10-Q 1 d10q.htm FORM 10-Q Form 10-Q
Table of Contents

UNITED STATES

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 June 30, 2005

 

¨ 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 1-4448

 


 

BAXTER INTERNATIONAL INC.

(Exact name of registrant as specified in its charter)

 


 

Delaware   36-0781620

(State or other jurisdiction of

incorporation or organization)

 

(I.R.S. Employer

Identification No.)

 

One Baxter Parkway, Deerfield, Illinois   60015-4633
(Address of principal executive offices)   (Zip Code)

 

847-948-2000

(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  x    No  ¨

 

The number of shares of the registrant’s Common Stock, par value $1.00 per share, outstanding as of July 29, 2005 was 622,507,876 shares.

 



Table of Contents

BAXTER INTERNATIONAL INC.

FORM 10-Q

For the quarterly period ended June 30, 2005

TABLE OF CONTENTS

 

         Page Number

PART I.   FINANCIAL INFORMATION     
Item 1.   Financial Statements     
   

Condensed Consolidated Statements of Income

   2
   

Condensed Consolidated Balance Sheets

   3
   

Condensed Consolidated Statements of Cash Flows

   4
   

Notes to Condensed Consolidated Financial Statements

   5
Item 2.   Management’s Discussion and Analysis of Financial Condition and Results of Operations    15
Item 3.   Quantitative and Qualitative Disclosures About Market Risk    31
Item 4.   Controls and Procedures    32
Review by Independent Registered Public Accounting Firm    33
Report of Independent Registered Public Accounting Firm    34
PART II.   OTHER INFORMATION     
Item 1.   Legal Proceedings    35
Item 4.   Submission of Matters to a Vote of Security Holders    41
Item 5   Other Information    42
Item 6.   Exhibits    42
Signature    43

Exhibits 

       44


Table of Contents

PART I. FINANCIAL INFORMATION

Item 1. Financial Statements

 

Baxter International Inc. and Subsidiaries

Condensed Consolidated Statements of Income (unaudited)

(in millions, except per share data)

 

     Three months
ended
June 30,


     Six months
ended
June 30,


 
     2005

     2004

     2005

     2004

 

Net sales

   $ 2,577      $ 2,379      $ 4,960      $ 4,588  

Cost and expenses

                                   

Cost of goods sold

     1,464        1,440        2,878        2,756  

Marketing and administrative expenses

     537        532        1,020        998  

Research and development expenses

     133        129        266        265  

Restructuring

     (104 )      543        (104 )      543  

Infusion pump charge

     77        —          77        —    

Net interest expense

     33        25        64        46  

Other expense, net

     25        42        49        63  
    


  


  


  


Total costs and expenses

     2,165        2,711        4,250        4,671  
    


  


  


  


Income (loss) from continuing operations before income taxes

     412        (332 )      710        (83 )

Income tax expense (benefit)

     88        (163 )      162        (101 )
    


  


  


  


Income (loss) from continuing operations

     324        (169 )      548        18  

Discontinued operations

     (2 )      (1 )      —          (12 )
    


  


  


  


Net income (loss)

   $ 322      $ (170 )    $ 548      $ 6  
    


  


  


  


Earnings (loss) per basic common share

   $ 0.52      $ (0.28 )    $ 0.88      $ 0.03  

Continuing operations

                                   

Discontinued operations

     —          —          —          (0.02 )
    


  


  


  


Net income (loss)

   $ 0.52      $ (0.28 )    $ 0.88      $ 0.01  
    


  


  


  


Earnings (loss) per diluted common share

   $ 0.51      $ (0.28 )    $ 0.88      $ 0.03  

Continuing operations

                                   

Discontinued operations

     —          —          —          (0.02 )
    


  


  


  


Net income (loss)

   $ 0.51      $ (0.28 )    $ 0.88      $ 0.01  
    


  


  


  


Weighted average number of common shares outstanding

                                   

Basic

     621        613        620        613  
    


  


  


  


Diluted

     626        613        624        617  
    


  


  


  


 

The accompanying notes are an integral part of these condensed consolidated financial statements.

 

2


Table of Contents

Baxter International Inc. and Subsidiaries

Condensed Consolidated Balance Sheets (unaudited)

(in millions, except shares)

 

     June 30,
2005


       December 31,
2004


 
Current assets                  

Cash and equivalents

   $ 1,428        $  1,109  

Accounts and other current receivables

     1,959        2,091  

Inventories

     1,944        2,135  

Short-term deferred income taxes

     235        297  

Prepaid expenses and other

     273        387  
    


    

Total current assets

     5,839        6,019  
    


    

Property, plant and equipment                  

At cost

     7,831        7,991  

Accumulated depreciation and amortization

     (3,674 )      (3,622 )
    


    

Net property, plant and equipment

     4,157        4,369  
    


    

Other assets                  

Goodwill

     1,560        1,648  

Other intangible assets

     502        547  

Other

     1,568        1,564  
    


    

Total other assets

     3,630        3,759  
    


    

Total assets    $ 13,626        $14,147  
    


    

Current liabilities                  

Short-term debt

   $ 500        $     207  

Current maturities of long-term debt and lease obligations

     950        154  

Accounts payable and accrued liabilities

     2,501        3,531  

Income taxes payable

     410        394  
    


    

Total current liabilities

     4,361        4,286  
    


    

Long-term debt and lease obligations      3,039        3,933  
    


    

Other long-term liabilities      2,016        2,223  
    


    

Commitments and contingencies                  
Stockholders’ equity                  

Common stock, $1 par value, authorized 2,000,000,000 shares, issued 648,414,492 shares in 2005 and 2004

     648        648  

Common stock in treasury, at cost, 26,856,182 shares in 2005 and 30,489,183 shares in 2004

     (1,323 )      (1,511 )

Additional contributed capital

     3,514        3,597  

Retained earnings

     2,807        2,259  

Accumulated other comprehensive loss

     (1,436 )      (1,288 )
    


    

Total stockholders’ equity

     4,210        3,705  
    


    

Total liabilities and stockholders’ equity    $ 13,626        $14,147  
    


    

 

The accompanying notes are an integral part of these condensed consolidated financial statements.

 

 

3


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Baxter International Inc. and Subsidiaries

Condensed Consolidated Statements of Cash Flows (unaudited)

(in millions)

 

     Six months
ended
June 30,


 
     2005

       2004

 

Cash flows from operations

                   

Income from continuing operations

   $ 548        $ 18  

Adjustments

                   

Depreciation and amortization

     292          295  

Deferred income taxes

     119          (203 )

Restructuring

     (104 )        543  

Infusion pump charge

     77          —    

Other

     33          147  

Changes in balance sheet items

                   

Accounts receivable

     20          (162 )

Inventories

     90          (75 )

Accounts payable and accrued liabilities

     (325 )        (229 )

Restructuring payments

     (73 )        (62 )

Other

     102          (20 )
    


    


Cash flows from continuing operations

     779          252  

Cash flows from discontinued operations

     (1 )        15  
    


    


Cash flows from operations

     778          267  
    


    


Cash flows from investing activities

                   

Capital expenditures

     (163 )        (229 )

Acquisitions (net of cash received) and investments in and advances to affiliates

     —            (20 )

Divestitures and other

     49          31  
    


    


Cash flows from investing activities

     (114 )        (218 )
    


    


Cash flows from financing activities

                   

Issuances of debt

     41          333  

Payments of obligations

     (443 )        (337 )

Increase in debt with maturities of three months or less, net

     312          81  

Common stock cash dividends

     (359 )        (361 )

Proceeds from stock issued under employee benefit plans

     90          75  

Purchases of treasury stock

     —            (18 )
    


    


Cash flows from financing activities

     (359 )        (227 )
    


    


Effect of currency exchange rate changes on cash and equivalents

     14          13  
    


    


Increase (decrease) in cash and equivalents

     319          (165 )

Cash and equivalents at beginning of period

     1,109          925  
    


    


Cash and equivalents at end of period

   $ 1,428        $ 760  
    


    


 

The accompanying notes are an integral part of these condensed consolidated financial statements.

 

4


Table of Contents

Baxter International Inc. and Subsidiaries

Notes to Condensed Consolidated Financial Statements (unaudited)

 

1. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

 

The unaudited interim condensed consolidated financial statements of Baxter International Inc. and its subsidiaries (the company or Baxter) have been prepared pursuant to the rules and regulations of the Securities and Exchange Commission (SEC). Accordingly, certain information and footnote disclosures normally included in financial statements prepared in accordance with generally accepted accounting principles (GAAP) have been condensed or omitted. These interim condensed consolidated financial statements should be read in conjunction with the consolidated financial statements and notes included in the company’s 2004 Annual Report to Stockholders (2004 Annual Report).

 

In the opinion of management, the interim condensed consolidated financial statements reflect all adjustments necessary for a fair presentation of the interim periods. All such adjustments, unless otherwise noted herein, are of a normal, recurring nature. The results of operations for the interim period are not necessarily indicative of the results of operations to be expected for the full year.

 

Certain reclassifications have been made to conform the 2004 financial statements and notes to the 2005 presentation.

 

Stock compensation plans

 

The company has a number of stock-based employee compensation plans, including stock option, stock purchase, restricted stock and restricted stock unit plans. The company measures stock-based compensation expense using the intrinsic value method of accounting. Generally, no expense is recognized for the company’s employee stock option and purchase plans. Expense is recognized relating to restricted stock and restricted stock unit grants and certain modifications to stock options.

 

Under the fair value method, additional expense would be recognized for the company’s employee stock option and purchase plans. The following table shows net income and earnings per share (EPS) had the company applied the fair value method of accounting for stock-based compensation.

 

 

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     Three months
ended
June 30,


    

Six months
ended

June 30,


 

(in millions, except per share data)        


   2005

     2004

     2005

     2004

 

Net income (loss), as reported

   $ 322      $ (170 )    $ 548      $ 6  

Add:

                                   

Stock-based employee compensation expense included in reported net income, net of tax

     2        12        2        12  

Deduct:

                                   

Total stock-based employee compensation expense determined under the fair value method, net of tax

     (18 )      (32 )      (30 )      (60 )
    


  


  


  


Pro forma net income (loss)

   $ 306      $ (190 )    $ 520      $ (42 )
    


  


  


  


Earnings (loss) per basic share

                                   

As reported

   $ 0.52      $ (0.28 )    $ 0.88      $ 0.01  

Pro forma

   $ 0.49      $ (0.31 )    $ 0.84      $ (0.07 )
    


  


  


  


Earnings (loss) per diluted share

                                   

As reported

   $ 0.51      $ (0.28 )    $ 0.88      $ 0.01  

Pro forma

   $ 0.49      $ (0.31 )    $ 0.83      $ (0.07 )
    


  


  


  


 

New accounting standards

 

In December 2004, the Financial Accounting Standards Board (FASB) revised and reissued Statement of Financial Accounting Standards (SFAS) No. 123, “Share-Based Payment” (SFAS No. 123-R), which requires companies to expense the value of employee stock options and similar awards. Due to an SEC amendment to Regulation S-X in April 2005, SFAS No. 123-R will become effective for the company on January 1, 2006. The new rules provide for one of two transition elections, either prospective application or restatement (back to January 1, 1995). The company plans to adopt SFAS No. 123-R on January 1, 2006 and has not yet decided which transition option the company will use. Management is in the process of analyzing the provisions of SFAS No. 123-R and assessing the impact on the company’s future consolidated financial statements.

 

In December 2004, the FASB issued SFAS No. 151, “Inventory Costs” (SFAS No. 151), which clarifies the accounting for abnormal amounts of idle facility expense, freight, handling costs and spoilage. SFAS No. 151 requires that those items be recognized as current period charges. In addition, the new standard requires that the allocation of fixed production overhead costs be based on the normal capacity of the production facilities. The company plans to adopt SFAS No. 151 on its effective date of January 1, 2006. Management is in the process of analyzing the new standard and has not yet determined the impact on the company’s consolidated financial statements.

 

2. SUPPLEMENTAL FINANCIAL INFORMATION

 

Net pension and other postemployment benefits expense

 

The following is a summary of net expense relating to the company’s pension and other postemployment benefit (OPEB) plans.

