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 SEPTEMBER 30, 2012MARCH 31, 2013

 

 ¨

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”, “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 September 30, 2012,March 31, 2013, there were 1,650,688,8591,642,551,939 shares outstanding of the Registrant’s $0.10 par value common stock.

 

 

 


BRISTOL-MYERS SQUIBB COMPANY

INDEX TO FORM 10-Q

SEPTEMBER 30, 2012MARCH 31, 2013

 

PART I—FINANCIAL INFORMATION

  

Item 1.

  

Financial Statements:

  

Consolidated Statements of Earnings

   3  

Consolidated Statements of Comprehensive Income

   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

   2928  

Item 3.

  

Quantitative and Qualitative DisclosuresDisclosure About Market Risk

   4643  

Item 4.

  

Controls and Procedures

   4643  

PART II—OTHER INFORMATION

  

Item 1.

  

Legal Proceedings

   4643  

Item 1A.

  

Risk Factors

   4643  

Item 2.

  

Issuer PurchasesPurchase of Equity Securities

   4644  

Item 6.

  

Exhibits

   4745  

Signatures

   4846  


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 September 30,  Nine Months Ended September 30, 
EARNINGS  2012  2011  2012  2011 

Net Sales

  $3,736  $5,345  $13,430  $15,790 
  

 

 

  

 

 

  

 

 

  

 

 

 

Cost of products sold

   987   1,407   3,535   4,231 

Marketing, selling and administrative

   1,071   1,019   3,077   2,987 

Advertising and product promotion

   167   205   585   672 

Research and development

   951   973   2,822   2,831 

Impairment charge for BMS-986094 intangible asset

   1,830       1,830     

Provision for restructuring

   29   8   71   92 

Litigation expense/(recoveries)

   50       (122    

Equity in net income of affiliates

   (40  (71  (150  (215

Other (income)/expense

   (50  (26  (45  (195
  

 

 

  

 

 

  

 

 

  

 

 

 

Total Expenses

   4,995   3,515   11,603   10,403 
  

 

 

  

 

 

  

 

 

  

 

 

 

Earnings/(Loss) Before Income Taxes

   (1,259  1,830   1,827   5,387 

Provision for/(benefit from) income taxes

   (546  475   250   1,358 
  

 

 

  

 

 

  

 

 

  

 

 

 

Net Earnings/(Loss)

   (713  1,355   1,577   4,029 
  

 

 

  

 

 

  

 

 

  

 

 

 

Net Earnings/(Loss) Attributable to Noncontrolling Interest

   (2  386   542   1,172 
  

 

 

  

 

 

  

 

 

  

 

 

 

Net Earnings/(Loss) Attributable to BMS

  $(711 $969  $1,035  $2,857 
  

 

 

  

 

 

  

 

 

  

 

 

 

Earnings/(Loss) per Common Share Attributable to BMS

     

Basic

  $(0.43 $0.57  $0.62  $1.67 

Diluted

  $(0.43 $0.56  $0.61  $1.66 

Dividends declared per common share

  $0.34  $0.33  $1.02  $0.99 
   Three Months Ended March 31, 
EARNINGS  2013  2012 

Net Sales

  $3,831  $5,251 
  

 

 

  

 

 

 

Cost of products sold

   1,063   1,303 

Marketing, selling and administrative

   994   1,002 

Advertising and product promotion

   189   194 

Research and development

   930   909 

Other (income)/expense

   (19  (184
  

 

 

  

 

 

 

Total Expenses

   3,157   3,224 
  

 

 

  

 

 

 

Earnings Before Income Taxes

   674   2,027 

Provision for income taxes

   51   545 
  

 

 

  

 

 

 

Net Earnings

   623   1,482 
  

 

 

  

 

 

 

Net Earnings Attributable to Noncontrolling Interest

   14   381 
  

 

 

  

 

 

 

Net Earnings Attributable to BMS

  $609  $1,101 
  

 

 

  

 

 

 

Earnings per Common Share

   

   Basic

  $0.37  $0.65 

   Diluted

  $0.37  $0.64 

Cash dividends declared per common share

  $0.35  $0.34 

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

BRISTOL-MYERS SQUIBB COMPANY

CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME

Dollars in Millions

(UNAUDITED)

 

                                        
  Three Months Ended
September 30,
  Nine Months Ended
September 30,
 
COMPREHENSIVE INCOME 2012  2011  2012  2011 

Net Earnings/(Loss)

 $(713 $1,355  $1,577  $4,029 

Other Comprehensive Income/(Loss):

    

Foreign currency translation

  21   (40  (1  (12

Foreign currency translation on net investment hedges

  (21  44   8   (13

Derivatives qualifying as cash flow hedges, net of taxes of $9 and $(23) for the three months ended September 30, 2012 and 2011, respectively; and $(8) and $3 for the nine months ended September 30, 2012 and 2011, respectively

  (26  60   1   3 

Derivatives qualifying as cash flow hedges reclassified to net earnings, net of taxes of $9 and $(9) for the three months ended September 30, 2012 and 2011, respectively; and $15 and $(16) for the nine months ended September 30, 2012 and 2011, respectively

  (13  18   (28  31 

Pension and postretirement benefits, net of taxes $(5) for the nine months ended September 30, 2012

          14     

Pension and postretirement benefits reclassified to net earnings, net of taxes of $(12) and $(11) for the three months ended September 30, 2012 and 2011, respectively; and $(35) and $(30) for the nine months ended September 30, 2012 and 2011, respectively

  24   19   70   56 

Available for sale securities, net of taxes of $9 and $(3) for the three months ended September 30, 2012 and 2011, respectively; and $8 and $(6) for the nine months ended September 30, 2012 and 2011, respectively

  38   6   45   24 

Available for sale securities reclassified to net earnings, net of taxes of $2 for the nine months ended September 30, 2012

          (8    
 

 

 

  

 

 

  

 

 

  

 

 

 

Total Other Comprehensive Income/(Loss)

  23   107   101   89 
 

 

 

  

 

 

  

 

 

  

 

 

 

Comprehensive Income/(Loss)

  (690  1,462   1,678   4,118 
 

 

 

  

 

 

  

 

 

  

 

 

 

Comprehensive Income/(Loss) Attributable to Noncontrolling Interest

  (2  386   542   1,172 
 

 

 

  

 

 

  

 

 

  

 

 

 

Comprehensive Income/(Loss) Attributable to Bristol-Myers Squibb Company

 $(688 $1,076  $1,136  $2,946 
 

 

 

  

 

 

  

 

 

  

 

 

 
                    
   Three Months Ended March 31, 
COMPREHENSIVE INCOME  2013  2012 

Net Earnings

  $623  $1,482 

Other Comprehensive Income/(Loss), net of taxes and reclassifications to earnings:

   

Derivatives qualifying as cash flow hedges

   41   (1

Pension and postretirement benefits

   27   38 

Available for sale securities

   4   (13

Foreign currency translation

   (19  15 

Foreign currency translation on net investment hedges

   18   (12
  

 

 

  

 

 

 

Other Comprehensive Income/(Loss)

   71   27 
  

 

 

  

 

 

 

Comprehensive Income

   694   1,509 
  

 

 

  

 

 

 

Comprehensive Income Attributable to Noncontrolling Interest

   14   381 
  

 

 

  

 

 

 

Comprehensive Income Attributable to BMS

  $680  $1,128 
  

 

 

  

 

 

 

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

BRISTOL-MYERS SQUIBB COMPANY

CONSOLIDATED BALANCE SHEETS

Dollars in Millions, Except Share and Per Share Data

(UNAUDITED)

 

                                            
ASSETS  September 30,
2012
 December 31,
2011
   March 31,
2013
 December 31,
2012
 

Current Assets:

      

Cash and cash equivalents

  $1,503  $5,776   $1,355  $1,656 

Marketable securities

   1,427   2,957    1,178   1,173 

Receivables

   2,889   3,743    3,308   3,083 

Inventories

   1,697   1,384    1,791   1,657 

Deferred income taxes

   1,339   1,200    1,828   1,597 

Prepaid expenses and other

   423   258    616   355 
  

 

  

 

   

 

  

 

 

Total Current Assets

   9,278   15,318    10,076   9,521 
  

 

  

 

   

 

  

 

 

Property, plant and equipment

   5,297   4,521    5,259   5,333 

Goodwill

   7,498   5,586    7,646   7,635 

Other intangible assets

   9,217   3,124    8,570   8,778 

Deferred income taxes

   179   688    190   203 

Marketable securities

   3,698   2,909    3,242   3,523 

Other assets

   877   824    975   904 
  

 

  

 

   

 

  

 

 

Total Assets

  $36,044  $32,970   $35,958  $35,897 
  

 

  

 

   

 

  

 

 

LIABILITIES

      

Current Liabilities:

      

Short-term borrowings and current portion of long-term debt

  $751  $115   $1,372  $826 

Accounts payable

   2,085   2,603    2,079   2,202 

Accrued expenses

   2,759   2,791    2,376   2,573 

Deferred income

   689   337    772   825 

Accrued rebates and returns

   1,122   1,170    938   1,054 

U.S. and foreign income taxes payable

   193   167    276   193 

Dividends payable

   596   597    601   606 
  

 

  

 

   

 

  

 

 

Total Current Liabilities

   8,195   7,780    8,414   8,279 
  

 

  

 

   

 

  

 

 

Pension, postretirement and postemployment liabilities

   1,473   2,017    1,638   1,882 

Deferred income

   4,006   866    4,101   4,024 

U.S. and foreign income taxes payable

   650   573    652   648 

Deferred income taxes

   748   107    473   383 

Other liabilities

   464   384    459   475 

Long-term debt

   6,608   5,376    6,522   6,568 
  

 

  

 

   

 

  

 

 

Total Liabilities

   22,144   17,103    22,259   22,259 
  

 

  

 

   

 

  

 

 

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 5,189 in 2012 and 5,268 in 2011, 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 2012 and 2011

   221   220 

Preferred stock, $2 convertible series, par value $1 per share: Authorized 10 million shares; issued and outstanding 5,085 in 2013 and 5,117 in 2012, 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 2013 and 2012

   221   221 

Capital in excess of par value of stock

   2,717   3,114    2,126   2,694 

Accumulated other comprehensive loss

   (2,944  (3,045   (3,131  (3,202

Retained earnings

   32,381   33,069    32,761   32,733 

Less cost of treasury stock – 558 million shares in 2012 and 515 million in 2011

   (18,475  (17,402

Less cost of treasury stock – 565 million common shares in 2013 and 570 million in 2012

   (18,318  (18,823
  

 

  

 

   

 

  

 

 

Total Bristol-Myers Squibb Company Shareholders’ Equity

   13,900   15,956    13,659   13,623 

Noncontrolling interest

       (89   40   15 
  

 

  

 

   

 

  

 

 

Total Equity

   13,900   15,867    13,699   13,638 
  

 

  

 

   

 

  

 

 

Total Liabilities and Equity

  $36,044  $32,970   $35,958  $35,897 
  

 

  

 

   

 

  

 

 

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

BRISTOL-MYERS SQUIBB COMPANY

CONSOLIDATED STATEMENTS OF CASH FLOWS

Dollars in Millions

(UNAUDITED)

 

                      
  Nine Months Ended September 30,   Three Months Ended March 31, 
  2012 2011   2013 2012 

Cash Flows From Operating Activities:

      

Net earnings

  $1,577  $4,029   $623  $1,482 

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

      

Net earnings attributable to noncontrolling interest

   (542  (1,172   (14  (381

Depreciation and amortization

   482   482 

Impairment charges

   2,118   28 

Depreciation and amortization, net

   213   139 

Deferred income taxes

   (737  273    (182  204 

Stock-based compensation

   108   120    49   42 

Impairment charges

   3   98 

Other

   21   (138   (3  10 

Changes in operating assets and liabilities:

      

Receivables

   643   (152   (318  (108

Inventories

   (135  (150   (163  (68

Accounts payable

   (321  309    (53  32 

Deferred income from diabetes collaboration

   3,570     

Other deferred income

   100   (7

Deferred income

   215   (44

U.S. and foreign income taxes payable

   82   (20   77   (22

Other

   (861  (330   (875  (997
  

 

  

 

   

 

  

 

 

Net Cash Provided by Operating Activities

   6,105   3,272 

Net Cash Provided by/(Used in) Operating Activities

   (428  387 
  

 

  

 

   

 

  

 

 

Cash Flows From Investing Activities:

      

Sale and maturities of marketable securities

   4,384   3,808 

Proceeds from sale and maturities of marketable securities

   551   2,190 

Purchases of marketable securities

   (3,501  (5,344   (278  (2,615

Additions to property, plant and equipment and capitalized software

   (373  (233   (115  (123

Sale of businesses and other investing activities

   16   147 

Purchase of businesses, net of cash acquired

   (7,530  (310

Proceeds from sale of businesses and other investing activities

   3   12 

Purchases of businesses, net of cash acquired

      (2,491
  

 

  

 

   

 

  

 

 

Net Cash Used in Investing Activities

   (7,004  (1,932

Net Cash Provided by/(Used in) Investing Activities

   161   (3,027
  

 

  

 

   

 

  

 

 

Cash Flows From Financing Activities:

      

Short-term borrowings/(repayments)

   20   67 

Short-term debt borrowings/(repayments)

   551   30 

Proceeds from issuance of long-term debt

   1,950        12    

Long-term debt repayments

   (2,108  (78      (109

Interest rate swap terminations

   2   296       2 

Stock option exercises

   397   365 

Issuance of common stock

   270   159 

Common stock repurchases

   (1,911  (859   (297  (339

Dividends paid

   (1,725  (1,694   (580  (579
  

 

  

 

   

 

  

 

 

Net Cash Used in Financing Activities

   (3,375  (1,903   (44  (836
  

 

  

 

   

 

  

 

 

Effect of Exchange Rates on Cash and Cash Equivalents

   1   1    10   7 
  

 

  

 

   

 

  

 

 

Decrease in Cash and Cash Equivalents

   (4,273  (562   (301  (3,469

Cash and Cash Equivalents at Beginning of Period

   5,776   5,033    1,656   5,776 
  

 

  

 

   

 

  

 

 

Cash and Cash Equivalents at End of Period

  $1,503  $4,471   $1,355  $2,307 
  

 

  

 

   

 

  

 

 

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

Note 1. BASIS OF PRESENTATION

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 (SEC) and United States (U.S.) generally accepted accounting principles (GAAP) for interim reporting. Under those rules, certain footnotes and other financial information that are normally required 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 September 30, 2012March 31, 2013 and December 31, 2011,2012, and the results of operations for the three and nine months ended September 30, 2012 and 2011 and cash flows for the ninethree months ended September 30, 2012March 31, 2013 and 2011.2012. 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, 20112012 included in the Annual Report on Form 10-K.

Certain prior period amounts have been reclassified to conform to the current period presentation. The presentation of depreciation and amortization in the consolidated statements of cash flows includes the depreciation of property, plant and equipment, and the amortization of intangible assets and deferred income. The provision for restructuring, equity in net income of affiliates, and litigation expense, net, previously presented separately on the consolidated statements of earnings, are currently presented as components of other (income)/expense.

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.assumptions. The most significant assumptions are employed in estimates used in determining the fair value and potential impairment of intangible assets; sales rebate and return accruals used in revenue recognition;accruals; legal contingencies; income taxes; and pension and postretirement benefits. Actual results may differ from estimated results.

Note 2. BUSINESS SEGMENT INFORMATION

BMS operates in a single segment 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. ProductsRegional commercial organizations are distributedused to distribute and sold through regional organizations that servesell the United States; Europe; Latin America, Middle East and Africa; Japan, Asia Pacific and Canada; and Emerging Markets defined as Brazil, Russia, India, China and Turkey.product. The business is also supported by global corporate staff functions. Segment information is consistent with the financial information regularly reviewed by the chief operating decision maker, the chief executive officer 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:

Net sales of key products were as follows:

  Three Months Ended March 31, 
Dollars in Millions  2013   2012 

Virology

    

Baraclude (entecavir)

  $366   $325 

Reyataz (atazanavir sulfate)

   361    358 

Sustiva (efavirenz) Franchise

   387    386 

Oncology

    

Erbitux* (cetuximab)

   162    179 

Sprycel (dasatinib)

   287    231 

Yervoy (ipilimumab)

   229    154 

Neuroscience

    

Abilify* (aripiprazole)

   522    621 

Metabolics

    

Bydureon* (exenatide extended-release for injectable suspension)

   52    N/A  

Byetta* (exenatide)

   85    N/A  

Forxiga (dapagliflozin)

   3    N/A  

Onglyza/Kombiglyze (saxagliptin/saxagliptin and metformin)

   202    161 

Immunoscience

    

Nulojix (belatacept)

   5    1 

Orencia (abatacept)

   320    254 

Cardiovascular

    

Avapro*/Avalide* (irbesartan/irbesartan-hydrochlorothiazide)

   46    207 

Eliquis (apixaban)

   22      

Plavix* (clopidogrel bisulfate)

   91    1,693 

Mature Products and All Other

   691    681 
  

 

 

   

 

 

 

Net Sales

  $3,831   $5,251 
  

 

 

   

 

 

 

 

  Three Months Ended September 30,  Nine Months Ended September 30, 
Dollars in Millions 2012  2011  2012  2011 

Plavix* (clopidogrel bisulfate)

 $64  $1,788  $2,498  $5,415 

Avapro*/Avalide* (irbesartan/irbesartan-hydrochlorothiazide)

  95   216   419   757 

Eliquis (apixaban)

          1     

Abilify* (aripiprazole)

  676   691   2,008   2,021 

Reyataz (atazanavir sulfate)

  363   391   1,127   1,153 

Sustiva (efavirenz) Franchise

  370   359   1,144   1,073 

Baraclude (entecavir)

  346   311   1,028   878 

Erbitux* (cetuximab)

  173   172   531   510 

Sprycel (dasatinib)

  263   211   738   576 

Yervoy (ipilimumab)

  179   121   495   216 

Orencia (abatacept)

  307   233   851   660 

Nulojix (belatacept)

  3       7   2 

Onglyza/Kombiglyze (saxagliptin/saxagliptin and metformin)

  178   127   511   320 

Byetta* (exenatide)

  55       55     

Bydureon* (exenatide extended-release for injectable suspension)

  20       20     

Mature Products and All Other

  644   725   1,997   2,209 
 

 

 

  

 

 

  

 

 

  

 

 

 

Net Sales

 $3,736  $5,345  $13,430  $15,790 
 

 

 

  

 

 

  

 

 

  

 

 

 
*

Indicates brand names of products which are trademarks not owned or wholly owned by BMS. Specific trademark ownership information can be found at the end of this quarterly report on Form 10-Q.

Note 3. ALLIANCES AND COLLABORATIONS

BMS maintains alliancesenters into alliance and collaborationscollaboration arrangements with various third parties for the development and commercialization of certain products. Unless otherwise noted,Both parties are active participants in the alliance operating activities and exposed to significant risks and rewards depending on the commercial success of the activities. BMS may either in-license intellectual property owned by the other party or out-license its intellectual property to the other party. These arrangements also typically include research, development, manufacturing, and/or commercial activities and can cover a single investigational compound or marketed product or multiple compounds and/or products in various life cycle stages.

When BMS is the principal in the customer sale, 100% of product sales are recognized. Otherwise, only BMS’s contractual share of alliance revenue is reported in net sales.

Payments between collaboration partners are presented in operating results associated withbased on the alliancesnature of the arrangement, including its contractual terms, the nature of the payments and collaborationsthe applicable accounting guidance. Upfront and contingent milestone payments made prior to product approval are generally treatedimmediately expensed and those payments made after product approval are amortized over the shorter of the contractual term or estimated life of the product. Upfront and contingent milestones received are amortized over the shorter of the contractual term or estimated life of the product. Other activities between BMS and its collaboration partners are presented in operating results as follows: product revenues

Payments to BMS from collaboration partners for supply arrangements, royalties, co-promotional and collaboration fees are presented in net sales when BMS’s collaboration partner is the principal in the customer sale.

Payments to collaboration partners from BMS sales are included in revenue;for supply arrangements, royalties, collaboration fees, profit sharing and distribution feesfees; and the amortization of upfront or contingent milestone payments made upon or after the regulatory approval date are included in cost of goods sold; post-approvalproducts sold.

Cost reimbursement payments between the parties for commercial expenses are included in marketing, selling, administrative, advertising and product promotion expenses.

Upfront and contingent milestone payments from collaboration partners to BMS prior to the regulatory approval date and cost reimbursement payments between the parties are included in research and development expenses.

The amortization of upfront and contingent milestone payments to BMS from collaboration partners, are deferred and amortized over the useful lifeequity in net income of the related products in cost of products sold; cost sharing reimbursements offset the intended operating expense; payments to BMS attributed to upfront, pre-approval milestoneaffiliates and other licensing payments that are deferred and amortized over the estimated useful life of the related products in other income/expense; income and expenses attributed to a collaboration’s non-core activities such as supply and manufacturing arrangements and compensation for opting-out of commercialization in certain countries, are included in other income/expense; partnerships(income)/expense.

All payments between BMS and joint venturesits collaboration partners are either consolidatedpresented in cash flows from operating activities, including profit distributions when the activities are conducted through a separate and distinct legal entity or accounted for under the equity method of accounting and related cash receipts and distributions are treated as operating cash flow.partnership.

See the 20112012 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

BMS has agreements with Sanofi for the codevelopment and cocommercialization ofAvapro*/Avalide* andPlavix*. The worldwide alliance operates under the framework of two geographic territories; one in the Americas (principally the U.S., Canada, Puerto Rico and Latin American countries) and Australia and the other in Europe and Asia. Accordingly, two territory partnerships were formed to manage central expenses, such as marketing, research and development and royalties, and to supply finished product to the individual countries. In general, at the country level, agreements either to copromote (whereby a partnership was formed between the parties to sell each brand) or to comarket (whereby the parties operate and sell their brands independently of each other) are in place.

BMS 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 included in net earnings/(loss) attributable to noncontrolling interest. BMS recognizes net sales in this territory and in comarketing countries outside this territory (e.g. Germany, Italy for irbesartan only, Spain and Greece). Sanofi acts as the operating partner and owns a 50.1% majority controlling interest in the territory covering Europe and Asia and BMS has a 49.9% ownership interest in this territory which is included in equity in net income of affiliates.

BMS and Sanofi have a separate partnership governing the copromotion of irbesartan in the U.S. Sanofi paid BMS $350 million for their acquisition of an interest in the irbesartan license for the U.S. upon formation of the alliance.

Summarized financial information related to this alliance is as follows:

  Three Months Ended September 30,  Nine Months Ended September 30, 
Dollars in Millions 2012  2011  2012  2011 

Territory covering the Americas and Australia:

    

Net sales

 $95  $1,936  $2,690  $5,959 

Royalty expense

  19   430   527   1,229 

Noncontrolling interest – pre-tax

  (7  590   847   1,764 

Distributions to/(from) Sanofi

  (290  523   768   1,824 

Territory covering Europe and Asia:

    

Equity in net income of affiliates

  45   75   163   226 

Profit distributions to BMS

  54   97   183   224 

Other:

    

Net sales in Europe comarketing countries and other

  64   68   227   213 

Amortization (income)/expense – irbesartan license fee

  (8  (7  (24  (23

Supply activities and development and opt-out royalty (income)/expense

  (53  6   (98  21 
Dollars in Millions       September 30,
2012
  December 31,
2011
 

Investment in affiliates – territory covering Europe and Asia

   $17  $37 

Deferred income – irbesartan license fee

    5   29 

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 September 30,  Nine Months Ended September 30, 
Dollars in Millions 2012  2011  2012  2011 

Net sales

 $248  $364  $886  $1,125 

Gross profit

  132   161   402   501 

Net income

  116   131   358   413 

In September 2012, BMS and Sanofi restructured the terms of the codevelopment and cocommercialization agreements discussed above. Effective as of January 1, 2013, subject in certain countries to the receipt of regulatory approvals, Sanofi will assume the worldwide operations of the alliance with the exception ofPlavix* for the U.S. and Puerto Rico. The alliance forPlavix* in these two markets will continue unchanged through December 2019 under the same terms as in the original alliance arrangements. In exchange for the rights being assumed by Sanofi, BMS will receive quarterly royalties from January 1, 2013 until December 31, 2018 and a terminal payment from Sanofi of $200 million at the end of 2018. All ongoing disputes between the companies have been resolved, including a one-time payment of $80 million by BMS to Sanofi related to theAvalide* supply disruption in the U.S. in 2011 (accrued for in 2011).

Otsuka

BMS has a worldwide commercialization agreement, excluding certain Asian countries, with Otsuka Pharmaceutical Co., Ltd. (Otsuka), to codevelop and copromoteAbilify*, for the treatment of schizophrenia, bipolar mania disorder and major depressive disorder, excluding certain Asia Pacific countries.disorder. The U.S. portion of the amended commercialization and manufacturing agreement was amended in 2009 and further amended in 2012, and it expires upon the expected loss of product exclusivity in April 2015. BeginningThe agreement expires in all EU countries in June 2014 and in each other non-U.S. country where we have the exclusive right to sellAbilify*, the agreement expires on January 1, 2012, the later of April 20, 2015 or loss of exclusivity in any such country.

Otsuka is the principal in most third-party net sales. Therefore, net sales recognized forAbilify* include only BMS’s contractual share of revenue recognized by BMStotal net sales to third party customers. In the U.S., BMS’s contractual share was 51.5% in 2012. Beginning January 1, 2013, BMS’s contractual share changed to the percentages of total U.S. net sales set forth in the U.S. was reduced from 53.5% in 2011 to 51.5% and will be further reduced in 2013.table below. BMS recognizes revenue based on the weighted-average forecast of expected annual sales (currently estimated at 35%).

