Table of Contents

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 10-Q

(Mark One)

 

  x QUARTERLY REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE QUARTERLY PERIOD ENDED JUNE 30, 2010

 

  ¨ 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 the past 90 days.    Yes   x     No   ¨

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).    Yes   x     No   ¨

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

Large accelerated filer   x     Accelerated filer   ¨     Non-accelerated filer   ¨     Smaller reporting company   ¨

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 June 30, 2010, there were 1,714,842,193 shares outstanding of the Registrant’s $0.10 par value common stock.

 

 

 


Table of Contents

BRISTOL-MYERS SQUIBB COMPANY

INDEX TO FORM 10-Q

June 30, 2010

 

PART I—FINANCIAL INFORMATION   

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  

Item 2.

  

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

   32

Item 3.

  

Quantitative and Qualitative Disclosures About Market Risk

   58

Item 4.

  

Controls and Procedures

   58
PART II—OTHER INFORMATION   

Item 1.

  

Legal Proceedings

   58

Item 2.

  

Issuer Purchases of Equity Securities

   58

Item 6.

  

Exhibits

   59

Signatures

   60


Table of Contents

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 June 30,     Six Months Ended June 30,  
EARNINGS    2010     2009     2010     2009  

Net Sales

   $ 4,768      $ 4,665      $ 9,575      $ 8,987   
                                

Cost of products sold

     1,277        1,225        2,583        2,390   

Marketing, selling and administrative

     894        922        1,794        1,823   

Advertising and product promotion

     263        298        475        546   

Research and development

     822        811        1,732        1,719   

Provision for restructuring

     24        19        35        38   

Litigation expense

            28               132   

Equity in net income of affiliates

     (85     (150     (182     (296

Other (income)/expense

     (19     (10     94        (82
                                

Total Expenses

     3,176        3,143        6,531        6,270   
                                

Earnings from Continuing Operations Before Income Taxes

     1,592        1,522        3,044        2,717   

Provision for income taxes

     324        353        675        628   
                                

Net Earnings from Continuing Operations

     1,268        1,169        2,369        2,089   
                                

Discontinued Operations:

        

Earnings, net of taxes

            129               130   

Gain on disposal, net of taxes

                            
                                

Net Earnings from Discontinued Operations

            129               130   
                                

Net Earnings

     1,268        1,298        2,369        2,219   
                                

Net Earnings Attributable to Noncontrolling Interest

     341        315        699        598   
                                

Net Earnings Attributable to Bristol-Myers Squibb Company

   $ 927      $ 983      $ 1,670      $ 1,621   
                                

Amounts Attributable to Bristol-Myers Squibb Company:

        

Net Earnings from Continuing Operations

   $ 927      $ 880      $ 1,670      $ 1,529   

Net Earnings from Discontinued Operations

            103               92   
                                

Net Earnings Attributable to Bristol-Myers Squibb Company

   $ 927      $ 983      $ 1,670      $ 1,621   
                                

Earnings per Common Share from Continuing Operations Attributable to Bristol-Myers Squibb Company:

        

Basic

   $ 0.54      $ 0.44      $ 0.97      $ 0.77   

Diluted

   $ 0.53      $ 0.44      $ 0.96      $ 0.77   

Earnings per Common Share Attributable to Bristol-Myers Squibb Company:

        

Basic

   $ 0.54      $ 0.49      $ 0.97      $ 0.81   

Diluted

   $ 0.53      $ 0.49      $ 0.96      $ 0.81   

Dividends declared per common share

   $ 0.32      $ 0.31      $ 0.64      $ 0.62   

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

 

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BRISTOL-MYERS SQUIBB COMPANY

CONSOLIDATED STATEMENTS OF

COMPREHENSIVE INCOME AND RETAINED EARNINGS

Dollars in Millions

(UNAUDITED)

 

     Three Months Ended June 30,     Six Months Ended June 30,  
     2010     2009     2010     2009  

COMPREHENSIVE INCOME

        

Net Earnings

   $ 1,268      $ 1,298      $ 2,369      $ 2,219   

Other Comprehensive Income/(Loss):

        

Foreign currency translation

     (6     95        (40     20   

Foreign currency translation on hedge of a net investment

     64        (35     143        (2

Derivatives qualifying as cash flow hedges, net of taxes of $(17) and $15 for the three months ended June 30, 2010 and 2009, respectively; and $(30) and $(2) for the six months ended June 30, 2010 and 2009, respectively

     40        (31     69        3   

Derivatives qualifying as cash flow hedges reclassified to net earnings, net of taxes of $2 and $7 for the three months ended June 30, 2010 and 2009, respectively; and $(3) and $14 for the six months ended June 30, 2010 and 2009, respectively

     (4     (21     6        (41

Pension and postretirement benefits, net of taxes of $4 and $(160) for the three months ended June 30, 2010 and 2009, respectively; and $4 and $(220) for the six months ended June 30, 2010 and 2009, respectively

     (12     295        (12     405   

Pension and postretirement benefits reclassified to net earnings, net of taxes of $(11) and $(20) for the three months ended June 30, 2010 and 2009, respectively; and $(23) and $(37) for the six months ended June 30, 2010 and 2009, respectively

     26        35        43        65   

Available for sale securities, net of taxes of $(2) and $(4) for the three months ended June 30, 2010 and 2009, respectively; and $(1) and $(5) for the six months ended June 30, 2010 and 2009, respectively

     17        12        32        14   
                                

Total Other Comprehensive Income/(Loss)

     125        350        241        464   
                                

Comprehensive Income

     1,393        1,648        2,610        2,683   
                                

Comprehensive Income Attributable to Noncontrolling Interest

     341        317        699        603   
                                

Comprehensive Income Attributable to Bristol-Myers Squibb Company

   $ 1,052      $ 1,331      $ 1,911      $ 2,080   
                                

RETAINED EARNINGS

        

Retained Earnings at January 1

  

  $ 30,760      $ 22,549   

Net Earnings Attributable to Bristol-Myers Squibb Company

  

    1,670        1,621   

Cash dividends declared

  

    (1,108     (1,234
                    

Retained Earnings at June 30

  

  $ 31,322      $ 22,936   
                    

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

 

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BRISTOL-MYERS SQUIBB COMPANY

CONSOLIDATED BALANCE SHEETS

Dollars in Millions, Except Share and Per Share Data

(UNAUDITED)

 

     June 30,
2010
    December 31,
2009
 

ASSETS

    

Current Assets:

    

Cash and cash equivalents

   $ 5,918      $ 7,683   

Marketable securities

     1,536        831   

Receivables

     3,172        3,164   

Inventories

     1,265        1,413   

Deferred income taxes

     796        611   

Prepaid expenses

     296        256   
                

Total Current Assets

     12,983        13,958   
                

Property, plant and equipment

     4,745        5,055   

Goodwill

     5,218        5,218   

Other intangible assets, net

     2,763        2,865   

Deferred income taxes

     1,331        1,636   

Marketable securities

     2,795        1,369   

Other assets

     1,216        907   
                

Total Assets

   $ 31,051      $ 31,008   
                

LIABILITIES

    

Current Liabilities:

    

Short-term borrowings

   $ 290      $ 231   

Accounts payable

     1,681        1,711   

Accrued expenses

     2,386        2,785   

Deferred income

     275        237   

Accrued rebates and returns

     671        622   

U.S. and foreign income taxes payable

     49        175   

Dividends payable

     556        552   
                

Total Current Liabilities

     5,908        6,313   
                

Pension, postretirement and postemployment liabilities

     1,248        1,658   

Deferred income

     915        949   

U.S. and foreign income taxes payable

     749        751   

Other liabilities

     409        422   

Long-term debt

     6,248        6,130   
                

Total Liabilities

     15,477        16,223   
                

Commitments and contingencies (Note 17)

    

EQUITY

    

Bristol-Myers Squibb Company Shareholders’ Equity:

    

Preferred stock, $2 convertible series, par value $1 per share: Authorized 10 million shares; issued and outstanding 5,366 in 2010 and 5,515 in 2009, liquidation value of $50 per share

              

Common stock, par value of $0.10 per share: Authorized 4.5 billion shares; 2.2 billion issued in both 2010 and 2009

     220        220   

Capital in excess of par value of stock

     3,697        3,768   

Accumulated other comprehensive loss

     (2,300     (2,541

Retained earnings

     31,322        30,760   

Less cost of treasury stock — 491 million common shares in both 2010 and 2009

     (17,271     (17,364
                

Total Bristol-Myers Squibb Company Shareholders’ Equity

     15,668        14,843   

Noncontrolling interest

     (94     (58
                

Total Equity

     15,574        14,785   
                

Total Liabilities and Equity

   $ 31,051      $ 31,008   
                

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

 

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BRISTOL-MYERS SQUIBB COMPANY

CONSOLIDATED STATEMENTS OF CASH FLOWS

Dollars in Millions

(UNAUDITED)

 

     Six Months Ended June 30,  
     2010     2009  

Cash Flows From Operating Activities:

    

Net earnings

   $ 2,369      $ 2,219   

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

    

Net earnings attributable to noncontrolling interest

     (699     (598

Depreciation

     246        231   

Amortization

     132        113   

Impairment of manufacturing operations

     200          

Deferred income taxes

     97        112   

Stock-based compensation

     96        88   

Other gains

     (15     (78

Changes in operating assets and liabilities:

    

Receivables

     (54     64   

Inventories

     12        (10

Deferred income

     9        75   

Accounts payable

     54        266   

U.S. and foreign income taxes payable

     (195     61   

Changes in other operating assets and liabilities

     (739     (1,295
                

Net Cash Provided by Operating Activities

     1,513        1,248   
                

Cash Flows From Investing Activities:

    

Proceeds from sale and maturities of marketable securities

     1,481        810   

Purchases of marketable securities

     (3,587     (1,913

Additions to property, plant and equipment and capitalized software

     (210     (365

Proceeds from sale of businesses, property, plant and equipment and other investments

     35        104   
                

Net Cash Used in Investing Activities

     (2,281     (1,364
                

Cash Flows From Financing Activities:

    

Short-term debt borrowings/(repayments)

     61        (30

Long-term debt borrowings

     6          

Long-term debt repayments

            (67

Interest rate swap termination

     98        191   

Dividends paid

     (1,103     (1,231

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

     122          

Common stock repurchases

     (165       

Proceeds from Mead Johnson initial public offering

            782   
                

Net Cash (Used in)/Provided by Financing Activities

     (981     (355
                

Effect of Exchange Rates on Cash and Cash Equivalents

     (16     2   
                

Decrease in Cash and Cash Equivalents

     (1,765     (469

Cash and Cash Equivalents at Beginning of Period

     7,683        7,976   
                

Cash and Cash Equivalents at End of Period

   $ 5,918      $ 7,507   
                

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

 

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Note 1. BASIS OF PRESENTATION AND NEW ACCOUNTING STANDARDS

Bristol-Myers Squibb Company (which may be referred to as Bristol-Myers Squibb, BMS or the Company) prepared these unaudited consolidated financial statements following the requirements of the Securities and Exchange Commission 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 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 financial position at June 30, 2010 and December 31, 2009, the results of operations for the three and six months ended June 30, 2010 and June 30, 2009, and cash flows for the six months ended June 30, 2010 and 2009. All intercompany balances and transactions have been eliminated. Material subsequent events are evaluated and disclosed through the report issuance date. These unaudited consolidated financial statements and the related notes should be read in conjunction with the audited consolidated financial statements for the year ended December 31, 2009 included in the Annual Report on Form 10-K.

Certain prior period amounts have been reclassified to conform to the current period presentation. Mead Johnson Nutrition Company (Mead Johnson) financial results, previously reported in the Mead Johnson segment, have been reported as discontinued operations for the three and six months ended June 30, 2009.

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 indicative of full year operating results.

The preparation of financial statements requires the use of management estimates and assumptions, based on complex judgments that are considered reasonable, that affect the reported amounts of assets, liabilities, revenues and expenses and disclosure of contingent assets and contingent liabilities at the date of the financial statements. The most significant assumptions are employed in estimates used in determining the fair value of intangible assets, restructuring charges and accruals, sales rebate and return accruals, legal contingencies, tax assets and tax liabilities, stock-based compensation expense, pension and postretirement benefits (including the actuarial assumptions), fair value of financial instruments with no direct or observable market quotes, inventory obsolescence, potential impairment of long-lived assets, allowances for bad debt, as well as in estimates used in applying the revenue recognition policy. Actual results may differ from estimated results.

New accounting standards were adopted on January 1, 2010, none of which had an impact on the consolidated financial statements upon adoption. Among other items, these standards:

 

   

Provide clarifying criteria in determining when a transferor has surrendered control over transferred financial assets and removed the concept of a qualifying special-purpose entity.

 

   

Require an ongoing reassessment of the primary beneficiary in a variable interest entity; eliminate the quantitative approach previously required in determining the primary beneficiary; and provide guidance in determining the primary beneficiary as the entity that has both the power to direct the activities of a variable interest entity that most significantly impacts the entities economic performance and has the obligation to absorb losses or the right to receive benefits for events significant to the variable interest entity.

The Company is currently evaluating the potential impact of an accounting standard that allows for the allocation of consideration received in a bundled revenue arrangement among the separate deliverables by introducing an estimated selling price method for valuing the elements if vendor-specific objective evidence or third-party evidence of a selling price is not available. The standard provides more flexibility in recognizing revenue for bundled arrangements and expands related disclosure requirements. It is effective either on a prospective basis for revenue arrangements entered into or materially modified in fiscal years beginning on or after June 15, 2010 or on a retrospective basis and early application is permitted.

 

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Note 2. ALLIANCES AND COLLABORATIONS

The Company maintains alliances and collaborations with various third parties for the development and commercialization of certain products. The following information summarizes the current operating trends of commercialized products. See the 2009 Annual Report on Form 10-K for a more complete description of the below agreements, including termination provisions, as well as disclosures of other alliances and collaborations.

sanofi

The Company has agreements with sanofi-aventis (sanofi) for the codevelopment and cocommercialization of AVAPRO*/AVALIDE* (irbesartan/irbesartan-hydrochlorothiazide), 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. 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 relating to these products in the applicable territory.

The Company acts as the operating partner and owns a 50.1% majority controlling interest in the territory covering the Americas and Australia and consolidates all country partnership results for this territory with sanofi’s 49.9% share of the results reflected as a noncontrolling interest. The Company recognizes net sales in this territory and in comarketing countries outside this territory (e.g., Germany, Italy for irbesartan only, Spain and Greece). Discovery royalties owed to sanofi are included in cost of products sold. Sanofi acts as the operating partner and owns a 50.1% majority controlling interest in the territory covering Europe and Asia. The Company’s 49.9% ownership interest in this territory is accounted for under the equity method with its share of operating results recognized in equity in net income of affiliates. Distributions of profits relating to the joint ventures among the Company and sanofi are included within operating activities in the consolidated statements of cash flows.

The Company and sanofi have a separate partnership governing the copromotion of irbesartan in the U.S. The Company recognizes other income related to the amortization of deferred income associated with sanofi’s $350 million payment to the Company for their acquisition of an interest in the irbesartan license for the U.S. upon formation of the alliance. Income attributed to certain supply activities and development and opt-out royalties with sanofi are reflected on a net basis in other income.

The following summarized financial information is reflected in the consolidated financial statements:

 

     Three Months Ended June 30,    Six Months Ended June 30,
Dollars in Millions    2010    2009    2010    2009

Territory covering the Americas and Australia:

           

Net sales

   $ 1,828    $ 1,725    $ 3,706    $ 3,330

Discovery royalty expense

     327      299      661      576

Noncontrolling interest – pre-tax

     500      424      1,020      815

Profit distributions to sanofi

     567      391      1,053      813

Territory covering Europe and Asia:

           

Equity in net income of affiliates

     88      154      188      301

Profit distributions to the Company

     85      115      154      242

Other:

           

Net sales comarketing countries and other

     106      127      208      259

Other income – irbesartan license fee

     8      8      16      16

Other income – supply activities and development and opt-out royalties

     9      10      31      21
               June 30,
2010
   December  31,
2009

Investment in affiliates – territory covering Europe and Asia

         $ 43    $ 10

Deferred income – irbesartan license fee

           75      91

 

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The following is summarized financial information for interests in the partnerships with sanofi for the territory covering Europe and Asia, which are not consolidated but are accounted for using the equity method:

 

     Three Months Ended June 30,    Six Months Ended June 30,
Dollars in Millions    2010    2009    2010    2009

Net sales

   $ 500    $ 772    $ 1,048    $ 1,527

Gross profit

     244      388      488      767

Net income

     193      295      387      584

Otsuka

The Company has a worldwide commercialization agreement (excluding certain countries) with Otsuka Pharmaceutical Co., Ltd. (Otsuka), to codevelop and copromote with Otsuka, ABILIFY* (aripiprazole), for the treatment of schizophrenia, bipolar mania disorder and major depressive disorder. In the U.S., Germany, France and Spain, where the product is invoiced to third-party customers by the Company on behalf of Otsuka, the Company recognizes alliance revenue for its contractual share of third-party net sales, which was reduced in the U.S. starting January 1, 2010 from 65% to 58% for 2010. Further reductions in the Company’s U.S. contractual share of revenue in the U.S. will occur on January 1, 2011 and January 1, 2012 under the terms of the commercialization agreement. Beginning January 1, 2010, Otsuka reimburses the Company 30% of ABILIFY* related operating expenses in the U.S. Reimbursements are netted principally in advertising and product promotion and selling, general and administrative expenses. The Company continues to receive 65% of third-party net sales in France, Germany and Spain with no expense reimbursement. In certain countries where the Company is presently the exclusive distributor for the product or has an exclusive right to sell ABILIFY*, the Company recognizes 100% of the net sales and related cost of products sold and expenses.

The Company paid Otsuka $400 million in April 2009 for extending the term of the commercialization and manufacturing agreement in the U.S. through April 2015. This payment is included in other assets and is being amortized as a reduction of net sales through the extension period. Previously capitalized milestone payments totaling $60 million are included in intangible assets and amortized to cost of products sold.

The Company and Otsuka also have an oncology collaboration for SPRYCEL (dasatinib) and IXEMPRA (ixabepilone) (the “Oncology Products”) in the U.S., Japan and the EU (the “Oncology Territory”). Beginning January 1, 2010, the Company pays a collaboration fee to Otsuka equal to 30% of the first $400 million annual net sales of the Oncology Products in the Oncology Territory, 5% of annual net sales between $400 million and $600 million, and 3% of annual net sales between $600 million and $800 million with additional trailing percentages of annual net sales over $800 million. This fee is included in cost of products sold. Otsuka will contribute 20% of the first $175 million of certain commercial operational expenses relating to the Oncology Products in the Oncology Territory and 1% of such costs in excess of $175 million. Reimbursements are netted principally in selling, general and administrative and advertising and product promotion.

The following summarized financial information related to this alliance is reflected in the consolidated financial statements:

 

     Three Months Ended June 30,    Six Months Ended June 30,
Dollars in Millions    2010     2009    2010     2009

ABILIFY* net sales, including amortization of extension payment

   $ 633      $ 643    $ 1,250      $ 1,232

Oncology Products collaboration fees

     32        —        62        —  

Otsuka’s reimbursement – operating expense

     (23     —        (48     —  

Amortization expense – extension payments

     16        16      32        16

Amortization expense – milestone payments

     2        2      4        4
                June 30,
2010
    December 31,
2009

Intangible assets:

         

Extension payment

        $ 319      $ 351

Milestone payments

          13        17

 

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Lilly

The Company has a collaboration with Eli Lilly and Company (Lilly) for the codevelopment and promotion of ERBITUX* (cetuximab) in the U.S., pursuant to a commercialization agreement with Lilly’s subsidiary, ImClone Systems Incorporated (ImClone), which expires as to ERBITUX* in September 2018. Lilly receives a distribution fee based on 39% of ERBITUX* net sales in North America, which is included in cost of products sold. In Japan, the Company shares rights to ERBITUX* under an agreement with Lilly and Merck KGaA and receives 50% of the pre-tax profit from Merck’s net sales of ERBITUX* in Japan which is further shared equally with Lilly. The Company’s 25% share of profits from commercialization in Japan is included in other income.

Previously capitalized milestone payments are being amortized through 2018 and are classified in costs of products sold.

The following summarized financial information related to this alliance is reflected in the consolidated financial statements:

 

     Three Months Ended June 30,    Six Months Ended June 30,
Dollars in Millions    2010    2009    2010    2009

Net sales

   $ 172    $ 173    $ 338    $ 337

Distribution fees

     67      67      132      131

Amortization expense – milestone payments

     9      10      19      19

Other income – Japan commercialization fee

     11      5      19      10
               June 30,
2010
   December  31,
2009

Intangible asset – milestone payments

         $ 304    $ 323

In January 2010, the Company and Lilly restructured the commercialization agreement described above as it relates to necitumumab (IMC-11F8), a novel targeted cancer therapy currently in Phase III development for non-small cell lung cancer. As restructured, both companies will share in the cost of developing and potentially commercializing necitumumab in the U.S., Canada and Japan. Lilly maintains exclusive rights to necitumumab in all other markets. The Company will fund 55% of development costs for studies that will be used only in the U.S. and will fund 27.5% for global studies. The Company and Lilly will share development costs in Japan equally. The Company will pay $250 million to Lilly as a milestone payment upon first approval in the U.S. In the U.S. and Canada, the Company will recognize sales and receive 55% of the profits for necitumumab. Lilly will provide 50% of the selling effort. In Japan, the Company and Lilly will share commercial costs and profits evenly. The agreement as it relates to necitumumab continues beyond patent expiration. It may be terminated at any time by the Company with 12 months advance notice (18 months if prior to launch), by either party for uncured material breach by the other or if both parties agree to terminate.

Gilead

The Company and Gilead Sciences, Inc. (Gilead) have a joint venture to develop and commercialize ATRIPLA* (efavirenz 600 mg/ emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg), a once-daily single tablet three-drug regimen combining the Company’s SUSTIVA (efavirenz) and Gilead’s TRUVADA* (emtricitabine and tenofovir disoproxil fumarate), in the U.S., Canada and Europe. The Company accounts for its participation in the U.S. joint venture under the equity method of accounting and recognizes its share of the joint venture results in equity in net income of affiliates in the consolidated statements of earnings.

In the U.S., Canada and most European countries, the Company records revenue for the bulk efavirenz component of ATRIPLA* upon sales of that product to third-party customers. Revenue for the efavirenz component is determined by applying a percentage to ATRIPLA* revenue to approximate revenue for the SUSTIVA brand. In a limited number of EU countries, the Company recognizes revenue for ATRIPLA* since the product is purchased from Gilead and then distributed to third-party customers.

The following summarized financial information related to this alliance is reflected in the consolidated financial statements:

 

     Three Months Ended June 30,     Six Months Ended June 30,  
Dollars in Millions    2010     2009     2010     2009  

Net sales

   $ 255      $ 206      $ 505      $ 388   

Equity in net loss of affiliates

     (3     (3     (6     (5

 

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AstraZeneca

The Company maintains two worldwide codevelopment and cocommercialization agreements with AstraZeneca PLC (AstraZeneca), The first is for the worldwide codevelopment and cocommercialization (excluding Japan) of ONGLYZA (saxagliptin), a DPP-IV inhibitor (Saxagliptin Agreement) and the second is for the worldwide codevelopment and cocommercialization (including Japan) of dapagliflozin, a sodium-glucose cotransporter-2 (SGLT2) inhibitor (SGLT2 Agreement). Both compounds are being studied for the treatment of diabetes and were discovered by the Company. Under each agreement, the two companies are jointly developing the clinical and marketing sterategy and share development and commercialization costs and profits and losses equally. Net reimbursements for development costs from AstraZeneca are included in research and development. Net reimbursements for commercial costs are included principally in advertising and product promotion and selling, general and administrative expenses. AstraZeneca’s share of profits is included in cost of goods sold.

Upfront licensing and milestone payments received for both compounds totaling $350 million, including $50 million received in the first quarter of 2010, are deferred and amortized over the useful life of the products into other income.

The Company and AstraZeneca launched ONGLYZA in the third quarter of 2009.

The following summarized financial information related to this alliance is reflected in the consolidated financial statements:

 

     Three Months Ended June 30,    Six Months Ended June 30,
Dollars in Millions    2010    2009    2010    2009

Net sales

   $ 28    $    $ 38    $

Amortization income – milestone payments

     7      3      13      6
               June 30,
2010
   December 31,
2009

Deferred income – milestone payments

         $ 305    $ 268

Exelixis

In June 2010, the Company terminated its global codevelopment and cocommercialization arrangement for XL184 (a MET/VEG/RET inhibitor), an oral anti-cancer compound with all rights returning to Exelixis, Inc. (Exelixis). As a result of the termination, the Company paid $17 million, which has been included in research and development expense. In addition, the Company is no longer obligated for contingent development and regulatory milestone payments of $295 million and sales milestone payments of $150 million. The Company will continue its license arrangement with Exelixis for XL281 and its other collaborations for three small molecule IND’s for codevelopment and copromotion.

 

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Note 3. BUSINESS SEGMENT INFORMATION

The BioPharmaceuticals segment is engaged in the discovery, development, licensing, manufacturing, marketing, distribution and sale of innovative medicines that help patients prevail over serious diseases. A global research and development organization and a global supply chain organization are utilized and responsible for the development and delivery of products to the market. Products are distributed and sold through five regional organizations that serve the United States; Europe; Latin America, Middle East and Africa; Japan, Asia Pacific and Canada; and Emerging Markets. The business is also supported by global corporate staff functions. The segment information presented below is consistent with the financial information regularly reviewed by the chief operating decision maker for purposes of evaluating performance, allocating resources, setting incentive compensation targets, and planning and forecasting future periods.

