding | 37,728,989 | ||
Series A Preferred Stock [Member] | |||
Entity Information [Line Items] | |||
Entity Common Stock, Shares Outstanding | 0 |
CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares |
Dec. 31, 2015 |
Dec. 31, 2014 |
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STOCKHOLDERS' EQUITY | ||
Preferred stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized (in shares) | 20,000 | 20,000 |
Common stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Common stock, shares authorized (in shares) | 200,000,000 | 200,000,000 |
Common stock, shares issued (in shares) | 36,834,933 | 24,458,018 |
Common stock, shares outstanding (in shares) | 36,834,933 | 24,458,018 |
Preferred Stock [Member] | ||
STOCKHOLDERS' EQUITY | ||
Shares designated to Series A (in shares) | 1,000 | 1,000 |
Preferred stock, shares issued (in shares) | 0 | 0 |
Preferred stock, shares outstanding (in shares) | 0 | 0 |
CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY (Parenthetical) |
12 Months Ended |
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Dec. 31, 2015
USD ($)
shares
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Issuance of stock in a private placement, fund raising costs | $ (198,423) |
Issuance of stock for acquisition of licensing rights, offering costs | $ (32,000) |
Cashless exercise of warrants (in shares) | shares | 361,516 |
Issuance of common stock (in shares) | shares | (392,857) |
Issuance of stock warrant in connection with promissory note, fundraising costs | $ (17,493) |
COMPANY OVERVIEW AND BASIS OF PRESENTATION |
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COMPANY OVERVIEW AND BASIS OF PRESENTATION [Abstract] | |||||||||||||||||||||||
COMPANY OVERVIEW AND BASIS OF PRESENTATION |
Company Overview ULURU Inc. (hereinafter “we”, “our”, “us”, “ULURU”, or the “Company”) is a Nevada corporation. We are a specialty pharmaceutical company committed to developing and commercializing a range of innovative wound care and mucoadhesive 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 The accompanying consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United State of America (“U.S. GAAP”) and include the accounts of ULURU Inc., a Nevada corporation, and its wholly-owned subsidiary, ULURU Delaware Inc., a Delaware corporation. Both companies have a December 31 fiscal year end. The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, as well as disclosure of contingent assets and liabilities at the date of the financial statements, and the reported amounts of revenues and expenses during the reporting periods. Actual results may differ from those estimates and assumptions. These differences are usually minor and are included in our consolidated financial statements as soon as they are known. Our estimates, judgments, and assumptions are continually evaluated based on available information and experience. Because of the use of estimates inherent in the financial reporting process, actual results could differ from those estimates. All intercompany transactions and balances have been eliminated in consolidation. Liquidity and Going Concern The Company is unable to assert that its liquidity will be sufficient to fund operations through the second quarter of 2016, and as a result, there is substantial doubt about our ability to continue as a going concern through the second quarter of 2016. These consolidated financial statements have been prepared with the assumption that we will continue as a going concern and will be able to realize its assets and discharge its liabilities in the normal course of business and do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or the amounts and classification of liabilities that may result from the inability of the Company to continue as a going concern. We may not be able to raise sufficient capital on acceptable terms, or at all, to continue operations and may not be able to execute any strategic transaction. Our liquidity, and our ability to raise additional capital or complete any strategic transaction, depends on a number of factors, including, but not limited to, the following:
The sale of additional equity or convertible debt securities will likely result in substantial additional dilution to our stockholders. If we raise additional funds through the incurrence of indebtedness, the obligations related to such indebtedness would be senior to rights of holders of our capital stock and could contain covenants that would restrict our operations. We also cannot predict what consideration might be available, if any, to us or our stockholders, in connection with any strategic transaction. Should strategic alternatives or additional capital not be available to us in the near term, or not be available on acceptable terms, we may be unable to realize value from its assets and discharge its liabilities in the normal course of business which may, among other alternatives, cause us to further delay, substantially reduce or discontinue operational activities to conserve its cash resources. |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES |
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SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES [Abstract] | |||||||||||
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES |
The following is a summary of significant accounting policies used in the preparation of these consolidated financial statements: Cash and Cash Equivalents Cash and cash equivalents include highly liquid investments with original maturities of three months or less. The carrying value of these cash equivalents approximates fair value. We invest cash in excess of immediate requirements in money market accounts, certificates of deposit, corporate commercial paper with high quality ratings, and U.S. government securities taking into consideration the need for liquidity and capital preservation. These investments are not held for trading or other speculative purposes. Accounts Receivable and Allowance for Doubtful Accounts Accounts receivable are recorded at the invoiced amount and do not bear interest. We estimate the collectability of our accounts receivable. In order to assess the collectability of these receivables, we monitor the current creditworthiness of each customer and analyze the balances aged beyond the customer's credit terms. Theses evaluations may indicate a situation in which a certain customer cannot meet its financial obligations due to deterioration of its financial viability, credit ratings or bankruptcy. The allowance requirements are based on current facts and are reevaluated and adjusted as additional information is received. Accounts receivable are subject to an allowance for collection when it is probable that the balance will not be collected. As of December 31, 2015 and 2014, the allowance for doubtful accounts was $100,672 and $887, respectively. For the years ended December 31, 2015 and 2014, the accounts written off as uncollectible were $14,347 and $779, respectively. Inventory Inventories are stated at the lower of cost or market value. Raw material inventory cost is determined on the first-in, first-out method. Costs of finished goods are determined by an actual cost method. We regularly review inventories on hand and write down the carrying value of our inventories for excess and potentially obsolete inventories based on historical usage and estimated future usage. In assessing the ultimate realization of our inventories, we are required to make judgments as to future demand requirements. As actual future demand or market conditions may vary from those projected by us, adjustment to inventories may be required. Prepaid Expenses and Deferred Charges As of December 31, 2015 and 2014, prepaid expenses were composed primarily of insurance policy costs. We amortize our insurance costs ratably over the term of each policy. Typically, our insurance policies are subject to renewal in July and October of each year. Property, Equipment and Leasehold Improvements Property, equipment, and leasehold improvements are recorded at cost. Depreciation is provided over the estimated useful lives of the related assets using the straight-line method. Estimated useful lives for property, equipment, and leasehold improvements categories are as follows:
Intangible Assets We expense internal patent and application costs as incurred because, even though we believe the patents and underlying processes have continuing value, the amount of future benefits to be derived from them are uncertain. Purchased patents are capitalized and amortized over the life of the patent. Licensing Rights Purchased licensing rights are capitalized and amortized over the life of the patent associated with the licensed product. Impairment of Assets In accordance with the provisions of Accounting Standards Codification (“ASC”) Topic 350-30, Intangibles Other than Goodwill, our policy is to evaluate whether there has been a permanent impairment in the value of long-lived assets and certain identifiable intangibles when certain events have taken place that indicate the remaining unamortized balance may not be recoverable, or at least annually to determine the current value of the intangible asset. When factors indicate that the intangible assets should be evaluated for possible impairment, we use an estimate of undiscounted cash flows. Considerable management judgment is necessary to estimate the undiscounted cash flows. Accordingly, actual results could vary significantly from management’s estimates. Debt Issuance Costs We defer debt issuance costs associated with the issuance of our promissory note payable and amortize those costs over the period of the promissory note obligation using the effective interest method. In 2015, we incurred $50,000 of debt issuance costs related to our promissory note payable with Inter-Mountain Capital Corp. During 2015 and 2014, we recorded amortization of approximately $27,000 and $7,000, respectively, of deferred financing costs. Unamortized debt issuance costs at December 31, 2015 and 2014 were approximately of $23,000 and nil, respectively. Accrual for Clinical Study Costs We record accruals for estimated clinical study costs. Clinical study costs represent costs incurred by clinical research organizations, or CROs, and clinical sites. These costs are recorded as a component of research and development expenses. We analyze the progress of the clinical trials, including levels of patient enrollment and/or patient visits, invoices received and contracted costs when evaluating the adequacy of the accrued liabilities. Significant judgments and estimates must be made and used in determining the accrued balance in any accounting period. Actual costs incurred may or may not match the estimated costs for a given accounting period. As of December 31, 2015 and 2014, the accrual for estimated clinical study costs was nil. Shipping and Handling Costs Shipping and handling costs incurred for product shipments are included in cost of goods sold. Income Taxes We use the liability method of accounting for income taxes pursuant to ASC Topic 740, Income Taxes. Under this method, deferred income taxes are recorded to reflect the tax consequences in future periods of temporary differences between the tax basis of assets and liabilities and their financial statement amounts at year-end. Revenue Recognition and Deferred Revenue License Fees We recognize revenue from license payments not tied to achieving a specific performance milestone ratably during the period over which we are obligated to perform services. The period over which we are obligated to perform services is estimated based on available facts and circumstances. Determination of any alteration of the performance period normally indicated by the terms of such agreements involves judgment on management's part. License revenues with no specific performance criteria are recognized when received from our foreign licensee and their various foreign sub-licensees as there is no control by us over the various foreign sub-licensees and no performance criteria to which we are subject. We recognize revenue from performance payments ratably, when such performance is substantially in our control and when we believe that completion of such performance is reasonably probable, over the period during which we estimate that we will complete such performance obligations. In circumstances where the arrangement includes a refund provision, we defer revenue recognition until the refund condition is no longer applicable unless, in our judgment, the refund circumstances are within our operating control and are unlikely to occur. Substantive at-risk milestone payments, which are based on achieving a specific performance milestone when performance of such milestone is contingent on performance by others or for which achievement cannot be reasonably estimated or assured, are recognized as revenue when the milestone is achieved and the related payment is due, provided that there is no substantial future service obligation associated with the milestone. Royalty Income We receive royalty revenues under license agreements with a number of third parties that sell products based on technology we have developed or to which we have rights. The license agreements provide for the payment of royalties to us based on sales of the licensed products. We record these revenues based on estimates of the sales that occurred during the relevant period. The relevant period estimates of sales are based on interim data provided by licensees and analysis of historical royalties we have been paid (adjusted for any changes in facts and circumstances, as appropriate). We maintain regular communication with our licensees in order to gauge the reasonableness of our estimates. Differences between actual royalty revenues and estimated royalty revenues are reconciled and adjusted for in the period in which they become known, typically the following quarter. Historically, adjustments have not been material based on actual amounts paid by licensees. As it relates to royalty income, there are no future performance obligations on our part under these license agreements. To the extent we do not have sufficient ability to accurately estimate revenue; we record it on a cash basis. Product Sales We recognize revenue and related costs from the sale of our products at the time the products are shipped to the customer. Provisions for returns, rebates, and discounts are established in the same period the related product sales are recorded. We review the supply levels of our products sold to major wholesalers in the U.S., primarily by reviewing reports supplied by our major wholesalers and available volume information for our products, or alternative approaches. When we believe wholesaler purchasing patterns have caused an unusual increase or decrease in the sales of a major product compared with underlying demand, we disclose this in our product sales discussion if we believe the amount is material to the product sales trend; however, we are not always able to accurately quantify the amount of stocking or destocking. Wholesaler stocking and destocking activity historically has not caused any material changes in the rate of actual product returns. We establish sales return accruals for anticipated product returns. We record the return amounts as a deduction to arrive at our net product sales. Consistent with Revenue Recognition accounting guidance, we estimate a reserve when the sales occur for future product returns related to those sales. This estimate is primarily based on historical return rates as well as specifically identified anticipated returns due to known business conditions and product expiry dates. Actual product returns have been nil over the past two years. We establish sales rebate and discount accruals in the same period as the related sales. The rebate and discount amounts are recorded as a deduction to arrive at our net product sales. We base these accruals primarily upon our historical rebate and discount payments made to our customer segment groups and the provisions of current rebate and discount contracts. Foreign currency transaction gain (loss) Our functional currency and our reporting currency is the U.S. dollar and foreign currency transactions are primarily undertaken in Euros. Monetary assets and liabilities are translated using the foreign currency exchange rate prevailing at the balance sheet date. Revenues, non-monetary assets and liabilities denominated in foreign currencies are translated at rates of foreign currency exchange in effect at the date of the transaction. Expenses are translated at average foreign currency exchange rates for the period. Gains and losses arising on translation or settlement of foreign currency denominated transactions or balances are included in the determination of net income. Research and Development Expenses Pursuant to ASC Topic 730, Research and Development, our research and development costs are expensed as incurred. Research and development expenses include, but are not limited to, salaries and benefits, laboratory supplies, facilities expenses, preclinical development cost, clinical trial and related clinical manufacturing expenses, contract services, consulting fees and other outside expenses. The cost of materials and equipment or facilities that are acquired for research and development activities and that have alternative future uses are capitalized when acquired. There were no such capitalized materials, equipment or facilities for the years ended December 31, 2015 and 2014. Basic and Diluted Net Loss Per Common Share In accordance with 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 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 and warrants from the calculation of diluted net loss per common share because all such securities are antidilutive for all periods presented. Concentrations of Credit Risk Concentration of credit risk with respect to financial instruments, consisting primarily of cash and cash equivalents, that potentially expose us to concentrations of