Share as a % of U.S. Net
Sales

$0 to $2.7 billion

50%

$2.7 billion to $3.2 billion

20%

$3.2 billion to $3.7 billion

  7%

$3.7 billion to $4.0 billion

  2%

$4.0 billion to $4.2 billion

  1%

In excess of $4.2 billion

20%

In the UK,United Kingdom, Germany, France, Spain, and Spain, BMS receives 65%beginning on March 1, 2013 in Italy, BMS’s contractual share of third-party net sales.sales is 65%. In these countries and the U.S., third-party customers are invoiced by BMS on behalf of Otsuka and alliance revenue is recognized whenAbilify* is shipped and all risks and rewards of ownership have been transferred to third-party customers. InBMS recognizes all of the net sales in certain countries where BMSit is presently the exclusive distributor for the product or has an exclusive right to sellAbilify*, BMS recognizes all of the net sales..

BMS purchases the productactive pharmaceutical ingredient from Otsuka and performs finish manufacturingcompletes the manufacture of the product for sale to third-party customers by BMS or Otsuka. Under the terms of the amended agreement,2009 U.S. amendment, BMS paid Otsuka $400 million in 2009, which is amortized as a reduction of net sales through the expected loss of U.S. exclusivity in April 2015. The unamortized balance is included in other assets. Otsuka receives a royalty based on 1.5% of total U.S. net sales.sales, which is included in cost of products sold. Otsuka iswas responsible for 30% of the U.S. expenses related to the commercialization ofAbilify* from 2010 through 2012. Under the 2012 U.S. amendment, Otsuka assumed responsibility for providing and funding all sales force efforts effective January 2013. In consideration, BMS also reimbursespaid Otsuka $27 million in January 2013, and will be responsible for its contractual share offunding certain operating expenses up to $82 million in 2013, $56 million in 2014 and $8 million in 2015. In the annual pharmaceutical company fee related toAbilify*.EU, Otsuka reimbursed BMS for the sales force effort it provided through March 31, 2013. Otsuka assumed responsibility for providing and funding sales force efforts in the EU effective April 2013.

BMS and Otsuka also have an oncology collaboration forSprycel andIxempra (ixabepilone) (the “Oncology Products”) in the U.S., Japan and the EU. The Company pays aEU (the Oncology Territory). A collaboration fee, included in cost of products sold, is paid to Otsuka equal to 30% ofbased on the first $400 million annual net sales of the Oncology Products in the Oncology Territory (U.S., Japan and Europe), 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 trailingfollowing percentages of annual net sales over $800 million. Annually,ofSprycel andIxempra:

   % of Net Sales
   2010 – 2012 2013 – 2020

$0 to $400 million

  30% 65%

$400 million to $600 million

    5% 12%

$600 million to $800 million

    3%   3%

$800 million to $1.0 billion

    2%   2%

In excess of $1.0 billion

    1%   1%

During these periods, Otsuka contributes 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.

Summarized financial information related to this alliance is as follows:

   Three Months Ended March 31, 
Dollars in Millions  2013  2012 

Abilify* net sales, net of amortization of extension payment

  $522  $621 

Oncology Products collaboration fee expense

   70   32 

Royalty expense

   17   17 

Reimbursement of operating expenses to/(from) Otsuka

   (6  (24

Amortization (income)/expense – extension payment

   16   16 

Amortization (income)/expense – upfront, milestone and other licensing payments

      2 
Dollars in Millions  March 31,
2013
  December 31,
2012
 

Other assets – extension payment

  $137  $153 

AstraZeneca

BMS and AstraZeneca have a diabetes alliance consisting of three worldwide codevelopment and commercialization agreements. One collaboration coversOnglyza,Kombiglyze XR (saxagliptin and metformin hydrochloride extended-release), andKomboglyze (saxagliptin and metformin immediate-release marketed in the EU); a second collaboration coversForxiga; and a third collaboration, entered into during August 2012, covers Amylin’s portfolio of products (Bydureon*,Byetta*,Symlin* (pramlintide acetate) and metreleptin, which is currently in development). The agreements for saxagliptin exclude Japan. In addition, Otsuka hasthis document unless specifically noted, we refer to bothKombiglyze andKomboglyze asKombiglyze.Onglyza andForxiga were discovered by BMS.Kombiglyze was codeveloped with AstraZeneca.Bydureon*,Byetta*,Symlin* and metreleptin were discovered by Amylin, LLC (Amylin), a wholly-owned subsidiary of BMS since August 2012.

BMS is the principal in third party customer net sales. Both companies jointly develop the clinical and marketing strategy and share commercialization expenses and profits and losses equally on a global basis and also share in development costs, with the exception ofForxiga development costs in Japan, which are borne by AstraZeneca.

In 2012, BMS received preliminary proceeds of $3.6 billion from AstraZeneca as consideration for entering into the Amylin-related collaboration including $73 million included in accrued expenses that is expected to be reimbursed back to AstraZeneca in the second quarter of 2013. The remaining $3.5 billion is accounted for as deferred income and amortized as a reduction to cost of products sold on a pro-rata basis over the estimated useful lives of the related long-lived assets assigned in the purchase price allocation (primarily intangible assets with a weighted-average estimated useful life of 12 years and property, plant and equipment with a weighted-average estimated useful life of 15 years). The net proceeds that BMS received from AstraZeneca as consideration for entering into the collaboration are subject to certain adjustments including the right to co-promotereceive an additional $135 million when AstraZeneca exercises its option for equal governance rights over certain key strategic and financial decisions regarding the collaboration, which it has indicated it intends to do pending required anti-trust approvals in certain international markets. BMS is entitled to reimbursements for 50% of capital expenditures related to Amylin. BMS and AstraZeneca agreed to share in certain tax attributes related to the Amylin collaboration. The preliminary proceeds of $3.6 billion that BMS received from AstraZeneca included $207 million related to sharing of certain tax attributes.

With respect to the other collaborations, BMS has received $300 million in upfront, milestone and other licensing payments related to saxagliptin to date and could receive up to an additional $300 million for sales-based milestones. BMS has also received $250 million in upfront, milestone and other licensing payments related to dapagliflozin to date, and could potentially receive up to an additional $150 million for development and regulatory milestones and up to an additional $390 million for sales-based milestones.

Summarized financial information related to these alliances is as follows:

                                            
   Three Months Ended March 31, 
Dollars in Millions  2013  2012 

Net sales

  $358  $161 

Profit sharing expense

   146   73 

Commercialization expense reimbursements to/(from) AstraZeneca

   (57  (12

Research and development expense reimbursements to/(from) AstraZeneca

   (17  4 

Amortization (income)/expense – upfront, milestone and other licensing receipts recognized in:

   

Cost of products sold

   (75   

Other (income)/expense

   (7  (10

Upfront, milestone and other licensing receipts:

   

Dapagliflozin

   80    
Dollars in Millions  March 31,
2013
  December 31,
2012
 

Deferred income – upfront, milestone and other licensing receipts

   

Amylin-related products

  $3,352  $3,423 

Saxagliptin

   204   208 

Dapagliflozin

   203   206 

Gilead

BMS and Gilead Sciences, Inc. (Gilead) have a joint venture to develop and commercializeSprycelAtripla* (efavirenz 600 mg/ emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg), a once-daily single tablet three-drug regimen for the treatment of human immunodeficiency virus (HIV) infection, combiningSustiva, a product of BMS, andTruvada* (emtricitabine and tenofovir disoproxil fumarate), a product of Gilead, in the U.S., Japan,Canada and Europe.

Net sales recognized forAtripla* include only the top five markets inbulk efavirenz component ofAtripla*. They are deferred until the EU.combined product is sold to third-party customers and are based on the relative ratio of the average respective net selling prices ofTruvada* andSustiva.

Summarized financial information related to this alliance is as follows:

 

  Three Months Ended September 30,  Nine Months Ended September 30, 
Dollars in Millions 2012  2011  2012  2011 

Abilify* net sales, including amortization of extension payment

 $676  $691  $2,008  $2,021 

Oncology Products collaboration fee expense

  36   30   103   100 

Royalty expense

  18   18   55   52 

Commercialization expense reimbursement to/(from) Otsuka

  (2  (15  (34  (37

Amortization (income)/expense – extension payment

  16   16   49   49 

Amortization (income)/expense – upfront, milestone and other licensing payments

  1   1   5   5 
Dollars in Millions       September 30,
2012
  December 31,
2011
 

Other assets – extension payment

   $170  $219 

Other intangible assets – upfront, milestone and other licensing payments

        5 
                                            
  Three Months Ended March 31, 
Dollars in Millions 2013   2012 

Net sales

  $           324    $           322 

Equity in net loss of affiliates

  4    4 

Lilly

BMS has an Epidermal Growth Factor Receptor (EGFR) commercialization agreement with Eli Lilly and Company (Lilly) through Lilly’s November 2008 acquisition of ImClone Systems Incorporated (ImClone) for the codevelopment and promotion ofErbitux* and necitumumab (IMC-11F8) in the U.S. which expires as toErbitux* in September 2018. BMS also has codevelopment and copromotion rights to both products in Canada and Japan.ErbituxErbitux** is indicated for use in the treatment of patients with metastatic colorectal cancer and for use in the treatment of squamous cell carcinoma of the head and neck. BMS is the principal in third party customer sales. Under the EGFR agreement, with respect toErbitux* sales in North America, Lilly receives a distribution fee based on a flat rate of 39% of net sales in North America plus reimbursement of certain royalties paid by Lilly.

In Japan, BMS shares rights toErbitux* under an agreement with Lilly and Merck KGaA and receives 50% of the pre-tax profit from Merck KGaA’s net sales ofErbitux* in Japan which is further shared equally with Lilly.

With respectIn March 2013, the Company and Lilly terminated the global codevelopment and cocommercialization arrangement for necitumumab (IMC-11F8), with all rights returning to Lilly. Discovered by ImClone, necitumumab is a fully human monoclonal antibody being investigated as an anticancer treatment and was part of the companies will share inalliance between the cost of developingCompany and potentially commercializing necitumumab in the U.S., Canada and Japan. Lilly maintains exclusive rights to necitumumab in all other markets. BMS will fund 55% of development costs for studies that will be used only in the U.S., 50% for Japan studies and 27.5% for global studies.Lilly.

BMS is amortizing $500 million of license acquisition costs associated with the EGFR commercialization agreement through 2018.

Summarized financial information related to this alliance is as follows:

 

  Three Months Ended
September 30,
  Nine Months Ended
September 30,
 
Dollars in Millions 2012  2011  2012  2011 

Net sales

 $173  $172  $531  $510 

Distribution fees and royalty expense

  71   72   220   212 

Research and development expense reimbursement to Lilly – necitumumab

  5   4   13   10 

Amortization (income)/expense – upfront, milestone and other licensing payments

  9   9   28   28 

Commercialization expense reimbursements to/(from) Lilly

  (4  (9  (14  (12

Japan commercialization profit sharing (income)/expense

  (9  (9  (28  (24

                                            
  Three Months Ended March 31, 
Dollars in Millions  2013 2012 

Net sales

  $162  $179 

Distribution fees and royalty expense

   67   74 

Research and development expense reimbursement to Lilly – necitumumab

      1 

Amortization (income)/expense – upfront, milestone and other licensing payments

   9   10 

Japan commercialization fee (income)/expense

   (4  (6
Dollars in Millions September 30,
2012
 December 31,
2011
   March 31,
2013
 December 31,
2012
 

Other intangible assets – upfront, milestone and other licensing payments

   $221  $249   $202  $211 

BMS acquiredPrior to BMS’s acquisition of Amylin Pharmaceuticals, Inc. (Amylin) on August 8, 2012, (see “—Note 4. Acquisitions” for further information). Amylin had previously entered into a settlement and termination agreement with Lilly regarding their collaboration for the global development and commercialization ofByetta* andBydureon* (exenatide products) under which the parties agreed to transition full responsibility of these products to Amylin. Although theThe transition of the U.S. operations was completed Lilly had not yet transitionedby the non-U.S. operations to Amylin. In September 2012, BMS provided notification to Lilly that BMS will assume essentially alltime of the acquisition. The transition of non-U.S. operations of the exenatide products during the first halfin a majority of markets was completed on April 1, 2013 and therefore terminateterminating Lilly’s exclusive right to non-U.S. commercialization of the exenatide products, subject to certain regulatory and other conditions.products. BMS is responsible for any non-U.S. losses incurred by Lilly during 2012 and 2013 up to a maximum of $60 million and is entitled to tiered royalties until the transition is complete.million.

GileadSanofi

In September 2012, BMS and Gilead Sciences, Inc. (Gilead) have a joint venture to developSanofi restructured the terms of the codevelopment and commercializecocommercialization agreements forAtripla*Plavix* (efavirenz 600 mg/ emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg), a once-daily single tablet three-drug regimenplatelet aggregation inhibitor, andAvapro*/Avalide*, an angiotension II receptor antagonist indicated for the treatment of human immunodeficiency virus (HIV) infection, combininghypertension and diabetic nephropathy. Effective January 1, 2013, Sanofi assumed essentially all of the worldwide operations of the alliance with the exception ofSustivaPlavix*,in the U.S. and Puerto Rico. The alliance forPlavix* in these two markets will continue unchanged through December 2019 under the same terms as in the original alliance arrangements described below. In exchange for the rights being assumed by Sanofi, BMS will receive quarterly royalties from January 1, 2013 until December 31, 2018 and a productterminal payment from Sanofi of BMS,$200 million at the end of 2018.

Beginning in 2013, all royalties received from Sanofi in the territory covering the Americas and Australia, opt-out markets, and former comarketing countries discussed below are presented in net sales, including $51 million in the three months ended March 31, 2013. Development and opt-out royalties were recognized in other (income)/expense in 2012. Royalties attributed to the territory covering Europe and Asia continue to be earned by the territory partnership and are included in equity in net income of affiliates. Additionally, equity in net income of affiliates for the three months ended March 31, 2013 includes $22 million of profit that was deferred prior to the restructuring of the agreement. Net sales attributed to the supply of irbesartan active pharmaceutical ingredient to Sanofi were $18 million and $38 million for the three months ended March 31, 2013 and 2012, respectively. The supply arrangement expires in 2015.

Prior to the restructuring, BMS’s worldwide alliance with Sanofi for the codevelopment and cocommercialization ofTruvada*Avapro*/Avalide* (emtricitabine and tenofovir disoproxil fumarate), a productPlavix* operated under the framework of Gilead,two geographic territories: one in the Americas (principally the U.S., Canada, Puerto Rico and Europe.

Net salesLatin American countries) and Australia, and the other in Europe and Asia. These two territory partnerships managed central expenses, such as marketing, research and development and royalties, and supply of finished product to individual countries. BMS acted as the operating partner and owned 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 bulk efavirenz component ofAtripla* are deferred untilresults reflected as a noncontrolling interest. BMS also recognized net sales in comarketing countries outside this territory (e.g., Germany, Italy for irbesartan only, Spain and Greece). Sanofi acted as the combined product is sold to third-party customers. Net sales foroperating partner and owned a 50.1% majority controlling interest in the efavirenz component are based on the relative ratio of the average respective net selling prices ofTruvada*territory covering Europe andSustiva. Asia and BMS has a 49.9% ownership interest in this territory.

Summarized financial information related to this alliance is as follows:

 

   Three Months Ended September 30,  Nine Months Ended September 30, 
Dollars in Millions  2012  2011  2012  2011 

Net sales

  $305  $289  $950  $858 

Equity in net loss of affiliates

   (6  (3  (14  (11

   Three Months Ended March 31, 
Dollars in Millions          2013                  2012         

Net sales

  $137  $1,900 

Royalty expense

   2   367 

Equity in net income of affiliates

   (40  (60

Other (income)/expense

   (10  (14

Noncontrolling interest – pre-tax

   24   605 

Distributions to Sanofi

      609 

Distributions to BMS

   31   67 
Dollars in Millions  March 31,
2013
  December 31,
2012
 

Investment in affiliates – territory covering Europe and Asia

  $18  $9 

Noncontrolling interest

   (6  (30

AstraZeneca

BMSThe following is summarized financial information for interests in the partnerships with Sanofi for the territory covering Europe and AstraZeneca Pharmaceuticals LP, a wholly-owned subsidiary of AstraZeneca, entered into a collaboration regarding the worldwide development and commercialization of Amylin’s portfolio of products. The arrangement is based on the framework of the existing diabetes alliance agreements discussed further below, including the equal sharing of profits and losses arising from the collaboration. AstraZeneca has indicated its intent to establish equal governance rights over certain key strategic and financial decisions regarding the collaboration pending required anti-trust approvals in certain international markets.

BMS received preliminary proceeds of $3.8 billion from AstraZeneca as consideration for entering into the collaboration during the current period, including $190 millionAsia, which is included in accrued expenses and expected to be reimbursed back to AstraZeneca. The remaining $3.6 billion wasare not consolidated but are accounted for as deferred income and is amortized as a reduction to cost of products sold on a pro-rata basis overusing the estimated useful lives of the related long-lived assets assigned in the purchase price allocation (primarily intangible assets with a weighted-average estimated useful life of 12 years and property, plant and equipment with a weighted-average estimated useful life of 15 years). The net proceeds that BMS will receive from AstraZeneca as consideration for entering into the collaboration are subject to certain other adjustments including the right to receive an additional $135 million when AstraZeneca exercises its option for equal governance rights.

BMS and AstraZeneca agreed to share in certain tax attributes related to the Amylin collaboration. The preliminary proceeds of $3.8 billion that BMS received from AstraZeneca included $207 million related to sharing of certain tax attributes.

In addition, BMS continues to maintain two worldwide codevelopment and cocommercialization agreements with AstraZeneca forOnglyza,Kombiglyze XR(saxagliptin and metformin hydrochloride extended-release),Komboglyze (saxagliptin and metformin immediate-release marketed in the EU) andForxiga(dapagliflozin). The agreements for saxagliptin exclude Japan which is not covered by the alliance.Onglyza,Kombiglyze andKomboglyze are indicated for use in the treatment of diabetes. In this document unless specifically noted, we refer to bothKombiglyze andKomboglyze asKombiglyze.Forxiga is currently being studied for the treatment of diabetes.Onglyza andForxiga were discovered by BMS.Kombiglyze was codeveloped with AstraZeneca. Both companies jointly develop the clinical and marketing strategy and share commercialization expenses and profits and losses equally on a global basis and also share in development costs, with the exception ofForxiga development costs in Japan, which are borne by AstraZeneca. BMS manufactures both products. BMS has opted to decline involvement in cocommercialization for both products in certain countries not in the BMS global commercialization network and instead receives compensation based on net sales recorded by AstraZeneca in these countries. Opt-out compensation recorded by BMS was not material in the three and nine months ended September 30, 2012.

BMS received $300 million in upfront, milestone and other licensing payments related to saxagliptin as of September 30, 2012 and $170 million in upfront, milestone and other licensing payments related to dapagliflozin as of September 30, 2012.

Summarized financial information related to this alliance is as follows:equity method:

 

  Three Months  Ended
September 30,
  Nine Months  Ended
September 30,
 
Dollars in Millions         2012                  2011          2012  2011 

Net sales

 $266  $127  $599  $320 

Profit sharing expense

  118   58   268   148 

Commercialization expense reimbursements to/(from) AstraZeneca

  (43  (11  (62  (30

Research and development expense reimbursements to/(from) AstraZeneca

  (17  4   (7  33 

Amortization (income)/expense – upfront, milestone and other licensing
payments recognized in:

    

Cost of products sold

  (50      (50    

Other (income)/expense

  (9  (10  (30  (28

Upfront, milestone and other licensing payments received:

    

Amylin-related products

  3,570       3,570     

Dapagliflozin

              120 
Dollars in Millions       September 30,
2012
  December 31,
2011
 

Deferred income – upfront, milestone and other licensing payments:

    

Amylin-related products

   $3,520  $  

Saxagliptin

    213   230 

Dapagliflozin

    129   142 

   Three Months Ended March 31, 
Dollars in Millions          2013                   2012         

Net sales

  $49   $319 

Gross profit

   37    138 

Net income

   36    122 

Pfizer

BMS and Pfizer Inc. (Pfizer) maintain a worldwide codevelopment and cocommercialization agreement forEliquis, an anticoagulant discovered by BMS for the prevention and treatment of atrial fibrillation and other arterial thrombotic conditions.Eliquis was approved in the European Union in November 2012 and in the U.S. and Japan in December 2012 to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation (NVAF). Pfizer funds 60% of all development costs under the initial development plan effective January 1, 2007. The companies jointly develop the clinical and marketing strategy and share commercialization expenses and profits equally on a global basis. In certain countries not in the BMS global commercialization network, Pfizer will commercializeEliquis alone and will pay BMS compensation to BMS based on a percentage of net sales. BMS manufactures the product globally.and is the principal in third party customer sales.

BMS has received $559$684 million in upfront, milestone and other licensing payments forEliquis as of September 30, 2012.to date, and could receive up to an additional $200 million for development and regulatory milestones.

Summarized financial information related to this alliance is as follows:

 

 Three Months Ended September 30, Nine Months Ended September 30,   Three Months Ended March 31, 
Dollars in Millions         2012                 2011                 2012                 2011                   2013                 2012         

Net sales

 $   $   $1  $    $22  $ 

Profit sharing expense

   10    

Commercialization expense reimbursement to/(from) Pfizer

  (6  (2  (14  (5   (12  (5

Research and development reimbursements to/(from) Pfizer

  (1  (16  10   (74   7   2 

Amortization (income)/expense – upfront, milestone and other
licensing payments

  (10  (8  (29  (24

Amortization (income)/expense – upfront, milestone and other licensing receipts

   (10  (10

Upfront, milestone and other licensing receipts

   125    
Dollars in Millions     September 30,
2012
 December 31,
2011
   March 31,
2013
 December 31,
2012
 

Deferred income – upfront, milestone and other licensing payments

   $405  $434 

Deferred income – upfront, milestone and other licensing receipts

  $512  $397 

Note 4. ACQUISITIONSThe Medicines Company

Amylin Pharmaceuticals, Inc. Acquisition

On August 8, 2012,In February 2013, BMS completedand The Medicines Company entered into a two year collaboration forRecothrom, a recombinant thrombin for use as a topical hemostat to control non-arterial bleeding during surgical procedures (previously acquired by BMS in connection with its acquisition of ZymoGenetics in 2010). Net sales ofRecothrom were $67 million in 2012. In connection with the outstanding sharescollaboration, The Medicines Company received the right to sell, distribute and marketRecothrom on a global basis for two years, and will have certain responsibilities related to regulatory matters. During the collaboration term, BMS will exclusively supplyRecothrom to The Medicines Company pursuant to a supply agreement at cost plus a markup and will also receive royalties equal to a tiered percentage of Amylin, a biopharmaceutical company focused on the discovery, development and commercializationnet sales of innovative medicines to treat diabetes and other metabolic diseases. Acquisition costs of $29 million were included in other expenses.

BMS obtained full U.S. commercialization rights to Amylin’s two primary commercialized assets,Bydureon*Recothrom, a once-weekly diabetes treatment andByetta*, a daily diabetes treatment, both of which are glucagon-like peptide-1 (GLP-1) receptor agonists approved in certain countries to improve glycemic control in adults with type 2 diabetes. BMS also obtained full commercialization rights toSymlin* (pramlintide acetate), an amylinomimetic approved in the U.S. for adjunctive therapy to mealtime insulin to treat diabetes. Goodwill generated from this acquisition was primarily. Certain employees directly attributed to the expansionbusiness and certain assets were transferred to The Medicines Company at the start of our diabetes franchise.the collaboration period, including theRecothrom Biologics License Application and related regulatory assets. BMS retained all other assets related toRecothrom including the patents, trademarks and inventory.

As part of the agreement, BMS granted The Medicines Company an option to acquire the patents, trademarks, inventory and certain other assets exclusively related toRecothrom at a price determined based on a multiple of sales plus the cost of any remaining inventory held by BMS at that time. If the option is not exercised, all assets previously transferred to The Medicines Company during the collaboration period revert back to BMS. The option may be exercised by The Medicines Company between February and August 2014, with closing to occur in February 2015.

As consideration for entering into the collaboration, BMS received $115 million at the start of the collaboration which was allocated to the license and other rights transferred to The Medicines Company ($80 million) and the fair value of the option to purchase the remaining assets at the end of the collaboration ($35 million). The allocation was based on the estimated fair value of the option after considering various market factors, including an analysis of any estimated excess of the fair value of the business over the potential purchase price if the option is exercised. The fair value of acquired intangible assets, including in-process researchthe option was determined using Level 3 inputs and development (IPRD), wasrecorded as a liability. Changes in the estimated utilizing the income method which risk adjusted the expected future net cash flows estimated to be generated from the compounds based upon estimated probabilities of technical and regulatory success (PTRS). All acquired intangible assets were valued utilizing a global view that considered all potential jurisdictions and indications. Actual cash flows are likely to be different than those assumed.

IPRD was attributed to metreleptin, an analogfair value of the human hormone leptine being studiedoption liability are recognized in other (income)/expense and developedwere not material in the three months ended March 31, 2013. The remaining $80 million will be recognized as alliance revenue throughout the term of the collaboration, of which $7 million was recognized during the three months ended March 31, 2013.

BMS will also recognize alliance revenue during the collaboration period for tiered royalties and supply of product. BMS will provide certain information technology, regulatory, order processing, distribution and other transitional services in exchange for a fee during a period up to six months commencing at the treatmentstart of diabetes and/or hypertriglyceridemiathe collaboration. Alliance revenue related to tiered royalties, product supply and other services were not material in pediatricthe three months ended March 31, 2013.

