Attached files

file filename
EXCEL - IDEA: XBRL DOCUMENT - BRISTOL MYERS SQUIBB COFinancial_Report.xls
EX-12 - COMPUTATION OF EARNINGS TO FIXED CHARGES - BRISTOL MYERS SQUIBB COdex12.htm
EX-10.(A) - FORM OF RESTRICTED STOCK UNITS AGREEMENT - BRISTOL MYERS SQUIBB COdex10a.htm
EX-32.(B) - SECTION 906 CFO CERTIFICATION LETTER - BRISTOL MYERS SQUIBB COdex32b.htm
EX-31.(B) - SECTION 302 CFO CERTIFICATION LETTER - BRISTOL MYERS SQUIBB COdex31b.htm
EX-31.(A) - SECTION 302 CEO CERTIFICATION LETTER - BRISTOL MYERS SQUIBB COdex31a.htm
EX-32.(A) - SECTION 906 CEO CERTIFICATION LETTER - BRISTOL MYERS SQUIBB COdex32a.htm
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 MARCH 31, 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 March 31, 2010, there were 1,719,674,383 shares outstanding of the Registrant’s $0.10 par value common stock.

 

 

 


Table of Contents

BRISTOL-MYERS SQUIBB COMPANY

INDEX TO FORM 10-Q

March 31, 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    51

Item 4.

  Controls and Procedures    51

PART II—OTHER INFORMATION

Item 1.

  Legal Proceedings    51

Item 2.

  Issuer Purchase of Equity Securities    51

Item 6.

  Exhibits    52

Signatures

   53


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 March 31,  
EARNINGS    2010     2009  

Net Sales

   $ 4,807      $ 4,322   
                

Cost of products sold

     1,306        1,165   

Marketing, selling and administrative

     900        901   

Advertising and product promotion

     212        248   

Research and development

     910        908   

Provision for restructuring

     11        19   

Litigation expense

            104   

Equity in net income of affiliates

     (97     (146

Other (income)/expense

     113        (72
                

Total Expenses

     3,355        3,127   
                

Earnings from Continuing Operations Before Income Taxes

     1,452        1,195   

Provision for income taxes

     351        275   
                

Net Earnings from Continuing Operations

     1,101        920   
                

Discontinued Operations:

    

Earnings, net of taxes

            1   

Gain on disposal, net of taxes

              
                

Net Earnings from Discontinued Operations

            1   
                

Net Earnings

     1,101        921   
                

Net Earnings Attributable to Noncontrolling Interest

     358        283   
                

Net Earnings Attributable to Bristol-Myers Squibb Company

   $ 743      $ 638   
                

Amounts Attributable to Bristol-Myers Squibb Company:

    

Net Earnings from Continuing Operations

   $ 743      $ 649   

Net Loss from Discontinued Operations

            (11
                

Net Earnings Attributable to Bristol-Myers Squibb Company

   $ 743      $ 638   
                

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

    

Basic

   $ 0.43      $ 0.33   

Diluted

   $ 0.43      $ 0.33   

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

    

Basic

   $ 0.43      $ 0.32   

Diluted

   $ 0.43      $ 0.32   

Dividends declared per common share

   $ 0.32      $ 0.31   

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

 

3


Table of Contents

BRISTOL-MYERS SQUIBB COMPANY

CONSOLIDATED STATEMENTS OF

COMPREHENSIVE INCOME AND RETAINED EARNINGS

Dollars in Millions

(UNAUDITED)

 

     Three Months Ended March 31,  
     2010     2009  

COMPREHENSIVE INCOME

    

Net Earnings

   $ 1,101      $ 921   

Other Comprehensive Income/(Loss):

    

Foreign currency translation

     (34     (75

Foreign currency translation on hedge of a net investment

     79        33   

Derivatives qualifying as cash flow hedges, net of taxes of $(13) in 2010 and $(17) in 2009

     29        34   

Derivatives qualifying as cash flow hedges reclassified to net earnings, net of taxes of $(5) in 2010 and $7 in 2009

     10        (20

Pension and postretirement benefits, net of taxes of $(60) in 2009

            110   

Pension and postretirement benefits reclassified to net earnings, net of taxes of $(12) in 2010 and $(17) in 2009

     17        30   

Available for sale securities, net of taxes of $(1) in 2010 and 2009

     15        2   
                

Total Other Comprehensive Income/(Loss)

     116        114   
                

Comprehensive Income

     1,217        1,035   
                

Comprehensive Income Attributable to Noncontrolling Interest

     358        286   
                

Comprehensive Income Attributable to Bristol-Myers Squibb Company

   $ 859      $ 749   
                

RETAINED EARNINGS

    

Retained Earnings at January 1

   $ 30,760      $ 22,549   

Net Earnings Attributable to Bristol-Myers Squibb Company

     743        638   

Cash dividends declared

     (554     (616
                

Retained Earnings at March 31

   $ 30,949      $ 22,571   
                

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

 

4


Table of Contents

BRISTOL-MYERS SQUIBB COMPANY

CONSOLIDATED BALANCE SHEETS

Dollars in Millions, Except Share and Per Share Data

(UNAUDITED)

 

     March 31,
2010
    December 31,
2009
 

ASSETS

    

Current Assets:

    

Cash and cash equivalents

   $ 5,135      $ 7,683   

Marketable securities

     1,641        831   

Receivables

     3,459        3,164   

Inventories

     1,284        1,413   

Deferred income taxes

     745        611   

Prepaid expenses

     268        256   
                

Total Current Assets

     12,532        13,958   
                

Property, plant and equipment

     4,822        5,055   

Goodwill

     5,218        5,218   

Other intangible assets, net

     2,813        2,865   

Deferred income taxes

     1,395        1,636   

Marketable securities

     2,997        1,369   

Other assets

     976        907   
                

Total Assets

   $ 30,753      $ 31,008   
                

LIABILITIES

    

Current Liabilities:

    

Short-term borrowings

   $ 208      $ 231   

Accounts payable

     1,752        1,711   

Accrued expenses

     2,477        2,785   

Deferred income

     265        237   

Accrued rebates and returns

     660        622   

U.S. and foreign income taxes payable

     101        175   

Dividends payable

     554        552   
                

Total Current Liabilities

     6,017        6,313   
                

Pension, postretirement and postemployment liabilities

     1,300        1,658   

Deferred income

     961        949   

U.S. and foreign income taxes payable

     745        751   

Other liabilities

     416        422   

Long-term debt

     6,081        6,130   
                

Total Liabilities

     15,520        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 5,402 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

     3,676        3,768   

Accumulated other comprehensive loss

     (2,425     (2,541

Retained earnings

     30,949        30,760   

Less cost of treasury stock — 485 million common shares in 2010 and 491 million in 2009

     (17,171     (17,364
                

Total Bristol-Myers Squibb Company Shareholders’ Equity

     15,249        14,843   

Noncontrolling interest

     (16     (58
                

Total Equity

     15,233        14,785   
                

Total Liabilities and Equity

   $ 30,753      $ 31,008   
                

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

 

5


Table of Contents

BRISTOL-MYERS SQUIBB COMPANY

CONSOLIDATED STATEMENTS OF CASH FLOWS

Dollars in Millions

(UNAUDITED)

 

     Three Months Ended March 31,  
     2010     2009  

Cash Flows From Operating Activities:

    

Net earnings

   $ 1,101      $ 921   

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

    

Net earnings attributable to noncontrolling interest

     (358     (283

Depreciation

     122        110   

Amortization

     65        57   

Impairment charge

     200          

Deferred income taxes

     90        27   

Stock-based compensation

     47        43   

Other gains

     (10     (44

Changes in operating assets and liabilities:

    

Receivables

     (309     81   

Inventories

     25        (18

Deferred income

     35        26   

Accounts payable

     119        206   

U.S. and foreign income taxes payable

     (106     71   

Changes in other operating assets and liabilities

     (557     (745
                

Net Cash Provided by Operating Activities

     464        452   
                

Cash Flows From Investing Activities:

    

Proceeds from sale of marketable securities

     453        80   

Purchases of marketable securities

     (2,880     (870

Additions to property, plant and equipment and capitalized software

     (129     (201

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

     37        65   
                

Net Cash Used in Investing Activities

     (2,519     (926
                

Cash Flows From Financing Activities:

    

Short-term debt (repayments)/borrowings

     (17     2   

Interest rate swap termination

            187   

Dividends paid

     (551     (616

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

     82          

Proceeds from Mead Johnson initial public offering

            782   
                

Net Cash (Used in)/Provided by Financing Activities

     (486     355   
                

Effect of Exchange Rates on Cash and Cash Equivalents

     (7     (25
                

Decrease in Cash and Cash Equivalents

     (2,548     (144

Cash and Cash Equivalents at Beginning of Period

     7,683        7,976   
                

Cash and Cash Equivalents at End of Period

   $ 5,135      $ 7,832   
                

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

 

6


Table of Contents

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 March 31, 2010 and December 31, 2009, and the results of operations and cash flows for the three months ended March 31, 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 months ended March 31, 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.

