UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 


FORM 10-Q

 


(Mark One)

xQUARTERLY REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE QUARTERLY PERIOD ENDED MARCH 31,JUNE 30, 2007

 

¨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: 1-1136

 


BRISTOL-MYERS SQUIBB COMPANY

(Exact name of registrant as specified in its charter)

 


 

Delaware 22-0790350

(State or other jurisdiction of

incorporation or organization)

 

(I.R.S. Employer

Identification No.)

345 Park Avenue, New York, N.Y. 10154

(Address of principal executive offices) (Zip Code)

(212) 546-4000

(Registrant’s telephone number, including area code)

 

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

 


Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to the filing requirements for at least the past 90 days.    Yes  x    No  ¨

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, or a non-accelerated filer. See definition of “accelerated filer and large accelerated filer” in Rule 12b-2 of the Exchange Act. (Check one):

Large Accelerated filer  x    Accelerated filer  ¨    Non-accelerated filer  ¨

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).    Yes  ¨    No   x

APPLICABLE ONLY TO CORPORATE ISSUERS:

At March 31,June 30, 2007, there were 1,968,065,3011,977,908,780 shares outstanding of the Registrant’s $.10 par value Common Stock.

 



BRISTOL-MYERS SQUIBB COMPANY

INDEX TO FORM 10-Q

MARCH 31,JUNE 30, 2007

 

Page

PART I—FINANCIAL INFORMATION

Item 1.

  
Item 1.

Financial Statements:

  

Consolidated Statements of Earnings

  3

Consolidated Statements of Comprehensive Income and Retained Earnings

  4

Consolidated Balance Sheets

  5

Consolidated Statements of Cash Flows

  6

Notes to Consolidated Financial Statements

  7-257

Item 2.

  

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

  26-4727

Item 3.

  

Quantitative and Qualitative Disclosures About Market Risk

  4858

Item 4.

  

Controls and Procedures

  4858

PART II—OTHER INFORMATION

  

Item 1.

  

Legal Proceedings

  4959

Item 1A.

  

Risk Factors

  4959

Item 2.

  

Unregistered Sales of Equity Securities and Use of Proceeds

  5060

Item 4.

  

Submission of Matters to a Vote of Security Holders

  50-5160

Item 6.

  

Exhibits

  5160

Signatures

  5261

PART I—FINANCIAL INFORMATION

 

Item 1.FINANCIAL STATEMENTS

BRISTOL-MYERS SQUIBB COMPANY

CONSOLIDATED STATEMENTS OF EARNINGS

Dollars and Shares in Millions, Except Per Share Data

(UNAUDITED)

 

  Three Months Ended March 31,   Three Months Ended
June 30,
  Six Months Ended 
June 30,
 
  2007 2006   2007 2006 2007 2006 

EARNINGS

        

Net Sales

  $4,476  $4,676   $4,928  $4,871  $ 9,404  $ 9,547 
                    

Cost of products sold

   1,392   1,476    1,549   1,568   2,941   3,044 

Marketing, selling and administrative

   1,158   1,238    1,209   1,181   2,367   2,419 

Advertising and product promotion

   269   295    368   352   637   647 

Research and development

   807   750    778   740   1,585   1,490 

Provision for restructuring, net

   37   1    7   3   44   4 

Litigation income, net

   —     (21)

Gain on sale of product asset

   —     (200)

Litigation expense/(income), net

   14   (14)  14   (35)

Gain on sale of product assets

   (26)  —     (26)  (200)

Equity in net income of affiliates

   (126)  (93)   (128)  (125)  (254)  (218)

Other expense, net

   22   37    —     56   22   93 
                    

Total expenses

   3,559   3,483    3,771   3,761   7,330   7,244 
                    

Earnings Before Minority Interest and Income Taxes

   917   1,193    1,157   1,110   2,074   2,303 

Provision for income taxes

   86   328    257   256   343   584 

Minority interest, net of taxes

   141   151    194   187   335   338 
                    

Net Earnings

  $690  $714   $706  $667  $1,396  $1,381 
                    

Earnings per Common Share

        

Basic

  $.35  $.36   $.36  $.34  $.71  $.71 

Diluted

  $.35  $.36   $.36  $.34  $.71  $.70 

Average Common Shares Outstanding

        

Basic

   1,962   1,957    1,968   1,960   1,965   1,959 

Diluted

   1,997   1,988    2,006   1,994   2,002   1,992 

Dividends declared per common share

  $.28  $.28   $.28  $.28  $.56  $.56 

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

BRISTOL-MYERS SQUIBB COMPANY

CONSOLIDATED STATEMENTS OF

COMPREHENSIVE INCOME AND RETAINED EARNINGS

Dollars in Millions

(UNAUDITED)

 

  Three Months Ended March 31,   Three Months Ended
June 30,
 Six Months Ended
June 30,
 
  2007 2006   2007 2006 2007 2006 

COMPREHENSIVE INCOME

        

Net Earnings

  $690  $714   $706  $667  $1,396  $1,381 

Other Comprehensive Income/(Loss):

        

Foreign currency translation

   19   20    15   49   34   69 

Deferred losses on derivatives qualifying as hedges, net of tax benefit of $11 million in 2006

   —     (32)

Deferred gains on pension and other postretirement benefits, net of tax liability of $3 million in 2007

   35   —   

Deferred gains/(losses) on available for sale securities, net of tax benefit of $2 million in 2007 and net of tax liability of $1 million in 2006

   (3)  2 

Deferred losses on derivatives qualifying as hedges, net of tax benefit of $1 and $19 for the three months ended June 30, 2007 and 2006, respectively; and net of tax benefit of $1 and $30 for the six months ended June 30, 2007 and 2006, respectively

   (1)  (48)  (1)  (80)

Deferred gains on pension and other postretirement benefits, net of tax liability of $12 and $15 for the three and six months ended June 30, 2007, respectively

   23   —     58   —   

Deferred gains on available for sale securities, net of tax liability of $2 for the three months ended June 30, 2007; and net of tax liability of $1 for the six months ended June 30, 2006

   3   —     —     2 
                    

Total Other Comprehensive Income/(Loss)

   51   (10)   40   1   91   (9)
                    

Comprehensive Income

  $741  $704   $746  $668  $1,487  $1,372 
                    

RETAINED EARNINGS

        

Retained Earnings, January 1

  $19,845  $20,464     $19,845  $20,464 

Cumulative effect of adoption of FIN No. 48

   27   —        27   —   

Net earnings

   690   714 

Net Earnings

     1,396   1,381 

Cash dividends declared

   (551)  (551)     (1,107)  (1,102)
                

Retained Earnings, March 31

  $20,011  $20,627 

Retained Earnings, June 30

    $20,161  $20,743 
                

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

BRISTOL-MYERS SQUIBB COMPANY

CONSOLIDATED BALANCE SHEETS

Dollars in Millions, Except Share and Per Share Data

(UNAUDITED)

 

  

March 31,

2007

 

December 31,

2006

   

June 30,

2007

 

December 31,

2006

 

ASSETS

      

Current Assets:

      

Cash and cash equivalents

  $2,214  $2,018   $        2,379  $2,018 

Marketable securities

   1,798   1,995    2,267   1,995 

Receivables, net of allowances of $168 and $150

   3,381   3,247 

Receivables, net of allowances of $167 in 2007 and $150 in 2006

   3,632   3,247 

Inventories, net

   2,096   2,079    2,224   2,079 

Deferred income taxes, net of valuation allowances

   684   649    670   649 

Prepaid expenses

   385   314    372   314 
              

Total Current Assets

   10,558   10,302    11,544   10,302 
              

Property, plant and equipment, net

   5,709   5,673    5,768   5,673 

Goodwill

   4,831   4,829    4,831   4,829 

Other intangible assets, net

   1,775   1,852    1,707   1,852 

Deferred income taxes, net of valuation allowances

   2,835   2,577    2,946   2,577 

Other assets

   383   342    379   342 
              

Total Assets

  $26,091  $25,575   $27,175  $25,575 
              

LIABILITIES

      

Current Liabilities:

      

Short-term borrowings

  $241  $187   $256  $187 

Accounts payable

   1,315   1,239    1,406   1,239 

Accrued expenses

   2,300   2,332    2,631   2,332 

Accrued rebates and returns

   846   823    818   823 

Deferred income

   387   411    443   411 

U.S. and foreign income taxes payable

   158   444    57   444 

Dividends payable

   552   552    556   552 

Accrued litigation liabilities

   508   508    522   508 
              

Total Current Liabilities

   6,307   6,496    6,689   6,496 
              

Pension and other postretirement liabilities

   944   942    959   942 

Deferred income

   444   354    707   354 

U.S. and foreign income taxes payable

   463   —      507   —   

Other liabilities

   540   544    573   544 

Long-term debt

   7,132   7,248    6,978   7,248 
              

Total Liabilities

   15,830   15,584    16,413   15,584 
              

Commitments and contingencies (Note 16)

      

STOCKHOLDERS’ EQUITY

      

Preferred stock, $2 convertible series: Authorized 10 million shares; issued and outstanding 5,984 in 2007 and 6,001 in 2006, liquidation value of $50 per share

   —     —   

Common stock, par value of $.10 per share: Authorized 4.5 billion shares; 2.2 billion issued in both 2007 and 2006

   220   220 

Preferred stock, $2 convertible series: Authorized 10 million shares; issued and outstanding 5,982 in 2007 and 6,001 in 2006, liquidation value of $50 per share

   —     —   

Common stock, par value of $.10 per share: Authorized 4.5 billion shares; 2.2 billion issued both in 2007 and 2006

   220   220 

Capital in excess of par value of stock

   2,520   2,498    2,561   2,498 

Accumulated other comprehensive loss

   (1,594)  (1,645)   (1,554)  (1,645)

Retained earnings

   20,011   19,845    20,161   19,845 
              
   21,157   20,918    21,388   20,918 

Less cost of treasury stock — 237 million common shares in 2007 and 238 million in 2006

   (10,896)  (10,927)

Less cost of treasury stock — 227 million common shares in 2007 and 238 million in 2006

   (10,626)  (10,927)
              

Total Stockholders’ Equity

   10,261   9,991    10,762   9,991 
              

Total Liabilities and Stockholders’ Equity

  $26,091  $25,575   $27,175  $25,575 
              

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

BRISTOL-MYERS SQUIBB COMPANY

CONSOLIDATED STATEMENTS OF CASH FLOWS

Dollars in Millions

(UNAUDITED)

 

  Three Months Ended March 31,   Six Months Ended
June 30,
 
  2007 2006   2007 2006 

Cash Flows From Operating Activities:

      

Net earnings

  $690  $714   $1,396  $1,381 

Adjustments to reconcile net earnings to net cash provided by operating activities:

      

Depreciation

   128   139    249   283 

Amortization

   88   87    176   180 

Deferred income tax expense/(benefits)

   (169)  68 

Litigation settlement income

   —     (21)

Deferred income tax (benefits)/expense

   (207)  322 

Litigation settlement expense/(income), net of recoveries

   14   (35)

Stock-based compensation expense

   31   37    67   71 

Provision for restructuring

   37   1    44   4 

Gain on sale of product assets and businesses

   —     (207)   (26)  (207)

Impairment charges and asset write-offs

   —     32    —     32 

Loss on disposal of property, plant and equipment

   —     3    9   7 

Under distribution of earnings from affiliates

   (16)  (13)   (60)  (63)

Unfunded pension expense

   51   57    103   111 

Changes in operating assets and liabilities:

      

Receivables

   (118)  160    (353)  98 

Inventories

   (1)  (75)   (143)  (101)

Prepaid expenses and other assets

   (82)  (27)   (53)  (37)

Litigation settlement payments, net of insurance recoveries

   —     (247)   —     (305)

Accounts payable and accrued expenses

   13   (474)   309   (422)

Product liability

   (6)  (15)   (21)  (25)

U.S. and foreign income taxes payable

   42   (120)   (25)  (322)

Other liabilities

   77   (16)

Deferred income and other liabilities

   347   (44)
              

Net Cash Provided by Operating Activities

   765   83    1,826   928 
              

Cash Flows From Investing Activities:

      

Purchases of and proceeds from marketable securities, net

   198   (55)   (269)  (6)

Additions to property, plant and equipment and capitalized software

   (202)  (202)   (408)  (362)

Proceeds from disposal of property, plant and equipment

   13   4    23   5 

Proceeds from sale of product assets and businesses

   —     226    26   226 

Milestone payments

   —     (250)   —     (280)

Purchase of other investments

   (2)  —      (2)  (5)
              

Net Cash Provided by/(Used in) Investing Activities

   7   (277)

Net Cash Used in Investing Activities

   (630)  (422)
              

Cash Flows From Financing Activities:

      

Short-term (repayments)/borrowings

   (51)  4 

Short-term repayments

   (37)  (42)

Long-term debt borrowings

   —     2    —     4 

Issuances of common stock under stock plans and excess tax benefits from share-based payment arrangements

   21   158    295   164 

Dividends paid

   (551)  (549)   (1,103)  (1,098)
              

Net Cash Used in Financing Activities

   (581)  (385)   (845)  (972)
              

Effect of Exchange Rates on Cash and Cash Equivalents

   5   6    10   18 
              

Increase/(Decrease) in Cash and Cash Equivalents

   196   (573)   361   (448)

Cash and Cash Equivalents at Beginning of Period

   2,018   3,050    2,018   3,050 
              

Cash and Cash Equivalents at End of Period

  $2,214  $2,477   $2,379  $2,602 
              

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

Note 1. Basis of Presentation and New Accounting Standards

Bristol-Myers Squibb Company (the Company) prepared these unaudited consolidated financial statements following the requirements of the Securities and Exchange Commission (SEC) and United States (U.S.) generally accepted accounting principles (GAAP) for interim reporting. Under those rules, certain footnotes and other financial information that are normally required by GAAP for annual financial statements can be condensed or omitted. The Company is responsible for the consolidated financial statements included in this Form 10-Q. These consolidated financial statements include all normal and recurring adjustments necessary for a fair presentation of the Company’s financial position at March 31,June 30, 2007 and December 31, 2006, the results of its operations for the three and six months ended June 30, 2007 and 2006 and the cash flows for the threesix months ended March 31,June 30, 2007 and 2006. These unaudited consolidated financial statements and the related notes should be read in conjunction with the consolidated financial statements and the related notes included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2006 (2006 Form 10-K).

Revenues, expenses, assets and liabilities can vary during each quarter of the year. Accordingly, the results and trends in these unaudited consolidated financial statements may not be the same as those for the full year.

The Company recognizes revenue when substantially all the risks and rewards of ownership have transferred to the customer. Generally, revenue is recognized at the time of shipment of products. In the case of certain sales made by the Nutritionals and Other Health Care segments and certain non-U.S. businesses within the Pharmaceuticals segment, revenue is recognized on the date of receipt by the purchaser. Revenues are reduced at the time of recognition to reflect expected returns that are estimated based on historical experience. Additionally, provisions are made at the time of revenue recognition for all discounts, rebates and estimated sales allowances based on historical experience updated for changes in facts and circumstances, as appropriate. Such provisions are recorded as a reduction of revenue.

In addition, the Company includes alliance revenue in net sales. The Company has agreements to promote pharmaceuticals discovered by other companies. Alliance revenue is based upon a percentage of the Company’s copromotion partners’ net sales and is earned when the related product is shipped by the copromotion partners and title passes to their customer.

The preparation of financial statements in conformity with GAAP requires the use of estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and contingent liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. The most significant assumptions are employed in estimates used in determining values of intangible assets, restructuring charges and accruals, sales rebate and return accruals, legal contingencies, tax assets and tax liabilities, stock-based compensation, accounting for retirement and postretirement benefits (including the actuarial assumptions), as well as in estimates used in applying the revenue recognition policy. Actual results may or may not differ from the estimated results.

In FebruaryJune 2007, the Financial Emerging Issues Task Force reached a consensus on Issue No. 07-3,Accounting Standards Board (FASB) issued Statement of Financial Accounting Standards (SFAS) No. 159,The Fair Value Option for Financial AssetsNonrefundable Advance Payments for Goods or Services Received for Use in Future Research and Financial LiabilitiesDevelopment Activities, which permits. Nonrefundable advance payments for goods or services that will be used or rendered for future research and development activities should be deferred and capitalized. Such amounts should be recognized as an entityexpense as the related goods are delivered or the services are performed, or when the goods or services are no longer expected to measure certain financial assets and financial liabilities at fair value. The objective of SFAS No. 159 is to improve financial reporting by allowing entities to mitigate volatility in reported earnings caused by the measurement of related assets and liabilities using different attributes, without having to apply complex hedge accounting provisions. Under SFAS No. 159, entities that elect the fair value option (by instrument) will report unrealized gains and losses in earnings at each subsequent reporting date. The fair value option election is irrevocable, unless a new election date occurs. SFAS No. 159 establishes presentation and disclosure requirements to help financial statement users understand the effect of the entity's election on its earnings, but does not eliminate disclosure requirements of other accounting standards. Assets and liabilities that are measured at fair value must be displayed on the face of the balance sheet.provided. This StatementIssue is effective for financial statements issued for fiscal years beginning after NovemberDecember 15, 2007.2007, and earlier application is not permitted. This consensus is to be applied prospectively for new contracts entered into on or after the effective date. The Company is evaluating the potential impact of this pronouncement.

In September 2006, the FASB issued SFAS No. 158,Employers’ Accounting for Defined Benefit Pensionconsensus and Other Postretirement Plans—an amendment of FASB Statements No. 87, 88, 106, and 132(R). This pronouncement requires an employer to recognize the overfunded or underfunded status of a defined benefit postretirement plan (other than a multiemployer plan) as an asset or liability in its statement of financial position and to recognize changes in that funded status in the year in which the changes occur through comprehensive income of a business entity. This pronouncement also requires an employer to measure the funded status of a plan as of the date of its year-end statement of financial position, with limited exceptions. The pronouncement does not require prior periods to be restated to reflect the impact of SFAS No. 158. The Company adopted SFAS No. 158 in the fiscal year ended December 31, 2006 and the adoption of this accounting pronouncement resulted in a $1,064 million reduction of accumulated other comprehensive income in stockholders’ equity, a $767 million reduction in total assets and a $297 million increase in total liabilities. The adoption of SFAS No. 158 did not impact the Company’s results of operations or cash flows.

Note 1. Basis of Presentation and New Accounting Standards (Continued)

In September 2006, the FASB issued SFAS No. 157,Fair Value Measurements. This pronouncement defines fair value, establishes a framework for measuring fair value and expands disclosures about fair value measurements. This Statement is effective for fiscal years beginning after November 15, 2007. The adoption of this accounting pronouncement is not expectedexpect it to have a material effect on the Company’s consolidated financial statements.

In September 2006, the SEC issued Staff Accounting Bulletin (SAB) No. 108,Considering the Effects of Prior Year Misstatements when Quantifying the Misstatements in Current Year Financial Statements, that expresses the staff's views regarding the process of quantifying financial statement misstatements. This bulletin is effective for any interim period of the first fiscal year ending after November 15, 2006. SAB No. 108 requires that companies utilize a “dual approach” to assess the quantitative effects of financial statement misstatements. The dual approach includes both an income statement focus and balance sheet focus assessment. The adoption of this bulletin did not have any effect on the Company’sits consolidated financial statements.

In July 2006, the FASBFinancial Accounting Standards Board (FASB) issued FASB Interpretation (FIN) No. 48,Accounting for Uncertainty in Income Taxes – an interpretation of FASB Statement No. 109 which, in the case of the Company, is effective as of January 1, 2007. FIN No. 48 clarifies the accounting for uncertainty in income taxes recognized in an enterprise’s financial statements in accordance with SFASStatement of Accounting Standards (SFAS) No. 109,Accounting for Income Taxes. FIN No. 48 requires that all tax positions be evaluated using a recognition threshold and measurement attribute for the financial statement recognition and measurement of a tax position taken or expected to be taken in a tax return. Differences between tax positions taken in a tax return and amounts recognized in the financial statements are recorded as adjustments to income taxes payable or receivable, or adjustments to deferred taxes, or both. FIN No. 48 also requires expanded disclosure at the end of each annual reporting period including a tabular reconciliation of unrecognized tax benefits. The Company adopted FIN No. 48 on January 1, 2007. As a result of the adoption of this accounting pronouncement, the Company recognized $27 million of previously unrecognized tax benefits, which was accounted for as an increase to the opening balance of retained earnings.

In March 2006,May 2007, the FASB issued SFASFASB Staff Position (FSP) FIN 48-1Definition of Settlement in FASB Interpretation No. 156,Accounting for Servicing of Financial Assets – an amendment of FASB Statement No. 14048. This pronouncement relates to the accounting for separately recognized servicing assets and servicing liabilities. This Statement, which is effective retroactively to January 1, 2007. FSP FIN 48-1 provides guidance on how to determine whether a tax position is effectively settled for fiscal years beginning after September 15, 2006.the purpose of recognizing previously unrecognized tax benefits. The adoption of this accounting pronouncementFSP FIN 48-1 did not have a materialany effect on the Company’s consolidated financial statements.

In February 2006, the FASB issued SFAS No. 155,Accounting for Certain Hybrid Financial Instruments, an amendment of FASB Statements No. 133 and 140. This pronouncement primarily resolves certain issues addressed in the implementation of SFAS No. 133,Accounting for Derivative Instruments and Hedging Activities, concerning beneficial interests in securitized financial assets. The Statement is effective for all financial instruments acquired, issued, or subject to a remeasurement event occurring after the beginning of the 2007 fiscal year. The adoption of this accounting pronouncement did not have a material effect on the Company’s consolidated financial statements.

In May 2005, the FASB issued SFAS No. 154,Accounting Changes and Error Corrections, which replaces Accounting Principles Board (APB) Opinion No. 20,Accounting Changes and SFAS No. 3,Reporting Accounting Changes in Interim Financial Statements. This pronouncement applies to all voluntary changes in accounting principle, and revises the requirements for accounting for and reporting a change in accounting principle. SFAS No. 154 requires retrospective application to prior periods' financial statements of a voluntary change in accounting principle, unless it is impracticable to do so. This pronouncement also requires that a change in the method of depreciation, amortization, or depletion for long-lived, non-financial assets be accounted for as a change in accounting estimate that is affected by a change in accounting principle. SFAS No. 154 is effective for accounting changes and corrections of errors made in fiscal years beginning after December 15, 2005. The Statement does not change the transition provisions of any existing accounting pronouncements, including those that are in a transition phase as of the effective date of SFAS No. 154. The adoption of this accounting pronouncement did not have a material effect on the Company’s consolidated financial statements.

In March 2005, the FASB issued FIN No. 47,Accounting for Conditional Asset Retirement Obligations. FIN No. 47 clarifies that an entity must record a liability for a conditional asset retirement obligation if the fair value of the obligation can be reasonably estimated. Asset retirement obligations covered by FIN No. 47 are those for which an entity has a legal obligation to perform an asset retirement activity, even if the timing and method of settling the obligation are conditional on a future event that may or may not be within the control of the entity. FIN No. 47 also clarifies when an entity would have sufficient information to reasonably estimate the fair value of an asset retirement obligation. The Company adopted the provisions of FIN No. 47 in the fiscal year ended December 31, 2005 and the adoption of this accounting pronouncement did not have a material effect on the Company’s consolidated financial statements.

Note 2. Alliances and Investments

Sanofi

The Company has agreements with Sanofi-Aventis (Sanofi) for the codevelopment and cocommercialization of AVAPRO*/AVALIDE* (irbesartan), an angiotensin II receptor antagonist indicated for the treatment of hypertension and diabetic nephropathy, and PLAVIX* (clopidogrel bisulfate), a platelet aggregation inhibitor. The worldwide alliance operates under the framework of two geographic territories; one in the Americas (principally the U.S., Canada, Puerto Rico and Latin American countries) and Australia and the other in Europe and Asia. Accordingly, two territory partnerships were formed to manage central expenses, such as marketing, research and development and royalties, and to supply finished product to the individual countries. In general, at the country level, agreements either to copromote (whereby a partnership was formed between the parties to sell each brand) or to comarket (whereby the parties operate and sell their brands independently of each other) are in place. The agreements expire on the later of (i) with respect to PLAVIX*, 2013 and, with respect to AVAPRO*/AVALIDE*, 2012 in the Americas and Australia and 2013 in Europe and Asia and (ii) the expiration of all patents and other exclusivity rights in the applicable territory.

The Company acts as the operating partner for the territory covering the Americas and Australia and owns a 50.1% majority controlling interest in this territory. Sanofi’s ownership interest in this territory is 49.9%. As such, the Company consolidates all country partnership results for this territory and records Sanofi’s share of the results as a minority interest, net of taxes, which was $137$189 million and $148$184 million for the three months ended March 31,June 30, 2007 and 2006, respectively, and $326 million and $332 million for the six months ended June 30, 2007 and 2006, respectively. The Company recorded sales in this territory and in comarketing countries outside this territory (Germany, Italy, Spain and Greece) of $1,208$1,486 million and $1,219$1,425 million for the three months ended March 31,June 30, 2007 and 2006, respectively, and $2,694 million and $2,644 million for the six months ended June 30, 2007 and 2006, respectively.

Cash flows from operating activities of the partnerships in the territory covering the Americas and Australia are recorded as operating activities within the Company’s consolidated statement of cash flows. Distributions of partnership profits to Sanofi and Sanofi’s funding of ongoing partnership operations occur on a routine basis and are also recorded within operating activities on the Company’s consolidated statement of cash flows.

Sanofi acts as the operating partner for the territory covering Europe and Asia and owns a 50.1% majority controlling interest in this territory. The Company’s ownership interest in the partnerships within this territory is 49.9%. The Company accounts for the investment in partnership entities in this territory under the equity method and records its share of the results in equity in net income of affiliates in the consolidated statement of earnings. The Company’s share of net income from these partnership entities before taxes was $123$126 million and $95$102 million for the three months ended March 31,June 30, 2007 and 2006, respectively, and $249 million and $197 million for the six months ended June 30, 2007 and 2006, respectively.

The Company routinely receives distributions of profits and provides funding for the ongoing operations of the partnerships in the territory covering Europe and Asia. These transactions are recorded as operating activities within the Company’s consolidated statement of cash flows.

In 2001, the Company and Sanofi formed an alliance for the copromotion of irbesartan, as part of which the Company contributed the irbesartan distribution rights in the U.S. and Sanofi paid the Company a total of $350 million in the two years ended December 31, 2002. The Company accounted for this transaction as a sale of an interest in a license, the $350 million was deferred and is being recognized in other income over the expected useful life of the license, which is approximately 11 years from the formation of the irbesartan copromotion alliance. The Company recognized other income of $8 million in each of the three months ended March 31,June 30, 2007 and 2006 and $16 million in each of the six month periods ended June 30, 2007 and 2006. The unrecognized portion of the deferred income is recorded in the liabilities section of the consolidated balance sheet and was $178$170 million as of March 31,June 30, 2007 and $186 million as of December 31, 2006.

The following is the summarized financial information for the Company’s equity investments in the partnership with Sanofi for the territory covering Europe and Asia:

   Three Months Ended
June 30,
  Six Months Ended
June 30,
Dollars in Millions  2007  2006  2007  2006

Net sales

  $752  $671  $1,485  $1,356

Gross profit

   582   526   1,147   1,055

Net income

   252   210   507   442

Note 2. Alliances and Investments (Continued)

Otsuka

The Company has a worldwide commercialization agreement with Otsuka Pharmaceutical Co., Ltd. (Otsuka), to codevelop and copromote with Otsuka ABILIFY* (aripiprazole) for the treatment of schizophrenia and related psychiatric disorders, except in Japan, China, Taiwan, North Korea, South Korea, the Philippines, Thailand, Indonesia, Pakistan and Egypt. The product is currently copromoted with Otsuka in the U.S., United Kingdom (UK), Germany, France and Spain. In the U.S., Germany and Spain, where the product is sold by an Otsuka affiliate as distributor, the Company records alliance revenue for its 65% contractual share of Otsuka’s net sales and records all expenses related to the product. The Company recognizes this alliance revenue when ABILIFY* is shipped and all risks and rewards of ownership have transferred to Otsuka's customers. In the UK, France and Italy, where the Company is presently the exclusive distributor for the product, the Company records 100% of the net sales and related cost of products sold and expenses. The Company also has an exclusive right to sell ABILIFY* in other countries in Europe, the Americas and a number of countries in Asia. In these countries the Company records 100% of the net sales and related cost of products sold.

Note 2. Alliances and Investments (Continued)

Under the terms of the agreement, the Company purchases the product from Otsuka and performs finish manufacturing for sale by the Company to its customers. The agreement expires in November 2012 in the U.S. and Puerto Rico. For the entire European Union (EU), the agreement expires in June 2014. In each other country where the Company has the exclusive right to sell ABILIFY*, the agreement expires on the later of the tenth anniversary of the first commercial sale in such country or expiration of the applicable patent in such country.

The Company recorded total revenue for ABILIFY* of $366$412 million and $283$324 million for the three months ended March 31,June 30, 2007 and 2006, respectively, and $778 million and $607 million for the six months ended June 30, 2007 and 2006, respectively. Total milestone payments made to Otsuka under the agreement through March 2007 were $217 million, of which $157 million was expensed as acquired in-process research and development in 1999. The remaining $60 million was capitalized in other intangible assets and is being amortized in cost of products sold over the remaining life of the agreement in the U.S., ranging from 8 to 11 years. The Company amortized in cost of products sold $2 million in each of the three months ended March 31,June 30, 2007 and 2006.2006 and $4 million and $3 million for the six months ended June 30, 2007 and 2006, respectively. The unamortized capitalized payment balance was $33$31 million as of March 31,June 30, 2007 and $35 million as of December 31, 2006.

ImClone

The Company has a commercialization agreement expiring in September 2018 with ImClone Systems Incorporated (ImClone), a biopharmaceutical company focused on developing targeted cancer treatments, for the codevelopment and copromotion of ERBITUX* in the U.S. In 2004,The agreement expires in September 2018. ERBITUX* was approved by the U.S. Food and Drug Administration (FDA) approved the Biologics License Application (BLA) for ERBITUX* for use in combination with irinotecan in the treatment of patients with Epidermal Growth Factor Receptor (EGFR)-expressing, metastatic colorectal cancer who are refractory to irinotecan-based chemotherapy and for use as a single agent in the treatment of patients with EGFR-expressing, metastatic colorectal cancer who are intolerant to irinotecan-based chemotherapy. Also in 2004 the FDA approved ImClone’s Chemistry, Manufacturing and Controls supplemental BLA for licensure of its BB36 manufacturing facility. In March 2006, the FDA approved ERBITUX* for use in the treatment of squamous cell carcinoma of the head and neck in combination with radiation or as monotherapy.March 2006. The Company paid $250 million as a milestone payment to ImClone for each of the FDA approvals in 2004 and 2006. Under the agreement, ImClone receives a distribution fee based on a flat rate of 39% of net sales in North America. In addition, the Company has the co-exclusive right to commercialize ERBITUX* in Japan (ImClone having previously granted co-exclusive right to Merck KGaA in Japan). In December 2004, the Company, its Japanese affiliate (BMKK), Merck KGaA, Merck Ltd., and ImClone executed a joint development agreement forwill share distribution rights to ERBITUX* with Merck KGaA in Japan. ERBITUX* is not yet marketed in Japan, although an application has been submitted with the Japanese Pharmaceuticals and Medical Devices Agency for the use of ERBITUX* in treating patients with advanced colorectal cancer.

The Company accounts for the $500 million approval milestones paid in 2004 and 2006 as license acquisitions, which were capitalized in other intangible assets and are being amortized in cost of products sold over the remaining term of the agreement which ends in 2018. The Company amortized into cost of products sold $10$9 million and $6$10 million for the three months ended March 31,June 30, 2007 and 2006, respectively, and $19 million and $16 million for the six months ended June 30, 2007 and 2006, respectively. The unamortized portion of the approval payments was $425$416 million at March 31,June 30, 2007 and $435 million at December 31, 2006.

The Company accounts for its investment in ImClone under the equity method and records its share of the results in equity in net income of affiliates in the consolidated statement of earnings. The Company’s recorded investment and the market value of its holdings in ImClone common stock was $114$119 million and approximately $587$509 million as of March 31,June 30, 2007, respectively, and $109 million and approximately $385 million as of December 31, 2006, respectively. The Company holds 14.4 million shares of ImClone stock, representing approximately 17% of ImClone’s shares outstanding at both March 31,June 30, 2007 and December 31, 2006. On a per share basis, the carrying value of the ImClone investment and the closing market price of the ImClone shares as of March 31,June 30, 2007 were $7.95$8.26 and $40.77,$35.36, respectively, compared to $7.59 and $26.76, respectively, as of December 31, 2006.

The Company determines its equity share in ImClone’s net income or loss by eliminating from ImClone’s results the milestone revenue ImClone recognizes for the $400 million in pre-approval milestone payments made by the Company from 2001 through 2003. The Company recorded $80 million of the pre-approval milestone payments as an equity investment and expensed the remaining $320 million as acquired in-process research and development during that period. Milestone revenue recognized by ImClone in excess of $400 million is not eliminated by the Company in determining its equity share in ImClone's results. For its share of ImClone’s results

Note 2. Alliances and Investments (Continued)

of operations, the Company recorded net income of $5$4 million and less than $1$24 million for the three months ended March 31,June 30, 2007 and 2006, respectively, and $9 million and $25 million for the six months ended June 30, 2007 and 2006, respectively. The Company recorded net sales for ERBITUX* of $160$162 million and $138$172 million for the three months ended March 31,June 30, 2007 and 2006, respectively.