 

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Table of Contents
     Three months
ended
June 30,


     Six months
ended
June 30,


 

(in millions)    


   2005

     2004

     2005

     2004

 

Pension benefits

                                   

Service cost

   $ 20      $ 20      $ 41      $ 40  

Interest cost

     40        37        81        76  

Expected return on plan assets

     (42 )      (46 )      (85 )      (94 )

Amortization of net loss, prior service cost and transition obligation

     21        15        42        31  
    


  


  


  


Net pension plan expense

   $ 39      $ 26      $ 79      $ 53  
    


  


  


  


OPEB

                                   

Service cost

   $ 1      $ 2      $ 3      $ 4  

Interest cost

     7        7        15        15  

Amortization of net loss and prior service cost

     1        3        4        5  
    


  


  


  


Net OPEB plan expense

   $ 9      $ 12      $ 22      $ 24  
    


  


  


  


 

In December 2003, the Medicare Prescription Drug, Improvement and Modernization Act (the Medicare Act) was signed into law. The Medicare Act introduces a prescription drug benefit under Medicare (Part D) as well as a federal subsidy to sponsors of retiree health-care benefit plans that provide a benefit that is at least actuarially equivalent to Medicare (Part D). The final regulations for determining whether plans are actuarially equivalent to Medicare (Part D) were issued in January 2005. Based on these final regulations, management expects the company’s OPEB plan to be actuarially equivalent to Medicare (Part D), and that the company will be eligible for the federal subsidy. In accordance with GAAP, the estimated reduction in the accumulated OPEB obligation due to the federal subsidy is reflected as an actuarial gain, and the gain is being amortized. The effect on the company’s consolidated financial statements is not expected to be material.

 

Second quarter 2004 charges

 

Financial results for the second quarter of 2004 included several charges. These charges, as summarized below, reduced pre-tax income from continuing operations by $115 million, and reduced net income by $20 million or $0.04 per diluted share.

 

Cost of goods sold included $45 million relating to inventory reserve and foreign currency hedge adjustments (principally due to certain changes within the BioScience segment), marketing and administrative expenses included $55 million relating to adjustments to the allowance for doubtful accounts (principally related to the company’s loan to Cerus Corporation), other expense included a $15 million impairment charge (related to the company’s Pathogen Inactivation program), and income tax expense reflected a $95 million benefit relating to these charges, as well as a reversal of reserves based on the completion of tax audits. Refer to the 2004 Annual Report for a more complete discussion of each of these adjustments.

 

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Table of Contents

Net interest expense

 

Net interest expense consisted of the following.

 

     Three months
ended
June 30,


     Six months
ended
June 30,


 

(in millions)    


   2005

     2004

     2005

     2004

 

Interest expense, net of capitalized interest

   $ 43      $ 30      $ 84      $ 58  

Interest income

   (10 )    (5 )    (20 )    (12 )
    

  

  

  

Net interest expense

   $ 33      $ 25      $ 64      $ 46  
    

  

  

  

 

Other expense, net

 

Other income and expense includes amounts relating to foreign exchange, minority interests and equity method investments. Other income and expense may also include other items, such as legal settlement gains and losses, asset impairment charges and divestitures gains and losses.

 

Charges relating to legal matters totaled $9 million in both the three- and six-month periods ended June 30, 2005. Asset impairment charges totaled $18 million in the three- and six-month periods ended June 30, 2004, including the $15 million Pathogen Inactivation program charge discussed above. Expense for the quarter and year-to-date period ended June 30, 2004 also included $6 million relating to the application of FASB Interpretation No. 45, “Guarantor’s Accounting and Disclosure Requirements for Guarantees, Including Indirect Guarantees of Indebtedness of Others” (FIN 45), to the company’s guarantee of the Shared Investment Plan loans (which were extended during the second quarter of 2004). Refer to the 2004 Annual Report for further information regarding the Shared Investment Plan.

 

Comprehensive income

 

Total comprehensive income was $153 million and $400 million for the three and six months ended June 30, 2005, respectively, and total comprehensive loss was $237 million and $46 million for the three and six months ended June 30, 2004, respectively. The increase in comprehensive income during the quarter and year-to-date period was principally related to increased net income and favorable movements in the company’s net investment hedges, partially offset by unfavorable currency translation adjustments.

 

Earnings per share

 

The numerator for both basic and diluted EPS is net income. The denominator for basic EPS is the weighted-average number of common shares outstanding during the period. The dilutive effect of outstanding employee stock options, employee stock purchase subscriptions and other common stock equivalents is reflected in the denominator for diluted EPS using the treasury stock method. The following is a reconciliation of basic shares to diluted shares.

 

     Three months
ended
June 30,


   Six months
ended
June 30,


(in millions)    


   2005

   2004

   2005

   2004

Basic shares

   621    613    620    613

Effect of dilutive securities

                   

Employee stock options

   4    —      4    3

Other

   1    —      —      1
    
  
  
  

Diluted shares

   626    613    624    617
    
  
  
  

 

 

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Inventories

 

Inventories consisted of the following.

 

(in millions)    


   June 30,
2005


   December 31,
2004


Raw Materials

   $ 419    $   456

Work in process

     624    754

Finished products

     901    925
    

  

Total inventories

   $ 1,944    $2,135
    

  

 

Goodwill

 

Goodwill at June 30, 2005 totaled $859 million for the Medication Delivery segment, $567 million for the BioScience segment and $134 million for the Renal segment. Goodwill at December 31, 2004 totaled $895 million for the Medication Delivery segment, $583 million for the BioScience segment and $170 million for the Renal segments. The reduction in the goodwill balance for each segment related to foreign currency fluctuations and for the Renal segment, a first quarter 2005 divestiture (which resulted in a $28 million reduction in the Renal segment’s goodwill balance).

 

Other intangible assets

 

The following is a summary of the company’s intangible assets subject to amortization at June 30, 2005 and December 31, 2004. Intangible assets with indefinite useful lives are not material.

 

(in millions, except amortization period data)          


   Developed
technology,
including patents


   Manufacturing,
distribution and
other contracts


   Other

   Total

June 30, 2005

                       

Gross intangible assets

   $778    $29    $ 75    $ 882

Accumulated amortization

   346    14      27      387
    
  
  

  

Net intangible assets

   $432    $15    $ 48    $ 495
    
  
  

  

Weighted-average amortization period (in years)

   14    8      20      15
    
  
  

  

December 31, 2004

                       

Gross intangible assets

   $804    $28    $ 80    $ 912

Accumulated amortization

   333    14      25      372
    
  
  

  

Net intangible assets

   $471    $14    $ 55    $ 540
    
  
  

  

Weighted-average amortization period (in years)

   14    8      20      15
    
  
  

  

 

The amortization expense for these intangible assets was $15 million and $16 million for the three months ended June 30, 2005 and 2004, respectively, and $29 million and $32 million for the six months ended June 30, 2005 and 2004, respectively. At June 30, 2005, the anticipated annual amortization expense for these intangible assets is $56 million in 2005, $53 million in 2006, $45 million in 2007, $41 million in 2008, $38 million in 2009 and $38 million in 2010.

 

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Product warranties

 

The following is a summary of activity in the product warranty liability.

 

    

As of and for the
three months
ended

June 30,


    

As of and for the

six months
ended

June 30,


 

(in millions)    


   2005

     2004

     2005

     2004

 

Beginning of period

   $ 57      $ 50      $ 57      $ 53  

New warranties and adjustments to existing warranties

   5      7      12      10  

Payments in cash or in kind

   (5 )    (5 )    (12 )    (11 )
    

  

  

  

End of period

   $ 57      $ 52      $ 57      $ 52  
    

  

  

  

 

Securitization arrangements

 

The company’s securitization arrangements resulted in net cash outflows of $34 million and $86 million for the three and six months ended June 30, 2005, respectively, and $147 million and $190 million for the three and six months ended June 30, 2004, respectively. A summary of the activity is as follows.

 

    

Three months
ended

June 30,


     Six months
ended
June 30,


 

(in millions)    


   2005

     2004

     2005

     2004

 

Sold receivables at beginning of period

   $ 539      $ 704      $ 594      $ 742  

Proceeds from sales of receivables

     382        318        738        693  

Cash collections (remitted to the owners of the receivables)

     (416 )      (465 )      (824 )      (883 )

Effect of currency exchange rate changes

     (20 )      (10 )      (23 )      (5 )
    


  


  


  


Sold receivables at end of period

   $ 485      $ 547      $ 485      $ 547  
    


  


  


  


 

Income taxes

 

The American Jobs Creation Act of 2004

 

No provision has been made for U.S. income taxes on the undistributed earnings of non-U.S. subsidiaries, as these earnings are currently deemed to be permanently invested.

 

In October 2004, the American Jobs Creation Act of 2004 (the Act) was enacted. The Act allows U.S. companies a one-time opportunity to repatriate non-U.S. earnings through 2005 at a 5.25% tax rate rather than the normal U.S. tax rate of 35%, provided that certain criteria, including qualified reinvestment, are met. Management is analyzing the provisions of the Act. Detailed final guidance necessary to implement the Act has not yet been issued by the Internal Revenue Service. Management has not yet determined the effects on the company’s plans or its consolidated financial statements. Management expects to complete its evaluation by the end of the third quarter of 2005.

 

Effective income tax rate

 

As discussed in Notes 1, 3 and 4, included in results of operations in both 2005 and 2004 were certain unusual or nonrecurring charges and income items. The company’s effective tax rate was impacted by these items, which were tax-effected at

 

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varying rates, depending on the particular tax jurisdictions. In addition, during the second quarter of 2005, principally due to ongoing improvements to the company’s geographic product sourcing, the company revised its estimate and recorded a year-to-date income tax adjustment totaling approximately $20 million, to reflect a lower full-year 2005 projected effective income tax rate (reducing the expected full-year 2005 effective income tax rate from 25%, as disclosed in the 2004 Annual Report, to approximately 22%).

 

3. RESTRUCTURING

 

Second quarter 2004 restructuring charge

 

During the second quarter of 2004, the company recorded a $543 million restructuring charge principally associated with management’s decision to implement actions to reduce the company’s overall cost structure and to drive sustainable improvements in financial performance. The charge was primarily for severance and costs associated with the closing of facilities (including the closure of additional plasma collection centers) and the exiting of contracts.

 

These actions include the elimination of over 4,000 positions, or 8% of the global workforce, as management reorganizes and streamlines the company. Approximately 50% of the positions being eliminated are in the United States. Approximately three-quarters of the estimated savings impact general and administrative expenses, with the remainder primarily impacting cost of sales. The eliminations impact all three of the company’s segments, along with the corporate headquarters and functions.

 

Included in the 2004 charge was $196 million relating to asset impairments, almost all of which was to write down property, plant and equipment (PP&E), based on market data for the assets. Also included in the 2004 charge was $347 million for cash costs, principally pertaining to severance and other employee-related costs. Approximately 80% of the targeted positions have been eliminated as of June 30, 2005. As discussed below, management adjusted the restructuring charge during the second quarter of 2005 based on changes in estimates.

 

Second quarter 2003 restructuring charge

 

During the second quarter of 2003, the company recorded a $337 million restructuring charge principally associated with management’s decision to close certain facilities and reduce headcount on a global basis. Management undertook these actions in order to position the company more competitively and to enhance profitability. The company closed plasma collection centers and a plasma fractionation facility. In addition, the company consolidated and integrated several facilities. Management discontinued Baxter’s recombinant hemoglobin protein program because it did not meet expected clinical milestones. Also included in the charge were costs related to other reductions in the company’s workforce.

 

Included in the 2003 charge was $128 million relating to asset impairments, principally to write down PP&E, goodwill and other intangible assets. The impairment loss relating to the PP&E was based on market data for the assets. The impairment loss relating to goodwill and other intangible assets was based on management’s assessment of the value of the related businesses. Also included in the 2003 charge was $209 million for cash costs, principally pertaining to severance and other employee-related costs associated with the elimination of approximately 3,200 positions worldwide. Substantially all of the targeted positions have been eliminated as of June 30, 2005, and the program is substantially complete. As discussed below, management adjusted the restructuring charge during the second quarter of 2005 based on changes in estimates.

 

 

11


Table of Contents

Restructuring reserves

 

The following summarizes activity in the company’s restructuring reserves through June 30, 2005.

 

(in millions)    


     Employee-
related
costs


       Contractual
and other
costs


       Total

 

2003 Restructuring Charge

                          

Charge

     $160        $  49        $209  

Utilization

     (63 )      (6 )      (69 )
      

    

    

Reserve at December 31, 2003

     97        43        140  

Utilization

     (74 )      (17 )      (91 )
      

    

    

Reserve at December 31, 2004

     23        26        49  

Utilization

     (5 )      (1 )      (6 )
      

    

    

Reserve at March 31, 2005

     18        25        43  

Utilization

     (5 )      —          (5 )

Adjustments

     (8 )      (20 )      (28 )
      

    

    

Reserve at June 30, 2005

     $    5        $    5        $10  
      

    

    

2004 Restructuring Charge

                          

Charge

     $212        $135        $347  

Utilization

     (60 )      (32 )      (92 )
      

    

    

Reserve at December 31, 2004

     152        103        255  

Utilization

     (26 )      (11 )      (37 )
      

    

    

Reserve at March 31, 2005

     126        92        218  

Utilization

     (19 )      (6 )      (25 )

Adjustments

     (40 )      (16 )      (56 )
      

    

    

Reserve at June 30, 2005

     $  67        $  70        $137  
      

    

    

 

With respect to the 2003 restructuring charge, the remaining reserve is expected to be utilized during 2005. With respect to the 2004 restructuring charge, approximately $50 million of the reserve is expected to be utilized during the second half of 2005, with the remainder to be utilized in 2006.