The annual goodwill impairment test was completed in the first quarter. The BioPharmaceuticals segment includes four separate reporting units based on geography which were aggregated for impairment testing purposes. Based upon results of the impairment test, the fair value of goodwill was substantially in excess of the related carrying value.

 

7


Table of Contents

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 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 March 31,
Dollars in Millions    2010    2009

Territory covering the Americas and Australia:

     

Net sales

   $ 1,878    $ 1,605

Discovery royalty expense

     334      277

Noncontrolling interest – pre-tax

     520      391

Profit distributions to sanofi

     486      422

Territory covering Europe and Asia:

     

Equity in net income of affiliates

     100      147

Profit distributions to the Company

     69      127

Other:

     

Net sales comarketing countries and other

     102      132

Other income – irbesartan license fee

     8      8

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

     22      11
     March 31,
2010
   December 31,
2009

Investment in affiliates – territory covering Europe and Asia

     41      10

Deferred income – irbesartan license fee

     83      91

 

8


Table of Contents

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 March 31,
Dollars in Millions    2010    2009

Net sales

   $ 548    $ 755

Gross profit

     244      379

Net income

     194      289

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; advertising and product promotion; and research and development.

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

 

     Three Months Ended March 31,
Dollars in Millions    2010     2009

ABILIFY* net sales, including amortization of extension payment of $(16) in 2010

   $ 617      $ 589

Oncology Products collaboration fees

     30       

Otsuka’s reimbursement – operating expense

     (25    

Amortization expense – milestone payments

     2        2
     March 31,
2010
    December 31,
2009

Intangible assets:

    

Extension payment

     335        351

Milestone payments

     15        17

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.

 

9


Table of Contents

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 March 31,
Dollars in Millions    2010    2009

Net sales

   $ 166    $ 164

Distribution fees

     65      67

Amortization expense – milestone payments

     10      9

Other income – Japan commercialization fee

     8      5
     March 31,
2010
   December 31,
2009

Intangible asset – milestone payments

     313      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 March 31,  
Dollars in Millions    2010     2009  

Net sales

   $ 250      $ 182   

Equity in net loss of affiliates

     (3     (2

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 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 will jointly develop the clinical and marketing strategy 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.

 

10


Table of Contents

Since the third quarter of 2009, the Company and AstraZeneca launched ONGLYZA in 17 countries including the U.S., Germany, the UK, Canada and Mexico.

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

 

     Three Months Ended March 31,
Dollars in Millions    2010    2009

Net sales

   $ 10    $

Amortization income – milestone payments

     6      3
     March 31,
2010
   December 31,
2009

Deferred income – milestone payments

     312      268

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 four regional organizations that serve the United States; Europe; Middle East, Africa and Other Western Hemisphere countries; and Emerging Markets and Pacific. 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 March 31,
Dollars in Millions    2010    2009

PLAVIX*

   $ 1,666    $ 1,435

AVAPRO*/AVALIDE*

     314      302

REYATAZ

     373      322

SUSTIVA Franchise (total revenue)

     335      292

BARACLUDE

     216      152

ERBITUX*

     166      164

SPRYCEL

     131      88

IXEMPRA

     29      24

ABILIFY*

     617      589

ORENCIA

     169      124

ONGLYZA

     10     

Other

     781      830
             

Net sales

   $ 4,807    $ 4,322
             

 

11


Table of Contents

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 March 31,  
Dollars in Millions    2010     2009  

BioPharmaceuticals segment income

   $ 1,233      $ 1,070   

Reconciling items:

    

Downsizing and streamlining of worldwide operations

     (11     (15

Impairment of manufacturing operations

     (200       

Accelerated depreciation, asset impairment and other shutdown costs

     (31     (30

Process standardization implementation costs

     (13     (20

Gain on sale of product lines, businesses and assets

            44   

Litigation charges

            (104

Upfront licensing and milestone payments

     (55     (145

Product liability

            (3

Noncontrolling interest

     529        398   
                

Earnings from continuing operations before income taxes

   $ 1,452      $ 1,195   
                

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. The Company is on target to create $2.5 billion in annual productivity cost savings and cost avoidance by 2012 of which approximately 90% is expected to be realized by the end of 2010. Subsequent 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 March 31,  
Dollars in Millions    2010    2009  

Provision for restructuring, net

   $ 11    $ 19   

Impairment of manufacturing operations

     200        

Accelerated depreciation, asset impairment and other shutdown costs

     31      26   

Process standardization implementation costs

     13      20   
               

Total cost

     255      65   

Gain on sale of product lines, businesses and assets

          (44
               

Net charges

   $ 255    $ 21   
               

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 and 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 223 and 215 for the three months ended March 31, 2010 and 2009, respectively.

 

12


Table of Contents

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

 

     Three Months Ended March 31, 2010     Three Months Ended March 31, 2009  
Dollars in Millions    Termination
Liability
    Other Exit
Costs
Liability
    Total     Termination
Liability
    Other Exit
Costs
Liability
    Total  

Liability at January 1

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

Charges

     19        1        20        15        6        21   

Changes in estimates

     (9            (9     (2            (2
                                                

Provision for restructuring, net

     10        1        11        13        6        19   

Charges in discontinued operations

                          8               8   

Foreign currency translation

     (3            (3                     

Spending

     (29     (1     (30     (41     (3     (44
                                                

Liability at March 31

   $ 135      $ 16      $ 151      $ 168      $ 24      $ 192   
                                                

In connection with the continued optimization of the manufacturing network, a definitive agreement was entered into on March 26, 2010 for the sale of manufacturing operations in Latina, Italy. The related assets met the held for sale criteria resulting in a $200 million impairment charge in the first quarter of 2010 attributed to the write-down of the respective assets to fair value less cost of sale. The impairment charge was included in other (income)/expense and included $124 million related to the facility and $76 million for inventory and spare parts. The remaining carrying value of the related assets is not significant and therefore not separately disclosed in the consolidated interim financial statements. The transaction is expected to be completed in the second quarter of 2010 resulting in additional charges of approximately $35 million.

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 in the first quarter of 2009.

 

Dollars in Millions    Three Months
Ended March 31,
2009
 

Net sales

   $ 693   
        

Earnings before income taxes

   $ 189   

Provision for income taxes(1)

     188   
        

Net earnings from discontinued operations

     1   

Less net earnings from discontinued operations attributable to noncontrolling interest

     12   
        

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

   $ (11
        

 

(1) Provision for income taxes include $130 million 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.

