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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 


 

FORM 10-Q

 


 

QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE

SECURITIES EXCHANGE ACT OF 1934

 

For the quarterly period ended June 30, 2004

 

Commission File Number 1-14798

 


 

IVAX DIAGNOSTICS, INC.

(Exact name of registrant as specified in its charter)

 


 

Delaware   11-3500746

(State or other jurisdiction of

incorporation or organization)

 

(I.R.S. Employer

Identification No.)

 

2140 North Miami Avenue, Miami, Florida 33127

(Address of principal executive offices) (Zip Code)

 

(305) 324-2300

(Registrant’s telephone number, including area code)

 


 

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.    Yes  x    No  ¨

 

Indicate by check mark whether the registrant is an accelerated filer (as defined in Rule 12b-2 of the Exchange Act).    Yes  ¨    No  x

 

Indicate the number of shares outstanding of each of the issuer’s classes of common stock, as of the latest practicable date.

 

27,019,829 shares of Common Stock, $ .01 par value, outstanding as of August 6, 2004.

 



Table of Contents

IVAX DIAGNOSTICS, INC.

 

INDEX

 

          PAGE NO.

PART I - FINANCIAL INFORMATION

    

Item 1- Financial Statements

    
    

Consolidated Balance Sheets as of June 30, 2004 (unaudited) and December 31, 2003

   2
    

Consolidated Statements of Operations (unaudited) for the three months and six months ended June 30, 2004 and 2003

   3
    

Consolidated Statements of Cash Flows (unaudited) for the six months ended June 30, 2004 and 2003

   4
    

Notes to Consolidated Financial Statements

   5

Item 2 - Management’s Discussion and Analysis of Financial Condition and Results of Operations

   11

Item 3 - Quantitative and Qualitative Disclosures About Market Risk

   19

Item 4 - Controls and Procedures

   20

PART II - OTHER INFORMATION

    

Item 1– Legal Proceedings

   21

Item 2 - Changes in Securities, Use of Proceeds and Issuer Purchases of Equity Securities

   22

Item 4 – Submission of Matters to a Vote of Security Holders

   23

Item 6 - Exhibits and Reports on Form 8-K

   23


Table of Contents

PART I - FINANCIAL INFORMATION

 

Item 1 - Financial Statements

 

IVAX DIAGNOSTICS, INC. AND SUBSIDIARIES

CONSOLIDATED BALANCE SHEETS

 

     June 30,
2004


    December 31,
2003


 
     (Unaudited)        
ASSETS                 

Current assets:

                

Cash and cash equivalents

   $ 12,554,278     $ 15,464,839  

Accounts receivable, net of allowances for doubtful accounts of $2,919,757 in 2004 and $2,897,833 in 2003

     6,999,146       6,676,910  

Inventories

     4,486,070       4,473,062  

Other current assets

     2,115,654       1,649,360  
    


 


Total current assets

     26,155,148       28,264,171  

Property, plant and equipment, net

     2,174,137       2,128,029  

Goodwill, net

     6,704,303       6,683,461  

Equipment on lease

     969,335       1,205,593  

Other assets

     71,661       84,240  
    


 


Total assets

   $ 36,074,584     $ 38,365,494  
    


 


LIABILITIES AND SHAREHOLDERS’ EQUITY                 

Current liabilities:

                

Accounts payable

   $ 1,442,666     $ 810,694  

Accrued expenses and other current liabilities

     2,700,707       3,119,941  
    


 


Total current liabilities

     4,143,373       3,930,635  
    


 


Other long-term liabilities

     530,790       471,577  
    


 


Commitments and contingencies

                

Shareholders’ equity:

                

Common stock, $0.01 par value, authorized 50,000,000 shares, issued and outstanding 27,019,829 in 2004 and 27,659,329 in 2003

     270,198       276,593  

Capital in excess of par value

     41,010,041       43,582,346  

Accumulated deficit

     (8,877,427 )     (9,101,104 )

Accumulated other comprehensive loss

     (1,002,391 )     (794,553 )
    


 


Total shareholders’ equity

     31,400,421       33,963,282  
    


 


Total liabilities and shareholders’ equity

   $ 36,074,584     $ 38,365,494  
    


 


 

The accompanying Notes to Consolidated Financial Statements are an integral part of these balance sheets.