credit risk due to the use of a limited number of banking institutions and due to maintaining cash balances in banks, which, at times, may exceed the limits of amounts insured by the Federal Deposit Insurance Corporation. During 2015 and 2014, we utilized Bank of America, N.A. as our banking institution. At December 31, 2015 and December 31, 2014 our cash and cash equivalents totaled $180,000 and $550,458, respectively. We also invest cash in excess of immediate requirements in money market accounts, certificates of deposit, corporate commercial paper with high quality ratings, and U.S. government securities. These investments are not held for trading or other speculative purposes. We are exposed to credit risk in the event of default by these high quality corporations. Concentration of credit risk with respect to trade accounts receivable are customers with balances that exceed 5% of total consolidated trade accounts receivable at December 31, 2015 and at December 31, 2014. As of December 31, 2015, one customer, being one of our international distributors, exceeded the 5% threshold, with 92%. Three customers, each being one of our international distributors, exceeded the 5% threshold at December 31, 2014, with 71%, 19%, and 9%, 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 A portion of our revenues and all of our expenses are denominated in U.S. dollars. We are expecting an increase in revenues in international territories denominated in a foreign currency. Certain of our licensing and distribution agreements in international territories are denominated in Euros. Currently, we do not employ forward contracts or other financial instruments to mitigate foreign currency risk. As our international operations continue to grow, we may engage in hedging activities to hedge our exposure to foreign currency risk. Fair Value of Financial Instruments In accordance with portions of ASC Topic 820, Fair Value Measurements, 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. Our financial instruments, including cash, cash equivalents, accounts receivable, and accounts payable are carried at cost, which approximates their fair value because of the short-term maturity of these instruments. We believe that the carrying value of our other receivable, notes receivable and accrued interest, and convertible note payable balances approximates fair value based on a valuation methodology using the income approach and a discounted cash flow model. Derivatives We occasionally issue financial instruments that contain an embedded instrument. At inception, we assess whether the economic characteristics of the embedded derivative instrument are clearly and closely related to the economic characteristics of the financial instrument (host contract), whether the financial instrument that embodies both the embedded derivative instrument and the host contract is currently measured at fair value with changes in fair value reported in earnings, and whether a separate instrument with the same terms as the embedded instrument would meet the definition of a derivative instrument. If the embedded derivative instrument is determined not to be clearly and closely related to the host contract, is not currently measured at fair value with changes in fair value reported in earnings, and the embedded derivative instrument would qualify as a derivative instrument, the embedded derivative instrument is recorded apart from the host contract and carried at fair value with changes recorded in current-period earnings. We determined that all embedded items associated with financial instruments during 2015 and 2014 which qualify for derivative treatment, were properly separated from their host. As of December 31, 2015 and 2014, we did not have any derivative instruments. |
THE EFFECT OF RECENTLY ISSUED ACCOUNTING STANDARDS |
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THE EFFECT OF RECENTLY ISSUED ACCOUNTING STANDARDS [Abstract] | |||
THE EFFECT OF RECENTLY ISSUED ACCOUNTING STANDARDS |
In February 2016, Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2016-02, “Leases (Topic 842)”, which requires an entity to recognize assets and liabilities arising from a lease for both financing and operating leases. The ASU will also require new qualitative and quantitative disclosures to help investors and other financial statement users better understand the amount, timing, and uncertainty of cash flows arising from leases. ASU 2016-02 is effective for fiscal years beginning after December 15, 2018, with early adoption permitted. We are currently evaluating the effect ASU No. 2016-02 will have on our consolidated financial statements. In July 2015, FASB issued Update No. 2015-11, "Simplifying the Measurement of Inventory." Under ASU No. 2015-11, inventory should be measured at the lower of cost and net realizable value. Subsequent measurement is unchanged for inventory measured using LIFO or the retail inventory method. ASU No. 2015-11 is effective for annual reporting periods beginning after December 15, 2016, and interim periods thereafter. We do not believe ASU No. 2015-11 will have a material impact on our consolidated financial statements. In April 2015, FASB issued Update No. 2015-03, Simplifying the Presentation of Debt Issuance Costs, which requires debt issuance costs related to a recognized debt liability to be presented in the balance sheet as a direct deduction from the carrying amount of that debt liability, consistent with debt discounts. The guidance is effective January 1, 2016 with early adoption permitted. The Company has elected early adoption as the guidance is a change in financial statement presentation only and will not have a material impact in the consolidated financial results. In August 2014, FASB issued ASU No. 2014-15, “Presentation of Financial Statements – Going Concern”. ASU No 2014-15 provides guidance regarding management’s responsibility to evaluate whether there exists substantial doubt about an organization’s ability to continue as a going concern and to provide related footnote disclosures in certain circumstances. ASU No. 2014-15 is effective for annual reporting periods beginning after December 15, 2016, and interim periods thereafter. We do not believe ASU No. 2015-15 will have a material effect on our financial position and results of operations. In May 2014, FASB issued ASU No. 2014-09, “Revenue from Contracts with Customers,” which supersedes the revenue recognition requirements of Accounting Standards Codification (“ASC”) Topic 605, “Revenue Recognition” and most industry-specific guidance on revenue recognition throughout the ASC. The new standard is principles-based and provides a five step model to determine when and how revenue is recognized. The core principle of the new standard is that revenue should be recognized when a company transfers promised goods or services to customers in an amount that reflects the consideration to which the Company expects to be entitled in exchange for those goods or services. The new standard also requires disclosure of qualitative and quantitative information surrounding the amount, nature, timing and uncertainty of revenues and cash flows arising from contracts with customers. The new standard will be effective for us in the first quarter of the year ending December 31, 2017 and can be applied either retrospectively to all periods presented or as a cumulative-effect adjustment as of the date of adoption. Early adoption is not permitted. We are currently evaluating the impact of adoption of ASU 2014-09 on our consolidated financial statements. There are no other new accounting pronouncements adopted or enacted during the year ended December 31, 2015 that had, or are expected to have, a material impact on our financial statements. |
SEGMENT INFORMATION |
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SEGMENT INFORMATION [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
SEGMENT INFORMATION |
We operate in one business segment: the research, development, and commercialization of pharmaceutical products. Our corporate headquarters in the United States collects proceeds from product sales, licensing fees, royalties, and sponsored research revenues from our arrangements with external customers and licensees. Our entire business is managed by a single management team, which reports to the Chief Executive Officer. Our revenues are currently derived primarily from nineteen licensees for international activities and our domestic sales activities for Altrazeal®. Revenues per geographic area, along with relative percentages of total revenues, for the year ended December 31, are summarized as follows:
A significant portion of our revenues are derived from a few major customers. Customers with greater than 10% of total revenues, along with their relative percentage of total revenues, for the year ended December 31 are represented on the following table:
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INVENTORY |
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INVENTORY [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||
INVENTORY |
As of December 31, 2015 and 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. For the years ended December 31, 2015 and 2014, we wrote off approximately $1,600 and $19,000, respectively, in obsolete inventories. The components of inventory, at the different stages of production, consisted of the following at December 31:
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PROPERTY, EQUIPMENT AND LEASEHOLD IMPROVEMENTS |
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PROPERTY, EQUIPMENT AND LEASEHOLD IMPROVEMENTS [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
PROPERTY, EQUIPMENT AND LEASEHOLD IMPROVEMENTS |
Property, equipment and leasehold improvements, net, consisted of the following at December 31:
Depreciation expense on property, equipment, and leasehold improvements was $180,480 and $237,388 for the years ended December 31, 2015 and 2014, respectively. |
INTANGIBLE ASSETS |
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INTANGIBLE ASSETS [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
INTANGIBLE ASSETS |
Intangible assets are comprised of patents acquired in October 2005. Intangible assets, net consisted of the following at December 31:
We performed an evaluation of our intangible assets for purposes of determining possible impairment as of December 31, 2015. Based upon recent market conditions and comparable market transactions for similar intangible assets, we determined that an income approach using a discounted cash flow model was an appropriate valuation methodology to determine each intangible asset’s fair value. The income approach converts future amounts to a single present value amount (discounted cash flow model). Our discounted cash flow models are highly reliant on various assumptions, including estimates of future cash flow (including long-term growth rates), discount rate, and expectations about variations in the amount and timing of cash flows and the probability of achieving the estimated cash flows, all of which we consider level 3 inputs for determination of fair value. We believe we have appropriately reflected our best estimate of the assumptions that market participants would use in determining the fair value of our intangible assets at the measurement date. Upon completion of the evaluation, the fair value of our intangible assets exceeded the recorded remaining book value. Amortization expense for intangible assets was $475,148 and $475,148 for the years ended December 31, 2015 and 2014, respectively. The future aggregate amortization expense for intangible assets, remaining as of December 31, 2015, is as follows:
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LICENSING RIGHTS |
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LICENSING RIGHTS [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
LICENSING RIGHTS |
On December 24, 2015, we entered into and closed the transaction contemplated by a License Purchase and Termination Agreement (the “Altrazeal Termination Agreement”) with Altrazeal Trading GmbH (“Altrazeal Trading”) and IPMD GmbH (“IPMD”). The Altrazeal Termination Agreement relates to the License and Supply Agreement dated January 11, 2012 (the “Altrazeal License”), under which Altrazeal Trading and its affiliates were authorized by the Company to distribute our Altrazeal® wound care product in the European Union, Australia, New Zealand, Middle East (excluding Jordan and Syria), North Africa, Albania, Bosnia, Croatia, Kosovo, Macedonia, Montenegro, and Serbia. Under the Altrazeal Termination Agreement, the Altrazeal License was assigned to the Company thereby effecting its termination and the Company’s 25% ownership interest in Altrazeal Trading was cancelled. In addition, the Company assumed from Altrazeal Trading and certain affiliated entities rights and future obligations under sub-distribution agreements in numerous territories within the scope of the Altrazeal License and related consulting agreements. Under the terms of the Altrazeal Termination Agreement, we agreed to pay to Altrazeal Trading a net transfer fee of €1,570,271 and to pay IPMD a transfer fee of €703,500. The net transfer fee to Altrazeal Trading includes adjustments for amounts owed by Altrazeal Trading to the Company. The Company is permitted to pay and did pay (a) to Altrazeal Trading by means of the issuance of 4,441,606 share of common stock together with warrants to purchase 444,161 shares of common stock and (b) to IPMD by means of the issuance of 2,095,241 shares of common stock, together with warrants to purchase 209,525 shares of common stock. The warrants have an exercise price of $0.68 per share and a term of one-year. Altrazeal Trading has also agreed to return inventory of Altrazeal® blisters held in its possession in an amount equal to €88,834 (“Inventory Payment”) on or before December 31, 2016. To the extent Altrazeal Trading does not return the entire inventory, we may deduct from the Inventory Payment €4.20 per Altrazeal® blister not returned in usable condition. Under the Altrazeal Termination Agreement, we also agreed to file within twenty (20) days of closing a registration statement registering the resale of 2,500,000 shares of common stock issued under the Altrazeal Termination Agreement and to use all commercially reasonable efforts to cause such registration Statement to become effective. In accordance with our obligations under the Altrazeal Termination Agreement, we filed with the SEC a registration statement that was declared effective on February 16, 2016. We are required to keep the registration statement effective at all times with respect to such 2,500,000 shares, other than permitted suspension periods, until the earliest of (i) June 24, 2016, (ii) the date when Altrazeal Trading and IPMD may sell all of the registered shares under Rule 144 under the Securities Act without volume limitations, or (iii) the date when Altrazeal Trading and IPMD no longer owns any of the registered shares. In connection with the Altrazeal Termination Agreement, we also entered into a Mutual Termination and Release Agreement, dated December 24, 2015, for the purpose of terminating the Binding Term Sheet dated May 12, 2015 with Altrazeal Trading and Firnron LTD (the “Term Sheet”). Under the Term Sheet, it was contemplated that the Company would acquire all of the remaining equity interests in Altrazeal Trading. Licensing rights, net consisted of the following at December 31:
We performed an evaluation of our licensing rights asset for purposes of determining possible impairment as of December 31, 2015. Based upon recent market conditions and comparable market transactions for similar licensing rights, we determined that an income approach using a discounted cash flow model was an appropriate valuation methodology to determine each licensing rights asset fair value. The income approach converts future amounts to a single present value amount (discounted cash flow model). Our discounted cash flow models are highly reliant on various assumptions, including estimates of future cash flow (including long-term growth rates), discount rate, and expectations about variations in the amount and timing of cash flows and the probability of achieving the estimated cash flows, all of which we consider level 3 inputs for determination of fair value. We believe we have appropriately reflected our best estimate of the assumptions that market participants would use in determining the fair value of our licensing rights asset at the measurement date. Upon completion of the evaluation, the fair value of our licensing rights asset exceeded the recorded remaining book value. Amortization expense for licensing rights asset was $6,271 and nil for the years ended December 31, 2015 and 2014, respectively. The future aggregate amortization expense for intangible assets, remaining as of December 31, 2015, is as follows:
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INVESTMENT IN UNCONSOLIDATED SUBSIDIARY |
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INVESTMENT IN UNCONSOLIDATED SUBSIDIARY [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
INVESTMENT IN UNCONSOLIDATED SUBSIDIARY |