Net sales of key products were as follows:

 

     Three Months Ended June 30,    Six Months Ended June 30,
Dollars in Millions    2010    2009    2010    2009

PLAVIX*

   $ 1,627    $ 1,539    $ 3,293    $ 2,974

AVAPRO*/AVALIDE*

     307      313      621      615

REYATAZ

     357      331      730      653

SUSTIVA Franchise (total revenue)

     331      312      666      604

BARACLUDE

     223      179      439      331

ERBITUX*

     172      173      338      337

SPRYCEL

     132      107      263      195

IXEMPRA

     29      29      58      53

ABILIFY*

     633      643      1,250      1,232

ORENCIA

     178      148      347      272

ONGLYZA

     28           38     

Other

     751      891      1,532      1,721
                           

Net sales

   $ 4,768    $ 4,665    $ 9,575    $ 8,987
                           

Segment income excludes the impact of significant items not indicative of current operating performance or ongoing results, and earnings attributed to sanofi and other noncontrolling interest. The reconciliation to earnings from continuing operations before income taxes was as follows:

 

     Three Months Ended June 30,     Six Months Ended June 30,  
Dollars in Millions    2010     2009     2010     2009  

BioPharmaceuticals segment income

   $ 1,180      $ 1,217      $ 2,413      $ 2,287   

Reconciling items:

        

Downsizing and streamlining of worldwide operations

     (24     (17     (35     (32

Impairment of manufacturing operations

     (15            (215       

Accelerated depreciation, asset impairment and other shutdown costs

     (27     (26     (58     (56

Pension settlements/curtailments

     (5     (25     (5     (25

Process standardization implementation costs

     (6     (25     (19     (45

Gain on sale of product lines, businesses and assets

            11               55   

Litigation charges

            (28            (132

Upfront licensing and milestone payments

     (17     (29     (72     (174

Debt buyback and swap terminations

            11               11   

Product liability

                          (3

Noncontrolling interest

     506        433        1,035        831   
                                

Earnings from continuing operations before income taxes

   $ 1,592      $ 1,522      $ 3,044      $ 2,717   
                                

 

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Note 4. RESTRUCTURING

The productivity transformation initiative (PTI) was designed to fundamentally change the way the business is run to meet the challenges of a changing business environment and to take advantage of the diverse opportunities in the marketplace as the transformation into a next-generation biopharmaceutical company continues. In addition to the PTI, a strategic process designed to achieve a culture of continuous improvement to enhance efficiency, effectiveness and competitiveness and to continue to improve the cost base has been implemented.

The following PTI and other restructuring charges were recognized:

 

     Three Months Ended June 30,     Six Months Ended June 30,  
Dollars in Millions    2010     2009     2010     2009  

Employee termination benefits

   $ 27      $ 19      $ 37      $ 32   

Other exit costs

     (3            (2     6   
                                

Provision for restructuring, net

     24        19        35        38   

Impairment of manufacturing operations

     15               215          

Accelerated depreciation, asset impairment and other shutdown costs

     27        24        58        50   

Pension plan curtailment charge

     5        25        5        25   

Process standardization implementation costs

     6        25        19        45   
                                

Total cost

     77        93        332        158   

Gain on sale of product lines, businesses and assets

            (11            (55
                                

Net charges

   $ 77      $ 82      $ 332      $ 103   
                                

Most of the accelerated depreciation, asset impairment and other shutdown costs were included in cost of products sold and primarily relate to the rationalization of the manufacturing network in the BioPharmaceuticals segment. These assets continue to be depreciated until the facility closures are completed. The remaining charges were primarily attributed to process standardization activities or attributed to pension plan curtailment charges both of which are recognized as incurred.

Restructuring charges included termination benefits for workforce reduction of manufacturing, selling, administrative, and research and development personnel across all geographic regions of approximately 260 and 140 for the three months ended June 30, 2010 and 2009, respectively, and approximately 480 and 355 for the six months ended June 30, 2010 and 2009, respectively.

The following table presents the detail of expenses incurred in connection with restructuring activities and related restructuring liability activity:

 

     Six Months Ended June 30, 2010     Six Months Ended June 30, 2009  
Dollars in Millions    Employee
Termination
Liability
    Other Exit
Costs
Liability
    Total     Employee
Termination
Liability
    Other Exit
Costs
Liability
    Total  

Liability at January 1

   $ 157      $ 16      $ 173      $ 188      $ 21      $ 209   
                                                

Charges

     31        3        34        32        6        38   

Changes in estimates

     6        (5     1                        
                                                

Provision for restructuring, net

     37        (2     35        32        6        38   

Charges in discontinued operations

                          9               9   

Foreign currency translation

     (6            (6                     

Spending

     (62     (7     (69     (75     (4     (79
                                                

Liability at June 30

   $ 126      $ 7      $ 133      $ 154      $ 23      $ 177   
                                                

In connection with the continued optimization of the manufacturing network, the operations in Latina, Italy were sold to International Chemical Investors, SE (ICI) on May 31, 2010 resulting in a $215 million loss. The loss consisted of a $200 million impairment charge recorded in the first quarter of 2010 attributed to the write-down of assets to fair value less cost of sale when the assets met the held for sale criteria and $15 million of other working capital adjustments and transaction related fees recorded upon closing in the second quarter. An €18 million ($22 million) 6% subordinated promissory note payable in installments by May 2017 was received as consideration. Additional charges may be required pertaining to the Company’s obligation to fund a portion of ICI’s future restructuring costs up to €19 million ($23 million).

As part of the transaction, a one year supply agreement was entered into with ICI in which the Company will be the non-exclusive supplier of certain products to ICI. Also, a three year tolling and manufacturing agreement, which can be extended for an additional two years, was entered into with ICI in which the Company will supply certain raw material products to be processed and finished at the Latina facility and then distributed by the Company in various markets.

 

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Note 5. DISCONTINUED OPERATIONS

Mead Johnson Nutrition Company Split-off

In February 2009, Mead Johnson Nutrition Company (Mead Johnson) completed an initial public offering (IPO) in which the Company received $782 million and retained an 83.1% interest in Mead Johnson. On December 23, 2009, the split-off of the remaining interest in Mead Johnson was completed in exchange for 269 million shares of the Company’s common stock. The results of the Mead Johnson business are included in discontinued operations for the three and six months ended June 30, 2009.

 

Dollars in Millions    Three Months
Ended June  30,
2009
   Six Months
Ended June 30,
2009

Net sales

   $ 719    $ 1,412
             

Earnings before income taxes

   $ 219    $ 408

Provision for income taxes (1)

     90      278
             

Net earnings from discontinued operations

     129      130

Less net earnings from discontinued operations attributable to noncontrolling interest

     26      38
             

Net earnings from discontinued operations attributable to Bristol-Myers Squibb Company

   $ 103    $ 92
             

 

(1) Provision for income taxes include $130 million for the six months ended June 30, 2009 of taxes incurred from the transfer of various international business units to Mead Johnson prior to the IPO.

Transitional Relationships with Discontinued Operations

Subsequent to the split-off, cash flows and income associated with the Mead Johnson business continued to be generated relating to activities that are transitional in nature and generally result from agreements that are intended to facilitate the orderly transfer of business operations. The agreements include, among others, services for accounting, customer service, distribution and manufacturing and generally expire no later than 18 months from the date of the split-off. The income generated from these transitional activities is included in other (income)/expense and is not expected to be material to the future results of operations or cash flows.

 

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Note 6. EARNINGS PER SHARE

 

     Three Months Ended June 30,     Six Months Ended June 30,  
Amounts in Millions, Except Per Share Data    2010     2009     2010     2009  

EPS Numerator – Basic:

        

Income from Continuing Operations Attributable to BMS

   $ 927      $ 880      $ 1,670      $ 1,529   

Earnings attributable to unvested restricted shares

     (3     (5     (7     (8
                                

Income from Continuing Operations Attributable to BMS common shareholders’

     924        875        1,663        1,521   

Net Earnings from Discontinued Operations Attributable to BMS (1)

            102               91   
                                

EPS Numerator – Basic

   $ 924      $ 977      $ 1,663      $ 1,612   
                                

EPS Denominator – Basic:

        

Average Common Shares Outstanding

     1,718        1,980        1,717        1,979   
                                

EPS – Basic:

        

Continuing Operations

   $ 0.54      $ 0.44      $ 0.97      $ 0.77   

Discontinued Operations

            0.05               0.04   
                                

Net Earnings

   $ 0.54      $ 0.49      $ 0.97      $ 0.81   
                                

EPS Numerator – Diluted:

        

Income from Continuing Operations Attributable to BMS

   $ 927      $ 880      $ 1,670      $ 1,529   

Earnings attributable to unvested restricted shares

     (3     (5     (7     (8
                                

Income from Continuing Operations Attributable to BMS common shareholders’

     924        875        1,663        1,521   

Net Earnings from Discontinued Operations Attributable to BMS (1)

            102               91   
                                

EPS Numerator – Diluted

   $ 924      $ 977      $ 1,663      $ 1,612   
                                

EPS Denominator – Diluted:

        

Average Common Shares Outstanding

     1,718        1,980        1,717        1,979   

Contingently convertible debt common stock equivalents

     1        1        1        1   

Incremental shares attributable to share-based compensation plans

     9        2        9        2   
                                

Average Common Shares Outstanding and Common Share Equivalents

     1,728        1,983        1,727        1,982   
                                

EPS – Diluted:

        

Continuing Operations

   $ 0.53      $ 0.44      $ 0.96      $ 0.77   

Discontinued Operations

            0.05               0.04   
                                

Net Earnings

   $ 0.53      $ 0.49      $ 0.96      $ 0.81   
                                

(1) Net Earnings from Discontinued Operations for EPS Calculation:

        

 Net Earnings from Discontinued Operations Attributable to BMS

   $      $ 103      $      $ 92   

 Earnings attributable to unvested restricted shares

            (1            (1
                                

 Net Earnings from Discontinued Operations Attributable to BMS for EPS Calculation

   $      $ 102      $      $ 91   
                                

Anti-dilutive weighted-average equivalent shares:

        

Stock incentive plans

     64        138        66        132   
                                

Total anti-dilutive shares

     64        138        66        132   
                                

 

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Note 7. INCOME TAXES

The effective income tax rate on earnings from continuing operations before income taxes was 20.4% and 22.2% for the three and six months ended June 30, 2010 compared to 23.2% and 23.1% for the three and six months ended June 30, 2009. The effective tax rate is lower than the U.S. statutory rate of 35% primarily due to the permanent reinvestment of offshore earnings from certain manufacturing operations.

The decrease in the effective income tax rate in the three months ended June 30, 2010, was due to:

 

   

A $66 million tax benefit in the second quarter of 2010 for the re-measurement of a U.S. contingent tax matter related to 2004.

 

   

An out-of-period tax adjustment of $59 million related to previously unrecognized net deferred tax assets primarily attributed to deferred profits for financial reporting purposes related to certain alliances as of December 31, 2009. This was partially offset by a reversal of a $17 million understatement of tax expense in the first quarter of 2010. These adjustments are not material to any current or prior periods nor are they expected to be material for the year ended December 31, 2010.

Partially offset by:

 

   

A favorable impact on the prior year rate from the research and development tax credit and deferral of income under the controlled foreign corporation “look-through” rules both of which expired on December 31, 2009.

 

   

A $40 million tax benefit in the second quarter of 2009 related to the final settlement of certain state audits.

In addition to the factors described above, the effective income tax rate in the six months ended June 30, 2010, included an unfavorable impact from a $21 million charge resulting from the reduction of deferred tax assets due to the enactment of healthcare reform. The deferred tax charge was required as a result of the elimination of the deductibility of retiree healthcare payments to the extent of tax-free Medicare Part D subsidies that are received. The change in deductibility is effective January 1, 2013.

U.S. income taxes have not been provided on undistributed earnings of foreign subsidiaries as these undistributed earnings have been invested or are expected to be permanently reinvested offshore. If, in the future, these earnings are repatriated to the U.S., or if such earnings are determined to be remitted in the foreseeable future, additional tax provisions would be required. Reforms to the international tax laws have been proposed that if adopted may increase taxes and reduce the results of operations and cash flows. Future income tax rates are also expected to be negatively impacted by healthcare reform including the enactment of an annual non-tax deductible pharmaceutical fee beginning in 2011 payable to the government.

The Company is currently under examination by a number of tax authorities which have proposed adjustments to tax for issues such as transfer pricing, certain tax credits and the deductibility of certain expenses. The Company estimates that it is reasonably possible that the total amount of unrecognized tax benefits at June 30, 2010 will decrease in the range of approximately $175 million to $205 million in the next twelve months as a result of the settlement of certain tax audits and other events. The expected change in unrecognized tax benefits, primarily settlement related, 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 reasonably be made at this time. The Company believes that it has adequately provided for all open tax years by tax jurisdiction.

 

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Note 8. FAIR VALUE MEASUREMENT

The fair value of financial assets and liabilities are classified in one of the following three categories:

 

     June 30, 2010    December 31, 2009
Dollars in Millions    Quoted
Prices in
Active
Markets for
Identical
Assets
(Level 1)
   Significant
Other
Observable
Inputs
(Level 2)
   Significant
Unobservable
Inputs

(Level 3)
   Total    Quoted
Prices in
Active
Markets for
Identical
Assets
(Level 1)
   Significant
Other
Observable
Inputs
(Level 2)
   Significant
Unobservable
Inputs

(Level 3)
   Total

Available for Sale:

                       

U.S. Treasury Bills

   $ 653    $    $    $ 653    $    $    $    $

U.S. Government Agency Securities

     602                602      225                225

Equity Securities

     5                5      11                11

Prime Money Market Funds

          4,089           4,089           5,807           5,807

Corporate Debt Securities

          1,614           1,614           837           837

Commercial Paper

          998           998           518           518

FDIC Insured Debt Securities

          359           359           252           252

U.S. Treasury Money Market Funds

          9           9           218           218

U.S. Government Agency Money Market Funds

                              24           24

Floating Rate Securities (FRS)

               47      47                91      91

Auction Rate Securities (ARS)

               90      90                88      88
                                                       

Total available for sale assets

     1,260      7,069      137      8,466      236      7,656      179      8,071
                                                       

Derivatives:

                       

Interest Rate Swap Derivatives

          392           392           165           165

Foreign Currency Forward Derivatives

          110           110           21           21
                                                       

Total derivative assets

          502           502           186           186
                                                       

Total assets at fair value

   $ 1,260    $ 7,571    $ 137    $ 8,968    $ 236    $ 7,842    $ 179    $ 8,257
                                                       

Derivatives:

                       

Foreign Currency Forward Derivatives

   $    $ 15    $    $ 15    $    $ 31    $    $ 31

Natural Gas Contracts

          2           2           1           1

Interest Rate Swap Derivatives

                              5           5
                                                       

Total derivative liabilities

          17           17           37           37
                                                       

Total liabilities at fair value

   $    $ 17    $    $ 17    $    $ 37    $    $ 37
                                                       

For financial assets and liabilities that utilize Level 1 and Level 2 inputs, direct and indirect observable price quotes are utilized, including LIBOR and EURIBOR yield curves, foreign exchange forward prices, NYMEX futures pricing and common stock price quotes. Below is a summary of valuation techniques for Level 1 and Level 2 financial assets and liabilities:

 

   

U.S. Treasury Bills, U.S. Government Agency Securities and U.S. Government Agency Money Market Funds – valued at the quoted market price from observable pricing sources at the reporting date.

 

   

Equity Securities – valued using quoted stock prices from New York Stock Exchange or National Association of Securities Dealers Automated Quotation System at the reporting date.

 

   

Prime Money Market Funds – net asset value of $1 per share.

 

   

Corporate Debt Securities and Commercial Paper – valued at the quoted market price from observable pricing sources at the reporting date.

 

   

FDIC Insured Debt Securities – valued at the quoted market price from observable pricing sources at the reporting date.

 

   

U.S. Treasury Money Market Funds – valued at the quoted market price from observable pricing sources at the reporting date.

 

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Interest rate swap derivative assets and liabilities – valued using LIBOR and EURIBOR yield curves, less credit valuation adjustments, at the reporting date. Counterparties to these contracts are highly-rated financial institutions, none of which experienced any significant downgrades since January 1, 2010. Valuations may fluctuate considerably from period-to-period due to volatility in underlying interest rates, driven by market conditions and the duration of the swap. In addition, credit valuation adjustment volatility may have a significant impact on the valuation of interest rate swaps due to changes in counterparty credit ratings and credit default swap spreads.

 

   

Foreign currency forward derivative assets and liabilities – valued using quoted forward foreign exchange prices at the reporting date. Counterparties to these contracts are highly-rated financial institutions, none of which experienced any significant downgrades since January 1, 2010. Valuations may fluctuate considerably from period-to-period due to volatility in the underlying foreign currencies. Short-term maturities of the foreign currency forward derivatives are less than two years; therefore, counterparty credit risk is not significant.

Valuation models are utilized that rely exclusively on Level 3 inputs due to the lack of observable market quotes for the ARS and FRS portfolio. These inputs are based on expected cash flow streams and collateral values including assessments of counterparty credit quality, default risk underlying the security, discount rates and overall capital market liquidity. The fair value of ARS was determined using internally developed valuations that were based in part on indicative bids received on the underlying assets of the securities and other evidence of fair value. Due to the current lack of an active market for FRS and the general lack of transparency into their underlying assets, other qualitative analysis are relied upon to value FRS including discussion with brokers and fund managers, default risk underlying the security and overall capital market liquidity. During the six months ended June 30, 2010, $55 million principal at par was received for FRS.

 

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Note 9. CASH, CASH EQUIVALENTS AND MARKETABLE SECURITIES

Cash and cash equivalents were $5,918 million at June 30, 2010 and $7,683 million at December 31, 2009 and consisted of prime money market funds, government agency securities and treasury securities. Cash equivalents primarily consist of highly liquid investments with original maturities of three months or less at the time of purchase and are recorded at cost, which approximates fair value.

The following table summarizes current and non-current marketable securities, accounted for as “available for sale” debt securities and equity securities:

 

     June 30, 2010    December 31, 2009
Dollars in Millions    Amortized
Cost Basis
   Unrealized
Gain in
Accumulated
OCI
   Unrealized
Loss in
Accumulated
OCI
    Fair
Value
   Amortized
Cost Basis
   Unrealized
Gain in
Accumulated
OCI
   Unrealized
Loss in
Accumulated
OCI
    Fair
Value

Current marketable securities:

                     

Certificates of deposit

   $ 780    $    $      $ 780    $ 501    $    $      $ 501

Commercial Paper

     185                  185      205                  205

U.S. Treasury Bills

     250                  250                      

Corporate debt securities

     266      4             270                      

FDIC insured debt securities

     51                  51                      

U.S. government agency securities

                           125                  125
                                                         

Total current

   $ 1,532    $ 4    $      $ 1,536    $ 831    $    $      $ 831
                                                         

Non-current marketable securities:

                     

Corporate debt securities

   $ 1,335    $ 18    $ (9   $ 1,344    $ 834    $ 5    $ (2   $ 837

U.S. government agency securities

     600      2             602      100                  100

U.S. Treasury Bills

     399      4             403                      

FDIC insured debt securities

     304      4             308      252                  252

Auction rate securities

     80      10             90      80      8             88

Floating rate securities (1)

     58           (11     47      113           (22     91

Other

     1                  1      1                  1
                                                         

Total non-current

   $ 2,777    $ 38    $ (20   $ 2,795    $ 1,380    $ 13    $ (24   $ 1,369
                                                         

Other assets:

                     

Equity securities

   $ 5    $    $      $ 5    $ 11    $    $      $ 11
                                                         

 

(1) All FRS have been in an unrealized loss position for 12 months or more at June 30, 2010.

The contractual maturities of non-current “available for sale” debt securities at June 30, 2010 were as follows:

 

Dollars in Millions

   1 to 5
Years
   Over 10
Years
   Total

Available for sale:

        

Corporate debt securities

   $ 1,344    $    $ 1,344

U.S. government agency securities

     602           602

U.S. Treasury Bills

     403           403

FDIC insured debt securities

     308           308

Floating rate securities

     47           47

Auction rate securities

          90      90

Other

     1           1
                    

Total available for sale

   $ 2,705    $ 90    $ 2,795
                    

 

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Note 10. RECEIVABLES

Receivables include:

 

Dollars in Millions    June 30
2010
   December 31,
2009

Trade receivables

   $ 1,896    $ 2,000

Less allowances

     91      103
             

Net trade receivables

     1,805      1,897

Alliance partners receivables

     950      870

Income tax refund claims

     190      103

Miscellaneous receivables

     227      294
             

Receivables

   $ 3,172    $ 3,164
             

Receivables are netted with deferred income related to alliance partners until recognition of income. As a result, alliance partner receivables and deferred income were reduced by $1,029 million and $730 million at June 30, 2010 and December 31, 2009, respectively. For additional information regarding alliance partners, see “—Note 2. Alliances and Collaborations.” Non-U.S. receivables sold on a nonrecourse basis were $447 million and $104 million for the six months ended June 30, 2010 and 2009, respectively. In the aggregate, receivables due from three pharmaceutical wholesalers in the U.S. represented 50% and 47% of total trade receivables at June 30, 2010 and December 31, 2009, respectively.

In the second quarter of 2010, the government of Greece announced that they intend to convert certain past due receivables from government run hospitals into non-interest bearing notes to be paid over one to three year periods. As a result, receivables of €41 million ($51 million) were reclassified to other long-term assets. A $9 million charge attributed to the imputed discount on the expected non-interest bearing loans over the expected collection period was recognized in the three months ended June 30, 2010 and has been included in other (income)/expense.

Note 11. INVENTORIES

Inventories include:

 

Dollars in Millions    June 30,
2010
   December 31,
2009

Finished goods

   $ 545    $ 580

Work in process

     446      630

Raw and packaging materials

     274      203
             

Inventories

   $ 1,265    $ 1,413
             

Inventories expected to remain on-hand beyond one year were $242 million and $249 million at June 30, 2010 and December 31, 2009, respectively, and were included in non-current other assets. In addition, $148 million of these inventories (plus $37 million of additional purchase obligations) currently cannot be sold in the U.S. until the U.S. Food and Drug Administration (FDA) approves a manufacturing process change. Inventories also include capitalized costs related to production of products for programs in Phase III development subject to final FDA approval of $57 million and $49 million at June 30, 2010 and December 31, 2009, respectively. The status of the regulatory approval process and the probability of future sales were considered in assessing the recoverability of these costs.

Note 12. PROPERTY, PLANT AND EQUIPMENT

Property, plant and equipment includes:

 

Dollars in Millions    June 30,
2010
   December 31,
2009

Land

   $ 135    $ 142

Buildings

     4,300      4,350

Machinery, equipment and fixtures

     3,103      3,563

Construction in progress

     690      840
             

Gross property, plant and equipment

     8,228      8,895

Less accumulated depreciation

     3,483      3,840
             

Property, plant and equipment

   $ 4,745    $ 5,055
             

 

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Note 13. EQUITY

Changes in common shares, treasury stock and capital in excess of par value of stock were as follows:

 

Dollars and Shares in Millions    Common Shares
Issued
   Treasury
Stock
    Cost
of
Treasury
Stock
    Capital in Excess
of Par Value

of Stock
 

Balance at January 1, 2009

   2,205    226      $ (10,566   $ 2,757   

Mead Johnson initial public offering

   —      —          —          942   

Employee stock compensation plans

   —      (2     58        4   
                           

Balance at June 30, 2009

   2,205    224      $ (10,508   $ 3,703   
                           

Balance at January 1, 2010

   2,205    491      $ (17,364   $ 3,768   

Stock repurchase program

   —      7        (173     —     

Employee stock compensation plans

   —      (7     266        (71
                           

Balance at June 30, 2010

   2,205    491      $ (17,271   $ 3,697   
                           

The accumulated balances related to each component of other comprehensive income/(loss) (OCI), net of taxes, were as follows:

 

Dollars in Millions    Foreign
Currency
Translation
    Derivatives
Qualifying
as
Effective
Hedges
    Pension and
Other
Postretirement
Benefits
    Available
for Sale
Securities
    Accumulated
Other
Comprehensive
Income/(Loss)
 

Balance at January 1, 2009

   $ (424   $ 14      $ (2,258   $ (51   $ (2,719

Other comprehensive income/(loss)

     18        (38     470        14        464   
                                        

Balance at June 30, 2009

   $ (406   $ (24   $ (1,788   $ (37   $ (2,255
                                        

Balance at January 1, 2010

   $ (343   $ (30   $ (2,158   $ (10   $ (2,541

Other comprehensive income/(loss)

     103        75        31        32        241   
                                        

Balance at June 30, 2010

   $ (240   $ 45      $ (2,127   $ 22      $ (2,300
                                        

The reconciliation of noncontrolling interest was as follows:

 

     Three Months Ended June 30,     Six Months Ended June 30,  
Dollars in Millions    2010     2009     2010     2009  

Balance at beginning of period

   $ (16   $ (208   $ (58   $ (33

Mead Johnson initial public offering

     —          —          —          (160

Net earnings attributable to noncontrolling interest

     505        456        1,033        864   

Other comprehensive income attributable to noncontrolling interest

     —          2        —          5   

Distributions

     (583     (410     (1,069     (836
                                

Balance at June 30

   $ (94   $ (160   $ (94   $ (160
                                

Noncontrolling interest is primarily related to the partnerships with sanofi for the territory covering the Americas for net sales of PLAVIX*. Net earnings attributable to noncontrolling interest are presented net of taxes of $165 million and $144 million for the three months ended June 30, 2010 and 2009, respectively, and $336 million and $271 million for the six months ended June 30, 2010 and 2009, respectively, in the consolidated statements of earnings with a corresponding increase to the provision for income taxes. Distribution of the partnership profits to sanofi and sanofi’s funding of ongoing partnership operations occur on a routine basis and are included within operating activities in the consolidated statements of cash flows. The above activity includes the pre-tax income and distributions related to these partnerships. Net earnings attributable to noncontrolling interest included in discontinued operations was $26 million and $38 million in the three and six months ended June 30, 2009, respectively.

Treasury stock is recognized at the cost to reacquire the shares. Shares issued from treasury are recognized utilizing the first-in first-out method.

In May 2010, the Board of Directors authorized the repurchase of up to $3.0 billion of common stock. Repurchases may be made either in the open market or through private transactions, including under repurchase plans established in accordance with Rule 10b5-1 under the Securities Exchange Act of 1934, as amended. The stock repurchase program does not have an expiration date but is expected to take place over the next few years. It may be suspended or discontinued at any time. During the three months ended June 30, 2010, the Company repurchased 7.3 million shares at the average price of approximately $23.75 per share and an aggregate cost of $173 million.