 

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IVAX DIAGNOSTICS, INC. AND SUBSIDIARIES

CONSOLIDATED STATEMENTS OF OPERATIONS

(Unaudited)

 

     Three Months

    Six months

 

Period Ended June 30,


   2004

   2003

    2004

   2003

 

Net revenues

   $ 5,005,699    $ 4,491,466     $ 9,737,889    $ 8,935,034  

Cost of sales

     2,035,932      1,769,506       3,919,191      3,780,635  
    

  


 

  


Gross profit

     2,969,767      2,721,960       5,818,698      5,154,399  
    

  


 

  


Operating expenses:

                              

Selling

     1,362,005      1,391,493       2,761,870      2,676,721  

General and administrative

     1,179,166      1,273,980       2,264,717      2,438,425  

Research and development

     316,464      343,775       634,830      690,501  
    

  


 

  


Total operating expenses

     2,857,635      3,009,248       5,661,417      5,805,647  
    

  


 

  


Income (loss) from operations

     112,132      (287,288 )     157,281      (651,248 )

Other income:

                              

Interest income

     42,133      90,413       84,133      141,620  

Other income, net

     75,760      112,172       25,812      150,983  
    

  


 

  


Total other income, net

     117,893      202,585       109,945      292,603  
    

  


 

  


Income (loss) before provision for income taxes

     230,025      (84,703 )     267,226      (358,645 )

Provision for income taxes

     25,421      23,063       43,549      36,481  
    

  


 

  


Net income (loss)

   $ 204,604    $ (107,766 )   $ 223,677    $ (395,126 )
    

  


 

  


Basic earnings (loss) per common share

   $ 0.01    $ 0.00     $ 0.01    $ (0.01 )
    

  


 

  


Diluted earnings (loss) per common share

   $ 0.01    $ 0.00     $ 0.01    $ (0.01 )
    

  


 

  


WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING:

                              

Basic

     27,631,155      27,538,703       27,651,345      27,528,945  
    

  


 

  


Diluted

     28,446,942      27,538,703       28,465,373      27,528,945  
    

  


 

  


 

The accompanying Notes to Consolidated Financial Statements are an integral part of these statements.

 

3


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IVAX DIAGNOSTICS AND SUBSIDIARIES

CONSOLIDATED STATEMENTS OF CASH FLOWS

(Unaudited)

 

Six months Ended June 30,


   2004

    2003

 

Cash flows from operating activities:

                

Net income (loss)

   $ 223,677     $ (395,126 )

Adjustments to reconcile net income (loss) to net cash flows provided by operating activities:

                

Depreciation and amortization

     567,389       579,628  

Provision for doubtful accounts receivable

     111,864       193,227  

Stock option compensation expense

     —         222,225  

Changes in operating assets and liabilities:

                

Accounts receivable

     (585,275 )     (800,282 )

Inventories

     (71,456 )     221,980  

Other current assets

     (506,248 )     (345,098 )

Other assets

     190       158  

Accounts payable and accrued expenses

     287,860       387,048  

Other long-term liabilities

     74,405       (10,445 )
    


 


Net cash flows provided by operating activities

     102,406       53,315  
    


 


Cash flows from investing activities:

                

Capital expenditures

     (217,824 )     (131,583 )

Acquisitions of equipment on lease

     (188,714 )     (443,262 )
    


 


Net cash flows used in investing activities

     (406,538 )     (574,845 )
    


 


Cash flows from financing activities:

                

Proceeds from stock option exercises

     49,800       249,830  

Repurchase of common stock

     (2,628,500 )     —    
    


 


Net cash flows provided by (used in) financing activities

     (2,578,700 )     249,830  
    


 


Effect of exchange rate changes on cash and cash equivalents

     (27,729 )     74,826  
    


 


Net decrease in cash and cash equivalents

     (2,910,561 )     (196,874 )

Cash and cash equivalents at the beginning of the period

     15,464,839       15,941,663  
    


 


Cash and cash equivalents at the end of the period

   $ 12,554,278     $ 15,744,789  
    


 


Supplemental disclosures:

                

Interest paid

   $ —       $ —    
    


 


Income tax payments

   $ 262,169     $ —    
    


 


 

The accompanying Notes to Consolidated Financial Statements are an integral part of these statements.