We use the equity method of accounting for investments in other companies that are not controlled by us and in which our interest is generally between 20% and 50% of the voting shares or we have significant influence over the entity, or both. Altrazeal Trading GmbH On January 11, 2012, we executed a shareholders’ agreement for the establishment of Altrazeal Trading Ltd., a single purpose entity to be used for the exclusive marketing of Altrazeal® throughout the European Union, Australia, New Zealand, North Africa, and the Middle East. As a result of this transaction, we received a non-dilutable 25% ownership interest in Altrazeal Trading Ltd. On February 1, 2014, Altrazeal Trading Ltd. transferred all of their rights and obligations under the existing shareholders’ agreement to Altrazeal Trading GmbH (“Altrazeal Trading”). As a result of this transfer, we received a non-dilutable 25% ownership interest in Altrazeal Trading. On December 24, 2015, we completed the Altrazeal Termination Agreement with Altrazeal Trading and IPMD GmbH (“IPMD”) as more fully described in Note 8. Under the Altrazeal Termination Agreement, our ownership interest in Altrazeal Trading was cancelled. ORADISC GmbH On October 19, 2012, we executed a shareholders’ agreement for the establishment of ORADISC GmbH, through which OraDisc™ erodible film technology products would be developed and marketed. We were entitled to receive a non-dilutable 25% ownership interest in ORADISC GmbH. Financial statements for the year ended December 31, 2015 have not been released to us and, therefore, we have not included the effect of the financial activities of ORADISC GmbH in our financial statements for such reporting period. We believe that our share of the cumulative losses of ORADISC GmbH for the years ended December 31, 2015, 2014, and 2013 would exceed the carrying value of our investment, therefore the equity method of accounting would be suspended for such reporting periods and no additional losses would be charged to operations. Based upon the unaudited financial statements for the years ended December 31, 2014 and 2013, our unrecorded share of ORADISC GmbH cumulative losses as of December 31, 2014 totaled $22,826. Summarized financial information for our investment in ORADISC GmbH assuming 100% ownership is as follows:
Altrazeal AG On February 1, 2014, we executed a shareholders’ agreement with Altrazeal AG, a single purpose entity for the marketing of Altrazeal® in several territories, including Africa (markets not already licensed), Latin America, Georgia, Turkmenistan, Ukraine, the Commonwealth of Independent States, Jordan, Syria, Asia and the Pacific (excluding China, Hong Kong, Macau, Taiwan, South Korea, Japan, Australia, and New Zealand). As a result of this transaction, we were entitled to receive a non-dilutable 25% ownership interest in Altrazeal AG. Audited or unaudited financial statements of Altrazeal AG for the years December 31, 2015 and 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 years ended December 31, 2015 and 2014 would exceed the carrying value of our investment, therefore the equity method of accounting would be suspended for such reporting periods and no additional losses would be charged to operations. |
ACCRUED LIABILITIES |
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ACCRUED LIABILITIES [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
ACCRUED LIABILITIES |
Accrued liabilities consisted of the following at December 31:
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CONVERTIBLE DEBT |
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CONVERTIBLE DEBT [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
CONVERTIBLE DEBT |
Debt Financing – April 2015 On April 15, 2015, we entered into a Securities Purchase Agreement dated April 14, 2015 (the “Purchase Agreement”) with Inter-Mountain Capital Corp. (“Inter-Mountain”) related to our issuance of a $550,000 Promissory Note (the “April 2015 Note”). The purchase price for the April 2015 Note, which reflects a $50,000 original issue discount, was $500,000. The Purchase Agreement also included representations and warranties, restrictive covenants and indemnification provisions standard for similar transactions. The April 2015 Note bears interest at the rate of 10.0% per annum, with monthly installment payments of $45,000 commencing on the date that is 120 calendar days after the issuance date of the April 2015 Note. At our option, subject to certain volume, price and other conditions, the monthly installments may be paid in whole, or in part, in cash or in Common Stock. If the monthly installments are paid in Common Stock, such shares being issued will be based on a price that is 80% of the average of the three lowest volume weighted average prices of the shares of Common Stock during the preceding twenty trading days. The percentage declines to 70% if the average of the three lowest volume weighted average prices of the shares of Common Stock during the preceding twenty trading days is less than $0.05 per share. The April 2015 Note is not subject to conversion at the discretion of Inter-Mountain. At our option, the outstanding principal balance of the April 2015 Note, or a portion thereof, may be prepaid in cash at 120% of the amount elected to be prepaid. The April 2015 Note is unsecured. Events of default under the April 2015 Note include failure to make required payments, the entry of a $100,000 judgment not stayed within 30 days, breach of representations or covenants under the transaction documents, various events associated with insolvency or failure to pay debts, delisting of the Common Stock, a restatement of financial statements and a default under certain other agreements. In the event of default, the interest rate under the April 2015 Note increases to 18% and the April 2015 Note becomes callable at a premium. In addition, Inter-Mountain has all remedies under law and equity. As part of the debt financing, Inter-Mountain also received a warrant (the “Warrant”) to purchase up to an aggregate of 194,118 shares of Common Stock. The Warrant has an exercise price of $0.85 per share and expires on April 30, 2020. The Warrant includes a standard net cashless exercise provision and provisions requiring proportionate adjustments in connection with a recapitalization transaction. As part of the debt financing, we entered into a Registration Rights Agreement whereby we agreed to prepare and file with the Securities and Exchange Commission (the “SEC”) a registration statement no later than May 11, 2015 and to cause such registration statement to be declared effective no later than 120 after the closing date and to keep such registration statement effective for a period of no less than 180 days. In accordance with our obligations under the Registration Rights Agreement, we filed with the SEC a registration statement that was declared effective on June 4, 2015. On January 11, 2016, we executed a Waiver Agreement with Inter-Mountain. The Waiver Agreement relates to the April 2015 Note and our failure to make the installment payment under the April 2015 Note due in November 2015 on a timely basis. Subsequent installment payments with respect to December 2015 and January 2016 have been made on a timely basis. Under the terms of the Waiver Agreement, we agreed to remit the November 2015 installment payment of $45,000 in cash and to pay Inter-Mountain an accommodation fee of $25,000, with the accommodation fee being added to the outstanding loan balance. Using specific guidelines in accordance with U.S. GAAP, we allocated the value of the proceeds received to the promissory note and to the warrant on a relative fair value basis. We calculated the fair value of the warrant issued with the debt instrument using the Black-Scholes valuation method, using the same assumptions used for valuing employee stock options, except the contractual life of the warrant was used. Using the effective interest method, the allocated fair value of the warrant was recorded as a debt discount and is being amortized over the expected term of the promissory note to interest expense. Information relating to the April 2015 Note is as follows:
For the year ended December 31, 2015, we issued 1,648,421 shares of Common Stock for four installment payments of principal and interest due under the April 2015 Note. The future minimum payments relating to the April 2015 Note, as of December 31, 2015, are as follows:
Convertible Note – June 2012 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. 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 became due as the outstanding balance under the June 2012 Note was 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 June 2012 Note beared interest at the rate of 8.0% per annum, with monthly installment payments of $83,333 commencing on the date that was 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. 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 beared 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 was 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 a conversion price of $1.08 per share or 115,741 shares of Common Stock. The July 2011 Note was collateralized by the grant of a security interest in the inventory, accounts receivables and capital equipment held by the Company. 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 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. The amount of interest cost recognized from our promissory note was $37,110 and nil for the years ended December 31, 2015 and 2014, respectively, and the amount of interest cost recognized from our convertible notes was nil and $20,853 for the years ended December 31, 2015 and 2014, respectively. The amount of debt discount amortized from our promissory note was $37,120 and nil for the years ended December 31, 2015 and 2014, respectively, and the amount of debt discount amortized from our convertible notes was nil and $(78,078) for the years ended December 31, 2015 and 2014, respectively. The amount of debt issuance costs amortized from our promissory note was $27,073 and nil for the years ended December 31, 2015 and 2014, respectively, and the amount of deferred financing costs amortized from our convertible notes was nil and $7,309 for the years ended December 31, 2015 and 2014, respectively. |
EQUITY TRANSACTIONS |
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EQUITY TRANSACTIONS [Abstract] | |||
EQUITY TRANSACTIONS |
Common Stock Transactions October 2015 Offering On September 6, 2015, we entered into a Securities Purchase Agreement with several institutional investors from Europe (collectively, the “Investors”) relating to an equity investment of $1,588,225 by the Investors for 4,179,539 shares of our common stock, at a per-share purchase price of $0.38 (the “October 2015 Offering”). As of the date of this Report, the October 2015 Offering has resulted in net proceeds to the Company of approximately $1,257,000, of which approximately $1,050,000 was received in October 2015 and $207,000 was received in November 2015. As part of the offering expenses, we paid to a European placement agent a referral fee equal to 12% of the gross proceeds immediately following each closing, provided that the investors are not U.S. Persons and were solicited outside the United States. We also entered into a Registration Rights Agreement with the Investors under which we agreed to prepare and file with the Securities and Exchange Commission (the “SEC”) a registration statement with respect to the resale of the Shares no later than September 26, 2015 and thereafter use all commercially reasonable efforts to cause such registration statement to become effective. In accordance with our obligations under the Registration Rights Agreement, we filed with the SEC a registration statement that was declared effective on October 9, 2015. We are required to keep such registration statement effective until the earliest of (i) the date that is six months after the Closing Date under the SPA, (ii) the date when the respective Investor may sell all of the Shares under Rule 144 without volume limitations, or (iii) the date the Investor no longer owns any of the Shares. |
STOCKHOLDERS' EQUITY |
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STOCKHOLDERS' EQUITY [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
STOCKHOLDERS' EQUITY |
Common Stock As of December 31, 2015, we had 36,834,933 shares of common stock issued and outstanding. For the year ended December 31, 2015, we issued 12,376,915 shares of Common Stock composed of 6,536,847 shares of Common Stock issued Altrazeal Trading and IPMD pursuant to the Altrazeal Termination Agreement (as described in Note 8), 3,830,131 shares of Common Stock issued European investors pursuant to the October 2015 Offering, 1,648,421 shares of Common Stock issued for installment payments due under the April 2015 with Inter-Mountain, and 361,516 shares of Common Stock issued for the cashless conversion of a warrant held by Inter-Mountain. Preferred Stock As of December 31, 2015, we had no shares of Series A Preferred Stock (the “Series A Shares”). For the year ended December 31, 2015, we did not issue any new Series A Shares. Warrants The following table summarizes the warrants outstanding and the number of shares of common stock subject to exercise as of December 31, 2015 and the changes therein during the two years then ended:
For the year ended December 31, 2015, we issued warrants to purchase up to an aggregate of 847,804 shares of our common stock which consisted of (i) a warrant issued to Altrazeal Trading pursuant to the Altrazeal Termination Agreement to purchase up to an aggregate of 444,161 shares of our common stock at an exercise price of $0.68 per share, (ii) a warrant issued to IPMD pursuant to the Altrazeal Termination Agreement to purchase up to an aggregate of 209,525 shares of our common stock at an exercise price of $0.68 per share, and (iii) a warrant issued to Inter-Mountain pursuant to the April 2015 Note to purchase up to an aggregate of 194,118 shares of our common stock at an exercise price of $0.85 per shares. Of the warrant shares subject to exercise as of December 31, 2015, expiration of the right to exercise is as follows:
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EARNINGS PER SHARE |
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EARNINGS PER SHARE |
Basic and Diluted Net Loss Per Share In accordance with 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 December 31:
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SHARE BASED COMPENSATION |
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SHARE BASED COMPENSATION [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
SHARE BASED COMPENSATION |
The Company’s share-based compensation plan, the 2006 Equity Incentive Plan (“Incentive Plan”), is administered by the compensation committee of the Board of Directors, which selects persons to receive awards and determines the number of shares subject to each award and the terms, conditions, performance measures and other provisions of the award. Our Board of Directors granted the following incentive stock option awards to executives or employees and nonstatutory stock option awards to directors or non-employees for the years ended December 31:
We account for share-based compensation under ASC Topic 718, Stock Compensation, which requires the measurement and recognition of compensation expense in the financial statements for all share-based payment awards made to employees, consultants, and directors is measured based on the estimated fair value 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 years ended December 31:
Stock Options (Incentive and Nonstatutory) The following table summarizes share-based compensation related to stock options for the years ended December 31:
At December 31, 2015, the balance of unearned share-based compensation to be expensed in future periods related to unvested stock option awards, as adjusted for expected forfeitures, is approximately $121,000. 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 December 31, 2015 and the changes therein during the two years then ended:
The following table presents the stock option grants outstanding and exercisable as of December 31, 2015:
Restricted Stock Awards Restricted stock awards, which typically vest over a period of six months to five years, are issued to certain key employees and are subject to forfeiture until the end of an established restriction period. We utilize the market price on the date of grant as the fair market value of restricted stock awards and expense the fair value on a straight-line basis over the vesting period. For the years ended December 31, 2015 and 2014, we did not grant any restricted stock awards. At December 31, 2015, the balance of unearned share-based compensation to be expensed in future periods related to restricted stock awards, as adjusted for expected forfeitures, is nil. Summary of Plans 2006 Equity Incentive Plan In March 2006, our Board adopted and our stockholders approved our Equity Incentive Plan, which initially provided for the issuance of up to 133,333 shares of our Common Stock pursuant to stock option and other equity awards. At the annual meetings of the stockholders held on May 8, 2007, December 17, 2009, June 15, 2010, June 14, 2012, June 13, 2013, and on June 5, 2014, our stockholders approved amendments to the Equity Incentive Plan to increase the total number of shares of Common Stock issuable under the Equity Incentive Plan pursuant to stock options and other equity awards by 266,667 shares, 200,000 shares, 200,000 shares, 400,000 shares, 600,000 shares, and 1,000,000 shares, respectively, to a total of 2,800,000 shares. In December 2006, we began issuing stock options to employees, consultants, and directors. The stock options issued generally vest over a period of one to four years and have a maximum contractual term of ten years. In January 2007, we began issuing restricted stock awards to our employees. Restricted stock awards generally vest over a period of six months to five years after the date of grant. Prior to vesting, restricted stock awards do not have dividend equivalent rights, do not have voting rights and the shares underlying the restricted stock awards are not considered issued and outstanding. Shares of Common Stock are issued on the date the restricted stock awards vest. As of December 31, 2015, we had granted options to purchase 2,061,167 shares of Common Stock since the inception of the Equity Incentive Plan, of which 1,664,573 were outstanding at a weighted average exercise price of $1.73 per share, and we had granted awards for 68,616 shares of restricted stock since the inception of the Equity Incentive Plan, of which none were outstanding. As of December 31, 2015, there were 1,065,981 shares that remained available for future grants under our Equity Incentive Plan. |
