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SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549


FORM 10-Q

     
x 
  Quarterly report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

For the quarterly period ended March 31, 2004

     
o 
  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 1-9957

Diagnostic Products Corporation

(Exact name of registrant as specified in its charter)
     
California   95-2802182
(State or other jurisdiction of   (IRS Employer
incorporation or organization)   Identification No.)

5700 West 96th Street
Los Angeles, California 90045

(Address of principal executive offices)

Registrant’s telephone number: (310) 645-8200

No change

(Former name, former address, and former fiscal year, if changed since last report)

Indicate by check mark whether the registrant is an accelerated filer (as defined in Exchange Act Rule 12b-2).

[ YES X ] [NO   ]

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   ]

The number of shares of Common Stock, no par value, outstanding as of May 4, 2004, was 29,058,846.



 


TABLE OF CONTENTS

PART I. FINANCIAL INFORMATION
ITEM I. FINANCIAL STATEMENTS
CONSOLIDATED STATEMENTS OF INCOME
CONSOLIDATED BALANCE SHEETS
CONSOLIDATED STATEMENTS OF CASH FLOWS
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
ITEM 4. CONTROLS AND PROCEDURES
PART II. OTHER INFORMATION
ITEM 6. EXHIBITS AND REPORTS ON FORM 8-K.
SIGNATURES
EXHIBIT INDEX
EXHIBIT 31.1
EXHIBIT 32.1
EXHIBIT 32.1


Table of Contents

PART I. FINANCIAL INFORMATION

ITEM I. FINANCIAL STATEMENTS

DIAGNOSTIC PRODUCTS CORPORATION AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF INCOME

(unaudited)

(Amounts In Thousands, Except Per Share Data)

                 
    Three Months Ended
    March 31,
    2004
  2003
SALES:
               
Non-Affiliated Customers
  $ 96,974     $ 80,247  
Unconsolidated Affiliates
    9,109       6,633  
 
   
 
     
 
 
Total Sales
    106,083       86,880  
COST OF SALES
    46,022       36,556  
 
   
 
     
 
 
Gross Profit
    60,061       50,324  
 
   
 
     
 
 
OPERATING EXPENSES:
               
Selling
    18,727       15,433  
Research and Development
    11,424       10,003  
General and Administrative
    9,665       8,599  
Equity in Income of Affiliates
    (2,130 )     (1,458 )
 
   
 
     
 
 
OPERATING EXPENSES - NET
    37,686       32,577  
 
   
 
     
 
 
OPERATING INCOME
    22,375       17,747  
Interest/Other (Expense) Income - Net
    (369 )     29  
 
   
 
     
 
 
INCOME BEFORE INCOME TAXES AND MINORITY INTEREST
    22,006       17,776  
PROVISION FOR INCOME TAXES
    6,602       5,155  
MINORITY INTEREST
    (53 )     (86 )
 
   
 
     
 
 
NET INCOME
  $ 15,457     $ 12,707  
 
   
 
     
 
 
EARNINGS PER SHARE:
               
BASIC
  $ .53     $ .44  
DILUTED
  $ .52     $ .43  
WEIGHTED AVERAGE SHARES OUTSTANDING:
               
BASIC
    28,972       28,622  
DILUTED
    29,944       29,544  

SEE ACCOMPANYING NOTES TO
CONSOLIDATED FINANCIAL STATEMENTS.

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Table of Contents

DIAGNOSTIC PRODUCTS CORPORATION AND SUBSIDIARIES
CONSOLIDATED BALANCE SHEETS

(unaudited)

                 
    March 31,   December 31,
(Dollars in Thousands)
 
  2004
  2003
Assets
               
CURRENT ASSETS:
               
Cash and cash equivalents
  $ 66,407     $ 69,843  
Accounts receivable (including receivables from unconsolidated affiliates of $11,611 and $6,701, respectively) – net of allowance for doubtful accounts of $3,267 and $3,195, respectively
    98,373       90,310  
Inventories
    89,220       86,502  
Prepaid expenses and other current assets
    5,071       5,500  
Deferred income taxes
    5,148       5,413  
 
   
 
     
 
 
Total current assets
    264,219       257,568  
 
   
 
     
 
 
PROPERTY, PLANT, AND EQUIPMENT:
               
Land and buildings
    58,998       58,711  
Machinery and equipment
    85,813       79,638  
Leasehold improvements
    9,439       9,384  
Construction in progress
    33,817       30,111  
 
   
 
     
 
 
Total
    188,067       177,844  
Less accumulated depreciation and amortization
    (76,479 )     (73,424 )
 
   
 
     
 
 
Property, plant, and equipment – net
    111,588       104,420  
INSTRUMENTS – net
    74,494       77,230  
DEFERRED INCOME TAXES
    15       255  
INVESTMENTS IN AFFILIATED COMPANIES
    31,361       29,822  
OTHER ASSETS — net
    11,813       4,864  
GOODWILL —Net of accumulated amortization of $11,943 and $12,190, respectively
    13,415       13,423  
 
   
 
     
 
 
TOTAL ASSETS
  $ 506,905     $ 487,582  
 
   
 
     
 
 
Liabilities and Shareholders’ Equity
               
CURRENT LIABILITIES:
               
Notes payable
  $ 16,687     $ 19,369  
Accounts payable
    21,031       20,983  
Accrued liabilities
    35,921       32,136  
Income taxes payable
    10,449       9,246  
 
   
 
     
 
 
Total current liabilities
    84,088       81,734  
MINORITY INTEREST
    2,741       2,848  
SHAREHOLDERS’ EQUITY:
               
Common Stock–no par value, authorized 60,000,000 shares at March 31, 2004 and December 31, 2003; outstanding 29,027,846 shares and 28,907,969 shares, respectively
    69,116       66,758  
Retained earnings
    349,849       336,129  
Accumulated other comprehensive income
    1,111       113  
 
   
 
     
 
 
Total shareholders’ equity
    420,076       403,000  
 
   
 
     
 
 
TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY
  $ 506,905     $ 487,582  
 
   
 
     
 
 

SEE ACCOMPANYING NOTES TO
CONSOLIDATED FINANCIAL STATEMENTS.