Note 2. Alliancesrespectively, and Investments (Continued)

$322 million and $310 million for the six months ended June 30, 2007 and 2006, respectively.

Gilead

In 2004, the Company and Gilead Sciences, Inc. (Gilead) entered into a joint venture to develop and commercialize a fixed-dose combination of the Company's SUSTIVA (efavirenz) and Gilead's TRUVADA* (emtricitabine and tenofovir disoproxil fumarate) in the U.S. and Canada. In July 2006, the FDA granted approval of ATRIPLA* (efavirenz 600 mg/ emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg) for the treatment of human immunodeficiency virus (HIV) infection in adults. ATRIPLA* is the first-ever once-daily single tablet regimen for HIV intended as a stand-alone therapy or in combination with other antiretrovirals.

Gilead records 100% of ATRIPLA* revenues and consolidates the results of the joint venture in its operating results. The Company records revenue for the bulk efavirenz component of ATRIPLA* upon sales of that product, by the joint venture with Gilead, to third party customers. The Company's revenue for the efavirenz component is determined by applying a percentage to ATRIPLA* revenue, which approximates revenue for the SUSTIVA brand. The Company recorded efavirenz revenues of $70$79 million and $149 million for the three and six months ended June 30, 2007, respectively, related to ATRIPLA* sales for the three months ended March 31, 2007.sales. The Company accounts for its participation in the joint venture under the equity method of accounting and records its share of the joint venture results in equity in net income of affiliates in the consolidated statement of earnings. The Company recorded an equity loss on the joint venture with Gilead of $2$3 million and $1 million for the three months ended March 31,June 30, 2007 and 2006, respectively, and $5 million and $2 million for the six months ended June 30, 2007 and 2006, respectively.

AstraZeneca

In January 2007, the Company entered into two worldwide (except for Japan) codevelopment and cocommercialization agreements with AstraZeneca PLC (AstraZeneca), one for the codevelopment and cocommercialization of saxagliptin, a DPP-IV inhibitor in Phase III clinical trials (Saxagliptin Agreement), and one for the codevelopment and cocommercialization of dapagliflozin, a SGLT2 inhibitor in Phase IIB clinical trials (SGLT2 Agreement). Both compounds are being studied for the treatment of diabetes and were discovered by the Company. Under the terms of the agreements, the Company received from AstraZeneca an upfront paymentspayment of $100 million in January 2007, which werewas deferred and areis being recognized over the life of the agreements into other income. The Company amortized into other income $2 million and $4 million for the three and six months ended June 30, 2007, respectively. The unamortized portion of the upfront payments was $96 million as of June 30, 2007. Milestone payments are expected to be received by the Company upon the successful achievement of various development and regulatory andevents as well as sales related milestones. Under the Saxagliptin Agreement, the Company could receive up to $300 million if all development and regulatory milestones are met and up to an additional $300 million if all sales-based milestones are met. Under the SGLT2 Agreement, the Company could receive up to $350 million if all development and regulatory milestones are met and up to an additional $300 million if all sales-based milestones are met. Under each agreement, the Company and AstraZeneca also share in development and commercialization costs. The majority of development costs under the initial development plans through 2009 will be paid by AstraZeneca and any additional development costs will generally be shared equally. The Company records in Research and Development expenses saxagliptin and dapagliflozin development costs net of its alliance partner’s share. Under each agreement, the two companies will jointly develop the clinical and marketing strategy and share commercialization expenses and profits/losses equally on a global basis, excluding Japan, and the Company will manufacture both products and, with certain limited exceptions, record net sales.

Pfizer

In April 2007, the Company and Pfizer Inc. (Pfizer) entered into a worldwide codevelopment and cocommercialization agreement for apixaban, an anticoagulant discovered by the Company being studied for the prevention and treatment of a broad range of venous and arterial thrombotic conditions. In accordance with the terms of the agreement, Pfizer made an upfront payment of $250 million to the Company in May 2007, which was deferred and is being recognized over the life of the agreement into other income. The Company amortized into other income $3 million for the three and six months ended June 30, 2007. The unamortized portion of the upfront payment was $247 million as of June 30, 2007. Pfizer will fund 60% of all development costs effective January 1, 2007 going forward, and the Company will fund 40%. The Company records in Research and Development expenses apixaban development costs net of its alliances partner’s share. The Company may also receive additional payments of up to $750 million from Pfizer based on development and regulatory milestones. The companies will jointly develop the clinical and marketing strategy of apixaban, and will share commercialization expenses and profits/losses equally on a global basis.

Note 3. Restructuring

2007 Activities

In the firstsecond quarter of 2007, the Company recorded pre-tax charges of $35$9 million, related to the termination benefits and other related costs for workforce reductions and streamlining of worldwide operations of approximately 350100 selling and operating personnel, primarily in the U.S., Latin America and Europe. These charges were increaseddecreased by a $2 million adjustment reflecting net changes in estimates for restructuring actions taken in prior periods.

The following table presents a detail of the charges by segment and type for the three months ended March 31,June 30, 2007. The Company expects to substantially complete these activities by early 2008.mid-2008.

 

  Termination
Benefits
 

Other

  Exit Costs  

        Total       
Dollars in Millions  Termination
Benefits
  Other Exit
Costs
  Total         

Pharmaceuticals

  $25  $—    $25  $5  $—    $5 

Nutritionals

   1   —     1 

Other Health Care

   9   1   10   3   —     3 
                   

Subtotal

   34   1   35   9   —     9 

Changes in estimates

   2   —     2   (2)  —     (2)
                   

Restructuring as reflected in the statement of earnings

  $36  $1  $37

Provision for restructuring, net

  $7  $—    $7 
                   

In the six months ended June 30, 2007, the Company recorded a pre-tax charge of $44 million related to the termination benefits and other related costs for workforce reductions and streamlining of worldwide operations of approximately 450 selling and administrative personnel primarily in the U.S., Latin America and Europe.

Note 3. Restructuring (Continued)The following table presents a detail of the charges by segment and type for the six months ended June 30, 2007. The Company expects to substantially complete these activities by mid-2008.

 

   Termination
Benefits
  

Other

  Exit Costs  

        Total      
Dollars in Millions         

Pharmaceuticals

  $30  $—    $    30

Nutritionals

   1   —     1

Other Health Care

   12   1   13
            

Provision for restructuring, net

  $43  $1  $44
            

2006 Activities

In the firstsecond quarter of 2006, the Company recorded pre-tax charges of $10$4 million, related to the termination benefits for workforce reductions and streamlining of worldwide operations of approximately 140 selling and operating personnel, primarily in Latin America.America and Canada. These charges were decreased by a $9$1 million adjustment reflecting net changes in estimates for restructuring actions taken in prior periods.

The following table presents a detail of the charges by segment and type for the three months ended March 31,June 30, 2006. The Company expects to substantially completecompleted these activities by late 2007.2006.

 

  Termination
Benefits
 Other
  Exit Costs  
        Total       
Dollars in Millions  Termination
Benefits
 Other Exit
Costs
  Total          

Pharmaceuticals

  $10  $—    $10   $4  $—    $    4 

Changes in estimates

   (9)  —     (9)   (1)  —     (1)
                    

Restructuring as reflected in the statement of earnings

  $1  $—    $1 

Provision for restructuring, net

  $3  $—    $3 
                    

In the six months ended June 30, 2006, the Company recorded a pre-tax charge of $14 million related to the termination benefits for workforce reductions and streamlining of worldwide operations of approximately 280 selling and administrative personnel primarily in the Americas. These charges were decreased by a $10 million adjustment reflecting changes in estimates for restructuring actions taken in prior periods.

Note 3. Restructuring (Continued)

The following table presents a detail of the charges by segment and type for the six months ended June 30, 2006. The Company substantially completed these activities by late 2006.

   Termination
Benefits
  Other
  Exit Costs  
        Total       
Dollars in Millions          

Pharmaceuticals

  $14  $—    $    14 

Changes in estimates

   (10)  —     (10)
             

Provision for restructuring, net

  $4  $—    $4 
             

Restructuring charges and spending against liabilities associated with prior and current actions are as follows:

 

  Employee
Termination
Liability
 

Other

  Exit Cost  
Liability

       Total       
Dollars in Millions  Employee
Termination
Liability
 Other
Exit Cost
Liability
 Total         

Balance at January 1, 2006

  $60  $—    $60   $60  $—    $    60 

Charges

   71   2   73    71   2   73 

Spending

   (44)  —     (44)   (44)  —     (44)

Changes in estimates

   (13)  (1)  (14)   (13)  (1)  (14)
                    

Balance at December 31, 2006

   74   1   75    74   1   75 

Charges

   34   1   35    43   1   44 

Spending

   (13)  (1)  (14)   (33)  (1)  (34)

Changes in estimates

   2   —     2 
                    

Balance at March 31, 2007

  $97  $1  $98 

Balance at June 30, 2007

  $84  $1  $85 
                    

Note 4. Acquisitions and Divestitures

In January 2006, the Company completed the sale of its inventory, trademark, patent and intellectual property rights in the U.S. related to DOVONEX*, a treatment for psoriasis, to Warner Chilcott Company, Inc. for $200 million in cash. In addition, the Company will receive a royalty equal to 5% of net sales of DOVONEX* through the end of 2007. As a result of this transaction, the Company recognized a pre-tax gain of $200 million ($130 million net of tax) in the first quarter of 2006.

In June 2007, the Company signed an agreement for the sale of the BUFFERIN* and EXCEDRIN* brands in Japan, Asia (excluding China and Taiwan) and certain Oceanic countries to Lion Corporation (Japan). This transaction was completed in July 2007 and, in accordance with the agreement, the Company received cash proceeds of $247 million, substantially all of which will be recognized as a pre-tax gain in the third quarter of 2007.

Note 5. Earnings Per Share

The numerator for basic earnings per share is net earnings available to common stockholders. The numerator for diluted earnings per share is net earnings available to common stockholders with interest expense added back for the assumed conversion of the convertible debt into common stock. The denominator for basic earnings per share is the weighted-average number of common stock outstanding during the period. The denominator for diluted earnings per share is weighted-average shares outstanding adjusted for the effect of dilutive stock options and restricted stock and assumed conversion of the convertible debt into common stock. The computations for basic and diluted earnings per common share are as follows:

 

  Three Months Ended March 31,  Three Months Ended
June 30,
  

  Six Months Ended  

June 30,

Amounts in Millions, Except Per Share Data

  2007  2006  2007  2006  2007  2006

Basic:

            

Net Earnings

  $690  $714  $706  $667  $1,396  $1,381
                  

Basic Earnings Per Share:

            

Average Common Shares Outstanding

   1,962   1,957   1,968   1,960   1,965   1,959
                  

Net Earnings per Common Share

  $.35  $.36  $.36  $.34  $.71  $.71
                  

Diluted:

            

Net Earnings

  $690  $714  $706  $667  $1,396  $1,381

Interest expense on conversion of convertible debt, net of taxes

   9   8   9   8   18   16
                  

Net Earnings available to Common Stockholders

  $699  $722  $715  $675  $1,414  $1,397
                  

Diluted Earnings Per Share:

            

Average Common Shares Outstanding

   1,962   1,957   1,968   1,960   1,965   1,959

Conversion of convertible debt

   29   29   29   29   29   29

Incremental shares outstanding assuming the exercise/vesting of dilutive stock options/restricted stock

   6   2   9   5   8   4
                  
   1,997   1,988   2,006   1,994   2,002   1,992
                  

Net Earnings per Common Share

  $.35  $.36  $.36  $.34  $.71  $.70
                  

Weighted-average shares issuable upon the exercise of stock options, which were not included in the diluted earnings per share calculation because they were not dilutive, were 11685 million and 165147 million for the three monthsmonth periods ended March 31,June 30, 2007 and 2006, respectively, and 80 million and 136 million for the six month periods ended June 30, 2007 and 2006, respectively.

Note 6. Other Expense, Net

The components of other expense, net are as follows:

 

  Three Months Ended
June 30,
 

  Six Months Ended  

June 30,

 
  Three Months Ended March 31,   2007 2006 2007 2006 
Dollars in Millions  2007 2006           

Interest expense

  $109  $116   $107  $124  $216  $240 

Interest income

   (53)  (62)   (62)  (65)  (115)  (127)

Foreign exchange transaction losses/(gains)

   8   (12)

Foreign exchange transaction (gains)/losses

   (5)  23   3   11 

Other, net

   (42)  (5)   (40)  (26)  (82)  (31)
                    

Other expense, net

  $22  $37   $—    $56  $22  $93 
                    

For each of the three months ended March 31, 2007 and 2006, interestInterest expense was increased by net interest swap losses of $1 million.$3 million and $4 million for the three and six months ended June 30, 2007, respectively, and $5 million and $6 million for the three and six months ended June 30, 2006, respectively. Interest income relates primarily to cash, cash equivalents and investments in marketable securities. Other, net includes income from third-party contract manufacturing, certain royalty income and expense, gains and losses on disposal of property, plant and equipment, certain other litigation matters and deferred income recognized.

Note 7. Income Taxes

The effective income tax rate on earnings before minority interest and income taxes was 9.4%22.2% and 16.5% for the three and six months ended March 31,June 30, 2007, respectively, compared to 27.5%23.1% and 25.4% for the three and six months ended March 31, 2006.June 30, 2006, respectively. The tax rate for the threesix months ended March 31,June 30, 2007 was favorably impacted by a tax benefit of $105 million in the first quarter of 2007 due to the favorable resolution of certain tax matters with the Internal Revenue Service (IRS) related to the deductibility of litigation settlement expenses and U.S. foreign tax credits claimed. TheIn addition, the lower tax rate in the first quarter ofthree and six months ended June 30, 2007 compared to the same periods in 2006 was also due to the re-enactment of the Research and Development tax credit in the fourth quarter of 2006, and the unfavorable impact in 2006 associated with the elimination of tax effect of a gain on the salebenefits under section 936 of the U.S. rightsInternal Revenue Code, partially offset by the implementation of tax planning strategies related to DOVONEX* in the first quarterutilization of 2006.certain charitable contributions.

U.S. income taxes have not been provided on the earnings of non-U.S. subsidiaries that are not projected to be distributed this year since the Company has invested or expects to invest such earnings permanently offshore. If in the future these earnings are repatriated to the U.S., or if the Company determines such earnings will be remitted in the foreseeable future, additional tax provisions would be required.

The Company has recorded significant deferred tax assets related to U.S. foreign tax credit and research tax credit carryforwards which expire in varying amounts beginning in 2012. Realization of foreign tax credit and research tax credit carryforwards is dependent on generating sufficient domestic-sourced taxable income prior to their expiration. Although realization is not assured, management believes it is more likely than not that these deferred tax assets will be realized. The amount of foreign tax credit and research tax credit carryforwards considered realizable, however, could be reduced in the near term if PLAVIX* is subject to either renewed or additional generic competition. If such events occur, the Company may need to record significant additional valuation allowances against these deferred tax assets. For a discussion of PLAVIX* related matters, see “—Note 16. Legal Proceedings and Contingencies” and “Management’s Discussion and Analysis—Executive Summary — PLAVIX*.Contingencies.

The Company files income tax returns in the U.S. Federal jurisdiction, and various state and foreign jurisdictions. With few exceptions, the Company is no longer subject to U.S. Federal, state and local, orand non-U.S. income tax examinations by tax authorities for years before 2002.authorities. The Company’s 2002 and 2003 U.S. Federal income tax returns are currently under examination by the IRS. As previously disclosed, the IRS proposed (1) a significant disallowance of certain litigation settlement expenses, and (2) a significant reduction in U.S. foreign tax credits claimed. In the first quarter of 2007, the Company recognized $105 million of tax benefit resulting from the favorable resolution of these matters.

The Company adopted the provisions of FIN No. 48 on January 1, 2007, resulting in the recognition of $27 million of previously unrecognized tax benefits which was accounted for as an increase to the opening balance of retained earnings. Including the adjustment on adoption of FIN No. 48, the Company’s total amount of unrecognized tax benefits as of January 1, 2007, excluding interest and penalties, was $960 million. The total amount of unrecognized tax benefits decreased to $907 million at June 30, 2007, primarily due to the tax benefit recognized from the favorable resolution of certain tax matters with the IRS, partially offset by additional reserves accrued during 2007. The Company classifies interest expense and penalties related to unrecognized tax benefits as income tax expense. The total amount of accrued interest and penalties was $84 million as of January 1, 2007 and $85 million as of June 30, 2007. Included in the balance of unrecognized tax benefits were $99 million of tax positions as of January 1, 2007 and $96 million as of June 30, 2007 for which the ultimate deductibility is highly certain but for which there is uncertainty as to the timing of such deductibility. Because of the impact of deferred tax accounting, other than interest and penalties, if applicable, the disallowance of the shorter deductibility period would not affect the annual effective tax rate but would accelerate the payment of cash to the taxing authority or utilization of tax attributes to the taxing authority to an earlier period.

The Company is currently under examination by a number of tax authorities, including all of the major jurisdictions listed in the table below, which have proposed adjustments to tax for issues such as transfer pricing, certain tax credits and the deductibility of certain expenses. The Company anticipates that it is reasonably possible that the total amount of unrecognized tax benefits at June 30, 2007 will decrease within 12 months of the date of adoption of FIN No. 48, in the range of approximately $320$220 million to $360$260 million as a result of the settlement of certain tax audits. Such settlements will involve the payment of additional taxes, the adjustment of certain deferred taxes, and/or the recognition of tax benefits. The Company also anticipates that it is reasonably possible that new issues will be raised by tax authorities which may require increases to the balance of unrecognized tax benefits, however, an estimate of such increases cannot be made.

The Company conducts business in various countries throughout the world and is subject to tax in numerous jurisdictions. As a result of its business activities, the Company files a significant number of tax returns that are subject to examination by various Federal, state, and local tax authorities. Following

Note 7. Income Taxes (Continued)

The following is a summary by significant jurisdiction of the years for which tax authorities may assert additional taxes against the Company based upon tax years currently under audit and subsequent years that will likely be audited:

 

United StatesU.S.  2002 to 2006
Canada  2001 to 2006
France  2004 to 2006
Germany  1999 to 2006
Italy  2002 to 2006
Mexico  20012002 to 2006

Note 8. Receivables

The major categories of receivables are as follows:

 

Dollars in Millions  March 31,
2007
  

December 31,

2006

  

June 30,

2007

  

December 31,

2006

Trade receivables

  $2,519  $2,400  $         2,682  $2,400

Miscellaneous receivables

   1,030   997   1,117   997
            
   3,549   3,397   3,799   3,397

Less allowances

   168   150   167   150
            

Receivables, net

  $3,381  $3,247  $3,632  $3,247
            

Miscellaneous receivables as of March 31,June 30, 2007 and December 31, 2006 include $714$790 million and $647 million, respectively, related toof receivables from alliance partners. For additional information on the Company's alliance partners, see “—Note 2. Alliances and Investments.”

Note 9. Inventories

The major categories of inventories are as follows:

 

Dollars in Millions  

March 31,

2007

  

December 31,

2006

  

June 30,

2007

  

December 31,

2006

Finished goods

  $896  $1,003  $            948  $1,003

Work in process

   761   682   831   682

Raw and packaging materials

   439   394   445   394
            

Inventories, net

  $2,096  $2,079  $2,224  $2,079
            

Note 10. Property, Plant and Equipment

The major categories of property, plant and equipment are as follows:

 

Dollars in Millions  

March 31,

2007

  

December 31,

2006

  

June 30,

2007

  

December 31,

2006

Land

  $254  $254  $            252  $254

Buildings

   4,679   4,630   4,735   4,630

Machinery, equipment and fixtures

   4,584   4,540   4,645   4,540

Construction in progress

   769   720   815   720
            
   10,286   10,144   10,447   10,144

Less accumulated depreciation

   4,577   4,471   4,679   4,471
            

Property, plant and equipment, net

  $5,709  $5,673  $5,768  $5,673
            

Note 11. Other Intangible Assets

As of March 31,June 30, 2007 and December 31, 2006, other intangible assets are as follows:

 

Dollars in Millions  March 31,
2007
  December 31,
2006

Patents / Trademarks

  $259  $258

Less accumulated amortization

   152   145
        

Patents / Trademarks, net

   107   113
        

Licenses

   660   659

Less accumulated amortization

   175   162
        

Licenses, net

   485   497
        

Technology

   1,787   1,787

Less accumulated amortization

   876   836
        

Technology, net

   911   951
        

Capitalized Software

   854   844

Less accumulated amortization

   582   553
        

Capitalized Software, net

   272   291
        

Other intangible assets, net

  $1,775  $1,852
        

Note 11. Other Intangible Assets (Continued)

Dollars in Millions       June 30,     
2007
  December 31,
2006

Patents / Trademarks

  $259  $258

Less accumulated amortization

   159   145
        

Patents / Trademarks, net

   100   113
        

Licenses

   660   659

Less accumulated amortization

   188   162
        

Licenses, net

   472   497
        

Technology

   1,787   1,787

Less accumulated amortization

   915   836
        

Technology, net

   872   951
        

Capitalized Software

   873   844

Less accumulated amortization

   610   553
        

Capitalized Software, net

   263   291
        

Other intangible assets, net

  $1,707  $1,852
        

Amortization expense for other intangible assets (the majority of which is included in Cost of Products Sold) for the three months ended March 31,June 30, 2007 and 2006 was $88 million and $87$93 million, respectively, and for the six months ended June 30, 2007 and 2006 was $176 million and $180 million, respectively.

Expected amortization expense related to the March 31,June 30, 2007 net carrying amount of other intangible assets is as follows:

 

Years Ending December 31:

  Dollars in Millions  Dollars in Millions

2007 (nine months)

  $258

2007 (six months)

  $172

2008

   291   294

2009

   267   270

2010

   251   256

2011

   238   242

Later Years

   470   473

Note 12. Accumulated Other Comprehensive Income/(Loss)

The accumulated balances related to each component of other comprehensive income/(loss) are as follows:

 

Dollars in Millions Foreign
Currency
Translation
 Deferred
Gains/(Loss) on
Effective Hedges
 

Minimum

Pension

Liability

Adjustment

 Deferred
Charges on Pension
and Other
Postretirement
Benefits
 Deferred
Gains/(Loss) on
Available for Sale
Securities
 Accumulated Other
Comprehensive
Income/(Loss)
   Foreign
Currency
    Translation    
 

Deferred
Gains/(Losses)

on

Effective
Hedges

 

Minimum

Pension

Liability
   Adjustment   

 Deferred
Charges on
Pension and
Other
Postretirement
Benefits
 

Deferred
Gains/(Losses)

on Available

for

Sale Securities

  

Accumulated

Other
Comprehensive
Income/(Loss)

 

Balance at January 1, 2006

 $(553) $16  $(229) $—    $1  $(765)  $(553) $16  $(229) $—    $1  $(765)

Other comprehensive income/(loss)

  20   (32)  —     —     2   (10)   69   (80)  —     —     2   (9)
                                     

Balance at March 31, 2006

 $(533) $(16) $(229) $—    $3  $(775)

Balance at June 30, 2006

  $(484) $(64) $(229) $—    $3  $(774)
                                     

Balance at January 1, 2007

 $(424) $(23) $—    $(1,211) $13  $(1,645)  $(424) $(23) $—    $(1,211) $13  $(1,645)

Other comprehensive income/(loss)

  19   —     —     35   (3)  51    34   (1)  —     58   —     91 
                                     

Balance at March 31, 2007

 $(405) $(23) $—    $(1,176) $10  $(1,594)

Balance at June 30, 2007

  $(390) $(24) $—    $(1,153) $13  $(1,554)
                                     

Note 13. Business Segments

The Company is organized in three reportable segments—Pharmaceuticals, Nutritionals and Other Health Care. The Pharmaceuticals segment is comprised of the global pharmaceutical and international consumer medicines businesses. The Nutritionals segment consists of Mead Johnson, primarily an infant formula and children’s nutritional business. The Other Health Care segment consists of the ConvaTec and Medical Imaging businesses.

 

   Three Months Ended March 31,
   Net Sales  

Earnings Before

Minority Interest

and Income Taxes

Dollars in Millions  2007  2006  2007  2006

Pharmaceuticals

  $3,457  $3,700  $825  $836

Nutritionals

   606   565   173   184

Other Health Care

   413   411   136   118
                

Health Care Group

   1,019   976   309   302
                

Total Segments

   4,476   4,676   1,134   1,138

Corporate/Other

   —     —     (217)  55
                

Total

  $4,476  $4,676  $917  $1,193
                

   Three Months Ended June 30,  Six Months Ended June 30, 
Dollars in Millions  Net Sales  Earnings Before
Minority Interest
and Income Taxes
  Net Sales  Earnings Before
Minority Interest
and Income Taxes
 
   2007  2006  2007  2006  2007  2006  2007  2006 

Pharmaceuticals

  $3,851  $3,859  $1,005  $943  $7,308  $7,559  $1,830  $1,779 

Nutritionals

   620   582   167   186   1,226   1,147   340   370 

Other Health Care

   457   430   160   134   870   841   296   252 
                                 

Health Care Group

   1,077   1,012   327   320   2,096   1,988   636   622 
                                 

Total Segments

   4,928   4,871   1,332   1,263   9,404   9,547   2,466   2,401 

Corporate/Other

   —     —     (175)  (153)  —     —     (392)  (98)
                                 

Total

  $4,928  $4,871  $1,157  $1,110  $9,404  $9,547  $2,074  $2,303 
                                 

Note 14. Pension and Other Postretirement Benefit Plans

The net periodic benefit cost of the Company’s defined benefit pension and postretirement benefit plans included the following components:

 

  Three Months Ended March 31,   Three Months Ended June 30, Six Months Ended June 30, 
  Pension Benefits Other Benefits   Pension Benefits Other Benefits Pension Benefits Other Benefits 
Dollars in Millions  2007 2006 2007 2006   2007 2006 2007 2006 2007 2006 2007 2006 

Service cost — benefits earned during the year

  $63  $58  $2  $3 

Service cost — benefits earned during the period

  $60  $59  $2  $2  $123  $117  $4  $5 

Interest cost on projected benefit obligation

   86   87   10   12    87   87   9   9   173   174   19   21 

Expected return on plan assets

   (109)  (111)  (7)  (8)   (109)  (111)  (6)  (6)  (218)  (222)  (13)  (14)

Amortization of prior service cost

   3   3   (1)  (1)   2   4   (1)  (1)  5   7   (2)  (2)

Amortization of loss

   34   44   2   1    35   45   1   1   69   89   3   2 

Amortization of transitional obligation

   —     1   —     —      —     (1)  —     —     —     —     —     —   
                                      

Net periodic benefit cost

   77   82   6   7    75   83   5   5   152   165   11   12 

Curtailments and settlements

   —     —     (1)  —      1   —     1   —     1   —     (1)  —   
                                      

Total net periodic benefit cost

  $77  $82  $5  $7   $76  $83  $6  $5  $153  $165  $10  $12 
                                      

Net actuarial loss and prior service cost amortized from accumulated other comprehensive income into net periodic benefit costs for the three and six months ended March 31,June 30, 2007 were $37 million and $74 million for pension benefits, respectively, and were de minimis and $1 million for other benefits.benefits, respectively.

Contributions

For the three and six months ended March 31,June 30, 2007, there were no cash contributions to the U.S. pension plans, and $22$11 million wasand $33 million, respectively, were contributed to the international pension plans. Although no minimum contributions will be required, the Company plansexpects to make cash contributions to the U.S. pension plans in 2007. The Company expects contributions to the international pension plans for the year ended December 31, 2007 will be in the range of $70 million to $90 million. There was no cash funding for other benefits.

Those cash benefit payments from the Company, which are classified as contributions under SFAS No. 132,Employers’ Disclosures about Pensions and Other Postretirement Benefits – an amendment of FASB Statements No. 87, 88 and 106, for the three and six months ended March 31,June 30, 2007, totaled $4$13 million and $17 million, respectively, for pension benefits and $16$18 million and $34 million, respectively, for other postretirement benefits.

Note 15. Employee Stock Benefit Plans

The following table summarizes stock-based compensation expense, net of tax, related to employee stock options, restricted stock, and long-term performance awards for the three and six months ended March 31,June 30, 2007 and 2006:

 

  Three Months Ended March 31, 
Dollars in Millions  2007 2006   Three Months Ended
June 30,
 Six Months Ended
June 30,
 
  2007 2006 2007 2006 

Cost of products sold

  $3  $4   $4  $4  $7  $8 

Marketing, selling and administrative

   19   22    21   20   40   42 

Research and development

   9   11    11   10   20   21 
                    

Total stock-based compensation expense

   31   37    36   34   67   71 

Deferred tax benefit

   (11)  (13)   (13)  (12)  (24)  (25)
                    

Stock-based compensation, net of tax

  $20  $24   $23  $22  $43  $46 
                    

There were no costs related to stock-based compensation that were capitalized during the period.

Employee Stock Plans

UnderOn May 1, 2007, the stockholders approved the Company’s 2007 Stock Award and Incentive Plan (the 2007 Plan). The 2007 Plan replaced the 2002 Stock Incentive Plan (the 2002 Plan) that expired on May 31, 2007. The 2007 Plan provides for 42 million new shares of common stock reserved for delivery to participants, plus shares remaining available for new grants under the 2002 Plan and shares recaptured from outstanding awards under the 2002 Plan. Only the number of shares actually delivered to participants in connection with an award after all restrictions have lapsed will be counted against the number of shares reserved.

Under both the 2007 Plan and the 2002 Plan, executive officers and key employees may be granted options to purchase the Company’s common stock at no less than 100% of the market price on the date the option is granted. Options generally become exercisable in installments of 25% per year on each of the first through the fourth anniversaries of the grant date and have a maximum term of 10 years. Generally, the Company issues shares for the stock option exercise from treasury stock. Additionally, the plan provides for the granting of stock appreciation rights whereby the grantee may surrender exercisable rights and receive common stock and/or cash measured by the excess of the market price of the common stock over the option exercise price.

Note 15. Employee Stock Benefit Plans (Continued)

Information related to stock option grants and exercises under both the 2007 Plan and the 2002 Plan are summarized as follows:

 

  Three Months Ended March 31,  Three Months Ended
June 30,
  

Six Months Ended
June 30,

Amounts in Millions, Except Per Share Data  2007  2006  2007  2006  2007  2006

Stock options granted

   13.6   11.9   0.9   0.5   14.5   12.4

Weighted-average grant-date fair value (per share)

  $6.00  $4.26  $6.50  $4.78  $6.03  $4.29

Total intrinsic value of stock options exercised

  $4  $16  $24  $1  $28  $17

Cash proceeds from exercise of stock options

  $23  $149  $278  $7  $301  $156

As of March 31,June 30, 2007, there was $146$130 million of total unrecognized compensation cost related to stock options that is expected to be recognized over a weighted-average period of 2.82.7 years.

At March 31,June 30, 2007, there were 163.3151.7 million and 123.9 millionof stock options outstanding and exercisable, respectively, with a weighted-average exercise price of $37.80$38.48 and $41.26, respectively.114.4 million stock options exercisable with a weighted-average exercise price of $42.25. The aggregate intrinsic value for these outstanding and exercisable stock options were $193$477 million and $112$265 million, respectively, and represents the total pre-tax intrinsic value, based on the Company’s averageclosing stock price of $27.76$31.56 on March 30,June 29, 2007, which would have been received by the option holders had all option holders exercised their options as of that date. The total number of in-the-money options exercisable as of March 31,June 30, 2007 was 3044.8 million.

Under the TeamShare Stock Option Plan, which terminated on January 3, 2005, options onunderlying 35.5 million shares have been exercised as of March 31,June 30, 2007.

Note 15. Employee Stock Benefit Plans (Continued)

The fair value of employee stock options granted in 2007 wereand 2006 was estimated on the date of the grant using the Black-Scholes option pricing model for stock options with a service condition, and the Monte Carlo simulation model for options with service and market conditions. The following assumptions:table presents the weighted-average assumptions used in the valuation:

 

Three Months Ended

March 31, 2007

Expected volatility

29.0%

Risk-free interest rate

4.7%

Dividend yield

4.5%

Expected life

6.3 years
   Three Months Ended
June 30,
  Six Months Ended
June 30,
 
   2007  2006  2007  2006 

Expected volatility

  27.9% 26.4% 29.0% 26.3%

Risk-free interest rate

  4.7% 4.8% 4.7% 4.6%

Dividend yield

  4.4% 4.7% 4.5% 4.8%

Expected life

  6.2 years  6.3 years  6.3 years  6.3 years 

Restricted Stock

TheBoth the 2007 Plan and the 2002 Stock Incentive Plan providesprovide for the granting of common stock to key employees, subject to restrictions as to continuous employment. Restrictions generally expire over a four-year period from the date of grant. Compensation expense is recognized over the restricted period. During the first quarter of 2007, the Company began granting restricted stock units instead of restricted stock. At March 31,June 30, 2007, there were 9.28.8 million shares of restricted stock and restricted stock units outstanding under the plan. For the three months ended March 31,June 30, 2007 and 2006, 3.40.1 million shares of restricted stock and restricted stock units were granted in each period with a weighted-average fair value of $28.88 and $24.97 per share, respectively. For the six months ended June 30, 2007 and 2006, 3.5 million and 2.93.0 million shares, respectively, of restricted stock and restricted stock units were granted with a weighted-average fair value of $27.03$27.08 and $22.73$22.79 per share, respectively.

Beginning on January 23, 2007, the fair value of nonvested shares of the Company’s common stock is determined based on the closing trading price of the Company’s common stock on the grant date. Prior to January 23, 2007, the fair value of nonvested shares of the Company’s common stock was determined based on the average trading price of the Company’s common stock on the grant date.