Valeant

In October 2012, BMS and adult patientsPharmaSwiss SA, a wholly-owned subsidiary of Valeant Pharmaceuticals International Inc. (Valeant) entered into a collaboration for certain mature brand products in Europe. In connection with inherited or acquired lipodystrophy.the collaboration, Valeant received the right to sell, distribute, and market the products in Europe through December 31, 2014 and will have certain responsibilities related to regulatory matters in the covered territory. During the collaboration term, BMS will exclusively supply the products to Valeant pursuant to a supply agreement at cost plus a markup.

As part of the agreement, BMS granted Valeant an option to acquire the trademarks and intellectual property exclusively related to the products at a price determined based on a multiple of sales. If the right is not exercised, all rights transferred to Valeant during the collaboration period revert back to BMS. The estimated useful lifeoption may be exercised by Valeant between January and June 2014, with closing to occur in December 2014.

As consideration for entering into the collaboration, BMS received $79 million at the start of the collaboration period which was allocated to the license and other rights transferred to Valeant ($61 million) and the cash flows utilized tofair value metreleptin assumed initial positive cash flows to commence shortly after the expected receipt of regulatory approvals, subject to trial results.

The results of Amylin’s operations are included in the consolidated financial statements from August 9, 2012.

Inhibitex, Inc. Acquisition

On February 13, 2012, BMS completed its acquisition of the outstanding sharesoption to purchase the remaining assets at the end of Inhibitex, Inc. (Inhibitex), a clinical-stage biopharmaceutical company focusedthe collaboration ($18 million). The allocation was based on developing products to prevent and treat serious infectious diseases. Acquisition coststhe estimated fair value of $12 million were included in other expense. BMS obtained Inhibitex’s lead asset, INX-189,the option after considering various market factors, including an oral nucleotide polymerase (NS5B) inhibitor in Phase II development foranalysis of any estimated excess of the treatmentfair value of chronic hepatitis C infections. Goodwill generated from this acquisition was primarily attributed tothe mature brands business over the potential purchase price if the option to offer a full portfolio of therapy choices for hepatitis infections as well as to provide additional levels of sustainability to BMS’s virology pipeline.

purchase is exercised at December 31, 2014. The fair value of IPRDthe option was determined using Level 3 inputs and recorded as a liability. Changes in the estimated utilizingfair value of the income methodoption liability are recognized in other (income)/expense and were not material for the three months ended March 31, 2013. The remaining $61 million will be recognized as alliance revenue throughout the term of the collaboration of which risk adjusted$7 million was recognized during the three months ended March 31, 2013.

BMS will also recognize revenue during the collaboration period for the supply of the product, and provide certain information technology, regulatory, order processing, distribution and other transitional services in exchange for a fee during the first six months of the collaboration. Alliance revenue related to product supply and other services were not material in the three months ended March 31, 2013.

Reckitt Benckiser Group plc

In February 2013, BMS and Reckitt Benckiser Group plc (RBL) agreed to enter into a three year collaboration regarding several over-the-counter-products sold primarily in Mexico and Brazil. The transaction is expected future net cash flows estimated to close during the second quarter of 2013, subject to customary closing conditions and regulatory approvals. Net sales of these products were approximately $100 million in 2012.

In connection with the collaboration, RBL will be generated fromresponsible for all sales, distribution, marketing and certain regulatory matters and BMS will be responsible for the compounds based upon estimated PTRS and a global view that considered all potential jurisdictions and indications.

IPRD was primarily attributed to INX-189. INX-189 wasexclusive supply of the products. Certain limited assets are expected to be most effective when used in combination therapy and it was assumed alltransferred to RBL at the start of the collaboration period, primarily the market participants would inherently maintain franchise synergiesauthorizations, as well as certain employees directly attributed to maximizing the cash flows of their existing virology pipeline assets. The cash flows utilized to value INX-189 included such synergies and also assumed initial positive cash flows to commence shortly after the expected receipt of regulatory approvals, subject to trial results.

In August 2012, the Company discontinued development of INX-189 in the interest of patient safety. As a result, the Company recognized a non-cash, pre-tax impairment charge of $1.8 billionbusiness. BMS will retain all other assets related to the IPRD intangible asset inbusiness including the third quarter of 2012. For further information discussionpatents, trademarks and inventory during the collaboration period.

As part of the impairment charge, see “—Note 12. Goodwillproposed agreement, BMS will grant RBL an option to acquire the patents, trademarks, inventory and Other Intangible Assets.”

The results of Inhibitex’s operations are included incertain other assets exclusively related to the consolidated financial statements from February 13, 2012.

Significant estimates utilizedproducts at the timeend of the valuationscollaboration at a price determined based on a multiple of sales (plus the cost of any remaining inventory held by BMS at the time). If the option is not exercised, all assets previously transferred to supportRBL during the collaboration period revert back to BMS.

BMS is expected to receive proceeds of $482 million at the start of the collaboration period which will be allocated to the license and other rights transferred to RBL and the fair valuesvalue of the commercialoption to purchase the remaining assets and compounds withinat the acquisitions include:end of the collaboration.

Note 4. OTHER (INCOME)/EXPENSE

Other (income)/expense includes:

 

Dollars in Millions  Fair value   Discount
rate utilized
  Estimated
useful life
(in years)
  Phase of
Development as
of acquisition date
  PTRS
Rate
utilized
 Year of first
projected positive
cash flow

Commercialized products:

          

Bydureon*

  $5,240    11.1 13  N/A  N/A N/A

Byetta*

   750    10.0 7  N/A  N/A N/A

Symlin*

   300    10.0 9  N/A  N/A N/A

IPRD:

          

BMS-986094 (formerly INX-189)

   1,830    12.0 11  Phase II  38% 2017

Metreleptin

   370    12.0 12  Phase III  75% 2014

The components of the cash paid to acquire Amylin and Inhibitex were as follows:

                                      
Dollars in Millions  Amylin   Inhibitex 

Total consideration transferred

  $5,218   $2,539 

Stock-based compensation expense

   94      
  

 

 

   

 

 

 

Total cash paid

  $5,312   $2,539 
  

 

 

   

 

 

 

The preliminary purchase price allocation for Amylin (pending final valuation of intangible assets and deferred income taxes) and the final purchase price allocation for Inhibitex were as follows:

                                      
Dollars in Millions       
Identifiable net assets:  Amylin  Inhibitex 

Cash

  $179  $46 

Marketable securities

   108   17 

Inventory

   178     

Property, plant and equipment

   773     

Developed technology rights

   6,290     

IPRD

   370   1,875 

Other assets

   136     

Debt obligations

   (2,020  (23

Other liabilities

   (339  (10

Deferred income taxes

   (1,156  (579
  

 

 

  

 

 

 

Total identifiable net assets

   4,519   1,326 
  

 

 

  

 

 

 

Goodwill

  $699  $1,213 
  

 

 

  

 

 

 

Cash paid for the acquisition of Amylin included payments of $5,093 million to its outstanding common stockholders and $219 million to holders of its stock options and restricted stock units (including $94 million attributed to accelerated vesting that was accounted for as stock compensation expense in the third quarter of 2012).

Pro forma supplemental financial information is not provided as the impacts of the acquisitions were not material to operating results in the year of acquisition. Goodwill, IPRD and all intangible assets valued in these acquisitions are non-deductible for tax purposes.

   Three Months Ended March 31, 
Dollars in Millions          2013                  2012         

Interest expense

  $50  $42 

Investment income

   (25  (36

Provision for restructuring

   33   22 

Litigation charges/(recoveries)

      (172

Equity in net income of affiliates

   (36  (57

Out-licensed intangible asset impairment

      38 

Gain on sale of product lines, businesses and assets

   (1   

Other income received from alliance partners, net

   (57  (46

Other

   17   25 
  

 

 

  

 

 

 

Other (income)/expense

  $(19 $(184
  

 

 

  

 

 

 

Note 5. RESTRUCTURING

The following is the provision for restructuring:

 

 Three Months Ended September 30, Nine Months Ended September 30,   Three Months Ended March 31, 
Dollars in Millions 2012 2011 2012 2011   2013   2012 

Employee termination benefits

 $21  $  4  $56  $72   $29   $19 

Other exit costs

  8   4   15   20    4    3 
 

 

  

 

  

 

  

 

   

 

   

 

 

Provision for restructuring

 $29  $8  $71  $92   $33   $22 
 

 

  

 

  

 

  

 

   

 

   

 

 

Restructuring charges included termination benefits for workforce reductions of manufacturing, selling, administrative, and research and development personnel across all geographic regions of approximately 185245 and 50120 for the three months ended September 30,March 31, 2013 and 2012, and 2011, respectively, and approximately 480 and 700 for the nine months ended September 30, 2012 and 2011, respectively.

The following table represents the activity of employee termination and other exit cost liabilities:

 

 Nine Months Ended September 30,   Three Months Ended March 31, 
Dollars in Millions 2012 2011   2013 2012 

Liability at January 1

 $77  $126   $167  $77 
 

 

  

 

   

 

  

 

 

Charges

  77   94    34   22 

Changes in estimates

  (6  (2   (1   
 

 

  

 

   

 

  

 

 

Provision for restructuring

  71   92    33   22 

Foreign currency translation

  (1  1 

Amylin acquisition

  26     

Spending

  (66  (119   (58  (21
 

 

  

 

   

 

  

 

 

Liability at September 30

 $ 107  $100 

Liability at March 31

  $142  $78 
 

 

  

 

   

 

  

 

 

Note 6. INCOME TAXES

The effective tax benefit rate was 43.4% on the pretax loss during the third quarter of 2012 compared to an effective tax rate of 26.0% on pretax earnings during the third quarter of 2011. The effective income tax rates were 13.7% and 25.2% duringrate on earnings was 7.6% for the ninethree months ended September 30, 2012March 31, 2013 and 2011, respectively.26.9% for the three months ended March 31, 2012. The overall tax benefit rate of 43.4% attributed to the pretax lossdecrease in the current quarter was due to the mix of earnings in low tax jurisdictions and pretax loss in the higher U.S. tax jurisdiction resulting from a $1,830 million intangible asset impairment charge. The impact of the impairment charge reduced the effective tax rate by 11 percentage points duringresulted primarily from favorable earnings mix between high and low tax jurisdictions attributable to lowerPlavix*sales and to a lesser extent, an internal transfer of intellectual property in the nine months ended September 30,fourth quarter of 2012. In addition, the retroactive reinstatement of the R&D tax credit and look thru exception for the full year 2012 was recognized in the first quarter of 2013 ($43 million).

The effective tax rate is typically lower than the U.S. statutory rate of 35% primarily attributable to undistributed earnings of certain foreign subsidiaries that have been considered or are expected to be indefinitely reinvested offshore. If these earnings are repatriated to the U.S. in the future, or if it was determined that such earnings are to be remitted in the foreseeable future, additional tax provisions would be required. Reforms to U.S. tax laws related to foreign earnings have been proposed and if adopted, may increase taxes, which could reduce the results of operations and cash flows.

The decrease in the effective tax rate in the nine months ended September 30, 2012 was due to:

Favorable earnings mix between high and low tax jurisdictions primarily attributed to the $1,830 million IPRD impairment charge in the U.S.

Partially offset by:

Lower tax benefits from contingent tax matters ($30 million charge in 2012 and $75 million benefit in 2011);

An unfavorable impact on the current year rate from the research and development tax credit, which was not extended as of September 30, 2012; and

Changes in prior period estimates upon finalizing U.S. tax returns resulting in a $54 million benefit in 2011.

BMS is currently under examinationaudited by a number of tax authorities which have proposed adjustmentsand significant disputes may arise related to tax for issues such as transfer pricing, certain tax credits and the deductibility of certain expenses. BMS estimates that it is reasonably possible that the total amount of unrecognized tax benefits at September 30, 2012March 31, 2013 could decrease in the range of approximately $20$375 million to $50$405 million in the next twelve months as a result of the settlement of certain tax audits and other events resulting in the payment of additional taxes, the adjustment of certain deferred taxes and/or the recognition of tax benefits. It is also reasonably possible that new issues will be raised by tax authorities which may require adjustments to the amount of unrecognized tax benefits; however, an estimate of such adjustments cannot reasonably be made at this time. BMS believes that it has adequately provided for all open tax years by tax jurisdiction.

Note 7. EARNINGS/(LOSS)EARNINGS PER SHARE

 

   Three Months Ended September 30,  Nine Months Ended September 30, 
Amounts in Millions, Except Per Share Data  2012  2011  2012  2011 

Net Earnings/(Loss) Attributable to BMS

  $(711 $969  $1,035  $2,857 

Earnings attributable to unvested restricted shares

       (2  (1  (6
  

 

 

  

 

 

  

 

 

  

 

 

 

Net Earnings/(Loss) Attributable to BMS common shareholders

  $(711 $967  $1,034  $2,851 
  

 

 

  

 

 

  

 

 

  

 

 

 

Earnings/(Loss) per share – basic

  $(0.43 $0.57  $0.62  $1.67 
  

 

 

  

 

 

  

 

 

  

 

 

 

Weighted-average common shares outstanding – basic

   1,666   1,698   1,679   1,703 

Contingently convertible debt common stock equivalents

       1   1   1 

Incremental shares attributable to share-based compensation plans

       16   17   13 
  

 

 

  

 

 

  

 

 

  

 

 

 

Weighted-average common shares outstanding – diluted

   1,666   1,715   1,697   1,717 
  

 

 

  

 

 

  

 

 

  

 

 

 

Earnings/(Loss) per share – diluted

  $(0.43 $0.56  $0.61  $1.66 
  

 

 

  

 

 

  

 

 

  

 

 

 

Anti-dilutive weighted-average equivalent shares – stock incentive plans

       11   2   28 
  

 

 

  

 

 

  

 

 

  

 

 

 

Contingently convertible debt common stock equivalents and incremental shares attributable to share-based compensation plans of 17 million were excluded from the per share calculation for the three months ended September 30, 2012 because of the net loss in that period.

   Three Months Ended March 31, 
Amounts in Millions, Except Per Share Data  2013   2012 

Net Earnings Attributable to BMS

  $609   $1,101 

Earnings attributable to unvested restricted shares

       (1
  

 

 

   

 

 

 

Net Earnings Attributable to BMS common shareholders

  $609   $1,100 
  

 

 

   

 

 

 

Earnings per share – basic

  $0.37   $0.65 
  

 

 

   

 

 

 

Weighted-average common shares outstanding – basic

   1,638    1,687 

Contingently convertible debt common stock equivalents

   1    1 

Incremental shares attributable to share-based compensation plans

   16    18 
  

 

 

   

 

 

 

Weighted-average common shares outstanding – diluted

   1,655    1,706 
  

 

 

   

 

 

 

Earnings per share – diluted

  $0.37   $0.64 
  

 

 

   

 

 

 

Anti-dilutive weighted-average equivalent shares – stock incentive plans

   1    7 
  

 

 

   

 

 

 

Note 8. FINANCIAL INSTRUMENTS

Financial instruments include cash and cash equivalents, marketable securities, accounts receivable and payable, debt instruments and derivatives. DueThe carrying amount of receivables and accounts payable approximates fair value due to their short-term maturity, the carrying amount of account receivables and payables approximate fair value. 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.maturity.

BMS has exposure to market risk due to changesChanges in currency exchange rates and interest rates. As a result, certainrates create exposure to market risk. 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 initial and periodic assessmentseffectiveness of the effectiveness in offsetting hedged exposures. Changes in fair value of derivatives that do not qualify for hedge accounting are recognized in earnings as they occur. Derivative financial instruments are not used for trading purposes.

All financialFinancial instruments including derivatives, are subject to counterparty credit risk which is considered as part of the overall fair value measurement. Counterparty credit risk is monitored on an ongoing basis and is mitigated by limiting amounts outstanding with any individual counterparty, utilizing conventional derivative financial instruments and only entering into agreements with counterparties that meet high credit quality standards. The consolidated financial statements would not be materially impacted if any counterparty failed to perform according to the terms of its agreement. Under the terms of the agreements, posting of collateralCollateral is not required by any party whether derivatives are in an asset or liability position.position under the terms of the agreements.

Fair Value Measurements –The fair values of financial instruments are classified into one of the following categories:

Level 1 inputs utilize non-binding quoted prices (unadjusted) in active markets that are accessible at the measurement date for identical assets or liabilities. The fair value hierarchy gives the highest priority to Level 1 inputs. These instruments include U.S. treasury securities.

Level 2 inputs includeutilize observable prices for similar instruments, non-binding quoted prices for identical or similar instruments in markets that are not active, and other observable inputs that can be corroborated by market data for substantially the full term of the assets or liabilities. These instruments include corporate debt securities, commercial paper, Federal Deposit Insurance Corporation (FDIC) insured debt securities, certificates of deposit, money market funds, foreign currency forward contracts, interest rate swap contracts, forward starting interest rate swap contracts, equity funds, fixed income funds and long-term debt. Additionally, certain corporate debt securities utilize a third-party matrix-pricingmatrix pricing model that uses significant inputs corroborated by market data for substantially the full term of the assets. Equity and fixed income funds are primarily invested in publicly traded securities and are valued at the respective net asset value of the underlying investments. There were no significant unfunded commitments or restrictions on redemptions related to equity and fixed income funds as of September 30, 2012.March 31, 2013. Level 2 derivative instruments are valued using London Interbank Offered Rate (LIBOR) and Euro Interbank Offered Rate (EURIBOR) yield curves, less credit valuation adjustments, and observable forward foreign exchange rates at the reporting date. Valuations of derivative contracts may fluctuate considerably from period-to-period due to volatility in underlying foreign currencies and underlying interest rates, which are driven by market conditions and the duration of the contract. Credit 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.

Level 3 unobservable inputs are used when little or no market data is available. Valuation models for the Auction Rate Security (ARS) and Floating Rate Security (FRS) portfolio 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 the ARS was determined using an internally developed valuation which was based in part on indicative bids received on the underlying assets of the security and other evidence of fair value. The ARS is a private placement security rated ‘BBB’‘BBB-’ by Standard and Poor’s as of March 31, 2013 and represents interests in insurance securitizations. Due to the current lack of an active market for the FRS and the general lack of transparency into itstheir underlying assets, other qualitative analysis is relied upon to value the FRS including discussions with brokers and fund managers, default risk underlying the security and overall capital marketmarkets liquidity. The fair value of written options to sell the assets of certain businesses in connection with collaboration agreements (see “—Note 3. Alliances and Collaborations” for further discussion) is based on an option pricing methodology that considers revenue and profitability projections, volatility, discount rates, and potential exercise price assumptions.

Available-For-Sale Securities and Cash Equivalents

The following table summarizes available-for-sale securities at September 30, 2012March 31, 2013 and December 31, 2011:2012:

 

  Amortized
Cost
   Gross
Unrealized
Gain in
Accumulated
OCI
   Gross
Unrealized
Loss in
Accumulated
OCI
  Gain/(Loss)
in

Income
   Fair
Value
   

 

Fair Value

 
Dollars in Millions     Level 1   Level 2   Level 3   Amortized
Cost
   Gross
Unrealized
Gain in
Accumulated
OCI
   Gross
Unrealized
Loss in
Accumulated
OCI
  Gain/(Loss)
in

Income
   Fair
Value
   

 

Fair Value

 

September 30, 2012

               

Marketable Securities

               
Dollars in Millions Amortized
Cost
   Gross
Unrealized
Gain in
Accumulated
OCI
   Gross
Unrealized
Loss in
Accumulated
OCI
  Gain/(Loss)
in

Income
   Fair
Value
   Level 1   Level 2   Level 3 
         

Certificates of Deposit

  $121   $    $   $    $121   $    $121   $    $173   $    $   $    $173   $    $173   $  

Corporate Debt Securities

   4,337    94             4,431         4,431         4,032    75             4,107         4,107      

Commercial Paper

   240                  240         240      

U.S. Treasury Securities

   150    1             151    151           

FDIC Insured Debt Securities

   50                  50         50      

Equity Funds

   51             5    56         56         52             10    62         62      

Fixed Income Funds

   46             1    47         47         47                  47         47      

ARS

   9    1             10              10    8    3             11              11 

FRS

   21         (2       19              19    21         (1       20              20 
  

 

   

 

   

 

  

 

   

 

   

 

   

 

   

 

   

 

   

 

   

 

  

 

   

 

   

 

   

 

   

 

 

Total Marketable Securities

  $5,025   $96   $(2 $6   $5,125   $151   $4,945   $29   $4,333   $78   $(1 $10   $4,420   $    $4,389   $31 
  

 

   

 

   

 

  

 

   

 

   

 

   

 

   

 

   

 

   

 

   

 

  

 

   

 

   

 

   

 

   

 

 

December 31, 2011

               

Marketable Securities

               

December 31, 2012

               

Certificates of Deposit

  $1,051   $    $   $    $1,051   $    $1,051   $    $34   $    $   $    $34   $    $34   $  

Corporate Debt Securities

   2,908    60    (3       2,965         2,965         4,305    72             4,377         4,377      

Commercial Paper

   1,035                  1,035         1,035      

U.S. Treasury Securities

   400    2             402    402              150                  150    150           

FDIC Insured Debt Securities

   302    1             303         303      

Equity Funds

   52             5    57         57      

Fixed Income Funds

   47                  47         47      

ARS

   80    12             92              92    8    3             11              11 

FRS

   21         (3       18              18    21         (1       20              20 
  

 

   

 

   

 

  

 

   

 

   

 

   

 

   

 

   

 

   

 

   

 

  

 

   

 

   

 

   

 

   

 

 

Total Marketable Securities

  $5,797   $75   $(6 $    $5,866   $402   $5,354   $110   $4,617   $75   $(1 $5   $4,696   $150   $4,515   $31 
  

 

   

 

   

 

  

 

   

 

   

 

   

 

   

 

   

 

   

 

   

 

  

 

   

 

   

 

   

 

   

 

 

The following table summarizes the classification of available for sale securities in the consolidated balance sheet:

 

                                            
Dollars in Millions  September 30,
2012
   December 31,
2011
   March 31,
2013
   December 31,
2012
 

Current Marketable Securities

  $1,427   $2,957   $1,178   $1,173 

Non-current Marketable Securities

   3,698    2,909    3,242    3,523 
  

 

   

 

   

 

   

 

 

Total Marketable Securities

  $5,125   $5,866   $4,420   $4,696 
  

 

   

 

   

 

   

 

 

Money market funds and other securities aggregating $1,203$935 million and $5,469$1,288 million at September 30, 2012March 31, 2013 and December 31, 2011,2012, respectively, were included in cash and cash equivalents and valued using Level 2 inputs.

At September 30, 2012, $3,688March 31, 2013, $3,231 million of non-current available for sale corporate debt securities and FRS mature within five years. All auction rate securities mature beyond 10 years.

The change in fair value for the investments in equity and fixed income funds are recognized in the results of operationsother (income)/expense and are designed to offset the changes in fair value of certain employee retirement benefits.

The following table summarizes the activity for financial assets utilizing Level 3 fair value measurements:

 

                                            
  2012 2011   2013   2012 

Fair value at January 1

  $110  $110   $31   $110 

Sales

   (81           (81
  

 

  

 

   

 

   

 

 

Fair value at September 30

  $29  $110 

Fair value at March 31

  $31   $29 
  

 

  

 

   

 

   

 

 

Qualifying Hedges

The following table summarizes the fair value of outstanding derivatives:

 

     September 30, 2012 December 31, 2011      March 31, 2013 December 31, 2012 
Dollars in Millions  

Balance Sheet Location

  Notional   Fair Value
(Level 2)
 Notional   Fair Value
(Level 2)
   

Balance Sheet Location

  Notional   Fair Value
(Level 2)
 Notional   Fair Value
(Level 2)
 

Derivatives designated as hedging instruments:

                  

Interest rate swap contracts

  

Other assets

  $573   $154  $579   $135   

Other assets

  $1,273   $134  $573   $146 

Foreign currency forward contracts

  

Other assets

   953    47 �� 1,347    88   

Other assets

   1,231    87   735    59 

Foreign currency forward contracts

  

Accrued expenses

   993    (23  480    (29  

Accrued expenses

   286    (7  916    (30

Forward starting interest rate swap contracts

  

Accrued expenses

   80            

Cash Flow Hedges—Hedges —Foreign currency forward contracts are primarily utilized to hedge forecasted intercompany inventory purchase transactions in certain foreign currencies. These forward contracts are designated as cash flow hedges with the effective portion of changes in fair value being temporarily reported in accumulated other comprehensive income (OCI)loss and recognized in earnings when the hedged item affects earnings. As of September 30, 2012, significant outstanding foreign currency forward contracts were primarily attributed to Euro and Japanese yen foreign currency forward contracts in the notional amount of $1,130 million and $504 million, respectively.

The net gaingains on foreign currency forward contracts qualifying for cash flow hedge accounting isare expected to be reclassified to cost of products sold within the next two years, including $33$67 million of pre-tax gains to be reclassified within the next 12 months. The notional amount of outstanding foreign currency forward contracts was primarily attributed to the Euro ($839 million) and Japanese yen ($365 million) at March 31, 2013.

During 2013, BMS entered into an aggregate $80 million notional amount of forward starting interest rate swap contracts maturing in December 2013 with several financial institutions to hedge the variability of probable forecasted interest expense. The Company designated these contracts as cash flow hedges, with effective changes in fair value recorded net of tax in accumulated other comprehensive loss.

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. Assessments to determine whether derivatives designated as qualifying hedges are highly effective in offsetting changes in the cash flows of hedged items are performed at inception and on a quarterly basis. Any ineffective portion of the change in fair value is included in current period earnings. The earnings impact related to discontinued cash flow hedges and hedge ineffectiveness was not significant during the three and nine months ended September 30, 2012March 31, 2013 and 2011.2012.

Net Investment Hedges—Hedges —Non-U.S. dollar borrowings of €541 million ($698696 million) are designated to hedge the foreign currency exposures of the net investment in certain foreign affiliates. These borrowings are designated as net investment hedges and recognized in long-term debt. The effective portion of foreign exchange gains or losses on the remeasurement of the debt is recognized in the foreign currency translation component of accumulated OCIother comprehensive loss with the related offset in long-term debt.