 

Second quarter 2005 adjustments to restructuring charges

 

During the second quarter of 2005, the company recorded a $104 million pre-tax benefit relating to the adjustment of restructuring charges recorded in 2004 and 2003. As detailed in the table above, $84 million of the adjustment related to improved estimates of restructuring reserves. The remaining $20 million represented asset disposal proceeds in excess of original estimates and finalization of certain employment termination arrangements.

 

The restructuring reserve adjustments principally related to severance and other employee-related costs. The company’s targeted headcount reductions are being achieved with a higher level of attrition than originally anticipated. Accordingly, the company’s severance payments are now projected to be lower than originally estimated. The remaining reserve adjustment principally related to changes in estimates regarding certain contract termination costs.

 

 

12


Table of Contents

4. INFUSION PUMP CHARGE

 

On July 21, 2005, the company announced that the United States Food and Drug Adminstration (FDA) had classified a March 15, 2005 company voluntary notice to customers regarding certain user interface and failure code issues relating to the company’s COLLEAGUE® Volumetric Infusion Pump as a Class I recall (FDA’s highest priority level) and that there had been reports of three deaths and six serious injuries that may have been associated with the issues identified in the March 15, 2005 voluntary notice. The same announcement also described a field corrective action letter sent to customers on July 20, 2005 (also designated a Class I recall), notifying customers that the company is in the process of developing an action plan to address design issues relating to COLLEAGUE pump failure codes (with which one of the three previously described deaths may have been associated). While these actions do not require customers to return their COLLEAGUE pumps, the company will voluntarily hold shipments of new COLLEAGUE pumps until design issues are resolved.

 

During the second quarter of 2005 the company recorded a $77 million charge for costs associated with correcting the COLLEAGUE infusion pump design issues. The charge recorded during the quarter represents management’s current estimate of the costs to be incurred to remediate these issues. The charge principally consists of materials, labor and freight costs. The actual costs relating to this matter may differ from management’s estimate. It is possible that additional charges may be required in future periods. It is also possible that actual costs relating to this matter may be less than estimated costs.

 

5. LEGAL PROCEEDINGS

 

“Part II - Item 1. Legal Proceedings” is incorporated herein by reference.

 

6. SEGMENT INFORMATION

 

The company operates in three segments, each of which is a strategic business that is managed separately because each business develops, manufactures and sells distinct products and services. The segments and a description of their products and services are as follows: Medication Delivery, which provides a range of intravenous solutions and specialty products that are used in combination for fluid replenishment, general anesthesia, nutrition therapy, pain management, antibiotic therapy and chemotherapy; BioScience, which develops biopharmaceuticals, biosurgery products, vaccines and blood collection, processing and storage products and technologies for transfusion therapies; and Renal, which develops products and provides services to treat end-stage kidney disease.

 

Certain items are maintained at the corporate level and are not allocated to the segments. They primarily include most of the company’s debt and cash and equivalents and related net interest expense, corporate headquarters costs, certain non-strategic investments and related income and expense, certain nonrecurring gains and losses, certain special charges (such as in-process research and development, restructuring and certain asset impairments), deferred income taxes, certain foreign currency fluctuations, certain employee benefit costs, the majority of the foreign currency and interest rate hedging activities, and certain litigation liabilities and related insurance receivables.

 

The $77 million second quarter 2005 charge associated with the COLLEAGUE infusion pump is reflected in the Medication Delivery segment’s pre-tax income for the three- and six-month periods ended June 30, 2005 in the table below. Refer to Note 4 for further information.

 

13


Table of Contents

Financial information for the company’s segments for the quarters and year-to-date periods ended June 30 is as follows.

 

    

Three months
ended

June 30,


   

Six months
ended

June 30,


 

(in millions)    


   2005

    2004

    2005

    2004

 

Net sales

                                

Medication Delivery

   $ 1,083     $ 1,006     $ 2,061     $ 1,932  

BioScience

     990       893       1,892       1,703  

Renal

     504       480       1,007       953  
    


 


 


 


Total

   $ 2,577     $ 2,379     $ 4,960     $ 4,588  
    


 


 


 


Pre-tax income from continuing operations

                                

Medication Delivery

   $ 120     $ 182     $ 277     $ 333  

BioScience

     265       137       469       259  

Renal

     94       93       191       172  

Other

     (67 )     (744 )     (227 )     (847 )
    


 


 


 


Total

   $ 412     $ (332 )   $ 710     $ (83 )
    


 


 


 


 

The following is a reconciliation of segment pre-tax income to income from continuing operations before income taxes per the consolidated income statements.

 

    

Three months
ended

June 30,


   

Six months
ended

June 30,


 

(in millions)    


   2005

    2004

    2005

    2004

 

Total pre-tax income from segments

   $ 479     $ 412     $ 937     $ 764  

Unallocated amounts

                                

Interest expense, net

     (33 )     (25 )     (64 )     (46 )

Restructuring

     104       (543 )     104       (543 )

Certain currency exchange rate fluctuations and hedging activities

     (19 )     (39 )     (43 )     (73 )

Asset dispositions and impairments, net

     —         (56 )     —         (56 )

Other corporate items

     (119 )     (81 )     (224 )     (129 )
    


 


 


 


Income (loss) from continuing operations before income taxes

   $ 412     $ (332 )   $ 710     $ (83 )
    


 


 


 


 

7. SUBSEQUENT EVENT—DECISION TO CEASE MANUFACTURING HEMODIALYSIS INSTRUMENTS

 

In July 2005, the company decided to discontinue the manufacture of HD instruments. Separately, the company entered into an agreement with Gambro to distribute Gambro’s HD instruments and related ancillary products. The company will have exclusive distribution rights throughout most of Latin America, and a non-exclusive arrangement in the United States and the rest of the world, excluding Japan where the company does not participate in the HD market. The decision to stop manufacturing HD instruments and the execution of the agreement with Gambro is consistent with the company’s strategy to optimize and improve the financial performance of the Renal business, focusing resources on peritoneal dialysis therapies while maintaining a broad portfolio of HD products. The company will continue to distribute its existing line of HD dialyzers, and provide HD solutions and concentrates that are manufactured by Baxter.

 

As a result of the decision to stop manufacturing HD instruments, management anticipates that charges for severance, contract termination and other costs will be incurred in future periods. While management has not finalized its exit plans, it currently estimates that the pre-tax cost will total between $40 million and $50 million.

 

14


Table of Contents

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

 

RESULTS OF CONTINUING OPERATIONS

 

NET SALES

 

    

Three months
ended

June 30,


  

Percent

change


   Six months
ended
June 30,


  

Percent

change


(in millions)    


   2005

   2004

      2005

   2004

  

Medication Delivery

   $ 1,083    $ 1,006    8%    $ 2,061    $ 1,932    7%

BioScience

     990      893    11%      1,892      1,703    11%

Renal

     504      480    5%      1,007      953    6%
    

  

  
  

  

  

Total net sales

   $ 2,577    $ 2,379    8%    $ 4,960    $ 4,588    8%
    

  

  
  

  

  

 

    

Three months
ended

June 30,


   Percent
change


   Six months
ended
June 30,


   Percent
change


(in millions)    


   2005

   2004

      2005

   2004

  

International

   $ 1,421    $ 1,285    11%    $ 2,760    $ 2,475    12%

United States

     1,156      1,094    6%      2,200      2,113    4%
    

  

  
  

  

  

Total net sales

   $ 2,577    $ 2,379    8%    $ 4,960    $ 4,588    8%
    

  

  
  

  

  

 

Foreign exchange benefited sales growth by 3 points during both the three- and six-month periods ended June 30, 2005, principally because the United States Dollar weakened relative to the Euro and the Japanese Yen. Foreign currency fluctuations favorably impacted sales growth for all three segments.

 

Medication Delivery

 

The Medication Delivery segment generated 8% and 7% sales growth for the three- and six-month periods ended June 30, 2005, respectively (including 3 percentage points due to the favorable impact of foreign currency fluctuations for both the quarter and year-to-date period).

 

The following is a summary of sales by significant product line.

 

    

Three months
ended

June 30,


  

Percent

change


    Six months
ended
June 30,


  

Percent

change


 

(in millions)    


   2005

   2004

     2005

   2004

  

IV Therapies

   $ 312    $ 288    8%     $ 608    $ 570    7%  

Drug Delivery

     226      202    12%       430      390    10%  

Infusion Systems

     245      233    5%       475      421    13%  

Anesthesia

     282      259    9%       513      501    2%  

Other

     18      24        (25% )     35      50    (30% )
    

  

  

 

  

  

Total net sales

   $ 1,083    $ 1,006    8%     $ 2,061    $ 1,932    7%  
    

  

  

 

  

  

 

IV Therapies

 

This product line principally consists of intravenous solutions and nutritional products. Because approximately two-thirds of IV Therapies’ sales are generated outside the United States, sales growth in this product line particularly benefited from the weakened United States Dollar. Sales growth, which was primarily due to increased volume, was strong in international markets, partially offset by lower sales of nutritional products used with automated compounding equipment in the United States.

 

15


Table of Contents

Drug Delivery

 

This product line primarily consists of pre-mixed drugs and contract services, principally for pharmaceutical and biotechnology customers. Contributing to sales growth for the second quarter of 2005 were increased contract services revenues as well as increased sales of small volume parenterals. Sales growth for the year-to-date period benefited from $9 million of sales during the first quarter of 2005 under an existing order from the United States Government related to its biodefense program. In addition, increased sales of certain generic and branded pre-mixed drugs contributed to sales growth in both the second quarter and first half of 2005, with the growth driven by increases in volume, partially offset by lower pricing.

 

Infusion Systems

 

Sales growth of electronic infusion pumps and related tubing sets during the second quarter and first six months of 2005 was primarily driven by higher sales volume of devices, and was particularly strong in the year-to-date period due to the timing of customers’ purchases. Refer to Note 4 and the discussion below regarding a charge recorded during the second quarter of 2005 relating to the COLLEAGUE infusion pump. As a result of the company’s decision to voluntarily stop shipping new COLLEAGUE infusion pumps, there will be no sales of these pumps until the issues are remediated. The company’s sales of COLLEAGUE pumps for the second half of 2004 totaled approximately $120 million.

 

Anesthesia

 

Sales of anesthesia products increased during the second quarter and first half of 2005, with sales growth in both periods reflecting increased volume and improved pricing, particularly with respect to one of the company’s proprietary products, SUPRANE (Desflurane, USP), an inhaled anesthetic agent. As discussed in prior filings, management continues to believe its sales volume and pricing of generic propofol could be negatively impacted by the entry of additional competitors into the marketplace in 2005. Late in the second quarter of 2005, a competitor launched a generic propofol product. The company’s sales of generic propofol in the second half of 2004 totaled approximately $120 million.

 

Other

 

This category primarily includes other hospital-distributed products. The decline in sales during the second quarter and first six months of 2005 was primarily due to the continued exit of certain lower-margin distribution businesses outside the United States.

 

BioScience

 

Sales in the BioScience segment increased 11% for both the three- and six-month periods ended June 30, 2005 (including 4 and 3 percentage points due to the favorable impact of foreign currency fluctuations for the quarter and year-to-date period, respectively).

 

16


Table of Contents

The following is a summary of sales by significant product line.

 

    

Three months
ended

June 30,


  

Percent

change


   Six months
ended
June 30,


  

Percent

change


 

(in millions)    


   2005

   2004

      2005

   2004

  

Recombinants

   $ 397    $ 320    24%    $ 741    $ 612    21%  

Plasma Proteins

     266      267    —        525      505    4%  

Antibody Therapy

     93      90    3%      182      170    7%  

Transfusion Therapies

     140      136    3%      273      276    (1% )

Other

     94      80    18%      171      140    22%  
    

  

  
  

  

  

Total net sales

   $ 990    $ 893    11%    $ 1,892    $ 1,703    11%  
    

  

  
  

  

  

 

Recombinants

 

The primary driver of sales growth in the BioScience segment during the second quarter and first half of 2005 was increased sales volume of recombinant Factor VIII products. Factor VIII products are used in the treatment of hemophilia A, which is a bleeding disorder caused by a deficiency in blood clotting Factor VIII. Sales growth for both the second quarter and first six months of 2005 was primarily fueled by the continued adoption by customers of the advanced recombinant therapy, ADVATE (Antihemophilic Factor (Recombinant), Plasma/Albumin-Free Method) rAHF-PFM, which received regulatory approval in the United States in July 2003 and in Europe in March 2004. Pricing also improved with the continued launch of ADVATE. Management expects sales volumes of ADVATE will continue to grow during the remainder of 2005 as the launch of this new product continues.