 

13


Table of Contents

Note 6. EARNINGS PER SHARE

 

     Three Months Ended March 31,  
Amounts in Millions, Except Per Share Data    2010     2009  

EPS Numerator – Basic:

    

Income from Continuing Operations Attributable to BMS

   $ 743      $ 649   

Earnings attributable to unvested restricted shares

     (3     (4
                

Income from Continuing Operations Attributable to BMS common shareholders’

     740        645   

Net Loss from Discontinued Operations Attributable to BMS(1)

            (11
                

EPS Numerator – Basic

   $ 740      $ 634   
                

EPS Denominator – Basic:

    

Average Common Shares Outstanding

     1,715        1,978   
                

EPS – Basic:

    

Continuing Operations

   $ 0.43      $ 0.33   

Discontinued Operations

            (0.01
                

Net Earnings

   $ 0.43      $ 0.32   
                

EPS Numerator – Diluted:

    

Income from Continuing Operations Attributable to BMS

   $ 743      $ 649   

Earnings attributable to unvested restricted shares

     (3     (4
                

Income from Continuing Operations Attributable to BMS common shareholders’

     740        645   

Net Loss from Discontinued Operations Attributable to BMS(1)

            (11
                

EPS Numerator – Diluted

   $ 740      $ 634   
                

EPS Denominator – Diluted:

    

Average Common Shares Outstanding

     1,715        1,978   

Contingently convertible debt common stock equivalents

     1        1   

Incremental shares attributable to share-based compensation plans

     9        2   
                

Average Common Shares Outstanding and Common Share Equivalents

     1,725        1,981   
                

EPS – Diluted:

    

Continuing Operations

   $ 0.43      $ 0.33   

Discontinued Operations

            (0.01
                

Net Earnings

   $ 0.43      $ 0.32   
                

(1) Net Loss of Discontinued Operations for EPS Calculation:

    

      Net Loss from Discontinued Operations Attributable to BMS

   $      $ (11

      Earnings attributable to unvested restricted shares

              
                

      Net Loss from Discontinued Operations Attributable to BMS for EPS Calculation

   $      $ (11
                

Anti-dilutive weighted-average equivalent shares:

    

Stock incentive plans

     70        123   
                

Total anti-dilutive shares

     70        123   
                

 

14


Table of Contents

Note 7. INCOME TAXES

The effective income tax rate on earnings from continuing operations before income taxes was 24.2% for the three months ended March 31, 2010 compared to 23.0% for the three months ended March 31, 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 increase in the effective income tax rate was due to:

 

   

An unfavorable impact on the current year rate 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 health care payments to the extent of tax-free Medicare Part D subsidies that are received. The change in deductibility is effective January 1, 2013.

 

   

A favorable impact on the prior year rate from the research and development tax credit and the controlled foreign corporation look-through credit, both of which expired on December 31, 2009 and were not extended as of March 31, 2010.

Partially offset by:

 

   

A favorable earnings mix due to reduced international PLAVIX* net sales in high tax jurisdictions.

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 March 31, 2010 will decrease in the range of approximately $115 million to $145 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.

 

15


Table of Contents

Note 8. FAIR VALUE MEASUREMENT

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

 

     March 31, 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

   $ 649    $    $    $ 649    $    $    $    $

U.S. Government Agency Securities

     600                600      225                225

Equity Securities

     6                6      11                11

Prime Money Market Funds

          3,479           3,479           5,807           5,807

Corporate Debt Securities

          1,591           1,591           837           837

Commercial Paper

          958           958           518           518

FDIC Insured Debt Securities

          355           355           252           252

U.S. Treasury Money Market Funds

          4           4           218           218

U.S. Government Agency Money Market Funds

                              24           24

Floating Rate Securities (FRS)

               91      91                91      91

Auction Rate Securities (ARS)

               90      90                88      88
                                                       

Total available for sale assets

     1,255      6,387      181      7,823      236      7,656      179      8,071
                                                       

Derivatives:

                       

Interest Rate Swap Derivatives

          231           231           165           165

Foreign Currency Forward Derivatives

          63           63           21           21
                                                       

Total derivative assets

          294           294           186           186
                                                       

Total assets at fair value

   $ 1,255    $ 6,681    $ 181    $ 8,117    $ 236    $ 7,842    $ 179    $ 8,257
                                                       

Derivatives:

                       

Foreign Currency Forward Derivatives

   $    $ 20    $    $ 20    $    $ 31    $    $ 31

Natural Gas Contracts

          3           3           1           1

Interest Rate Swap Derivatives

                              5           5
                                                       

Total derivative liabilities

          23           23           37           37
                                                       

Total liabilities at fair value

   $    $ 23    $    $ 23    $    $ 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.

 

16


Table of Contents
   

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 during 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 during 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.

 

17


Table of Contents

Note 9. CASH, CASH EQUIVALENTS AND MARKETABLE SECURITIES

Cash and cash equivalents were $5,135 million at March 31, 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:

 

     March 31, 2010     December 31, 2009  
Dollars in Millions    Cost    Fair
Value
   Carrying
Value
   Unrealized
Gain/(Loss) in
Accumulated
OCI
    Cost    Fair
Value
   Carrying
Value
   Unrealized
Gain/(Loss) in
Accumulated
OCI
 

Current marketable securities:

                      

Certificates of deposit

   $ 828    $ 828    $ 828    $      $ 501    $ 501    $ 501    $   

Commercial Paper

     433      433      433             205      205      205        

U.S. Treasury Bills

     250      250      250                              

Corporate debt securities

     80      80      80                              

FDIC insured debt securities

     50      50      50                              

U.S. government agency securities

                           125      125      125        
                                                          

Total current

   $ 1,641    $ 1,641    $ 1,641    $      $ 831    $ 831    $ 831    $   
                                                          

Non-current marketable securities:

                      

Corporate debt securities

   $ 1,508    $ 1,511    $ 1,511    $ 9      $ 836    $ 837    $ 837    $ 3   

U.S. government agency securities

     600      600      600             100      100      100        

U.S. Treasury Bills

     399      399      399                              

FDIC insured debt securities

     304      305      305      1        252      252      252        

Auction rate securities

     114      90      90      10        114      88      88      8   

Floating rate securities(1)

     105      91      91      (15     113      91      91      (22

Other

     1      1      1             1      1      1        
                                                          

Total non-current

   $ 3,031    $ 2,997    $ 2,997    $ 5      $ 1,416    $ 1,369    $ 1,369    $ (11
                                                          

Other assets:

                      

Equity securities

   $ 6    $ 6    $ 6    $      $ 11    $ 11    $ 11    $   
                                                          

 

(1) All FRS have been in an unrealized loss position for 12 months or more at March 31, 2010.

The contractual maturities of non-current “available for sale” debt securities at March 31, 2010 were as follows:

 

Dollars in Millions    1 to 5
Years
   Over 10
Years
   Total

Available for sale:

        

Corporate debt securities

   $ 1,511    $    $ 1,511

U.S. government agency securities

     600           600

U.S. Treasury Bills

     399           399

FDIC insured debt securities

     305           305

Floating rate securities

     91           91

Auction rate securities

          90      90

Other

     1           1
                    

Total available for sale

   $ 2,907    $ 90    $ 2,997
                    

 

18


Table of Contents

Note 10. RECEIVABLES

Receivables include:

 

Dollars in Millions    March 31,
2010
   December 31,
2009

Trade receivables

   $ 2,060    $ 2,000

Less allowances

     99      103
             

Net trade receivables

     1,961      1,897

Alliance partners receivables

     1,052      870

Income tax refund claims

     129      103

Miscellaneous receivables

     317      294
             

Receivables

   $ 3,459    $ 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 $756 million and $730 million at March 31, 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 $111 million and $46 million for the three months ended March 31, 2010 and 2009, respectively. In the aggregate, receivables due from three pharmaceutical wholesalers in the U.S. represented 47% of total trade receivables at March 31, 2010 and December 31, 2009.

Note 11. INVENTORIES

Inventories include:

 

Dollars in Millions    March 31,
2010
   December 31,
2009

Finished goods

   $ 430    $ 580

Work in process

     641      630

Raw and packaging materials

     213      203
             

Inventories

   $ 1,284    $ 1,413
             

Inventories expected to remain on-hand beyond one year were $234 million and $249 million at March 31, 2010 and December 31, 2009, respectively, and were included in non-current other assets. In addition, $108 million of these inventories (plus $77 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.