As of March 31,June 30, 2007, there was $199$180 million of total unrecognized compensation cost related to nonvested restricted stock and restricted stock units, which is expected to be recognized over a weighted-average period of 3.23.0 years. The total fair value of shares and share units that vested during the three and six months ended March 31,June 30, 2007 was $5 million and $27 million, respectively, and during the three and six months ended June 30, 2006 was $22$5 million and $3$8 million, respectively.

Long-Term Performance Awards

The 2002 Stock Incentive Plan also incorporatesprovided for the Company'sgranting of long-term performance awards. These awards, which arewere delivered in the form of a target number of performance shares, have a three-year cycle. The 2005 through 2007 and the 2006 through 2008 awards will be based 50% on cumulative earnings per share and 50% on cumulative sales, with the ultimate payout modified by the Company’s total stockholder return versus the 11 companies in its proxy peer group. Maximum performance for all three measures will result in a maximum payout of 253% of target. For 2007 through 2009, the awards will have annual goals, set at the beginning of each performance period, based 50% on earnings per share and 50% on sales. Maximum performance will result in a maximum

Note 15. Employee Stock Benefit Plans (Continued)

payout of 220%. If threshold targets are not met for the performance period, no payment will be made under the long-term performance award plan. At March 31,June 30, 2007, there were 1.51.6 million performance shares outstanding under the plan. During the three months ended March 31,June 30, 2007, 0.1 million performance shares were granted, with a fair value of $28.68 per share. There were no performance shares granted during the three months ended June 30, 2006. During the six months ended June 30, 2007 and 2006, 0.20.3 million and 0.6 million performance shares were granted, respectively, with a fair value of $27.01$27.35 and $20.00 per share, respectively.

The 2005 though 2007 award was valued based on the market price of the Company’s common stock at the time of the award. For the 2006 through 2008 award, the fair value of each long-term performance award was estimated on the date of grant using a Monte Carlo simulation model. For the 2007 through 2009 award, because the award does not contain a market condition, the fair value was based on the closing trading price of the Company’s common stock on the grant date.

At March 31,June 30, 2007, there was $9$15 million of total unrecognized compensation cost related to long-term performance awards, which is expected to be recognized over a weighted-average period of 2.52.2 years.

The 2007 Plan provides for the granting of performance awards, which may be earned upon achievement or satisfaction of performance conditions as may be specified by the Company. For the six months ended June 30, 2007, there were no performance awards granted under the 2007 Plan.

Note 16. Legal Proceedings and Contingencies

Various lawsuits, claims, proceedings and investigations are pending involving the Company and certain of its subsidiaries. In accordance with SFAS No. 5,Accounting for Contingencies, the Company records accruals for such contingencies when it is probable that a liability will be incurred and the amount of loss can be reasonably estimated. These matters involve antitrust, securities, patent infringement, pricing, sales and marketing practices, environmental, health and safety matters, consumer fraud, employment matters, product liability and insurance coverage.

The most significant of these matters are described in “Item 8. Financial Statements and Supplemental Data—Note 21. Legal Proceedings and ContingenciesContingencies” in the Company’s 2006 Form 10-K. With a few exceptions, the following discussion is limited to certain recent developments related to these previously described matters, and any new matters that have not previously been described in a prior report. Accordingly, the disclosure below should be read in conjunction with those earlier reports. Unless noted to the contrary, all matters described in those earlier reports remain outstanding and the status is consistent with what has previously been reported.

There can be no assurance that there will not be an increase in the scope of pending matters or that any future lawsuits, claims, proceedings or investigations will not be material. Management continues to believe, as previously disclosed, that during the next few years, the aggregate impact, beyond current reserves, of these and other legal matters affecting the Company is reasonably likely to be material to the Company’s results of operations and cash flows, and may be material to its financial condition and liquidity. For a further discussion of the risks and uncertainties relating to the matters discussed below, see “Item 1A. Risk Factors” in the Company’s 2006 Form 10-K, and “Part II. Item 1A. Risk Factors” below.

INTELLECTUAL PROPERTY

PLAVIX* Litigation

PLAVIX* is currently the Company’s largest product ranked by net sales. Net sales of PLAVIX* were $3.2 billion for the year ended December 31, 2006, and $938 million$2.1 billion for the first quarter ofsix months ended June 30, 2007. U.S. net sales of PLAVIX* for the same periods were $2.7 billion, and $787 million,$1.8 billion, respectively. The PLAVIX* patents are subject to a number of challenges in the U.S, including the litigation with Apotex Inc. and Apotex Corp. (Apotex) described below, and other less significant markets for the product. It is not possible reasonably to estimate the impact of these lawsuits on the Company. However, loss of market exclusivity of PLAVIX* and sustained generic competition would be material to the Company’s sales of PLAVIX*, results of operations and cash flows, and could be material to the Company’s financial condition and liquidity. The Company and its product partner, Sanofi, (the Companies) intend to vigorously pursue enforcement of their patent rights in PLAVIX*.

PLAVIX* Litigation – United StatesU.S.

Patent Infringement Litigation against Apotex and Related Matters

The Company’s U.S. territory partnership under its alliance with Sanofi is a plaintiff in a pending patent infringement lawsuit instituted in the U.S. District Court for the Southern District of New York (District court) entitled Sanofi-Synthelabo, Sanofi-Synthelabo, Inc. and Bristol-Myers Squibb Sanofi Pharmaceuticals Holding Partnership v. Apotex. The suit was filed in March 2002, and is based on U.S. Patent No. 4,847,265 (the ‘265 Patent), a composition of matter patent, which discloses and claims, among other things, the hydrogen sulfate salt of clopidogrel, a medicine made available in the U.S. by the Companies as PLAVIX*. Plaintiffs’ infringement position is based on defendants’ filing of their Abbreviated New Drug Applications (aNDA) with the FDA, seeking approval to sell generic clopidogrel bisulfate prior to the expiration of the composition of matter patent in 2011. The defendants responded by alleging that the patent is invalid and/or unenforceable.

Note 16. Legal Proceedings and Contingencies (Continued)

In March 2006, the Companies announced that they had executed a proposed settlement agreement (the March Agreement) with Apotex to settle the pending patent infringement lawsuit. In response to concerns expressed by the Federal Trade Commission (FTC) and state attorneys general, the parties modified the March Agreement (the Modified Agreement) in May 2006. In July 2006, the Companies announced that the Modified Agreement had failed to receive required antitrust clearance from the state attorneys general. On August 8, 2006, Apotex launched a generic version of clopidogrel bisulfate.

On August 31, 2006, the District court issued a preliminary injunction in which it ordered Apotex to halt sales of generic clopidogrel bisulfate, but the CourtDistrict court did not order Apotex to recall product from its customers. In September 2006, the Company and Sanofi each posted $200 million toward a $400 million bond with the District court as collateral in support of the preliminary injunction. This collateral was reported as marketable securities on the Company’s consolidated balance sheet. The U.S. Court of Appeals for the Federal Circuit hassubsequently affirmed the District court’s issuance of the injunction, and Apotex’s motion for reconsideration and/or rehearing was denied on January 19, 2007. Additionally, the District court has stayed certain additional antitrust counterclaims brought by Apotex pending the outcome of the trial.injunction. The trial commenced on January 22, 2007, and trial testimony ended on February 15, 2007. Post-trial briefingOn June 19, 2007, the District court issued an opinion and order upholding the validity and enforceability of the ‘265 Patent, maintaining the main patent protection for PLAVIX* in the U.S. until November 2011. The District court also ruled that Apotex’s generic clopidogrel bisulfate product infringed the ‘265 Patent and permanently enjoined Apotex from engaging in any activity that infringes the ‘265 patent, including marketing its generic product in the U.S. until after the patent expires. The amount of damages will be set at a later time. Apotex has appealed the decision to the U.S. Court of Appeals for the Federal Circuit. The District court has stayed certain antitrust counterclaims brought by Apotex pending the

Note 16. Legal Proceedings and Contingencies (Continued)

outcome of the appeal. Additionally, on June 21, 2007, the District court ordered release of the $400 million bond and release of the issuer of the bond from any liability in connection with the bond. As a result, the Company’s obligations under the collateral arrangements with respect to the bond were effectively terminated.

The Company’s U.S. territory partnership under its alliance with Sanofi is completealso a plaintiff in three additional pending patent infringement lawsuits against Dr. Reddy’s Laboratories, Inc. and Dr. Reddy’s Laboratories, LTD (Dr. Reddy’s), Teva Pharmaceuticals USA, Inc. (Teva) and Cobalt Pharmaceuticals Inc. (Cobalt), all related to the ’265 Patent. A trial date for the action against Dr. Reddy's has not been set. The patent infringement actions against Teva and Cobalt were stayed pending resolution of the Apotex litigation, and the parties are awaitingto those actions agreed to be bound by the outcome of the litigation against Apotex, although Teva and Cobalt can appeal the outcome of the litigation. Consequently, on July 12, 2007, the District court’s decision.

On April 18, 2007, Apotexcourt entered judgements against Cobalt and Teva and permanently enjoined Cobalt and Teva from engaging in any activity that infringes the ‘265 Patent until after the Patent expires. Each of Dr. Reddy’s and Teva have filed an aNDA with the FDA, and all exclusivity periods and statutory stay periods under the Hatch-Waxman Act have expired. Accordingly, final approval by the FDA would provide each company authorization to distribute a lawsuit in Canadageneric clopidogrel bisulfate product in the Ontario Superior Court of Justice entitled Apotex Inc.U.S., subject to various legal remedies for which the Companies may apply including injunctive relief and Apotex Corp. v. Sanofi-Aventis, Sanofi-Synthelabo Inc., Bristol-Myers Squibb Company, and Bristol-Myers Squibb Sanofi Pharmaceuticals Holding Partnership seeking a payment of $60 million, plus interest related to the break-up of the proposed settlement agreement. The Company believes that Apotex’s claim is completely without merit and intends to vigorously defend its position.damages.

It is not possible at this time reasonably to assess the outcomes of the litigations withappeal by Apotex of the District court’s decision, or the other PLAVIX* patent litigations their impact on the Company, or the timing of any renewed generic competition for PLAVIX* from Apotex or additional generic competition for PLAVIX* from other third-party generic pharmaceutical companies. However, if Apotex were to prevail in an appeal of the patent litigation, the Company would expect to face renewed generic competition for PLAVIX* from Apotex promptly thereafter. As noted above, lossLoss of market exclusivity for PLAVIX* and/or sustained generic competition would be material to the Company’s sales of PLAVIX*, results of operations and cash flows, and could be material to the Company’s financial condition and liquidity.

As previously disclosed, the launch of the generic clopidogrel bisulfate product by Apotex in August 2006 had a significant adverse effect on PLAVIX* sales in 2006 which the Company estimates to be in the range of $1.2 billion to $1.4 billion. In the first quarter of 2007, U.S. sales of PLAVIX* declined 7% to $787 million compared to the same period in 2006 due primarily to the residual supply of generic clopidogrel bisulfate in the market. U.S. sales of PLAVIX* were $1.0 billion in the second quarter of 2007. The Company estimates the adverse effect of the at-risk launch of generic clopidogrel bisulfate to be in the range of $300$200 million to $350$250 million for the first quarter of 2007 and $50 million to $100 million for the second quarter of 2007. The Company expectsbelieves the supply of the generic product in distribution channels will continue to have a declining residual impact on PLAVIX* net sales andhas been substantially depleted as of June 30, 2007. However, the Company’s overall financial results at least through the second quarter of 2007. The full impact of Apotex’s launch cannot be estimated with certainty at this time and will depend on a number of factors, including, among others, the amount of generic product sold by Apotex; whether the Companies prevailCompany prevails in Apotex’s appeal of the underlying patent litigation; and even if the Companies prevailCompany prevails in the pendingappeal of the patent case, the extent to which the launch by Apotex will permanently adversely impact the pricing and prescription demand for PLAVIX*, the amount of damages that wouldwill be sought and/or recovered by the CompaniesCompany and Apotex’s ability to pay such damages.

On May 10,As also previously disclosed, on June 11, 2007, the Company andresolved the investigation by the Antitrust Division of the U.S. Department of Justice (DOJ) reached an agreement in principle to resolve the previously disclosed investigation by the Antitrust Division regardinginto the proposed settlement with Apotex of the pending PLAVIX* patent litigation. Under the agreement in principle, the Company or a subsidiary of the Company will pleadlitigation by pleading guilty to criminal charges consistingtwo counts of two violations of Sectionviolating 18 U.S.C Sec. 1001 of U.S. Code Title 18 (relating to false statements to a government agency) carrying an aggregate statutory maximum(the Plea) and paid a fine of $1 million. The charges relate to representations made byAs part of the Plea, the Company acknowledged that a former Company senior executive made oral representations to Apotex for the purpose of causing Apotex to conclude that the Company would not launch an authorized generic in the event that the parties reached a final revised settlement agreement. Those representations included the former senior executive's statement that he expected to oppose personally the launch of an authorized generic in the future, his statement that he expected to advocate against such a launch, and his implied suggestion that the Company's former Chief Executive Officer (CEO) shared his views. The failure to disclose this information to the FTC in connection with the FTC's review of the Company during the renegotiation of the proposed settlement agreement with Apotex in May 2006 that were not disclosedModified Agreement operated as incomplete and therefore false statements to the FTC. The agreement in principle is contingent onCompany also acknowledged its responsibility for the parties’ agreement to the terms of a final agreement and acceptanceconduct of the plea by the court in which it is entered. There can be no assurance that the agreement in principle will be finalized or that the plea will be accepted. If the agreement in principle is not finalized or the plea is not accepted, it is not possible to assess the ultimate resolution of this investigation or its impact on the Company. former senior executive.

Although there can be no assurance, the Company does not believe that resolution of this investigation in accordance with the agreement in principlePlea should have a material impact on its ability to participate in federal procurement or health care programs.

As previously disclosed, the Company entered into a Deferred Prosecution Agreement (DPA) with the U.S. Attorney’s Office for the District of New Jersey (USAO) on June 15, 2005. Pursuant to the DPA, the USAO filed a criminal complaint against the Company alleging conspiracy to commit securities fraud, but deferred prosecution of the Company and will dismiss the complaint after two years if the Company satisfies all the requirements of the DPA. The Company has advised the USAO of the terms of the agreement in principle between the Company and the Antitrust Division. The U.S. Attorney for the District of New Jersey has advised the Company, although the guilty plea that is contemplated by the agreement in principle constitutes a violation of the DPA, the Company has cured that breach by terminating the employment of certain former officers of the Company as well as other actions taken to prevent the recurrence of the issues and events that led to this matter. The U.S. Attorney also has advised the Company that, assuming resolution of this investigation in accordance with the agreement in principle, and assuming the Company’s compliance with the DPA between May 10, 2007, and June 15, 2007, it is the USAO’s intention to terminate the DPA on June 15, 2007, and to seek dismissal with prejudice of the deferred charges pursuant to the DPA on a timely basis.

As previously disclosed, the Company has been served with a Civil Investigative Demand by the FTC requesting documents and information related to the proposed settlement. In addition, as previously disclosed, on April 13, 2007, the Company received a subpoena from the New York State Attorney General’s Office — Antitrust Bureau for documents related to the proposed settlement. The Company is cooperating fully with the investigations. Itit is not possible at this time reasonably to assess the impact of the proposed settlement with the Antitrust Division described abovePlea on the previously disclosed investigations by the FTC and the New York State Attorney General’s Office – Anti-trust Bureau, the outcome of the investigations or their impact on the Company.

Note 16. Legal Proceedings and Contingencies (Continued)

See “Securities Litigation & Investigations” below for a further discussion of certain securities litigation relating to efforts to settle the PLAVIX* patent litigation with Apotex.

PLAVIX* Litigation—International

Sanofi-Synthelabo and Sanofi-Synthelabo Canada Inc. instituted a prohibition action in the Federal Court of Canada against Apotex Inc. and the Minister of Health in response to a Notice of Allegation (NOA) from Apotex Inc. directed against Canadian Patent No. 1,336,777 (the ‘777 Patent) covering clopidogrel bisulfate. Apotex’s NOA indicated that it had filed an Abbreviated New Drug Submission (ANDS) for clopidogrel bisulfate tablets and that it sought approval (a Notice of Compliance) of that ANDS before the expiration of the ‘777 Patent, which is scheduled for August 12, 2012. Apotex’s NOA further alleged that the ‘777 Patent was invalid or not infringed. In March 2005, the Canadian Federal Court of Ottawa rejected Apotex’s challenge to the Canadian PLAVIX* patent and held that the asserted claims are novel, not obvious and infringed, and granted Sanofi’s application for an order of prohibition

Note 16. Legal Proceedings and Contingencies (Continued)

against the Minister of Health and Apotex Inc.Apotex. That order of prohibition precludes approval of Apotex’s ANDS until the patent expires in 2012, unless the Federal Court’s decision is reversed on appeal. Apotex filed an appeal, which the Canadian Federal Court of Appeal heard on December 12-13, 2006. On December 22, 2006, the Federal Court of Appeal dismissed Apotex’s appeal and upheld the Federal Court’s issuance of the order of prohibition. On February 20, 2007, Apotex filed leave to appeal this decision to the Supreme Court of Canada. Briefing is complete on Apotex’s motion forOn July 5, 2007, the Supreme Court of Canada granted Apotex leave to appeal the decision of the Canadian Federal Court of Appeal’s decision toAppeal.

Shareholder Derivative Lawsuit

In September 2006, certain members of the Board, current and former officers, and the Company were named in a derivative complaint,Steven W. Sampson v. Peter R. Dolan, et al., filed in the New York State Supreme CourtCourt. On July 27, 2007, the parties filed with the court a stipulation of Canada.dismissal without prejudice. The Supreme Court of CanadaCompany expects the court will decide whether to allowenter an order dismissing the appeal to proceed or it may dismiss the appeal.case.

OTHER INTELLECTUAL PROPERTY LITIGATION

TEQUIN (injectable form)

The Company and Kyorin Pharmaceuticals Co., Ltd. (Kyorin) commenced a patent infringement action in March 2005, against Apotex in the U.S. District Court for the Southern District of New York, relating to injectable forms of the antibiotic gatifloxacin, for which Kyorin holds the composition of matter patent and which the Company previously marketed as TEQUIN. The Company no longer sells the product in the U.S. The action related to Apotex’s filing of an aNDA for a generic version of injectable gatifloxacin with P(IV) certifications that the composition of the matter patent, which expires December 2007 but which was granted a patent term extension until December 2009, is invalid. On March 29, 2007, the parties submitted a joint stipulation of dismissal that ended the lawsuit.

ORENCIA

In January 2006, Repligen Corporation (Repligen) and the Regents of the University of Michigan filed a complaint against the Company in the U.S. District Court for the Eastern District of Texas, Marshall Division. ORENCIA was launched in February 2006. The complaint alleges that the Company’s then-anticipated sales of ORENCIA will infringe U.S. Patent No. 6,685,541. Repligen has since amended the complaint to include ongoing and future sales of ORENCIA. The trial is now scheduled to commence in April 2008.

In August 2006, Zymogenetics, Inc. filed a complaint against the Company in the U.S. District Court for the District of Delaware. The complaint alleges that the Company’s manufacture and sales of ORENCIA infringe U.S. Patents Nos. 5,843,725 and 6,018,026. The trial is now scheduled to commence in August 2008.

ABILIFY*

As previously disclosed, Otsuka has received formal notices from each of Teva, Pharmaceuticals USA (Teva), Barr Pharmaceuticals, Inc. (Barr), Sandoz Inc. (Sandoz), Synthon Laboratories, Inc. (Synthon), Sun Pharmaceuticals Ltd. (Sun), and Apotex stating that each has filed an aNDA with the FDA for various dosage forms of aripiprazole, which the Company and Otsuka comarket in the U.S. as ABILIFY*. Each of the notices further states that its aNDA contains a p(IV) certification directed to U.S. Patent No. 5,006,528 (‘528(the ‘528 Patent), which covers aripiprazole and expires in October 2014. In addition, each of the notices purports to provide Otsuka with the respective p(IV) certification. These certifications contain various allegations regarding the validity and enforceability of the ‘528 Patent. Otsuka has sole rights to enforce the ‘528 Patent. Otsuka has filed patent infringement actions based on the ‘528 Patent against Teva, Barr, Sandoz, Sun and Apotex in the U.S. District Court for the District of New Jersey, and against Synthon in the U.S. District Court for the Middle District of North Carolina. Sun and Synthon have filed motions to dismiss the case for lack of jurisdiction.

It is not possible at this time reasonably to assess the outcome of these lawsuits or their impact on the Company.

Note 16. Legal Proceedings and Contingencies (Continued)

GENERAL COMMERCIAL LITIGATION

Weisz & Stephenson Litigations

As previously reported, the Company was a defendant, along with many other pharmaceutical companies and pharmacies, in two class actions,Weisz v. Bristol-Myers Squibb Co., et al., and Stephenson v. Bristol-Myers Squibb Co., et alal.,, in which there were allegations of unfair business practices and untrue and misleading advertising under various California statutes. Defendants filedThe court granted motions to dismiss these actions on procedural and other grounds. On April 27, 2007, the court granted the motions as to the Company, but theWeisz case will continue as to other defendants. Final judgments of dismissal as to the Company were entered on May 31, 2007. This concludes the Company’s involvement in these matters unless plaintiffs appeal the court’s decision and the appeal is upheld.

SECURITIES LITIGATION & INVESTIGATIONS

D&K Health Care Resources Litigation

In November 2004,As previously disclosed, a class action complaint was filed in the U.S. District Court for the Eastern District of Missouri against the Company, D&K Health Care Resources, Inc. (D&K) and several current and former D&K directors and officers. The complaint allegesalleged that the Company participated in fraudulently inflating the value of D&K stock by allegedly engaging in improper “channel-stuffing” agreement with D&K. In June 2006, the Court granted the Company’s motion to dismiss the complaint, which the plaintiffs are able to appeal.complaint. In March 2007, the Court granted preliminary approval of a settlement between the lead plaintiff and the D&K defendants. IfAt the settlement hearing held on June 5, 2007, the Court entered a final judgment and order of dismissal, and granted final approval byof the Court, the proposedsettlement. The settlement would resolveresolves all claims relating to the subject matter of the action, including the dismissed claim against the Company.

Minneapolis Firefighters’ Relief Association and Jean Lai Litigations

In June and July 2007, two putative class action complaints,Minneapolis Firefighters’ Relief Assoc. v. Bristol-Myers Squibb Co., et al., 07 CV 5867 (Judge Crotty) and Jean Lai v. Bristol-Myers Squibb Company, et al., 07 CIV 6259, were filed in the U.S. District for the Southern District of New York against the Company’s former CEO, Peter Dolan and current Chief Financial Officer, Andrew Bonfield. The Court has scheduledcomplaints allege violations of securities laws for allegedly failing to disclose material information relating to efforts to settle the final settlement hearing for June 5, 2007.PLAVIX* patent infringement litigation with Apotex.

The Company intends to defend itself vigorously in these lawsuits. It is not possible at this time to reasonably assess the outcome of these lawsuits, or the potential impact on the Company.

PRICING, SALES AND PROMOTIONAL PRACTICES LITIGATION AND INVESTIGATIONS

As previously reported,disclosed, the Company, together with a number of defendants, is a defendant in a number of private civil matters relating to its pricing practices. In addition, the Company, together with a number of other pharmaceutical manufacturers, has received subpoenas and other document requests from various government agencies seeking records relating to its pricing, sales, marketing practices and best price reporting.

Note 16. Legal Proceedings and Contingencies (Continued)

Investigations – Office of the U.S. Attorney, Massachusetts

As previously reported,disclosed, the Company, the DOJ, and the Office of the U.S. Attorney for the District of Massachusetts have reached an agreement in principle, subject to approval by the DOJ, to settle several investigations involving the Company’s drug pricing, sales and marketing activities. The agreement in principle provides for a civil resolution and an expected payment of $499 million. The agreement in principle involves matters that have been actively investigated by and discussed with the DOJ and the U.S. Attorney for the District of Massachusetts over a number of years, including matters relating to (1) the pricing for certain products sold several years ago by a subsidiary, which had been reimbursed by governmental health care programs; 2) financial relationships between that subsidiary and certain customers and other entities; 3) certain consulting programs; 4) the promotion of ABILIFY* for unapproved indications; 5) the calculation of certain Medicaid rebates for SERZONE (nefazodone hydrochloride); and 6) the pricing for certain of the Company’s products reimbursed by governmental health care programs. The agreement contemplates that States will choose to participate in the settlement. There would be no criminal charges against the Company with respect to those matters. The agreement in principle also provides for the Company to enter into a corporate integrity agreement with the Office of Inspector General of the U.S. Department of Health and Human Services. The settlement is contingent upon the parties’ agreement to the terms of a final settlement agreement, including on the terms of the corporate integrity agreement and approval by the DOJ. There can be no assurance that the settlement will be finalized, or that all the States will choose to participate. The agreement in principle only covers those matters outlined above, and the DOJ, the U.S. Attorney for the District of Massachusetts and the States have indicated that they may pursue other matters outside the scope of the expected settlement, and in that event such matters could result in the assertion of civil and/or criminal claims.

Also as previously reported,disclosed, as a result of the agreement in principle, the Company has recorded aggregate reserves in the amount of $499 million for these matters. In accordance with GAAP, the aggregate reserves reflect the Company’s estimate of the expected probable loss with respect to these matters, assuming the settlement is finalized. If the settlement is not finalized, and/or if certain States choose not to participate, the amount reserved may not reflect eventual losses.

Furthermore, there are other open investigations on other issues being conducted by various Federal and state agencies as well as by certain Congressional committees. The Company is producing documents and actively cooperating with these investigations, which could result in the assertion of civil and/or criminal claims.

It is not possible at this time reasonably to assess the outcome of the investigations described above, or of any additional matters that the DOJ and the Office of the U.S. Attorney for the District of Massachusetts may pursue, or the potential impact on the Company.

As previously disclosed, in 2004, the Company undertook an analysis of its methods and processes for calculating prices for reporting under governmental rebate and pricing programs related to its U.S. Pharmaceuticals business. The analysis was completed in early 2005. Based on the analysis, the Company identified the need for revisions to its methodology and processes used for calculating reported pricing and related rebate amounts and implemented these revised methodologies and processes beginning with its reporting to the Federal government agency with primary responsibility for these rebate and price reporting obligations, the Centers for Medicare and Medicaid Services (CMS) in the first quarter of 2005. In addition, using the revised methodologies and processes, the Company also has recalculated the “Best Price” and “Average Manufacturer’s Price” required to be reported under the Company’s Federal Medicaid rebate agreement and certain state agreements, and the corresponding revised rebate liability amounts under those programs for the three-year period 2002 to 2004. Upon completion of the analysis in early 2005, the Company determined that the estimated rebate liability for those programs for the three-year period 2002 to 2004 was less than the rebates that had been paid by the Company for such period. Accordingly, in the fourth quarter of 2004, the Company recorded a reduction to the rebate liability in the amount of the estimated overpayment. Due to the uncertainty surrounding the recoverability of the Company’s estimated overpayment, the Company also recorded a reserve in an amount equal to the estimated overpayment at the end of 2004.

As also previously disclosed, the Company has submitted the proposed revisions and updated estimates discussed above to CMS for review. In July 2007, CMS notified the Company that it had completed its review and the Company may proceed with submitting revised pricing data for the period 2002 to 2004 subject to further conditions related to the calculation of Best Price and Average Manufacturer’s Price. At this time, it is not possible reasonably to assess the full amount of the rebates that could be recouped from the states or the timing of any such recovery. The Company expects that any such recovery will not have a material impact to its results of operations in any quarter.

Note 16. Legal Proceedings and Contingencies (Continued)

Litigation

As previously reported,disclosed, the Company, together with a number of other pharmaceutical manufacturers, is a defendant in private class actions, as well as suits brought by the attorneys general of numerous states, many New York counties, and the City of New York, which are pending in federal and state courts. In these actions, plaintiffs allege defendants caused the Average Wholesale Prices (AWPs) of their products to be inflated, thereby injuring government programs, entities and persons who reimbursed prescription drugs based on AWPs. The federal cases and several of the state attorney general actions and suits of New York Counties and the City

Note 16. Legal Proceedings and Contingencies (Continued)

of New York have been consolidated for pre-trial purposes in the U.S. District Court for the District of Massachusetts (AWP MDL). The Court in the AWP MDL has certified three classes of persons and entities who paid for or reimbursed for seven of the Company’s physician-administered drugs. The non-jury trial for Classes 2 and 3 (insurance companies and health and welfare funds in Massachusetts) commenced November 2006 and testimony ended January 2007. On June 21, 2007, the Court issued its decision in the non-jury trial for Classes 2 and 3, finding the Company liable for violation of Massachusetts consumer protection law with respect to certain oncology drugs for certain years. The Court has not yet issued a decision. Trialfound damages of $183,454 for Class 3 and instructed the parties to apply the Court’s opinion to ascertain damages for Class 2. The Company will appeal the decision to the U.S. Court of Appeals for the First Circuit. On June 26, 2007, the Company settled the claims of Class 1 (Medicare Part B beneficiaries nationwide) for $13 million, plus half the costs of class notice up to a maximum payment of $1 million. A hearing for preliminary approval of the Class 1 settlement is scheduled to begin on July 23,for August 9, 2007.

The Company has recorded reserves of $14 million for these matters. In accordance with GAAP, the reserve reflects the Company’s estimate of minimal probable loss with respect to these maters, assuming the settlement is finalized. If the settlement is not finalized, the amount reserved may not reflect eventual losses. It is not possible at this time reasonably to assess the outcome of the litigation matters described above, or their potential impact on the Company.

PRODUCT LIABILITY LITIGATION

The Company is a party to various product liability lawsuits. As previously reported, these lawsuits involve, among other things, hormone replacement therapy products and the Company’s SERZONE prescription drug. In addition to lawsuits, the Company also faces unfiled claims involving these and other products.

SERZONE

SERZONE is an antidepressant that was launched by the Company in May 1994 in Canada and in March 1995 in the U.S. As previously reported,disclosed, in 2002, a number of lawsuits, including several class actions, were filed against the Company in Canada alleging, among other things, that the Company knew or should have known about the hepatic risks posed by SERZONE an antidepressant marketed by the Company, and failed to adequately warn physicians and users of the risks. In addition to the cases filed in the U.S., class actions were filed in Canada. Without admitting any wrongdoing or liability, in February 2006,October 2004, the Company executed anentered into a settlement agreement in principle with respect to all claims in the U.S. and its territories regarding SERZONE. In September 2005, the Court issued an opinion granting final approval of the SERZONE claims in Canada. Pursuant to the termssettlement. As of the proposed settlement,June 30, 2007, all claims will be dismissed, the litigation will be terminated, the defendants will receive releases and the Company committed to paying at least $1 million into funds for class members. The settlement of the Canadian claims must be approved by the Ontario Superior Court of Justice and the Québec Superior Court, District of Montreal. The Approval Hearing for the Settlementmatters in the Ontario action brought on behalf of Class Members resident in Canada, excluding Québec, occurred on April 24, 2007. The Approval Hearing in the Québec action brought on behalf of Class Members resident in Québec occurred on April 17, 2007. There can be no assurance that the settlement will be approved or finalized.U.S. have been dismissed.

Hormone Replacement Therapy

The plaintiffs in this mass-tort litigation allege, among other things, that various hormone therapy products, including hormone therapy products formerly manufactured by the Company (ESTRACE*, Estradiol, DELESTROGEN* and OVCON*) cause breast cancer, stroke, blood clots, cardiac and other injuries in women, that the defendants were aware of these risks and failed to warn consumers. As of March 31,June 30, 2007, the Company was a defendant in 316318 lawsuits filed on behalf of approximately 1,2261,221 plaintiffs in federal and state courts throughout the U.S.

ENVIRONMENTAL PROCEEDINGS

As previously reported, the Company is a party to several environmental proceedings and other matters, and is responsible under various state, Federal and foreign laws, including the Comprehensive Environmental Response, Compensation and Liability Act, (CERCLA), for certain costs of investigating and/or remediating contamination resulting from past industrial activity at the Company’s current or former sites or at waste disposal or reprocessing facilities operated by third parties.

CERCLA Matters

With respect to CERCLA matters for which the Company is responsible under various state, Federal and foreign laws, the Company typically estimates potential costs based on information obtained from the U.S. Environmental Protection Agency (EPA), or counterpart state agency and/or studies prepared by independent consultants, including the total estimated costs for the site and the expected cost-sharing, if any, with other “potentially responsible parties”, and the Company accrues liabilities when they are probable and reasonably estimable. As of March 31,June 30, 2007, the Company estimated its share of the total future costs for these sites to be

Note 16. Legal Proceedings and Contingencies (Continued)

approximately $70$69 million, recorded as other liabilities, which represents the sum of best estimates or, where no simple estimate can reasonably be made, estimates of the minimal probable amount among a range of such costs (without taking into account any potential recoveries from other parties, which are not currently expected).

