-----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, MQRPiFy3XZ60oAHtaf+Byuw7GxRDrk39tPENV0hPopFGd/AYrpldC6S01SPnQZHm qy/XRFre5BYssJnbl2kwRQ== 0001168220-09-000015.txt : 20090330 0001168220-09-000015.hdr.sgml : 20090330 20090330160731 ACCESSION NUMBER: 0001168220-09-000015 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20090330 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20090330 DATE AS OF CHANGE: 20090330 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: 09714287 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_033009.htm FORM 8-K 03/30/2009 form8k_033009.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 30, 2009

 
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,”  “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, 2008 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.





 

 












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 30, 2009
 
By:
/s/ Terrance K. Wallberg
 
   
Terrance K. Wallberg
   
Vice President and Chief Financial Officer


 
 

 






Exhibit No.
Description
99.1
Press Release dated March 30, 2009
 

 

 
 

 

EX-99.1 2 ex_99-1.htm PRESS RELEASE DATED 03/30/2009 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, 2008
 

 
Addison, Texas, March 30, 2009; ULURU Inc. (NYSE Alternext: ULU) today announced its financial results for the fourth quarter and year ended December 31, 2008.

For the fourth quarter of 2008, the Company reported a net loss of $2.9 million, or $0.04 per share, compared with a net loss of $0.9 million, or $0.01 per share, for the same period last year.  For the year ended December 31, 2008, the Company reported a net loss of $9.8 million, or $0.15 per share, compared with a net loss of $4.2 million, or $0.07 per share, in the same period of 2007.  At December 31, 2008, the Company held cash and cash equivalents of $7.6 million, compared with $13.9 million at December 31, 2007.

Commenting on the financial results Renaat Van den Hooff, President and CEO stated, “The increase in operating expenses continues to be driven by costs associated with the commercial and clinical development of Altrazeal™ and Altrazeal™ Silver.  These investments are necessary in order to give visibility to the clinical successes obtained with our Altrazeal™ products and to keep our future product development milestones on track”.
Recent accomplishments related to our wound care franchise include:
·  
Altrazeal™ has been applied on an estimated 3,000 patients in treatment of a variety of wounds; with a significant number of these cases being well documented with data and pictures detailing the wound healing process;
·  
Four posters have been published and over thirty abstracts for posters and oral presentations have been submitted and accepted to be presented at several prominent wound care conferences in the upcoming months;
·  
To date, four articles with Altrazeal™ case studies have been submitted for publication in influential wound care journals; and
·  
Dr. Jeffrey A. Niezgoda, MD, FACHM, FACEP, FAPWCA, the Medical Director of The Centers for Comprehensive Wound Care and Hyperbaric Oxygen Therapy at St. Luke’s Medical Center in Milwaukee, Wisconsin and a nationally recognized wound care expert, accepted the position of Chairman of ULURU’s Scientific Advisory Board.

Mr. Van den Hooff continued, “We are now in the process of working through the purchasing cycle at a growing number of institutions that have observed successful clinical experiences with Altrazeal™. In parallel we are in dialogue with the Food and Drug Administration related to the approval of Altrazeal™ Silver, and our research and development team is on track to finalize the development and regulatory submission for Altrazeal™ Collagen in the fourth quarter of 2009.”
 
 
 

 
Operating Results
 
Revenue for the fourth quarter of 2008 was $257,000, compared to $834,000 for the fourth quarter of 2007.  For the year ended December 31, 2008, revenue was $733,000, compared to $1,466,000 in the same period of 2007.  The decrease in revenue from the fourth quarter of 2007 compared to the fourth quarter of 2008 was due to a decrease in licensing as 2007 included a non-recurring license fee of approximately $576,000 associated with our Zindaclin® product.  The decrease in revenue from the year ended December 2007 compared to the year ended December 2008 is due to decreases of $243,000 in sponsored research income and $679,000 in Zindaclin® license fees, both of which were non-recurring revenues in 2007.  These decreases were partially offset by product sales of Altrazeal™ and Aphthasol™ of approximately $184,000 that occurred this year with no associated product sales occurring in 2007.