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DIAGNOSTIC PRODUCTS CORPORATION AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF CASH FLOWS

(unaudited)

                 
    Three Months Ended
    March 31,
(Dollars in Thousands)
 
  2004
  2003
CASH FLOWS FROM OPERATING ACTIVITIES:
               
Net income
  $ 15,457     $ 12,707  
Adjustments to reconcile net income to net cash flows from operating activities:
               
    Depreciation and amortization
    7,774       8,355  
    Deferred income taxes
    260          
    Equity in undistributed income of unconsolidated affiliates
    (1,787 )     (1,458 )
Changes in operating assets and liabilities:
               
    Accounts receivable
    (8,629 )     (4,385 )
    Inventories
    (2,426 )     (658 )
    Prepaid expenses and other current assets
    395       2,811  
    Other assets
    (1,250 )        
    Accounts payable
    1,926       (2,120 )
    Accrued liabilities
    (1,999 )     (4,639 )
    Income taxes payable
    1,133       2,289  
 
   
 
     
 
 
Net cash flows from operating activities
    10,854       12,902  
 
   
 
     
 
 
CASH FLOWS USED FOR INVESTING ACTIVITIES:
               
    Additions to property, plant, and equipment
    (9,744 )     (24,773 )
    Instruments
    (3,012 )     (7,262 )
 
   
 
     
 
 
Net cash flows used for investing activities
    (12,756 )     (32,035 )
 
   
 
     
 
 
CASH FLOWS USED FOR FINANCING ACTIVITIES:
               
    Repayments of notes payable-net
    (2,253 )     (955 )
    Proceeds from exercise of stock options
    2,358       632  
    Cash dividends paid
    (1,737 )     (1,717 )
 
   
 
     
 
 
Net cash flows used for financing activities
    (1,632 )     (2,040 )
 
   
 
     
 
 
EFFECT OF EXCHANGE RATE CHANGES ON CASH
    98       34  
 
   
 
     
 
 
NET DECREASE IN CASH AND CASH EQUIVALENTS
    (3,436 )     (21,139 )
CASH AND CASH EQUIVALENTS AT BEGINNING OF PERIOD
    69,843       54,284  
 
   
 
     
 
 
CASH AND CASH EQUIVALENTS AT END OF PERIOD
  $ 66,407     $ 33,145  
 
   
 
     
 
 

SEE ACCOMPANYING NOTES TO
CONSOLIDATED FINANCIAL STATEMENTS.

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DIAGNOSTIC PRODUCTS CORPORATION AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

(unaudited)

Note 1 – Basis of Presentation

The information for the three months ended March 31, 2004 and 2003 has not been audited by independent public accountants, but includes all adjustments (consisting of normal recurring accruals) that are, in the opinion of management, necessary to a fair statement of the results for such periods.

Certain information and footnote disclosure normally included in financial statements prepared in accordance with accounting principles generally accepted in the United States of America have been omitted pursuant to the requirements of the Securities and Exchange Commission, although the Company believes that the disclosures included in these financial statements are adequate to make the information not misleading.

The consolidated financial statements should be read in conjunction with the consolidated financial statements and notes thereto included in the Company’s 2003 Annual Report on Form 10-K as filed with the Securities and Exchange Commission.

The results of operations for the three-month period ended March 31, 2004 are not necessarily indicative of the results to be expected for the year ending December 31, 2004. Basic earnings per share is computed by dividing net income by the weighted-average number of shares outstanding. Diluted earnings per share includes the dilutive effect of stock options.

Note 2 – Inventories

Inventories by major categories are summarized as follows:

                 
    March 31,   December 31,
(Dollars in Thousands)
 
  2004
  2003
Raw materials
  $ 38,759     $ 39,145  
Work in process
    40,201       38,761  
Finished goods
    10,260       8,596  
 
   
 
     
 
 
Total
  $ 89,220     $ 86,502  
 
   
 
     
 
 

Note 3 – Goodwill and Intangibles

Goodwill results primarily from the Company’s purchase of certain of its foreign distributors. Intangible assets at March 31, 2004 consist of purchased technology licenses totaling $11,813,000, which is net of accumulated amortization of $187,000. Of that amount, approximately $4.8 million represents licenses purchased during the second quarter of 2003. Amortization expense for the 2003 licenses for the quarter ended March 31, 2004 totaled $44,000 and for each of the next five fiscal years is estimated to be $181,000, $233,000, $293,000, $449,000, and $535,000, respectively. The remaining licenses totaling approximately $7 million were purchased at the end of the first quarter of 2004 and will be amortized in future periods based on the underlying estimated benefit derived.