EMPLOYMENT BENEFIT PLAN |
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EMPLOYMENT BENEFIT PLAN [Abstract] | |||
EMPLOYMENT BENEFIT PLAN |
We maintain a defined contribution or 401(k) Plan for our qualified employees. Participants may contribute a percentage of their compensation on a pre-tax basis, subject to a maximum annual contribution imposed by the Internal Revenue Code. We may make discretionary matching contributions as well as discretionary profit-sharing contributions to the 401(k) Plan. Our contributions to the 401(k) Plan are made in cash and vest immediately. The Company’s common stock is not an investment option available to participants in the 401(k) Plan. We contributed $18,861 and $24,674 to the 401(k) Plan during the years ended December 31, 2015 and 2014, respectively. |
FAIR VALUE MEASUREMENTS |
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FAIR VALUE MEASUREMENTS [Abstract] | ||||||||||||||||||||||||||||||||||||||||||
FAIR VALUE MEASUREMENTS |
In accordance with 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:
Assets and liabilities are classified in their entirety based on the lowest level of input that is significant to the fair value measurements. We review the fair value hierarchy classification on a quarterly basis. Changes in the observability of valuation inputs may result in a reclassification of levels for certain securities within the fair value hierarchy. Our financial instruments, including cash, cash equivalents, accounts receivable, and accounts payable are carried at cost, which approximates their fair value because of the short-term maturity of these instruments. We believe that the carrying value of our notes receivable and accrued interest and convertible note payable balances approximates fair value based on a valuation methodology using the income approach and a discounted cash flow model. The fair value of our financial instruments consisted of the following at December 31:
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INCOME TAXES |
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INCOME TAXES [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
INCOME TAXES |
There was no current federal tax provision or benefit recorded for any period since inception, nor were there any recorded deferred income tax assets, as such amounts were completely offset by valuation allowances. Deferred tax assets as of December 31, 2015, of $19,905,250 were reduced to zero, after considering the valuation allowance of $19,905,250, since there is no assurance of future taxable income. As of December 31, 2015 we have consolidated net operating loss carryforwards (“NOL”) and research credit carryforwards for income tax purposes of approximately $53,941,331 and $552,553, respectively. The following are the consolidated operating loss carryforwards and research credit carryforwards that will begin expiring as follows:
The Tax Reform Act of 1986 contains provisions, which limit the amount of NOL and tax credit carryforwards that companies may utilize in any one year in the event of cumulative changes in ownership over a three-year period in excess of 50%. Since the effective date of the Tax Reform Act of 1986, the Company has completed significant share issuances in 2003 and 2006 which may significantly limit our ability to utilize our NOL and tax credit carryforwards against taxable earnings in future periods. Ownership changes in future periods may place additional limits on our ability to utilize NOLs and tax credit carryforwards. An analysis of the tax effects of temporary differences that give rise to significant portions of the deferred tax assets and deferred tax liabilities at December 31, 2015 and 2014 are as follows:
The valuation allowance increased by $915,874 and $644,443 in 2015 and 2014, respectively. The following is a reconciliation of the expected statutory federal income tax rate to our actual income tax rate for the years ended December 31:
Effective January 1, 2007, we adopted ASC Topic 740, Accounting for Uncertainty in Income Taxes. ASC Topic 740 is a comprehensive model for how a company should recognize, measure, present, and disclose in its financial statements uncertain tax positions that we have taken or expects to take on a tax return. If an income tax position exceeds a more likely than not (greater than 50%) probability of success upon tax audit, we will recognize an income tax benefit in its financial statements. Additionally, companies are required to accrue interest and related penalties, if applicable, on all tax exposures consistent with jurisdictional tax laws. We did not have any unrecognized tax benefits and there was no effect on our financial condition or results of operations as a result of implementing ASC Topic 740. Federal income tax returns for fiscal years 2012 through 2015 remain open and subject to examination by the Internal Revenue Service. We file and remit state income taxes in various states where we have determined it is required to file state income taxes. Our filings with those states remain open for audit for the fiscal years 2012 through 2015. We do not believe there will be any material changes in our unrecognized tax positions over the next 12 months. Our policy is that we recognize interest and penalties accrued on any unrecognized tax benefits as a component of income tax expense. As of the date of adoption of ASC 740, we did not have any accrued interest or penalties associated with any unrecognized tax benefits nor was any interest expense recognized during the period. The liability for unrecognized tax benefits is zero at December 31, 2015 and 2014. |
COMMITMENTS AND CONTINGENCIES |
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COMMITMENTS AND CONTINGENCIES [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
COMMITMENTS AND CONTINGENCIES |
Operating Leases On January 31, 2006 we entered into a lease agreement for office and laboratory space in Addison, Texas. The lease commenced on April 1, 2006 and originally continued until April 1, 2013. The lease required a minimum monthly lease obligation of $9,330, which was inclusive of monthly operating expenses, until April 1, 2011 and at such time increased to $9,776, which was inclusive of monthly operating expenses. On February 22, 2013, we executed an Amendment to Lease Agreement (the “Lease Amendment”) that renewed and extended our lease until March 31, 2015. The Lease Amendment required a minimum monthly lease obligation of $9,193, which was inclusive of monthly operating expenses, until March 31, 2014 and at such time, increased to $9,379, which was inclusive of monthly operating expenses. On March 17, 2015, we executed a Second Amendment to Lease Agreement (the “Second Amendment”) that renewed and extended our lease until March 31, 2018. The Second Amendment requires a minimum monthly lease obligation of $9,436, which is inclusive of monthly operating expenses. On December 10, 2010 we entered into a lease agreement for certain office equipment that commenced on February 1, 2011 and continued until February 1, 2015 and required a minimum lease obligation of $744 per month. On January 16, 2015 we entered into a new lease agreement for certain office equipment. The new office equipment lease, that commenced on February 1, 2015 and continues until February 1, 2018, requires a minimum lease obligation of $551 per month. The future minimum lease payments under the 2013 office lease and the 2015 equipment lease are as follows as of December 31, 2015:
Rent expense for our operating leases amounted to $121,623 and $123,716 for the years ended December 31, 2015 and 2014, respectively. Indemnification In accordance with our restated articles of incorporation and our amended and restated bylaws, we have indemnification obligations to our officers and directors for certain events or occurrences, subject to certain limits, while they are serving at our request in their respective capacities. 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. In November 2015, Helmut Kerschbaumer was appointed as the interim President and Chief Executive Officer of the Company. Mr. Kerschbaumer currently serves as a director of Altrazeal Trading GmbH, Altrazeal AG, and Melmed Holding AG (collectively, the “Altrazeal Distributors”) and Mr. Kuehne currently serves as a director of Altrazeal AG. In such capacities, Mr. Kerschbaumer may be considered, either singularly or collectively, to have control of, and make investment and business decisions on behalf of the Altrazeal Distributors and Mr. Kuehne may be considered, either singularly of collectively, to have control of, and make investment and business decisions on behalf of Altrazeal AG. Each of Mr. Kerschbaumer and Mr. Kuehne currently serves as a director of ORADISC GmbH and in such capacity, Mr. Kerschbaumer and Mr. Kuehne may each be considered, either singularly or collectively, to have control of, and make investment and business decisions on behalf of the ORADISC GmbH. As of December 31, 2015, we were party to AG Agreement with Altrazeal AG for the marketing and distribution of Altrazeal in various international territories. In late March 2016, we provided Altrazeal AG with a notice identifying certain breaches in the AG Agreement. On or about March 24, 2015, we learned that Altrazeal AG had commenced an insolvency proceeding in Austria and immediately sent an additional notice of termination referencing the insolvency. We are in the process of reaching out to sub-distributors in the territories covered by the AG Agreement for the purpose of accepting orders directly from, and fulfilling order directly to, such sub-distributors. We are also party to a License and Supply Agreement with ORADISC GmbH for the marketing of applications of our OraDisc™ erodible film technology for dental applications including benzocaine (OraDisc™ B), re-mineralization dental strips, fluoride dental strips, long-acting breath freshener, amlexanox (OraDisc™ A). We also granted to ORADISC GmbH a twenty-four month option to utilize the OraDisc™ erodible film technology for drug delivery for migraine, nausea and vomiting, cough and cold, and pain. The initial twenty-four month option period to utilize the OraDisc™ erodible film technology by ORADISC GmbH was extended until December 31, 2015. In addition, this option expanded the applications for use to include anti-psychotics, neurologic products, and actives for the treatment of erectile dysfunction. On December 30, 2015, we received notice from ORADISC GmbH of their exercise of the option. We informed ORADISC GmbH that the right to utilize the OraDisc™ erodible film technology under the option expired by its terms. In March 2016, the Company has learned that insolvency proceedings have been initiated with an Austrian commercial court with respect to IPMD GmbH, one of the Company’s largest stockholders, and that its affiliated operating entities, Altrazeal AG and Oradisc GmbH, each being a distributor of the Company’s products, might be affected by such insolvency proceeding filing. We also learned that Altrazeal AG has initiated similar insolvency proceedings in Switzerland. We are continuing to evaluate our position with respect to IPMD GmbH, Altrazeal AG, and Oradisc GmbH in light of this recent development. For the years ended December 31, 2015 and 2014, the Company recorded revenues, in approximate numbers, of $795,000 and $802,000, respectively, with the various Altrazeal Distributors, which represented approximately 85% and 93% of our total revenues. As of December 31, 2015 and 2014, Altrazeal Distributors had an outstanding net accounts receivable, in approximate numbers, of $3,000 and $798,000, respectively, which represented approximately 3% and 99% of our net outstanding accounts receivables. Temporary Advances Mr. Kerschbaumer is an officer and an indirect shareholder of IPMD and Mr. Kuehne is an indirect shareholder of IPMD and may each be considered, either singularly or collectively, to have control of, and make investment and business decisions on behalf of IPMD. The Company received temporary working capital advances from IPMD of $180,000 in July 2015 and $40,000 in September 2015. The Company repaid $220,000 to IPMD in October 2015. The Company received temporary working capital advances from Mr. Gray of $18,000 in April 2015, $30,000 in June 2015, and $10,300 in August 2015. The Company repaid $18,000 and $3,000 to Mr. Gray in April 2015 and September 2015, respectively. The Company received temporary working capital advances from Terrance K. Wallberg, the Company’s Vice President and Chief Financial Officer, of $10,000 in April 2015 and $3,000 in September 2015. The Company repaid $10,000 and $3,000 to Mr. Wallberg in April 2015 and September 2015, respectively. License Purchase and Termination Agreement On December 24, 2015, we entered into and closed the transaction contemplated by a License Purchase and Termination Agreement (the “Altrazeal Termination Agreement”) with Altrazeal Trading GmbH (“Altrazeal Trading”) and IPMD GmbH (“IPMD”). The Altrazeal Termination Agreement relates to the License and Supply Agreement dated January 11, 2012 (the “Altrazeal License”), under which Altrazeal Trading and its affiliates were authorized by the Company to distribute our Altrazeal® wound care product in the European Union, Australia, New Zealand, Middle East (excluding Jordan and Syria), North Africa, Albania, Bosnia, Croatia, Kosovo, Macedonia, Montenegro, and Serbia. Under the Altrazeal Termination Agreement, the Altrazeal License was assigned to the Company thereby effecting its termination and the Company’s 25% ownership interest in Altrazeal Trading was cancelled. In addition, the Company assumed from Altrazeal Trading and certain affiliated entities rights and future obligations under sub-distribution agreements in numerous territories within the scope of the Altrazeal License and related consulting agreements. Under the terms of the Altrazeal Termination Agreement, we agreed to pay to Altrazeal Trading a net transfer fee of €1,570,271 and to pay IPMD a transfer fee of €703,500. The net transfer fee to Altrazeal Trading includes adjustments for amounts owed by Altrazeal Trading to the Company. The Company is permitted to pay and did pay (a) to Altrazeal Trading by means of the issuance of 4,441,606 share of common stock together with warrants to purchase 444,161 shares of common stock, and (b) to IPMD by means of the issuance of 2,095,241 shares of common stock, together with warrants to purchase 209,525 shares of common stock. The warrants have an exercise price of $0.68 per share and a term of one-year. Altrazeal Trading has also agreed to return inventory of Altrazeal® blisters held in its possession in an amount equal to €88,834 (“Inventory Payment”) on or before December 31, 2016. To the extent Altrazeal Trading does not return the entire inventory, we may deduct from the Inventory Payment €4.20 per Altrazeal® blister not returned in usable condition. Under the Altrazeal Termination Agreement, we also agreed to file within twenty (20) days of closing a registration statement registering the resale of 2,500,000 shares of common stock issued under the Altrazeal Termination Agreement and to use all commercially reasonable efforts to cause such registration Statement to become effective. In accordance with our obligations under the Altrazeal Termination Agreement, we filed with the SEC a registration statement that was declared effective on February 16, 2016. We are required to keep the registration statement effective at all times with respect to such 2,500,000 shares, other than permitted suspension periods, until the earliest of (i) June 24, 2016, (ii) the date when Altrazeal Trading and IPMD may sell all of the registered shares under Rule 144 under the Securities Act without volume limitations, or (iii) the date when Altrazeal Trading and IPMD no longer owns any of the registered shares. In connection with the Altrazeal Termination Agreement, we also entered into a Mutual Termination and Release Agreement, dated December 24, 2015, for the purpose of terminating the Binding Term Sheet dated May 12, 2015 with Altrazeal Trading and Firnron LTD (the “Term Sheet”). Under the Term Sheet, it was contemplated that the Company would acquire all of the remaining equity interests in Altrazeal Trading. 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 December 31, 2015, the following table summarizes the compensation temporarily deferred and subsequent repayments:
As of December 31, 2015, the Company’s obligation for temporarily deferred compensation was $533,564 of which $259,981 was included in accrued liabilities and $273,583 was included in accounts payable, respectively. As of December 31, 2014, the Company’s obligation for temporarily deferred compensation was $150,000 of which $62,500 was included in accrued liabilities and $87,500 was included in accounts payable, respectively. Contingent Milestone Obligations We are subject to paying Access Pharmaceuticals, Inc. (“Access”) for certain milestones based on our achievement of certain annual net sales, cumulative net sales, and/or our having reached certain defined technology milestones including licensing agreements and advancing products to clinical development. As of December 31, 2015, the future milestone obligations that we are subject to paying Access, if the milestones related thereto are achieved, total $4,750,000. Such milestones are based on total annual sales of 20 and 40 million dollars of certain products, annual sales of 20 million dollars of any one certain product, and cumulative sales of such products of 50 and 100 million dollars. On March 7, 2008, we terminated the license agreement with ProStrakan Ltd. for Amlexanox-related products in the United Kingdom and Ireland. As part of the termination, we agreed to pay ProStrakan Ltd. a royalty of 30% on any future payments received by us from a new licensee in the United Kingdom and Ireland territories, up to a maximum of $1,400,000. On November 17, 2008, we entered into a licensing agreement for Amlexanox-related product rights to the United Kingdom and Ireland territories with MEDA AB. |