 

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Note 14. PENSION, POSTRETIREMENT AND POSTEMPLOYMENT LIABILITIES

The net periodic benefit cost of defined benefit pension and postretirement benefit plans includes:

 

     Three Months Ended June 30,     Six Months Ended June 30,  
     Pension Benefits     Other
Benefits
    Pension Benefits     Other
Benefits
 
Dollars in Millions    2010     2009     2010     2009     2010     2009     2010     2009  

Service cost — benefits earned during the period

   $ 11      $ 48      $ 2      $ 2      $ 22      $ 107      $ 4      $ 3   

Interest cost on projected benefit obligation

     86        89        8        10        173        193        15        19   

Expected return on plan assets

     (112     (107     (6     (5     (225     (233     (12     (10

Amortization of prior service cost/(benefit)

            1        (1     (1            4        (2     (2

Amortization of net actuarial loss

     24        28        3        2        48        70        6        5   
                                                                

Net periodic benefit cost

     9        59        6        8        18        141        11        15   

Settlements

     5                             5                        

Curtailments and special termination benefits

     6        25                      9        25                 
                                                                

Total net periodic benefit cost

   $ 20      $ 84      $ 6      $ 8      $ 32      $ 166      $ 11      $ 15   
                                                                

Continuing operations

   $ 20      $ 82      $ 6      $ 8      $ 32      $ 161      $ 11      $ 14   

Discontinued operations

            2                             5               1   
                                                                

Total net periodic benefit cost

   $ 20      $ 84      $ 6      $ 8      $ 32      $ 166      $ 11      $ 15   
                                                                

Contributions to the U.S. pension plans are expected to approximate $330 million during 2010, of which $315 million was contributed in the six months ended June 30, 2010. Contributions to the international plans are expected to range from $85 million to $100 million in 2010, of which $48 million was contributed in the six months ended June 30, 2010.

In connection with the amendments of the U.S. Retirement Income Plan and several other plans, the crediting of future benefits relating to service was eliminated effective December 31, 2009. In addition, actuarial gains and losses are amortized over the expected weighted-average remaining lives of the participants (32 years). Net periodic benefit costs are reduced as a result of these changes. Pension settlement charges resulting in an acceleration of previously deferred actuarial losses might be required in future periods if lump sum payments for individual plans exceed the sum of the related plan’s service cost and interest cost.

Certain enhancements were made to the defined contribution plans in the U.S. and Puerto Rico allowing for increased matching and additional Company contributions effective January 1, 2010. The expense attributed to these plans was $44 million and $14 million for the three months ended June 30, 2010 and 2009, respectively, and $95 million and $27 million for the six months ended June 30, 2010 and 2009, respectively.

Note 15. EMPLOYEE STOCK BENEFIT PLANS

Stock-based compensation expense was as follows:

 

     Three Months Ended June 30,    Six Months Ended June 30,
Dollars in Millions    2010    2009    2010    2009

Stock options

   $ 14    $ 18    $ 27    $ 36

Restricted stock

     23      19      46      35

Long-term performance awards

     12      8      23      17
                           

Total stock-based compensation expense

   $ 49    $ 45    $ 96    $ 88
                           

Continuing operations

   $ 49    $ 42    $ 96    $ 82

Discontinued operations

          3           6
                           

Total stock-based compensation expense

   $ 49    $ 45    $ 96    $ 88
                           

Deferred tax benefit related to stock-based compensation expense:

           

Continuing operations

   $ 16    $ 14    $ 31    $ 27

Discontinued operations

          1           2
                           

Total deferred tax benefit related to stock-based compensation expense

   $ 16    $ 15    $ 31    $ 29
                           

In the six months ended June 30, 2010, 3.1 million restricted stock units, 1.4 million market share units and 1.7 million long-term performance share units were granted. The weighted-average grant date fair value for restricted stock units, market share units and long-term performance share units granted during the six months ended June 30, 2010 was $24.73, $24.69 and $23.65, respectively.

 

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Restricted stock units vest ratably over a four year period. Market share units vest ratably over a four year period based on share price performance. The fair value of market share units was estimated on the date of grant using a model applying multiple input variables that determine the probability of satisfying market conditions. Long-term performance share units are determined based on the achievement of annual performance goals, but are not vested until the end of the three year period.

Total compensation costs related to nonvested awards not yet recognized and the weighted-average period over which such awards are expected to be recognized at June 30, 2010 were as follows:

 

Dollars in Millions    Stock Options    Restricted Stock    Long-Term
Performance
Awards

Unrecognized compensation cost

   $ 60    $ 209    $ 40

Expected weighted-average period of compensation cost to be recognized

     2.1 years      2.1 years      1.5 years

Note 16. FINANCIAL INSTRUMENTS

Financial instruments include cash and cash equivalents, marketable securities, receivables, accounts payable, debt instruments and derivatives. Due to their short term maturity, the carrying amount of receivables and accounts payable approximate fair value. For further information about cash, cash equivalents and marketable securities, see “—Note 9. Cash, Cash Equivalents and Marketable Securities.”

There is exposure to market risk due to changes in currency exchange rates and interest rates. As a result, certain derivative financial instruments are used when available on a cost-effective basis to hedge the underlying economic exposure. These instruments qualify as cash flow, net investment and fair value hedges upon meeting certain criteria, including effectiveness of offsetting hedged exposures. Changes in fair value of derivatives that do not qualify for hedge accounting are recognized in earnings as they occur. All financial instruments, including derivatives, are subject to counterparty credit risk which is considered as part of the overall fair value measurement. Derivative financial instruments are not used for trading purposes.

Foreign currency forward contracts are used to manage cash flow exposures. The primary net foreign currency exposures hedged are the Euro, Japanese yen, Canadian dollar, British pound, Australian dollar and Mexican peso. Fixed-to-floating interest rate swaps are used as part of the interest rate risk management strategy. These swaps generally qualify for fair-value hedge accounting treatment. Certain net asset changes due to foreign exchange volatility are generally hedged through non-U.S. dollar borrowings which qualify as a net investment hedge.

Qualifying Hedges

Cash Flow Hedges

Foreign Currency Forward Contracts — Foreign currency forward contracts are utilized to hedge forecasted intercompany and other transactions for certain foreign currencies. These contracts are designated as foreign currency cash flow hedges when appropriate. The effective portion of changes in fair value for the designated foreign currency hedges is temporarily reported in accumulated OCI and recognized in earnings when the hedged item affects earnings. The net deferred gains on foreign currency forward contracts qualifying for cash flow hedge accounting are expected to be reclassified to earnings within the next two years.

Effectiveness is assessed at the inception of the hedge and on a quarterly basis. These assessments determine whether derivatives designated as qualifying hedges continue to be highly effective in offsetting changes in the cash flows of hedged items. Any ineffective portion of change in fair value is included in current period earnings. The impact of hedge ineffectiveness on earnings was not significant during the three and six months ended June 30, 2010. Cash flow hedge accounting is discontinued when the forecasted transaction is no longer probable of occurring on the originally forecasted date, or 60 days thereafter, or when the hedge is no longer effective. Discontinued foreign currency forward hedges resulted in a pre-tax gain of $9 million and $11 million during the three and six months ended June 30, 2010, respectively, which was recognized in other (income)/expense.

Interest Rate Contracts — Terminated swaps that qualify as cash flow hedges are recognized in accumulated OCI and amortized to earnings over the remaining life of the debt when the hedged debt remains outstanding.

 

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The impact on OCI and earnings from derivative instruments qualifying as cash flow hedges was as follows:

 

     Six Months Ended June 30,  
     Foreign Currency
Forward
Contracts
    Natural Gas
Contracts
    Forward
Starting
Swaps
    Total Impact  
Dollars in Millions    2010     2009     2010     2009     2010     2009     2010     2009  

Net carrying amount at January 1

   $ (11   $ 35      $ (1   $ (2   $ (18   $ (19   $ (30   $ 14   

Cash flow hedges deferred in OCI

     99        3               2                      99        5   

Cash flow hedges reclassified to cost of products sold/interest expense (effective portion)

     9        (55                                 9        (55

Change in deferred taxes

     (33     13               (1                   (33     12   
                                                                

Net carrying amount at June 30

   $ 64      $ (4   $ (1   $ (1   $ (18   $ (19   $ 45      $ (24
                                                                

Hedge of Net Investment

Non-U.S. dollar borrowings, primarily the €500 Million Notes due 2016 and €500 Million Notes due 2021, ($1.2 billion total), are used to hedge the foreign currency exposures of the net investment in certain foreign affiliates. These borrowings are designated as a hedge of a net investment. At June 30, 2010, €294 million ($363 million) of the Notes due 2016 have been dedesignated.

The impact on OCI and earnings from non-derivative debt designated net investment hedges was as follows:

 

     Six Months Ended June 30,  
     Net Investment Hedges  
Dollars in Millions    2010     2009  

Net carrying amount at January 1

   $ (169   $ (131

Change in spot value of non-derivative debt designated as a hedge

     202        (2

Gain recognized in other (income)/expense, net (overhedged portion)

     (59       
                

Net carrying amount at June 30

   $ (26   $ (133
                

Fair Value Hedges

Interest Rate Contracts — Derivative instruments are used as part of an interest rate risk management strategy, principally fixed-to-floating interest rate swaps that are designated as fair-value hedges.

The swaps and underlying debt for the benchmark risk being hedged are recorded at fair value. Swaps are intended to create an appropriate balance of fixed and floating rate debt. The basis adjustment to debt with qualifying fair value hedging relationships is amortized to earnings as an adjustment to interest expense over the remaining life of the debt when the underlying swap is terminated prior to maturity.

In May 2010, fixed-to-floating interest rate swap agreements of $237 million notional amount and €500 million notional amount were terminated generating total proceeds of $116 million which included accrued interest of $18 million and a basis adjustment of $98 million which was deferred and will be amortized to interest expense over the remaining life of the underlying debt.

In January 2010, fixed-to-floating interest rate swaps were executed to convert $332 million of the 6.80% Debentures due 2026 and $147 million of the 7.15% Debentures due 2023 from fixed rate debt to variable rate debt. These swaps qualified as a fair value hedge for each debt instrument.

The impact on earnings from interest rate swaps that qualified as fair value hedges was as follows:

 

     Three Months Ended June 30,     Six Months Ended June 30,  
Dollars in Millions    2010     2009     2010     2009  

Recognized in interest expense

   $ (33   $ (29   $ (72   $ (53

Amortization of basis adjustment from swap terminations recognized in interest expense

     (8     (7     (15     (12
                                

Total

   $ (41   $ (36   $ (87   $ (65
                                

 

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Table of Contents

The impact on long-term debt from interest rate swaps that qualify as fair value hedges and other items were as follows:

 

Dollars in Millions    June 30,
2010
    December 31,
2009
 

Principal value

   $ 5,425      $ 5,622   

Adjustments to Principal Value:

    

Fair value of interest rate swaps

     392        160   

Unamortized basis adjustment from swap terminations

     460        377   

Unamortized bond discounts

     (29     (29
                

Total

   $ 6,248      $ 6,130   
                

Total interest expense, including interest on long-term debt and interest rate swaps, amounted to $32 million and $42 million for the three months ended June 30, 2010 and 2009, respectively, and $65 million and $94 million for the six months ended June 30, 2010 and 2009, respectively.

Non-Qualifying Foreign Exchange Contracts

Foreign currency forward contracts are used to offset exposure to foreign currency-denominated monetary assets, liabilities and earnings. The primary objective of these contracts is to protect the U.S. dollar value of foreign currency-denominated monetary assets, liabilities and earnings from the effects of volatility in foreign exchange rates that might occur prior to their receipt or settlement in U.S. dollars. These contracts are not designated as hedges and are adjusted to fair value through other (income)/expense as they occur, and substantially offset the change in fair value of the underlying foreign currency denominated monetary asset, liability or earnings.

In the first quarter of 2010, foreign currency forward contracts were used to hedge anticipated earnings denominated in Australian and Canadian dollars throughout 2010. These contracts are not designated as qualifying hedges, and therefore, gains or losses on these derivatives will be recognized in earnings in other (income)/expense as they occur.

The effect of non-qualifying hedges was a $6 million gain and $3 million gain for the three and six months ended June 30, 2010, respectively, and was not significant for 2009.

The following table summarizes the fair value of outstanding derivatives:

 

        June 30, 2010   December 31, 2009       June 30, 2010     December 31, 2009  
Dollars in Millions   Balance Sheet Location   Notional   Fair
Value
  Notional   Fair
Value
 

Balance Sheet Location

  Notional   Fair
Value
    Notional   Fair
Value
 

Derivatives designated as hedging instruments:

                   

Interest rate contracts

  Other assets   $ 3,152   $ 392   $ 3,134   $ 165   Accrued expenses   $   $      $ 597   $ (5

Foreign currency forward contracts

  Other assets     807     106     780     21   Accrued expenses     424     (15     731     (31

Hedge of net investments

                    Long-term debt     874     (874     1,256     (1,256

Natural gas contracts

                    Accrued expenses     *     (2     *     (1
                                       

Subtotal

        498       186         (891       (1,293
                                       

Derivatives not designated as hedging instruments:

                   

Foreign currency forward contracts

  Other assets     114     4           Accrued expenses                      
                                       

Total Derivatives

      $ 502     $ 186       $ (891     $ (1,293
                                       

* The notional value of natural gas contracts was 1 million and 2 million decatherms at June 30, 2010 and December 31, 2009, respectively.

The derivative financial instruments present certain market and counterparty risks; however, concentration of counterparty risk is mitigated by using banks worldwide with Standard & Poor’s and Moody’s long-term debt ratings of A or higher. In addition, only conventional derivative financial instruments are utilized. The consolidated financial statements would not be materially impacted if any counterparties failed to perform according to the terms of its agreement. Currently, collateral or any other form of securitization is not required to be furnished by the counterparties to derivative financial instruments.

For a discussion on the fair value of financial instruments, see “—Note 8. Fair Value Measurement.”

 

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Note 17. LEGAL PROCEEDINGS AND CONTINGENCIES

Various lawsuits, claims, government investigations and other legal proceedings are pending involving the Company and certain of its subsidiaries. The Company recognizes 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, among other things, antitrust, securities, patent infringement, pricing, sales and marketing practices, environmental, commercial, health and safety matters, consumer fraud, employment matters, product liability and insurance coverage. The most significant of these matters are described below.

Although the Company believes it has substantial defenses in these matters, there can be no assurance that there will not be an increase in the scope of pending matters or that any future lawsuits, claims, government investigations or other legal proceedings will not be material.

INTELLECTUAL PROPERTY

PLAVIX* Litigation

PLAVIX* is currently the Company’s largest product ranked by net sales. 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 in other less significant markets for the product. The Company and its product partner, sanofi, (the Companies) intend to vigorously pursue enforcement of their patent rights in PLAVIX*.

PLAVIX* Litigation – U.S.

Patent Infringement Litigation against Apotex and Related Matters

As previously disclosed, the Company’s U.S. territory partnership under its alliance with sanofi is a plaintiff in a pending patent infringement lawsuit instituted in the United States 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 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*. Also, as previously reported, the District Court upheld 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.

Apotex appealed the District Court’s decision and on December 12, 2008, the United States Court of Appeals for the Federal Circuit (Circuit Court) affirmed the District Court’s ruling sustaining the validity of the ‘265 Patent. Apotex filed a petition with the Circuit Court for a rehearing en banc , and in March 2009, the Circuit Court denied Apotex’s petition. The case has been remanded to the District Court for further proceedings relating to damages. In July 2009, Apotex filed a petition for writ of certiorari with the U.S. Supreme Court requesting the Supreme Court to review the Circuit Court’s decision. In November 2009, the U.S. Supreme Court denied the petition, declining to review the Circuit Court’s decision. In December 2009, the Company filed a motion in the District Court for summary judgment on damages, and in January 2010, Apotex filed a motion seeking a stay of the ongoing damages proceedings pending the outcome of the reexamination of the PLAVIX* patent by the U.S. Patent and Trademark Office (PTO) described below. In April 2010, the District Court denied Apotex’s motion to stay the proceedings. The Company’s summary judgment motion remains pending.

As previously disclosed, the Company’s U.S. territory partnership under its alliance with sanofi is also a plaintiff in five additional patent infringement lawsuits against Dr. Reddy’s Laboratories, Inc. and Dr. Reddy’s Laboratories, LTD (Dr. Reddy’s), Teva Pharmaceuticals USA, Inc. (Teva), Cobalt Pharmaceuticals Inc. (Cobalt), Watson Pharmaceuticals, Inc. and Watson Laboratories, Inc. (Watson) and Sun Pharmaceuticals (Sun). The lawsuits against Dr. Reddy’s, Teva and Cobalt relate to the ‘265 Patent. In May 2009, Dr Reddy’s signed a consent judgment in favor of sanofi and BMS conceding the validity and infringement of the ‘265 Patent. As previously reported, the patent infringement actions against Teva and Cobalt were stayed pending resolution of the Apotex litigation, and the parties to those actions agreed to be bound by the outcome of the litigation against Apotex. Consequently, on July 12, 2007, the District Court entered judgments 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. Cobalt and Teva each filed an appeal. In July 2009, the Circuit Court issued a mandate in the Teva appeal binding Teva to the decision in the Apotex litigation. In August 2009, Cobalt consented to entry of judgment in its appeal agreeing to be bound by Circuit Court’s decision in the Apotex litigation. The lawsuit against Watson, filed in October 2004, was based on U.S. Patent No. 6,429,210 (the ‘210 Patent), which discloses and claims a particular crystalline or polymorph form of the hydrogen sulfate salt of clopidogrel, which is marketed as PLAVIX*. In December 2005, the Court permitted Watson to pursue its declaratory judgment counterclaim with respect to U.S. Patent No. 6,504,030. In January 2006, the Court

 

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approved the parties’ stipulation to stay this case pending the outcome of the trial in the Apotex matter. On May 1, 2009, BMS and Watson entered into a stipulation to dismiss the case. In April 2007, Pharmastar filed a request for inter partes reexamination of the ‘210 Patent at the PTO. The PTO granted this request in July of 2007 and in July 2009, the PTO vacated the reexamination proceeding. The lawsuit against Sun, filed on July 11, 2008, is based on infringement of the ‘265 Patent and the ‘210 Patent. With respect to the ‘265 Patent, Sun has agreed to be bound by the outcome of the Apotex litigation. Each of Dr. Reddy’s, Teva, Cobalt, Watson and Sun have filed an aNDA with the FDA, and, with respect to Dr. Reddy’s, Teva, Cobalt and Watson 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.

On June 1, 2009, Apotex filed a request for ex parte reexamination of the ‘265 Patent at the PTO and in August 2009, the PTO agreed to reexamine the patent. In December 2009, the PTO issued a non-final office action rejecting several claims covering PLAVIX* including the claim that was previously upheld in the litigation against Apotex referred to above. Sanofi responded to the office action in February 2010. The PTO has issued an ex parte Reexamination Certificate withdrawing the rejections in the non-final office action and confirming patentability of all the claims of the ‘265 Patent. Apotex has filed a second request for ex parte reexamination of the ‘265 Patent and in June 2010, the PTO denied Apotex’s request to reexamine the patent again.

It is not possible at this time reasonably to assess the outcome of the 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. Loss 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. Additionally, it is not possible at this time reasonably to assess the amount of damages that could be recovered by the Company and Apotex’s ability to pay such damages in the event the Company prevails in the patent litigation.

Additionally, on November 13, 2008, Apotex filed a lawsuit in New Jersey Superior Court entitled, Apotex Inc., et al. v. sanofi-aventis, et al ., seeking payment of $60 million, plus interest, related to the break-up of the proposed settlement agreement.

PLAVIX* Litigation – International

PLAVIX* – Australia

As previously disclosed, sanofi was notified that, in August 2007, GenRx Proprietary Limited (GenRx) obtained regulatory approval of an application for clopidogrel bisulfate 75mg tablets in Australia. GenRx, formerly a subsidiary of Apotex, has since changed its name to Apotex. In August 2007, Apotex filed an application in the Federal Court of Australia seeking revocation of sanofi’s Australian Patent No. 597784 (Case No. NSD 1639 of 2007). Sanofi filed counterclaims of infringement and sought an injunction. On September 21, 2007, the Australian court granted sanofi’s injunction. A subsidiary of the Company was subsequently added as a party to the proceedings. In February 2008, a second company, Spirit Pharmaceuticals Pty. Ltd., also filed a revocation suit against the same patent. This case was consolidated with the Apotex case and a trial occurred in April 2008. On August 12, 2008, the Federal Court of Australia held that claims of Patent No. 597784 covering clopidogrel bisulfate, hydrochloride, hydrobromide, and taurocholate salts were valid. The Federal Court also held that the process claims, pharmaceutical composition claims, and claim directed to clopidogrel and its pharmaceutically acceptable salts were invalid. The Company and sanofi filed notices of appeal in the Full Court of the Federal Court of Australia (Full Court) appealing the holding of invalidity of the claim covering clopidogrel and its pharmaceutically acceptable salts, process claims, and pharmaceutical composition claims which have stayed the Federal Court’s ruling. Apotex filed a notice of appeal appealing the holding of validity of the clopidogrel bisulfate, hydrochloride, hydrobromide, and taurocholate claims. A hearing on the appeals occurred in February 2009. On September 29, 2009, the Full Federal Court of Australia held all of the claims of Patent No. 597784 invalid. In November 2009, the Company and sanofi applied to the High Court of Australia (High Court) for special leave to appeal the judgment of the Full Court. In March 2010, the High Court denied the Company and sanofi’s request to hear the appeal of the Full Court decision. The case has been remanded to the Federal Court for further proceedings related to damages. It is expected the amount of damages will not be material to the Company.

PLAVIX* – EU

As previously disclosed, in 2007, YES Pharmaceutical Development Services GmbH (YES Pharmaceutical) filed an application for marketing authorization in Germany for an alternate salt form of clopidogrel. This application relied on data from studies that were originally conducted by sanofi and BMS for PLAVIX* and were still the subject of data protection in the EU. Sanofi and BMS have filed an action against YES Pharmaceutical and its partners in the administrative court in Cologne objecting to the mandatory authorization. This matter is currently pending.

 

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PLAVIX* – Canada (Apotex, Inc.)

On April 22, 2009, Apotex filed an impeachment action against sanofi in the Federal Court of Canada alleging that sanofi’s Canadian Patent No. 1,336,777 (the ‘777 Patent) is invalid. The ‘777 Patent covers clopidogrel bisulfate and was the patent at issue in the prohibition action in Canada previously disclosed in which the Canadian Federal Court of Ottawa rejected Apotex’s challenge to the ‘777 Patent, held that the asserted claims are novel, not obvious and infringed, and granted sanofi’s application for an order of prohibition against the Minister of Health and Apotex, precluding approval of Apotex’s Abbreviated New Drug Submission until the patent expires in 2012, which decision was affirmed on appeal by both the Federal Court of Appeal and the Supreme Court of Canada. On June 8, 2009, sanofi filed its defense to the impeachment action and filed a suit against Apotex for infringement of the ‘777 Patent.

OTHER INTELLECTUAL PROPERTY LITIGATION

ABILIFY*

As previously disclosed, Otsuka has filed patent infringement actions against Teva, Barr Pharmaceuticals, Inc. (Barr), Sandoz Inc. (Sandoz), Synthon Laboratories, Inc (Synthon), Sun Pharmaceuticals (Sun), Zydus Pharmaceuticals USA, Inc., and Apotex relating to U.S. Patent No. 5,006,528, which covers aripiprazole and expires in April 2015 (including the additional six-month pediatric exclusivity period). Aripiprazole is comarketed by the Company and Otsuka in the U.S. as ABILIFY*. The lawsuits are currently pending in the U.S. District Court for the District of New Jersey and a trial is scheduled to begin in August 2010. The 30-month stay under the Hatch-Waxman Act is believed to expire in November 2010. Accordingly, final approval by the FDA would provide each generic company authorization to distribute a generic aripiprazole product in the U.S., subject to various legal remedies for which Otsuka may apply including injunctive relief and damages.

It is not possible at this time to reasonably assess the outcome of these lawsuits or their impact on the Company. If, however, a generic company were to launch “at risk” or if Otsuka were not to prevail in these lawsuits, generic competition would likely result in substantial decreases in the sales of ABILIFY* in the U.S., which would have a material adverse effect on the results of operations and cash flows and could be material to financial condition.

ATRIPLA*

In April 2009, Teva filed an aNDA to manufacture and market a generic version of ATRIPLA*. Teva sent Gilead a Paragraph IV certification letter challenging two of the fifteen Orange Book listed patents for ATRIPLA*. ATRIPLA* is the product of a joint venture between the Company and Gilead. In May 2009, Gilead filed a patent infringement action against Teva in the U.S. District Court for the Southern District of New York (SDNY). In January 2010, the Company received a notice that Teva amended its aNDA and is challenging eight additional Orange Book listed patents for ATRIPLA*. In March 2010, the Company and Merck, Sharp & Dohme Corp. filed a patent infringement action against Teva also in the SDNY relating to two U.S. Patents which claim crystalline or polymorph forms of efavirenz. In March 2010, Gilead filed two patent infringement actions against Teva in the SDNY relating to six Orange Book listed patents for ATRIPLA*. At this time, the Company’s patent rights covering efavirenz composition of matter and method of use have not been challenged. It is not possible at this time to reasonably assess the outcome of these lawsuits or their impact on the Company.

REYATAZ

Teva has filed aNDAs to manufacture and market generic versions of all four dosage forms REYATAZ (100, 150, 200 and 300 mg). The Company received a Paragraph IV certification letter from Teva challenging the two Orange Book listed patents for REYATAZ. In December 2009, the Company and Novartis Pharmaceutical Corporation (Novartis) filed a patent infringement lawsuit in the U.S. District Court for the District of Delaware (Delaware District Court) against Teva for infringement of the two listed patents covering REYATAZ, which we believe triggered an automatic 30-month stay of approval of Teva’s aNDA. Subsequent patent infringement lawsuits were filed. It is not possible at this time to reasonably assess the outcome of these lawsuits or their impact on the Company.

 

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GENERAL COMMERCIAL LITIGATION

Clayworth Litigation

As previously disclosed, the Company, together with a number of other pharmaceutical manufacturers, was named as a defendant in an action filed in California State Superior Court in Oakland, James Clayworth et al. v. Bristol-Myers Squibb Company, et al ., alleging that the defendants conspired to fix the prices of pharmaceuticals by agreeing to charge more for their drugs in the U.S. than they charge outside the U.S., particularly Canada, and asserting claims under California’s Cartwright Act and unfair competition law. The plaintiffs sought trebled monetary damages, injunctive relief and other relief. In December 2006, the Court granted the Company and the other manufacturers’ motion for summary judgment based on the pass-on defense, and judgment was then entered in favor of defendants. In July 2008, judgment in favor of defendants was affirmed by the California Court of Appeals. In July 2010, the California Supreme Court reversed the Court of Appeal’s judgment and the matter will be remanded to the Superior Court for further proceedings. It is not possible at this time reasonably to assess the outcome of this lawsuit or its impact on the Company in the event plaintiffs are successful on appeal.