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Note 4 – Comprehensive Income

Comprehensive income is summarized as follows:

                 
    Three Months Ended March 31,
(Dollars in Thousands)
 
  2004
  2003
Net income
  $ 15,457     $ 12,707  
Foreign currency translation adjustment
    (638 )     2,343  
Unrealized gain on foreign exchange contracts Net of tax impact
    1,636          
 
   
 
     
 
 
Comprehensive income
  $ 16,455     $ 15,050  
 
   
 
     
 
 

The Company does not provide for U.S. income taxes on foreign currency translation adjustments because it does not provide for such taxes on undistributed earnings of foreign subsidiaries.

Note 5 – Segment and Product Line Information

The Company considers its manufactured instruments and medical immunodiagnostic test kits as one operating segment, as the kits are required to run the instruments and utilize similar technology and instrument manufacturing processes. The Company manufactures its instruments and kits principally from facilities in the United States and the United Kingdom. Kits and instruments are sold to hospitals, medical centers, clinics, physicians, and other clinical laboratories throughout the world through a network of distributors, including consolidated distributors located in the United Kingdom, Germany, Czech Republic, Poland, Spain, The Netherlands, Belgium, Luxemborg, Finland, Norway, France, Australia, New Zealand, China, Brazil, Uruguay, Bolivia, Venezuela, Costa Rica, Panama, Sweden, Latvia, Lithuania, Estonia, and Denmark.

The Company sells its instruments and immunodiagnostic test kits under several product lines. Product line sales information is as follows:

                 
    Three Months Ended
    March 31,
(Dollars in Thousands)
 
  2004
  2003
Sales:
               
IMMULITE (includes service)
  $ 96,266     $ 75,653  
Radioimmunoassay (“RIA”)
    6,405       6,793  
Other (Includes DPC and non-DPC products)
    3,412       4,434  
 
   
 
     
 
 
 
  $ 106,083     $ 86,880  
 
   
 
     
 
 

The Company is organized and managed by geographic area. Transactions between geographic segments are accounted for as normal sales for internal reporting and management purposes with all intercompany amounts eliminated in consolidation. Sales are attributed to geographic areas based on the location from which the instrument or kit is shipped to the customer. Information reviewed by the Company’s chief operating decision maker on significant geographic segments is prepared on the same basis as the consolidated financial statements and is as follows:

                                                         
            Euro/DPC Limited   DPC Biermann   DPC Medlab           Less:Intersegment    
    United States
  (United Kingdom)
  (German Group)*
  (Brazilian Group)*
  Other
  Elimination
  Total
(Dollars in Thousands)                                                        
Three Months Ended March 31, 2004
                                                       
Sales
  $ 65,172     $ 20,611     $ 14,552     $ 7,852     $ 25,013     $ (27,117 )   $ 106,083  
Net income
    7,301       4,747       680       (121 )     2,744       106       15,457  
Three Months Ended March 31, 2003
                                                       
Sales
  $ 56,678     $ 15,073     $ 12,675     $ 6,202     $ 21,144     $ (24,892 )   $ 86,880  
Net income
    7,024       2,883       420       (197 )     2,427       150       12,707  

*DPC Biermann includes the Company’s operations in Germany, the Czech Republic, Slovenia, Croatia, and Poland. DPC Medlab includes the Company’s operations in Brazil, Uruguay, Venezuela, Honduras, Guatemala, Costa Rica, Panama, El Salvador, and Bolivia.

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Note 6 – Pro Forma Stock-Based Compensation

The Company has stock option plans under which options have historically been granted at exercise prices equal to the market price at the date of grant. Options granted vest over periods of three to nine years and expire ten years from the date of grant.

Pursuant to Statement of Financial Accounting Standards (“SFAS”) No. 123, “Accounting for Stock-Based Compensation,” the Company has elected to account for its employee stock options under Accounting Principles Board (“APB”) Opinion No. 25, “Accounting for Stock Issued to Employees,” which recognizes expense based on the intrinsic value at the date of grant. As stock options have been issued with exercise prices equal to the respective market prices at grant date, no compensation expense has resulted. In December 2002, the Financial Accounting Standards Board (“FASB”) issued SFAS No. 148, “Accounting for Stock-Based Compensation—Transition and Disclosure, an amendment of FASB Statement No. 123,” which provides alternative methods of transition for a voluntary change to the fair value based method of accounting for stock-based employee compensation. SFAS No. 148 also amends the disclosure requirements of SFAS No. 123 to require prominent disclosures in both annual and interim financial statements about the method of accounting for stock-based employee compensation and the effect of the method used on reported results. The Company elected to maintain the intrinsic method of accounting for stock options under APB No. 25. Had compensation cost for all options granted been determined based on the fair value at grant date consistent with SFAS No. 123, the Company’s net earnings and earnings per share would have been as follows:

(Amounts in Thousands, except per share data)

                 
    Three Months Ended
    March 31
    2004
  2003
Net Earnings:
               
As Reported
  $ 15,457     $ 12,707  
Pro Forma expense
    (673 )     (738 )
 
   
 
     
 
 
Pro Forma
  $ 14,784     $ 11,969  
 
   
 
     
 
 
Net Earnings Per Share
               
Basic:
               
As Reported
  $ 0.53     $ 0.44  
Pro Forma Adjustment
    (0.02 )     (0.02 )
 
   
 
     
 
 
Pro Forma
  $ 0.51     $ 0.42  
 
   
 
     
 
 
Diluted:
               
