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Share Name | Share Symbol | Market | Type |
---|---|---|---|
ULURU Inc (GM) | USOTC:ULUR | OTCMarkets | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
0.00 | 0.00% | 0.000001 | 0.000001 | 0.000001 | 0.00 | 01:00:00 |
Nevada
|
41-2118656
|
(State or Other Jurisdiction of
|
(I.R.S. Employer Identification No.)
|
Incorporation or Organization)
|
4452 Beltway Drive
Addison, Texas
|
75001
|
(Address of Principal Executive Offices)
|
(Zip Code)
|
Large accelerated filer
o
|
Accelerated filer
o
|
Non-accelerated filer
o
|
Smaller reporting company
þ
|
ITEM 1.
|
Finan
cial Statements.
|
June 30, 2016
|
December 31, 2015
|
|||||||
(Unaudited)
|
(Audited)
|
|||||||
ASSETS
|
||||||||
Current Assets
|
||||||||
Cash and cash equivalents
|
$ | 718,135 | $ | 180,000 | ||||
Accounts receivable, net
|
53,103 | 89,378 | ||||||
Accounts receivable – related party, net
|
--- | 2,805 | ||||||
Inventory
|
582,039 | 531,421 | ||||||
Prepaid expenses and deferred charges
|
51,120 | 123,201 | ||||||
Total Current Assets
|
1,404,397 | 926,805 | ||||||
Property, Equipment and Leasehold Improvements, net
|
191,087 | 257,417 | ||||||
Other Assets
|
||||||||
Intangible asset - patents, net
|
2,483,617 | 2,720,541 | ||||||
Intangible asset - licensing rights, net
|
3,344,997 | 3,506,235 | ||||||
Investment in unconsolidated subsidiary
|
--- | --- | ||||||
Deposits
|
20,964 | 18,069 | ||||||
Total Other Assets
|
5,849,578 | 6,244,845 | ||||||
TOTAL ASSETS
|
$ | 7,445,062 | $ | 7,429,067 | ||||
LIABILITIES AND STOCKHOLDERS' EQUITY
|
||||||||
Current Liabilities
|
||||||||
Accounts payable
|
$ | 1,811,387 | $ | 1,780,197 | ||||
Accrued liabilities
|
250,757 | 402,214 | ||||||
Accrued interest
|
625 | --- | ||||||
Promissory notes payable, net of unamortized debt discount and debt issuance costs, current portion
|
114,728 | 315,058 | ||||||
Deferred revenue, current portion
|
5,764 | 42,934 | ||||||
Total Current Liabilities
|
2,183,261 | 2,540,403 | ||||||
Long Term Liabilities
|
||||||||
Deferred revenue, net of current portion
|
401,368 | 685,287 | ||||||
Total Long Term Liabilities
|
401,368 | 685,287 | ||||||
TOTAL LIABILITIES
|
2,584,629 | 3,225,690 | ||||||
COMMITMENTS AND CONTINGENCIES
|
--- | --- | ||||||
STOCKHOLDERS' EQUITY
|
||||||||
Preferred stock - $0.001 par value; 20,000 shares authorized;
|
||||||||
Preferred Stock Series A, 1,000 shares designated; no shares issued and outstanding at June 30, 2016 and December 31, 2015, respectively
|
--- | --- | ||||||
Common Stock - $0.001 par value; 200,000,000 shares authorized;
|
||||||||
62,974,431 and 36,834,933 shares issued and outstanding at June 30, 2016 and December 31, 2015, respectively
|
62,975 | 36,835 | ||||||
Additional paid-in capital
|
62,240,416 | 60,426,915 | ||||||
Accumulated (deficit)
|
(57,442,958 | ) | (56,260,373 | ) | ||||
TOTAL STOCKHOLDERS’ EQUITY
|
4,860,433 | 4,203,377 | ||||||
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY
|
$ | 7,445,062 | $ | 7,429,067 | ||||
The accompanying notes are an integral part of these condensed consolidated financial statements.
