EX-99.1 2 ex_99-1.htm PRESS RELEASE DATED MARCH 24, 2010 ex_99-1.htm
 
 
 
ULURU NEWS

Contact: Company
Renaat Van den Hooff
President & CEO
Terry K. Wallberg
Vice President & CFO
(214) 905-5145


ULURU INC.
 
REPORTS FINANCIAL RESULTS FOR FOURTH QUARTER AND YEAR ENDED DECEMBER 31, 2009
 
 
Addison, Texas, March 24, 2010; ULURU Inc. (NYSE AMEX: ULU) today announced its financial results for the fourth quarter and year ended December 31, 2009.
 
For the fourth quarter of 2009, the Company reported a net loss of $1.7 million, or $0.02 per share, compared with a net loss of $2.9 million, or $0.04 per share, for the same period last year.  For the year ended December 31, 2009, the Company reported a net loss of $9.2 million, or $0.14 per share, compared with a net loss of $9.8 million, or $0.15 per share, in the same period of 2008. At December 31, 2009, the Company held cash and cash equivalents of approximately $1.9 million, compared with $7.6 million at December 31, 2008.  As of March 1, 2010, the Company held cash and cash equivalents of approximately $2.34 million.
 
Commenting on the financial results Renaat Van den Hooff, President and CEO stated, “During the fourth quarter we continued with our restructured business operation which has provided us with a reduced cost structure while allowing us to further our strategic goals. We have expanded our network of high quality independent sales representatives throughout the country. We are continuing to expand our new customer base since the implementation of our new sales and marketing approach and we are encouraged that this strategy will result in accelerated revenue growth.”
 
Mr. Van den Hooff continued: “During the past year, Altrazeal™ has continued to generate very positive clinical results and demonstrate its versatility in a wide variety of wound types and clinical settings. We completed our first randomized clinical trial, published two peer reviewed journal articles and made 39 poster presentations, some of which were authored by nationally recognized key opinion leaders.  In 2010 the continued clinical progress will be further communicated to doctors and nurses through a series of poster presentations and workshops, starting in April 2010 with the upcoming major wound care conferences including APWCA and SAWC.  Also, in 2009 we obtained a temporary HCPCS code for reimbursement for Altrazeal™.  We also established relationships with several authorized Medicare billing companies. From a business development perspective we have made significant progress with prospective partners and we expect to enter into several strategic partnerships in the course of 2010”
 
Mr. Van den Hooff added: “Lastly, we completed a sale of our common stock in February 2010 that provided us with net proceeds of approximately $900,000.  Based on our current business plan, we believe that our existing liquidity, projected sales of our existing products together with licensing and other anticipated revenues, will allow us to meet our working capital requirements at least through the third quarter of 2011.”
 
 
 
 
 
Operating Results
 
Revenues
 
Revenues for the fourth quarter of 2009 were $233,000, compared to $257,000 for the fourth quarter of 2008.  The decrease of approximately $14,000 in revenues from the fourth quarter of 2008 compared to the fourth quarter of 2009 was primarily due to lower licensing fees of $34,000 relating to our Zindaclin® and OraDisc™ technologies and a decrease of $32,000 in sponsored research.
 
For the year ended December 31, 2009, revenues were $668,000, compared to $733,000 for the same period of 2008.  The decrease of approximately $66,000 in revenues was entirely due to lower Aphthasol™ product sales of $166,000 as our distributor did not purchase any Aphthasol™ in 2009.
 
Research and Development
 
Research and development expenses for the fourth quarter of 2009 were $244,000, including $34,000 in share-based compensation, compared to $861,000, including $43,000 in share-based compensation, for the fourth quarter of 2008.  The decrease of approximately $617,000 in research and development expenses was primarily due to lower costs of $296,000 associated with decreased development efforts associated with our Altrazeal™ and OraDisc™ technologies.  There were also lower costs associated with regulatory consulting of $78,000 and savings of $217,000 due to the Company’s compensation reduction plan that was initiated in June 2009.
 
For the year ended December 2009, research and development expenses were $2.25 million, including $320,000 in share-based compensation, compared to $3.5 million, including $162,000 in share-based compensation, for the same period in 2008. The decrease of approximately $1.25 million in research and development expenses was due primarily to the Company’s business plan restructuring in July 2009 which contributed to decreases in direct research costs of $908,000 and in scientific personnel costs of $350,000.
 
 
 
 
 
Selling, general and administrative
 
Selling, general and administrative expenses for the fourth quarter of 2009 were $624,000, including $130,000 in share-based compensation, compared to $2.02 million, including $232,000 in share-based compensation, for the fourth quarter of 2008.  The decrease of approximately $1.4 million in selling, general and administrative expenses was due primarily to reduced costs for marketing and selling expenses of $1.0 million related to the implementation of the Company’s revised sales and marketing plan, savings of $164,000 in administrative costs due to the Company’s compensation reduction plan, and a decrease in legal and consulting fees of $135,000.
 