Fair Value Hedges—Hedges —Fixed-to-floating interest rate swap contracts are designated as fair value hedges and are used as part of an interest rate risk management strategy to create an appropriate balance of fixed and floating rate debt. The swaps and underlying debt for the benchmark risk being hedged are recorded at fair value. When the underlying swap is terminated prior to maturity, the fair value basis adjustment to the underlying debt instrument is amortized into earnings as an adjustment to interest expense over the remaining term of the debt.

During the nine months ended September 30, 2011,2013, fixed-to-floating interest rate swap agreements of $1.6 billioncontracts were executed to convert $500 million notional amount and €1.0 billion notional amount were terminated generating total proceeds of $356 million (including accrued interest of $66 million). The basis adjustment from the swap terminations is amortized as interest expense over the remaining life of the underlying debt.

The adjustment to debt from interest rate swaps that qualify as fair value hedges and other items was as follows:

Dollars in Millions  September 30,
2012
  December 31,
2011
 

Principal Value

  $6,601  $4,669 

Adjustments to Principal Value:

   

Fair value of interest rate swaps

   154   135 

Unamortized basis adjustment from swap terminations

   528   594 

Unamortized bond discounts

   (56  (22
  

 

 

  

 

 

 

Total

  $7,227  $5,376 
  

 

 

  

 

 

 

Current portion of long-term debt

  $619  $  

Long-term debt

   6,608   5,376 

During the three months ended September 30, 2012, $2.0 billion of senior unsecured notes were issued: $750 million in aggregate principal amount of 0.875% Notes dueDue 2017 $750and $200 million in aggregate principalnotional amount of 2.000%5.45% Notes due 2022Due 2018 from fixed rate debt to variable rate debt.

Long-term debt and $500 million in aggregate principal amountthe current portion of 3.250% Notes due 2042 in a registered public offering. Interest on the notes will be paid semi-annually on each February 1 and August 1 beginning February 1, 2013. The notes rank equally in right of payment with all of BMS’s existing and future senior unsecured indebtedness. BMS may redeem the notes, in whole or in part, at any time at a predetermined redemption price. The net proceeds of the note issuances were $1,950 million, which is net of a discount of $36 million and deferred loan issuance costs of $14 million.

Commercial paper was issued and matured during the three months ended September 30, 2012 with an average amount outstanding of $526 million at a weighted-average interest rate of 0.15%. There were no commercial paper borrowings at September 30, 2012.

Substantially all of the $2.0 billionlong-term debt obligations assumed in the acquisition of Amylin were repaid during the three months ended September 30, 2012, including a promissory note with Lilly with respect to a revenue sharing obligation and Amylin senior notes due 2014.

Debt repurchase activity was as follows:includes:

 

   Nine Months Ended September 30, 
Dollars in Millions  2012   2011 

Principal amount

  $2,052   $     71 

Carrying value

   2,081    88 

Repurchase price

   2,108    78 

Notional amount of interest rate swaps terminated

   6    34 

Swap termination proceeds

   2    6 

Total (gain)/loss

   27    (10
                                            
Dollars in Millions  March 31,
2013
  December 31,
2012
 

Principal Value

  $6,609  $6,631 

Adjustments to Principal Value:

   

Fair value of interest rate swap contracts

   134   146 

Unamortized basis adjustment from interest rate swap contract terminations

   490   509 

Unamortized bond discounts

   (53  (54
  

 

 

  

 

 

 

Total

  $7,180  $7,232 
  

 

 

  

 

 

 

Current portion of long-term debt

  $658  $664 

Long-term debt

   6,522   6,568 

The fair value of debt was $8,350$8,112 million at September 30, 2012March 31, 2013 and $6,406$8,285 million at December 31, 20112012 and was valued using Level 2 inputs. Interest payments were $125$49 million and $52$33 million for the ninethree months ended September 30,March 31, 2013 and 2012, and 2011, respectively, net of amounts related to interest rate swap contracts.

In July 2012, BMS entered intoThe average amount of commercial paper outstanding was $211 million at a new $1.5 billion five year revolving credit facility. There are no financial covenants underweighted-average interest rate of 0.14% during the new facility. This revolving credit facility is in addition to the Company’s existing $1.5 billion revolving credit facilitythree months ended March 31, 2013. The maximum month end amount of commercial paper outstanding was $600 million, which was established in September 2011 with a syndicate of lenders. Thereoutstanding at March 31, 2013. No commercial paper borrowings were no borrowings under either revolving credit facilityoutstanding at September 30, 2012 and December 31, 2011.

2012.

Debt repurchase activity was as follows:

                                            
   Three Months Ended March 31, 
Dollars in Millions  2013   2012 

Principal amount

  $    $    80 

Carrying value

       90 

Repurchase price

    ��  109 

Notional amount of interest rate swaps terminated

       6 

Swap termination proceeds

       2 

Total loss

       19 

Note 9. RECEIVABLES

Receivables include:

 

                                            
Dollars in Millions  September 30,
2012
 December 31,
2011
   March 31,
2013
 December 31,
2012
 

Trade receivables

  $1,844  $2,397   $1,897  $1,812 

Less allowances

   (110  (147   (99  (104
  

 

  

 

   

 

  

 

 

Net trade receivables

   1,734   2,250    1,798   1,708 

Alliance partners receivables

   755   1,081 

Alliance receivables

   969   857 

Prepaid and refundable income taxes

   202   256    336   319 

Miscellaneous receivables

   198   156 

Other

   205   199 
  

 

  

 

   

 

  

 

 

Receivables

  $2,889  $3,743   $3,308  $3,083 
  

 

  

 

   

 

  

 

 

Receivables are netted with deferred income related to alliance partners until recognition of income. As a result, alliance partner receivables and deferred income were reduced by $1,081$1,047 million and $901$1,056 million at September 30, 2012March 31, 2013 and December 31, 2011,2012, respectively. For additional information regarding alliance partners, see “—Note 3. Alliances and Collaborations.” Non-U.S. receivables sold on a nonrecourse basis were $734$224 million and $806$213 million for the ninethree months ended September 30,March 31, 2013 and 2012, and 2011, respectively. In the aggregate, receivables due from three pharmaceutical wholesalers in the U.S. represented 39%40% and 55%37% of total trade receivables at September 30, 2012March 31, 2013 and December 31, 2011,2012, respectively.

Note 10. INVENTORIES

Inventories include:

 

                                            
Dollars in Millions  September 30,
2012
   December 31,
2011
   March 31,
2013
   December 31,
2012
 

Finished goods

  $533   $478   $569   $572 

Work in process

   868    646    884    814 

Raw and packaging materials

   296    260    338    271 
  

 

   

 

   

 

   

 

 

Inventories

  $1,697   $1,384   $1,791   $1,657 
  

 

   

 

   

 

   

 

 

Inventories of $374 million expected to remain on-hand beyond one year wereare included in non-currentother assets (including $29and were $376 million of inventories at risk). The status of the regulatory approval processMarch 31, 2013 and the probability of future sales were considered in assessing the recoverability of these costs.$424 million at December 31, 2012.

Note 11. PROPERTY, PLANT AND EQUIPMENT

Property, plant and equipment includes:

 

                                            
Dollars in Millions  September 30,
2012
 December 31,
2011
   March 31,
2013
 December 31,
2012
 

Land

  $114  $137   $113  $114 

Buildings

   4,897   4,545    5,028   4,963 

Machinery, equipment and fixtures

   3,648   3,437    3,806   3,695 

Construction in progress

   623   262    426   611 
  

 

  

 

   

 

  

 

 

Gross property, plant and equipment

   9,282   8,381    9,373   9,383 

Less accumulated depreciation

   (3,985  (3,860   (4,114  (4,050
  

 

  

 

   

 

  

 

 

Property, plant and equipment

  $5,297  $4,521   $5,259  $5,333 
  

 

  

 

   

 

  

 

 

Depreciation expense was $274$108 million and $333$85 million for the ninethree months ended September 30,March 31, 2013 and 2012, and 2011, respectively.

Note 12. GOODWILL AND OTHER INTANGIBLE ASSETS

Changes in the carrying amount of goodwill during the nine months ended September 30, 2012 were as follows:

Dollars in Millions    

Balance at January 1, 2012

  $5,586 

Inhibitex acquisition

   1,213 

Amylin acquisition

   699 
  

 

 

 

Balance at September 30, 2012

  $7,498 
  

 

 

 

Qualitative factors were assessed in the first quarter in determining whether it was more likely than not that the fair value of our aggregated geographic reporting units exceeded its carrying value. Examples of qualitative factors assessed included our share price, our financial performance compared to budgets, long-term financial plans, macroeconomic, industry and market conditions as well as the substantial excess of fair value over the carrying value of net assets from the annual impairment test performed in the prior year. Positive and negative influences of each relevant factor were assessed both individually and in the aggregate and as a result it was concluded that no additional quantitative testing was required.

At September 30, 2012March 31, 2013 and December 31, 2011,2012, other intangible assets consisted of the following:

 

      September 30, 2012   December 31, 2011                                             
Dollars in Millions  Estimated
Useful Lives
   Gross
Carrying
Amount
   Accumulated
Amortization
   Net
Carrying
Amount
   Gross
Carrying
Amount
   Accumulated
Amortization
   Net
Carrying
Amount
   March 31,
2013
 December 31,
2012
 

Licenses

   2 – 15 years    $1,178   $526   $652   $1,218   $443   $775   $1,159  $1,160 

Developed technology rights

   7 – 15 years     8,777    1,439    7,338    2,608    1,194    1,414    8,827   8,827 

Capitalized software

   3 – 10 years     1,189    919    270    1,147    857    290    1,204   1,200 

In-process research and development

   668   668 
    

 

   

 

   

 

   

 

   

 

   

 

   

 

  

 

 

Total finite-lived intangible assets

     11,144    2,884    8,260    4,973    2,494    2,479 
    

 

   

 

   

 

   

 

   

 

   

 

 

IPRD

     957         957    645         645 

Gross other intangible assets

   11,858   11,855 

Less accumulated amortization

   (3,288  (3,077
    

 

   

 

   

 

   

 

   

 

   

 

   

 

  

 

 

Total other intangible assets

    $12,101   $2,884   $9,217   $5,618   $2,494   $3,124   $8,570  $8,778 
    

 

   

 

   

 

   

 

   

 

   

 

   

 

  

 

 

The changes in the carrying amount of other intangible assets for the nine months ended September 30, 2012 and 2011 were as follows:

Dollars in Millions  2012  2011 

Other intangible assets carrying amount at January 1

  $3,124  $3,370 

Capitalized software and other additions

   44   54 

Acquisitions

   8,535   160 

Amortization expense

   (394  (261

Impairment charges

   (2,092  (30

Other

       (97
  

 

 

  

 

 

 

Other intangible assets, net carrying amount at September 30

  $9,217  $3,196 
  

 

 

  

 

 

 

Annual amortizationAmortization expense of other intangible assets is expected to be approximately $650was $216 million in 2012, $900and $101 million in 2013, $900 million in 2014, $800 million in 2015, $800 million in 2016 and an aggregate $4.6 billion beyond 2016.

On August 23, 2012, BMS announced that it has discontinued development of BMS-986094 (formerly known as INX-189), a nucleotide polymerase (NS5B) inhibitor that was in Phase II development for the treatment of hepatitis C. The decision was made in the interest of patient safety, based on a rapid, thoroughthree months ended March 31, 2013 and ongoing assessment of patients in a Phase II study that was voluntarily suspended on August 1, 2012. BMS acquired BMS-986094 with its acquisition of Inhibitex in February 2012. As a result of the termination of this development program, BMS recognized a $1,830 million pre-tax impairment charge related to the IPRD intangible asset.2012, respectively.

Note 13. DEFERRED INCOME

Deferred income includes:

 

                                  ��         
Dollars in Millions  September 30,
2012
   December 31,
2011
   March 31,
2013
   December 31,
2012
 

Upfront, milestone and other licensing payments

  $4,311   $882   $4,484   $4,346 

Atripla* deferred revenue

   211    113    271    339 

Gain on sale-leaseback transactions

   104    120    91    99 

Other

   69    88    27    65 
  

 

   

 

   

 

   

 

 

Total deferred income

  $4,695   $1,203   $4,873   $4,849 
  

 

   

 

   

 

   

 

 

Current portion

  $689   $337   $772   $825 

Non-current portion

   4,006    866    4,101    4,024 

For further information pertaining to upfront, milestone and other licensing payments, including $3.6 billion of proceeds received from AstraZeneca related to the Amylin collaboration during the third quarter of 2012, see “—Note 3. Alliances and Collaborations.”

Amortization of deferred income was $186$111 million and $112$47 million for the ninethree months ended September 30,March 31, 2013 and 2012, and 2011.respectively.

Note 14. EQUITY

 

  Common Stock   Capital in  Excess
of Par Value
of Stock
  Retained
Earnings
  Treasury Stock Noncontrolling
Interest
   Common Stock   Capital in Excess
of Par Value
of Stock
  Retained
Earnings
  Treasury Stock Noncontrolling
Interest
 
Dollars and Shares in Millions  Shares   Par Value    Shares Cost   Shares   Par Value    Shares Cost 

Balance at January 1, 2011

   2,205   $220   $3,682  $31,636   501  $(17,454 $(75

Net earnings attributable to BMS

                 2,857             

Balance at January 1, 2012

   2,205   $220   $3,114  $33,069   515  $(17,402 $(89

Net earnings

                 1,101           607 

Cash dividends declared

                 (1,696                             (575            

Stock repurchase program

                     30   (858                         10   (323    

Employee stock compensation plans

             (456      (20  923        1    1    (289      (8  439     

Net earnings attributable to noncontrolling interest

                             1,781 

Distributions

                             (1,842                             (609
  

 

   

 

   

 

  

 

  

 

  

 

  

 

   

 

   

 

   

 

  

 

  

 

  

 

  

 

 

Balance at September 30, 2011

   2,205   $220   $3,226  $32,797   511  $(17,389 $(136

Balance at March 31, 2012

   2,206   $221   $2,825  $33,595   517  $(17,286 $(91

Balance at January 1, 2012

   2,205   $220   $3,114  $33,069   515  $(17,402 $(89

Net earnings attributable to BMS

                 1,035             

Balance at January 1, 2013

   2,208   $221   $2,694  $32,733   570  $(18,823 $15 

Net earnings

                 609           26 

Cash dividends declared

                 (1,723                             (581            

Stock repurchase program

                     58   (1,914                         8   (298    

Employee stock compensation plans

   3    1    (397      (15  841                  (568      (13  803     

Net earnings attributable to noncontrolling interest

                             854 

Distributions

                             (765                             (1
  

 

   

 

   

 

  

 

  

 

  

 

  

 

   

 

   

 

   

 

  

 

  

 

  

 

  

 

 

Balance at September 30, 2012

   2,208   $221   $2,717  $32,381   558  $(18,475 $  

Balance at March 31, 2013

   2,208   $221   $2,126  $32,761   565  $(18,318 $40 
  

 

   

 

   

 

  

 

  

 

  

 

  

 

   

 

   

 

   

 

  

 

  

 

  

 

  

 

 

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

In June 2012,May 2010, the Board of Directors authorized the repurchase of up to $3.0 billion of common stock and in June 2012 increased its authorization for the repurchase of common stock by an additional $3.0 billion. Repurchases may be made either in the open market or through private transactions, including under repurchase plans established in accordance with Rule 10b5-1 under the Securities Exchange Act of 1934. The stock repurchase program does not have an expiration date and is expected to take place over a couple of years. It may be suspended or discontinued at any time.

Noncontrolling interest is primarily related to the partnerships with Sanofi for the territory covering the Americas for net sales ofPlavixPlavix**. Net earnings attributable to noncontrolling interest are presented net of a tax benefittaxes of $2$12 million and taxes of $209$229 million for the three months ended September 30,March 31, 2013 and 2012, and 2011, respectively, and taxes of $318 million and $609 million for the nine months ended September 30, 2012 and 2011, respectively, in the consolidated statements of earnings with a corresponding increase or decrease 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. The above activity includes the pre-tax income and distributions related to these partnerships.

The components of other comprehensive income/(loss) were as follows:

                                                                  
   Pretax  Tax  After tax 

Three months ended March 31, 2012

    

Derivatives qualifying as cash flow hedges:(a)

    

Unrealized gains

  $14  $(9 $5 

Reclassified to net earnings

   (8  2   (6
  

 

 

  

 

 

  

 

 

 

Derivatives qualifying as cash flow hedges

   6   (7  (1

Pension and postretirement benefits:(b)

    

Actuarial gains

   19   (5  14 

Amortization

   36   (12  24 
  

 

 

  

 

 

  

 

 

 

Pension and postretirement benefits

   55   (17  38 

Available for sale securities:

    

Unrealized losses

   (2  (1  (3

Realized gains

   (10     (10
  

 

 

  

 

 

  

 

 

 

Available for sale securities(c)

   (12  (1  (13

Foreign currency translation

   3      3 
  

 

 

  

 

 

  

 

 

 
  $52  $(25 $27 
  

 

 

  

 

 

  

 

 

 

Three months ended March 31, 2013

    

Derivatives qualifying as cash flow hedges:(a)

    

Unrealized gains

  $69  $(23 $46 

Reclassified to net earnings

   (10  5   (5
  

 

 

  

 

 

  

 

 

 

Derivatives qualifying as cash flow hedges

   59   (18  41 

Pension and postretirement benefits - Amortization(b)

   38   (11  27 

Available for sale securities - Unrealized gains(c)

   3   1   4 

Foreign currency translation

   (1     (1
  

 

 

  

 

 

  

 

 

 
  $99  $(28 $71 
  

 

 

  

 

 

  

 

 

 

(a)

Reclassifications to net earnings of derivatives qualifying as effective hedges are recognized in cost of products sold.

(b)

Actuarial losses and prior service cost are amortized into cost of products sold, research and development, and marketing, selling and administrative expenses as appropriate.

(c)

Realized (gains)/losses on available for sale securities are recognized in other (income)/expense.

The accumulated balances related to each component of other comprehensive income/(loss) (OCI),loss, 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, 2011

 $(222 $(20 $(2,163 $34  $(2,371

Other comprehensive income/(loss)

  (25  34   56   24   89 
 

 

 

  

 

 

  

 

 

  

 

 

  

 

 

 

Balance at September 30, 2011

 $(247 $14  $(2,107 $58  $(2,282
 

 

 

  

 

 

  

 

 

  

 

 

  

 

 

 

Balance at January 1, 2012

 $(238 $36  $(2,905 $62  $(3,045

Other comprehensive income/(loss)

  7   (27  84   37   101 
 

 

 

  

 

 

  

 

 

  

 

 

  

 

 

 

Balance at September 30, 2012

 $(231 $9  $(2,821 $99  $(2,944
 

 

 

  

 

 

  

 

 

  

 

 

  

 

 

 
                                            
Dollars in Millions March 31,
2013
  December 31,
2012
 

Derivatives qualifying as cash flow hedges

 $50  $9 

Pension and other postretirement benefits

  (2,996  (3,023

Available for sale securities

  69   65 

Foreign currency translation

  (254  (253
 

 

 

  

 

 

 

Accumulated other comprehensive loss

 $(3,131 $(3,202
 

 

 

  

 

 

 

Note 15. PENSION AND POSTRETIREMENT BENEFIT PLANS

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

 

    Three Months Ended September 30,   Nine Months Ended September 30,   Three Months Ended March 31, 
    Pension Benefits   Other Benefits   Pension Benefits   Other Benefits   Pension Benefits Other Benefits 

Dollars in Millions

    2012   2011   2012   2011   2012   2011   2012   2011   2013 2012 2013 2012 

Service cost – benefits earned during the year

    $7   $11   $1   $2   $24   $32   $5   $6   $10  $10  $1  $2 

Interest cost on projected benefit obligation

     79    83    5    7    237    253    16    20    74   79   3   6 

Expected return on plan assets

     (125   (116   (6   (7   (377   (349   (19   (20   (132  (126  (6  (6

Amortization of prior service cost/(benefit)

     (1             (1   (2        (1   (2   (1        (1

Amortization of net actuarial loss

     32    28    2    2    97    85    8    5    38   33      3 

Curtailments

                              (1          

Settlements

     3    2              3                
    

 

   

 

   

 

   

 

   

 

   

 

   

 

   

 

   

 

  

 

  

 

  

 

 

Total net periodic benefit cost

    $(5  $8   $2   $3   $(18  $20   $9   $9 

Net periodic (benefit)/cost

  $(11 $(4 $(2 $4 
    

 

   

 

   

 

   

 

   

 

   

 

   

 

   

 

   

 

  

 

  

 

  

 

 

Contributions to the U.S. pension plans are expected to be approximately $340approximate $185 million during 2012,2013, of which $323$155 million was contributed in the ninethree months ended September 30, 2012.March 31, 2013. Contributions to the international plans are expected to range from $65$60 million to $80$70 million in 2012,2013, of which $49$38 million was contributed in the ninethree months ended September 30, 2012.March 31, 2013.

The expense attributed to defined contribution plans in the U.S. was $47 million and $48 million for both the three months ended September 30,March 31, 2013 and 2012, and 2011, and $143 million and $133 million for the nine months ended September 30, 2012 and 2011, respectively.

Note 16. EMPLOYEE STOCK BENEFIT PLANS

Stock-based compensation expense was as follows:

 

  Three Months Ended September 30,  Nine Months Ended September 30, 
Dollars in Millions 2012  2011  2012  2011 

Stock options

 $(1 $7  $4  $20 

Restricted stock

  9   19   46   59 

Market share units

  4   6   17   17 

Long-term performance awards

  14   7   41   24 

Amylin stock options and restricted stock units (See Note 4)

  94       94     
 

 

 

  

 

 

  

 

 

  

 

 

 

Total stock-based compensation expense

 $120  $39  $202  $120 
 

 

 

  

 

 

  

 

 

  

 

 

 

Income tax benefit

 $38  $13  $66  $41 
 

 

 

  

 

 

  

 

 

  

 

 

 

The acceleration of unvested stock options and restricted stock units in connection with the acquisition of Amylin resulted in stock-based compensation expense for the three and nine months ended September 30, 2012.

                
   Three Months Ended March 31, 
Dollars in Millions  2013   2012 

Stock options

  $    $3 

Restricted stock

   18    19 

Market share units

   8    6 

Long-term performance awards

   23    14 
  

 

 

   

 

 

 

Total stock-based compensation expense

  $49   $42 
  

 

 

   

 

 

 

Deferred tax benefit related to stock-based compensation expense

  $16   $14 
  

 

 

   

 

 

 

In the nine months ended September 30, 2012, 3.0first quarter of 2013, 2.3 million restricted stock units, 1.11.0 million market share units and 1.72.5 million long-term performance share units were granted. The weighted-average grant date fair value was $37.37 for restricted stock units and $37.40 for market share units and long-term performance share units granted during the nine months ended September 30, 2012 was $32.70, $31.85 and $32.33, respectively.units.

Substantially all restricted stock units vest ratably over a four year period based on share price performance.period. Market share units vest ratably over a four year period and the number of shares ultimately issued is 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 determineconsiders the probability of satisfying market conditions. Long-termThe number of shares issued when long-term performance share units arevest is determined based on the achievement of annual performance goals, but aregoals. Long-term performance share units do not vestedvest until the end of the three year plan period.

TotalUnrecognized compensation costscost related to nonvested awards not yet recognized and the weighted-average period over which such awards areof $367 million is expected to be recognized at September 30, 2012 were as follows:over a weighted-average period of 2.6 years.

Dollars in Millions  Stock
Options
   Restricted
Stock
   Market
Share Units
   Long-Term
Performance
Awards
 

Unrecognized compensation cost

  $4   $165   $39   $42 

Expected weighted-average period in years of compensation cost to be recognized

   0.4    2.8    2.9    1.4 

Note 17. LEGAL PROCEEDINGS AND CONTINGENCIES

The Company and certain of its subsidiaries are involved in various lawsuits, claims, government investigations and other legal proceedings that arise in the ordinary course of business. 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 patent infringement, antitrust, securities, pricing, sales and marketing practices, environmental, commercial, health and safety matters, consumer fraud, employment matters, product liability and insurance coverage. Legal proceedings that are material or that the Company believes could become material 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. Unless otherwise noted, the Company is unable to assess the outcome of the respective litigation nor is it able to provide an estimated range of potential loss. Furthermore, failure to enforce our patent rights would likely result in substantial decreases in the respective product sales from generic competition.

INTELLECTUAL PROPERTY

Atripla*

In April 2009, Teva filed an abbreviated New Drug Application (aNDA) to manufacture and market a generic version ofAtripla*.Atripla*is a single tablet three-drug regimen combining the Company’sSustiva and Gilead’sTruvada*. As of this time, the Company’s U.S. patent rights coveringSustiva’s composition of matter and method of use have not been challenged. Teva sent Gilead a Paragraph IV certification letter challenging two of the fifteen Orange Book-listed patents forAtripla*. 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 challenging eight additional Orange Book-listed patents forAtripla*. In March 2010, the Company and Merck, Sharp & Dohme Corp. (Merck) 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. A trial in that lawsuit is currently scheduled for June 2013. In March 2010, Gilead filed two patent infringement actions against Teva in the SDNY relating to six Orange Book-listed patents forAtripla* and in February 2013, Gilead and Teva reached an agreement in principle to settle the lawsuit on the patents covering tenofovir disoproxil fumarate. It is not possible at this time to reasonably assess the outcome of these lawsuits or their impact on the Company.

