0001168220-13-000016.txt : 20130401 0001168220-13-000016.hdr.sgml : 20130401 20130401091632 ACCESSION NUMBER: 0001168220-13-000016 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20130401 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20130401 DATE AS OF CHANGE: 20130401 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: 0913 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-33618 FILM NUMBER: 13729059 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_040113.htm FORM 8-K APRIL 1, 2013 form8k_040113.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): April 1, 2013

 
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, 2012 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 April 1, 2013, ULURU Inc. (the “Company”) issued a press release reporting the financial results for its fiscal quarter and year ended December 31, 2012.  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: April 1, 2013
 
By:
 /s/ Terrance K. Wallberg
 
   
Terrance K. Wallberg
   
Vice President and Chief Financial Officer


 
 

 





EXHIBIT INDEX

Exhibit No.
Description
 

 

 
 

 

EX-99.1 2 ex_99-1.htm PRESS RELEASE, DATED APRIL 1, 2013 ex_99-1.htm


ULURU NEWS

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


ULURU INC.
 
REPORTS FINANCIAL RESULTS FOR FOURTH QUARTER AND YEAR ENDING DECEMBER 31, 2012

- Review of 2012 Operating Activities -
- Provides Business Outlook for 2013 -


Addison, Texas, April 1, 2013; ULURU Inc. (OTCQB: ULUR) today announced its financial results for the fourth quarter and year ended December 31, 2012 and provided a review of its operating activities.

Significant progress has been made over the past 12 months, including:
 
¬  
Securing the necessary financing, on favorable terms, to execute our business plan;
 
¬  
Significantly expanding the international commercialization activities for Altrazeal® including launching the product in Austria and Australia;
 
¬  
Expansion of key opinion leader support for Altrazeal® in major international markets;
 
¬  
Commenced the establishment of an international network of distribution partners to expand the Altrazeal® selling and marketing activities globally;
 
¬  
Shipment of the first order of the veterinary form of Altrazeal® to our strategic partner;
 
¬  
Launch of the innovative Altrazeal® 0.75 gram blister pack; and
 
¬  
Entering into a strategic collaboration to develop the oral applications of our OraDisc mucoadhesive film technology.
 

During 2012, the Company has laid the foundation for a rapid increase in revenues and the advancement of the Company towards profitability. In the upcoming 12 months our business outlook is for major expansion of commercialization actives for Altrazeal® in international markets, including the following:
 
¬  
Altrazeal® being marketed in over 15 markets worldwide;
 
¬  
Expanding the network of distribution partners to cover all major international markets excluding Japan; and
 
¬  
Positioning Altrazeal® to be marketed in all major markets by 2014.

By achieving the above objectives the Company is projecting to be cash flow positive by the fourth quarter of 2013.

Commenting on the 2012 activities and the business outlook for 2013, Kerry P. Gray, President and CEO stated, “I am very pleased with our accomplishments and the progress that has been made during 2012, which was achieved with limited resources. The Company has now been positioned for rapid revenue growth and advancement towards profitability. The international exposure to Altrazeal® that has been generated and the positive response received from both healthcare professionals and potential strategic partners is very exciting. We look forward to a major transformation of the Company over the upcoming 12 months as we move towards establishing a predictable and rapidly growing revenue stream.”

For the fourth quarter of 2012, the Company reported a net loss of $1.0 million, or $0.10 per share, compared with a net loss of $0.9 million, or $0.13 per share, for the same period last year.  For the year ending December 31, 2012, the Company reported a net loss of $3.5 million, or $0.42 per share, compared with a net loss of $4.1 million, or $0.67 per share, in the same period of 2011.

Revenues
Revenues for the fourth quarter of 2012 were $165,000, compared to $256,000 for the fourth quarter of 2011.  The decrease of approximately $91,000 in revenues from the fourth quarter of 2011 compared to the fourth quarter of 2012 was primarily due to a decrease of $188,000 in Aphthasol® product sales as we did not sell any Aphthasol® to our domestic distributor in the fourth quarter of 2012 and a decrease of $17,000 in Aphthasol® royalties.  These decreases were partially offset by increased Altrazeal® product sales.

For the year ending December 31, 2012, revenues were $371,000, compared to $485,000 for the same period of 2011.  The decrease of approximately $114,000 was due primarily to a decrease of $188,000 in Aphthasol® product sales as we did not sell any Aphthasol® to our domestic distributor in 2012.  This decrease was partially offset by increased Altrazeal® product sales.

Research and Development
Research and development expenses for the fourth quarter of 2012 were $316,000, including $1,000 in share-based compensation, compared to $198,000, including $17,000 in share-based compensation, for the fourth quarter of 2011.  The increase of approximately $118,000 in research and development expenses was due to increases in regulatory costs of $71,000, consulting and direct research costs of $97,000 related to Altrazeal®, and clinical study costs of $20,000.  These increases were partially offset by lower scientific compensation costs of $69,000 related to share-based compensation and lower head count.

For the year ending December 2012, research and development expenses were $833,000, including $10,000 in share-based compensation, compared to $947,000, including $70,000 in share-based compensation, for the same period in 2011. The decrease of approximately $114,000 in research and development expenses was due primarily to lower scientific compensation costs of $157,000 related to share-based compensation and lower head count and lower costs for regulatory consulting fees of $70,000.  These decreases were partially offset by a $90,000 increase in regulatory costs and a $20,000 increase in clinical study costs.