 

Plasma Proteins

 

Sales of plasma-based products (excluding antibody therapies) were flat in the second quarter and grew in the first half of 2005 primarily due to increased sales volume of FEIBA, an anti-inhibitor coagulant complex, and the company’s plasma-based sealant, TISSEEL. This growth was partially offset by lower sales of plasma to third parties as a result of management’s decision to exit certain lower-margin contracts and, in the second quarter, to the impact of the timing of certain tenders outside the United States. During the first quarter of 2005, and effective in the third quarter of 2005, the company and the American Red Cross terminated their contract manufacturing agreement and replaced it with a plasma procurement agreement. For the second half of 2005, this new arrangement is expected to result in lower revenues for the Plasma Proteins product line as compared to the prior arrangement (this impact is expected to be offset by increased sales in the Antibody Therapy product line, as further discussed below).

 

Antibody Therapy

 

Higher sales of IVIG (intravenous immunoglobulin), which is used in the treatment of immune deficiencies, fueled sales growth during the second quarter and first half of 2005, primarily due to continued pricing recovery in the United States. Sales volume is expected to grow in the second half of the year as a result of the agreement with the American Red Cross which, as discussed above, is effective in the third quarter of 2005. Also contributing to sales growth during the second quarter of 2005 were sales of WinRho ® SDF [Rho(D) Immune Globulin Intravenous (Human)], which is a product used to treat a critical bleeding disorder. The company acquired the United States marketing and distribution rights relating to this product late in the first quarter of 2005. In addition, a liquid formulation of IVIG, which received regulatory approval in the United States in April 2005, is expected to be launched in the fourth quarter of 2005.

 

 

17


Table of Contents

Transfusion Therapies

 

Sales of transfusion therapies products, which are products and systems for use in the collection and preparation of blood and blood components, continued to be unfavorably impacted by consolidation in the plasma industry during the second quarter and first half of 2005.

 

Other

 

Other BioScience products primarily consist of vaccines and non-plasma-based sealant products. Sales of vaccines, which are impacted by the timing of government tenders, increased during both the second quarter and first six months of 2005, and primarily related to increased sales volume of NeisVac-C (for the prevention of meningitis C) and FSME Immun (for the prevention of tick-borne encephalitis). The company’s non-plasma-based sealants are relatively new products, and sales increased significantly in both the three-month and six-month periods ended June 30, 2005, as the company continues to launch these products.

 

Renal

 

Sales from continuing operations in the Renal segment increased 5% and 6% for the three- and six-month periods ended June 30, 2005, respectively (including 5 percentage points due to the favorable impact of foreign currency fluctuations in both the quarter and year-to-date periods), with sales growth principally generated in international markets.

 

The following is a summary of sales by significant product line.

 

    

Three months
ended

June 30,


  

Percent

change


   

Six months
ended

June 30,


  

Percent

change


 

(in millions)    


   2005

   2004

     2005

   2004

  

PD Therapy

   $ 385    $ 357    8%     $    759    $ 702    8%  

HD Therapy

     114      118    (3% )     240      242    (1% )

Other

     5      5    —   %       8      9    (11% )
    

  

  

 

  

  

Total net sales

   $ 504    $ 480    5%     $ 1,007    $ 953    6%  
    

  

  

 

  

  

 

PD Therapy

 

Peritoneal dialysis, or PD Therapy, is a dialysis treatment method for end-stage renal disease. PD Therapy, which is used primarily at home, uses the peritoneal membrane, or abdominal lining, as a natural filter to remove waste from the bloodstream. In addition to the favorable impact of foreign exchange, the sales growth in both periods was primarily driven by an increased number of patients in the majority of markets, principally in Asia, Latin America and Europe. Changes in the pricing of the segment’s PD Therapy products were not a significant factor. Increased penetration of PD Therapy products continues to be strong in emerging markets, where many people with end-stage renal disease are currently under-treated.

 

HD Therapy

 

Hemodialysis, or HD Therapy, is another form of end-stage renal disease dialysis therapy, which is generally performed in a hospital or outpatient center. HD Therapy works by removing wastes and fluid from the blood by using a machine and a filter, also known as a dialyzer. This product line includes sales of products as well as revenues from the Renal Therapy Services (RTS) businesses outside the United States. The sales decline during the second quarter of 2005 was principally due to the divestiture of the RTS business in Taiwan at the end of the first quarter of 2005 (the company’s revenues relating to the

 

18


Table of Contents

RTS business in Taiwan totaled approximately $20 million per quarter in 2004). The remainder of the decline in the quarter and year-to-date period was due to lower sales of dialyzers and related hardware. In July 2005, the company decided to discontinue the manufacture of HD instruments. Separately, the company entered into an agreement with Gambro to distribute Gambro’s HD instruments and related ancillary products. Refer to further discussion below. The decision and new agreement are not expected to have a significant impact on sales.

 

GROSS MARGIN AND EXPENSE RATIOS

 

    

Three months
ended

June 30,


  

Change


   

Six months
ended

June 30,


  

Change


 
     2005

   2004

     2005

   2004

  

Gross margin

   43.2%    39.5%    3.7 pts     42.0%    39.9%    2.1 pts  

Marketing and administrative expenses

   20.8%    22.4%    (1.6 pts )   20.6%    21.8%    (1.2 pts )

 

Gross Margin

 

The improvement in gross margin in both the second quarter and first half of 2005 was principally driven by increased sales of higher-margin recombinant products, cost savings related to the company’s restructuring initiatives (as further discussed below), and improvements in the plasma proteins business. These increases were partially offset by increased costs associated with the company’s pension plans in both the quarter and six-month period (as further discussed below). Refer to the discussion below regarding a $77 million charge recorded in the second quarter of 2005 relating to the Medication Delivery segment’s COLLEAGUE infusion pumps. This charge is included as a separate line item in the consolidated statements of income. In addition, refer to Note 2 regarding certain charges recorded during the second quarter of 2004 which reduced the company’s gross margin in the prior year quarter and year-to-date period.

 

Marketing and Administrative Expenses

 

The marketing and administrative expenses ratio improved as a result of cost savings relating to the company’s restructuring initiatives and other actions designed to reduce the company’s expense base. In addition, as discussed in Note 2, certain charges were recorded during the second quarter of 2004 which increased the company’s expense ratio in the prior year quarter and year-to-date period. These reductions in expenses from 2004 to 2005 were partially offset by the impact of increased pension plan costs, reserves for bad debts and legal costs in 2005.

 

Pension Plan Expenses

 

Pension plan expenses increased $13 million in the second quarter of 2005 and $26 million in the first half of 2005, partially reducing the above-mentioned improvements to the company’s gross margin and expense ratios. The increased pension plan expenses were due to changes in the discount rate and expected return on assets assumptions, as well as increased amortization of unrecognized losses.

 

 

19


Table of Contents

RESEARCH AND DEVELOPMENT

 

    

Three months
ended

June 30,


  

Percent

change


  

Six months
ended

June 30,


  

Percent

change


 

(in millions)    


   2005

   2004

      2005

   2004

  

Research and development (R&D) expenses

   $ 133    $ 129    3%    $ 266    $ 265    %

As a percent of sales

     5.2%      5.4%           5.4%      5.8%       

 

R&D expenses increased in the second quarter of 2005 and were flat for the first half of 2005, with increased spending on certain projects, principally in the BioScience segment, offset by restructuring-related cost savings. Management expects that full-year 2005 R&D expenses will increase over the prior year as the company invests in various R&D projects.

 

RESTRUCTURING

 

Second quarter 2004 restructuring charge

 

During the second quarter of 2004, the company recorded a $543 million restructuring charge principally associated with management’s decision to implement actions to reduce the company’s overall cost structure and to drive sustainable improvements in financial performance. The charge was primarily for severance and costs associated with the closing of facilities (including the closure of additional plasma collection centers) and the exiting of contracts.

 

These actions include the elimination of over 4,000 positions, or 8% of the global workforce, as management reorganizes and streamlines the company. Approximately 50% of the positions being eliminated are in the United States. Approximately three-quarters of the estimated savings impact general and administrative expenses, with the remainder primarily impacting cost of sales. The eliminations impact all three of the company’s segments, along with the corporate headquarters and functions.

 

During the three- and six-month periods ended June 30, 2005, $25 million and $62 million, respectively, of the reserve for cash costs was utilized. Approximately $50 million of the remaining reserve is expected to be utilized during the second half of 2005, with the remainder to be utilized in 2006. The cash expenditures are being funded with cash generated from operations. Approximately 80% of the targeted positions have been eliminated as of June 30, 2005. See discussion below and Note 3 for additional information, including a discussion of restructuring charge adjustments recorded in the second quarter of 2005 based on changes in estimates.

 

Management’s original estimates of the benefits of the program are unchanged. Management continues to project that these initiatives will yield savings of approximately $0.20 to $0.25 per diluted share for full-year 2005 (assuming a constant diluted share count), or incremental savings of $0.15 to $0.20 as compared to full-year 2004. Savings for the second quarter and first half of 2005 were consistent with management’s original estimates. Once fully implemented in 2006, management anticipates total annual savings will be approximately $0.30 to $0.35 per diluted share (assuming a constant diluted share count), or incremental savings of $0.10 as compared to full-year 2005.

 

 

20


Table of Contents

Second quarter 2003 restructuring charge

 

This program is substantially complete, and management does not expect incremental cost savings in 2005. The remaining reserve principally relates to severance and other cash payments to be made in the future, and these payments are being funded with cash generated from operations. See discussion below as well as Note 3 for additional information, including a discussion of restructuring charge adjustments recorded in the second quarter of 2005 based on changes in estimates.

 

Second quarter 2005 adjustments to restructuring charges

 

During the second quarter of 2005, the company recorded a $104 million pre-tax benefit relating to the adjustment of restructuring charges recorded in 2004 and 2003. The restructuring reserve adjustments principally related to severance and other employee-related costs. The company’s targeted headcount reductions are being achieved with a higher level of attrition than originally anticipated. Accordingly, the company’s severance payments are now projected to be lower than originally estimated. The remaining reserve adjustment principally related to changes in estimates regarding certain contract termination costs, certain adjustments related to asset disposal proceeds being in excess of original estimates, and the finalization of certain employment termination arrangements. Refer to Note 3 for additional information.

 

INFUSION PUMP CHARGE

 

During the second quarter of 2005 the company recorded a $77 million charge for costs associated with correcting the COLLEAGUE infusion pump design issues. The charge recorded during the quarter represents management’s current estimate of the costs to be incurred to remediate these issues. The charge principally consists of materials, labor and freight costs. The actual costs relating to this matter may differ from management’s estimate. It is possible that additional charges may be required in future periods. It is also possible that actual costs relating to this matter may be less than estimated costs. Refer to Note 4 for further information. Refer to Part II- Item 5. Other Information for additional discussion of related regulatory matters.

 

SUBSEQUENT EVENT – DECISION TO CEASE MANUFACTURING HEMODIALYSIS INSTRUMENTS

 

In July 2005, the company decided to discontinue the manufacture of HD instruments. Separately, the company entered into an agreement with Gambro to distribute Gambro’s HD instruments and related ancillary products. The company will have exclusive distribution rights throughout most of Latin America, and a non-exclusive arrangement in the United States and the rest of the world, excluding Japan where the company does not participate in the HD market. The decision to stop manufacturing HD instruments and the execution of the agreement with Gambro is consistent with the company’s strategy to optimize and improve the financial performance of the Renal business, focusing resources on peritoneal dialysis therapies while maintaining a broad portfolio of HD products. The company will continue to distribute its existing line of HD dialyzers, and provide HD solutions and concentrates that are manufactured by Baxter.

 

As a result of the decision to stop manufacturing HD instruments, management anticipates that charges for severance, contract termination and other costs will be incurred in future periods. While management has not finalized its exit plans, it currently estimates that the pre-tax cost will total between $40 million and $50 million.

 

 

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NET INTEREST EXPENSE

 

Net interest expense increased $8 million and $18 million for the quarter and six-month period, respectively, principally due to higher interest rates and the execution of the net investment hedge mirror strategy, as further discussed below.

 

OTHER EXPENSE, NET

 

Other expense, net decreased for both the quarter and six-month period ended June 30, 2005. Other expense, net in both periods principally consisted of amounts relating to foreign exchange, minority interests, and equity method investments. Refer to Note 2 for additional information.

 

PRE-TAX INCOME

 

Refer to Note 6 to the condensed consolidated financial statements for a summary of financial results by segment. Certain items are maintained at the company’s corporate headquarters and are not allocated to the segments. They primarily include certain foreign currency fluctuations, the majority of the foreign currency and interest rate hedging activities, net interest expense, income and expense related to certain non-strategic investments, corporate headquarters costs, certain employee benefit plan costs, certain nonrecurring gains and losses and certain special charges (such as in-process research and development, restructuring and certain asset impairments). Included in Note 6 is a table that reconciles financial results for the segments to the consolidated company’s results. The following is a summary of significant factors impacting the segments’ financial results.

