0001193125-12-341189.txt : 20120807 0001193125-12-341189.hdr.sgml : 20120807 20120807170543 ACCESSION NUMBER: 0001193125-12-341189 CONFORMED SUBMISSION TYPE: 10-Q PUBLIC DOCUMENT COUNT: 11 CONFORMED PERIOD OF REPORT: 20120630 FILED AS OF DATE: 20120807 DATE AS OF CHANGE: 20120807 FILER: COMPANY DATA: COMPANY CONFORMED NAME: Merck & Co. Inc. CENTRAL INDEX KEY: 0000310158 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 221918501 STATE OF INCORPORATION: NJ FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 10-Q SEC ACT: 1934 Act SEC FILE NUMBER: 001-06571 FILM NUMBER: 121014154 BUSINESS ADDRESS: STREET 1: ONE MERCK DRIVE STREET 2: P.O. BOX 100 CITY: WHITEHOUSE STATION STATE: NJ ZIP: 08889-0100 BUSINESS PHONE: 908-423-4840 MAIL ADDRESS: STREET 1: ONE MERCK DRIVE STREET 2: P.O. BOX 100 CITY: WHITEHOUSE STATION STATE: NJ ZIP: 08889-0100 FORMER COMPANY: FORMER CONFORMED NAME: SCHERING PLOUGH CORP DATE OF NAME CHANGE: 19920703 10-Q 1 d351112d10q.htm FORM 10-Q FORM 10-Q

UNITED STATES SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-Q

(Mark One)

 

þ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended June 30, 2012

OR

 

¨ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from         to         

Commission File No. 1-6571

Merck & Co., Inc.

One Merck Drive

Whitehouse Station, N.J. 08889-0100

(908) 423-1000

 

Incorporated in New Jersey  

I.R.S. Employer

Identification No. 22-1918501

The number of shares of common stock outstanding as of the close of business on July 31, 2012:    3,045,632,274

Indicate by check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.  Yes þ    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 þ    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 the definitions of “large accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act. (Check one):

 

Large accelerated filer þ

  Accelerated filer ¨   Non-accelerated filer ¨   Smaller reporting company ¨
  (Do not check if a 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 þ


Part I - Financial Information

Item 1.  Financial Statements

MERCK & CO., INC. AND SUBSIDIARIES

INTERIM CONSOLIDATED STATEMENT OF INCOME

(Unaudited, $ in millions except per share amounts)

 

         Three Months Ended     
June  30,
              Six Months Ended      
June  30,
 
          2012            2011                2012          2011  

Sales

      $     12,311          $     12,151              $     24,041          $     23,732   

Costs, Expenses and Other

         

Materials and production

    4,112        4,284          8,150        8,343   

Marketing and administrative

    3,249        3,525          6,322        6,689   

Research and development

    2,165        1,936          4,026        4,094   

Restructuring costs

    144        668          363        654   

Equity income from affiliates

    (142     (55       (253     (193

Other (income) expense, net

    103        121            247        744   
      9,631        10,479            18,855        20,331   

Income Before Taxes

    2,680        1,672          5,186        3,401   

Taxes on Income

    860        (382         1,599        276   

Net Income

    $       1,820        $       2,054          $       3,587        $       3,125   

Less: Net Income Attributable to Noncontrolling Interests

    27        30            56        58   

Net Income Attributable to Merck & Co., Inc.

    $       1,793        $       2,024            $       3,531        $       3,067   

Basic Earnings per Common Share Attributable to

         

Merck & Co., Inc. Common Shareholders

    $         0.59        $         0.65            $         1.16        $         0.99   

Earnings per Common Share Assuming Dilution Attributable

         

to Merck & Co., Inc. Common Shareholders

    $         0.58        $         0.65            $         1.15        $         0.98   

Dividends Declared per Common Share

    $         0.42        $         0.38            $         0.84        $         0.76   

The accompanying notes are an integral part of this consolidated financial statement.

 

- 2 -


MERCK & CO., INC. AND SUBSIDIARIES

INTERIM CONSOLIDATED STATEMENT OF COMPREHENSIVE INCOME

(Unaudited, $ in millions)

 

    Three Months Ended
June 30,
        

Six Months Ended

June 30,

 
          2012                2011                     2012               2011      

Net Income Attributable to Merck & Co., Inc.

    $ 1,793          $ 2,024               $ 3,531          $ 3,067    

Other Comprehensive Income Net of Taxes:

            

Net unrealized gain (loss) on derivatives, net of reclassifications

    102          (30)            44          (137)   

Net unrealized gain (loss) on investments, net of reclassifications

            (4)            30          (5)   

Benefit plan net gain (loss) and prior service cost (credit), net of amortization

    18          10             18          28    

Cumulative translation adjustment

    (30)         418               (86)         554    
      91          394                       440    

Comprehensive Income Attributable to Merck & Co., Inc.

    $       1,884          $        2,418               $       3,537          $       3,507    

The accompanying notes are an integral part of this consolidated financial statement.

 

- 3 -


MERCK & CO., INC. AND SUBSIDIARIES

CONSOLIDATED BALANCE SHEET

(Unaudited, $ in millions except per share amounts)

 

      June 30,  
2012  
    December 31,
2011
 

Assets

    

Current Assets

    

Cash and cash equivalents

   $ 16,752      $ 13,531   

Short-term investments

     698        1,441   

Accounts receivable (net of allowance for doubtful accounts of $144 in 2012 and $131 in 2011)

     8,152        8,261   

Inventories (excludes inventories of $1,490 in 2012 and $1,379 in 2011 classified in Other assets - see Note 6)

     6,249        6,254   

Deferred income taxes and other current assets

     3,788        3,694   

Total current assets

     35,639        33,181   

Investments

     4,085        3,458   

Property, Plant and Equipment, at cost, net of accumulated depreciation of $17,049 in 2012 and $16,176 in 2011

     15,867        16,297   

Goodwill

     12,158        12,155   

Other Intangibles, Net

     31,620        34,302   

Other Assets

     6,156        5,735   
     $         105,525      $ 105,128   

Liabilities and Equity

    

Current Liabilities

    

Loans payable and current portion of long-term debt

   $ 3,922      $ 1,990   

Trade accounts payable

     1,674        2,023   

Accrued and other current liabilities

     8,917        10,170   

Income taxes payable

     1,091        781   

Dividends payable

     1,308        1,281   

Total current liabilities

     16,912        16,245   

Long-Term Debt

     15,057        15,525   

Deferred Income Taxes and Noncurrent Liabilities

     15,883        16,415   

Merck & Co., Inc. Stockholders’ Equity

    

Common stock, $0.50 par value

    

Authorized - 6,500,000,000 shares

    

Issued - 3,577,103,522 shares in 2012 and 2011

     1,788        1,788   

Other paid-in capital

     40,550        40,663   

Retained earnings

     39,950        38,990   

Accumulated other comprehensive loss

     (3,126     (3,132
     79,162        78,309   

Less treasury stock, at cost:

    

538,194,526 shares in 2012 and 536,109,713 shares in 2011

     23,968        23,792   

Total Merck & Co., Inc. stockholders’ equity

     55,194        54,517   

Noncontrolling Interests

     2,479        2,426   

Total equity

     57,673        56,943   
     $ 105,525      $ 105,128   

The accompanying notes are an integral part of this consolidated financial statement.

 

- 4 -


MERCK & CO., INC. AND SUBSIDIARIES

INTERIM CONSOLIDATED STATEMENT OF CASH FLOWS

(Unaudited, $ in millions)

 

          Six Months Ended      
June 30,
 
          2012              2011      

Cash Flows from Operating Activities

   

Net income

      $       3,587          $       3,125   

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

   

Depreciation and amortization

    3,594        3,663   

Intangible asset impairment charges

    136        439   

Equity income from affiliates

    (253     (193

Dividends and distributions from equity affiliates

    122        121   

Deferred income taxes

    (365     (841

Share-based compensation

    169        200   

Other

    143        (456

Net changes in assets and liabilities

    (2,059     (1,485

Net Cash Provided by Operating Activities

    5,074        4,573   

Cash Flows from Investing Activities

   

Capital expenditures

    (762     (689

Purchases of securities and other investments

    (4,001     (3,066

Proceeds from sales of securities and other investments

    4,174        2,890   

Dispositions of businesses, net of cash divested

    -        323   

Acquisitions of businesses, net of cash acquired

    -        (373

Other

    21        (28

Net Cash Used in Investing Activities

    (568     (943

Cash Flows from Financing Activities

   

Net change in short-term borrowings

    1,637        1,396   

Payments on debt

    (2     (1,265

Purchases of treasury stock

    (985     (314

Dividends paid to stockholders

    (2,559     (2,351

Proceeds from exercise of stock options

    601        162   

Other

    (3     (57

Net Cash Used in Financing Activities

    (1,311     (2,429

Effect of Exchange Rate Changes on Cash and Cash Equivalents

    26        241   

Net Increase in Cash and Cash Equivalents

    3,221        1,442   

Cash and Cash Equivalents at Beginning of Year

    13,531        10,900   

Cash and Cash Equivalents at End of Period

    $     16,752        $     12,342   

The accompanying notes are an integral part of this consolidated financial statement.

 

- 5 -


Notes to Consolidated Financial Statements (unaudited)

1.   Basis of Presentation

The accompanying unaudited interim consolidated financial statements of Merck & Co., Inc. (“Merck” or the “Company”) have been prepared pursuant to the rules and regulations for reporting on Form 10-Q. Accordingly, certain information and disclosures required by accounting principles generally accepted in the United States for complete consolidated financial statements are not included herein. These interim statements should be read in conjunction with the audited financial statements and notes thereto included in Merck’s Form 10-K filed on February 28, 2012.

The results of operations of any interim period are not necessarily indicative of the results of operations for the full year. In the Company’s opinion, all adjustments necessary for a fair presentation of these interim statements have been included and are of a normal and recurring nature.

Certain reclassifications have been made to prior year amounts to conform to the current year presentation.

Recently Adopted Accounting Standards

In the first quarter of 2012, the Company retrospectively adopted amended guidance issued by the Financial Accounting Standards Board (the “FASB”) on the presentation of comprehensive income in financial statements. As a result of adopting this standard, the Company has presented a separate Statement of Comprehensive Income. The adoption of this new guidance did not impact the Company’s financial position, results of operations or cash flows.

Recently Issued Accounting Standards

In July 2012, the FASB issued amended guidance that simplifies how an entity tests indefinite-lived intangibles for impairment. The amended guidance will allow companies to first assess qualitative factors to determine whether it is more-likely-than-not that an indefinite-lived intangible asset is impaired as a basis for determining whether it is necessary to perform the quantitative impairment test. The updated guidance is effective for annual and interim impairment tests performed for fiscal years beginning after September 15, 2012, with early adoption permitted. The Company is currently evaluating the impact of adoption on its financial position and results of operations.

2.   Restructuring

Merger Restructuring Program

In February 2010, subsequent to the Merck and Schering-Plough Corporation (“Schering-Plough”) merger (the “Merger”), the Company commenced actions under a global restructuring program (the “Merger Restructuring Program”) in conjunction with the integration of the legacy Merck and legacy Schering-Plough businesses. This Merger Restructuring Program is intended to optimize the cost structure of the combined company. In July 2011, the Company announced the latest phase of the Merger Restructuring Program during which the Company expects to reduce its workforce measured at the time of the Merger by an additional 12% to 13% across the Company worldwide. A majority of the workforce reductions in this phase of the Merger Restructuring Program relate to manufacturing (including Animal Health), administrative and headquarters organizations. Previously announced workforce reductions of approximately 17% in earlier phases of the program primarily reflect the elimination of positions in sales, administrative and headquarters organizations, as well as from the sale or closure of certain manufacturing and research and development sites and the consolidation of office facilities. The Company will continue to hire employees in strategic growth areas of the business as necessary. The Company will continue to pursue productivity efficiencies and evaluate its manufacturing supply chain capabilities on an ongoing basis which may result in future restructuring actions.

The Company recorded total pretax restructuring costs of $291 million and $808 million in the second quarter of 2012 and 2011, respectively, and $568 million and $921 million in the first six months of 2012 and 2011, respectively, related to this program. Since inception of the Merger Restructuring Program through June 30, 2012, Merck has recorded total pretax accumulated costs of approximately $5.7 billion and eliminated approximately 20,230 positions comprised of employee separations, as well as the elimination of contractors and vacant positions. The restructuring actions under the Merger Restructuring Program are expected to be substantially completed by the end of 2013, with the exception of certain actions, principally manufacturing-related, which are expected to be substantially completed by 2015. The Company originally estimated the total cumulative pretax costs for this program to be approximately $5.8 billion to $6.6 billion and the Company now expects the cumulative costs to be near the upper end of this range. The Company estimates that approximately two-thirds of the cumulative pretax costs relate to cash outlays, primarily related to employee separation expense. Approximately one-third of the

 

- 6 -


Notes to Consolidated Financial Statements (unaudited) (continued)

 

cumulative pretax costs are non-cash, relating primarily to the accelerated depreciation of facilities to be closed or divested.

2008 Global Restructuring Program

In October 2008, Merck announced a global restructuring program (the “2008 Restructuring Program”) to reduce its cost structure, increase efficiency, and enhance competitiveness. As part of the 2008 Restructuring Program, the Company expects to eliminate approximately 7,200 positions — 6,800 active employees and 400 vacancies — across the Company worldwide. Pretax restructuring costs of $(4) million and $1 million were recorded in the second quarter of 2012 and 2011, respectively, and $10 million and $5 million were recorded in the first six months of 2012 and 2011, respectively, related to the 2008 Restructuring Program. Since inception of the 2008 Restructuring Program through June 30, 2012, Merck has recorded total pretax accumulated costs of $1.6 billion and eliminated approximately 6,390 positions comprised of employee separations and the elimination of contractors and vacant positions. The 2008 Restructuring Program was substantially completed in 2011, with the exception of certain manufacturing-related actions, which are expected to be completed by 2015, with the total cumulative pretax costs estimated to be up to $2.0 billion. The Company estimates that two-thirds of the cumulative pretax costs relate to cash outlays, primarily from employee separation expense. Approximately one-third of the cumulative pretax costs are non-cash, relating primarily to the accelerated depreciation of facilities to be closed or divested.

For segment reporting, restructuring charges are unallocated expenses.

The following tables summarize the charges related to Merger Restructuring Program and 2008 Restructuring Program activities by type of cost:

 

    Three Months Ended June 30, 2012          Six Months Ended June 30, 2012  
($ in millions)   Separation
Costs
    Accelerated
Depreciation
     Other     Total           Separation
Costs
    Accelerated
Depreciation
           Other     Total  

Merger Restructuring Program

                                                                           

Materials and production

  $ -      $ 56       $         20      $ 76         $ -      $ 33          $ 37      $ 70   

Marketing and administrative

    -        20         1        21           -        43            2        45   

Research and development

    -        41         -        41           -        82            4        86   

Restructuring costs

    124        -         29        153             304        -              63        367   
      124        117         50        291             304        158              106        568   

2008 Restructuring Program

                                                                           

Materials and production

    -        1         4        5           -        3            11        14   

Restructuring costs

    (13     -         4        (9          (11     -              7        (4
      (13     1         8        (4          (11     3              18        10   
    $         111      $         118       $ 58      $        287           $        293      $        161            $        124      $         578   
   

 

Three Months Ended June 30, 2011

         Six Months Ended June 30, 2011  
($ in millions)   Separation
Costs
    Accelerated
Depreciation
     Other     Total           Separation
Costs
    Accelerated
Depreciation
           Other     Total  

Merger Restructuring Program

                                                                           

Materials and production

  $ -      $ 91       $ 5      $ 96         $ -      $ 152          $ 5      $ 157   

Marketing and administrative

    -        22         1        23           -        45            1        46   

Research and development

    -        38         (22     16           -        80            (19     61   

Restructuring costs

    646        -         27        673             607        -              50        657   
      646        151         11        808             607        277              37        921   

2008 Restructuring Program

                                                                           

Materials and production

    -        4         2        6           -        6            2        8   

Restructuring costs

    (7     -         2        (5          (8     -              5        (3
      (7     4         4        1             (8     6              7        5   
    $ 639      $ 155       $ 15      $ 809           $ 599      $ 283            $ 44      $ 926   

Separation costs are associated with actual headcount reductions, as well as those headcount reductions which were probable and could be reasonably estimated. In the second quarter of 2012 and 2011, approximately 780 positions and 585 positions, respectively, were eliminated under the Merger Restructuring Program. In addition, approximately 60 positions were eliminated in the second quarter of 2011 under the 2008 Restructuring Program. In the first six months of 2012 and 2011, approximately 1,800 positions and 1,335 positions, respectively, were eliminated under the Merger Restructuring Program and approximately 140 positions and 180 positions,

 

- 7 -


Notes to Consolidated Financial Statements (unaudited) (continued)

 

respectively, were eliminated under the 2008 Restructuring Program. These position eliminations were comprised of actual headcount reductions and the elimination of contractors and vacant positions.

Accelerated depreciation costs primarily relate to manufacturing, research and administrative facilities and equipment to be sold or closed as part of the programs. Accelerated depreciation costs represent the difference between the depreciation expense to be recognized over the revised useful life of the site, based upon the anticipated date the site will be closed or divested, and depreciation expense as determined utilizing the useful life prior to the restructuring actions. All of the sites have and will continue to operate up through the respective closure dates, and since future cash flows were sufficient to recover the respective book values, Merck was required to accelerate depreciation of the site assets rather than write them off immediately. Site closure dates, particularly related to manufacturing locations, have been and may continue to be adjusted to reflect changes resulting from regulatory or other factors.

Other activity in 2012 and 2011 includes asset abandonment, shut-down and other related costs. Additionally, other activity includes employee-related costs such as curtailment, settlement and termination charges associated with pension and other postretirement benefit plans (see Note 12) and share-based compensation costs.

The following table summarizes the charges and spending relating to Merger Restructuring Program and 2008 Restructuring Program activities for the six months ended June 30, 2012:

 

($ in millions)    Separation
Costs
    Accelerated
Depreciation
      Other           Total        

Merger Restructuring Program

                                

Restructuring reserves January 1, 2012

   $ 1,144      $ -      $ 51      $ 1,195   

Expense

     304        158        106        568   

(Payments) receipts, net

     (634     -        (66     (700

Non-cash activity

     -        (158     (51     (209

Restructuring reserves June 30, 2012 (1)

   $      814      $             -      $           40      $          854   

2008 Restructuring Program

                                

Restructuring reserves January 1, 2012

   $ 126      $ -      $ -      $ 126   

Expense

     (11     3        18        10   

(Payments) receipts, net

     (15     -        (8     (23

Non-cash activity

     -        (3     (10     (13

Restructuring reserves June 30, 2012 (1)

   $ 100      $ -      $ -      $ 100   

 

(1) 

The cash outlays associated with the Merger Restructuring Program are expected to be substantially completed by the end of 2013 with the exception of certain actions, principally manufacturing-related, which are expected to be substantially completed by 2015. The cash outlays associated with the remaining restructuring reserves for the 2008 Restructuring Program are primarily manufacturing-related and are expected to be completed by the end of 2015.

Legacy Schering-Plough Program

Prior to the Merger, Schering-Plough commenced a Productivity Transformation Program which was designed to reduce and avoid costs and increase productivity. The Company recorded accelerated depreciation costs included in Materials and production costs of $2 million and $7 million for the second quarter of 2012 and 2011, respectively, and $4 million and $16 million for the first six months of 2012 and 2011, respectively. The remaining reserve associated with this program, which is substantially complete, was $18 million at June 30, 2012.

3.   Acquisitions, Divestitures, Research Collaborations and License Agreements

In April 2012, the Company entered into an agreement with Endocyte, Inc. (“Endocyte”) to develop and commercialize Endocyte’s novel investigational therapeutic candidate vintafolide (MK-8109). Vintafolide is currently being evaluated in a Phase III clinical trial for platinum-resistant ovarian cancer (PROCEED) and a Phase II trial for non-small cell lung cancer. Under the agreement, Merck gained worldwide rights to develop and commercialize vintafolide. Endocyte received a $120 million upfront payment, which the Company recorded in Research and development expenses in the second quarter of 2012, and is eligible for milestone payments of up to $880 million based on the successful achievement of development, regulatory and commercialization goals for vintafolide for a total of six cancer indications. In addition, if vintafolide receives regulatory approval, Endocyte will receive an equal share of the profit in the United States as well as a royalty on sales of

 

- 8 -


Notes to Consolidated Financial Statements (unaudited) (continued)

 

the product in the rest of the world. Endocyte has retained the right to co-promote vintafolide with Merck in the United States and Merck has the exclusive right to promote vintafolide in the rest of world. Endocyte will be responsible for the majority of funding and completion of the PROCEED trial. Merck will be responsible for most other development activities, all other costs and will have most decision rights for vintafolide. Merck has the right to terminate the agreement on 90 days notice. Merck and Endocyte both have the right to terminate the agreement due to the material breach or insolvency of the other party. Endocyte has the right to terminate the agreement in the event that Merck challenges an Endocyte patent right relating to vintafolide. Upon termination of the agreement, depending upon the circumstances, the parties have varying rights and obligations with respect to the continued development and commercialization of vintafolide and, in the case of termination for cause by Merck, certain royalty obligations and U.S. profit and loss sharing.

In May 2011, Merck completed the acquisition of Inspire Pharmaceuticals, Inc. (“Inspire”), a specialty pharmaceutical company focused on developing and commercializing ophthalmic products. Under the terms of the merger agreement, Merck acquired all outstanding shares of common stock of Inspire at a price of $5.00 per share in cash for a total of approximately $420 million. The transaction was accounted for as an acquisition of a business; accordingly, the assets acquired and liabilities assumed were recorded at their respective fair values as of the acquisition date. The determination of fair value requires management to make significant estimates and assumptions. In connection with the acquisition, substantially all of the purchase price was allocated to Inspire’s product and product right intangible assets and related deferred tax liabilities, a deferred tax asset relating to Inspire’s net operating loss carryforwards, and goodwill. This transaction closed on May 16, 2011, and accordingly, the results of operations of the acquired business have been included in the Company’s results of operations since the acquisition date. Pro forma financial information has not been included because Inspire’s historical financial results are not significant when compared with the Company’s financial results.

In March 2011, the Company sold the Merck BioManufacturing Network, a provider of contract manufacturing and development services for the biopharmaceutical industry and wholly owned by Merck, to Fujifilm Corporation (“Fujifilm”). Under the terms of the agreement, Fujifilm purchased all of the equity interests in two Merck subsidiaries which together owned all of the assets of the Merck BioManufacturing Network comprising facilities located in Research Triangle Park, North Carolina and Billingham, United Kingdom. As part of the agreement with Fujifilm, Merck has committed to purchase certain development and manufacturing services at fair value from Fujifilm over a three-year period following the closing of the transaction. The transaction resulted in a gain of $127 million in the first six months of 2011 reflected in Other (income) expense, net.

4.   Collaborative Arrangements

The Company continues its strategy of establishing external alliances to complement its substantial internal research capabilities, including research collaborations, licensing preclinical and clinical compounds and technology platforms to drive both near- and long-term growth. The Company supplements its internal research with a licensing and external alliance strategy focused on the entire spectrum of collaborations from early research to late-stage compounds, as well as new technologies across a broad range of therapeutic areas. These arrangements often include upfront payments and royalty or profit share payments, contingent upon the occurrence of certain future events linked to the success of the asset in development, as well as expense reimbursements or payments to the third party.

Cozaar/Hyzaar

In 1989, Merck and E.I. duPont de Nemours and Company (“DuPont”) agreed to form a long-term research and marketing collaboration to develop a class of therapeutic agents for high blood pressure and heart disease, discovered by DuPont, called angiotensin II receptor antagonists, which include Cozaar and Hyzaar. In return, Merck provided DuPont marketing rights in the United States and Canada to its prescription medicines, Sinemet and Sinemet CR (the Company has since regained global marketing rights to Sinemet and Sinemet CR). Pursuant to a 1994 agreement with DuPont, the Company has an exclusive licensing agreement to market Cozaar and Hyzaar in return for royalties and profit share payments to DuPont. The patents that provided market exclusivity in the United States and in a number of major European markets for Cozaar and Hyzaar expired in 2010.

Remicade/Simponi

In 1998, a subsidiary of Schering-Plough entered into a licensing agreement with Centocor Ortho Biotech Inc. (“Centocor”), a Johnson & Johnson (“J&J”) company, to market Remicade, which is prescribed for the treatment of inflammatory diseases. In 2005, Schering-Plough’s subsidiary exercised an option under its contract with Centocor for license rights to develop and commercialize Simponi, a fully human monoclonal antibody. The Company had exclusive marketing rights to both products outside the United States, Japan and

 

- 9 -


Notes to Consolidated Financial Statements (unaudited) (continued)

 

certain other Asian markets. In December 2007, Schering-Plough and Centocor revised their distribution agreement regarding the development, commercialization and distribution of both Remicade and Simponi, extending the Company’s rights to exclusively market Remicade to match the duration of the Company’s exclusive marketing rights for Simponi. In addition, Schering-Plough and Centocor agreed to share certain development costs relating to Simponi’s auto-injector delivery system. On October 6, 2009, the European Commission approved Simponi as a treatment for rheumatoid arthritis and other immune system disorders in two presentations – a novel auto-injector and a prefilled syringe. As a result, the Company’s marketing rights for both products extend for 15 years from the first commercial sale of Simponi in the European Union (the “EU”) following the receipt of pricing and reimbursement approval within the EU. In April 2011, Merck and J&J reached an agreement to amend the agreement governing the distribution rights to Remicade and Simponi. Under the terms of the amended distribution agreement, Merck relinquished marketing rights for Remicade and Simponi to J&J in territories including Canada, Central and South America, the Middle East, Africa and Asia Pacific effective July 1, 2011. Merck retained exclusive marketing rights throughout Europe, Russia and Turkey (the “Retained Territories”). In addition, beginning July 1, 2011, all profits derived from Merck’s exclusive distribution of the two products in the Retained Territories are being equally divided between Merck and J&J. J&J also received a one-time payment from Merck of $500 million in April 2011, which the Company recorded as a charge to Other (income) expense, net in the first quarter of 2011.

5.   Financial Instruments

Derivative Instruments and Hedging Activities

The Company manages the impact of foreign exchange rate movements and interest rate movements on its earnings, cash flows and fair values of assets and liabilities through operational means and through the use of various financial instruments, including derivative instruments.

A significant portion of the Company’s revenues and earnings in foreign affiliates is exposed to changes in foreign exchange rates. The objectives and accounting related to the Company’s foreign currency risk management program, as well as its interest rate risk management activities are discussed below.

Foreign Currency Risk Management

The Company has established revenue hedging, balance sheet risk management and net investment hedging programs to protect against volatility of future foreign currency cash flows and changes in fair value caused by volatility in foreign exchange rates.

The objective of the revenue hedging program is to reduce the potential for longer-term unfavorable changes in foreign exchange rates to decrease the U.S. dollar value of future cash flows derived from foreign currency denominated sales, primarily the euro and Japanese yen. To achieve this objective, the Company will hedge a portion of its forecasted foreign currency denominated third-party and intercompany distributor entity sales that are expected to occur over its planning cycle, typically no more than three years into the future. The Company will layer in hedges over time, increasing the portion of third-party and intercompany distributor entity sales hedged as it gets closer to the expected date of the forecasted foreign currency denominated sales, such that it is probable the hedged transaction will occur. The portion of sales hedged is based on assessments of cost-benefit profiles that consider natural offsetting exposures, revenue and exchange rate volatilities and correlations, and the cost of hedging instruments. The hedged anticipated sales are a specified component of a portfolio of similarly denominated foreign currency-based sales transactions, each of which responds to the hedged currency risk in the same manner. The Company manages its anticipated transaction exposure principally with purchased local currency put options, which provide the Company with a right, but not an obligation, to sell foreign currencies in the future at a predetermined price. If the U.S. dollar strengthens relative to the currency of the hedged anticipated sales, total changes in the options’ cash flows offset the decline in the expected future U.S. dollar equivalent cash flows of the hedged foreign currency sales. Conversely, if the U.S. dollar weakens, the options’ value reduces to zero, but the Company benefits from the increase in the U.S. dollar equivalent value of the anticipated foreign currency cash flows.

In connection with the Company’s revenue hedging program, a purchased collar option strategy may be utilized. With a purchased collar option strategy, the Company writes a local currency call option and purchases a local currency put option. As compared to a purchased put option strategy alone, a purchased collar strategy reduces the upfront costs associated with purchasing puts through the collection of premium by writing call options. If the U.S. dollar weakens relative to the currency of the hedged anticipated sales, the purchased put option value of the collar strategy reduces to zero and the Company benefits from the increase in the U.S. dollar equivalent value of its anticipated foreign currency cash flows, however this benefit would be capped at the strike level of the written call.

 

- 10 -


Notes to Consolidated Financial Statements (unaudited) (continued)

 

If the U.S. dollar strengthens relative to the currency of the hedged anticipated sales, the written call option value of the collar strategy reduces to zero and the changes in the purchased put cash flows of the collar strategy would offset the decline in the expected future U.S. dollar equivalent cash flows of the hedged foreign currency sales.

The Company may also utilize forward contracts in its revenue hedging program. If the U.S. dollar strengthens relative to the currency of the hedged anticipated sales, the increase in the fair value of the forward contracts offsets the decrease in the expected future U.S. dollar cash flows of the hedged foreign currency sales. Conversely, if the U.S. dollar weakens, the decrease in the fair value of the forward contracts offsets the increase in the value of the anticipated foreign currency cash flows.

The fair values of these derivative contracts are recorded as either assets (gain positions) or liabilities (loss positions) in the Consolidated Balance Sheet. Changes in the fair value of derivative contracts are recorded each period in either current earnings or Other comprehensive income (“OCI”), depending on whether the derivative is designated as part of a hedge transaction and, if so, the type of hedge transaction. For derivatives that are designated as cash flow hedges, the effective portion of the unrealized gains or losses on these contracts is recorded in Accumulated other comprehensive income (“AOCI”) and reclassified into Sales when the hedged anticipated revenue is recognized. The hedge relationship is highly effective and hedge ineffectiveness has been de minimis. For those derivatives which are not designated as cash flow hedges, unrealized gains or losses are recorded in Sales each period. The cash flows from these contracts are reported as operating activities in the Consolidated Statement of Cash Flows. The Company does not enter into derivatives for trading or speculative purposes.

The primary objective of the balance sheet risk management program is to mitigate the exposure of foreign currency denominated net monetary assets of foreign subsidiaries where the U.S. dollar is the functional currency from the effects of volatility in foreign exchange. In these instances, Merck principally utilizes forward exchange contracts, which enable the Company to buy and sell foreign currencies in the future at fixed exchange rates and economically offset the consequences of changes in foreign exchange from the monetary assets. Merck routinely enters into contracts to offset the effects of exchange on exposures denominated in developed country currencies, primarily the euro and Japanese yen. For exposures in developing country currencies, the Company will enter into forward contracts to partially offset the effects of exchange on exposures when it is deemed economical to do so based on a cost-benefit analysis that considers the magnitude of the exposure, the volatility of the exchange rate and the cost of the hedging instrument. The Company will also minimize the effect of exchange on monetary assets and liabilities by managing operating activities and net asset positions at the local level.

Monetary assets and liabilities denominated in a currency other than the functional currency of a given subsidiary are remeasured at spot rates in effect on the balance sheet date with the effects of changes in spot rates reported in Other (income) expense, net. The forward contracts are not designated as hedges and are marked to market through Other (income) expense, net. Accordingly, fair value changes in the forward contracts help mitigate the changes in the value of the remeasured assets and liabilities attributable to changes in foreign currency exchange rates, except to the extent of the spot-forward differences. These differences are not significant due to the short-term nature of the contracts, which typically have average maturities at inception of less than one year.

The Company also uses forward exchange contracts to hedge its net investment in foreign operations against movements in exchange rates. The forward contracts are designated as hedges of the net investment in a foreign operation. The Company hedges a portion of the net investment in certain of its foreign operations and measures ineffectiveness based upon changes in spot foreign exchange rates. The effective portion of the unrealized gains or losses on these contracts is recorded in foreign currency translation adjustment within OCI, and remains in AOCI until either the sale or complete or substantially complete liquidation of the subsidiary. The cash flows from these contracts are reported as investing activities in the Consolidated Statement of Cash Flows.

Foreign exchange risk is also managed through the use of foreign currency debt. The Company’s senior unsecured euro-denominated notes have been designated as, and are effective as, economic hedges of the net investment in a foreign operation. Accordingly, foreign currency transaction gains or losses due to spot rate fluctuations on the euro-denominated debt instruments are included in foreign currency translation adjustment within OCI. Included in the cumulative translation adjustment are pretax gains (losses) of $92 million and $(178) million for the first six months of 2012 and 2011, respectively, from the euro-denominated notes.

 

- 11 -


Notes to Consolidated Financial Statements (unaudited) (continued)

 

Interest Rate Risk Management

The Company may use interest rate swap contracts on certain investing and borrowing transactions to manage its net exposure to interest rate changes and to reduce its overall cost of borrowing. The Company does not use leveraged swaps and, in general, does not leverage any of its investment activities that would put principal capital at risk.

In June 2011, the Company terminated nine interest rate swap contracts with a total notional amount of $3.5 billion. These swaps effectively converted $3.5 billion of its fixed-rate notes, with maturity dates varying from March 2015 to June 2019, to floating rate instruments. As a result of the swap terminations, the Company received $175 million in cash, which included $36 million in accrued interest. The corresponding $139 million basis adjustment of the debt associated with the terminated swap contracts was deferred and is being amortized as a reduction of interest expense over the respective term of the notes. The cash flows from these contracts are reported as operating activities in the Consolidated Statement of Cash Flows.

At June 30, 2011, the Company was a party to 13 pay-floating, receive-fixed interest rate swap contracts with notional amounts of $1.9 billion in the aggregate designated as fair value hedges of fixed-rate notes in which the notional amounts match the amount of the hedged fixed-rate notes. The interest rate swap contracts were designated hedges of the fair value changes in the notes attributable to changes in the benchmark London Interbank Offered Rate (“LIBOR”) swap rate. The fair value changes in the notes attributable to changes in the benchmark interest rate were recorded in interest expense and offset by the fair value changes in the swap contracts. The Company terminated certain of these interest rate swap contracts in the third quarter of 2011 and the remaining interest rate swap contracts matured in the fourth quarter of 2011. The cash flows from these contracts are reported as operating activities in the Consolidated Statement of Cash Flows.

Presented in the table below is the fair value of derivatives segregated between those derivatives that are designated as hedging instruments and those that are not designated as hedging instruments:

 

         June 30,2012      December 31, 2011  
         Fair Value of Derivative      U.S. Dollar      Fair Value of Derivative      U.S. Dollar  

($ in millions)

  Balance Sheet Caption      Asset         Liability         Notional         Asset         Liability         Notional   

Derivatives Designated as Hedging Instruments

  

Foreign exchange contracts (current)

 

Deferred income taxes and other current assets

     $ 279       $ -       $ 5,005         $ 196       $ -       $ 3,727   

Foreign exchange contracts (non-current)

 

Other assets

     470         -         5,177         420         -         4,956   

Foreign exchange contracts (current)

 

Accrued and other current liabilities

     -         13         411         -         53         1,718   

Foreign exchange contracts (non-current)

 

Deferred income taxes and noncurrent liabilities

     -         7         436         -         1         104   
           $ 749       $ 20       $ 11,029         $ 616       $ 54       $ 10,505   

Derivatives Not Designated as Hedging Instruments

  

Foreign exchange contracts (current)

 

Deferred income taxes and other current assets

     $ 100       $ -       $ 4,511         $ 139       $ -       $ 5,306   

Foreign exchange contracts (non-current)

 

Other assets

     35         -         339         -         -         -   

Foreign exchange contracts (current)

 

Accrued and other current liabilities

     -         28         3,740         -         54         5,013   
           $ 135       $ 28       $ 8,590         $ 139       $ 54       $ 10,319   
           $ 884       $ 48       $ 19,619         $ 755       $ 108       $ 20,824   

 

- 12 -


Notes to Consolidated Financial Statements (unaudited) (continued)

 

The table below provides information on the location and pretax gain or loss amounts for derivatives that are: (i) designated in a fair value hedging relationship, (ii) designated in a cash flow hedging relationship, (iii) designated in a foreign currency net investment hedging relationship and (iv) not designated in a hedging relationship:

 

           Three Months Ended      
June 30,
                Six Months Ended      
June 30,
 
($ in millions)          2012                 2011                       2012                 2011        

 

 

Derivatives designated in fair value hedging relationships

            

 

Interest rate swap contracts

            

Amount of gain recognized in Other (income) expense, net on derivatives

     $       -      $       (126)            $       -      $       (163)   

Amount of loss recognized in Other (income) expense, net on hedged item

     -        126             -        163    

Derivatives designated in foreign currency cash flow hedging relationships

            

 

Foreign exchange contracts

            

Amount of loss reclassified from AOCI to Sales

     26        20             53        27    

Amount of (gain) loss recognized in OCI on derivatives

     (154     69             (34     252    

Derivatives designated in foreign currency net investment hedging relationships

            

 

Foreign exchange contracts

            

Amount of gain recognized in Other (income) expense, net on derivatives (1)

     (2     (2)            (11     (8)   

Amount of loss (gain) recognized in OCI on derivatives

     86        33             (56     34    

Derivatives not designated in a hedging relationship

            

 

Foreign exchange contracts

            

Amount of (gain) loss recognized in Other (income) expense, net on derivatives (2)

     (279     33             (26     349    

 

 

 

(1) 

There was no ineffectiveness on the hedge. Represents the amount excluded from hedge effectiveness testing.

(2) 

These derivative contracts mitigate changes in the value of remeasured foreign currency denominated monetary assets and liabilities attributable to changes in foreign currency exchange rates.

