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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 March 31, 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.

 

27,673,204 shares of Common Stock, $ .01 par value, outstanding as of May 5, 2004.

 



IVAX DIAGNOSTICS, INC.

 

INDEX

 

          PAGE NO.

PART I - FINANCIAL INFORMATION

    

Item 1 -

  

Financial Statements

    
    

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

   2
    

Consolidated Statements of Operations (unaudited) for the three months ended March 31, 2004 and 2003

   3
    

Consolidated Statements of Cash Flows (unaudited) for the three months ended March 31, 2004 and 2003

   4
    

Notes to Consolidated Financial Statements (unaudited)

   5

Item 2 -

  

Management’s Discussion and Analysis of Financial Condition and Results of Operations

   10

Item 3 -

  

Quantitative and Qualitative Disclosures about Market Risk

   17

Item 4 -

  

Controls and Procedures

   18

PART II - OTHER INFORMATION

    

Item 1 -

  

Legal Proceedings

   19

Item 6 -

  

Exhibits and Reports on Form 8-K

   20

 


PART I - FINANCIAL INFORMATION

 

Item 1 - Financial Statements

 

IVAX DIAGNOSTICS, INC. AND SUBSIDIARIES

CONSOLIDATED BALANCE SHEETS

 

     March 31,
2004


    December 31,
2003


 
     (Unaudited)        
ASSETS                 

Current assets:

                

Cash and cash equivalents

   $ 15,998,395     $ 15,464,839  

Accounts receivable, net of allowances for doubtful accounts of $2,890,667 in 2004 and $2,897,833 in 2003

     6,674,132       6,676,910  

Inventories

     4,314,203       4,473,062  

Other current assets

     1,594,279       1,649,360  
    


 


Total current assets

     28,581,009       28,264,171  

Property, plant and equipment, net

     2,115,777       2,128,029  

Equipment on lease

     1,042,013       1,205,593  

Goodwill, net

     6,698,145       6,683,461  

Other assets

     80,660       84,240  
    


 


Total assets

   $ 38,517,604     $ 38,365,494  
    


 


LIABILITIES AND SHAREHOLDERS’ EQUITY                 

Current liabilities:

                

Accounts payable

   $ 791,590     $ 810,694  

Accrued expenses and other current liabilities

     3,344,378       3,119,941  
    


 


Total current liabilities

     4,135,968       3,930,635  
    


 


Other long-term liabilities

     503,073       471,577  
    


 


Commitments and contingencies

                

Shareholders’ equity:

                

Common stock, $0.01 par value, authorized 50,000,000 shares, issued and outstanding 27,673,204 in 2004 and 27,659,329 in 2003

     276,732       276,593  

Capital in excess of par value

     43,623,207       43,582,346  

Accumulated deficit

     (9,082,031 )     (9,101,104 )

Accumulated other comprehensive loss

     (939,345 )     (794,553 )
    


 


Total shareholders’ equity

     33,878,563       33,963,282  
    


 


Total liabilities and shareholders’ equity

   $ 38,517,604     $ 38,365,494  
    


 


 

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

 

2


IVAX DIAGNOSTICS, INC. AND SUBSIDIARIES

CONSOLIDATED STATEMENTS OF OPERATIONS

(Unaudited)

 

Three Months Ended March 31,    2004

    2003

 

Net revenues

   $ 4,732,190     $ 4,443,568  

Cost of sales

     1,883,259       2,011,129  
    


 


Gross profit

     2,848,931       2,432,439  
    


 


Operating expenses:

                

Selling

     1,399,865       1,285,228  

General and administrative

     1,085,551       1,164,445  

Research and development

     318,366       346,726  
    


 


Total operating expenses

     2,803,782       2,796,399  
    


 


Income (loss) from operations

     45,149       (363,960 )
    


 


Other income (expense):

                

Interest income

     42,000       51,207  

Other income (expense), net

     (49,948 )     38,811  
    


 


Total other income (expense), net

     (7,948 )     90,018  
    


 


Income (loss) before income taxes

     37,201       (273,942 )

Provision for income taxes

     18,128       13,418  
    


 


Net income (loss)

   $ 19,073     $ (287,360 )
    


 


Basic earnings (loss) per common share

   $ —       $ (.01 )
    


 


Diluted earnings (loss) per common share

   $ —       $ (.01 )
    


 


WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING:

                

Basic

     27,671,536       27,519,079  
    


 


Diluted

     28,463,602       27,519,079  
    


 


 

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

 

3


IVAX DIAGNOSTICS AND SUBSIDIARIES

CONSOLIDATED STATEMENTS OF CASH FLOWS

(Unaudited)

 

Three Months Ended March 31,    2004

    2003

 

Cash flows from operating activities:

                

Net income (loss)

   $ 19,073     $ (287,360 )

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

                

Depreciation and amortization

     303,396       287,024  

Provision for doubtful accounts receivable

     35,055       71,985  

Stock option compensation expense

     —         148,650  

Changes in operating assets and liabilities:

                

Accounts receivable

     (136,611 )     (545,655 )

Inventories

     120,468       305,835  

Other current assets

     22,857       (41,210 )