As Reported
  $ 0.52     $ 0.43  
Pro Forma Adjustment
    (0.03 )     (0.02 )
 
   
 
     
 
 
Pro Forma
  $ 0.49     $ 0.41  
 
   
 
     
 
 

Note 7 – New Accounting Pronouncements

In January 2003, the FASB issued FASB Interpretation No. (“FIN”) 46, “Consolidation of Variable Interest Entities” (“FIN 46”). In December 2003, FIN 46 was replaced by FASB interpretation No. 46R “Consolidation of Variable Interest Entities.” FIN 46R clarifies the application of Accounting Research Bulletin No. 51, “Consolidated Financial Statements,” to certain entities in which equity investors do not have the characteristics of a controlling financial interest or do not have sufficient equity at risk for the entity to finance its activities without additional subordinate financial support from other parties. FIN 46R requires an enterprise to consolidate a variable interest entity if that enterprise will absorb a majority of the entity’s expected losses, is entitled to receive a majority of the entity’s expected residual returns, or both. FIN 46R was effective for special-purpose entities being evaluated under FIN 46R for consolidation on December 31, 2003 and was effective for all other entities being evaluated on March 31, 2004. The adoption of FIN 46R did not have a material impact on the Company’s financial position or results of operations.

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Note 8 – Commitments and Contingent Liabilities

The Company is continuing to cooperate with the SEC and the United States Justice Department in their review of certain improper payments by the Company’s Chinese subsidiary first discovered internally by the Company in the fourth quarter of 2002. The Company is also continuing to evaluate its internal policies and procedures to promote compliance with applicable laws. The Company’s activities in this regard resulted in the termination of the general manager of the Chinese subsidiary in the first quarter of 2004 as a result of his failure to follow payment-related procedures implemented on the advice of outside counsel. An independent committee of the Board continues to oversee these issues and is conducting an inquiry. Government and other actions related to this matter may have a material adverse effect on future operations in China. For the year ended December 31, 2003, the Chinese subsidiary had sales of $9.8 million. In the first quarter of 2004 the Company’s Chinese subsidiary had sales of $2.1 million. In the fourth quarter of 2002, the Company accrued $1.5 million for actual and estimated costs to resolve this matter. As of March 31, 2004, $1.4 million remains in the accrual, which consists principally of estimated penalties and/or fines that the Company may incur to resolve this matter. In addition, the Company recorded a charge of $1.4 million to its 2002 fourth quarter tax provision related to the possible non-deductibility of the payments in China. During the third quarter of 2003, the Company recorded an additional charge of $0.9 million to its income tax provision for this and other Chinese tax-related matters. Additional legal expenses of approximately $884,000 and $33,000 have been incurred and charged to general and administrative expense during the year ended December 31, 2003 and quarter ended March 31, 2004, respectively. It is anticipated that legal fees for issues related to China will increase in the remainder of 2004.

In February 2004, the Company was informed by the FDA that, based on inspectional findings that included data integrity and procedural issues, the Company was subject to the FDA’s Application Integrity Policy. The FDA suspended its review of all applications submitted by the Company and will defer the review of any future applications until the FDA determines that the Company has resolved these issues. The resolution process consists of developing and implementing a corrective action plan that will be audited by a third party and reviewed by the FDA. The Company believes that 12 months is a reasonable time for such actions to take place. During this time, the Company is not restricted by the FDA with regard to introducing new tests outside of the United States. However, the Company’s inability to introduce new tests in the United States pending resolution of this matter may have a negative impact on its future sales and profits.

ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

Forward-Looking Statements

Except for the historical information contained herein, this report and the following discussion in particular contain forward-looking statements (identified by the words “estimate,” “project,” “anticipate,” “plan,” “expect,” “intend,” “believe,” “hope,” and similar expressions) which are based upon management’s current expectations and speak only as of the date made. These forward-looking statements are subject to risks, uncertainties, and factors that could cause actual results to differ materially from the results anticipated in the forward-looking statements. These risks and uncertainties include:

  the Company’s ability to successfully market new and existing products;
 
  the Company’s ability to keep abreast of technological innovations and successfully incorporate them into new products;
 
  the Company’s dependence on sole suppliers for key chemical components in the IMMULITE assays;
 
  the Company’s ability to address and resolve issues relating to the FDA’s Application Integrity Policy;
 
  the risks inherent in the development and release of new products, such as delays, unforeseen costs, technical difficulties, and regulatory approvals
 
  competitive pressures, including technological advances and patents obtained by competitors;
 
  environmental risks related to substances regulated by various federal, state, and international laws;
 
  currency risks based on the relative strength or weakness of the U.S. dollar;
 
  domestic and foreign governmental health care regulation and cost containment measures;
 
  political and economic instability in certain foreign markets;
 
  changes in accounting standards promulgated by the Financial Accounting Standards Board, the Securities and Exchange Commission, the Public Company Accounting Oversight Board, or the American Institute of Certified Public Accountants; and

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  the effects of governmental or other actions relating to certain payments by the Company’s Chinese subsidiary.

Overview

DPC develops and manufactures automated diagnostic test systems and related reagent test kits that are used by hospital, reference, and physicians’ office laboratories throughout the world. The Company’s principal product line, IMMULITE, is a fully automated, computer-driven modular system that uses specialized proprietary software to provide rapid, accurate test results that reduce the customer’s labor and reagent costs. The Company’s immunoassay tests provide critical information useful to physicians in the diagnosis, monitoring, management, and prevention of various diseases.