Note 16. Legal Proceedings and Contingencies (Continued)

Puerto Rico Air Emissions Civil Litigation

As previously reported,disclosed, the Company is one of several defendants, including many of the major U.S. pharmaceutical companies, in a purported class action suit filed in Superior Court in Puerto Rico in February 2000 relating to air emissions from a government owned and operated wastewater treatment facility. In April 2006, the Company executed an individual settlement with the plaintiffs in the amount of approximately $0.5 million, subject to certain conditions, including that the Court would decide to certify the case as a class action. The Court deferred decision on class certification pending its review of expert reports on the facility’s operations, and ongoing efforts to reach a global settlement. In March 2007, with the Court’s assistance, the parties reached a tentative global settlement, which would resolve all claims in the litigation. The terms of the proposed settlement were discussed with the Court at a status conferenceconferences held onin May 2,and June 2007. The Court instructed the parties to submit aA draft settlement agreement was presented to the Court byat the June 1,15, 2007 status conference. The parties are finalizing the terms of the settlement, which is expected to be filed with the court in August 2007. Under the terms of the settlement, certain measures, including capital improvements, will be implemented at the wastewater treatment facility to minimize the potential for odor emissions. The defendants also agreed to pay plaintiffs $4.8 million in settlement of all claims. The Company’s share of the payment to plaintiffs is less than $1 million. A hearing to certify the class is scheduled for August 9, 2007 and a hearing to approve the settlement is scheduled for October 18, 2007.

Passaic River (NJ) Remediation and Natural Resource Damages Claims

As previously reported,disclosed, in September 2003, the New Jersey Department of Environmental Protection (NJDEP) issued an administrative enforcement Directive and Notice under the New Jersey Spill Compensation and Control Act requiring the Company and approximately 65 other companies to perform an assessment of natural resource damages and to implement unspecified interim remedial measures to restore conditions in the Lower Passaic River.River (LPR). The Directive alleges that the Company is liable because it historically sent bulk waste to the former Inland Chemical Company facility in Newark, NJ (now owned by McKesson Corp. (McKesson)) for reprocessing, and that releases of hazardous substances from this facility have migrated into Newark Bay and continue to have an adverse impact on the Lower Passaic RiverLPR watershed. Subsequently, the EPA also issued a notice letter under CERCLA to numerous parties—parties, but not including the Company—Company, seeking their cooperation in a Remedial Investigation/Feasibility Study (RI/FS) of conditions in substantially the same portion of the Passaic RiverLPR that is the subject of the NJDEP’s Directive. A group of these other parties entered into a consent agreement with EPA in 2004, to finance a portion of the RI/FS. The EPA has not yet determined the estimated cost of the study. Under the 2004 consent agreement,under which the private party group committed to pay roughly half of the $20 million estimated for the RI/FS by EPA at that time, subject to revision and future negotiation. The RI/FS, now projected to run until 2011, may also lead to clean-up actions, directed by the EPA and the Army Corps of Engineers. However, the EPA recently has substantially increased its estimate of the scope and cost of the RI/FS;FS and, as a result, the private party group has persuaded the EPA to allow the group to perform most of the remaining RI/FS tasks. By the group’s estimate, total costs to complete the RI/FS and related tasks now exceed $54$50 million. The group has negotiated an amended consent agreement with the EPA to conduct the remaining RI/FS work, which became effective in May 2007. In conjunction with those efforts, the Company and McKesson have committed to acceptaccepted an offer from the private party group for members to buy out of remaining RI/FS tasks. That group is actively negotiating with the EPA; if successful, those negotiations will result in an amended consent agreement.

In response to these developments, the Company has reached an agreement in principle with McKesson under which the Company will contribute approximately $110,000 towards RI/FS tasks. In addition, the EPA recently announced plans to shareconsider the costsimplementation of an anticipated agreed portion“early-action” remedial measures to address the most highly-contaminated portions of the LPR while the RI/FS tasks.is being completed. The EPA has indicated it expects to select any such actions early in 2008. Also, the federal trustee agencies with responsibility for natural resources associated with the LPR have proposed that the private party group enter into an agreement to assess natural resource damages in the LPR. The group expects to discuss the proposal with the trustees in the near future. The extent of any liability the Company may face for these and related requirements cannot yet be determined.

MACT Compliance—Puerto Rico Facilities (Barceloneta and Humacao)WAGE & HOUR LITIGATION

In March 2005,On June 28, 2007, a former sales manager for the Company, commencedfiled a voluntary environmental auditputative class action complaint in the Superior Court of its Barcelonetathe State of California for the County of Alameda,Kin Fung, et al. v. Bristol-Myers Squibb Company, et al., (Case Number RG07333147), alleging that the Company violated California wage and Humacao, Puerto Rico facilitieshour laws by, among other things, not paying overtime compensation to determine their compliance withFung and a putative class of similarly situated sales employees.

On June 28, 2007, another former sales manager for the EPA’s regulations regardingCompany, filed a putative class action complaint in the maximum achievable control technology requirementsU.S. District Court for emissionsthe Southern District of hazardous air pollutants from pharmaceuticals production (Pharmaceutical MACT). New York,Beth Amendola v. Bristol-Myers Squibb Company, et al. (Docket No. 07-CV-6088), alleging that the Company violated the federal Fair Labor Standards Act by, among other things, not paying overtime compensation to Ms. Amendola and a putative class of similarly situated sales employees.

The Company submittedintends to vigorously defend itself in these lawsuits. As the EPA an audit report forabove matters are in the Humacao facility in June 2005 and for the Barceloneta facility in July 2005, which disclosed potential violationsvery early stages of the Pharmaceutical MACT requirements at both facilities. The Company and the EPA are currently in discussions regarding resolution of this matter. The Companylitigation, it is awaiting a response from EPA with respect to resolution of this matter.

Note 17. Subsequent Events

In April 2007, the Company and Pfizer Inc. (Pfizer) entered into a worldwide collaboration to develop and commercialize apixaban, an anticoagulant discovered by the Company being studied for the prevention and treatment of a broad range of venous and arterial thrombotic conditions. In accordance with the terms of the agreement Pfizer made an upfront payment of $250 million to the Company. Pfizer will fund 60% of all development costs effective January 1, 2007 going forward, and the Company will fund 40%. The Company may also receive additional payments of up to $750 million from Pfizer based on development and regulatory milestones. The companies will jointly develop the clinical and marketing strategy of apixaban, and will share commercialization expenses and profits/losses equally on a global basis. In a separate agreement, the companies will also collaborate on the research, development and commercialization of a Pfizer discovery program which includes advanced pre-clinical compounds with potential applications for the treatment of metabolic disorders, including obesity and diabetes. Pfizer will be responsible for all research and early-stage

Note 17. Subsequent Events16. Legal Proceedings and Contingencies (Continued)

development activities for

not possible at this time reasonably to assess the metabolic disorders program,outcome of the litigation matters described above, but it is not expected that their outcome would be material to the Company’s results of operations and the companies will jointly conduct Phase III developmentcash flows, or be material to its financial condition and commercialization activities. The Company will make an upfront payment of $50 million to Pfizer as part of this agreement. The companies will share all development and commercialization expenses along with profits/losses on a 60%-40% basis, with Pfizer assuming the larger share of both expenses and profits/losses.liquidity.

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

Executive Summary

Bristol-Myers Squibb Company (BMS, the Company) is a worldwide pharmaceutical and related health care products company whose mission is to extend and enhance human life by providing the highest quality pharmaceutical and related health care products. The Company is engaged in the discovery, development, licensing, manufacturing, marketing, distribution and sale of pharmaceuticals and related health care products.

As previously disclosed, on June 15, 2005, the Company entered into a Deferred Prosecution Agreement (DPA) with the United States Attorney’s Office (USAO) for the District of New Jersey resolving the investigation by the USAO of the Company relating to wholesaler inventory and various accounting matters covered by the Company’s settlement with the Securities and Exchange Commission (SEC). Pursuant to the DPA, the USAO filed a criminal complaint against the Company alleging conspiracy to commit securities fraud, but agreed to defer prosecution of the Company and dismiss the complaint after two years if the Company satisfied all of the requirements of the DPA. On June 15, 2007, the DPA expired and the complaint has been dismissed. The Company has no on-going obligations under the DPA. For additional discussion on the DPA, see “—SEC Consent Order and Deferred Prosecution Agreement” below.

Strategy

The Company continues to execute its strategy for long-term growth and is currently on track with its strategic transition. The Company’s strategy includes the ongoing process of transforming and streamlining itself to maximize the resources that support delivering the full value of its pipeline and portfolio to shareholders. This transformation will include a comprehensive cost reduction program, incremental to current efforts that will include workforce reductions in some areas and the rationalization of some facilities. The Company expects to incur restructuring charges in connection with this program, however, the amount and the timing of these charges cannot be reasonably estimated at this time.

PLAVIX*

The Company’s largest product ranked by net sales is PLAVIX* (clopidogrel bisulfate) with United States (U.S.) sales of $2.7 billion in 2006. The composition of matter patent for PLAVIX*, which expires in 2011, is currently the subject of patent litigation in the U.S. with Apotex Inc. and Apotex Corp. (Apotex) and with other generic companies, as well as in other less significant jurisdictions. The Company has previously disclosed certain developments in the pending PLAVIX* litigation with Apotex, including the at-risk launch of a generic clopidogrel bisulfate product by Apotex in August 2006.

As noted above, Apotex launched a generic clopidogrel bisulfate product that competes with PLAVIX* on August 8, 2006. On August 31, 2006, the U.S. District Court for the Southern District of New York (District court) granted a motion by the Company and its product partner, Sanofi-Aventis (Sanofi), to enjoin further sales of Apotex’s generic clopidogrel bisulfate product, but did not order Apotex to recall product from its customers. The District court’s grant of a preliminary injunction has beenwas affirmed on appeal. The trial testimony ended on February 15, 2007. On June 19, 2007, and the parties are awaiting the District court’s decision.court issued an opinion and order upholding the validity and enforceability of the U.S. Patent No. 4,847,265 (the ‘265 Patent), maintaining the main patent protection for PLAVIX* in the U.S. until November 2011. The District court also ruled that Apotex’s generic clopidogrel bisulfate product infringed the ‘265 Patent and permanently enjoined Apotex from engaging in any activity that infringes the ‘265 patent, including marketing its generic product in the U.S. until after the patent expires. The amount of damages will be set at a later time. Apotex has appealed the decision to the U.S. Court of Appeals for the Federal Circuit.

The at-risk launch of generic clopidogrel bisulfate had a significant adverse effect on net sales of PLAVIX*, which the Company estimates to be in a range of $1.2 billion to $1.4 billion in 2006, and $300$200 million to $350$250 million in the first quarter of 2007 and $50 million to $100 million in the second quarter of 2007. Estimated total U.S. prescription demand for clopidogrel bisulfate (branded and generic) increased by 13% in 2006 compared to 2005, while estimated total U.S. prescription demand for branded PLAVIX* decreased by 20% in the same period. Estimated total U.S. prescription demand for clopidogrel bisulfate (branded and generic) increased by 18%9% and 11% in the first and second quarter of 2007, respectively, compared to 2006, while estimated total U.S. prescription demand for branded PLAVIX* decreased by 28%36% and increased 1% in the same period.periods, respectively. The Company expectsbelieves that the supply of generic clopidogrel bisulfate that was sold into distribution channels following the Apotex at-risk launch in August 2006 will have a residual impact on PLAVIX* net sales andwas substantially depleted at June 30, 2007, however, the Company's overall financial results into at least the second quarter of 2007. The full amount and duration of the impact will depend on the amount of generic product Apotex sold into the distribution channel and other factors.

The Company’s U.S. territory partnership under its alliance with Sanofi is also a plaintiff in three additional pending patent infringement lawsuits against Dr. Reddy’s Laboratories, Inc. and Dr. Reddy’s Laboratories, LTD (Dr. Reddy’s), Teva Pharmaceuticals USA, Inc. (Teva) and Cobalt Pharmaceuticals Inc. (Cobalt), all related to the U.S. Patent No. 4,847,265.‘265 Patent. A trial date for the action against Dr.

Reddy's has not been set. The patent infringement actions against Teva and Cobalt have beenwere stayed pending resolution of the Apotex litigation, and the parties to those actions have agreed to be bound by the outcome of the litigation against Apotex, although Teva and Cobalt can appeal the outcome of the litigation. Consequently, on July 12, 2007, the District court entered judgements against Cobalt and Teva and permanently enjoined Cobalt and Teva from engaging in any activity that infringes the ‘265 Patent until after the Paten expires. Each of Dr. Reddy’s and Teva have filed an Abbreviated New Drug Application with the U.S. Food and Drug Administration (FDA), and all exclusivity periods and statutory stay periods under the Hatch-Waxman Act have expired. Accordingly, final approval by the FDA would provide each company authorization to distribute a generic clopidogrel bisulfate product in the U.S., subject to various legal remedies for which the Companies may apply including injunctive relief and damages.

The Company continues to believe that the PLAVIX* patents are valid and infringed, and with Sanofi, is vigorously pursuing enforcement of their patent rights in PLAVIX*. It is not possible at this time reasonably to assess the ultimate outcome of the ongoing patent litigation withappeal by Apotex of the District court’s decision, or of the other PLAVIX* patent litigations or the timing of any renewed generic competition for PLAVIX* from Apotex or additional generic competition for PLAVIX* from other third-party generic pharmaceutical companies. However, if Apotex were to prevail at trial,in an appeal of the patent litigation, the Company would expect to face renewed generic competition for PLAVIX* from Apotex promptly thereafter.

On May 10, 2007, the Company and the Antitrust Division of the U.S. Department of Justice (DOJ) reached an agreement in principle to resolve the previously disclosed investigation by the Antitrust Division regarding the proposed settlement with Apotex of the pending PLAVIX* patent litigation. Under the agreement in principle, the Company or a subsidiary of the Company will plead guilty to criminal charges consisting of two violations of Section 1001 of U.S. Code Title 18 (relating to false statements to a government agency) carrying an aggregate statutory maximum fine of $1 million. The agreement in principle is contingent on the parties’ agreement to the terms of a final agreement and acceptance of the plea by the court in which it is entered. There can be no assurance that the agreement in principle will be finalized or that the plea will be accepted. If the agreement in principle is not finalized or the plea is not accepted, it is not possible to assess the ultimate resolution of this investigation or its impact on the Company. Although there can be no assurance, the Company does not believe that resolution of this investigation in accordance with the agreement in principle should have a material impact on its ability to participate in federal procurement or health care programs. The U.S. Attorney’s Office for the District of New Jersey (USAO) has advised the Company that, assuming resolution of this investigation in accordance with the agreement in principle, and assuming the Company’s compliance with the Deferred Prosecution Agreement (DPA) between May 10, 2007, and June 15, 2007, it is the USAO’s intention to terminate the DPA on June 15, 2007, and to seek dismissal with prejudice of the deferred charges pursuant to the DPA on a timely basis.

As previously disclosed, the Company has been served with a Civil Investigative Demand by the Federal Trade Commission (FTC) requesting documents and information related to the proposed settlement. In addition, as previously disclosed, on April 13, 2007, the Company received a subpoena from the New York State Attorney General’s Office - Antitrust Bureau for documents related to the proposed settlement. The Company is cooperating fully with the investigations. It is not possible at this time reasonably to assess the impact of the proposed agreement in principle with the Antitrust Division described above or a final agreement on the investigations, the outcome of the investigations or their impact on the Company.

For additional discussion of legal matters, including the PLAVIX* patent litigation and related legal matters, the Antitrust Division, FTC and New York State Attorney General’s Office investigations related to the proposed settlement with Apotex and the terms of the DPA, and SEC Consent, see “Item 1. Financial Statements—Note 16. Legal Proceedings and Contingencies” as well asContingencies,” “—OUTLOOK” below and “—“Item 7. Management’s Discussion and Analysis – SEC Consent Order and Deferred Prosecution Agreement” below.in the Company’s 2006 Form 10-K. For additionala further discussion of the risks and uncertainties relating to the matters discussed above, see “Item 1A. Risk Factors” in the Company’s 2006 Form 10-K and “Part II. Item 1A. Risk Factors” below.

New Product, Pipeline and PipelineProduct Developments

The Company submitted applications to the U.S. and European regulatory authorities seeking to change the recommended starting dose of SPRYCEL to 100 mg once daily, from 70 mg twice daily, for patients with chronic-phase chronic myeloid leukemia with resistance or intolerance to prior therapy including imatinib. In July 2007, the FDA accepted the SPRYCEL supplemental New Drug Application (sNDA) for priority review, and the Committee for Human Medicinal Products of the European Medicines Agency (EMEA) granted a positive opinion on the Company’s submission. The target action date for the SPRYCEL sNDA is mid-November 2007, and a final EMEA decision is expected by September 2007.

Two sNDAs for the atypical antipsychotic ABILIFY* were accepted by the FDA for priority review for the treatment of pediatric patients (13-17 years old) with schizophrenia in June 2007 and for the treatment of adults with major depressive disorder as adjunctive to antidepressant therapy in July 2007.

In July 2007, the Company and ImClone Systems Incorporated (ImClone) amended the terms of their agreement for the codevelopment and copromotion of ERBITUX* in North America. Under this amendment, the companies have jointly agreed to expand the investment in the ongoing clinical development plan for ERBITUX*. Development costs, up to a threshold value, will be the sole responsibility of the Company; costs in excess of this threshold will be shared by both companies according to a pre-determined ratio. With this additional funding, the companies intend to further explore the use of ERBITUX* in additional tumor types including brain, breast, bladder, gastric, lung, pancreas and prostate.

In June 2007, the FDA accepted a New Drug Application (NDA) for the investigational compound ixabepilone. The proposed indications for ixabepilone are as a monotherapy to treat patients with metastatic or locally advanced breast cancer after failure of an anthracycline, a taxane, and capecitabine and in combination with capecitabine to treat patients with metastatic or locally advanced breast cancer after failure of an anthracycline and a taxane. The NDA has been granted priority review, with a target action date in late October 2007.

In June 2007, the FDA accepted a supplemental Biologics License Application (sBLA) for ERBITUX*. With this application, the Company and ImClone Systems Incorporated (ImClone) seek to include evidence of improved overall survival in the product labeling for ERBITUX* in the third-line treatment of patients with metastatic colorectal cancer (mCRC). If the sBLA is approved, ERBITUX* would be the only biologic therapy to demonstrate overall survival as a single agent in patients with mCRC. The ERBITUX* sBLA has been granted a priority review, with a likely action date of early October 2007.

ORENCIA was approved by the European Commission in May 2007, and has received approval and/or reimbursement in several European markets, including the United Kingdom, Germany, Austria, Sweden, the Netherlands and Denmark.

The Company and its partner AstraZeneca PLC (AstraZeneca) decided in July 2007 to move the investigational compound dapagliflozin, a selective inhibitor of the sodium-glucose transporter 2 being studied for the treatment of diabetes, into Phase III testing based on results of Phase II clinical trials

In May 2007, the Company and Isis Pharmaceuticals, Inc. (Isis) entered into a collaborative agreement to discover, develop and commercialize novel antisense drugs targeting proprotein convertase subtilisin kexin 9 for the prevention and treatment of cardiovascular disease. The Company made an upfront payment of $15 million to Isis as part of this agreement and will provide Isis with at least $9 million in research funding over a period of three years.

In April 2007, the Company and Pfizer Inc. (Pfizer) entered into a worldwide collaboration to develop and commercialize apixaban, an anticoagulant discovered by the Company being studiedcollaborative agreement for the prevention and treatment of a broad range of venous and arterial thrombotic conditions. In accordance with the terms of the agreement Pfizer made an upfront payment of $250 million to the Company. Pfizer will fund 60% of all development costs effective January 1, 2007 going forward, and the Company will fund 40%. The Company may also receive additional payments of up to $750 million from Pfizer based on development and regulatory milestones. The companies will jointly develop the clinical and marketing strategy of apixaban, and will share commercialization expenses and profits/losses equally on a global basis. In a separate agreement, the companies will also collaborate on the research, development and commercialization of a Pfizer discovery program which includes advanced pre-clinical compounds with potential applications for the

treatment of metabolic disorders, including obesity and diabetes. Pfizer will be responsible for all research and early-stage development activities for the metabolic disorders program, and the companies will jointly conduct Phase III development and commercialization activities. The Company will make an upfront payment of $50 million to Pfizer as part of this agreement. The companies will share all development and commercialization expenses along with profits/losses on a 60%-40% basis, with Pfizer assuming the larger share of both expenses and profits/losses.

In April 2007, the FDA approved an update to the ORENCIA product labeling regarding the progression of structural joint damage – an important measure in the treatment of rheumatoid arthritis (RA). The indication was strengthened from “slowing” to “inhibiting” the progression of structural damage in adult patients with moderately to severely active RA who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs, such as methotrexate or tumor necrosis factor antagonists.

In March 2007, the Committee for Medicinal Products for Human Use of the European Medicines Agency granted a positive opinion on the Company's application for ORENCIA in Europe for the treatment of RA.

In April 2007, the FDA Cardio-Renal Advisory Committee voted unanimously to recommend approval of a new indication for AVALIDE*, as initial treatment of some patients for hypertension. AVALIDE*, a fixed-dose combination of irbesartan and hydrochlorothiazide, is currently approved for the treatment of hypertension, for hypertensive patients with blood pressure uncontrolled on monotherapy. The proposed labeling would no longer require starting or titrating monotherapy. If approved, the new indication for AVALIDE* would be for the first-line treatment of hypertension in patients who are unlikely to obtain their blood pressure goals on monotherapy.

In February 2007, the Company and ImClone Systems Incorporated (ImClone) submitted an application to the Japanese Pharmaceuticals and Medical Devices Agency for the use of ERBITUX* in treating patients with advanced colorectal cancer. The Japanese submission was based on results from studies conducted in Europe and Japan which confirm the activity of ERBITUX* in patients with metastatic colorectal cancer. The filing in Japan is a result of a development collaboration between the Company, ImClone and Merck KGaA of Darmstadt, Germany.

In February 2007, BARACLUDE was added to the American Association for the Study of Liver Disease treatment guidelines for hepatitis B as a first-line treatment option. BARACLUDE also received approval and/or reimbursement in additional key European markets throughout the first quarter, including Italy.

During the first quarter, SPRYCEL received approval and/or reimbursement in additional European markets, including Ireland, Norway, Sweden and Greece, and was also approved in Canada and New Zealand.

In February 2007, the Company and Adnexus Therapeutics (Adnexus) entered into a worldwide alliance to discover, develop and commercialize Adnectin-based therapeutics for important oncology-related targets. Under the terms of the agreement, the Company made an upfront payment of $20 million and Adnexus is also eligible to receive regulatory milestone payments of up to $210 million per product, as well as royalties on product sales and sales-based milestone payments.

In December 2006, the Company entered into a collaboration agreement with Exelixis Pharmaceuticals, Inc. (Exelixis) to discover, develop and commercialize novel targeted therapies for the treatment of cancer. The agreement became effective in January 2007 and in accordance with the terms of the agreement, the Company made an upfront payment of $60 million to Exelixis. Exelixis is also eligible to receive $20 million for each of up to three investigational drug candidates selected by the Company. The companies will share equally all development costs along with commercial profits in the U.S.

Three Months Results of Operations

 

  Three Months Ended March 31, 
      % of Net Sales 

Dollars in Millions

  Three Months Ended June 30, 

2007

  

2006

  

% Change

  % of Net Sales 
  2007 2006 % Change 2007 2006   2007 2006 

Net Sales

  $4,476  $4,676  (4)%    $4,928  $4,871  1%  

Earnings before Minority Interest and Income Taxes

  $917  $1,193  (23)% 20.5% 25.5%  $1,157  $1,110  4% 23.5% 22.8%

Provision for Income Taxes

  $86  $328  (74)%    $257  $256  —     

Effective tax rate

   9.4%  27.5%      22.2%  23.1%   

Net Earnings

  $690  $714  (3)% 15.4% 15.3%  $706  $667  6% 14.3% 13.7%

FirstSecond quarter 2007 net sales decreased 4%,increased 1% to $4.9 billion, including a 2% favorable foreign exchange impact to $4.5 billion compared to the same period in 2006. U.S. net sales decreased 5%increased 1% to $2.5$2.8 billion infor the first quarter of 2007 compared to the same period in 2006, primarily due to loss of exclusivity of PRAVACHOL and lower sales of PLAVIX*, partially offset bythe continued growth of other key brandsproducts and sales of newer products.products, mostly offset by the impact of generic clopidogrel bisulfate and increased generic competition for PRAVACHOL. International net sales remained constant at $2.0increased 2% to $2.1 billion, including a 5% favorable foreign exchange impact.

The composition of the change in sales is as follows:

 

   Analysis of % Change 

Three Months Ended March 31,

  Total Change Volume Price  Foreign
Exchange
 

Three Months Ended June 30,

  Total Change  Analysis of % Change 
 Volume Price Foreign Exchange 

2007 vs. 2006

  (4)% (6)% —    2%  1% (2)% 1% 2%

In general, the Company’s business is not seasonal. For information on U.S. pharmaceuticals prescriber demand, reference is made to the tabletables within Business SegmentsEstimated End-User Demand under the Pharmaceuticals sectionsections below, which setsset forth a comparison of changes in net sales to the estimated total prescription growth (for both retail and mail order customers) for certain of the Company’s top 15 pharmaceutical products and new products sold by the U.S. Pharmaceuticals business.

The Company operates in three reportable segments—Pharmaceuticals, Nutritionals and Other Health Care. The percent of the Company’s net sales by segment were as follows:

 

  Three Months Ended March 31,   Three Months Ended June 30, 
  Net Sales % of Total Net Sales   Net Sales % of Total Net Sales 
Dollars in Millions  2007  2006  % Change 2007 2006   2007  2006  % Change 2007 2006 

Pharmaceuticals

  $3,457  $3,700  (7)% 77.2% 79.1%  $3,851  $3,859  —    78.1% 79.2%

Nutritionals

   606   565  7% 13.5% 12.1%   620   582  7% 12.6% 12.0%

Other Health Care

   413   411  —    9.3% 8.8%   457   430  6% 9.3% 8.8%
                            

Health Care Group

   1,019   976  4% 22.8% 20.9%   1,077   1,012  6% 21.9% 20.8%
                            

Total

  $4,476  $4,676  (4)% 100.0% 100.0%  $4,928  $4,871  1% 100.0% 100.0%
                            

The Company recognizes revenue net of various sales adjustments to arrive at net sales as reported on the Consolidated Statement of Earnings. These adjustments are referred to as gross-to-net sales adjustments. The following table sets forth the reconciliation of the Company’s gross sales to net sales by each significant category of gross-to-net sales adjustments:

 

  Three Months Ended March 31,   Three Months Ended
June 30,
 
Dollars in Millions  2007 2006   2007 2006 

Gross Sales

  $5,198  $5,454   $5,607  $5,612 

Gross-to-Net Sales Adjustments

      

Prime Vendor Charge-Backs

   (184)  (192)   (151)  (189)

Women, Infants and Children (WIC) Rebates

   (215)  (225)   (214)  (219)

Managed Health Care Rebates and Other Contract Discounts

   (85)  (101)   (105)  (97)

Medicaid Rebates

   (53)  (74)   (43)  (45)

Cash Discounts

   (56)  (63)   (63)  (62)

Sales Returns

   (42)  (43)   (26)  (42)

Other Adjustments

   (87)  (80)   (77)  (87)
              

Total Gross-to-Net Sales Adjustments

   (722)  (778)   (679)  (741)
              

Net Sales

  $4,476  $4,676   $4,928  $4,871 
              

The decrease in gross-to-net adjustmentsprime vendor charge-backs for the three months ended March 31,June 30, 2007 compared to the same period in 2006 was primarily driven bydue to lower gross sales. Managed health care rebatessales of TAXOL® (paclitaxel), PRAVACHOL and PARAPLATIN as a result of exclusivity. Sales returns decreased primarily due to higher accruals in 2006 as a result of the exclusivity lossdiscontinued commercialization of PRAVACHOL, which also reduced Medicaid rebates. Medicaid rebates also decreased across other Cardiovascular products due to lower gross sales volume and lower utilization.TEQUIN.

The following table sets forth the activities and ending balances of each significant category of gross-to-net sales adjustments:

Dollars in Millions  Prime
Vendor
Charge-
Backs
  Women,
Infants and
Children
(WIC)
Rebates
  Managed
Health Care
Rebates and
Other
Contract
Discounts
  Medicaid
Rebates
  Cash
Discounts
  Sales Returns  Other
Adjustments
  Total 

Balance at January 1, 2006

  $107  $252  $167  $326  $26  $185  $124  $1,187 

Provision related to sales made in current period

   706   867   381   174   221   200   348   2,897 

Provision related to sales made in prior periods

   (3)  5   (33)  —     3   30   (9)  (7)

Returns and payments

   (747)  (894)  (405)  (363)  (232)  (196)  (343)  (3,180)

Impact of foreign currency translation

   —     —     1   —     —     2   4   7 
                                 

Balance at December 31, 2006

   63   230   111   137   18   221   124   904 

Provision related to sales made in current period

   185   214   89   53   56   32   87   716 

Provision related to sales made in prior periods

   (1)  1   (4)  —     —     10   —     6 

Returns and payments

   (183)  (203)  (77)  (44)  (56)  (40)  (97)  (700)

Impact of foreign currency translation

   —     —     1   —     —     —     1   2 
                                 

Balance at March 31, 2007

  $64  $242  $120  $146  $18  $223  $115  $928 
                                 

In 2007, no significant revisions were made to the estimates for gross-to-net sales adjustments related to sales made in prior periods.

Pharmaceuticals

The composition of the change in pharmaceutical sales is as follows:

 

      Analysis of % Change

Three Months Ended March 31,

   Total Change  Volume  Price  Foreign Exchange

Three Months Ended June 30,

  Total Change  

Analysis of % Change

 
  Volume Price Foreign Exchange 

2007 vs. 2006

   (7)%  (9)%    2%  —    (3)% 1% 2%

Worldwide Pharmaceutical sales decreased 7%,remained relatively constant at $3,851 million in the second quarter of 2007, including a 2% favorable foreign exchange impact, compared to $3,457$3,859 million in the first quarter of 2007 compared to the same period in 2006.

U.S. pharmaceutical sales decreased 6%increased 2% to $1,944$2,243 million in the firstsecond quarter of 2007 compared to $2,205 million in the same period in 2006, primarily due to the loss of exclusivity of PRAVACHOL and lower sales of PLAVIX*, partially offset by continued growth of other key products and sales of newer products BARACLUDE, ORENCIA and SPRYCEL. In aggregate, estimated U.S. wholesaler inventory levels of the Company’s key pharmaceutical products soldSPRYCEL, partially offset by the U.S. Pharmaceutical business at the endimpact of the first quarter decreased to less than twogeneric clopidogrel bisulfate and a half weeks.increased generic competition for PRAVACHOL.

International pharmaceutical sales decreased 7%3%, including a 4%5% favorable foreign exchange impact, to $1,513$1,608 million for the firstsecond quarter of 2007 compared to $1,654 million in the same period in 2006. The decrease was due primarily to a decline in PRAVACHOL and TAXOL® (paclitaxel) sales resulting from increased generic competition in Europe, partially offset by strong sales growth in Virology products REYATAZ and the SUSTIVA Franchise, and increased sales of newer products including BARACLUDE, ABILIFY* and SPRYCEL. The Company’s reported international sales do not include copromotion sales reported by its alliance partner, Sanofi, for PLAVIX* and AVAPRO*/AVALIDE*, which continuedcontinue to show growth in the firstsecond quarter of 2007 compared to the same period in 2006.2007.

Key pharmaceutical products and their sales, representing 78%79% and 77% of total pharmaceutical sales in the firstsecond quarter of 2007 and 2006, are as follows:

 

  Three Months Ended March 31,   Three Months Ended June 30, 
Dollars in Millions  2007  2006  % Change   2007  2006  % Change 
Cardiovascular            

PLAVIX*

  $938  $986  (5)%  $1,189  $1,145  4%

AVAPRO*/AVALIDE*

   270   233  16%   297   280  6%

PRAVACHOL

   135   536  (75)%   132   323  (59)%

COUMADIN

   46   55  (16)%   52   55  (5)%
Virology            

REYATAZ

   263   207  27%   254   236  8%

SUSTIVA Franchise (total revenue)

   226   175  29%   233   193  21%

BARACLUDE

   45   11  **   59   14  **
Oncology            

ERBITUX*

   160   138  16%   162   172  (6)%

TAXOL® (paclitaxel)

   111   147  (24)%   95   149  (36)%

SPRYCEL

   21         35   —    —   
Affective (Psychiatric) Disorders            

ABILIFY* (total revenue)

   366   283  29%   412   324  27%
Immunoscience            

ORENCIA

   41   5  **   55   18  **
Other Pharmaceuticals            

EFFERALGAN

   81   68  19%   69   62  11%


**In excess of 200%.

 

Sales of PLAVIX*, a platelet aggregation inhibitor that is part of the Company’s alliance with Sanofi, decreased 5%increased 4%, including a 1% favorable foreign exchange impact, to $938$1,189 million in the firstsecond quarter of 2007 from $986$1,145 million in the same period in 2006. Sales of PLAVIX* decreased 7%increased 3% in the U.S. in the firstsecond quarter of 2007 to $787$1,015 million from $850$988 million in the same period in 2006. This was2006 primarily due to the impact of residual sales of generic clopidogrel bisulfate, partially offset by the replenishment of branded PLAVIX* inventory in the distribution channels. U.S. PLAVIX* net sales in the first quarter of 2007 increased by 129% compared to $343 million in the fourth quarter of 2006 as generic clopidogrel bisulfate inventory in the distribution channels is depleted.demand. The Company estimatesestimated the adverse effectimpact of the at-risk launch of generic clopidogrel bisulfate to be in the range of $300$50 million to $350$100 million for the firstsecond quarter of 2007 as inventory of generic clopidogrel bisulfate in the distribution channels was substantially depleted at June 30, 2007. Estimated total U.S. prescription demand for clopidogrel bisulfate (branded and generic) increased by 18%11% in the firstsecond quarter of 2007 compared to 2006, while estimated total U.S. prescription demand for branded PLAVIX* increased 1% in the same period. While market exclusivity for PLAVIX* is expected to expire in 2011 in the U.S. and 2013 in the majority of the European markets, the composition of matter patent for PLAVIX* is the subject of litigation. For additional information on the PLAVIX* litigations, as well as the generic launch by Apotex, see “—PLAVIX*” above and “Item 1. Financial Statements—Note 16. Legal Proceedings and Contingencies.”