Baraclude

In August 2010, Teva filed an aNDA to manufacture and market generic versions ofBaraclude. The Company received a Paragraph IV certification letter from Teva challenging the one Orange Book-listed patent forBaraclude, U.S. Patent No. 5,206,244 (the ‘244 Patent). In September 2010, the Company filed a patent infringement lawsuit in the U.S. District Court for the District of Delaware (Delaware District Court) against Teva for infringement. In February 2013, the Delaware District Court ruled against the Company and invalidated the ‘244 Patent. The Company has appealed the Delaware District Court’s decision. Upon final FDA approval of its aNDA, Teva could launch its generic product. There could be a rapid and significant negative impact on U.S. sales ofBaraclude beginning in 2013. U.S. net sales ofBaraclude were $241 million in 2012.

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 Inc. (Apotex), has since changed its name to Apotex. In August 2007, Apotex filed an application in the Federal Court of Australia (the Federal Court) 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 Federal 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 Court 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 forPlavix*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 marketing authorization. This matter is currently pending, although these specific marketing authorizations now have been withdrawn from the market.

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. On June 8, 2009, Sanofi filed its defense to the impeachment action and filed a suit against Apotex for infringement of the ‘777 Patent. The trial was completed in June 2011 and in December 2011, the Federal Court of Canada issued a decision that the ‘777 Patent is invalid. Sanofi is appealinghas appealed this decision though generic companies have since entered the market.

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. (Zydus),market and Apotex relating to U.S. Patent No. 5,006,528, (‘528 Patent) 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. asAbilify*. A non-jury trial in the U.S. District Court for the District of New Jersey (NJ District Court) against Teva/Barr and Apotex was completed in August 2010. In November 2010, the NJ District Court upheld the validity and enforceability of the ‘528 Patent, maintaining the main patent protection forAbilify*in the U.S. until April 2015. The NJ District Court also ruled that the defendants’ generic aripiprazole product infringed the ‘528 Patent and permanently enjoined them from engaging in any activity that infringes the ‘528 Patent, including marketing their generic product in the U.S. until after the patent (including the six-month pediatric extension) expires. Sandoz, Synthon, Sun and Zydus are also bound by the NJ District Court’s decision. In December 2010, Teva/Barr and Apotex appealed thisa decision to the U.S. Court of Appeals for the Federal Circuit (Federal Circuit). In May 2012, the Federal Circuit affirmed the NJ District Court’s decision. In June 2012, Apotex filed a petition for rehearingen banc which was denied.

Atripla*

In April 2009, Teva filed an abbreviated New Drug Application (aNDA) to manufacture and market a generic version ofAtripla*.Atripla*is a single tablet three-drug regimen combining the Company’sSustiva and Gilead’sTruvada*. As of this time, the Company’s U.S. patent rights coveringSustiva’s composition of matter and method of use have not been challenged. Teva sent Gilead a Paragraph IV certification letter challenging two of the fifteen Orange Book-listed patents forAtripla*.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 challenging eight additional Orange Book-listed patents forAtripla*. In March 2010, the Company and Merck, Sharp & Dohme Corp. (Merck) 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 forAtripla*. Trial is expected in 2013. It is not possible atlater this time to reasonably assess the outcome of these lawsuits or their impact on the Company.

Baraclude

In August 2010, Teva filed an aNDA to manufacture and market generic versions ofBaraclude. The Company received a Paragraph IV certification letter from Teva challenging the one Orange Book-listed patent forBaraclude, U.S. Patent No. 5,206,244, which expires in 2015. In September 2010, the Company filed a patent infringement lawsuit in the U.S. District Court for the District of Delaware against Teva for infringement of the listed patent coveringBaraclude, which triggered an automatic 30-month stay of approval of Teva’s aNDA. A trial took place in mid-October 2012 and the Company is currently awaiting a decision. If Teva were to prevail, there could be a significant impact on sales ofBaraclude in the U.S. In June 2012, the Company filed a patent infringement lawsuit against Sandoz following the receipt of a Paragraph IV certification letter challenging the same Orange-Book listed patent. It is not possible at this time to reasonably assess the outcome of these lawsuits or their impact on the Company.year.

Sprycel

In September 2010, Apotex filed an aNDA to manufacture and market generic versions ofSprycel. The Company received a Paragraph IV certification letter from Apotex challenging the four Orange Book listed patents forSprycel, including the composition of matter patent. In November 2010, the Company filed a patent infringement lawsuit in the NJ District Court against Apotex for infringement of the four Orange Book listed patents coveringSprycel, which triggered an automatic 30-month stay of approval of Apotex’s aNDA. In October 2011, the Company received a Paragraph IV notice letter from Apotex informing the Company that it is seeking approval of generic versions of the 80 mg and 140 mg dosage strengths ofSprycel and challenging the same four Orange Book listed patents. In November 2011, BMS filed a patent infringement suit against Apotex on the 80 mg and 140 mg dosage strengths in the NJ District Court. This case has been consolidated with the suit filed in November 2010. Trial is currently scheduled for September 2013. Discovery in this matter is ongoing. It is not possible at this time to reasonably assess the outcome of this lawsuit or its impact on the Company.

Sustiva—EU

In January 2012, Teva obtained a European marketing authorization for Efavirenz Teva 600 mg tablets. In February 2012, the Company and Merck filed lawsuits and requests for injunctions against Teva in the Netherlands, Germany and the U.K. for infringement of Merck’s European Patent No. 0582455 and Supplementary Protection Certificates expiring in November 2013. As of SeptemberDecember 2012, requests for injunctions have been granted in the U.K. and denied in the Netherlands and Germany. The Company and Merck have are appealing the denial of injunctionsthe request for injunction in the Netherlands. It is not possible at this time to reasonably assess the outcome of these lawsuits or their impact on the Company.

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 Superior Court in Oakland, James Clayworth et al. v. Bristol-Myers Squibb Company, et al., alleging that the defendants conspired to fix the prices of pharmaceuticals by agreeing to charge more for their drugs in the U.S. than they charge outside the U.S., particularly Canada, and asserting claims under California’s Cartwright Act and unfair competition law. The plaintiffs sought trebled monetary damages, injunctive relief and other relief. In December 2006, the Court granted the Company and the other manufacturers’ motion for summary judgment based on the pass-on defense, and judgment was then entered in favor of defendants. In July 2008, judgment in favor of defendants was affirmed by the California Court of Appeals. In July 2010, the California Supreme Court reversed the California Court of Appeal’s judgment and the matter was remanded to the California Superior Court for further proceedings. In March 2011, the defendants’ motion for summary judgment was granted and judgment was entered in favor of the defendants. The plaintiffs appealed that decision and the California Court of Appeals affirmed summary judgment for the defendants. In October 2012, the plaintiffs filed a petition seeking review by the California Supreme Court which is pending. It is not possible at this time to determinewas denied in November 2012. Plaintiffs have filed a petition seeking a Writ of Certiorari with the outcome of the appeal.U.S. Supreme Court.

Remaining Apotex Matters Related toPlavix*

As previously disclosed, in November 2008, Apotex filed a lawsuit in New Jersey Superior Court entitled,Apotex Inc., et al. v. sanofi-aventis, et al., seeking payment of $60 million, plus interest calculated at the rate of 1% per month from the date of the filing of the lawsuit, until paid, related to the break-up of a March 2006 proposed settlement agreement relating to the-then pendingPlavix*patent litigation against Apotex. In April 2011, the New Jersey Superior Court granted the Company’s cross-motion for summary judgment motion and denied Apotex’s motion for summary judgment. Apotex has appealed these decisions.decisions and the New Jersey Appellate Division reversed the grant of summary judgments. The case has been remanded back to the Superior Court for additional proceedings. It is not possible at this time to determinereasonably assess the outcome of any appeal fromthis lawsuit or its impact on the New Jersey Superior Court’s decisions.Company.

In January 2011, Apotex filed a lawsuit in Florida State Court, Broward County, alleging breach of contract relating to the May 2006 proposed settlement agreement with Apotex relating to the then pendingPlavix* patent litigation. Discovery has concluded.Apotex is seeking damages for the amount of profits it alleges it would have received from selling its generic clopidogrel bisulfate for somewhere between 8 and 11.5 months had the May 2006 agreement been approved by regulators. The Company and Sanofi have moved for summary judgment.judgment which was denied in November 2012. A trial was held in March 2013 and a jury verdict was delivered in favor of the Company. It is possible that Apotex may appeal this decision.

PRICING, SALES AND PROMOTIONAL PRACTICES LITIGATION AND INVESTIGATIONS

Abilify* Federal Subpoena

In January 2012, the Company received a subpoena from the United States Attorney’s Office for the Southern District of New York requesting information related to, among other things, the sales and marketing ofAbilify*. It is not possible at this time to assess the outcome of this matter or its potential impact on the Company.

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 certainAbilify* marketing practices violated those respective 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.

Abilify* Co-Pay Assistance Litigation

In March 2012, the Company and its partner Otsuka were named as co-defendants in a putative class action lawsuit filed by union health and welfare funds in the SDNY. Plaintiffs are challenging the legality of theAbilify*co-pay assistance program under the Federal Antitrust and the Racketeer Influenced and Corrupt Organizations laws, and seeking damages. The Company and Otsuka have filed a motion to dismiss the complaint. It is not possible at this time to reasonably assess the outcome of this litigation 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 fourtwo state attorneys general suits pending in state courts around the country.in Pennsylvania and Wisconsin. Beginning in August 2010, the Company was the defendant in a trial in the Commonwealth Court of Pennsylvania (Commonwealth Court), brought by the Commonwealth of Pennsylvania. In September 2010, the jury issued a verdict for the Company, finding that the Company was not liable for fraudulent or negligent misrepresentation; however, the Commonwealth Court judge issued a decision on a Pennsylvania consumer protection claim that did not go to the jury, finding the Company liable for $28 million and enjoining the Company from contributing to the provision of inflated AWPs. The Company has moved to vacate the decision and the Commonwealth has moved for a judgment notwithstanding the verdict, which the Commonwealth Court denied. The Company has appealed the decision to the Pennsylvania Supreme Court. The Company has reached agreementsCourt and oral argument is scheduled to take place in principle to resolve the suits brought by the Mississippi and Louisiana Attorneys General.May 2013.

Qui Tam Litigation

In March 2011, the Company was served with an unsealed qui tam complaint filed by three former sales representatives in California Superior Court, County of Los Angeles. The California Department of Insurance has elected to intervene in the lawsuit. The complaint alleges the Company paid kickbacks to California providers and pharmacies in violation of California Insurance Frauds Prevention Act, Cal. Ins. Code § 1871.7. Discovery is ongoing. It is not possible at this time to reasonably assess the outcome of this lawsuit or its 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 in various state and federal courts claiming personal injury damage allegedly sustained after usingPlavix*. Currently, more than 2,000over 3,000 claims are filed in state and federal courts in various states including California, Illinois, New Jersey, and New York, Alabama, IowaYork. In February 2013, the Judicial Panel on Multidistrict Litigation granted the Company and Pennsylvania. The defendants terminated the previously disclosed tolling agreement effective as of September 1, 2012.Sanofi’s motion to establish a multidistrict litigation to coordinate federal pretrial proceedings inPlavix* product liability and related cases in New Jersey Federal Court. It is not possible at this time to reasonably assess the outcome of these lawsuits or the potential impact on the Company.

Reglan*

The Company is one of a number of defendants in numerous lawsuits, on behalf of approximately 2,700 plaintiffs, claiming personal injury allegedly sustained after usingReglan* or another brand of the generic drug metoclopramide, a product indicated for gastroesophageal reflux and certain other gastrointestinal disorders. The Company, through its generic subsidiary, Apothecon, Inc., distributed metoclopramide tablets manufactured by another party between 1996 and 2000. It is not possible at this time to reasonably assess the outcome of these lawsuits or the potential impact on the Company.lawsuits. The resolution of these pending lawsuits, however, is not expected to have a material 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* andOvcon*) 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. The Company has agreed to resolve the claims of approximately 400 plaintiffs. As of October 2012,April 2013, the Company remains a defendant in approximately 35 actively pending lawsuits 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. The resolution of these remaining lawsuits is not expected to have a material impact on the Company.

Byetta* and Bydureon*

Amylin, now a wholly-owned subsidiary of the Company (see “—Note 4. Acquisitions”), and Lilly are co-defendants in product liability litigation related toByetta* and Bydureon*. As of September 30, 2012,April 2013, there were approximatelyover 100 separate lawsuits pending on behalf of approximately 555over 575 plaintiffs in various courts in the U.S. The vast majority of these cases have been brought by individuals who allege personal injury sustained after usingByetta*, primarily pancreatitis, and, in some cases, claiming alleged wrongful death. Of these, theThe Company has agreed in principle to resolve the claims of approximately 200over 300 plaintiffs. The vast majority of cases are pending in California state court, where the Judicial Council has granted Amylin’s petition for a “coordinated proceeding” for all California state court cases alleging harm from the alleged use ofByetta*. Amylin and Lilly are currently scheduled for trial in two separate single plaintiffthe fourth quarter of 2013. A number of recently filed cases for the first half of 2013, the first of which is currently scheduled to beginpending in February.federal court allege thatByetta* caused pancreatic cancer. We cannot reasonably predict the outcome of any lawsuit, claim or proceeding. However, given that Amylin has product liability insurance coverage for existing claims and future related claims involvingByetta*, it is currently expected the amount of damages, if any, will not be material to the Company.

BMS-986094

In August 2012, the Company announced that it had discontinued development of BMS-986094, an investigational compound which was being tested in clinical trials to treat the hepatitis C virus infection due to the emergence of a serious safety issue. To date, five lawsuits have been filed against the Company in Texas State Court by plaintiffs, which have beenwere removed to Federal Court, alleging that they participated in the Phase II study of BMS-986094 and suffered injuries as a result thereof. The Company has resolved four of the five filed claims and the vast majority of claims that have surfaced to date in this matter. In total, slightly fewer than 300 patients were administered the compound at various doses and durations as part of the clinical trials. The resolution of thesethe remaining lawsuit and any other potential future lawsuits is not expected to have a material 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 $71$68 million at September 30, 2012,March 31, 2013, which represents the sum of best estimates or, where no best estimate can reasonably be made, estimates of the minimal probable amount among a range of such costs (without taking into account any potential recoveries from other parties).

New Brunswick Facility—Environmental & Personal Injury Lawsuits

Since May 2008, over 250 lawsuits have been filed against the Company in New Jersey Superior Court by or on behalf of current and former residents of New Brunswick, New Jersey who live or have lived adjacent to the Company’s New Brunswick facility. The complaints either allege various personal injuries damages resulting from alleged soil and groundwaterenvironmental contamination on their property stemming from historical operations at the New Brunswick facility and historical operations at that site, or are claims for medical monitoring. A portion of these complaints also assert claims for alleged property damage. 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. Discovery is ongoing. Since October 2011, over 100150 additional cases have been filed in New Jersey Superior Court and removed by the Company to United States District Court, District of New Jersey. Accordingly, there are in excess of 400 cases between the state and federal court actions. Discovery is ongoing. 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 the 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, and avoid litigation. A central component of the agreement is the provision by the Company of interim funding to help defray cleanup costs and assure the work is not interrupted. The Company transmitted interim funding payments in December 2007 and November 2009. The parties commenced mediation in late 2008; however, those efforts were not successful and the parties moved to a binding allocation process. The parties are expected to conduct fact and expert discovery, followed by formal evidentiary hearings and written argument. Hearings likely will be scheduled for late 2012 or earlymid-to-late 2013. In addition, in September 2009, the Township and BOE filed suits against several other parties alleged to have contributed waste materials to the site. The Company does not currently believe that it is responsible for any additional amounts beyond the two interim payments totaling $4 million already transmitted. Any additional possible loss is not expected to be material.

OTHER PROCEEDINGS

Italy Investigation

In July 2011, the Public Prosecutor in Florence, Italy (Italian Prosecutor) initiated a criminal investigation against the Company’s subsidiary in Italy (BMS Italy). The allegations against the Company relate to alleged activities of a former employee who left the Company in the 1990s. The Italian Prosecutor also had requested interim measures that a judicial administrator be appointed to temporarily run the operations of BMS Italy. In October 2012, the parties reached an agreement to resolve the request for interim measures which resulted in the Italian Prosecutor withdrawing the request and this request was accepted by the Florence Court. It is not possible at this time to assess the outcome of the underlying investigation or its potential impact on the Company.

SEC Germany Investigation

In October 2006, the SEC informed the Company that it had begun a formal inquiry into the activities of certain of the Company’s German pharmaceutical subsidiaries and its employees and/or agents. 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 (FCPA). The Company is cooperating with the SEC.

FCPA Investigation

In March 2012, the Company received a subpoena from the SEC. The subpoena, issued in connection with an investigation under the FCPA, primarily relates to sales and marketing practices in various countries. The Company is cooperating with the government in its investigation of these matters.

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 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.

The following key events and transactions occurred during the currentfirst quarter of 2013 as discussed in further detail in the Strategy Product and Pipeline Developments and Results of Operations sections of Management’s Discussion and Analysis:Analysis.

 

  

OverallNet sales continued to decline as a result ofand earnings declined primarily from the loss of exclusivity ofPlavixPlavix** (clopidogrel bisulfate) andAvapro*/Avalide*(irbesartan/irbesartan-hydrochlorothiazide) (irbesartan/irbesartan hydrochlorothiazide).

The development of BMS-986094 (formerly INX-189), a compound which we acquired as part of our acquisition of Inhibitex, Inc. (Inhibitex) to treat hepatitis C, was discontinued in the interest of patient safety resulting in a $1.8 billion pre-tax impairment charge.

We acquired Amylin Pharmaceuticals, Inc (Amylin) and expanded our existing alliance arrangement with AstraZeneca PLC (AstraZeneca) to include Amylin-related products.

Eliquis(apixaban) was launched for the reduction of the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation (NVAF) in the U.S., Europe, Japan and Canada.Eliquis is part of our strategic alliance with Pfizer, Inc. (Pfizer).

Forxiga (dapagliflozin) continues to be launched for the treatment of type 2 diabetes in various EU markets.Forxiga is part of our alliance with AstraZeneca.

  

We had regulatory developments pertainingentered into a two year collaboration with The Medicines Company forRecothrom, a recombinant thrombin for use as a topical hemostat toEliquis(apixaban),Forxiga (dapagliflozin) andOrencia (abatacept) control non-arterial bleeding during surgical procedures (previously acquired in connection with our 2010 acquisition of ZymoGenetics).

We agreed to enter into a three year collaboration with Reckitt Benckiser Group plc for several over-the-counter-products sold primarily in Mexico and Brazil, which is expected to close during the second quarter of 2013.

Highlights

The following table is a summary ofsummarizes our financial highlights:

 

 Three Months Ended September 30, Nine Months Ended September 30,   Three Months Ended March 31, 
Dollars in Millions, except per share data 2012 2011 2012 2011   2013 2012 

Net Sales

 $3,736  $5,345  $13,430  $15,790   $3,831  $5,251 

Total Expenses

  4,995   3,515   11,603   10,403    3,157   3,224 

Earnings/(Loss) before Income Taxes

  (1,259  1,830   1,827   5,387 

Provision for/(Benefit from) Income Taxes

  (546  475   250   1,358 

Earnings before Income Taxes

   674   2,027 

Provision for Income Taxes

   51   545 

Effective tax rate

  43.4  26.0  13.7  25.2   7.6  26.9

Net Earnings/(Loss) Attributable to BMS

    

Net Earnings Attributable to BMS

   

GAAP

  (711  969   1,035   2,857    609   1,101 

Non-GAAP

  685   1,044   2,587   3,015    679   1,094 

Diluted Earnings/(Loss) Per Share

    

Diluted Earnings Per Share

   

GAAP

  (0.43  0.56   0.61   1.66    0.37   0.64 

Non-GAAP

  0.41   0.61   1.52   1.75    0.41   0.64 

Cash, Cash Equivalents and Marketable Securities

    6,628   11,012    5,775   8,614 

Our non-GAAP financial measures, including non-GAAP earnings and related earnings per share (EPS) information, are adjusted to exclude specified items which represent certain costs, expenses, gains and losses and other items impacting the comparability of financial results. For a detailed listing of all specified items and further information and reconciliations of non-GAAP financial measures see “—Non-GAAP Financial Measures” below.

Strategy

Over the past few years, we transformed our Company into a focused biopharmaceutical company. We continue to focus on sustaining our business and building a foundation for the future. We plan to achieve this foundationfuture by growing our newer key marketed products, advancing our pipeline portfolio and managing our costs. We also plan to expand our presence in emerging markets, with a tailored approach to each market. We expect that our portfolio will become increasingly diversified across products and geographies over the next few years. We also expect that we can continue to improve our cost base and realize significant cost savings and avoidance over the next few years.

We experienced substantial exclusivity losses this yearin 2012 forPlavix*andAvapro*/Avalide*, which together had more than $8approximately $1.8 billion of U.S. net sales in 2011. We will also face additional exclusivity losses in the coming years. We had been preparing for this for a numberfirst quarter of years.2012. As expected, we have experienced a rapid, precipitous, and material decline inPlavix* andAvapro*/Avalide* net sales and a reduction in net income and operating cash flow. Such eventsflow, which are the norm in the industry when companies experience thea loss of exclusivity offor a significant product. We will face additional exclusivity losses in the coming years. We also face significant challenges with an increasingly complex global and regulatory environment and global economic uncertainty, particularly in the European Union (EU)., and an increasingly complex global and regulatory environment. We believe our strategy to grow our newer marketed products and our robust research and development (R&D) pipeline particularly within the therapeutic areas of immuno-oncology, cardiovascular/metabolic disease and virology, position us well for the future.

We continue to expand our biologics capabilities. We still rely significantly on small molecules as our strongest, most reliable starting point for discovering potential new medicines, but large molecules or biologics, which are derived from recombinant DNA technologies are becoming increasingly important. Currently, more than one in three40% of our pipeline compounds are biologics, as are four of our key marketed products, includingYervoy(ipilimumab).products.

We also continue to support our pipeline with our licensing and acquisitions strategy, referred to as our “string of pearls.” During the third quarter of 2012, we acquired Amylin, a biopharmaceutical company dedicated to the discovery, development and commercialization of innovative medicines for patients with diabetes and other metabolic diseases. Following the completion of our acquisition of Amylin, we entered into a collaboration with AstraZeneca Pharmaceuticals LP, a wholly-owned subsidiary of AstraZeneca, which builds upon our existing alliance, further expanding our collaboration strategy. We are currently integrating the Amylin business into our development, manufacturing and commercial operations. We are also seeking to build relationships with academic organizations that have innovative programs and capabilities that complement our own internal R&D efforts.

Product and Pipeline Developments

We manage our R&D programs on a portfolio basis, investing resources in each stage of research and development from early discovery through late-stage development. OurWe continually evaluate our portfolio of R&D assets is evaluated continually to ensure that there is an appropriatea balance of early-stage and late-stage programs to support future growth. We consider our R&D programs that have entered into Phase III development to be significant, as these programs constitute our late-stage development pipeline. These Phase III development programs include both investigational compounds in Phase III development for initial indications and marketed products that are in Phase III development for additional indications or formulations. Spending on these programs represents approximately 30-40% of our annual R&D expenses. No individual investigational compound or marketed product represented 10% or more of our R&D expenses in any of the last three years. While we do not expect all of our late-stage development programs to make it to market, our late-stage development programsthese are the R&D programs that could potentially have an impact on our revenue and earnings within the next few years. The following are the recent significant developments in our marketed products and our late-stage pipeline:

Hepatitis C Portfolio — (Daclatasvir — a NS5A replication complex inhibitor in development; Asunaprevir — a NS3 protease inhibitor in development; BMS-791325 — a NS5B non-nucleoside polymerase inhibitor in development)

In April 2013, at the European Association for the Study of the Liver in Amsterdam, the Company announced new Phase II data demonstrating that 12- and 24-week triple direct-acting antiviral (DAA) treatment regimens of daclatasvir, asunaprevir, and BMS-791325 showed high rates of sustained virologic response of up to 94% in treatment-naive, genotype 1 chronic hepatitis C patients, at time points ranging from 4 to 36 weeks post-treatment. The Food and Drug Administration (FDA) designated this triple-DAA regimen as a Breakthrough Therapy for the treatment of chronic hepatitis C.

EliquisBaraclude (entecavir) —an oral Factor Xa inhibitor indicated in the EUantiviral agent for the prevention of venous thromboembolic events (VTE) in adult patients who have undergone elective hip or knee replacement surgery and in development for stroke prevention in patients with atrial fibrillation (AF) and the prevention and treatment of venous thromboembolic disorders that is part of our strategic alliance with Pfizer, Inc. (Pfizer)chronic hepatitis B

 

  

In October 2012,February 2013, the Company announcedU.S. District Court for the District of Delaware invalidated the composition of matter patent coveringBaraclude, which was scheduled to expire in a publication inThe Lancet that the reductions in stroke or systemic embolism, major bleeding2015. See “Item 1. Financial Statements — Note 17. Legal Proceedings and mortality demonstrated withEliquis compared to warfarin in the ARISTOTLE trial were consistent across a wide range of stroke and bleeding risk scores in patients with nonvalvular atrial fibrillation (NVAF).Contingencies” for further discussion.

Sustiva (efavirenz) — a non-nucleoside reverse transcriptase inhibitor for the treatment of HIV

  

In September 2012,February 2013, the Food and Drug Administration (FDA) acknowledged receiptCompany announced that the FDA has granted an additional six-month period of exclusivity to marketSustiva. Exclusivity forSustiva in the resubmission of the New Drug Application (NDA) forEliquisU.S. is now scheduled to reduce the risk of stroke and systemic embolismexpire in patients with NVAF. The FDA deemed the application a complete response to its June 2012 Complete Response Letter that requested additional information on data management and verification from the ARISTOTLE trial. The FDA assigned a new Prescription Drug User Fee Act goal date of March 17, 2013.2015.