DPC manufactures over 400 immunodiagnostic test kits (also called “reagents” or “assays”) using several different technologies and assay formats. The IMMULITE instruments are closed systems, meaning that they will not perform other manufacturers’ tests. Accordingly, a major factor in the successful marketing of these systems is the ability to offer a broad menu of assays. In addition to the IMMULITE assays, we sell a broad range of tests based on other technologies that can be performed manually using the customer’s own laboratory equipment, such as radioimmunoassay (RIA) and enzyme immunoassay (EIA) tests.

In addition to breadth of menu, major competitive factors for the IMMULITE instruments include time-to-first result (how quickly the instrument performs the test), ease of use, and overall cost effectiveness. Because of these competitive factors and the rapid technological developments that characterize the industry, the Company devotes approximately 10% of its annual revenues to research and development activities, all of which are expensed as incurred.

The Company’s products are sold throughout the world directly through affiliated and independent distributors. Historically, foreign sales (including U.S. export sales, sales to non-consolidated subsidiaries and independent distributors, and sales of consolidated subsidiaries) have accounted for more than 70% of revenues; although, in recent years, domestic sales growth has outpaced foreign sales growth.

The Company derives revenues from two principal sources: reagent (test kit) sales and IMMULITE instrument placements. The Company recognizes sales of test kits upon shipment and transfer of title to the customer.

IMMULITE instruments are placed with customers under many different types of arrangements that generally fall into the following categories: sale, lease, reagent rental, and soft placement. The Company sells instruments directly to end-users, to third party leasing companies that lease the instruments to end-users, and to independent distributors that then resell the instruments to their customers. Instrument sales, which represent the smallest component of placements, are recognized upon shipment and transfer of title. The Company also sells instruments under sales-type leases, which are recorded as revenue upon shipment in an amount equal to the present value of the future minimum lease payments to be received over the lease term.

Many instruments are placed other than by outright sale or capital lease. The Company enters into various types of operating lease arrangements with customers that generally provide for terms of three to five years and periodic rental payments. Revenue on these types of leases is recognized on a pro rata basis over the term of the lease. When an instrument is placed on a reagent rental basis, the customer agrees to pay a mark-up on reagents, but is not charged for the instrument. The Company also places instruments at no charge to the customer (“soft placement”) subject to the customer’s agreement to purchase a minimum amount of reagents. In reagent rentals and soft placements, the only revenue recognized is based on reagent shipments. Under operating lease, rental, and soft placements, DPC continues to own the instrument that is placed with the customer. These instruments are generally amortized on a straight-line basis over five years and maintenance costs are expensed as incurred. The Company also enters into service contracts with customers and recognizes service revenue over the related contract life (related costs are expensed as incurred).

Two important indicators used by management to evaluate financial performance are instrument shipments and reagent utilization. The number of IMMULITE instruments that the Company reports as being shipped in any period is net of returned instruments, such as returns at the end of a lease or rental or trade-ins on the purchase of a new model. The Company refurbishes and seeks to place returned instruments at reduced prices. Because of the different methods in which instruments are placed, total instrument sales vary from period to period based on the relative mix of placement methods, and such sales do not necessarily have a direct correlation to the number of instruments shipped during the period.

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An important measure of the penetration of IMMULITE reagent sales is the average amount of reagent sales per instrument shipped. It takes a number of weeks or months after an instrument is shipped for it to become fully functional with regard to reagent utilization. The Company calculates average reagent utilization for a fiscal period by dividing IMMULITE reagent sales for the period by the total number of instruments shipped as of the end of the previous fiscal period.

Results of Operations

SUMMARY FINANCIAL DATA

(Dollars in thousands, except for share data)

                         
    Q1 2004
  % change
  Q1 2003
Sales
  $ 106,083       22.1 %   $ 86,880  
Gross Profit
    60,061               50,324  
% of sales
    56.6 %             57.9 %
Operating Expenses:
                       
Selling
    18,727               15,433  
Research and Development
    11,424               10,003  
General and Administrative
    9,665               8,599  
Equity in Income of Affiliates
    (2,130 )             (1,458 )
 
   
 
             
 
 
Total Operating Expenses
    37,686       15.7 %     32,577  
% of sales
    35.4 %             37.5 %
 
   
 
             
 
 
Operating Income
    22,375       26.1 %     17,747  
% of sales
    21.1 %             20.4 %
Interest/Other (Expense) Income net
    (369 )             29  
 
   
 
             
 
 
Income Before Income Taxes and Minority interest
    22,006               17,776  
Provision for Income Taxes
    6,602               5,155  
Income Tax Rate
    30.0 %             29.0 %
Minority Interest
    (53 )             (86 )
 
   
 
             
 
 
Net Income
  $ 15,457       21.6 %   $ 12,707  
 
   
 
             
 
 
Earnings per share:
                       
Basic
  $ .53             $ .44  
Diluted
  $ .52             $ .43  

Sales

The Company’s sales increased 22% in the first quarter of 2004 to $106.1 million compared to sales of $86.9 million in the first quarter of 2003. Sales of all IMMULITE products, instruments, service, and reagents in the first quarter of 2004 was $96.3 million, a 27% increase over 2003. In the first quarter of 2004, IMMULITE products represented 91% of sales versus 87% in 2003. Various categories of IMMULITE product line sales in the first quarter of 2004 and 2003 are shown in the following chart:

IMMULITE Product Line Sales (000’s omitted)

