-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, RrTP5IwZsJlweAA3Up0y4F7Bg9D8mDB1Peq+DyISVzRZXI/Q//iVwCLv6se7eWBK 1CuzXDJvM8J3nLkiIxaEmw== 0001168220-10-000019.txt : 20100324 0001168220-10-000019.hdr.sgml : 20100324 20100324163217 ACCESSION NUMBER: 0001168220-10-000019 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20100324 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20100324 DATE AS OF CHANGE: 20100324 FILER: COMPANY DATA: COMPANY CONFORMED NAME: ULURU INC. CENTRAL INDEX KEY: 0001168220 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 412118656 STATE OF INCORPORATION: NV FISCAL YEAR END: 1205 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-33618 FILM NUMBER: 10702108 BUSINESS ADDRESS: STREET 1: 4452 BELTWAY DRIVE CITY: ADDISON STATE: TX ZIP: 75001 BUSINESS PHONE: 214-905-5145 MAIL ADDRESS: STREET 1: 4452 BELTWAY DRIVE CITY: ADDISON STATE: TX ZIP: 75001 FORMER COMPANY: FORMER CONFORMED NAME: OXFORD VENTURES INC DATE OF NAME CHANGE: 20020225 8-K 1 form8k_032410.htm FORM 8K MARCH 24, 2010 form8k_032410.htm
 


 
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549

FORM 8-K

CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934

Date of report (Date of earliest event reported): March 24, 2010

 
ULURU Inc.
(Exact Name of Registrant as Specified in its Charter)


         
Nevada
 
000-49670
 
41-2118656
(State or Other Jurisdiction of
Incorporation)
 
(Commission File Number)
 
(I.R.S. Employer
Identification No.)
         


 
4452 Beltway Drive
Addison, Texas 75001
(Address of principal executive offices) (Zip Code)
 
Registrant’s telephone number, including area code: (214) 905-5145
 
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
o
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
o
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
o
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
o
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))


 
 

 


SAFE HARBOR STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995

Information included in this Form 8-K may contain forward-looking statements within the meaning of Section 27A of the Securities Act and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”).  This information may involve known and unknown risks, uncertainties and other factors which may cause our actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by any forward-looking statements.  Forward-looking statements, which involve assumptions and describe our future plans, strategies and expectations, are generally identifiable by use of the words “may,” “will,” “should,” “expect,” “anticipate,” “estimate,” “believe, 221;  “intend,” or “project” or the negative of these words or other variations on these words or comparable terminology.  Forward-looking statements are based on assumptions that may be incorrect, and there can be no assurance that any projections or other expectations included in any forward-looking statements will come to pass.  Our actual results could differ materially from those expressed or implied by the forward-looking statements as a result of various factors including, but not limited to the factors and risks 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.  Except as required by applicable laws, we undertake no obligation to update publicly any forward-looking statements for any reason, even if new information becomes available or other events occur in the future.


Item 2.02
Results of Operations and Financial Condition.

On March 24, 2010, ULURU Inc. (the “Company”) issued a press release reporting the financial results for its fiscal quarter and year ended December 31, 2009.  A copy of the press release is attached to this Current Report on Form 8-K (“Current Report”) as Exhibit 99.1 and is incorporated herein solely for purposes of this Item 2.02 disclosure.

The information in Item 2.02 of this Current Report, including Exhibit 99.1 attached hereto, is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of such section.  The information in Item 2.02 of this Current Report, including Exhibit 99.1, shall not be incorporated by reference into any filing under the Securities Act of 1933, as amended (the “Securities Act”), or the Exchange Act, regardless of any incorporation by reference language in any such filing.


Item 9.01
Financial Statements and Exhibits
   
(d)
Exhibits
   
Exhibit No.
Description




SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 
ULURU Inc.
   
Date: March 24, 2010
 
By:
/s/ Terrance K. Wallberg
 
   
Terrance K. Wallberg
   
Vice President and Chief Financial Officer


 
 

 





EXHIBIT INDEX

Exhibit No.
Description
99.1
Press Release dated March 24, 2010

 
 

 

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 M edicare 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 incre ase 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," "g oal," "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 act ual 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  
 
 
 
 
 
 

 

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