Nivolumab — a fully human monoclonal antibody that binds to the programmed death receptor-1 (PD-1) on T and NKT cells that is being investigated as anti-cancer treatment.

The FDA has granted Fast Track designation for nivolumab in three tumor types: non-small-cell lung cancer, renal cell carcinoma and advanced melanoma.

Abilify*(aripiprazole) — an antipsychotic agent for the treatment of schizophrenia, bipolar mania disorder and major depressive disorder and is part of our strategic alliance with Otsuka

  

In September 2012, the Company and Pfizer received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP). The CHMP recommended thatEliquis be granted approval for the prevention of stroke and systemic embolism in adult patients with NVAF and one or more risk factors for stroke. The CHMP’s positive opinion will now be reviewed byJanuary 2013, the European Commission which has the authority to approve medicinesapprovedAbilify* for the EU.treatment of pediatric bipolar mania.

Forxiga—an oral SGLT2sodium-glucose cotransporter (SGLT2) inhibitor for the treatment of diabetes that is part of our alliance with AstraZeneca

 

  

The Company has met withIn March 2013, the FDAJapanese Ministry of Health, Labor and now has a path forwardWelfare also accepted for potential approvalreview the regulatory submission forForxiga infor the U.S. The Company will provide additional data from ongoing studies totreatment of type 2 diabetes.

In January 2013, China’s State Food and Drug Administration accepted for review the FDA and expects to be able to resubmit the NDAregulatory submission forForxiga in mid-2013. At this time,for the Company expects that the FDA will have a six–month period in which to review the resubmission and will hold an Advisory Committee meeting.treatment of type 2 diabetes.

Brivanib—Eliquis — an investigational anti-cancer agent

In July 2012,oral Factor Xa inhibitor, targeted at stroke prevention in NVAF and the Company announced that brivanib did not meet its primary overall survival objective based upon a non-inferiority statistical design in the Phase III BRISK-FL clinical trialprevention and treatment of brivanib versus sorafenib as first-line treatment in patients with advanced hepatocellular carcinoma.

venous thromboembolic (VTE) disorders.Erbitux* (cetuximab)—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*Eliquis is part of our strategic alliance with Eli Lilly and Company (Lilly).Pfizer.

 

  

In July 2012, the FDA granted fullEliquis received regulatory approval ofErbitux* in combination with the chemotherapy regimen FOLFIRI (irinotecan, 5-fluorouracil, leucovorin) for the first-line treatmentreduction of the risk of stroke and systemic embolism in patients with KRAS mutation-negative epidermal growth factor receptor-expressing metastatic colorectal cancer as determined by FDA-approved tests for the use.

Yervoy—a monoclonal antibody for the treatment of patients with unresectable (inoperable) or metastatic melanoma

In September 2012, the Company announced at the European Society for Medical Oncology 2012 Congress long-term follow-up data of the 024 study which evaluated newly-diagnosed patients treated withYervoy 10mg/kgNVAF in combination with dacarbazine versus dacarbazine aloneSouth Korea in January, in Israel and five-year follow-up data from the rollover 025 study which evaluated patients withYervoy0.3 mg/kg or 10 mg/kg. The survival rates observedRussia in study 024 at years threeFebruary, and four were not only stable but higher in patients treated withYervoyplus dacarbazine versus patients who received dacarbazine alone. The estimated survival ratesMexico and Colombia in the 025 study remained unchanged or relatively stable at five years compared to four years in newly-diagnosed patients and previously-diagnosed patients.

Onglyza/Kombiglyze (saxagliptin/once daily combination of saxagliptin and metformin hydrochloride extended-release)—a treatment for type 2 diabetes that is part of our strategic alliance with AstraZeneca

In July 2012, the Company and AstraZeneca announced at the 17th World Congress on Heart Disease the results of analyses showing thatOnglyza 5mg demonstrated improvements across key measures of blood sugar control (glycosylated hemoglobin levels, or HbA1c; fasting plasma glucose, or FPG and post-prandial glucose, or PPG) compared to placebo in adult patients with type 2 diabetes at high risk for cardiovascular disease.April 2013.

  

Marketing authorizationEliquis received regulatory approval forKomboglyze, the twice daily, fixed dose combinationprevention of saxagliptinvenous thromboembolic events in adult patients who have undergone elective hip or knee replacement surgery in China in January and immediate-release metformin, was granted by the European Commission in November 2011. Due to a technical manufacturing issue, launches will beginMexico in the fourth quarter of 2012.April 2013.

Orencia—a fusion protein indicated for rheumatoid arthritis (RA)

In October 2012, the European Commission granted marketing authorization for a subcutaneous formulation ofOrenciain combination with methotrexate for the treatment of moderate to severe active rheumatoid arthritis in adults.

Baraclude (entecavir)—an oral antiviral agent for the treatment of chronic hepatitis B

In October 2012, a labeling update forBaraclude was approved by the FDA to include data on African Americans and liver transplant recipients with chronic hepatitis B infection.

In addition, in August 2012, the Company discontinued development of BMS-986094. This decision was made in the interest of patient safety. See “Item 1. Financial Statements—Note 12. Goodwill and Other Intangible Assets” for further information.

RESULTS OF OPERATIONS

Net Sales

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

 

 Three Months Ended September 30, Nine Months Ended September 30, 
     2012 vs. 2011     2012 vs. 2011  Three Months Ended March 31, 2013 vs. 2012 
 Net Sales Analysis of % Change Net Sales Analysis of % Change  Net Sales Analysis of % Change 
Dollars in Millions 2012 2011 Total
Change
 Volume Price Foreign
Exchange
 2012 2011 Total
Change
 Volume Price Foreign
Exchange
  2013 2012 Total
Change
 Volume Price Foreign
Exchange
 

United States

 $1,985  $3,477   (43)%    (45)%    2%       $8,029  $10,289   (22)%    (28)%    6%       $1,971  $3,501   (44)%    (43)%    (1)%     

Europe

  800   916   (13)%    2%    (4)%    (11)%    2,548   2,738   (7)%    4%    (3)%    (8)%    946   922   3 %    4 %    (2)%    1 %  

Japan, Asia Pacific and Canada

  438   464   (6)%        (4)%    (2)%    1,281   1,375   (7)%    (3)%    (3)%    (1)%  

Latin America, the Middle East
and Africa

  208   230   (10)%    (4)%        (6)%    654   664   (2)%    1%    2%    (5)%  

Emerging Markets

  230   238   (3)%    2%        (5)%    686   659   4%    9%    (1)%    (4)%  

Other

  75   20   **    N/A    N/A        232   65   **    N/A    N/A      

Rest of the World

  765   748   2 %    7 %    (1)%    (4)%  

Other(a)

  149   80   86 %    N/A    N/A     
 

 

  

 

      

 

  

 

      

 

  

 

     

Total

 $3,736  $5,345   (30)%    (28)%    1%    (3)%   $13,430  $15,790   (15)%    (16)%    3%    (2)%    3,831   5,251   (27)%    (26)%    (1)%     
 

 

  

 

      

 

  

 

      

 

  

 

     

 

**(a)

Change in excess of 100%Other net sales include royalties and other alliance-related revenues for products not sold by our regional commercial organizations.

Our total net sales decreased in 2012 primarily due to declines in sales ofPlavix* andAvapro*/Avalide* following the losses of exclusivity of these products in the U.S. and unfavorable foreign exchange, partially offset by higher average net selling prices, continued growth in most key products and sales ofByetta*(exenatide) andBydureon* (exenatide extended-release for injectable suspension) from our Amylin acquisition.

The change in U.S. net sales attributed to volume reflects the recent exclusivity losses ofPlavix* in May 2012 andAvapro*/Avalide*, in March 2012, partially offset by increased demand for most key products, and the addition ofByettaByetta*(exenatide),Bydureon*(exenatide extended-release for injection suspension) andSymlin*(pramlintide acetate) following the completion of our acquisition of Amylin in third quarter of 2012 ($153 million in the first quarter of 2013) and the launch ofEliquis andBydureon.in the first quarter of 2013. The change in U.S. net sales attributed to price was a result of higher average net selling prices forAbilify*(aripiprazole) andPlavix*, partially offset by the reduction in our contractual share ofAbilify* net sales.sales from 51.5% in 2012 to 35% based upon a weighted-average forecast of expected annual net sales in 2013 (4% impact) partially offset by higher average net selling prices. See “—Key Products” for further discussion of sales by key product.

Net sales in Europe decreased primarilyincreased due to unfavorable foreign exchange andsales growth of most key products partially offset by lower sales of certain mature brands from divestitures and generic competition as well as generic competition forPlavix* andAvapro*/Avalide*partially offset by sales growth of most key products. and certain mature brands.The change in net sales was negatively impacted by continuing fiscal challenges in many European countries as healthcare payers, including government agencies, have reduced and are expected to continue to reduce healthcare costs through actions that directly or indirectly impose additional price reductions. These measures include, but are not limited to, mandatory discounts, rebates, other price reductions and other restrictive measures.

Net sales in Japan, Asia Pacific and Canada decreasedRest of the World increased due to higher demand forBaraclude,Sprycel (dasatinib) andOrencia (abatacept), which was partially offset by generic competition forPlavix* andAvapro*/Avalide*and unfavorable foreign exchange, particularly in Canada as well as lower mature brand sales from generic competition and divestitures partially offset by higher demand forBaraclude (entecavir),Sprycel(dasatinib), andOrencia.Japan.

Other net sales increased due to additional sales of bulk active pharmaceutical ingredienthigher royalty revenue resulting from the restructured Sanofi agreement and revenue attributed to our alliance partner as well as enhanced royalty-related revenue.the Valeant and The Medicines Company collaborations.

No single country outside the U.S. contributed more than 10% of total net sales during the three and nine months ended September 30, 2012March 31, 2013 and 2011.2012.

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 products. U.S. and non-U.S. net sales are categorized based upon the location of the customer.

We recognize revenue net of gross-to-net sales adjustments that are further described in “—Critical Accounting Policies” in the Company’s 20112012 Annual Report on Form 10-K. Our contractual share ofAbilify* andAtripla* sales is reflected net of all gross-to-net sales adjustments in gross sales.

The reconciliation Although not presented as a gross-to-net adjustment in the below tables, our share of our gross sales to net sales by each significant category ofAbilify* andAtripla* gross-to-net sales adjustments was as follows:were $308 million in 2013 and $354 million in 2012.

  Three Months Ended September 30,  Nine Months Ended September 30, 
Dollars in Millions 2012  2011  2012  2011 

Gross Sales

 $4,225  $6,081  $15,127  $17,761 

Gross-to-Net Sales Adjustments

    

Charge-Backs Related to Government Programs

  (137  (206  (505  (571

Cash Discounts

  (36  (71  (154  (210

Managed Healthcare Rebates and Other Contract Discounts

  (98  (233  (182  (514

Medicaid Rebates

  (93  (137  (296  (404

Sales Returns

  6   (7  (228  (27

Other Adjustments

  (131  (82  (332  (245
 

 

 

  

 

 

  

 

 

  

 

 

 

Total Gross-to-Net Sales Adjustments

  (489  (736  (1,697  (1,971
 

 

 

  

 

 

  

 

 

  

 

 

 

Net Sales

 $3,736  $5,345  $13,430  $15,790 
 

 

 

  

 

 

  

 

 

  

 

 

 

Gross-to-Net Adjustments as a Percentage of Gross Sales

  12%    12%    11%    11%  
 

 

 

  

 

 

  

 

 

  

 

 

 

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

 

Dollars in Millions Charge-Backs
Related to
Government
Programs
 Cash
Discounts
 Managed
Healthcare
Rebates and
Other Contract
Discounts
 Medicaid
Rebates
 Sales
Returns
 Other
Adjustments
 Total  Charge-Backs
Related to
Government
Programs
 Cash
Discounts
 Healthcare
Rebates and
Other Contract
Discounts
 Medicaid
Rebates
 Sales
Returns
 Other
Adjustments
 Total 

Balance at January 1, 2012

 $(51 $(28 $(417 $(411 $(161 $(181 $(1,249

Balance at January 1, 2013

 $(41 $(13 $(175 $(351 $(345 $(183 $(1,108

Provision related to sales made in current period

  (505  (153  (249  (333  (234  (338  (1,812  (131  (35  (91  (87  (26  (123  (493

Provision related to sales made in prior periods

      (1  67   37   6   6   115            36   22      58 

Returns and payments

  522   166   422   354   60   323   1,847   138   33   91   152   22   114   550 

Amylin acquisition

  (2  (1  (34  (13  (23  (3  (76

Impact of foreign currency translation

                  (1  1             1      1   4   6 
 

 

  

 

  

 

  

 

  

 

  

 

  

 

  

 

  

 

  

 

  

 

  

 

  

 

  

 

 

Balance at September 30, 2012

 $(36 $(17 $(211 $(366 $(353 $(192 $(1,175

Balance at March 31, 2013

 $(34 $(15 $(174 $(250 $(326 $(188 $(987
 

 

  

 

  

 

  

 

  

 

  

 

  

 

  

 

  

 

  

 

  

 

  

 

  

 

  

 

 

Changes in theThe reconciliation of gross sales to net sales by each significant category of gross-to-net sales adjustment ratesadjustments was as follows:

   Three Months Ended March 31, 
Dollars in Millions  2013  2012 

Gross Sales

  $4,266  $5,878 

Gross-to-Net Sales Adjustments

   

Charge-backs related to government programs

   (131  (192

Cash discounts

   (35  (69

Managed healthcare rebates and other contract discounts

   (91  (66

Medicaid rebates

   (51  (103

Sales returns

   (4  (100

Other adjustments

   (123  (97
  

 

 

  

 

 

 

Total Gross-to-Net Sales Adjustments

   (435  (627
  

 

 

  

 

 

 

Net Sales

  $3,831  $5,251 
  

 

 

  

 

 

 

Gross-to-net sales adjustments as a percentage of gross sales were 10% in 2013 and 11% in 2012 and are primarily a function of changes in sales mix and contractual and legislative discounts and rebates. Gross-to-net sales adjustments decreased due to:

 

Essentially all gross-to-net adjustment categories adjustments decreased in 2013 as result of changes inPlavix* sales following its loss of exclusivity.

  

Managed healthcare rebates and other contract discounts decreasedincreased primarily due to a reductionAmylin-related product sales. No significant amounts were related toPlavix* in prioreither period rebate and discount accruals based upon actual invoices received,because the nonrenewal ofPlavix* contract discounts in the MedicareMedicaid Part D program were not renewed as of January 1, 2012, and the decrease in sales ofPlavix* following the loss of exclusivity.2012.

Medicaid rebates also decreased primarily due to a reduction in prior period managed Medicaid accruals based upon actual invoices received.

  

The provision for sales returns was increased in 2012 as a result of the loss of exclusivity in the U.S. ofPlavix* in May 2012 andAvapro*/Avalide* in March 2012.. The U.S. sales return reserves for these productsPlavix* andAvapro*/Avalide* at September 30, 2012March 31, 2013 were $191$146 million and were determined after considering several factors including estimated inventory levels in the distribution channels. In accordance with Company policy, these products are eligible to be returned between six months prior to and twelve12 months after product expiration. Additional adjustmentsSales returns in 2013 included a $22 million reduction in the U.S. sales return reserve forPlavix* established in 2012 due to higher inventory work down in the wholesaler distribution channel than previously expected. Adjustments to these reserves might be required in the future for revised estimates to various assumptions including actual returns which are generally not expected to occur until 2014.

Other adjustments are primarily related to non-U.S. markets and increased in 2013 as a result of government austerity measures.

Key Products

Net sales of key products represent 83%82% and 86%87% of total net sales forin the three months ended September 30,first quarter of 2013 and 2012, and 2011, respectively, and 85% and 86% of total net sales for the nine months ended September 30, 2012 and 2011, respectively. The following table presents U.S. and international net sales by key product,products, the percentage change from the prior period, and the foreign exchange impact when compared to the prior period. Commentary detailing theThe reasons for significant variances for key products isare provided below:

 

  Three Months Ended September 30,   Nine Months Ended September 30,   Three Months Ended March 31, 
Dollars in Millions  2012   2011   %
Change
   % Change
Attributable
to Foreign
Exchange
   2012   2011   %
Change
   % Change
Attributable
to Foreign
Exchange
   2013   2012   %
Change
   % Change
Attributable
to Foreign
Exchange
 

Key Products

                        

Plavix* (clopidogrel bisulfate)

  $  64   $  1,788    (96)%         $  2,498   $  5,415    (54)%       

U.S.

   41    1,672    (98)%          2,372    5,060    (53)%       

Non-U.S.

   23    116    (80)%          126    355    (65)%     (2)%  

Avapro*/Avalide*

(irbesartan/irbesartan-hydrochlorothiazide)

   95    216    (56)%     (3)%     419    757    (45)%     (2)%  

U.S.

   7    121    (94)%          127    414    (69)%       

Non-U.S.

   88    95    (7)%     (4)%     292    343    (15)%     (3)%  

Eliquis (apixaban)

             N/A     N/A     1         N/A     N/A  

U.S.

                                        

Non-U.S.

             N/A     N/A     1         N/A     N/A  

Abilify* (aripiprazole)

   676    691    (2)%     (2)%     2,008    2,021    (1)%     (3)%  

Virology

        

Baraclude (entecavir)

  $  366   $  325    13%     (1)%  

U.S.

   502    505    (1)%          1,472    1,482    (1)%          68    56    21%       

Non-U.S.

   174    186    (6)%     (9)%     536    539    (1)%     (9)%     298    269    11%     (2)%  

Reyataz (atazanavir sulfate)

   363    391    (7)%     (4)%     1,127    1,153    (2)%     (3)%     361    358    1%       

U.S.

   194    184    5%          577    554    4%          193    188    3%       

Non-U.S.

   169    207    (18)%     (7)%     550    599    (8)%     (7)%     168    170    (1)%       

Sustiva (efavirenz) Franchise

   370    359    3%     (3)%     1,144    1,073    7%     (2)%     387    386           

U.S.

   245    222    10%          752    665    13%          251    254    (1)%       

Non-U.S.

   125    137    (9)%     (9)%     392    408    (4)%     (7)%     136    132    3%     1%  

Baraclude (entecavir)

   346    311    11%     (4)%     1,028    878    17%     (2)%  

U.S.

   61    51    20%          175    150    17%       

Non-U.S.

   285    260    10%     (4)%     853    728    17%     (3)%  

Oncology

        

Erbitux* (cetuximab)

   173    172    1%     1%     531    510    4%          162    179    (9)%       

U.S.

   166    168    (1)%          512    497    3%          158    176    (10)%       

Non-U.S.

   7    4    75%     (2)%     19    13    46%     (2)%     4    3    33%       

Sprycel (dasatinib)

   263    211    25%     (6)%     738    576    28%     (5)%     287    231    24%     (3)%  

U.S.

   107    78    37%          290    207    40%          115    95    21%       

Non-U.S.

   156    133    17%     (10)%     448    369    21%     (8)%     172    136    26%     (5)%  

Yervoy (ipilimumab)

   179    121    48%     (5)%     495    216    **     (6)%     229    154    49%       

U.S.

   123    109    13%          361    204    77%          159    117    36%       

Non-U.S.

   56    12    **     **     134    12    **     **     70    37    89%       

Orencia (abatacept)

   307    233    32%     (3)%     851    660    29%     (2)%  

Neuroscience

        

Abilify* (aripiprazole)

   522    621    (16)%       

U.S.

   328    445    (26)%       

Non-U.S.

   194    176    10%       

Metabolics

        

Bydureon* (exenatide extended-release for injectable suspension)

   52    N/A     N/A     N/A  

U.S.

   209    154    36%          575    444    30%          52    N/A     N/A       

Non-U.S.

   98    79    24%     (9)%     276    216    28%     (6)%     N/A     N/A     N/A     N/A  

Nulojix (belatacept)

   3                   7    2    **       

Byetta* (exenatide)

   85    N/A     N/A     N/A  

U.S.

   84    N/A     N/A       

Non-U.S.

   1    N/A     N/A     N/A  

Forxiga (dapagliflozin)

   3    N/A     N/A     N/A  

U.S.

   3                   6    2    **          N/A     N/A     N/A       

Non-U.S.

             N/A     N/A     1         N/A     N/A     3    N/A     N/A     N/A  

Onglyza/Kombiglyze (saxagliptin/saxagliptin

and metformin)

   178    127    40%     (3)%     511    320    60%     (3)%     202    161    25%     (1)%  

U.S.

   127    91    40%          368    228    61%          140    120    17%       

Non-U.S.

   51    36    42%     (9)%     143    92    55%     (12)%     62    41    51%     (3)%  

Immunoscience

        

Nulojix (belatacept)

   5    1    **     N/A  

U.S.

   4    1    **       

Non-U.S.

   1        **     N/A  

Orencia (abatacept)

   320    254    26%     (2)%  

U.S.

   214    171    25%       

Non-U.S.

   106    83    28%     (6)%  

 

**

Change in excess of 100%.

 Three Months Ended September 30, Nine Months Ended September 30,  Three Months Ended March 31, 
Dollars in Millions 2012 2011 %
Change
 % Change
Attributable
to Foreign
Exchange
 2012 2011 %
Change
 % Change
Attributable
to Foreign
Exchange
  2013 2012 %
Change
 % Change
Attributable
to Foreign
Exchange
 

Key Products (continued)

        

Byetta* (exenatide)

 $  55  $  —    N/A    N/A   $  55  $  —    N/A    N/A  

Key Products continued

    

Cardiovascular

    

Avapro*/Avalide* (irbesartan/irbesartan-hydrochlorothiazide)

 $  46  $  207   (78)%    1%  

U.S.

  55       N/A        55       N/A           108   (100)%     

Non-U.S.

                                  46   99   (54)%    1%  

Bydureon* (exenatide extended-release for
injectable suspension)

  20       N/A    N/A    20       N/A    N/A  

Eliquis (apixaban)

  22      N/A    N/A  

U.S.

  20       N/A        20       N/A        17   N/A    N/A     

Non-U.S.

                                  5      N/A    N/A  

Plavix* (clopidogrel bisulfate)

  91   1,693   (95)%     

U.S.

  66   1,648   (96)%     

Non-U.S.

  25   45   (44)%    3%  

Mature Products and All Other

  644   725   (11)%    (6)%    1,997   2,209   (10)%    (5)%    691   681   1%    (1)%  

U.S.

  125   122   2%        367   382   (4)%        122   122        

Non-U.S.

  519   603   (14)%    (5)%    1,630   1,827   (11)%    (4)%    569   559   2%    (1)%  

 

**

Change in excess of 100%.

Plavix*—a platelet aggregation inhibitor that is part of our alliance with Sanofi

U.S. net sales decreased due to the loss of exclusivity in May 2012. Estimated total U.S. prescription demand decreased 95% and 48% for the three and nine months ended September 30, 2012, respectively. Net sales included the impact of a $30 million reduction of inventory in the distribution channel that resulted in a reduction of sales returns reserve during the three months ended September 30, 2012.

International net sales continue to be negatively impacted by generic clopidogrel products in the EU, Canada, and Australia.

Avapro*/Avalide* (known in the EU asAprovel*/Karvea*)—an angiotensin II receptor blocker for the treatment of hypertension and diabetic nephropathy that is also part of the Sanofi alliance

U.S. net sales decreased due to the exclusivity loss ofAvapro*/Avalide* in March 2012. Total estimated U.S. prescription demand decreased 89% and 65% for the three and nine months ended September 30, 2012, respectively.

International net sales decreased due to lower demand including generic competition in certain EU markets and Canada.

Eliquis—an oral Xa inhibitor for the prevention of VTE in adult patients who have undergone elective hip or knee replacement surgery and in development for the prevention and treatment of venous thromboembolic disorders and stroke prevention in patients with AF that is part of our strategic alliance with Pfizer

Eliquis is approved in the EU and several other international countries for VTE prevention with launches continuing in many of those countries.

Abilify*Baraclude—an antipsychoticoral antiviral agent for the treatment of schizophrenia, bipolar mania disorder and major depressive disorder that is part of our strategic alliance with Otsukachronic hepatitis B

 

•      U.S. net sales decreased as fluctuations in retail buying patterns and the reduction in our contractual share of net sales recognized from 53.5% in 2011 to 51.5% in 2012 more than offset higher average net selling prices. Estimated total U.S. prescription demand decreased 1% for the three months ended September 30, 2012 and increased 1% for the nine months ended September 30, 2012.

U.S. net sales increased primarily due to higher demand. Estimated U.S. prescription demand increased 6%. We may experience a rapid and significant decline in U.S. net sales due to possible generic competition following a Federal court’s decision in February 2013 invalidating the composition of matter patent.

International net sales decreasedincreased primarily due unfavorable foreign exchange partially offset byto higher prescription demand.

Reyataz—a protease inhibitor for the treatment of HIVthe human immunodeficiency virus (HIV)

 

U.S. net sales increased due to higher average net selling prices. Estimated total U.S. prescription demand decreased 6% and 3% for the three and nine months ended September 30, 2012, respectively.8%.

International net sales decreased due toremained relatively flat as lower demand resulting from competing products in Europe was partially offset by the timing of government purchases in certain countries and unfavorable foreign exchange.countries.

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

 

U.S. net sales increased due toremained relatively flat as fluctuations in retail buying patterns and lower demand were partially offset by higher average net selling prices. Estimated total U.S. prescription demand decreased 2% and 1% for the three and nine months ended September 30, 2012.4%.

International net sales decreasedincreased due to unfavorable foreign exchange.

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

Worldwide net sales increased primarily due to continued strong demand in international markets.higher demand.

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 increased primarilydecreased due to higherlower demand.

Sprycel—an oral inhibitor of multiple tyrosine kinases indicated for the treatment of adults with chronic, accelerated, or myeloid or lymphoid blast phase chronic myeloid leukemia with resistance or intolerance to prior therapy, includingGleevec* (imatinib mesylate)meslylate) and first-line treatment of adults.adults with Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase.Sprycel is part of our strategic alliance with Otsuka.