|
Three Months Ended June 30,
|
Six months Ended June 30,
|
|||||||||||||||
2016
|
2015
|
2016
|
2015
|
|||||||||||||
Revenues
|
||||||||||||||||
License fees
|
$ | 259,813 | $ | 15,979 | $ | 361,089 | $ | 30,518 | ||||||||
Product sales, net
|
4,520 | 243,018 | 12,036 | 523,127 | ||||||||||||
Total Revenues
|
264,333 | 258,997 | 373,125 | 553,645 | ||||||||||||
Costs and Expenses
|
||||||||||||||||
Cost of product sold
|
528 | 81,286 | 1,451 | 182,816 | ||||||||||||
Research and development
|
135,331 | 219,335 | 271,490 | 423,494 | ||||||||||||
Selling, general and administrative
|
384,900 | 495,034 | 703,701 | 941,191 | ||||||||||||
Amortization of intangible assets
|
199,526 | 118,461 | 398,162 | 235,622 | ||||||||||||
Depreciation
|
33,165 | 46,218 | 66,330 | 104,527 | ||||||||||||
Total Costs and Expenses
|
753,450 | 960,334 | 1,441,134 | 1,887,650 | ||||||||||||
Operating (Loss)
|
(489,117 | ) | (701,337 | ) | (1,068,009 | ) | (1,334,005 | ) | ||||||||
Other Income (Expense)
|
||||||||||||||||
Interest and miscellaneous income
|
515 | 69 | 537 | 211 | ||||||||||||
Interest expense
|
(44,445 | ) | (63,185 | ) | (91,203 | ) | (76,154 | ) | ||||||||
Equity in earnings (loss) of unconsolidated subsidiary
|
--- | --- | --- | --- | ||||||||||||
Foreign currency transaction gain (loss)
|
(3,196 | ) | 35,074 | 1,090 | (57,704 | ) | ||||||||||
Accommodation fee due on promissory note
|
--- | --- | (25,000 | ) | --- | |||||||||||
(Loss) Before Income Taxes
|
(536,243 | ) | (729,379 | ) | (1,182,585 | ) | (1,467,652 | ) | ||||||||
Income taxes
|
--- | --- | --- | --- | ||||||||||||
Net (Loss)
|
$ | (536,243 | ) | $ | (729,379 | ) | $ | (1,182,585 | ) | $ | (1,467,652 | ) | ||||
Basic and diluted net (loss) per common share
|
$ | (0.01 | ) | $ | (0.03 | ) | $ | (0.02 | ) | $ | (0.06 | ) | ||||
Weighted average number of common shares outstanding
|
62,974,431 | 24,767,889 | 50,316,681 | 24,613,809 | ||||||||||||
The accompanying notes are an integral part of these consolidated financial statements.
|
Six months Ended June 30,
|
||||||||
2016
|
2015
|
|||||||
OPERATING ACTIVITIES :
|
||||||||
Net loss
|
$ | (1,182,585 | ) | $ | (1,467,652 | ) | ||
Adjustments to reconcile net loss to net cash used in operating activities:
|
||||||||
Amortization of intangible assets
|
398,162 | 235,622 | ||||||
Depreciation
|
66,330 | 104,527 | ||||||
Share-based compensation for stock and options issued to employees
|
15,913 | 24,933 | ||||||
Share-based compensation for options issued to non-employees
|
30,102 | 120,253 | ||||||
Equity in earnings (loss) of unconsolidated subsidiary
|
--- | --- | ||||||
Amortization of debt discount on promissory note
|
26,012 | 11,035 | ||||||
Amortization of debt issuance costs
|
18,658 | 8,103 | ||||||
Common stock issued for services
|
36,000 | --- | ||||||
Common stock issued for interest due on promissory note
|
2,239 | --- | ||||||
Accommodation fee due on promissory note
|
25,000 | --- | ||||||
Change in operating assets and liabilities:
|
||||||||
Accounts receivable
|
39,080 | (450,038 | ) | |||||
Inventory
|
(50,618 | ) | (212,530 | ) | ||||
Prepaid expenses and deferred charges
|
72,080 | 77,145 | ||||||
Deposits
|
(2,895 | ) | --- | |||||
Accounts payable
|
31,190 | 449,744 | ||||||
Accrued liabilities
|
(151,457 | ) | 53,800 | |||||
Accrued interest
|
625 | 11,764 | ||||||
Deferred revenue
|
(321,089 | ) | 7,402 | |||||
Total
|
235,332 | 441,760 | ||||||
Net Cash Used in Operating Activities
|
(947,253 | ) | (1,025,892 | ) | ||||
INVESTING ACTIVITIES :
|
||||||||
Purchase of property and equipment
|
--- | (787 | ) | |||||
Net Cash Used in Investing Activities
|
--- | (787 | ) | |||||
FINANCING ACTIVITIES :
|
||||||||
Proceeds from sale of common stock and warrants, net
|
1,732,338 | --- | ||||||
Proceeds from issuance of convertible note and warrant, net
|
--- | 485,008 | ||||||
Offering costs associated with acquisition of licensing rights in 2015
|
(21,950 | ) | --- | |||||
Offering cost adjustment – preferred stock sale in 2011
|
--- | 10,509 | ||||||
Repayment of principle due on promissory note
|
(225,000 | ) | --- | |||||
Net Cash Provided by Financing Activities
|
1,485,388 | 495,517 | ||||||
Net Increase (Decrease) in Cash
|
538,135 | (531,162 | ) | |||||
Cash, beginning of period
|
180,000 | 550,458 | ||||||
Cash, end of period
|
$ | 718,135 | $ | 19,296 | ||||
SUPPLEMENTAL CASH FLOW DISCLOSURE:
|
||||||||
Cash paid for interest
|
$ | 14,239 | $ | 1,601 | ||||
Non-cash investing and financing activities:
|
||||||||
Issuance of common stock for principle due on promissory note
|
$ | 45,000 | --- | |||||
The accompanying notes are an integral part of these condensed consolidated financial statements.