RxUSA Wholesale Litigation

As previously disclosed, in July 2006, a complaint was filed by drug wholesaler RxUSA Wholesale, Inc. in the U.S. District Court for the Eastern District of New York against the Company, 15 other drug manufacturers, five drug wholesalers, two officers of defendant McKesson and a wholesale distribution industry trade group, RxUSA Wholesale, Inc. v. Alcon Labs., Inc., et al . The complaint alleges violations of Federal and New York antitrust laws, as well as various other laws. Plaintiff claims that defendants allegedly engaged in anti-competitive acts that resulted in the exclusion of plaintiff from the relevant market and seeks $586 million in damages before any trebling, and other relief. In September 2009, the District Court granted the Company’s and other defendants’ motions to dismiss. Plaintiff has appealed the District Court’s decision to the U.S. Court of Appeals for the Second Circuit.

ANTITRUST LITIGATION

As previously disclosed, 18 lawsuits comprised of both individual suits and purported class actions have been filed against the Company in U.S. District Court, Southern District of Ohio, Western Division, by various plaintiffs, including pharmacy chains (individually and as assignees, in whole or in part, of certain wholesalers), various health and welfare benefit plans/funds and individual residents of various states. These lawsuits allege, among other things, that the purported settlement with Apotex of the patent infringement litigation violated the Sherman Act and related laws. Plaintiffs are seeking, among other things, permanent injunctive relief barring the Apotex settlement and/or monetary damages. The putative class actions filed on behalf of direct purchasers have been consolidated under the caption In re: Plavix Direct Purchaser Antitrust Litigation , and the putative class actions filed on behalf of indirect purchasers have been consolidated under the caption In re: Plavix Indirect Purchaser Antitrust Litigation . Amended complaints were filed on October 19, 2007. Defendants filed a consolidated motion to dismiss in December 2007. In March 2010, the District Court granted the defendants’ motion to dismiss with respect to all the direct purchaser claims. The motion to dismiss with respect to the indirect purchasers claims remains pending. In April 2010, the direct purchaser plaintiffs filed a motion for reconsideration with the District Court. It is not possible at this time to reasonably assess the outcome of these lawsuits or their impact on the Company.

PRICING, SALES AND PROMOTIONAL PRACTICES LITIGATION AND INVESTIGATIONS

ABILIFY* State Attorneys General Investigation

In March 2009, the Company received a letter from the Delaware Attorney General’s Office advising of a multi-state coalition investigating whether certain ABILIFY* marketing practices violated those states’ consumer protection statutes. It is not possible at this time to reasonably assess the outcome of this investigation or its potential impact on the Company.

AWP Litigation

As previously disclosed, the Company, together with a number of other pharmaceutical manufacturers, has been a defendant in a number of private class actions as well as suits brought by the attorneys general of various states. In these actions, plaintiffs allege that 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 Company remains a defendant in four state attorneys general suits pending in state courts around the country. The Company is currently scheduled to go to trial in August 2010 in the Commonwealth Court of Pennsylvania.

As previously reported, one set of class actions were consolidated in the U.S. District Court for the District of Massachusetts (AWP MDL). In August 2009, the District Court granted preliminary approval of a proposed settlement of the AWP MDL plaintiffs’ claims against the Company for $19 million, plus half the costs of class notice up to a maximum payment of $1 million. A final approval hearing is currently scheduled to occur in July 2010.

 

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California 340B Litigation

As previously disclosed, in August 2005, the County of Santa Clara filed a purported class action against the Company and numerous other pharmaceutical manufacturers on behalf of itself and a putative class of other cities and counties in California, as well as the covered entities that purchased drugs pursuant to the 340B drug discount program, alleging that manufacturers did not provide proper discounts to covered entities. Discovery in this matter is ongoing. In May 2009, the U.S. District Court for the Northern District of California denied plaintiff’s motion, without prejudice, to certify the class.

It is not possible at this time to reasonably assess the outcome of this lawsuit, or its potential impact on the Company.

PRODUCT LIABILITY LITIGATION

The Company is a party to various product liability lawsuits. As previously disclosed, in addition to lawsuits, the Company also faces unfiled claims involving its products.

PLAVIX*

As previously disclosed, the Company and certain affiliates of sanofi are defendants in a number of individual lawsuits claiming personal injury allegedly sustained after using PLAVIX*, most of which appear before the United States District Court for the District of New Jersey (NJ District Court). As of June 30, 2010, the companies were defendants in 23 actions before the NJ District Court and have executed tolling agreements with respect to unfiled claims by potential additional plaintiffs. It is not possible at this time to reasonably assess the outcomes of these lawsuits or their potential impact on the Company.

Hormone Replacement Therapy

The Company is one of a number of defendants in a mass-tort litigation in which plaintiffs 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 June 30, 2010, the Company was a defendant in over 300 lawsuits filed on behalf of approximately 500 plaintiffs in federal and state courts throughout the U.S. All of the Company’s hormone therapy products were sold to other companies between January 2000 and August 2001. It is not possible at this time reasonably to assess the outcome of the lawsuits in which the Company is a party or their impact on the Company.

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, or counterpart state or foreign 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. The Company estimated its share of future costs for these sites to be $65 million at June 30, 2010, which represents the sum of best estimates or, where no best 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).

New Brunswick Facility – Environmental & Personal Injury Lawsuits

As previously disclosed, in May 2008, over 100 lawsuits were filed against the Company in Superior Court, Middlesex County, NJ, by or on behalf of current and former residents of New Brunswick, NJ who live or have lived adjacent to the Company’s New Brunswick facility. The complaints allege various personal injuries and property damage resulting from alleged soil and groundwater contamination on their property stemming from historical operations at the New Brunswick facility. In October 2008, the New Jersey Supreme Court granted Mass Tort status to these cases and transferred them to the New Jersey Superior Court in Atlantic County for centralized case management purposes. The Company intends to defend itself vigorously in this litigation. It is not possible at this time to reasonably assess the outcome of these lawsuits, or the potential impact on the Company.

 

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North Brunswick Township Board of Education

As previously disclosed, in October 2003, the Company was contacted by counsel representing the North Brunswick, NJ Board of Education (BOE) regarding a site where waste materials from E.R. Squibb and Sons may have been disposed from the 1940’s through the 1960’s. Fill material containing industrial waste and heavy metals in excess of residential standards was discovered during an expansion project at the North Brunswick Township High School, as well as at a number of neighboring residential properties and adjacent public park areas. In January 2004, the New Jersey Department of Environmental Protection (NJDEP) sent the Company and others an information request letter about possible waste disposal at the site, to which the Company responded in March 2004. The BOE and the Township, as the current owners of the school property and the park, are conducting and jointly financing soil remediation work and ground water investigation work under a work plan approved by NJDEP, and have asked the Company to contribute to the cost. The Company is actively monitoring the clean-up project, including its costs. To date, neither the school board nor the Township has asserted any claim against the Company. Instead, the Company and the local entities have negotiated an agreement to attempt to resolve the matter by informal means, including mediation and binding allocation as necessary. A central component of the agreement is the provision by the Company of interim funding to help defray cleanup costs and assure the work is not interrupted. The Company transmitted interim funding payments in December 2007 and November 2009. The parties commenced mediation in late 2008; however, those efforts were not successful and the parties have moved to a binding allocation process. In addition, in September 2009, the Township and BOE filed suits against several other parties alleged to have contributed waste materials to the site.

OTHER PROCEEDINGS

SEC Germany Investigation

As previously disclosed, in October 2004, the SEC notified the Company that it was conducting an informal inquiry into the activities of certain of the Company’s German pharmaceutical subsidiaries and its employees and/or agents. In October 2006, the SEC informed the Company that its inquiry had become formal. The SEC’s inquiry encompasses matters formerly under investigation by the German prosecutor in Munich, Germany, which have since been resolved. The Company understands the inquiry concerns potential violations of the Foreign Corrupt Practices Act. The Company is cooperating with the SEC.

Medarex Shareholder Litigation

On July 22, 2009, the Company and Medarex announced the signing of a merger agreement providing for the acquisition of Medarex by the Company, through a tender offer, for $16.00 per share in cash. Following that announcement, certain Medarex shareholders filed similar lawsuits in state and federal court relating to this transaction against Medarex, the members of Medarex’s board of directors, and the Company.

Following the consolidation of the state court actions, on August 20, 2009, the parties entered into a memorandum of understanding (MOU), pursuant to which the parties reached an agreement in principle to settle all of the state and federal actions. Pursuant to the agreements in the MOU, among other things, Medarex made certain supplemental disclosures during the tender offer period. The parties also agreed to present to the Superior Court of New Jersey, Mercer County (NJ Superior Court) a Stipulation of Settlement and any other documentation as may be required in order to obtain approval by the court of the settlement and the dismissal of the actions upon the terms set forth in the MOU. In July 2010, the proposed settlement was approved by the NJ Superior Court and a Final Judgment was entered on July 16, 2010. An objector to the settlement has filed a motion asking the Court to reconsider its approval of the settlement.

 

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

Executive Summary

Bristol-Myers Squibb Company (which may be referred to as Bristol-Myers Squibb, BMS, the Company, we, our or us) is a global biopharmaceutical company, consisting of global pharmaceutical/biotechnology and international consumer medicines businesses, whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. We license, manufacture, market, distribute and sell pharmaceutical products on a global basis.

We completed the split-off of Mead Johnson Nutritional Company (Mead Johnson) in December 2009 in which we exchanged all of our shares of Mead Johnson for 269 million outstanding shares of our common stock. As such, the results of the Mead Johnson business for the three and six months ended June 30, 2009 are now included in net earnings from discontinued operations.

Healthcare Reform

U.S. Healthcare Reform Legislation

The Patient Protection and Affordable Care Act (HR 3590) and a reconciliation bill containing a package of changes to the healthcare bill were signed into law during March 2010. The new legislation makes extensive changes to the current system of healthcare insurance and benefits intended to broaden coverage and reduce costs. These bills significantly change how Americans receive healthcare coverage and how they pay for it. They also have a significant impact on companies, in particular those companies in the pharmaceutical industry and other healthcare related industries, including BMS.

We have experienced and will continue to experience additional financial costs and certain other changes to our business as the new healthcare law is implemented. The following are the most significant changes that will affect our Company:

 

   

Retroactive to January 1, 2010, minimum rebates on our Medicaid drug sales have increased from 15.1 percent to 23.1 percent. In addition, Medicaid rebates have also been extended to drugs used in risk-based Medicaid managed care plans beginning in March 2010.

 

   

Beginning later in 2010, we will extend discounts to certain critical access hospitals, cancer hospitals and other covered entities as required by the expansion of the 340B Drug Pricing Program under the Public Health Services Act.

 

   

Beginning in 2011, we will provide a 50 percent discount on our brand-name drugs to patients who fall within the Medicare Part D coverage gap, also referred to as the “Donut Hole.”

 

   

Beginning in 2011, we will pay an annual non-tax deductible fee to the federal government based on an allocation of our market share of branded prior year sales to certain government programs including Medicare, Medicaid, Department of Veterans Affairs, Department of Defense and TriCare. This fee is expected to be classified either as a reduction to net sales or as an operating expense pending further guidance from authoritative bodies.

The new healthcare law also provides clarity about the process for approval of generic biologic products in the U.S. Our biologic products will receive 12 years of data exclusivity, with a potential six-month pediatric extension, before a generic company can enter the market. After we have marketed a biologic product for 4 years, a generic manufacturer may challenge one or more of the patents for that product.

Higher rebates to Medicaid and Medicaid managed care plans reduced our net sales by $72 million and $128 million and pre-tax income by $55 million and $104 million in the three and six months ended June 30, 2010, respectively. Quarterly rebates are expected to increase substantially throughout 2010 as a result of additional discounts for the Medicaid managed care plans and 340B program. With the addition of the new Medicare Part D “Donut Hole” discounts and annual pharmaceutical company fee in 2011, we expect the negative impact of healthcare reform in 2011 to be approximately twice the impact expected in 2010. The aggregate financial impact of healthcare reform over the next few years depends on a number of factors, including but not limited to pending implementation guidance, potential changes in sales volume eligible for the new rebates, discounts or fees, and the impact of cost sharing arrangements with certain alliance partners. A positive impact on our net sales from the expected increase in the number of people with healthcare coverage could potentially occur in the future, but is not expected until 2014 at the earliest.

We also recognized a one-time tax charge of $21 million in the first quarter of 2010 due to the elimination of the tax deductibility of a portion of our retiree healthcare costs.

 

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Strategy

Over the past few years, we have transformed our Company into a focused biopharmaceutical company, a transformation that encompasses all areas of our business and operations. With the expected loss of exclusivity in the U.S. for our largest product, PLAVIX*, in less than two years, after which time we expect a rapid, precipitous decline in PLAVIX* net sales and a reduction in net income and operating cash flow, we are focused on building a foundation for the future. We plan to achieve this foundation by continuing to support and grow our currently marketed products, advancing our late-stage pipeline, managing our costs, and maintaining and improving our financial strength with a strong balance sheet. We are also focusing on emerging markets with the intent of developing and commercializing innovative products in key high-growth markets tailoring the approach to each market. We also remain focused on our acquisition and licensing strategy known as the “string-of-pearls”. We did not enter into any new licensing or acquisition transactions in the second quarter of 2010.

As part of our strategy to manage costs, we continue to execute our productivity transformation initiative (PTI), through which we expect to realize $2.5 billion in annual cost savings and cost avoidance by the end of 2012 based on previous strategic plans for future years. To achieve this, we are reducing general and administrative operations by simplifying, standardizing and outsourcing certain processes and services, rationalizing our mature brands portfolio, consolidating our global manufacturing network while eliminating complexity and enhancing profitability, simplifying our geographic footprint and implementing a more efficient go-to-market model. For instance, in the second quarter we divested our manufacturing operations in Latina, Italy. We expect to realize approximately 90% of the PTI cost savings and cost avoidance on an annualized run-rate basis by the end of 2010. Because the expected $2.5 billion of annual cost savings and avoidance is based on previous strategic plans for future years and because our progress is measured on an annualized run-rate basis, the amount of cost savings and avoidance does not correlate directly with our results of operations. Approximately 60% of the expected $2.5 billion in annual cost savings and cost avoidance relates to marketing, selling and administrative expenses, 20-25% relates to costs of products sold, and 15-20% relates to research and development expenses. In addition to the PTI, we are also moving towards a culture of continuous improvement to enhance efficiency, effectiveness and competitiveness.

Financial Highlights

The following table is a summary of operating activity:

 

     Three Months Ended June 30,    Six Months Ended June 30,
Dollars in Millions, except per share data    2010    2009    2010    2009

Net Sales

   $ 4,768    $ 4,665    $ 9,575    $ 8,987

Segment Income

     1,180      1,217      2,413      2,287

Net Earnings from Continuing Operations Attributable to BMS

     927      880      1,670      1,529

Net Earnings from Discontinued Operations Attributable to BMS

          103           92

Net Earnings Attributable to BMS

     927      983      1,670      1,621

Diluted Earnings Per Share from Continuing Operations Attributable to BMS

     0.53      0.44      0.96      0.77

Non-GAAP Diluted Earnings Per Share from Continuing Operations Attributable to BMS

     0.54      0.48      1.10      0.90

Cash, Cash Equivalents and Marketable Securities

           10,249      9,103

Net sales increased 2% for the three months ended June 30, 2010 and increased 7% for the six months ended June 30, 2010 as increased U.S. sales of PLAVIX* and other key products were offset by decreases in mature brand sales and the impact of healthcare reform during both periods.

Segment income decreased 3% for the three months ended June 30, 2010 and increased 6% for the six months ended June 30, 2010. Both periods benefitted from increased sales as well as reduced advertising and product promotion spending, and were negatively impacted by increased noncontrolling interest due to higher profitability attributed to PLAVIX* in the U.S., reduced equity income of affiliates due to decreases in international PLAVIX* net sales from generic competition and increased investment to support our late stage pipeline, recent acquisitions and collaborations.

Net earnings from continuing operations attributable to BMS were impacted by segment results and specified items. Both the three and six months ended June 30, 2010 benefitted from a lower effective tax rate than prior periods.

 

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Diluted earnings per share (EPS) from continuing operations increased 20% and 25% for the three and six months ended June 30, 2010, respectively, primarily due to the reduction in the outstanding number of shares from the Mead Johnson split-off.

Our non-GAAP financial measures, including non-GAAP earnings from continuing operations and related EPS information, are adjusted to exclude certain costs, expenses, gains and losses and other specified items. Our non-GAAP diluted EPS from continuing operations increased 13% and 22% for the three and six months ended June 30, 2010, respectively, after adjusting for specified items of $17 million and $86 million during the three months ended June 30, 2010 and 2009, respectively, and $241 million and $266 million during the six months ended June 30, 2010 and 2009, respectively. For a detailed listing of all specified items and further information and reconciliations of non-GAAP financial measures, see “—Specified Items” and “—Non-GAAP Financial Measures” below.

Cash flows from operating activities amounted to $1.5 billion during the six months ended June 30, 2010. Primary nonoperating uses of cash, cash equivalents and marketable securities included dividend payments of $1.1 billion, common stock repurchases of $165 million and capital expenditures of $210 million.

Product and Pipeline Developments

The Company manages its research and development (R&D) programs on a portfolio basis, investing resources in each stage of research and development, from early discovery through late-stage development. Our late-stage development programs, which are our investigational compounds that are in Phase III clinical development and our marketed products that are in Phase III development for additional indications or formulations, represent approximately 30-40% of our annual R&D expenses. No individual investigational compound or marketed product represented 10% or more of our R&D expenses in any of the last three years. The following are the recent significant developments relating to our marketed products and our late-stage pipeline.

ONGLYZA – a once-daily oral tablet for the treatment of type 2 diabetes that is part of our strategic alliance with AstraZeneca PLC (AstraZeneca)

 

   

In June 2010, the Company and AstraZeneca announced results from a 52-week Phase IIIb study in adults with type 2 diabetes who had inadequate glycemic control on metformin therapy plus diet and exercise. The study found that the addition of ONGLYZA 5 mg to existing metformin therapy achieved the primary objective of demonstrating non-inferiority compared to the addition of titrated glipizide (sulphonylurea) to existing metformin therapy in reducing glycosylated hemoglobin levels. The study also found that treatment with ONGLYZA 5 mg plus metformin resulted in a statistically significant lower proportion of subjects reporting hypoglycemic events and statistically significant weight loss compared to titrated glipizide plus metformin. ONGLYZA 5 mg plus metformin also resulted in a significantly smaller rise per week in HbA1c from week 24 to week 52 compared to titrated glipizide plus metformin.

 

   

In June 2010, the Company and AstraZeneca announced results from a 76-week Phase III study of ONGLYZA as initial combination therapy with metformin, which produced long-term glycemic improvements (as measured by HbA1c levels) in treatment-naïve adults with type 2 diabetes mellitus inadequately controlled on diet and exercise compared to treatment with an investigational 10 mg dose of ONGLYZA or metformin alone. The study also demonstrated that a higher number of patients were able to achieve the American Diabetes Association recommended glycosylated hemoglobin level target of less than 7% with ONGLYZA and metformin as initial combination therapy, compared to monotherapy of either treatment at week 76.

Dapagliflozin – an oral compound in Phase III development for the treatment of diabetes that is part of our strategic alliance with AstraZeneca

 

   

In June 2010, findings from a 24-week Phase III clinical study were published that demonstrated that dapagliflozin, administered as monotherapy, achieved statistically significant mean reductions at 5 mg and 10 mg doses once daily in the primary endpoint of glycosylated hemoglobin levels in treatment-naïve adult patients with newly diagnosed type 2 diabetes, compared to placebo.

 

   

In June 2010, results from a 24-week Phase III clinical study were presented that demonstrated that the addition of dapagliflozin achieved reductions in the primary endpoint, glycosylated hemoglobin level, in inadequately controlled type 2 diabetes patients who were treated with insulin (with or without oral anti-diabetes medications (OADS)), compared to placebo plus insulin (with or without OADS). The study also demonstrated that dapagliflozin achieved reductions in the secondary endpoints that evaluated the change in total body weight from baseline, change in baseline from in mean daily insulin dose and change from baseline in fasting plasma glucose.

 

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ORENCIA – a fusion protein indicated for rheumatoid arthritis

 

   

In July 2010, the European Commission approved a new indication for ORENCIA, in combination with methotrexate (MTX), for the treatment of moderate to severe rheumatoid arthritis in adult patients who have responded inadequately to previous therapy with one or more disease-modifying anti-rheumatic drugs including MTX or a TNF-alpha inhibitor.

SPRYCEL – an oral inhibitor of multiple tyrosine kinases indicated for the treatment of adults with chronic, accelerated, or myeloid or lymphoid blast phase chronic myeloid leukemia with resistance or intolerance to prior therapy, including GLEEVEC* (imatinib meslylate), which is part of our strategic alliance with Otsuka Pharmaceutical Co., Ltd. (Otsuka).

 

   

In July 2010, the U.S. Food and Drug Administration (FDA) accepted for priority review the sNDA for SPRYCEL for the treatment of adult patients with newly diagnosed chronic myeloid leukemia in chronic phase. The Prescription Drug User Fee Act (PDUFA) date, the date by which action from the FDA is expected, is October 28, 2010.

 

   

In April 2010, the Type II Variation submission for SPRYCEL for the treatment of adult patients with newly diagnosed chronic myeloid leukemia in chronic phase was validated by the European Medicines Agency.

 

   

In June 2010, the Company and Otsuka announced Phase III study results in which SPRYCEL 100 mg once daily demonstrated a superior rate of confirmed complete cytogenetic response compared to GLEEVEC*. The study showed that 77 percent of SPRYCEL patients versus 66 percent of GLEEVEC* patients achieved confirmed complete cytogenetic response rates by 12 months.

 

   

In June 2010, the Company and Otsuka announced four year follow-up results from a Phase III randomized, open-label, dose-optimization study of SPRYCEL in chronic-phase chronic myeloid leukemia patients resistant or intolerant to GLEEVEC*. At four years, for all patients administered SPRYCEL 100 mg once daily, overall survival was 82% (95% CI: 76%-88%) and progression-free survival was 66% (95% CI: 57%-74%). The four-year safety data from this study are consistent with the previously reported safety profile of SPRYCEL 100 mg once daily.

Apixaban – an oral Factor Xa inhibitor in Phase III development for the prevention of venous thromboembolic disorders, the treatment of acute coronary syndrome and stroke prevention in atrial fibrillation that is part of our strategic alliance with Pfizer, Inc. (Pfizer)

 

   

In June 2010, the Company and Pfizer announced that the Phase III AVERROES clinical trial of apixaban in patients with atrial fibrillation is closing early due to clear evidence of efficacy. An interim analysis by the Independent Data Monitoring Committee showed a clinically important reduction in stroke and systematic embolism in patients with atrial fibrillation considered intolerant of or unsuitable for warfarin therapy who received apixaban as compared to aspirin. This interim analysis also demonstrated an acceptable safety profile for apixaban compared to aspirin.

Belatacept – a fusion protein with novel immunosuppressive activity targeted at prevention of solid organ transplant rejection. The FDA accepted for filing and review our submission of a biologic license application for belatacept in September 2009.

 

   

In May 2010, the FDA issued a complete response letter regarding the Biologics License Application for belatacept in kidney transplant. While no new clinical studies have been requested, the complete response letter requests 36 month data from the ongoing Phase III studies to further evaluate the long-term effects of belatacept. The Biologics License Application submitted for belatacept included 24 month data from the Phase III studies. Other requests raised in the letter primarily relate to information to support the manufacturing of belatacept and the proposed risk evaluation and mitigation strategy (REMS). We are working with the FDA to provide the data as soon as they are available and we expect to be able to provide a response to the FDA by the fourth quarter of this year.

 

   

In May 2010, belatacept was the subject of eight clinical presentations related to kidney transplantation at the American Transplant Congress.

 

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Ipilimumab – a monoclonal antibody currently in Phase III development for the treatment of metastatic melanoma. It is also being studied for lung cancer as well as adjuvant melanoma and hormone-refractory prostate cancer.

 

   

In May 2010, the ipilimumab Marketing Authorization Application for metastatic melanoma in pre-treated patients was validated by the European Medicines Agency.

 

   

In June 2010, the Company announced positive results from a Phase III randomized double blind study of ipilimumab which demonstrated that overall survival was significantly extended in patients with previously-treated metastatic melanoma who received ipilimumab. The results were statistically significant for patients receiving ipilimumab alone or ipilimumab in combination with a gp100 peptide vaccine when compared to those patients who received the control therapy of gp100 alone. Forty-four to 46 percent of patients treated with ipilimumab were alive at one year compared to 25 percent of patients treated with the control arm. At two years, 22 to 24 percent of patients treated with ipilimumab were alive compared to 14 percent of patients treated with the control arm.

 

   

In May 2010, the Company announced positive results from a randomized Phase II study evaluating ipilimumab in combination with standard chemotherapy in previously untreated patients with advanced non-small cell lung cancer. The study, known as 041, met the predefined criteria for significant improvement (p-value of <0.1) in immune-related progression-free survival, the primary endpoint, over chemotherapy alone. An additional analysis of progression-free survival, assessed using the traditional modified World Health Organization criteria, also reached statistical significance in one of the two dosing schedules that combined ipilimumab with standard chemotherapy.

XL184 – In June 2010, the Company terminated its development collaboration with Exelixis, Inc. (Exelixis) for the experimental cancer drug XL184 with all rights returning to Exelixis.

Three Months Results of Operations

Our results of continuing operations exclude the results of the Mead Johnson business prior to its split-off in December 2009. This business has been segregated from continuing operations and included in discontinued operations for the three months ended June 30, 2009, see “—Discontinued Operations” below.

Our results of continuing operations were as follows:

 

     Three Months Ended June 30,  
Dollars in Millions    2010     2009     % Change  

Net Sales

   $ 4,768      $ 4,665      2

Earnings from Continuing Operations before Income Taxes

   $ 1,592      $ 1,522      5

% of net sales

     33.4     32.6  

Provision for Income Taxes

   $ 324      $ 353      (8 )% 

Effective tax rate

     20.4     23.2  

Net Earnings from Continuing Operations

   $ 1,268      $ 1,169      8

% of net sales

     26.6     25.1  

Attributable to Noncontrolling Interest

   $ 341      $ 289      18

% of net sales

     7.2     6.2  

Attributable to Bristol-Myers Squibb Company

   $ 927      $ 880      5

% of net sales

     19.4     18.9  

 

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Net Sales

The composition of the change in net sales was as follows:

 

     Three Months Ended June 30,     2010 vs. 2009  
     Net Sales     Analysis of % Change  
Dollars in Millions    2010    2009    Total
Change
    Volume     Price     Foreign
Exchange
 

U.S.

