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8-K - FORM 8-K NOVEMBER 15, 2012 - ULURU Inc.form8k_111512.htm


ULURU NEWS

Contact: Company
Kerry P. Gray
President & CEO
Terry K. Wallberg
Vice President & CFO
(214) 905-5145

ULURU INC.
 
REPORTS THIRD QUARTER 2012 FINANCIAL RESULTS
 
 
Addison, Texas, November 15, 2012; ULURU Inc. (OTCQB: ULUR) today announced its financial results for the quarter ended September 30, 2012 and provided a review of its operating activities.

Since our last quarterly report, significant progress has been made and the company has achieved numerous important commercial and financial goals including:
 
▬  
Received our first order of Altrazeal® for Europe which will be shipped shortly
 
▬  
Entered into a strategic collaboration for the development of our mucoadhesive OraDisc™ technology
 
▬  
Arranged a $2 million financing at a 122% premium to market
 
▬  
Completed the production of 0.75 gram Altrazeal® blister pack and made the initial shipment to Australia
 
▬  
Made the first shipment to our commercial partner of the veterinary product Derazil®.
 

Based upon our achievements to date in 2012, we are on target to achieve our previously stated objectives for the year, which include:
 
·  
Launch of Altrazeal® in the veterinary market
 
·  
Launch of Altrazeal® in Australia
 
·  
Launch of Altrazeal® in four markets in 2012
 
·  
Completion of manufacturing scale-up for the new 0.75 gram dosage size of Altrazeal®
 
·  
Completion of equity and debt financings to fund the Company’s business plan
 
·  
Entering additional strategic commercialization agreements
 
Commenting on the commercial activities, Kerry P. Gray, President and CEO, stated, “The progress that has been made in the first nine months has been outstanding and provides us with confidence for the achievement of rapid revenue growth in 2013. The introduction of Altrazeal® in Australia which is supported by excellent clinical experiences and the positive clinical response that is being experienced in Europe bodes well for the rapid market adoption of Altrazeal®.  Achieving the shipment of the 0.75 gram blister pack of Altrazeal® to Australia and the initial shipment of Derazil® all within a 5 day period is a tremendous achievement for a small organization. I believe with the necessary financing in place, a network of outstanding strategic partners and the excellent clinical success of Altrazeal® we are well placed as we enter 2013.”

For the third quarter of 2012, the Company reported a net loss of $0.8 million, or $0.10 per share, compared with a net loss of $1.0 million, or $0.18 per share, for the same period last year.  For the nine months ended September 30, 2012, the reported loss has been decreased compared to prior year from $3.2 million, or $0.55 per share, to $2.6 million, or $0.32 per share.

Operating Results

Revenues
Revenues for the third quarter of 2012 were $89,000, as compared to $74,000 for the third quarter of 2011.  The increase in revenues is due primarily to increased Altrazeal product sales.

Cost of Goods Sold
Cost of goods sold for the third quarter of 2012 was $113,000, as compared to $11,000 for the third quarter of 2011.  The increase in cost of goods sold is due primarily to increased Altrazeal product sales and from the write-off of $79,000 in obsolete finished goods.

Research and Development
Research and development expenses for the third quarter of 2012 were $153,000, including no share-based compensation, as compared to $233,000, which included $17,000 in share-based compensation, for the third quarter of 2011.  The decrease of approximately $80,000 in research and development expenses was primarily due to lower costs for regulatory consulting of $20,000, lower scientific compensation costs of $60,000 related to share-based compensation and a lower head-count.

Selling, General and Administrative
Selling, general and administrative expenses for the third quarter of 2012 were $376,000, including $8,000 in share-based compensation, as compared to $567,000, which included $25,000 in share-based compensation, for the third quarter of 2011.  The decrease of approximately $191,000 in selling, general and administrative expenses was primarily due to lower costs for compensation of $51,000, lower consulting costs for investor relations of $47,000, lower sales & marketing costs of $29,000 due to a revised sales and marketing plan, decreased costs for insurance of $16,000, reduced costs for corporate travel of $12,000, and lower legal costs of $14,000.

Other income and Other expenses
Interest expense for the third quarter of 2012 was $134,000 as compared to $23,000 for the third quarter of 2011.  The increase of approximately $111,000 is primarily attributable to costs associated with our convertible debt.

Commenting on the financial results Kerry P. Gray, President and CEO, stated, “Revenue for the third quarter was basically in line with our projections.  Our expenses during the quarter remain consistent with our business plan as we continue to limit expenses to revenue generating activities. Over the course of the year we have continued to reduce our operating expenses.  Financial performance in the fourth quarter will show continued improvement as revenues will increase significantly due to the sale of Altrazeal® in additional markets and our initial shipment of Derazil®.”