At June 30, 2012, the Company estimates $2 million of pretax net unrealized gains on derivatives maturing within the next 12 months that hedge foreign currency denominated sales over that same period will be reclassified from AOCI to Sales. The amount ultimately reclassified to Sales may differ as foreign exchange rates change. Realized gains and losses are ultimately determined by actual exchange rates at maturity.

Investments in Debt and Equity Securities

Information on available-for-sale investments is as follows:

 

    June 30, 2012         December 31, 2011  
    Fair     Amortized     Gross Unrealized         Fair     Amortized     Gross Unrealized  
($ in millions)   Value     Cost     Gains     Losses         Value     Cost     Gains     Losses  

 

     

 

 

 

 

Corporate notes and bonds

  $ 2,787      $ 2,759      $ 30      $ (2)        $ 2,032      $ 2,024      $ 16      $ (8)   

U.S. government and agency securities

    773        772        1                 1,021        1,018        3          

Asset-backed securities

    441        439        2                 292        292        1        (1)   

Mortgage-backed securities

    271        270        2        (1)          223        223        1        (1)   

Commercial paper

    220        220        -                 1,029        1,029        -          

Foreign government bonds

    76        75        1                 72        72        -          

Other debt securities

    3        1        2                 3        1        2          

Equity securities

    383        354        29                 397        383        14          

 

 
  $ 4,954      $ 4,890      $ 67      $ (3)        $ 5,069      $ 5,042      $ 37      $ (10)   

 

 

Available-for-sale debt securities included in Short-term investments totaled $698 million at June 30, 2012. Of the remaining debt securities, $3.4 billion mature within five years. At June 30, 2012, there were no debt securities pledged as collateral.

 

- 13 -


Notes to Consolidated Financial Statements (unaudited) (continued)

 

Fair Value Measurements

Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. The Company uses a fair value hierarchy which maximizes the use of observable inputs and minimizes the use of unobservable inputs when measuring fair value. There are three levels of inputs used to measure fair value with Level 1 having the highest priority and Level 3 having the lowest:

Level 1 - Quoted prices (unadjusted) in active markets for identical assets or liabilities.

Level 2 - Observable inputs other than Level 1 prices, such as quoted prices for similar assets or liabilities, or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities.

Level 3 - Unobservable inputs that are supported by little or no market activity. Level 3 assets are those whose values are determined using pricing models, discounted cash flow methodologies, or similar techniques with significant unobservable inputs, as well as instruments for which the determination of fair value requires significant judgment or estimation. The Company had no Level 3 assets at June 30, 2012 or December 31, 2011.

If the inputs used to measure the financial assets and liabilities fall within more than one level described above, the categorization is based on the lowest level input that is significant to the fair value measurement of the instrument.

Financial Assets and Liabilities Measured at Fair Value on a Recurring Basis

Financial assets and liabilities measured at fair value on a recurring basis are summarized below:

 

     Fair Value Measurements Using           Fair Value Measurements Using  
      Quoted Prices
In Active
Markets for
 Identical Assets 
(Level 1)
     Significant
Other
Observable
Inputs
(Level 2)
     Significant
Unobservable
Inputs
(Level 3)
     Total            Quoted Prices
In Active
Markets for
 Identical Assets 
(Level 1)
     Significant
Other
Observable
Inputs
(Level 2)
     Significant
Unobservable
Inputs
(Level 3)
     Total  
($ in millions)    June 30, 2012            December 31, 2011  

Assets

                          

Investments

                          

Corporate notes and bonds

   $ -       $ 2,787       $ -       $ 2,787          $ -       $ 2,032       $ -       $ 2,032   

U.S. government and agency securities

     -         773         -         773            -         1,021         -         1,021   

Asset-backed securities (1)

     -         441         -         441            -         292         -         292   

Mortgage-backed securities (1)

     -         271         -         271            -         223         -         223   

Commercial paper

     -         220         -         220            -         1,029         -         1,029   

Foreign government bonds

     -         76         -         76            -         72         -         72   

Equity securities

     203         9         -         212            205         22         -         227   

Other debt securities

     -         3         -         3            -         3         -         3   
       203         4,580         -         4,783              205         4,694         -         4,899   

Other assets

                          

Securities held for employee compensation

     171         -         -         171            170         -         -         170   
                          

Derivative assets (2)

                          

Purchased currency options

     -         763         -         763            -         613         -         613   

Forward exchange contracts

     -         121         -         121            -         142         -         142   
       -         884         -         884              -         755         -         755   

Total assets

   $           374       $      5,464       $             -       $      5,838            $           375       $      5,449       $             -       $      5,824   

Liabilities

                          

Derivative liabilities (2)

                          

Forward exchange contracts

   $ -       $ 48       $ -       $ 48          $ -       $ 107       $ -       $ 107   

Written currency options

     -         -         -         -            -         1         -         1   

Total liabilities

   $ -       $ 48       $ -       $ 48            $ -       $ 108       $ -       $ 108   

 

(1) 

Primarily all of the asset-backed securities are highly-rated (Standard & Poor’s rating of AAA and Moody’s Investors Service rating of Aaa), secured primarily by credit card, auto loan, and home equity receivables, with weighted-average lives of primarily 5 years or less. Mortgage-backed securities represent AAA-rated securities issued or unconditionally guaranteed as to payment of principal and interest by U.S. government agencies.

(2) 

The fair value determination of derivatives includes the impact of the credit risk of counterparties to the derivatives and the Company’s own credit risk, the effects of which were not significant.

 

- 14 -


Notes to Consolidated Financial Statements (unaudited) (continued)

 

There were no transfers between Level 1 and Level 2 during the first six months of 2012. As of June 30, 2012, Cash and cash equivalents of $16.8 billion included $15.9 billion of cash equivalents (which would be considered Level 2 in the fair value hierarchy).

Other Fair Value Measurements

Some of the Company’s financial instruments, such as cash and cash equivalents, receivables and payables, are reflected in the balance sheet at carrying value, which approximates fair value due to their short-term nature.

The estimated fair value of loans payable and long-term debt (including current portion) at June 30, 2012 was $21.2 billion compared with a carrying value of $19.0 billion and at December 31, 2011 was $19.5 billion compared with a carrying value of $17.5 billion. Fair value was estimated using recent observable market prices and would be considered Level 2 in the fair value hierarchy.

Concentrations of Credit Risk

On an ongoing basis, the Company monitors concentrations of credit risk associated with corporate and government issuers of securities and financial institutions with which it conducts business. Credit exposure limits are established to limit a concentration with any single issuer or institution. Cash and investments are placed in instruments that meet high credit quality standards, as specified in the Company’s investment policy guidelines. Approximately 40% of the Company’s cash and cash equivalents are invested in five highly rated money market funds.

The majority of the Company’s accounts receivable arise from product sales in the United States and Europe and are primarily due from drug wholesalers and retailers, hospitals, government agencies, managed health care providers and pharmacy benefit managers. The Company monitors the financial performance and credit worthiness of its customers so that it can properly assess and respond to changes in their credit profile. The Company also continues to monitor economic conditions, including the volatility associated with international sovereign economies, and associated impacts on the financial markets and its business, taking into consideration the global economic downturn and the sovereign debt issues in certain European countries. The Company continues to monitor the credit and economic conditions within Greece, Spain, Italy and Portugal, among other members of the EU. These economic conditions, as well as inherent variability of timing of cash receipts, have resulted in, and may continue to result in, an increase in the average length of time that it takes to collect accounts receivable outstanding. As such, time value of money discounts have been recorded for those customers for which collection of accounts receivable is expected to be in excess of one year. The Company does not expect to have write-offs or adjustments to accounts receivable which would have a material adverse effect on its financial position, liquidity or results of operations.

At June 30, 2012, the Company’s accounts receivable in Greece, Italy, Spain and Portugal totaled approximately $1.0 billion. Of this amount, hospital and public sector receivables were approximately $700 million in the aggregate, of which approximately 16%, 38%, 28% and 18% related to Greece, Italy, Spain and Portugal, respectively. As of June 30, 2012, the Company’s total accounts receivable outstanding for more than one year were approximately $200 million, of which approximately 70% related to accounts receivable in Greece, Italy, Spain and Portugal, mostly comprised of hospital and public sector receivables.

During the second quarter of 2012, the Company collected approximately $500 million of accounts receivable in connection with the Spanish government’s debt stabilization/stimulus plan. In addition, in the second and first quarters of 2012, the Company completed non-recourse factorings of approximately $120 million and $110 million, respectively, of hospital and public sector accounts receivable in Italy.

As previously disclosed, the Company received zero coupon bonds from the Greek government in settlement of 2007-2009 receivables related to certain government sponsored institutions. The Company had recorded impairment charges to reduce the bonds to fair value. During 2011, the Company sold a portion of these bonds and the remainder was sold during the first quarter of 2012.

Derivative financial instruments are executed under International Swaps and Derivatives Association master agreements. The master agreements with several of the Company’s financial institution counterparties also include credit support annexes. These annexes contain provisions that require collateral to be exchanged depending on the value of the derivative assets and liabilities, the Company’s credit rating, and the credit rating of the

 

- 15 -


Notes to Consolidated Financial Statements (unaudited) (continued)

 

counterparty. As of June 30, 2012 and December 31, 2011, the Company had received cash collateral of $539 million and $327 million, respectively, from various counterparties and the obligation to return such collateral is recorded in Accrued and other current liabilities. The Company had not advanced any cash collateral to counterparties as of June 30, 2012 or December 31, 2011.

6.    Inventories

Inventories consisted of:

 

($ in millions)          June 30,       
2012
      December 31,  
2011
 

Finished goods

  $ 1,808      $ 1,983   

Raw materials and work in process

    5,705        5,396   

Supplies

    265        297   

Total (approximates current cost)

    7,778        7,676   

Reduction to LIFO costs

    (39     (43
    $ 7,739      $ 7,633   

Recognized as:

   

Inventories

  $ 6,249      $ 6,254   

Other assets

    1,490        1,379   

Amounts recognized as Other assets are comprised almost entirely of raw materials and work in process inventories. At both June 30, 2012 and December 31, 2011, these amounts included $1.3 billion of inventories not expected to be sold within one year. In addition, these amounts included $169 million and $127 million at June 30, 2012 and December 31, 2011, respectively, of inventories produced in preparation for product launches.

7.    Other Intangibles

In connection with mergers and acquisitions, the Company measures the fair value of marketed products and research and development pipeline programs and capitalizes these amounts. During the second quarter of 2012 and 2011, the Company recorded $127 million and $19 million, respectively, and during the first six months of 2012 and 2011, recorded $136 million and $321 million, respectively, of in-process research and development (“IPR&D”) impairment charges within Research and development expenses primarily for pipeline programs that had previously been deprioritized and were deemed to have no alternative use in the period. Also, during the second quarter of 2011, the Company recorded an intangible asset impairment charge of $118 million within Materials and production costs related to a marketed product. The Company may recognize additional non-cash impairment charges in the future related to other pipeline programs or marketed products and such charges could be material.

8.    Joint Ventures and Other Equity Method Affiliates

Equity income from affiliates reflects the performance of the Company’s joint ventures and other equity method affiliates and was comprised of the following:

 

   

    Three Months Ended    

June 30,

       

    Six Months Ended    

June 30,

 
($ in millions)   2012      2011          2012      2011  

AstraZeneca LP

  $ 140         $ 44        $ 253       $ 177   

Other (1)

    2           11            -         16   
    $ 142         $ 55          $ 253       $ 193   

 

(1) 

Includes results from Sanofi Pasteur MSD.

AstraZeneca LP

In 1998, Merck and Astra completed the restructuring of the ownership and operations of their existing joint venture whereby Merck acquired Astra’s interest in KBI Inc. (“KBI”) and contributed KBI’s operating assets to a new U.S. limited partnership, Astra Pharmaceuticals L.P. (the “Partnership”), in exchange for a 1% limited partner interest. Astra contributed the net assets of its wholly owned subsidiary, Astra USA, Inc., to the Partnership in

 

- 16 -


Notes to Consolidated Financial Statements (unaudited) (continued)

 

exchange for a 99% general partner interest. The Partnership, renamed AstraZeneca LP (“AZLP”) upon Astra’s 1999 merger with Zeneca Group Plc, became the exclusive distributor of the products for which KBI retained rights.

In June 2012, Merck and AstraZeneca amended the 1998 option agreement which gave AstraZeneca the option to buy Merck’s common stock interest in KBI and, through it, Merck’s interest in Nexium and Prilosec as well as AZLP. The updated agreement eliminates AstraZeneca’s option to acquire Merck’s interest in KBI in 2012 and provides AstraZeneca a new option to acquire Merck’s interest in KBI in June 2014. As a result of the amended agreement, Merck will continue to record supply sales and equity income from the partnership for the remainder of 2012 and 2013. In 2014, AstraZeneca has the option to purchase Merck’s interest in KBI based in part on the value of Merck’s interest in Prilosec and Nexium. AstraZeneca’s option is exercisable between March 1, 2014 and April 30, 2014. If AstraZeneca chooses to exercise this option, the closing date is expected to be June 30, 2014. Under the amended agreement, AstraZeneca will make a payment to Merck upon closing of $327 million, reflecting an estimate of the fair value of Merck’s interest in Nexium and Prilosec. This portion of the exercise price is subject to a true-up in 2018 based on actual sales from closing in 2014 to June 2018. The exercise price will also include an additional amount equal to a multiple of ten times Merck’s average 1% annual profit allocation in the partnership for the three-years prior to exercise. The Company believes that it is likely that AstraZeneca will exercise its option in 2014.

Summarized financial information for AZLP is as follows:

 

     Three Months Ended          Six Months Ended  
     June 30,          June 30,  
($ in millions)    2012      2011           2012      2011  

Sales

   $ 1,150       $           1,181         $ 2,192       $           2,336   

Materials and production costs

     520         516           959         1,061   

Other expense, net

     350         345             732         646   

Income before taxes (1)

   $ 280       $ 320           $ 501       $ 629   

 

(1) 

Merck’s partnership returns from AZLP are generally contractually determined and are not based on a percentage of income from AZLP, other than with respect to Merck’s 1% limited partnership interest.

9.    Contingencies and Environmental Liabilities

The Company is involved in various claims and legal proceedings of a nature considered normal to its business, including product liability, intellectual property, and commercial litigation, as well as additional matters such as antitrust actions and environmental matters. Except for the Vioxx Litigation and the ENHANCE Litigation (each as defined below) for which separate assessments are provided in this Note, in the opinion of the Company, it is unlikely that the resolution of these matters will be material to the Company’s financial position, results of operations or cash flows.

Given the preliminary nature of the litigation discussed below, including the Vioxx Litigation and the ENHANCE Litigation, and the complexities involved in these matters, the Company is unable to reasonably estimate a possible loss or range of possible loss for such matters until the Company knows, among other factors, (i) what claims, if any, will survive dispositive motion practice, (ii) the extent of the claims, including the size of any potential class, particularly when damages are not specified or are indeterminate, (iii) how the discovery process will affect the litigation, (iv) the settlement posture of the other parties to the litigation and (v) any other factors that may have a material effect on the litigation.

The Company records accruals for contingencies when it is probable that a liability has been incurred and the amount can be reasonably estimated. These accruals are adjusted periodically as assessments change or additional information becomes available. For product liability claims, a portion of the overall accrual is actuarially determined and considers such factors as past experience, number of claims reported and estimates of claims incurred but not yet reported. Individually significant contingent losses are accrued when probable and reasonably estimable. Legal defense costs expected to be incurred in connection with a loss contingency are accrued when probable and reasonably estimable.

The Company’s decision to obtain insurance coverage is dependent on market conditions, including cost and availability, existing at the time such decisions are made. The Company has evaluated its risks

 

- 17 -


Notes to Consolidated Financial Statements (unaudited) (continued)

 

and has determined that the cost of obtaining product liability insurance outweighs the likely benefits of the coverage that is available and as such, has no insurance for certain product liabilities effective August 1, 2004.

Vioxx Litigation

Product Liability Lawsuits

As previously disclosed, Merck is a defendant in approximately 100 federal and state lawsuits (the “Vioxx Product Liability Lawsuits”) alleging personal injury or economic loss as a result of the purchase or use of Vioxx. Most of the remaining cases are coordinated in a multidistrict litigation in the U.S. District Court for the Eastern District of Louisiana (the “Vioxx MDL”) before Judge Eldon E. Fallon.

There is one U.S. Vioxx Product Liability Lawsuit currently scheduled for trial in 2012. Merck has previously disclosed the outcomes of several Vioxx Product Liability Lawsuits that were tried prior to 2012. All post-trial appeals have been resolved.

There are pending in various U.S. courts putative class actions purportedly brought on behalf of individual purchasers or users of Vioxx seeking reimbursement for alleged economic loss. In the Vioxx MDL proceeding, approximately 30 such class actions remain. In June 2010, Merck moved to strike the class claims or for judgment on the pleadings regarding the master complaint, which includes the above-referenced cases, and briefing on that motion was completed in September 2010. The Vioxx MDL court heard oral argument on Merck’s motion in October 2010 and took it under advisement.

In 2008, a Missouri state court certified a class of Missouri plaintiffs seeking reimbursement for out-of-pocket costs relating to Vioxx. The Vioxx MDL court issued an order in April 2012 enjoining the Missouri plaintiffs from offering any evidence that does not sufficiently exclude damages attributable to claims already settled through the prior personal injury and third-party payor settlements and from executing any judgment obtained through admission of such evidence. The Missouri plaintiffs have appealed that decision to the U.S. Court of Appeals for the Fifth Circuit, which has set an expedited briefing schedule on plaintiffs’ appeal. Trial has been rescheduled for November 1, 2012, in light of the appeal. In Indiana, plaintiffs filed a motion to certify a class of Indiana Vioxx purchasers in a case pending before the Circuit Court of Marion County, Indiana. That case has been dormant for several years. In April 2010, a Kentucky state court denied Merck’s motion for summary judgment and certified a class of Kentucky plaintiffs seeking reimbursement for out-of-pocket costs relating to Vioxx. The trial court subsequently entered an amended class certification order in January 2011. Merck appealed that order to the Kentucky Court of Appeals and, on February 10, 2012, the Kentucky Court of Appeals reversed the trial court’s amended class certification order and denied certification. The plaintiff has petitioned the Kentucky Supreme Court to review the Court of Appeals’ order. Merck opposed the petition, and the Kentucky Supreme Court has not yet ruled.

Merck has also been named as a defendant in several lawsuits brought by, or on behalf of, government entities. Six of these suits are being brought by state Attorneys General and one has been brought on behalf of a county. All of these actions except for an action brought by the Kentucky Attorney General are in the Vioxx MDL proceeding. These actions allege that Merck misrepresented the safety of Vioxx. These suits seek recovery for expenditures on Vioxx by government-funded health care programs, such as Medicaid, and/or penalties for alleged Consumer Fraud Act violations. Judge Fallon remanded the Kentucky case to state court on January 3, 2012. Merck’s petition to appeal that decision to the U.S. Court of Appeals for the Fifth Circuit was denied. The lawsuit brought by the county is a putative class action filed by Santa Clara County, California on behalf of all similarly situated California counties. Merck moved for judgment on the pleadings in the case brought by Santa Clara County in September 2011. The court granted Merck’s motion on March 20, 2012, but gave the county leave to file an amended complaint.

Shareholder Lawsuits

As previously disclosed, in addition to the Vioxx Product Liability Lawsuits, various putative class actions and individual lawsuits under federal securities laws and state laws have been filed against Merck and various current and former officers and directors (the “Vioxx Securities Lawsuits”). The Vioxx Securities Lawsuits are coordinated in a multidistrict litigation in the U.S. District Court for the District of New Jersey before Judge Stanley R. Chesler, and have been consolidated for all purposes. In August 2011, Judge Chesler granted in part and denied in part Merck’s motion to dismiss the Fifth Amended Class Action Complaint in the consolidated securities action. Among other things, the claims based on statements made on or after the voluntary withdrawal of Vioxx on September 30, 2004 have been dismissed. In October 2011, defendants answered the Fifth Amended Class Action Complaint. Discovery is currently proceeding in accordance with the court’s scheduling order.

 

- 18 -


Notes to Consolidated Financial Statements (unaudited) (continued)

 

As previously disclosed, several individual securities lawsuits filed by foreign institutional investors also are consolidated with the Vioxx Securities Lawsuits. In October 2011, plaintiffs filed amended complaints in each of the pending individual securities lawsuits. Also in October 2011, a new individual securities lawsuit was filed in the District of New Jersey by several foreign institutional investors; that case is also consolidated with the Vioxx Securities Lawsuits. On January 20, 2012, defendants filed motions to dismiss in one of the individual lawsuits (the “ABP Lawsuit”). Briefing on the motions to dismiss was completed on March 26, 2012. On August 1, 2012, Judge Chesler granted in part and denied in part the motions to dismiss the ABP Lawsuit. Among other things, certain alleged misstatements and omissions were dismissed as inactionable and all state law claims were dismissed in full. By stipulation and order, defendants are not required to respond to the complaints in the remaining individual securities lawsuits until on or about September 15, 2012.

Insurance

The Company has Directors and Officers insurance coverage applicable to the Vioxx Securities Lawsuits with remaining stated upper limits of approximately $175 million. As a result of the previously disclosed insurance arbitration, additional insurance coverage for these claims should also be available, if needed, under upper-level excess policies that provide coverage for a variety of risks. There are disputes with the insurers about the availability of some or all of the Company’s insurance coverage for these claims and there are likely to be additional disputes. The amounts actually recovered under the policies discussed in this paragraph may be less than the stated upper limits.

Investigations

As previously disclosed, Merck received subpoenas from the Department of Justice (the “DOJ”) requesting information related to Merck’s research, marketing and selling activities with respect to Vioxx in a federal health care investigation under criminal statutes. As previously disclosed, in March 2009, Merck received a letter from the U.S. Attorney’s Office for the District of Massachusetts identifying it as a target of the grand jury investigation regarding Vioxx. In 2010, the Company established a $950 million reserve (the “Vioxx Liability Reserve”) in connection with the anticipated resolution of the DOJ’s investigation.

In November 2011, the Company announced that it had reached a resolution with federal and state authorities regarding this matter, pending court approval. Under civil settlement agreements signed with the United States and individually with 44 states and the District of Columbia, Merck paid approximately two-thirds of the Vioxx Liability Reserve to resolve civil allegations related to Vioxx. As a result, the United States and the participating states have released Merck from civil liability related to the government’s allegations regarding the sale and promotion of Vioxx. The Company also has agreed to plead guilty to one count of misdemeanor misbranding of Vioxx under the Federal Food, Drug, and Cosmetic Act by promoting the drug for the treatment of rheumatoid arthritis prior to the approval of that indication by the U.S. Food and Drug Administration (the “FDA”) in April 2002. The Company paid a fine of approximately one-third of the Vioxx Liability Reserve to the federal government as part of the plea agreement.

In December 2011, the U.S. District Court for the District of Massachusetts conducted a hearing with regard to the resolution. During that hearing, the parties advised the court as to the nature of the resolution and the core documents comprising the resolution. On April 19, 2012, the court accepted the resolution and thereafter the Company made the payments noted above.

International Lawsuits

As previously disclosed, in addition to the lawsuits discussed above, Merck has been named as a defendant in litigation relating to Vioxx in Australia, Brazil, Canada, Europe and Israel (collectively, the “Vioxx Foreign Lawsuits”). As previously disclosed, the Company has entered into an agreement to resolve all claims related to Vioxx in Canada. The agreement is pending approval by courts in Canada’s provinces.

Reserves

The Company believes that it has meritorious defenses to the remaining Vioxx Product Liability Lawsuits, Vioxx Securities Lawsuits and Vioxx Foreign Lawsuits (collectively, the “Vioxx Lawsuits”) and will vigorously defend against them. In view of the inherent difficulty of predicting the outcome of litigation, particularly where there are many claimants and the claimants seek indeterminate damages, the Company is unable to predict the outcome of these matters and, at this time, cannot reasonably estimate the possible loss or range of loss with respect to the remaining Vioxx Lawsuits. As previously disclosed, the Company has a reserve with respect to the Canada Settlement Agreement. The Company also has an immaterial remaining reserve relating to the Vioxx investigation discussed above for the non-participating states with which litigation is continuing. The Company has established no other liability reserves with respect to the Vioxx Litigation. Unfavorable outcomes in the Vioxx Litigation could have a material adverse effect on the Company’s financial position, liquidity and results of operations.

 

- 19 -


Notes to Consolidated Financial Statements (unaudited) (continued)

 

Other Product Liability Litigation

Fosamax

As previously disclosed, Merck is a defendant in product liability lawsuits in the United States involving Fosamax (the “Fosamax Litigation”). As of June 30, 2012, approximately 3,615 cases, which include approximately 4,175 plaintiff groups, had been filed and were pending against Merck in either federal or state court, including one case which seeks class action certification, as well as damages and/or medical monitoring. In approximately 1,200 of these actions, plaintiffs allege, among other things, that they have suffered osteonecrosis of the jaw (“ONJ”), generally subsequent to invasive dental procedures, such as tooth extraction or dental implants and/or delayed healing, in association with the use of Fosamax. In addition, plaintiffs in approximately 2,415 of these actions generally allege that they sustained femur fractures and/or other bone injuries (“Femur Fractures”) in association with the use of Fosamax.

Cases Alleging ONJ and/or Other Jaw Related Injuries

In August 2006, the Judicial Panel on Multidistrict Litigation (the “JPML”) ordered that certain Fosamax product liability cases pending in federal courts nationwide should be transferred and consolidated into one multidistrict litigation (the “Fosamax ONJ MDL”) for coordinated pre-trial proceedings. The Fosamax ONJ MDL has been transferred to Judge John Keenan in the U.S. District Court for the Southern District of New York. As a result of the JPML order, approximately 950 of the cases are before Judge Keenan. In the first Fosamax ONJ MDL trial, Boles v. Merck, the Fosamax ONJ MDL court declared a mistrial because the eight person jury could not reach a unanimous verdict. The Boles case was retried in June 2010 and resulted in a verdict in favor of the plaintiff in the amount of $8 million. Merck filed post-trial motions seeking judgment as a matter of law or, in the alternative, a new trial. In October 2010, the court denied Merck’s post-trial motions but sua sponte ordered a remittitur reducing the verdict to $1.5 million. Plaintiff rejected the remittitur ordered by the court and requested a new trial on damages, which is scheduled to take place on September 18, 2012. Merck intends to appeal the verdict in Boles after the new trial on damages has concluded. Three other cases have been tried to verdict in the Fosamax ONJ MDL. Defense verdicts in favor of Merck were returned in each of those three cases.

In February 2011, Judge Keenan ordered that there will be two further bellwether trials conducted in the Fosamax ONJ MDL. Spano v. Merck and Jellema v. Merck were selected by the court to be tried in 2012, but each case was dismissed by the plaintiffs. On March 28, 2012, the court selected Scheinberg v. Merck as the next case to be tried and set the trial date for January 14, 2013.

Outside the Fosamax ONJ MDL, in Florida, Carballo v. Merck has been set for trial on October 15, 2012 and Anderson v. Merck has been set for trial on January 14, 2013.

In addition, in July 2008, an application was made by the Atlantic County Superior Court of New Jersey requesting that all of the Fosamax cases pending in New Jersey be considered for mass tort designation and centralized management before one judge in New Jersey. In October 2008, the New Jersey Supreme Court ordered that all pending and future actions filed in New Jersey arising out of the use of Fosamax and seeking damages for existing dental and jaw-related injuries, including ONJ, but not solely seeking medical monitoring, be designated as a mass tort for centralized management purposes before Judge Carol E. Higbee in Atlantic County Superior Court. As of June 30, 2012, approximately 240 ONJ cases were pending against Merck in Atlantic County, New Jersey. In July 2009, Judge Higbee entered a Case Management Order (and various amendments thereto) setting forth a schedule that contemplates completing fact and expert discovery in an initial group of cases to be reviewed for trial. In February 2011, the jury in Rosenberg v. Merck, the first trial in the New Jersey coordinated proceeding, returned a verdict in Merck’s favor. In April 2012, the jury in Sessner v. Merck, the second case tried in New Jersey, also returned a verdict in Merck’s favor.

In California, the parties are reviewing the claims of two plaintiffs in the Carrie Smith, et al. v. Merck case and the claims in Pedrojetti v. Merck. The cases of one or more of these plaintiffs are expected to be tried in 2013.

Discovery is ongoing in the Fosamax ONJ MDL litigation, the New Jersey coordinated proceeding, and the remaining jurisdictions where Fosamax cases are pending. The Company intends to defend against these lawsuits.

Cases Alleging Femur Fractures

In March 2011, Merck submitted a Motion to Transfer to the JPML seeking to have all federal cases alleging Femur Fractures consolidated into one multidistrict litigation for coordinated pre-trial proceedings. The Motion to Transfer was granted in May 2011, and all federal cases involving allegations of Femur Fracture have been or will be transferred to a multidistrict litigation in the District of New Jersey (the “Fosamax Femur Fracture MDL”). As a result of the JPML order, approximately 510 cases were pending in the Fosamax Femur Fracture MDL as of June 30, 2012. A Case Management Order has been entered that requires the parties to review

 

- 20 -


Notes to Consolidated Financial Statements (unaudited) (continued)

 

40 cases (later reduced to 33 cases) with a fact discovery deadline of July 31, 2012 and an expert discovery deadline of November 28, 2012. Judge Joel Pisano has selected four cases to be tried as the initial bellwether cases in the Fosamax Femur Fracture MDL and has set an April 8, 2013 trial date for the first bellwether case.

As of June 30, 2012, approximately 1,535 cases alleging Femur Fractures have been filed in New Jersey state court and are pending before Judge Higbee in Atlantic County Superior Court. The parties have selected an initial group of 30 cases to be reviewed through fact discovery. Plaintiffs subsequently dismissed or advised that they will dismiss seven of the cases that were selected and discovery in the remaining cases is continuing. Judge Higbee has set March 4, 2013 as the date for the first trial of the New Jersey state Femur Fracture cases.

As of June 30, 2012, approximately 350 cases alleging Femur Fractures have been filed in California state court. A petition was filed seeking to coordinate all Femur Fracture cases filed in California state court before a single judge in Orange County, California. The petition was granted and Judge Steven Perk is now presiding over the coordinated proceedings. No scheduling order has yet been entered.

Additionally, there are nine Femur Fracture cases pending in other state courts. A trial date has been set for August 12, 2013 for the Barnes case pending in Alabama state court.

Discovery is ongoing in the Fosamax Femur Fracture MDL and in state courts where Femur Fracture cases are pending and the Company intends to defend against these lawsuits.

NuvaRing

As previously disclosed, beginning in May 2007, a number of complaints were filed in various jurisdictions asserting claims against the Company’s subsidiaries Organon USA, Inc., Organon Pharmaceuticals USA, Inc., Organon International (collectively, “Organon”), and the Company arising from Organon’s marketing and sale of NuvaRing, a combined hormonal contraceptive vaginal ring. The plaintiffs contend that Organon and Schering-Plough, among other things, failed to adequately design and manufacture NuvaRing and failed to adequately warn of the alleged increased risk of venous thromboembolism (“VTE”) posed by NuvaRing, and/or downplayed the risk of VTE. The plaintiffs seek damages for injuries allegedly sustained from their product use, including some alleged deaths, heart attacks and strokes. The majority of the cases are currently pending in a federal multidistrict litigation (the “NuvaRing MDL”) venued in Missouri and in a coordinated proceeding in New Jersey state court.

As of June 30, 2012, there were approximately 1,100 NuvaRing cases. Of these cases, approximately 950 are or will be pending in the NuvaRing MDL in the U.S. District Court for the Eastern District of Missouri before Judge Rodney Sippel, and approximately 135 are pending in coordinated discovery proceedings in the Bergen County Superior Court of New Jersey before Judge Brian R. Martinotti. Six additional cases are pending in various other state courts.

Pursuant to orders of Judge Sippel in the NuvaRing MDL, the parties originally selected a pool of more than 20 cases to prepare for trial and that pool has since been narrowed to eight cases from which the first trials in the NuvaRing MDL will be selected. Pursuant to Judge Martinotti’s order in the New Jersey proceeding, the parties selected 10 trial pool cases to be prepared for trial and the first trial is expected to commence in February 2013. The parties have completed fact discovery in the originally selected trial pool cases in each jurisdiction and the Company anticipates expert discovery to be completed in those first trial pool cases by the summer of 2012. Certain replacement trial pool cases remain in fact discovery. Moreover, on January 31, 2012, the parties in the New Jersey coordinated proceeding selected an additional 10 trial pool cases for completion of fact discovery.

The Company anticipates filing motions related to the admissibility of expert testimony beginning in the summer of 2012 and continuing through the fall with status conferences to be held in each coordinated proceeding following the completion of briefing to discuss the timing of hearings related to the motions. The Company expects substantive hearings on those motions to take place in late 2012. The Company anticipates that status conferences will be held in each coordinated proceeding following rulings on the substantive evidentiary motions to determine a methodology for selecting the first cases to be tried. The Company intends to defend against these lawsuits.

Propecia/Proscar

As previously disclosed, Merck is a defendant in product liability lawsuits in the United States involving Propecia and/or Proscar. As of June 30, 2012, approximately 200 lawsuits involving a total of approximately 325 plaintiffs (in a few instances spouses are joined in the suits) who allege that they have experienced persistent sexual side effects following cessation of treatment with Propecia and/or Proscar have been filed against Merck. The lawsuits, which are in their early stages, are pending in federal courts in New Jersey, Washington, Washington D.C., Florida, Illinois, Colorado, Missouri and Ohio, and in state court in New Jersey.

 

- 21 -


Notes to Consolidated Financial Statements (unaudited) (continued)

 

The federal lawsuits have been consolidated for pretrial purposes in a federal MDL before Judge John Gleeson of the Eastern District of New York. The matters pending in state court in New Jersey have been consolidated before Judge Jessica Mayer in Middlesex County. The Company intends to defend against these lawsuits.

Governmental Proceedings

As publicly disclosed, on June 21, 2012, the U.S. District Court for the Eastern District of Pennsylvania unsealed a complaint that has been filed against the Company under the federal False Claims Act by two former employees alleging, among other things, that the Company defrauded the U.S. government by falsifying data in connection with a clinical study conducted on the mumps component of the Company’s M-M-R II vaccine. The complaint alleges the fraud took place between 1999 and 2001. The U.S. government had the right to participate in and take over the prosecution of this lawsuit, but has advised the Company that it will decline to exercise that right. Thus, the two former employees are pursuing the lawsuit without the involvement of the U.S. government. The Company intends to defend against this lawsuit.

Vytorin/Zetia Litigation

As previously disclosed, in April 2008, a Merck shareholder filed a putative class action lawsuit in federal court which has been consolidated in the District of New Jersey with another federal securities lawsuit under the caption In re Merck & Co., Inc. Vytorin Securities Litigation. An amended consolidated complaint was filed in October 2008 and named as defendants Merck; Merck/Schering-Plough Pharmaceuticals, LLC; and certain of the Company’s current and former officers and directors. The complaint alleges that Merck delayed releasing unfavorable results of the ENHANCE clinical trial regarding the efficacy of Vytorin and that Merck made false and misleading statements about expected earnings, knowing that once the results of the ENHANCE study were released, sales of Vytorin would decline and Merck’s earnings would suffer. In December 2008, Merck and the other defendants moved to dismiss this lawsuit on the grounds that the plaintiffs failed to state a claim for which relief can be granted. In September 2009, the court denied defendants’ motion to dismiss. In June 2011, lead plaintiffs filed a motion for leave to further amend the consolidated complaint, which was granted on February 7, 2012. On February 9, 2012, plaintiffs filed a second amended consolidated complaint, which defendants answered on February 23, 2012. In February 2012, the parties completed briefing on lead plaintiffs’ motion for class certification. That motion is now pending before the court. On March 1, 2012, defendants filed a motion for summary judgment. That motion is now fully briefed and pending before the court.

There is a similar consolidated, putative class action securities lawsuit pending in the District of New Jersey, filed by a Schering-Plough shareholder against Schering-Plough and its former Chairman, President and Chief Executive Officer, Fred Hassan, under the caption In re Schering-Plough Corporation/ENHANCE Securities Litigation. The amended consolidated complaint was filed in September 2008 and names as defendants Schering-Plough; Merck/Schering-Plough Pharmaceuticals; certain of the Company’s current and former officers and directors; and underwriters who participated in an August 2007 public offering of Schering-Plough’s common and preferred stock. In December 2008, Schering-Plough and the other defendants filed motions to dismiss this lawsuit on the grounds that the plaintiffs failed to state a claim for which relief can be granted. In September 2009, the court denied defendants’ motions to dismiss. In February 2012, the parties completed briefing on lead plaintiffs’ motion for class certification. That motion is now pending before the court. On March 1, 2012, the Schering-Plough defendants filed a motion for partial summary judgment and the underwriter defendants filed a motion for summary judgment. Those motions are now fully briefed and pending before the court.

As previously disclosed, in April 2008, a member of a Merck ERISA plan filed a putative class action lawsuit against Merck and certain of the Company’s current and former officers and directors alleging they breached their fiduciary duties under ERISA. Since that time, there have been other similar ERISA lawsuits filed against Merck in the District of New Jersey, and all of those lawsuits have been consolidated under the caption In re Merck & Co., Inc. Vytorin ERISA Litigation. A consolidated amended complaint was filed in February 2009, and names as defendants Merck and various current and former members of the Company’s Board of Directors. The plaintiffs allege that the ERISA plans’ investment in Merck stock was imprudent because Merck’s earnings were dependent on the commercial success of its cholesterol drug Vytorin, and defendants knew or should have known that the results of a scientific study would cause the medical community to turn to less expensive drugs for cholesterol management. On May 24, 2012, the plaintiffs filed an unopposed motion for preliminary approval of settlement, conditional certification of a settlement class, approval of the class notice, and scheduling of a final fairness hearing. The court granted that motion on June 22, 2012 and scheduled a hearing on final approval of the settlement for September 25, 2012. Pursuant to the settlement agreement, Merck’s insurers have paid $10.4 million into a settlement fund which (after enumerated costs, fees, and awards are withdrawn) will be allocated to members of the settlement class according to a plan of allocation to be approved by the court. The settlement agreement provides that, in exchange for such consideration, the plaintiffs and settlement class members will issue broad releases with prejudice.