                         
    2004
  2003
    Sales
  % change from 2003
  Sales
IMMULITE 2000
                       
Reagents
  $ 54,977       33.1 %   $ 41,295  
Instruments and Service
    10,009       90.9       5,242  
 
   
 
     
 
     
 
 
Total
  $ 64,986       39.6 %   $ 46,537  
IMMULITE (including IMMULITE 1000)
                       
Reagents
  $ 27,107       7.3 %   $ 25,257  
Instruments and Service
    4,173       8.1       3,859  
 
   
 
     
 
     
 
 
Total
  $ 31,280       7.4 %   $ 29,116  
 
   
 
     
 
     
 
 
IMMULITE Product Line Sales
  $ 96,266       27.3 %   $ 75,653  
 
   
 
     
 
     
 
 

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The Company shipped a total of 209 IMMULITE systems during the first quarter of 2004, including 158 IMMULITE 2000 systems and 51 IMMULITE 1000 systems. The total base of IMMULITE systems shipped grew to 9,242, including 3,102 IMMULITE 2000 systems. In the first quarter of 2003 the Company shipped a total of 216 IMMULITE systems, including 141 IMMULITE 2000 systems.

The reduction in the number of IMMULITE 1000’s shipped is a result of the time that the IMMULITE 1000 and its predecessor system, the IMMULITE, have been available in the market, which is over ten years. The Company also ships IMMULITE systems that have been returned by customers and refurbished by the Company. These refurbished systems are not included in the Company’s count of units shipped. In the fourth quarter of 2003 the Company reduced the price of the IMMULITE 2000 in anticipation of the release of the IMMULITE 2500 in early 2004. The IMMULITE 2000 has a longer sales process than the IMMULITE 1000 due to its higher sales price, and the IMMULITE 2000 experiences a longer time delay between instrument placement and the ramp-up of reagent sales. The Company expects to experience a similar sales cycle and reagent ramp-up cycle with the IMMULITE 2500 as with the IMMULITE 2000. The 2500, which will reduce the time it takes to get a result for certain tests, most importantly tests for the emergency room to aid in the diagnosis of cardiac conditions, will be sold at a higher price than the IMMULITE 2000, and sales of the 2500 may erode sales of the 2000. The IMMULITE 2500 will be released in May 2004. The Company has 74 tests which have been approved by the FDA for introduction on the IMMULITE 2500.

The increase in IMMULITE 2000 instrument and service revenue is due to a greater number of instruments being sold rather than rented or soft placed and an increase in revenue from service and parts. Included in IMMULITE 2000 equipment sales is revenue relating to the Company’s sample management system (SMS), a sample handling device that can be attached to the IMMULITE 2000. The increase in IMMULITE instrument and service revenue was primarily due to an increase in service revenue.

For the first quarter of 2004, IMMULITE 2000 reagent utilization per instrument was $18,674 and IMMULITE reagent utilization per instrument was $4,452 as compared to the first quarter of 2003, when they were $17,217 and $4,383, respectively. Increases in utilization on the IMMULITE 2000 are in part a result of a larger test menu including Hepatitis B tests and the strength of the Euro relative to the dollar. The slight increase in utilization on the IMMULITE is a result of the strength of the Euro relative to the dollar. A drop in average utilization per instrument on the IMMULITE is expected as high volume IMMULITE installations are replaced with IMMULITE 2000’s and incremental IMMULITE placements go into lower volume environments.

Sales of the Company’s RIA products declined approximately 6% in the first quarter of 2004, representing 6% of sales, compared to 8% of sales in the first quarter of 2003. This trend is expected to continue. Sales of other DPC products declined to $1.8 million in the first quarter of 2004 from $3.1 million in the first quarter of 2003. The primary reason for this was a decline in the Company’s micro-plate allergy product line. The Company ceased manufacturing this product line at the end of 2003 because of the availability of allergy testing on the IMMULITE 2000. These sales will continue to decline as inventories are depleted. Sales of non-DPC products, primarily through its consolidated international affiliates, increased 22% in the first quarter of 2004 to $1.6 million and remained at 2% of sales.

In the first quarter of 2004, sales to domestic customers grew by 21%, and remained at 28% of total sales. The increase in domestic sales was due to increased penetration into most customer segments. Foreign sales (including U.S. export sales, sales to non-consolidated foreign subsidiaries, and sales of consolidated subsidiaries) as a percentage of total sales were approximately 72% in the first quarter of 2004 and 2003. Europe, the Company’s principal foreign market, represented 50% of sales in the first quarter of 2004 and 48% of sales in 2003. Sales in the Company’s German subsidiary, which includes the Czech Republic and Poland, increased 15% primarily as a result of the strength of the Euro. Sales in the Brazil region, which includes certain other Central and South American countries, accounted for approximately 7% of total sales in the first quarter of 2004, an increase of 27% over the first quarter of 2003. Much of this increase came from the strengthening of the Brazilian Real relative to the U.S. dollar. In the past few years, the Real has been very volatile relative to the dollar.

Due to the significance of foreign sales, the Company is subject to currency risks based on the relative strength or weakness of the U.S. dollar. In periods when the U.S. dollar is strengthening, the effect of translation of financial statements of consolidated affiliates is that of lower sales and net income. In periods where the dollar is weakening, the impact is the reverse. Based on comparative exchange rates in the first quarter of 2004 and 2003, the dollar weakened relative to the Euro and the Brazilian Real. The Company’s hedging strategy

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reduced the favorable impact of the strong Euro on its profit. The effect of the changes of exchange rates on sales was a positive 9%. Due to intense competition, the Company’s foreign distributors are generally unable to increase prices to offset this negative effect when the U.S. dollar is strong.