These amounts include capitalized costs related to production of products for programs in Phase III development subject to final U.S. Food and Drug Administration approval of $52 million and $49 million at March 31, 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    March 31,
2010
   December 31,
2009

Land

   $ 140    $ 142

Buildings

     4,277      4,350

Machinery, equipment and fixtures

     3,170      3,563

Construction in progress

     787      840
             

Gross property, plant and equipment

     8,374      8,895

Less accumulated depreciation

     3,552      3,840
             

Property, plant and equipment

   $ 4,822    $ 5,055
             

 

19


Table of Contents

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     56        (38
                           

Balance at March 31, 2009

   2,205    224      $ (10,510   $ 3,661   
                           

Balance at January 1, 2010

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

Employee stock compensation plans

   —      (6     193        (92
                           

Balance at March 31, 2010

   2,205    485      $ (17,171   $ 3,676   
                           

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)

     (42     14        140        2        114   
                                        

Balance at March 31, 2009

   $ (466   $ 28      $ (2,118   $ (49   $ (2,605
                                        

Balance at January 1, 2010

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

Other comprehensive income/(loss)

     45        39        17        15        116   
                                        

Balance at March 31, 2010

   $ (298   $ 9      $ (2,141   $ 5      $ (2,425
                                        

The reconciliation of noncontrolling interest was as follows:

 

Dollars in Millions    2010     2009  

Balance at January 1

   $ (58   $ (33

Mead Johnson initial public offering

     —          (160

Net earnings attributable to noncontrolling interest

     528        408   

Other comprehensive income attributable to noncontrolling interest

     —          3   

Distributions

     (486     (426
                

Balance at March 31

   $ (16   $ (208
                

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 $171 million and $127 million for three months ended March 31, 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 $12 million in the first quarter of 2009.

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

 

20


Table of Contents

Note 14. PENSION, POSTRETIREMENT AND POSTEMPLOYMENT LIABILITIES

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

 

     Three Months Ended March 31,  
     Pension Benefits     Other Benefits  
Dollars in Millions    2010     2009     2010     2009  

Service cost — benefits earned during the period

   $ 11      $ 59      $ 2      $ 1   

Interest cost on projected benefit obligation

     87        104        7        9   

Expected return on plan assets

     (113     (126     (6     (5

Amortization of prior service cost/(benefit)

            3        (1     (1

Amortization of net actuarial loss

     24        42        3        3   
                                

Net periodic benefit cost

     9        82        5        7   

Curtailments and special termination benefits

     3                        
                                

Total net periodic benefit cost

   $ 12      $ 82      $ 5      $ 7   
                                

Continuing operations

   $ 12      $ 79      $ 5      $ 6   

Discontinued operations

            3               1   
                                

Total net periodic benefit cost

   $ 12      $ 82      $ 5      $ 7   
                                

Contributions to the U.S. pension plans are expected to approximate $330 million during 2010, of which $305 million was contributed in the three months ended March 31, 2010. Contributions to the international plans are expected to range from $85 million to $100 million in 2010, of which $20 million was contributed in the three months ended March 31, 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 $51 million and $13 million for the three months ended March 31, 2010 and 2009, respectively.

Note 15. EMPLOYEE STOCK BENEFIT PLANS

Stock-based compensation expense was as follows:

 

     Three Months Ended March 31,
Dollars in Millions    2010    2009

Stock options

   $ 13    $ 18

Restricted stock

     23      16

Long-term performance awards

     11      9
             

Total stock-based compensation expense

   $ 47    $ 43
             

Continuing operations

   $ 47    $ 40

Discontinued operations

          3
             

Total stock-based compensation expense

   $ 47    $ 43
             

Deferred tax benefit related to stock-based compensation expense

   $ 15    $ 13
             

In the first quarter of 2010, 3.0 million restricted stock units, 1.3 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 first quarter of 2010 was $24.62, $24.67 and $23.56, respectively.

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.

 

21


Table of Contents

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 March 31, 2010 were as follows:

 

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

Unrecognized compensation cost

   $ 71    $ 235    $ 49

Expected weighted-average period of compensation cost to be recognized

     2.2 years      2.6 years      1.6 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 months ended March 31, 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 $2 million during the three months ended March 31, 2010 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.

 

22


Table of Contents

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

 

     Three Months Ended March 31,  
     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

     44        53        (2     (2                   42        51   

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

     15        (27                                 15        (27

Change in deferred taxes

     (19     (11     1        1                      (18     (10
                                                                

Net carrying amount at March 31

   $ 29      $ 50      $ (2   $ (3   $ (18   $ (19   $ 9      $ 28   
                                                                

Hedge of Net Investment

Non-U.S. dollar borrowings, primarily the €500 Million Notes due 2016 and €500 Million Notes due 2021, ($1.3 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.

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

 

     Three Months Ended March 31,  
     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

     112        38   

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

     (33     (5
                

Net carrying amount at March 31

   $ (90   $ (98
                

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 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 March 31,  
Dollars in Millions    2010     2009  

Recognized in interest expense

   $ (39   $ (24

Amortization of basis adjustment from swap terminations recognized in interest expense

     (7     (5
                

Total

   $ (46   $ (29
                

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    March 31,
2010
    December 31,
2009
 

Principal value

   $ 5,509      $ 5,622   

Adjustments to Principal Value:

    

Fair value of interest rate swaps

     231        160   

Unamortized basis adjustment from swap terminations

     370        377   

Unamortized bond discounts

     (29     (29
                

Total

   $ 6,081      $ 6,130   
                

 

23


Table of Contents

Total interest expense amounted to $33 million and $52 million for the three months ended March 31, 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 not significant for the three months ended March 31, 2010 and 2009.

The following table summarizes the fair value of outstanding derivatives:

 

          March 31, 2010    December 31, 2009         March 31, 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    $ 4,098    $ 231    $ 3,134    $ 165    Accrued expenses    $    $      $ 597    $ (5

Foreign currency forward contracts

   Other assets      1,056      63      780      21    Accrued expenses      272      (17     731      (31

Hedge of net investments

                          Long-term debt      938      (938     1,256      (1,256

Natural gas contracts

                          Accrued expenses      *      (3     *      (1
                                                                

Subtotal

        5,154      294      3,914      186         1,210      (958     2,584      (1,293
                                                                

Derivatives not designated as hedging instruments:

                            

Foreign currency forward contracts

   Other assets                        Accrued expenses      155      (3            
                                                                

Total Derivatives

      $ 5,154    $ 294    $ 3,914    $ 186       $ 1,365    $ (961   $ 2,584    $ (1,293
                                                                

 

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

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.”

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 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.

 

24


Table of Contents

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. It is not reasonably possible to estimate the impact of these lawsuits on the Company. However, loss of market exclusivity of PLAVIX* and sustained generic competition in the U.S. would be material to the Company’s net sales of PLAVIX*, results of operations and cash flows, and could be material to the Company’s financial condition and liquidity. The Company and its product partner, sanofi, (the Companies) intend to vigorously pursue enforcement of their patent rights in PLAVIX*.

PLAVIX* Litigation – 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 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.

 

25


Table of Contents

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. In March 2010, the PTO issued a notice of intent to issue 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. In April 2010, Apotex filed a petition requesting the PTO delay the issuance of the Reexamination Certificate and filed a second request for ex parte reexamination of the ‘265 Patent.

It is not possible at this time reasonably to assess the outcome of the reexamination of the ‘265 Patent by the PTO, or the other PLAVIX* patent litigations or the timing of any renewed generic competition for PLAVIX* from Apotex or additional generic competition for PLAVIX* from other third-party generic pharmaceutical companies. 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 the 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.

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.