Research and development expenses for the fourth quarter of 2008 were $860,000, including $42,000 in share-based compensation, compared to $638,000, including $39,000 in share-based compensation, for the fourth quarter of 2007.  For the year ended December 31, 2008, research and development expenses were $3.5 million, including $162,000 in share-based compensation, compared to $2.2 million, including $136,000 in share-based compensation, in the same period of 2007. The increase of approximately $1.3 million in research and development expenses was primarily due to development costs associated with our new Altrazeal™ Silver wound care product, clinical study expenses for Altrazeal™ and Altrazeal™ Silver, continued development costs for OraDisc™ technologies, regulatory consulting expenses, and additional scientific personnel.

Selling, general and administrative expenses for the fourth quarter of 2008 were $2.0 million, including $232,000 in share-based compensation, compared to $0.9 million, including $182,000 in share-based compensation, for the fourth quarter of 2007.  For the year ended December 31, 2008, selling, general and administrative expenses were $6.0 million, including $862,000 in share-based compensation, compared to $3.0 million, including $447,000 in share-based compensation, in the same period of 2007. The increase of approximately $3.0 million in selling, general and administrative expenses in 2008 was primarily due to costs of approximately $2.3 million associated with the implementation of our Altrazeal™ sales and marketing efforts that commenced in June 2008, compensation costs associated with the hiring of our executive vice president of operations, and increases in share-based compensation.


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 transmucosal delivery system and Nanoflex™ Aggregate technology. For further information about ULURU Inc., please visit our website at www.uluruinc.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 expected launch of our wound dressing product, development of a silver containing product, impact on cost of the production scale-up, the launch of additional products, and our expectation that our licensing fees will increase and offset increased expenses. When used in this press release, the words "may," "targets," "goal," "could," "should," "would," "believe," "feel," "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, pre-clinical results for our products, and advantages of 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, 2008 and other reports filed by us with the Securities and Exchange Commission

 
 

 

ULURU Inc.
SUMMARY OF RESULTS


STATEMENTS OF OPERATIONS DATA



   
Three Months Ended
December 31,
   
Year ended
December 31,
 
   
2008
   
2007
   
2008
   
2007
 
REVENUES
                       
License fees
  $ 164,459     $ 740,509     $ 230,308     $ 909,252  
Royalty income
    45,135       61,530       286,303       281,491  
Product sales
    14,607       ---       184,050       ---  
Other
    32,316       31,500       32,810       275,001  
Total Revenues
    256,517       833,539       733,471       1,465,744  
                                 
COSTS AND EXPENSES
                               
Cost of goods sold
    2,604       ---       140,822       ---  
Research and development
    859,533       637,550       3,503,638       2,211,698  
Selling, general and administrative
    2,025,750       935,476       5,992,097       3,045,065  
Amortization
    272,102       272,095       1,082,571       1,078,351  
Depreciation
    32,346       20,050       114,048       72,942  
Total Costs and Expenses
    3,192,335       1,865,171       10,833,176       6,408,056  
                                 
OPERATING (LOSS)
    ( 2,935,818 )     (1,031,632 )     (10,099,705 )     (4,942,312 )
                                 
Other Income (Expense)
                               
Interest and miscellaneous income
    47,269       174,953       317,070       791,687  
Interest expense
    ---       (431 )     ---       (2,006 )
                                 
(LOSS) BEFORE INCOME TAXES
    ( 2,888,549 )     (857,110 )     (9,782,635 )     (4,152,631 )
                                 
Income taxes
    ---       ---       ---       ---  
NET (LOSS)
  $ (2,888,549 )   $ (857,110 )   $ (9,782,635 )   $ (4,152,631 )
                                 
                                 
Basic and diluted net (loss) per common share
  $ (0.04 )   $ (0.01 )   $ (0.15 )   $ (0.07 )
                                 
WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING
    65,509,481       62,370,593       63,775,653       61,798,882  
                                 


 
 

 


ULURU Inc.
SELECTED CONDENSED CONSOLIDATED BALANCE SHEET DATA


   
December 31, 2008
   
December 31, 2007
 
   
(Audited)
   
(Audited)
 
             
  Cash and cash equivalents
  $ 7,567,588     $ 13,979,828  
  Current assets
    9,312,041       15,536,146  
  Property and equipment, net
    1,828,040       1,532,881  
  Other assets
    9,985,988       11,053,976  
  Total assets
    21,126,069       28,123,003  
                 
  Current liabilities
    2,243,113       1,389,989  
  Long term liabilities – deferred revenue
    1,356,526       495,281  
  Total liabilities
    3,599,639       1,885,270  
  Total stockholders’ equity
    17,526,430       26,237,733  




 
 

 

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