|
NOTE 1.
|
COMPANY OVERVIEW AND BASIS OF PRESENTATION
|
NOTE 2.
|
SIGNIFICANT ACCOUNTING POLICIES
|
NOTE 3.
|
THE EFFECT OF RECENTLY ISSUED ACCOUNTING STANDARDS
|
NOTE 4.
|
SEGMENT INFORMATION
|
Three Months Ended June 30,
|
Six months Ended June 30,
|
|||||||||||||||||||||||||||||||
Revenues
|
2016
|
%
|
2015
|
%
|
2016
|
%
|
2015
|
%
|
||||||||||||||||||||||||
Domestic
|
$ | 4,520 | 2 | % | $ | 7,085 | 3 | % | $ | 12,036 | 3 | % | $ | 13,887 | 3 | % | ||||||||||||||||
International
|
259,813 | 98 | % | 251,912 | 97 | % | 361,089 | 97 | % | 539,758 | 97 | % | ||||||||||||||||||||
Total
|
$ | 264,333 | 100 | % | $ | 258,997 | 100 | % | $ | 373,125 | 100 | % | $ | 553,645 | 100 | % |
Three Months Ended June 30,
|
Six months Ended June 30,
|
||||||||||||||||
Customers
|
Product
|
2016
|
2015
|
2016
|
2015
|
||||||||||||
Customer A
|
Altrazeal®
|
--- | 91 | % | --- | 92 | % | ||||||||||
Customer B
|
Altrazeal®
|
88 | % | 2 | % | 64 | % | 2 | % | ||||||||
Customer C
|
Altrazeal®
|
--- | 1 | % | 25 | % | 1 | % | |||||||||
Total
|
88 | % | 94 | % | 89 | % | 95 | % | |||||||||
NOTE 5.
|
INVENTORY
|
Inventory
|
June 30, 2016
|
December 31, 2015
|
||||||
Raw materials
|
$ | 37,566 | $ | 38,037 | ||||
Work-in-progress
|
444,070 | 485,123 | ||||||
Finished goods
|
100,403 | 8,261 | ||||||
Total
|
$ | 582,039 | $ | 531,421 |
NOTE 6.
|
PROPERTY, EQUIPMENT and LEASEHOLD IMPROVEMENTS
|
Property, equipment and leasehold improvements
|
June 30, 2016
|
December 31, 2015
|
||||||
Laboratory equipment
|
$ | 424,888 | $ | 424,888 | ||||
Manufacturing equipment
|
1,604,894 | 1,604,894 | ||||||
Computers, office equipment, and furniture
|
153,865 | 153,865 | ||||||
Computer software
|
4,108 | 4,108 | ||||||
Leasehold improvements
|
95,841 | 95,841 | ||||||
2,283,596 | 2,283,596 | |||||||
Less: accumulated depreciation and amortization
|
(2,092,509 | ) | (2,026,179 | ) | ||||
Property, equipment and leasehold improvements, net
|
$ | 191,087 | $ | 257,417 |
NOTE 7.