 

26


Table of Contents

PLAVIX* – Canada (Cobalt)

As previously disclosed, sanofi and Sanofi-Synthelabo Canada instituted a prohibition action in the Federal Court of Canada against Cobalt and the Minister of Health in response to a NOA from Cobalt directed against the ‘777 Patent and Canadian Patent No. 2,334,870 (the ‘870 Patent). Cobalt’s NOA indicated that it has filed an ANDS for clopidogrel bisulfate tablets and that it sought a Notice of Compliance for that ANDS before the expiration of the ‘777 and ‘870 Patents. Cobalt alleged that the ‘777 Patent was invalid and that the ‘870 Patent was invalid and not infringed. Following the Supreme Court of Canada decision in Apotex Inc. v. Sanofi-Synthelabo Canada Inc., 2008 SCC 61, dismissing Apotex’s appeal and upholding the validity of the ’777 Patent as described above, the Federal Court of Canada granted sanofi’s application for an order of prohibition against the Minister of Health and Cobalt precluding approval of Cobalt’s ANDS until the ’777 Patent expires in 2012. Sanofi did not pursue the prohibition action with respect to the ’870 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. The 30-month stay under the Hatch-Waxman Act expires in 2010. Accordingly, final approval by the FDA, which could possibly occur as early as May 2010, 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 has amended its aNDA and is now 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

In October 2009, Teva filed an aNDA to manufacture and market a generic version of REYATAZ. 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 triggered an automatic 30-month stay of approval of Teva’s aNDA. In February and March 2010, the Company received notices that Teva amended its aNDA seeking approval of generic versions of additional capsule dosage forms of REYATAZ. In March and April 2010, the Company and Novartis filed patent infringement lawsuits in the Delaware District Court against Teva for infringement of the two Orange Book listed patents for REYATAZ. The patent infringement action filed in March 2010 has been consolidated with the lawsuit filed by the Company and Novartis in December 2009.

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

 

27


Table of Contents

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 November 2008, the California Supreme Court granted the plaintiffs’ petition for review. 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.

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.

 

28


Table of Contents

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 December 31, 2009, 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 December 31, 2009, 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 $67 million at March 31, 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, which are not currently expected).

Passaic River (NJ) Remediation and Natural Resource Damages Claim

As previously disclosed, in September 2003, the New Jersey Department of Environmental Protection (NJDEP) issued an administrative enforcement Directive requiring the Company and other companies to perform an assessment of natural resource damages and to implement unspecified interim remedial measures to restore conditions in the Lower Passaic River (LPR). The Directive named the Company due to releases from a nearby bulk chemical reprocessing facility operated by a predecessor of McKesson Corp. Subsequently, the EPA issued notice letters to numerous parties, but not the Company, requesting performance of a Remedial Investigation/Feasibility Study (RI/FS) of conditions in the LPR. Under a consent agreement with EPA in 2004, a group of

 

29


Table of Contents

these other parties committed to pay roughly half of the $20 million estimated for the RI/FS by EPA at that time. The EPA thereafter substantially increased its estimate of the scope and cost of the RI/FS and, as a result, the EPA agreed to allow the group to perform most of the remaining RI/FS tasks. By the group’s estimate, total costs to complete the RI/FS and related tasks now exceed $50 million. The group has negotiated an amended consent agreement with the EPA to conduct the remaining RI/FS work, which became effective in May 2007. As part of that process, the Company and McKesson have bought out of remaining RI/FS tasks.

Separately, the Company has agreed to pay approximately $110 thousand towards RI/FS tasks previously funded by McKesson and work cooperatively going forward, subject to later reallocation. In mid-2007 the EPA announced plans to seek implementation of “early-action” remedial measures to address the most highly-contaminated portions of the LPR while the RI/FS is being completed. Also, a sub-group of the cooperating private parties have commenced discussions with federal natural resource trustee agencies concerning an agreement to assess natural resource damages in the LPR. The remaining parties, including the Company and McKesson, have declined to discuss the proposal at least until the scope and cost of the “early-actions” sought by the EPA are more thoroughly understood.

In 2006, NJDEP filed suit against a set of parties tied to a facility suspected of significant discharges to the LPR to recover costs and unspecified damages. That case languished until recently, when the defendants filed third-party claims against most members of the cooperating group and numerous other parties. Those claims also seek contribution to the costs of the various actions the defendants are funding on other response actions related to the LPR. The defendants did not name the Company in those claims. The other group members are actively discussing strategy and coordinated actions; for now, the Company is not participating in those efforts. While the group currently does not plan to add the Company to the litigation, it remains to be seen whether any of the other new defendants will do so. The extent of any liability the Company may face for these and related risks cannot yet be determined.

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 adjacent to the Company’s New Brunswick facility. The complaints allege various personal injuries and property damage resulting from 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.

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 initial 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. The parties expect a resolution later in 2010. In addition, in September 2009, the Township and BOE filed suits against several other parties alleged to have contributed waste materials to the site. Although per the mediation agreement the BOE and Township have agreed to forbear from asserting claims against the Company, it remains to be seen whether any of the defendants in these new suits will seek to implead the Company.

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.

 

30


Table of Contents

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. The proposed settlement has been filed with the NJ Superior Court and remains subject to approval by the court.

 

31


Table of Contents

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 the 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 months ended March 31, 2009 are now included in net earnings from discontinued operations. We continued to execute our string-of-pearls strategy in the first quarter of 2010 with the restructuring of our commercialization agreement with Eli Lilly and Company (Lilly) and our global agreement for the development and commercialization of AGN-209323 with Allergan, Inc. (Allergan).

Healthcare Reform

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 will 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 market 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.

During the first quarter of 2010, higher rebates to Medicaid and Medicaid managed care plans reduced our net sales by $49 million and pre-tax income by $42 million. 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 not until 2014 at the earliest.

During the first quarter of 2010, we also recognized a tax charge of $21 million due to the elimination of the tax deductibility of a portion of our retiree healthcare costs.

 

32


Table of Contents

Strategy

We have transformed our Company into a next-generation biopharmaceutical company with a focus on establishing a solid foundation for future growth, maximizing our operational leverage and maintaining our financial strength with a strong balance sheet.

We maintain a portfolio of key medicines focused on helping patients prevail over serious diseases. Our strategy is to optimize our established brands (e.g., PLAVIX*, ABILIFY*, AVAPRO*/AVALIDE*, REYATAZ); maximize our recently launched products (e.g., BARACLUDE, ORENCIA, SPRYCEL, ATRIPLA*, IXEMPRA, ONGLYZA) to offset future loss of patent exclusivity of established brands; and continue to advance our late-stage pipeline as a vehicle for future growth (e.g., ipilimumab, belatacept, dapagliflozin, apixaban, brivanib). 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 continue to execute our productivity transformation initiative (PTI) to enhance efficiency, effectiveness and competitiveness. This includes the continued optimization of our mature brands business and reduction of our global manufacturing facilities resulting in a more focused and efficient supply-chain model. We expect to meet our PTI targets and are implementing a culture of continuous improvement.

We focus on maintaining and improving our financial strength to support growth by reducing our working capital and capital expenditures through internal initiatives and capital resource allocations to continue our string-of-pearls strategy and enable strategic transactions, which could range from collaboration and license agreements to the acquisition of companies. In the first quarter of 2010, we entered into a collaboration agreement with Allergan in March 2010 and restructured our collaboration with Lilly in January 2010.

Financial Highlights

The following table is a summary of operating activity:

 

     Three Months Ended March 31,  
Dollars in Millions, except per share data    2010    2009  

Net Sales

   $ 4,807    $ 4,322   

BioPharmaceuticals Segment Income

     1,233      1,070   

Net Earnings from Continuing Operations Attributable to BMS

     743      649   

Net Loss from Discontinued Operations Attributable to BMS

          (11

Net Earnings Attributable to BMS

     743      638   

Diluted Earnings Per Share from Continuing Operations Attributable to BMS

     0.43      0.33   

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

     0.56      0.42   

Cash, Cash Equivalents and Marketable Securities

     9,773      9,104   

Net Sales

Net sales increased 11%, including a 3% favorable foreign exchange impact. U.S. net sales increased 11% to $3.1 billion. International net sales increased 11%, including an 8% favorable foreign exchange impact, to $1.7 billion.