There was a similar consolidated, putative class action ERISA lawsuit pending in the District of New Jersey, filed by a member of a Schering-Plough ERISA plan against Schering-Plough and certain of its then-current and former officers and directors, alleging they breached their fiduciary duties under ERISA, bearing the caption In re Schering-Plough Corp. ENHANCE ERISA

 

- 22 -


Notes to Consolidated Financial Statements (unaudited) (continued)

 

Litigation. The consolidated amended complaint was filed in October 2009 and named as defendants Schering-Plough, various then-current and former members of Schering-Plough’s Board of Directors and then-current and former members of committees of Schering-Plough’s Board of Directors. On February 10, 2012, the plaintiffs filed an executed class action settlement agreement and preliminary approval order. The court signed the preliminary approval order on February 16, 2012, and held a final fairness hearing on May 30, 2012. On May 31, 2012, the court issued an opinion, order, and final judgment. Among other things, the final judgment dismissed this action with prejudice, provided releases to the defendants, and approved the settlement agreement pursuant to which Merck’s insurers have paid $12.25 million into a settlement fund.

Discovery in the lawsuits referred to in this section (collectively, the “ENHANCE Litigation”) has concluded. The Company believes that it has meritorious defenses to the ENHANCE Litigation and intends to vigorously defend against these lawsuits. The Company is unable to predict the outcome of these matters and at this time cannot reasonably estimate the possible loss or range of loss with respect to the ENHANCE Litigation. Unfavorable outcomes resulting from the ENHANCE Litigation could have a material adverse effect on the Company’s financial position, liquidity and results of operations.

Insurance

The Company has Directors and Officers insurance coverage applicable to the Vytorin shareholder lawsuits brought by legacy Schering-Plough shareholders with stated upper limits of approximately $250 million, which is currently being used to partially fund the Company’s legal fees. There are disputes with the insurers about the availability of some or all of the Company’s insurance coverage for these claims and there are likely to be additional disputes. The amounts actually recovered under the policies discussed in this paragraph may be less than the stated limits. The Company also has Fiduciary and other insurance for the Vytorin ERISA lawsuits which funded the costs of the two ERISA settlements discussed above.

Commercial Litigation

AWP Litigation

As previously disclosed, the Company and/or certain of its subsidiaries remain defendants in cases brought by various states alleging manipulation by pharmaceutical manufacturers of Average Wholesale Prices (“AWP”), which are sometimes used by public and private payors in calculating provider reimbursement levels. The outcome of these lawsuits could include substantial damages, the imposition of substantial fines and penalties and injunctive or administrative remedies.

Since the start of 2012, the Company has settled certain AWP cases brought by the states of Alabama, Alaska, Kansas, Kentucky, Louisiana, and Mississippi. The Company and/or certain of its subsidiaries continue to be defendants in cases brought by six states.

A motion has also been filed to reinstate the Company as a defendant in a putative class action in New Jersey State court which alleges on behalf of third-party payers and individuals that manufacturers inflated drug prices by manipulation of AWPs and other means. This case was dismissed against the Company without prejudice in 2007.

K-DUR Antitrust Litigation

As previously disclosed, in June 1997 and January 1998, Schering-Plough settled patent litigation with Upsher-Smith, Inc. (“Upsher-Smith”) and ESI Lederle, Inc. (“Lederle”), respectively, relating to generic versions of K-DUR, Schering-Plough’s long-acting potassium chloride product supplement used by cardiac patients, for which Lederle and Upsher-Smith had filed Abbreviated New Drug Applications (“ANDAs”). Following the commencement of an administrative proceeding by the U.S. Federal Trade Commission (the “FTC”) in 2001 alleging anti-competitive effects from those settlements (which has been resolved in Schering-Plough’s favor), putative class and non-class action suits were filed on behalf of direct and indirect purchasers of K-DUR against Schering-Plough, Upsher-Smith and Lederle and were consolidated in a multi-district litigation in the U.S. District Court for the District of New Jersey. These suits claimed violations of federal and state antitrust laws, as well as other state statutory and common law causes of action, and sought unspecified damages. In April 2008, the indirect purchasers voluntarily dismissed their case. In March 2010, the District Court granted summary judgment to the defendants on the remaining lawsuits and dismissed the matter in its entirety. However, in July 2012, the Third Circuit Court of Appeals reversed the District Court’s judgment and remanded the case for further proceedings. At the same time, the Third Circuit upheld a December 2008 decision by the District Court to certify certain direct purchaser plaintiffs’ claims as a class action. The Company intends to seek further judicial review.

Coupon Litigation

Since March 2012, a number of private health plans have filed separate putative class action lawsuits against the Company alleging that Merck’s coupon programs injured health insurers by reducing beneficiary co-payment amounts, thereby allegedly causing beneficiaries to purchase higher-priced drugs than they otherwise would have purchased and increasing the insurers’ reimbursement costs. The actions, which were filed in U.S. District Court for the District of New Jersey and the Southern District of Illinois, seek damages and injunctive relief barring the Company from issuing coupons that would reduce beneficiary co-pays on

 

- 23 -


Notes to Consolidated Financial Statements (unaudited) (continued)

 

behalf of putative nationwide classes of health insurers. Similar actions relating to manufacturer coupon programs have been filed against several other pharmaceutical manufacturers in a variety of federal courts. The Company intends to defend against these lawsuits.

Patent Litigation

From time to time, generic manufacturers of pharmaceutical products file ANDAs with the FDA seeking to market generic forms of the Company’s products prior to the expiration of relevant patents owned by the Company. To protect its patent rights, the Company may file patent infringement lawsuits against such generic companies. Certain products of the Company (or marketed via agreements with other companies) currently involved in such patent infringement litigation in the United States include: AzaSite, Cancidas, Emend for Injection, Nasonex, Nexium, Noxafil, Vytorin and Zetia. Similar lawsuits defending the Company’s patent rights may exist in other countries. The Company intends to vigorously defend its patents, which it believes are valid, against infringement by generic companies attempting to market products prior to the expiration of such patents. As with any litigation, there can be no assurance of the outcomes, which, if adverse, could result in significantly shortened periods of exclusivity for these products and, with respect to legacy Schering-Plough products, potentially significant intangible asset impairment charges.

AzaSite — In May 2011, a patent infringement suit was filed in the United States against Sandoz Inc. (“Sandoz”) in respect of Sandoz’s application to the FDA seeking pre-patent expiry approval to market a generic version of AzaSite. The lawsuit automatically stays FDA approval of Sandoz’s ANDA until October 2013 or until an adverse court decision, if any, whichever may occur earlier.

Cancidas — In November 2009, a patent infringement lawsuit was filed in the United States against Teva Parenteral Medicines, Inc. (“TPM”) in respect of TPM’s application to the FDA seeking pre-patent expiry approval to sell a generic version of Cancidas. That lawsuit has been dismissed with no rights granted to TPM. Also, in March 2010, a patent infringement lawsuit was filed in the United States against Sandoz in respect of Sandoz’s application to the FDA seeking pre-patent expiry approval to sell a generic version of Cancidas. In April 2012, the parties entered into a settlement agreement allowing Sandoz to sell a generic version of Cancidas commencing on August 28, 2017.

Emend for Injection — In May 2012, a patent infringement lawsuit was filed in the United States against Sandoz in respect of Sandoz’s application to the FDA seeking pre-patent expiry approval to market a generic version of Emend for Injection. The lawsuit automatically stays FDA approval of Sandoz’s ANDA until July 2015 or until an adverse court decision, if any, whichever may occur earlier. In June 2012, a patent infringement lawsuit was filed in the United States against Accord Healthcare, Inc. US, Accord Healthcare, Inc. and Intas Pharmaceuticals Ltd (collectively, “Intas”) in respect of Intas’ application to the FDA seeking pre-patent expiry approval to market a generic version of Emend for Injection. The lawsuit automatically stays FDA approval of Intas’ ANDA until July 2015 or until an adverse court decision, if any, whichever may occur earlier.

Integrilin — In February 2009, a patent infringement lawsuit was filed (jointly with Millennium Pharmaceuticals, Inc.) in the United States against TPM in respect of TPM’s application to the FDA seeking approval to sell a generic version of Integrilin prior to the expiry of the last to expire listed patent. In October 2011, the parties entered a settlement agreement allowing TPM to sell a generic version of Integrilin beginning June 2, 2015.

Nasonex — In December 2009, a patent infringement suit was filed in the United States against Apotex Corp. (“Apotex”) in respect of Apotex’s application to the FDA seeking pre-patent expiry approval to market a generic version of Nasonex. A trial in this matter was held in April 2012. A decision was issued on June 15, 2012, holding that the Merck patent covering mometasone furoate monohydrate was valid, but that it was not infringed by Apotex’s proposed product. The finding of non-infringement is under appeal.

Nexium — Patent infringement lawsuits were brought (jointly with AstraZeneca) in the United States against the following generic companies: Ranbaxy Laboratories Ltd., IVAX Pharmaceuticals, Inc. (later acquired by Teva Pharmaceuticals, Inc. (“Teva”)), Dr. Reddy’s Laboratories, Sandoz, Lupin Ltd., Hetero Drugs Limited Unit III (“Hetero”) and Torrent Pharmaceuticals Ltd. in response to each generic company’s application seeking pre-patent expiry approval to sell a generic version of Nexium. Settlements have been reached in each of these lawsuits, the terms of which provide that the respective generic company may bring a generic version of esomeprazole product to market on May 27, 2014. In addition, a patent infringement lawsuit was also filed (jointly with AstraZeneca) in February 2010 in the United States against Sun Pharma Global Fze (“Sun Pharma”) in respect of its application to the FDA seeking pre-patent expiry approval to sell a generic version of Nexium IV, which lawsuit was settled with an agreement which provides that Sun Pharma will be entitled to bring its generic esomeprazole IV product to market in the United States on January 1, 2014. Finally, additional patent infringement lawsuits have been filed (jointly with AstraZeneca) in the United States against Hamni USA, Inc. (“Hamni”) and Mylan Laboratories Limited (“Mylan Labs”) related to their applications to the FDA seeking pre-patent expiry approval to sell generic versions of Nexium. The Hamni and Mylan Labs applications to the FDA remain stayed until May 2013 and August 2014, respectively, or until earlier adverse court decisions, if any.

 

- 24 -


Notes to Consolidated Financial Statements (unaudited) (continued)

 

Noxafil — In May 2011, a patent infringement suit was filed in the United States against Sandoz in respect of Sandoz’s application to the FDA seeking pre-patent expiry approval to market a generic version of Noxafil. In May 2012, Sandoz withdrew its challenge to Merck’s Noxafil patents and the lawsuit has been dismissed.

NuvaRing — In February 2011, a patent infringement suit was brought against Merck in the International Trade Commission (the “ITC”) by Femina Pharma Incorporated (“Femina”) in respect of the product NuvaRing. The complaint alleged that NuvaRing infringes a patent owned by Femina. Femina’s ITC complaint sought an exclusion order against the importation of NuvaRing into the United States. A hearing began in the ITC proceeding on January 17, 2012 and on January 18, 2012 Femina withdrew its complaint and terminated the action. In addition, in November 2011, Femina brought a patent infringement lawsuit against Merck in the Eastern District of Virginia asserting that NuvaRing infringes the same patent. That case was stayed pending the outcome of the ITC proceeding. In April 2012, Femina voluntarily withdrew its lawsuit.

Propecia — In December 2010, a patent infringement lawsuit was filed in the United States against Hetero in respect of Hetero’s application to the FDA seeking pre-patent expiry approval to sell a generic version of Propecia. In March 2011, the Company settled this lawsuit with Hetero by agreeing to allow Hetero to sell a generic 1 mg finasteride product beginning on July 1, 2013. By virtue of a previous litigation settlement agreement, another generic manufacturer has been given the right to enter the U.S. market in January 2013.

Temodar — In July 2007, a patent infringement action was filed (jointly with Cancer Research Technologies, Limited (“CRT”)) in the United States against Barr Laboratories (“Barr”) (later acquired by Teva) in respect of Barr’s application to the FDA seeking pre-patent expiry approval to sell a generic version of Temodar. In January 2010, the court issued a decision finding the CRT patent unenforceable on grounds of prosecution laches and inequitable conduct. In November 2010, the appeals court issued a decision reversing the trial court’s finding. In December 2010, Barr filed a petition seeking a rehearing en banc of the appeal, which petition was denied. In June 2011, Barr filed a petition for review by the U.S. Supreme Court, which was denied. By virtue of an agreement that Barr not launch a product during the appeal process, the Company has agreed that Barr can launch a product in August 2013.

In September 2010, a patent infringement lawsuit was filed (jointly with CRT) in the United States against Sun Pharmaceutical Industries Inc. (“Sun”) in respect of Sun’s application to the FDA seeking pre-patent expiry approval to sell a generic version of Temodar. The lawsuit automatically stayed FDA approval of Sun’s ANDA until February 2013 or until an adverse court decision, if any, whichever may occur earlier. In November 2010, a patent infringement lawsuit was filed (jointly with CRT) in the United States against Accord HealthCare Inc. (“Accord”) in respect of its application to the FDA seeking pre-patent expiry approval to sell a generic version of Temodar. The lawsuit automatically stayed FDA approval of Accord’s application until April 13, 2013 or until an adverse court decision, if any, whichever may occur earlier. The Company and CRT entered into agreements with Sun and Accord to stay the respective lawsuits pending the outcome of the U.S. Supreme Court appeal process in the Barr lawsuit. In light of the U.S. Supreme Court’s denial of Barr’s petition, Sun and Accord withdrew their challenges to the Temodar patent and the respective lawsuits have been withdrawn.

Vytorin — In December 2009, a patent infringement lawsuit was filed in the United States against Mylan Pharmaceuticals, Inc. (“Mylan”) in respect of Mylan’s application to the FDA seeking pre-patent expiry approval to sell a generic version of Vytorin. A trial against Mylan jointly in respect of Zetia and Vytorin was conducted in December 2011. In April 2012, the court issued a decision finding the patent valid and enforceable. Accordingly, Mylan’s ANDA will not be approvable until April 25, 2017. Mylan has appealed that decision. In February 2010, a patent infringement lawsuit was filed in the United States against Teva in respect of Teva’s application to the FDA seeking pre-patent expiry approval to sell a generic version of Vytorin. In July 2011, the patent infringement lawsuit was dismissed and Teva agreed not to sell generic versions of Zetia or Vytorin until the Company’s exclusivity rights expire on April 25, 2017, except in certain circumstances. In August 2010, a patent infringement lawsuit was filed in the United States against Impax Laboratories Inc. (“Impax”) in respect of Impax’s application to the FDA seeking pre-patent expiry approval to sell a generic version of Vytorin. An agreement was reached with Impax to stay the lawsuit pending the outcome of the lawsuit with Mylan. In October 2011, a patent infringement lawsuit was filed in the United States against Actavis Inc. (“Actavis”) in respect to Actavis’ application to the FDA seeking pre-patent expiry approval to sell a generic version of Vytorin.

 

- 25 -


Notes to Consolidated Financial Statements (unaudited) (continued)

 

An agreement was reached with Actavis to stay the lawsuit pending the outcome of the lawsuit with Mylan.

Zetia — In March 2007, a patent infringement lawsuit was filed in the United States against Glenmark Pharmaceuticals Inc., USA and its parent corporation (collectively, “Glenmark”) in respect of Glenmark’s application to the FDA seeking pre-patent expiry approval to sell a generic version of Zetia. In May 2010, Glenmark agreed to a settlement by virtue of which Glenmark will be permitted to launch its generic product in the United States on December 12, 2016, subject to receiving final FDA approval. In June 2010, a patent infringement lawsuit was filed in the United States against Mylan in respect of Mylan’s application to the FDA seeking pre-patent expiry approval to sell a generic version of Zetia. A trial against Mylan jointly in respect of Zetia and Vytorin was conducted in December 2011. In April 2012, the court issued a decision finding the patent valid and enforceable. Accordingly, Mylan’s ANDA will not be approvable until April 25, 2017. Mylan has appealed that decision. In September 2010, a patent infringement lawsuit was filed in the United States against Teva in respect of Teva’s application to the FDA seeking pre-patent expiry approval to sell a generic version of Zetia. In July 2011, the patent infringement lawsuit was dismissed without any rights granted to Teva.

Other Litigation

There are various other pending legal proceedings involving the Company, principally product liability and intellectual property lawsuits. While it is not feasible to predict the outcome of such proceedings, in the opinion of the Company, either the likelihood of loss is remote or any reasonably possible loss associated with the resolution of such proceedings is not expected to be material to the Company’s financial position, results of operations or cash flows either individually or in the aggregate.

Legal Defense Reserves

Legal defense costs expected to be incurred in connection with a loss contingency are accrued when probable and reasonably estimable. Some of the significant factors considered in the review of these legal defense reserves are as follows: the actual costs incurred by the Company; the development of the Company’s legal defense strategy and structure in light of the scope of its litigation; the number of cases being brought against the Company; the costs and outcomes of completed trials and the most current information regarding anticipated timing, progression, and related costs of pre-trial activities and trials in the associated litigation. The amount of legal defense reserves as of June 30, 2012 and December 31, 2011 of approximately $250 million and $240 million, respectively, represents the Company’s best estimate of the minimum amount of defense costs to be incurred in connection with its outstanding litigation; however, events such as additional trials and other events that could arise in the course of its litigation could affect the ultimate amount of legal defense costs to be incurred by the Company. The Company will continue to monitor its legal defense costs and review the adequacy of the associated reserves and may determine to increase the reserves at any time in the future if, based upon the factors set forth, it believes it would be appropriate to do so.

Environmental Matters

The Company and its subsidiaries are parties to a number of proceedings brought under the Comprehensive Environmental Response, Compensation and Liability Act, commonly known as Superfund, and other federal and state equivalents. These proceedings seek to require the operators of hazardous waste disposal facilities, transporters of waste to the sites and generators of hazardous waste disposed of at the sites to clean up the sites or to reimburse the government for cleanup costs. The Company has been made a party to these proceedings as an alleged generator of waste disposed of at the sites. In each case, the government alleges that the defendants are jointly and severally liable for the cleanup costs. Although joint and several liability is alleged, these proceedings are frequently resolved so that the allocation of cleanup costs among the parties more nearly reflects the relative contributions of the parties to the site situation. The Company’s potential liability varies greatly from site to site. For some sites the potential liability is de minimis and for others the final costs of cleanup have not yet been determined. While it is not feasible to predict the outcome of many of these proceedings brought by federal or state agencies or private litigants, in the opinion of the Company, such proceedings should not ultimately result in any liability which would have a material adverse effect on the financial position, results of operations, liquidity or capital resources of the Company. The Company has taken an active role in identifying and providing for these costs and such amounts do not include any reduction for anticipated recoveries of cleanup costs from former site owners or operators or other recalcitrant potentially responsible parties.

As previously disclosed, approximately 2,200 plaintiffs have filed an amended complaint against Merck and 12 other defendants in U.S. District Court, Eastern District of California asserting claims under the Clean Water Act, the Resource Conservation and Recovery Act, as well as negligence and nuisance. The suit seeks damages for personal injury, diminution of property value, medical monitoring and other alleged real and personal property damage associated with groundwater, surface water and soil contamination found at the site of a former Merck

 

- 26 -


Notes to Consolidated Financial Statements (unaudited) (continued)

 

subsidiary in Merced, California. Certain of the other defendants in this suit have settled with plaintiffs regarding some or all aspects of plaintiffs’ claims. This lawsuit is proceeding in a phased manner. A jury trial commenced in February 2011 during which a jury was asked to make certain factual findings regarding whether contamination moved off-site to any areas where plaintiffs could have been exposed to such contamination and, if so, when, where and in what amounts. Defendants in this “Phase 1” trial included Merck and three of the other original 12 defendants. In March 2011, the Phase 1 jury returned a mixed verdict, finding in favor of Merck and the other defendants as to some, but not all, of plaintiffs’ claims. Specifically, the jury found that contamination from the site did not enter or affect plaintiffs’ municipal water supply wells or any private domestic wells. The jury found, however, that plaintiffs could have been exposed to contamination via air emissions prior to 1994, as well as via surface water in the form of storm drainage channeled into an adjacent irrigation canal, including during a flood in April 2006. In response to post-trial motions by Merck and other defendants, on September 7, 2011, the court entered an order setting aside a part of the Phase 1 jury’s findings that had been in favor of plaintiffs. Specifically, the court held that plaintiffs could not have been exposed to any contamination in surface or flood water during the April 2006 flood or, in fact, at any time later than 1991. Merck’s motion for reconsideration of the remainder of the jury’s Phase I verdict that was adverse to Merck was denied. Following the retirement of the judge handling this case, on September 21, 2011, the case was assigned to Judge David O. Carter of the U.S. District Court for the Central District of California. Judge Carter selected 10 plaintiffs whose claims would be reviewed and, depending on the outcome of Merck’s anticipated summary judgment motions, possibly tried in early 2013. Plaintiffs subsequently withdrew the claim of one of those 10 plaintiffs, leaving nine whose claims may proceed to trial. The court has dismissed the claims of 1,083 of the plaintiffs in this action whose claims were precluded by aspects of the Phase I jury findings and the court’s subsequent orders.

10.  Equity

 

                                                                                                                                      
                                Accumulated                              
                   Other            Other                    Non-         
     Common Stock           Paid-In             Retained       Comprehensive      Treasury Stock      Controlling         
($ and shares in millions)    Shares       Par Value        Capital      Earnings     Loss      Shares      Cost        Interests      Total  

 

Balance January 1, 2011

     3,577       $ 1,788         $ 40,701         $ 37,536      $ (3,216)         495         $     (22,433)        $ 2,429         $       56,805     

Net income attributable to
Merck & Co., Inc.

     -         -           -           3,067        -           -           -            -           3,067     

Cash dividends declared on common stock

     -         -           -           (2,360     -           -           -            -           (2,360)    

Treasury stock shares purchased

     -         -           -           -        -           9           (314)          -           (314)    

Share-based compensation plans and other

     -         -           (44)         -        -           (10)         331            -           287     

Other comprehensive income

     -         -           -           -        440           -           -            -           440     

Net income attributable to noncontrolling interests

     -         -           -           -        -           -           -            58           58     

Distributions attributable to noncontrolling interests

     -         -           -           -        -           -           -            (61)          (61)    

 

 

Balance June 30, 2011

     3,577       $ 1,788         $ 40,657         $ 38,243      $ (2,776)         494       $ (22,416)        $ 2,426         $ 57,922     

 

 

 

Balance January 1, 2012

     3,577       $ 1,788         $ 40,663         $ 38,990      $ (3,132)         536         $ (23,792)        $ 2,426         $ 56,943     

Net income attributable to
Merck & Co., Inc.

     -         -           -           3,531        -           -           -            -           3,531     

Cash dividends declared on common stock

     -         -           -           (2,571     -           -           -            -           (2,571)    

Treasury stock shares purchased

     -         -           -           -        -           26           (985)          -           (985)    

Share-based compensation plans and other

     -         -           (113)         -        -           (24)         809            -           696     

Other comprehensive income

     -         -           -           -        6           -           -            -           6     

Net income attributable to noncontrolling interests

     -         -           -           -        -           -           -            56           56     

Distributions attributable to noncontrolling interests

     -         -           -           -        -           -           -            (3)          (3)    

 

 

Balance June 30, 2012

     3,577       $ 1,788         $ 40,550         $ 39,950      $ (3,126)         538         $ (23,968)        $ 2,479         $ 57,673     

 

 

In connection with the 1998 restructuring of Astra Merck Inc., the Company assumed $2.4 billion par value preferred stock with a dividend rate of 5% per annum, which is carried by KBI and included in Noncontrolling interests on the Consolidated Balance Sheet. If AstraZeneca exercises its option to acquire Merck’s interest in AZLP (see Note 8), this preferred stock obligation will be retired.

 

- 27 -


Notes to Consolidated Financial Statements (unaudited) (continued)

 

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

 

($ in millions)        Derivatives          Investments            Employee
Benefit 
Plans
         Cumulative
    Translation
    Adjustment
     Accumulated 
Other 
Comprehensive 
Loss 
 

 

 

 

Balance January 1, 2011

   $ 41        $ 31        $ (2,043)       $ (1,245)           $     (3,216)    

Other comprehensive (loss) income

     (137)         (5)         28          554          440     

 

 

Balance at June 30, 2011

   $ (96)       $ 26        $ (2,015)       $ (691)           $ (2,776)    

 

 

 

Balance January 1, 2012

   $       $ 21        $ (2,346)       $ (811)           $ (3,132)    

Other comprehensive income (loss)

     44          30          18          (86)         6     

 

 

Balance at June 30, 2012

   $ 48        $ 51        $ (2,328)       $ (897)           $ (3,126)    

 

 

Included in cumulative translation adjustment are pretax gains of approximately $340 million for the first six months of 2011 relating to translation impacts of intangible assets recorded in conjunction with the Merger.

11.  Share-Based Compensation Plans

The Company has share-based compensation plans under which employees and non-employee directors may be granted restricted stock units (“RSUs”). In addition, the Company grants options to purchase shares of Company common stock at the fair market value at the time of grant and performance share units (“PSUs”) to certain management-level employees. The Company recognizes the fair value of share-based compensation in net income on a straight-line basis over the requisite service period.

The following table provides amounts of share-based compensation cost recorded in the Consolidated Statement of Income:

 

       Three Months Ended    
June 30,
         Six Months Ended      
June 30,
 
  

 

 

    

 

 

 

($ in millions)

     2012            2011             2012            2011       

 

 

 

Pretax share-based compensation expense

       $ 93      $ 107             $ 169      $ 200    

Income tax benefit

     (29     (37)          (53     (69)    

 

 

Total share-based compensation expense, net of taxes

       $ 64      $ 70             $ 116      $ 131    

 

 

During the first six months of 2012 and 2011, the Company granted 7 million RSUs with a weighted-average grant date fair value of $39.29 per RSU and 8 million RSUs with a weighted-average grant date fair value of $36.47 per RSU, respectively.

During the first six months of 2012 and 2011, the Company granted 7 million options with a weighted-average exercise price of $39.26 per option and 8 million options with a weighted-average exercise price of $36.55 per option, respectively. The weighted-average fair value of options granted for the first six months of 2012 and 2011 was $5.46 and $5.37 per option, respectively, and was determined using the following assumptions:

 

               Six Months Ended           
June 30,
 
     2012         2011   

 

 

 

Expected dividend yield

     4.4%         4.3%   

Risk-free interest rate

     1.3%         2.6%   

Expected volatility

     25.3%         23.2%   

Expected life (years)

     7.0          7.0    

 

 

At June 30, 2012, there was $555 million of total pretax unrecognized compensation expense related to nonvested stock options, RSU and PSU awards which will be recognized over a weighted-average period of 2.0 years. For segment reporting, share-based compensation costs are unallocated expenses.

 

- 28 -


Notes to Consolidated Financial Statements (unaudited) (continued)

 

12.  Pension and Other Postretirement Benefit Plans

The Company has defined benefit pension plans covering eligible employees in the United States and in certain of its international subsidiaries. The net cost of such plans consisted of the following components:

 

     Three Months Ended
June 30,
     Six Months Ended
June 30,
 
($ in millions)          2012                  2011                  2012                  2011        

 

 

 

Service cost

     $ 141        $ 151          $ 283        $ 303    

Interest cost

     166          180          332          359    

Expected return on plan assets

     (244)         (242)         (488)         (485)   

Net amortization

     48          46          96          91    

Termination benefits

                             17    

Curtailments

     (1)         (6)         (1)         (10)   

Settlements

                             (1)   

 

 
     $ 114        $ 136          $ 231        $ 274    

 

 

The Company provides medical, dental and life insurance benefits, principally to its eligible U.S. retirees and similar benefits to their dependents, through its other postretirement benefit plans. The net cost of such plans consisted of the following components:

 

     Three Months Ended
June 30,
     Six Months Ended
June 30,
 
($ in millions)          2012                  2011                  2012                  2011        

 

 

 

Service cost

     $ 21        $ 28          $ 42        $ 56    

Interest cost

     31          35          62          71    

Expected return on plan assets

     (34)         (36)         (68)         (71)   

Net amortization

     (8)         (6)         (16)         (9)   

Termination benefits

                               

Curtailments

     (2)                 (4)           

 

 
     $ 11        $ 25          $ 21        $ 54    

 

 

In connection with restructuring actions (see Note 2), termination charges for the three and six months ended June 30, 2012 and 2011 were recorded on pension and other postretirement benefit plans related to expanded eligibility for certain employees exiting Merck. Also, in connection with these restructuring actions, curtailments were recorded on pension and other postretirement benefit plans and settlements were recorded on pension plans as reflected in the tables above.

13.  Other (Income) Expense, Net

Other (income) expense, net, consisted of:

 

     Three Months Ended
June 30,
     Six Months Ended
June 30,
 
($ in millions)          2012                  2011                  2012                  2011        

 

 

 

Interest income

     $ (76)       $ (39)         $ (129)       $ (69)   

Interest expense

     172          170          346          345    

Exchange losses

     13                  80          43    

Other, net

     (6)         (11)         (50)         425    

 

 
     $ 103        $ 121          $ 247        $ 744    

 

 

 

- 29 -


Notes to Consolidated Financial Statements (unaudited) (continued)

 

As a result of significant collections of accounts receivable in Spain during the second quarter (see Note 5), the Company recognized incremental interest income of approximately $35 million in the second quarter and first six months of 2012 for accelerated accretion of time value of money discounts related to these receivables. Other, net (as presented in the table above) for the first six months of 2011 reflects a $500 million charge related to the resolution of the arbitration proceeding involving the Company’s rights to market Remicade and Simponi (see Note 4), as well as a $127 million gain on the sale of certain manufacturing facilities and related assets. Interest paid for the six months ended June 30, 2012 and 2011 was $324 million and $194 million, respectively, which excludes commitment fees. Interest paid for the six months ended June 30, 2011 is net of $175 million received by the Company from the termination of certain interest rate swap contracts during the period (see Note 5).

14.  Taxes on Income

The effective tax rates of 32.1% and 30.8% for the second quarter and first six months of 2012 and (22.8)% and 8.1% for the second quarter and first six months of 2011 reflect the impacts of acquisition-related costs and restructuring costs, partially offset by the beneficial impact of foreign earnings. In addition, the effective tax rates for the second quarter and first six months of 2011 also reflect a net favorable impact relating to the settlement of Merck’s 2002-2005 federal income tax audit as discussed below, as well as the net favorable impact of certain foreign and state tax rate changes that resulted in a net $230 million reduction of deferred tax liabilities on intangibles established in purchase accounting. In addition, the effective tax rate for the first six months of 2011 also reflects the impact of the $500 million charge related to the resolution of the arbitration proceeding with J&J.

In April 2011, the Internal Revenue Service (the “IRS”) concluded its examination of Merck’s 2002-2005 federal income tax returns and as a result the Company was required to make net payments of approximately $465 million. The Company’s unrecognized tax benefits for the years under examination exceeded the adjustments related to this examination period and therefore the Company recorded a net $700 million tax provision benefit in the second quarter of 2011. This net benefit reflects the decrease of unrecognized tax benefits for the years under examination partially offset by increases to the unrecognized tax benefits for years subsequent to the examination period as a result of this settlement. The Company disagrees with the IRS treatment of one issue raised during this examination and is appealing the matter through the IRS administrative process.

As previously disclosed, the Canada Revenue Agency (the “CRA”) has proposed adjustments for 1999 and 2000 relating to intercompany pricing matters and, in July 2011, the CRA issued assessments for other miscellaneous audit issues for tax years 2001-2004. These adjustments would increase Canadian tax due by approximately $330 million plus approximately $390 million of interest through June 30, 2012. The Company disagrees with the positions taken by the CRA and believes they are without merit. The Company continues to contest the assessments through the CRA appeals process. The CRA is expected to prepare similar adjustments for later years. Management believes that resolution of these matters will not have a material effect on the Company’s financial position or liquidity.

15.  Earnings Per Share

The Company calculates earnings per share pursuant to the two-class method, which is an earnings allocation formula that determines earnings per share for common stock and participating securities according to dividends declared and participation rights in undistributed earnings. Under this method, all earnings (distributed and undistributed) are allocated to common shares and participating securities based on their respective rights to receive dividends. RSUs and certain PSUs granted before December 31, 2009 to certain management level employees participate in dividends on the same basis as common shares and such dividends are nonforfeitable by the holder. As a result, these RSUs and PSUs meet the definition of a participating security. For RSUs and PSUs issued on or after January 1, 2010, dividends declared during the vesting period are payable to the employees only upon vesting and therefore such RSUs and PSUs do not meet the definition of a participating security.

 

- 30 -


Notes to Consolidated Financial Statements (unaudited) (continued)

 

The calculations of earnings per share under the two-class method are as follows:

 

     Three Months Ended
June 30,
     Six Months Ended
June 30,
 
($ and shares in millions except per share amounts)          2012                  2011                  2012                  2011        

 

 

 

Basic Earnings per Common Share

           

Net income attributable to Merck & Co., Inc.

     $ 1,793       $     2,024           $ 3,531       $         3,067     

Less: Income allocated to participating securities

     1         4           3         8     

 

 

Net income allocated to common shareholders

     $ 1,792       $ 2,020           $ 3,528       $ 3,059     

 

 

 

Average common shares outstanding

     3,041         3,086           3,042         3,085     

 

 
     $ 0.59       $ 0.65           $ 1.16       $ 0.99     

 

 

 

Earnings per Common Share Assuming Dilution

           

Net income attributable to Merck & Co., Inc.

     $ 1,793       $ 2,024           $ 3,531       $ 3,067     

Less: Income allocated to participating securities

     1         4           3         8     

 

 

Net income allocated to common shareholders

     $ 1,792       $ 2,020           $ 3,528       $ 3,059     

 

 

 

Average common shares outstanding

     3,041         3,086           3,042         3,085     

Common shares issuable (1)

     31         24           32         21     

 

 

Average common shares outstanding assuming dilution

     3,072         3,110           3,074         3,106     

 

 
     $ 0.58       $ 0.65           $ 1.15       $ 0.98     

 

 

 

(1)

Issuable primarily under share-based compensation plans.

For the three months ended June 30, 2012 and 2011, 107 million and 138 million, respectively, and for the first six months of 2012 and 2011, 112 million and 173 million, respectively, of common shares issuable under share-based compensation plans were excluded from the computation of earnings per common share assuming dilution because the effect would have been antidilutive.

16.        Segment Reporting

The Company’s operations are principally managed on a products basis and are comprised of four operating segments – Pharmaceutical, Animal Health, Consumer Care and Alliances (which includes revenue and equity income from the Company’s relationship with AZLP). The Animal Health, Consumer Care and Alliances segments are not material for separate reporting and are included in all other in the table below. The Pharmaceutical segment includes human health pharmaceutical and vaccine products marketed either directly by the Company or through joint ventures. Human health pharmaceutical products consist of therapeutic and preventive agents, generally sold by prescription, for the treatment of human disorders. The Company sells these human health pharmaceutical products primarily to drug wholesalers and retailers, hospitals, government agencies and managed health care providers such as health maintenance organizations, pharmacy benefit managers and other institutions. Vaccine products consist of preventive pediatric, adolescent and adult vaccines, primarily administered at physician offices. The Company sells these human health vaccines primarily to physicians, wholesalers, physician distributors and government entities. A large component of pediatric and adolescent vaccines is sold to the U.S. Centers for Disease Control and Prevention Vaccines for Children program, which is funded by the U.S. government. Additionally, the Company sells vaccines to the Federal government for placement into vaccine stockpiles. The Company also has animal health operations that discover, develop, manufacture and market animal health products, including vaccines, which the Company sells to veterinarians, distributors and animal producers. Additionally, the Company has consumer care operations that develop, manufacture and market over-the-counter, foot care and sun care products, which are sold through wholesale and retail drug, food chain and mass merchandiser outlets.

 

- 31 -


Notes to Consolidated Financial Statements (unaudited) (continued)

 

Sales of the Company’s products were as follows:

 

                          Three Months Ended                    
June 30,
                          Six Months Ended                    
June 30,
 
($ in millions)    2012      2011      2012      2011  

 

 

Primary Care and Women’s Health

           

Cardiovascular

           

Zetia

     $ 632         $ 592           $ 1,246         $ 1,174     

Vytorin

     445         459           889         939     

Diabetes and Obesity

           

Januvia

     1,058         779           1,977         1,518     

Janumet

     411         321           802         626     

Respiratory

           

Singulair

     1,431         1,354           2,771         2,682     

Nasonex

     293         323           668         696     

Clarinex

     140         209           273         364     

Asmanex

     51         47           99         107     

Dulera

     50         25           89         37     

Women’s Health and Endocrine

           

Fosamax

     186         221           370         429     

NuvaRing

     157         154           303         297     

Follistim AQ

     125         143           241         276     

Implanon

     85         81           161         141     

Cerazette

     72         66           139         125     

Other

           

Maxalt

     154         131           310         304     

Arcoxia

     117         100           229         214     

Avelox

     44         61           117         167     

Hospital and Specialty

           

Immunology

           

Remicade

     518         842           1,037         1,595     

Simponi

     76         75           150         129     

Infectious Disease

           

Isentress

     398         337           735         629     

PegIntron

     183         154           345         319     

Cancidas

     166         168           311         326     

Victrelis

     126         21           238         22     

Invanz

     110         103           211         189     

Primaxin

     104         136           192         272     

Noxafil

     66         56           125         110     

Oncology

           

Temodar

     225         234           461         481     

Emend

     145         120           247         207     

Other

           

Cosopt/Trusopt

     105         122           229         236     

Bridion

     60         47           118         89     

Integrilin

     60         56           113         120     

Diversified Brands

           

Cozaar/Hyzaar

     337         406           674         832     

Propecia

     100         112           208         218     

Zocor

     96         107           199         234     

Claritin Rx

     48         65           134         186     

Remeron

     66         57           123         117     

Proscar

     55         53           106         113     

Vasotec/Vaseretic

     49         59           102         116     

Vaccines (1)

           

Gardasil

     324         277           608         490     

ProQuad/M-M-R II/Varivax

     316         291           571         535     

RotaTeq

     142         148           284         272     

Zostavax

     148         122           224         146     

Pneumovax

     101         64           213         143     

Other pharmaceutical (2) 

     985         1,062           2,000         1,957     

 

 

Total Pharmaceutical segment sales

     10,560         10,360           20,642         20,179     

 

 

Other segment sales (3) 

     1,680         1,690           3,273         3,323     

 

 

Total segment sales

     12,240         12,050           23,915         23,502     

 

 

Other (4)

     71         101           126         230     

 

 
     $ 12,311         $ 12,151           $ 24,041         $ 23,732     

 

 

 

(1) 

These amounts do not reflect sales of vaccines sold in most major European markets through the Company’s joint venture, Sanofi Pasteur MSD, the results of which are reflected in Equity income from affiliates. These amounts do, however, reflect supply sales to Sanofi Pasteur MSD.