|
INTANGIBLE ASSETS
|
Intangible assets – patents
|
June 30, 2016
|
December 31, 2015
|
||||||
Patent - Amlexanox (Aphthasol®)
|
$ | 2,090,000 | $ | 2,090,000 | ||||
Patent - Amlexanox (OraDisc™ A)
|
6,873,080 | 6,873,080 | ||||||
Patent - OraDisc™
|
73,000 | 73,000 | ||||||
Patent - Hydrogel nanoparticle aggregate
|
589,858 | 589,858 | ||||||
9,625,938 | 9,625,938 | |||||||
Less: accumulated amortization
|
( 7,142,321 | ) | (6,905,397 | ) | ||||
Intangible assets - patents, net
|
$ | 2,483,617 | $ | 2,720,541 |
Calendar Years
|
Future Amortization
Expense
|
|||
2016 (Six months)
|
$ | 239,526 | ||
2017
|
475,148 | |||
2018
|
475,148 | |||
2019
|
475,148 | |||
2020
|
476,450 | |||
2021 & Beyond
|
342,197 | |||
Total
|
$ | 2,483,617 |
Intangible assets - licensing rights
|
June 30, 2016
|
December 31, 2015
|
||||||
European Union, Australia, New Zealand, Middle East (excluding Jordan and Syria), North Africa, Albania, Bosnia, Croatia, Kosovo, Macedonia, Montenegro, and Serbia.
|
$ | 3,512,506 | $ | 3,512,506 | ||||
Less: accumulated amortization
|
(167,509 | ) | (6,271 | ) | ||||
Intangible assets - licensing rights, net
|
$ | 3,344,997 | $ | 3,506,235 |
Calendar Years
|
Future Amortization
Expense
|
|||
2016 (Six months)
|
$ | 163,910 | ||
2017
|
325,148 | |||
2018
|
325,148 | |||
2019
|
325,148 | |||
2020
|
325,148 | |||
2021 & Beyond
|
1,880,495 | |||
Total
|
$ | 3,344,997 |
NOTE 8.
|
INVESTMENTS IN UNCONSOLIDATED ENTITIES
|
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 9.
|
ACCRUED LIABILITIES
|
Accrued Liabilities
|
June 30, 2016
|
December 31, 2015
|
||||||
Accrued compensation/benefits
|
$ | 240,940 | $ | 329,131 | ||||
Accrued insurance payable
|
6,806 | 73,074 | ||||||
Accrued property taxes
|
3,000 | --- | ||||||
Product rebates/returns
|
11 | 9 | ||||||
Total accrued liabilities
|
$ | 250,757 | $ | 402,214 |
NOTE 10.
|
PROMISSORY NOTE PAYABLE
|
As of June 30, 2016
|
||||||||||||||||||||||||||
Transaction
|
Initial
Principal
Amount
|
Interest
Rate
|
Maturity
Date
|
Conversion Price (1)
|
Principal
Balance
|
Unamortized
Debt
Discount
|
Unamortized Debt Issuance Costs
|
Carrying
Value
|
||||||||||||||||||
April 2015 Note
|
$ | 550,000 | 10.0 | % |
08/12/2016
|
$ | 125,000 | $ | 6,003 | $ | 4,269 | $ | 114,728 | |||||||||||||
Total
|
$ | 550,000 | $ | 125,000 | $ | 6,003 | $ | 4,269 | $ | 114,728 |
(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.
|
Payments Due By Period
|
||||||||||||||||||||||||
Transaction
|
Total
|
2016
|
2017
|
2018
|
2019
|
2020
|
||||||||||||||||||
April 2015 Note
|
$ | 125,000 | $ | 125,000 | $ | --- | $ | --- | $ | --- | $ | --- | ||||||||||||
Total
|
$ | 125,000 | $ | 125,000 | $ | --- | $ | --- | $ | --- | $ | --- |
NOTE 11.
|
EQUITY TRANSACTIONS
|
NOTE 12.
|
STOCKHOLDERS’ EQUITY
|
Number of Shares of Common Stock Subject to Exercise
|
Weighted – Average
Exercise Price
|
|||||||
Balance as of December 31, 2015
|
1,774,193 | $ | 0.77 | |||||
Warrants issued
|
25,245,442 | $ | 0.09 | |||||
Warrants exercised
|
--- | --- | ||||||
Warrants cancelled
|
(35,000 | ) | $ | 1.20 | ||||
Balance as of June 30, 2016
|
26,984,635 | $ | 0.13 |
Date of Expiration
|
Number of Warrant Shares of Common Stock Subject to Expiration
|
|||
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 | |||
March 30, 2021
|
25,245,442 | |||
Total
|
26,984,635 |
NOTE 13.