 

   

Sales growth was led by continued increases in PLAVIX* (clopidogrel bisulfate) of 18% in the U.S. and 16% worldwide.

 

   

The virology portfolio continued to demonstrate worldwide strong sales growth, led by BARACLUDE (entecavir) of 42%, REYATAZ (atazanavir sulfate) of 16%, and the SUSTIVA (efavirenz) Franchise of 15%.

 

   

Worldwide growth of ORENCIA (abatacept) was 36% and SPRYCEL (dasatinib) was 49%.

 

   

Worldwide growth of ABILIFY* (aripiprazole) was 5% despite the reduction in our contractual share of revenues from 65% to 58% in the U.S.

 

   

ERBITUX* (cetuximab) net sales increased 1%.

 

   

ONGLYZA (saxagliptin) has been submitted to regulatory authorities in more than 55 countries, approved in 38 and launched in 17 countries. Net sales were $10 million worldwide.

 

   

Healthcare reform had a 1% negative effect on net sales in the first quarter of 2010.

 

33


Table of Contents

BioPharmaceuticals Segment Income

The increase in BioPharmaceuticals segment income is attributed to:

 

   

Increased net sales of certain key products noted above.

 

   

Reduced spending within advertising and product promotion on certain key products to coincide with the products life cycle.

Partially offset by:

 

   

Increased investments within our research and development pipeline, excluding the impact of upfront licensing and milestone payments.

 

   

Reduced equity in net income of affiliates due to decreases in international PLAVIX* net sales from generic competition.

Net Earnings from Continuing Operations Attributable to Bristol-Myers Squibb Company

The increase is attributed to:

 

   

Improved BioPharmaceuticals segment operating performance.

Partially offset by:

 

   

Unfavorable impact of specified items in 2010 — current quarter includes the impairment charge on a manufacturing operation in Latina, Italy.

 

   

Increase in effective tax rate — current quarter tax rate includes impact of write-down of deferred tax assets attributed to Medicare Part D subsidy which is no longer deductible for tax purposes beginning in 2013.

Net Earnings from Discontinued Operations Attributable to Bristol-Myers Squibb Company

In 2009, we completed the split-off of Mead Johnson. The results of the Mead Johnson business for the first quarter of 2009 are included in discontinued operations.

Diluted Earnings Per Share from Continuing Operations

Diluted earnings per share (EPS) from continuing operations increased 30% due to improved operating results driven by the activities discussed above as well as the reduction in the outstanding number of shares by 269 million from the Mead Johnson split-off described above.

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 33% after adjusting for specified items of $224 million and $180 million during the three months ended March 31, 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, Cash Equivalents and Marketable Securities

Cash flows from operating activities amounted to $464 million during the three months ended March 31, 2010. Primary nonoperating uses of cash, cash equivalents and marketable securities included dividend payments of $551 million and capital expenditures of $129 million.

Product and Pipeline Developments

PLAVIX*

 

   

In March 2010, the Company and sanofi-aventis (sanofi) announced revisions to the U.S. prescribing information for PLAVIX*, which include a boxed warning. The boxed warning concerns the diminished effectiveness of PLAVIX* in patients who have a genetic variation leading to reduced formation of the active metabolite. These patients, who are designated as poor metabolizers, represent, according to prescribing information, approximately 2% of whites, 4% of blacks and 14% of Chinese. The percentage of poor metabolizers is estimated to be approximately 3% of the population, based on published studies. These revisions are in addition to the updates to the PLAVIX* label reported in November 2009 with warnings about the use of PRILOSEC* (omeprazole) and certain other drugs that could interfere with PLAVIX* by reducing its effectiveness.

 

34


Table of Contents
   

In March 2010, the Company and sanofi announced the approval by the European Commission of the dual antiplatelet combination tablet DUOPLAVIN*/DUOCOVER* (clopidogrel 75 mg and acetylsalicylic acid 100mg or 75 mg), which is indicated for the prevention of atherothrombotic events in adult patients already taking both clopidogrel and acetylsalicylic acid (ASA).

ONGLYZA

 

   

In March 2010, the Company and AstraZeneca PLC (AstraZeneca) announced that the U.S. Food and Drug Administration (FDA) has accepted for review a New Drug Application (NDA) for an investigational fixed dose combination of ONGLYZA and metformin HCL extended-release tablets as a once-daily treatment for type 2 diabetes mellitus in adults. The NDA, which was submitted to the FDA in December 2009, is based on bioequivalence data and data from the ONGLYZA Phase III clinical trial program which included studies for the coadministration of ONGLYZA and immediate release metformin, as an adjunct to diet and exercise, in adult patients with type 2 diabetes inadequately controlled on metformin alone and in treatment-naive adult patients. The Prescription Drug User Fee Act (PDUFA) date—the date by which a decision from the U.S. Food and Drug Administration (FDA) is expected—for combination therapy is October 29, 2010.

 

   

In March 2010, the Company and AstraZeneca announced the commencement of the “Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes Mellitus” trial (SAVOR-TIMI 53), a multicenter, randomized, double-blind, placebo-controlled Phase IV study, to evaluate treatment with ONGLYZA in adult type 2 diabetes patients with cardiovascular risk factors. The five year study will follow approximately 12,000 patients with type 2 diabetes, who have either a history of previous cardiovascular events or multiple risk factors for vascular disease, and includes patients with renal impairment.

ORENCIA

 

   

In January 2010, the European Commission approved ORENCIA in combination with methotrexate for the treatment of moderate to severe active polyarticular juvenile idiopathic arthritis in pediatric patients six years of age and older who have had an insufficient response to other disease-modifying anti-rheumatic drugs, including at least one TNF inhibitor.

Apixaban

 

   

In March 2010, results from the ADVANCE-2 study were published in The Lancet. Results, which were presented in July, 2009, showed that apixaban, an oral anticoagulant, was statistically superior to 40 mg once daily enoxaparin in reducing the incidence of venous thromboembolism in patients undergoing elective total knee replacement surgery, according to ADVANCE-2 study results. The study results also showed numerically lower rates of major and clinically relevant non-major bleeding in patients treated with apixaban compared to those treated with enoxaparin. These latter results did not meet statistical significance.

 

   

In March 2010, the apixaban Marketing Authorization Application (MAA) for the prevention of venous thromboembolic (VTE) events in adult patients who have undergone elective hip or knee replacement was validated by the European Medicines Agency (EMA).

AGN-209323

 

   

In March 2010, the Company announced a global collaboration agreement with Allergan for the development and commercialization of AGN-209323, a Phase II-ready, orally administered small molecule in clinical development for neuropathic pain.

Belatacept

 

   

In March 2010, the FDA’s Cardiovascular and Renal Drugs Advisory Committee voted 13 to 5 to recommend approval of belatacept, a selective co-simulation blocker for the prophylaxis of acute rejection in de novo kidney transplant patients. The biologic license application for belatacept was accepted for filing and review by the FDA in September 2009 for an indication of prophylaxis of organ rejection and preservation of a functioning allograft in adult patients receiving renal transplants with use in combination with an interleukin-2 (IL-2) receptor antagonist, a mycophenolic acid (MPA), and corticosteroids. The FDA is not bound by the recommendations of its Advisory Committee, but takes its advice into consideration when reviewing new drug applications. The PDUFA date for belatacept is May 1, 2010.

 

   

In February 2010, the belatacept MAA for the treatment of prophylaxis of organ rejection in kidney transplant patients was validated by the EMA.