(2) 

Other pharmaceutical primarily includes sales of other human health pharmaceutical products not listed separately.

(3) 

Reflects other non-reportable segments, including Animal Health and Consumer Care, and revenue from the Company’s relationship with AZLP primarily relating to sales of Nexium. Revenue from AZLP was $223 million and $306 million for the second quarter of 2012 and 2011, respectively, and $409 million and $628 million for the first six months of 2012 and 2011, respectively.

(4) 

Other revenues are primarily comprised of miscellaneous corporate revenues, third-party manufacturing sales, sales related to divested products or businesses and supply sales not included in segment results. The declines in other revenues in the second quarter and first six months of 2012 as compared with the same periods of 2011 reflect lower third-party manufacturing sales, which for the year-to-date period were attributable in part to the divestiture of certain manufacturing facilities in the first quarter of 2011.

 

- 32 -


Notes to Consolidated Financial Statements (unaudited) (continued)

 

A reconciliation of segment profits to Income before taxes is as follows:

 

     Three Months Ended
June 30,
     Six Months Ended
June 30,
 
($ in millions)          2012                  2011                  2012                  2011        

 

 

 

Segment profits:

           

Pharmaceutical segment

     $       6,906        $ 6,443          $ 13,502        $ 12,659    

Other segments

     774          726          1,578          1,517    
  

 

 

 

Total segment profits

     7,680          7,169          15,080          14,176    

Other profits (losses)

     45          34          (28)         (15)   

Unallocated:

           

Interest income

     76          39          129          69    

Interest expense

     (172)         (170)         (346)         (345)   

Equity income from affiliates

     11          (87)         (9)         (81)   

Depreciation and amortization

     (574)         (623)         (1,135)         (1,194)   

Research and development

     (1,930)         (1,679)         (3,573)         (3,618)   

Amortization of purchase accounting adjustments

     (1,226)         (1,225)         (2,455)         (2,504)   

Restructuring costs

     (144)         (668)         (363)         (654)   

Arbitration settlement charge

                             (500)   

Other unallocated, net

     (1,086)         (1,118)         (2,114)         (1,933)   

 

 
     $ 2,680        $ 1,672          $ 5,186        $ 3,401    

 

 

Segment profits are comprised of segment sales less standard costs and certain operating expenses directly incurred by the segments. For internal management reporting presented to the chief operating decision maker, Merck does not allocate materials and production costs, other than standard costs, the majority of research and development expenses or general and administrative expenses, nor the cost of financing these activities. Separate divisions maintain responsibility for monitoring and managing these costs, including depreciation related to fixed assets utilized by these divisions and, therefore, they are not included in segment profits. In addition, costs related to restructuring activities, as well as the amortization of purchase adjustments are not allocated to segments.

Other profits (losses) are primarily comprised of miscellaneous corporate profits (losses), as well as operating profits (losses) related to third-party manufacturing sales, divested products or businesses and other supply sales.

Other unallocated, net includes expenses from corporate and manufacturing cost centers, product intangible asset impairment charges, gains or losses on sales of businesses and assets and other miscellaneous income or expense items.

 

- 33 -


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

U.S. Health Care Reform Legislation

In 2010, the United States enacted major health care reform legislation. Various market reforms advanced in 2011 and will continue through full implementation in 2014.

Effective in 2011, the law requires pharmaceutical manufacturers to pay a 50% discount to Medicare Part D beneficiaries when they are in the Medicare Part D coverage gap (i.e., the so-called “donut hole”). Approximately $38 million and $36 million was recorded as a reduction to revenue in the second quarter of 2012 and 2011, respectively, and $76 million and $70 million for the first six months of 2012 and 2011, respectively, related to the estimated impact of this provision of health care reform.

Also, beginning in 2011, pharmaceutical manufacturers are required to pay an annual health care reform fee. The total annual industry fee, which was $2.5 billion in 2011 and will be $2.8 billion in 2012, is assessed on each company in proportion to its share of sales to certain government programs, such as Medicare and Medicaid. The Company’s portion of the annual fee is payable no later than September 30 of the applicable calendar year and is not tax deductible. Each year, the liability related to the annual fee is estimated by the Company and recorded in full during the first quarter with a corresponding offset to a deferred asset. The deferred asset is amortized to Marketing and administrative expenses on a straight-line basis (net of any revisions) during the year. The liability related to the annual fee recognized in 2012 was $190 million and for 2011 was $162 million. The Company recognized expenses of $48 million and $43 million for the second quarter of 2012 and 2011, respectively, and $95 million and $85 million for the first six months of 2012 and 2011, respectively, related to this fee.

Arbitration Settlement

In April 2011, Merck and Johnson & Johnson (“J&J”) reached an agreement to amend the agreement governing the distribution rights to Remicade (infliximab) and Simponi (golimumab). This agreement concluded the arbitration proceeding J&J initiated in May 2009. Under the terms of the amended distribution agreement, Merck relinquished marketing rights for Remicade and Simponi to J&J in territories including Canada, Central and South America, the Middle East, Africa and Asia Pacific effective July 1, 2011. Merck retained exclusive marketing rights throughout Europe, Russia and Turkey (the “Retained Territories”). In addition, beginning July 1, 2011, all profits derived from Merck’s exclusive distribution of the two products in the Retained Territories are being equally divided between Merck and J&J. J&J also received a one-time payment from Merck of $500 million in April 2011.

Singulair Patent Expiries

The patent that provided U.S. market exclusivity for Singulair expired in August 2012. In addition, the patent that provides market exclusivity for Singulair will expire in a number of major European markets in February 2013. The Company expects a significant and rapid reduction in sales thereafter in those markets. The patent that provides market exclusivity for Singulair in Japan will expire in 2016. For the full year of 2011, sales of Singulair were $3.5 billion in the United States, $724 million in Europe and $641 million in Japan.

Operating Results

Sales

Worldwide sales were $12.3 billion for the second quarter of 2012, an increase of 1% compared with the second quarter of 2011. Global sales for the first six months of 2012 were $24.0 billion, an increase of 1% compared with the same period in 2011. Foreign exchange unfavorably affected global sales performance by 4% and 2% for the second quarter and first six months of 2012, respectively. The revenue increases largely reflect higher sales of Januvia (sitagliptin), Victrelis (boceprevir), Janumet (sitagliptin/metformin hydrochloride HCI), Gardasil [human papillomavirus quadrivalent (types 6, 11, 16 and 18) vaccine, recombinant], Isentress (raltegravir), Singulair (montelukast sodium) and Zostavax [Zoster Vaccine Live]. Also contributing to revenue growth in both periods were higher sales of the Company’s animal health products. These increases were partially offset by lower sales of Remicade due to the relinquishment of marketing rights in certain territories as a result of the arbitration settlement discussed above. Sales growth was also negatively affected by lower revenue from the Company’s relationship with AstraZeneca LP (“AZLP”), as well as by lower sales of Cozaar (losartan potassium), Hyzaar (losartan potassium hydrochlorothiazide), Clarinex (desloratadine) and Primaxin (imipenem and cilastatin sodium).

While several of the Company’s brands experienced positive volume growth trends in the European Union (the “EU”) in the first half of 2012, the environment in the EU continues to be challenging. Many countries have announced austerity measures, which include the implementation of pricing actions to reduce prices of generic and patented drugs. While the Company is taking steps to mitigate the impact in the EU, the austerity measures continued to negatively affect the Company’s revenue performance in the first six months of 2012 and the Company anticipates high mid-single digit pricing pressures for the full year of 2012 across Europe as well as from the biennial price reductions in Japan.

 

- 34 -


Sales of the Company’s products were as follows:

 

                          Three Months Ended                    
June 30,
                          Six Months Ended                    
June 30,
 
($ in millions)    2012      2011      2012      2011  

 

 

Primary Care and Women’s Health

           

Cardiovascular

           

Zetia

     $ 632       $ 592           $ 1,246       $ 1,174     

Vytorin

     445         459           889         939     

Diabetes and Obesity

           

Januvia

     1,058         779           1,977         1,518     

Janumet

     411         321           802         626     

Respiratory

           

Singulair

     1,431         1,354           2,771         2,682     

Nasonex

     293         323           668         696     

Clarinex

     140         209           273         364     

Asmanex

     51         47           99         107     

Dulera

     50         25           89         37     

Women’s Health and Endocrine

           

Fosamax

     186         221           370         429     

NuvaRing

     157         154           303         297     

Follistim AQ

     125         143           241         276     

Implanon

     85         81           161         141     

Cerazette

     72         66           139         125     

Other

           

Maxalt

     154         131           310         304     

Arcoxia

     117         100           229         214     

Avelox

     44         61           117         167     

Hospital and Specialty

           

Immunology

           

Remicade

     518         842           1,037         1,595     

Simponi

     76         75           150         129     

Infectious Disease

           

Isentress

     398         337           735         629     

PegIntron

     183         154           345         319     

Cancidas

     166         168           311         326     

Victrelis

     126         21           238         22     

Invanz

     110         103           211         189     

Primaxin

     104         136           192         272     

Noxafil

     66         56           125         110     

Oncology

           

Temodar

     225         234           461         481     

Emend

     145         120           247         207     

Other

           

Cosopt/Trusopt

     105         122           229         236     

Bridion

     60         47           118         89     

Integrilin

     60         56           113         120     

Diversified Brands

           

Cozaar/Hyzaar

     337         406           674         832     

Propecia

     100         112           208         218     

Zocor

     96         107           199         234     

Claritin Rx

     48         65           134         186     

Remeron

     66         57           123         117     

Proscar

     55         53           106         113     

Vasotec/Vaseretic

     49         59           102         116     

Vaccines (1)

           

Gardasil

     324         277           608         490     

ProQuad/M-M-R II/Varivax

     316         291           571         535     

RotaTeq

     142         148           284         272     

Zostavax

     148         122           224         146     

Pneumovax

     101         64           213         143     

Other pharmaceutical (2) 

     985         1,062           2,000         1,957     

 

 

Total Pharmaceutical segment sales

     10,560         10,360           20,642         20,179     

 

 

Other segment sales (3) 

     1,680         1,690           3,273         3,323     

 

 

Total segment sales

     12,240         12,050           23,915         23,502     

 

 

Other (4)

     71         101           126         230     

 

 
     $ 12,311       $ 12,151           $ 24,041       $ 23,732     

 

 
(1) 

These amounts do not reflect sales of vaccines sold in most major European markets through the Company’s joint venture, Sanofi Pasteur MSD, the results of which are reflected in Equity income from affiliates. These amounts do, however, reflect supply sales to Sanofi Pasteur MSD.

(2) 

Other pharmaceutical primarily includes sales of other human health pharmaceutical products not listed separately.

(3) 

Reflects other non-reportable segments, including Animal Health and Consumer Care, and revenue from the Company’s relationship with AZLP primarily relating to sales of Nexium. Revenue from AZLP was $223 million and $306 million for the second quarter of 2012 and 2011, respectively, and $409 million and $628 million for the first six months of 2012 and 2011, respectively.

(4) 

Other revenues are primarily comprised of miscellaneous corporate revenues, third-party manufacturing sales, sales related to divested products or businesses and supply sales not included in segment results. The declines in other revenues in the second quarter and first six months of 2012 as compared with the same periods of 2011 reflect lower third-party manufacturing sales, which for the year-to-date period were attributable in part to the divestiture of certain manufacturing facilities in the first quarter of 2011.

 

- 35 -


The provision for discounts includes indirect customer discounts that occur when a contracted customer purchases directly through an intermediary wholesale purchaser, known as chargebacks, as well as indirectly in the form of rebates owed based upon definitive contractual agreements or legal requirements with private sector and public sector (Medicaid and Medicare Part D) benefit providers, after the final dispensing of the product by a pharmacy to a benefit plan participant. These discounts, in the aggregate, reduced revenues by $1.5 billion and $1.3 billion for the three months ended June 30, 2012 and 2011, respectively, and $3.0 billion and $2.5 billion for the six months ended June 30, 2012 and 2011, respectively. Inventory levels at key U.S. wholesalers for each of the Company’s major pharmaceutical products are generally less than one month.

Pharmaceutical Segment

Primary Care and Women’s Health

Cardiovascular

Sales of Zetia (ezetimibe) (also marketed as Ezetrol outside the United States), a cholesterol-absorption inhibitor, were $632 million in the second quarter of 2012, an increase of 7% compared with the second quarter of 2011, and were $1.2 billion for the first six months of 2012, an increase of 6% compared with the same period in 2011. Foreign exchange unfavorably affected global sales performance by 2% and 1% in the second quarter and first six months of 2012, respectively. The sales increases reflect positive performance in the United States due to pricing, partially offset by volume declines. Sales growth in the first six months of 2012 also reflects volume growth in Japan and the emerging markets. Sales of Vytorin (ezetimibe/simvastatin) (marketed outside the United States as Inegy), a combination product containing the active ingredients of both Zetia and Zocor (simvastatin), were $445 million and $889 million in the second quarter and first six months of 2012, respectively, representing declines of 3% and 5%, respectively, compared with the same periods in 2011. Foreign exchange unfavorably affected global sales performance by 4% and 2% in the second quarter and first six months of 2012, respectively. The sales declines reflect volume declines in the United States, partially offset by pricing in the United States and volume growth in international markets.

In March 2012, the Data Safety Monitoring Board (the “DSMB”) of the IMPROVE-IT trial, a large cardiovascular outcomes study evaluating ezetimibe/simvastatin against simvastatin alone in patients presenting with acute coronary syndrome, completed the second pre-specified interim efficacy analysis of the study. The DSMB conducted the planned interim efficacy analysis after the trial had reached approximately 75% of the targeted 5,250 clinical endpoints called for in the study design. The DSMB recommended that the study continue without change in design and stated it planned to review the data again in approximately nine months. That review has been scheduled for March 2013, at which point nine months of additional data will have been adjudicated. Merck remains blinded to IMPROVE-IT safety and efficacy data. IMPROVE-IT is an 18,000 patient event-driven trial and, based on the current rate at which events are being reported, the Company now anticipates the targeted 5,250 clinical endpoints for study completion will be reached in 2014.

Diabetes and Obesity

Global sales of Januvia, Merck’s dipeptidyl peptidase-4 (“DPP-4”) inhibitor for the treatment of type 2 diabetes, were $1.1 billion in the second quarter of 2012 and $2.0 billion for the first six months of 2012, representing increases of 36% and 30%, respectively, compared with the same periods of 2011, reflecting volume growth in international markets, including in Japan, and in the United States. DPP-4 inhibitors represent a class of prescription medications that improve blood sugar control in patients with type 2 diabetes by enhancing a natural body system called the incretin system, which helps to regulate glucose by affecting the beta cells and alpha cells in the pancreas.

Worldwide sales of Janumet, Merck’s oral antihyperglycemic agent that combines sitagliptin (Januvia) with metformin in a single tablet to target all three key defects of type 2 diabetes, were $411 million for the second quarter of 2012 and $802 million for the first six months of 2012, representing increases of 28% in each of those periods compared with the same periods of 2011, reflecting growth in the United States, Europe and the emerging markets.

In February 2012, the U.S. Food and Drug Administration (the “FDA”) approved Janumet XR, a treatment for type 2 diabetes that combines sitagliptin with extended-release metformin. Janumet XR provides a convenient once-daily treatment option for health care providers and patients who need help to control their blood sugar.

 

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As previously disclosed, on February 17, 2012, the FDA sent a Warning Letter to the Company relating to Januvia and Janumet stating that the Company did not fulfill a post-marketing requirement for a 3-month pancreatic safety study in a diabetic rodent model treated with sitagliptin. Merck has been in communication with the FDA regarding this study and Merck’s efforts to complete it in a timely and satisfactory manner. Under the terms of the Warning Letter, within 30 days from the date of the letter, the Company must submit to the FDA a final study protocol for a new 3-month rodent study that will satisfy the FDA’s requirements and a proposed revised timetable for completion of the study. Within 6 months from the date of the letter, the FDA expects that the Company will have obtained agreement with the FDA on an adequate study protocol and will have initiated the study. The letter states that failure to correct the violation may result in regulatory actions by the FDA, including, but not limited to, civil money penalties. The Company has reached an agreement with the FDA on a study protocol and is proceeding with the study. Merck remains fully committed to fulfilling the FDA’s requirements.

Respiratory

Worldwide sales for Singulair, a once-a-day oral medicine for the chronic treatment of asthma and for the relief of symptoms of allergic rhinitis, were $1.4 billion for the second quarter of 2012 and $2.8 billion for the first six months of 2012, increases of 6% and 3%, respectively, compared with the same periods in 2011. The patent that provided U.S. market exclusivity for Singulair expired in August 2012. In addition, the patent that provides market exclusivity for Singulair will expire in a number of major European markets in February 2013. The Company expects a significant and rapid reduction in sales thereafter in those markets. The patent that provides market exclusivity for Singulair in Japan will expire in 2016. For the full year of 2011, sales of Singulair were $3.5 billion in the United States, $724 million in Europe and $641 million in Japan.

Global sales of Nasonex (mometasone furoate monohydrate), an inhaled nasal corticosteroid for the treatment of nasal allergy symptoms, were $293 million for the second quarter of 2012 and $668 million for the first six months of 2012, representing declines of 9% and 4%, respectively, compared with the same periods of 2011. Foreign exchange unfavorably affected global sales performance by 3% and 1% for the second quarter and first six months of 2012, respectively. The sales declines were driven by unfavorable pricing in Europe, as well as lower volumes in the United States and the emerging markets. In addition, for the year-to-date period in 2012, lower volumes in Japan also contributed to the sales decline. In June 2012, the U.S. District Court for the District of New Jersey ruled against the company in a patent infringement suit against Apotex Inc. and Apotex Corp. (collectively “Apotex”) holding that Apotex’s generic version of Nasonex does not infringe on the Company’s patent (see Note 9 to the interim consolidated financial statements). Apotex is seeking FDA approval to sell its generic version of Nasonex. If generic versions become available, significant losses of Nasonex sales in the U.S. market are anticipated and could result in a material non-cash impairment charge related to the Nasonex intangible asset. U.S. sales of Nasonex were $604 million for the full year of 2011. As a result of the unfavorable U.S. District Court decision, the Company evaluated the Nasonex intangible asset for impairment and concluded that it was not impaired. The Company has appealed the U.S. District Court decision.

Global sales of Clarinex (marketed as Aerius in many countries outside the United States), a non-sedating antihistamine, were $140 million for the second quarter of 2012 and $273 million for the first six months of 2012, decreases of 33% and 25%, respectively, compared with the same periods of 2011, reflecting volume declines in Europe as a result of generic competition. As previously disclosed, by virtue of litigation settlements, certain generic manufacturers have been given the right to enter the U.S. market in 2012. The U.S. patent and exclusivity periods otherwise expire in 2020. In July 2012, a generic manufacturer launched a generic version of Clarinex in the United States. Accordingly, the Company anticipates that U.S. sales of Clarinex will be negatively impacted in the third and fourth quarters of 2012 and beyond. U.S. sales of Clarinex were $197 million for the full year of 2011.

Women’s Health and Endocrine

Worldwide sales for Fosamax (alendronate sodium) and Fosamax Plus D (alendronate sodium/cholecalciferol) (marketed as Fosavance throughout the EU and as Fosamac in Japan) for the treatment and, in the case of Fosamax, prevention of osteoporosis were $186 million for the second quarter of 2012 and $370 million for the first six months of 2012, representing declines of 16% and 14%, respectively, over the comparable periods of 2011. These medicines have lost market exclusivity in the United States and have also lost market exclusivity in most major European markets. Accordingly, the Company is experiencing sales declines within the Fosamax product franchise and the Company expects the declines to continue.

Worldwide sales of NuvaRing (etonogestrel/ethinyl estradiol vaginal ring), a vaginal contraceptive product, were $157 million for the second quarter of 2012 and $303 million for the first six months of 2012, increases of 2% in each of these periods compared with the same periods of 2011, largely reflecting volume growth in the emerging markets. Foreign exchange negatively affected sales performance by 4% and 3% for the second quarter and first six months of 2012, respectively.

 

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Global sales of Follistim AQ (follitropin beta injection) (marketed in most countries outside the United States as Puregon), a biological fertility treatment, were $125 million for the second quarter of 2012 and $241 million for the first six months of 2012, declines of 12% and 13%, respectively, compared with the same periods of 2011, largely driven by volume declines in Europe. Puregon lost market exclusivity in the EU in August 2009. Foreign exchange unfavorably affected global sales performance by 3% and 2% for the second quarter and first six months of 2012, respectively.

The Company is currently experiencing difficulty manufacturing certain women’s health products. The Company is working to resolve these issues.

In August 2011, Zoely (nomegestrol acetate 2.5 mg/17b-estradiol 1.5 mg), an oral contraceptive, was granted marketing authorization by the European Commission (the “EC”) for use by women to prevent pregnancy. Zoely is a combined oral contraceptive tablet containing a unique monophasic combination of two hormones: nomegestrol acetate, a highly selective progesterone-derived progestin, and 17-beta estradiol, an estrogen that is similar to the one naturally present in a woman’s body. In November 2011, Merck received a Complete Response Letter from the FDA for NOMAC/E2 (MK-8175A), which is being marketed as Zoely in the EU. The Company is planning to conduct an additional clinical study requested by the FDA and update the application in the future.

Other

Global sales of Maxalt (rizatriptan benzoate), a product for the acute treatment of migraine, were $154 million for the second quarter of 2012, an increase of 17% compared with the second quarter of 2011, largely reflecting positive performance in the United States primarily due to favorable pricing, partially offset by declines in Europe and Canada. Sales of Maxalt were $310 million for the first six months of 2012, an increase of 2% compared with the first six months of 2011, reflecting favorable pricing in the United States, as well as volume growth in Japan, partially offset by volume declines in the United States and declines in Europe and Canada. The patent that provides U.S. market exclusivity for Maxalt will expire in December 2012. U.S. sales of Maxalt were $451 million for the full year of 2011. In addition, the patent that provides market exclusivity for Maxalt is scheduled to expire in a number of major European markets in February 2013. However, the Company has applied for a six-month pediatric extension in the EU, which has been granted by most major countries and the Company expects to obtain the extension in the remaining countries by February 2013. The Company anticipates that sales in the United States and in these European markets will decline significantly after these patent expiries.

Other products included in the Primary Care and Women’s Health customer business line include among others, Asmanex (mometasone furoate inhalation powder), an inhaled corticosteroid for asthma; Dulera (mometasone furoate/formoterol fumarate dihydrate) Inhalation Aerosol, a fixed-dose combination asthma treatment; Implanon (etonogestrel implant), a single-rod subdermal contraceptive implant; Cerazette (desogestrol), a progestin only oral contraceptive; Arcoxia (etoricoxib) for the treatment of arthritis and pain; and Avelox (moxifloxacin hydrochloride), which the Company only markets in the United States, a broad-spectrum fluoroquinolone antibiotic for the treatment of certain respiratory and skin infections. In January 2012, Merck received a Complete Response Letter from the FDA on the Company’s supplemental New Drug Application for Dulera, for the treatment of chronic obstructive pulmonary disease. The Company is evaluating next steps.

Hospital and Specialty

Immunology

Sales of Remicade, a treatment for inflammatory diseases, were $518 million for the second quarter of 2012 and $1.0 billion for the first six months of 2012, declines of 38% and 35%, respectively, compared with the same periods of 2011. Prior to July 1, 2011, Remicade was marketed by the Company outside of the United States (except in Japan and certain other Asian markets). As a result of the agreement reached in April 2011 to amend the agreement governing the distribution rights to Remicade and Simponi (as discussed above), effective July 1, 2011, Merck relinquished marketing rights for these products in certain territories including Canada, Central and South America, the Middle East, Africa and Asia Pacific. Sales performance in 2012 as compared with 2011 reflects these changes. In the Retained Territories, Remicade sales declined 6% in the second quarter of 2012 and 1% in the first six months of 2012, which reflect 8% and 6% unfavorable impacts, respectively, from foreign exchange. Sales of Simponi, a once-monthly subcutaneous treatment for certain inflammatory diseases, were $76 million in the second quarter of 2012 compared with $75 million in the second quarter of 2011, and were $150 million for the first six months of 2012 compared with $129 million for the first six months of 2011. In the Retained Territories, sales of Simponi grew 29% and 49% for the second quarter and first six months of 2012, respectively, due in part to ongoing launches. In July 2012, a submission was made to the European Medicines Agency requesting approval of Simponi for

 

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the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to conventional therapy.

Infectious Disease

Global sales of Isentress, an HIV integrase inhibitor for use in combination with other antiretroviral agents for the treatment of HIV-1 infection, were $398 million in the second quarter of 2012, an increase of 18% compared with the second quarter of 2011, and $735 million in the first six months of 2012, an increase of 17% compared with the first six months of 2011, primarily reflecting volume growth in the United States, Latin America and the Eastern Europe, Middle East and Africa region. Foreign exchange unfavorably affected global sales performance by 5% and 3% in the second quarter and first six months of 2012, respectively.

Worldwide sales of PegIntron (peginterferon alpha-2b), a treatment for chronic hepatitis C, were $183 million for the second quarter of 2012, an increase of 19% compared with the second quarter of 2011, and were $345 million for the first six months of 2012, an increase of 8% compared with the same period in 2011, reflecting volume growth and favorable pricing in the United States and volume growth in the Eastern Europe, Middle East and Africa region.

In May 2011, the FDA approved Victrelis, the Company’s innovative oral medicine for the treatment of chronic hepatitis C. Victrelis is approved for the treatment of chronic hepatitis C genotype 1 infection, in combination with peginterferon alfa and ribavirin, in adult patients (18 years of age and older) with compensated liver disease, including cirrhosis, who are previously untreated or who have failed previous interferon and ribavirin therapy. Victrelis is an antiviral agent designed to interfere with the ability of the hepatitis C virus to replicate by inhibiting a key viral enzyme. In July 2011, the EC approved Victrelis. The EC’s decision grants a single marketing authorization that is valid in the 27 countries that are members of the EU, as well as unified labeling applicable to Iceland, Liechtenstein and Norway. Victrelis is approved in 43 countries and has launched in 23 of those markets. Sales of Victrelis were $126 million and $238 million for the second quarter and first six months of 2012, respectively, compared with $21 million and $22 million for the second quarter and first six months of 2011, respectively.

Sales of Primaxin, an anti-bacterial product, were $104 million in the second quarter of 2012 and $192 million for the first six months of 2012, representing declines of 24% and 30%, respectively, compared with the same periods of 2011, primarily reflecting volume declines in the United States, Europe and for the year-to-date period the Eastern Europe, Middle East Africa region, partially offset by volume growth in China. Patents on Primaxin have expired worldwide and multiple generics have been launched. Accordingly, the Company is experiencing a decline in sales of Primaxin and the Company expects the decline to continue.

Oncology

Sales of Temodar (temozolomide) (marketed as Temodal outside the United States), a treatment for certain types of brain tumors, were $225 million for the second quarter of 2012 and $461 million for the first six months of 2012, representing declines of 4% compared with the same periods of 2011, primarily reflecting generic competition in Europe, mitigated in part by price increases in the United States. Temodar lost patent exclusivity in the EU in 2009. As previously disclosed, by agreement, one generic manufacturer has been given the right to enter the U.S. market in August 2013. The U.S. patent and exclusivity periods otherwise will expire in February 2014.

Global sales of Emend (aprepitant), for the prevention of chemotherapy-induced and post-operative nausea and vomiting, were $145 million in the second quarter of 2012, an increase of 21% compared with the second quarter of 2011, and were $247 million for the first six months of 2012, an increase of 19% compared with the first six months of 2011, primarily reflecting volume growth in the United States and Japan.

Other

Worldwide sales of ophthalmic products Cosopt (dorzolamide hydrochloride-timolol maleate ophthalmic solution) and Trusopt (dorzolamide hydrochloride ophthalmic solution) were $105 million in the second quarter of 2012, a decline of 14% compared with the second quarter of 2011, and were $229 million for the first six months of 2012, a decrease of 3% compared with the same period in 2011, primarily reflecting lower sales in Europe. The year-to-date decline was mitigated in part by higher Cosopt sales in Japan. Foreign exchange unfavorably affected global sales performance by 5% and 2% for the second quarter and first six months of 2012, respectively. The patent that provided U.S. market exclusivity for Cosopt and Trusopt has expired. Trusopt has also lost market exclusivity in a

 

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number of major European markets. The patent for Cosopt will expire in a number of major European markets in March 2013 and the Company expects sales in those markets to decline significantly thereafter.

In February 2012, the FDA approved Cosopt PF (dorzolamide hydrochloride-timolol maleate ophthalmic solution), Merck’s preservative-free formulation of Cosopt ophthalmic solution, indicated for the reduction of elevated intraocular pressure in appropriate patients with open-angle glaucoma or ocular hypertension.

Bridion (sugammadex), for the reversal of certain muscle relaxants used during surgery, is currently approved and has been launched in many countries outside of the United States. Sales of Bridion were $60 million and $47 million for the second quarter of 2012 and 2011, respectively, and were $118 million and $89 million for the first six months of 2012 and 2011, respectively. Bridion is in Phase III development in the United States.

In 2009, the FDA approved Saphris (asenapine), an antipsychotic indicated for the treatment of schizophrenia in adults and for the acute treatment, as monotherapy or adjunctive therapy to lithium or valproate, of manic or mixed episodes associated with bipolar I disorder in adults. In 2010, asenapine, sold under the brand name Sycrest, received marketing approval in the EU for the treatment of moderate to severe manic episodes associated with bipolar I disorder in adults. In 2010, Merck and H. Lundbeck A/S (“Lundbeck”) announced a worldwide commercialization agreement for Sycrest sublingual tablets (5 mg, 10 mg). Under the terms of the agreement, Lundbeck paid a fee and makes product supply payments in exchange for exclusive commercial rights to Sycrest in all markets outside the United States, China and Japan. Merck’s sales of Saphris were $43 million and $23 million in the second quarter of 2012 and 2011, respectively, and were $83 million and $46 million for the first six months of 2012 and 2011, respectively. Merck continues to focus on building the brand awareness of Saphris in the United States and the Company continues to monitor and assess Saphris/Sycrest and the related intangible asset. If increasing the brand awareness or Lundbeck’s on-going launch of the product in the EU is not successful, the Company may take a non-cash impairment charge with respect to Saphris/Sycrest, and such charge could be material.

In February 2012, the FDA approved Zioptan (tafluprost ophthalmic solution), a preservative-free prostaglandin analog ophthalmic solution for reducing elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension. Merck has exclusive commercial rights to tafluprost in Western Europe (excluding Germany), North America, South America, Africa, the Middle East, India and Australia. Zioptan is marketed as Saflutan in certain markets outside the United States.

Other products contained in the Hospital and Specialty customer business line include among others, Cancidas (caspofungin acetate), an anti-fungal product; Invanz (ertapenem sodium) for the treatment of certain infections; Noxafil (posaconazole) for the prevention of certain invasive fungal infections; and Integrilin (eptifibatide) Injection, a treatment for patients with acute coronary syndrome, which is sold by the Company in the United States and Canada. The compound patent that provides U.S. market exclusivity for Cancidas expires in September 2013.

Diversified Brands

Merck’s diversified brands are human health pharmaceutical products that are approaching the expiration of their marketing exclusivity or are no longer protected by patents in developed markets, but continue to be a core part of the Company’s offering in other markets around the world.

Global sales of Cozaar and its companion agent Hyzaar (a combination of Cozaar and hydrochlorothiazide), treatments for hypertension, declined 17% in the second quarter of 2012 and 19% in the first six months of 2012 compared with the same periods of 2011. The patents that provided market exclusivity for Cozaar and Hyzaar in the United States and in a number of major European markets expired in 2010. Accordingly, the Company is experiencing significant declines in Cozaar and Hyzaar sales and the Company expects the declines to continue.

Other products contained in the Diversified Brands customer business line include among others, Propecia (finasteride), a product for the treatment of male pattern hair loss; Zocor, a statin for modifying cholesterol; prescription Claritin (loratadine), a treatment for seasonal outdoor allergies and year-round indoor allergies; Remeron (mirtazapine), an antidepressant; Proscar (finasteride), a urology product for the treatment of symptomatic benign prostate enlargement; and Vasotec (enalapril maleate) and Vaseretic (enalapril maleate-hydrochlorothiazide), hypertension and/or heart failure products.

 

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Vaccines

The following discussion of vaccines does not include sales of vaccines sold in most major European markets through Sanofi Pasteur MSD (“SPMSD”), the Company’s joint venture with Sanofi Pasteur, the results of which are reflected in Equity income from affiliates (see “Selected Joint Venture and Affiliate Information” below). Supply sales to SPMSD, however, are included.

Worldwide sales of Gardasil recorded by Merck grew 17% in the second quarter of 2012 to $324 million and rose 24% to $608 million for the first six months of 2012 driven by positive performance in the United States and the launch in Japan. In addition, growth in the Asia Pacific region also contributed to the performance of Gardasil in the year-to-date period. Gardasil, the world’s top-selling human papillomavirus (“HPV”) vaccine, is indicated for girls and women 9 through 26 years of age for the prevention of cervical, vulvar, vaginal and anal cancer caused by HPV types 16 and 18, certain precancerous or dysplastic lesions caused by HPV types 6, 11, 16 and 18, and genital warts caused by HPV types 6 and 11. Gardasil is also approved in the United States for use in boys and men 9 through 26 years of age for the prevention of anal cancer caused by HPV types 16 and 18, anal dyplasias and precancerous lesions caused by HPV types 6, 11, 16 and 18, and genital warts caused by HPV types 6 and 11.

In recent years, the Company has experienced difficulties in producing its varicella zoster virus (“VZV”)-containing vaccines. These difficulties have in the past resulted in supply constraints for ProQuad, Varivax and Zostavax. The Company is manufacturing bulk varicella and is producing doses of Varivax and Zostavax.

ProQuad [Measles, Mumps, Rubella and Varicella Virus Vaccine Live], a pediatric combination vaccine to help protect against measles, mumps, rubella and varicella, one of the VZV-containing vaccines, is not currently available for ordering. The Company anticipates that ProQuad will become available in the fourth quarter of 2012. Merck’s sales of ProQuad were $37 million in the first quarter of 2011 when ProQuad was last available.

Merck’s sales of Varivax, a vaccine to help prevent chickenpox (varicella), were $216 million for the second quarter of 2012 compared with $206 million for the second quarter of 2011 and were $392 million for the first six months of 2012 compared with $350 million for the first six months of 2011 reflecting positive performance in the United States from volume growth and favorable pricing. Merck’s sales of M-M-R II [Measles, Mumps and Rubella Virus Vaccine Live], a vaccine to help protect against measles, mumps and rubella, were $101 million for the second quarter of 2012 compared with $86 million for the second quarter of 2011 and were $180 million for the first six months of 2012 compared with $149 million for the first six months of 2011 reflecting higher volumes in the United States.

Global sales of RotaTeq [Rotavirus Vaccine, Live, Oral, Pentavalent], a vaccine to help protect against rotavirus gastroenteritis in infants and children, recorded by Merck were $142 million in the second quarter of 2012, a decline of 4% compared with the second quarter of 2011, primarily reflecting lower public sector sales in the United States, partially offset by volume growth in the Eastern Europe, Middle East and Africa region. Sales for the first six months of 2012 were $284 million, an increase of 4% compared with the first six months of 2011, reflecting volume growth in the emerging markets, particularly within the Latin America and Eastern Europe, Middle East and Africa regions, partially offset by lower public sector sales in the United States.

Merck’s sales of Zostavax, a vaccine to help prevent shingles (herpes zoster) in adults 50 years of age and older, were $148 million in the second quarter of 2012 as compared with $122 million in the second quarter of 2011 and were $224 million in the first six months of 2012 compared with $146 million in the first six months of 2011. The Company experienced supply issues in 2011 and filled a significant number of backorders during the second quarter of 2011. The Company has resumed a normal supply schedule for Zostavax in the United States. No broad international launches or immunization programs are currently planned for 2012.

Merck’s sales of Pneumovax [pneumococcal vaccine polyvalent], a vaccine to help prevent pneumococcal disease, were $101 million in the second quarter of 2012 compared with $64 million in the second quarter of 2011 and were $213 million in the first six months of 2012 compared with $143 million in the first six months of 2011, reflecting favorable pricing in the United States and volume growth in the United States and in Japan.

The Company anticipates that Merck’s adult formulation of Vaqta [Hepatitis A Vaccine, Inactivated], a vaccine against hepatitis A, will be available in the third quarter of 2012.

 

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Other

Animal Health

Animal Health includes pharmaceutical and vaccine products for the prevention, treatment and control of disease in all major farm and companion animal species. Animal Health sales are affected by intense competition and the frequent introduction of generic products. Global sales of Animal Health products totaled $865 million for the second quarter of 2012, an increase of 8% compared with the second quarter of 2011. Foreign exchange unfavorably affected global sales performance by 6% in the second quarter of 2012. The increased sales reflect positive performance in cattle and swine products. Sales of Animal Health products for the first six months of 2012 were $1.7 billion, an increase of 8% compared with the same period in 2011, which reflects a 4% unfavorable effect from foreign exchange. The sales growth reflects growth in cattle, swine, companion animal and poultry products.