 
 

 


About ULURU Inc.:
ULURU Inc. is a specialty pharmaceutical company focused on the development of a portfolio of wound management and oral care products to provide patients and consumers improved clinical outcomes through controlled delivery utilizing its innovative Nanoflex® Aggregate technology and OraDisc™ transmucosal delivery system. For further information about ULURU Inc., please visit our website at www.uluruinc.com.  For further information about Altrazeal®, please visit our website at www.altrazeal.com.

This press release contains certain statements that are forward-looking within the meaning of Section 27a of the Securities Act of 1933, as amended, including but not limited to statements made relating to future financial performance of ULURU Inc. (the "Company"), the anticipated launch of Altrazeal® in various markets and countries, the completion of strategic alliances, the anticipated market adoption of Altrazeal®, the clinical and economic benefits of Altrazeal®, the improvement in financial performance in the fourth quarter of 2012, the achievement of rapid revenue growth in 2013, and the timing of shipments of Altrazeal®.  When used in this press release, the words “believe,” "expect" and "anticipate" and similar expressions may be indicative of forward-looking statements including without limitation statements relating to the regulatory results for our products.  These statements by their nature involve substantial risks and uncertainties, certain of which are beyond the Company's control. Any forward-looking statement speaks only as of the date on which such statement is made, and the Company undertakes no obligation to update any forward-looking statement or statements to reflect events or circumstances after the date on which such statement is made or to reflect the occurrence of an unanticipated event. Further, management cannot assess the impact of each such factor on the business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements.   These statements are subject to numerous risks and uncertainties, including but not limited to the risk factors detailed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2011 and other reports filed by us with the Securities and Exchange Commission.

 
 

 

ULURU Inc.
SUMMARY OF RESULTS


STATEMENTS OF OPERATIONS DATA


   
Three Months Ended
 September 30,
   
Nine Months Ended
 September 30,
 
   
2012
   
2011
   
2012
   
2011
 
REVENUES
                       
License fees
  $ 11,400     $ 6,184     $ 29,163     $ 18,349  
Royalty income
    16,633       18,861       49,918       51,528  
Product sales, net
    60,889       48,607       126,057       159,132  
Total Revenues
    88,922       73,652       205,138       229,009  
                                 
COSTS AND EXPENSES
                               
Cost of goods sold
    113,415       11,065       135,745       35,545  
Research and development
    152,985       233,087       517,196       749,049  
Selling, general and administrative
    375,767       566,541       1,365,836       1,779,045  
Amortization of intangible assets
    119,763       206,454       356,687       612,632  
Depreciation
    75,219       75,359       225,691       227,665  
Total Costs and Expenses
    837,149       1,092,506       2,601,155       3,403,936  
                                 
OPERATING (LOSS)
    (748,227 )     (1,018,854 )     (2,396,017 )     (3,174,927 )
                                 
Other Income (Expense)
                               
Interest and miscellaneous income
    30,720       1,857       33,745       9,485  
Interest expense
    (134,218 )     (22,545 )     (191,008 )     (48,839 )
(LOSS) Before Income Taxes
    (851,725 )     (1,039,542 )     (2,553,280 )     (3,214,281 )
                                 
Income taxes
    ---       ---       ---       ---  
NET (LOSS)
  $ (851,725 )   $ (1,039,542 )   $ (2,553,280 )   $ (3,214,281 )
                                 
Less preferred stock dividends
    (12,288 )     (462 )     (35,168 )     (462 )
NET (LOSS) Allocable to Common Stockholders
  $ (864,013 )   $ (1,040,004 )   $ (2,588,448 )   $ (3,214,743 )
                                 
                                 
Basic and diluted net (loss) per common share
  $ (0.10 )   $ (0.18 )   $ (0.32 )   $ (0.55 )
                                 
WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING
    8,267,755       5,928,084       8,106,117       5,850,900  
                                 
   


 
 

 


ULURU Inc.

SELECTED CONDENSED CONSOLIDATED BALANCE SHEET DATA


   
September 30, 2012
   
December 31, 2011
 
   
(Unaudited)
   
(Audited)
 
             
  Cash and cash equivalents
  $ 36,557     $ 46,620  
  Current assets
    1,193,463       1,349,456  
  Property and equipment, net
    911,117       1,072,460  
  Other assets
    5,740,331       4,640,504  
  Total assets
    7,844,911       7,062,420  
                 
  Current liabilities
    2,477,520       2,053,867  
  Long term liabilities – convertible notes payable
    2,000,866       234,882  
  Long term liabilities – deferred revenue
    846,953       672,282  
  Total liabilities
    5,325,339       2,961,031  
  Total stockholders’ equity
    2,519,572       4,101,389