BMS-790052

 

   

In April 2010, week 12 data from a Phase IIa study of BMS-790052, an NS5A inhibitor under investigation for the treatment of Hepatitis C virus (HCV), were presented at the European Association for the Study of the Liver (EASL). The data show that once-daily dosing of the NS5A inhibitor plus peginterferon-alpha-2a and ribavirin produces high rates of extended rapid virologic response in treatment-naive HCV-genotype 1 subjects, compared to peginterferon-alpha-2a and ribavirin alone. The rate of adverse events was comparable across BMS-790052 dosing arms and placebo.

 

35


Table of Contents

Three Months Results of Operations

Our results of continuing operations exclude the results related to 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 March 31, 2009, see “—Discontinued Operations” below.

Our results of continuing operations were as follows:

 

     Three Months Ended March 31,  
Dollars in Millions    2010     2009     % Change  

Net Sales

   $ 4,807      $ 4,322      11

Earnings from Continuing Operations before Income Taxes

   $ 1,452      $ 1,195      22

% of net sales

     30.2     27.6  

Provision for Income Taxes

   $ 351      $ 275      28

Effective tax rate

     24.2     23.0  

Net Earnings from Continuing Operations

   $ 1,101      $ 920      20

% of net sales

     22.9     21.3  

Attributable to Noncontrolling Interest

   $ 358      $ 271      32

% of net sales

     7.4 %      6.3 %   

Attributable to Bristol-Myers Squibb Company

   $ 743      $ 649      14

% of net sales

     15.5 %      15.0 %   

Net Sales

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

 

     Three Months Ended March 31,     2010 vs. 2009  
     Net Sales     Analysis of % Change  
Dollars in Millions    2010    2009    Total
Change
    Volume     Price     Foreign
Exchange
 

U.S.

   $ 3,099    $ 2,784    11   5   6     

Non-U.S.

     1,708      1,538    11   3        8
                      

Total

   $ 4,807    $ 4,322    11   4   4   3
                      

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 75% of total growth in U.S. net sales.

International net sales increased 11%, including an 8% favorable foreign exchange impact, due to a weakening U.S. dollar against many foreign currencies when compared to the previous period. International net sales increased due to growth in various key products, including BARACLUDE, the HIV portfolio (which includes REYATAZ and the SUSTIVA Franchise), ABILIFY*, SPRYCEL, and ORENCIA, which more than offset decreases in PLAVIX* and mature brands. PLAVIX* international net sales were down 3%, including an 11% favorable foreign exchange impact. PLAVIX* international net sales decreased due to generic competition in comarketing countries. Our reported international net sales do not include copromotion sales reported by our alliance partner 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.

 

36


Table of Contents

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 March 31,  
Dollars in Millions    2010     2009  

Gross Sales

   $ 5,285      $ 4,739   

Gross-to-Net Sales Adjustments

    

Prime Vendor Charge-Backs

     (136     (116

Cash Discounts

     (66     (60

Managed Healthcare Rebates and Other Contract Discounts

     (115     (100

Medicaid Rebates

     (96     (63

Sales Returns

     1        (25

Other Adjustments

     (66     (53
                

Total Gross-to-Net Sales Adjustments

     (478     (417
                

Net Sales

   $ 4,807      $ 4,322   
                

Gross-to-net sales adjustments as a percentage of gross sales were 9.0% in 2010 and 8.8% in 2009. Goss-to-net sales adjustments are primarily a function of gross sales and are typically correlated with current sales trends, changes in sales mix and contractual and legislative discount rates.

The enactment of healthcare reform in March 2010 impacted the Medicaid rebates adjustment for the three months ended March 31, 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 for products including LYSODREN, PRAVACHOL, COUMADIN, 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

     137        66        115        100        16        67        501   

Provision related to sales made in prior periods

     (1                   (4     (17     (1     (23

Returns and payments

     (137     (65     (109     (54     (20     (50     (435

Impact of foreign currency translation

                                 (1     (4     (5
                                                        

Balance at March 31, 2010

   $ 41      $ 27      $ 205      $ 208      $ 147      $ 100      $ 728   
                                                        

 

37


Table of Contents

Net sales of key products represent 84% and 81% of total net sales in the first quarter of 2010 and 2009, respectively. The following table details U.S. and international net sales by key products, 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 for key products is provided below:

 

     Three Months Ended March 31,        
Dollars in Millions    2010    2009    % Change     % Change
Attributable to
Foreign Exchange
 

Cardiovascular

          

PLAVIX*

          

U.S.

   $ 1,531    $ 1,296    18     

Non-U.S.

     135      139    (3)   11

Total

     1,666      1,435    16   1

AVAPRO*/AVALIDE*

          

U.S.

     186      173    8     

Non-U.S.

     128      129    (1)   13

Total

     314      302    4   5

Virology

          

REYATAZ

          

U.S.

     186      176    6     

Non-U.S.

     187      146    28   9

Total

     373      322    16   4

SUSTIVA Franchise (total revenue)

          

U.S.

     214      190    13     

Non-U.S.

     121      102    19   8

Total

     335      292    15   3

BARACLUDE

          

U.S.

     42      36    17     

Non-U.S.

     174      116    50   9

Total

     216      152    42   7

Oncology

          

ERBITUX*

          

U.S.

     163      162    1     

Non-U.S.

     3      2    50   9

Total

     166      164    1     

SPRYCEL

          

U.S.

     38      30    27     

Non-U.S.

     93      58    60   14

Total

     131      88    49   9

IXEMPRA

          

U.S.

     25      22    14     

Non-U.S.

     4      2    100   3

Total

     29      24    21     

Neuroscience

          

ABILIFY*

          

U.S.

     470      481    (2)     

Non-U.S.

     147      108    36   10

Total

     617      589    5   2

Immunoscience

          

ORENCIA

          

U.S.

     126      99    27     

Non-U.S.

     43      25    72   14

Total

     169      124    36   3

Metabolics

          

ONGLYZA

          

U.S.

     6         N/A      N/A   

Non-U.S.

     4         N/A      N/A   

Total

     10         N/A      N/A   

 

38


Table of Contents

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 and increased demand. Estimated total U.S. prescription demand increased 2%.

 

   

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 increased primarily due to higher average net selling prices partially offset by a 14% decrease in estimated total U.S. prescription demand.

 

   

International net sales decreased primarily due to decreased prescription demand offset by higher average selling prices and favorable foreign exchange.

REYATAZ — a protease inhibitor for the treatment of HIV

 

   

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

 

   

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%.

 

   

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

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

 

   

Worldwide net sales increased primarily due to continued strong demand in both international and U.S. markets.

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 by us almost exclusively in the U.S., net sales remained flat primarily due to the continued impact of retrospective subset analyses of clinical trial results released in 2008. Under these analyses, a treatment benefit was not shown for ERBITUX* in patients whose tumors had certain types of genetic K-ras mutations.

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 increased primarily due to demand.

 

39


Table of Contents

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%, increased Medicaid rebates from healthcare reform and $16 million of amortization of the $400 million extension payment. The decrease was partially offset by increased overall demand and higher average net selling prices. Estimated total U.S. prescription demand increased 9%.

 

   

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

ORENCIA — a fusion protein indicated for adult patients with moderate to severe rheumatoid arthritis who have had an inadequate response to one or more currently available treatments, such as methotrexate or anti-tumor necrosis factor therapy

 

   

Worldwide net sales increased primarily due to increases in demand.

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

 

   

ONGLYZA has been submitted to regulatory authorities in more than 55 countries, approved in 38 and launched in 17 countries including the U.S., Germany, the UK, Canada and Mexico.

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.