LEGAL PROCEEDINGS |
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LEGAL PROCEEDINGS [Abstract] | |||
LEGAL PROCEEDINGS |
On or about August 22, 2014, Inter-Mountain Capital Corp. (“Inter-Mountain”) filed a Complaint against ULURU in the U.S. Federal Court for the District of Utah, Central Division. The Complaint relates to Inter-Mountain’s delivery of a notice of a cashless exercise with respect to its last remaining warrant to purchase Common Stock on or about May 1, 2014 purporting to exercise it with respect to the delivery of 782,284 shares of Common Stock under the non-standard cashless exercise or conversion provisions in the warrant. The Company declined to honor the exercise on the basis that, as a result of an amendment to the warrant agreed to in December 2013, the warrant was exercisable, on a cashless basis, with respect to only 261,516 shares of Common Stock as of May 1, 2014. Inter-Mountain alleged that the Company’s refusal to honor the exercise constituted a breach of the warrant, breach of implied covenant of good faith and fair dealing, unjust enrichment, a violation of securities laws and common law fraud and sought actual damages, consequential damages, treble damages, specific performance, attorneys’ fees and costs and other relief. Answers and counterclaims were filed. On April 15, 2015, the Company and Inter-Mountain entered into a Settlement Agreement (the “Settlement Agreement”) for the purpose of settling the pending litigation between the Company and Inter-Mountain. Under the Settlement Agreement and related documents, the Company and Inter-Mountain agreed that Inter-Mountain would exercise the warrant and receive 361,516 shares of Common Stock. The Settlement Agreement also included standard releases and anticipated the prompt filing of dismissal documents. As part of the settlement, the Company and Inter-Mountain signed and closed under the Securities Purchase Agreement described in Note 10. From time to time, we may be involved in litigation relating to claims arising out of our operations in the normal course of business. We are not currently a party to any legal proceedings, the adverse outcome of which, in management’s opinion, individually or in the aggregate, would have a material adverse effect on the results of our operations or financial position. There are no material proceedings to which any director, officer or any of our affiliates, any owner of record or beneficially of more than five percent of any class of our voting securities, or any associate of any such director, officer, our affiliates, or security holder, is a party adverse to us or our consolidated subsidiary or has a material interest adverse thereto; however, one or more events may lead to a formal dispute or proceeding in the future. In March 2016, the Company has learned that insolvency proceedings have been initiated with an Austrian commercial court with respect to IPMD GmbH, one of the Company’s largest stockholders, and that its affiliated operating entities, Altrazeal AG and Oradisc GmbH, each being a distributor of the Company’s products, might be affected by such insolvency proceeding filing. We also learned that Altrazeal AG has initiated similar insolvency proceedings in Switzerland. Litigation may result if these events and our relationship with these entities are effected by these insolvency proceedings. |
SUBSEQUENT EVENTS |
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SUBSEQUENT EVENTS [Abstract] | |||
SUBSEQUENT EVENTS |
On January 11, 2016, we executed a Waiver Agreement with Inter-Mountain. The Waiver Agreement relates to the April 2015 Note and our failure to make the installment payment under the April 2015 Note due in November 2015 on a timely basis. Subsequent installment payments with respect to December 2015 and January 2016 have been made on a timely basis. Under the terms of the Waiver Agreement, we agreed to remit the November 2015 installment payment of $45,000 in cash and to pay Inter-Mountain an accommodation fee of $25,000, with the accommodation fee being added to the outstanding loan balance. On March 29, 2016, we entered into a Stock Purchase Agreement for the offer and sale of 25,245,442 shares of common stock and warrants to purchase an additional 25,245,442 shares of common stock at a purchase price of $0.0713 per unit consisting of one share and one warrant to purchase common stock, for an aggregate purchase price of $1,800,000. (the “March 2016 Offering). The warrants have an exercise price of $0.0871 per share and a five-year term. The warrants also include cashless exercise provisions and a “full ratchet” anti-dilution provision under which the exercise price of such warrants resets to any lower sales price at which the Company offers or sells common stock or common stock equivalents for one year (subject to standard exceptions). |
COMPANY OVERVIEW AND BASIS OF PRESENTATION (Policies) |
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COMPANY OVERVIEW AND BASIS OF PRESENTATION [Abstract] | |||||||||||||||||||||
Basis of Presentation | Basis of Presentation The accompanying consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United State of America (“U.S. GAAP”) and include the accounts of ULURU Inc., a Nevada corporation, and its wholly-owned subsidiary, ULURU Delaware Inc., a Delaware corporation. Both companies have a December 31 fiscal year end. The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, as well as disclosure of contingent assets and liabilities at the date of the financial statements, and the reported amounts of revenues and expenses during the reporting periods. Actual results may differ from those estimates and assumptions. These differences are usually minor and are included in our consolidated financial statements as soon as they are known. Our estimates, judgments, and assumptions are continually evaluated based on available information and experience. Because of the use of estimates inherent in the financial reporting process, actual results could differ from those estimates. All intercompany transactions and balances have been eliminated in consolidation. |
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Liquidity and Going Concern | Liquidity and Going Concern The Company is unable to assert that its liquidity will be sufficient to fund operations through the second quarter of 2016, and as a result, there is substantial doubt about our ability to continue as a going concern through the second quarter of 2016. These consolidated financial statements have been prepared with the assumption that we will continue as a going concern and will be able to realize its assets and discharge its liabilities in the normal course of business and do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or the amounts and classification of liabilities that may result from the inability of the Company to continue as a going concern. We may not be able to raise sufficient capital on acceptable terms, or at all, to continue operations and may not be able to execute any strategic transaction. Our liquidity, and our ability to raise additional capital or complete any strategic transaction, depends on a number of factors, including, but not limited to, the following:
The sale of additional equity or convertible debt securities will likely result in substantial additional dilution to our stockholders. If we raise additional funds through the incurrence of indebtedness, the obligations related to such indebtedness would be senior to rights of holders of our capital stock and could contain covenants that would restrict our operations. We also cannot predict what consideration might be available, if any, to us or our stockholders, in connection with any strategic transaction. Should strategic alternatives or additional capital not be available to us in the near term, or not be available on acceptable terms, we may be unable to realize value from its assets and discharge its liabilities in the normal course of business which may, among other alternatives, cause us to further delay, substantially reduce or discontinue operational activities to conserve its cash resources. |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies) |
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Dec. 31, 2015 | |||||||||
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES [Abstract] | |||||||||
Cash and Cash Equivalents | Cash and Cash Equivalents Cash and cash equivalents include highly liquid investments with original maturities of three months or less. The carrying value of these cash equivalents approximates fair value. We invest cash in excess of immediate requirements in money market accounts, certificates of deposit, corporate commercial paper with high quality ratings, and U.S. government securities taking into consideration the need for liquidity and capital preservation. These investments are not held for trading or other speculative purposes. |
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Accounts Receivable and Allowance for Doubtful Accounts | Accounts Receivable and Allowance for Doubtful Accounts Accounts receivable are recorded at the invoiced amount and do not bear interest. We estimate the collectability of our accounts receivable. In order to assess the collectability of these receivables, we monitor the current creditworthiness of each customer and analyze the balances aged beyond the customer's credit terms. Theses evaluations may indicate a situation in which a certain customer cannot meet its financial obligations due to deterioration of its financial viability, credit ratings or bankruptcy. The allowance requirements are based on current facts and are reevaluated and adjusted as additional information is received. Accounts receivable are subject to an allowance for collection when it is probable that the balance will not be collected. As of December 31, 2015 and 2014, the allowance for doubtful accounts was $100,672 and $887, respectively. For the years ended December 31, 2015 and 2014, the accounts written off as uncollectible were $14,347 and $779, respectively. |
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Inventory | Inventory Inventories are stated at the lower of cost or market value. Raw material inventory cost is determined on the first-in, first-out method. Costs of finished goods are determined by an actual cost method. We regularly review inventories on hand and write down the carrying value of our inventories for excess and potentially obsolete inventories based on historical usage and estimated future usage. In assessing the ultimate realization of our inventories, we are required to make judgments as to future demand requirements. As actual future demand or market conditions may vary from those projected by us, adjustment to inventories may be required. |
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Prepaid Expenses and Deferred Charges | Prepaid Expenses and Deferred Charges As of December 31, 2015 and 2014, prepaid expenses were composed primarily of insurance policy costs. We amortize our insurance costs ratably over the term of each policy. Typically, our insurance policies are subject to renewal in July and October of each year. |
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Property, Equipment and Leasehold Improvements | Property, Equipment and Leasehold Improvements Property, equipment, and leasehold improvements are recorded at cost. Depreciation is provided over the estimated useful lives of the related assets using the straight-line method. Estimated useful lives for property, equipment, and leasehold improvements categories are as follows:
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Intangible Assets | Intangible Assets We expense internal patent and application costs as incurred because, even though we believe the patents and underlying processes have continuing value, the amount of future benefits to be derived from them are uncertain. Purchased patents are capitalized and amortized over the life of the patent. |
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Licensing Rights | Licensing Rights Purchased licensing rights are capitalized and amortized over the life of the patent associated with the licensed product. |
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Impairment of Assets | Impairment of Assets In accordance with the provisions of Accounting Standards Codification (“ASC”) Topic 350-30, Intangibles Other than Goodwill, our policy is to evaluate whether there has been a permanent impairment in the value of long-lived assets and certain identifiable intangibles when certain events have taken place that indicate the remaining unamortized balance may not be recoverable, or at least annually to determine the current value of the intangible asset. When factors indicate that the intangible assets should be evaluated for possible impairment, we use an estimate of undiscounted cash flows. Considerable management judgment is necessary to estimate the undiscounted cash flows. Accordingly, actual results could vary significantly from management’s estimates. |
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Debt Issuance Costs | Debt Issuance Costs We defer debt issuance costs associated with the issuance of our promissory note payable and amortize those costs over the period of the promissory note obligation using the effective interest method. In 2015, we incurred $50,000 of debt issuance costs related to our promissory note payable with Inter-Mountain Capital Corp. During 2015 and 2014, we recorded amortization of approximately $27,000 and $7,000, respectively, of deferred financing costs. Unamortized debt issuance costs at December 31, 2015 and 2014 were approximately of $23,000 and nil, respectively. |
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Accrual for Clinical Study Costs | Accrual for Clinical Study Costs We record accruals for estimated clinical study costs. Clinical study costs represent costs incurred by clinical research organizations, or CROs, and clinical sites. These costs are recorded as a component of research and development expenses. We analyze the progress of the clinical trials, including levels of patient enrollment and/or patient visits, invoices received and contracted costs when evaluating the adequacy of the accrued liabilities. Significant judgments and estimates must be made and used in determining the accrued balance in any accounting period. Actual costs incurred may or may not match the estimated costs for a given accounting period. As of December 31, 2015 and 2014, the accrual for estimated clinical study costs was nil. |
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Shipping and Handling Costs | Shipping and Handling Costs Shipping and handling costs incurred for product shipments are included in cost of goods sold. |
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Income Taxes | Income Taxes We use the liability method of accounting for income taxes pursuant to ASC Topic 740, Income Taxes. Under this method, deferred income taxes are recorded to reflect the tax consequences in future periods of temporary differences between the tax basis of assets and liabilities and their financial statement amounts at year-end. |
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Revenue Recognition and Deferred Revenue | Revenue Recognition and Deferred Revenue License Fees We recognize revenue from license payments not tied to achieving a specific performance milestone ratably during the period over which we are obligated to perform services. The period over which we are obligated to perform services is estimated based on available facts and circumstances. Determination of any alteration of the performance period normally indicated by the terms of such agreements involves judgment on management's part. License revenues with no specific performance criteria are recognized when received from our foreign licensee and their various foreign sub-licensees as there is no control by us over the various foreign sub-licensees and no performance criteria to which we are subject. We recognize revenue from performance payments ratably, when such performance is substantially in our control and when we believe that completion of such performance is reasonably probable, over the period during which we estimate that we will complete such performance obligations. In circumstances where the arrangement includes a refund provision, we defer revenue recognition until the refund condition is no longer applicable unless, in our judgment, the refund circumstances are within our operating control and are unlikely to occur. Substantive at-risk milestone payments, which are based on achieving a specific performance milestone when performance of such milestone is contingent on performance by others or for which achievement cannot be reasonably estimated or assured, are recognized as revenue when the milestone is achieved and the related payment is due, provided that there is no substantial future service obligation associated with the milestone. Royalty Income We receive royalty revenues under license agreements with a number of third parties that sell products based on technology we have developed or to which we have rights. The license agreements provide for the payment of royalties to us based on sales of the licensed products. We record these revenues based on estimates of the sales that occurred during the relevant period. The relevant period estimates of sales are based on interim data provided by licensees and analysis of historical royalties we have been paid (adjusted for any changes in facts and circumstances, as appropriate). We maintain regular communication with our licensees in order to gauge the reasonableness of our estimates. Differences between actual royalty revenues and estimated royalty revenues are reconciled and adjusted for in the period in which they become known, typically the following quarter. Historically, adjustments have not been material based on actual amounts paid by licensees. As it relates to royalty income, there are no future performance obligations on our part under these license agreements. To the extent we do not have sufficient ability to accurately estimate revenue; we record it on a cash basis. Product Sales We recognize revenue and related costs from the sale of our products at the time the products are shipped to the customer. Provisions for returns, rebates, and discounts are established in the same period the related product sales are recorded. We review the supply levels of our products sold to major wholesalers in the U.S., primarily by reviewing reports supplied by our major wholesalers and available volume information for our products, or alternative approaches. When we believe wholesaler purchasing patterns have caused an unusual increase or decrease in the sales of a major product compared with underlying demand, we disclose this in our product sales discussion if we believe the amount is material to the product sales trend; however, we are not always able to accurately quantify the amount of stocking or destocking. Wholesaler stocking and destocking activity historically has not caused any material changes in the rate of actual product returns. We establish sales return accruals for anticipated product returns. We record the return amounts as a deduction to arrive at our net product sales. Consistent with Revenue Recognition accounting guidance, we estimate a reserve when the sales occur for future product returns related to those sales. This estimate is primarily based on historical return rates as well as specifically identified anticipated returns due to known business conditions and product expiry dates. Actual product returns have been nil over the past two years. We establish sales rebate and discount accruals in the same period as the related sales. The rebate and discount amounts are recorded as a deduction to arrive at our net product sales. We base these accruals primarily upon our historical rebate and discount payments made to our customer segment groups and the provisions of current rebate and discount contracts. |