 

U.S. net sales increased primarily due to higher demand and higher average net selling prices.demand. Estimated total U.S. prescription demand increased 22% and 33% for the three and nine months ended September 30, 2012, respectively.18%.

International net sales increased due to higher demand partially offset by unfavorable foreign exchange.demand.

Yervoy—a monoclonal antibody for the treatment of patients with unresectable (inoperable) or metastatic melanoma

 

U.S. net sales increased due to the recognition of $27 million of net sales that were previously deferred until sufficient historical experience to estimate sales returns was developed and higher demand.

International net sales increased due to higher demand.

Abilify* —an antipsychotic agent for the treatment of schizophrenia, bipolar mania disorder and major depressive disorder and is part of our strategic alliance with Otsuka

U.S. net sales decreased due to a reduction in our contractual share of net sales from 51.5% in 2012 to an estimated 35% in 2013, which was partially offset by higher average net selling prices. Estimated U.S. prescription demand decreased 2%.

International net sales increased due to higher demand.

Bydureon* — a once-weekly GLP-1 receptor agonist for the treatment of type 2 diabetes that is part of our strategic alliance with AstraZeneca

  

YervoyBydureon* was launched by Amylin in the U.S. in the first quarter of 2012 and in certain EU in the second quarter of 20112012. U.S. net sales are included in our results following the completion of our acquisition of Amylin in the third quarter of 2012.

Byetta* — a twice daily glucagon-like peptide-1 (GLP-1) receptor agonist for the treatment of type 2 diabetes that is part of our strategic alliance with AstraZeneca

Byetta* net sales are included in our results following the completion of our acquisition of Amylin in the third quarter of 2012.

Forxiga — an oral sodium-glucose cotransporter (SGLT2) inhibitor for the treatment of diabetes that is part of our alliance with AstraZeneca

Forxiga was launched for the treatment of type 2 diabetes in a limited number of EU markets during the fourth quarter of 2012 and continues to be launched in a numbervarious EU markets.

Onglyza/Kombiglyze (known in the EU asOnglyza/Komboglyze) — a once-daily oral tablet for the treatment of type 2 diabetes that is part of our strategic alliance with AstraZeneca

U.S. net sales of international countries sinceOnglyza/Kombiglyze increased primarily due to higher average net selling prices and higher overall demand. Estimated U.S. prescription demand increased 8%.

International net sales increased primarily due to higher demand.

Nulojix — a fusion protein with novel immunosuppressive activity targeted at prevention of kidney transplant rejection

Nulojix was approved and launched in the second quarter ofU.S. and EU during 2011.

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

 

  

U.S. net sales increased primarily due to higher demand and higher average net selling prices. Estimated U.S. prescription demand for the subcutaneous formulation ofOrencia launchedincreased 149%. The intravenous formulation ofOrencia does not have prescription-level data as it is not dispensed through retail and mail order channels.

International net sales increased primarily due to higher demand, including the launch of theOrenciasubcutaneous formulation (SC) in certain European markets beginning in the fourthsecond quarter of 2011.2012, which was partially offset by unfavorable foreign exchange in Japan.

Avapro*/Avalide* (known in the EU asAprovel*/Karvea*) — an angiotensin II receptor blocker for the treatment of hypertension and diabetic nephropathy that is part of the Sanofi alliance

U.S. net sales are no longer recognized following the restructured Sanofi agreement.

International net sales increased primarily duewere impacted by changes attributed to increasedthe restructured Sanofi agreement and continue to be negatively impacted by lower demand partially offset by unfavorable foreign exchange.including generic competition in certain EU markets and Canada.

NulojixEliquisa fusion protein with novel immunosuppressive activity an oral Factor Xa inhibitor, targeted at stroke prevention in adult patients with NVAF and the prevention and treatment of kidney transplant rejectionVTE disorders.Eliquis is part of our strategic alliance with Pfizer.

 

  

NulojixEliquis was approved and launched in the U.S., Europe, Japan and Canada in the EU during 2011.first quarter of 2013 for the reduction of the risk of stroke and systemic embolism in patients with NVAF.

Onglyza/KombiglyzePlavix*(known in the EU asOnglyza/Komboglyze)—a once-daily oral tablet for the treatment of type 2 diabetesplatelet aggregation inhibitor that is part of our strategic alliance with AstraZenecaSanofi

 

U.S. net sales increased primarilydecreased due to higher overall demand.the loss of exclusivity in May 2012. Estimated U.S. prescription demand decreased 98%.

International net sales increased primarily duewere impacted by changes attributed to higher overall demand partially offsetthe restructured Sanofi agreement and continue to be negatively impacted by unfavorable foreign exchange.generic clopidogrel products in the EU, Canada, and Australia.

Byetta*—a twice daily glucagon-like peptide-1 (GLP-1) receptor agonist for the treatment of type 2 diabetes

Byetta* was acquired from our acquisition of Amylin in August 2012.

Bydureon*—a once-weekly GLP-1 receptor agonist for the treatment of type 2 diabetes

Bydureon* was acquired from our acquisition of Amylin in August 2012.

Mature Products and All Other—Other — includes all other products, including those which have lost exclusivity in major markets, over-the-counter brands and royalty-relatedroyalty revenue

 

U.S. net sales remained flat as sales ofSymlin*, which were included in our results following the acquisition of Amylin in the third quarter of 2012, were offset by lower demand and generic erosion of other products.

U.S.International net sales decreased asincreased due to revenue attributed to certain collaborations which was partially offset by the continued generic erosion of certain products was partially offset by higher average net selling prices.other products.

International net sales decreased due to continued generic erosion of certain brands and unfavorable foreign exchange.

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, federalFederal facilities including Veterans Administration hospitals, and long-term care, among others.Erbitux*,Yervoy andNulojix,and the intravenous formulation ofOrencia are parenterally administered products and do not have prescription-level data as these products are not dispensed through retail and mail order channels. The data is provided by Wolters Kluwer Health, except forSprycel andOrencia SC subcutaneous formulation,, and is based on the Source Prescription Audit. As of December 31, 2011,Sprycel andOrencia SC subcutaneous formulation demand is based uponon information from the Next-Generation Prescription Service version 2.0 of the National Prescription Audit provided by IMS Health (IMS).Health. The data is a product of each respective service providers’ own recordkeeping and projection processes and therefore subject to the inherent limitations of estimates based on sampling and may include a margin of error.

Prior to December 31, 2011,Sprycel demand was calculated based upon data obtained from the IMS National Sales Perspectives Audit. Since management believes information from the IMS National Prescription Audit more accurately reflects subscriber demand trends versus pill data from the IMS National Sales Perspectives Audit, all prior yearSprycel data has been restated to reflect information from the IMS National Prescription Audit.

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 ofcalculating these estimates and will monitor the quality of our own and third-party data used in such calculations.

We calculated the estimated total U.S. prescription change on a weighted-average basis to reflect thatas mail order prescriptions include a greater volume of product supplied, compared to retail prescriptions. Mail order prescriptions typically reflect a 90-day prescription whereas retail prescriptions typically reflect a 30-day prescription. The calculation is derived by multiplying mail order prescription data by a factor of approximately 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 in retail and mail order channels. We use this methodology for our internal demand reporting.

Estimated End-User Demand

The following table sets forth each of our key products sold by the U.S. for the three and nine months ended September 30, 2012 compared to the same period in the prior year: (i) change in reported U.S. net sales for each period; (ii) 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 (iii) months of inventory on hand in the wholesale distribution channel.

   Three Months Ended September 30,   Nine Months Ended September 30,   At September 30, 
   % Change in U.S.
Net Sales
   % Change in U.S.
Total Prescriptions
   % Change in U.S.
Net Sales
   % Change in U.S.
Total Prescriptions
   Months on Hand 
Dollars in Millions  2012   2011   2012   2011   2012   2011   2012   2011   2012   2011 

Plavix*

   (98)%     9%     (95)%     (6)%     (53)%     11%     (48)%     (5)%     1.6    0.5 

Avapro*/Avalide*

   (94)%     (28)%     (89)%     (42)%     (69)%     (21)%     (65)%     (38)%     0.9    0.5 

Abilify*

   (1)%     9%     (1)%     4%     (1)%     4%     1%     5%     0.4    0.4 

Reyataz

   5%     (3)%     (6)%     1%     4%     (1)%     (3)%     2%     0.5    0.4 

Sustiva Franchise(a)

   10%     (2)%     (2)%     7%     13%     2%     (1)%     8%     0.5    0.4 

Baraclude

   20%     11%     12%     8%     17%     15%     11%     9%     0.5    0.5 

Erbitux*(b)

   (1)%     8%     N/A     N/A     3%     2%     N/A     N/A     0.5    0.5 

Sprycel

   37%     66%     22%     27%     40%     63%     33%     19%     0.7    0.6 

Yervoy(b)(d)

   13%     N/A     N/A     N/A     77%     N/A     N/A     N/A     0.6    0.6 

Orencia(c)

   36%     12%     N/A     N/A     30%     11%     N/A     N/A     0.5    0.4 

Nulojix(b)(d)

        N/A     N/A     N/A     **     N/A     N/A     N/A     1.0    9.8 

Onglyza/Kombiglyze

   40%     **     42%     **     61%     **     56%     **     0.4    0.4 

Byetta*(e)

   N/A     N/A     N/A     N/A     N/A     N/A     N/A     N/A     0.8    N/A  

Bydureon*(e)

   N/A     N/A     N/A     N/A     N/A     N/A     N/A     N/A     0.7    N/A  

(a)

TheSustiva Franchise includes sales ofSustiva, as well as revenue of bulk efavirenz included in the combination therapyAtripla*. The months on hand relates only toSustiva.

(b)

Erbitux*,Yervoy andNulojix are parenterally administered products and do not have prescription-level data as physicians do not write prescriptions for these products.

(c)

Orencia intravenous formulation is a parenterally administered product and does not have prescription-level data as physicians do not write prescriptions for this product. TheOrencia subcutaneous formulation is not parenterally administered and was launched in the U.S. in the fourth quarter of 2011.

(d)

Yervoy andNulojix were launched in the U.S. in the second quarter of 2011.

(e)

Byetta* andBydureon* were acquired from our acquisition of Amylin in the third quarter of 2012.

**

Change in excess of 100%.

Pursuant to the Securities and Exchange Commission (SEC) Consent Order described in our 20112012 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 ade minimis exception. Estimated levels of inventory in the distribution channel in excess of one month on hand for these products were not material to our results of operations as of the dates indicated. Below are U.S. products that had estimated levels of inventory in the distribution channel in excess of one month at September 30, 2012,March 31, 2013, and international products that had estimated levels of inventory in the distribution channel in excess of one month on hand at June 30,December 31, 2012:

Plavix* had 1.61.5 months of inventory on hand in the U.S. compared to 2.21.3 months of inventory on hand at June 30,December 31, 2012 due to the loss of exclusivity in May 2012. We expect a gradual decrease in inventory on hand ofPlavix* to occur over the next few years as product in the wholesale distribution channel beginscontinues to be worked down or returned following the rapid, precipitous, and material decline in sales ofPlavix*.returned. Levels of inventory on hand in the wholesale and retail distribution channels were considered in assessing the sales return reserves established as of September 30, 2012.at March 31, 2013.

DafalganEliquis, an analgesic product sold principally in Europe, had 1.25.2 months of inventory on hand at direct customers comparedin the U.S. to 1.0 month ofsupport the initial product launch. This inventory on hand at December 31, 2011. The level of inventory on hand was dueis nominal and is expected to be worked down over the ordering patterns of private pharmacists in France.next few months as demand for this new product increases post launch.

EfferalganDafalgan, an analgesic product sold principally in Europe, had 1.1 months of inventory on hand internationally at direct customers compared to 1.0 month of inventory on hand at JuneSeptember 30, 2012 and December 31, 2011.2012. The level of inventory on hand was due to the ordering patterns of private pharmacists in France.

Luftal, an antacid product, had 1.1 months of inventory on hand at direct customers compared to 1.9 months of inventory on hand at December 31, 2011. The level of inventory on hand decreased as inventory was worked down following the relaunch of an alternate form.

Fervex, a cold and flu product, had 3.81.6 months of inventory on hand internationally at direct customers compared to 5.31.5 months of inventory on hand at December 31, 2011.September 30, 2012. The level of inventory on hand decreased following the peak flu season, but remained above averagewas due to the ordering patternpatterns of pharmacists in Brazil.

Fervex, a cold and flu product, had 2.9 months of inventory on hand internationally at direct customers, at March 31, 2013 and September 30, 2012. The level of inventory on hand was due to the ordering patterns of pharmacists in France.

In the U.S., for all products sold exclusively through wholesalers or through distributors, we generally determineddetermine our months on hand estimates using inventory levels of product on hand and the amount of out-movement provided by our three largest wholesalers and our distributors. Our three largest wholesalers account for approximately 90% of total gross sales of U.S. products. 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 recordkeeping processes.

For ourOur non-U.S. businesses 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 whereWhen 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 estimate such data, including using factors such 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. Factors that may affect our estimates include generic competition, seasonality of products, direct customer purchases in light of price increases, new product launches, new warehouse openings by direct customers, new customer stockings by direct customers and expected direct customer purchases for governmental bidding situations. As a result, 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 September 30, 2012March 31, 2013 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 ade minimis exception, in the next annualquarterly report on Form 10-K.10-Q.

Expenses

 

   Three Months Ended September 30,   Nine Months Ended September 30, 
Dollars in Millions  2012   2011   % Change   2012   2011   % Change 

Cost of products sold

  $      987   $      1,407    (30)%    $      3,535   $      4,231    (16)%  

Marketing, selling and administrative

   1,071    1,019    5%     3,077    2,987    3%  

Advertising and product promotion

   167    205    (19)%     585    672    (13)%  

Research and development

   951    973    (2)%     2,822    2,831      

Impairment charge for BMS-986094 intangible asset

   1,830         N/A     1,830         N/A  

Provision for restructuring

   29    8    **     71    92    (23)%  

Litigation expense/(recoveries)

   50         N/A     (122)          N/A  

Equity in net income of affiliates

   (40)     (71)     44%     (150)     (215)     30%  

Other (income)/expense

   (50)     (26)     92%     (45)     (195)     (77)%  
  

 

 

   

 

 

     

 

 

   

 

 

   

Total Expenses

  $4,995   $3,515    42%    $11,603   $10,403    12%  
  

 

 

   

 

 

     

 

 

   

 

 

   

**

Change in excess of 100%.

   Three Months Ended March 31, 
Dollars in Millions  2013  2012  % Change 

Cost of products sold

  $    1,063  $    1,303   (18)%  

Marketing, selling and administrative

   994   1,002   (1)%  

Advertising and product promotion

   189   194   (3)%  

Research and development

   930   909   2 %  

Other (income)/expense

   (19  (184  (90)%  
  

 

 

  

 

 

  

Total Expenses

  $3,157  $3,224   (2)%  
  

 

 

  

 

 

  

Cost of products sold decreased primarily due to lower sales volume following the loss of exclusivity ofPlavix* andAvapro*/Avalide*which resulted in lower royalties in connection with our Sanofi alliance and favorable foreign exchange partially offset by impairment charges in the second quarter of 2012 and higher net amortization costs resulting from the Amylin acquisition (netin the third quarter of the amortization of Amylin collaboration proceeds).2012. Cost of products sold as a percentage of net sales was 26.4%27.7% in 2013 and 26.3%24.8% in the three months ended September 30, 2012 and 2011, respectively,reflected a less favorable product mix as a result of royalties and 26.3%profit sharing expenses in connection with our alliances and 26.8%higher amortization costs in the nine months ended September 30, 2012 and 2011.2013.

Impairment charges of $147 million were recognized during the second quarter of 2012, of which $120 million was related to a partial write-down to fair value of developed technology costs related to a non-key product acquired in the acquisition of ZymoGenetics, Inc. (ZymoGenetics). The developed technology impairment charge resulted from continued competitive pricing pressures and a reduction in the undiscounted projected cash flows to an amount less than the carrying value of the intangible asset at June 30, 2012. The impairment charge was calculated as the difference between the fair value of the asset based on the discounted value of the estimated future cash flows and the carrying value of the intangible asset. The remaining $27 million impairment charge related to the abandonment of a manufacturing facility resulting from the outsourcing of a manufacturing process.

Marketing, selling and administrative expenses increaseddecreased primarily due to a reduction in 2012 primarily as a result of the Amylin acquisition ($86 million, including $67 millionsales related activities for certain key products to the accelerated vesting of stock options and restricted stock units), which wascoincide with their respective lifecycles partially offset by a reduction in sales-related activities forPlavix*increased spending to support the launch of new products andAvapro*/Avalide*.Marketing, selling and administrative expenses were also impacted by favorable foreign exchange. additional spending following the Amylin acquisition.

Research and development expenses decreasedincreased primarily from higher clinical grant spending and additional spending following the net impactAmylin acquisition partially offset by $58 million of upfront, milestone, and other licensing payments and IPRD impairment charges. Refer to “Specified Items” included in “—Non-GAAP Financial Measures” for amounts attributed to each period. Other licensing payments included $88 million in the first quarter of 2011 associated with the amendment of an intellectual property license agreement forYervoy prior to its approval. IPRD impairment charges relate toin 2012 for in-process research and development (IPRD) projects previously acquired in the Medarex, Inc. (Medarex) acquisition and Inhibitex acquisition (including $45 million in the second quarter of 2012 related to FV-100, a nucleoside inhibitor for the reduction of shingles-associated pain) resultingacquisition. The impairment charges resulted from unfavorable clinical trial results and decisions to cease further development. Research and development expenses also included $59 million of expenses related to the Amylin acquisition (including $27 million related to the accelerated vesting of Amylin stock options and restricted stock units) and favorable foreign exchange.

A $1.8 billion impairment charge was recognized when the development of BMS-986094 (formerly INX-189), a compound which we acquired as part of our acquisition of Inhibitex to treat hepatitis C, was discontinued in the interest of patient safety. See “Item 1. Financial Statements—Note 12. Goodwill and Other Intangible Assets” for further information.

Provision for restructuring was primarily attributable to employee termination benefits.

Litigation recoveries, in the nine months ended September 30, 2012, included $172 million for our share of the Apotex damages award concerningPlavix* partially offset by increases in reserves.

Equity in net income of affiliates decreased due to the continued impact of generic competition on internationalPlavix* net sales, the conversion of certain territories to opt-out markets and unfavorable foreign exchange.

Other (income)/expense includes:

 

 Three Months Ended September 30, Nine Months Ended September 30,   Three Months Ended March 31, 
Dollars in Millions 2012 2011 2012 2011   2013 2012 

Interest expense

 $48  $40  $131  $103   $50  $42 

Investment income

  (27  (23  (85  (69   (25  (36

Provision for restructuring

   33   22 

Litigation charges/(recoveries)

      (172

Equity in net income of affiliates

   (36  (57

Out-licensed intangible asset impairment

          38           38 

Gain on sale of product lines, businesses and assets

      (25  (3  (36   (1   

Other income received from alliance partners, net

  (96  (44  (225  (107   (57  (46

Pension curtailments and settlements

  3   2   3   (1

Litigation charges/(recoveries)

      1   22   (105

Product liability charges

      10       36 

Other

  22   13   74   (16   17   25 
 

 

  

 

  

 

  

 

   

 

  

 

 

Other (income)/expense

 $(50 $(26 $(45 $(195  $(19 $(184
 

 

  

 

  

 

  

 

   

 

  

 

 

 

Interest expense increased due to the termination of interest rate swap contracts in 2011 and higher borrowings in 2012.2013.

 

Investment income in 2012 included a $10 million gain from the sale of auction rate securitiessecurities.

Provision for restructuring was primarily attributable to employee termination benefits for continuous improvement initiatives. Additional employee termination costs of approximately $200 million are expected to be incurred in 2013 as a result of workforce reductions in several European countries. The majority of these costs will not be recognized until the first quartercompletion of 2012.discussions with local workers council subject to local regulations. The expected employee reductions are primarily attributed to sales force reductions resulting from the restructuring of the Sanofi and Otsuka agreements and streamlining operations due to challenging market conditions in Europe.

Litigation charges/(recoveries) in 2012 included $172 million for our share of the Apotex damages award concerningPlavix*.

Equity in net income of affiliates is primarily related to our international partnership with Sanofi in Europe and Asia which decreased in 2013 as a result of our restructuring of the Sanofi agreement and continues to be negatively impacted by generic competition forPlavix* in Europe and Asia.

 

Out-licensed intangible asset impairment charges are related to assets that were previously acquired in the Medarex and ZymoGenetics, Inc. acquisitions and resulted from unfavorable clinical trial results and/or the abandonment of the programs. Similar charges of $15 million were included in research and development in 2011.

 

Other income from alliance partners, net increased due to lower sales-based development royalties payable to Sanofi, a new supply agreement related to the Sanofi partnership and amortization of certain upfront, milestone and other licensing payments.

Product liability charges in 2011 were for additional reserves in connection with the breast implant settlement program.

Additional pension settlement charges may be recognized in the future, particularly with the U.S. pension plans due to a lower threshold resulting from the elimination of service costs and potentially higher lump sum payments.

Other includes acquisition-related expenses and losses on debt repurchases.

Other income from alliance partners, net includes income earned from the Sanofi partnership and amortization of certain upfront, milestone and other licensing payments related to other alliances. The decrease in U.S.Plavix* net sales resulted in lower development royalties owed to Sanofi in 2013. Royalty revenues from Sanofi (except in Europe and Asia) are presented in net sales beginning in 2013 as a result of the restructuring of our Sanofi agreement. See “Item 1. Financial Statements—Note 3. Alliances and Collaborations” for further discussion.

Non-GAAP Financial Measures

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

Specified items were as follows:

 

  Three Months Ended September 30,  Nine Months Ended September 30, 
Dollars in Millions, except per share data 2012  2011  2012  2011 

Accelerated depreciation, asset impairment and other shutdown costs

 $   $19  $147  $60 

Amortization of acquired Amylin intangible assets

  91       91     

Amortization of Amylin collaboration proceeds

  (46      (46    

Amortization of Amylin inventory adjustment

  9       9     
 

 

 

  

 

 

  

 

 

  

 

 

 

Cost of products sold

  54   19   201   60 

Stock compensation from accelerated vesting of Amylin awards

  67       67     

Process standardization implementation costs

  3   5   16   19 
 

 

 

  

 

 

  

 

 

  

 

 

 

Marketing, selling and administrative

  70   5   83   19 

Stock compensation from accelerated vesting of Amylin awards

  27       27     

Upfront, milestone and other licensing payments

  21   69   21   207 

IPRD impairment

      13   103   28 
 

 

 

  

 

 

  

 

 

  

 

 

 

Research and development

  48   82   151   235 

Impairment charge for BMS-986094 intangible asset

  1,830       1,830     

Provision for restructuring

  29   8   71   92 

Litigation expense/(recoveries)

  50       (122    

Gain on sale of product lines, businesses and assets

      (12      (12

Acquisition-related expenses

  29       42     

Litigation charges/(recoveries)

          22   (102

Product liability charges

      10       36 

Out-licensed intangible asset impairment

          38     

Loss on debt repurchase

  8       27     
 

 

 

  

 

 

  

 

 

  

 

 

 

Other (income)/expense

  37   (2  129   (78

Decrease to pretax income

  2,118   112   2,343   328 

Income tax on items above

  (722  (37  (791  (99

Specified tax benefit*

              (71
 

 

 

  

 

 

  

 

 

  

 

 

 

Income taxes

  (722  (37  (791  (170
 

 

 

  

 

 

  

 

 

  

 

 

 

Decrease to net earnings

 $1,396  $75  $1,552  $158 
 

 

 

  

 

 

  

 

 

  

 

 

 

                    
   Three Months Ended March 31, 
Dollars in Millions  2013  2012 

Amortization of acquired Amylin intangible assets

  $138  $ 

Amortization of Amylin collaboration proceeds

   (67   

Amortization of Amylin inventory adjustment

   14    
  

 

 

  

 

 

 

Cost of products sold

   85    

Marketing, selling and administrative*

   1   8 

Research and development**

      58 

Provision for restructuring

   33   22 

Acquisition related expenses

      12 

Litigation charges/(recoveries)

      (172

Out-licensed intangible asset impairment

      38 

Loss on debt repurchase

      19 

Upfront, milestone and other licensing receipts

   (14   
  

 

 

  

 

 

 

Other (income)/expense

   19   (81

Increase/(decrease) to pretax income

   105   (15

(Income tax)/tax benefit on items above

   (35  8 
  

 

 

  

 

 

 

Increase/(decrease) to net earnings

  $70  $(7
  

 

 

  

 

 

 
*

The 2011 specified tax benefit relates to releases of tax reserves that were specifiedSpecified items in prior periods.marketing, selling and administrative are process standardization implementation costs.

**

Specified items in research and development in 2012 are IPRD impairment charges.