 

40


Table of Contents

Estimated End-User Demand

The following table sets forth for each of our key products sold by the U.S. for the three months ended March 31, 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 March 31,              At March 31,
     Total U.S. Net Sales    % Change in U.S.
Net Sales
   % Change in U.S.
Total Prescriptions
   Months on
Hand
     2010    2009    2010    2009    2010    2009    2010    2009
Dollars in Millions                                        

PLAVIX*

   $ 1,531    $ 1,296    18%    14%    2%    4%    0.4    0.4

AVAPRO*/AVALIDE*

     186      173    8%    (1)%    (14)%    (9)%    0.4    0.4

REYATAZ

     186      176    6%    10%    7%    7%    0.4    0.5

SUSTIVA Franchise (a)

     214      190    13%    9%    10%    9%    0.4    0.5

BARACLUDE

     42      36    17%    24%    12%    19%    0.5    0.6

ERBITUX*(b)

     163      162    1%    (12)%    N/A    N/A    0.4    0.4

SPRYCEL

     38      30    27%    50%    7%    12%    0.7    0.7

IXEMPRA(b)

     25      22    14%    (12)%    N/A    N/A    0.5    0.6

ABILIFY*

     470      481    (2)%    38%    9%    31%    0.3    0.4

ORENCIA(b)

     126      99    27%    36%    N/A    N/A    0.4    0.4

ONGLYZA(c)

     6               N/A    N/A    0.5   

 

(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.

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 are obligated to disclose products with levels of inventory in excess of one month on hand or expected demand, subject to a de minimis exception. The following are international products that had estimated levels of inventory in the distribution channel in excess of one month on hand at December 31, 2009:

At December 31, 2009, VIDEX/VIDEX EC, an antiviral product, had approximately 1.3 months of inventory on hand internationally at direct customers compared to approximately 1.1 months of inventory on hand at September 30, 2009. The level of inventory on hand was primarily due to government purchasing patterns in Brazil and Mexico.

At December 31, 2009, FERVEX, a cold and flu product had approximately 3.9 months of inventory on hand internationally at direct customers compared to approximately 1.7 months of inventory on hand at September 30, 2009. The increased level of inventory on hand was primarily due to the ordering patterns of private pharmacists in France and the initial stocking of a new distributor in Russia.

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.

 

41


Table of Contents

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 March 31, 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.

Geographic Areas

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

 

     Three Months Ended March 31,
     Net Sales    % of Total Net Sales
Dollars in Millions    2010    2009    % Change    2010    2009

United States

   $ 3,099    $ 2,784    11%      64%      65%

Europe, Middle East and Africa

     1,023      953      7%      21%      22%

Other Western Hemisphere

     361      275    31%        8%        6%

Pacific

     324      310      5%        7%        7%
                          

Total

   $ 4,807    $ 4,322    11%    100%    100%
                          

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

Net sales in Europe, Middle East and Africa increased primarily due to a 6% favorable foreign exchange impact in addition to increased sales of ABILIFY*, the HIV portfolio, SPRYCEL, BARACLUDE and ORENCIA, partially offset by decreases in net sales of certain mature brands and increased generic competition for PLAVIX*.

Net sales in the Other Western Hemisphere countries increased primarily due to a 16% favorable foreign exchange impact in addition to increased sales of the HIV portfolio, SPRYCEL and ABILIFY*, partially offset by decreased net sales of certain mature brands.

Net sales in the Pacific region were impacted by an 8% 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.

No single country outside the U.S. contributed more than 10% of our total net sales during the quarters ended March 31, 2010 and 2009. The combined net sales in emerging markets, which includes Brazil, Russia, India, China and Turkey, approximated 4% during the quarters ended March 31, 2010 and 2009.

 

42


Table of Contents

Expenses

 

     Three Months Ended March 31,
     Expenses    % of Net Sales
Dollars in Millions    2010    2009    % Change    2010    2009

Cost of products sold

   $ 1,306    $ 1,165    12%    27.2%    27.0%

Marketing, selling and administrative

     900      901       18.7%    20.8%

Advertising and product promotion

     212      248    (15)%    4.4%    5.7%

Research and development

     910      908       18.9%    21.0%

Provision for restructuring

     11      19    (42)%    0.2%    0.4%

Litigation expense

          104    (100)%       2.4%

Equity in net income of affiliates

     (97)      (146)    (34)%    (2.0)%    (3.3)%

Other (income)/expense

     113      (72)    **    2.4%    (1.6)%
                          

Total Expenses

   $ 3,355    $ 3,127    7%    69.8%    72.4%
                          

 

** Change in excess of 200%.

Cost of products sold

Cost of products sold as a percentage of net sales was negatively impacted by an unfavorable foreign exchange impact, 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 related to the SPRYCEL and IXEMPRA Oncology collaboration beginning in 2010. These negative impacts were partially offset by favorable product mix, higher average selling prices, reduced manufacturing costs when compared to the prior period and realized manufacturing efficiencies from PTI initiatives.

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, which amounted to $30 million for the three months ended March 31, 2010, relating to the oncology collaboration for SPRYCEL and IXEMPRA. See “Item 1. Financial Statements—Note 2. Alliances and Collaborations” for further discussion.

Marketing, selling and administrative

Spending remained relatively flat as Otsuka’s reimbursement of certain ABILIFY*, SPRYCEL and IXEMPRA operating expenses, which began on January 1, 2010, and the reduction in our ABILIFY* sales force, as Otsuka established its own sales force for the promotion of the above products, offset increased spending for the ONGLYZA launch and other pipeline products and an unfavorable 3% foreign exchange impact. See “Item 1. Financial Statements—Note 2. Alliances and Collaborations” for further discussion.

Advertising and product promotion

The decrease is attributed to reduced spending on promotion of certain key products to coincide with the 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 and an unfavorable 2% foreign exchange impact.

Research and development

Spending remained relatively flat as increases to support our pipeline and recently acquired pearls and unfavorable foreign exchange were offset by decreased upfront licensing and milestone payments. Upfront licensing and milestone payments were $55 million during the first quarter of 2010 attributed to Allergan and PDL BioPharma Inc. and $145 million in the first quarter of 2009 attributed to ZymoGenetics and Nissan.

Provision for restructuring

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

Litigation expense

The 2009 expense was primarily due to the establishment of a $100 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 is 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.”

 

43


Table of Contents

Other (income)/expense

Other (income)/expense include:

 

     Three Months Ended March 31,  
Dollars in Millions    2010     2009  

Interest expense

   $ 33      $ 52   

Interest income

     (15     (13

Impairment of manufacturing operations

     200          

Foreign exchange transaction gains

     (16     (13

Gain on sale of product lines, businesses and assets

     (10     (44

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

     (50     (35

Other

     (29     (19
                

Other (income)/expense

   $ 113      $ (72
                

 

 

Interest expense decreased primarily due to additional debt swapped for floating interest rates during 2010 and 2009 and lower overall interest rate on floating rate debt.

 

 

Impairment of manufacturing operations attributed to the write-down of a facility held for sale 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 payments related to our alliances.

Specified Items

During the quarters ended March 31, 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 March 31, 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

   $    $    $    $ 11    $    $    $ 11

Impairment of manufacturing operations

                              200      200

Accelerated depreciation, asset impairment and other shutdown costs

     31                               31

Process standardization implementation costs

          13                          13
                                                

Total Restructuring

     31      13           11           200      255

Other:

                    

Upfront licensing and milestone payments

               55                     55
                                                

Total

   $ 31    $ 13    $ 55    $ 11    $    $ 200      310
                                            

Income taxes on items above

                       (86)
                        

Decrease to Net Earnings from Continuing Operations

                     $ 224
                        

 

44


Table of Contents

Three Months Ended March 31, 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

   $    $    $    $ 15    $    $    $ 15

Accelerated depreciation, asset impairment and other shutdown costs

     26                4                30

Process standardization implementation costs

          20                          20

Gain on sale of product lines, businesses and assets

                              (44)      (44)
                                                

Total Restructuring

     26      20           19           (44)      21

Other:

                    

Litigation charges

                         104           104

Upfront licensing payments

               145                     145

Product liability

     8                          (5)      3
                                                

Total

   $ 34    $ 20    $ 145    $ 19    $ 104    $ (49)      273
                                            

Income taxes on items above