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SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549


FORM 10-Q

Mark One

     
[X]   QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
EXCHANGE ACT OF 1934
     
    For The Quarterly Period Ended June 30, 2002
     
OR    
     
[   ]   TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
EXCHANGE ACT OF 1934
     
    For the Transition Period from ___________________ to ___________________

COMMISSION FILE NUMBER 0-1000

CHROMAVISION MEDICAL SYSTEMS, INC.


(Exact name of registrant as specified in its charter)
     
DELAWARE   75-2649072

 
(State or other jurisdiction of incorporation or organization)   (IRS Employer Identification Number)

33171 PASEO CERVEZA
SAN JUAN CAPISTRANO, CA
 

92675

 

(Address of principal executive offices)
 
(Zip code)

(949) 443-3355


(Registrant’s telephone number, including area code)

NOT APPLICABLE
(Former name, former address and former fiscal year, if changed since last report)

     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, and (2) has been subject to such filing requirements for the past 90 days.

     Yes [X]       No [   ]

As of August 7, 2002 there were 25,323,199 shares outstanding of the Issuer’s Common Stock, $.01 par value.

 


TABLE OF CONTENTS

PART I — Item 1
Condensed Consolidated Balance Sheets
Condensed Consolidated Statements of Operations
Condensed Consolidated Statements of Cash Flows
Notes to Condensed Consolidated Financial Statements
PART I
Item 2 MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
Item 3 Quantitative and Qualitative Disclosures About Market Risk.
PART II
Item 2 Changes in Securities and Use of Proceeds
Item 4 Submission of Matters to a Vote of Security Holders
PART II
Item 6- Exhibits and Reports on Form 8-K
SIGNATURES
EXHIBIT INDEX
EXHIBIT 99.1


Table of Contents

CHROMAVISION MEDICAL SYSTEMS, INC. AND SUBSIDIARIES

Table of Contents

                 
            Page
           
PART I
 
FINANCIAL INFORMATION
       
 
Item 1
 
Financial Statements (Unaudited)
       
 
       
Condensed Consolidated Balance Sheets as of June 30, 2002 and December 31, 2001
    3  
 
       
Condensed Consolidated Statements of Operations for the three and six months ended June 30, 2002 and 2001
    4  
 
       
Condensed Consolidated Statements of Cash Flows for the six months ended June 30, 2002 and 2001
    5  
 
       
Notes to Condensed Consolidated Financial Statements
    6  
 
Item 2
 
Management’s Discussion and Analysis of Financial Condition and Results of Operations
    10  
 
Item 3
 
Quantitative and Qualitative Disclosure about Market Risk
    13  
 
PART II
 
OTHER INFORMATION
       
 
Item 2
 
Changes in Securities and Use of Proceeds
    14  
 
Item 4
 
Submission of Matters to a Vote of Security Holders
    14  
 
Item 6
 
Exhibits and Reports on Form 8-K
    15  
 
SIGNATURES  
 
    16  

-2-


Table of Contents

PART I — Item 1

CHROMAVISION MEDICAL SYSTEMS, INC. AND SUBSIDIARIES

Condensed Consolidated Balance Sheets
(Unaudited)

Assets

                              
      June 30,   December 31,
      2002   2001
     
 
Current assets:
               
 
Cash and cash equivalents
  $ 6,418,440     $ 7,401,078  
 
Accounts receivable, net
    1,970,571       1,738,497  
 
Other
    254,764       157,071  
 
   
     
 
Total current assets
    8,643,775       9,296,646  
 
Property and equipment, net
    4,919,788       5,251,149  
 
Other
    733,294       517,426  
 
   
     
 
Total assets
  $ 14,296,857     $ 15,065,221  
 
   
     
 
Liabilities and Stockholders’ Equity
Current liabilities:
               
 
Accounts payable
  $ 325,949     $ 832,439  
 
Accrued payroll
    950,831       759,012  
 
Accrued liabilities
    696,042       1,349,495  
 
Investment banking fee payable
          1,000,000  
 
   
     
 
Total current liabilities
    1,972,822       3,940,946  
 
   
     
 
Series D redeemable convertible preferred stock, $1,000 par value, 12,500 shares, authorized, outstanding 11,230 shares in 2002 and 12,500 shares in 2001
    8,359,429       8,567,371  
Commitments and contingencies
               
Stockholders’ equity:
               
 
Series C convertible preferred stock, $.01 par value, authorized 200,000 shares, none issued and outstanding
           
 
Common stock $.01 par value, authorized 50,000,000 shares, issued and outstanding 25,323,099 shares in 2002 and 20,188,425 shares in 2001
    253,231       201,884  
 
Additional paid-in capital
    74,599,717       66,631,637  
 
Accumulated deficit
    (70,811,489 )     (64,188,809 )
 
Accumulated other comprehensive loss
    (76,853 )     (87,808 )
 
   
     
 
 
Total stockholders’ equity
    3,964,606       2,556,904  
 
   
     
 
Total liabilities and stockholders’ equity
  $ 14,296,857     $ 15,065,221  
 
   
     
 

See accompanying notes to condensed consolidated financial statements.