 

Medication Delivery

 

Pre-tax income decreased 34% and 17% for the three and six months ended June 30, 2005, respectively. Pre-tax income for both the three-and six-month periods ended June 30, 2005 includes the $77 million charge associated with the COLLEAGUE infusion pump. Refer to discussion above as well as Note 4 for additional information. Aside from the charge, growth in pre-tax income in both the quarter and year-to-date periods was primarily the result of sales growth, the close management of costs, restructuring-related benefits, and foreign currency fluctuations.

 

BioScience

 

Pre-tax income increased 93% and 81% for the three and six months ended June 30, 2005, respectively. The increase in pre-tax income was primarily due to strong sales growth, a higher gross margin, the close management of costs, restructuring-related benefits and foreign currency fluctuations, partially offset by increased R&D spending. As discussed above, the improved gross margin was due to a favorable sales mix, with strong sales of higher-margin recombinant products, as well as improved pricing in certain product lines.

 

Renal

 

Pre-tax income increased 1% and 11% for the three and six months ended June 30, 2005, respectively. The increase in pre-tax income was primarily due to sales growth, the close management of costs, restructuring-related benefits and foreign currency fluctuations.

 

 

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INCOME TAXES

 

As discussed in the notes to the consolidated financial statements, included in results of operations in both 2005 and 2004 were certain unusual or nonrecurring charges and income items. The company’s effective tax rate was impacted by these items, which were tax-effected at varying rates, depending on the particular tax jurisdictions. In addition, during the second quarter of 2005, principally due to ongoing improvements to the company’s geographic product sourcing, the company revised its estimate and recorded a year-to-date income tax adjustment totaling approximately $20 million, to reflect a lower full-year 2005 projected effective income tax rate (reducing the expected full-year 2005 effective income tax rate from 25%, as disclosed in the 2004 Annual Report, to approximately 22%).

 

The American Jobs Creation Act of 2004

 

No provision has been made for U.S. income taxes on the undistributed earnings of non-U.S. subsidiaries, as these earnings are currently deemed to be permanently invested.

 

In October 2004, the American Jobs Creation Act of 2004 (the Act) was enacted. The Act allows U.S. companies a one-time opportunity to repatriate non-U.S. earnings through 2005 at a 5.25% tax rate rather than the normal U.S. tax rate of 35%, provided that certain criteria, including qualified reinvestment, are met. Management is analyzing the provisions of the Act. Detailed final guidance necessary to implement the Act has not yet been issued by the Internal Revenue Service. Management has not yet determined the effects on the company’s plans or its consolidated financial statements. Management expects to complete its evaluation by the end of the third quarter of 2005.

 

INCOME AND EARNINGS PER DILUTED SHARE FROM CONTINUING OPERATIONS

 

Income (loss) from continuing operations was $324 million and ($169) million for the three months ended June 30, 2005 and 2004, respectively, and $548 million and $18 million for the six months ended June 30, 2005 and 2004, respectively. Income (loss) from continuing operations per diluted share was $0.51 and ($0.28) for the three months ended June 30, 2005 and 2004, respectively, and $0.88 and $0.03 for the three and six months ended June 30, 2005 and 2004, respectively. The significant factors contributing to the growth are discussed above.

 

DISCONTINUED OPERATIONS

 

Refer to the 2004 Annual Report regarding the 2002 decision to divest the majority of the Renal segment’s services businesses. Discontinued operations generated a net loss of $2 million for the second quarter of 2005 and a net loss of $1 million for the second quarter of 2004. No earnings were generated for the first six months of 2005, and a net loss of $12 million was generated for the first half of 2004. The divestiture plan is substantially complete, and is expected to be fully completed during 2005.

 

CRITICAL ACCOUNTING POLICIES

 

The preparation of financial statements in accordance with generally accepted accounting principles (GAAP) requires management to make estimates and judgments that affect the reported amounts of assets, liabilities, revenues and expenses. A summary of the company’s significant accounting policies is included in Note 1 to the company’s consolidated financial statements for the year ended December 31, 2004, included in the 2004 Annual Report. Certain of the company’s accounting policies are considered critical, as these policies are the most important to the depiction of the company’s financial statements and require significant, difficult or complex judgments by management, often employing the use of estimates about the effects of matters that are inherently uncertain. Such policies are summarized in the Management’s Discussion and Analysis of Financial Condition and Results of Operations section in the 2004 Annual Report. There have been no significant changes in the application of the critical accounting policies since December 31, 2004.

 

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LIQUIDITY AND CAPITAL RESOURCES

 

CASH FLOWS

 

Cash flows from operations

 

Continuing operations Cash flows from continuing operations increased during the first six months of 2005 as compared to the prior year. The increase in cash flows was primarily due to increased earnings (before non-cash items), improved working capital management, and the settlement of certain mirror cross-currency swaps (as further discussed below), partially offset by increased payments related to restructuring programs and higher contributions to the company’s pension trust relating to the United States and Puerto Rico pension plans.

 

Accounts Receivable

 

Cash flows relating to accounts receivable increased as management continues to increase its focus on working capital efficiency. With this increased focus, the company improved its accounts receivable collections. Days sales outstanding improved from 60.5 days at June 30, 2004 to 58.4 days at June 30, 2005. In addition, proceeds from the factoring of receivables increased and cash outflows relating to the company’s securitization arrangements decreased (as detailed in Note 2) during the first half of 2005.

 

Inventories

 

The following is a summary of inventories at June 30, 2005 and December 31, 2004, as well as inventory turns for the second quarter of 2005 and 2004, by segment.

 

     Inventories

  

Inventory turns for the six

months ended June 30,


(in millions, except inventory turn data)    


   June 30,
2005


   December 31,
2004


   2005

   2004

BioScience

   $ 1,136    $1,332    1.78    1.66

Medication Delivery

     581    587    4.30    3.83

Renal

     227    216    4.00    3.71
    

  
  
  

Total

   $ 1,944    $2,135    2.90    2.61
    

  
  
  

 

Inventories decreased $191 million from December 31, 2004 to June 30, 2005. The decline was primarily related to plasma inventories. Due to the recently executed agreement with the American Red Cross (discussed above), plasma inventories are expected to increase somewhat during the second half of 2005. Inventory turns are impacted by seasonality in certain of the company’s businesses, and are generally highest in the fourth quarter of the year, and lower earlier in the year, for these businesses.

 

Other

 

Contributing to the increase in cash flows from operations during the first half of 2005 was a $55 million cash inflow related to the settlement of certain mirror cross-currency swaps during the first half of 2005. Refer to the net investment hedges section below for further information regarding these swaps. Partially offsetting these cash inflows were increased payments associated with restructuring programs, with cash payments increasing $11 million, from $62 million in the first half of 2004 to $73 million in the first half of 2005. The company also made $46 million of increased contributions to its pension trust relating to its United States and Puerto Rico pension plans, from $54 million in the first half of 2004 to $100 million in the first half of 2005.

 

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Discontinued operations Discontinued operations generated net cash outflows of $1 million and cash inflows of $15 million in the first six months of 2005 and 2004, respectively. The cash inflow in the prior year period primarily consisted of divestiture proceeds. As discussed above, the company has divested the majority of the discontinued operations and plans to complete the divestiture plan in 2005.

 

Cash flows from investing activities

 

Capital Expenditures

 

Capital expenditures decreased $66 million for the six months ended June 30, 2005, from $229 million in 2004 to $163 million in 2005, partially due to the timing of expenditures. Management expects to spend approximately $550 million in capital expenditures for full-year 2005.

 

Acquisitions and Investments In and Advances to Affiliates

 

There were no net cash flows relating to acquisitions or investments in and advances to affiliates during the first six months of 2005. There were $20 million of payments in the first six months of 2004, which primarily related to the 2003 acquisition of certain assets of Alpha Therapeutic Corporation, which are included in the BioScience segment.

 

Divestitures and Other

 

Net cash flows relating to divestitures and other totaled $49 million during the first half of 2005 and $31 million in the first half of 2004. The 2005 total principally related to the collection of a loan from Cerus Corporation, a company in which Baxter owns approximately 1% of the common stock, and the cash proceeds relating to the divestiture of the Renal segment’s RTS business in Taiwan. The 2004 total principally related to the sale of a building and the return of collateral.

 

Cash flows from financing activities

 

Debt Issuances, Net of Payments of Obligations

 

Net cash flows relating to debt issuances, net of payments of obligations, decreased $167 million in the first half of 2005, from $77 million of net cash inflows in 2004 to $90 million of net cash outflows in 2005. Included in the net total for 2005 and 2004 were $363 million and $40 million, respectively, in cash outflows associated with the settlement of certain of the company’s cross-currency swap agreements. Refer to further discussion below.

 

Other Financing Activities

 

Common stock cash dividends were substantially unchanged as compared to the prior year quarter. Cash received for stock issued under employee benefit plans increased by $15 million, from $75 million in the first half of 2004 to $90 million in the first half of 2005, primarily due to a higher level of employee stock option exercises coupled with a higher average option exercise price, partially offset by reduced cash proceeds from the employee stock purchase plans. Stock repurchases decreased from 2004 to 2005. In the first half of 2004 the company paid $18 million to repurchase stock from Shared Investment Plan (SIP) participants. Refer to the 2004 Annual Report for further information regarding the SIP and these repurchases. There were no repurchases during the first half of 2005.

 

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CREDIT FACILITIES, ACCESS TO CAPITAL, AND COMMITMENTS

 

Refer to the 2004 Annual Report for further discussion of the company’s credit facilities, access to capital, and commitments and contingencies.

 

Credit facilities

 

The company had $1.4 billion of cash and equivalents at June 30, 2005. The company maintains three revolving credit facilities, which totaled approximately $2.0 billion at June 30, 2005. One of the facilities totals $640 million and matures in October 2007, another facility totals $800 million and matures in September 2009, and the third facility, which is denominated in Euros and was entered into in January 2005, totals approximately $600 million and matures in January 2008. The facilities enable the company to borrow funds on an unsecured basis at variable interest rates. The company has never drawn on these facilities. Management believes these credit facilities are adequate to support ongoing operational requirements. The credit facilities contain certain covenants, including a maximum net-debt-to-capital ratio and a minimum interest coverage ratio. At June 30, 2005, the company was in compliance with all financial covenants. The company’s net-debt-to-capital ratio, as defined below, of 30.1% at June 30, 2005 was well below the credit facilities’ net-debt-to-capital covenant. Similarly, the company’s actual interest coverage ratio of 9.0 to 1 in the second quarter of 2005 was well in excess of the minimum interest coverage ratio covenant. The net-debt-to-capital ratio, which is calculated in accordance with the company’s primary credit agreements, and is not a measure defined by GAAP, is calculated as net debt (short-term and long-term debt and lease obligations, less cash and equivalents) divided by capital (the total of net debt and stockholders’ equity). The net-debt-to-capital ratio at June 30, 2005 and the corresponding covenant in the company’s credit agreements give 70% equity credit to the company’s equity units. Refer to the 2004 Annual Report for a description of the equity units. The minimum interest coverage ratio is a four-quarter rolling calculation of the total of income from continuing operations before income taxes plus interest expense (before interest income), divided by interest expense (before interest income). Baxter also maintains certain other short-term credit arrangements.

 

Access to capital

 

Management intends to fund short-term and long-term obligations as they mature through cash on hand, future cash flows from operations, by issuing additional debt, or by issuing common stock. As of June 30, 2005, the company has approximately $399 million of shelf registration statement capacity available for the issuance of debt, common stock or other securities, and for general corporate purposes.

 

The company’s ability to generate cash flows from operations, issue debt, enter into other financing arrangements and attract long-term capital on acceptable terms could be adversely affected in the event there is a material decline in the demand for the company’s products, deterioration in the company’s key financial ratios or credit ratings, or other significantly unfavorable changes in conditions. Management believes it has sufficient financial flexibility in the future to issue debt, enter into other financing arrangements, and attract long-term capital on acceptable terms as may be needed to support the company’s growth objectives.

 

Short-term debt and current maturities of long-term debt and lease obligations

 

The increase in short-term debt from December 31, 2004 to June 30, 2005 principally related to increased commercial paper ($0 at December 31, 2004 to approximately $300 million at June 30, 2005). The increase in current maturities of long-term debt and lease obligations from December 31, 2004 to June 30, 2005 principally related to the reclassification of approximately $800 million of notes due in the first quarter of 2006 from long-term to short-term.

 

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Credit ratings

 

The company’s credit ratings at June 30, 2005 were as follows.