 

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IVAX DIAGNOSTICS, INC. AND SUBSIDIARIES

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

(Unaudited)

 

(1) GENERAL:

 

The accompanying unaudited interim consolidated financial statements have been prepared pursuant to the rules and regulations of the Securities and Exchange Commission for reporting on Form 10-Q and, therefore, do not include all information normally included in audited financial statements. However, in the opinion of management, all adjustments (consisting of only normal recurring adjustments) necessary to present fairly the results of operations, financial position and cash flows have been made. The results of operations and cash flows for the six months ended June 30, 2004 are not necessarily indicative of the results of operations and cash flows which may be reported for the remainder of 2004. The interim consolidated financial statements should be read in conjunction with the consolidated financial statements and the notes to consolidated financial statements included in the IVAX Diagnostics, Inc. (“IVAX Diagnostics,” “the Company,” “we,” “us,” “our”) Annual Report on Form 10-K for the year ended December 31, 2003. Certain prior period amounts presented in the consolidated financial statements have been reclassified to conform to the current period’s designation.

 

On March 14, 2001, b2bstores.com Inc. (“b2bstores.com”), IVAX Corporation (“IVAX”) and IVAX Diagnostics, Inc., a wholly-owned subsidiary of IVAX at that date (the “pre-merger IVAX Diagnostics”), consummated a merger of the pre-merger IVAX Diagnostics into b2bstores.com pursuant to which all of the issued and outstanding shares of the pre-merger IVAX Diagnostics were converted into 20,000,000 shares of b2bstores.com stock and b2bstores.com’s name was changed to IVAX Diagnostics, Inc.

 

(2) CASH EQUIVALENTS AND SHORT-TERM MARKETABLE SECURITIES:

 

The Company owns certain short-term investments in marketable debt securities with original maturities of three months or less that are classified as cash equivalents.

 

Substantially all cash and cash equivalents are presently held at one national securities brokerage firm. Accordingly, the Company is subject to credit risk if this brokerage firm is unable to repay the balance in the account or deliver the Company’s securities or if the brokerage firm should become bankrupt or otherwise insolvent. At June 30, 2004 and December 31, 2003, the Company owned no marketable securities. It is the Company’s policy to invest in select money market instruments, municipal securities and corporate issuers.

 

(3) INVENTORIES:

 

Inventories consist of the following:

 

     June 30,
2004


   December 31,
2003


Raw materials

   $ 1,759,373    $ 1,611,794

Work-in-process

     417,892      340,301

Finished goods

     2,308,805      2,520,967
    

  

Total inventories

   $ 4,486,070    $ 4,473,062
    

  

 

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(4) CONCENTRATION OF CREDIT RISK:

 

The Company performs periodic credit evaluations of its customers’ financial condition and provides allowances for doubtful accounts as required. The Company’s accounts receivables are generated from sales made from both in the United States and Italy. As of June 30, 2004 and December 31, 2003, $4,992,882 and $4,721,125, respectively, of the Company’s net accounts receivable were due in Italy. Of the total net accounts receivable, 57.8% at June 30, 2004 and 59.6% at December 31, 2003 were due from hospitals and laboratories controlled by the Italian government.

 

(5) EARNINGS (LOSS) PER SHARE:

 

A reconciliation of the denominator of the basic and diluted earnings (loss) per share computation is as follows:

 

     Three Months

   Six months

Period Ended June 30,


   2004

   2003

   2004

   2003

Basic weighted average shares outstanding

   27,631,155