-3-


Table of Contents

CHROMAVISION MEDICAL SYSTEMS, INC. AND SUBSIDIARIES

Condensed Consolidated Statements of Operations
(Unaudited)

                                                       
          Three Months Ended   Six Months Ended
          June 30,   June 30,
         
 
          2002   2001   2002   2001
         
 
 
 
Revenue:
                               
 
Fee per use
  $ 2,147,979     $ 691,287     $ 3,865,048     $ 1,162,831  
 
System sales
    45,853       258,136       119,353       735,136  
 
   
     
     
     
 
     
Total revenue
    2,193,832       949,423       3,984,401       1,897,967  
Cost of revenue
    392,286       195,080       784,171       400,808  
 
   
     
     
     
 
     
Gross profit
    1,801,546       754,343       3,200,230       1,497,159  
 
   
     
     
     
 
Operating expenses:
                               
 
Selling, general and administrative
    2,819,528       2,724,977       5,435,641       5,304,441  
 
Research and development
    1,524,957       1,780,645       3,054,210       3,697,984  
 
   
     
     
     
 
   
Total operating expenses
    4,344,485       4,505,622       8,489,851       9,002,425  
 
   
     
     
     
 
   
Loss from operations
    (2,542,939 )     (3,751,279 )     (5,289,621 )     (7,505,266 )
 
   
     
     
     
 
Other income
    13,989       51,331       36,289       166,512  
 
   
     
     
     
 
     
Loss before income taxes
    (2,528,950 )     (3,699,948 )     (5,253,332 )     (7,338,754 )
Income taxes
                       
 
   
     
     
     
 
Net loss
    (2,528,950 )     (3,699,948 )     (5,253,332 )     (7,338,754 )
Accretion of and dividends on redeemable, convertible preferred stock
    (842,800 )           (1,369,348 )      
 
   
     
     
     
 
Net loss attributable to common stock
  $ (3,371,750 )   $ (3,699,948 )   $ (6,622,680 )   $ (7,338,754 )
 
   
     
     
     
 
Basic and diluted net loss per common share
  $ (.16 )   $ (.18 )   $ (.29 )   $ (.36 )
 
   
     
     
     
 
Weighted average number of common shares outstanding
    21,166,647       20,145,169       23,043,709       20,124,923  
 
   
     
     
     
 

See accompanying notes to condensed consolidated financial statements.

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Table of Contents

CHROMAVISION MEDICAL SYSTEMS, INC. AND SUBSIDIARIES

Condensed Consolidated Statements of Cash Flows
(Unaudited)

                         
        Six Months Ended
        June 30,
       
        2002   2001
       
 
Cash flows from operating activities:
               
Net loss
  $ (5,253,332 )   $ (7,338,754 )
Adjustments to reconcile net loss to net cash used in operating activities:
               
   
Depreciation and amortization
    1,335,483       977,922  
 
Changes in operating assets and liabilities:
               
   
Accounts receivable, net
    (221,974 )     (337,374 )
   
Other assets
    (305,629 )     (278,631 )
   
Accounts payable
    (507,338 )     267,120  
   
Accrued payroll
    189,729       103,593  
   
Investment banking fee payable
    (1,000,000 )      
   
Accrued liabilities
    (347,536 )     151,929  
 
   
     
 
   
Net cash used in operating activities
    (6,110,597 )     (6,454,195 )
 
   
     
 
Cash flows from investing activities:
               
Additions to property and equipment
    (1,004,123 )     (1,060,813 )
 
   
     
 
   
Net cash used in investing activities
    (1,004,123 )     (1,060,813 )
 
   
     
 
Cash flows from financing activities:
               
Proceeds from exercise of stock options and issuance of stock under employee stock purchase plan
    82,837       441,019  
Sale of common stock
    6,425,021        
Offering costs
    (377,685 )     (8,930 )
 
   
     
 
   
Net cash provided by financing activities
    6,130,173       432,089  
 
   
     
 
Effect of exchange rate changes on cash and cash equivalents
    1,909       7,384  
   
Net increase (decrease) in cash and cash equivalents
    (982,638 )     (7,075,535 )
Cash and cash equivalents beginning of period
    7,401,078       9,797,698  
 
   
     
 
Cash and cash equivalents end of period
  $ 6,418,440     $ 2,722,163  
 
   
     
 
Supplemental disclosure of cash flow information:
               
Non-cash investing and financing activities:
               
Issuance of common stock in lieu of cash for preferred stock dividend payable
  $ 590,680     $  
Accretion of preferred stock dividend
  $ 307,290     $  
Accretion of preferred stock
  $ 1,062,058     $  

See accompanying notes to condensed consolidated financial statements.