The reconciliations from GAAP to Non-GAAP were as follows:

 

   Three Months Ended September 30,  Nine Months Ended September 30, 
Dollars in Millions, except per share data  2012  2011  2012  2011 

Net Earnings/(Loss) Attributable to BMS – GAAP

  $(711 $969  $1,035  $2,857 

Earnings attributable to unvested restricted shares

       (2  (1  (6
  

 

 

  

 

 

  

 

 

  

 

 

 

Net Earnings/(Loss) used for Diluted EPS Calculation – GAAP

  $(711 $967  $1,034  $2,851 
  

 

 

  

 

 

  

 

 

  

 

 

 

Net Earnings/(Loss) – GAAP

  $(711 $969  $1,035  $2,857 

Less Specified Items

   1,396   75   1,552   158 
  

 

 

  

 

 

  

 

 

  

 

 

 

Net Earnings – Non-GAAP

   685   1,044   2,587   3,015 

Earnings attributable to unvested restricted shares

       (2  (1  (6
  

 

 

  

 

 

  

 

 

  

 

 

 

Net Earnings used for Diluted EPS Calculation – Non-GAAP

  $685  $1,042  $2,586  $3,009 
  

 

 

  

 

 

  

 

 

  

 

 

 

Average Common Shares Outstanding – Diluted – GAAP

   1,666   1,715   1,697   1,717 

Contingently convertible debt common stock equivalents

   1             

Incremental shares attributable to share-based compensation plans

   16             
  

 

 

  

 

 

  

 

 

  

 

 

 

Average Common Shares Outstanding – Diluted – Non-GAAP

   1,683   1,715   1,697   1,717 

Diluted Earnings/(Loss) Per Share – GAAP

  $(0.43 $0.56  $0.61  $1.66 

Diluted EPS Attributable to Specified Items

   0.84   0.05   0.91   0.09 
  

 

 

  

 

 

  

 

 

  

 

 

 

Diluted Earnings/(Loss) Per Share – Non-GAAP

  $0.41  $0.61  $1.52  $1.75 
  

 

 

  

 

 

  

 

 

  

 

 

 
                
   Three Months Ended March 31, 
Dollars in Millions, except per share data  2013   2012 

Net Earnings Attributable to BMS – GAAP

  $609   $1,101 

Earnings attributable to unvested restricted shares

       (1
  

 

 

   

 

 

 

Net Earnings used for Diluted EPS Calculation – GAAP

  $609   $1,100 
  

 

 

   

 

 

 

Net Earnings Attributable to BMS – GAAP

  $609   $1,101 

Less Specified Items

   70    (7
  

 

 

   

 

 

 

Net Earnings Attributable to BMS – Non-GAAP

   679    1,094 

Earnings attributable to unvested restricted shares

       (1
  

 

 

   

 

 

 

Net Earnings used for Diluted EPS Calculation – Non-GAAP

  $679   $1,093 
  

 

 

   

 

 

 

Average Common Shares Outstanding – Diluted

   1,655    1,706 

Diluted EPS – GAAP

  $0.37   $0.64 

Diluted EPS Attributable to Specified Items

   0.04     
  

 

 

   

 

 

 

Diluted EPS – Non-GAAP

  $0.41   $0.64 
  

 

 

   

 

 

 

Income Taxes

Common stock equivalents were included in the calculation of GAAPThe effective income tax rate on earnings per share for all periods presented above exceptwas 7.6% for the three months ended September 30, 2012, because they were anti-dilutive due toMarch 31, 2013 and 26.9% for the loss.

Income Taxes

The effective tax benefit rate was 43.4% on the pretax loss during the third quarter of 2012 compared to an effective tax rate of 26.0% on pretax earnings during the third quarter of 2011. The effective income tax rates were 13.7% and 25.2% during the ninethree months ended September 30, 2012 and 2011, respectively.March 31, 2012. The overall tax benefit rate of 43.4% attributed to the pretax lossdecrease in the current quarter was due to the mix of earnings in low tax jurisdictions and pretax loss in the higher U.S. tax jurisdiction resulting from a $1.8 billion intangible asset impairment charge. The impact of the impairment charge reduced the effective tax rate by 11 percentage points duringresulted primarily from favorable earnings mix between high and low tax jurisdictions attributable to lowerPlavix*sales and to a lesser extent, an internal transfer of intellectual property in the nine months ended September 30,fourth quarter of 2012. In addition, the retroactive reinstatement of the R&D tax credit and look thru exception for the full year 2012 was recognized in the first quarter of 2013 ($43 million). The transfer of selected intellectual property rights outside the U.S. (for existing and new products) is part of our strategy to place key assets closer to where manufacturing, distribution, and other operational decisions are made.

Historically, the effective tax rate is typically lower than the U.S. statutory rate of 35% due to our decision to indefinitely reinvest the earnings for certain of our manufacturing operations in Ireland and Puerto Rico. We have favorable tax rates in Ireland and Puerto Rico under grants not scheduled to expire prior to 2023. See “Item 1. Financial Statements—Note 6. Income Taxes” for further discussion.

Noncontrolling Interest

Noncontrolling interest is primarily related to our partnerships with Sanofi for the territory covering the Americas related toPlavix*andAvapro*/Avalide* net sales. See “Item 1. Financial Statements—Note 3. Alliances and Collaborations.”Collaborations” for further discussion of our Sanofi partnership for the territory covering the Americas. The decrease in noncontrolling interest resulted from the May 2012 exclusivity loss ofPlavix*in the U.S and the March 2012 exclusivity lossU.S. ofAvapro*/Avalide* in the U.S.March 2012 andPlavix* in May 2012. A summary of noncontrolling interest is as follows:

 

                                                                                                                                            
 Three Months Ended September 30, Nine Months Ended September 30,   Three Months Ended March 31, 
Dollars in Millions 2012 2011 2012 2011   2013 2012 

Sanofi partnerships

 $(7 $590  $847  $1,764   $24  $605 

Other

  3   5   12   17    2   5 
 

 

  

 

  

 

  

 

   

 

  

 

 

Noncontrolling interest-pre-tax

  (4  595   859   1,781    26   610 

Income taxes

  (2  209   317   609    12   229 
 

 

  

 

  

 

  

 

   

 

  

 

 

Net earnings attributable to noncontrolling interest-net of taxes

 $(2 $386  $542  $1,172   $14  $381 
 

 

  

 

  

 

  

 

   

 

  

 

 

FINANCIAL POSITION, LIQUIDITY, AND CAPITAL RESOURCES

Our net cashdebt position was as follows:

 

                                                                                                  ��                 
Dollars in Millions   September 30,
2012
 December 31,
2011
   March 31,
2013
 December 31,
2012
 

Cash and cash equivalents

   $1,503  $5,776   $1,355  $1,656 

Marketable securities – current

    1,427   2,957    1,178   1,173 

Marketable securities – non-current

    3,698   2,909    3,242   3,523 
   

 

  

 

   

 

  

 

 

Total cash, cash equivalents and marketable securities

    6,628   11,642 

Cash, cash equivalents and marketable securities

   5,775   6,352 

Short-term borrowings and current portion of long-term debt

    (751  (115   (1,372  (826

Long-term debt

    (6,608  (5,376   (6,522  (6,568
   

 

  

 

   

 

  

 

 

Net cash/(debt) position

   $(731 $6,151 
   

 

  

 

 

Net debt position

  $(2,119 $(1,042
  

 

  

 

 

Working capital

   $1,083  $7,538   $1,668  $1,242 

The reduction in net cashdebt position increased by $1.1 billion during the first quarter of 2013 due to the timing of payments with our collaboration partners, Medicaid rebates, annual employee bonuses, pension contributions and other working capital during 2012 resulted primarily from net cash usedrequirements. See “—Cash Flows” in connection with the acquisitions of Amylin and Inhibitex. this section for further information.

Cash, cash equivalents and marketable securities held in the U.S. were approximately $2.0 billion$253 million at September 30, 2012.March 31, 2013. Most of the remaining $4.6$5.5 billion is held primarily in low-tax jurisdictions and is attributable to earnings that are expected to be indefinitely reinvested offshore. Cash repatriations are subject to restrictions in certain jurisdictions and may be subject to withholding and additional U.S. income taxes. During the third quarter of 2012, we began to issueWe started issuing commercial paper to meet near-term domestic liquidity requirements following the Amylin acquisition.during 2012. The average amount of commercial paper outstanding was $211 million at a weighted-average interest rate of 0.14% during the three months ended September 30, 2012 was $526 million with a weighted-average interest rateMarch 31, 2013. The maximum month-end amount of 0.15%. There were no month-end commercial paper borrowings outstanding during the third quarter of 2012.was $600 million, which was outstanding at March 31, 2013. We maywill likely continue to issue commercial paper to meet our domestic liquidity requirements in the future.needs.

Our investment portfolio includes non-current marketable securities which are subject to changes in fair value as a result of interest rate fluctuations and other market factors, which may impact our results of operations. Our investment policy places limits on these investments and the amount and time to maturity of investments with any institution. The policy also requires that investments are only entered into with corporate and financial institutions that meet high credit quality standards. See “Item 1. Financial Statements—Note 8. Financial Instruments.”

In July 2012, BMS entered into a newWe currently have two separate $1.5 billion five-year revolving credit facilityfacilities from a syndicate of lenders which containslenders. The facilities provide for customary terms and conditions with no financial covenants and isare extendable on any anniversary date with the consent of the lenders. This revolving credit facility is in addition to the Company’s existing $1.5 billion five-year revolving credit facility. There are no financial covenants under either facility. ThereNo borrowings were no borrowings outstanding under either revolving credit facility at September 30, 2012March 31, 2013 and December 31, 2011.2012.

In July 2012, in connection with the Amylin acquisition, BMS issued $2.0 billion of senior unsecured notes in a registered public offering consisting of $750 million in aggregate principal amount of 0.875% Notes due 2017, $750 million in aggregate principal amount of 2.000% Notes due 2022 and $500 million in aggregate principal amount of 3.250% Notes due 2042.

In August 2012, BMS completed its acquisition of Amylin for an aggregate purchase price of $5.3 billion. BMS also assumed Amylin’s net debt and a contractual payment obligation to Eli Lilly & Company, together totaling $2.0 billion (substantially all of which was repaid during the three months ended September 30, 2012). The acquisition was financed through the use of existing cash balances, the issuance of commercial paper and long-term debt borrowings described above.

BMS received preliminary proceeds of $3.8 billion from AstraZeneca as consideration for entering into the collaboration during the current period, including $190 million which is recorded in accrued expenses and expected to be reimbursed back to AstraZeneca during the fourth quarter. The net proceeds that BMS will receive from AstraZeneca as consideration for entering into the collaboration are subject to certain other adjustments including the right to receive an additional $135 million when AstraZeneca exercises its option for equal governance rights.

As discussed in “—Strategy” above, we lost exclusivity in the U.S. for our largest product,Plavix*, in May 2012 which has resulted in a rapid, precipitous, and material decline in operating cash flow. Additional regulations in the U.S. could be passed in the future which could further reduce our results of operations, operating cash flow, liquidity and financial flexibility. We also continue to monitor the potential impact of the economic conditions in certain European countries and the related impact on prescription trends, pricing discounts, creditworthiness of our customers and our ability to collect outstanding receivables from our direct customers. Currently, we believe these economic conditions in the EU will not have a material impact on our liquidity, cash flow or financial flexibility.

Although not material, certain European government-backed entities with a higher risk of default were identified by monitoring economic factors including credit ratings, credit-default swap rates and debt-to-gross domestic product ratios in addition to entity specific factors. Our creditHistorically, our exposure to government-backed trade receivables in Greece, Portugal, Italy and Spain iswas limited by factoring receivables and deferring revenues until the collection of cash and accruing additional bad debt reserves. Our net receivables in these countries were approximately $233 million at September 30, 2012, of which approximately 75% was from government-backed entities. Duringcash.

However, during 2012, counterparties in our factoring arrangements suspended factoring of receivables from Spanish and Portuguese government-backed entities and limited factoring of receivables from certain Italian government-backed entities. Sales of trade receivables in Italy, Portugal and Spain were $250 million in 2012 and $384 million in 2011. Our credit exposures in Europe may increase in the future due to further reductions in our factoring arrangements and the ongoing sovereign debt crisis. Our credit exposure to trade receivables in Greece, Portugal, Italy and Spain was $251 million at March 31, 2013, of which approximately 75% was from government-backed entities. Sales of trade receivables in Italy, Portugal and Spain were $72 million in 2013 and $73 million in 2012. Sales of receivables in Japan were $484$152 million in 20122013 and $422$140 million in 2011.2012. Our sales agreements do not allow for recourse in the event of uncollectibility and we do not retain interest to the underlying assets once sold.

We continue to manage our operating cash flows with initiatives designed to improveby focusing on working capital items that are most directly affected by changes in sales volume, such as receivables, inventories, and accounts payable. During 2012, the following changes in receivables, inventories and accounts payable resulted primarily from the rapid reduction ofPlavix* sales, the acquisition of Amylin and timing of expenditures in the ordinary course of business. The following summarizes these components expressed as a percentage of trailing twelve months’ net sales:

 

Dollars in Millions September 30,
2012
  % of Trailing
Twelve Month
Net Sales
  December 31,
2011
  % of Trailing
Twelve Month
Net Sales
 

Net trade receivables

 $1,734   9.2 $2,250   10.6

Inventories

  1,697   9.0  1,384   6.5

Accounts payable

  (2,085  (11.0)%   (2,603  (12.2)% 
 

 

 

   

 

 

  

Total

 $1,346   7.1 $1,031   4.9
 

 

 

   

 

 

  

                                            
Dollars in Millions  March 31,
2013
  December 31,
2012
 

Net trade receivables

  $1,798  $1,708 

Inventories

   1,791   1,657 

Accounts payable

   (2,079  (2,202
  

 

 

  

 

 

 

Total

  $1,510  $1,163 
  

 

 

  

 

 

 

Credit Ratings

Moody’s Investors Service long-term and short-term credit ratings are currently A2 and Prime-1, respectively, and their long-term credit outlook remains stable. Standard & Poor’s (S&P) long-term and short-term credit ratings are currently A+ and A-1+, respectively, and their long-term credit outlook remains stable. S&P upgraded our short-term credit rating from A-1 to A-1+ in May 2012. Fitch Ratings (Fitch) long-term and short-term credit ratings are currently A and F1, respectively, and their long-term credit outlook remains negative. Fitch lowered our long-term credit rating from A+ to A in July 2012. Our credit ratings are considered investment grade. TheseOur long-term ratings designatereflect the agencies’ opinion that we have a low default risk but are somewhat susceptible to adverse effects of changes in circumstances and economic conditions. TheseOur short-term ratings designatereflect the agencies’ opinion that we have the strongestan extremely strong capacity for timely repayment.

Cash Flows

The following is a discussion of cash flow activities:

 

                      
 Nine Months Ended
September 30,
   Three Months Ended March 31, 
Dollars in Millions 2012 2011   2013 2012 

Cash flow provided by/(used in):

     

Operating activities

 $6,105  $3,272   $(428 $387 

Investing activities

  (7,004  (1,932   161   (3,027

Financing activities

  (3,375  (1,903   (44  (836

Operating Activities

Cash flow from operating activities represents the cash receipts and cash disbursements from all of our activities other than investing activities and financing activities. Operating cash flow is derived by adjusting net earnings for noncontrolling interest, non-cash operating items, gains and losses attributed to investing and financing activities and changes in operating assets and liabilities resulting from timing differences between the receiptsreceipt and payments of cash and when the transactions are recognized in our results of operations. As a result, changes in cash from operating activities reflect the timing of cash collections from customers and alliance partners; payments to suppliers, alliance partners and employees; pension contributionscontributions; and tax payments in the ordinary course of business. Preliminary proceedsMost pension contributions and annual employee bonuses are paid in the first quarter of $3.8 billionthe year and were approximately $600 million in 2013 and $800 million in 2012.

The $815 million decrease in operating cash flow compared to the first quarter of 2012 is primarily attributable to:

Lower operating cash flows attributed toPlavix* andAvapro*/Avalide* sales reductions following the loss of exclusivity of these products in the first half of 2012 (approximately $600 million);

The timing of payments with our collaboration partners, Medicaid rebates and other additional working capital requirements in 2013 (approximately $500 million); and

The Apotex damage award received in 2012 from AstraZeneca as consideration for entering into the Amylin collaboration.($172 million)

Partially offset by:

Upfront and contingent milestone proceeds in 2013 ($320 million); and

Lower pension contributions and annual employee bonus payments in 2013 (approximately $200 million).

Investing Activities

 

Cash was used to fund the acquisition of Amylin for $5.0 billion and Inhibitex for $2.5 billion in 2012.

Net sales and maturities of marketable securities of $883$273 million in 2012 were primarily attributed to the Amylin acquisition.timing of investment maturities and the management of domestic liquidity requirements. Net purchases of marketable securities of $1.5 billionwere $425 million in 2011 were primarily attributable2012 due to the timing of additional investments in time deposits and highly-ratedhighly rated corporate debt securities with maturities greater than 90 days.

Other investing activities included litigation recoveries of $102 million in 2011.

Financing Activities

 

Dividend payments were $1.7 billion$580 million in both 20122013 and 2011.$579 million in 2012. Dividends declared per common share totaled $1.02 for the nine months ended September 30, 2012were $0.35 in 2013 and $0.99 for the nine months ended September 30, 2011.$0.34 in 2012. Dividend decisions are made on a quarterly basis by our Board of Directors.

Proceeds of $2.0 billion were received from the issuance of senior unsecured notes.Cash used to repurchase common stock was $297 million in 2013 and $339 million in 2012.

RepaymentsCommercial paper borrowings were $600 million in 2013.

Proceeds from stock option exercises were $270 million in 2013 (including $55 million of debt assumedcash retained from excess tax benefits) and $159 million in 2012 (including $37 million of cash retained from excess tax benefits) and will vary from period to period based on fluctuations in the Amylin acquisition were $2.0 billion.market value of our stock relative to the exercise price of the stock options and other factors.

Management periodically evaluates potential opportunities to repurchase certain debt securities and terminate certain interest rate swap contracts prior to their maturity. Cash outflows related to the repurchase of debt were $109 million in 2012 and $78 million2012. There were no debt repurchases in 2011.

In June 2012, the Board of Directors increased its authorization for the repurchase of common stock by $3.0 billion. There is $2.3 billion of common stock repurchase capacity remaining as of September 30, 2012. Common stock was repurchased in the amount of $1.9 billion in 2012 and $859 million in 2011.

Proceeds from stock option exercises were $397 million in 2012 and $365 million in 2011 and will vary from period to period based upon fluctuations in the market value of our stock relative to the exercise price of the stock options and other factors.2013.

CRITICAL ACCOUNTING POLICIES

For a discussion of our critical accounting policies, see “Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations” in our 20112012 Annual Report on Form 10-K.

SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS

This quarterly report on Form 10-Q (including documents incorporated by reference) and other written and oral statements we make from time to time contain certain “forward-looking” statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. You can identify these forward-looking statements by the fact they use words such as “should”, “expect”, “anticipate”, “estimate”, “target”, “may”, “project”, “guidance”, “intend”, “plan”, “believe” and other words and terms of similar meaning and expression in connection with any discussion of future operating or financial performance. One can also identify forward-looking statements by the fact that they do not relate strictly to historical or current facts. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes to differ materially from current expectations. These statements are likely to relate to, among other things, our goals, plans and projections regarding our financial position, results of operations, cash flows, market position, product development, product approvals, sales efforts, expenses, performance or results of current and anticipated products and the outcome of contingencies such as legal proceedings and financial results, which are based on current expectations that involve inherent risks and uncertainties, including internal or external factors that could delay, divert or change any of them in the next several years. We have included important factors in the cautionary statements included in this report and in the 20112012 Annual Report on Form 10-K, particularly under “Item 1A. Risk Factors,” that we believe could cause actual results to differ materially from any forward-looking statement.

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

Item 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

For a discussion of our market risk, see “Item 7A. Quantitative and Qualitative Disclosures About Market Risk” in our 20112012 Annual Report on Form 10-K.

Item 4. CONTROLS AND PROCEDURES

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

In August 2012, Bristol-Myers Squibb Company (the Company) completed its acquisition of Amylin Pharmaceuticals, Inc. (Amylin) which represents a material changeThere were no changes in the Company’s internal control over financial reporting since management’s last assessment of effectiveness. Amylin’s operations utilize separate information and accounting systems and processes and it was not possible to complete an evaluation and review ofduring the internal controls over financial reporting since the completion of the acquisition. Management intends to complete its assessment of the effectiveness of internal control over financial reporting for Amylin within one year of the acquisition date. Excluding the Amylin acquisition, there were no changes in our internal control over financial reportingquarter ended March 31, 2013 that have materially affected, or are reasonably likely to materially affect, the Company’s internal control over financial reporting.

PART II—OTHER INFORMATION

Item 1. LEGAL PROCEEDINGS

Information pertaining to legal proceedings can be found in “Item 1. Financial Statements—Note 17. Legal Proceedings and Contingencies,” to the interim consolidated financial statements, and is incorporated by reference herein.

Item 1A. RISK FACTORS

There have been no material changes from the risk factors disclosed in the Company’s 20112012 Annual Report on Form 10-K.

Item 2. ISSUER PURCHASES OF EQUITY SECURITIES

The following table summarizes the surrenders of our equity securities during the nine monthsthree month period ended September 30, 2012:March 31, 2013:

 

Period

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

January 1 to 31, 2012

   5,482,912   $33.35    5,477,200   $1,005 

February 1 to 29, 2012

   4,372,415   $32.22    4,360,900   $864 

March 1 to 31, 2012

   1,750,695   $32.51        $864 
  

 

 

     

 

 

   

Three months ended March 31, 2012

   11,606,022      9,838,100   
  

 

 

     

 

 

   

April 1 to 30, 2012

   5,613,737   $33.42    5,606,834   $677 

May 1 to 31, 2012

   5,876,829   $33.14    5,858,755   $483 

June 1 to 30, 2012

   4,912,492   $34.52    4,906,631   $3,313 
  

 

 

     

 

 

   

Three months ended June 30, 2012

   16,403,058      16,372,220   
  

 

 

     

 

 

   

July 1 to 31, 2012

   6,304,273   $35.30    6,299,644   $3,091 

August 1 to 31, 2012

   16,960,023   $32.36    16,949,219   $2,543 

September 1 to 30, 2012

   8,052,099   $33.36    8,045,000   $2,274 
  

 

 

     

 

 

   

Three months ended September 30, 2012

   31,316,395      31,293,863   
  

 

 

     

 

 

   

Nine months ended September 30, 2012

   59,325,475      57,504,183   
  

 

 

     

 

 

   

Period

  Total Number of
Shares Purchased(a)
   Average Price Paid
per Share(a)
   Total Number of
    Shares Purchased as    
Part of Publicly
Announced Plans or
Programs(b)
   Approximate Dollar
    Value of Shares that    
May Yet Be

Purchased Under the
Plans or Programs(b)
 
Dollars in Millions, Except Per Share Data                

January 1 to 31, 2013

   3,206,822   $34.25    3,191,812   $1,672 

February 1 to 28, 2013

   2,466,156   $36.67    2,452,642   $1,583 

March 1 to 31, 2013

   4,780,971   $38.45    2,510,200   $1,484 
  

 

 

     

 

 

   

Three months ended March 31, 2013

   10,453,949      8,154,654   
  

 

 

     

 

 

   

 

(a)

The difference between total number of shares purchased and the total number of shares purchased as part of publicly announced programs is due todifferent because shares of common stock are withheld by us from employee restricted stock awards in order to satisfy our applicable tax withholding obligations.

(b)

In May 2010, the Board of Directors authorized the repurchase of up to $3.0 billion of common stock. In June 2012, the Board of Directors increased its authorization for the repurchase of common stock by an additional $3.0 billion. The repurchase program does not have an expiration date and is expected to take place over a couple of years.may be suspended or discontinued at any time.

Item 6. EXHIBITS

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

 

Exhibit No.

 

Description

10a.  12.Master Restructuring Agreement by and between Bristol-Myers Squibb Company and Sanofi dated as of September 27, 2012.†
  12.  Computation of Earnings to Fixed Charges.
31a.  Section 302 Certification Letter.
31b.  Section 302 Certification Letter.
32a.  Section 906 Certification Letter.
32b.  Section 906 Certification Letter.
101.  

The following financial statements from the Bristol-Myers Squibb Company Quarterly Report on Form 10-Q for the quarter ended September 30, 2012,March 31, 2013, formatted in Extensible Business Reporting Language (XBRL):
(i) consolidated statements of earnings, (ii) consolidated statements of comprehensive income and retained earnings, (iii) consolidated balance sheets, (iv) consolidated statements of cash flows, and (v) the notes to the consolidated financial statements.

 

† Confidential treatment has been requested for certain portions which are omitted in the copy of the exhibit electronically filed with the Commission. The omitted information has been filed separately with the Commission pursuant to the Company’s application for confidential treatment.

*        Indicates, in this Form 10-Q, brand names of products, which are registered trademarks not solely owned by the Company or its subsidiaries.Byetta,Bydureon, andSymlinare trademarks of Amylin Pharmaceuticals, LLC and AstraZeneca Pharmaceuticals LP;Erbitux is a trademark of Eli Lilly and Company;Avapro/Avapro/Avalide (known in the EU asAprovel/Aprovel/Karvea) andPlavix are trademarks of Sanofi;Abilify is a trademark of Otsuka Pharmaceutical Co., Ltd.;Truvada is a trademark of Gilead Sciences, Inc.;Gleevec is a trademark of Novartis AG;Atripla is a trademark of Bristol-Myers Squibb and Gilead Sciences, LLC;Estrace andOvcon are trademarks of Warner-Chilcott Company, LLC;Reglan is a trademark of Alaven Pharmaceutical LLC;Humira is a trademark of Abbott Laboratories; andDelestrogen is a trademark of JHP Pharmaceuticals, Inc.LLC;Reglan is a trademark of ANIP Acquisition Company. Brand names of products that are in all italicized letters, without an asterisk, are registered trademarks of BMS and/or one of its subsidiaries.

SIGNATURES

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

 

 

BRISTOL-MYERS SQUIBB COMPANY

(REGISTRANT)

Date: October 24, 2012April 25, 2013

 

By:

 

/s/ Lamberto Andreotti

  

Lamberto Andreotti

  

Chief Executive Officer

Date: October 24, 2012April 25, 2013

 

By:

 

/s/ Charles Bancroft

  

Charles Bancroft

  

Executive Vice President and Chief Financial Officer

 

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