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Foreign currency transaction gain (loss) | Foreign currency transaction gain (loss) Our functional currency and our reporting currency is the U.S. dollar and foreign currency transactions are primarily undertaken in Euros. Monetary assets and liabilities are translated using the foreign currency exchange rate prevailing at the balance sheet date. Revenues, non-monetary assets and liabilities denominated in foreign currencies are translated at rates of foreign currency exchange in effect at the date of the transaction. Expenses are translated at average foreign currency exchange rates for the period. Gains and losses arising on translation or settlement of foreign currency denominated transactions or balances are included in the determination of net income. |
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Research and Development Expenses | Research and Development Expenses Pursuant to ASC Topic 730, Research and Development, our research and development costs are expensed as incurred. Research and development expenses include, but are not limited to, salaries and benefits, laboratory supplies, facilities expenses, preclinical development cost, clinical trial and related clinical manufacturing expenses, contract services, consulting fees and other outside expenses. The cost of materials and equipment or facilities that are acquired for research and development activities and that have alternative future uses are capitalized when acquired. There were no such capitalized materials, equipment or facilities for the years ended December 31, 2015 and 2014. |
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Basic and Diluted Net Loss Per Common Share | Basic and Diluted Net Loss Per Common Share In accordance with ASC Topic 260, Earnings per Share, 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 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 and warrants from the calculation of diluted net loss per common share because all such securities are antidilutive for all periods presented. |
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Concentrations of Credit Risk | Concentrations of Credit Risk Concentration of credit risk with respect to financial instruments, consisting primarily of cash and cash equivalents, that potentially expose us to concentrations of credit risk due to the use of a limited number of banking institutions and due to maintaining cash balances in banks, which, at times, may exceed the limits of amounts insured by the Federal Deposit Insurance Corporation. During 2015 and 2014, we utilized Bank of America, N.A. as our banking institution. At December 31, 2015 and December 31, 2014 our cash and cash equivalents totaled $180,000 and $550,458, respectively. We also invest cash in excess of immediate requirements in money market accounts, certificates of deposit, corporate commercial paper with high quality ratings, and U.S. government securities. These investments are not held for trading or other speculative purposes. We are exposed to credit risk in the event of default by these high quality corporations. Concentration of credit risk with respect to trade accounts receivable are customers with balances that exceed 5% of total consolidated trade accounts receivable at December 31, 2015 and at December 31, 2014. As of December 31, 2015, one customer, being one of our international distributors, exceeded the 5% threshold, with 92%. Three customers, each being one of our international distributors, exceeded the 5% threshold at December 31, 2014, with 71%, 19%, and 9%, 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. |
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Concentrations of Foreign Currency Risk | Concentrations of Foreign Currency Risk A portion of our revenues and all of our expenses are denominated in U.S. dollars. We are expecting an increase in revenues in international territories denominated in a foreign currency. Certain of our licensing and distribution agreements in international territories are denominated in Euros. Currently, we do not employ forward contracts or other financial instruments to mitigate foreign currency risk. As our international operations continue to grow, we may engage in hedging activities to hedge our exposure to foreign currency risk. |
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Fair Value of Financial Instruments | Fair Value of Financial Instruments In accordance with portions of ASC Topic 820, Fair Value Measurements, 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. Our financial instruments, including cash, cash equivalents, accounts receivable, and accounts payable are carried at cost, which approximates their fair value because of the short-term maturity of these instruments. We believe that the carrying value of our other receivable, notes receivable and accrued interest, and convertible note payable balances approximates fair value based on a valuation methodology using the income approach and a discounted cash flow model. |
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Derivatives | Derivatives We occasionally issue financial instruments that contain an embedded instrument. At inception, we assess whether the economic characteristics of the embedded derivative instrument are clearly and closely related to the economic characteristics of the financial instrument (host contract), whether the financial instrument that embodies both the embedded derivative instrument and the host contract is currently measured at fair value with changes in fair value reported in earnings, and whether a separate instrument with the same terms as the embedded instrument would meet the definition of a derivative instrument. If the embedded derivative instrument is determined not to be clearly and closely related to the host contract, is not currently measured at fair value with changes in fair value reported in earnings, and the embedded derivative instrument would qualify as a derivative instrument, the embedded derivative instrument is recorded apart from the host contract and carried at fair value with changes recorded in current-period earnings. We determined that all embedded items associated with financial instruments during 2015 and 2014 which qualify for derivative treatment, were properly separated from their host. As of December 31, 2015 and 2014, we did not have any derivative instruments. |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Tables) |
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Dec. 31, 2015 | |||||||||
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES [Abstract] | |||||||||
Estimated useful lives for property and equipment | Estimated useful lives for property, equipment, and leasehold improvements categories are as follows:
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SEGMENT INFORMATION (Tables) |
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SEGMENT INFORMATION [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Revenues per geographic area | Revenues per geographic area, along with relative percentages of total revenues, for the year ended December 31, are summarized as follows:
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Customers with greater than 10% of total sales | Customers with greater than 10% of total revenues, along with their relative percentage of total revenues, for the year ended December 31 are represented on the following table:
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INVENTORY (Tables) |
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INVENTORY [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||
Inventory | The components of inventory, at the different stages of production, consisted of the following at December 31:
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PROPERTY, EQUIPMENT AND LEASEHOLD IMPROVEMENTS (Tables) |
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PROPERTY, EQUIPMENT AND LEASEHOLD IMPROVEMENTS [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Property, equipment and leasehold improvements | Property, equipment and leasehold improvements, net, consisted of the following at December 31:
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INTANGIBLE ASSETS (Tables) |
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Dec. 31, 2015 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
INTANGIBLE ASSETS [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Intangible assets | Intangible assets, net consisted of the following at December 31:
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Future aggregate amortization expense for intangible assets | The future aggregate amortization expense for intangible assets, remaining as of December 31, 2015, is as follows:
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LICENSING RIGHTS (Tables) |
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Finite-Lived Intangible Assets [Line Items] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of finite-lived intangible assets | Intangible assets, net consisted of the following at December 31:
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Future aggregate amortization expense for intangible assets | The future aggregate amortization expense for intangible assets, remaining as of December 31, 2015, is as follows:
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Licensing Agreements [Member] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Schedule of finite-lived intangible assets | Licensing rights, net consisted of the following at December 31:
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Future aggregate amortization expense for intangible assets | The future aggregate amortization expense for intangible assets, remaining as of December 31, 2015, is as follows:
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INVESTMENT IN UNCONSOLIDATED SUBSIDIARY (Tables) |
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ORADISC GmbH [Member] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Equity Method Investments [Line Items] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Summarized financial information for investment | Summarized financial information for our investment in ORADISC GmbH assuming 100% ownership is as follows:
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ACCRUED LIABILITIES (Tables) |
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ACCRUED LIABILITIES [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Accrued liabilities | Accrued liabilities consisted of the following at December 31:
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CONVERTIBLE DEBT (Tables) |
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CONVERTIBLE DEBT [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Information relating to convertible notes payable | Information relating to the April 2015 Note is as follows:
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Schedule of future minimum payments relating to our convertible notes payable | The future minimum payments relating to the April 2015 Note, as of December 31, 2015, are as follows:
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STOCKHOLDERS' EQUITY (Tables) |
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STOCKHOLDERS' EQUITY [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Warrants outstanding and number of shares of common stock subject to exercise | The following table summarizes the warrants outstanding and the number of shares of common stock subject to exercise as of December 31, 2015 and the changes therein during the two years then ended:
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Expiration dates for warrants subject to exercise | Of the warrant shares subject to exercise as of December 31, 2015, expiration of the right to exercise is as follows:
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EARNINGS PER SHARE (Tables) |
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EARNINGS PER SHARE [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||
Common shares excluded from calculating basic and diluted net loss per common share | Shares used in calculating basic and diluted net loss per common share exclude these potential common shares as of December 31:
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SHARE BASED COMPENSATION (Tables) |
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Stock option awards granted | Our Board of Directors granted the following incentive stock option awards to executives or employees and nonstatutory stock option awards to directors or non-employees for the years ended December 31:
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Weighted average assumptions to estimate the fair value of share based awards | 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 years ended December 31:
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Allocated share-based compensation expense | The following table summarizes share-based compensation related to stock options for the years ended December 31:
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Stock option activity | The following table summarizes the stock options outstanding and the number of shares of common stock subject to exercise as of December 31, 2015 and the changes therein during the two years then ended:
|
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Stock option grants outstanding and exercisable | The following table presents the stock option grants outstanding and exercisable as of December 31, 2015:
|
FAIR VALUE MEASUREMENTS (Tables) |
12 Months Ended | |||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Dec. 31, 2015 | ||||||||||||||||||||||||||||
FAIR VALUE MEASUREMENTS [Abstract] | ||||||||||||||||||||||||||||
Fair value of our financial instruments | The fair value of our financial instruments consisted of the following at December 31:
|
INCOME TAXES (Tables) |
12 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dec. 31, 2015 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
INCOME TAXES [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Expiration of consolidated operating loss carryforwards and research credit carryforwards | The following are the consolidated operating loss carryforwards and research credit carryforwards that will begin expiring as follows:
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Deferred tax assets and deferred tax liabilities | An analysis of the tax effects of temporary differences that give rise to significant portions of the deferred tax assets and deferred tax liabilities at December 31, 2015 and 2014 are as follows:
|
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Reconciliation of expected statutory federal income tax rate to actual income tax rate | The following is a reconciliation of the expected statutory federal income tax rate to our actual income tax rate for the years ended December 31:
|
COMMITMENTS AND CONTINGENCIES (Tables) |
12 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Dec. 31, 2015 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
COMMITMENTS AND CONTINGENCIES [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Future minimum lease payments | The future minimum lease payments under the 2013 office lease and the 2015 equipment lease are as follows as of December 31, 2015:
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Summary of compensation earned, compensation paid in cash, and compensation temporarily deferred | As of December 31, 2015, the following table summarizes the compensation temporarily deferred and subsequent repayments:
|
SEGMENT INFORMATION (Details) |
12 Months Ended | |
---|---|---|
Dec. 31, 2015
USD ($)
Segment
Licensee
|
Dec. 31, 2014
USD ($)
|
|
SEGMENT INFORMATION [Abstract] | ||
Number of business segments | Segment | 1 | |
Number of international licensees | Licensee | 19 | |
Revenues per geographic area [Abstract] | ||