Consumer Care

Consumer Care products include over-the-counter, foot care and sun care products such as Claritin non-drowsy antihistamines; MiraLAX, a treatment for occasional constipation; Dr. Scholl’s foot care products; and Coppertone sun care products. Global sales of Consumer Care products were $552 million for the second quarter of 2012, an increase of 2% compared with the second quarter of 2011 and were $1.1 billion for the first six months of 2012, an increase of 5% compared with the first six months of 2011. The increased sales in both periods reflect higher sales of MiraLAX, Claritin and Coppertone, partially offset by lower sales of Marvelon, an oral contraceptive, which is an over-the-counter product in China. Consumer Care product sales are affected by competition and consumer spending patterns.

Costs, Expenses and Other

In February 2010, subsequent to the Merck and Schering-Plough Corporation (“Schering-Plough”) merger (the “Merger”), the Company commenced actions under a global restructuring program (the “Merger Restructuring Program”) in conjunction with the integration of the legacy Merck and legacy Schering-Plough businesses. This Merger Restructuring Program is intended to optimize the cost structure of the combined company. In July 2011, the Company announced the latest phase of the Merger Restructuring Program during which the Company expects to reduce its workforce measured at the time of the Merger by an additional 12% to 13% across the Company worldwide. A majority of the workforce reductions in this phase of the Merger Restructuring Program relate to manufacturing (including Animal Health), administrative and headquarters organizations. Previously announced workforce reductions of approximately 17% in earlier phases of the program primarily reflect the elimination of positions in sales, administrative and headquarters organizations, as well as from the sale or closure of certain manufacturing and research and development sites and the consolidation of office facilities. The Company will continue to hire employees in strategic growth areas of the business as necessary. The Company will continue to pursue productivity efficiencies and evaluate its manufacturing supply chain capabilities on an ongoing basis which may result in future restructuring actions.

The Company recorded total pretax restructuring costs of $291 million and $808 million in the second quarter of 2012 and 2011, respectively, and $568 million and $921 million for the first six months of 2012 and 2011, respectively, related to this program. The restructuring actions under the Merger Restructuring Program are expected to be substantially completed by the end of 2013, with the exception of certain actions, principally manufacturing-related, which are expected to be substantially completed by 2015. The Company originally estimated the total cumulative pretax costs for this program to be approximately $5.8 billion to $6.6 billion and the Company now expects the cumulative costs to be near the upper end of this range. The Company estimates that approximately two-thirds of the cumulative pretax costs relate to cash outlays, primarily related to employee separation expense. Approximately one-third of the cumulative pretax costs are non-cash, relating primarily to the accelerated depreciation of facilities to be closed or divested. The Company expects the Merger Restructuring Program to yield annual savings by the end of 2013 of approximately $3.5 billion to $4.0 billion and annual savings upon completion of the program of approximately $4.0 billion to $4.6 billion. These cost savings, which are expected to come from all areas of the Company’s pharmaceutical business, are in addition to the previously announced ongoing cost reduction initiatives at both legacy companies. Additional savings will come from non-restructuring-related activities.

In October 2008, Merck announced a global restructuring program (the “2008 Restructuring Program”) to reduce its cost structure, increase efficiency, and enhance competitiveness. As part of the 2008 Restructuring Program, the Company expects to eliminate approximately 7,200 positions — 6,800 active employees and 400 vacancies — across the Company worldwide. Pretax restructuring costs of $(4) million and $1 million were recorded in the second quarter of 2012 and 2011, respectively, and $10 million and $5 million were recorded in the first six months of 2012 and 2011, respectively, related to the 2008 Restructuring Program. The 2008 Restructuring Program was substantially completed in 2011, with the exception of certain manufacturing-related actions, which

 

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are expected to be completed by 2015, with the total cumulative pretax costs estimated to be up to $2.0 billion. The Company estimates that two-thirds of the cumulative pretax costs relate to cash outlays, primarily from employee separation expense. Approximately one-third of the cumulative pretax costs are non-cash, relating primarily to the accelerated depreciation of facilities to be closed or divested. Merck expects the 2008 Restructuring Program to yield cumulative pretax savings of $3.8 billion to $4.2 billion from 2008 to 2013.

The Company anticipates that total costs associated with restructuring activities in 2012 for the Merger Restructuring Program and the 2008 Restructuring Program will be in the range of $800 million to $1.1 billion.

The costs associated with all of these restructuring activities are primarily comprised of accelerated depreciation recorded in Materials and production, Marketing and administrative and Research and development and separation costs recorded in Restructuring costs (see Note 2 to the interim consolidated financial statements).

Materials and Production

Materials and production costs were $4.1 billion for the second quarter of 2012, a decline of 4% compared with the second quarter of 2011, and were $8.2 billion for the first six months of 2012, a decline of 2% compared with the first six months of 2011. Costs in both the second quarter of 2012 and 2011 include $1.2 billion, and for both the first six months of 2012 and 2011 include $2.5 billion, of expenses for the amortization of intangible assets recognized in connection with mergers and acquisitions. Costs in the second quarter and first six months of 2011 include an intangible asset impairment charge of $118 million. Also included in materials and production costs were costs associated with restructuring activities which amounted to $83 million and $109 million in the second quarter of 2012 and 2011, respectively, and $88 million and $181 million in the first six months of 2012 and 2011, respectively, including accelerated depreciation and asset write-offs related to the planned sale or closure of manufacturing facilities. Separation costs associated with manufacturing-related headcount reductions have been incurred and are reflected in Restructuring costs as discussed below.

Gross margin was 66.6% in the second quarter of 2012 compared with 64.7% in the second quarter of 2011 and was 66.1% in the first six months of 2012 compared with 64.8% in the first six months of 2011. The amortization of intangible assets, impairment charges and restructuring charges noted above had an unfavorable effect on gross margin of 10.6 and 12.0 percentage points for the second quarter of 2012 and 2011, respectively, and 10.6 and 11.9 percentage points for the first six months of 2012 and 2011, respectively. Excluding these impacts, the gross margins in 2012 as compared with the same periods of 2011 reflect improvements resulting from changes in product mix and lower costs due to manufacturing efficiencies.

Marketing and Administrative

Marketing and administrative expenses were $3.2 billion in the second quarter of 2012, a decline of 8% compared with the second quarter of 2011, and were $6.3 billion in the first six months of 2012, a decrease of 5% compared with the first six months of 2011. The declines were due to ongoing productivity measures, as well as the favorable impact of foreign exchange. Expenses for the second quarter of 2012 and 2011 included restructuring costs of $21 million and $23 million, respectively, and for the first six months of 2012 and 2011 $45 million and $46 million, respectively, primarily related to accelerated depreciation for facilities to be closed or divested. Separation costs associated with sales force reductions have been incurred and are reflected in Restructuring costs as discussed below. Marketing and administrative expenses also include $64 million and $77 million of acquisition-related costs in the second quarter of 2012 and 2011, respectively, and $115 million and $135 million for the first six months of 2012 and 2011, respectively, consisting largely of integration costs.

Research and Development

Research and development expenses were $2.2 billion for the second quarter of 2012, an increase of 12% compared with the second quarter of 2011, and were $4.0 billion for the first six months of 2012, a decline of 2% compared with the first six months of 2011. Research and development expenses are comprised of the costs directly incurred by Merck Research Labs (“MRL”), the Company’s research and development division that focuses on human health-related activities, which were approximately $1.1 billion and $1.2 billion in the second quarter of 2012 and 2011, respectively, and were $2.2 billion and $2.3 billion in the first six months of 2012 and 2011, respectively. Also included in research and development expenses are costs incurred by other divisions in support of research and development activities, including depreciation, production and general administrative, as well as certain costs from operating segments, including Pharmaceutical, Animal Health and Consumer Care, which were $888 million and $742 million in the aggregate for the second quarter of 2012 and 2011, respectively, and $1.6 billion and $1.5 billion for the first six months of 2012 and 2011, respectively. Research and development expenses in 2012 and 2011 were favorably affected by cost savings resulting from restructuring activities.

 

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Research and development expenses also include in-process research and development (“IPR&D”) impairment charges and research and development related restructuring charges. During the second quarter of 2012 and 2011, the Company recorded $127 million and $19 million, respectively, and for the first six months of 2012 and 2011 $136 million and $321 million, respectively, of IPR&D impairment charges primarily for programs that had previously been deprioritized and were deemed to have no alternative use during the period. The Company may recognize additional non-cash impairment charges in the future for the cancellation or delay of other pipeline programs that were measured at fair value and capitalized in connection with mergers and acquisitions and such charges could be material. Research and development expenses also reflect accelerated depreciation and asset abandonment costs associated with restructuring activities of $41 million and $16 million in the second quarter of 2012 and 2011, respectively, and $86 million and $61 million, respectively, in the first six months of 2012 and 2011. Included in research and development expenses in the second quarter and first six months of 2012 is a $120 million upfront payment related to an agreement with Endocyte, Inc. (“Endocyte”). See “Research and Development Update” below.

Restructuring Costs

Restructuring costs, primarily representing separation and other related costs associated with restructuring activities, were $144 million and $363 million for the second quarter and first six months of 2012, nearly all of which related to the Merger Restructuring Program. Restructuring costs were $668 million and $654 million for the second quarter and first six months of 2011, respectively. Separation costs were incurred associated with actual headcount reductions, as well as estimated expenses under existing severance programs for headcount reductions that were probable and could be reasonably estimated. Merck eliminated approximately 780 positions in the second quarter of 2012, all of which related to the Merger Restructuring Program. During the first six months of 2012, Merck eliminated approximately 1,940 positions of which 1,800 related to the Merger Restructuring Program and 140 related to the 2008 Restructuring Program. For the second quarter of 2011, Merck eliminated 645 positions of which 585 related to the Merger Restructuring Program and 60 related to the 2008 Restructuring Program. During the first six months of 2011, Merck eliminated approximately 1,515 positions of which 1,335 related to the Merger Restructuring Program and 180 related to the 2008 Restructuring Program. These position eliminations are comprised of actual headcount reductions, and the elimination of contractors and vacant positions. Also included in restructuring costs are curtailment, settlement and termination charges associated with pension and other postretirement benefit plans, share-based compensation and shutdown costs. For segment reporting, restructuring costs are unallocated expenses. Additional costs associated with the Company’s restructuring activities are included in Materials and production, Marketing and administrative and Research and development. (See Note 2 to the interim consolidated financial statements.)

Equity Income from Affiliates

Equity income from affiliates, which reflects the performance of the Company’s joint ventures and other equity method affiliates, primarily AZLP, was $142 million in the second quarter of 2012 compared with $55 million in the second quarter of 2011 and $253 million for the first six months of 2012 compared with $193 million in the first six months of 2011 largely reflecting higher equity income from AZLP. (See “Selected Joint Venture and Affiliate Information” below.)

Other (Income) Expense, Net

Other (income) expense, net was $103 million of expense in the second quarter of 2012 compared with $121 million of expense in the second quarter of 2011 and $247 million of expense in the first six months of 2012 compared with $744 million of expense in the first six months of 2011. Included in other (income) expense, net during the first six months of 2011 was a $500 million charge related to the resolution of the arbitration proceeding involving the Company’s rights to market Remicade and Simponi (see Note 4 to the interim consolidated financial statements), as well as a $127 million gain on the sale of certain manufacturing facilities and related assets.

Segment Profits

    

Three Months Ended

June 30,

        

Six Months Ended

June 30,

 
($ in millions)    2012        2011           2012        2011  

Pharmaceutical segment profits

     $         6,906         $         6,443           $         13,502         $         12,659   

Other non-reportable segment profits

     774           726           1,578           1,517   

Other

     (5,000        (5,497          (9,894        (10,775

Income before income taxes

     $ 2,680         $ 1,672             $ 5,186         $ 3,401   

 

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Segment profits are comprised of segment sales less standard costs and certain operating expenses directly incurred by the segment and components of equity income or loss from affiliates and depreciation and amortization expenses. For internal management reporting presented to the chief operating decision maker, Merck does not allocate materials and production costs, other than standard costs, the majority of research and development expenses or general and administrative expenses, nor the cost of financing these activities. Separate divisions maintain responsibility for monitoring and managing these costs, including depreciation related to fixed assets utilized by these divisions and, therefore, they are not included in segment profits. Also excluded from the determination of segment profits are the arbitration settlement charge and a gain on the sale of certain manufacturing facilities and related assets recorded in 2011, the amortization of purchase accounting adjustments and other acquisition-related costs, intangible asset impairment charges, restructuring costs, taxes paid at the joint venture level and a portion of equity income. Additionally, segment profits do not reflect other expenses from corporate and manufacturing cost centers and other miscellaneous income or expense. These unallocated items are reflected in “Other” in the above table. Also included in “Other” are miscellaneous corporate profits (losses), as well as operating profits (losses) related to third-party manufacturing sales, divested products or businesses, and other supply sales.

Pharmaceutical segment profits rose 7% in both the second quarter and first six months of 2012 driven largely by the increases in sales discussed above, as well as lower operating expenses.

Taxes on Income

The effective tax rates of 32.1% and 30.8% for the second quarter and first six months of 2012 and (22.8)% and 8.1% for the second quarter and first six months of 2011 reflect the impacts of acquisition-related costs and restructuring costs, partially offset by the beneficial impact of foreign earnings. In addition, the effective tax rates for the second quarter and first six months of 2011 also reflect the net favorable impact of approximately $700 million relating to the settlement of Merck’s 2002-2005 federal income tax audit, as well as the favorable impact of certain foreign and state tax rate changes that resulted in a net $230 million reduction of deferred tax liabilities on intangibles established in purchase accounting. In addition, the effective tax rate for the first six months of 2011 also reflects the impact of the $500 million charge related to the resolution of the arbitration proceeding with J&J.

Net Income and Earnings per Common Share

Net income attributable to Merck & Co., Inc. was $1.8 billion for the second quarter of 2012 compared with $2.0 billion for the second quarter of 2011 and $3.5 billion for the first six months of 2012 compared with $3.1 billion for the first six months of 2011. Earnings per common share assuming dilution attributable to Merck & Co., Inc. common shareholders (“EPS”) for the second quarter of 2012 were $0.58 compared with $0.65 in the second quarter of 2011 and were $1.15 for the first six months of 2012 compared with $0.98 for the first six months of 2011. The declines in net income and EPS in the second quarter of 2012 as compared with the second quarter of 2011 are primarily due to the favorable impact of tax items in 2011 as noted above, as well as higher research and development expenses, partially offset by lower restructuring costs and lower marketing and administrative expenses, as well as the arbitration settlement charge recorded in 2011. The increases in net income and EPS in the first six months of 2012 as compared with the same period in 2011 were primarily due to lower restructuring costs, lower marketing and administrative expenses, lower intangible asset impairment charges and the arbitration settlement charge recorded in 2011, partially offset by the favorable impact of tax items in 2011.

Non-GAAP Income and Non-GAAP EPS

Non-GAAP income and non-GAAP EPS are alternative views of the Company’s performance used by management that Merck is providing because management believes this information enhances investors’ understanding of the Company’s results. Non-GAAP income and non-GAAP EPS exclude certain items because of the nature of these items and the impact that they have on the analysis of underlying business performance and trends. The excluded items consist of acquisition-related costs, restructuring costs and certain other items. These excluded items are significant components in understanding and assessing financial performance. Therefore, the information on non-GAAP income and non-GAAP EPS should be considered in addition to, but not in lieu of, net income and EPS prepared in accordance with generally accepted accounting principles in the United States (“GAAP”). Additionally, since non-GAAP income and non-GAAP EPS are not measures determined in accordance with GAAP, they have no standardized meaning prescribed by GAAP and, therefore, may not be comparable to the calculation of similar measures of other companies.

Non-GAAP income and non-GAAP EPS are important internal measures for the Company. Senior management receives a monthly analysis of operating results that includes non-GAAP income and non-GAAP EPS and the performance of the Company is measured on this basis along with other performance metrics. Senior management’s annual compensation is derived in part using non-GAAP income and non-GAAP EPS.

 

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A reconciliation between GAAP financial measures and non-GAAP financial measures is as follows:

 

      Three Months Ended
June 30,
    Six Months Ended
June 30,
 
($ in millions except per share amounts)    2012      2011     2012      2011  

 

Pretax income as reported under GAAP

   $ 2,680       $ 1,672      $ 5,186       $ 3,401   

Increase (decrease) for excluded items:

          

Acquisition-related costs

     1,417         1,440        2,706         3,097   

Restructuring costs

     289         816        582         942   

Other items:

          

Arbitration settlement charge

     -         -        -         500   

Loss (gain) on sale of manufacturing facilities and related assets

     -         7        -         (127
       4,386         3,935        8,474         7,813   

 

Taxes on income as reported under GAAP

     860         (382     1,599         276   

Estimated tax benefit on excluded items

     272         407        548         738   

Tax benefit from settlement of federal income tax audit

     -         700        -         700   

Tax benefit from foreign and state tax rate changes

     -         230        -         230   
       1,132         955        2,147         1,944   

Non-GAAP net income

     3,254         2,980        6,327         5,869   

Less: Net income attributable to noncontrolling interests

     27         30        56         58   

Non-GAAP net income attributable to Merck & Co., Inc.

   $ 3,227       $ 2,950      $ 6,271       $ 5,811   

 

EPS assuming dilution as reported under GAAP

   $ 0.58       $ 0.65      $ 1.15       $ 0.98   

EPS difference (1)

     0.47         0.30        0.89         0.89   

Non-GAAP EPS assuming dilution

   $ 1.05       $ 0.95      $ 2.04       $ 1.87   

 

(1) 

Represents the difference between calculated GAAP EPS and calculated non-GAAP EPS, which may be different than the amount calculated by dividing the impact of the excluded items by the weighted-average shares for the applicable period.

Acquisition-Related Costs

Non-GAAP income and non-GAAP EPS exclude the impact of certain amounts recorded in connection with mergers and acquisitions. These amounts include the amortization of intangible assets and inventory step-up, as well as intangible asset impairment charges. Also excluded are integration and transaction costs associated with the Merger, as well as other costs associated with mergers and acquisitions, such as severance costs which are not part of the Company’s formal restructuring programs. These costs are excluded because management believes that these costs are not representative of ongoing normal business activities.

Restructuring Costs

Non-GAAP income and non-GAAP EPS exclude costs related to restructuring actions, including restructuring activities related to the Merger (see Note 2 to the interim consolidated financial statements). These amounts include employee separation costs and accelerated depreciation associated with facilities to be closed or divested. Accelerated depreciation costs represent the difference between the depreciation expense to be recognized over the revised useful life of the site, based upon the anticipated date the site will be closed or divested, and depreciation expense as determined utilizing the useful life prior to the restructuring actions. The Company has undertaken restructurings of different types during the covered periods and therefore these charges should not be considered non-recurring; however, management excludes these amounts from non-GAAP income and non-GAAP EPS because it believes it is helpful for understanding the performance of the continuing business.

Certain Other Items

Non-GAAP income and non-GAAP EPS exclude certain other items. These items represent substantive, unusual items that are evaluated on an individual basis. Such evaluation considers both the quantitative and the qualitative aspect of their unusual nature and generally represent items that, either as a result of their nature or magnitude, management would not anticipate that they would occur as part of the Company’s normal business on a regular basis. Certain other items are comprised of the arbitration settlement charge and the gain associated with the sale of certain manufacturing facilities and related assets recorded in 2011 discussed above. Also excluded from non-GAAP income and non-GAAP EPS are the tax benefits from the settlement of a federal income tax audit and the favorable impact of certain foreign and state tax rate changes that resulted in a net reduction of deferred tax liabilities on intangibles established in purchase accounting.

 

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Research and Development Update

In July 2012, Merck announced an update on the Phase III trial assessing fracture risk reduction with odanacatib (MK-0822), the Company’s investigational cathepsin K inhibitor for osteoporosis. The Data Monitoring Committee (the “DMC”) for the study recently completed its first planned interim analysis for efficacy and recommended that the study be closed early due to robust efficacy and a favorable benefit-risk profile. As a result, Merck is taking steps to close the trial. The DMC noted that safety issues remain in certain selected areas and made recommendations with respect to following up on them. Merck’s previously announced plan to conduct a blinded extension trial will allow further monitoring of the issues. The extension trial will also continue to measure efficacy. Merck anticipates submitting regulatory applications for approval of odanacatib in the United States and EU in the first half of 2013 and Japan in the third quarter of 2013.

In June 2012, Merck announced new data from two pivotal Phase III efficacy trials for suvorexant (MK-4305), an investigational medicine Merck is developing for the treatment of insomnia. In the studies, suvorexant significantly reduced the time it took patients to fall asleep and increased the time that patients stayed asleep as early as the first night and at the three-month time point compared to placebo. The investigational medicine met statistical significance for all primary endpoints except for one measurement at month 3 in one of the trials. These data were presented at SLEEP 2012, the 26th Annual Meeting of the Associated Professional Sleep Societies. Merck plans to file a New Drug Application (“NDA”) for suvorexant with the FDA in 2012. If approved, suvorexant would be the first medicine approved in a new class of medicines, called orexin receptor antagonists, for use in patients with difficulty falling or staying asleep. Commercial launch timing will be impacted by FDA approval and evaluation by the Controlled Substance Staff of the FDA and Drug Enforcement Agency.

Also in June 2012, Merck announced that the FDA issued a Complete Response Letter regarding the NDA for ridaforolimus. Ridaforolimus is an investigational oral mTOR inhibitor under development for maintenance therapy for patients with metastatic soft tissue or bone sarcoma who have stable disease or better after four or more cycles of chemotherapy. The Complete Response Letter states that the FDA cannot approve the application in its present form, and that additional clinical trial(s) would need to be conducted to further assess safety and efficacy. The Company is evaluating next steps. Merck also is in ongoing discussions with health authorities in Europe and other countries as part of their application procedures for ridaforolimus for the treatment of metastatic soft-tissue or bone sarcomas in patients who had a favorable response to chemotherapy. Additionally, Merck is studying ridaforolimus in combination with other mechanisms in several tumor types. As part of an exclusive license agreement with ARIAD Pharmaceuticals, Inc. (“ARIAD”), Merck is responsible for the development and worldwide commercialization of ridaforolimus in oncology. ARIAD has exercised its option to co-promote ridaforolimus for sarcoma if the drug is approved in the United States.

In March 2012, Merck announced that the FDA issued a Complete Response Letter regarding Merck’s NDA for Atozet (MK-0653C), an investigational combination medicine for the treatment of primary or mixed hyperlipidemia. In the letter, the FDA advised Merck that it has completed its review of the submission and stated that additional data are needed. Merck is planning to submit additional information to the FDA for ezetimibe and atorvastatin by the end of 2012. The previously disclosed patent litigation with Pfizer has been resolved.

As previously disclosed, the 14,000-patient Phase III event-driven clinical study of V503, the Company’s investigational 9-valent HPV vaccine candidate, is ongoing. V503 incorporates antigens against five additional cancer-causing HPV types as compared with Gardasil. Based on the current rate at which disease endpoints are being reported in the study, Merck now anticipates filing a Biologics License Application for V503 with the FDA in 2013.

MK-0524B is a drug candidate that combines the novel approach to raising HDL cholesterol and lowering triglycerides from extended-release niacin combined with laropiprant and simvastatin in one combination product. In July 2012, Merck placed the MK-0524B program on hold for business reasons and no longer anticipates filing an NDA for MK-0524B with the FDA in 2014. This has no impact on the HPS2-THRIVE trial or the MK-0524A program, both of which are continuing as planned.

In April 2012, the Company entered into an agreement with Endocyte to develop and commercialize Endocyte’s novel investigational therapeutic candidate vintafolide (MK-8109). Vintafolide is currently being evaluated in a Phase III clinical trial for platinum-resistant ovarian cancer (PROCEED) and a Phase II trial for non-small cell lung cancer. Under the agreement, Merck gained worldwide rights to develop and commercialize vintafolide. Endocyte received a $120 million upfront payment, which the Company recorded in Research and development expenses in the second quarter of 2012, and is eligible for milestone payments of up to $880 million based on the successful achievement of development, regulatory and commercialization goals for vintafolide for a total of six cancer indications. In addition, if vintafolide receives regulatory approval, Endocyte will receive an equal share of the profit in the United States as well as a royalty on sales of the product in the rest of the world. Endocyte has retained the right to co-promote vintafolide with Merck in the United States and Merck has the exclusive right to promote vintafolide in the rest of world. Endocyte will be responsible for the majority of funding and completion of the PROCEED trial. Merck will be responsible for most other development activities, all other costs and have most decision rights for vintafolide. Merck has the right to terminate the agreement on

 

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90 days notice. Merck and Endocyte both have the right to terminate the agreement due to the material breach or insolvency of the other party. Endocyte has the right to terminate the agreement in the event that Merck challenges an Endocyte patent right relating to vintafolide. Upon termination of the agreement, depending upon the circumstances, the parties have varying rights and obligations with respect to the continued development and commercialization of vintafolide and, in the case of termination for cause by Merck, certain royalty obligations and U.S. profit and loss sharing. Endocyte plans to file an application for vintafolide in the EU for the treatment of folate receptor positive platinum-resistant ovarian cancer in 2012. Endocyte remains responsible for the development, manufacture and commercialization worldwide of etarfolatide, a non-invasive companion diagnostic imaging agent that is used to identify folate receptor positive tumor cells.

The chart below reflects the Company’s research pipeline as of July 27, 2012. Candidates shown in Phase III include specific products and the date such candidate entered into Phase III development. Candidates shown in Phase II include the most advanced compound with a specific mechanism or, if listed compounds have the same mechanism, they are each currently intended for commercialization in a given therapeutic area. Small molecules and biologics are given MK-number designations and vaccine candidates are given V-number designations. Candidates in Phase I, additional indications in the same therapeutic area and additional claims, line extensions or formulations for in-line products are not shown.

 

Phase II   Phase III (Phase III entry date)   Under Review

Allergy

 MK-8237, Immunotherapy(1)

Cancer

MK-0646 (dalotuzumab)

MK-1775

MK-2206

MK-7965 (dinaciclib)

Contraception, Medicated IUS

MK-8342

Diabetes Mellitus

MK-3102

Hepatitis C

 MK-5172

Insomnia

MK-3697

MK-6096

Migraine

 MK-1602

Overactive Bladder

MK-4618

Pneumoconjugate Vaccine

 V114

Psoriasis

 MK-3222

Rheumatoid Arthritis

 MK-8457

 

Allergy

 MK-7243, Grass pollen (March 2008)(1)

 MK-3641, Ragweed (September 2009)(1)

Atherosclerosis

MK-0524A (extended-release niacin/laropiprant) (U.S.) (December 2005)

MK-0524B (extended-release niacin/laropiprant/simvastatin) (July 2007)(2)

MK-0859 (anacetrapib) (May 2008)

Atrial Fibrillation

 MK-6621 (vernakalant i.v.) (U.S.) (August 2003)(3)

Clostridium difficile Infection

MK-3415A (actoxumab/bezlotoxumab) (November 2011)

Contraception

 MK-8175A (NOMAC/E2) (U.S.) (June 2006)(4)

Diabetes and Atherosclerosis

MK-0431E (sitagliptin/atorvastatin) (October 2011)

Fertility

MK-8962 (corifollitropin alfa for injection) (U.S.) (July 2006)

Hepatitis C

 MK-7009 (vaniprevir) (June 2011)(5)

Herpes Zoster

V212 (inactivated VZV vaccine) (December 2010)

HPV-Related Cancers

 V503 (HPV vaccine (9 valent)) (September 2008)

Insomnia

 MK-4305 (suvorexant) (December 2009)

Neuromuscular Blockade Reversal

MK-8616 (Bridion) (U.S.) (November 2005)

Osteoporosis

 MK-0822 (odanacatib) (September 2007)

Parkinson’s Disease

 MK-3814 (preladenant) (July 2010)

Pediatric Hexavalent Combination Vaccine

 V419 (April 2011)

Platinum-Resistant Ovarian Cancer

 MK-8109 (vintafolide) (April 2011)(6)

Thrombosis

 MK-5348 (vorapaxar) (September 2007)

 

Atherosclerosis

 MK-0653C (Atozet) (U.S.)(7)

Sarcoma

MK-8669 (ridaforolimus) (EU) (U.S.)(8)

 

 

 

   

Footnotes:

 

(1)  North American rights only.

(2) In July 2012, Merck placed the MK-0524B program on hold.

(3The program remains on hold in the United States. The Company plans to have further discussions with the FDA.

(4)  In November 2011, Merck received a Complete Response letter from the FDA for NOMAC/E2 (MK-8175A). The Company is planning to conduct an additional clinical study requested by the FDA and update the application in the future.

(5)  For development in Japan only.

(6)  Vintafolide started Phase III clinical trials in April 2011 sponsored by Endocyte Inc.

(7)  In March 2012, Merck received a Complete Response Letter from the FDA for Atozet (MK-0653C). Merck is planning to submit additional information to the FDA.

(8)  In June 2012, Merck received a Complete Response Letter from the FDA for ridaforolimus (MK-8669). The Company is evaluating next steps.

 

 

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Selected Joint Venture and Affiliate Information

AstraZeneca LP

In 1998, Merck and Astra completed the restructuring of the ownership and operations of their existing joint venture whereby Merck acquired Astra’s interest in KBI Inc. (“KBI”) and contributed KBI’s operating assets to a new U.S. limited partnership, Astra Pharmaceuticals L.P. (the “Partnership”), in exchange for a 1% limited partner interest. Astra contributed the net assets of its wholly owned subsidiary, Astra USA, Inc., to the Partnership in exchange for a 99% general partner interest. The Partnership, renamed AstraZeneca LP (“AZLP”) upon Astra’s 1999 merger with Zeneca Group Plc, became the exclusive distributor of the products for which KBI retained rights.

In June 2012, Merck and AstraZeneca amended the 1998 option agreement which gave AstraZeneca the option to buy Merck’s common stock interest in KBI and, through it, Merck’s interest in Nexium and Prilosec as well as AZLP. The updated agreement eliminates AstraZeneca’s option to acquire Merck’s interest in KBI in 2012 and provides AstraZeneca a new option to acquire Merck’s interest in KBI in June 2014. As a result of the amended agreement, Merck will continue to record supply sales and equity income from the partnership for the remainder of 2012 and 2013. In 2014, AstraZeneca has the option to purchase Merck’s interest in KBI based in part on the value of Merck’s interest in Prilosec and Nexium. AstraZeneca’s option is exercisable between March 1, 2014 and April 30, 2014. If AstraZeneca chooses to exercise this option, the closing date is expected to be June 30, 2014. Under the amended agreement, AstraZeneca will make a payment to Merck upon closing of $327 million, reflecting an estimate of the fair value of Merck’s interest in Nexium and Prilosec. This portion of the exercise price is subject to a true-up in 2018 based on actual sales from closing in 2014 to June 2018. The exercise price will also include an additional amount equal to a multiple of ten times Merck’s average 1% annual profit allocation in the partnership for the three-years prior to exercise. The Company believes that it is likely that AstraZeneca will exercise its option in 2014. If AstraZeneca exercises its option, the Company will no longer record equity income from AZLP and supply sales to AZLP will decline substantially.

Sanofi Pasteur MSD

In 1994, Merck and Pasteur Mérieux Connaught (now Sanofi Pasteur S.A.) established an equally-owned joint venture to market vaccines in Europe and to collaborate in the development of combination vaccines for distribution in Europe. Total vaccine sales reported by SPMSD were $229 million and $243 million in the second quarter of 2012 and 2011, respectively, and were $435 million and $430 million for the first six months of 2012 and 2011, respectively. SPMSD sales of Gardasil were $60 million and $66 million for the second quarter of 2012 and 2011, respectively, and were $115 million and $124 million for the first six months of 2012 and 2011, respectively.

The Company records the results from its interest in AZLP and SPMSD in Equity income from affiliates.

Liquidity and Capital Resources

($ in millions)   

June 30,

2012

     December 31,
2011
 

Cash and investments

   $         21,535           $         18,430     

Working capital

     18,727           16,936     

Total debt to total liabilities and equity

     18.0%         16.7%   

During the first six months of 2012, cash provided by operating activities was $5.1 billion compared with $4.6 billion in the first six months of 2011. Cash provided by operating activities in the first six months of 2012 reflects the payment of $960 million (including interest) related to the resolution of certain litigation related to Vioxx. See Note 9 to the interim consolidated financial statements. Cash provided by operating activities continues to be the Company’s primary source of funds to finance operating needs, capital expenditures, treasury stock purchases and dividends paid to shareholders. The global economic downturn and the sovereign debt issues, among other factors, have adversely impacted foreign receivables in certain European countries (see Note 5 to the interim consolidated financial statements). While the Company continues to receive payment on these receivables, including significant collections during the second quarter in connection with the Spanish government’s debt stabilization/stimulus plan, these conditions have resulted in an increase in the average length of time it takes to collect accounts receivable outstanding thereby adversely affecting cash provided by operating activities.

Cash used in investing activities was $568 million in the first six months of 2012 compared with $943 million in the first six months of 2011 primarily reflecting higher proceeds from the sales of securities and other investments and lower use of funds for the acquisitions of businesses, partially offset by higher purchases of

 

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securities and other investments. In addition, the Company received proceeds from the disposition of businesses in the first six months of 2011. Cash used in financing activities in the first six months of 2012 was $1.3 billion compared with $2.4 billion in the first six months of 2011. The lower use of cash in financing activities was primarily driven by lower payments on debt, higher proceeds from the exercise of stock options and an increase in short-term borrowings, partially offset by higher purchases of treasury stock and higher dividends paid to stockholders.

At June 30, 2012, the total of worldwide cash and investments was $21.5 billion, including $17.5 billion of cash, cash equivalents and short-term investments and $4.1 billion of long-term investments. Generally, 80% - 90% of these cash and investments are held by foreign subsidiaries and would be subject to significant tax payments if such cash and investments were repatriated in the form of dividends. The Company records U.S. deferred tax liabilities for certain unremitted earnings, but when amounts earned overseas are expected to be indefinitely reinvested outside of the United States, no accrual for U.S. taxes is provided. The amount of cash and investments held by U.S. and foreign subsidiaries fluctuates due to a variety of factors including the timing and receipt of payments in the normal course of business. Cash provided by operating activities in the United States continues to be the Company’s primary source of funds to finance domestic operating needs, capital expenditures, treasury stock purchases and dividends paid to shareholders.

In April 2011, the Internal Revenue Service (the “IRS”) concluded its examination of Merck’s 2002-2005 federal income tax returns and as a result the Company was required to make net payments of approximately $465 million. The Company’s unrecognized tax benefits for the years under examination exceeded the adjustments related to this examination period and therefore the Company recorded a net $700 million tax provision benefit in the second quarter of 2011. This net benefit reflects the decrease of unrecognized tax benefits for the years under examination partially offset by increases to the unrecognized tax benefits for years subsequent to the examination period as a result of this settlement. The Company disagrees with the IRS treatment of one issue raised during this examination and is appealing the matter through the IRS administrative process.

As previously disclosed, the Canada Revenue Agency (the “CRA”) has proposed adjustments for 1999 and 2000 relating to intercompany pricing matters and, in July 2011, the CRA issued assessments for other miscellaneous audit issues for tax years 2001-2004. These adjustments would increase Canadian tax due by approximately $330 million plus approximately $390 million of interest through June 30, 2012. The Company disagrees with the positions taken by the CRA and believes they are without merit. The Company continues to contest the assessments through the CRA appeals process. The CRA is expected to prepare similar adjustments for later years. Management believes that resolution of these matters will not have a material effect on the Company’s financial position or liquidity.

Capital expenditures totaled $762 million and $689 million for the first six months of 2012 and 2011, respectively. Capital expenditures for full year 2012 are estimated to be $2.2 billion.

Dividends paid to stockholders were $2.6 billion and $2.4 billion for the first six months of 2012 and 2011, respectively. In May and July 2012, the Board of Directors declared a quarterly dividend of $0.42 per share on the Company’s common stock for the third and fourth quarters, respectively, of 2012.

In April 2011, Merck’s Board of Directors approved additional purchases of up to $5 billion of Merck’s common stock for its treasury. The Company purchased $985 million of its common stock (26 million shares) for its treasury during the first six months of 2012. The Company has approximately $3.5 billion remaining under this program. The treasury stock purchases have no time limit and will be made over time on the open market, in block transactions or in privately negotiated transactions.

In May 2012, the Company terminated its existing credit facilities and entered into a new $4.0 billion, five-year credit facility maturing in May 2017. The facility provides backup liquidity for the Company’s commercial paper borrowing facility and is to be used for general corporate purposes. The Company has not drawn funding from this facility.

Critical Accounting Policies

The Company’s significant accounting policies, which include management’s best estimates and judgments, are included in Note 2 to the consolidated financial statements for the year ended December 31, 2011 included in Merck’s Form 10-K filed on February 28, 2012. Certain of these accounting policies are considered critical as disclosed in the Critical Accounting Policies and Other Matters section of Management’s Discussion and Analysis of Financial Condition and Results of Operations included in Merck’s Form 10-K because of the potential for a significant impact on the financial statements due to the inherent uncertainty in such estimates. There have been no significant changes in the Company’s critical accounting policies since December 31, 2011.

 

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Recently Issued Accounting Standards Not Yet Adopted

In July 2012, the Financial Accounting Standards Board issued amended guidance that simplifies how an entity tests indefinite-lived intangibles for impairment. The amended guidance will allow companies to first assess qualitative factors to determine whether it is more-likely-than-not that an indefinite-lived intangible asset is impaired as a basis for determining whether it is necessary to perform the quantitative impairment test. The updated guidance is effective for annual and interim impairment tests performed for fiscal years beginning after September 15, 2012, with early adoption permitted. The Company is currently evaluating the impact of adoption on its financial position and results of operations.