The Company is continuing to cooperate with the SEC and the United States Justice Department in their review of certain improper payments by the Company’s subsidiary first discovered internally by the Company in the fourth quarter of 2002. The Company is also continuing to evaluate its internal policies and procedures to promote compliance with applicable laws. The Company’s activities in this regard resulted in the termination of the general manager of the Chinese subsidiary in the first quarter of 2004 as a result of his failure to follow payment-related procedures implemented on the advice of outside counsel. An independent committee of the Board continues to oversee these issues and is conducting an inquiry. Government and other actions related to this matter may have a material adverse effect on future operations in China. For the year ended December 31, 2003, the Chinese subsidiary had sales of $9.8 million. In the first quarter of 2004 the Company’s Chinese subsidiary had sales of $2.1 million. In the fourth quarter of 2002, the Company accrued $1.5 million for actual and estimated costs to resolve this matter. As of March 31, 2004, $1.4 million remains in the accrual, which consists principally of estimated penalties and/or fines that the Company may incur to resolve this matter. In addition, the Company recorded a charge of $1.4 million to its 2002 fourth quarter tax provision related to the possible non-deductibility of the payments in China. During the third quarter of 2003, the Company recorded an additional charge of $0.9 million to its income tax provision for this and other Chinese tax-related matters. Additional legal expenses of approximately $884,000 and $33,000 have been incurred and charged to general and administrative expense during the year ended December 31, 2003 and quarter ended March 31, 2004, respectively. It is anticipated that legal fees for issues related to China will increase in the remainder of 2004.

In February 2004, the Company was informed by the FDA that, based on inspectional findings that included data integrity and procedural issues, the Company was subject to the FDA’s Application Integrity Policy. The FDA suspended its review of all applications submitted by the Company and will defer the review of any future applications until the FDA determines that the Company has resolved these issues. The resolution process consists of developing and implementing a corrective action plan that will be audited by a third party and reviewed by the FDA. The Company believes that 12 months is a reasonable time for such actions to take place. During this time, the Company is not restricted by the FDA with regard to introducing new tests outside of the United States. However, the Company’s inability to introduce new tests in the United States pending resolution of this matter may have a negative impact on its future sales and profits.

Cost of Sales

Gross margin decreased to 56.6% in the first quarter of 2004 from 57.9% in the first quarter of 2003. This decrease was due in part to a reduction in the price of the IMMULITE 2000 in anticipation of the release of the IMMULITE 2500, an increase in the costs of service and manufacturing costs in Los Angeles, an increase in reagent royalties, and an increase in IMMULITE 2000 instrument sales. All products manufactured in the United States are dollar-based. However, a large percentage of these products are sold to company-owned international distributors, which sell the products in their local currencies. In periods of a weakening dollar, sales as measured in dollars increase, resulting in higher gross margins. A strengthening dollar generally results in lower gross margins at international distributors.

Operating Expenses and Other

Total operating expenses (selling, research and development, and general and administrative) as a percentage of sales fell to 35.5% in the first quarter of 2004 from 37.5% in the same period of 2003, although all categories increased in absolute dollars to support increased levels of sales. Included in general and administrative expenses was $33,000 in the first quarter of 2004 and $650,000 in the first quarter of 2003 related to the Company’s internal investigation of certain payments by its Chinese subsidiary. The review of this matter is ongoing. See Note 8 of Notes to the Consolidated Financial Statements.

Equity in income of affiliates represents the Company’s share of earnings in non-consolidated affiliates, principally the 45%-owned Italian distributor. The amount increased to $2.1 million in 2004 from $1.5 million in 2003.

Interest/other (expense) income-net includes interest income, interest expense, and foreign exchange transaction losses and gains. The net amount was expense of $369,000 in the first quarter of 2004 versus income of $29,000 in 2003. This difference was driven in part by a $705,000 change in foreign currency transaction

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losses to a loss of $206,000 in 2004 from a gain of $499,000 in 2003, net of a reduction in interest expense and other expense of $307,000, which was in part due to the capitalization of interest related to the Company’s construction projects.

Income Taxes and Minority Interest

The Company’s effective tax rate includes federal, state, and foreign taxes. The Company’s tax rate increased to 30.0% in the first quarter of 2004 from 29.0% in the first quarter of 2003.

Net Income

Net income increased 22% to $15.5 million in the first quarter of 2004 or $.52 per diluted share from $12.7 million or $.43 per diluted share in the first quarter of 2003.

Contractual Obligations and Commitments

The Company’s contractual obligations and commitments have not changed significantly from those discussed in Item 7 of the Company’s annual report on Form 10-K for the year ended December 31, 2003.

Critical Accounting Policies

The preparation of financial statements in conformity with accounting principles generally accepted in the United States of America requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. These estimates and assumptions include, but are not limited to, allowance for bad debts, allowance for slow moving and obsolete inventories, useful lives selected for depreciating property, plant, and equipment, valuation allowances for deferred income taxes, estimates used in the recoverability of long-lived assets, and contingency reserves established with respect to the Company’s Chinese subsidiary. Management bases its estimates and assumptions on historical experience and on various other factors that it believes to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities.