2007 compared to 2006, while estimated total U.S. prescription demand for branded PLAVIX* decreased by 28% in the same period. While market exclusivity for PLAVIX* is expected to expire in 2011 in the U.S. and 2013 in the majority of the European markets, the composition of matter patent for PLAVIX* is the subject of litigation, including the litigation with Apotex as noted above. The testimony in the trial in the underlying patent litigation ended on February 15, 2007. Post-trial briefing is complete and the parties are awaiting the Court’s decision. If Apotex were to prevail at trial in the underlying patent litigation or if there is additional competition for PLAVIX* from other third-party generic pharmaceutical companies, PLAVIX* would face renewed generic competition. For additional information on the PLAVIX* litigations, as well as the generic launch by Apotex, see “—PLAVIX*” above and “Item 1. Financial Statements—Note 16. Legal Proceedings and Contingencies.”

 

Sales of AVAPRO*/AVALIDE*, an angiotensin II receptor blocker for the treatment of hypertension, also part of the Sanofi alliance, increased 16%6%, including a 2% favorable foreign exchange impact, to $270$297 million in the firstsecond quarter of 2007 from $233$280 million in the same period in 2006. U.S. sales increased 17%2% to $163$170 million in the firstsecond quarter of 2007 from $139$167 million compared toin the same period in 2006, primarily due to higher average net selling prices. Estimated total U.S. prescription demand decreased approximately 1%2% compared to 2006. International sales increased 14%12%, including a 5%6% favorable foreign exchange impact, to $107$127 million in the first quarter of 2007 from $94compared to $113 million in the same period in 2006. Market exclusivity for AVAPRO*/AVALIDE* (known in the European Union (EU) as APROVEL*/KARVEA*) is expected to expire in 2012 (including pediatric extension) in the U.S. and in countries in the EU; AVAPRO*/AVALIDE* is not currently marketed in Japan.

 

Sales of PRAVACHOL, an HMG Co-A reductase inhibitor, decreased 75%59%, including a 1%2% favorable foreign exchange impact, to $135$132 million in the firstsecond quarter of 2007 from $536$323 million in the same period in 2006, due to loss of market exclusivity resulting inincreased generic competition for most strengths in the U.S. beginningand key European markets. Market exclusivity protection expired in April 2006 and generic competition in key European markets, including France beginning in July 2006. Estimated totalthe U.S. prescription demand decreased approximately 86% compared to 2006. Market exclusivity in the EU ended in 2004, with the exception of Sweden, where expiration occurred in March 2006, Italy, where expiration will occur in January 2008, and France, where generic competition that was not authorized by the Company commenced in July 2006.

 

Sales of COUMADIN, an oral anti-coagulant used predominantly in patients with atrial fibrillation or deep venous thrombosis/pulmonary embolism, decreased 16%5%, including a 1% favorable foreign exchange impact, to $46$52 million in the firstsecond quarter of 2007 compared to $55 million in the same period in 2006, primarily due to continued competition. Estimated total U.S. prescription demand decreased approximately 17%16% compared to 2006. Market exclusivity for COUMADIN expired in the U.S. in 1997.

Sales of REYATAZ, a protease inhibitor for the treatment of human immunodeficiency virus (HIV), increased 27%8%, including a 3% favorable foreign exchange impact, to $263$254 million in the firstsecond quarter of 2007 from $207$236 million in the same period in 2006. U.S. sales increased 20%13% to $143$138 million in the firstsecond quarter of 2007 from $119$122 million in the same period in 2006, primarily due to higher demand. Estimated total U.S. prescription demand increased approximately 17%13% compared to 2006. International sales increased 36%2%, including a 7%6% favorable foreign exchange impact, to $120$116 million in the firstsecond quarter of 2007 from $88$114 million in the same period in 2006, primarily due to increased demand in Europe, Latin America and Canada.2006. Market exclusivity for REYATAZ is expected to expire in 2017 in the U.S., in countries in the EU and in Japan.

 

Total revenue forSales of the SUSTIVA Franchise, a non-nucleoside reverse transcriptase inhibitor for the treatment of HIV, increased 29%21%, including a 4%3% favorable foreign exchange impact, to $226$233 million in the firstsecond quarter of 2007 from $175$193 million in the same period in 2006. U.S. sales increased 28% to $147 million in the second quarter of 2007 from $115 million in the same period in 2006, primarily due to higher demand. Estimated total U.S. prescription growth increased approximately 25% compared to 2006. International sales increased 10%, including a 7% favorable foreign exchange impact, to $86 million in the second quarter of 2007 from $78 million in the same period in 2006. In July 2006, the Company and Gilead Sciences, Inc. (Gilead) launched ATRIPLA*, a once-daily single tablet three-drug regimen for HIV intended as a stand-alone therapy or in combination with other antiretrovirals. Total revenue for the SUSTIVA Franchise includes sales of SUSTIVA as well as revenue from bulk efavirenz included in the combination therapy ATRIPLA*. The Company records revenue for the bulk efavirenz component of ATRIPLA* upon sales of ATRIPLA* by the joint venture with Gilead to third-party customers. The Company has a composition of matter patent that expires in 2013 in the U.S. and in countries in the EU; the Company does not, but others do, market SUSTIVA in Japan. For additional information on revenue recognition of the SUSTIVA Franchise, see “Item 1. Financial Statements—Note 2. Alliances and Investments.”

 

Sales of BARACLUDE, an oral antiviral agent for the treatment of chronic hepatitis B, increased to $45$59 million in the firstsecond quarter of 2007 from $11$14 million in the same period of 2006, as the product becomes commercialized in international markets and continuesdue to grow in the U.S.continued growth across all markets. The Company has a composition of matter patent that expires in the U.S. in 2010 and in Japan, Germany, France and the United Kingdom (UK)UK in 2011. As previously disclosed, BARACLUDE was launched in China in February 2006. As also previously disclosed, there is uncertainty about China’s exclusivity laws and due to this uncertainty, it is possible that one or more companies in China could receive marketing authorization from China’s health authority by the end of 2007.

was launched in China in February 2006. As also previously disclosed, there is uncertainty about China’s exclusivity laws and due to this uncertainty, it is possible that one or more companies in China could receive marketing authorization from China’s health authority by the end of 2007.

 

Sales of ERBITUX*, which is sold by the Company almost exclusively in the U.S., increased 16%decreased 6% to $160$162 million in the firstsecond quarter of 2007 from $138$172 million in the same period in 2006, due to increased demand for usage in the treatment of head and neck cancer. ERBITUX* net sales decreased 4% compared to the fourth quarter of 2006 reflecting increased competition in the colorectal cancer market. ERBITUX* is marketed by the Company under a distribution and copromotion agreement with ImClone. A use patent relating to combination therapy with cytotoxic treatments expires in 2017. There is no patent covering monotherapy. Currently, generic versions of biological products cannot be approved under U.S. law. However, the law could change in the future. Even in the absence of new legislation, the FDA is taking steps toward allowing generic versions of certain biologics. The Company’s right to market ERBITUX* in North America and Japan under its agreement with ImClone expires in September 2018. The Company does not, but others do, market ERBITUX* in countries in the EU.

 

 

 

Sales of TAXOL® (paclitaxel), an anti-cancer agent sold almost exclusively in non-U.S. markets, decreased 24%, including a 1% favorable foreign exchange impact,36% to $111$95 million in the firstsecond quarter of 2007 from $147$149 million in the same period in 2006, primarily due to increased generic competition in Europe and generic entry in Japan during the third quarter of 2006. Market exclusivity protection for TAXOL® (paclitaxel) expired in 2000 in the U.S. and in 2003 in countries in the EU. Two generic paclitaxel products have received regulatory approval in Japan, of which one has entered the market.

 

Sales of SPRYCEL, an oral inhibitor of multiple tyrosine kinases, for the treatment of adults with chronic, accelerated, or myeloid or lymphoid blast phase chronic myloid leukemia with resistance or intolerance to prior therapy, including GLEEVEC* (imatinib meslylate), were $21$35 million for the firstsecond quarter of 2007, compared to $14$21 million in the fourthfirst quarter of 2006.2007. SPRYCEL was launched in the U.S. in July 2006 and in certain European markets in the fourth quarter of 2006. During the first quarter of 2007, SPRYCEL received approval in several additional European markets, including Ireland, Norway, Sweden and Greece, and was also approved in Canada and New Zealand. Market exclusivity for SPRYCEL is expected to expire in 2020 in the U.S. and in certain European markets, pending patent grant.

 

Total revenue for ABILIFY*, an antipsychotic agent for the treatment of schizophrenia, acute bipolar mania and bipolar disorder, increased 29%27%, including a 2% favorable foreign exchange impact, to $366$412 million in the firstsecond quarter of 2007 from $283$324 million in the same period in 2006. U.S. sales increased 27%21% to $293$322 million in the firstsecond quarter of 2007 from $231$267 million in the same period in 2006, primarily due to higher demand and higher average net selling prices. Estimated total U.S. prescription demand increased approximately 14%13% compared to the same period last year. International sales continued to gain momentum, increasing 40%, including a 10% favorable foreign exchange impact, to $73 million in the first quarter of 2007 from $52 million in the same period in 2006. Total revenue for ABILIFY* primarily consists of alliance revenue representing the Company’s 65% share of net sales in countries where it copromotes with Otsuka Pharmaceutical Co., Ltd. (Otsuka), and the product is sold by an Otsuka affiliate as a distributor. Otsuka’s market exclusivity protection for ABILIFY* is expected to expire in 2014 in the U.S. (including the granted patent term extension). For information on patent litigations relating to ABILIFY, see “Item 1. Financial Statements—Note 16. Legal Proceedings and Contingencies.” The Company also has the right to copromote ABILIFY* in several European countries (the UK, France, Germany and Spain) and to act as exclusive distributor for the product in the rest of the EU. Market exclusivity protection for ABILIFY* is expected to expire in 2009 for countries in the EU (and may be extended until 2014 if pending supplemental protection certificates are granted). The Company’s contractual right to market ABILIFY* expires in November 2012 in the U.S. and Puerto Rico and, for the countries in the EU where the Company has the exclusive right to market ABILIFY* until June 2014. For additional information on revenue recognition of ABILIFY*, see “Item 1. Financial Statements—Note 2. Alliances and Investments.”

International sales increased 58%, including an 11% favorable foreign exchange impact, to $90 million in the second quarter of 2007 from $57 million in the same period in 2006 due to continued growth across European markets. Total revenue for ABILIFY* primarily consists of alliance revenue representing the Company’s 65% share of net sales in countries where it copromotes with Otsuka Pharmaceutical Co., Ltd. (Otsuka), and the product is sold by an Otsuka affiliate as a distributor. Otsuka’s market exclusivity protection for ABILIFY* is expected to expire in 2014 in the U.S. (including the granted patent term extension). For information on patent litigations relating to ABILIFY, see “Item 1. Financial Statements—Note 16. Legal Proceedings and Contingencies.” The Company also has the right to copromote ABILIFY* in several European countries (the UK, France, Germany and Spain) and to act as exclusive distributor for the product in the rest of the EU. Market exclusivity protection for ABILIFY* is expected to expire in 2009 for countries in the EU (and may be extended until 2014 if pending supplemental protection certificates are granted). The Company’s contractual right to market ABILIFY* expires in November 2012 in the U.S. and Puerto Rico and, for the countries in the EU where the Company has the exclusive right to market ABILIFY* until June 2014. For additional information on revenue recognition of ABILIFY*, see “Item 1. Financial Statements—Note 2. Alliances and Investments.”

 

Sales of ORENCIA, a fusion protein indicated for adult patients with moderate to severe RArheumatoid arthritis who have had an inadequate response to one or more currently available treatments, such as methotrexate or anti-tumor necrosis factor therapy, increased to $41$55 million in the firstsecond quarter of 2007 from $5$18 million in the same period in 2006. ORENCIA was launched in the U.S. in February 2006 and Canada in August 2006. The Company has a composition of matter patent that expires in the U.S. in 2016 and the patentbut may be eligible for patent term restoration, which could possibly extend the term. As noted above, generic versions of biological products cannot be approved under U.S. law, but the law could change in the future. For information on intellectual property litigation relating to ORENCIA, see “Item 1. Financial Statements—Note 16. Legal Proceedings and Contingencies.”

Sales of EFFERALGAN, a formulation of acetaminophen for pain relief sold principally in Europe, increased 19%11%, including a 9%7% favorable foreign exchange impact, to $81$69 million in the firstsecond quarter of 2007 from $68$62 million in the same period in 2006, primarily due2006.

In most instances, the basic exclusivity loss date indicated above is the expiration date of the patent that claims the active ingredient of the drug or the method of using the drug for the approved indication. In some instances, the basic exclusivity loss date indicated is the expiration date of the data exclusivity period. In situations where there is only data exclusivity without patent protection, a competitor could seek regulatory approval prior to the expiration of the data exclusivity period by submitting its own clinical trial data to obtain marketing approval. The Company assesses the market exclusivity period for each of its products on a severe 2007 flu season.case-by-case basis. The length of market exclusivity for any of the Company’s products is difficult to predict with certainty because of the complex interaction between patent and regulatory forms of exclusivity and other factors. There can be no assurance that a particular product will enjoy market exclusivity for the full period of time that the Company currently anticipates. The estimates of market exclusivities reported above are for business planning purposes only and are not intended to reflect the Company’s legal opinion regarding the strength or weakness of any particular patent or other legal position.

The estimated U.S. prescription change data provided above includes information only from the retail and mail order channels and does not reflect information from other channels, such as hospitals, institutions and long-term care, among others. The estimated prescription data is based on the Next-Generation Prescription Services (NGPS) version 2.0 provided by IMS Health (IMS), a supplier of market research for the pharmaceutical industry, as described below.

The Company has calculated the estimated total U.S. prescription change and estimated therapeutic category share based on NGPS version 2.0 data on a weighted-average basis to reflect the fact that mail order prescriptions include a greater volume of product supplied compared to retail prescriptions. Mail order prescriptions typically reflect a 90 day prescription whereas retail prescriptions typically reflect a 30 day prescription. The calculation is derived by multiplying NGPS mail order prescription data by a factor that approximates three and adding to this the NGPS retail prescriptions. The Company believes that this calculation of the estimated total U.S. prescription change and estimated therapeutic category share based on the weighted-average approach with respect to the retail and mail order channels provides a superior estimate of total prescription demand. The Company uses this methodology for its internal demand forecasts.

In most instances, the basic exclusivity loss date indicated above is the expiration date of the patent that claims the active ingredient of the drug or the method of using the drug for the approved indication. In some instances, the basic exclusivity loss date indicated is the expiration date of the data exclusivity period. In situations where there is only data exclusivity without patent protection, a competitor could seek regulatory approval prior to the expiration of the data exclusivity period by submitting its own clinical trial data to obtain marketing approval. The Company assesses the market exclusivity period for each of its products on a case-by-case basis. The length of market exclusivity for any of the Company’s products is difficult to predict with certainty because of the complex interaction between patent and regulatory forms of exclusivity and other factors. There can be no assurance that a particular product will enjoy market exclusivity for the full period of time that the Company currently anticipates. The estimates of market exclusivities reported above are for business planning purposes only and are not intended to reflect the Company’s legal opinion regarding the strength or weakness of any particular patent or other legal position.

Estimated End-User Demand

U.S. Pharmaceuticals

The following tables set forth for each of the Company’s top 15 pharmaceutical products (based on 2006 annual net sales) sold by the U.S. Pharmaceuticals business, for the three months ended March 31,June 30, 2007 compared to the same periods in the prior year: (i) changes in reported U.S. net sales for the period; (ii) estimated total U.S. prescription change for the retail and mail order channels calculated by the Company based on NGPS version 2.0 data on a weighted-averageweighted average basis; and (iii) the estimated U.S. therapeutic category share of the applicable product calculated by the Company based on NGPS version 2.0 data on a weighted-average basis. Prior year prescription data has been adjusted to conform to the NGPS version 2.0 data.

 

   Three Months Ended March 31, 2007  Month Ended March 31, 2007 
   

Change in
U.S.

Net Sales(a)

  

Change in U.S.

Total Prescriptions(b)

  

Estimated TRx

Therapeutic

Category Share (b, c)

 

ABILIFY* (total revenue)

  27% 14% 12%

AVAPRO*/AVALIDE*

  17  (1) 13 

BARACLUDE

  89  127  25 

COUMADIN

  (19) (17) 14 

ERBITUX*(d)

  16  N/A  N/A 

GLUCOPHAGE* Franchise

  (16) (39) 1 

KENALOG(e)

  (22) N/A  N/A 

ORENCIA(d)

  ** N/A  N/A 

PARAPLATIN(d)

  (29) N/A  N/A 

PLAVIX*

  (7) (28) 65 

PRAVACHOL

  (81) (86) 1 

REYATAZ(f)

  20  17  19 

SPRYCEL(g)

  —    —    5 

SUSTIVA Franchise(f, h)(total revenue)

  33  25  34 

ZERIT

  (37) (26) 4 

  

Three Months Ended

June 30, 2007

 Month Ended
June 30, 2007
 
  Change in
U.S.
Net Sales(a)
 Change in U.S.
Total Prescriptions(b)
 Estimated TRx
Therapeutic
Category Share (b, c)
 

ABILIFY* (total revenue)

  21% 13% 13%

AVAPRO*/AVALIDE*

  2  (2) 13 

BARACLUDE

  122  77  27 

COUMADIN

  (7) (16) 14 

ERBITUX*(d)

  (7) N/A  N/A 

GLUCOPHAGE* Franchise

  (23) (33) 1 

KENALOG(e)

  18  N/A  N/A 

ORENCIA(d)

  194  N/A  N/A 

PARAPLATIN(d)

  (50) N/A  N/A 

PLAVIX*

  3  1  86 

PRAVACHOL

  (63) (74) 1 

REYATAZ(f)

  13  13  19 

SPRYCEL(g)

  —    —    5 

SUSTIVA Franchise(f, h)(total revenue)

  28  25  35 

ZERIT

  (17) (27) 4 
  Three Months Ended March 31, 2006 Month Ended March 31, 2006   

Three Months Ended

June 30, 2006

 Month Ended
June 30, 2006
 
  

Change

in U.S.

Net Sales(a)

 

Change in U.S.

Total Prescriptions(b)

 

Estimated TRx

Therapeutic

Category Share (b, c)

   

Change in
U.S.

Net Sales(a)

 

Change in U.S.

Total Prescriptions(b)

 Estimated TRx
Therapeutic
Category Share(b, c)
 

ABILIFY* (total revenue)

  43% 29% 12%  34% 22% 12%

AVAPRO*/AVALIDE*

  36  4  15   6  2  14 

BARACLUDE

  —    —    15   80  ** 20 

COUMADIN

  12  (28) 18   10  (21) 17 

ERBITUX*(d)

  56  N/A  N/A   77  N/A  N/A 

GLUCOPHAGE* Franchise

  (36) (48) 1   (50) (51) 1 

KENALOG(e)

  109  N/A  N/A   47  N/A  N/A 

ORENCIA(d)

  —    N/A  N/A   —    N/A  N/A 

PARAPLATIN(d)

  (53) N/A  N/A   ** N/A  N/A 

PLAVIX*

  26  13  87   20  12  87 

PRAVACHOL

  17  (17) 6   (64) (59) 1 

REYATAZ(f)

  29  16  18   24  13  19 

SPRYCEL(g)

  —    —    —     —    —    —   

SUSTIVA(f)

  5  2  31   19  4  31 

ZERIT

  (27) (35) 6   (31) (33) 6 

(a)Reflects percentage change in net sales in dollar terms, including change in average selling prices and wholesaler buying patterns.
(b)Derived by multiplying NGPS mail order prescription data by a factor that approximates three and adding to this the NGPS retail prescriptions.
(c)The therapeutic categories are determined by the Company as those products considered to be in direct competition with the Company’s own products. The products listed above compete in the following therapeutic categories: ABILIFY* (antipsychotics), AVAPRO*/AVALIDE* (angiotensin receptor blockers), BARACLUDE (oral antiviral agent), COUMADIN (warfarin), ERBITUX* (oncology), GLUCOPHAGE* Franchise (oral antidiabetics), KENALOG (intra-articular/intramuscular steroid), ORENCIA (fusion protein), PARAPLATIN (carboplatin), PLAVIX* (antiplatelet agents), PRAVACHOL (HMG CoA reductase inhibitors), REYATAZ and the SUSTIVA Franchise (antiretrovirals—third agents excluding NORVIR* and TRIZIVIR*), SPRYCEL (TKIs for leukemia), SUSTIVA Franchise (antiretrovirals—third agents excluding NORVIR* and TRIZIVIR*) and ZERIT (nucleoside reverse transcriptase inhibitors).
(d)ERBITUX*, PARAPLATINORENCIA and ORENCIAPARAPLATIN are parenterally administered products and do not have prescription-level data as physicians do not write prescriptions for these products. The Company believes therapeutic category share information provided by third parties for these products may not be reliable and accordingly, none is presented here.

(e)The Company does not have prescription level data because the product is not dispensed through a retail pharmacy. The Company believes therapeutic category share information provided by third parties for this product may not be reliable and accordingly, none is presented here.

(f)REYATAZ and the SUSTIVA Franchise have been recalculated as a percentage share of antiretrovirals third agents excluding NORVIR* and TRIZIVIR*.
(g)SPRYCEL was launched in the U.S. in July 2006.
(h)Beginning in the third quarter of 2006, SUSTIVA Franchise (total revenue) includes sales of SUSTIVA, as well as revenue of bulk efavirenz included in the combination therapy, ATRIPLA*. The therapeutic category share information and change in U.S. total prescriptions growth for SUSTIVA Franchise (antiretrovirals – third agents excluding NORVIR* and TRIZIVIR*) includes both branded SUSTIVA and ATRIPLA* prescription units.

**In excess of 200%.

The Company is reporting REYATAZ’sREYATAZ's estimated TRx category share within the antiretrovirals – antiretrovirals—third agents (excluding NORVIR* and TRIZIVIR*) category rather than the protease inhibitors (excluding NORVIR*) category. The Company believes that the antiretrovirals - antiretrovirals—third agents (excluding NORVIR* and TRAZIVIR*TRIZIVIR*) category more closely reflects the use of protease inhibitors, which has evolved and competes with other products within the antiretrovirals – antiretrovirals—third agents (excluding NORVIR* and TRAZIVIR*TRIZIVIR*) category. The historical trends of growth in REYATAZ’sREYATAZ's estimated TRx category share between the two categories are not materially different.

On July 23, 2007, IMS issued a Product News bulletin announcing that it had revised its previously issued projected prescription and unit volumes for PLAVIX* and Apotex’s generic clopidogrel bisulfate product, which IMS had overstated for the months August 2006 through June 2007 due to market events surrounding the at-risk launch of generic clopidogrel bisulfate. Due to these unique circumstances, the high degree of volatility and the compressed timeframe of these events, IMS applied a custom approach to estimate PLAVIX* and generic clopidogrel bisulfate product and market volumes beginning in July 2007.

The IMS overstatement of PLAVIX* prescription and unit volumes did not impact the Company’s financial results or its reported net sales for PLAVIX* for the quarters ended September 30, 2006, December 31, 2006 or March 31, 2007.

The following table sets forth the Company’s (i) previously reported estimated prescription change data and estimated therapeutic category share based on National Prescription Audit (NPA) data for the quarters ended September 30, 2006 and December 31, 2006; (ii) previously reported estimated prescription change data and estimated therapeutic category share based on NGPS version 2.0 data for the quarter ended March 31, 2007; and (iii) revised estimated prescription change data and estimated therapeutic category share based on revised NGPS version 2.0 data using the IMS custom approach.

   PLAVIX*  Clopidogrel Bisulfate
(Branded and Generic)
 
   

As Reported

(NPA Data)

  

Revised

(NGPS v2 Data)

  

As Reported

(NPA Data)

  

Revised

(NGPS v2 Data)

 

Change in U.S. Total Prescriptions

     

Three Months Ended March 31, 2007(a)

  (28)% (36)% 18% 9%

Three Months Ended December 31, 2006

  (64) (70) 14  11 

Three Months Ended September 30, 2006

  (32) (36) 14  11 

Twelve Months Ended December 31, 2006

  (18) (21) 14  12 

Nine Months Ended September 30, 2006

  (2) (4) N/A  N/A 

Estimated TRx Therapeutic Category Share

     

Month Ended March 31, 2007(a)

  65  62  N/A  N/A 

Month Ended December 31, 2006

  34  29  N/A  N/A 

Month Ended September 30, 2006

  23  19  N/A  N/A 

(a)NGPS version 2.0 data

The above IMS overstated data also impacted the Company’s previously reported estimate of the adverse effect of the at-risk launch of generic clopidogrel bisulfate of $300 million to $350 million for the three months ended March 31, 2007. Based on the revised data issued by IMS, the Company now estimates the adverse effect of the at-risk launch of generic clopidogrel bisulfate to be $200 million to $250 million for the three months ended March 31, 2007.

The estimated prescription change data and estimated therapeutic category share reported throughout this Form 10-Q only include information from the retail and mail order channels and do not reflect information from other channels, such as hospitals, institutions and long-term care, among others. The data provided by IMS are a product of IMS’ own record-keeping processes and are themselves estimates based on IMS’ sampling procedures, subject to the inherent limitations of estimates based on sampling.

International Pharmaceuticals, Nutritionals and Other Health Care

As previously disclosed, for the Company’s Pharmaceuticals business outside of the U.S., Nutritionals and Other Health Care business units around the world, the Company has significantly more direct customers, limited information on direct customer product level inventory and corresponding out-movement information and the reliability of third party demand information, where available, varies widely. Accordingly, the Company relies on a variety of methods to estimate direct customer product level inventory and to calculate months on hand for these business units. As such, the information required to estimate months on hand in the direct customer distribution channel for non-U.S. Pharmaceuticals business for the quarter ended June 30, 2007 is not available prior to the filing of this quarterly report on Form 10-Q. The Company will disclose this information on its website and furnish it on Form 8-K approximately 60 days after the end of the second quarter.

The following table, which was posted on the Company’s web site and filed on Form 8-K on May 31, 2007, sets forth for each of the Company’s key pharmaceutical products sold by the Company’s International Pharmaceuticals business, including the top 15 pharmaceutical products sold in the Company’s major non-U.S. countries (based on 2006 net sales), and for each of the key products sold by the other reporting segments listed below, the percentage change in the Company’s estimated ultimate patient/consumer demand for the months of March 2007 and December 2006 compared to the same periods in the prior year.

   % Change in Demand on a Constant U.S. Dollar Basis 
   March 2007
vs. March 2006
  

December 2006

vs. December 2005

 

International Pharmaceuticals

   

ABILIFY* (total revenue)

  5% 15%

AVAPRO*/AVALIDE*

  5  6 

BARACLUDE

  23  **

BUFFERIN*

  —    11 

CAPOTEN

  (6) (16)

DAFALGAN

  —    5 

EFFERALGAN

  (1) 2 

MAXIPIME

  (4) (23)

MONOPRIL

  (8) (10)

ORENCIA

  ** N/A 

PERFALGAN

  1  17 

PLAVIX*

  1  (8)

PRAVACHOL

  (1) (63)

REYATAZ

  16  23 

SPRYCEL

  N/A  N/A 

SUSTIVA Franchise (total revenue)

  3  4 

TAXOL® (paclitaxel)

  (5) (18)

VIDEX/VIDEX EC

  11  (33)

Nutritionals

   

ENFAMIL/ENFAGROW

  6  6 

NUTRAMIGEN

  4  17 

Other Health Care

   

ConvaTec

   

Ostomy

  5  —   

Wound Therapeutics

  3  5 

Medical Imaging

   

CARDIOLITE

  (8) (5)

**In excess of 200%.

Estimated Inventory Months on Hand in the Distribution Channel

U.S. Pharmaceuticals

The following tables set forth for each of the Company’s top 15 pharmaceutical products (based on 2006 annual net sales) sold by the Company’s U.S. Pharmaceuticals business, the U.S. Pharmaceuticals net sales and the estimated number of months on hand of the applicable product in the U.S. wholesaler distribution channel for the quarters ended June 30, 2007 and 2006 and March 31, 2007 and 2006 and December 31, 2006 and 2005.2006.

 

   March 31, 2007  March 31, 2006
(Dollars in Millions)  Net Sales  Months on Hand  Net Sales  Months on Hand

ABILIFY* (total revenue)

  $293  0.4  $231  0.5

AVAPRO*/AVALIDE*

   163  0.4   139  0.4

BARACLUDE

   17  0.6   9  1.0

COUMADIN

   38  0.7   47  0.6

ERBITUX*

   158  0.3   136  —  

GLUCOPHAGE* Franchise

   21  0.6   25  0.7

KENALOG

   18  0.5   23  0.7

ORENCIA

   40  0.3   5  0.9

PARAPLATIN

   5  13.8   7  1.2

PLAVIX*

   787  0.6   850  0.4

PRAVACHOL

   57  0.6   302  0.4

REYATAZ

   143  0.7   119  0.6

SPRYCEL

   10  0.7   —    —  

SUSTIVA Franchise(a) (total revenue)

   144  0.7   108  0.5

ZERIT

   12  0.6   19  0.7

  December 31, 2006  December 31, 2005  June 30, 2007  June 30, 2006
(Dollars in Millions)  Net Sales  Months on Hand  Net Sales  Months on Hand
Dollars in Millions  Net Sales  Months on Hand  Net Sales  Months on Hand

ABILIFY* (total revenue)

  $294  0.5  $175  0.6  $322  0.4  $267  0.5

AVAPRO*/AVALIDE*

   182  0.5   168  0.6   170  0.4   167  0.5

BARACLUDE

   18  0.7   4  0.7   20  0.7   9  0.7

COUMADIN

   48  0.8   50  0.8   43  0.7   46  0.8

ERBITUX*

   165  0.4   121  —     160  0.4   172  —  

GLUCOPHAGE* Franchise

   16  0.7   29  0.7   17  0.6   22  0.6

KENALOG

   24  0.8   23  0.9   26  0.5   22  0.8

ORENCIA

   31  0.4   —    —     53  0.5   18  0.3

PARAPLATIN

   6  5.8   5  0.9   1  17.5   2  1.7

PLAVIX*

   343  0.6   906  0.6   1,015  0.4   988  0.5

PRAVACHOL

   50  0.6   366  0.6   47  0.5   128  1.0

REYATAZ

   144  0.7   110  0.5   138  0.6   122  0.6

SPRYCEL

   11  1.4   —    —     14  0.8   —    —  

SUSTIVA Franchise(a) (total revenue)

   144  0.7   102  0.6   147  0.7   115  0.5

ZERIT

   19  0.9   21  0.8   15  0.7   18  0.7
  March 31, 2007  March 31, 2006
Dollars in Millions  Net Sales  Months on Hand  Net Sales  Months on Hand

ABILIFY* (total revenue)

  $293  0.4  $231  0.5

AVAPRO*/AVALIDE*

   163  0.4   139  0.4

BARACLUDE

   17  0.6   9  1.0

COUMADIN

   38  0.7   47  0.6

ERBITUX*

   158  0.3   136  —  

GLUCOPHAGE* Franchise

   21  0.6   25  0.7

KENALOG

   18  0.5   23  0.7

ORENCIA

   40  0.3   5  0.9

PARAPLATIN

   5  13.8   7  1.2

PLAVIX*

   787  0.6   850  0.4

PRAVACHOL

   57  0.6   302  0.4

REYATAZ

   143  0.7   119  0.6

SPRYCEL

   10  0.7   —    —  

SUSTIVA Franchise(a) (total revenue)

   144  0.7   108  0.5

ZERIT

   12  0.6   19  0.7

(a)Beginning in the third quarter of 2006, the SUSTIVA Franchise includes sales of SUSTIVA, as well as revenue of bulk efavirenz included in the combination therapy, ATRIPLA*. The estimated months on hand of the product in the U.S. wholesale distribution channel only include branded SUSTIVA inventory.

In October 2004, the U.S. pediatric exclusivity period for PARAPLATIN expired. The resulting entry of multiple generic competitors for PARAPLATIN led to a significant decrease in demand for PARAPLATIN, which in turn led to the months on hand of the product in the U.S. wholesaler distribution channel exceeding one month on hand at June 30, 2007, March 31, 2007, December 31,June 30, 2006 and March 31, 2006. The estimated value of PARAPLATIN inventory in the U.S. wholesaler distribution channel over one month on hand was approximately $0.3 million at June 30, 2007, $0.4 million at March 31, 2007, $0.6$1.4 million at December 31,June 30, 2006 and $0.9 million at March 31, 2006. The Company no longer produces PARAPLATIN for the U.S. market and will continue to monitor PARAPLATIN wholesaler inventory levels until they have been depleted.

SPRYCEL was launched in the U.S. in July 2006. Consistent with customary practice at the time of a new product launch, the Company’s U.S. wholesalers built inventories of the product to meet expected demand, and at December 31, 2006, the estimated value of SPRYCEL inventory in the U.S. wholesaler distribution channel exceeded one month on hand by approximately $1.4 million. As of March 31, 2007, SPRYCEL inventory in the U.S. wholesaler distribution channel has been worked down to less than one month on hand.