For the year ended December 2009, selling, general and administrative expenses were $5.67 million, including $1.3 million in share-based compensation, compared to $6.0 million, including $0.9 million of share-based compensation, for the same period in 2008.  The decrease of approximately $327,000 in selling, general and administrative expenses was influenced by the Company’s business plan restructuring in July 2009 which contributed to reductions in several areas, the majority occurring in sales and marketing cost savings of $283,000 as we transitioned to an independent sales representative model.  These expense decreases were partially offset by an increase in legal fees of $203,000 associated with filings made with the Securities and Exchange Commission, financing activities (including our completed stock offering in November 2009), and the proposed York Pharma acquisition.  The increase in administrative compensation includes approximately $394,000 of share-based compensation expense.
 
Other income and other expenses
 
Interest and miscellaneous income for the fourth quarter of 2009 was $274 as compared to $47,000 for the fourth quarter of 2008.  The decrease of approximately $47,000 is attributable to lower cash balances and interest yields during the fourth quarter of 2009.
 
For the year ended December 2009, interest and miscellaneous income was $43,000 compared to $317,000 for the same period of 2008.  The decrease of $274,000 is attributable to lower cash balances and interest yields during 2009.
 
On December 31, 2009, we performed an evaluation of our intangible assets for purposes of determining possible impairment.  Upon completion of the evaluation, the fair value of our intangible assets exceeded the recorded remaining book value, except for the valuation of the patent associated with our Zindaclin® technology.  We recognized an impairment charge of $716,633 for the year ended December 31, 2009.  There was no impairment loss for the year ended December 31, 2008.
 
 
 
 
 
 
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"), our current belief that we have sufficient liquidity in order to successfully execute our business plan through the third quarter of 2011, the publication of articles and posters, positive clinical results of Altrazeal, the effect of cost-savings programs, our plan to conserve cash, anticipated accelerated revenue growth, the launch of additional products, the outcome of strategic partnerships and our expected completion of strategic partnership negotiations by the end of the year.  When used in this press release, the words "may," "targets," "goal," "could," "should," "would," "believe," "feel," "hope," "expects," "confident," "anticipate," "estimate," "intend," "plan," "potential" and similar expressions may be indicative of forward-looking statements including without limitation statements relating to the progress of our technology, clinical and regulatory results for our products, advantages of our products, and cost saving initiatives.  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, 2009 and other reports filed by us with the Securities and Exchange Commission.
 
 
 
 
 
ULURU Inc.
SUMMARY OF RESULTS
 
 
STATEMENTS OF OPERATIONS DATA
 
 
   
(Unaudited)
    
(Audited)
  
   
Three Months Ended December 31,
    
Years Ended December 31,
  
   
2009
    
2008
    
2009
    
2008
  
REVENUES
                        
License fees
   $ 120,735     $ 164,459     $ 193,290     $ 230,308  
Royalty income
     50,908       45,135       255,738       286,303  
Product sales
     61,249       14,607       180,731       184,050  
Other
     ---       32,316       38,190       32,810  
Total Revenues
     232,892       256,517       667,949       733,471  
                                 
COSTS AND EXPENSES
                                
Cost of goods sold
     12,290       2,604       35,073       140,822  
Research and development
     244,083       860,673       2,250,153       3,503,638  
Selling, general and administrative
     624,242       2,024,611       5,665,559       5,992,097  
Amortization of intangible assets
     272,102       272,102       1,065,390       1,082,571  
Depreciation
     46,424       32,345       186,690       114,048  
Total Costs and Expenses
     1,199,141       3,192,335       9,202,865       10,833,176  
                                 
OPERATING (LOSS)
     ( 966,249 )     (2,935,818 )     (8,534,916 )     (10,099,705 )
                                 
Other Income (Expense)
                                
Interest and miscellaneous income
     274       47,269       42,571       317,070  
Interest expense
     (12,692 )     ---       (14,619 )     ---  
Impairment of intangible assets
     (716,633 )     ---       (716,633 )     ---  
Loss on sale of equipment
     ---       ---       (2,121 )     ---  
(LOSS) BEFORE INCOME TAXES
     ( 1,695,300 )     (2,888,549 )     (9,225,718 )     (9,782,635 )
                                 
Income taxes
     ---       ---       ---       ---  
NET (LOSS)
   $ (1,695,300 )   $ (2,888,549 )   $ (9,225,718 )   $ (9,782,635 )
                                 
                                 
Basic and diluted net (loss) per common share
   $ (0.02 )   $ (0.04 )   $ (0.14 )   $ (0.15 )
                                 
WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING
     71,456,653       65,509,481       67,168,941       63,775,653  
                                 
 
 
 
 
 
 
 
 
 
ULURU Inc.
SELECTED CONSOLIDATED BALANCE SHEET DATA
 
 
   
December 31, 2009
    
December 31, 2008
  
             
  Cash and cash equivalents
   $ 1,934,177     $ 7,567,588  
  Current assets
     3,544,850       9,312,041  
  Property and equipment, net
     1,631,557       1,828,040  
  Other assets
     8,203,965       9,985,988  
  Total assets
     13,380,372       21,126,069  
                 
  Current liabilities
     929,771       2,243,113  
  Long term liabilities – deferred revenue
     1,272,843       1,356,526  
  Total liabilities
     2,202,614       3,599,639  
  Total stockholders’ equity
     11,177,758       17,526,430