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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 September 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   (I.R.S. Employer
incorporation or organization)   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 November 8, 2004.

 



Table of Contents

IVAX DIAGNOSTICS, INC.

 

INDEX

 

     PAGE NO.

PART I - FINANCIAL INFORMATION

    

Item 1

     Financial Statements     
         Consolidated Balance Sheets as of September 30, 2004 (unaudited) and December 31, 2003    2
         Consolidated Statements of Operations (unaudited) for the three months and nine months ended September 30, 2004 and 2003    3
         Consolidated Statements of Cash Flows (unaudited) for the nine months ended September 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

     Unregistered Sales of Equity Securities and Use of Proceeds    22

Item 6

     Exhibits    23


Table of Contents

PART I - FINANCIAL INFORMATION

 

Item 1 - Financial Statements

 

IVAX DIAGNOSTICS, INC. AND SUBSIDIARIES

CONSOLIDATED BALANCE SHEETS

 

     September 30,
2004


    December 31,
2003


 
     (Unaudited)        
ASSETS                 

Current assets:

                

Cash and cash equivalents

   $ 11,909,340     $ 15,464,839  

Accounts receivable, net of allowances for doubtful accounts of $2,985,287 in 2004 and $2,897,833 in 2003

     7,105,568       6,676,910  

Inventories

     4,796,946       4,473,062  

Other current assets

     2,146,903       1,649,360  
    


 


Total current assets

     25,958,757       28,264,171  

Property, plant and equipment, net

     2,227,947       2,128,029  

Goodwill, net

     6,691,829       6,683,461  

Equipment on lease

     870,583       1,205,593  

Other assets

     70,663       84,240  
    


 


Total assets

   $ 35,819,779     $ 38,365,494  
    


 


LIABILITIES AND SHAREHOLDERS’ EQUITY                 

Current liabilities:

                

Accounts payable

   $ 1,179,643     $ 810,694  

Accrued expenses and other current liabilities

     2,639,379       3,119,941  
    


 


Total current liabilities

     3,819,022       3,930,635  
    


 


Other long-term liabilities

     569,410       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

     (8,971,503 )     (9,101,104 )

Accumulated other comprehensive loss

     (877,389 )     (794,553 )
    


 


Total shareholders’ equity

     31,431,347       33,963,282  
    


 


Total liabilities and shareholders’ equity

   $ 35,819,779     $ 38,365,494  
    


 


 

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

 

2


Table of Contents

IVAX DIAGNOSTICS, INC. AND SUBSIDIARIES

CONSOLIDATED STATEMENTS OF OPERATIONS

(Unaudited)

 

Period Ended September 30,


   Three Months

    Nine Months

 
     2004

    2003

    2004

    2003

 

Net revenues

   $ 4,582,855     $ 4,343,688     $ 14,320,744     $ 13,278,722  

Cost of sales

     1,938,441       1,712,614       5,857,632       5,493,249  
    


 


 


 


Gross profit

     2,644,414       2,631,074       8,463,112       7,785,473  
    


 


 


 


Operating expenses:

                                

Selling

     1,488,862       1,329,331       4,250,732       4,006,052  

General and administrative

     1,080,540       1,196,470       3,345,257       3,634,895  

Research and development

     327,039       304,561       961,869       995,062  
    


 


 


 


Total operating expenses

     2,896,441       2,830,362       8,557,858       8,636,009  
    


 


 


 


Loss from operations

     (252,027 )     (199,288 )     (94,746 )     (850,536 )

Other income:

                                

Interest income

     53,433       40,150       137,566       181,770  

Other income (expense), net

     77,761       (5,465 )     103,573       145,518  
    


 


 


 


Total other income, net

     131,194       34,685       241,139       327,288  
    


 


 


 


Income (loss) before provision for income taxes

     (120,833 )     (164,603 )     146,393       (523,248 )

Provision for (benefit from) income taxes

     (26,757 )     18,581       16,792       55,062  
    


 


 


 


Net income (loss)

   $ (94,076 )   $ (183,184 )   $ 129,601     $ (578,310 )
    


 


 


 


Basic earnings (loss) per common share

   $ 0.00     $ (0.01 )   $ 0.00     $ (0.02 )
    


 


 


 


Diluted earnings (loss) per common share

   $ 0.00     $ (0.01 )   $ 0.00     $ (0.02 )
    


 


 


 


WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING:

                                

Basic

     27,019,829       27,643,848       27,448,896       27,567,667  
    


 


 


 


Diluted

     27,019,829       27,643,848       28,253,534       27,567,667  
    


 


 


 


 

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

 

3


Table of Contents

IVAX DIAGNOSTICS AND SUBSIDIARIES

CONSOLIDATED STATEMENTS OF CASH FLOWS

(Unaudited)

 

Nine Months Ended September 30,


   2004

    2003

 

Cash flows from operating activities:

                

Net income (loss)

   $ 129,601     $ (578,310 )

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

                

Depreciation and amortization

     837,438       826,516  

Provision for doubtful accounts receivable

     133,638       205,917  

Stock option compensation expense

     —         222,225  

Changes in operating assets and liabilities:

                

Accounts receivable

     (614,360 )     (568,722 )

Inventories

     (345,124 )     48,478  

Other current assets

     (458,088 )     (212,264 )

Other assets

     252       4,060  

Accounts payable and accrued expenses

     (83,598 )     464,552  

Other long-term liabilities

     56,802       10,906  
    


 


Net cash (used in) flows provided by operating activities

     (343,439 )     423,358  
    


 


Cash flows from investing activities:

                

Capital expenditures

     (343,207 )     (212,050 )

Acquisitions of equipment on lease

     (264,566 )     (555,271 )
    


 


Net cash flows used in investing activities

     (607,773 )     (767,321 )
    


 


Cash flows from financing activities:

                

Proceeds from stock option exercises

     49,800       262,320  

Repurchase of common stock

     (2,628,500 )     —    
    


 


Net cash flows (used in) provided by financing activities

     (2,578,700 )     262,320  
    


 


Effect of exchange rate changes on cash and cash equivalents

     (25,587 )     96,069  
    


 


Net (decrease) increase in cash and cash equivalents

     (3,555,499 )     14,426  

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

   $ 11,909,340     $ 15,956,089  
    


 


Supplemental disclosures:

                

Interest paid

   $ —       $ —    
    


 


Income tax payments

   $ 266,662     $ —    
    


 


 

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

 

4


Table of Contents

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 nine months ended September 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 September 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:

 

     September 30,
2004


   December 31,
2003


Raw materials</