For all products other than ERBITUX* and ORENCIA, the Company determines the above months on hand estimates by dividing the estimated amount of the product in the U.S. wholesaler distribution channel by the estimated amount of out-movement of the product from the U.S. wholesaler distribution channel over a period of 31 days, all calculated as described below. Factors that may influence the Company’s estimates include generic competition, seasonality of products, wholesaler purchases in light of increases in wholesaler list prices, new product launches, new warehouse openings by wholesalers and new customer stockings by wholesalers. In addition, such estimates are calculated using third-party data, which represent their own record-keeping processes and as such, may also reflect estimates.

The Company maintains inventory management agreements (IMAs) with most of its U.S. Pharmaceuticals wholesalers, which account for nearly 100% of total gross sales of U.S. pharmaceutical products. Under the current terms of the IMAs, the Company’s three largest wholesaler customers provide the Company with weekly information with respect to inventory levels of product on hand and the amount of out-movement of products. These three wholesalers accounted for nearly 90% of total gross sales of U.S. pharmaceuticalPharmaceuticals products in the firstsecond quarter of 2007. The inventory information received from these wholesalers excludes inventory held by intermediaries to whom they sell, such as retailers and hospitals, and excludes goods in transit to such wholesalers. The Company uses the information provided by these three wholesalers as of the Friday closest to quarter end to calculate the amount of inventory on hand for these wholesalers at the applicable quarter end. This amount is then increased by the Company’s estimate of goods in transit to these wholesalers based on the Company’s records of sales to these wholesalers, which have not been reflected in the weekly data provided by the wholesalers. Under the Company’s revenue recognition policy, sales are recorded when substantially all the risks and rewards of ownership are transferred, which in the U.S. Pharmaceuticals business is generally when product is shipped. In such cases, goods in transit to a wholesaler are owned by the applicable wholesaler and, accordingly, are reflected in the calculation of inventories in the wholesaler distribution channel. The Company determines the out-movement of a product from these wholesalers over a period of 31 days by using the most recent four weeks of out-movement of a product as provided by these wholesalers and extrapolating such amount to a 31 day basis. The Company estimates for each product, inventory levels on hand and out-movements for all its U.S. Pharmaceuticals business wholesaler customers, by adjusting the three largest wholesalers’ inventory levels and out-movements by a factor that approximates the other remaining wholesalers’ percentage share of total gross sales for such product in the U.S. In addition, the Company receives inventory information from these other wholesalers on a selective basis for certain key products.

The Company’s U.S. Pharmaceuticals business through the IMAs discussed above, has arrangements with substantially all of its direct wholesaler customers and requires those wholesalers to maintain inventory at levels that are no more than one month of their demand.

ORENCIA was launched in February 2006. From launch through the second quarter of 2006, the Company distributed ORENCIA through an exclusive distribution arrangement with a single distributor. Following approval of the supplemental Biologics License ApplicationsBLA that allows a third party to manufacture ORENCIA at an additional site, the exclusive distribution arrangement terminated on July 17, 2006 and the Company expanded its distribution network for ORENCIA to multiple distributors. The above estimates of months on hand was calculated by dividing the inventories of ORENCIA held by these distributors at the end of the quarter by the out-movement of the product over the last 31 day period, as reported by these distributors. The inventory on hand and out-movements reported by these distributors are a product of the distributors’ own record-keeping processes.

In the first and second quarter of 2006, the Company sold ERBITUX* to intermediaries (such as wholesalers and specialty oncology distributors) and shipped ERBITUX* directly to the end-users of the product who are the customers of those intermediaries.

Beginning in the third quarter of 2006, the Company expanded its distribution model to include two distributors who then held ERBITUX* inventory. One additional distributor was added for ERBITUX* in the first quarter of 2007. The Company recognizes revenue upon such shipment consistent with its revenue recognition policy.

The above estimate of months on hand was calculated by dividing the inventories of ERBITUX* held by the distributors for their own accounts as reported by the distributors as of the end of the quarter by the out-movements of the product reported by the distributors over the last 31 day period. The inventory levels reported by the distributors are a product of their record-keeping process.

As previously disclosed,

Estimated Inventory Months on Hand in the Distribution Channel

The following table, which was posted on the Company’s website and filed on Form 8-K on May 31, 2007, sets forth for each of the Company’s key products sold by the businesses listed below, the net sales of the applicable product for each of the quarters ended March 31, 2007, December 31, 2006, March 31, 2006 and December 31, 2005, and the estimated number of months on hand of the applicable product in the direct customer distribution channel for the Company’sbusiness as of the end of each of the four quarters. The estimates of months on hand for key products described below for the International Pharmaceuticals business are based on data collected for all of the Company’s significant business units outside of the U.S., Nutritionals Also described further below is information on non-key product(s) where the amount of inventory on hand at direct customers is more than approximately one month and Other Health Carethe impact is not de minimis. For the other non-Pharmaceuticals reporting segments, estimates are based on data collected for the U.S. and all significant business units aroundoutside of the world,U.S.

   March 31, 2007  December 31, 2006  March 31, 2006  December 31, 2005
(Dollars in Millions)  Net Sales  

Months

on Hand

  Net Sales  

Months

on Hand

  Net Sales  

Months

on Hand

  Net Sales  

Months

on Hand

International Pharmaceuticals

                

ABILIFY* (total revenue)

  $73  0.6  $68  0.7  $52  0.6  $49  0.6

AVAPRO*/AVALIDE*

   107  0.5   125  0.6   94  0.5   109  0.6

BARACLUDE

   28  0.7   18  0.8   2  1.1   1  —  

BUFFERIN*

   24  0.5   32  0.5   22  0.6   36  0.7

CAPOTEN

   26  0.8   31  0.8   35  0.8   38  0.8

DAFALGAN

   44  1.2   40  1.0   37  1.4   34  1.2

EFFERALGAN

   81  1.1   74  0.7   68  1.2   74  1.0

MAXIPIME

   29  0.5   33  0.6   40  0.8   48  0.8

MONOPRIL

   36  0.8   35  0.9   46  1.1   43  0.9

ORENCIA

   1  0.3   1  —     —    —     —    —  

PERFALGAN

   58  0.5   54  0.5   46  0.6   43  0.6

PLAVIX*

   151  0.5   153  0.6   136  0.5   155  0.6

PRAVACHOL

   78  0.6   96  0.8   234  1.5   218  0.8

REYATAZ

   120  0.9   111  1.0   88  0.6   78  0.6

SPRYCEL

   11  0.4   3  0.5   —    —     —    —  

SUSTIVA Franchise(a) (total revenue)

   82  0.5   78  0.5   67  0.5   68  0.6

TAXOL®(paclitaxel)

   107  0.7   128  0.7   143  0.6   176  0.8

VIDEX/VIDEX EC

   27  1.1   29  1.4   31  0.8   34  0.9

Nutritionals

                

ENFAMIL/ENFAGROW

   326  0.8   338  0.9   304  0.9   330  1.0

NUTRAMIGEN

   52  0.9   54  1.0   48  1.0   48  1.1

Other Health Care

                

ConvaTec

                

Ostomy

   130  0.9   151  1.0   123  0.9   145  1.0

Wound Therapeutics

   107  0.9   123  1.0   98  0.9   112  0.9

Medical Imaging

                

CARDIOLITE

   99  0.7   103  0.9   103  0.8   100  1.0

(a)Beginning in the third quarter of 2006, the SUSTIVA Franchise includes sales of SUSTIVA, as well as revenue of bulk efavirenz included in the combination therapy, ATRIPLA*. The estimated months on hand of the product in the distribution channel only include branded SUSTIVA inventory.

The above months on hand information represents the Company’s estimates of aggregate product level inventory on hand at direct customers divided by the expected demand for the applicable product. Expected demand is the estimated ultimate patient/consumer demand calculated based on estimated end-user consumption or direct customer out-movement data over the most recent 31 day period or other reasonable period. Factors that may affect the Company’s estimates include generic competition, seasonality of products, direct customer purchases in light of price increases, new product or product presentation launches, new warehouse openings by direct customers, new customer stockings by direct customers and expected direct customer purchases for governmental bidding situations.

The Company relies on a variety of methods to calculate months on hand for these businesses and reporting segments. Where available, the Company has significantly morerelies on information provided by third parties to determine estimates of aggregate product level inventory on hand at direct customers and expected demand. For the businesses and reporting segments listed above, however, the Company has limited information on direct customer product level inventory, end-user consumption and correspondingdirect customer out-movement information anddata.

Further, the reliabilityquality of third party demand information, where available, varies widely. Accordingly,In some circumstances, such as the case with new products or seasonal products, such historical end-user consumption or out-movement information may not be available or applicable. In such cases, the Company relies on a variety of methods to estimateuses estimated prospective demand. In cases where direct customer product level inventory, andultimate patient/consumer demand or out-movement data do not exist or are otherwise not available, the Company has developed a variety of other methodologies to calculate estimates of such data, including using such factors as historical sales made to direct customers and third party market research data related to prescription trends and end-user demand.

As of March 31, 2006, BARACLUDE, an oral antiviral agent, had approximately 1.1 months of inventory on hand for these business units. As such, the information required to estimate monthsat direct customers. The level of inventory on hand is due primarily to stocking of the product in the direct customer distribution channel for non-U.S. Pharmaceuticals business for the quarter endedsupport of its recent launch in China.

As of March 31, 2007, March 31, 2006 and December 31, 2005, DAFALGAN, an analgesic product sold principally in Europe, had approximately 1.2, 1.4 and 1.2 months of inventory on hand, respectively, at direct customers. The level of inventory on hand was due primarily to private pharmacists purchasing DAFALGAN approximately once every eight weeks and the seasonality of the product.

As of March 31, 2007 and March 31, 2006, EFFERALGAN, an analgesic product sold principally in Europe, had approximately 1.1 and 1.2 months of inventory on hand, respectively, at direct customers. The level of inventory on hand is not available priordue primarily to private pharmacists purchasing EFFERALGAN approximately once every eight weeks and the seasonality of the product.

As of March 31, 2006, MONOPRIL, a cardiovascular product, had approximately 1.1 months of inventory on hand at direct customers. The level of inventory on hand was due primarily to supply of the product in support of its inclusion in a government program in Russia.

As of March 31, 2006, PRAVACHOL, a cardiovascular product, had approximately 1.5 months of inventory on hand at direct customers. The increased level of inventory on hand was due primarily to an increase in orders from a significant direct customer in France.

As of March 31, 2007 and December 31, 2006, VIDEX/VIDEX EC, an antiviral product, had approximately 1.1 and 1.4 months of inventory on hand, respectively, at direct customers. The increased level of inventory on hand is due primarily to government purchasing patterns in Brazil. The Company is contractually obligated to provide VIDEX/VIDEX EC to the filingBrazilian government upon placement of this quarterly reportan order for product by the government. Under the terms of the contract, the Company has no control over the inventory levels relating to such orders.

As of December 31, 2005, NUTRAMIGEN, an infant nutritional product sold principally in the U.S., had approximately 1.1 months of inventory on Form 10-Q.hand at direct customers. The Company will disclose this informationlevel of inventory on its website and furnish it on Form 8-K approximately 60 days afterhand at the end of the first quarter.quarter ended December 31, 2005 was due primarily to holiday stocking by retailers.

The Company continuously seeks to improve the quality of its estimates of months on hand of inventories held by its direct customers including thorough review of its methodologies and processes for calculation of these estimates and review and analysis of its own and third parties’ data used in such calculations. The Company expects that it will continue to review and refine its methodologies and processes for calculation of these estimates and will continue to review and analyze its own and third parties’ data in such calculations. The Company also has and will continue to take steps to expedite the receipt and processing of data for the non-U.S. Pharmaceuticals business.

HEALTH CARE GROUP

The combined firstsecond quarter 2007 revenues from the Health Care Group increased 4%6%, including a 3% favorable foreign exchange impact, to $1.0$1.1 billion compared to the same period in 2006.

Nutritionals

The composition of the change in nutritional sales is as follows:

 

   Analysis of % Change   Total Change  Analysis of % Change 

Three Months Ended March 31,

  Total Change Volume Price Foreign Exchange

Three Months Ended June 30,

  Total Change  Volume Price Foreign Exchange 

2007 vs. 2006

  7% 3% 2% 2%   2% 2% 3%

Key Nutritional product lines and their sales, representing 96% and 95% of total Nutritional sales in the firstsecond quarter of 2007 and 2006 respectively, are as follows:

 

  Three Months Ended March 31,   Three Months Ended June 30, 
Dollars in Millions  2007  2006  % Change   2007  2006  % Change 

Infant Formulas

  $421  $385  9%  $435  $417  4%

ENFAMIL

   254   237  7%   267   253  6%

Toddler/Children’s Nutritionals

   161   152  6%   163   141  16%

ENFAGROW

   72   67  7%   70   59  19%

Worldwide Nutritional sales increased 7%, including a 2%3% favorable foreign exchange impact, to $606$620 million in the firstsecond quarter of 2007 from $565$582 million in the same period in 2006. U.S. Nutritional sales increased 11%decreased 2% to $274$275 million in the firstsecond quarter of 2007, primarily due to decreased sales of infant formula and other pediatric nutritionals. International Nutritional sales increased 15% to $345 million in the second quarter of 2007, including a 6% favorable foreign exchange impact, primarily due to increased sales of toddlers and children’s nutritional products and ENFAMIL, the Company’s best-selling infant formula. International Nutritional sales increased 4% to $332 million in the first quarter of 2007, including a 3% favorable foreign exchange impact.

Other Health Care

The Other Health Care segment includes ConvaTec and the Medical Imaging business. The composition of the change in Other Health Care segment sales is as follows:

 

        Analysis of % Change  

Three Months Ended March 31,

  Total Change  Volume Price Foreign Exchange

2007 vs. 2006

    (1)% (2)% 3%

   Total Change  Analysis of % Change 

Three Months Ended June 30,

   Volume  Price  Foreign Exchange 

2007 vs. 2006

  6% 3% —    3%

Other Health Care sales by business and their key products for the firstsecond quarter of 2007 and 2006 were as follows:

 

  Three Months Ended March 31,  

%
Change

   Three Months Ended June 30, 
Dollars in Millions  2007  2006    2007  2006  % Change 

ConvaTec

  $254  $230  10%  $286  $262  9%

Ostomy

   130   123  6%   150   141  6%

Wound Therapeutics

   107   98  9%   119   107  11%

Medical Imaging

   159   181  (12)%   171   168  2%

CARDIOLITE

   99   103  (4)%   106   105  1%

 

Worldwide ConvaTec sales increased 10%, including a 5% favorable foreign exchange impact, to $254 million in the first quarter of 2007 from $230 million in the same period of 2006. Sales of wound therapeutic products increased 9%, including a 5% favorable foreign exchange impact, to $107$286 million in the firstsecond quarter of 2007 from $98$262 million in the same period in 2006. Sales of wound therapeutic products increased 11%, including a 5% favorable foreign exchange impact, to $119 million in the second quarter of 2007 from $107 million in the same period in 2006, primarily due to continued growth of AQUACEL.

 

Worldwide Medical Imaging sales decreased 12%increased 2% to $159$171 million in the firstsecond quarter of 2007 from $181$168 million in the same period in 2006, primarily due to higher sales in 2006 for Technetium Tc99m Generators and a 4% decrease for CARDIOLITE primarily due to lower U.S. average selling prices. The key patent for CARDIOLITE expires in January 2008.2006.

Geographic Areas

In general, the Company’s products are available in most countries in the world. The largest markets are in the U.S., France, Spain, Canada, Japan, Spain, Italy, MexicoGermany and Germany.Mexico. The Company’s sales by geographic areas were as follows:

 

  Three Months Ended March 31,   

Three Months Ended June 30,

 
  Net Sales % of Net Sales   Net Sales % of Total Net Sales 
Dollars in Millions  2007  2006  % Change 2007 2006   2007  2006  % Change 2007 2006 

United States

  $2,505  $2,638  (5)% 56% 56%  $2,830  $2,806  1% 57% 58%

Europe, Middle East and Africa

   1,091   1,164  (6)% 24% 25%   1,131   1,173  (4)% 23% 24%

Other Western Hemisphere

   381   397  (4)% 9% 9%   418   395  6% 9% 8%

Pacific

   499   477  5% 11% 10%   549   497  10% 11% 10%
                            

Total

  $4,476  $4,676  (4)% 100% 100%  $4,928  $4,871  1% 100% 100%
                            

Sales in the U.S. decreased 5%increased 1%, primarily due to the loss of exclusivity of PRAVACHOL and lower sales of PLAVIX*, partially offset by the continued growth of ABILIFY*, REYATAZ, the SUSTIVA Franchise, AVAPRO*/AVALIDE*, ERBITUX*PLAVIX* and BARACLUDE,REYATAZ, as well as sales of newer products BARACLUDE, ORENCIA and SPRYCEL.SPRYCEL, partially offset by increased generic competition for PRAVACHOL.

Sales in Europe, Middle East and Africa decreased 6%4%, including a 7%6% favorable foreign exchange impact, as a result of sales decline of PRAVACHOL and TAXOL® (paclitaxel) resulting from increased generic competition. This decrease in sales was partially offset by increased sales in major European markets of ABILIFY*, SPRYCEL, REYATAZ, EFFERALGANBARACLUDE, the SUSTIVA Franchise and EFFERALGAN.

Sales in the Other Western Hemisphere countries increased 6%, including a 4% favorable foreign exchange impact, primarily due to increased sales of PLAVIX* in Canada and Mexico, partially offset by the discontinued commercialization of TEQUIN.

Sales in the Pacific region increased 10%, including a 4% favorable foreign exchange impact, primarily due to increased sales of BARACLUDE in China and Japan, as well as increased sales of Nutritional products across the region, partially offset by lower sales of TAXOL® (paclitaxel) in Japan due to generic competition.

Expenses

   Three Months Ended June 30, 
   Expenses  % of Net Sales 
Dollars in Millions  2007  2006  % Change  2007  2006 

Cost of products sold

  $1,549  $1,568  (1)% 31.4% 32.2%

Marketing, selling and administrative

   1,209   1,181  2% 24.5% 24.2%

Advertising and product promotion

   368   352  5% 7.5% 7.2%

Research and development

   778   740 ��5% 15.8% 15.2%

Provision for restructuring, net

   7   3  133% 0.1% 0.1%

Litigation expense/(income), net

   14   (14) 200% 0.3% (0.3)%

Gain on sale of product assets

   (26)  —    (100)% (0.5)% —   

Equity in net income of affiliates

   (128)  (125) (2)% (2.6)% (2.6)%

Other expense, net

   —     56  (100)% —    1.2%
                

Total Expenses, net

  $3,771  $3,761  —    76.5% 77.2%
                

**In excess of 200%.

Cost of products sold, as a percentage of net sales, decreased to 31.4% in the second quarter of 2007 compared to 32.2% in the same period in 2006. In the second quarter of 2006, the Company reclassified into cost of products sold $24 million or 0.5% as a percentage of sales, of certain costs which were reported in marketing, selling and administrative expenses in the first quarter of 2006. In addition to the reclassification, the decrease was due primarily to sales growth of higher margin products.

Marketing, selling and administrative expenses increased 2% to $1,209 million in the second quarter of 2007 compared to the same period in 2006, due to a 2% increase resulting from the reclassification of certain costs in 2006 mentioned above.

Advertising and product promotion spending increased 5% to $368 million in the second quarter of 2007 from $352 million in the same period in 2006, driven primarily by increased investments in the nutritional business as well as product introduction costs related to international pharmaceuticals.

Research and development expenses increased 5% to $778 million in the second quarter of 2007 from $740 million in the same period in 2006. This increase primarily reflects higher licensing upfront and milestone payments and continued investments in late-stage compounds, partially offset by sharing of codevelopment costs with alliance partners AstraZeneca and Pfizer. The second quarter 2007 milestone and upfront payments related to agreements with Isis and Albany Molecular Research, Inc. Research and development spending dedicated to pharmaceutical products increased to 19.0% of pharmaceutical sales in the second quarter of 2007, compared to 17.8% in the same period in 2006.

Restructuring programs have been implemented to downsize, realign and streamline operations in order to increase productivity, reduce operating expenses and to rationalize the Company’s manufacturing network and the sales and marketing organizations. Actions under the second quarter 2007 restructuring programs are expected to be complete by mid-2008, while actions under the second quarter 2006 restructuring programs were substantially completed by late 2006. As a result of these actions, the Company expects the future annual benefit to earnings before minority interest and income taxes to be approximately $6 million and $4 million for the second quarter 2007 and 2006 programs, respectively. For additional information on restructuring, see “Item 1. Financial Statements—Note 3. Restructuring.”

Litigation expense of $14 million in the second quarter of 2007 was related to reserves recorded for the proposed settlement of certain pharmaceutical pricing and sales litigations. Litigation income of $14 million in the second quarter of 2006 was related to the settlement of a litigation matter. For additional information on litigation charges, see “Item 1. Financial Statements—Note 16. Legal Proceedings and Contingencies—Pricing, Sales and Promotional Practices Litigation and Investigations.”

The gain on sale of product assets of $26 million in 2007 was for the sale of certain assets related to dermatology products.

Equity in net income of affiliates for the second quarter of 2007 was $128 million, compared to $125 million in the second quarter of 2006. Equity in net income of affiliates is principally related to the Company’s international joint venture with Sanofi and investment in ImClone. The $3 million increase in equity in net income of affiliates is primarily due to increased net income in the Sanofi joint venture, partially offset by decreased net income from the equity investments in ImClone. For additional information on equity in net income of affiliates, see “Item 1. Financial Statements—Note 2. Alliances and Investments.”

Other expense, net, was $56 million in the second quarter of 2006. Other expense, net, includes net interest expense, foreign exchange gains and losses, income from third-party contract manufacturing, certain royalty income and expense, gains and losses on disposal of property, plant and equipment, certain other litigation matters, and deferred income recognized. The $56 million decrease in other expense, net, in 2007 from 2006 was primarily due to a net favorability resulting from foreign exchange movements, higher income from third-party contract manufacturing and lower net interest expense. For additional information, see “Item 1. Financial Statements—Note 6. Other Expense, Net.”

During the quarters ended June 30, 2007 and 2006, the Company recorded specified expense/(income) items that affected the comparability of results of the periods presented herein, which are set forth in the following tables:

Three Months Ended June 30, 2007

Dollars in Millions  

Cost of

products sold

  Research
and
development
  Provision for
restructuring,
net
  Litigation
settlement
expense, net
  Gain on sale
of product
assets
  Total 

Litigation Matters:

           

Litigation settlement

  $—    $—    $—    $14  $—    $14 

Other:

           

Upfront and milestone payments

   —     17   —     —     —     17 

Accelerated depreciation

   13   —     —     —     —     13 

Downsizing and streamlining of worldwide operations

   —     —     7   —     —     7 

Gain on sale of product assets

   —     —     —     —     (26)  (26)
                         
  $13  $17  $7  $14  $(26)  25 
                      

Income taxes on items above

            (5)
              

Reduction to Net Earnings

           $20 
              

Three Months Ended June 30, 2006

Dollars in Millions  Cost of
products sold
  Research and
development
  Provision for
restructuring, net
  Litigation
income, net
  Total 

Litigation Matters:

         

Commercial litigation

  $—    $—    $—    $(14) $(14)

Other:

         

Accelerated depreciation

   20   1   —     —     21 

Downsizing and streamlining of worldwide operations

   —     —     3   —     3 
                     
  $20  $1  $3  $(14)  10 
                  

Income taxes on items above

          3 
            

Reduction to Net Earnings

         $13 
            

Earnings Before Minority Interest and Income Taxes

   

Earnings Before Minority Interest

and Income Taxes

 
   Three Months Ended June 30, 
Dollars in Millions  2007  2006  % Change 

Pharmaceuticals

  $1,005  $943  7%

Nutritionals

   167   186  (10)%

Other Health Care

   160   134  19%
          

Health Care Group

   327   320  2%
          

Total segments

   1,332   1,263  5%

Corporate/Other

   (175)  (153) 14%
          

Total

  $1,157  $1,110  4%
          

In the second quarter of 2007, earnings before minority interest and income taxes increased 4% to $1,157 million from $1,110 million in the second quarter of 2006. The increase was primarily driven by continued growth of key products, improved gross margins, net favorability resulting from foreign exchange movements and lower net interest expense, partially offset by lower sales of PRAVACHOL and TAXOL® (paclitaxel), investment in advertising and product promotion, higher research and development expenses and the net impact of items that affected the comparability of results as discussed above.

PHARMACEUTICALS

Earnings before minority interest and income taxes increased to $1,005 million in the second quarter of 2007 from $943 million in the second quarter of 2006 primarily due to continued growth of key products and improved gross margins, partially offset by continued investment in research and development, including upfront and milestone payments and lower sales of PRAVACHOL and TAXOL® (paclitaxel).

HEALTH CARE GROUP

Nutritionals

Earnings before minority interest and income taxes decreased to $167 million in the second quarter of 2007 from $186 million in the second quarter of 2006, primarily due to increased investment in advertising and product promotion and spending in other operating expenses, partially offset by growth in international sales.

Other Health Care

Earnings before minority interest and income taxes increased to $160 million in the second quarter of 2007 from $134 million in the second quarter of 2006, primarily due to higher ConvaTec sales and lower operating expenses in Medical Imaging resulting from restructuring actions implemented in prior periods.

CORPORATE / OTHER

Loss before minority interest and income taxes was $175 million in the second quarter of 2007 compared to $153 million in the second quarter of 2006. The increase was primarily due to litigation expense in 2007 compared to litigation income in 2006, partially offset by favorability resulting from net foreign exchange movements and gain on sale of product assets in 2007.

Income Taxes

The effective income tax rate on earnings before minority interest and income taxes was 22.2% in the second quarter of 2007 compared to 23.1% in the second quarter of 2006. The decrease is due primarily to the re-enactment of the Research and Development tax credit in the fourth quarter of 2006 and the unfavorable impact in 2006 associated with the elimination of tax benefits under section 936 of the Internal Revenue Code (IRC), partially offset by the implementation of tax planning strategies related to the utilization of certain charitable contributions.

Six Months Results of Operations

Except as noted below, the factors affecting the second quarter comparisons all affected the six month comparisons.

   Six Months Ended June 30, 
            % of Net Sales 
Dollars in Millions  2007  2006  %
Change
  2007  2006 

Net Sales

  $9,404  $9,547  (1)%  

Earnings before Minority Interest and Income Taxes

  $2,074  $2,303  (10)% 22.1% 24.1%

Provision for Income Taxes

  $343  $584  (41)%  

Effective tax rate

   16.5%  25.4%   

Net Earnings

  $1,396  $1,381  1% 14.8% 14.5%

Net sales for the first six months of 2007 decreased 1% to $9.4 billion, including a 2% favorable foreign exchange impact, compared to the same period in 2006. U.S. net sales decreased 2% to $5.3 billion in 2007 compared to 2006 due to loss of exclusivity of PRAVACHOL and the impact of generic clopidogrel bisulfate, partially offset by growth in other key products. International sales decreased 1%, including a 5% favorable foreign exchange impact, to $4.1 billion.

The composition of the change in sales is as follows:

      Analysis of % Change 

Six Months Ended June 30,

  Total Change  Volume  Price  Foreign Exchange 

2007 vs. 2006

  (1)% (4)% 1% 2%

The percent of the Company’s net sales by segment were as follows:

   Six Months Ended June 30, 
   Net Sales  % of Total Net Sales 
Dollars in Millions  2007  2006  % Change  2007  2006 

Pharmaceuticals

  $7,308  $7,559  (3)% 77.7% 79.2%

Nutritionals

   1,226   1,147  7% 13.0% 12.0%

Other Health Care

   870   841  3% 9.3% 8.8%
                

Health Care Group

   2,096   1,988  5% 22.3% 20.8%
                

Total

  $9,404  $9,547  (1)% 100.0% 100.0%
                

The following table sets forth the reconciliation of the Company’s gross sales to net sales by each significant category of gross-to-net sales adjustments:

   Six Months Ended June 30, 
Dollars in Millions  2007  2006 

Gross Sales

  $10,805  $11,066 

Gross-to-Net Sales Adjustments

   

Prime Vendor Charge-Backs

   (335)  (381)

Women, Infants and Children (WIC) Rebates

   (429)  (444)

Managed Health Care Rebates and Other Contract Discounts

   (190)  (198)

Medicaid Rebates

   (96)  (119)

Cash Discounts

   (119)  (125)

Sales Returns

   (68)  (85)

Other Adjustments

   (164)  (167)
         

Total Gross-to-Net Sales Adjustments

   (1,401)  (1,519)
         

Net Sales

  $9,404  $9,547 
         

The decrease in prime vendor charge-backs in the six months ended June 30, 2007 compared to the same period in 2006 was primarily due to lower sales of TAXOL® (paclitaxel), PRAVACHOL and PARAPLATIN as a result of exclusivity loss. Medicaid rebates decreased due to lower utilization for PLAVIX* as well as lower gross sales volume in other products. Sales returns decreased primarily due to higher accruals in 2006 as a result of the discontinued commercialization of TEQUIN.

The following table sets forth the activities and ending balances of each significant category of gross-to-net sales adjustments:

Dollars in Millions Prime
Vendor
Charge-
Backs
  Women,
Infants
and
Children
(WIC)
Rebates
  Managed
Health
Care
Rebates
and
Other
Contract
Discounts
  Medicaid
Rebates
  Cash
Discounts
  Sales
Returns
  Other
Adjustments
  Total 

Balance at January 1, 2006

 $107  $252  $167  $326  $26  $185  $124  $1,187 

Provision related to sales
made in current period

  706   867   381   174   221   200   348   2,897 

Provision related to sales made in prior periods

  (3)  5   (33)  —     3   30   (9)  (7)

Returns and payments

  (747)  (894)  (405)  (363)  (232)  (196)  (343)  (3,180)

Impact of foreign currency translation

  —     —     1   —     —     2   4   7 
                                

Balance at December 31, 2006

  63   230   111   137   18   221   124   904 

Provision related to sales made in current period

  336   428   195   96   118   69   166   1,408 

Provision related to sales made in prior periods

  (1)  1   (5)  —     1   (1)  (2)  (7)

Returns and payments

  (339)  (408)  (178)  (98)  (114)  (100)  (174)  (1,411)

Impact of foreign currency translation

  —     —     3   —     —     2   1   6 
                                

Balance at June 30, 2007

 $59  $251  $126  $135  $23  $191  $115  $900 
                                

In 2007, no significant revisions were made to the estimates for gross-to-net sales adjustments related to sales made in prior periods.

Pharmaceuticals

The composition of the change in pharmaceutical sales is as follows:

      Analysis of % Change 

Six Months Ended June 30,

  Total Change  Volume  Price  Foreign Exchange 

2007 vs. 2006

  (3)% (6)% 1% 2%

For the six months ended June 30, 2007, worldwide Pharmaceuticals sales decreased 3% to $7,308 million including a 2% favorable foreign exchange impact, compared to the same period in 2006. U.S. pharmaceutical sales decreased 2% to $4,187 million from $4,281 in 2006 due to loss of exclusivity of PRAVACHOL and the impact of generic clopidogrel bisulfate, partially offset by growth in other key products, while international pharmaceutical sales decreased 5%, including a 4% favorable foreign exchange impact to $3,121 million in the first six months of 2007 from $3,278 million in 2006.

Key pharmaceutical products and their sales, representing 79% and 77% of total pharmaceutical sales in the first six months of 2007 and 2006, respectively, are as follows:

   Six Months Ended June 30,    
(Dollars in Millions)  2007  2006  % Change 

Cardiovascular

      

PLAVIX*

  $2,127  $2,131  —   

AVAPRO*/AVALIDE*

   567   513  11%

PRAVACHOL

   267   859  (69)%

COUMADIN

   98   110  (11)%

Virology

      

REYATAZ

   517   443  17%

SUSTIVA Franchise (total revenue)

   459   368  25%

BARACLUDE

   104   25  **

Oncology

      

ERBITUX*

   322   310  4%

TAXOL®(paclitaxel)

   206   296  (30)%

SPRYCEL

   56   —    —   

Affective (Psychiatric) Disorders

      

ABILIFY* (total revenue)

   778   607  28%

Immunoscience

      

ORENCIA

   96   23  **

Other Pharmaceuticals

      

EFFERALGAN

   150   130  15%

**In excess of 200%

Sales of PLAVIX* remained relatively constant at $2,127 million in the first six months of 2007. Sales of PLAVIX* decreased 2% in the U.S. in the first six months of 2007 to $1,802 million from $1,838 million in the same period in 2006 due to the impact of residual sales of generic clopidogrel bisulfate. The Company estimates the adverse effect of generic clopidogrel bisulfate to be in the range of $250 million to $350 million for the first six months of 2007. Estimated total U.S. prescription demand for clopidogrel bisulfate (branded and generic) increased approximately 10% in the first six months of 2007 compared to 2006, while estimated total U.S. prescription demand for branded PLAVIX* decreased by 18% in the same period. For further discussion of certain issues related to IMS’ revised data for PLAVIX*, see “—Estimated End User Demand” above.

Sales of AVAPRO*/AVALIDE* increased 11%, including a 2% favorable foreign exchange impact, to $567 million from $513 million in 2006. U.S. sales increased to $333 million in 2007 compared with $306 million in 2006. Estimated total U.S. prescription demand decreased approximately 2% compared to 2006. International sales increased 13%, including a 6% favorable foreign exchange impact, to $234 million from $207 million in 2006.