   $ 3,105    $ 2,974    4   1   3     

Non-U.S.

     1,663      1,691    (2 )%         (3 )%    1
                      

Total

   $ 4,768    $ 4,665    2   1   1     
                      

Various key U.S. products contributed to the growth in net sales. PLAVIX* represented 48% of total U.S. net sales and contributed 79% of total growth in U.S. net sales.

International net sales decreased 2%, including a 1% favorable foreign exchange impact. Three months ended June 30, 2010 net sales were negatively impacted by mature brands divested in prior periods; a 10% reduction in PLAVIX* net sales (including a 5% favorable foreign exchange impact) due to generic competition in comarketing countries; and increased pricing pressures in certain European countries. Offsetting these decreases were increases in various key products, including BARACLUDE (29%), ABILIFY* (14%), the HIV portfolio (4%) (which includes REYATAZ and the SUSTIVA Franchise), SPRYCEL (22%) and ORENCIA (28%). Our reported international net sales do not include copromotion sales reported by our alliance partner sanofi-aventis (sanofi) for PLAVIX* and AVAPRO*/AVALIDE*.

In general, our business is not seasonal. For information on U.S. pharmaceutical prescriber demand, reference is made to the table within “—Estimated End-User Demand” below, which sets forth a comparison of changes in net sales to the estimated total prescription growth (for both retail and mail order customers) for certain of our key pharmaceuticals and new products. The U.S. and non-U.S. net sales are categorized based upon the location of the customer.

We recognize revenue net of various sales adjustments to arrive at net sales as reported in the consolidated statements of earnings. These adjustments are referred to as gross-to-net sales adjustments. The reconciliation of our gross sales to net sales by each significant category of gross-to-net sales adjustments was as follows:

 

     Three Months Ended June 30,  
Dollars in Millions    2010     2009  

Gross Sales

   $ 5,287      $ 5,061   

Gross-to-Net Sales Adjustments

    

Prime Vendor Charge-Backs

     (132     (129

Cash Discounts

     (68     (63

Managed Healthcare Rebates and Other Contract Discounts

     (124     (114

Medicaid Rebates

     (118     (35

Sales Returns

     (12     (13

Other Adjustments

     (65     (42
                

Total Gross-to-Net Sales Adjustments

     (519     (396
                

Net Sales

   $ 4,768      $ 4,665   
                

Gross-to-net sales adjustments as a percentage of gross sales were 9.8% in 2010 and 7.8% in 2009 and are typically correlated with gross sales trends, changes in sales mix and contractual and legislative discounts and rebates.

The enactment of healthcare reform in March 2010 impacted the Medicaid rebates adjustment for the three months ended June 30, 2010 due to the increase in the minimum Medicaid rebate on drug sales from 15.1% to 23.1% retroactive to January 1, 2010 and the extension of the Medicaid rebate rate to drugs sold to risk-based Medicaid managed care organizations. The 2009 Medicaid rebates were impacted by the Center for Medicare and Medicaid Services policy group’s approval of the Company’s revised calculations for determining Medicaid rebates for the three year period 2002 through 2004, resulting in a $34 million reduction in the Medicaid liability at June 30, 2009. Expected future increases to gross-to-net sales adjustments related to healthcare reform are further discussed in “—Executive Summary—Healthcare Reform” above.

 

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Net sales of key products represented 84% and 81% of total net sales in the second quarter of 2010 and 2009, respectively. The following table details U.S. and international net sales by key product, the percentage change from the prior period and the foreign exchange impact when compared to the prior period. Commentary detailing the reasons for significant variances is provided below:

 

     Three Months Ended June 30,
Dollars in Millions    2010    2009    %
Change
   % Change
Attributable to
Foreign Exchange

Cardiovascular

           

PLAVIX*

           

U.S.

   $ 1,496    $ 1,393    7%   

Non-U.S.

     131      146    (10)%    5%

Total

     1,627      1,539    6%    1%

AVAPRO*/AVALIDE*

           

U.S.

     170      179    (5)%   

Non-U.S.

     137      134    2%    3%

Total

     307      313    (2)%    1%

Virology

           

REYATAZ

           

U.S.

     185      169    9%   

Non-U.S.

     172      162    6%    (2)%

Total

     357      331    8%    (1)%

SUSTIVA Franchise (total revenue)

           

U.S.

     213      194    10%   

Non-U.S.

     118      118       (4)%

Total

     331      312    6%    (1)%

BARACLUDE

           

U.S.

     42      39    8%   

Non-U.S.

     181      140    29%    3%

Total

     223      179    25%    2%

Oncology

           

ERBITUX*

           

U.S.

     168      171    (2)%   

Non-U.S.

     4      2    100%    9%

Total

     172      173    (1)%   

SPRYCEL

           

U.S.

     42      33    27%   

Non-U.S.

     90      74    22%   

Total

     132      107    23%   

IXEMPRA

           

U.S.

     26      26      

Non-U.S.

     3      3       4%

Total

     29      29      

Neuroscience

           

ABILIFY*

           

U.S.

     491      518    (5)%   

Non-U.S.

     142      125    14%    (2)%

Total

     633      643    (2)%    (1)%

Immunoscience

           

ORENCIA

           

U.S.

     137      116    18%   

Non-U.S.

     41      32    28%   

Total

     178      148    20%   

Metabolics

           

ONGLYZA

           

U.S.

     23         N/A    N/A

Non-U.S.

     5         N/A    N/A

Total

     28         N/A    N/A

 

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PLAVIX * — a platelet aggregation inhibitor that is part of our alliance with sanofi

 

   

U.S. net sales increased primarily due to higher average net selling prices. Estimated total U.S. prescription demand decreased 1%.

 

   

International net sales continue to be negatively impacted by the launch of generic clopidogrel products in comarketing countries. The impact was partially offset by favorable foreign exchange. We expect continued erosion of PLAVIX* net sales in the EU, which will impact both our international net sales and our equity in net income of affiliates.

 

   

See “Item 1. Financial Statements—Note 17. Legal Proceedings and Contingencies—PLAVIX* Litigation,” for further discussion on PLAVIX* exclusivity litigation in both the U.S. and EU.

AVAPRO*/AVALIDE * (known in the EU as APROVEL*/KARVEA*) — an angiotensin II receptor blocker for the treatment of hypertension and diabetic nephropathy that is also part of the sanofi alliance

 

   

U.S. net sales decreased primarily due to a 17% reduction in estimated total U.S. prescription demand partially offset by higher average net selling prices.

 

   

International net sales increased primarily due to favorable foreign exchange.

REYATAZ — a protease inhibitor for the treatment of HIV

 

   

U.S. net sales increased primarily due to higher estimated total U.S. prescription demand of 6%.

 

   

International net sales increased primarily due to higher demand across most international markets.

SUSTIVA Franchise — a non-nucleoside reverse transcriptase inhibitor for the treatment of HIV, which includes SUSTIVA (efavirenz), an antiretroviral drug, and bulk efavirenz, which is also included in the combination therapy, ATRIPLA* (efavirenz 600mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg), a product sold through a joint venture with Gilead Sciences, Inc. (Gilead)

 

   

U.S. net sales increased primarily due to higher demand as well as higher average net selling prices. Estimated total U.S. prescription demand increased 10%.

BARACLUDE — an oral antiviral agent for the treatment of chronic hepatitis B

 

   

Sold primarily in international markets, net sales increased mainly due to continued higher demand.

 

   

U.S. net sales increased primarily due to higher estimated U.S. prescription demand of 15%.

ERBITUX* — a monoclonal antibody designed to exclusively target and block the Epidermal Growth Factor Receptor, which is expressed on the surface of certain cancer cells in multiple tumor types as well as normal cells and is currently indicated for use against colorectal cancer and head and neck cancer. ERBITUX* is part of our strategic alliance with Lilly

 

   

Sold almost exclusively in the U.S., net sales remained relatively flat.

SPRYCEL — an oral inhibitor of multiple tyrosine kinases, for the treatment of adults with chronic, accelerated, or myeloid or lymphoid blast phase chronic myeloid leukemia with resistance or intolerance to prior therapy, including GLEEVEC* (imatinib meslylate), which is part of our strategic alliance with Otsuka

 

   

U.S. net sales increased primarily due to increased demand and higher average net selling prices. Estimated total U.S. demand increased 7%.

 

   

International net sales increased primarily due to higher demand.

IXEMPRA a microtubule inhibitor for the treatment of patients with metastatic or locally advanced breast cancer and is part of our strategic alliance with Otsuka

 

   

Worldwide net sales remained flat.

ABILIFY* — an antipsychotic agent for the treatment of schizophrenia, bipolar mania disorder and major depressive disorder and is part of the Company’s strategic alliance with Otsuka

 

   

U.S. net sales decreased primarily due to the reduction in our contractual share of net sales recognized from 65% to 58% and increased Medicaid rebates from healthcare reform. The decrease was partially offset by higher average net selling prices and increased overall demand. Estimated total U.S. prescription demand increased 5%.

 

   

International net sales increased primarily due to increased prescription demand.

 

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ORENCIA — a fusion protein indicated for rheumatoid arthritis

 

   

U.S. net sales increased due to demand and higher average selling prices.

 

   

International net sales increased primarily due to higher demand.

ONGLYZA — a once-daily oral tablet for the treatment of type 2 diabetes

 

   

ONGLYZA was launched in various countries after the second quarter of 2009.

The estimated U.S. prescription change data provided throughout this report includes information only from the retail and mail order channels and does not reflect product demand within other channels such as hospitals, home health care, clinics, federal facilities including VA hospitals, and long-term care, among others. The data is provided by Wolters Kluwer Health (WK), except for SPRYCEL, and based on the Source Prescription Audit which is a product of WK's own recordkeeping and projection processes. As such, the data is subject to the inherent limitations of estimates based on sampling and may include a margin of error.

The change in SPRYCEL demand is calculated based upon tablets sold though retail and mail order channels based upon data obtained from the IMS Health (IMS) National Sales Perspectives Audit, which is a product of IMS’s own recordkeeping and projection processes. As such, the data is subject to the inherent limitations of estimates based on sampling and may include a margin of error.

We continuously seek to improve the quality of our estimates of prescription change amounts and ultimate patient/consumer demand by reviewing the calculation methodologies employed, and analyzing internal and third-party data. We expect to continue to review and refine our methodologies and processes for calculation of these estimates and will monitor the quality of our own and third parties’ data used in such calculations.

We calculated the estimated total U.S. prescription change on a weighted-average basis to reflect the fact that mail order prescriptions include a higher average volume of product supplied per dispensed prescription, 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 mail order prescription data by a factor that approximates three and adding to this the retail prescriptions. We believe that a calculation of estimated total U.S. prescription change based on this weighted-average approach provides a superior estimate of total prescription demand, with respect to the retail and mail order channels. We use this methodology for our internal demand reporting.

Estimated End-User Demand

The following table sets forth for each of our key products sold in the U.S. for the three months ended June 30, 2010 compared to the same period in the prior year: (i) total U.S. net sales for the period; (ii) change in reported U.S. net sales for the period; (iii) estimated total U.S. prescription change for the retail and mail order channels calculated by us based on third-party data on a weighted-average basis and (iv) months of inventory on hand in the wholesale distribution channel.

 

               Three Months Ended June 30,              At June 30,
     Total U.S. Net Sales    % Change in U.S.
Net  Sales
   % Change in U.S.
Total Prescriptions
   Months on
Hand
Dollars in Millions    2010    2009    2010    2009    2010    2009    2010    2009

PLAVIX*

   $ 1,496    $ 1,393    7%    15%    (1)%    3%    0.4    0.4

AVAPRO*/AVALIDE*

     170      179    (5)%    (3)%    (17)%    (10)%    0.4    0.4

REYATAZ

     185      169    9%    6%    6%    7%    0.4    0.5

SUSTIVA Franchise (a)

     213      194    10%    13%    10%    9%    0.4    0.5

BARACLUDE

     42      39    8%    11%    15%    12%    0.5    0.5

ERBITUX* (b)

     168      171    (2)%    (11)%    N/A    N/A    0.4    0.4

SPRYCEL

     42      33    27%    57%    7%    8%    0.7    0.8

IXEMPRA (b)

     26      26          N/A    N/A    0.5    0.6

ABILIFY*

     491      518    (5)%    29%    5%    29%    0.4    0.4

ORENCIA (b)

     137      116    18%    33%    N/A    N/A    0.4    0.4

ONGLYZA (c)

     23         N/A    N/A    N/A    N/A    0.4   

 

(a) The SUSTIVA Franchise (total revenue) includes sales of SUSTIVA, as well as revenue of bulk efavirenz included in the combination therapy ATRIPLA*.
(b) ERBITUX*, IXEMPRA and ORENCIA are parenterally administered products and do not have prescription-level data as physicians do not write prescriptions for these products.
(c) ONGLYZA was launched in the U.S. in August 2009.

 

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Pursuant to the U.S. Securities and Exchange Commission (SEC) Consent Order described in our 2009 Annual Report on Form 10-K, we monitor the level of inventory on hand in the U.S. wholesaler distribution channel and outside of the U.S. in the direct customer distribution channel. We disclose products with levels of inventory in excess of one month on hand or expected demand, subject to a de minimis exception. In the case of the Company’s U.S. Pharmaceuticals products at June 30, 2010, there were no products to disclose. The following are international products that had estimated levels of inventory in the distribution channel in excess of one month on hand at March 31, 2010:

At March 31, 2010, VIDEX/VIDEX EC, an antiviral product, had approximately 1.8 months of inventory on hand internationally at direct customers compared to approximately 1.3 months of inventory on hand at December 31, 2009. The level of inventory on hand was primarily due to government purchasing patterns in Brazil.

At March 31, 2010, FERVEX, a cold and flu product had approximately 7.4 months of inventory on hand internationally at direct customers compared to approximately 3.9 months of inventory on hand at December 31, 2009. The increased level of inventory on hand was primarily due to lower demand attributed to a mild flu season.

At March 31, 2010, LUFTAL, an antacid product, had approximately 1.2 months of inventory on hand internationally at direct customers. The level of inventory on hand was due to the recent launch of LUFTAL in Mexico.

At March 31, 2010, PRINCIPEN, an antibiotic, had approximately 1.2 months of inventory on hand internationally at direct customers compared to approximately 0.8 months of inventory on hand at December 31, 2009. The increased level of inventory on hand was primarily due to a temporary build-up of inventory as a result of a distributor change in Mexico at month-end.

At March 31, 2010, PICOT, an antacid product, had approximately 1.3 months of inventory on hand internationally at direct customers compared to approximately 0.9 months of inventory on hand at December 31, 2009. The increased level of inventory on hand was primarily due to a temporary build-up of inventory as a result of a distributor change in Mexico at month-end.

At March 31, 2010, TEMPRA, an analgesic product, had approximately 1.1 months of inventory on hand internationally at direct customers compared to approximately 0.9 months of inventory on hand at December 31, 2009. The increased level of inventory on hand was primarily due to a temporary build-up of inventory as a result of a distributor change in Mexico at month-end.

In the U.S., for all products sold exclusively through wholesalers or through distributors, we determined our months on hand estimates using information with respect to inventory levels of product on hand and the amount of out-movement of products provided by our three largest wholesalers, which account for approximately 90% of total gross sales of U.S. products, and provided by some of our distributors. Factors that may influence our 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, these estimates are calculated using third-party data, which may be impacted by their record keeping processes.

For products in the U.S. that are not sold exclusively through wholesalers or distributors and for our business outside of the U.S., we have 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. In cases where direct customer product level inventory, ultimate patient/consumer demand or out-movement data does not exist or is otherwise not available, we have 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. Accordingly, we rely on a variety of methods to estimate direct customer product level inventory and to calculate months on hand for these business units. Factors that may affect our 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. As such, all of the information required to estimate months on hand in the direct customer distribution channel for non-U.S. businesses for the quarter ended June 30, 2010 is not available prior to the filing of this quarterly report on Form 10-Q. We will disclose any product with levels of inventory in excess of one month on hand or expected demand for the current quarter, subject to a de minimis exception, in the next quarterly report on Form 10-Q.

 

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Geographic Areas

In general, our products are available in most countries in the world. The largest markets are the U.S., France, Canada, Japan, Italy, Spain, Germany, China and the United Kingdom. Our net sales by geographic area, based on the location of the customer, were as follows:

 

     Three Months Ended June 30,
     Net Sales    % of Total Net Sales
Dollars in Millions    2010    2009    % Change    2010    2009

United States

   $ 3,105    $ 2,974    4%      65%      64%  

Europe

     822      883    (7)%      17%      19%  

Latin America, Middle East and Africa

     199      215    (7)%      4%      4%  

Japan, Asia Pacific and Canada

     403      372    8%      9%      8%  

Emerging Markets

     201      174    16%      4%      4%  

Other

     38      47    (19)%      1%      1%  
                          

Total

   $ 4,768    $ 4,665    2%      100%      100%  
                          

Net sales in the U.S. increased primarily due to items previously discussed in “—Net Sales” above.

Net sales in Europe decreased primarily due to a 4% unfavorable foreign exchange impact due to the strengthening of the U.S. dollar against the Euro and the British pound. Increased net sales of ABILIFY*, the HIV portfolio, BARACLUDE, SPRYCEL and ORENCIA were partially offset by decreases in net sales of certain mature brands and increased generic competition for PLAVIX*. Due to the heightening financial challenges in European countries, healthcare payers continue to explore ways to reduce the cost of healthcare including actions that would directly or indirectly impose additional price reductions and support the expanded use of generic drugs. These measures include, but are not limited to, mandatory discounts, rebates and other price reductions on product sales.

Net sales in Latin America, Middle East and Africa decreased primarily due to decreased net sales of certain mature brands, partially offset by a 1% favorable foreign exchange impact.

Net sales in Japan, Asia Pacific and Canada were impacted by a 10% favorable foreign exchange impact. Excluding the impact of foreign exchange, increased sales of BARACLUDE and SPRYCEL were more than offset by decreased net sales of PLAVIX* and TAXOL attributed to increasing generic competition as well as decreased net sales of certain mature brands.

Emerging Markets include Brazil, Russia, India, China and Turkey. Net sales in Emerging Markets increased primarily due to a 6% favorable foreign exchange impact in addition to increased sales of BARACLUDE, REYATAZ and ABILIFY*.

No country outside the U.S. contributed more than 10% of our total net sales during the three months ended June 30, 2010 and 2009.

Expenses

 

     Three Months Ended June 30,
     Expenses    % of Net Sales
Dollars in Millions    2010    2009    % Change    2010    2009

Cost of products sold

   $ 1,277    $ 1,225    4%    26.8%    26.3%

Marketing, selling and administrative

     894      922    (3)%    18.8%    19.8%

Advertising and product promotion

     263      298    (12)%    5.5%    6.4%

Research and development

     822      811    1%    17.2%    17.4%

Provision for restructuring

     24      19    26%    0.5%    0.4%

Litigation expense

          28    (100)%       0.6%

Equity in net income of affiliates

     (85)      (150)    (43)%    (1.8)%    (3.2)%

Other (income)/expense

     (19)      (10)    90%    (0.4)%    (0.3)%
                          

Total Expenses

   $ 3,176    $ 3,143    1%    66.6%    67.4%
                          

 

** Change in excess of 200%.

Cost of products sold

The increase in cost of products sold as a percentage of net sales was primarily attributed to the reduction in our share of ABILIFY* sales related to the extended commercialization and manufacturing agreement for ABILIFY*, the collaboration fee paid to Otsuka related to the SPRYCEL and IXEMPRA Oncology collaboration beginning in 2010 and higher manufacturing costs partially offset by a more favorable product mix.

 

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Beginning in the first quarter of 2010, our portion of ABILIFY*’s U.S. net sales recognized decreased from 65% to 58%. In addition, we began to pay a collaboration fee to Otsuka, totaling $32 million for the three months ended June 30, 2010, under the Oncology collaboration for SPRYCEL and IXEMPRA. See “Item 1. Financial Statements—Note 2. Alliances and Collaborations” for further discussion.

Marketing, selling and administrative

The decrease was primarily due to Otsuka’s reimbursement of certain ABILIFY*, SPRYCEL and IXEMPRA operating expenses, beginning January 1, 2010, the reduction in our ABILIFY* sales force, as Otsuka established its own sales force for the promotion of the above products, and a reduction in sales related activities of certain key products to coincide with their respective life cycles, offset by increased spending for the ONGLYZA launch and other pipeline products. See “Item 1. Financial Statements—Note 2. Alliances and Collaborations” for further discussion.

Advertising and product promotion

The decrease was attributed to reduced spending on the promotion of certain key products to coincide with their product life cycle and Otsuka’s reimbursement of certain ABILIFY*, SPRYCEL and IXEMPRA advertising and product promotion expenses partially offset by increased spending for the ONGLYZA launch and other pipeline products.

Research and development

The increase was attributed to additional support of our maturing pipeline and compounds obtained from our string-of-pearls strategy and a $17 million payment to Exelixis to end our development collaboration for the experimental cancer drug XL184. Upfront licensing and milestone payments of $29 million were paid to ZymoGenetics and Albany Molecular in the second quarter of 2009. There were no upfront and milestone payments in the second quarter of 2010.

Provision for restructuring

The changes in provision for restructuring were primarily attributable to the timing of certain PTI and continuous improvement initiatives.

Litigation expense

The 2009 expense was primarily due to the establishment of an additional $25 million reserve related to securities litigation. For further details refer to “Item 1. Financial Statements—Note 17. Legal Proceedings and Contingencies.”

Equity in net income of affiliates

The decrease was attributed to the continued impact of generic clopidogrel competition on international PLAVIX* net sales. This unfavorable trend is expected to continue in future periods. For additional information, see “Item 1. Financial Statements—Note 2. Alliances and Collaborations.”

Other (income)/expense

Other (income)/expense includes:

 

     Three Months Ended June 30,  
Dollars in Millions    2010     2009  

Interest expense

   $ 32      $ 42   

Interest income

     (16     (14

Impairment and loss on sale of manufacturing operations

     15          

Gain on debt buyback and termination of interest rate swap agreements

            (11

Net foreign exchange transaction (gains)/losses

     (16     17   

Gain on sale of product lines, businesses and assets

     (5     (11

Net royalty income and amortization of upfront licensing and milestone payments received from alliance partners

     (44     (34

Pension curtailment and settlement charges

     14        25   

Other

     1        (24
                

Other (income)/expense

   $ (19   $ (10
                

 

   

Interest expense decreased primarily due to lower interest rates.

 

   

Impairment and loss on sale of manufacturing operations was attributed to the disposal of our manufacturing operations in Latina, Italy. See “Item 1. Financial Statements—Note 4. Restructuring.”

 

   

Net royalty and alliance partners’ activity includes income earned from the sanofi partnership and amortization of certain upfront licensing and milestone receipts related to our alliances.

 

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Specified Items

During the quarters ended June 30, 2010 and 2009, the following specified items affected the comparability of results of the periods presented herein. Specified items are excluded from segment income.

Three Months Ended June 30, 2010

 

Dollars in Millions    Cost of
products
sold
   Marketing,
selling and
administrative
   Research
and
development
   Provision for
restructuring
   Litigation
expense
   Other
(income)/
expense
   Total  

Restructuring Activity:

                    

Downsizing and streamlining of worldwide operations

   $    $    $    $ 24    $    $    $ 24   

Impairment and loss on sale of manufacturing operations

                              15      15   

Accelerated depreciation, asset impairment and other shutdown costs

     27                               27   

Pension settlements/curtailments

                              5      5   

Process standardization implementation costs

          6                          6   
                                                  

Total Restructuring

     27      6           24           20      77   

Other:

                    

Upfront licensing, milestone and other payments

               17                     17   
                                                  

Total

   $ 27    $ 6    $ 17    $ 24    $    $ 20      94   
                                            

Income taxes on items above

     (18

Out-of-period tax adjustment

     (59
                          

Decrease to Net Earnings from Continuing Operations

   $ 17   
                          

Three Months Ended June 30, 2009

 

Dollars in Millions    Cost of
products
sold
   Marketing,
selling and
administrative
   Research
and
development
   Provision for
restructuring
   Litigation
expense
   Other
(income)/
expense
    Total  

Restructuring Activity:

                   

Downsizing and streamlining of worldwide operations

   $    $    $    $ 17    $    $      $ 17   

Accelerated depreciation, asset impairment and other shutdown costs

     24                2                  26   

Pension settlements/curtailments

                              25        25   

Process standardization implementation costs

          25                            25   

Gain on sale of product lines, businesses and assets

                              (11     (11
                                                   

Total Restructuring

     24      25           19           14        82   

Other:

                   

Litigation charges

                         28             28   

Upfront licensing and milestone payments

               29                       29   

Debt buyback and swap terminations

                              (11     (11
                                                   

Total

   $ 24    $ 25    $ 29    $ 19    $ 28    $ 3        128   
                                             

Income taxes on items above

  

    (42
                         

Decrease to Net Earnings from Continuing Operations

  

  $ 86   
                         

Non-GAAP Financial Measures

Our non-GAAP financial measures, including non-GAAP earnings from continuing operations and related EPS information, are adjusted to exclude certain costs, expenses, gains and losses and other specified items that due to their substantive and unusual nature are evaluated on an individual basis. Non-GAAP information is intended to portray the results of our baseline performance which include the discovery, development, licensing, manufacturing, marketing, distribution and sale of pharmaceutical products on a global basis and to enhance an investor’s overall understanding of our past financial performance and prospects for the future. For example, non-GAAP earnings and EPS information is an indication of our baseline performance before items that are considered by us to not be reflective of our ongoing results. In addition, this information is among the primary indicators we use as a basis for evaluating performance, allocating resources, setting incentive compensation targets, and planning and forecasting for future periods. This information is not intended to be considered in isolation or as a substitute for net earnings or diluted EPS prepared in accordance with GAAP.

Among the items in GAAP measures but excluded for purposes of determining adjusted earnings and other adjusted measures are: charges related to implementation of the PTI; gains or losses from the purchase or sale of businesses, product lines or investments; discontinued operations; restructuring and other exit costs; accelerated depreciation charges; asset impairments; charges and

 

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recoveries relating to significant legal proceedings; upfront licensing and milestone payments for in-licensing of products that have not achieved regulatory approval, which are immediately expensed; special initiative funding to the Bristol-Myers Squibb Foundation; and significant tax events. For a detailed listing of items that are excluded from the non-GAAP earnings from continuing operations, see “—Specified Items” above. Similar charges or gains for some of these items have been recognized in prior periods and it is reasonably possible that they will reoccur in future periods.