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Table of Contents

CHROMAVISION MEDICAL SYSTEMS, INC. AND SUBSIDIARIES

Notes to Condensed Consolidated Financial Statements
(Unaudited)

(1) BASIS OF PRESENTATION

These interim condensed consolidated financial statements should be read in conjunction with the consolidated financial statements and notes thereto included in our 2001 annual report filed on Form 10-K with the Securities and Exchange Commission.

The accompanying unaudited condensed consolidated financial statements reflect all adjustments which, in the opinion of management, are necessary for a fair presentation of the financial position and the results of operations for the interim periods presented. All such adjustments are of a normal, recurring nature. Certain amounts have been reclassified to conform to the current period presentation. The results of our operations for any interim period are not necessarily indicative of the results to be obtained for a full fiscal year.

(2) NET LOSS PER SHARE

Options to purchase 3,451,382 and 3,097,425 shares of common stock with a weighted average option price of $5.83 and $6.21 were outstanding at June 30, 2002 and 2001, respectively, and were excluded from the computation of diluted net loss per share as the effect would be antidilutive. For the six month period ended June 30, 2002, dilutive potential common shares of approximately 2,955,745 issuable upon conversion of convertible preferred stock and 546,615 shares issuable upon exercise of related warrants have also been excluded from the computation of diluted loss per share as their effect is antidilutive. See Note 7 to the Notes to Condensed Consolidated Financial Statements regarding the agreement with Safeguard Delaware, Inc. pursuant to which, at June 30, 2002, Safeguard had invested $6,425,021 in exchange for 4,053,641 shares of our Common Stock, had agreed to invest and additional $574,979 in exchange for our Common Stock and had acquired 10,370 of the 12,500 outstanding shares of our Series D Cumulative Convertible Preferred Stock (the “Series D Preferred Stock).

(3) CURRENCY TRANSLATION

The financial position and results of operations of our foreign subsidiaries are generally determined using the local currency as the functional currency. Assets and liabilities of these subsidiaries are translated at the exchange rate in effect at the balance sheet date. Income statement accounts are translated at the average rate of exchange prevailing during the period.

(4) COMPREHENSIVE LOSS

     Our total comprehensive loss is summarized as follows:

                                                 
    Three Months Ended June 30,   Six Months Ended June 30,
   
 
    2002   2001   2002   2001
   
 
 
 
Net loss
  $ (2,528,950 )   $ (3,699,948 )   $ (5,253,332 )   $ (7,338,754 )
Foreign currency translation adjustment
    10,080       (2,420 )     10,955       15,529  
 
   
     
     
     
 
Comprehensive loss
  $ (2,518,870 )   $ (3,702,368 )   $ (5,242,377 )   $ (7,323,225 )
 
   
     
     
     
 

(5) BUSINESS SEGMENTS

We operate in one business segment engaged in the development, manufacture and marketing of an automated cellular imaging system (ACIS®) designed to substantially improve the accuracy, sensitivity, and reproducibility of cell imaging and analysis.

     The following table represents our business segment information by geographic area:

                                                 
    Three Months Ended June 30,   Six Months Ended June 30,
   
 
    2002   2001   2002   2001
   
 
 
 
Net sales
                               
United States
  $ 2,139,516     $ 837,295     $ 3,837,995     $ 1,756,558  
Europe(a)
    54,316       112,128       146,406       141,409  
 
   
     
     
     
 

-6-


Table of Contents

                                                 
    Three Months Ended June 30,   Six Months Ended June 30,
   
 
    2002   2001   2002   2001
   
 
 
 
Total net sales
    2,193,832     $ 949,423       3,984,401     $ 1,897,967  
 
   
     
     
     
 
Operating loss
                               
United States
  $ (2,421,608 )   $ (3,693,957 )   $ (5,103,071 )   $ (7,269,989 )
Europe(a)
    (121,331 )     (57,322 )     (186,550 )     (235,277 )
 
   
     
     
     
 
Total operating loss
  $ (2,542,939 )   $ (3,751,279 )   $ (5,289,621 )   $ (7,505,266 )
 
   
     
     
     
 
   
Identifiable assets   June 30, 2002   December 31, 2001
   
 
United States
    14,046,072       14,814,642  
Europe(a)
    250,785       250,579  
 
   
     
 
Total assets
    14,296,857       15,065,221