Sales of PRAVACHOL decreased 69%, including a 1% favorable foreign exchange impact, to $267 million from $859 million in 2006. Estimated total U.S. prescriptions demand decreased approximately 82% compared to 2006.

Sales of COUMADIN decreased 11%, to $98 million in 2007 compared to $110 million in 2006.

Sales of REYATAZ increased 17%, including a 3% favorable foreign exchange impact, to $517 million in 2007 compared to $443 million in 2006. U.S. sales increased 17% to $281 million in 2007 compared to $241 million in 2006. International sales increased 17%, including a 7% favorable foreign currency impact, to $236 million compared to $202 million in 2006, primarily due to increased demand in Europe, Latin America and Canada. Estimated total U.S. prescription demand increased approximately 15% compared to 2006.

Total revenue for the SUSTIVA Franchise.Franchise increased 25%, including a 3% favorable foreign exchange impact, to $459 million from $368 million in the same period in 2006. U.S. sales increased to $291 million in 2007 compared with $223 million in 2006. International sales increased 16%, including an 8% favorable foreign currency impact, to $168 million compared to $145 million in 2006. Estimated total U.S. prescription growth increased approximately 25% compared to 2006.

Sales of BARACLUDE increased to $104 million in the first six months of 2007 from $25 million in the same period of 2006.

Sales of ERBITUX* increased 4% to $322 million in 2007 from $310 million in the same period in 2006, primarily due to increased demand for usage in the treatment of head and neck cancer.

Sales of TAXOL® (paclitaxel) decreased 30% to $206 million in 2007 from $296 million in the same period in 2006.

Sales of SPRYCEL were $56 million for the first six months of 2007.

Total revenue for ABILIFY* increased 28%, including a 2% favorable foreign exchange impact, to $778 million in 2007 from $607 million in 2006. U.S. sales increased 23% in the first half of 2007 compared to 2006. Estimated total U.S. prescription demand increased approximately 13% compared to 2006. International sales increased 50% including an 11% favorable foreign exchange impact to $163 million compared to $109 million in 2006.

Sales of ORENCIA increased to $96 million in the first six months of 2007 from $23 million in the same period in 2006.

Sales of EFFERALGAN increased 15%, including an 8% favorable foreign exchange impact, to $150 million in 2007 from $130 million in 2006 primarily due to a severe 2007 flu season.

The estimated U.S. prescription change data provided above includes information only from the retail and mail order channels and does not reflect information from other channels, such as hospitals, institutions and long-term care, among others. The estimated prescription data is based on NGPS version 2.0 data provided by IMS.

Estimated End-User Demand

The following tables set forth for each of the Company’s top 15 pharmaceutical products (based on 2006 annual net sales) sold by the U.S. Pharmaceuticals business, for the six months ended June 30, 2007 compared to the same periods in the prior year: (i) changes in reported U.S. net sales for the period; and (ii) estimated total U.S. prescription change for the retail and mail order channels calculated by the Company based on NGPS version 2.0 data on a weighted average basis. Prior year prescription data has been adjusted to conform to the NGPS version 2.0 data.

   Six Months Ended June 30, 2007  Six Months Ended June 30, 2006 
   

Change

in U.S.

Net Sales(a)

  

% Change

in U.S. Total Prescriptions (b)

  

Change

in U.S.

Net Sales(a)

  

% Change

in U.S. Total Prescriptions (b)

 

ABILIFY* (total revenue)

  23% 13% 38  25 

AVAPRO*/AVALIDE*

  9  (2) 18  3 

BARACLUDE

  106  98  ** **

COUMADIN

  (13) (16) 11  (25)

ERBITUX*(c)

  3  N/A  67  N/A 

GLUCOPHAGE* Franchise

  (19) (36) (43) (49)

KENALOG(d)

  (2) N/A  73  N/A 

ORENCIA(c)

  ** N/A  —    N/A 

PARAPLATIN(c)

  (33) N/A  (36) N/A 

PLAVIX*

  (2) (18) 23  13 

PRAVACHOL

  (76) (82) (30) (38)

REYATAZ

  17  15  27  15 

SPRYCEL(e)

  —    —    —    —   

SUSTIVA Franchise(f) (total revenue)

  30  25  12  3 

ZERIT

  (27) (27) (29) (34)

(a)Reflects percentage change in net sales in dollar terms, including change in average selling prices and wholesaler buying patterns.
(b)Derived by multiplying NGPS mail order prescription data by a factor that approximates three and adding to this the NGPS retail prescriptions.
(c)ERBITUX*, ORENCIA and PARAPLATIN are parenterally administered products and do not have prescription-level data as physicians do not write prescriptions for these products.
(d)The Company does not have prescription level data because the product is not dispensed through a retail pharmacy.
(e)SPRYCEL was launched in the U.S. in July 2006.
(f)Beginning in the third quarter of 2006, SUSTIVA Franchise (total revenue) includes sales of SUSTIVA, as well as revenue of bulk efavirenz included in the combination therapy, ATRIPLA*.
**In excess of 200%.

For an explanation of the data presented above, the calculation of such data and certain issues relating to IMS’ revised data for PLAVIX*, see “—Three Months Results of Operations.”

HEALTH CARE GROUP

For the first six months of 2007, the combined revenues from the Health Care Group increased 5% including a 3% favorable foreign exchange impact to $2.1 billion compared to the same period in 2006.

Nutritionals

The composition of the change in nutritional sales is as follows:

      Analysis of % Change 

Six Months Ended June 30,

  Total Change  Volume  Price  Foreign Exchange 

2007 vs. 2006

  7% 3% 2% 2%

Key Nutritional product lines and their sales, representing 96% and 95% of total Nutritional sales in the first six months of 2007 and 2006, respectively, are as follows:

   Six Months Ended June 30, 
Dollars in Millions  2007  2006  % Change 

Infant Formulas

  $856  $802  7%

ENFAMIL

   521   490  6%

Toddler/Children’s Nutritionals

   324   293  11%

ENFAGROW

   142   126  13%

Worldwide Nutritional sales increased 7%, including a 2% favorable foreign exchange impact, to $1,226 million in the first six months of 2007 from $1,147 million in the same period in 2006. U.S. Nutritional sales increased 4% to $549 million in the first six months of 2007, primarily due to increased sales of ENFAMIL, the Company best-selling infant formula, partially offset by decreased sales in other pediatric nutritionals. International Nutritional sales increased 10% to $677 million for the first six months of 2007, including a 5% favorable foreign exchange impact.

Other Health Care

The composition of the change in Other Health Care segment sales is as follows:

      Analysis of % Change 

Six Months Ended June 30,

  Total Change  Volume  Price  Foreign Exchange 

2007 vs. 2006

  3% 1% (1)% 3%

Other Health Care sales by business and their key products for the six months ended June 30, 2007 and 2006 were as follows:

   Six Months Ended June 30, 
Dollars in Millions  2007  2006  %
Change
 

ConvaTec

  $540  $492  10%

Ostomy

   280   264  6%

Wound Therapeutics

   226   205  10%

Medical Imaging

   330   349  (5)%

CARDIOLITE

   205   208  (1)%

Worldwide ConvaTec sales increased 10%, including a 5% favorable foreign exchange impact, to $540 million for the first six months of 2007 from $492 million in the same period of 2006. Sales of wound therapeutic products increased 10%, including a 5% favorable foreign exchange impact, to $226 million in the first six months of 2007 from $205 million in the same period in 2006.

Worldwide Medical Imaging sales decreased 5% to $330 million for the first six months of 2007 from $349 million in the same period in 2006, primarily due to higher sales in 2006 for Technetium Tc99m Generators and lower U.S. average selling prices for CARDIOLITE. The key patent for CARDIOLITE expires in January 2008.

Geographic Areas

The Company’s sales by geographic areas were as follows:

   Six Months Ended June 30, 
   Net Sales  % of Total Net Sales 
Dollars in Millions  2007  2006  % Change  2007  2006 

United States

  $5,335  $5,444  (2)% 57% 57%

Europe, Middle East and Africa

   2,222   2,337  (5)% 24% 25%

Other Western Hemisphere

   799   792  1% 8% 8%

Pacific

   1,048   974  8% 11% 10%
                

Total

  $9,404  $9,547  (2)% 100% 100%
                

Sales in the U.S. decreased 2%, primarily due to the loss of exclusivity of PRAVACHOL and the impact of generic clopidogrel bisulfate, partially offset by the continued growth of ABILIFY*, the SUSTIVA Franchise, REYATAZ, AVAPRO*/AVALIDE* and ERBITUX*, as well as sales of newer products BARACLUDE, ORENCIA and SPRYCEL.

Sales in Europe, Middle East and Africa decreased 5%, including a 7% favorable foreign exchange impact.

Sales in the Other Western Hemisphere countries decreased 4%increased 1%, including a 1% unfavorablefavorable foreign exchange impact, primarily due to increased sales of PLAVIX* offset by the discontinued commercialization of TEQUIN and lower sales of REYATAZ and TAXOL® (paclitaxel) in Mexico and Canada.

Sales in the Pacific region increased 5%8%, including a 3% favorable foreign exchange impact, primarily due to increased sales of BARACLUDE in China, Japan and Korea, as well as increased sales of Nutritional products in Thailand.impact.

Expenses

 

  Three Months Ended March 31,   Six Months Ended June 30, 
  Expenses % of Net Sales   Expenses % of Net Sales 
Dollars in Millions  2007 2006 % Change 2007 2006   2007 2006 % Change 2007 2006 

Cost of products sold

  $1,392  $1,476  (6)% 31.1% 31.6%  $2,941  $3,044  (3)% 31.3% 31.9%

Marketing, selling and administrative

   1,158   1,238  (6)% 25.9% 26.5%   2,367   2,419  (2)% 25.2% 25.3%

Advertising and product promotion

   269   295  (9)% 6.0% 6.3%   637   647  (2)% 6.8% 6.8%

Research and development

   807   750  8% 18.0% 16.0%   1,585   1,490  6% 16.9% 15.6%

Provision for restructuring, net

   37   1  ** 0.8% —      44   4  ** 0.4% 0.1%

Litigation income, net

   —     (21) 100% —    (0.4)%

Gain on sale of product asset

   —     (200) 100% —    (4.3)%

Litigation expense/(income), net

   14   (35) 140% 0.1% (0.4)%

Gain on sale of product assets

   (26)  (200) 87% (0.3)% (2.1)%

Equity in net income of affiliates

   (126)  (93) (35)% (2.8)% (2.0)%   (254)  (218) (17)% (2.7)% (2.3)%

Other expense, net

   22   37  (41)% 0.5% 0.8%   22   93  (76)% 0.2% 1.0%
                            

Total Expenses, net

  $3,559  $3,483  2% 79.5% 74.5%  $7,330  $7,244  1% 77.9% 75.9%
                            


**In excess of 200%.

 

Cost of products sold, as a percentage of net sales, decreased to 31.1%31.3% in the first quartersix months of 2007 compared to 31.6%31.9% in the same period in 2006. This decrease was2006, primarily due primarily to lower charges for asset impairment and accelerated depreciation in the current year and sales growth of higher margin products, partially offset by $24 million of certain costs, which were reported in marketing, selling and administrative expenses in the same period in 2006.products.

 

Marketing, selling and administrative expenses decreased 6%2% to $1,158$2,367 million in the first quartersix months of 2007 compared to the same period in 2006, including a 2% decrease resulting from the above-mentioned classification in 2006,due to lower expenses for PRAVACHOLU.S. and lower U.S.Europe selling expenses.

 

Advertising and product promotion spending decreased by 9%2% to $269$637 million in the first quarter of 2007 from $295 million in the same period in 2006, driven primarily bydue to lower spending within the pharmaceutical business, partially offset by increased investment in the nutritionals business.

 

Research and development expenses increased by 8%6% to $807$1,585 million in the first quartersix months of 2007 from $750$1,490 million in the same period in 2006. This increase primarily reflects higher licensing upfront paymentsResearch and continued investmentsdevelopment spending dedicated to pharmaceutical products increased to 20.4% of pharmaceuticals sales in late-stage compounds, partially offset by an alliance partner’s sharethe first six months of codevelopment costs related2007, compared to saxagliptin and dapagliflozin. The first quarter 2007 upfront payments related to18.3% in the Exelixis and Adnexus alliance and collaborative agreements.same period in 2006.

 

Restructuring programs have been implemented to downsize, realign and streamline operations in order to increase productivity, reduce operating expenses and to rationalize the Company’s manufacturing network, research facilities, and the sales and marketing organizations. Actions under the first quarter 2007 restructuring programsprogram are expected to be complete by early 2008,mid-2008, while actions under the first quarter 2006 restructuring programs are expected to be completeprogram were substantially completed by late 2007.2006. As a result of these actions, the Company expects the future annual benefit to earnings from continuing operations before minority interest and income taxes to be approximately $45$51 million and $9$13 million for the first quarter 2007 and 2006 programs, respectively. For additional information on restructuring, see “Item 1. Financial Statements—Note 3. Restructuring.”

Litigation incomeexpense of $21$14 million in the first quartersix months of 2007 was related to reserves recorded for the proposed settlement of certain pharmaceutical pricing and sales litigations. Litigation income of $35 million in the first six months of 2006 was related to an insurance recovery for previously settled litigation matters. For additional information onmatters as well as from the settlement of a litigation charges, see “Item 1. Financial Statements—Note 16. Legal Proceedings and Contingencies—Other Securities Matters.”matter.

 

The gain on sale of product assetassets of $26 million in 2007 was for the sale of certain assets related to dermatology products. The gain on sale of product assets of $200 million in 2006 was for the sale of inventory, patent and intellectual property rights related to DOVONEX*. For additional information, see “Item 1. Financial Statements—Note 4. Acquisitions and Divestitures.”

 

Equity in net income of affiliates for the first quartersix months of 2007 was $126$254 million, compared to $93with $218 million in the first quartersix months of 2006. Equity in net income of affiliates is principally related to the Company’s international joint venture with Sanofi and investment in ImClone. The $33 million increase in equity in net income of affiliates is primarily due to increased net income in the Sanofi joint venture. For additional information on equity in net income of affiliates, see “Item 1. Financial Statements—Note 2. Alliances and Investments.”

Other expense, net was $22 million in the first quarter 2007 compared to $37and $93 million in the first quartersix months of 2006. Other expense, net includes net interest expense, foreign exchange gains2007 and losses, income from third-party contract manufacturing, certain royalty income and expense, gains and losses on disposal of property, plant and equipment, and certain other litigation matters.2006, respectively. The $15$71 million decrease in other expense, net in 2007 from 2006 was primarily due to a charge for commercial litigation in 2006, partially offset by alower net unfavorability in foreign exchange movements.interest expense and higher income from third-party contract manufacturing. For additional information, see “Item 1. Financial Statements—Note 6. Other Expense, Net.”

During the quarterssix months ended March 31,June 30, 2007 and 2006, the Company recorded specified expense/(income)/expense items that affected the comparability of results of the periods presented herein, which are set forth in the following tables:table.

ThreeSix Months Ended March 31,June 30, 2007

Dollars in Millions  Cost of
products sold
  Research and
development
  Provision for
restructuring, net
  Total   

Cost of

products
sold

  Research
and
development
  

Provision for
restructuring,

net

  Litigation
settlement
expense,
net
  

Gain
on

sale of
product
assets

 Total 

Upfront payments

  $—    $80  $—    $80 

Litigation Matters:

           

Litigation settlement

  $—    $—    $—    $14  $—    $14 

Other:

           

Upfront and milestone payments

   —     97   —     —     —     97 

Downsizing and streamlining of worldwide operations

   —     —     37   37    —     —     44   —     —     44 

Accelerated depreciation

   16   —     —     16    29   —     —     —     —     29 

Gain on sale of product assets

   —     —     —     —     (26)  (26)
                                
  $16  $80  $37   133   $29  $97  $44  $14  $(26)  158 
                            

Income taxes on items above

         (40)            (45)

Change in estimate for taxes on a prior year specified item

         (39)            (39)
                       

Reduction to Net Earnings

        $54            $74 
                       

ThreeSix Months Ended March 31,June 30, 2006

Dollars in Millions Cost of
products
sold
 Marketing,
selling and
admin
 Research
and
development
 Provision for
restructuring,
net
 Litigation
income,
net
  

Gain
on

sale of

product
asset

  Other
expense,
net
 Total 

Litigation Matters:

        

Insurance recovery

 $—   $—   $—   $—   $(21) $—    $—   $(21)

Commercial litigations

  —    —    —    —    (14)  —     40  26 
                           
  —    —    —    —    (35)  —     40  5 

Other:

        

Accelerated depreciation, asset impairment and contract termination

  66  4  1  —    —     —     —    71 

Downsizing and streamlining of worldwide operations

  —    —    —    4  —     —     —    4 

Upfront and milestone payments

  —    —    18  —    —     —     —    18 

Gain on sale of product asset

  —    —    —    —    —     (200)  —    (200)
                           
 $66 $4 $19 $4 $(35) $(200) $40  (102)
                           

Income taxes on items above

         52 

Minority interest, net of taxes

         (13)
           

Increase to Net Earnings

        $(63)
           

Dollars in Millions  Cost of
products
sold
  Research and
development
  Marketing,
selling and
admin
  Provision for
restructuring,
net
  Litigation
settlement
expense /
(income)
  

Other

Expense, net

  Gain on sale
of product
asset
  Total 
Litigation Matters:              

Insurance recovery

  $—    $—    $—    $—    $(21) $—    $  $(21)

Commercial litigation

   —     —     —     —        40        40 
                                 
   —     —     —     —     (21)  40        19 
Other:              

Accelerated depreciation and asset impairment

   46     —     4     —        —        50 

Upfront payments

   —     18     —     —        —        18 

Downsizing and streamlining of worldwide operations

   —     —     —     1        —        1 

Gain on sale of product asset

   —     —     —     —        —     (200)  (200)
                                 
  $46    $18    $4    $1    $(21) $40    $(200)  (112)
                              

Income taxes on items above

               48 

Minority interest, net of taxes

               (13)
                 

Increase to Net Earnings

              $(77)
                 

Earnings Before Minority Interest and Income Taxes

 

  Earnings Before Minority Interest
and Income Taxes
 
  

Earnings Before Minority Interest

and Income Taxes

Three Months Ended March 31,

   Six Months Ended June 30, 
Dollars in Millions  2007 2006  %Change   2007 2006 % Change 

Pharmaceuticals

  $825  $836  (1)%  $1,830  $1,779  3%

Nutritionals

   173   184  (6)%   340   370  (8)%

Other Health Care

   136   118  15%   296   252  17%
                

Health Care Group

   309   302  2%   636   622  2%
                

Total segments

   1,134   1,138      2,466   2,401  3%

Corporate/Other

   (217)  55  **   (392)  (98) **
                

Total

  $917  $1,193  (23)%  $2,074  $2,303  (10)%
                

**In excess of 200%.

In the first quartersix months of 2007, earnings before minority interest and income taxes decreased 23%10% to $917$2,074 million from $1,193$2,303 million in the first quartersix months of 2006. The decrease was primarily driven by the net impact of items that affected the comparability of results as discussed above, lower sales of PRAVACHOL and TAXOL®(paclitaxel) and PLAVIX*, partially offset by continued growth of other key products, improved gross margins, lower operatingmarketing, selling and administrative and advertising and promotion expenses, and an increase in equity in net income of affiliates.affiliates, partially offset by continued investment in research and development.

PHARMACEUTICALS

Earnings before minority interest and income taxes decreasedincreased to $825$1,830 million in the first quartersix months of 2007 from $836$1,779 million in the first quartersix months of 2006 primarily driven by loss of exclusivity of PRAVACHOL, lower sales of PLAVIX* and higher upfront payments in research and development, partially offset by continued growth of other key products and lower operating expenses.2006.

HEALTH CARE GROUP

Nutritionals

Earnings before minority interest and income taxes decreased to $173$340 million in the first quartersix months of 2007 from $184$370 million in the first quartersix months of 2006, primarily due to increased investment in advertising and product promotion and the establishment of an allowance for a doubtful account in 2007,2007. The decrease was partially offset by growth sales and higher gross margin.

Other Health Care

Earnings before minority interest and income taxes increased to $136$296 million in the first quartersix months of 2007 from $118$252 million in the first quartersix months of 2006, primarily driven by lower operating expenses.2006.

CORPORATE / CORPORATE/OTHER

Loss before minority interest and income taxes was $217$392 million in the first quartersix months of 2007 compared to earnings of $55$98 million in the first quartersix months of 2006. The difference was primarily due to the gain on sale of DOVONEX* and insurance recovery for previously settled litigation matters, both in 2006, and unfavorability in net foreign exchange movements.2006.

Income Taxes

The effective income tax rate on earnings before minority interest and income taxes was 9.4%16.5% for the threesix months ended March 31,June 30, 2007 compared to 27.5%25.4% for the threesix months ended March 31,June 30, 2006. The 2007 tax rate for the three months ended March 31, 2007 was favorably impacted by a tax benefit of $105 million due to the favorable resolution of certain tax matters with the Internal Revenue Service (IRS) related to the deductibility of litigation settlement expenses and U.S. foreign tax credits claimed. The lower tax rate in the first quarter of 2007 compared to 2006 was also due to the re-enactment of the Research and Development tax credit in the fourth quarter of 2006, and the unfavorable impact in 2006 associated with the elimination of tax effect of a gain on the salebenefits under section 936 of the rightsIRC, partially offset by the implementation of tax planning strategies related to DOVONEX* in the first quarterutilization of 2006.certain charitable contributions.

Financial Position, Liquidity and Capital Resources

Cash, cash equivalents and marketable securities were approximately $4.6 billion at June 30, 2007 and $4.0 billion at March 31, 2007 and December 31, 2006. The Company continues to maintain a sufficient level of working capital, which was approximately $4.3$4.9 billion at March 31,June 30, 2007 and $3.8 billion at December 31, 2006.

As noted above, on June 19, 2007 the trialDistrict court issued an opinion and order upholding the validity, enforceability and maintaining the main patent protection for PLAVIX* in the underlying patent litigation involving PLAVIX* ended on February 15, 2007 andU.S. until November 2011. Apotex has appealed the parties are awaitingdecision to the Court’s decision.U.S. Court of Appeals for the Federal Circuit. If Apotex were to prevail at trial,upon appeal, the Company would expect that PLAVIX* would face renewed generic competition promptly thereafter. Subject to these risks, the Company currently believes that, in the absence of renewed or additional generic competition for PLAVIX* from other generic pharmaceutical companies, in 2007 and future periods, cash generated by its U.S. operations, together with existing cash, cash equivalents, marketable securities and borrowings from the capital markets, to be sufficient to cover cash needs for working capital, capital expenditures (which the Company expects to include substantial investments in facilities to increase and maintain the Company’s capacity to provide biologics on a commercial scale), milestone payments and dividends paid in the U.S. Cash and cash equivalents, marketable securities, the conversion of other working-capital items and borrowings are expected to fund near-term operations.operations outside the U.S.

Under any circumstances, renewed or additional generic competition for PLAVIX* would be material to the Company’s sales of PLAVIX* and results of operations and cash flows, and could be material to the Company’s financial condition and liquidity.

Additional information about the pending PLAVIX* patent litigation and the recent adverse developments is included in “Item 1. Financial Statements—Note 16. Legal Proceedings and Contingencies—Intellectual Property—PLAVIX* Litigation” and “—Executive Summary—PLAVIX*” above.

Cash and cash equivalents at March 31,June 30, 2007 primarily consisted of U.S. dollar denominated bank deposits with an original maturity of three months or less. Marketable securities at March 31,June 30, 2007 primarily consisted of U.S. dollar denominated floating rate instruments with a ‘AAA/aaa’ credit rating. Due to the nature of these instruments, the Company considers it reasonable to expect that their fair market values will not be significantly impacted by a change in interest rates, and that they can be liquidated for cash at short notice.

In September 2006, the Company and Sanofi each posted $200 million towards a $400 million bond with the District court as collateral in support of the preliminary injunction issued on August 31, 2006. This collateral was reported as marketable securities on the Company’s consolidated balance sheet. As a result of the outcome of the PLAVIX* patent litigation noted above, on June 21, 2007, the District court ordered release of the $400 million bond and release of the issuer of the bond from any liability in connection with the bond. As such, the Company’s obligations under the collateral arrangements with respect to the bond were effectively terminated.

Short-term borrowings were $241$256 million at March 31,June 30, 2007, compared to $187 million at December 31, 2006. The $105 million of Yen Notes, due February 2008 was reclassified from long-term debt to short-term borrowings.borrowings in the first quarter of 2007. The Company maintains cash balances and short-term investments in excess of short-term borrowings.

Long-term debt was $7.1$7.0 billion at March 31,June 30, 2007 compared to $7.2 billion at December 31, 2006.

The Moody’s Investors Service (Moody’s) long-term and short-term credit ratings for the Company are currently A2 and Prime-1, respectively. Moody’s long-term credit rating remains on stable outlook. Standard & Poor’s (S&P) long-term and short-term credit ratings for the Company are currently A+ and A-1, respectively. S&P’s&P revised its long-term credit rating remains on negative outlook.outlook to stable from negative. Fitch Ratings (Fitch) long-term and short-term credit ratings for the Company are currently A+ and F1, respectively. Fitch continues to place the Company onRating Watch Negative.

The following is a discussion of working capital:

 

Dollars in Millions  

March 31,

2007

  December 31,
2006
  June 30, 2007  December 31, 2006

Working capital

  $4,251  $3,806  $4,855  $3,806

The increase in working capital of $445 million$1.1 billion from December 31, 2006 to March 31,June 30, 2007 was impacted by:

An increase in cash and marketable securities primarily due to upfront payments received from alliance partners and cash proceeds from the exercise of stock options.

 

Higher receivables primarily due to an increase in PLAVIX* sales in the U.S. and funding to the joint venture with Gilead.

 

IncreaseAn increase in prepaid expensesinventories due to the timing of advertisingraw material purchases and product promotional spending.increased production for certain products in anticipation of rationalization of the Company’s manufacturing network.

 

Reclassification of certain tax contingencies from current U.S. and foreign income taxes payable to non-current upon the adoption of Financial Accounting Standards Board Interpretation (FIN) No. 48 on January 1, 2007.

 

Increase in short-term borrowings due to the reclassification of the Yen Notes, due February 2008 from long-term debt, partially offset by a decrease in other borrowings.

Higher accounts payable due to an increase in raw material purchases as well as the timing of raw materialthose purchases.

Higher accrued royalties and an increase in liabilities following a decrease in the fair value of interest rate swaps.

The following is a discussion of cash flow activities:

 

  Three Months Ended March 31,   Six Months Ended June 30, 
Dollars in Millions  2007 2006   2007 2006 

Cash flow provided by/(used in):

      

Operating activities

  $765  $83   $1,826  $928 

Investing activities

   7   (277)   (630)  (422)

Financing activities

   (581)  (385)   (845)  (972)

Net cash provided by operating activities was $765$1,826 million in 2007 and $83$928 million in 2006. The $682$898 million increase in 2007 compared to 2006positive cash flow variance is mainly attributable to net changes in operating assets and liabilities of $739$1,219 million, partially offset by lowerhigher net earnings of $24$15 million and lower net changes in adjustments to net earnings for $33of $336 million.

Net negative changes in adjustments to net earnings in 2007 compared to 2006, of $33$336 million, mainly included:

 

A $200 million positive cash flow variance due to the gain on sale of a product asset in 2006.

A $237$529 million negative cash flow variance in the deferred income tax expense/(benefit)./expense. The 2007 adjustments included the settlementdeferred tax benefits from upfront cash receipts from alliance partners and the resolution of certain tax mattersan audit issue with the IRS, the tax effect of certain milestone payments and additional Research and Development credit.IRS. The 2006 adjustments included deferred tax charges for the payment of litigation settlements and the utilization of foreign tax effectscredits related to the revocation of certainsection 936 election for a domestic subsidiary.

A $181 million positive cash legal settlements.flow variance due to the lower gain on sale of product assets in 2007 compared to 2006.

Net positive changes in operating assets and liabilities in 2007 compared to 2006, of $739$1,219 million, mainly included:

 

A $487$731 million positive cash flow variance from accounts payable and accrued expenses primarily due to a significant pay down of payables in 2006 compared to 2007, higher purchases of raw materials in 2007, and a reduction of accrued rebates and returns in the first quarter of 2006 primarily resulting from lower sales volume.volume, a significant pay down of payables in early 2006 resulting from lower payment of invoices in December 2005 and an increase in accrued royalties in 2007.

 

A $278$451 million negative cash flow variance from receivables primarily due to the recovery of PLAVIX* sales volume in 2007 and lower collection in 2007 resulting from lower PRAVACHOL sales as well as lower sales volume for PLAVIX* in December 2006 compared to December 2005.sales.

 

A $247$391 million positive cash flow variance in deferred income and other liabilities mainly due to $350 million of upfront cash receipts from alliance partners in 2007.

A $305 million positive cash flow variance in litigation primarily due to settlement payments in 2006 for atwo DPA installmentinstallments and the Vanlev litigation, partially offset by insurance recoveries for unrelated matters.

 

A $162$297 million positive cash flow variance in income taxes payable primarily due to a refund claim related to the paymentsrevocation of withholding taxessection 936 election for a domestic subsidiary and the expected utilization of certain foreign tax credits, both in 2006 as well as lower income taxes paid in 2007 compared to 2006.

A $93 million positive cash flow variance in other liabilities mainly due to an upfront cash payment received from an alliance partner in 2007.

Net cash provided by investing activities was $7 million in 2007 compared to net cash used in investing activities of $277was $630 million in 2007 and $422 million in 2006. The $284$208 million positivenegative cash flow variance is primarily attributable to:

 

A $253$280 million positive cash flow variance from licensing milestone payments in 2006 to ImClone and Somerset Pharmaceuticals, Inc.

A $263 million negative cash flow variance mainly from the salenet purchase of marketable securities in 2007.

 

A $200 million negative cash flow variance fromdue to proceeds forfrom the sale of a product asset in 2006.

A $250 million positive cash flow variance from milestone payments in 2006 related to ImClone.

Net cash used in financing activities was $581$845 million in 2007 compared to $385and $972 million in 2006. The $196$127 million negativepositive cash flow variance wasis mainly attributable to:

 

A $137$131 million negativepositive cash flow variance mainly from lowerhigher cash proceeds from the exercise of stock options in 2007 compared to 2006.

During the threesix months ended March 31,June 30, 2007 and 2006, the Company did not purchase any of its common stock.

For each of the three and six month periods ended March 31,June 30, 2007 and 2006, dividends declared per common share were $.28.$.28 and $.56, respectively. The Company paid $551$552 million and $549$1,103 million in dividends for the three and six months ended March 31,June 30, 2007, respectively, and March 31,$549 million and $1,098 million for the three and six months ended June 30, 2006, respectively. Dividend decisions are made on a quarterly basis by the Board of Directors (the Board).

Contractual Obligations

For a discussion of the Company’s contractual obligations, see “Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations’ in the Company’s 2006 Form 10-K. In the first quartersix months of 2007, the Company committed an additional $268$266 million over the next six to seven years for the extension of two administrative contracts and $154 million for a new six year research and development contract.

SEC Consent Order and Deferred Prosecution Agreement

As previously disclosed, on August 4, 2004, the Company entered into a final settlement with the Securities and Exchange Commission (SEC),SEC, concluding an investigation concerning certain wholesaler inventory and accounting matters. The settlement was reached through a Consent, a copy of which was attached as Exhibit 10 to the Company’s quarterly report on Form 10-Q for the period ended September 30, 2004.

Under the terms of the Consent, the Company agreed, subject to certain defined exceptions, to limit sales of all products sold to its direct customers (including wholesalers, distributors, hospitals, retail outlets, pharmacies and government purchasers) based on expected demand or on amounts that do not exceed approximately one month of inventory on hand, without making a timely public disclosure of any change in practice. The Company also agreed in the Consent to certain measures that it has implemented including: (a) establishing a formal review and certification process of its annual and quarterly reports filed with the SEC; (b) establishing a business risk and disclosure group; (c) retaining an outside consultant to comprehensively study and help re-engineer the Company’s accounting and financial reporting processes; (d) publicly disclosing any sales incentives offered to direct customers for the purpose of inducing them to purchase products in excess of expected demand; and (e) ensuring that the Company’s budget process gives appropriate weight to inputs that come from the bottom to the top, and not just those that come from the top to the bottom, and adequately documenting that process.

Further, the Company agreed in the Consent to retain an “Independent Advisor” through the date that the Company’s Form 10-K for the year ended 2005 was filed with the SEC.

The Independent Advisor continued to serve as the Monitor under the DPA discussed below through April 12, 2007.

As previously disclosed, on June 15, 2005, the Company entered into a DPA with the USAO for the District of New Jersey resolving the investigation by the USAO of the Company relating to wholesaler inventory and various accounting matters covered by the Company’s settlement with the SEC. Pursuant to the DPA, the USAO filed a criminal complaint against the Company alleging conspiracy to commit securities fraud, but will defer prosecution of the Company and dismiss the complaint after two years if the Company satisfies all of the requirements of the DPA. A copy of the DPA was filed as Exhibit 99.2 to a Form 8-K filed by the Company on June 16, 2005 and is incorporated by reference hereto as Exhibit 10w to the Form 10-K for the fiscal year ended December 31, 2006.