A reconciliation of GAAP to non-GAAP follows:

 

     Three Months Ended June 30, 2010     Three Months Ended June 30, 2009  
Dollars in Millions, except per share data    GAAP     Specified
Items
   Non-GAAP     GAAP     Specified
Items
   Non-GAAP  

Net Earnings from Continuing Operations Attributable to BMS

   $ 927      $ 17    $ 944      $ 880      $ 86    $ 966   

Earnings attributable to unvested restricted shares

     (3          (3     (5          (5
                                              

Net Earnings from Continuing Operations Attributable to BMS used for Diluted EPS Calculation

   $ 924      $ 17    $ 941      $ 875      $ 86    $ 961   
                                              

Average Common Shares Outstanding—Diluted

     1,728             1,728        1,983             1,983   

Diluted EPS from Continuing Operations Attributable to BMS

   $ 0.53      $ 0.01    $ 0.54      $ 0.44      $ 0.04    $ 0.48   

Income Taxes

The effective income tax rate on earnings from continuing operations before income taxes was 20.4% for the three months ended June 30, 2010 compared to 23.2% for the three months ended June 30, 2009. See “Item 1. Financial Statements—Note 7. Income Taxes” for further discussion.

Discontinued Operations

As discussed in our 2009 Annual Report on Form 10-K, we completed the split-off of Mead Johnson in December 2009. The results of the Mead Johnson business are included in net earnings from discontinued operations for the three months ended June 30, 2009. See “Item 1. Financial Statements—Note 5. Discontinued Operations” for further discussion.

Noncontrolling Interest

Noncontrolling interest is primarily related to our partnerships with sanofi for the territory covering the Americas related to PLAVIX* net sales. See “Item 1. Financial Statements—Note 2. Alliances and Collaborations” for further discussion. The increase in noncontrolling interest corresponds to increased net sales of PLAVIX* in the U.S. Net earnings from discontinued operations attributable to noncontrolling interest primarily relates to the 16.9% of Mead Johnson owned by the public prior to the split-off. A summary of noncontrolling interest is as follows:

 

     Three Months Ended June 30,
Dollars in Millions    2010    2009

sanofi partnerships

   $ 500    $ 424

Other

     6      9
             

Noncontrolling interest—pre-tax

     506      433

Income taxes

     165      144
             

Net earnings from continuing operations attributable to noncontrolling interest—net of taxes

     341      289

Net earnings from discontinued operations attributable to noncontrolling interest—net of taxes

          26
             

Net earnings attributable to noncontrolling interest—net of taxes

   $ 341    $ 315
             

 

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Six Months Results of Operations

Our results of continuing operations exclude the results of the Mead Johnson business prior to its split-off in December 2009. This business has been segregated from continuing operations and included in discontinued operations for the six months ended June 30, 2009, see “—Discontinued Operations” below.

Our results of continuing operations were as follows:

 

     Six Months Ended June 30,  
Dollars in Millions    2010     2009     % Change  

Net Sales

   $ 9,575      $ 8,987      7

Earnings from Continuing Operations before Income Taxes

   $ 3,044      $ 2,717      12

% of net sales

     31.8     30.2  

Provision for Income Taxes

   $ 675      $ 628      7

Effective tax rate

     22.2     23.1  

Net Earnings from Continuing Operations

   $ 2,369      $ 2,089      13

% of net sales

     24.7     23.2  

Attributable to Noncontrolling Interest

   $ 699      $ 560      25

% of net sales

     7.3     6.2  

Attributable to Bristol-Myers Squibb Company

   $ 1,670      $ 1,529      9

% of net sales

     17.4     17.0  

Net Sales

The composition of the change in net sales was as follows:

 

     Six Months Ended June 30,    2010 vs. 2009  
     Net Sales    Analysis of % Change  
Dollars in Millions    2010    2009    Total
Change
    Volume     Price     Foreign
Exchange
 

U.S.

   $ 6,194    $ 5,740    8   3   5     

Non-U.S.

     3,381      3,247    4   2   (2 )%    4
                      

Total

   $ 9,575    $ 8,987    7   3   2   2
                      

Most of the key U.S. products contributed to the growth in net sales. PLAVIX* represented 49% of total U.S. net sales and contributed 74% of total growth in U.S. net sales.

International net sales increased 4%, including a 4% favorable foreign exchange impact due to growth in various key products, including BARACLUDE (39%), ABILIFY* (24%), the HIV portfolio (13%), SPRYCEL (39%) and ORENCIA (47%). Offsetting these increases were a decrease in mature brand sales and a 7% reduction in PLAVIX* net sales (including an 8% favorable foreign exchange impact).

In general, our business is not seasonal. For information on U.S. pharmaceutical prescriber demand, reference is made to the table within “—Estimated End-User Demand” below, which sets forth a comparison of changes in net sales to the estimated total prescription growth (for both retail and mail order customers) for certain of our key pharmaceuticals and new products. The U.S. and non-U.S. net sales are categorized based upon the location of the customer.

 

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The reconciliation of our gross sales to net sales by each significant category of gross-to-net sales adjustments was as follows:

 

     Six Months Ended June 30,  
Dollars in Millions    2010     2009  

Gross Sales

   $ 10,572      $ 9,800   

Gross-to-Net Sales Adjustments

    

Prime Vendor Charge-Backs

     (268     (245

Cash Discounts

     (134     (123

Managed Healthcare Rebates and Other Contract Discounts

     (239     (214

Medicaid Rebates

     (214     (98

Sales Returns

     (11     (38

Other Adjustments

     (131     (95
                

Total Gross-to-Net Sales Adjustments

     (997     (813
                

Net Sales

   $ 9,575      $ 8,987   
                

Gross-to-net sales adjustments as a percentage of gross sales were 9.4% in 2010 and 8.3% in 2009 and are typically correlated with gross sales trends, changes in sales mix and contractual and legislative discounts and rebates.

The enactment of healthcare reform in March 2010 impacted the Medicaid rebates adjustment for the six months ended June 30, 2010 due to the increase in the minimum Medicaid rebate on drug sales from 15.1% to 23.1% retroactive to January 1, 2010 and the extension of the above rebate increase on drugs sold to risk-based Medicaid managed care organizations. Expected future increases to gross-to-net sales adjustments related to healthcare reform are further discussed in “—Executive Summary—Healthcare Reform” above.

Prime vendor charge-backs and managed healthcare rebates and other contract discounts increased primarily due to higher average PLAVIX* selling prices and increased sales. Sales returns decreased primarily due to reduced provisions from various mature brands and certain key brands including REYATAZ and ORENCIA based upon a reduction in historical returns for such products.

The activities and ending balances of each significant category of gross-to-net sales reserve adjustments were as follows:

 

Dollars in Millions    Prime Vendor
Charge-Backs
    Cash
Discounts
    Managed
Healthcare
Rebates and Other
Contract Discounts
    Medicaid
Rebates
    Sales
Returns
    Other
Adjustments
    Total  

Balance at January 1, 2010

   $ 42      $ 26      $ 199      $ 166      $ 169      $ 88      $ 690   

Provision related to sales made in current period

     269        134        238        215        31        133        1,020   

Provision related to sales made in prior periods

     (1            1        (1     (20     (2     (23

Returns and payments

     (273     (134     (218     (152     (40     (126     (943

Impact of foreign currency translation

                   (1            (2     (7     (10
                                                        

Balance at June 30, 2010

   $ 37      $ 26      $ 219      $ 228      $ 138      $ 86      $ 734   
                                                        

 

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Net sales of key products represented 84% and 81% of total net sales in the first six months of 2010 and 2009, respectively. The following table details U.S. and international net sales by key product, the percentage change from the prior period and the foreign exchange impact when compared to the prior period. Commentary detailing the reasons for significant variances is provided below:

 

     Six Months Ended June 30,
Dollars in Millions    2010    2009    % Change    % Change
Attributable to
Foreign Exchange

Cardiovascular

           

PLAVIX*

           

U.S.

   $ 3,027    $ 2,689    13%   

Non-U.S.

     266      285    (7)%    8%

Total

     3,293      2,974    11%    1%

AVAPRO*/AVALIDE*

           

U.S.

     356      352    1%   

Non-U.S.

     265      263    1%    7%

Total

     621      615    1%    3%

Virology

           

REYATAZ

           

U.S.

     371      345    8%   

Non-U.S.

     359      308    17%    3%

Total

     730      653    12%    1%

SUSTIVA Franchise (total revenue)

           

U.S.

     427      384    11%   

Non-U.S.

     239      220    9%    2%

Total

     666      604    10%    1%

BARACLUDE

           

U.S.

     84      75    12%   

Non-U.S.

     355      256    39%    6%

Total

     439      331    33%    4%

Oncology

           

ERBITUX*

           

U.S.

     331      333    (1)%   

Non-U.S.

     7      4    75%    9%

Total

     338      337      

SPRYCEL

           

U.S.

     80      63    27%   

Non-U.S.

     183      132    39%    6%

Total

     263      195    35%    4%

IXEMPRA

           

U.S.

     51      48    6%   

Non-U.S.

     7      5    40%    4%

Total

     58      53    9%   

Neuroscience

           

ABILIFY*

           

U.S.

     961      999    (4)%   

Non-U.S.

     289      233    24%    3%

Total

     1,250      1,232    1%   

Immunoscience

           

ORENCIA

           

U.S.

     263      215    22%   

Non-U.S.

     84      57    47%    6%

Total

     347      272    28%    1%

Metabolics

           

ONGLYZA

           

U.S.

     29         N/A    N/A

Non-U.S.

     9         N/A    N/A

Total

     38         N/A    N/A

 

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PLAVIX *

 

   

U.S. net sales increased primarily due to higher average net selling prices and, to a lesser extent, increased demand. Estimated total U.S. prescription demand increased 1%.

 

   

International net sales continue to be negatively impacted by the launch of generic clopidogrel products in comarketing countries. The impact was partially offset by favorable foreign exchange. We expect continued erosion of PLAVIX* net sales in the EU, which will impact both our international net sales and our equity in net income of affiliates.

 

   

See “Item 1. Financial Statements—Note 17. Legal Proceedings and Contingencies—PLAVIX* Litigation,” for further discussion on PLAVIX* exclusivity litigation in both the U.S. and EU.

AVAPRO*/AVALIDE *

 

   

U.S. net sales increased primarily due to higher average net selling prices partially offset by a 15% decrease in estimated total U.S. prescription demand.

 

   

International net sales increased primarily due to higher average selling prices partially offset by decreased prescription demand.

REYATAZ

 

   

U.S. net sales increased primarily due to higher estimated total U.S. prescription demand of 7%.

 

   

International net sales increased primarily due to higher demand across most international markets.

SUSTIVA Franchise

 

   

U.S. net sales increased primarily due to higher demand as well as higher average net selling prices. Estimated total U.S. prescription demand increased 10%.

 

   

International net sales increased primarily due to continued demand in the EU.

BARACLUDE

 

   

Sold primarily in international markets, net sales increased primarily due to higher demand.

 

   

U.S. net sales increased primarily due to higher estimated U.S. prescription demand of 14%.

ERBITUX*

 

   

Sold almost exclusively in the U.S., net sales remained relatively flat.

 

SPRYCEL

 

   

U.S. net sales increased primarily due to increased demand and higher average net selling prices. Estimated total U.S. demand increased 7%.

 

   

International net sales increased primarily due to higher demand.

 

IXEMPRA

 

   

Worldwide net sales increased primarily due to higher demand.

 

ABILIFY*

 

   

U.S. net sales decreased primarily due to the reduction in our contractual share of net sales recognized from 65% to 58% and increased Medicaid rebates from healthcare reform. The decrease was partially offset by increased overall demand and higher average net selling prices. Estimated total U.S. prescription demand increased 7%.

 

   

International net sales increased primarily due to increased prescription demand and a favorable foreign exchange impact.

 

ORENCIA

 

   

U.S. net sales increased due to demand and higher average selling prices.

 

   

International net sales increased primarily due to higher demand.

For an explanation of the U.S. prescription data presented above and the calculation of such data, see “—Three Months Results of Operations.”

 

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Estimated End-User Demand

The following table sets forth for each of our key products sold by the U.S. for the six months ended June 30, 2010 compared to the same period in the prior year: (i) total U.S. net sales for the period; (ii) change in reported U.S. net sales for the period; (iii) estimated total U.S. prescription change for the retail and mail order channels calculated by us based on third-party data on a weighted-average basis and (iv) months of inventory on hand in the wholesale distribution channel.

 

     Six Months Ended June 30,
     Total U.S. Net Sales    % Change in U.S.
Net Sales
   % Change in U.S.
Total Prescriptions
Dollars in Millions    2010    2009    2010    2009    2010    2009

PLAVIX*

   $ 3,027    $ 2,689    13%      15%      1%      3%  

AVAPRO*/AVALIDE*

     356      352    1%      (2)%      (15)%      (9)%  

REYATAZ

     371      345    8%      8%      7%      7%  

SUSTIVA Franchise (a)

     427      384    11%      11%      10%      9%  

BARACLUDE

     84      75    12%      17%      14%      15%  

ERBITUX* (b)

     331      333    (1)%      (12)%      N/A      N/A  

SPRYCEL

     80      63    27%      54%      7%      5%  

IXEMPRA (b)

     51      48    6%      (6)%      N/A      N/A  

ABILIFY*

     961      999    (4)%      33%      7%      30%  

ORENCIA (b)

     263      215    22%      34%      N/A      N/A  

ONGLYZA (c)

     29         N/A      —      N/A      N/A  

 

(a) The SUSTIVA Franchise (total revenue) includes sales of SUSTIVA, as well as revenue of bulk efavirenz included in the combination therapy ATRIPLA*.
(b) ERBITUX*, IXEMPRA and ORENCIA are parenterally administered products and do not have prescription-level data as physicians do not write prescriptions for these products.
(c) ONGLYZA was launched in the U.S. in August 2009.

For an explanation of the data presented above and the calculation of such data, see “—Three Months Results of Operations.”

Geographic Areas

In general, our products are available in most countries in the world. The largest markets are the U.S., France, Canada, Italy, Japan, Spain, Germany, China and the United Kingdom. Our net sales by geographic area, based on the location of the customer, were as follows:

 

     Six Months Ended June 30,
     Net Sales    % of Total Net Sales
Dollars in Millions    2010    2009    % Change    2010    2009

United States

   $ 6,194    $ 5,740    8%      65%      64%  

Europe

     1,708      1,710    —      18%      19%  

Latin America, Middle East and Africa

     424      411    3%      4%      4%  

Japan, Asia Pacific and Canada

     774      698    11%      8%      8%  

Emerging Markets

     404      340    19%      4%      4%  

Other

     71      88    (19)%      1%      1%  
                          

Total

   $ 9,575    $ 8,987    7%      100%      100%  
                          

Net sales in the U.S. increased primarily due to items previously discussed in “—Net Sales” above.

Net sales in Europe remained flat including a 1% favorable foreign exchange impact. Increased sales of ABILIFY*, the HIV portfolio, SPRYCEL, BARACLUDE and ORENCIA were offset by decreases in net sales of certain mature brands and increased generic competition for PLAVIX*. Due to the heightening financial challenges in European countries, healthcare payers continue to explore ways to reduce the cost of healthcare including actions that would directly or indirectly impose additional price reductions and support the expanded use of generic drugs. The negative impact of such measures to our business include, but is not limited to, mandatory discounts and other price reductions on product sales.

Net sales in Latin America, Middle East and Africa increased primarily due to a 4% favorable foreign exchange impact in addition to increased sales of SPRYCEL, BARACLUDE, REYATAZ and ORENCIA, partially offset by decreased net sales of certain mature brands.

Net sales in Japan, Asia Pacific and Canada were impacted by a 12% favorable foreign exchange impact. Excluding the impact of foreign exchange, increased sales of BARACLUDE, SPRYCEL, ABILIFY*, ORENCIA and REYATAZ were offset by decreased net sales of PLAVIX* and TAXOL attributed to increasing generic competition as well as decreased net sales of certain mature brands.

 

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Net sales in Emerging Markets increased primarily due to a 7% favorable foreign exchange impact in addition to increased sales of BARACLUDE, REYATAZ, SPRYCEL and ABILIFY*.

No country outside the U.S. contributed more than 10% of our total net sales during the six months ended June 30, 2010 and 2009.

Expenses

 

     Six Months Ended June 30,
     Expenses    % of Net Sales
Dollars in Millions    2010    2009    % Change    2010    2009

Cost of products sold

   $ 2,583    $ 2,390    8%    27.0%    26.6%

Marketing, selling and administrative

     1,794      1,823    (2)%    18.7%    20.3%

Advertising and product promotion

     475      546    (13)%    5.0%    6.1%

Research and development

     1,732      1,719    1%    18.1%    19.1%

Provision for restructuring

     35      38    (8)%    0.4%    0.4%

Litigation expense

          132    (100)%       1.5%

Equity in net income of affiliates

     (182)      (296)    (39)%    (1.9)%    (3.3)%

Other (income)/expense

     94      (82)    **    0.9%    (0.9)%
                          

Total Expenses

   $ 6,531    $ 6,270    4%    68.2%    69.8%
                          

 

** Change in excess of 200%.

Cost of products sold

The increase in cost of products sold as a percentage of net sales was primarily attributed to the reduction in our share of ABILIFY* sales related to the extended commercialization and manufacturing agreement for ABILIFY*, and the collaboration fee paid to Otsuka under the SPRYCEL and IXEMPRA Oncology collaboration beginning in 2010 partially offset by higher average net selling prices and a more favorable product mix.

Marketing, selling and administrative

The decrease was primarily attributed to Otsuka’s reimbursement of certain ABILIFY*, SPRYCEL and IXEMPRA operating expenses, beginning January 1, 2010, the reduction in our ABILIFY* sales force, as Otsuka established its own sales force for the promotion of the above products, and a reduction in sales related activities of certain key products to coincide with their respective life cycles, offset by increased spending for the ONGLYZA launch and other pipeline products.

Advertising and product promotion

The decrease was attributed to reduced spending on the promotion of certain key products to coincide with their product life cycle and Otsuka’s reimbursement of certain ABILIFY*, SPRYCEL and IXEMPRA advertising and product promotion expenses partially offset by increased spending for the ONGLYZA launch and other pipeline products.

Research and development

The increase was attributed to additional support of our maturing pipeline and compounds obtained from our string-of-pearls strategy and a $17 million payment to Exelixis to end our development collaboration for the experimental cancer drug XL184 partially offset by decreased upfront licensing and milestone payments. Upfront licensing and milestone payments of $55 million were paid to Allergan and PDL BioPharma Inc. during the first six months of 2010 and $174 million were paid to ZymoGenetics, Nissan and Albany Molecular in the first six months of 2009.

Provision for restructuring

The changes in provision for restructuring were primarily attributable to the timing of the implementation of certain PTI and continuous improvement initiatives.

Litigation expense

The 2009 expense was primarily due to the establishment of a $125 million reserve related to securities litigation. For further details refer to “Item 1. Financial Statements—Note 17. Legal Proceedings and Contingencies.”

 

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Equity in net income of affiliates

The decrease was attributed to the continued impact of generic clopidogrel competition on international PLAVIX* net sales.

Other (income)/expense

Other (income)/expense includes:

 

     Six Months Ended June 30,  
Dollars in Millions    2010     2009  

Interest expense

   $ 65      $ 94   

Interest income

     (31     (27

Impairment and loss on sale of manufacturing operations

     215          

Gain on debt buyback and termination of interest rate swap agreements

            (11

Net foreign exchange transaction (gains)/losses

     (32     4   

Gain on sale of product lines, businesses and assets

     (15     (55

Net royalty income and amortization of upfront licensing and milestone payments received from alliance partners

     (94     (69

Pension curtailment and settlement charges

     14        25   

Other

     (28     (43
                

Other (income)/expense

   $ 94      $ (82
                

 

 

Interest expense decreased primarily due to lower interest rates.

 

 

Impairment and loss on sale of manufacturing operations was attributed to the disposal of our manufacturing operations in Latina, Italy. See “Item 1. Financial Statements—Note 4. Restructuring.”

 

 

Gain on sale of product lines, businesses and assets were primarily related to the sale of mature brands, including the Pakistan business in 2009.

 

 

Net royalty and alliance partners’ activity includes income earned from the sanofi partnership and amortization of certain upfront licensing and milestone receipts related to our alliances.

Specified Items

During the six months ended June 30, 2010 and 2009, the following specified items affected the comparability of results of the periods presented herein. Specified items are excluded from segment income.

Six Months Ended June 30, 2010

 

Dollars in Millions    Cost of
products
sold
   Marketing,
selling and
administrative
   Research
and
development
   Provision for
restructuring
   Litigation
expense
   Other
(income)/
expense
   Total  

Restructuring Activity:

                    

Downsizing and streamlining of worldwide operations

   $    $    $    $ 35    $    $    $ 35   

Impairment and loss on sale of manufacturing operations

                              215      215   

Accelerated depreciation, asset impairment and other shutdown costs

     58                               58   

Pension settlements/curtailments

                              5      5   

Process standardization implementation costs

          19                          19   
                                                  

Total Restructuring

     58      19           35           220      332   

Other:

                    

Upfront licensing, milestone and other payments

               72                     72   
                                                  

Total

   $ 58    $ 19    $ 72    $ 35    $    $ 220      404   
                                            

Income taxes on items above

                       (104

Out-of-period tax adjustment

                       (59
                          

Decrease to Net Earnings from Continuing Operations

                     $ 241   
                          

 

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Six Months Ended June 30, 2009

 

Dollars in Millions    Cost of
products
sold
   Marketing,
selling and
administrative
   Research
and
development
   Provision for
restructuring
   Litigation
expense
   Other
(income)/
expense
    Total  

Restructuring Activity:

                   

Downsizing and streamlining of worldwide operations

   $    $    $    $ 32    $    $      $ 32   

Accelerated depreciation, asset impairment and other shutdown costs

     50                6                  56   

Pension settlements/curtailments

                              25        25   

Process standardization implementation costs

          45                            45   

Gain on sale of product lines, businesses and assets

                              (55     (55
                                                   

Total Restructuring

     50      45           38           (30     103   

Other:

                   

Litigation charges

                         132             132   

Upfront licensing and milestone payments

               174                       174   

Debt buyback and swap terminations

                              (11     (11

Product liability

     8                          (5     3   
                                                   

Total

   $ 58    $ 45    $ 174    $ 38    $ 132    $ (46     401   
                                             

Income taxes on items above

  

    (135
                         

Decrease to Net Earnings from Continuing Operations

  

  $ 266   
                         

Non-GAAP Financial Measures

A reconciliation of GAAP to non-GAAP follows:

 

     Six Months Ended June 30, 2010     Six Months Ended June 30, 2009  
Dollars in Millions, except per share data    GAAP     Specified
Items
   Non-GAAP     GAAP     Specified
Items
   Non-GAAP  

Net Earnings from Continuing Operations Attributable to BMS

   $ 1,670      $ 241    $ 1,911      $ 1,529      $ 266    $ 1,795   

Earnings attributable to unvested restricted shares

     (7          (7     (9          (9
                                              

Net Earnings from Continuing Operations Attributable to BMS used for Diluted EPS Calculation

   $ 1,663      $ 241    $ 1,904      $ 1,520      $ 266    $ 1,786   
                                              

Average Common Shares Outstanding—Diluted

     1,727             1,727        1,982             1,982   

Diluted EPS from Continuing Operations Attributable to BMS

   $ 0.96      $ 0.14    $ 1.10      $ 0.77      $ 0.13    $ 0.90   

For an explanation of the data presented above, see “—Three Months Results of Operations.”

Income Taxes

The effective income tax rate on earnings from continuing operations before income taxes was 22.2% for the six months ended June 30, 2010 compared to 23.1% for the six months ended June 30, 2009. See “Item 1. Financial Statements—Note 7. Income Taxes” for further discussion.

Discontinued Operations

As discussed in our 2009 Annual Report on Form 10-K, we completed the split-off of Mead Johnson in December 2009. The results of the Mead Johnson business are included in net earnings from discontinued operations for the six months ended June 30, 2009. See “Item 1. Financial Statements—Note 5. Discontinued Operations” for further discussion.

 

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Noncontrolling Interest

Noncontrolling interest is primarily related to our partnerships with sanofi for the territory covering the Americas related to PLAVIX* net sales. See “Item 1. Financial Statements—Note 2. Alliances and Collaborations” for further discussion. The increase in noncontrolling interest corresponds to increased net sales of PLAVIX* in the U.S. Net earnings from discontinued operations attributable to noncontrolling interest primarily relates to the 16.9% of Mead Johnson owned by the public prior to the split-off. A summary of noncontrolling interest is as follows:

 

     Six Months Ended June 30,
Dollars in Millions    2010    2009

sanofi partnerships

   $ 1,020    $ 815

Other

     15      16
             

Noncontrolling interest—pre-tax

     1,035      831

Income taxes

     336      271
             

Net earnings from continuing operations attributable to noncontrolling interest—net of taxes

     699      560

Net earnings from discontinued operations attributable to noncontrolling interest—net of taxes

          38
             

Net earnings attributable to noncontrolling interest—net of taxes

   $ 699    $ 598
             

Financial Position, Liquidity and Capital Resources

Net cash position was as follows:

 

Dollars in Millions    June 30,
2010
   December 31,
2009

Cash and cash equivalents

   $ 5,918    $ 7,683

Marketable securities—current

     1,536      831

Marketable securities—non-current

     2,795      1,369
             

Total

     10,249      9,883
             

Short-term borrowings, including current portion of long-term debt

     290      231

Long-term debt

     6,248      6,130
             

Total debt

     6,538      6,361
             

Net cash position

   $ 3,711    $ 3,522
             

We maintain a significant level of working capital, which was approximately $7.1 billion at June 30, 2010 and $7.6 billion at December 31, 2009. In 2010 and future periods, we expect cash generated by our 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, strategic alliances and acquisitions, milestone payments, dividends paid in the U.S and common stock repurchases.

Beginning with the second quarter of 2009, we diversified our investment portfolio and acquired non-current marketable securities, including purchases of corporate debt securities. These investments are subject to changes in fair value as a result of interest rate fluctuations and other market factors, which may impact our results of operations. Our investment policy places limits on these investments and the amount and time to maturity of investments with any institution. The policy also requires that investments are only made with highly rated corporate and financial institutions. See “Item 1. Financial Statements—Note 9. Cash, Cash Equivalents and Marketable Securities.”