Item 4.  Controls and Procedures

Management of the Company, with the participation of its Chief Executive Officer and Chief Financial Officer, has evaluated the effectiveness of the Company’s disclosure controls and procedures over financial reporting for the period covered by this Form 10–Q. Based on this assessment, the Company’s Chief Executive Officer and Chief Financial Officer have concluded that as of June 30, 2012, the Company’s disclosure controls and procedures are effective. There have been no changes in internal control over financial reporting for the period covered by this report that have materially affected, or are reasonably likely to materially affect, the Company’s internal control over financial reporting.

CAUTIONARY FACTORS THAT MAY AFFECT FUTURE RESULTS

This report and other written reports and oral statements made from time to time by the Company may contain so-called “forward-looking statements,” all of which are based on management’s current expectations and are subject to risks and uncertainties which may cause results to differ materially from those set forth in the statements. One can identify these forward-looking statements by their use of words such as “anticipates,” “expects,” “plans,” “will,” “estimates,” “forecasts,” “projects” and other words of similar meaning. One can also identify them by the fact that they do not relate strictly to historical or current facts. These statements are likely to address the Company’s growth strategy, financial results, product development, product approvals, product potential and development programs. One must carefully consider any such statement and should understand that many factors could cause actual results to differ materially from the Company’s forward-looking statements. These factors include inaccurate assumptions and a broad variety of other risks and uncertainties, including some that are known and some that are not. No forward-looking statement can be guaranteed and actual future results may vary materially.

The Company does not assume the obligation to update any forward-looking statement. One should carefully evaluate such statements in light of factors, including risk factors, described in the Company’s filings with the Securities and Exchange Commission, especially on Forms 10-K, 10-Q and 8-K. In Item 1A. “Risk Factors” of the Company’s Annual Report on Form 10-K for the year ended December 31, 2011, as filed on February 28, 2012, the Company discusses in more detail various important risk factors that could cause actual results to differ from expected or historic results. The Company notes these factors for investors as permitted by the Private Securities Litigation Reform Act of 1995. One should understand that it is not possible to predict or identify all such factors. Consequently, the reader should not consider any such list to be a complete statement of all potential risks or uncertainties.

 

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PART II - Other Information

Item 1.  Legal Proceedings

The information called for by this Item is incorporated herein by reference to Note 9 included in Part I, Item 1, Financial Statements (unaudited) — Notes to Consolidated Financial Statements.

Item 2.  Unregistered Sales of Equity Securities and Use of Proceeds

Issuer purchases of equity securities for the three months ended June 30, 2012 were as follows:

ISSUER PURCHASES OF EQUITY SECURITIES

 

              ($ in millions)

Period

    Total Number  
of Shares
Purchased
(1)
      Average Price  
Paid Per

Share
        Approximate Dollar Value of Shares       
That May Yet Be Purchased

Under the Plans or Programs(1)

April 1 - April 30

    3,897,300        $38.41   $3,880

May 1 - May 31

    4,529,400        $38.13   $3,707

June 1 - June 30

    5,341,400        $38.52   $3,501

Total

    13,768,100        $38.36   $3,501

(1)All shares purchased during the period were made as part of a plan approved by the Board of Directors in April 2011 to purchase up to $5 billion in Merck shares.

 

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Item 6.  Exhibits

Number

    

Description

         3.1

     Restated Certificate of Incorporation of Merck & Co., Inc. (November 3, 2009) – Incorporated by reference to Current Report on Form 8-K filed on November 4, 2009

         3.2

     By-Laws of Merck & Co., Inc. (effective January 1, 2012) – Incorporated by reference to Current Report on Form 8-K filed December 21, 2011

       31.1

     Rule 13a – 14(a)/15d – 14(a) Certification of Chief Executive Officer

       31.2

     Rule 13a – 14(a)/15d – 14(a) Certification of Chief Financial Officer

       32.1

     Section 1350 Certification of Chief Executive Officer

       32.2

     Section 1350 Certification of Chief Financial Officer

       101

     The following materials from Merck & Co., Inc.’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2012, formatted in XBRL (Extensible Business Reporting Language): (i) the Consolidated Statement of Income, (ii) the Consolidated Statement of Comprehensive Income, (iii) the Consolidated Balance Sheet, (iv) the Consolidated Statement of Cash Flows, and (v) Notes to Consolidated Financial Statements.

 

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Signatures

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

 

    MERCK & CO., INC.  
Date: August 7, 2012     /s/ Bruce N. Kuhlik  
    BRUCE N. KUHLIK  
    Executive Vice President and General Counsel  
Date: August 7, 2012     /s/ John Canan  
    JOHN CANAN  
    Senior Vice President Finance - Global Controller  

 

- 54 -


EXHIBIT INDEX

 

Number

    

Description

   3.1          Restated Certificate of Incorporation of Merck & Co., Inc. (November 3, 2009) – Incorporated by reference to Current Report on Form 8-K filed on November 4, 2009
   3.2          By-Laws of Merck & Co., Inc. (effective January 1, 2012) – Incorporated by reference to Current Report on Form 8-K filed December 21, 2011
  31.1          Rule 13a – 14(a)/15d – 14(a) Certification of Chief Executive Officer
  31.2          Rule 13a – 14(a)/15d – 14(a) Certification of Chief Financial Officer
  32.1          Section 1350 Certification of Chief Executive Officer
  32.2          Section 1350 Certification of Chief Financial Officer
  101           The following materials from Merck & Co., Inc.’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2012, formatted in XBRL (Extensible Business Reporting Language): (i) the Consolidated Statement of Income, (ii) the Consolidated Statement of Comprehensive Income, (iii) the Consolidated Balance Sheet, (iv) the Consolidated Statement of Cash Flows, and (v) Notes to Consolidated Financial Statements.

 

- 55 -

EX-31.1 2 d351112dex311.htm RULE 13A - 14(A)/15D - 14(A) CERTIFICATION OF CHIEF EXECUTIVE OFFICER RULE 13A - 14(A)/15D - 14(A) CERTIFICATION OF CHIEF EXECUTIVE OFFICER

Exhibit 31.1    

CERTIFICATION

I, Kenneth C. Frazier, certify that:

1.     I have reviewed this quarterly report on Form 10-Q of Merck & Co., Inc.;

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

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

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

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

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

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

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

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

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

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

 

 

 

Date:          August 7, 2012
By:  

/s/ Kenneth C. Frazier

  KENNETH C. FRAZIER
  Chairman, President and Chief Executive Officer
EX-31.2 3 d351112dex312.htm RULE 13A - 14(A)/15D - 14(A) CERTIFICATION OF CHIEF FINANCIAL OFFICER RULE 13A - 14(A)/15D - 14(A) CERTIFICATION OF CHIEF FINANCIAL OFFICER

Exhibit 31.2     

CERTIFICATION

I, Peter N. Kellogg, certify that:

1.     I have reviewed this quarterly report on Form 10-Q of Merck & Co., Inc.;

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

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

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

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

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

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

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

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

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

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

 

 

Date:          August 7, 2012   
By:  

/s/ Peter N. Kellogg

  
  PETER N. KELLOGG   
  Executive Vice President & Chief Financial Officer   
EX-32.1 4 d351112dex321.htm SECTION 1350 CERTIFICATION OF CHIEF EXECUTIVE OFFICER SECTION 1350 CERTIFICATION OF CHIEF EXECUTIVE OFFICER

Exhibit 32.1

Section 1350

Certification of Chief Executive Officer

 

 

 

Pursuant to 18 U.S.C. Section 1350, the undersigned officer of Merck & Co., Inc. (the “Company”), hereby certifies that the Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2012 (the “Report”) fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934 and that the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.

 

 

 

Dated:   August 7, 2012    

/s/ Kenneth C. Frazier

 
    Name:     KENNETH C. FRAZIER
    Title:     Chairman, President and Chief Executive Officer
EX-32.2 5 d351112dex322.htm SECTION 1350 CERTIFICATION OF CHIEF FINANCIAL OFFICER SECTION 1350 CERTIFICATION OF CHIEF FINANCIAL OFFICER

Exhibit 32.2

 

Section 1350

Certification of Chief Financial Officer

 

 

 

Pursuant to 18 U.S.C. Section 1350, the undersigned officer of Merck & Co., Inc. (the “Company”), hereby certifies that the Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2012 (the “Report”) fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934 and that the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.

 

 

 