Selling, general and administrative
Selling, general and administrative expenses for the fourth quarter of 2012 were $425,000, including $8,000 in share-based compensation, compared to $498,000, including $25,000 in share-based compensation, for the fourth quarter of 2011.  The decrease of approximately $73,000 in selling, general and administrative expenses was primarily due to lower costs for compensation of $37,000, decreased sales & marketing costs of $80,000 due to a revised marketing plan, and lower insurance costs of $20,000.  These decreases were partially offset by a $60,000 increase in costs for investor relations consulting.

For the year ending December 2012, selling, general and administrative expenses were $1,791,000, including $36,000 in share-based compensation, compared to $2,277,000 million, including $102,000 of share-based compensation, for the same period in 2011.  The decrease of approximately $486,000 in selling, general and administrative expenses was primarily due to lower costs for compensation of $184,000, sales & marketing costs of $245,000 due to a revised marketing plan, and legal costs relating to our patents of $63,000.

Amortization of Intangible Assets
Amortization expense for the fourth quarter of 2012 was $120,000 as compared to $157,000 for the fourth quarter of 2011 and is comprised of amortization associated with our acquired patents.  The decrease of $37,000 is attributable to the expiration of the amortization of the Aphthasol® patent in November 2011.
 
For the year ending December 2012, amortization expense was $476,000 as compared to $769,000 for the same period of 2011.  The decrease of $293,000 is attributable to the expiration of the amortization of the Aphthasol® patent in November 2011.

Interest Expense
Interest expense for the fourth quarter of 2012 was $137,000 as compared to $18,000 for the fourth quarter of 2011.  The increase of approximately $119,000 is primarily attributable to costs associated with our convertible debt.

For the year ending December 2012, interest expense was $328,000 as compared to $67,000 for the same period of 2011.  The increase of approximately $261,000 is primarily attributable to costs associated with our convertible debt.

Mr. Gray continued, “The 2012 operating results reflect a significant improvement in our reported loss from 2011 and is due principally to the positive effects of our business restructuring and tight controls over our operating expenses.  We have established an expense base that is not projected to increase significantly as our operating activities expand. With the projected increase in revenues for 2013, we are forecasting a significant improvement in operating results.”

 
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 progress of our technology, clinical and regulatory results for our products, advantages of our products, and cost saving initiatives, anticipated product launches and regulatory filings, near term revenue opportunities and anticipated extensions of product lines. 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. 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 ending December 31, 2012 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,
 
   
2012
   
2011
   
2012
   
2011
 
Revenues
                       
License fees
  $ 11,400     $ 4,494     $ 40,563     $ 22,843  
Royalty income
    ---       17,128       49,918       68,656  
Product sales
    154,056       233,905       280,113       393,037  
Total Revenues
    165,456       255,527       370,594       484,536  
                                 
Cost and Expenses
                               
Cost of goods sold
    107,793       167,609       243,538       203,154  
Research and development
    315,735       197,504       832,931       946,553  
Selling, general and administrative
    425,385       497,761       1,791,221       2,276,806  
Amortization of intangible assets
    119,763       156,500       476,450       769,132  
Depreciation
    65,583       75,359       291,274       303,024  
Total Costs and Expenses
    1,034,259       1,094,733       3,635,414       4,498,669  
Operating (Loss)
    (868,803 )     (839,206 )     (3,264,820 )     (4,014,133 )
                                 
Other Income (Expense)
                               
Interest and miscellaneous income
    27,974       1,856       61,719       11,341  
Interest expense
    (137,240 )     (18,461 )     (328,248 )     (67,300 )
Equity in earnings (loss) of unconsolidated subsidiary
    ---       ---       ---       ---  
(Loss) Before Income Taxes
    (978,069 )     (855,811 )     (3,531,349 )     (4,070,092 )
                                 
Income taxes
    ---       ---       ---       ---  
Net (Loss)
  $ (978,069 )   $ (855,811 )   $ (3,531,349 )   $ (4,070,092 )
                                 
Less preferred stock dividends
    (12,288 )     (3,925 )     (47,456 )     (4,387 )
Net (Loss) Allocable to Common Stockholders
  $ (990,357 )   $ (859,736 )   $ (3,578,805 )   $ (4,074,479 )
                                 
                                 
                                 
Basic and diluted net (loss) per common share
  $ (0.10 )   $ (0.13 )   $ (0.42 )   $ (0.67 )
                                 
Weighted average number of common shares outstanding
    9,648,036       6,702,759       8,493,703       6,065,615  
                                 

 
 
 

 


ULURU Inc.
SELECTED CONSOLIDATED BALANCE SHEET DATA
 
   
December 31, 2012
   
December 31, 2011
 
             
  Cash and cash equivalents
  $ 21,549     $ 46,620  
  Current assets
    1,115,982       1,349,456  
  Property and equipment, net
    845,535       1,072,460  
  Other assets
    5,366,600       4,640,504  
  Total assets
    7,328,117       7,062,420  
                 
  Current liabilities
    3,889,734       2,053,867  
  Long term liabilities – convertible note payable
    751,543       234,882  
  Long term liabilities – deferred revenue
    835,553       672,282  
  Total liabilities
    5,476,830       2,961,031  
  Total stockholders’ equity
    1,851,287       4,101,389