Management does not believe that any of its estimates involve assumptions about matters that are highly uncertain or that different reasonable estimates, or changes in accounting estimates that are reasonably likely to occur, would have a material impact on the financial statements. To the extent there are material differences between management’s estimates and actual results, future results of operations will be affected. However, management’s experience has been that the differences between estimates and actual results have been immaterial, and appropriate adjustments to the consolidated financial statements are made as soon as the differences become known.

Liquidity and Capital Resources

The Company has adequate working capital and sources of capital to carry on its current business and to meet its existing capital requirements. At March 31, 2004 and December 31, 2003, the Company had cash and cash equivalents of $66.4 million and $69.8 million, respectively. Net cash flow from operating activities was $10.9 million in the first quarter of 2004 and $12.9 million in the first quarter of 2003. The decrease is primarily a result of an increase in accounts receivable and inventories, a smaller reduction in prepaid expenses and other current assets net of an increase in net income, a reduction in accounts payable, and a smaller increase in accrued liabilities. Additions to property, plant, and equipment in the first quarter of 2004 were $9.7 million, compared to $24.8 million in the first quarter of 2003. In 2003 the increase in plant, property, and equipment was related to the purchase of a new corporate headquarters building for approximately $22 million. In 2004 the increase in plant, property, and equipment was in great part related to the fitting out of the Company’s new corporate headquarters building and the construction of a new building in Wales. It is anticipated that the Company’s new headquarters will be occupied in the third quarter of 2004, and that the total fit-out cost will be approximately $20 million, of which approximately $6.4 million had been spent as of the end of the first quarter. The Company’s new 30,000 square foot building in Wales should be completed in the second quarter of 2004 at a total cost of approximately $9 million. Cash used for the placement of IMMULITE systems under sales-type and operating leases and rentals (for periods of generally three to five years) was $3.0 million in the first quarter of 2004 compared to $7.3 million in the first quarter of 2003, reflecting a greater number of

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instruments that are sold outright. The Company decreased borrowings by $2.3 million in the first quarter of 2004 and by $1.0 million in the first quarter of 2003. The Company’s foreign operations are subject to risks, such as currency devaluations, associated with political and economic instability. See discussion above under “Results of Operations.”

The Company has a $20 million domestic unsecured line of credit under which there were no borrowings outstanding at March 31, 2004 or December 31, 2003. The Company had other notes payable (consisting of bank borrowings by the Company’s foreign consolidated subsidiaries payable in their local currency, some of which are guaranteed by the Company) of $16.7 million at March 31, 2004 compared to $19.4 million at December 31, 2003. The Company received $2.4 million from the exercise of stock options in the first quarter of 2004 versus $632,000 in the first quarter of 2003. The Company has paid a quarterly cash dividend of $.06 per share, on a split-adjusted basis, since 1995.

New Accounting Pronouncements

In January 2003, the FASB issued FASB Interpretation No. (“FIN”) 46, “Consolidation of Variable Interest Entities” (“FIN 46”). In December 2003, FIN 46 was replaced by FASB interpretation No. 46R “Consolidation of Variable Interest Entities.” FIN 46R clarifies the application of Accounting Research Bulletin No. 51, “Consolidated Financial Statements,” to certain entities in which equity investors do not have the characteristics of a controlling financial interest or do not have sufficient equity at risk for the entity to finance its activities without additional subordinate financial support from other parties. FIN 46R requires an enterprise to consolidate a variable interest entity if that enterprise will absorb a majority of the entity’s expected losses, is entitled to receive a majority of the entity’s expected residual returns, or both. FIN 46R was effective for special-purpose entities being evaluated under FIN 46R for consolidation on December 31, 2003 and was effective for all other entities being evaluated on March 31, 2004. The adoption of FIN 46R did not have a material impact on the Company’s financial position or results of operations.

ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

There has been no material change during the quarter ended March 31, 2004, from the disclosures about market risk provided in the Company’s Annual Report on Form 10-K for the year ended December 31, 2003.

ITEM 4. CONTROLS AND PROCEDURES

Based on their evaluation of the Company’s disclosure controls and procedures as of March 31, 2004, the Chief Executive Officer and Chief Financial Officer of the Company have concluded that such disclosure controls and procedures were adequate and effective and designed to ensure that material information relating to the Company and its consolidated subsidiaries would be made known to them by others within those entities. There has been no change in the Company’s internal control over financial reporting identified in connection with such evaluation that occurred during the Company’s last fiscal quarter that has materially affected or is reasonably likely to materially affect the Company’s internal control over financial reporting.

PART II. OTHER INFORMATION

ITEM 6. EXHIBITS AND REPORTS ON FORM 8-K.

(a) Exhibits

  31.1   Certificate of Chief Executive Officer
  31.2   Certificate of Chief Financial Officer
  32.1   Section 906 Officers’ Certification

(b) Reports on Form 8-K. –None

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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 thereunto duly authorized.

DIAGNOSTIC PRODUCTS CORPORATION
(Registrant)

         
/s/ Michael Ziering

Michael Ziering
  President and
Chief Executive Officer and
Chairman of the Board
(Principal Executive Officer)
Director
  May 10, 2004
/s/ James L. Brill

James L. Brill
  Vice President-Finance
(Principal Financial and Accounting
Officer)
  May 10, 2004

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EXHIBIT INDEX

     
31.1
  Certificate of Chief Executive Officer
31.2
  Certificate of Chief Financial Officer
32.1
  Section 906 Officers’ Certification