We continue to monitor the potential impact of the deteriorating economic conditions in certain European countries further discussed in “—Geographic Areas” above and the related impact on prescription trends, pricing discounts, creditworthiness of our customers, and our ability to collect outstanding receivables from such countries. Currently, we believe these conditions will not have a material impact on our liquidity, cash flow, or financial flexibility.

We have a $2.0 billion five year revolving credit facility from a syndicate of lenders maturing in December 2011, which is extendable with the consent of the lenders. This facility contains customary terms and conditions, including a financial covenant whereby the ratio of consolidated net debt to consolidated capital cannot exceed 50% at the end of each quarter. We have been in compliance with this covenant since the inception of this facility. There were no borrowings outstanding under this revolving credit facility at June 30, 2010 and December 31, 2009.

As an additional source of liquidity, we sell trade accounts receivables, principally from non-U.S. governments and hospital customers primarily in Japan, Italy, Portugal and Spain, to third parties. The receivables are sold on a nonrecourse basis and approximated $447 million and $104 million during the six months ended June 30, 2010 and 2009, respectively. Our sales agreements do not allow for recourse in the event of uncollectibility and we do not retain interest to the underlying asset once sold.

 

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Cash, cash equivalents and marketable securities held outside the U.S. was approximately $6.2 billion at June 30, 2010 and $5.3 billion at December 31, 2009 which is either utilized to fund non-U.S. operations or repatriated back to the U.S. where taxes have been previously provided. Cash repatriations are subject to restrictions in certain jurisdictions and may be subject to withholding and other taxes.

Credit Ratings

Moody’s Investors Service (Moody’s) long-term and short-term credit ratings are currently A2 and Prime-1, respectively, and their long-term credit rating remains on stable outlook. Standard & Poor’s (S&P) long-term and short-term credit ratings are currently A+ and A-1, respectively, and their long-term credit rating remains on stable outlook. Fitch Ratings (Fitch) long-term and short-term credit ratings are currently A+ and F1, respectively, and their long-term credit rating remains on stable outlook. Our credit ratings are considered investment grade. These ratings for long-term securities designate that we have a low default risk but are somewhat susceptible to adverse effects of changes in circumstances and economic conditions. These ratings for short-term obligations designate that we have the strongest capacity for timely repayment.

Cash Flows

The following is a discussion of cash flow activities:

 

     Six Months Ended June 30,  
Dollars in Millions    2010     2009  

Cash flow provided by/(used in):

    

Operating activities

   $ 1,513      $ 1,248   

Investing activities

     (2,281     (1,364

Financing activities

     (981     (355

Operating Activities

Cash flow from operating activities represents the cash receipts and cash disbursements related to all of our activities other than investing activities and financing activities. Operating cash flow is derived by adjusting net earnings for:

 

   

Noncontrolling interest;

 

   

Non-cash operating items such as depreciation and amortization, impairment charges and stock-based compensation charges;

 

   

Gains and losses attributed to investing and financing activities such as gains and losses on the sale of product lines and businesses; and

 

   

Changes in operating assets and liabilities which reflect timing differences between the receipt and payment of cash associated with transactions and when they are recognized in results of operations.

The net impact of the changes in operating assets and liabilities, which are discussed in more detail below, include the impact of changes in receivables, inventories, deferred income, accounts payable, income taxes receivable/payable and other operating assets and liabilities.

The net impact of the changes in operating assets and liabilities aggregated to a net cash outflow of $913 million and $839 million during the six months ended June 30, 2010 and 2009, respectively. These items included the impact of changes in receivables, inventories, deferred income, accounts payable, income taxes receivable/payable and other operating assets and liabilities which are discussed in more detail below.

We continue to maximize our operating cash flows with our working capital initiative designed to continue to improve working capital items that are most directly affected by changes in sales volume, such as receivables, inventories and accounts payable. Those improvements are being driven by several actions including additional non-recourse factoring of non-US trade receivables, revised contractual payment terms with customers and vendors, enhanced collection processes and various supply chain initiatives designed to optimize inventory levels. Progress in this area is monitored each period and is a component of our annual incentive plan. The following summarizes certain working capital components expressed as a percentage of trailing twelve months’ net sales.

 

Dollars in Millions    June 30,
2010
    % of Trailing
Twelve Month
Net Sales
   December 31,
2009
    % of Trailing
Twelve Month
Net Sales

Net trade receivables

   $ 1,805      9.3%    $ 1,897      10.1%

Inventories

     1,265      6.5%      1,413      7.5%

Accounts payable

     (1,681   (8.6)%      (1,711   (9.1)%
                     

Total

   $ 1,389      7.2%    $ 1,599      8.5%
                     

 

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During the first six months of 2010, changes in operating assets and liabilities resulted in a net cash outflow of $913 million which was impacted by:

 

   

Cash outflows from other operating assets and liabilities ($739 million) primarily related to the pension funding in excess of current year expense ($331 million) and decreases in accrued bonuses and salaries due to the timing of payments ($226 million); and

 

   

Cash outflows from U.S. and foreign income tax payable ($195 million) primarily attributed to timing of tax payment.

In the first six months of 2009, changes in operating assets and liabilities resulted in a net cash outflow of $839 million which was impacted by:

 

   

Cash outflows from other operating assets and liabilities ($1.3 billion) primarily related to pension funding in excess of current year expense ($504 million), alliance payment to Otsuka which will be amortized as a reduction of net sales through the ABILIFY* extension period ($400 million) and decreases in accrued bonuses and salaries due to the timing of payments ($292 million); and

 

   

Cash inflows from accounts payable ($266 million) primarily attributed to the timing of vendor and alliance payments, as well as the impact of the above noted working capital initiative.

Investing Activities

Net cash used in investing activities was $2.3 billion in the first six months of 2010 and included:

 

   

Net purchases of marketable securities ($2.1 billion); and

 

   

Capital expenditures ($210 million).

Net cash used in investing activities was $1.4 billion in the first six months of 2009 and included:

 

   

Net purchases of marketable securities ($1.1 billion); and

 

   

Capital expenditures ($365 million); and

 

   

Proceeds from the divestiture of mature brand businesses ($68 million), including the Pakistan business ($32 million).

Financing Activities

Net cash used in financing activities was $981 million in the first six months of 2010 and included:

 

   

Dividend payments ($1.1 billion); and

 

   

Common stock repurchase ($165 million); partially offset by

 

   

Net proceeds from the exercise of stock options ($122 million); and

 

   

Net proceeds from the termination of interest rate swap agreements ($98 million).

Net cash used in financing activities was $355 million in the first six months of 2009 and included:

 

   

Dividend payments ($1.2 billion); and

 

   

Repurchase of 5.875% Notes due 2036 ($67 million); partially offset by

 

   

Net proceeds from the Mead Johnson initial public offering ($782 million); and

 

   

Net proceeds from the termination of interest rate swap agreements ($191 million).

Dividends declared per common share were $0.64 for the six months ended June 30, 2010 and $0.62 for the six months ended June 30, 2009. We paid $1.1 billion and $1.2 billion in dividends for the six months ended June 30, 2010 and June 30, 2009, respectively. The decrease in total dividends, despite the per share increase, is primarily attributed to the 269 million share reduction from the Mead Johnson split-off. Dividend decisions are made on a quarterly basis by our Board of Directors.

 

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Critical Accounting Policies

For a discussion of our critical accounting policies, see “Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations” in our 2009 Annual Report on Form 10-K.

The enactment of healthcare reform impacted certain judgments and estimates related to our accrued rebates and returns. See “—Executive Summary—Healthcare Reform” above for further detail.

Special Note Regarding Forward-Looking Statements

This quarterly report on Form 10-Q (including documents incorporated by reference) and other written and oral statements we make 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” 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, our goals, plans and projections regarding our 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. We have included important factors in the cautionary statements included in our 2009 Annual Report on Form 10-K, particularly under “Item 1A. Risk Factors,” that we believe could cause actual results to differ materially from any forward-looking statement.

Although we believe we have been prudent in our 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. We undertake no obligation to release publicly any revisions to forward-looking statements as a result of new information, future events or otherwise.

 

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Item 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

For a discussion of our market risk, see “Item 7A. Quantitative and Qualitative Disclosures About Market Risk” in our 2009 Annual Report on Form 10-K.

For information regarding executions of fixed-to-floating interest rate swaps and foreign currency forward contracts, see “Item 1. Financial Statements—Note 16. Financial Instruments.”

Item 4. CONTROLS AND PROCEDURES

Management, with the participation of the Chief Executive Officer and Chief Financial Officer, evaluated the effectiveness of our disclosure controls and procedures. Based on their evaluation, as of the end of the period covered by this Form 10-Q, the Chief Executive Officer and Chief Financial Officer have concluded that such 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. Legal Proceedings and Contingencies,” to the interim consolidated financial statements, and is incorporated by reference herein.

Item 2. ISSUER PURCHASES OF EQUITY SECURITIES

The following table summarizes the surrenders and repurchases of our equity securities during the six month period ended June 30, 2010:

 

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)
Dollars in Millions, Except Per Share Data                    

January 1 to 31, 2010

   4,280    $ 25.07       $ 2,220

February 1 to 28, 2010

   4,589    $ 24.19       $ 2,220

March 1 to 31, 2010

   1,492,277    $ 24.60       $ 2,220
               

Three months ended March 31, 2010

   1,501,146         
               

April 1 to 30, 2010

   9,065    $ 26.67       $ 2,220

May 1 to 31, 2010

   4,742,159    $ 23.48    4,731,211    $ 2,889

June 1 to 30, 2010

   2,556,972    $ 24.28    2,548,826    $ 2,827
               

Three months ended June 30, 2010

   7,308,196       7,280,037   
               

Six months ended June 30, 2010

   8,809,342       7,280,037   
               

 

(a) The difference between total number of shares purchased and the total number of shares purchased as part of publicly announced programs is due to shares of common stock withheld by us from employee restricted stock awards in order to satisfy our applicable tax withholding obligations.
(b) In May 2010, we announced that the Board of Directors authorized the purchase of up to $3 billion of our common stock. The repurchase program does not have an expiration date and is expected to take place over a few years. In May 2010, the Board of Directors also terminated the program previously announced in June 2001 pursuant to which up to $14 billion of common stock had been authorized to be purchased and approximately $2.2 billion remained yet to be repurchased.

 

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Item 6. EXHIBITS

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

 

Exhibit No.

 

Description

3a.   Certificate of Amendment to the Amended and Restated Certificate of Incorporation, effective as of May 7, 2010 (incorporated herein by reference to Exhibit 3a. to the Form 8-K dated May 4, 2010 and filed on May 10, 2010).
3b.   Certificate of Amendment to the Amended and Restated Certificate of Incorporation, effective as of May 7, 2010 (incorporated herein by reference to Exhibit 3b. to the Form 8-K dated May 4, 2010 and filed on May 10, 2010).
3c.   Bylaws of Bristol-Myers Squibb Company, as amended effective May 4, 2010 (incorporated herein by reference to Exhibit 3c. to the Form 8-K dated May 4, 2010 and filed on May 10, 2010).
10a.   Bristol-Myers Squibb Company 2007 Senior Executive Performance Incentive Plan (as amended and restated effective June 8, 2010).
12.   Computation of Earnings to Fixed Charges.
31a.   Section 302 Certification Letter.
31b.   Section 302 Certification Letter.
32a.   Section 906 Certification Letter.
32b.   Section 906 Certification Letter.
101.   The following financial statements from the Bristol-Myers Squibb Company Quarterly Report on Form 10-Q for the quarter ended June 30, 2010, formatted in Extensive Business Reporting Language (XBRL): (i) consolidated statements of earnings, (ii) consolidated statements of comprehensive income and retained earnings, (iii) consolidated balance sheets, (iv) consolidated statements of cash flows, and (v) the notes to the consolidated financial statements.

 

* Indicates, in this Form 10-Q, brand names of products, which are registered trademarks not owned by the Company or its subsidiaries. ERBITUX is a trademark of Eli Lilly; AVAPRO/AVALIDE (known in the EU as APROVEL/KARVEA), PLAVIX is a trademark of sanofi-aventis; ABILIFY is a trademark of Otsuka Pharmaceutical Co., Ltd.; TRUVADA is a trademark of Gilead Sciences, Inc.; GLEEVEC is a trademark of Novartis AG; ATRIPLA is a trademark of Bristol-Myers Squibb and Gilead Sciences, LLC; ESTRACE and OVCON are trademarks of Warner-Chilcott Company, LLC; and DELESTROGEN is a trademark of JHP Pharmaceuticals, Inc.

 

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SIGNATURES

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

 

   

BRISTOL-MYERS SQUIBB COMPANY

(R EGISTRANT )

Date: July 22, 2010   By:  

  /s/ Lamberto Andreotti

   

  Lamberto Andreotti

  Chief Executive Officer

Date: July 22, 2010   By:  

  /s/ Charles Bancroft

   

  Charles Bancroft

  Chief Financial Officer

 

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EXHIBIT 10a.

BRISTOL-MYERS SQUIBB COMPANY

2007 SENIOR EXECUTIVE PERFORMANCE INCENTIVE PLAN

(As Amended and Restated effective June 8, 2010)

1. Purpose . The purpose of this 2007 Senior Executive Performance Incentive Plan (the “Plan”) is to aid Bristol-Myers Squibb Company, a Delaware corporation (together with its successors and assigns, the “Company”), in attracting, retaining, motivating and rewarding executive employees of the Company or its subsidiaries or affiliates by providing for awards that will serve as an incentive to annual performance by executive employees who contribute materially to the success of the Company and its subsidiaries and affiliates. The Plan authorizes annual incentive awards that are intended to qualify as “performance-based compensation” that is tax deductible without limitation under Section 162(m) of the Internal Revenue Code.

2. Definitions . In addition to the terms defined in Section 1 above and elsewhere in the Plan, the following capitalized terms used in the Plan have the respective meanings set forth in this Section:

(a) “Award” means the amount of a Participant’s Award Opportunity in respect of a given Performance Year determined by the Committee to have been earned and to be payable or potentially payable to the Participant, subject to any conditions as may be imposed by the Committee.

(b) “Award Opportunity” means a specified percentage of the Award Pool that a Participant potentially may earn in a specified Performance Year, subject to such additional requirements as the Committee may impose. An Award Opportunity constitutes a conditional right to receive an Award.

(c) “Award Pool” means a hypothetical cash amount equal to two percent of the Pretax Earnings for a specified Performance Year. Pretax Earnings for this purpose may not include Pretax Earnings from any period not included in the designated Performance Year and, if Performance Years overlap, the Committee must specify counting rules so that the aggregate of Award Pools for such Performance Years does not exceed the limit of two percent of the Pretax Earnings during the relevant periods.

(d) “Beneficiary” means the person, persons, trust or trusts designated as being entitled to receive the benefits under a Participant’s Award Opportunity or Award upon and following a Participant’s death. Unless otherwise determined by the Committee, a Participant may designate a person, persons, trust or trusts as his or her Beneficiary, and in the absence of a designated Beneficiary the Participant’s Beneficiary shall be as specified in Section 8(a). Unless otherwise determined by the Committee, any designation of a Beneficiary other than a Participant’s spouse shall be subject to the written consent of such spouse.

(e) “Board” means the Company’s Board of Directors.

(f) “Code” means the Internal Revenue Code of 1986, as amended. References to any provision of the Code or regulation thereunder include any successor provisions and regulations, and reference to regulations includes any applicable guidance or pronouncement of the Department of the Treasury and Internal Revenue Service.

(g) “Committee” means the Compensation and Management Development Committee of the Board, the composition and governance of which is established in the Committee’s Charter as approved from time to time by the Board and subject to other corporate governance documents of the Company. No action of the Committee shall be void or deemed to be without authority due to the failure of any member, at the time the action was taken, to meet any qualification standard set forth in the Committee Charter or this Plan. The Committee may specify that any of its actions shall be subject to the approval of the Board.

 

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(h) “Covered Employee” means a person designated by the Committee as likely, with respect to a given fiscal year of the Company, to be the Chief Executive Officer or one of the other persons who will be named executive officers whose compensation potentially will be subject to the limitations on tax deductibility under Code Section 162(m) for that year (or a later year in which an Award may be settled). This designation generally is required at the time an Award Opportunity is granted.

(i) “Pretax Earnings” means the Company’s earnings from continuing operations on a consolidated basis before deduction of income taxes as reported (or to be reported) in the Company’s financial statements, less pretax minority interest expenses, and excluding discontinued operations, extraordinary items and other non-recurring items, in each case as determined in accordance with generally accepted accounting principles or identified in the Company’s financial statements, notes to the financial statements, management’s discussion and analysis or other filings with the U.S. Securities and Exchange Commission.

(j) “Participant” means a person who has been granted an Award Opportunity or Award under the Plan which remains outstanding.

(k) “Performance Year” means the fiscal year or portion thereof specified by the Committee as the period over which Pretax Earnings are to be measured as a basis for determining the level of funding of the Award Pool.

(l) “Retirement” means a Participant’s Termination of Employment with the Company or a subsidiary or affiliate in the following circumstances:

 

  (i) At or after the Participant’s 65th birthday; or

 

  (ii) At or after the Participant’s 55th birthday having completed 10 years of service with the Company and/or its subsidiaries and affiliates; or

 

  (iii) Such termination is by the Company or a subsidiary or affiliate not for cause and is not voluntary on the part of the Participant, at or after the Participant has attained age plus years of service (rounded up to the next higher whole number) which equals at least 70 and the Participant has completed 10 years of service with the Company and/or its subsidiaries and affiliates, and the Participant has executed a general release and has agreed to be subject to covenants relating to noncompetition, nonsolicitation and other commitments for the protection of the Company’s business as then may be required by the Committee (subject to Section 7(e)(x)).

(m) “Termination of Employment” means the termination of a Participant’s employment with the Company or a subsidiary or affiliate for any reason, immediately after which the Participant is not employed by the Company or any subsidiary or affiliate; provided, however, that with respect to any distribution of a Deferred Portion (as defined in Section 6(a)), Termination of Employment shall mean a Participant’s “separation from service” within the meaning of Treasury Regulation § 1.409A-1(h).

3. Administration .

(a) Authority of the Committee . The Plan shall be administered by the Committee, which shall have full and final authority, in each case subject to and consistent with the provisions of the Plan, to select eligible employees of the Company and its subsidiaries to become Participants; to grant Award Opportunities; to prescribe documents setting terms of Award Opportunities and Awards (such Award

 

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documents need not be identical for each Participant or each Award), amendments thereto, and rules and regulations for the administration of the Plan and amendments thereto (“Regulations”); to construe and interpret the Plan and Award documents and correct defects, supply omissions or reconcile inconsistencies therein; and to make all other decisions and determinations as the Committee may deem necessary or advisable for the administration of the Plan. Decisions of the Committee with respect to the administration and interpretation of the Plan shall be final, conclusive, and binding upon all persons interested in the Plan, including Participants, Beneficiaries, and other persons claiming rights from or through a Participant, and stockholders (except as may be otherwise determined by the Board). The express grant of any specific power to the Committee, and the taking of any action by the Committee, shall not be construed as limiting any power or authority of the Committee.

(b) Manner of Exercise of Committee Authority . The Committee may act through subcommittees, including for purposes of qualifying Award Opportunities and Awards under Code Section 162(m) as performance-based compensation, in which case the subcommittee shall be subject to any limitations under the Committee Charter, and the acts of the subcommittee shall be deemed to be acts of the Committee hereunder. The Committee may delegate to one or more officers or managers of the Company or any subsidiary or affiliate, or committees thereof, the authority, subject to such terms as the Committee shall determine, to perform such functions, including administrative functions, as the Committee may determine, to the extent that such delegation (i) will not cause Award Opportunities and Awards intended to qualify as performance-based compensation under Code Section 162(m) to fail to so qualify, and (ii) will not result in a related-party transaction with an executive officer required to be disclosed under Item 404(a) of Regulation S-K (in accordance with Instruction 5.a.ii thereunder) under the Exchange Act.

(c) Limitation of Liability . The Committee and each member thereof, and any person acting pursuant to authority delegated by the Committee, shall be entitled, in good faith, to rely or act upon any report or other information furnished by any executive officer, other officer or employee of the Company or a subsidiary or affiliate, the Company’s independent auditors, consultants or any other agents assisting in the administration of the Plan. Members of the Committee, any person acting pursuant to authority delegated by the Committee, and any officer or employee of the Company or a subsidiary or affiliate acting at the direction or on behalf of the Committee or a delegee shall not be personally liable for any action or determination taken or made in good faith with respect to the Plan, and shall, to the extent permitted by law, be fully indemnified and protected by the Company with respect to any such action or determination.

4. Eligibility and Per-Person Limits . Employees of the Company or any subsidiary or affiliate who are or may become executive officers of the Company may be selected by the Committee to participate in this Plan in a specified Performance Year. The maximum Award Opportunity of any individual Participant who is the Chief Executive Officer during any part of a Performance Year shall be 20% of the Award Pool for that Performance Year and for any other individual Participant shall be 15% of the Award Pool for that Performance Year, provided that the aggregate of all Award Opportunities under this Plan for that Performance Year may not exceed 100% of the Award Pool.

5. Designation and Earning of Award Opportunities .

(a) Designation of Award Opportunities . The Committee shall select employees to participate in the Plan and designate the Performance Year of such participation. The Committee shall designate, for each such Participant, the Award Opportunity such Participant may earn for such Performance Year and any conditions to the earning of such Award Opportunity or portions thereof (in addition to the requirement that Pretax Earnings be achieved in order to fund the Award Pool). Award Opportunities will be denominated in cash and Awards will be payable in cash, except that the Committee may denominate an Award Opportunity in shares of Common Stock or equity awards based on Common Stock or provide for payment of a cash-denominated Award Opportunity in the form of such shares or equity awards if and to the extent that the shares or equity awards are available under the 2007 Stock Award and Incentive Plan (or a successor thereto) and authorized for use hereunder in accordance with applicable requirements of such other plan. Except for shares drawn from such other plan, no shares of Common Stock are specifically reserved for issuance under this Plan.

 

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(b) Award Opportunities of Covered Employees. If the Committee determines that an Award Opportunity to be granted to an eligible person who is designated a Covered Employee by the Committee should qualify as performance-based compensation for purposes of Code Section 162(m), the Committee will specify the Performance Year and the Participant’s Award Opportunity by the date which is the earlier of (i) 90 days after the beginning of the applicable Performance Year or (ii) the time 25% of such Performance Year has elapsed. Any settlement or other event which would change the form of payment from that originally specified shall be implemented in a manner such that the Award does not, solely for that reason, fail to qualify as performance-based compensation for purposes of Code Section 162(m).

(c) Additional Participants and Award Opportunity Designations During a Performance Year . At any time during a Performance Year, the Committee may select a new employee or a newly promoted employee to participate in the Plan for that Performance Year and/or designate, for any such Participant, an Award Opportunity (or additional Award Opportunity) for such Performance Year or a different Performance Year. In determining the amount of the Award Opportunity for such Participant under this Section 5(c), the Committee may take into account the portion of the Performance Year already elapsed, the performance achieved during such elapsed portion of the Performance Year, and such other considerations as the Committee may deem relevant.

(d) Determination of Award . During the year following the Performance Year, within a reasonable time after the end of each Performance Year and financial results for the Performance Year have become available (but not later than March 15), the Committee will determine the extent to which the Award Pool is funded and Award Opportunities for the Performance Year have been earned, and the Award for each Participant for such Performance Year. The Committee may not adjust the amount of an Award under Section 5(b) upward so that the Award exceeds the level of earning of the related Award Opportunity actually achieved based on Pretax Earnings performance. Unless otherwise determined by the Committee (or otherwise provided under a separate agreement, plan or policy conferring rights on the Participant), the Award shall be deemed earned and vested as of the final day of the Performance Year, subject to the subsequent determinations by the Committee pursuant to this Section 5(d) as to the level of funding of the Award Pool, earning of Award Opportunities and resulting individual Awards. No Participant shall have a legal right to receive an Award prior to the time the Award is earned and vested. In making determinations under this Section 5(d), the Committee retains full discretion to reduce or eliminate the level of funding of the Award Pool, Award Opportunities or final Award amounts, provided that, after the end of the Performance Year and before the determination of Awards under Section 5(c), such negative discretion may only be exercised in the event of extraordinary circumstances, not reasonably foreseeable before the end of the Performance Year, deemed by the Committee to adversely affect the Plan and its purposes or the business results intended to be promoted by the Plan.

(e) Written Determinations. Determinations by the Committee under this Section 5, including Award Opportunities, the level of Pretax Earnings for the Performance Year and the resulting funding of the Award Pool, and the amount of any Award earned shall be recorded in writing. With regard to Awards intended to qualify under Section 162(m), the Committee will certify, in a manner conforming to applicable regulations under Section 162(m), prior to settlement of each such Award granted to a Covered Employee, that the Award (and any related Award Opportunity) has been earned and other material terms upon which earning of the Award was conditioned have been satisfied.

(f) Other Terms of Award Opportunities and Awards . Subject to the terms of this Plan, the Committee may specify, prior to the Performance Year, the circumstances in which Award Opportunities and Awards shall be paid or forfeited in the event of a change in control, Termination of Employment or other event occurring prior to the end of a Performance Year or the circumstances in which such an event (occurring at any time) will alter the timing of settlement of an Award. With respect to Award Opportunities and Awards under Section 5(b), any payments resulting from a change in control or Termination of Employment need not qualify as performance-based compensation under Section 162(m) if authorizing such non-qualifying payments would not disqualify the Award Opportunity or Award from Section 162(m) qualification in cases in which no change in control or Termination of Employment in fact has occurred.

 

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(g) Adjustments . The Committee is authorized to make adjustments during the Performance Year in the terms and conditions of, and the criteria included in, Award Opportunities in recognition of unusual or nonrecurring events, including acquisitions and dispositions of businesses and assets, affecting the Company and its subsidiaries or other business unit, or the financial statements of the Company or any subsidiary, or in response to changes in applicable laws, regulations, accounting principles, tax rates and regulations or business conditions or in view of the Committee’s assessment of the business strategy of the Company, any subsidiary or affiliate or business unit thereof, economic and business conditions, personal performance of a Participant, and any other circumstances deemed relevant; provided, however, that no such adjustment shall be authorized or made if and to the extent that the existence or exercise of such authority (i) would affect the definition of “Pretax Earnings” so as to increase the amount thereof; (ii) would cause an Award Opportunity or Award under Section 5(b) intended to qualify as performance-based compensation under Code Section 162(m) and regulations thereunder to fail to so qualify, or (iii) would cause the Committee to be deemed to have authority to change the targets, within the meaning of Treasury Regulation § 1.162-27(e)(4)(vi), with respect to Award Opportunities under Section 5(b) intended to qualify as performance-based compensation under Code Section 162(m) and regulations thereunder.