 

     Standard & Poor’s

   Fitch

   Moody’s

Ratings

              

Senior debt

   A-    BBB+    Baa1

Short-term debt

   A2    F2    P2

Outlook

   Negative    Stable    Negative

 

Any future downgrades of Baxter’s credit ratings may unfavorably impact the financing costs related to the company’s credit arrangements and future debt issuances.

 

Any future credit rating downgrades or changes in outlook would not affect the company’s ability to draw on its credit facilities, and would not result in an acceleration of the scheduled maturities of any of the company’s outstanding debt.

 

Certain specified rating agency downgrades, if they occur in the future, could require the company to post collateral for, or immediately settle certain of its arrangements. No collateral was required to be posted at June 30, 2005. In addition, in the event of certain specified downgrades (Baa3 or BBB-, depending on the rating agency), the company would no longer be able to securitize new receivables under certain of its securitization arrangements. However, any downgrade of credit ratings would not impact previously securitized receivables. Refer to the 2004 Annual Report for further information.

 

Net investment hedges

 

As further discussed in the 2004 Annual Report, the company has historically hedged the net assets of certain of its foreign operations using a combination of foreign currency denominated debt and cross-currency swaps. The cross-currency swaps have served as effective hedges for accounting purposes and have reduced volatility in the company’s stockholders’ equity balance and net-debt-to-capital ratio (as any increase or decrease in the fair value of the swaps relating to changes in spot currency exchange rates is offset by the change in value of the hedged net assets of the foreign operations relating to changes in spot currency exchange rates).

 

Because the United States Dollar has weakened relative to the hedged currency, the hedged net assets have increased in value over time, while the cross-currency swaps have decreased in value over time. At June 30, 2005, as presented in the following table, the company had a pre-tax net liability of $733 million relating to these cross-currency swap agreements. Of this total, $71 million was short-term, and $662 million was long-term.

 

The company reevaluated its net investment hedge strategy in the fourth quarter of 2004 and decided to reduce the use of these instruments as a risk-management tool. Management intends to settle the swaps that mature in 2005 using cash flows from operations.

 

In addition, in order to reduce financial risk and uncertainty through the maturity (or cash settlement) dates of the cross-currency swaps, the company has executed offsetting or mirror cross-currency swaps. As of the date of execution, these mirror swaps effectively fixed the net amount that the company will ultimately pay to settle the cross-currency swap agreements subject to this strategy. After execution, as

 

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the market value of the fixed portion of the original portfolio decreases, the market value of the mirror swaps increases by an approximately offsetting amount, and vice versa. The mirror swaps will be settled when the offsetting existing swaps are settled. The following is a summary, by maturity date, of the mark-to-market position of the original cross-currency swaps portfolio, as well as the mirror swap portfolio, and the total mark-to-market position as of June 30, 2005 (in millions).

 

Maturity date    


   Original
swaps


   Mirror
swaps


   Total

2005

   $  67    $  4    $ 71

2007

   28    9      37

2008

   222    76      298

2009

   327    —        327
    
  
  

Total

   $644    $89    $ 733
    
  
  

 

Approximately $406 million, or 55%, of the total swaps net liability of $733 million as of June 30, 2005 has been fixed by the mirror swaps.

 

As discussed in the 2004 Annual Report and above, for the mirrored swaps, the company no longer realizes the favorable interest rate differential between the two currencies, and this results in increased net interest expense. The amount of increased net interest expense will vary based on floating interest rates and foreign exchange rates, and the timing of the company’s settlements.

 

As discussed above, during the first half of 2005, the company settled certain cross-currency swaps agreements (and related mirror swaps, as applicable), and made net payments totaling $308 million. In accordance with Statement of Financial Accounting Standards (SFAS) No. 149, “Amendment of Statement 133 on Derivative Instruments and Hedging Activities,” when the original cross-currency swaps are settled, the cash flows are reported within the financing section of the consolidated statement of cash flows. When the mirror swaps are settled, the cash flows are reported in the operating section of the consolidated statement of cash flows. Of the $308 million in net settlement payments, $363 million of cash outflows were included in the financing section and $55 million of cash inflows were included in the operating section.

 

The total swaps net liability decreased from $1.172 billion at December 31, 2004 to $733 million at June 30, 2005 due to the $308 million settlement payments and a $131 million favorable movement in the foreign currency rate.

 

LEGAL CONTINGENCIES

 

Refer to Note 5 and “Part II - Item 1. Legal Proceedings” for a discussion of the company’s legal contingencies. Upon resolution of any of these uncertainties, the company may incur charges in excess of presently established reserves. While such a future charge could have a material adverse impact on the company’s net income or cash flows in the period in which it is recorded or paid, based on the advice of counsel, management believes that any outcome of these actions, individually or in the aggregate, will not have a material adverse effect on the company’s consolidated financial position.

 

NEW ACCOUNTING STANDARDS

 

In December 2004, the Financial Accounting Standards Board (FASB) revised and reissued Statement of Financial Accounting Standards (SFAS) No. 123, “Share-Based Payment” (SFAS No. 123-R), which requires companies to expense the value of employee stock options and similar awards. Due to an SEC amendment to Regulation S-X in April 2005, SFAS No. 123-R will become effective for the company on

 

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January 1, 2006. The new rules provide for one of two transition elections, either prospective application or restatement (back to January 1, 1995). The company plans to adopt SFAS No. 123-R on January 1, 2006 and has not yet decided which transition option the company will use. Management is in the process of analyzing the provisions of SFAS No. 123-R and assessing the impact on the company’s future consolidated financial statements.

 

In December 2004, the FASB issued SFAS No. 151, “Inventory Costs” (SFAS No. 151), which clarifies the accounting for abnormal amounts of idle facility expense, freight, handling costs and spoilage. SFAS No. 151 requires that those items be recognized as current period charges. In addition, the new standard requires that the allocation of fixed production overhead costs be based on the normal capacity of the production facilities. The company plans to adopt SFAS No. 151 on its effective date of January 1, 2006. Management is in the process of analyzing the new standard and has not yet determined the impact on the company’s consolidated financial statements.

 

FORWARD-LOOKING INFORMATION

 

The matters discussed in this report that are not historical facts include forward-looking statements and include statements with respect to COLLEAGUE infusion pumps and other regulatory matters, restructuring programs progress and related reserves, sales and pricing forecasts, litigation outcomes, future costs relating to HD instruments, and developments with respect to credit and credit ratings. These statements are based on the company’s current expectations and involve numerous risks and uncertainties. Many factors may cause actual results to differ, possibly materially, from those expressed in the forward-looking statements. These factors include, but are not limited to:

 

    the company’s ability to realize in a timely manner the anticipated benefits of restructuring initiatives;

 

    the impact of geographic and/or product mix on the company’s sales;

 

    actions of regulatory bodies and other government authorities, including the Food and Drug Administration and foreign counterparts that could delay, limit or suspend product sales and distribution, including with respect to the COLLEAGUE infusion pump;

 

    product quality and/or patient safety concerns, leading to product recalls, withdrawals, launch delays or declining sales;

 

    product development risks;

 

    interest rates;

 

    technological advances in the medical field;

 

    demand for and market acceptance risks for new and existing products, such as ADVATE (Antihemophilic Factor (Recombinant), Plasma/Albumin-Free Method) rAHF-PFM, and other technologies;

 

    the impact of competitive products and pricing, including generic competition, drug reimportation and disruptive technologies;

 

    inventory reductions or fluctuations in buying patterns by wholesalers or distributors;

 

    foreign currency exchange rates;

 

    the availability of acceptable raw materials and component supply;

 

    global regulatory, trade and tax policies;

 

    regulatory, legal or other developments relating to the company’s A, AF and AX series dialyzers;

 

    the ability to obtain adequate insurance coverage at reasonable cost;

 

    the ability to enforce patents;

 

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    patents of third parties preventing or restricting the company’s manufacture, sale or use of affected products or technology;

 

    reimbursement policies of government agencies and private payers;

 

    internal and external factors that could impact commercialization;

 

    results of product testing; and

 

    other factors described elsewhere in this report or in the company’s other filings with the Securities and Exchange Commission.

 

Currency fluctuations are also a significant variable for global companies, especially fluctuations in local currencies where hedging opportunities are not economic or not available. If the United States Dollar strengthens significantly against foreign currencies, the company’s ability to realize projected growth rates in its sales and net earnings outside the United States, as reported in United States Dollars, could be negatively impacted.

 

Please refer to the company’s Annual Report on Form 10-K and other documents filed by the company with the Securities and Exchange Commission, which are available on the company’s website, for more details concerning important factors that could cause actual results to differ materially. The company does not undertake to update its forward-looking statements.

 

 

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Item 3. Quantitative and Qualitative Disclosures About Market Risk

 

Currency risk

 

For a complete discussion, refer to the caption “Financial Instrument Market Risk” in the company’s 2004 Annual Report. As part of its risk-management program, the company performs sensitivity analyses to assess potential changes in the fair value of its foreign exchange instruments relating to hypothetical and reasonably possible near-term movements in foreign exchange rates.

 

A sensitivity analysis of changes in the fair value of foreign exchange forward and option contracts outstanding at June 30, 2005, while not predictive in nature, indicated that if the United States Dollar uniformly fluctuated unfavorably by 10% against all currencies, on a net-of-tax basis, the net liability balance of $44 million with respect to those contracts would increase by $65 million.

 

With respect to the company’s cross-currency swap agreements (including the outstanding mirror swaps) discussed in Management’s Discussion and Analysis of Financial Condition and Results of Operations, if the United States Dollar uniformly weakened by 10%, on a net-of-tax basis, the net liability balance of $462 million with respect to those contracts outstanding at June 30, 2005 would increase by $66 million. Any increase or decrease in the fair value of cross-currency swap agreements designated as hedges of the net assets of foreign operations relating to changes in spot currency exchange rates is offset by the change in the value of the hedged net assets relating to changes in spot currency exchange rates. With respect to the portion of the cross-currency swap portfolio that is no longer designated as a net investment hedge, but is fixed via the mirror swaps, as the fair value of this fixed portion of the portfolio decreases, the fair value of the mirror swaps increases by an approximately offsetting amount, and vice versa.

 

The sensitivity analysis model recalculates the fair value of the foreign currency forward, option and cross-currency swap contracts outstanding at June 30, 2005 by replacing the actual exchange rates at June 30, 2005 with exchange rates that are 10% unfavorable to the actual exchange rates for each applicable currency. All other factors are held constant. These sensitivity analyses disregard the possibility that currency exchange rates can move in opposite directions and that gains from one currency may or may not be offset by losses from another currency. The analyses also disregard the offsetting change in value of the underlying hedged transactions and balances.

 

Interest rate and other risks

 

For a complete discussion, refer to the caption “Financial Instrument Market Risk” in the company’s 2004 Annual Report. There have been no significant changes from the information discussed therein.

 

 

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Item 4. Controls and Procedures

 

The company carried out an evaluation, under the supervision and with the participation of the company’s Disclosure Committee and the company’s management, including the Chief Executive Officer and Chief Financial Officer, of the effectiveness of the company’s disclosure controls and procedures (as such term is defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended (the “Exchange Act”)) as of the end of the quarterly period covered by this report. The company’s disclosure controls and procedures are designed to ensure that information required to be disclosed by the company in the reports it files or submits under the Exchange Act is recorded, processed, summarized and reported on a timely basis and that such information is accumulated and communicated to management, including the Chief Executive Officer and Chief Financial Officer, as appropriate, to allow timely decisions regarding required disclosure. Based on that evaluation, the Chief Executive Officer and Chief Financial Officer concluded that the company’s disclosure controls and procedures are effective as of June 30, 2005.

 

Changes in Internal Control over Financial Reporting

 

During the first quarter of 2005, the company began to outsource the transaction processing activities of the company’s business in one European country and certain previously centralized activities (expense report processing, accounts payable, accounts receivable, fixed asset and intercompany accounting). After an analysis of the limited outsourcing that began during the first quarter, the company decided to discontinue this outsourcing initiative and to continue to perform these activities internally. Other than the item mentioned above, there has been no change in Baxter’s internal control over financial reporting (as such term is defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) that occurred during the quarter ended June 30, 2005 that has materially affected, or is reasonably likely to materially affect, Baxter’s internal control over financial reporting.

 

 

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Review by Independent Registered Public Accounting Firm

 

Reviews of the interim condensed consolidated financial information included in this Quarterly Report on Form 10-Q for the three and six months ended June 30, 2005 and 2004 have been performed by PricewaterhouseCoopers LLP, the company’s independent registered public accounting firm. Their report on the interim condensed consolidated financial information follows. This report is not considered a report within the meaning of Sections 7 and 11 of the Securities Act of 1933 and therefore, the independent accountants’ liability under Section 11 does not extend to it.