|
EARNINGS PER SHARE
|
June 30, 2016
|
December 31, 2015
|
|||||||
Warrants to purchase Common Stock
|
26,984,635 | 1,774,193 | ||||||
Stock options to purchase Common Stock
|
714,571 | 1,664,573 | ||||||
Common stock issuable upon the assumed conversion of payments due under our promissory note from April 2015 (1)
|
2,101,759 | 1,934,718 | ||||||
Total
|
29,800,965 | 5,373,484 |
(1)
|
As part of the April 2015 Note, at our option, subject to certain volume, price and other conditions, the monthly installments of principle and interest due under the April 2015 Note 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 $0.06 per share (80% of the average of the three lowest volume weighted average prices of the shares of Common Stock during the preceding twenty trading days prior to June 30, 2016), subject to certain ownership limitations.
|
NOTE 14.
|
SHARE BASED COMPENSATION
|
Three Months Ended
June 30,
|
Six Months Ended
June 30,
|
|||||||||||||||
2016
|
2015
|
2016
|
2015
|
|||||||||||||
Research and development
|
$ | 323 | $ | 18,819 | $ | 8,993 | $ | 37,431 | ||||||||
Selling, general and administrative
|
17,825 | 51,019 | 37,022 | 107,755 | ||||||||||||
Total share-based compensation expense
|
$ | 18,148 | $ | 69,838 | $ | 46,015 | $ | 145,186 |
Stock Options
|
Weighted Average Exercise Price per Share
|
|||||||
Outstanding as of December 31, 2015
|
1,664,573 | $ | 1.73 | |||||
Granted
|
--- | --- | ||||||
Forfeited/cancelled
|
(950,002 | ) | $ | 1.27 | ||||
Exercised
|
--- | --- | ||||||
Outstanding as of June 30, 2016
|
714,571 | $ | 2.35 |
Options Outstanding
|
Options Exercisable
|
|||||||||||||||||
Stock Options Outstanding
|
Weighted Average Exercise Price per Share
|
Weighted Average Remaining Contractual Life in Years
|
Stock Options Exercisable
|
Weighted Average Exercise Price per Share
|
||||||||||||||
422,500 | $ | 0.33 | 6.7 | 322,500 | $ | 0.33 | ||||||||||||
240,000 | 1.15 | 8.2 | 75,000 | 1.15 | ||||||||||||||
52,071 | 24.20 | 1.1 | 52,071 | 24.20 | ||||||||||||||
714,571 | $ | 2.35 | 6.8 | 449,571 | $ | 3.23 |
NOTE 15.
|
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
|
June 30, 2016
|
December 31, 2015
|
||||||
Liabilities:
|
||||||||
Promissory note – April 2015
|
$ | 125,000 | $ | 370,000 | ||||
NOTE 16.
|
INCOME TAXES
|
NOTE 17.
|
COMMITMENTS AND CONTINGENCIES
|
Calendar Years
|
Future Lease Expense
|
|||
2016 (Six months)
|
$ | 59,920 | ||
2017
|
119,840 | |||
2018
|
28,858 | |||
2019
|
--- | |||
2020
|
--- | |||
Total
|
$ | 208,618 |
Name
|
2016
|
2015
|
2014 – 2011 |
Total
|
||||||||||||
Kerry P. Gray (1) (2) (3) (4)
|
$ | --- | $ | 275,153 | $ | 150,000 | $ | 425,153 | ||||||||
Terrance K. Wallberg
|
(33,540 | ) | 53,540 | --- | 20,000 | |||||||||||
Other employees
|
(54,871 | ) | 54,871 | --- | --- | |||||||||||
Total
|
$ | (88,411 | ) | $ | 383,564 | $ | 150,000 | $ | 445,153 |
(1)
|
On November 19, 2015, Mr. Gray resigned as the Company’s President and Chief Executive Officer and on February 18, 2016 resigned as a director for the Company.
|
(2)
|
During 2015, Mr. Gray temporarily deferred compensation of $275,153 which consisted of $51,770 earned as salary compensation for his duties as President of the Company, $186,083 for his duties as Chairman of the Executive Committee of the Company’s Board of Directors, and $37,300 as a temporary advance of working capital.
|
(3)
|
During 2014, Mr. Gray temporarily deferred compensation of $150,000 which consisted of $62,500 earned as salary compensation for his duties as President of the Company and $87,500 for his duties as Chairman of the Executive Committee of the Company’s Board of Directors. During 2014, Mr. Gray was also repaid $269,986 of temporarily deferred compensation, of which $100,000 was used by Mr. Gray for funding required pursuant to a Securities Purchase Agreement, dated March 14, 2013 (the “March 2013 Offering”). Prior to 2014, over a three year period Mr. Gray temporarily deferred, at various times, aggregate compensation of $582,486 and during the same time period was also repaid $312,500 of temporarily deferred compensation, of which $300,000 was used by Mr. Gray for funding required pursuant to the March 2013 Offering.