Total Revenues | $ 935,739 | $ 863,857 |
Total Revenue, percentage | 100.00% | 100.00% |
Reportable Geographical Components [Member] | Domestic [Member] | ||
Revenues per geographic area [Abstract] | ||
Total Revenues | $ 28,030 | $ 37,465 |
Total Revenue, percentage | 3.00% | 4.00% |
Reportable Geographical Components [Member] | International [Member] | ||
Revenues per geographic area [Abstract] | ||
Total Revenues | $ 907,709 | $ 826,392 |
Total Revenue, percentage | 97.00% | 96.00% |
SEGMENT INFORMATION, Reporting Segment (Details) |
12 Months Ended | |
---|---|---|
Dec. 31, 2015 |
Dec. 31, 2014 |
|
Revenue, Major Customer [Line Items] | ||
Sales from major customer, percentage | 100.00% | 100.00% |
Revenue [Member] | Customer Concentration Risk [Member] | ||
Revenue, Major Customer [Line Items] | ||
Sales from major customer, percentage | 76.00% | 91.00% |
Revenue [Member] | Customer Concentration Risk [Member] | Customer A [Member] | Altrazeal [Member] | ||
Revenue, Major Customer [Line Items] | ||
Sales from major customer, percentage | 58.00% | 80.00% |
Revenue [Member] | Customer Concentration Risk [Member] | Customer B [Member] | Altrazeal [Member] | ||
Revenue, Major Customer [Line Items] | ||
Sales from major customer, percentage | 18.00% | 11.00% |
INVENTORY (Details) - USD ($) |
12 Months Ended | |
---|---|---|
Dec. 31, 2015 |
Dec. 31, 2014 |
|
INVENTORY [Abstract] | ||
Obsolete finished goods | $ 1,600 | $ 19,000 |
Components of inventory [Abstract] | ||
Raw materials | 38,037 | 41,648 |
Work-in-progress | 485,123 | 271,571 |
Finished goods | 8,261 | 12,438 |
Total | $ 531,421 | $ 325,657 |
ACCRUED LIABILITIES (Details) - USD ($) |
Dec. 31, 2015 |
Dec. 31, 2014 |
---|---|---|
Accrued Liabilities [Abstract] | ||
Accrued compensation/benefits | $ 329,131 | $ 96,795 |
Accrued taxes - payroll | 0 | 106,299 |
Accrued insurance payable | 73,074 | 69,815 |
Product rebates/returns | 9 | 13 |
Other | 0 | 279 |
Total accrued liabilities | $ 402,214 | $ 273,201 |
EQUITY TRANSACTIONS (Details) - USD ($) |
1 Months Ended | 12 Months Ended | ||
---|---|---|---|---|
Nov. 30, 2015 |
Oct. 31, 2015 |
Dec. 31, 2015 |
Dec. 31, 2014 |
|
Common Stock Transactions [Abstract] | ||||
Equity investment | $ 1,588,225 | |||
Issuance of shares of common stock under securities purchase agreement (in shares) | 4,179,539 | |||
Share price (in dollars per share) | $ 0.38 | |||
Proceeds from offering | $ 207,000 | $ 1,050,000 | $ 1,257,027 | $ 0 |
Percentage of referral fee to european placement agent | 12.00% |
STOCKHOLDERS' EQUITY (Details) - shares |
12 Months Ended | |
---|---|---|
Dec. 31, 2015 |
Dec. 31, 2014 |
|
Common Stock [Abstract] | ||
Common stock, shares issued (in shares) | 36,834,933 | 24,458,018 |
Common stock, shares outstanding (in shares) | 36,834,933 | 24,458,018 |
Common stock issued during period (in shares) | 12,376,915 | |
Number of shares of common stock issued for Altrazeal Trading and IPMD pursuant (in shares) | 6,536,847 | |
Stock issued in lieu of offering agreement (in shares) | 3,830,131 | |
Inter-Mountain [Member] | ||
Common Stock [Abstract] | ||
Common stock issued for the cashless conversion of a warrant (in shares) | 361,516 | |
April 2015 Note [Member] | Inter-Mountain [Member] | ||
Common Stock [Abstract] | ||
Number shares of common stock issued for installment payments (in shares) | 1,648,421 | |
Preferred Stock [Member] | ||
Preferred Stock [Abstract] | ||
Preferred stock, shares issued (in shares) | 0 |
STOCKHOLDERS' EQUITY, Warrants (Details) |
12 Months Ended | |||
---|---|---|---|---|
Dec. 31, 2015
$ / shares
shares
|
Dec. 31, 2014
$ / shares
shares
|
Dec. 31, 2015
$ / shares
shares
|
Apr. 15, 2015
shares
|
|
Warrants and number of shares of common stock subject to exercise [Roll Forward] | ||||
Balance (in shares) | 1,676,401 | 4,665,451 | ||
Warrants issued (in shares) | 847,804 | 80,000 | ||
Warrants exercised (in shares) | (392,857) | (3,000,000) | ||
Warrants cancelled (in shares) | (357,155) | (69,050) | ||
Balance (in shares) | 1,774,193 | 1,676,401 | ||
Warrants, weighted-average exercise price [Abstract] | ||||
Balance (in dollars per share) | $ / shares | 1.14 | 0.82 | ||
Warrants issued (in dollars per share) | $ / shares | 0.72 | 1.20 | ||
Warrants exercised (in dollars per share) | $ / shares | 0.35 | 0.60 | ||
Warrants cancelled (in dollars per share) | $ / shares | 2.85 | 3.22 | ||
Balance (in dollars per share) | $ / shares | 0.77 | 1.14 | ||
Warrant shares subject to expiration [Abstract] | ||||
Number of warrant shares of common stock subject to expiration (in shares) | 1,774,193 | 4,665,451 | 1,774,193 | |
Aggregate shares of common stock issued upon exercise of warrants (in shares) | 847,804 | 361,516 | ||
Inter-Mountain [Member] | April 2015 Note [Member] | ||||
Warrant shares subject to expiration [Abstract] | ||||
Aggregate shares of common stock issued upon exercise of warrants (in shares) | 194,118 | |||
Exercise price of warrants (in dollars per share) | $ / shares | $ 0.85 | |||
Altrazeal Trading [Member] | ||||
Warrant shares subject to expiration [Abstract] | ||||
Aggregate shares of common stock issued upon exercise of warrants (in shares) | 444,161 | |||
Exercise price of warrants (in dollars per share) | $ / shares | $ 0.68 | |||
IPMD [Member] | ||||
Warrant shares subject to expiration [Abstract] | ||||
Aggregate shares of common stock issued upon exercise of warrants (in shares) | 209,525 | |||
Exercise price of warrants (in dollars per share) | $ / shares | $ 0.68 | |||
June 13, 2016 [Member] | ||||
Warrants and number of shares of common stock subject to exercise [Roll Forward] | ||||
Balance (in shares) | 35,000 | |||
Warrant shares subject to expiration [Abstract] | ||||
Number of warrant shares of common stock subject to expiration (in shares) | 35,000 | 35,000 | ||
July 16, 2016 [Member] | ||||
Warrants and number of shares of common stock subject to exercise [Roll Forward] | ||||
Balance (in shares) | 116,667 | |||
Warrant shares subject to expiration [Abstract] | ||||
Number of warrant shares of common stock subject to expiration (in shares) | 116,667 | 116,667 | ||
July 28, 2016 [Member] | ||||
Warrants and number of shares of common stock subject to exercise [Roll Forward] | ||||
Balance (in shares) | 34,722 | |||
Warrant shares subject to expiration [Abstract] | ||||
Number of warrant shares of common stock subject to expiration (in shares) | 34,722 | 34,722 | ||
December 24, 2016 [Member] | ||||
Warrants and number of shares of common stock subject to exercise [Roll Forward] | ||||
Balance (in shares) | 653,686 | |||
Warrant shares subject to expiration [Abstract] | ||||
Number of warrant shares of common stock subject to expiration (in shares) | 653,686 | 653,686 | ||
March 14, 2018 [Member] | ||||
Warrants and number of shares of common stock subject to exercise [Roll Forward] | ||||
Balance (in shares) | 660,000 | |||
Warrant shares subject to expiration [Abstract] | ||||
Number of warrant shares of common stock subject to expiration (in shares) | 660,000 | 660,000 | ||
January 15, 2019 [Member] | ||||
Warrants and number of shares of common stock subject to exercise [Roll Forward] | ||||
Balance (in shares) | 80,000 | |||
Warrant shares subject to expiration [Abstract] | ||||
Number of warrant shares of common stock subject to expiration (in shares) | 80,000 | 80,000 | ||
April 30, 2020 [Member] | ||||
Warrants and number of shares of common stock subject to exercise [Roll Forward] | ||||
Balance (in shares) | 194,118 | |||
Warrant shares subject to expiration [Abstract] | ||||
Number of warrant shares of common stock subject to expiration (in shares) | 194,118 | 194,118 |
EARNINGS PER SHARE (Details) - $ / shares |
12 Months Ended | ||||||
---|---|---|---|---|---|---|---|
Dec. 31, 2015 |
Dec. 31, 2014 |
||||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||||||
Antidilutive securities excluded from calculating basic and diluted net loss per common share (in shares) | 5,373,484 | 3,376,308 | |||||
Conversion price per share (in dollars per share) | [1] | $ 0 | |||||
Warrants to Purchase Common Stock [Member] | |||||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||||||
Antidilutive securities excluded from calculating basic and diluted net loss per common share (in shares) | 1,774,193 | 1,676,401 | |||||
Stock Options to Purchase Common Stock [Member] | |||||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||||||
Antidilutive securities excluded from calculating basic and diluted net loss per common share (in shares) | 1,664,573 | 1,699,907 | |||||
Common Stock Issuable upon the Assumed Conversion of Payments due Under our Promissory Note from April 2015 [Member] | |||||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||||||
Antidilutive securities excluded from calculating basic and diluted net loss per common share (in shares) | [2] | 1,934,718 | 0 | ||||
Percentage of weighted average prices of shares of common stock | 80.00% | ||||||
Preceding number of trading days to calculate weighted average common stock price | 20 days | ||||||
Declined percentage of weighted average prices of shares of common stock | 70.00% | ||||||
Weighted average price of shares of common stock, Maximum (in dollars per share) | $ 0.05 | ||||||
Conversion price per share (in dollars per share) | $ 0.10 | ||||||
|
SHARE BASED COMPENSATION (Details) - USD ($) |
12 Months Ended | ||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Jun. 05, 2014 |
Jun. 13, 2013 |
Jun. 14, 2012 |
Jun. 15, 2010 |
Dec. 17, 2009 |
May. 08, 2007 |
Dec. 31, 2015 |
Dec. 31, 2014 |
||||||||||||
Incentive Stock Options [Member] | |||||||||||||||||||
Options Granted [Abstract] | |||||||||||||||||||
Quantity (in shares) | [1] | 0 | 125,000 | ||||||||||||||||
Weighted average fair value per share (in dollars per share) | [1] | $ 0 | $ 0.81 | ||||||||||||||||
Fair value | [1] | $ 0 | $ 101,171 | ||||||||||||||||
Weighted average assumptions to estimate the fair value of share-based awards [Abstract] | |||||||||||||||||||
Expected volatility | [2] | 0.00% | 107.66% | ||||||||||||||||
Risk-fee interest rate % | [3] | 0.00% | 1.75% | ||||||||||||||||
Expected term | 0 years | 5 years | |||||||||||||||||
Dividend yield | [4] | 0.00% | 0.00% | ||||||||||||||||
Options, Outstanding [Roll Forward] | |||||||||||||||||||
Granted (in shares) | [1] | 0 | 125,000 | ||||||||||||||||
Non-statutory Stock Options [Member] | |||||||||||||||||||
Options Granted [Abstract] | |||||||||||||||||||
Quantity (in shares) | [5] | 0 | 560,000 | ||||||||||||||||
Weighted average fair value per share (in dollars per share) | [5] | $ 0 | $ 0.81 | ||||||||||||||||
Fair value | [5] | $ 0 | $ 453,250 | ||||||||||||||||
Weighted average assumptions to estimate the fair value of share-based awards [Abstract] | |||||||||||||||||||
Expected volatility | [2] | 0.00% | 107.66% | ||||||||||||||||
Risk-fee interest rate % | [3] | 0.00% | 1.75% | ||||||||||||||||
Expected term | 0 years | 5 years | |||||||||||||||||
Dividend yield | [4] | 0.00% | 0.00% | ||||||||||||||||
Options, Outstanding [Roll Forward] | |||||||||||||||||||
Granted (in shares) | [5] | 0 | 560,000 | ||||||||||||||||
Stock Options [Member] | |||||||||||||||||||
Options Granted [Abstract] | |||||||||||||||||||
Quantity (in shares) | 0 | 685,000 | |||||||||||||||||
Options, Outstanding [Roll Forward] | |||||||||||||||||||
Outstanding, beginning of period (in shares) | 1,699,907 | 1,014,907 | |||||||||||||||||
Granted (in shares) | 0 | 685,000 | |||||||||||||||||
Forfeited/cancelled (in shares) | (35,334) | 0 | |||||||||||||||||
Exercised (in shares) | 0 | 0 | |||||||||||||||||
Outstanding, end of period (in shares) | 1,664,573 | 1,699,907 | |||||||||||||||||
Outstanding, Weighted Average Exercise Price [Roll Forward] | |||||||||||||||||||
Outstanding, beginning of period (in dollars per share) | $ 1.73 | $ 2.12 | |||||||||||||||||
Granted (in dollars per share) | 0 | 1.15 | |||||||||||||||||
Forfeited/cancelled (in dollars per share) | 1.77 | 0 | |||||||||||||||||
Exercised (in dollars per share) | 0 | 0 | |||||||||||||||||
Outstanding, end of period (in dollars per share) | $ 1.73 | $ 1.73 | |||||||||||||||||
Nonvested Awards, unearned share-based compensation [Abstract] | |||||||||||||||||||
Unearned share-based compensation expense | $ 121,000 | ||||||||||||||||||
Unearned share-based compensation, recognition period | 21 months | ||||||||||||||||||
Restricted Stock [Member] | |||||||||||||||||||
Nonvested Awards, unearned share-based compensation [Abstract] | |||||||||||||||||||
Unearned share-based compensation expense | $ 0 | ||||||||||||||||||
Restricted Stock [Member] | Minimum [Member] | |||||||||||||||||||
Additional disclosures [Abstract] | |||||||||||||||||||
Vesting period | 6 months | ||||||||||||||||||
Restricted Stock [Member] | Maximum [Member] | |||||||||||||||||||
Additional disclosures [Abstract] | |||||||||||||||||||
Vesting period | 5 years | ||||||||||||||||||
Contractual term | 10 years | ||||||||||||||||||
2006 Equity Incentive Plan [Member] | |||||||||||||||||||
Additional disclosures [Abstract] | |||||||||||||||||||
Number of shares authorized (in shares) | 133,333 | ||||||||||||||||||
Number of additional shares authorized (in shares) | 1,000,000 | 600,000 | 400,000 | 200,000 | 200,000 | 266,667 | 2,800,000 | ||||||||||||
Number of shares available for grant (in shares) | 1,065,981 | ||||||||||||||||||
2006 Equity Incentive Plan [Member] | Stock Options [Member] | |||||||||||||||||||
Additional disclosures [Abstract] | |||||||||||||||||||
Number of options granted to date (in shares) | 2,061,167 | ||||||||||||||||||
2006 Equity Incentive Plan [Member] | Stock Options [Member] | Minimum [Member] | |||||||||||||||||||
Additional disclosures [Abstract] | |||||||||||||||||||
Vesting period | 1 year | ||||||||||||||||||
2006 Equity Incentive Plan [Member] | Stock Options [Member] | Maximum [Member] | |||||||||||||||||||
Additional disclosures [Abstract] | |||||||||||||||||||
Vesting period | 4 years | ||||||||||||||||||
2006 Equity Incentive Plan [Member] | Restricted Stock [Member] | |||||||||||||||||||
Additional disclosures [Abstract] | |||||||||||||||||||
Number of restricted shares granted to date (in shares) | 68,616 | ||||||||||||||||||
2006 Equity Incentive Plan [Member] | Restricted Stock [Member] | Minimum [Member] | |||||||||||||||||||
Additional disclosures [Abstract] | |||||||||||||||||||
Vesting period | 6 months | ||||||||||||||||||
2006 Equity Incentive Plan [Member] | Restricted Stock [Member] | Maximum [Member] | |||||||||||||||||||
Additional disclosures [Abstract] | |||||||||||||||||||
Vesting period | 5 years | ||||||||||||||||||
|
SHARE BASED COMPENSATION, Allocated Compensation expense (Details) - Stock Options [Member] - USD ($) |
12 Months Ended | |
---|---|---|
Dec. 31, 2015 |
Dec. 31, 2014 |
|
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||
Share-based compensation expense | $ 152,984 | $ 149,170 |
Research and Development [Member] | ||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||
Share-based compensation expense | 69,028 | 35,861 |
Selling, General and Administrative [Member] | ||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||
Share-based compensation expense | $ 83,956 | $ 113,309 |
SHARE BASED COMPENSATION, Stock options grant outstanding and excercisable (Details) |
12 Months Ended |
---|---|
Dec. 31, 2015
$ / shares
shares
| |
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items] | |
Stock Options Outstanding (in shares) | shares | 1,664,573 |
Options Outstanding, Weighted Average Exercise Price per Share (in dollars per share) | $ / shares | $ 1.73 |
Options Outstanding, Weighted Average Remaining Contractual Life in Years | 6 years 9 months 18 days |
Stock Options Exercisable (in shares) | shares | 897,073 |
Options Exercisable, Weighted Average Exercise Price per Share (in dollars per share) | $ / shares | $ 2.45 |
Exercise Price Range 1 [Member] | |
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items] | |
Stock Options Outstanding (in shares) | shares | 882,500 |
Options Outstanding, Weighted Average Exercise Price per Share (in dollars per share) | $ / shares | $ 0.33 |
Options Outstanding, Weighted Average Remaining Contractual Life in Years | 7 years 2 months 12 days |
Stock Options Exercisable (in shares) | shares | 640,000 |
Options Exercisable, Weighted Average Exercise Price per Share (in dollars per share) | $ / shares | $ 0.33 |
Exercise Price Range 2 [Member] | |
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items] | |
Stock Options Outstanding (in shares) | shares | 680,000 |
Options Outstanding, Weighted Average Exercise Price per Share (in dollars per share) | $ / shares | $ 1.15 |
Options Outstanding, Weighted Average Remaining Contractual Life in Years | 6 years 10 months 24 days |
Stock Options Exercisable (in shares) | shares | 155,000 |
Options Exercisable, Weighted Average Exercise Price per Share (in dollars per share) | $ / shares | $ 1.15 |
Exercise Price Range 3 [Member] | |
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items] | |
Stock Options Outstanding (in shares) | shares | 33,334 |
Options Outstanding, Weighted Average Exercise Price per Share (in dollars per share) | $ / shares | $ 2.55 |
Options Outstanding, Weighted Average Remaining Contractual Life in Years | 4 years 3 months 18 days |
Stock Options Exercisable (in shares) | shares | 33,334 |
Options Exercisable, Weighted Average Exercise Price per Share (in dollars per share) | $ / shares | $ 2.55 |
Exercise Price Range 4 [Member] | |
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items] | |
Stock Options Outstanding (in shares) | shares | 68,739 |
Options Outstanding, Weighted Average Exercise Price per Share (in dollars per share) | $ / shares | $ 25.07 |
Options Outstanding, Weighted Average Remaining Contractual Life in Years | 1 year 7 months 6 days |
Stock Options Exercisable (in shares) | shares | 68,739 |
Options Exercisable, Weighted Average Exercise Price per Share (in dollars per share) | $ / shares | $ 25.07 |
EMPLOYMENT BENEFIT PLAN (Details) - USD ($) |