Under the DPA, among other things, the Company agreed to include in its Forms 10-Q and 10-K filed with the SEC and in its annual report to shareholders the following information: (a) estimated wholesaler/direct customer inventory levels of the top fifteen (15) products sold by the U.S. Pharmaceuticals business; (b) for major non-U.S. countries, estimated aggregate wholesaler/direct-customer inventory levels of the top fifteen (15) pharmaceutical products sold in such countries taken as a whole measured by aggregate annual sales in such countries; (c) arrangements with and policies concerning wholesaler/direct customers and other distributors for these products, including efforts by the Company to control and monitor wholesaler/distributor inventory levels; and (d) data concerning prescriptions or other measures of end-user demand for these products. Pursuant to the DPA, the Company also agreed to include in such filings and reports information on acquisition, divestiture, and restructuring reserve policies and activity, and rebate accrual policies and activity.

The Company also agreed to implement remedial measures already undertaken or mandated in the Consent and in the settlements of the derivative litigation and the Federal securities class action relating to wholesaler inventory and various accounting matters. In addition, the Company agreed to undertake additional remedial actions, corporate reforms and other actions, including: (a) appointing an additional non-executive Director acceptable to the USAO; (b) establishing and maintaining a training and education program on topics that include corporate citizenship and financial reporting obligations; (c) making an additional $300 million payment into the shareholder compensation fund established in connection with the Consent; (d) not engaging in or attempting to engage in any criminal conduct as that term is defined in the DPA; (e) continuing to cooperate with the USAO, including with respect to the ongoing investigation regarding individual current and former employees of the Company; and (f) retaining a Monitor. Also as part of the DPA, the Board separated the roles of Chairman and Chief Executive Officer (CEO) of the Company and on June 15, 2005, elected a Non-Executive Chairman.

The Monitor had defined powers and responsibilities under the DPA, including to oversee the Company’s compliance with all of the terms of the DPA, the Consent and the settlements of the derivative action and the Federal securities class action. The Monitor had the authority to require the Company to take any steps he believes necessary to comply with the terms of the DPA and the Company was required to adopt all recommendations made by the Monitor, unless the Company objected to the recommendation and the USAO agreed that adoption of the recommendation should not be required. In addition, the Monitor reported to the USAO, on at least a quarterly basis, as to the Company’s compliance with the DPA and the implementation and effectiveness of the internal controls, financial reporting, disclosure processes and related compliance functions of the Company. These powers and responsibilities of the Monitor ended on April 12, 2007. The Monitor is expected to file a final report with the USAO on or about May 31, 2007.

On September 12, 2006, the Board announced that the Company’s then current CEO and General Counsel would be leaving their respective positions effective immediately. The announcement took place after the Board received and considered reports from the Company’s outside counsel on issues relating to the PLAVIX* patent litigation with Apotex and a preliminary recommendation from the Monitor to terminate the employment of such individuals. The Monitor’s recommendation followed an investigation initiated by the USAO, conducted by the Monitor and the USAO, into corporate governance issues relating to the Company’s negotiations on a proposed settlement with Apotex. The Company had been advised by the Monitor and the USAO that the investigation did not involve matters that are the subject of the ongoing investigation by the Antitrust Division of the Department of Justice into the PLAVIX* settlement agreement. The investigation included a review of whether there was any violation of Federal securities laws in connection with the proposed settlement with Apotex under the terms of the SEC Consent. As previously disclosed, the Monitor has completed his investigation and submitted his report on the investigation to the USAO. The Monitor’s report did not find any violation of the Consent or the Federal securities laws in connection with the proposed settlement. The Monitor concluded that the Company had violated certain paragraphs of the DPA related to governance matters. The USAO has advised the Company that he believes the

matters cited in the Monitor’s report have been fully remediated and, accordingly, that he does not intend to take any action under the DPA with respect to the Monitor’s report. For additional information on the pending PLAVIX* patent litigation and the Antitrust Division investigation, see “Item 1. Financial Statements—Note 16. Legal Proceedings and Contingencies.”

As noted above under the DPA, the Company agreed to not engage or attempt to engage in criminal conduct. “Criminal conduct” is defined under the DPA as a) any crime related to the Company’s business activities committed by one or more executive officers or directors; b) securities fraud, accounting fraud, financial fraud or other business fraud materially affecting the books and records of publicly filed reports of the Company, and c) obstruction of justice. The USAO, in its discretion, may prosecute the Company for any Federal crimes for which the USAO has knowledge, including the matters that were the subject of the criminal complaint referenced above, should the USAO determine that the Company committed any criminal conduct.

On May 10, 2007, the Company and the Antitrust Division of the DOJ reached an agreement in principle to resolve the previously disclosed investigation by the Antitrust Division regarding the proposed settlement with Apotex of the pending PLAVIX* patent litigation. Under the agreement in principle, the Company or a subsidiary of the Company will plead guilty to criminal charges consisting of two violations of Section 1001 of U.S. Code Title 18 (relating to false statements to a government agency) carrying an aggregate statutory maximum fine of $1 million. The charges relate to representations made by a former senior executive of the Company during the renegotiation of the proposed settlement agreement with Apotex in May 2006 that were not disclosed to the FTC. The agreement in principle is contingent on the parties’ agreement to the terms of a final agreement and acceptance of the plea by the court in which it is entered. There can be no assurance that the agreement in principle will be finalized or that the plea will be accepted. If the agreement in principle is not finalized or the plea is not accepted, it is not possible to assess the ultimate resolution of this investigation or its impact on the Company. Although there can be no assurance, the Company does not believe that resolution of this investigation in accordance with the agreement in principle should have a material impact on its ability to participate in federal procurement or health care programs.

The Company has advised the USAO of the terms of the agreement in principle between the Company and the Antitrust Division. The U.S. Attorney for the District of New Jersey has advised the Company, although the guilty plea that is contemplated by the agreement in principle constitutes a violation of the DPA, the Company has cured that breach by terminating the employment of certain former officers of the Company as well as other actions taken to prevent the recurrence of the issues and events that led to this matter. The U.S. Attorney also has advised the Company that, assuming resolution of this investigation in accordance with the agreement in principle, and assuming the Company’s compliance with the DPA between May 10, 2007, and June 15, 2007, it is the USAO’s intention to terminate the DPA on June 15, 2007, and to seek dismissal with prejudice of the deferred charges pursuant to the DPA on a timely basis.

The Company has established a company-wide policy to limit its sales to direct customers for the purpose of complying with the Consent. This policy includes the adoption of various procedures to monitor and limit sales to direct customers in accordance with the terms of the Consent. These procedures include a governance process to escalate to appropriate management levels potential questions or concerns regarding compliance with the policy and timely resolution of such questions or concerns. In addition, compliance with the policy is monitored on a regular basis.

The Company maintains IMAs with most of its U.S. pharmaceutical wholesalers that account for nearly 100% of total gross sales of U.S. pharmaceutical products. Under the current terms of the IMAs, the Company’s three largest wholesaler customers provide the Company with weekly information with respect to months on hand product level inventories and the amount of out-movement of products. These three wholesalers currently account for approximately 90% of total gross sales of U.S. pharmaceutical products in the firstsecond quarter of 2007, as well as 2006 and 2005. The inventory information received from these wholesalers, together with the Company’s internal information, is used to estimate months on hand product level inventories at these wholesalers. The Company estimates months on hand product inventory levels for its U.S. PharmaceuticalPharmaceuticals business’s wholesaler customers other than the three largest wholesalers by extrapolating from the months on hand calculated for the three largest wholesalers. The Company considers whether any adjustments are necessary to these extrapolated amounts based on such factors as historical sales of individual products made to such other wholesalers and third-party market research data related to prescription trends and patient demand. In contrast, for the Company’s Pharmaceutical business outside of the U.S., Nutritionals and Other Health Care business units around the world, the Company has significantly more direct customers, limited information on direct customer product level inventory and corresponding out-movement information and the reliability of third-party demand information, where available, varies widely. Accordingly, the Company relies on a variety of methods to estimate months on hand product level inventories for these business units.

The Company discloses for each of its top fifteen (15) pharmaceutical products (based on 2006 net sales) and pharmaceutical products that the Company views as current and future key products sold by the U.S. Pharmaceuticals business the amount of net sales and the estimated number of months on hand in the U.S. wholesaler distribution channel as of the end of the immediately preceding quarter and as of the end of the applicable quarter as well as corresponding information for the prior year in its quarterly and annual reports on Forms 10-Q and 10-K. The Company discloses corresponding information for the top fifteen pharmaceutical products and pharmaceutical products that the Company views as key brands and new products sold within its major non-U.S. countries, as described above. For all other business units, the Company discloses on a quarterly basis the key product level inventories. The information required to estimate months on hand product level inventories in the direct customer distribution for the non-U.S. Pharmaceuticals businesses is not available prior to the filing of the quarterly report on Form 10-Q for an applicable quarter. Accordingly, the Company discloses this information on its website approximately 60 days after the end of the applicable quarter and furnishes it on Form 8-K, and in the Company’s Form 10-Q for the following quarter. In addition to the foregoing quarterly disclosure, the Company will include all the foregoing information for all business units for the immediately preceding quarter and of the applicable quarter as well as corresponding information for the prior year in its Annual Report on Form 10-K. For products not described above, if the inventory at direct customers exceeds approximately one month on hand, the Company will disclose the estimated months on hand for such product(s), except where the impact on the Company is de minimis.

The Company has enhanced and will continue to seek to enhance its methods to estimate months on hand product inventory levels for the U.S. Pharmaceuticals business and for the non-U.S. Pharmaceuticals businesses around the world, taking into account the complexities described above. The Company also has taken and will continue to take steps to expedite the receipt and processing of data for the non-U.S. Pharmaceuticals businesses.

The Company believes the above-described procedures provide a reasonable basis to ensure compliance with boththe Consent.

As previously disclosed, on June 15, 2005, the Company entered into a DPA with the USAO for the District of New Jersey resolving the investigation by the USAO of the Company relating to wholesaler inventory and various accounting matters covered by the Company’s settlement with the SEC. Pursuant to the DPA, the USAO filed a criminal complaint against the Company alleging conspiracy to commit securities fraud, but agreed to defer prosecution of the Company and dismiss the complaint after two years if the Company satisfied all of the requirements of the DPA. A copy of the DPA was filed as Exhibit 99.2 to a Form 8-K filed by the Company on June 16, 2005 and is incorporated by reference hereto as Exhibit 10w to the Form 10-K for the fiscal year ended December 31, 2006. Under the terms of the DPA, the Company agreed to retain a Monitor. The Monitor had defined powers and responsibilities under the DPA, including to oversee the Company’s compliance with all of the terms of the DPA, the Consent and the settlements of the derivative action and the Federal securities class action. These powers and responsibilities of the Monitor ended on April 12, 2007. The Monitor filed a final report with the USAO on June 8, 2007. On June 15, 2007 the DPA expired and provides sufficientthe complaint has been dismissed. The Company has no on-going obligations under the DPA.

For additional information to comply with disclosure requirements of both.on the pending PLAVIX* patent litigation and related legal matters and the FTC and New York State Attorney General’s Office investigations and the DPA, see “Item 1. Financial Statements—Note 16. Legal Proceedings and Contingencies” and “Item 7. Management’s Discussion and Analysis – SEC Consent Order and Deferred Prosecution Agreement” in the Company’s 2006 Form 10-K.

Critical Accounting Policies

For a discussion of the Company’s critical accounting policies, see “Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations” in the Company’s 2006 Form 10-K.

Outlook

The Company expects the generic clopidogrel bisulfate sold into distribution channels following the Apotex at-risk launch in August 2006 will have a residual impact on PLAVIX* net sales and the Company’s overall financial results into at least the second quarter of 2007; the full amount and duration of the impact will depend on the amount of generic product Apotex sold into the distribution channels and other factors.

For 2007, the Company expects reductions of net sales for products that have lost exclusivity in previous years to moderate to a range between $900 million and $1.0 billion, as compared to $1.4 billion in 2006. While the Company expects generic clopidogrel bisulfate inventory in the market to have a continued residual impact on 2007 PLAVIX* net sales, the Company does expect PLAVIX* net sales and earnings growth in 2007, assuming the absence of renewed or additional generic competition. The Company expects increased prescription demand for PLAVIX* as well as for other key brands and newly launched products. Compared to 2006, the gross margin is expected to improve due to net sales growth of higher margin products, lower margin erosion related to exclusivity losses, and manufacturing efficiencies. Marketing, selling and administrative expense is expected to remain relatively unchanged as the Company continues to focus on high value primary care and specialist physicians and implements various productivity initiatives. The Company expects to continue to increase investments to develop additional new compounds and support the introduction of new products.

The Company and its subsidiaries are the subject of a number of significant pending lawsuits, claims, proceedings and investigations in addition to the pending PLAVIX* litigation, described above. It is not possible at this time reasonably to assess the final outcome of these investigations or litigations. Management continues to believe, as previously disclosed, that the aggregate impact, beyond current reserves, of the pending PLAVIX* patent litigation, these other litigations and investigations and other legal matters affecting the Company is reasonably likely to be material to the Company's results of operations and cash flows, and may be material to its financial condition and liquidity.

As previously disclosed, the composition of matter patent for PLAVIX*, which expires in 2011, is subject to litigation in the U.S. with Apotex, Inc. The trial testimony ended on February 15, 2007 and the parties are awaiting the Court’s decision. If Apotex were to prevail in the trial in the patent litigation, the Company would expect to face renewed generic competition for PLAVIX* promptly thereafter. There are other pending PLAVIX* patent litigations in the U.S. and in other less significant markets for the product. The Company continues to believe that the PLAVIX* patents are valid and infringed, and with Sanofi, is vigorously pursuing these cases.

It is not possible at this time reasonably to assess the ultimate outcome of the patent litigation with Apotex or of the other PLAVIX* patent litigations, or the timing of any renewed generic competition for PLAVIX* from Apotex or additional generic competition for PLAVIX* from other generic pharmaceutical companies. Loss of market exclusivity of PLAVIX* and/or the development of sustained generic competition would be material to the Company’s sales of PLAVIX*, results of operations and cash flows, and could be material to the Company’s financial condition and liquidity. PLAVIX* is the Company’s largest product by net sales, and U.S. net sales for PLAVIX* were $2.7 billion in 2006.

On May 10, 2007, the Company and the Antitrust Division of the DOJ reached an agreement in principle to resolve the previously disclosed investigation by the Antitrust Division regarding the proposed settlement with Apotex of the pending PLAVIX* patent litigation. Under the agreement in principle, the Company or a subsidiary of the Company will plead guilty to criminal charges consisting of two violations of Section 1001 of U.S. Code Title 18 (relating to false statements to a government agency) carrying an aggregate statutory maximum fine of $1 million. The agreement in principle is contingent on the parties’ agreement to the terms of a final agreement and acceptance of the plea by the court in which it is entered. There can be no assurance that the agreement in principle will be finalized or that the plea will be accepted. If the agreement in principle is not finalized or the plea is not accepted, it is not possible to assess the ultimate resolution of this investigation or its impact on the Company. Although there can be no assurance, the Company does not believe that resolution of this investigation in accordance with the agreement in principle should have a material impact on its ability to participate in federal procurement or health care programs. The USAO has advised the Company that, assuming resolution of this investigation in accordance with the agreement in principle, and assuming the Company’s compliance with the DPA between May 10, 2007, and June 15, 2007, it is the USAO’s intention to terminate the DPA on June 15, 2007, and to seek dismissal with prejudice of the deferred charges pursuant to the DPA on a timely basis.

As previously disclosed, the Company has been served with a Civil Investigative Demand by the FTC requesting documents and information related to the proposed settlement. In addition, as previously disclosed, on April 13, 2007, the Company received a subpoena from the New York State Attorney General’s Office — Antitrust Bureau for documents related to the proposed settlement. The Company is cooperating fully with the investigations. It is not possible at this time reasonably to assess the impact of the proposed agreement in principle with the Antitrust Division described above or a final agreement on the investigations, the outcome of the investigations or their impact on the Company.

As previously disclosed, in December 2006, the Company, the DOJ and the Office of the U.S. Attorney for the District of Massachusetts have reached an agreement in principle, subject to approval by the DOJ, to settle several investigations involving the Company’s drug pricing, and sales and marketing activities. The agreement in principle provides for a civil resolution and an expected payment of $499 million, which is fully reserved. There would be no criminal charges against the Company. The agreement in principle also provides for the Company to enter into a corporate integrity agreement with the Office of Inspector General of the U.S. Department of Health and Human Services. The settlement is contingent upon the parties’ agreement to the terms of a final settlement agreement, including on the terms of the corporate integrity agreement, and approval by the DOJ. There can be no assurance that the settlement will be finalized.

For additional discussion of legal matters, including the PLAVIX* patent litigation and related legal matters, the Antitrust Division, FTC and New York State Attorney General’s Office investigations related to the proposed settlement with Apotex and the terms of the DPA and SEC Consent, see “Item 1. Financial Statements — Note 16. Legal Proceedings and Contingencies,” “—PLAVIX*” and “—SEC Consent Order and Deferred Prosecution Agreement” above. For a further discussion of the risks and uncertainties relating to the matters discussed above, see “Item 1A. Risk Factors” in the Company’s 2006 Form 10-K and “Part II. Item 1A. Risk Factors” below.

Special Note Regarding Forward-Looking Statements

This quarterly report on Form 10-Q (including documents incorporated by reference) and other written and oral statements the Company makes from time to time contain certain “forward-looking” statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. You can identify these forward-looking statements by the fact they use words such as “should”, “expect”, “anticipate”, “estimate”, “target”, “may”, “project”, “guidance”, “intend”, “plan”,

“believe” “believe” and other words and terms of similar meaning and expression in connection with any discussion of future operating or financial performance. One can also identify forward-looking statements by the fact that they do not relate strictly to historical or current facts. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes to differ materially from current expectations. These statements are likely to relate to, among other things, the Company’s goals, plans and projections regarding its financial position, results of operations, cash flows, market position, product development, product approvals, sales efforts, expenses, performance or results of current and anticipated products and the outcome of contingencies such as legal proceedings, and financial results, which are based on current expectations that involve inherent risks and uncertainties, including internal or external factors that could delay, divert or change any of them in the next several years. The Company has included important factors in the cautionary statements included in its 2006 Annual Report on Form 10-K, Form 10-Q for the quarterly period ended March 31, 2007 and in this quarterly report, particularly under “Item 1A. Risk Factors”, that the Company believes could cause actual results to differ materially from any forward-looking statement.

Although the Company believes it has been prudent in its plans and assumptions, no assurance can be given that any goal or plan set forth in forward-looking statements can be achieved and readers are cautioned not to place undue reliance on such statements, which speak only as of the date made. The Company undertakes no obligation to release publicly any revisions to forward-looking statements as a result of new information, future events or otherwise.

Item 3.QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

For a discussion of the Company’s market risk, see “Item 7A. Quantitative and Qualitative Disclosures About Market Risk” in the Company’s 2006 Form 10-K.

In the threesix months ended March 31,June 30, 2007, the Company purchased $32$96 million notional amount of put options and sold $16$293 million notional amount of forward contracts (in several currencies) to partially hedge the exchange impact primarily related to forecasted intercompany inventory purchases for up to the next 1917 months. In addition, the Company purchased $107 million notional amount of put options and sold $55$73 million notional amount of forward contracts (in several currencies) to partially hedge other forecasted currency exposures. Furthermore, the Company sold $18a net $276 million notional amount of forward contracts to hedge the exchange impact related to certain Europrimarily Japanese Yen denominated third party receivables.

 

Item 4.CONTROLS AND PROCEDURES

Management of the Company, with the participation of its Chief Executive Officer and Chief Financial Officer, evaluated the effectiveness of the Company’s disclosure controls and procedures. Based on their evaluation, as of the end of the period covered by this Form 10-Q, the Company’s Chief Executive Officer and Chief Financial Officer have concluded that the Company’s disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended) are effective.

PART II—OTHER INFORMATION

 

Item 1.LEGAL PROCEEDINGS

Information pertaining to legal proceedings can be found in “Item 1. Financial Statements—Note 17.16. Legal Proceedings and Contingencies,” to the interim consolidated financial statements, and is incorporated by reference herein.

 

Item 1A.RISK FACTORS

There have been no material changes in our risk factors from those disclosed in our 2006 Annual Report on Form 10-K or Form 10-Q for the quarter ended March 31, 2007, except for the following.following:

The patent infringement lawsuit with Apotex Inc. and Apotex Corp. (Apotex) involving PLAVIX* is ongoing, and there is a risk of generic competition from Apotex and from other generic pharmaceutical companies.

Although, as noted above, the U.S. District Court for the Southern District of New York (District court) issued an opinion and order upholding the validity and enforceability of the ‘265 Patent relating to PLAVIX* patent, ruled that Apotex’s generic clopidogrel bisulfate product infringed the patent and enjoined Apotex from engaging in any activity that infringes that patent, the PLAVIX* patent infringement lawsuit is still ongoing and there is a risk that the Company could face generic competition from Apotex and from other generic pharmaceutical companies. Apotex has filed a notice of appeal with the U.S. Court of Appeals for the Federal Circuit. If Apotex were to prevail in its appeal of the District court’s decision, the Company could face renewed generic competition for PLAVIX* from Apotex promptly thereafter. Loss of market exclusivity for PLAVIX* and/or sustained generic competition would be material to the Company’s results of operations and cash flows and could be material to its financial condition and liquidity. It is not possible at this time reasonably to assess the outcomes of the appeal by Apotex of the District court’s decision, or the other PLAVIX* patent litigations or the timing of any renewed generic competition for PLAVIX* from Apotex or additional generic competition for PLAVIX* from other third-party generic pharmaceutical companies.

There are legal matters in which adverse outcomes could negatively affect the Company’s business.

On May 10, 2007, the Company and the Antitrust Division of the U.S. Department of Justice reached an agreement in principle to resolve the previously disclosed investigation by the Antitrust Division regarding the proposed settlement with Apotex of the pending PLAVIX* patent litigation. Under the agreement in principle, the Company or a subsidiary of the Company will plead guilty to criminal charges consisting of two violations of Section 1001 of U.S. Code Title 18 (relating to false statements to a government agency) carrying an aggregate statutory maximum fine of $1 million. The agreement in principle is contingent on the parties’ agreement to the terms of a final agreement and acceptance of the plea by the court in which it is entered. There can be no assurance that the agreement in principle will be finalized or that the plea will be accepted. If the agreement in principle is not finalized or the plea is not accepted, it is not possible to assess the ultimate resolution of this investigation or its impact on the Company. Although there can be no assurance, the Company does not believe that resolution of this investigation in accordance with the agreement in principle should have a material impact on its ability to participate in federal procurement or health care programs. The U.S. Attorney’s Office for the District of New Jersey (USAO) has advised the Company that, assuming resolution of this investigation in accordance with the agreement in principle, and assuming the Company’s compliance with the DPA between May 10, 2007, and June 15, 2007, it is the USAO’s intention to terminate the Deferred Prosecution Agreement (DPA) on June 15, 2007, and to seek dismissal with prejudice of the deferred charges pursuant to the DPA on a timely basis.

As previously disclosed, the Company has been served with a Civil Investigative Demand by the Federal Trade Commission (FTC) requesting documents and information related to the proposed settlement.settlement with Apotex of the pending PLAVIX* patent litigation. In addition, as previously disclosed, on April 13, 2007, the Company received a subpoena from the New York State Attorney General’s Office Antitrust Bureau for documents related to the proposed settlement. The Company is cooperating fully with the investigations. As noted above, on June 11, 2007, the Company resolved the investigation by the Antitrust Division of the U.S. Department of Justice (DOJ) into the proposed settlement of the PLAVIX* patent litigation by pleading guilty to two counts of violating 18 U.S.C Sec. 1001 (relating to false statements to a government agency) (the Plea) and paid a fine of $1 million. It is not possible at this time reasonably to assess the impact of the proposed agreement in principle with the Antitrust Division described above or a final agreementPlea on the investigations by the FTC and the New York State Attorney General’s Office – Anti-trust Bureau, the outcome of the investigations or their impact on the Company.

The Company has continuing obligations under the DPA andU.S. Securities and Exchange Commission (SEC) Consent Order relating to wholesaler inventory and various accounting matters, pursuant to which the Company agreed to implement certain remedial measures including all recommendations made by the Independent Monitor under with the DPA, undertake corporate reforms, and to include additional disclosuredisclosures in its periodic reports filed with the SEC and Annual Reportannual report to shareholders.

The Company is currently involved in various lawsuits, claims, proceedings and government investigations, any of which can preclude or delay commercialization of products or adversely affect operations, profitability, liquidity or financial condition, including (i) intellectual property disputes; (ii) sales and marketing practices in the U.S. and internationally; (iii) adverse decisions in litigation, including product liability and commercial cases; (iv) recalls or withdrawals of pharmaceutical products or forced closings of manufacturing plants; (v) the failure to fulfill obligations under supply contracts with the government and other customers which may result in liability; (vi) product pricing and promotion matters; (vii) lawsuits and claims asserting violations of securities, antitrust, federal and state pricing and other laws; (viii) environmental, health and safety matters; and (ix) tax liabilities. There can be no assurance that there will not be an increase in scope of these matters ofor there will not be additional lawsuits, claims, proceedings or investigations in the future; nor is there any assurance that these matters will not have a material adverse impact on the Company.

Additional information about legal matters, including the pending PLAVIX* patent litigation and related legal matters is included in “Item 1. Financial Statements — Statements—Note 16. Legal Proceedings and Contingencies,” “Item 2. Management’s Discussion and Analysis — Analysis—Executive Summary — Plavix*Summary—PLAVIX*,” “—SEC Consent Order and DeterredDeferred Prosecution Agreement,” and “— Outlook.Agreement.

Item 2.UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS

The following table summarizes the surrenders of the Company’s equity securities in connection with stock option and restricted stock programs during the three-monthsix-month period ended March 31,June 30, 2007:

 

Period

  

Total Number of

Shares
Purchased(a)

  Average Price
Paid per Share(a)
  Total Number of Shares
Purchased as Part of
Publicly Announced
Plans or Programs(b)
  

Approximate Dollar

Value of Shares that May
Yet Be Purchased Under
the Plans or Programs(b)

  

Total Number of

Shares Purchased(a)

  Average Price Paid
per Share(a)
  Total Number of Shares
Purchased as Part of
Publicly Announced Plans
or Programs(b)
  Approximate Dollar Value
of Shares that May Yet Be
Purchased Under the Plans
or Programs(b)
Dollars in Millions Except Per Share Data                        

January 1 to 31, 2007

  11,191  $26.10  —    $2,220  11,191  $26.10  —    $2,220

February 1 to 28, 2007

  8,819  $28.13  —    $2,220  8,819  $28.13  —    $2,220

March 1 to 31, 2007

  290,683  $26.91  —    $2,220  290,683  $26.91  —    $2,220
                  

Three months ended March 31, 2007

  310,693    —      310,693      
                  

April 1 to 30, 2007

  11,307  $27.33  —    $2,220

May 1 to 31, 2007

  203,148  $30.16  —    $2,220

June 1 to 30, 2007

  7,448  $30.91  —    $2,220
         

Three months ended June 30, 2007

  221,903      
         

Six months ended June 30, 2007

  532,596      
         

(a)Reflects the following transactions during the threesix months ended March 31, 2007 forJune 30, 2007: (i) the surrender to the Company of 310,693166,630 shares of Common Stock to pay the exercise price and to satisfy tax withholding obligations in connection with the exercise of employee stock options, and (ii) the surrender to the Company of 365,966 shares of Common Stock to satisfy tax withholding obligations in connection with the vesting of restricted stock issued to employees.
(b)In June 2001, the Company announced that the Board of Directors authorized the purchase of up to $14 billion of Company common stock. During the threesix months ended March 31,June 30, 2007, no shares were repurchased pursuant to this program and no purchases of any shares under this program are expected infor the remainder of 2007.

 

Item 4.SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS

The Annual MeetingItem 4 of Stockholders was held on May 1, 2007Form 10-Q for the purpose of:

A. the election of nine directors;

B. ratification of the appointment of Deloitte & Touche LLP as the Company’s independent registered public accounting firm;

C. approval of the Company’squarterly period ended March 31, 2007 Stock Award and Incentive Plan;

D. approval of the Company’s 2007 Senior Executive Performance Incentive Plan;

E. voting on a stockholder proposal on executive compensation disclosure;

F. voting on a stockholder proposal on recoupment; and

G. voting on a stockholder proposal on cumulative voting.

The following persons were elected to serve as directors and received the number of votes set opposite their respective names.is hereby incorporated by reference.

 

   For     Against     Abstain

Lewis B. Campbell

  1,554,732,273    153,644,868    15,988,663

James M. Cornelius

  1,678,752,780    30,088,072    15,524,952

Louis J. Freeh

  1,554,564,174    154,514,355    15,287,274

Laurie H. Glimcher, M.D.

  1,554,676,222    153,488,305    16,201,276

Michael Grobstein

  1,686,346,337    21,595,649    16,423,817

Leif Johansson

  1,622,306,986    86,242,155    15,816,663

James D. Robinson III

  1,609,283,062    99,122,212    15,960,530

Vicki L. Sato, Ph.D.

  1,685,125,546    23,739,584    15,500,674

R. Sanders Williams, M.D.

  1,687,951,609    20,607,670    15,806,525

The appointment of Deloitte & Touche LLP was ratified with a vote of 1,687,947,960 shares in favor of the appointment, with 22,253,485 shares voting against, 14,162,359 shares abstaining and zero broker non-votes.

The 2007 Stock Award and Incentive Plan was approved by a vote of 1,227,991,917 shares in favor, with 155,822,850 shares voting against, 18,406,018 shares abstaining and 322,145,019 broker non-votes.

The 2007 Senior Executive Performance Incentive Plan was approved by a vote of 1,459,094,585 shares in favor, with 245,415,764 shares voting against, 19,826,414 shares abstaining and zero broker non-votes.

The stockholder-proposed resolution on executive compensation disclosure received a vote of 120,857,362 shares in favor, with 1,264,157,876 shares voting against, 17,220,441 shares abstaining and 322,130,125 broker non-votes.

The stockholder-proposed resolution on recoupment received a vote of 129,086,728 shares in favor, with 1,237,197,982 shares voting against, 35,939,929 shares abstaining and 322,141,165 broker non-votes.

The stockholder-proposed resolution on cumulative voting received a vote of 657,839,040 shares in favor, with 724,085,867 shares voting against, 20,313,767 shares abstaining and 322,127,130 broker non-votes.

Item 6.EXHIBITS

Exhibits (listed by number corresponding to the Exhibit Table of Item 601 in Regulation S-K).

 

Exhibit Number and Description  Page
10s.10.1  Form of Non-Qualified Stock OptionPerformance Shares Agreement (filed herewith).  E-10-1
10v.10.2  Form of Restricted Stock UnitsAircraft Time Sharing Agreement (filed herewith).E-10-2
10hh.Senior Executive Severance Plan, as amended effective April 26, 2007 (incorporated herein by reference to Exhibit 10.2 to the Form 8-K dated April 24, 2007 and filed on April 27, 2007).—  
10jj.Bristol-Myers Squibb Company 2007 Stock Award and Incentive Plan, effective as of May 1, 2007 (incorporated herein by reference to Annex B to the 2007 Proxy Statement dated March 22, 2007).—  
10kk.Bristol-Myers Squibb Company 2007 Senior Executive Performance Incentive Plan, effective as of May 1, 2007 (incorporated herein by reference to Annex C to the 2007 Proxy Statement dated March 22, 2007).—  
10ll.Letter Agreement dated April 26, 2007 between James M. Cornelius and Bristol-Myers Squibb Company (incorporated herein by reference to Exhibit 10.1 to the Form 8-K dated April 24, 2007 and filed on April 27, 2007)(filed herewith).  —  
E-10-2
31a.  Section 302 Certification Letter.  E-31-1
31b.  Section 302 Certification Letter.  E-31-2
32a.  Section 906 Certification Letter.  E-32-1
32b.  Section 906 Certification Letter.  E-32-2


*Indicates, in this Form 10-K,10-Q, brand names of products, which are registered trademarks not owned by the Company or its subsidiaries. ERBITUX is a trademark of ImClone Systems Incorporated; AVAPRO/AVALIDE (known in the EUEuropean Union as APROVEL/KARVEA), and PLAVIX is a trademarkare trademarks of Sanofi-Aventis.; GLUCOPHAGE is a trademark of Merck Sante S.A.S., an associate of Merck KGaA of Darmstadt, Germany; ABILIFY is a trademark of Otsuka Pharmaceutical Co., Ltd.; TRUVADA is a trademark of Gilead Sciences, Inc.; BUFFERIN, EXCEDRIN and GLEEVEC is a trademarkare trademarks of Novartis AG; ATRIPLA is a trademark of Bristol-Myers Squibb and Gilead Sciences, LLC; DOVONEX is a trademark of Leo Pharma A/S; NORVIR is a trademark of Abbott Laboratories; TRIZIVIR is a trademark of Glaxo Group Ltd.; ESTRACE is a trademark of Galen (Chemicals) Ltd.Lts.; DELESTROGEN is a trademark of Jones Pharma Inc.; OVCON is a trademark of Warner Chilcott Company, Inc.; NORVIR is a trademark of Abbott Laboratories; TRIZIVIR is a trademark of Glaxo Group Ltd.

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

 

 

BRISTOL-MYERS SQUIBB COMPANY

(REGISTRANT)

Date: May 10,July 31, 2007 By: 

/s/ James M. Cornelius

  

James M. Cornelius

Chief Executive Officer

Date: May 10,July 31, 2007 By: 

/s/ Andrew R. J. Bonfield

  

Andrew R. J. Bonfield

Chief Financial Officer

 

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