|
(4)
|
The Company is asserting in a dispute with Mr. Gray that amounts recorded as being owed to Mr. Gray are not in fact owed to Mr. Gray or are offset by amounts Mr. Gray owes to the Company.
|
NOTE 18.
|
LEGAL PROCEEDINGS
|
NOTE 19.
|
SUBSEQUENT EVENTS
|
ITEM 2.
|
Manage
ment’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 muco-adhesive film technology (OraDisc
TM
) 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 its affiliates;
|
§
|
As a result of a breach by Altrazeal AG of its obligations under our licensing agreement, we currently do not have a direct distributor acting on our behalf in the territories previously covered by the AG Agreement, which included 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). We now have the opportunity to potentially form direct relationships with sub-distributors in the territories previously covered by the AG Agreement for the purpose of accepting orders directly from, and fulfilling orders directly to, such sub-distributors;
|
§
|
We have determined that creating a product roadmap with line extensions is necessary to respond to market interest in Altrazeal®;
|
§
|
As a result of a breach by ORADISC GmbH of its obligations under our licensing agreement, we have regained control of all of the OraDisc™ rights and we have the opportunity to develop and commercialize products utilizing our OraDisc™ film technology ourselves or together with other partners;
|
§
|
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.
|
Three Months Ended June 30,
|
||||||||
Technology
|
2016
|
2015
|
||||||
Wound care & nanoparticle
|
$ | 33,000 | $ | 71,000 | ||||
OraDisc™
|
4,000 | 4,000 | ||||||
Aphthasol® & other technologies
|
--- | 1,000 | ||||||
Total
|
$ | 37,000 | $ | 76,000 |
Six months Ended June 30,
|
||||||||
Technology
|
2016
|
2015
|
||||||
Wound care & nanoparticle
|
$ | 46,000 | $ | 143,000 | ||||
OraDisc™
|
8,000 | 8,000 | ||||||
Aphthasol® & other technologies
|
--- | 2,000 | ||||||
Total
|
$ | 54,000 | $ | 153,000 |
Consolidated Cash Flow Data
|
||||||||
Six Months Ended June 30,
|
||||||||
Net Cash Provided by (Used in)
|
2016
|
2015
|
||||||
Operating activities
|
$ | (947,000 | ) | $ | (1,026,000 | ) | ||
Investing activities
|
--- | (1,000 | ) | |||||
Financing activities
|
1,485,000 | 496,000 | ||||||
Net increase (decrease) in cash and cash equivalents
|
$ | 538,000 | $ | (531,000 | ) |
§
|
our ability, or inability, 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, and other issues associated with, 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
|
$ | 125,000 | $ | 125,000 | $ | --- | $ | --- | $ | --- | ||||||||||
Operating leases
|
$ | 208,618 | $ | 119,840 | $ | 88,778 | $ | --- | $ | --- | ||||||||||
Total contractual cash obligations
|
$ | 333,618 | $ | 244,840 | $ | 88,778 | $ | --- | $ | --- |
ITEM 3.
|
Quant
itative and Qualitative Disclosures About Market Risk.
|
ITEM 4.
|
C
ont
rols and Procedures.
|
ITEM 1.
|
Leg
al Proceedings.
|
ITEM 1A.
|
Ris
k Factors.
|
ITEM 2.
|
Unreg
istered Sales of Equity Securities and Use of Proceeds.
|
ITEM 3.
|
Defaults
Upon Senior Securities.
|
ITEM 4.
|
Min
e Safety Disclosures.
|
ITEM 5.
|
Othe
r Information.
|
ITEM 6.
|
Exh
ibits.
|
ULURU Inc.
|
||||
Date: August 15, 2016
|
By:
|
/s/ Helmut Kerschbaumer
|
||
Helmut Kerschbaumer
|
||||
Interim Chief Executive Officer and President
|
||||
(Principal Executive Officer)
|
||||
Date: August 15, 2016
|
By:
|
/s/ Terrance K. Wallberg
|
||
Terrance K. Wallberg
|
||||
Chief Financial Officer and Vice President
|
||||
(Principal Financial and Accounting Officer)
|
1 Year ULURU (GM) Chart |
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