 

 

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Report of Independent Registered Public Accounting Firm

 

To the Board of Directors and Stockholders of

Baxter International Inc.:

 

We have reviewed the accompanying condensed consolidated balance sheet of Baxter International Inc. and its subsidiaries as of June 30, 2005, and the related condensed consolidated statements of income for each of the three-month and six-month periods ended June 30, 2005 and 2004 and the condensed consolidated statements of cash flows for the six-month periods ended June 30, 2005 and 2004. These interim financial statements are the responsibility of the Company’s management.

 

We conducted our review in accordance with the standards of the Public Company Accounting Oversight Board (United States). A review of interim financial information consists principally of applying analytical procedures and making inquiries of persons responsible for financial and accounting matters. It is substantially less in scope than an audit conducted in accordance with the standards of the Public Company Accounting Oversight Board (United States), the objective of which is the expression of an opinion regarding the financial statements taken as a whole. Accordingly, we do not express such an opinion.

 

Based on our review, we are not aware of any material modifications that should be made to the accompanying condensed consolidated interim financial statements for them to be in conformity with accounting principles generally accepted in the United States of America.

 

We have previously audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States), the consolidated balance sheet as of December 31, 2004, and the related consolidated statements of income, cash flows and stockholders’ equity and comprehensive income for the year then ended, management’s assessment of the effectiveness of the Company’s internal control over financial reporting as of December 31, 2004 and the effectiveness of the Company’s internal control over financial reporting as of December 31, 2004; and in our report dated March 14, 2005, we expressed (i) an unqualified opinion on those consolidated financial statements, (ii) an unqualified opinion on management’s assessment of the effectiveness of the Company’s internal control over financial reporting, and (iii) an adverse opinion on the effectiveness of the Company’s internal control over financial reporting. The consolidated financial statements and management’s assessment of the effectiveness of internal control over financial reporting referred to above are not presented herein. In our opinion, the information set forth in the accompanying condensed consolidated balance sheet as of December 31, 2004, is fairly stated in all material respects in relation to the consolidated balance sheet from which it has been derived.

 

/s/ PricewaterhouseCoopers LLP

 

PricewaterhouseCoopers LLP

Chicago, Illinois

August 1, 2005

 

 

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PART II. OTHER INFORMATION

 

Item 1. Legal Proceedings

 

Baxter and certain of its subsidiaries are named as defendants in a number of lawsuits, claims and proceedings. These cases and claims raise difficult and complex factual and legal issues and are subject to many uncertainties and complexities, including, but not limited to, the facts and circumstances of each particular case and claim, the jurisdiction in which each suit is brought, and differences in applicable law. Baxter has established reserves in accordance with generally accepted accounting principles for certain of the matters discussed below. For these matters, there is a possibility that resolution of the matters could result in an additional loss in excess of presently established reserves. Also, there is a possibility that resolution of certain of the company’s legal contingencies for which there is no reserve could result in a loss. Management is not able to estimate the amount of such loss or additional loss (or range of loss or additional loss). However, management believes that, while such a future charge could have a material adverse impact on the company’s net income and net cash flows in the period in which it is recorded or paid, no such charge would have a material adverse effect on Baxter’s consolidated financial position.

 

Product Liability

 

Mammary Implant Litigation

 

Baxter, together with certain of its subsidiaries, is currently a defendant in various courts in a number of lawsuits seeking damages for injuries of various types allegedly caused by silicone mammary implants previously manufactured by the Heyer-Schulte division of American Hospital Supply Corporation (AHSC). AHSC, which was acquired by Baxter in 1985, divested its Heyer-Schulte division in 1984. It is not known how many of these claims and lawsuits involve products manufactured and sold by Heyer-Schulte, as opposed to other manufacturers. In December 1998, a panel of independent medical experts appointed by a federal judge announced its findings that reported medical studies contained no clear evidence of a connection between silicone mammary implants and traditional or atypical systemic diseases. In June 1999, a similar conclusion was announced by a committee of independent medical experts from the Institute of Medicine, an arm of the National Academy of Sciences. The majority of the claims and lawsuits against the company have been resolved. Certain of the proceedings are ongoing, as described below.

 

As of June 30, 2005, Baxter International, together with certain of its subsidiaries, was named as a defendant or co-defendant in 35 lawsuits relating to mammary implants, brought by approximately 91 plaintiffs, of which 80 are implant plaintiffs and the remainder are consortium or second generation plaintiffs. Of those plaintiffs, two currently are included in the Lindsey class action Revised Settlement described below, which accounts for one of the pending lawsuits against the company. Additionally, 34 plaintiffs have opted out of the Revised Settlement (representing approximately 21 pending lawsuits), and the status of the remaining plaintiffs with pending lawsuits is unknown. Some of the opt-out plaintiffs filed their cases naming multiple defendants and without product identification; thus, the company believes that not all of the opt-out plaintiffs will have viable claims against the company. As of June 30, 2005, 25 of the opt-out plaintiffs had confirmed Heyer-Schulte mammary implant product identification. Furthermore, during the second quarter of 2005, Baxter obtained dismissals, or agreements for dismissals, with respect to 9 plaintiffs.

 

In addition to the individual suits against the company, a class action on behalf of all women with silicone mammary implants was filed on March 23, 1994 and is pending in the United States District Court (U.S.D.C.) for the Northern District of Alabama involving most manufacturers of such implants, including Baxter as successor to AHSC (Lindsey, et al., v. Dow Corning, et al., U.S.D.C., N. Dist. Ala.,

 

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CV 94-P-11558-S). The class action was certified for settlement purposes only by the court on September 1, 1994, and the settlement terms were subsequently revised and approved on December 22, 1995 (the Revised Settlement). All appeals directly challenging the Revised Settlement have been dismissed. In addition to the Lindsey class action, the company also has been named in three other purported class actions in various state and provincial courts, only one of which is certified.

 

Baxter believes that a substantial portion of its liability and defense costs for mammary implant litigation will be covered by insurance, subject to self-insurance retentions, exclusions, conditions, coverage gaps, policy limits and insurer insolvency.

 

Plasma-Based Therapies Litigation

 

Baxter currently is a defendant in a number of claims and lawsuits brought by individuals who have hemophilia, and their families, all seeking damages for injuries allegedly caused by anti-hemophilic factor concentrates VIII or IX derived from human blood plasma (factor concentrates) processed by the company from the late 1970s to the mid-1980s. The typical case or claim alleges that the individual was infected with the HIV virus by factor concentrates, which contained the HIV virus. None of these cases involves factor concentrates currently processed by the company.

 

As of June 30, 2005, Baxter was named as a defendant in 82 lawsuits most of which have been or are expected to be consolidated in the U.S.D.C. for the Northern District of Illinois and has received 161 claims in the United States, France, Ireland, Italy, Japan, Spain and Argentina. Among the lawsuits, the company and other manufacturers have been named as defendants in 70 lawsuits pending or expected to be transferred to the U.S.D.C. for the Northern District of Illinois on behalf of claimants, who are primarily non-U.S. residents, seeking unspecified damages for HIV and/or Hepatitis C infections from their use of plasma-based factor concentrates. In March 2005, the District Court denied plaintiff’s motion to certify the purported classes. Thereafter, plaintiffs have filed additional lawsuits on behalf of individual claimants outside of the United States. The defendants, including Baxter, have filed motions to dismiss these lawsuits based on forum non conveniens grounds. The U.S.D.C. for the Northern District of Illinois has approved a settlement of U.S. federal court HIV factor concentrate cases. As of December 31, 2004, all 6,246 claimant groups eligible to participate in the settlement have been paid.

 

In addition, Immuno International AG (Immuno), acquired by Baxter in 1996, has unsettled claims and lawsuits for damages for injuries allegedly caused by its plasma-based therapies. The typical claim alleges that the individual with hemophilia was infected with HIV and/or Hepatitis C by factor concentrates. Immuno’s successor is a participant in a foundation that would make payments to Italian applicants who are HIV positive. At least 370 applications are pending before that foundation. Additionally, Immuno faces multiple claims stemming from its vaccines and other biologically derived therapies. A portion of the liability and defense costs related to these claims will be covered by insurance, subject to exclusions, conditions, policy limits and other factors. Pursuant to the stock purchase agreement between the company and Immuno, as revised in April 1999, approximately 26 million Swiss Francs, which is the equivalent of approximately $20 million based on the exchange rate as of June 30, 2005, of the purchase price is being withheld to cover these contingent liabilities.

 

Baxter is currently named in a number of claims and lawsuits brought by individuals who infused the company’s GAMMAGARD IVIG (intravenous immunoglobulin), all of whom are seeking damages for Hepatitis C infections allegedly caused by infusing GAMMAGARD IVIG. As of June 30, 2005, Baxter was a defendant in nine lawsuits and has received notice of four claims in the United States, France, Denmark, Italy, Germany and Spain. One class action in the United States has been certified. In September 2000, the U.S.D.C. for the Central District of California approved a settlement of the class action that would provide financial compensation for U.S. individuals who used GAMMAGARD IVIG between January 1993 and February 1994.

 

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The company believes that a substantial portion of the liability and defense costs related to its plasma-based therapies litigation will be covered by insurance, subject to self-insurance retentions, exclusions, conditions, coverage gaps, policy limits and insurer insolvency.

 

Althane Dialyzers Litigation

 

Baxter was named as a defendant in a number of civil cases seeking unspecified damages for alleged injury from exposure to Baxter’s Althane series of dialyzers, which were withdrawn from the market in 2001. All of these suits have been resolved, although the possibility of additional suits being filed cannot be excluded. Currently, there are a number of claims from Croatian citizens and one from the Spanish Ministry of Health, although suits have not been filed. The company previously reached settlements with a number of families of patients who died or were injured in Spain, Croatia and the United States allegedly after undergoing hemodialysis on an Althane dialyzer. The U.S. government is investigating the matter and Baxter received a subpoena in December 2002 to provide documents. Baxter is fully cooperating with the Department of Justice.

 

Vaccines Litigation

 

As of June 30, 2005, Baxter and certain of its subsidiaries have been named as defendants, along with others, in 142 lawsuits filed in various state and U.S. federal courts, four of which are purported class actions, seeking damages, injunctive relief and medical monitoring for claimants alleged to have contracted autism or other attention deficit disorders as a result of exposure to vaccines for childhood diseases containing the preservative, Thimerosal. These vaccines were formerly manufactured and sold by North American Vaccine, Inc., which was acquired by Baxter in June 2000, as well as other companies. As of December 31, 2004, ten suits have been dismissed based on the application of the National Vaccine Injury Compensation Act. Additional Thimerosal cases may be filed in the future against Baxter and companies that marketed Thimerosal-containing products.

 

Other

 

As of September 30, 1996, the date of the spin-off of Allegiance Corporation (Allegiance) from Baxter, Allegiance assumed the defense of litigation involving claims related to Allegiance’s businesses, including certain claims of alleged personal injuries as a result of exposure to natural rubber latex gloves. Allegiance, which merged with Cardinal Health in 1999, has not been named in most of this litigation but has defended and indemnified Baxter pursuant to certain contractual obligations for all expenses and potential liabilities associated with claims pertaining to latex gloves. As of June 30, 2005, the company has been named as a defendant in 10 lawsuits.

 

Pricing

 

As of June 30, 2005, Baxter International and certain of its subsidiaries were named as defendants, along with others, in approximately 40 lawsuits brought in various state and U.S. federal courts which allege that Baxter and other defendants reported artificially inflated average wholesale prices for Medicare and Medicaid eligible drugs. These cases have been brought by private parties on behalf of various purported classes of purchasers of Medicare and Medicaid eligible drugs, as well as by state attorneys general. As further explained below, all but nine of these cases were consolidated in the U.S.D.C. for the District of Massachusetts for pretrial case management under Multi District Litigation rules. In July 2005, the defendants, including Baxter, removed an additional five lawsuits from state courts to the U.S.D.C. for

 

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the District of Massachusetts. Claimants seek unspecified damages and declaratory and injunctive relief under various state and/or federal statutes. After the partial dismissal of the consolidated amended complaint, Plaintiffs filed an amended master consolidated class action complaint that the defendants, including Baxter, moved to dismiss. In February 2004, the court granted in part and denied in part defendants’ motion to dismiss. The lawsuits against Baxter include eight lawsuits brought by state attorneys general, which allege that prices for Medicare and Medicaid eligible drugs were artificially inflated and seek unspecified damages, injunctive relief, civil penalties, disgorgement, forfeiture and restitution. Specifically, in January 2002, the Attorney General of Nevada filed a civil suit in the Second Judicial District Court of Washoe County, Nevada. In February 2002, the Attorney General of Montana filed a civil suit in the First Judicial District Court of Lewis and Clark County, Montana. In June 2003, the U.S.D.C. for the District of Massachusetts remanded the Nevada case to Washoe County, Nevada and denied plaintiffs’ motion to remand the Montana case. In January 2004, the District Court remanded another case filed in state court to the Superior Court of Maricopa County, Arizona. In March 2004, the Attorney General of Pennsylvania filed a civil suit in the Commonwealth Court of Pennsylvania. That action was dismissed in February 2005. In March 2005, the Attorney General of Pennsylvania filed an amended complaint. In May 2004, the Attorney General of Texas filed a civil suit in the District Court of Travis County, Texas. In June 2004, the Attorney General of Wisconsin filed a civil suit in the Circuit Court of Dane County, Wisconsin. In November 2004, the Attorney General of Kentucky filed a civil suit in the Circuit Court of Franklin County, Kentucky. During the first quarter of 2005, Baxter was named as a defendant in 14 additional cases, 13 of which have been served upon the company. Additionally, during April 2005 Baxter was named as a defendant in eight cases, five of which have been served. In January 2005, the Attorney General of Alabama filed a civil suit in the Circuit Court of Montgomery County, Alabama. In February 2005, the Attorney General of Illinois filed a civil suit in the Circuit Court of Cook County, Illinois. In July 2005, the lawsuits filed by the attorneys general of Pennsylvania, Wisconsin, Kentucky, Alabama and Illinois were removed by the defendants to the U.S.D.C. for the District of Massachusetts. Each of the state attorneys general has moved to remand these cases. Various state and federal agencies are conducting civil investigations into the marketing and pricing practices of Baxter and others with respect to Medicare and Medicaid reimbursement. These investigations may result in additional cases being filed by various state attorneys general.