Dated:   August 7, 2012    

/s/ Peter N. Kellogg

 
    Name:     PETER N. KELLOGG
    Title:     Executive Vice President & Chief Financial Officer
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Vintafolide is currently being evaluated in a Phase III clinical trial for platinum-resistant ovarian cancer (PROCEED) and a Phase II trial for non-small cell lung cancer. Under the agreement, Merck gained worldwide rights to develop and commercialize vintafolide. Endocyte received a $120 million upfront payment, which the Company recorded in <i>Research and development</i> expenses in the second quarter of 2012, and is eligible for milestone payments of up to $880 million based on the successful achievement of development, regulatory and commercialization goals for vintafolide for a total of six cancer indications. In addition, if vintafolide receives regulatory approval, Endocyte will receive an equal share of the profit in the United States as well as a royalty on sales of the product in the rest of the world. Endocyte has retained the right to co-promote vintafolide with Merck in the United States and Merck has the exclusive right to promote vintafolide in the rest of world. Endocyte will be responsible for the majority of funding and completion of the PROCEED trial. Merck will be responsible for most other development activities, all other costs and will have most decision rights for vintafolide. Merck has the right to terminate the agreement on 90 days notice. Merck and Endocyte both have the right to terminate the agreement due to the material breach or insolvency of the other party. Endocyte has the right to terminate the agreement in the event that Merck challenges an Endocyte patent right relating to vintafolide. Upon termination of the agreement, depending upon the circumstances, the parties have varying rights and obligations with respect to the continued development and commercialization of vintafolide and, in the case of termination for cause by Merck, certain royalty obligations and U.S. profit and loss sharing. </font></p> <p style="margin-top:12px;margin-bottom:0px; text-indent:6%" align="justify"><font style="font-family:times new roman" size="2"> In May 2011, Merck completed the acquisition of Inspire Pharmaceuticals, Inc. (&#8220;Inspire&#8221;), a specialty pharmaceutical company focused on developing and commercializing ophthalmic products. Under the terms of the merger agreement, Merck acquired all outstanding shares of common stock of Inspire at a price of $5.00 per share in cash for a total of approximately $420 million. The transaction was accounted for as an acquisition of a business; accordingly, the assets acquired and liabilities assumed were recorded at their respective fair values as of the acquisition date. The determination of fair value requires management to make significant estimates and assumptions. In connection with the acquisition, substantially all of the purchase price was allocated to Inspire&#8217;s product and product right intangible assets and related deferred tax liabilities, a deferred tax asset relating to Inspire&#8217;s net operating loss carryforwards, and goodwill. This transaction closed on May&#160;16, 2011, and accordingly, the results of operations of the acquired business have been included in the Company&#8217;s results of operations since the acquisition date. 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As part of the agreement with Fujifilm, Merck has committed to purchase certain development and manufacturing services at fair value from Fujifilm over a three-year period following the closing of the transaction. 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The Company supplements its internal research with a licensing and external alliance strategy focused on the entire spectrum of collaborations from early research to late-stage compounds, as well as new technologies across a broad range of therapeutic areas. 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In return, Merck provided DuPont marketing rights in the United States and Canada to its prescription medicines, <i>Sinemet</i> and <i>Sinemet CR </i>(the Company has since regained global marketing rights to <i>Sinemet</i> and <i>Sinemet CR</i>). Pursuant to a 1994 agreement with DuPont, the Company has an exclusive licensing agreement to market <i>Cozaar</i> and <i>Hyzaar</i> in return for royalties and profit share payments to DuPont. The patents that provided market exclusivity in the United States and in a number of major European markets for <i>Cozaar </i>and <i>Hyzaar </i>expired in 2010. </font></p> <p style="margin-top:12px;margin-bottom:0px"><font style="font-family:times new roman" size="2"><i>Remicade/Simponi </i></font></p> <p style="margin-top:0px;margin-bottom:0px; text-indent:6%" align="justify"><font style="font-family:times new roman" size="2"> In 1998, a subsidiary of Schering-Plough entered into a licensing agreement with Centocor Ortho Biotech Inc. (&#8220;Centocor&#8221;), a Johnson&#160;&#038; Johnson (&#8220;J&#038;J&#8221;) company, to market <i>Remicade,</i> which is prescribed for the treatment of inflammatory diseases. In 2005, Schering-Plough&#8217;s subsidiary exercised an option under its contract with Centocor for license rights to develop and commercialize <i>Simponi</i>, a fully human monoclonal antibody. The Company had exclusive marketing rights to both products outside the United States, Japan and certain other Asian markets. In December 2007, Schering-Plough and Centocor revised their distribution agreement regarding the development, commercialization and distribution of both <i>Remicade </i>and <i>Simponi</i>, extending the Company&#8217;s rights to exclusively market <i>Remicade </i>to match the duration of the Company&#8217;s exclusive marketing rights for <i>Simponi</i>. In addition, Schering-Plough and Centocor agreed to share certain development costs relating to <i>Simponi&#8217;s</i> auto-injector delivery system. On October&#160;6, 2009, the European Commission approved <i>Simponi </i>as a treatment for rheumatoid arthritis and other immune system disorders in two presentations&#160;&#8211; a novel auto-injector and a prefilled syringe. As a result, the Company&#8217;s marketing rights for both products extend for 15&#160;years from the first commercial sale of <i>Simponi </i>in the European Union (the &#8220;EU&#8221;) following the receipt of pricing and reimbursement approval within the EU. In April 2011, Merck and J&#038;J reached an agreement to amend the agreement governing the distribution rights to <i>Remicade</i> and <i>Simponi</i>. Under the terms of the amended distribution agreement, Merck relinquished marketing rights for <i>Remicade</i> and <i>Simponi</i> to J&#038;J in territories including Canada, Central and South America, the Middle East, Africa and Asia Pacific effective July&#160;1, 2011. Merck retained exclusive marketing rights throughout Europe, Russia and Turkey (the &#8220;Retained Territories&#8221;). In addition, beginning July&#160;1, 2011, all profits derived from Merck&#8217;s exclusive distribution of the two products in the Retained Territories are being equally divided between Merck and J&#038;J. 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The objectives and accounting related to the Company&#8217;s foreign currency risk management program, as well as its interest rate risk management activities are discussed below. </font></p> <p style="margin-top:12px;margin-bottom:0px"><font style="font-family:times new roman" size="2"><i>Foreign Currency Risk Management </i></font></p> <p style="margin-top:0px;margin-bottom:0px; text-indent:6%" align="justify"><font style="font-family:times new roman" size="2">The Company has established revenue hedging, balance sheet risk management and net investment hedging programs to protect against volatility of future foreign currency cash flows and changes in fair value caused by volatility in foreign exchange rates. </font></p> <p style="margin-top:12px;margin-bottom:0px; text-indent:6%" align="justify"><font style="font-family:times new roman" size="2"> The objective of the revenue hedging program is to reduce the potential for longer-term unfavorable changes in foreign exchange rates to decrease the U.S. dollar value of future cash flows derived from foreign currency denominated sales, primarily the euro and Japanese yen. To achieve this objective, the Company will hedge a portion of its forecasted foreign currency denominated third-party and intercompany distributor entity sales that are expected to occur over its planning cycle, typically no more than three years into the future. The Company will layer in hedges over time, increasing the portion of third-party and intercompany distributor entity sales hedged as it gets closer to the expected date of the forecasted foreign currency denominated sales, such that it is probable the hedged transaction will occur. The portion of sales hedged is based on assessments of cost-benefit profiles that consider natural offsetting exposures, revenue and exchange rate volatilities and correlations, and the cost of hedging instruments. The hedged anticipated sales are a specified component of a portfolio of similarly denominated foreign currency-based sales transactions, each of which responds to the hedged currency risk in the same manner. The Company manages its anticipated transaction exposure principally with purchased local currency put options, which provide the Company with a right, but not an obligation, to sell foreign currencies in the future at a predetermined price. If the U.S. dollar strengthens relative to the currency of the hedged anticipated sales, total changes in the options&#8217; cash flows offset the decline in the expected future U.S. dollar equivalent cash flows of the hedged foreign currency sales. Conversely, if the U.S. dollar weakens, the options&#8217; value reduces to zero, but the Company benefits from the increase in the U.S. dollar equivalent value of the anticipated foreign currency cash flows. </font></p> <p style="margin-top:12px;margin-bottom:0px; text-indent:6%" align="justify"><font style="font-family:times new roman" size="2">In connection with the Company&#8217;s revenue hedging program, a purchased collar option strategy may be utilized. With a&#160;purchased&#160;collar option strategy, the Company writes a local currency call option and purchases a local currency put option. As compared to a purchased put option strategy alone, a purchased collar strategy reduces the upfront costs associated with purchasing puts through the collection of premium by writing call options. If the U.S. dollar weakens relative to the currency of the hedged anticipated sales,&#160;the purchased put option value of the collar strategy reduces to zero and the Company benefits from the increase in the U.S. dollar equivalent value of its anticipated foreign currency cash flows, however this benefit would be capped at the strike level of the written call.If the U.S. dollar strengthens relative to the currency of the hedged anticipated sales, the&#160;written call option value of the collar strategy reduces to zero&#160;and the changes in the purchased put cash flows of the collar strategy would offset the decline in the expected future U.S. dollar equivalent cash flows of the hedged foreign currency sales. </font></p> <p style="margin-top:12px;margin-bottom:0px; text-indent:6%" align="justify"><font style="font-family:times new roman" size="2">The Company may also utilize forward contracts in its revenue hedging program. If the U.S. dollar strengthens relative to the currency of the hedged anticipated sales, the increase in the fair value of the forward contracts offsets the decrease in the expected future U.S. dollar cash flows of the hedged foreign currency sales. Conversely, if the U.S. dollar weakens, the decrease in the fair value of the forward contracts offsets the increase in the value of the anticipated foreign currency cash flows. </font></p> <p style="margin-top:12px;margin-bottom:0px; text-indent:6%" align="justify"><font style="font-family:times new roman" size="2"> The fair values of these derivative contracts are recorded as either assets (gain positions) or liabilities (loss positions) in the Consolidated Balance Sheet. Changes in the fair value of derivative contracts are recorded each period in either current earnings or <i>Other comprehensive income</i> (&#8220;<i>OCI</i>&#8221;), depending on whether the derivative is designated as part of a hedge transaction and, if so, the type of hedge transaction. For derivatives that are designated as cash flow hedges, the effective portion of the unrealized gains or losses on these contracts is recorded in <i>Accumulated other comprehensive income</i> (&#8220;<i>AOCI</i>&#8221;) and reclassified into <i>Sales</i> when the hedged anticipated revenue is recognized. The hedge relationship is highly effective and hedge ineffectiveness has been <i>de minimis</i>. For those derivatives which are not designated as cash flow hedges, unrealized gains or losses are recorded in <i>Sales</i> each period. The cash&#160;flows from these contracts are reported as operating activities&#160;in the Consolidated Statement of&#160;Cash Flows. The Company does not enter into derivatives for trading or speculative purposes. </font></p> <p style="margin-top:12px;margin-bottom:0px; text-indent:6%" align="justify"><font style="font-family:times new roman" size="2">The primary objective of the balance sheet risk management program is to mitigate the exposure of foreign currency denominated net monetary assets of foreign subsidiaries where the U.S. dollar is the functional currency from the effects of volatility in foreign exchange. In these instances, Merck principally utilizes forward exchange contracts, which enable the Company to buy and sell foreign currencies in the future at fixed exchange rates and economically offset the consequences of changes in foreign exchange from the monetary assets. Merck routinely enters into contracts to offset the effects of exchange on exposures denominated in developed country currencies, primarily the euro and Japanese yen. For exposures in developing country currencies, the Company will enter into forward contracts to partially offset the effects of exchange on exposures when it is deemed economical to do so based on a cost-benefit analysis that considers the magnitude of the exposure, the volatility of the exchange rate and the cost of the hedging instrument. The Company will also minimize the effect of exchange on monetary assets and liabilities by managing operating activities and net asset positions at the local level. </font></p> <p style="margin-top:12px;margin-bottom:0px; text-indent:6%" align="justify"><font style="font-family:times new roman" size="2"> Monetary assets and liabilities denominated in a currency other than the functional currency of a given subsidiary are remeasured at spot rates in effect on the balance sheet date with the effects of changes in spot rates reported in <i>Other (income) expense, net</i>. The forward contracts are not designated as hedges and are marked to market through <i>Other (income) expense, net</i>. Accordingly, fair value changes in the forward contracts help mitigate the changes in the value of the remeasured assets and liabilities attributable to changes in foreign currency exchange rates, except to the extent of the spot-forward differences. These differences are not significant due to the short-term nature of the contracts, which typically have average maturities at inception of less than one year. </font></p> <p style="margin-top:12px;margin-bottom:0px; text-indent:6%" align="justify"><font style="font-family:times new roman" size="2">The Company also uses forward exchange contracts to hedge its net investment in foreign operations against movements in exchange rates. The forward contracts are designated as hedges of the net investment in a foreign operation. The Company hedges a portion of the net investment in certain of its foreign operations and measures ineffectiveness based upon changes in spot foreign exchange rates. The effective portion of the unrealized gains or losses on these contracts is recorded in foreign currency translation adjustment within <i>OCI</i>, and remains in <i>AOCI </i>until either the sale or complete or substantially complete liquidation of the subsidiary. The cash flows from these contracts are reported as investing activities in the Consolidated Statement of Cash Flows. </font></p> <p style="margin-top:12px;margin-bottom:0px; text-indent:6%" align="justify"><font style="font-family:times new roman" size="2">Foreign exchange risk is also managed through the use of foreign currency debt. The Company&#8217;s senior unsecured euro-denominated notes have been designated as, and are effective as, economic hedges of the net investment in a foreign operation. Accordingly, foreign currency transaction gains or losses due to spot rate fluctuations on the euro-denominated debt instruments are included in foreign currency translation adjustment within <i>OCI</i>. Included in the cumulative translation adjustment are pretax gains (losses) of $92 million and $(178) million for the first six months of 2012 and 2011, respectively, from the euro-denominated notes. </font></p> <p style="font-size:1px;margin-top:12px;margin-bottom:0px">&#160;</p> <p style="margin-top:0px;margin-bottom:0px"><font style="font-family:times new roman" size="2"><i>Interest Rate Risk Management </i></font></p> <p style="margin-top:0px;margin-bottom:0px; text-indent:6%" align="justify"><font style="font-family:times new roman" size="2">The Company may use interest rate swap contracts on certain investing and borrowing transactions to manage its net exposure to interest rate changes and to reduce its overall cost of borrowing. 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The Company terminated certain of these interest rate swap contracts in the third quarter of 2011 and the remaining interest rate swap contracts matured in the fourth quarter of 2011. 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These accruals are adjusted periodically as assessments change or additional information becomes available. For product liability claims, a portion of the overall accrual is actuarially determined and considers such factors as past experience, number of claims reported and estimates of claims incurred but not yet reported. Individually significant contingent losses are accrued when probable and reasonably estimable. Legal defense costs expected to be incurred in connection with a loss contingency are accrued when probable and reasonably estimable. </font></p> <p style="margin-top:12px;margin-bottom:0px; text-indent:6%" align="justify"><font style="font-family:times new roman" size="2">The Company&#8217;s decision to obtain insurance coverage is dependent on market conditions, including cost and availability, existing at the time such decisions are made. The Company has evaluated its risks and has determined that the cost of obtaining product liability insurance outweighs the likely benefits of the coverage that is available and as such, has no insurance for certain product liabilities effective August&#160;1, 2004. </font></p> <p style="margin-top:12px;margin-bottom:0px"><font style="font-family:times new roman" size="2"><b><i>Vioxx </i></b><b>Litigation </b> </font></p> <p style="margin-top:12px;margin-bottom:0px"><font style="font-family:times new roman" size="2"> <i>Product Liability Lawsuits </i></font></p> <p style="margin-top:0px;margin-bottom:0px; text-indent:6%" align="justify"><font style="font-family:times new roman" size="2">As previously disclosed, Merck is a defendant in approximately 100 federal and state lawsuits (the &#8220;<i>Vioxx</i> Product Liability Lawsuits&#8221;) alleging personal injury or economic loss as a result of the purchase or use of <i>Vioxx</i>. 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In the <i>Vioxx</i> MDL proceeding, approximately 30 such class actions remain. In June 2010, Merck moved to strike the class claims or for judgment on the pleadings regarding the master complaint, which includes the above-referenced cases, and briefing on that motion was completed in September 2010. The <i>Vioxx</i> MDL court heard oral argument on Merck&#8217;s motion in October 2010 and took it under advisement. </font></p> <p style="margin-top:12px;margin-bottom:0px; text-indent:6%" align="justify"><font style="font-family:times new roman" size="2">In 2008, a Missouri state court certified a class of Missouri plaintiffs seeking reimbursement for out-of-pocket costs relating to <i>Vioxx. </i>The <i>Vioxx </i>MDL court issued an order in April 2012 enjoining the Missouri plaintiffs from offering any evidence that does not sufficiently exclude damages attributable to claims already settled through the prior personal injury and third-party payor settlements and from executing any judgment obtained through admission of such evidence. The Missouri plaintiffs have appealed that decision to the U.S. Court of Appeals for the Fifth Circuit, which has set an expedited briefing schedule on plaintiffs&#8217; appeal. Trial has been rescheduled for November&#160;1, 2012, in light of the appeal. In Indiana, plaintiffs filed a motion to certify a class of Indiana <i>Vioxx </i>purchasers in a case pending before the Circuit Court of Marion County, Indiana. That case has been dormant for several years. In April 2010, a Kentucky state court denied Merck&#8217;s motion for summary judgment and certified a class of Kentucky plaintiffs seeking reimbursement for out-of-pocket costs relating to <i>Vioxx</i>. The trial court subsequently entered an amended class certification order in January 2011. Merck appealed that order to the Kentucky Court of Appeals and, on February&#160;10, 2012, the Kentucky Court of Appeals reversed the trial court&#8217;s amended class certification order and denied certification. The plaintiff has petitioned the Kentucky Supreme Court to review the Court of Appeals&#8217; order. Merck opposed the petition, and the Kentucky Supreme Court has not yet ruled. </font></p> <p style="margin-top:12px;margin-bottom:0px; text-indent:6%" align="justify"><font style="font-family:times new roman" size="2">Merck has also been named as a defendant in several lawsuits brought by, or on behalf of, government entities. Six of these suits are being brought by state Attorneys General and one has been brought on behalf of a county. All of these actions except for an action brought by the Kentucky Attorney General are in the <i>Vioxx</i> MDL proceeding. These actions allege that Merck misrepresented the safety of <i>Vioxx</i>. These suits seek recovery for expenditures on <i>Vioxx </i>by government-funded health care programs, such as Medicaid, and/or penalties for alleged Consumer Fraud Act violations. Judge Fallon remanded the Kentucky case to state court on January&#160;3, 2012. Merck&#8217;s petition to appeal that decision to the U.S. Court of Appeals for the Fifth Circuit was denied. The lawsuit brought by the county is a putative class action filed by Santa&#160;Clara County, California on behalf of all similarly situated California counties. Merck moved for judgment on the pleadings in the case brought by Santa Clara County in September 2011. The court granted Merck&#8217;s motion on March&#160;20, 2012, but gave the county leave to file an amended complaint. </font></p> <p style="margin-top:12px;margin-bottom:0px"><font style="font-family:times new roman" size="2"><i>Shareholder Lawsuits </i></font></p> <p style="margin-top:0px;margin-bottom:0px; text-indent:6%" align="justify"><font style="font-family:times new roman" size="2">As previously disclosed, in addition to the <i>Vioxx </i>Product Liability Lawsuits, various putative class actions and individual lawsuits under federal securities laws and state laws have been filed against Merck and various current and former officers and directors (the &#8220;<i>Vioxx </i>Securities Lawsuits&#8221;). The <i>Vioxx</i> Securities Lawsuits are coordinated in a multidistrict litigation in the U.S. District Court for the District of New Jersey before Judge Stanley R. Chesler, and have been consolidated for all purposes. In August 2011, Judge Chesler granted in part and denied in part Merck&#8217;s motion to dismiss the Fifth Amended Class Action Complaint in the consolidated securities action. Among other things, the claims based on statements made on or after the voluntary withdrawal of <i>Vioxx</i> on September&#160;30, 2004 have been dismissed. In October 2011, defendants answered the Fifth Amended Class Action Complaint. Discovery is currently proceeding in accordance with the court&#8217;s scheduling order. </font></p> <p style="font-size:1px;margin-top:12px;margin-bottom:0px">&#160;</p> <p style="margin-top:0px;margin-bottom:0px; text-indent:6%" align="justify"><font style="font-family:times new roman" size="2">As previously disclosed, several individual securities lawsuits filed by foreign institutional investors also are consolidated with the <i>Vioxx </i>Securities Lawsuits. In October 2011, plaintiffs filed amended complaints in each of the pending individual securities lawsuits. Also in October 2011, a new individual securities lawsuit was filed in the District of New Jersey by several foreign institutional investors; that case is also consolidated with the <i>Vioxx</i> Securities Lawsuits. On January&#160;20, 2012, defendants filed motions to dismiss in one of the individual lawsuits (the &#8220;ABP Lawsuit&#8221;). Briefing on the motions to dismiss was completed on March&#160;26, 2012. On August 1, 2012, Judge Chesler granted in part and denied in part the motions to dismiss the ABP Lawsuit. Among other things, certain alleged misstatements and omissions were dismissed as inactionable and all state law claims were dismissed in full. By stipulation and order, defendants are not required to respond to the complaints in the remaining individual securities lawsuits until on or about September 15, 2012. </font></p> <p style="margin-top:12px;margin-bottom:0px"><font style="font-family:times new roman" size="2"><i>Insurance </i></font></p> <p style="margin-top:0px;margin-bottom:0px; text-indent:6%" align="justify"><font style="font-family:times new roman" size="2">The Company has Directors and Officers insurance coverage applicable to the <i>Vioxx </i>Securities Lawsuits with remaining stated upper limits of approximately $175&#160;million. As a result of the previously disclosed insurance arbitration, additional insurance coverage for these claims should also be available, if needed, under upper-level excess policies that provide coverage for a variety of risks. There are disputes with the insurers about the availability of some or all of the Company&#8217;s insurance coverage for these claims and there are likely to be additional disputes. The amounts actually recovered under the policies discussed in this paragraph may be less than the stated upper limits. </font></p> <p style="margin-top:12px;margin-bottom:0px"><font style="font-family:times new roman" size="2"><i>Investigations </i></font></p> <p style="margin-top:0px;margin-bottom:0px; text-indent:6%" align="justify"><font style="font-family:times new roman" size="2">As previously disclosed, Merck received subpoenas from the Department of Justice (the &#8220;DOJ&#8221;) requesting information related to Merck&#8217;s research, marketing and selling activities with respect to <i>Vioxx </i>in a federal health care investigation under criminal statutes. As previously disclosed, in March 2009, Merck received a letter from the U.S. Attorney&#8217;s Office for the District of Massachusetts identifying it as a target of the grand jury investigation regarding <i>Vioxx</i>. In 2010, the Company established a $950 million reserve (the &#8220;<i>Vioxx </i>Liability Reserve&#8221;) in connection with the anticipated resolution of the DOJ&#8217;s investigation. </font></p> <p style="margin-top:12px;margin-bottom:0px; text-indent:6%" align="justify"><font style="font-family:times new roman" size="2">In November 2011, the Company announced that it had reached a resolution with federal and state authorities regarding this matter, pending court approval. Under civil settlement agreements signed with the United States and individually with 44 states and the District of Columbia, Merck paid approximately two-thirds of the <i>Vioxx</i> Liability Reserve to resolve civil allegations related to <i>Vioxx</i>. 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As previously disclosed, the Company has a reserve with respect to the Canada Settlement Agreement. The Company also has an immaterial remaining reserve relating to the <i>Vioxx</i> investigation discussed above for the non-participating states with which litigation is continuing. The Company has established no other liability reserves with respect to the <i>Vioxx</i> Litigation. 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In addition, plaintiffs in approximately 2,415 of these actions generally allege that they sustained femur fractures and/or other bone injuries (&#8220;Femur Fractures&#8221;) in association with the use of <i>Fosamax</i>. </font></p> <p style="margin-top:12px;margin-bottom:0px; text-indent:6%" align="justify"><font style="font-family:times new roman" size="2"><i>Cases Alleging ONJ and/or Other Jaw Related Injuries</i> </font></p> <p style="margin-top:12px;margin-bottom:0px; text-indent:6%" align="justify"><font style="font-family:times new roman" size="2">In August 2006, the Judicial Panel on Multidistrict Litigation (the &#8220;JPML&#8221;) ordered that certain <i>Fosamax </i>product liability cases pending in federal courts nationwide should be transferred and consolidated into one multidistrict litigation (the &#8220;<i>Fosamax </i>ONJ MDL&#8221;) for coordinated pre-trial proceedings. The <i>Fosamax </i>ONJ MDL has been transferred to Judge John Keenan in the U.S.&#160;District Court for the Southern District of New York. As a result of the JPML order, approximately 950 of the cases are before Judge Keenan. In the first <i>Fosamax </i>ONJ MDL trial, <i>Boles&#160;v. Merck</i>, the <i>Fosamax </i>ONJ MDL court declared a mistrial because the eight person jury could not reach a unanimous verdict. The <i>Boles </i>case was retried in June 2010 and resulted in a verdict in favor of the plaintiff in the amount of $8&#160;million. Merck filed post-trial motions seeking judgment as a matter of law or, in the alternative, a new trial. In October 2010, the court denied Merck&#8217;s post-trial motions but <i>sua sponte </i>ordered a remittitur reducing the verdict to $1.5&#160;million. Plaintiff rejected the remittitur ordered by the court and requested a new trial on damages, which is scheduled to take place on September&#160;18, 2012. Merck intends to appeal the verdict in <i>Boles</i> after the new trial on damages has concluded. Three other cases have been tried to verdict in the <i>Fosamax</i> ONJ MDL. Defense verdicts in favor of Merck were returned in each of those three cases. </font></p> <p style="margin-top:12px;margin-bottom:0px; text-indent:6%" align="justify"><font style="font-family:times new roman" size="2">In February 2011, Judge Keenan ordered that there will be two further bellwether trials conducted in the <i>Fosamax </i>ONJ MDL. <i>Spano v. Merck </i>and <i>Jellema v. Merck </i>were selected by the court to be tried in 2012, but each case was dismissed by the plaintiffs. On March&#160;28, 2012, the court selected <i>Scheinberg v. Merck</i> as the next case to be tried and set the trial date for January&#160;14, 2013. </font></p> <p style="margin-top:12px;margin-bottom:0px; text-indent:6%" align="justify"><font style="font-family:times new roman" size="2">Outside the <i>Fosamax </i>ONJ MDL, in Florida, <i>Carballo v. Merck</i> has been set for trial on October&#160;15, 2012 and <i>Anderson v. Merck</i> has been set for trial on January&#160;14, 2013. </font></p> <p style="margin-top:12px;margin-bottom:0px; text-indent:6%" align="justify"><font style="font-family:times new roman" size="2"> In addition, in July 2008, an application was made by the Atlantic County Superior Court of New Jersey requesting that all of the <i>Fosamax </i>cases pending in New Jersey be considered for mass tort designation and centralized management before one judge in New Jersey. In October 2008, the New Jersey Supreme Court ordered that all pending and future actions filed in New Jersey arising out of the use of <i>Fosamax </i>and seeking damages for existing dental and jaw-related injuries, including ONJ, but not solely seeking medical monitoring, be designated as a mass tort for centralized management purposes before Judge Carol E. Higbee in Atlantic County Superior Court. As of June&#160;30, 2012, approximately 240 ONJ cases were pending against Merck in Atlantic County, New Jersey. In July 2009, Judge Higbee entered a Case Management Order (and various amendments thereto) setting forth a schedule that contemplates completing fact and expert discovery in an initial group of cases to be reviewed for trial. In February&#160;2011, the jury in <i>Rosenberg&#160;v. Merck</i>, the first trial in the New Jersey coordinated proceeding, returned a verdict in Merck&#8217;s favor. In April 2012, the jury in <i>Sessner v. Merck</i>, the second case tried in New Jersey, also returned a verdict in Merck&#8217;s favor. </font></p> <p style="margin-top:12px;margin-bottom:0px; text-indent:6%" align="justify"><font style="font-family:times new roman" size="2"> In California, the parties are reviewing the claims of two plaintiffs in the <i>Carrie Smith, et al. v. Merck</i> case and the claims in <i>Pedrojetti v. Merck</i>. The cases of one or more of these plaintiffs are expected to be tried in 2013. </font></p> <p style="margin-top:12px;margin-bottom:0px; text-indent:6%" align="justify"><font style="font-family:times new roman" size="2">Discovery is ongoing in the <i>Fosamax </i>ONJ MDL litigation, the New Jersey coordinated proceeding, and the remaining jurisdictions where <i>Fosamax </i>cases are pending. The Company intends to defend against these lawsuits. </font></p> <p style="margin-top:12px;margin-bottom:0px; text-indent:6%" align="justify"><font style="font-family:times new roman" size="2"><i>Cases Alleging Femur Fractures</i> </font></p> <p style="margin-top:12px;margin-bottom:0px; text-indent:6%" align="justify"><font style="font-family:times new roman" size="2">In March 2011, Merck submitted a Motion to Transfer to the JPML seeking to have all federal cases alleging Femur Fractures consolidated into one multidistrict litigation for coordinated pre-trial proceedings. The Motion to Transfer was granted in May 2011, and all federal cases involving allegations of Femur Fracture have been or will be transferred to a multidistrict litigation in the District of New Jersey (the &#8220;<i>Fosamax </i>Femur Fracture MDL&#8221;). As a result of the JPML order, approximately 510 cases were pending in the <i>Fosamax</i> Femur Fracture MDL as of June&#160;30, 2012. A Case Management Order has been entered that requires the parties to review 40 cases (later reduced to 33 cases) with a fact discovery deadline of July&#160;31, 2012 and an expert discovery deadline of November&#160;28, 2012. Judge Joel Pisano has selected four cases to be tried as the initial bellwether cases in <i></i>the<i> Fosamax</i> Femur Fracture MDL and has set an April&#160;8, 2013 trial date for the first bellwether case. </font></p> <p style="margin-top:12px;margin-bottom:0px; text-indent:6%" align="justify"><font style="font-family:times new roman" size="2">As of June&#160;30, 2012, approximately 1,535 cases alleging Femur Fractures have been filed in New Jersey state court and are pending before Judge Higbee in Atlantic County Superior Court. The parties have selected an initial group of 30 cases to be reviewed through fact discovery. Plaintiffs subsequently dismissed or advised that they will dismiss seven of the cases that were selected and discovery in the remaining cases is continuing. Judge Higbee has set March&#160;4, 2013 as the date for the first trial of the New Jersey state Femur Fracture cases. </font></p> <p style="margin-top:12px;margin-bottom:0px; text-indent:6%" align="justify"><font style="font-family:times new roman" size="2">As of June&#160;30, 2012, approximately 350 cases alleging Femur Fractures have been filed in California state court. A petition was filed seeking to coordinate all Femur Fracture cases filed in California state court before a single judge in Orange County, California. The petition was granted and Judge Steven Perk is now presiding over the coordinated proceedings. No scheduling order has yet been entered. </font></p> <p style="margin-top:12px;margin-bottom:0px; text-indent:6%" align="justify"><font style="font-family:times new roman" size="2">Additionally, there are nine Femur Fracture cases pending in other state courts. A trial date has been set for August&#160;12, 2013 for the <i>Barnes</i> case pending in Alabama state court. </font></p> <p style="margin-top:12px;margin-bottom:0px; text-indent:6%" align="justify"><font style="font-family:times new roman" size="2"> Discovery is ongoing in the <i>Fosamax</i> Femur Fracture MDL and in state courts where Femur Fracture cases are pending and the Company intends to defend against these lawsuits. </font></p> <p style="margin-top:12px;margin-bottom:0px"><font style="font-family:times new roman" size="2"><i>NuvaRing </i></font></p> <p style="margin-top:0px;margin-bottom:0px; text-indent:6%" align="justify"><font style="font-family:times new roman" size="2">As previously disclosed, beginning in May 2007, a number of complaints were filed in various jurisdictions asserting claims against the Company&#8217;s subsidiaries Organon USA, Inc., Organon Pharmaceuticals USA, Inc., Organon International (collectively, &#8220;Organon&#8221;), and the Company arising from Organon&#8217;s marketing and sale of <i>NuvaRing</i>, a combined hormonal contraceptive vaginal ring. The plaintiffs contend that Organon and Schering-Plough, among other things, failed to adequately design and manufacture <i>NuvaRing</i> and failed to adequately warn of the alleged increased risk of venous thromboembolism (&#8220;VTE&#8221;) posed by <i>NuvaRing</i>, and/or downplayed the risk of VTE. The plaintiffs seek damages for injuries allegedly sustained from their product use, including some alleged deaths, heart attacks and strokes. The majority of the cases are currently pending in a federal multidistrict litigation (the &#8220;<i>NuvaRing </i>MDL&#8221;) venued in Missouri and in a coordinated proceeding in New Jersey state court. </font></p> <p style="margin-top:12px;margin-bottom:0px; text-indent:6%" align="justify"><font style="font-family:times new roman" size="2">As of June&#160;30, 2012, there were approximately 1,100 <i>NuvaRing </i>cases. Of these cases, approximately 950 are or will be pending in the <i>NuvaRing </i>MDL in the U.S.&#160;District Court for the Eastern District of Missouri before Judge Rodney Sippel, and approximately 135 are pending in coordinated discovery proceedings in the Bergen County Superior Court of New Jersey before Judge Brian R. Martinotti. Six additional cases are pending in various other state courts. </font></p> <p style="margin-top:12px;margin-bottom:0px; text-indent:6%" align="justify"><font style="font-family:times new roman" size="2">Pursuant to orders of Judge Sippel in the<i> NuvaRing</i> MDL, the parties originally selected a pool of more than 20 cases to prepare for trial and that pool has since been narrowed to eight cases from which the first trials in the <i>NuvaRing</i> MDL will be selected. Pursuant to Judge Martinotti&#8217;s order in the New Jersey proceeding, the parties selected 10 trial pool cases to be prepared for trial and the first trial is expected to commence in February 2013. The parties have completed fact discovery in the originally selected trial pool cases in each jurisdiction and the Company anticipates expert discovery to be completed in those first trial pool cases by the summer of 2012. Certain replacement trial pool cases remain in fact discovery. Moreover, on January&#160;31, 2012, the parties in the New Jersey coordinated proceeding selected an additional 10 trial pool cases for completion of fact discovery. </font></p> <p style="margin-top:12px;margin-bottom:0px; text-indent:6%" align="justify"><font style="font-family:times new roman" size="2">The Company anticipates filing motions related to the admissibility of expert testimony beginning in the summer of 2012 and continuing through the fall with status conferences to be held in each coordinated proceeding following the completion of briefing to discuss the timing of hearings related to the motions. The Company expects substantive hearings on those motions to take place in late 2012. The Company anticipates that status conferences will be held in each coordinated proceeding following rulings on the substantive evidentiary motions to determine a methodology for selecting the first cases to be tried. The Company intends to defend against these lawsuits. </font></p> <p style="margin-top:12px;margin-bottom:0px"><font style="font-family:times new roman" size="2"><i>Propecia/Proscar </i></font></p> <p style="margin-top:0px;margin-bottom:0px; text-indent:6%" align="justify"><font style="font-family:times new roman" size="2"> As previously disclosed, Merck is a defendant in product liability lawsuits in the United States involving <i>Propecia</i> and/or <i>Proscar</i>. As of June&#160;30, 2012, approximately&#160;200 lawsuits involving a total of approximately&#160;325 plaintiffs (in a few instances spouses are&#160;joined in the suits)&#160;who allege that they&#160;have experienced persistent sexual side effects following cessation of treatment with <i>Propecia </i>and/or <i>Proscar</i> have been filed against Merck. The lawsuits, which are in their early stages, are pending in federal courts in New Jersey, Washington, Washington D.C., Florida, Illinois, Colorado, Missouri and Ohio, and in state court in New Jersey. The federal lawsuits have been consolidated for pretrial purposes in a federal MDL before Judge John Gleeson of the Eastern District of New York. The matters pending in state court in New Jersey have been consolidated before Judge Jessica Mayer in Middlesex County. The Company intends to defend against these lawsuits. </font></p> <p style="margin-top:12px;margin-bottom:0px"><font style="font-family:times new roman" size="2"><b>Governmental Proceedings</b> </font></p> <p style="margin-top:0px;margin-bottom:0px; text-indent:6%" align="justify"><font style="font-family:times new roman" size="2">As publicly disclosed, on June 21, 2012, the U.S. District Court for the Eastern District of Pennsylvania unsealed a complaint that has been filed against the Company under the federal False Claims Act by two former employees alleging, among other things, that the Company defrauded the U.S. government by falsifying data in connection with a clinical study conducted on the mumps component of the Company&#8217;s <i>M-M-R</i> II vaccine. The complaint alleges the fraud took place between 1999 and 2001. The U.S. government had the right to participate in and take over the prosecution of this lawsuit, but has advised the Company that it will decline to exercise that right. Thus, the two former employees are pursuing the lawsuit without the involvement of the U.S. government. The Company intends to defend against this lawsuit. </font></p> <p style="margin-top:18px;margin-bottom:0px"><font style="font-family:times new roman" size="2"><b><i>Vytorin/Zetia </i></b><b>Litigation </b><b><i> </i></b></font></p> <p style="margin-top:0px;margin-bottom:0px; text-indent:6%" align="justify"><font style="font-family:times new roman" size="2">As previously disclosed, in April 2008, a Merck shareholder filed a putative class action lawsuit in federal court which has been consolidated in the District of New Jersey with another federal securities lawsuit under the caption <i>In re Merck&#160;&#038; Co., Inc. Vytorin Securities Litigation</i>. An amended consolidated complaint was filed in October 2008 and named as defendants Merck; Merck/Schering-Plough Pharmaceuticals, LLC; and certain of the Company&#8217;s current and former officers and directors. The complaint alleges that Merck delayed releasing unfavorable results of the ENHANCE clinical trial regarding the efficacy of <i>Vytorin</i> and that Merck made false and misleading statements about expected earnings, knowing that once the results of the ENHANCE study were released, sales of <i>Vytorin</i> would decline and Merck&#8217;s earnings would suffer. In December 2008, Merck and the other defendants moved to dismiss this lawsuit on the grounds that the plaintiffs failed to state a claim for which relief can be granted. In September 2009, the court denied defendants&#8217; motion to dismiss. In June 2011, lead plaintiffs filed a motion for leave to further amend the consolidated complaint, which was granted on February&#160;7, 2012. On February&#160;9, 2012, plaintiffs filed a second amended consolidated complaint, which defendants answered on February&#160;23, 2012. In February 2012, the parties completed briefing on lead plaintiffs&#8217; motion for class certification. That motion is now pending before the court. On March&#160;1, 2012, defendants filed a motion for summary judgment. That motion is now fully briefed and pending before the court. </font></p> <p style="margin-top:12px;margin-bottom:0px; text-indent:6%" align="justify"><font style="font-family:times new roman" size="2">There is a similar consolidated, putative class action securities lawsuit pending in the District of New Jersey, filed by a Schering-Plough shareholder against Schering-Plough and its former Chairman, President and Chief Executive Officer, Fred Hassan, under the caption <i>In re Schering-Plough Corporation/ENHANCE Securities Litigation</i>. The amended consolidated complaint was filed in September 2008 and names as defendants Schering-Plough; Merck/Schering-Plough Pharmaceuticals; certain of the Company&#8217;s current and former officers and directors; and underwriters who participated in an August 2007 public offering of Schering-Plough&#8217;s common and preferred stock. In December 2008, Schering-Plough and the other defendants filed motions to dismiss this lawsuit on the grounds that the plaintiffs failed to state a claim for which relief can be granted. In September 2009, the court denied defendants&#8217; motions to dismiss. In February 2012, the parties completed briefing on lead plaintiffs&#8217; motion for class certification. That motion is now pending before the court. On March&#160;1, 2012, the Schering-Plough defendants filed a motion for partial summary judgment and the underwriter defendants filed a motion for summary judgment. Those motions are now fully briefed and pending before the court. </font></p> <p style="margin-top:12px;margin-bottom:0px; text-indent:6%" align="justify"><font style="font-family:times new roman" size="2">As previously disclosed, in April 2008, a member of a Merck ERISA plan filed a putative class action lawsuit against Merck and certain of the Company&#8217;s current and former officers and directors alleging they breached their fiduciary duties under ERISA. Since that time, there have been other similar ERISA lawsuits filed against Merck in the District of New Jersey, and all of those lawsuits have been consolidated under the caption <i>In re Merck&#160;&#038; Co., Inc. Vytorin ERISA Litigation</i>. A consolidated amended complaint was filed in February 2009, and names as defendants Merck and various current and former members of the Company&#8217;s Board of Directors. The plaintiffs allege that the ERISA plans&#8217; investment in Merck stock was imprudent because Merck&#8217;s earnings were dependent on the commercial success of its cholesterol drug <i>Vytorin, </i>and defendants knew or should have known that the results of a scientific study would cause the medical community to turn to less expensive drugs for cholesterol management. On May&#160;24, 2012, the plaintiffs filed an unopposed motion for preliminary approval of settlement, conditional certification of a settlement class, approval of the class notice, and scheduling of a final fairness hearing. The court granted that motion on June 22, 2012 and scheduled a hearing on final approval of the settlement for September 25, 2012. Pursuant to the settlement agreement, Merck&#8217;s insurers have paid $10.4 million into a settlement fund which (after enumerated costs, fees, and awards are withdrawn) will be allocated to members of the settlement class according to a plan of allocation to be approved by the court. The settlement agreement provides that, in exchange for such consideration, the plaintiffs and settlement class members will issue broad releases with prejudice. </font></p> <p style="margin-top:12px;margin-bottom:0px; text-indent:6%" align="justify"><font style="font-family:times new roman" size="2">There was a similar consolidated, putative class action ERISA lawsuit pending in the District of New Jersey, filed by a member of a Schering-Plough ERISA plan against Schering-Plough and certain of its then-current and former officers and directors, alleging they breached their fiduciary duties under ERISA, bearing the caption <i>In re Schering-Plough Corp. ENHANCE ERISA</i> <i>Litigation</i>. The consolidated amended complaint was filed in October 2009 and named as defendants Schering-Plough, various then-current and former members of Schering-Plough&#8217;s Board of Directors and then-current and former members of committees of Schering-Plough&#8217;s Board of Directors. On February&#160;10, 2012, the plaintiffs filed an executed class action settlement agreement and preliminary approval order. The court signed the preliminary approval order on February&#160;16, 2012, and held a final fairness hearing on May&#160;30, 2012. On&#160;May&#160;31, 2012, the court issued an opinion, order, and final judgment. Among other things, the final judgment dismissed this action with prejudice, provided releases to the defendants, and approved the settlement agreement pursuant to which Merck&#8217;s insurers have paid $12.25 million into a settlement fund. </font></p> <p style="margin-top:12px;margin-bottom:0px; text-indent:6%" align="justify"><font style="font-family:times new roman" size="2">Discovery in the lawsuits referred to in this section (collectively, the &#8220;ENHANCE Litigation&#8221;) has concluded. The Company believes that it has meritorious defenses to the ENHANCE Litigation and intends to vigorously defend against these lawsuits. The Company is unable to predict the outcome of these matters and at this time cannot reasonably estimate the possible loss or range of loss with respect to the ENHANCE Litigation. Unfavorable outcomes resulting from the ENHANCE Litigation could have a material adverse effect on the Company&#8217;s financial position, liquidity and results of operations. </font></p> <p style="margin-top:12px;margin-bottom:0px"><font style="font-family:times new roman" size="2"><i>Insurance </i></font></p> <p style="margin-top:0px;margin-bottom:0px; text-indent:6%" align="justify"><font style="font-family:times new roman" size="2"> The Company has Directors and Officers insurance coverage applicable to the <i>Vytorin</i> shareholder lawsuits brought by legacy Schering-Plough shareholders with stated upper limits of approximately $250&#160;million, which is currently being used to partially fund the Company&#8217;s legal fees. There are disputes with the insurers about the availability of some or all of the Company&#8217;s insurance coverage for these claims and there are likely to be additional disputes. The amounts actually recovered under the policies discussed in this paragraph may be less than the stated limits. The Company also has Fiduciary and other insurance for the <i>Vytorin </i>ERISA lawsuits which funded the costs of the two ERISA settlements discussed above. </font></p> <p style="margin-top:12px;margin-bottom:0px"><font style="font-family:times new roman" size="2"><b>Commercial Litigation </b></font></p> <p style="margin-top:12px;margin-bottom:0px"><font style="font-family:times new roman" size="2"><i>AWP Litigation </i></font></p> <p style="margin-top:0px;margin-bottom:0px; text-indent:6%" align="justify"><font style="font-family:times new roman" size="2"> As previously disclosed, the Company and/or certain of its subsidiaries remain defendants in cases brought by various states alleging manipulation by pharmaceutical manufacturers of Average Wholesale Prices (&#8220;AWP&#8221;), which are sometimes used by public and private payors in calculating provider reimbursement levels. The outcome of these lawsuits could include substantial damages, the imposition of substantial fines and penalties and injunctive or administrative remedies. </font></p> <p style="margin-top:12px;margin-bottom:0px; text-indent:6%" align="justify"><font style="font-family:times new roman" size="2">Since the start of 2012, the Company has settled certain AWP cases brought by the states of Alabama, Alaska, Kansas, Kentucky, Louisiana, and Mississippi. The Company and/or certain of its subsidiaries continue to be defendants in cases brought by six states. </font></p> <p style="margin-top:12px;margin-bottom:0px; text-indent:6%" align="justify"><font style="font-family:times new roman" size="2">A motion has also been filed to reinstate the Company as a defendant in a putative class action in New Jersey State court which alleges on behalf of third-party payers and individuals that manufacturers inflated drug prices by manipulation of AWPs and other means. This case was dismissed against the Company without prejudice in 2007. </font></p> <p style="margin-top:12px;margin-bottom:0px"><font style="font-family:times new roman" size="2"><i>K-DUR Antitrust Litigation </i></font></p> <p style="margin-top:0px;margin-bottom:0px; text-indent:6%" align="justify"><font style="font-family:times new roman" size="2"> As previously disclosed, in June 1997 and January 1998, Schering-Plough settled patent litigation with Upsher-Smith, Inc. (&#8220;Upsher-Smith&#8221;) and ESI Lederle, Inc. (&#8220;Lederle&#8221;), respectively, relating to generic versions of K-DUR, Schering-Plough&#8217;s long-acting potassium chloride product supplement used by cardiac patients, for which Lederle and Upsher-Smith had filed Abbreviated New Drug Applications (&#8220;ANDAs&#8221;). Following the commencement of an administrative proceeding by the U.S. Federal Trade Commission (the &#8220;FTC&#8221;) in 2001 alleging anti-competitive effects from those settlements (which has been resolved in Schering-Plough&#8217;s favor), putative class and non-class action suits were filed on behalf of direct and indirect purchasers of K-DUR against Schering-Plough, Upsher-Smith and Lederle and were consolidated in a multi-district litigation in the U.S. District Court for the District of New Jersey. These suits claimed violations of federal and state antitrust laws, as well as other state statutory and common law causes of action, and sought unspecified damages. In April 2008, the indirect purchasers voluntarily dismissed their case. In March 2010, the District Court granted summary judgment to the defendants on the remaining lawsuits and dismissed the matter in its entirety. However, in July 2012, the Third Circuit Court of Appeals reversed the District Court&#8217;s judgment and remanded the case for further proceedings. At the same time, the Third Circuit upheld a December 2008 decision by the District Court to certify certain direct purchaser plaintiffs&#8217; claims as a class action. The Company intends to seek further judicial review. </font></p> <p style="margin-top:12px;margin-bottom:0px"><font style="font-family:times new roman" size="2"><i>Coupon Litigation </i></font></p> <p style="margin-top:0px;margin-bottom:0px; text-indent:6%" align="justify"><font style="font-family:times new roman" size="2">Since March 2012, a number of private health plans have filed separate putative class action&#160;lawsuits against the Company alleging&#160;that Merck&#8217;s coupon programs injured health insurers by reducing beneficiary co-payment amounts, thereby&#160;allegedly causing&#160;beneficiaries to purchase higher-priced drugs than they otherwise would have purchased&#160;and increasing the insurers&#8217; reimbursement costs.&#160;The actions, which were filed in U.S. District Court for the District of New Jersey and the Southern District of Illinois,&#160;seek damages and injunctive relief barring&#160;the Company&#160;from issuing coupons&#160;that would reduce beneficiary&#160;co-pays on behalf of putative nationwide classes of health insurers.&#160;Similar actions&#160;relating to manufacturer coupon programs have been&#160;filed against several other pharmaceutical manufacturers in a variety of federal courts. The Company intends to defend against these lawsuits. </font></p> <p style="margin-top:12px;margin-bottom:0px"><font style="font-family:times new roman" size="2"><b>Patent Litigation </b></font></p> <p style="margin-top:0px;margin-bottom:0px; text-indent:6%" align="justify"><font style="font-family:times new roman" size="2">From time to time, generic manufacturers of pharmaceutical products file ANDAs with the FDA seeking to market generic forms of the Company&#8217;s products prior to the expiration of relevant patents owned by the Company. To protect its patent rights, the Company may file patent infringement lawsuits against such generic companies. Certain products of the Company (or marketed via agreements with other companies) currently involved in such patent infringement litigation in the United States include: AzaSite,<i> Cancidas</i>, <i>Emend</i> for Injection, <i>Nasonex</i>, Nexium, <i>Noxafil, Vytorin </i>and <i>Zetia</i>. Similar lawsuits defending the Company&#8217;s patent rights may exist in other countries. The Company intends to vigorously defend its patents, which it believes are valid, against infringement by generic companies attempting to market products prior to the expiration of such patents. As with any litigation, there can be no assurance of the outcomes, which, if adverse, could result in significantly shortened periods of exclusivity for these products and, with respect to legacy Schering-Plough products, potentially significant intangible asset impairment charges. </font></p> <p style="margin-top:12px;margin-bottom:0px; text-indent:6%" align="justify"><font style="font-family:times new roman" size="2">AzaSite &#8212;&#160;In May 2011, a patent infringement suit was filed in the United States against Sandoz Inc. (&#8220;Sandoz&#8221;) in respect of Sandoz&#8217;s application to the FDA seeking pre-patent expiry approval to market a generic version of AzaSite. The lawsuit automatically stays FDA approval of Sandoz&#8217;s ANDA until October 2013 or until an adverse court decision, if any, whichever may occur earlier. </font></p> <p style="margin-top:12px;margin-bottom:0px; text-indent:6%" align="justify"><font style="font-family:times new roman" size="2"> <i>Cancidas</i>&#160;&#8212;&#160;In November 2009, a patent infringement lawsuit was filed in the United States against Teva Parenteral Medicines, Inc. (&#8220;TPM&#8221;) in respect of TPM&#8217;s application to the FDA seeking pre-patent expiry approval to sell a generic version of <i>Cancidas</i>. That lawsuit has been dismissed with no rights granted to TPM. Also, in March 2010, a patent infringement lawsuit was filed in the United States against Sandoz in respect of Sandoz&#8217;s application to the FDA seeking pre-patent expiry approval to sell a generic version of <i>Cancidas</i>. In April 2012, the parties entered into a settlement agreement allowing Sandoz to sell a generic version of <i>Cancidas</i> commencing on August&#160;28, 2017. </font></p> <p style="margin-top:12px;margin-bottom:0px; text-indent:6%" align="justify"><font style="font-family:times new roman" size="2"><i>Emend</i> for Injection&#160;&#8212;&#160;In May 2012, a patent infringement lawsuit was filed in the United States against Sandoz in respect of Sandoz&#8217;s application to the FDA seeking pre-patent expiry approval to market a generic version of <i>Emend</i> for Injection. The lawsuit automatically stays FDA approval of Sandoz&#8217;s ANDA until July 2015 or until an adverse court decision, if any, whichever may occur earlier. In June 2012, a patent infringement lawsuit was filed in the United States against Accord Healthcare, Inc. US, Accord Healthcare, Inc. and Intas Pharmaceuticals Ltd (collectively, &#8220;Intas&#8221;) in respect of Intas&#8217; application to the FDA seeking pre-patent expiry approval to market a generic version of <i>Emend</i> for Injection. The lawsuit automatically stays FDA approval of Intas&#8217; ANDA until July 2015 or until an adverse court decision, if any, whichever may occur earlier. </font></p> <p style="margin-top:12px;margin-bottom:0px; text-indent:6%" align="justify"><font style="font-family:times new roman" size="2"> <i>Integrilin</i>&#160;&#8212;&#160;In February 2009, a patent infringement lawsuit was filed (jointly with Millennium Pharmaceuticals, Inc.) in the United States against TPM in respect of TPM&#8217;s application to the FDA seeking approval to sell a generic version of <i>Integrilin </i>prior to the expiry of the last to expire listed patent. In October 2011, the parties entered a settlement agreement allowing TPM to sell a generic version of <i>Integrilin</i> beginning June&#160;2, 2015. </font></p> <p style="margin-top:12px;margin-bottom:0px; text-indent:6%" align="justify"><font style="font-family:times new roman" size="2"><i>Nasonex</i>&#160;&#8212;&#160;In December 2009, a patent infringement suit was filed in the United States against Apotex Corp. (&#8220;Apotex&#8221;) in respect of Apotex&#8217;s application to the FDA seeking pre-patent expiry approval to market a generic version of <i>Nasonex</i>. A trial in this matter was held in April 2012. A decision was issued on June&#160;15, 2012, holding that the Merck patent covering mometasone furoate monohydrate was valid, but that it was not infringed by Apotex&#8217;s proposed product. The finding of non-infringement is under appeal. </font></p> <p style="margin-top:12px;margin-bottom:0px; text-indent:6%" align="justify"><font style="font-family:times new roman" size="2">Nexium &#8212; Patent infringement lawsuits were brought (jointly with AstraZeneca) in the United States against the following generic companies: Ranbaxy Laboratories Ltd., IVAX Pharmaceuticals, Inc. (later acquired by Teva Pharmaceuticals, Inc. (&#8220;Teva&#8221;)), Dr.&#160;Reddy&#8217;s Laboratories, Sandoz, Lupin Ltd., Hetero Drugs Limited Unit III (&#8220;Hetero&#8221;) and Torrent Pharmaceuticals Ltd. in response to each generic company&#8217;s application seeking pre-patent expiry approval to sell a generic version of Nexium. Settlements have been reached in each of these lawsuits, the terms of which provide that the respective generic company may bring a generic version of esomeprazole product to market on May 27, 2014. In addition, a patent infringement lawsuit was also filed (jointly with AstraZeneca) in February 2010 in the United States against Sun Pharma Global Fze (&#8220;Sun Pharma&#8221;) in respect of its application to the FDA seeking pre-patent expiry approval to sell a generic version of Nexium IV, which lawsuit was settled with an agreement which provides that Sun Pharma will be entitled to bring its generic esomeprazole IV product to market in the United States on January&#160;1, 2014. Finally, additional patent infringement lawsuits have been filed (jointly with AstraZeneca) in the United States against Hamni USA, Inc. (&#8220;Hamni&#8221;) and Mylan Laboratories Limited (&#8220;Mylan Labs&#8221;) related to their applications to the FDA seeking pre-patent expiry approval to sell generic versions of Nexium. The Hamni and Mylan Labs applications to the FDA remain stayed until May 2013 and August 2014, respectively, or until earlier adverse court decisions, if any. </font></p> <p style="font-size:1px;margin-top:12px;margin-bottom:0px">&#160;</p> <p style="margin-top:0px;margin-bottom:0px; text-indent:6%" align="justify"><font style="font-family:times new roman" size="2"><i>Noxafil</i>&#160;&#8212;&#160;In May 2011, a patent infringement suit was filed in the United States against Sandoz in respect of Sandoz&#8217;s application to the FDA seeking pre-patent expiry approval to market a generic version of <i>Noxafil</i>. In May 2012, Sandoz withdrew its challenge to Merck&#8217;s <i>Noxafil</i> patents and the lawsuit has been dismissed. </font></p> <p style="margin-top:12px;margin-bottom:0px; text-indent:6%" align="justify"><font style="font-family:times new roman" size="2"><i>NuvaRing</i>&#160;&#8212;&#160;In February 2011, a patent infringement suit was brought against Merck in the International Trade Commission (the &#8220;ITC&#8221;) by Femina Pharma Incorporated (&#8220;Femina&#8221;) in respect of the product <i>NuvaRing</i>. The complaint alleged that <i>NuvaRing</i> infringes a patent owned by Femina. Femina&#8217;s ITC complaint sought an exclusion order against the importation of <i>NuvaRing</i> into the United States. A hearing began in the ITC proceeding on January&#160;17, 2012 and on January&#160;18, 2012 Femina withdrew its complaint and terminated the action. In addition, in November 2011, Femina brought a patent infringement lawsuit against Merck in the Eastern District of Virginia asserting that <i>NuvaRing</i> infringes the same patent. That case was stayed pending the outcome of the ITC proceeding. In April 2012, Femina voluntarily withdrew its lawsuit. </font></p> <p style="margin-top:12px;margin-bottom:0px; text-indent:6%" align="justify"><font style="font-family:times new roman" size="2"><i>Propecia</i>&#160;&#8212;&#160;In December 2010, a patent infringement lawsuit was filed in the United States against Hetero in respect of Hetero&#8217;s application to the FDA seeking pre-patent expiry approval to sell a generic version of <i>Propecia</i>. In March 2011, the Company settled this lawsuit with Hetero by agreeing to allow Hetero to sell a generic 1 mg finasteride product beginning on July&#160;1, 2013. By virtue of a previous litigation settlement agreement, another generic manufacturer has been given the right to enter the U.S. market in January 2013. </font></p> <p style="margin-top:12px;margin-bottom:0px; text-indent:6%" align="justify"><font style="font-family:times new roman" size="2"><i>Temodar</i>&#160;&#8212;&#160;In July 2007, a patent infringement action was filed (jointly with Cancer Research Technologies, Limited (&#8220;CRT&#8221;)) in the United States against Barr Laboratories (&#8220;Barr&#8221;) (later acquired by Teva) in respect of Barr&#8217;s application to the FDA seeking pre-patent expiry approval to sell a generic version of <i>Temodar</i>. In January 2010, the court issued a decision finding the CRT patent unenforceable on grounds of prosecution laches and inequitable conduct. In November 2010, the appeals court issued a decision reversing the trial court&#8217;s finding. In December 2010, Barr filed a petition seeking a rehearing <i>en banc</i> of the appeal, which petition was denied. In June 2011, Barr filed a petition for review by the U.S. Supreme Court, which was denied. By virtue of an agreement that Barr not launch a product during the appeal process, the Company has agreed that Barr can launch a product in August 2013. </font></p> <p style="margin-top:12px;margin-bottom:0px; text-indent:6%" align="justify"><font style="font-family:times new roman" size="2">In September 2010, a patent infringement lawsuit was filed (jointly with CRT) in the United States against Sun Pharmaceutical Industries Inc. (&#8220;Sun&#8221;) in respect of Sun&#8217;s application to the FDA seeking pre-patent expiry approval to sell a generic version of <i>Temodar</i>. The lawsuit automatically stayed FDA approval of Sun&#8217;s ANDA until February 2013 or until an adverse court decision, if any, whichever may occur earlier. In November 2010, a patent infringement lawsuit was filed (jointly with CRT) in the United States against Accord HealthCare Inc. (&#8220;Accord&#8221;) in respect of its application to the FDA seeking pre-patent expiry approval to sell a generic version of <i>Temodar</i>. The lawsuit automatically stayed FDA approval of Accord&#8217;s application until April&#160;13, 2013 or until an adverse court decision, if any, whichever may occur earlier. The Company and CRT entered into agreements with Sun and Accord to stay the respective lawsuits pending the outcome of the U.S. Supreme Court appeal process in the Barr lawsuit. In light of the U.S. Supreme Court&#8217;s denial of Barr&#8217;s petition, Sun and Accord withdrew their challenges to the <i>Temodar</i> patent and the respective lawsuits have been withdrawn. </font></p> <p style="margin-top:12px;margin-bottom:0px; text-indent:6%" align="justify"><font style="font-family:times new roman" size="2"><i>Vytorin</i>&#160;&#8212;&#160;In December 2009, a patent infringement lawsuit was filed in the United States against Mylan Pharmaceuticals, Inc. (&#8220;Mylan&#8221;) in respect of Mylan&#8217;s application to the FDA seeking pre-patent expiry approval to sell a generic version of <i>Vytorin</i>. A trial against Mylan jointly in respect of <i>Zetia</i> and <i>Vytorin</i> was conducted in December 2011. In April 2012, the court issued a decision finding the patent valid and enforceable. Accordingly, Mylan&#8217;s ANDA will not be approvable until April&#160;25, 2017. Mylan has appealed that decision. In February 2010, a patent infringement lawsuit was filed in the United States against Teva in respect of Teva&#8217;s application to the FDA seeking pre-patent expiry approval to sell a generic version of <i>Vytorin</i>. In July 2011, the patent infringement lawsuit was dismissed and Teva agreed not to sell generic versions of <i>Zetia</i> or <i>Vytorin</i> until the Company&#8217;s exclusivity rights expire on April&#160;25, 2017, except in certain circumstances. In August 2010, a patent infringement lawsuit was filed in the United States against Impax Laboratories Inc. (&#8220;Impax&#8221;) in respect of Impax&#8217;s application to the FDA seeking pre-patent expiry approval to sell a generic version of <i>Vytorin</i>. An agreement was reached with Impax to stay the lawsuit pending the outcome of the lawsuit with Mylan. In October 2011, a patent infringement lawsuit was filed in the United States against Actavis Inc. (&#8220;Actavis&#8221;) in respect to Actavis&#8217; application to the FDA seeking pre-patent expiry approval to sell a generic version of <i>Vytorin</i>. An agreement was reached with Actavis to stay the lawsuit pending the outcome of the lawsuit with Mylan. </font></p> <p style="margin-top:12px;margin-bottom:0px; text-indent:6%" align="justify"><font style="font-family:times new roman" size="2"> <i>Zetia&#160;&#8212;&#160;</i>In March 2007, a patent infringement lawsuit was filed in the United States against Glenmark Pharmaceuticals Inc., USA and its parent corporation (collectively, &#8220;Glenmark&#8221;) in respect of Glenmark&#8217;s application to the FDA seeking pre-patent expiry approval to sell a generic version of <i>Zetia</i>. In May 2010, Glenmark agreed to a settlement by virtue of which Glenmark will be permitted to launch its generic product in the United States on December&#160;12, 2016, subject to receiving final FDA approval. In June 2010, a patent infringement lawsuit was filed in the United States against Mylan in respect of Mylan&#8217;s application to the FDA seeking pre-patent expiry approval to sell a generic version of <i>Zetia</i>. A trial against Mylan jointly in respect of <i>Zetia</i> and <i>Vytorin</i> was conducted in December 2011. In April 2012, the court issued a decision finding the patent valid and enforceable. Accordingly, Mylan&#8217;s ANDA will not be approvable until April&#160;25, 2017. Mylan has appealed that decision. In September 2010, a patent infringement lawsuit was filed in the United States against Teva in respect of Teva&#8217;s application to the FDA seeking pre-patent expiry approval to sell a generic version of <i>Zetia</i>. In July 2011, the patent infringement lawsuit was dismissed without any rights granted to Teva. </font></p> <p style="margin-top:12px;margin-bottom:0px"><font style="font-family:times new roman" size="2"><b>Other Litigation </b></font></p> <p style="margin-top:0px;margin-bottom:0px; text-indent:6%" align="justify"><font style="font-family:times new roman" size="2"> There are various other pending legal proceedings involving the Company, principally product liability and intellectual property lawsuits. While it is not feasible to predict the outcome of such proceedings, in the opinion of the Company, either the likelihood of loss is remote or any reasonably possible loss associated with the resolution of such proceedings is not expected to be material to the Company&#8217;s financial position, results of operations or cash flows either individually or in the aggregate. </font></p> <p style="margin-top:12px;margin-bottom:0px"><font style="font-family:times new roman" size="2"><b>Legal Defense Reserves </b></font></p> <p style="margin-top:0px;margin-bottom:0px; text-indent:6%" align="justify"><font style="font-family:times new roman" size="2">Legal defense costs expected to be incurred in connection with a loss contingency are accrued when probable and reasonably estimable. Some of the significant factors considered in the review of these legal defense reserves are as follows: the actual costs incurred by the Company; the development of the Company&#8217;s legal defense strategy and structure in light of the scope of its litigation; the number of cases being brought against the Company; the costs and outcomes of completed trials and the most current information regarding anticipated timing, progression, and related costs of pre-trial activities and trials in the associated litigation. The amount of legal defense reserves as of June&#160;30, 2012 and December&#160;31, 2011 of approximately $250 million and $240 million, respectively, represents the Company&#8217;s best estimate of the minimum amount of defense costs to be incurred in connection with its outstanding litigation; however, events such as additional trials and other events that could arise in the course of its litigation could affect the ultimate amount of legal defense costs to be incurred by the Company. The Company will continue to monitor its legal defense costs and review the adequacy of the associated reserves and may determine to increase the reserves at any time in the future if, based upon the factors set forth, it believes it would be appropriate to do so. </font></p> <p style="margin-top:12px;margin-bottom:0px"><font style="font-family:times new roman" size="2"><b>Environmental Matters </b></font></p> <p style="margin-top:0px;margin-bottom:0px; text-indent:6%" align="justify"><font style="font-family:times new roman" size="2">The Company and its subsidiaries are parties to a number of proceedings brought under the Comprehensive Environmental Response, Compensation and Liability Act, commonly known as Superfund, and other federal and state equivalents. These proceedings seek to require the operators of hazardous waste disposal facilities, transporters of waste to the sites and generators of hazardous waste disposed of at the sites to clean up the sites or to reimburse the government for cleanup costs. The Company has been made a party to these proceedings as an alleged generator of waste disposed of at the sites. In each case, the government alleges that the defendants are jointly and severally liable for the cleanup costs. Although joint and several liability is alleged, these proceedings are frequently resolved so that the allocation of cleanup costs among the parties more nearly reflects the relative contributions of the parties to the site situation. The Company&#8217;s potential liability varies greatly from site to site. For some sites the potential liability is <i>de minimis </i>and for others the final costs of cleanup have not yet been determined. While it is not feasible to predict the outcome of many of these proceedings brought by federal or state agencies or private litigants, in the opinion of the Company, such proceedings should not ultimately result in any liability which would have a material adverse effect on the financial position, results of operations, liquidity or capital resources of the Company. The Company has taken an active role in identifying and providing for these costs and such amounts do not include any reduction for anticipated recoveries of cleanup costs from former site owners or operators or other recalcitrant potentially responsible parties. </font></p> <p style="margin-top:12px;margin-bottom:0px; text-indent:6%" align="justify"><font style="font-family:times new roman" size="2">As previously disclosed, approximately 2,200 plaintiffs have filed an amended complaint against Merck and 12 other defendants in U.S.&#160;District Court, Eastern District of California asserting claims under the Clean Water Act, the Resource Conservation and Recovery Act, as well as negligence and nuisance. The suit seeks damages for personal injury, diminution of property value, medical monitoring and other alleged real and personal property damage associated with groundwater, surface water and soil contamination found at the site of a former Merck subsidiary in Merced, California. Certain of the other defendants in this suit have settled with plaintiffs regarding some or all aspects of plaintiffs&#8217; claims. This lawsuit is proceeding in a phased manner. A jury trial commenced in February 2011 during which a jury was asked to make certain factual findings regarding whether contamination moved off-site to any areas where plaintiffs could have been exposed to such contamination and, if so, when, where and in what amounts. Defendants in this &#8220;Phase 1&#8221; trial included Merck and three of the other original 12 defendants. In March 2011, the Phase 1 jury returned a mixed verdict, finding in favor of Merck and the other defendants as to some, but not all, of plaintiffs&#8217; claims. Specifically, the jury found that contamination from the site did not enter or affect plaintiffs&#8217; municipal water supply wells or any private domestic wells. The jury found, however, that plaintiffs could have been exposed to contamination via air emissions prior to 1994, as well as via surface water in the form of storm drainage channeled into an adjacent irrigation canal, including during a flood in April 2006. In response to post-trial motions by Merck and other defendants, on September&#160;7, 2011, the court entered an order setting aside a part of the Phase 1 jury&#8217;s findings that had been in favor of plaintiffs. Specifically, the court held that plaintiffs could not have been exposed to any contamination in surface or flood water during the April 2006 flood or, in fact, at any time later than 1991. Merck&#8217;s motion for reconsideration of the remainder of the jury&#8217;s Phase I verdict that was adverse to Merck was denied. Following the retirement of the judge handling this case, on September&#160;21, 2011, the case was assigned to Judge David O. Carter of the U.S. District Court for the Central District of California. Judge Carter selected 10 plaintiffs whose claims would be reviewed and, depending on the outcome of Merck&#8217;s anticipated summary judgment motions, possibly tried in early 2013. Plaintiffs subsequently withdrew the claim of one of those 10 plaintiffs, leaving nine whose claims may proceed to trial. 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In addition, the effective tax rates for the second quarter and first six months of 2011 also reflect a net favorable impact relating to the settlement of Merck&#8217;s 2002-2005 federal income tax audit as discussed below, as well as the net favorable impact of certain foreign and state tax rate changes that resulted in a net $230 million reduction of deferred tax liabilities on intangibles established in purchase accounting. 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This net benefit reflects the decrease of unrecognized tax benefits for the years under examination partially offset by increases to the unrecognized tax benefits for years subsequent to the examination period as a result of this settlement. The Company disagrees with the IRS treatment of one issue raised during this examination and is appealing the matter through the IRS administrative process. </font></p> <p style="margin-top:12px;margin-bottom:0px; text-indent:6%" align="justify"><font style="font-family:times new roman" size="2"> As previously disclosed, the Canada Revenue Agency (the &#8220;CRA&#8221;) has proposed adjustments for 1999 and 2000 relating to intercompany pricing matters and, in July 2011, the CRA issued assessments for other miscellaneous audit issues for tax years 2001-2004. These adjustments would increase Canadian tax due by approximately $330 million plus approximately $390 million of interest through June&#160;30, 2012. The Company disagrees with the positions taken by the CRA and believes they are without merit. The Company continues to contest the assessments through the CRA appeals process. The CRA is expected to prepare similar adjustments for later years. 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Jun. 30, 2012
LegalMatter
AWP Litigation [Member]
 