Other assets

     —         158  

Accounts payable and accrued expenses

     259,538       652,775  

Other long-term liabilities

     42,304       16,390  
    


 


Net cash flows provided by operating activities

     666,080       608,592  
    


 


Cash flows from investing activities:

                

Capital expenditures

     (77,320 )     (34,530 )

Acquisitions of equipment on lease

     (71,463 )     (157,488 )
    


 


Net cash flows used in investing activities

     (148,783 )     (192,018 )
    


 


Cash flows from financing activities:

                

Exercise of stock options

     41,000       —    
    


 


Net cash flows provided by financing activities

     41,000       —    
    


 


Effect of exchange rate changes on cash and cash equivalents

     (24,741 )     30,930  
    


 


Net increase in cash and cash equivalents

     533,556       447,504  

Cash and cash equivalents at the beginning of the year

     15,464,839       15,941,663  
    


 


Cash and cash equivalents at the end of the period

   $ 15,998,395     $ 16,389,167  
    


 


Supplemental disclosures:

                

Interest paid

   $ —       $ —    
    


 


Income tax payments (refunds)

   $ —       $ —    
    


 


 

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

 

4


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 three months ended March 31, 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 March 31, 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:

 

     March 31,
2004


   December 31,
2003


Raw materials

   $ 1,559,599    $ 1,611,794

Work-in-process

     318,376      340,301

Finished goods

     2,436,228      2,520,967
    

  

Total inventories

   $ 4,314,203    $ 4,473,062
    

  

 

5


(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 the United States and Italy. As of March 31, 2004 and December 31, 2003, $4,600,188 and $4,721,125, respectively, of the Company’s net accounts receivable were due in Italy. Of the total net accounts receivable, 57.1% at March 31, 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 Ended March 31,    2004

   2003

Basic weighted average shares outstanding

   27,671,536    27,519,079

Effect of dilutive securities – stock options and warrants

   792,066    —  
    
  

Diluted weighted average number of shares outstanding

   28,463,602    27,519,079
    
  

Not included in the calculation of diluted earnings (loss) per share because their impact is antidilutive:

         

Stock options and warrants outstanding

   684,948    2,433,828
    
  

 

(6) INCOME TAXES:

 

The provision for income taxes consists of the following:

 

Three Months Ended March 31,    2004

   2003

Current:

             

Foreign

   $ 18,128    $ 13,418
    

  

 

The Company’s income tax provision for the three months ended March 31, 2004 and 2003 was different from the amount computed on the income or loss before provision for income taxes at the statutory rate of 35% primarily due to the expected utilization of prior period net operating losses to offset current taxable income for the three months ended March 31, 2004 and the non-recognition of the benefits of domestic taxable losses for the three months ended March 31, 2003. Included in the loss before provision for income taxes was nondeductible stock option compensation expense of $148,650 in the three month period ended March 31, 2003.

 

The Company has established a full valuation allowance on its net domestic deferred tax assets, which are primarily comprised of net operating loss carryforwards. The portion of these domestic net operating loss carryforwards generated prior to March 14, 2001, the consummation date of the merger between b2bstores.com and the pre–merger IVAX Diagnostics, then a wholly-owned subsidiary of IVAX, were utilized by IVAX. On a separate return basis, no recognition of that utilization is reflected in the accompanying consolidated financial statements. Domestic net operating losses generated by the Company after March 14, 2001 are approximately $5,930,000 and $5,955,000 at March 31, 2004 and December 31, 2003, respectively. These net operating losses will begin to expire in 2021. Foreign deferred tax assets totaled $877,368 at March 31, 2004, of which $865,052 is included in other current assets and $12,316 is included in other assets. As of December 31, 2003, $884,649 and $12,595 was included in other current assets and other assets, respectively. Realization of net deferred tax assets is dependent upon generating

 

6


sufficient future taxable income through operations or tax planning strategies. Although realization is not assured, management believes that it is more likely than not that the net deferred tax asset will be realized.

 

(7) COMPREHENSIVE LOSS:

 

The components of the Company’s comprehensive loss are as follows:

 

Three Months Ended March 31,    2004

    2003

 

Net income (loss)

   $ 19,073     $ (287,360 )

Foreign currency translations adjustments

     (144,792 )     229,648  
    


 


Comprehensive loss

   $ (125,719 )   $ (57,712 )
    


 


 

(8) STOCK-BASED COMPENSATION:

 

The Company’s pro forma net loss and pro forma weighted average fair value of options granted, with related assumptions, assuming the Company had adopted the fair value method of accounting for all stock-based compensation arrangements consistent with the provisions of Statement of Financial Accounting Standard (“SFAS”) No. 148, Accounting for Stock Based Compensation – Transition and Disclosure and SFAS No. 123, Stock-Based Compensation, using the Black-Scholes option pricing model, are indicated below:

 

Three Months Ended March 31,    2004

    2003

 

Net income (loss) as reported

   $ 19,073     $ (287,360 )

Deduct: Total stock-based employee compensation expense determined under fair value based method for all awards, net of related tax effects

     74,710       70,530