6. Settlement of Awards .

(a) Current and Deferred Portions . The Committee may require or may permit a Participant to elect deferred payment of a percentage (not less than 25%) of an Award (the “Deferred Portion”). Any Award or portion of an Award which the Committee does not require and the Participant does not validly request to be deferred shall be paid in accordance with Section 6(b) (the “Current Portion”). Any Deferred Portion, and any rights of a Participant to elect deferral, shall be subject to the terms and conditions stated in Section 7(e) and in any Regulations. A Participant may elect deferral of settlement of an Award only by filing a valid deferral election, on such form as the Committee may require, with the Company not later than December 31 of the year preceding the Performance Year or at such other election date as the Committee may specify in accordance with Code Section 409A (as required by Section 7(e)). The Current Portion and the Deferred Portion for each performance year, and installments payable as the Deferred Portion, each shall be deemed a separate payment for purposes of Code Section 409A.

(b) Settlement of Award . Any Current Portion of an Award shall be paid and settled by the Company promptly after the date of determination by the Committee under Section 5(d) hereof. The Current Portion of any Award shall be paid no later than March 15 of the year following the end of the Performance Year to which the Award relates.

(c) Tax Withholding . The Company and its subsidiaries and affiliates shall deduct from any payment in settlement of a Participant’s Award or from any other payment to the Participant, including wages, any Federal, state, or local withholding or other tax or charge which is then required to be deducted under applicable law with respect to the Award. If any Award is to be settled by delivery of Common Stock, the Company may at its election withhold shares to cover such withholding taxes. Participants may elect to have the deduction of taxes cover the amount of any applicable tax payable by the Participant in excess of the mandatory withholding tax, with such incremental tax determined on the basis of the highest marginal tax rate applicable to such Participant, except that if shares of Common Stock are to be withheld, such shares may be withheld only to the extent of the mandatory withholding taxes.

(d) Non-Transferability . In addition to the restrictions under Section 7(e)(vii), an Award Opportunity, any resulting Award, including any Deferred Portion, and any other right hereunder shall be non-assignable and non-transferable, and shall not be pledged, encumbered, or hypothecated to or in favor of any party or subject to any lien, obligation, or liability of the Participant to any party other than the Company or a subsidiary or affiliate, except that a Participant may designate a Beneficiary pursuant to the provisions of Section 8.

 

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7. Deferral of Payments . Any Deferred Portion of an Award shall be subject to the following (certain provisions of Section 7(e) apply also to the Current Portion of an Award):

(a) Notional Investment Funds. At such time as may be specified by the Committee, the Participant shall determine, subject to the approval of the Committee, the portion of his or her Deferred Portion that is to be valued by reference to the Performance Incentive Fixed Income Fund (the “Fixed Income Fund”), the portion that is to be valued by reference to the Performance Incentive Company Stock Fund (the “Stock Fund”) and the portion that shall be valued by reference to any other fund(s) (collectively, the “Funds”) which may be established by the Committee for this purpose. The Committee may from time to time determine whether the Fund(s) used to value the account of any Participant may be changed from the Fund(s) currently used to any other Fund established for use under this Plan, subject to Section 7(e).

(b) Payments in Settlement of Deferred Portions . Unless otherwise determined by the Committee and subject to Section 7(e), payments of a Participant’s Deferred Portions shall be made as follows: Payment of the total amount of a Participant’s Deferred Portions shall be made to the Participant or, in case of the death of the Participant prior to the commencement of payments of Deferred Portions, to the Participant’s Beneficiary, in lump sum or in installments (as permitted by the Committee and elected by the Participant) commencing within 30 days (subject to Section 8(a)) after the Participant shall cease, by reason of death or otherwise, to be an employee of the Company; provided that the only distribution dates that may be permitted hereunder will be dates complying with requirements under Code Section 409A, which among other things may require a six-month delay in a distribution to a “key employee” following separation from service (in accordance with Section 7(e)(ii)(B)). Certain provisions governing the timing of payment in the event of death are specified in Section 8(a) below. In case of the death of any Participant after the commencement of installment payments, the then remaining unpaid balance of Deferred Portions shall continue to be paid in installments, at such times and in such manner as if such Participant were living, to the Beneficiary(ies) of the Participant.

(c) Conduct of Participant Following Termination of Employment.  If, following the date on which a Participant shall cease to be an employee of the Company, the Participant shall at any time either disclose to unauthorized persons confidential information relative to the business of the Company or otherwise act or conduct themselves in a manner which the Committee shall determine is inimical or contrary to the best interest of the Company, the Company’s obligation to make any further payment on account of the Participant’s Deferred Portions that resulted from mandatory deferrals shall forthwith terminate. The determination of the Committee as to whether an event has occurred resulting in a forfeiture or a termination or reduction of the Company’s obligation in accordance with the provisions of this Section 7 shall be conclusive.

(d) Fund Composition and Valuation.  Deferred Portions of Awards under the Plan shall be valued and maintained as follows:

 

  (i) In accordance with the provisions, and subject to the conditions, of the Plan and the Regulations, the Deferred Portion as established by the Committee shall be valued in reference to the Participants’ account(s) in the Fixed Income Fund, in the Company Stock Fund, and in any other Fund(s) established under this Plan. Account balances shall be maintained as dollar values, units or share equivalents as appropriate based upon the nature of the Fund. Unless otherwise determined by the Committee, for unit or share-based Funds, the number of units or shares credited shall be based upon the established unit or share value as of the last day of the quarter preceding the crediting of the Deferred Portion.

 

  (ii) Investment income credited to Participants’ accounts under the Fixed Income Fund shall be determined by the Committee based upon the prevailing rates of return experienced by the Company. The Company shall advise Participants of the current valuations of the Fixed Income Fund as appropriate to facilitate deferral decisions, investment choices and to communicate payout levels. The Company Stock Fund shall consist of units each valued as one share of Common Stock of the Company (par value $.10).

 

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  (iii) Nothing contained in the Fund definitions in Sections 7(d)(i) and (ii) shall require the Company to segregate or earmark any cash, shares, or other property to determine Fund values, maintain Participant account levels or for any other purpose.

 

  (iv) The establishment of the Fixed Income Fund and the Stock Fund as detailed in Sections 7(d)(i) and (ii) shall not preclude the right of the Committee to direct the establishment of additional investment Funds or to discontinue those Funds. In establishing such Funds, the Committee shall determine the criteria to be used for determining the value of such Funds.

(e) Certain Provisions to Ensure Compliance with Section 409A. Other provisions of the Plan notwithstanding, the terms of any Deferred Portion (which term includes earnings thereon), including any authority of the Company and rights of the Participant with respect to the Deferred Portion, shall be limited to those terms permitted under Section 409A, and any terms not permitted under Section 409A shall be automatically modified and limited to the extent necessary to conform with Section 409A but only to the extent that such modification or limitation is permitted under Code Section 409A and the regulations and guidance issued thereunder. In addition, other provisions of the Plan notwithstanding, the following rules will apply:

 

  (i) Elections to defer any portion of an Award will be permitted only at times in compliance with Section 409A in accordance with the rules set forth on Exhibit A to the Company’s 2007 Stock Award and Incentive Plan, as amended, which Exhibit is hereby incorporated into and made a part of this Plan;

 

  (ii) Distribution. Except as provided in Section 7(e)(iii) hereof, no Deferred Portion shall be distributable to a Participant (or his or her beneficiary) except upon the occurrence of one of the following (or a date related to the occurrence of one of the following), which must be specified in a written document governing such Deferred Portion and otherwise meet the requirements of Treasury Regulation § 1.409A-3:

 

  (A) Specified Time. A specified time or a fixed schedule.

 

  (B) Separation from Service. The Participant’s separation from service (within the meaning of Treasury Regulation § 1.409A-1(h) and other applicable rules under Code Section 409A); provided, however, that if the Participant is a “key employee” (as defined in Code Section 416(i) without regard to paragraph (5) thereof) and any of the Company’s stock is publicly traded on an established securities market or otherwise, settlement under this Section 7(e)(ii)(B) shall instead occur at the expiration of the six-month period under Section 409A(a)(2)(B)(i). In the case of installments, this delay shall not affect the timing of any installment otherwise payable after the six-month delay period.

 

  (C) Death. The death of the Participant.

 

  (D) Disability. The date the Participant has experienced a 409A Disability (as defined below).

 

  (E) 409A Ownership/Control Change. The occurrence of a 409A Ownership/Control Change (as defined below).

 

E-10-7


  (iii) No Acceleration. The distribution of a Deferred Portion may not be accelerated prior to the time specified in accordance with Section 7(e)(iii) hereof, except in the case of one of the following events:

 

  (A) Unforeseeable Emergency. The occurrence of an Unforeseeable Emergency, as defined below, but only if the net amount payable upon such settlement does not exceed the amounts necessary to relieve such emergency plus amounts necessary to pay taxes reasonably anticipated as a result of the settlement, after taking into account the extent to which the emergency is or may be relieved through reimbursement or compensation from insurance or otherwise or by liquidation of the Participant’s other assets (to the extent such liquidation would not itself cause severe financial hardship), or by cessation of deferrals under the Plan. Upon a finding that an Unforeseeable Emergency has occurred with respect to a Participant, any election of the Participant to defer compensation that will be earned in whole or part by services in the year in which the emergency occurred or is found to continue will be immediately cancelled.

 

  (B) Domestic Relations Order. The Deferred Portion may permit the acceleration of the exercise or distribution time or schedule to an individual other than the Participant as may be necessary to comply with the terms of a domestic relations order (as defined in Section 414(p)(1)(B) of the Code).

 

  (C) Conflicts of Interest. Such Deferred Portion may permit the acceleration of the settlement time or schedule as may be necessary to comply with an ethics agreement with the Federal government or to comply with a Federal, state, local or foreign ethics law or conflict of interest law in compliance with Treasury Regulation § 1.409A-3(j)(4)(iii).

 

  (D) Change. The Committee may exercise the discretionary right to accelerate the vesting of any unvested compensation deemed to be a Deferred Portion upon a 409A Ownership/Control Change or to terminate the Plan upon or within 12 months after a 409A Ownership/Control Change, or otherwise to the extent permitted under Treasury Regulation § 1.409A-3(j)(4)(ix), or accelerate settlement of such Deferred Portion in any other circumstance permitted under Treasury Regulation § 1.409A-3(j)(4).

 

  (iv) Definitions. For purposes of this Section 7(e), the following terms shall be defined as set forth below:

 

  (A) “409A Ownership/Control Change” shall be deemed to have occurred if, in connection with any event otherwise defined as a change in control under any applicable Company document, there occurs a change in the ownership of the Company, a change in effective control of the Company, or a change in the ownership of a substantial portion of the assets of the Company, as defined in Treasury Regulation § 1.409A-3(i)(5).

 

  (B) “409A Disability” means an event which results in the Participant being (i) unable to engage in any substantial gainful activity by reason of any medically determinable physical or mental impairment that can be expected to result in death or can be expected to last for a continuous period of not less than 12 months, or (ii), by reason of any medically determinable physical or mental impairment that can be expected to result in death or can be expected to last for a continuous period of not less than 12 months, receiving income replacement benefits for a period of not less than three months under an accident and health plan covering employees of the Company or its subsidiaries.

 

E-10-8


  (C) “Unforeseeable Emergency” means a severe financial hardship to the Participant resulting from an illness or accident of the Participant, the Participant’s spouse, or a dependent (as defined in Code Section 152, without regard to Code Sections 152(b)(1), (b)(2), and (d)(1)(B)) of the Participant, loss of the Participant’s property due to casualty, or similar extraordinary and unforeseeable circumstances arising as a result of events beyond the control of the Participant, and otherwise meeting the definition set forth in Treasury Regulation § 1.409A-3(i)(3).

 

  (v) Time of Distribution. In the case of any distribution of a Deferred Portion, if the timing of such distribution is not otherwise specified in the Plan or an applicable agreement or other governing document, the distribution shall be made within 60 days after the date at which the settlement of the Deferred Portion is specified to occur. In the case of both the Current Portion and the Deferred Portion, the Participant shall have no influence on any determination as to the tax year in which the distribution will be made.

 

  (vi) Determination of “Key Employee.” For purposes of a distribution under Section 7(e)(ii)(B), status of a Participant as a “key employee” shall be determined annually under the Company’s administrative procedure for such determination for purposes of all plans subject to Code Section 409A.

 

  (vii) Non-Transferability. Other provisions of the Plan notwithstanding, no Current Portion, Deferred Portion or other right of a Participant under the Plan shall be subject to anticipation, alienation, sale, transfer, assignment, pledge, encumbrance, attachment, or garnishment by creditors of the Participant or the Participant’s Beneficiary.

 

  (viii) Distribution Changes. The Committee may, in its discretion, require or permit on an elective basis a change in the distribution terms applicable to a Deferred Portion in accordance with, and to the fullest extent permitted by, applicable guidance of the Internal Revenue Service (including Proposed Treasury Regulation § 1.409A, Preamble § XI.C and IRS Notice 2005-1), and otherwise in accordance with Section 409A and regulations thereunder. The Senior Vice President — Human Resources of the Company is authorized to permit election of different deferral periods provided that any such modifications may not otherwise increase the benefits to Participants or the costs of a Deferred Portion to the Company (other than through changes in value of the notional investment). Other provisions of this Plan notwithstanding, changes to distribution timing resulting from amendments to this Plan in 2008 shall not have the affect of accelerating distributions into 2008 or causing distributions that otherwise would have occurred in 2008 to be deferred until a year after 2008.

 

  (ix) Scope and Application of this Provision. For purposes of this provision, references to a term or event (including any authority or right of the Company or a Participant) being “permitted” under Section 409A mean that the term or event will not cause the Participant to be deemed to be in constructive receipt of compensation relating to the Deferred Portion prior to the distribution of cash, shares or other property or to be liable for payment of interest or a tax penalty under Section 409A.

 

  (x)

Release or Other Termination Agreement. If the Company requires a Participant to execute a release, non-competition, or other agreement as a condition to receipt of a payment upon or following a Termination of Employment, the Company will supply to

 

E-10-9


 

the Participant a form of such release or other document not later than the date of the Participant’s Termination of Employment, which must be returned within the time period required by law and must not be revoked by the Participant within the applicable time period in order for Participant to satisfy any such condition. If any amount payable during a fixed period following Termination of Employment is subject to such a requirement and the fixed period would begin in one year and end in the next, the Company, in determining the time of payment of any such amount, will not be influenced by the timing of any action of the Participant including execution of such a release or other document and expiration of any revocation period. In particular, the Company will be entitled in its discretion to deposit any such payment in escrow during either year comprising such fixed period, so that such deposited amount is constructively received and taxable income to the Participant upon deposit but with distribution from such escrow remaining subject to the Participant’s execution and non-revocation of such release or other document.

 

  (xi) Limitation on Setoffs. No setoff by the Company to satisfy any obligation of the participant to the Company is permitted against a 409A Deferral except at the time of distribution of such 409A Deferral.

 

  (xii) Special Disability Provision. In case of a Disability of a Participant, for any Deferred Portion the Company shall determine whether there has occurred a “separation from service” as defined under Treasury Regulation § 1.409A-1(h) based on Participant’s circumstances, in which case such Disability will be treated as a separation from service for purposes of determining the time of payment of such Deferred Portion. The Company’s determination hereunder will be made initially within 30 days after the Disability and each March and December thereafter.

8. Designation of and Payments to Beneficiaries .

(a) Distributions in the Event of Death. If a Participant has died and then or thereafter a Current or Deferred Portion becomes distributable to the Participant, such payment will be distributed to the Participant’s Beneficiary; provided, however, that a person or trust will be deemed a Beneficiary only if he or it is surviving on the date of death of the Participant and if the Participant has designated such person or trust as a Beneficiary in his or her most recent written and duly filed Beneficiary designation (i.e., any new Beneficiary designation under the Plan cancels a previously filed Beneficiary designation). If no Beneficiary is living at the time of Participant’s death, any subsequent payment will be distributable to the person or persons in the first of the following classes of successive preference:

 

  (i) Widow or Widower, if then living;

 

  (ii) Surviving children, equally;

 

  (iii) Surviving parents, equally;

 

  (iv) Surviving brothers and sisters, equally; and

 

  (v) Executors or administrators;

and the term “Beneficiary” as used in the Plan shall include such person or persons. In case of the death, any Current or Deferred Portion (as to which installment payments have not commenced; if payable in installments, this timing rule applies to commencement of installments) will become payable to the estate 30 days after the death of the employee. The representatives of the Participant’s estate shall be obligated to provide to the Company such documentation as the Committee may reasonably require, but in any event distribution hereunder may not be delayed beyond the end of the year in which the specified payment date

 

E-10-10


falls (and the Current Portion must be paid within the short-term deferral period under Section 409A). If the Participant dies after the commencement of installment payments, the then remaining unpaid balance of Deferred Portions shall continue to be paid in installments, at such times and in such manner as if such Participant were living, to the Beneficiary(ies).

(b) Terms and Conditions Applicable to a Beneficiary. A Beneficiary, transferee, or other person claiming any rights under the Plan from or through any Participant shall be subject to all terms and conditions of the Plan and any Award document applicable to such Participant, except as otherwise determined by the Committee, and to any additional terms and conditions deemed necessary or appropriate by the Committee.

9. Additional Forfeiture Provisions Applicable to Awards . Awards shall be subject to the Company’s policy providing that the Company will, to the extent permitted by governing law, require reimbursement of any bonus paid to executive officers and certain other officers where: (i) the payment was predicated upon the achievement of certain financial results that were subsequently the subject of a restatement, (ii) in the Board’s view the Participant engaged in misconduct that caused or partially caused the need for the restatement, and (iii) a lower payment would have been made to the Participant based upon the restated financial results. In each such instance, the Company will seek to recover the Participant’s entire Award for the relevant period, plus a reasonable rate of interest. Any successor or additional policy in effect at the date an Award is determined shall apply to such Award.

10. General Provisions .

(a) Changes to this Plan . The Committee may at any time amend, alter, suspend, discontinue, or terminate this Plan, and such action shall not be subject to the approval of the Company’s stockholders or Participants; provided, however, that any amendment to the Plan beyond the scope of the Committee’s authority shall be subject to the approval of the Board of Directors; provided further, that any amendment to the Plan shall be subject to stockholder approval if and to the extent required so that Award Opportunities and Awards under Section 5(b) can continue to qualify under Code Section 162(m), and provided further, that, without the consent of the Participant, no such action shall materially impair the rights of a Participant with respect to an Award as to which the Committee no longer retains a right to exercise negative discretion to eliminate the payment in settlement of the Award that previously was earned and vested.

(b) Participant Acceptance of Plan and Award Terms. By accepting any Award or other benefit under the Plan, a Participant and each person claiming under or through him or her shall be conclusively deemed to have accepted, ratified and consented to any action taken or made under the Plan by the Company, the Board, the Committee or any other committee appointed by the Board, and to have agreed to all terms and conditions under the Plan and otherwise specified in connection with such Award.

(c) Section 162(m) of the Code . Unless otherwise determined by the Committee, the provisions of this Plan shall be administered and interpreted in accordance with Section 162(m) of the Code to ensure the deductibility by the Company of payment in settlement of Awards to Covered Employees.

(d) Unfunded Status of Participant Rights . Award Opportunities, Awards, accounts, deferred amounts, and related rights of a Participant under the Plan represent unfunded deferred compensation obligations of the Company for ERISA and federal income tax purposes and, with respect thereto, the Participant shall have rights no greater than those of an unsecured general creditor of the Company.

(e) Nonexclusivity of the Plan . The adoption of this Plan shall not be construed as creating any limitations on the power of the Board or Committee to adopt such other compensation arrangements as it may deem desirable for any Participant or non-participating employee, including authorization of annual incentives under other plans and arrangements.

 

E-10-11


(f) No Right to Continued Employment. Neither the Plan, its adoption, its operation, nor any action taken under the plan shall be construed as giving any employee the right to be retained or continued in the employ of the Company or any of its subsidiaries or affiliates, nor shall it interfere in any way with the right and power of the Company or any of its subsidiaries or affiliates to dismiss or discharge any employee or take any action that has the effect of terminating any employee’s employment at any time.

(g) Severability. The invalidity of any provision of the Plan or a document hereunder shall not be deemed to render the remainder of this Plan or such document invalid.

(h) Successors . The Company shall require any successor (whether direct or indirect, by purchase, merger, consolidation or otherwise, and whether or not the corporate existence of the Company continues) to all or substantially all of the business and/or assets of the Company to expressly assume and agree to perform the Company’s obligations under the Plan in the same manner and to the same extent that the Company would be required to perform it if no such succession had taken place; provided, however, that such successor may replace the Plan with a Plan substantially equivalent in opportunity and achievability, as determined by a nationally recognized compensation consulting firm, and covering the persons who were Participants at the time of such succession. Any successor and the ultimate parent company of such successor shall in any event be subject to the requirements of this Section 10(h) to the same extent as the Company. Subject to the foregoing, the Company may transfer and assign its rights and obligations hereunder.

(i) Governing Law . The validity, construction, and effect of the Plan and any rules and regulations or document hereunder, to the extent not otherwise governed by the Code or the laws of the United States, shall be determined in accordance with the laws of the State of New York, without giving effect to principles of conflicts of laws.

(j) Effective Date of Plan; Stockholder Approval; Termination of Plan . This Plan shall be effective January 1, 2008, providing that it has previously been approved by vote of a majority of stockholders present in person or represented by proxy and entitled to vote on the matter at the Company’s 2007 Annual Meeting of Stockholders. The Plan will terminate at such time as may be determined by the Board of Directors. This amendment and restatement of the Plan was adopted June 8, 2010.

 

E-10-12

EXHIBIT 12.

Computation of Earnings to Fixed Charges

 

Ratio of Earnings to Fixed Charges:    Six Months
Ended June 30,
   Years Ended December 31,
Dollars in Millions    2010    2009    2008    2007    2006    2005

Earnings

                 

Earnings from continuing operations before income taxes

   $ 3,044    $ 5,602    $ 4,776    $ 2,523    $ 1,450    $ 3,398

Less:

                 

Noncontrolling interest in pre-tax income of subsidiaries that have not incurred fixed charges

     1,020      1,717      1,444      1,106      609      812

Equity in net income of affiliates

     182      550      617      524      474      334

Capitalized interest

     4      13      21      24      16      8
                                         

Income adjusted for equity income

     1,838      3,322      2,694      869      351      2,244

Add:

                 

Fixed charges

     94      242      387      497      560      403

Distributed income of equity investments

     88      550      590      488      439      383
                                         

Total Earnings

   $ 2,020    $ 4,114    $ 3,671    $ 1,854    $ 1,350    $ 3,030
                                         

Fixed Charges

                 

Interest

   $ 65    $ 184    $ 310    $ 422    $ 498    $ 349

Capitalized interest

     4      13      21      24      16      8

One-third of rental expense (1)

     25      45      56      51      46      46
                                         

Total Fixed Charges

   $ 94    $ 242    $ 387    $ 497    $ 560    $ 403
                                         

Ratio of Earnings to Fixed Charges

     21.49      17.00      9.49      3.73      2.41      7.52

 

(1)

Rents included in the computation consist of one-third of rental expense which the Company believes to be a conservative estimate of an interest factor in its leases.

 

E-12-1

EXHIBIT 31a.

CERTIFICATION BY THE CHIEF EXECUTIVE OFFICER

PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002

I, Lamberto Andreotti, certify that:

 

1. I have reviewed Bristol-Myers Squibb Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2010;

 

2. Based on my knowledge, this quarterly report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this quarterly report;

 

3. Based on my knowledge, the financial statements, and other financial information included in this quarterly report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this quarterly report;

 

4. The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined by Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

 

a. designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this quarterly report is being prepared;

 

b. designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

 

c. evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

 

d. disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting;

 

5. The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of registrant’s board of directors (or persons performing the equivalent function):

 

a. all significant deficiencies and material weaknesses in the design or operation of internal controls over financial reporting, which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

 

b. any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal controls over financial reporting.

Date: July 22, 2010

 

/s/ Lamberto Andreotti

Lamberto Andreotti

Chief Executive Officer

 

E-31-1

EXHIBIT 31b.

CERTIFICATION BY THE CHIEF FINANCIAL OFFICER

PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002

I, Charles Bancroft, certify that:

 

1. I have reviewed Bristol-Myers Squibb Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2010;

 

2. Based on my knowledge, this quarterly report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this quarterly report;

 

3. Based on my knowledge, the financial statements, and other financial information included in this quarterly report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this quarterly report;

 

4. The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined by Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

 

a. designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this quarterly report is being prepared;

 

b. designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
c. evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
d. disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting;

 

5. The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of registrant’s board of directors (or persons performing the equivalent function):

 

a. all significant deficiencies and material weaknesses in the design or operation of internal controls over financial reporting, which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
b. any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal controls over financial reporting.

Date: July 22, 2010

 

/s/ Charles Bancroft

Charles Bancroft

Chief Financial Officer

 

E-31-2

EXHIBIT 32a.

Certification by the Chief Executive Officer Pursuant to 18 U. S. C. Section 1350, as

Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002

Pursuant to 18 U.S.C. Section 1350, I, Lamberto Andreotti, hereby certify that, to the best of my knowledge, Bristol-Myers Squibb Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2010 (the Report), as filed with the Securities and Exchange Commission on July 22, 2010, fully complies with the requirements of Section 13(a) or Section 15(d) of the Securities Exchange Act of 1934, as amended, and that the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of Bristol-Myers Squibb Company.

 

/s/ Lamberto Andreotti

Lamberto Andreotti

Chief Executive Officer

July 22, 2010

 

E-32-1

EXHIBIT 32b.

Certification by the Chief Financial Officer Pursuant to 18 U. S. C. Section 1350, as

Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002

Pursuant to 18 U.S.C. Section 1350, I, Charles Bancroft, hereby certify that, to the best of my knowledge, Bristol-Myers Squibb Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2010 (the Report), as filed with the Securities and Exchange Commission on July 22, 2010, fully complies with the requirements of Section 13(a) or Section 15(d) of the Securities Exchange Act of 1934, as amended, and that the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of Bristol-Myers Squibb Company.

 

/s/ Charles Bancroft

Charles Bancroft

Chief Financial Officer

July 22, 2010

 

E-32-2