 

Securities Laws and Other

 

In July 2003, the Midwest Regional Office of the Securities and Exchange Commission (SEC) requested that the company voluntarily provide information concerning certain revisions to the company’s growth and earnings forecasts during 2003. In connection with this inquiry, in July 2004 the SEC sought information regarding the establishment of certain reserves as well as events in connection with the company’s restatement of its consolidated financial statements, previously announced in July 2004. The company is cooperating fully with the SEC.

 

In August 2002, six purported class action lawsuits were filed in the U.S.D.C. for the Northern District of Illinois naming Baxter and its then Chief Executive Officer and then Chief Financial Officer as defendants. These lawsuits, which were consolidated and sought recovery of unspecified damages, alleged that the defendants violated the federal securities laws by making misleading statements that allegedly caused Baxter common stock to trade at inflated levels. In December 2002, plaintiffs filed their consolidated amended class action complaint which named nine additional Baxter officers as defendants. In July 2003, the U.S.D.C. for the Northern District of Illinois dismissed in its entirety the consolidated amended class action complaint. In July 2004, the Seventh Circuit Court of Appeals reversed the order of dismissal and remanded the case to the District Court. In September 2004, the Seventh Circuit Court of Appeals denied motions by Baxter for rehearing, rehearing en banc and to stay the order to remand the case pending a petition for a writ of certiorari to the U.S. Supreme Court. In December 2004, Baxter filed its petition for a writ of certiorari in the U.S. Supreme Court. Plaintiffs filed a revised consolidated

 

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amended complaint in the District Court in November 2004. Baxter filed its motion to dismiss the complaint in December 2004. The District Court denied Baxter’s motion to dismiss in February 2005. In March 2005, the U.S. Supreme Court denied Baxter’s petition for certiorari.

 

In July 2004, a purported class action lawsuit was filed in the U.S.D.C. for the Northern District of Illinois, in connection with the previously disclosed restatement, naming Baxter and its current Chief Executive Officer and Chief Financial Officer and their predecessors as defendants. The lawsuit, which seeks recovery of unspecified damages, alleges that the defendants violated the federal securities laws by making false and misleading statements regarding the company’s financial results, which allegedly caused Baxter common stock to trade at inflated levels during the period between April 2001 and July 2004. Three similar purported class action lawsuits were filed in the third quarter of 2004 in the U.S.D.C. for the Northern District of Illinois against the same defendants. These cases have been consolidated before a single judge. In January 2005, plaintiffs filed a consolidated amended complaint in the District Court. In February 2005, Baxter filed its motion to dismiss. In May 2005, the District Court granted Baxter’s motion to dismiss this action in its entirety. One of the consolidated plaintiffs has moved to alter the judgment terminating its case and to file an amended complaint. That motion is pending before the District Court.

 

In October 2004, a solitary plaintiff filed a purported class action against Baxter in the Circuit Court of Cook County, Illinois alleging a breach of federal securities law through Baxter International’s secondary offering of common stock in September 2003. The plaintiff alleges that the offering price of these shares was artificially inflated by virtue of the financial statements that the company filed prior to and concurrent with the offering, which the company later amended in connection with the restatement, and seeks unspecified damages. In November 2004, Baxter removed this case to the U.S.D.C. for the Northern District of Illinois. In December 2004, plaintiff moved to remand the proceeding to state court. In May 2005, the District Court remanded the case back to state court.

 

The company believes that it may be subject to additional class action litigation and regulatory proceedings in connection with the events preceding the restatement announced in the third quarter of 2004.

 

In October 2004, a sole plaintiff filed a purported class action in the U.S.D.C. for the Northern District of Illinois against Baxter and its current Chief Executive Officer and Chief Financial Officer and their predecessors for alleged violations of the Employee Retirement Income Security Act of 1974, as amended. Plaintiff alleges that these defendants, along with the Administrative and Investment Committees of the company’s Incentive Investment Plan and Puerto Rico Savings and Investment Plan (the Plans), which are the company’s 401(k) plans, breached their fiduciary duties to the Plans’ participants by offering Baxter common stock as an investment option in each of the Plans during the period of January 2001 to October 2004. Plaintiff alleges that Baxter common stock traded at artificially inflated prices during this period and seeks unspecified damages and declaratory and equitable relief. The plaintiff seeks to represent a class of the Plans’ participants who elected to acquire Baxter common stock through the Plans between January 2001 and the present. The defendants have moved to dismiss this action and the motion currently is pending before the District Court.

 

In August and September 2004, three plaintiffs filed separate derivative complaints in the Circuit Court of Cook County, Illinois against the company’s Chief Executive Officer and Chief Financial Officer and certain other current and former officers and directors of the company. These actions, which plaintiffs purport to bring on the company’s behalf, seek unspecified damages for alleged breaches of fiduciary duty in connection with the company’s disclosures of its financial results between April 2001 and July 2004. These three cases have been consolidated before one judge in the state court.

 

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During the first quarter of 2005, Baxter and Haemonetics Corporation (Haemonetics) have been engaged in a binding arbitration proceeding brought by Haemonetics. Haemonetics alleged that Baxter breached supply contracts assigned to it in connection with Baxter’s acquisition of assets from Alpha Corporation in 2003. Baxter denied the allegations. In May 2005, the arbitration panel awarded Haemonetics $27.7 million, plus attorneys’ fees.

 

In April 2003, A. Nattermann & Cie GmbH and Aventis Behring L.L.C. filed a patent infringement lawsuit in the U.S.D.C. for the District of Delaware naming Baxter Healthcare Corporation as the defendant. In November 2003, plaintiffs dismissed the lawsuit without prejudice. The complaint, which sought injunctive relief, alleged that Baxter’s planned manufacture and sale of ADVATE would infringe United States Patent No. 5,565,427. A reexamination of the patent is pending before the United States Patent and Trademark Office.

 

Baxter has been named a potentially responsible party (PRP) for environmental clean-up at a number of sites. Under the United States Superfund statute and many state laws, generators of hazardous waste that is sent to a disposal or recycling site are liable for clean-up of the site if contaminants from that property later leak into the environment. The laws generally provide that a PRP may be held jointly and severally liable for the costs of investigating and remediating the site.

 

In addition to the cases discussed above, Baxter is a defendant in a number of other claims, investigations and lawsuits. Based on the advice of counsel, management does not believe that, individually or in the aggregate, these other claims, investigations and lawsuits will have a material adverse effect on the company’s results of operations, cash flows or consolidated financial position.

 

 

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

 

The company’s annual meeting of stockholders was held on May 3, 2005, for the purpose of electing directors, ratifying the appointment of PricewaterhouseCoopers LLP as the company’s independent registered public accounting firm and voting on the stockholder proposals listed below. Proxies for the meeting were solicited pursuant to Section 14(a) of the Securities Exchange Act of 1934 and there was no solicitation in opposition to management’s solicitation. Each of management’s nominees for directors, as listed in the proxy statement, was elected with the number of votes set forth below.

 

NAME    


     FOR

   ABSTAINED/WITHHELD

To hold office for two years:

         

Blake E. Devitt

   533,080,996    5,669,605

To hold office for three years:

         

Joseph B. Martin, M.D., Ph.D.

   533,121,028    5,629,573

Robert L. Parkinson, Jr.

   530,476,516    8,274,085

Thomas T. Stallkamp

   519,885,857    18,864,744

Albert P.L. Stroucken

   533,077,273    5,673,328

 

In addition to the directors listed above, directors whose term of office as a director continued after the meeting are: Walter E. Boomer, John D. Forsyth, Gail D. Fosler, James R. Gavin III, M.D., Ph.D., Peter S. Hellman, Carole Shapazian and K.J. Storm.

 

The results of the other matters voted upon at the annual meeting are as follows:

 

PROPOSAL    


 

FOR


 

AGAINST


 

ABSTAINED


 

BROKER NON-VOTES


The appointment of PricewaterhouseCoopers LLP as the company’s independent registered public accounting firm in 2005 was approved.

  508,806,791   26,293,567   3,650,243  

The stockholder proposal relating to cumulative voting in the election of directors was not approved.

  194,496,478   223,116,699   56,747,620   64,389,804

The stockholder proposal relating to restrictions on services performed by the independent registered public accounting firm was not approved.

  55,680,412   412,250,755   6,429,630   64,389,804

The stockholder proposal relating to the annual election of directors was approved.

  368,378,655   47,954,339   58,027,803   64,389,804

 

 

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Item 5. Other Information

 

On July 21, 2005, the company announced that the FDA had classified a March 15, 2005 company voluntary notice to customers regarding certain user interface and failure code issues relating to the company’s COLLEAGUE® Volumetric Infusion Pump as a Class I recall (FDA’s highest priority level) and that there had been reports of three deaths and six serious injuries that may have been associated with the issues identified in the March 15, 2005 voluntary notice. The same announcement also described a field corrective action letter sent to customers on July 20, 2005 (also designated a Class I recall), notifying customers that the company is in the process of developing an action plan to address design issues relating to COLLEAGUE pump failure codes (with which one of the three previously described deaths may have been associated). While these actions do not require customers to return their COLLEAGUE pumps, the company will voluntarily hold shipments of new COLLEAGUE pumps until design issues are resolved. Refer to Part I, Item 2 for additional information.

 

The company is working to correct the issues with the COLLEAGUE pump. Nevertheless, as more fully described in the company’s filing on Form 10-K, Part I, Item 1, “Government Regulation,” the operations of the company and many of its products are subject to extensive regulation and review. Thus, the company is subject to possible administrative and legal actions by FDA and other agencies. Such actions may include product recalls, product seizures, injunctions to halt manufacture and distribution, and other civil sanctions, as well as in certain circumstances criminal sanctions. From time to time, the company has instituted voluntary compliance actions, such as removing products from the market and efforts to improve the effectiveness of quality systems. The company continues to work with the FDA with respect to its observations and investigation of these issues and remains committed to enhancing quality systems and processes across the company.

 

Item 6. Exhibits

 

Exhibits required by Item 601 of Regulation S-K are listed in the Exhibit Index hereto.

 

 

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Signature

 

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.

 

    BAXTER INTERNATIONAL INC.
                    (Registrant)
Date: August 8, 2005        
    By:  

/s/ John J. Greisch


        John J. Greisch
        Corporate Vice President and Chief Financial Officer

 

 

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EXHIBITS FILED WITH OR FURNISHED TO THE SECURITIES AND EXCHANGE COMMISSION

 

Number    

 

Description of Exhibit    


10.1   Baxter International Inc. Non-Employee Director Compensation Plan adopted as of May 6, 2004 and amended through May 4, 2005
10.2   Guaranty Agreement entered as of January 7, 2005 and amended through June 1, 2005 by Baxter International Inc. in favor of J.P. Morgan Europe Limited as Agent in respect of obligations of Baxter Healthcare S.A. under the Credit Agreement of the same date.
15   Letter Re Unaudited Interim Financial Information
31.1   Certification of Chief Executive Officer pursuant to Rule 13a-14(a)/15d-14(a) of the Securities Exchange Act of 1934
31.2   Certification of Chief Financial Officer pursuant to Rule 13a-14(a)/15d-14(a) of the Securities Exchange Act of 1934
32.1   Certification of Chief Executive Officer Pursuant to 18 U.S.C. 1350
32.2   Certification of Chief Financial Officer Pursuant to 18 U.S.C. 1350

 

 

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