12 Months Ended | |
---|---|---|
Dec. 31, 2015 |
Dec. 31, 2014 |
|
EMPLOYMENT BENEFIT PLAN [Abstract] | ||
Contributions made to 401(k) plan | $ 18,861 | $ 24,674 |
FAIR VALUE MEASUREMENTS (Details) - USD ($) |
Dec. 31, 2015 |
Dec. 31, 2014 |
---|---|---|
Promissory Note April 2015 [Member] | ||
Liabilities [Abstract] | ||
Convertible note payable | $ 370,000 | $ 0 |
INCOME TAXES (Details) - USD ($) |
12 Months Ended | |
---|---|---|
Dec. 31, 2015 |
Dec. 31, 2014 |
|
Expiration of Operating Loss Carryforwards and Research Credit Carryforwards [Line Items] | ||
Consolidated Operating Loss Carryforwards | $ 53,941,331 | |
Research Activities Carryforwards | $ 552,553 | |
Period of cumulative changes in ownership considered for limit on operating loss and tax credit carryforwards | 3 years | |
Minimum percentage of cumulative changes in ownership considered for limit on operating loss and tax credit carryforwards | 50.00% | |
Deferred tax assets [Abstract] | ||
Net operating loss carryforwards | $ 19,179,724 | $ 18,279,724 |
Intangible assets | 132,836 | 188,944 |
Other | 605,231 | 554,404 |
Total gross deferred tax assets | 19,917,791 | 19,023,072 |
Deferred tax liabilities [Abstract] | ||
Property and equipment | 12,541 | 33,696 |
Total gross deferred tax liabilities | 12,541 | 33,696 |
Net total of deferred assets and liabilities | 19,905,250 | 18,989,376 |
Valuation allowance | (19,905,250) | (18,989,376) |
Net deferred tax assets | 0 | 0 |
Increase in valuation allowance | 915,874 | 644,443 |
Reconciliation of expected statutory federal income tax rate to actual income tax rate [Abstract] | ||
Expected income tax (benefit) at federal statutory tax rate -35% | (961,543) | (681,109) |
Permanent differences | 53,653 | 52,273 |
Research tax credits | (21,113) | (19,491) |
Amortization of deferred start up costs | 0 | 0 |
Valuation allowance | 929,003 | 648,327 |
Income tax expense | $ 0 | 0 |
Federal statutory tax rate | 35.00% | |
Liability for unrecognized tax benefits | $ 0 | $ 0 |
2021 [Member] | ||
Expiration of Operating Loss Carryforwards and Research Credit Carryforwards [Line Items] | ||
Consolidated Operating Loss Carryforwards | 34,248 | |
Research Activities Carryforwards | 0 | |
2023 [Member] | ||
Expiration of Operating Loss Carryforwards and Research Credit Carryforwards [Line Items] | ||
Consolidated Operating Loss Carryforwards | 95,666 | |
Research Activities Carryforwards | 0 | |
2024 [Member] | ||
Expiration of Operating Loss Carryforwards and Research Credit Carryforwards [Line Items] | ||
Consolidated Operating Loss Carryforwards | 910,800 | |
Research Activities Carryforwards | 13,584 | |
2025 [Member] | ||
Expiration of Operating Loss Carryforwards and Research Credit Carryforwards [Line Items] | ||
Consolidated Operating Loss Carryforwards | 1,687,528 | |
Research Activities Carryforwards | 21,563 | |
2026 [Member] | ||
Expiration of Operating Loss Carryforwards and Research Credit Carryforwards [Line Items] | ||
Consolidated Operating Loss Carryforwards | 11,950,281 | |
Research Activities Carryforwards | 60,797 | |
2027 [Member] | ||
Expiration of Operating Loss Carryforwards and Research Credit Carryforwards [Line Items] | ||
Consolidated Operating Loss Carryforwards | 3,431,365 | |
Research Activities Carryforwards | 85,052 | |
2028 [Member] | ||
Expiration of Operating Loss Carryforwards and Research Credit Carryforwards [Line Items] | ||
Consolidated Operating Loss Carryforwards | 8,824,940 | |
Research Activities Carryforwards | 139,753 | |
2029 [Member] | ||
Expiration of Operating Loss Carryforwards and Research Credit Carryforwards [Line Items] | ||
Consolidated Operating Loss Carryforwards | 6,889,761 | |
Research Activities Carryforwards | 81,940 | |
2030 [Member] | ||
Expiration of Operating Loss Carryforwards and Research Credit Carryforwards [Line Items] | ||
Consolidated Operating Loss Carryforwards | 5,113,583 | |
Research Activities Carryforwards | 41,096 | |
2031 [Member] | ||
Expiration of Operating Loss Carryforwards and Research Credit Carryforwards [Line Items] | ||
Consolidated Operating Loss Carryforwards | 3,728,626 | |
Research Activities Carryforwards | 43,592 | |
2032 [Member] | ||
Expiration of Operating Loss Carryforwards and Research Credit Carryforwards [Line Items] | ||
Consolidated Operating Loss Carryforwards | 3,695,792 | |
Research Activities Carryforwards | 8,690 | |
2033 [Member] | ||
Expiration of Operating Loss Carryforwards and Research Credit Carryforwards [Line Items] | ||
Consolidated Operating Loss Carryforwards | 3,187,559 | |
Research Activities Carryforwards | 15,882 | |
2034 [Member] | ||
Expiration of Operating Loss Carryforwards and Research Credit Carryforwards [Line Items] | ||
Consolidated Operating Loss Carryforwards | 1,797,031 | |
Research Activities Carryforwards | 19,491 | |
2035 [Member] | ||
Expiration of Operating Loss Carryforwards and Research Credit Carryforwards [Line Items] | ||
Consolidated Operating Loss Carryforwards | 2,594,151 | |
Research Activities Carryforwards | $ 21,113 |
COMMITMENTS AND CONTINGENCIES (Details) |
1 Months Ended | 2 Months Ended | 9 Months Ended | 12 Months Ended | 14 Months Ended | 23 Months Ended | 48 Months Ended | 60 Months Ended | ||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Oct. 31, 2015
USD ($)
|
Sep. 30, 2015
USD ($)
|
Aug. 31, 2015
USD ($)
|
Jul. 31, 2015
USD ($)
|
Jun. 30, 2015
USD ($)
|
Nov. 30, 2015
USD ($)
|
Oct. 31, 2015
USD ($)
|
Apr. 30, 2015
USD ($)
|
Mar. 31, 2014
USD ($)
|
Dec. 31, 2015
USD ($)
$ / shares
shares
|
Dec. 31, 2015
USD ($)
$ / shares
shares
|
Dec. 31, 2015
USD ($)
$ / shares
€ / shares
shares
|
Mar. 16, 2015
USD ($)
|
Dec. 31, 2014
USD ($)
shares
|
Dec. 31, 2013
USD ($)
|
Mar. 30, 2016
USD ($)
|
Feb. 22, 2013
USD ($)
|
Feb. 01, 2015
USD ($)
|
Mar. 31, 2011
USD ($)
|
Dec. 31, 2015
EUR (€)
shares
|
Dec. 31, 2012
USD ($)
|
Dec. 31, 2011
USD ($)
|
Mar. 07, 2008
USD ($)
|
||||||||
Future minimum lease payments [Abstract] | ||||||||||||||||||||||||||||||
2016 | $ 119,840 | $ 119,840 | $ 119,840 | |||||||||||||||||||||||||||
2017 | 119,840 | 119,840 | 119,840 | |||||||||||||||||||||||||||
2018 | 28,858 | 28,858 | 28,858 | |||||||||||||||||||||||||||
2019 | 0 | 0 | 0 | |||||||||||||||||||||||||||
2020 | 0 | 0 | 0 | |||||||||||||||||||||||||||
Total | 268,538 | 268,538 | 268,538 | |||||||||||||||||||||||||||
Rent expense for operating lease | 121,623,000 | $ 123,716,000 | ||||||||||||||||||||||||||||
Related Party Obligations [Abstract] | ||||||||||||||||||||||||||||||
Outstanding accounts receivable | $ 2,805 | $ 2,805 | $ 2,805 | $ 798,147 | ||||||||||||||||||||||||||
Concentration risk, percentage | 100.00% | 100.00% | ||||||||||||||||||||||||||||
Increase (decrease) in working capital advances | $ 220,000 | $ 0 | ||||||||||||||||||||||||||||
License purchase and termination agreement [Abstract] | ||||||||||||||||||||||||||||||
Issuance of common stock (in shares) | shares | 12,376,915 | |||||||||||||||||||||||||||||
Common stock for resale of shares issued (in shares) | shares | 36,834,933 | 36,834,933 | 36,834,933 | 24,458,018 | 36,834,933 | |||||||||||||||||||||||||
Summary of compensation earned, compensation paid in cash, and compensation temporarily deferred [Abstract] | ||||||||||||||||||||||||||||||
Deferred compensation liability | $ 383,564 | $ 383,564 | $ 383,564 | $ (144,986) | $ (126,769) | $ 244,903 | $ 176,852 | |||||||||||||||||||||||
Deferred compensation | 533,564 | 533,564 | 533,564 | 150,000 | ||||||||||||||||||||||||||
Proceeds from issuance of common stock under March 2013 offering | $ 207,000 | $ 1,050,000 | 1,257,027 | 0 | ||||||||||||||||||||||||||
Compensation accounts payable | 273,583 | 273,583 | 273,583 | 87,500 | ||||||||||||||||||||||||||
Compensation accrued liabilities | 259,981 | 259,981 | 259,981 | 62,500 | ||||||||||||||||||||||||||
Temporary advance of working capital | 220,000 | 0 | ||||||||||||||||||||||||||||
Milestone payments [Line Items] | ||||||||||||||||||||||||||||||
Future milestone obligations | 4,750,000 | 4,750,000 | 4,750,000 | |||||||||||||||||||||||||||
Kerry P. Gray [Member] | ||||||||||||||||||||||||||||||
Related Party Obligations [Abstract] | ||||||||||||||||||||||||||||||
Increase (decrease) in working capital advances | $ 10,300 | $ 30,000 | $ 18,000 | 37,300 | ||||||||||||||||||||||||||
Increase (decrease) in receivables | $ 3,000 | 18,000 | ||||||||||||||||||||||||||||
Summary of compensation earned, compensation paid in cash, and compensation temporarily deferred [Abstract] | ||||||||||||||||||||||||||||||
Deferred compensation liability | [1],[2],[3] | 275,153 | 275,153 | 275,153 | (119,986) | (91,000) | 220,673 | 140,313 | ||||||||||||||||||||||
Deferred compensation | [1],[2],[3] | 425,153 | 425,153 | 425,153 | ||||||||||||||||||||||||||
Repayment of temporarily deferred compensation | 269,986 | 312,500 | ||||||||||||||||||||||||||||
Proceeds from issuance of common stock under March 2013 offering | 100,000 | 300,000 | ||||||||||||||||||||||||||||
Temporary advance of working capital | $ 10,300 | $ 30,000 | 18,000 | 37,300 | ||||||||||||||||||||||||||
Kerry P. Gray [Member] | Temporarily Deferred Compensation [Member] | ||||||||||||||||||||||||||||||
Summary of compensation earned, compensation paid in cash, and compensation temporarily deferred [Abstract] | ||||||||||||||||||||||||||||||
Deferred compensation | 275,153 | 275,153 | 275,153 | 150,000 | 221,500 | |||||||||||||||||||||||||
Kerry P. Gray [Member] | Separation Agreement [Member] | ||||||||||||||||||||||||||||||
Summary of compensation earned, compensation paid in cash, and compensation temporarily deferred [Abstract] | ||||||||||||||||||||||||||||||
Deferred compensation | 11,500 | |||||||||||||||||||||||||||||
Kerry P. Gray [Member] | President [Member] | ||||||||||||||||||||||||||||||
Summary of compensation earned, compensation paid in cash, and compensation temporarily deferred [Abstract] | ||||||||||||||||||||||||||||||
Deferred compensation | 51,770 | 51,770 | 51,770 | 62,500 | ||||||||||||||||||||||||||
Kerry P. Gray [Member] | Board of Directors Chairman [Member] | ||||||||||||||||||||||||||||||
Summary of compensation earned, compensation paid in cash, and compensation temporarily deferred [Abstract] | ||||||||||||||||||||||||||||||
Deferred compensation | 186,083 | 186,083 | 186,083 | 87,500 | 210,000 | |||||||||||||||||||||||||
Terrance K. Wallberg [Member] | ||||||||||||||||||||||||||||||
Related Party Obligations [Abstract] | ||||||||||||||||||||||||||||||
Increase (decrease) in working capital advances | 3,000 | 10,000 | ||||||||||||||||||||||||||||
Increase (decrease) in receivables | 3,000 | 10,000 | ||||||||||||||||||||||||||||
Summary of compensation earned, compensation paid in cash, and compensation temporarily deferred [Abstract] | ||||||||||||||||||||||||||||||
Deferred compensation liability | 53,540 | 53,540 | 53,540 | (25,000) | (35,769) | 24,230 | 36,539 | |||||||||||||||||||||||
Deferred compensation | 53,540 | 53,540 | 53,540 | |||||||||||||||||||||||||||
Temporary advance of working capital | 3,000 | $ 10,000 | ||||||||||||||||||||||||||||
Other employees [Member] | ||||||||||||||||||||||||||||||
Summary of compensation earned, compensation paid in cash, and compensation temporarily deferred [Abstract] | ||||||||||||||||||||||||||||||
Deferred compensation liability | 54,871 | 54,871 | 54,871 | 0 | $ 0 | $ 0 | $ 0 | |||||||||||||||||||||||
Deferred compensation | $ 54,871 | $ 54,871 | $ 54,871 | |||||||||||||||||||||||||||
Altrazeal Trading GmbH [Member] | ||||||||||||||||||||||||||||||
License purchase and termination agreement [Abstract] | ||||||||||||||||||||||||||||||
Ownership interest in percentage | 25.00% | |||||||||||||||||||||||||||||
Transfer fees | € | € 1,570,271 | |||||||||||||||||||||||||||||
Issuance of common stock (in shares) | shares | 4,441,606 | |||||||||||||||||||||||||||||
Warrants to purchase common stock (in shares) | shares | 444,161 | |||||||||||||||||||||||||||||
Warrants of exercise price (in dollars per share) | $ / shares | $ 0.68 | $ 0.68 | $ 0.68 | |||||||||||||||||||||||||||
Period of warrants term | 1 year | |||||||||||||||||||||||||||||
Inventory payments | € | € 88,834 | |||||||||||||||||||||||||||||
Deduction in inventory payment (in dollars per share) | € / shares | $ 4.20 | |||||||||||||||||||||||||||||
Number of days closing a registration statement | 20 days | |||||||||||||||||||||||||||||
Common stock for resale of shares issued (in shares) | shares | 2,500,000 | 2,500,000 | 2,500,000 | 2,500,000 | ||||||||||||||||||||||||||
Altrazeal Distributors [Member] | ||||||||||||||||||||||||||||||
Related Party Obligations [Abstract] | ||||||||||||||||||||||||||||||
Related party sales | $ 795,000 | 802,000 | ||||||||||||||||||||||||||||
Outstanding accounts receivable | $ 3,000 | $ 3,000 | $ 3,000 | $ 798,000 | ||||||||||||||||||||||||||
Altrazeal Distributors [Member] | Accounts Receivable [Member] | ||||||||||||||||||||||||||||||
Related Party Obligations [Abstract] | ||||||||||||||||||||||||||||||
Concentration risk, percentage | 3.00% | 99.00% | ||||||||||||||||||||||||||||
Altrazeal Distributors [Member] | Sales Revenue, Net [Member] | ||||||||||||||||||||||||||||||
Related Party Obligations [Abstract] | ||||||||||||||||||||||||||||||
Concentration risk, percentage | 85.00% | 93.00% | ||||||||||||||||||||||||||||
IPMD GmbH [Member] | ||||||||||||||||||||||||||||||
Related Party Obligations [Abstract] | ||||||||||||||||||||||||||||||
Increase (decrease) in working capital advances | 40,000 | $ 180,000 | ||||||||||||||||||||||||||||
Increase (decrease) in receivables | $ 220,000 | |||||||||||||||||||||||||||||
License purchase and termination agreement [Abstract] | ||||||||||||||||||||||||||||||
Transfer fees | € | € 703,500 | |||||||||||||||||||||||||||||
Issuance of common stock (in shares) | shares | 2,095,241 | |||||||||||||||||||||||||||||
Warrants to purchase common stock (in shares) | shares | 209,525 | |||||||||||||||||||||||||||||
Summary of compensation earned, compensation paid in cash, and compensation temporarily deferred [Abstract] | ||||||||||||||||||||||||||||||
Temporary advance of working capital | $ 40,000 | $ 180,000 | ||||||||||||||||||||||||||||
Office and Laboratory Space [Member] | ||||||||||||||||||||||||||||||
Operating Leased Assets [Line Items] | ||||||||||||||||||||||||||||||
Minimum monthly lease obligation | $ 9,193 | $ 9,436 | $ 9,379 | $ 9,776 | $ 9,330 | |||||||||||||||||||||||||
Office Equipment [Member] | ||||||||||||||||||||||||||||||
Operating Leased Assets [Line Items] | ||||||||||||||||||||||||||||||
Minimum monthly lease obligation | $ 744 | |||||||||||||||||||||||||||||
Office Equipment [Member] | Subsequent Event [Member] | ||||||||||||||||||||||||||||||
Operating Leased Assets [Line Items] | ||||||||||||||||||||||||||||||
Minimum monthly lease obligation | $ 551 | |||||||||||||||||||||||||||||
Access Pharmaceuticals [Member] | Annual Sales, Certain Products [Member] | Minimum [Member] | ||||||||||||||||||||||||||||||
Milestone payments [Line Items] | ||||||||||||||||||||||||||||||
Milestone for payment | $ 20,000,000 | |||||||||||||||||||||||||||||
Access Pharmaceuticals [Member] | Annual Sales, Certain Products [Member] | Maximum [Member] | ||||||||||||||||||||||||||||||
Milestone payments [Line Items] | ||||||||||||||||||||||||||||||
Milestone for payment | 40,000,000 | |||||||||||||||||||||||||||||
Access Pharmaceuticals [Member] | Annual Sales, Any One Certain Product [Member] | ||||||||||||||||||||||||||||||
Milestone payments [Line Items] | ||||||||||||||||||||||||||||||
Milestone for payment | 20,000,000 | |||||||||||||||||||||||||||||
Access Pharmaceuticals [Member] | Cumulative Sales, Certain Products [Member] | Minimum [Member] | ||||||||||||||||||||||||||||||
Milestone payments [Line Items] | ||||||||||||||||||||||||||||||
Milestone for payment | 50,000,000 | |||||||||||||||||||||||||||||
Access Pharmaceuticals [Member] | Cumulative Sales, Certain Products [Member] | Maximum [Member] | ||||||||||||||||||||||||||||||
Milestone payments [Line Items] | ||||||||||||||||||||||||||||||
Milestone for payment | $ 100,000,000 | |||||||||||||||||||||||||||||
ProStrakan Ltd [Member] | ||||||||||||||||||||||||||||||
Milestone payments [Line Items] | ||||||||||||||||||||||||||||||
Royalty percentage | 30.00% | 30.00% | 30.00% | 30.00% | 30.00% | |||||||||||||||||||||||||
ProStrakan Ltd [Member] | Maximum [Member] | ||||||||||||||||||||||||||||||
Milestone payments [Line Items] | ||||||||||||||||||||||||||||||
Future milestone obligations | $ 1,400,000 | $ 1,400,000 | $ 1,400,000 | $ 1,400,000 | ||||||||||||||||||||||||||
|
LEGAL PROCEEDINGS (Details) - shares |
May. 01, 2014 |
Dec. 31, 2015 |
Apr. 15, 2015 |
---|---|---|---|
LEGAL PROCEEDINGS [Abstract] | |||
Number of shares under non-standard cashless exercise (in shares) | 782,284 | ||
Number of shares exercisable on cashless basis (in shares) | 261,516 | ||
Number of common shares issued on exercise of warrants (in shares) | 847,804 | 361,516 |
SUBSEQUENT EVENTS (Details) - USD ($) |
12 Months Ended | |||
---|---|---|---|---|
Mar. 29, 2016 |
Jan. 11, 2016 |
Dec. 31, 2015 |
Apr. 15, 2015 |
|
Subsequent Event [Line Items] | ||||
Common stock issued during period (in shares) | 12,376,915 | |||
Aggregate shares of common stock issued upon exercise of warrants (in shares) | 847,804 | 361,516 | ||
Purchase price (in dollars per share) | $ 0.38 | |||
Subsequent Event [Member] | ||||
Subsequent Event [Line Items] | ||||
Monthly installment | $ 45,000 | |||
Accommodation fee | $ 25,000 | |||
March 2016 Offering [Member] | Subsequent Event [Member] | ||||
Subsequent Event [Line Items] | ||||
Common stock issued during period (in shares) | 25,245,442 | |||
Aggregate shares of common stock issued upon exercise of warrants (in shares) | 25,245,442 | |||
Purchase price (in dollars per share) | $ 0.0713 | |||
Proceeds from issuance or sale of equity | $ 1,800,000 | |||
Exercise price of warrants (in dollars per share) | $ 0.0871 | |||
Term of warrants | 5 years |
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