Loss Contingencies [Line Items]  
Loss contingency, pending claims number 6
XML 14 R48.htm IDEA: XBRL DOCUMENT v2.4.0.6
Joint Ventures and Other Equity Method Affiliates (Details Textual) (USD $)
In Millions, unless otherwise specified
1 Months Ended 12 Months Ended
Jun. 30, 2012
Dec. 31, 2008
Joint Ventures and Other Equity Method Affiliates (Textual) [Abstract]    
Annual profit allocation exercisable period 3 years  
Multiple of average annual profit allocation to be included in option exercise price 10  
AstraZeneca LP [Member]
   
Schedule of Equity Method Investments [Line Items]    
Limited partner interest in AZLP   1.00%
General partner interest in AZLP   99.00%
Agreed-upon payment by AstraZeneca at closing for exercise of option $ 327  
XML 15 R70.htm IDEA: XBRL DOCUMENT v2.4.0.6
Segment Reporting (Details Textual) (USD $)
In Millions, unless otherwise specified
3 Months Ended 6 Months Ended
Jun. 30, 2012
Jun. 30, 2011
Jun. 30, 2012
Jun. 30, 2011
Segment Reporting (Textual) [Abstract]        
Number of operating segments     4  
AZLP [Member]
       
Segment Reporting (Textual) [Abstract]        
Revenue from AstraZeneca LP $ 223 $ 306 $ 409 $ 628
XML 16 R55.htm IDEA: XBRL DOCUMENT v2.4.0.6
Contingencies and Environmental Liabilities (Details Textual 6) (USD $)
In Millions, unless otherwise specified
6 Months Ended
Jun. 30, 2012
Dec. 31, 2011
Jun. 30, 2012
Environmental Matters [Member]
Plaintiffs
Defendant
Sep. 21, 2011
Environmental Matters [Member]
Plaintiffs
Loss Contingencies [Line Items]        
Number of plaintiff groups     2,200  
Number of other defendants in environmental matters     12  
Number of other defendants in phase 1 trial     3  
Number of cases settled or dismissed     1,083  
Number of plaintiffs selected by Judge for review       10
Number of plaintiffs whose claims may proceed to trial       9
Contingencies and Environmental Liabilities (Textual) [Abstract]        
Legal defense costs reserve $ 250 $ 240    
XML 17 R46.htm IDEA: XBRL DOCUMENT v2.4.0.6
Joint Ventures and Other Equity Method Affiliates (Details) (USD $)
In Millions, unless otherwise specified
3 Months Ended 6 Months Ended
Jun. 30, 2012
Jun. 30, 2011
Jun. 30, 2012
Jun. 30, 2011
Equity income from affiliates        
Equity income from affiliates $ 142 $ 55 $ 253 $ 193
Other [Member]
       
Equity income from affiliates        
Equity income from affiliates 2 11   16
AstraZeneca LP [Member]
       
Equity income from affiliates        
Equity income from affiliates $ 140 $ 44 $ 253 $ 177
XML 18 R33.htm IDEA: XBRL DOCUMENT v2.4.0.6
Segment Reporting (Tables)
6 Months Ended
Jun. 30, 2012
Segment Reporting [Abstract]  
Sales of the Company's products

Sales of the Company’s products were as follows:

 

                                 
                         Three Months Ended                    
June 30,
                         Six Months Ended                    
June 30,
 
($ in millions)   2012     2011     2012     2011  

 

 

Primary Care and Women’s Health

                               

Cardiovascular

                               

Zetia

    $ 632       $ 592         $ 1,246       $ 1,174    

Vytorin

    445       459         889       939    

Diabetes and Obesity

                               

Januvia

    1,058       779         1,977       1,518    

Janumet

    411       321         802       626    

Respiratory

                               

Singulair

    1,431       1,354         2,771       2,682    

Nasonex

    293       323         668       696    

Clarinex

    140       209         273       364    

Asmanex

    51       47         99       107    

Dulera

    50       25         89       37    

Women’s Health and Endocrine

                               

Fosamax

    186       221         370       429    

NuvaRing

    157       154         303       297    

Follistim AQ

    125       143         241       276    

Implanon

    85       81         161       141    

Cerazette

    72       66         139       125    

Other

                               

Maxalt

    154       131         310       304    

Arcoxia

    117       100         229       214    

Avelox

    44       61         117       167    

Hospital and Specialty

                               

Immunology

                               

Remicade

    518       842         1,037       1,595    

Simponi

    76       75         150       129    

Infectious Disease

                               

Isentress

    398       337         735       629    

PegIntron

    183       154         345       319    

Cancidas

    166       168         311       326    

Victrelis

    126       21         238       22    

Invanz

    110       103         211       189    

Primaxin

    104       136         192       272    

Noxafil

    66       56         125       110    

Oncology

                               

Temodar

    225       234         461       481    

Emend

    145       120         247       207    

Other

                               

Cosopt/Trusopt

    105       122         229       236    

Bridion

    60       47         118       89    

Integrilin

    60       56         113       120    

Diversified Brands

                               

Cozaar/Hyzaar

    337       406         674       832    

Propecia

    100       112         208       218    

Zocor

    96       107         199       234    

Claritin Rx

    48       65         134       186    

Remeron

    66       57         123       117    

Proscar

    55       53         106       113    

Vasotec/Vaseretic

    49       59         102       116    

Vaccines (1)

                               

Gardasil

    324       277         608       490    

ProQuad/M-M-R II/Varivax

    316       291         571       535    

RotaTeq

    142       148         284       272    

Zostavax

    148       122         224       146    

Pneumovax

    101       64         213       143    

Other pharmaceutical (2) 

    985       1,062         2,000       1,957    

 

 

Total Pharmaceutical segment sales

    10,560       10,360         20,642       20,179    

 

 

Other segment sales (3) 

    1,680       1,690         3,273       3,323    

 

 

Total segment sales

    12,240       12,050         23,915       23,502    

 

 

Other (4)

    71       101         126       230    

 

 
      $ 12,311       $ 12,151         $ 24,041       $ 23,732    

 

 

 

(1 ) 

These amounts do not reflect sales of vaccines sold in most major European markets through the Company’s joint venture, Sanofi Pasteur MSD, the results of which are reflected in Equity income from affiliates. These amounts do, however, reflect supply sales to Sanofi Pasteur MSD.

(2 ) 

Other pharmaceutical primarily includes sales of other human health pharmaceutical products not listed separately.

(3 ) 

Reflects other non-reportable segments, including Animal Health and Consumer Care, and revenue from the Company’s relationship with AZLP primarily relating to sales of Nexium. Revenue from AZLP was $223 million and $306 million for the second quarter of 2012 and 2011, respectively, and $409 million and $628 million for the first six months of 2012 and 2011, respectively.

(4 ) 

Other revenues are primarily comprised of miscellaneous corporate revenues, third-party manufacturing sales, sales related to divested products or businesses and supply sales not included in segment results. The declines in other revenues in the second quarter and first six months of 2012 as compared with the same periods of 2011 reflect lower third-party manufacturing sales, which for the year-to-date period were attributable in part to the divestiture of certain manufacturing facilities in the first quarter of 2011.

Reconciliation of segment profits to Income Before Taxes

A reconciliation of segment profits to Income before taxes is as follows:

 

                                 
    Three Months Ended
June 30,
    Six Months Ended
June 30,
 
($ in millions)         2012                 2011                 2012                 2011        

 

 

 

Segment profits:

                               

Pharmaceutical segment

    $       6,906      $ 6,443        $ 13,502      $ 12,659   

Other segments

    774        726        1,578        1,517   
   

 

 

 

Total segment profits

    7,680        7,169        15,080        14,176   

Other profits (losses)

    45        34        (28)       (15)  

Unallocated:

                               

Interest income

    76        39        129        69   

Interest expense

    (172)       (170)       (346)       (345)  

Equity income from affiliates

    11        (87)       (9)       (81)  

Depreciation and amortization

    (574)       (623)       (1,135)       (1,194)  

Research and development

    (1,930)       (1,679)       (3,573)       (3,618)  

Amortization of purchase accounting adjustments

    (1,226)       (1,225)       (2,455)       (2,504)  

Restructuring costs

    (144)       (668)       (363)       (654)  

Arbitration settlement charge

                      (500)  

Other unallocated, net

    (1,086)       (1,118)       (2,114)       (1,933)  

 

 
      $ 2,680      $ 1,672        $ 5,186      $ 3,401   

 

 
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Equity (Details 1) (USD $)
In Millions, unless otherwise specified
3 Months Ended 6 Months Ended
Jun. 30, 2012
Jun. 30, 2011
Jun. 30, 2012
Jun. 30, 2011
Accumulated balances related to each component of other comprehensive income (loss)        
Derivatives, Beginning balance     $ 4 $ 41
Derivatives, Other comprehensive (loss) income 102 (30) 44 (137)
Derivatives, Ending balance 48 (96) 48 (96)
Investments, Beginning balance     21 31
Investments, Other comprehensive (loss) income 1 (4) 30 (5)
Investments, Ending balance 51 26 51 26
Employee Benefit Plans, Beginning balance     (2,346) (2,043)
Benefit plan net gain (loss) and prior service cost (credit), net of amortization 18 10 18 28
Employee Benefit Plans, Ending balance (2,328) (2,015) (2,328) (2,015)
Cumulative Translation Adjustment, beginning balance     (811) (1,245)
Cumulative Translation Adjustment, Other comprehensive (loss) income (30) 418 (86) 554
Cumulative Translation Adjustment, ending balance (897) (691) (897) (691)
Accumulated Other Comprehensive Loss, Beginning Balance     (3,132) (3,216)
Accumulated Other Comprehensive Loss, Other comprehensive (loss) income 91 394 6 440
Accumulated Other Comprehensive Loss, Ending Balance $ (3,126) $ (2,776) $ (3,126) $ (2,776)
XML 21 R25.htm IDEA: XBRL DOCUMENT v2.4.0.6
Financial Instruments (Tables)
6 Months Ended
Jun. 30, 2012
Financial Instruments [Abstract]  
Fair value of derivatives segregated between those derivatives that are designated as hedging instruments and those that are not designated as hedging instruments

Presented in the table below is the fair value of derivatives segregated between those derivatives that are designated as hedging instruments and those that are not designated as hedging instruments:

 

                                                     
        June 30,2012     December 31, 2011  
        Fair Value of Derivative     U.S. Dollar     Fair Value of Derivative     U.S. Dollar  

($ in millions)

  Balance Sheet Caption     Asset       Liability       Notional       Asset       Liability       Notional  

Derivatives Designated as Hedging Instruments

  

Foreign exchange contracts (current)

 

Deferred income taxes and other current assets

    $ 279     $ -     $ 5,005       $ 196     $ -     $ 3,727  

Foreign exchange contracts (non-current)

 

Other assets

    470       -       5,177       420       -       4,956  

Foreign exchange contracts (current)

 

Accrued and other current liabilities

    -       13       411       -       53       1,718  

Foreign exchange contracts (non-current)

 

Deferred income taxes and noncurrent liabilities

    -       7       436       -       1       104  
          $ 749     $ 20     $ 11,029       $ 616     $ 54     $ 10,505  

Derivatives Not Designated as Hedging Instruments

  

Foreign exchange contracts (current)

 

Deferred income taxes and other current assets

    $ 100     $ -     $ 4,511       $ 139     $ -     $ 5,306  

Foreign exchange contracts (non-current)

 

Other assets

    35       -       339       -       -       -  

Foreign exchange contracts (current)

 

Accrued and other current liabilities

    -       28       3,740       -       54       5,013  
          $ 135     $ 28     $ 8,590       $ 139     $ 54     $ 10,319  
          $ 884     $ 48     $ 19,619       $ 755     $ 108     $ 20,824  
Location and pretax gain or loss amounts for derivatives that are: (i) designated in a fair value hedging relationship, (ii) designated in a cash flow hedging relationship, (iii) designated in a foreign currency net investment hedging relationship and (iv) not designated in a hedging relationship

The table below provides information on the location and pretax gain or loss amounts for derivatives that are: (i) designated in a fair value hedging relationship, (ii) designated in a cash flow hedging relationship, (iii) designated in a foreign currency net investment hedging relationship and (iv) not designated in a hedging relationship:

 

                                     
          Three Months Ended      
June 30,
              Six Months Ended      
June 30,
 
($ in millions)         2012                 2011                     2012                 2011        

 

 

Derivatives designated in fair value hedging relationships

                                   

 

Interest rate swap contracts

                                   

Amount of gain recognized in Other (income) expense, net on derivatives

    $       -     $       (126)           $       -     $       (163)  

Amount of loss recognized in Other (income) expense, net on hedged item

    -       126            -       163   
           

Derivatives designated in foreign currency cash flow hedging relationships

                                   

 

Foreign exchange contracts

                                   

Amount of loss reclassified from AOCI to Sales

    26       20            53       27   

Amount of (gain) loss recognized in OCI on derivatives

    (154     69            (34     252   
           

Derivatives designated in foreign currency net investment hedging relationships

                                   

 

Foreign exchange contracts

                                   

Amount of gain recognized in Other (income) expense, net on derivatives (1)

    (2     (2)           (11     (8)  

Amount of loss (gain) recognized in OCI on derivatives

    86       33            (56     34   
           

Derivatives not designated in a hedging relationship

                                   

 

Foreign exchange contracts

                                   

Amount of (gain) loss recognized in Other (income) expense, net on derivatives (2)

    (279     33            (26     349   

 

 

 

(1) 

There was no ineffectiveness on the hedge. Represents the amount excluded from hedge effectiveness testing.

(2) 

These derivative contracts mitigate changes in the value of remeasured foreign currency denominated monetary assets and liabilities attributable to changes in foreign currency exchange rates.

Gross unrealized gains and losses on available-for-sale investments recorded in Accumulated Other Comprehensive Income ("AOCI")

Information on available-for-sale investments is as follows:

 

                                                                     
    June 30, 2012         December 31, 2011  
    Fair     Amortized     Gross Unrealized         Fair     Amortized     Gross Unrealized  
($ in millions)   Value     Cost     Gains     Losses         Value     Cost     Gains     Losses  

 

       

 

 

 

 

Corporate notes and bonds

  $ 2,787     $ 2,759     $ 30     $ (2)         $ 2,032     $ 2,024     $ 16     $ (8)  

U.S. government and agency securities

    773       772       1                 1,021       1,018       3        

Asset-backed securities

    441       439       2                 292       292       1       (1)  

Mortgage-backed securities

    271       270       2       (1)           223       223       1       (1)  

Commercial paper

    220       220       -                 1,029       1,029       -        

Foreign government bonds

    76       75       1                 72       72       -        

Other debt securities

    3       1       2                 3       1       2        

Equity securities

    383       354       29                 397       383       14        

 

 
    $ 4,954     $ 4,890     $ 67     $ (3)         $ 5,069     $ 5,042     $ 37     $ (10)  

 

 
Financial assets and liabilities measured at fair value on a recurring basis

Financial assets and liabilities measured at fair value on a recurring basis are summarized below:

 

                                                                     
    Fair Value Measurements Using         Fair Value Measurements Using  
     Quoted Prices
In Active
Markets for
 Identical Assets 
(Level 1)
    Significant
Other
Observable
Inputs
(Level 2)
    Significant
Unobservable
Inputs
(Level 3)
    Total          Quoted Prices
In Active
Markets for
 Identical Assets 
(Level 1)
    Significant
Other
Observable
Inputs
(Level 2)
    Significant
Unobservable
Inputs
(Level 3)
    Total  
($ in millions)   June 30, 2012          December 31, 2011  

Assets

                                                                   

Investments

                                                                   

Corporate notes and bonds

  $ -     $ 2,787     $ -     $ 2,787         $ -     $ 2,032     $ -     $ 2,032  

U.S. government and agency securities

    -       773       -       773           -       1,021       -       1,021  

Asset-backed securities (1)

    -       441       -       441           -       292       -       292  

Mortgage-backed securities (1)

    -       271       -       271           -       223       -       223  

Commercial paper

    -       220       -       220           -       1,029       -       1,029  

Foreign government bonds

    -       76       -       76           -       72       -       72  

Equity securities

    203       9       -       212           205       22       -       227  

Other debt securities

    -       3       -       3           -       3       -       3  
      203       4,580       -       4,783           205       4,694       -       4,899  
                   

Other assets

                                                                   

Securities held for employee compensation

    171       -       -       171           170       -       -       170  
                                                                     

Derivative assets (2)

                                                                   

Purchased currency options

    -       763       -       763           -       613       -       613  

Forward exchange contracts

    -       121       -       121           -       142       -       142  
      -       884       -       884           -       755       -       755  

Total assets

  $           374     $      5,464     $             -     $      5,838         $           375     $      5,449     $             -     $      5,824  
                   

Liabilities

                                                                   

Derivative liabilities (2)

                                                                   

Forward exchange contracts

  $ -     $ 48     $ -     $ 48         $ -     $ 107     $ -     $ 107  

Written currency options

    -       -       -       -           -       1       -       1  

Total liabilities

  $ -     $ 48     $ -     $ 48         $ -     $ 108     $ -     $ 108  

 

(1) 

Primarily all of the asset-backed securities are highly-rated (Standard & Poor’s rating of AAA and Moody’s Investors Service rating of Aaa), secured primarily by credit card, auto loan, and home equity receivables, with weighted-average lives of primarily 5 years or less. Mortgage-backed securities represent AAA-rated securities issued or unconditionally guaranteed as to payment of principal and interest by U.S. government agencies.

(2) 

The fair value determination of derivatives includes the impact of the credit risk of counterparties to the derivatives and the Company’s own credit risk, the effects of which were not significant.

XML 22 R50.htm IDEA: XBRL DOCUMENT v2.4.0.6
Contingencies and Environmental Liabilities (Details Textual 1) (USD $)
In Millions, unless otherwise specified
1 Months Ended
Jun. 30, 2012
Fosamax bellwether trials [Member]
LegalMatter
Feb. 28, 2011
Fosamax bellwether trials [Member]
LegalMatter
Jun. 30, 2012
Fosamax [Member]
Plaintiffs
LegalMatter
Jun. 30, 2012
Fosamax [Member]
Femur Fracture [Member]
LegalMatter
Jun. 30, 2012
Fosamax [Member]
Femur Fracture [Member]
Federal MDL [Member]
LegalMatter
Jun. 30, 2012
Fosamax [Member]
Femur Fracture [Member]
Other state court [Member]
LegalMatter
Jun. 30, 2012
Fosamax [Member]
Femur Fracture [Member]
New Jersey state court [Member]
LegalMatter
Jun. 30, 2012
Fosamax [Member]
Femur Fracture [Member]
California State Court [Member]
LegalMatter
Jun. 30, 2012
Fosamax [Member]
Cases Alleging ONJ [Member]
LegalMatter
Jun. 30, 2012
Fosamax [Member]
Cases Alleging ONJ [Member]
New Jersey state court [Member]
LegalMatter
Oct. 31, 2010
Fosamax [Member]
ONJ MDL [Member]
Federal [Member]
Jun. 30, 2010
Fosamax [Member]
ONJ MDL [Member]
Federal [Member]
Jun. 30, 2012
Fosamax [Member]
ONJ MDL [Member]
Federal [Member]
LegalMatter
Loss Contingencies [Line Items]                          
Loss contingency, pending claims number 4 2 3,615 2,415 510 9 1,535 350 1,200 240     950
Number of plaintiff groups     4,175                    
Verdict amount in favor of the plaintiff                       $ 8  
Reduced verdict amount                     $ 1.5    
Initial number of cases selected for review         40   30            
Subsequent number of cases selected for review         33                
Number of cases settled or dismissed             7            
XML 23 R42.htm IDEA: XBRL DOCUMENT v2.4.0.6
Financial Instruments (Details Textual) (USD $)
6 Months Ended 6 Months Ended 3 Months Ended
Jun. 30, 2012
Jun. 30, 2011
Contract
Dec. 31, 2011
Dec. 31, 2010
Jun. 30, 2012
Spanish government's debt stabilization/stimulus plan [Member]
Jun. 30, 2012
Greece [Member]
Jun. 30, 2012
Italy [Member]
Mar. 31, 2012
Italy [Member]
Jun. 30, 2012
Spain [Member]
Jun. 30, 2012
Portugal [Member]
Accounts, Notes, Loans and Financing Receivable [Line Items]                    
Percentage of aggregate total hospital and public sector accounts receivable related to Greece, Italy, Spain and Portugal           16.00% 38.00%   28.00% 18.00%
Accounts receivable collected         $ 500,000,000          
Receivables factored during period             120,000,000 110,000,000    
Financial Instruments (Textual) [Abstract]                    
Maximum planning cycle of third-party sales hedges 3 years                  
Maximum average period of maturities of contracts in years 1 year                  
Aggregate notional amount for pay-floating, receive-fixed interest rate swap contracts, designated as fair value hedges for fixed-rate notes   1,900,000,000                
Pre tax net unrealized loss on derivatives maturing within next 12 months estimated to be reclassified from AOCI to sales 2,000,000                  
Available-for-sale debt securities maturing after one year through five years 3,400,000,000                  
Weighted-average lives of asset-backed securities 5 years or less                  
Cash and cash equivalents 16,752,000,000 12,342,000,000 13,531,000,000 10,900,000,000            
Cash equivalents 15,900,000,000                  
Fair value of loans payable and long-term debt, including current portion 21,200,000,000   19,500,000,000              
Carrying value of Loans payable and long-term debt, including current portion 19,000,000,000   17,500,000,000              
Available-for-sale debt securities included in Short-term investments 698,000,000                  
Hospital and public sector receivables in Greece, Italy, Spain and Portugal 700,000,000                  
Percentage of accounts receivables outstanding for more than one year that relate to Greece, Italy, Spain and Portugal 70.00%                  
Cash collateral received from counterparties 539,000,000   327,000,000              
Pretax gains (losses) from euro-denominated notes included in cumulative translation adjustments 92,000,000 (178,000,000)                
Accounts receivable outstanding for more than one year 200,000,000                  
Total accounts receivable in Greece, Italy, Spain and Portugal 1,000,000,000                  
Number of swap contracts terminated   9                
Notional amount of swap contracts terminated   3,500,000,000                
Hedged fixed rate notes related to terminated interest rate swaps   3,500,000,000                
Cash received from interest rate swap termination   175,000,000                
Accrued interest received on termination of swap contracts   36,000,000                
Deferred and amortized swap contracts   $ 139,000,000                
XML 24 R37.htm IDEA: XBRL DOCUMENT v2.4.0.6
Acquisitions, Divestitures, Research Collaborations and License Agreements (Details) (USD $)
In Millions, except Per Share data, unless otherwise specified
1 Months Ended 6 Months Ended
May 30, 2011
Jun. 30, 2012
Jun. 30, 2011
Acquisitions Divestitures Research Collaborations and License Agreements (Textual) [Abstract]      
Upfront payment related to licensing agreement   $ 120  
Potential future milestone payments   880  
Gain on sale of manufacturing facilities and related assets     127
Purchase price for acquisition $ 420    
Amount of cash paid per share for acquisition $ 5.00    
XML 25 R52.htm IDEA: XBRL DOCUMENT v2.4.0.6
Contingencies and Environmental Liabilities (Details Textual 3) (Propecia/Proscar [Member])
Jun. 30, 2012
Plaintiffs
LegalMatter
Propecia/Proscar [Member]
 
Loss Contingencies [Line Items]  
Loss contingency, pending claims number 200
Number of plaintiff groups 325
XML 26 R67.htm IDEA: XBRL DOCUMENT v2.4.0.6
Earnings per Share (Details Textual)
In Millions, unless otherwise specified
3 Months Ended 6 Months Ended
Jun. 30, 2012
Jun. 30, 2011
Jun. 30, 2012
Jun. 30, 2011
Earnings Per Share (Textual) [Abstract]        
Common shares issuable under share-based compensation plans excluded from diluted earnings per common share 107 138 112 173
XML 27 R61.htm IDEA: XBRL DOCUMENT v2.4.0.6
Share-Based Compensation Plans (Details Textual) (USD $)
In Millions, except Per Share data, unless otherwise specified
6 Months Ended
Jun. 30, 2012
Jun. 30, 2011
Share-Based Compensation (Textual) [Abstract]    
Number of RSUs granted during the period 7 8
Weighted-average grant date fair value of RSUs issued during the period $ 39.29 $ 36.47
Options granted by company 7 8
Weighted- average exercise price of options granted in period $ 39.26 $ 36.55
Weighted- average fair value per option granted $ 5.46 $ 5.37
Total pre tax unrecognized compensation expense related to nonvested stock options, RSU and PSU awards $ 555  
Weighted average period in years of recognition for nonvested stock options, RSU and PSU awards 2 years  
XML 28 R47.htm IDEA: XBRL DOCUMENT v2.4.0.6
Joint Ventures and Other Equity Method Affiliates (Details 1) (AstraZeneca LP [Member], USD $)
In Millions, unless otherwise specified
3 Months Ended 6 Months Ended
Jun. 30, 2012
Jun. 30, 2011
Jun. 30, 2012
Jun. 30, 2011
AstraZeneca LP [Member]
       
Summarized financial information for AZLP        
Sales $ 1,150 $ 1,181 $ 2,192 $ 2,336
Materials and production costs 520 516 959 1,061
Other expense, net 350 345 732 646
Income before taxes $ 280 $ 320 $ 501 $ 629
XML 29 R9.htm IDEA: XBRL DOCUMENT v2.4.0.6
Acquisitions, Divestitures, Research Collaborations and License Agreements
6 Months Ended
Jun. 30, 2012
Acquisitions, Divestitures, Research Collaborations and License Agreements [Abstract]  
Acquisitions, Divestitures, Research Collaborations and License Agreements

3.   Acquisitions, Divestitures, Research Collaborations and License Agreements

In April 2012, the Company entered into an agreement with Endocyte, Inc. (“Endocyte”) to develop and commercialize Endocyte’s novel investigational therapeutic candidate vintafolide (MK-8109). Vintafolide is currently being evaluated in a Phase III clinical trial for platinum-resistant ovarian cancer (PROCEED) and a Phase II trial for non-small cell lung cancer. Under the agreement, Merck gained worldwide rights to develop and commercialize vintafolide. Endocyte received a $120 million upfront payment, which the Company recorded in Research and development expenses in the second quarter of 2012, and is eligible for milestone payments of up to $880 million based on the successful achievement of development, regulatory and commercialization goals for vintafolide for a total of six cancer indications. In addition, if vintafolide receives regulatory approval, Endocyte will receive an equal share of the profit in the United States as well as a royalty on sales of the product in the rest of the world. Endocyte has retained the right to co-promote vintafolide with Merck in the United States and Merck has the exclusive right to promote vintafolide in the rest of world. Endocyte will be responsible for the majority of funding and completion of the PROCEED trial. Merck will be responsible for most other development activities, all other costs and will have most decision rights for vintafolide. Merck has the right to terminate the agreement on 90 days notice. Merck and Endocyte both have the right to terminate the agreement due to the material breach or insolvency of the other party. Endocyte has the right to terminate the agreement in the event that Merck challenges an Endocyte patent right relating to vintafolide. Upon termination of the agreement, depending upon the circumstances, the parties have varying rights and obligations with respect to the continued development and commercialization of vintafolide and, in the case of termination for cause by Merck, certain royalty obligations and U.S. profit and loss sharing.

In May 2011, Merck completed the acquisition of Inspire Pharmaceuticals, Inc. (“Inspire”), a specialty pharmaceutical company focused on developing and commercializing ophthalmic products. Under the terms of the merger agreement, Merck acquired all outstanding shares of common stock of Inspire at a price of $5.00 per share in cash for a total of approximately $420 million. The transaction was accounted for as an acquisition of a business; accordingly, the assets acquired and liabilities assumed were recorded at their respective fair values as of the acquisition date. The determination of fair value requires management to make significant estimates and assumptions. In connection with the acquisition, substantially all of the purchase price was allocated to Inspire’s product and product right intangible assets and related deferred tax liabilities, a deferred tax asset relating to Inspire’s net operating loss carryforwards, and goodwill. This transaction closed on May 16, 2011, and accordingly, the results of operations of the acquired business have been included in the Company’s results of operations since the acquisition date. Pro forma financial information has not been included because Inspire’s historical financial results are not significant when compared with the Company’s financial results.

In March 2011, the Company sold the Merck BioManufacturing Network, a provider of contract manufacturing and development services for the biopharmaceutical industry and wholly owned by Merck, to Fujifilm Corporation (“Fujifilm”). Under the terms of the agreement, Fujifilm purchased all of the equity interests in two Merck subsidiaries which together owned all of the assets of the Merck BioManufacturing Network comprising facilities located in Research Triangle Park, North Carolina and Billingham, United Kingdom. As part of the agreement with Fujifilm, Merck has committed to purchase certain development and manufacturing services at fair value from Fujifilm over a three-year period following the closing of the transaction. The transaction resulted in a gain of $127 million in the first six months of 2011 reflected in Other (income) expense, net.

XML 30 R62.htm IDEA: XBRL DOCUMENT v2.4.0.6
Pension and Other Postretirement Benefit Plans (Details) (USD $)
In Millions, unless otherwise specified
3 Months Ended 6 Months Ended
Jun. 30, 2012
Jun. 30, 2011
Jun. 30, 2012
Jun. 30, 2011
Pension Plans, Defined Benefit [Member]
       
Components of net cost of defined benefit plans        
Service cost $ 141 $ 151 $ 283 $ 303
Interest cost 166 180 332 359
Expected return on plan assets (244) (242) (488) (485)
Net amortization 48 46 96 91
Termination benefits 4 7 9 17
Curtailments (1) (6) (1) (10)
Settlements       (1)
Net periodic benefit cost 114 136 231 274
Other Postretirement Benefit Plans, Defined Benefit [Member]
       
Components of net cost of defined benefit plans        
Service cost 21 28 42 56
Interest cost 31 35 62 71
Expected return on plan assets (34) (36) (68) (71)
Net amortization (8) (6) (16) (9)
Termination benefits 3 4 5 6
Curtailments (2)   (4) 1
Net periodic benefit cost $ 11 $ 25 $ 21 $ 54
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Inventories (Details) (USD $)
In Millions, unless otherwise specified
Jun. 30, 2012
Dec. 31, 2011
Inventories    
Finished goods $ 1,808 $ 1,983
Raw materials and work in process 5,705 5,396
Supplies 265 297
Total (approximates current cost) 7,778 7,676
Reduction to LIFO costs (39) (43)
Inventories 7,739 7,633
Recognized as:    
Inventories 6,249 6,254
Other assets $ 1,490 $ 1,379

XML 33 R29.htm IDEA: XBRL DOCUMENT v2.4.0.6
Share-Based Compensation Plans (Tables)
6 Months Ended
Jun. 30, 2012
Share-Based Compensation Plans [Abstract]  
Amounts of share-based compensation cost recorded in the Consolidated Statement of Income

The following table provides amounts of share-based compensation cost recorded in the Consolidated Statement of Income:

 

                                 
      Three Months Ended    
June 30,
        Six Months Ended      
June 30,
 
   

 

 

   

 

 

 

($ in millions)

    2012           2011           2012           2011      

 

 

 

Pretax share-based compensation expense

      $ 93     $ 107           $ 169     $ 200   

Income tax benefit

    (29     (37)        (53     (69)   

 

 

Total share-based compensation expense, net of taxes

      $ 64     $ 70           $ 116     $ 131   

 

 
Assumptions used to determine weighted-average fair value of options granted

The weighted-average fair value of options granted for the first six months of 2012 and 2011 was $5.46 and $5.37 per option, respectively, and was determined using the following assumptions:

 

                 
              Six Months Ended           
June 30,
 
      2012       2011  

 

 

 

Expected dividend yield

    4.4%       4.3%  

Risk-free interest rate

    1.3%       2.6%  

Expected volatility

    25.3%       23.2%  

Expected life (years)

    7.0        7.0   

 

 
XML 34 R28.htm IDEA: XBRL DOCUMENT v2.4.0.6
Equity (Tables)
6 Months Ended
Jun. 30, 2012
Equity [Abstract]  
Shareholders' Equity
                                                                         
                            Accumulated                          
                Other           Other                 Non-        
    Common Stock          Paid-In            Retained       Comprehensive     Treasury Stock     Controlling        
($ and shares in millions)   Shares      Par Value       Capital     Earnings     Loss     Shares     Cost       Interests     Total  

 

Balance January 1, 2011

    3,577     $ 1,788       $ 40,701       $ 37,536     $ (3,216)       495       $     (22,433)      $ 2,429       $       56,805    

Net income attributable to
Merck & Co., Inc.

    -       -         -         3,067       -         -         -          -         3,067    

Cash dividends declared on common stock

    -       -         -         (2,360     -         -         -          -         (2,360)   

Treasury stock shares purchased

    -       -         -         -       -         9         (314)        -         (314)   

Share-based compensation plans and other

    -       -         (44)       -       -         (10)       331          -         287    

Other comprehensive income

    -       -         -         -       440         -         -          -         440    

Net income attributable to noncontrolling interests

    -       -         -         -       -         -         -          58         58    

Distributions attributable to noncontrolling interests

    -       -         -         -       -         -         -          (61)        (61)   

 

 

Balance June 30, 2011

    3,577     $ 1,788       $ 40,657       $ 38,243     $ (2,776)       494     $ (22,416)      $ 2,426       $ 57,922    

 

 

 

Balance January 1, 2012

    3,577     $ 1,788       $ 40,663       $ 38,990     $ (3,132)       536       $ (23,792)      $ 2,426       $ 56,943    

Net income attributable to
Merck & Co., Inc.

    -       -         -         3,531       -         -         -          -         3,531    

Cash dividends declared on common stock

    -       -         -         (2,571     -         -         -          -         (2,571)   

Treasury stock shares purchased

    -       -         -         -       -         26         (985)        -         (985)   

Share-based compensation plans and other

    -       -         (113)       -       -         (24)       809          -         696    

Other comprehensive income

    -       -         -         -       6         -         -          -         6    

Net income attributable to noncontrolling interests

    -       -         -         -       -         -         -          56         56    

Distributions attributable to noncontrolling interests

    -       -         -         -       -         -         -          (3)        (3)   

 

 

Balance June 30, 2012

    3,577     $ 1,788       $ 40,550       $ 39,950     $ (3,126)       538       $ (23,968)      $ 2,479       $ 57,673    

 

 
Accumulated balances related to each component of other comprehensive income (loss)

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

 

                                         
($ in millions)       Derivatives         Investments           Employee
Benefit 
Plans
        Cumulative
    Translation
    Adjustment
    Accumulated 
Other 
Comprehensive 
Loss 
 

 

 

 

Balance January 1, 2011

  $ 41      $ 31      $ (2,043)     $ (1,245)         $     (3,216)   

Other comprehensive (loss) income

    (137)       (5)       28        554        440    

 

 

Balance at June 30, 2011

  $ (96)     $ 26      $ (2,015)     $ (691)         $ (2,776)   

 

 

 

Balance January 1, 2012

  $     $ 21      $ (2,346)     $ (811)         $ (3,132)   

Other comprehensive income (loss)

    44        30        18        (86)       6    

 

 

Balance at June 30, 2012

  $ 48      $ 51      $ (2,328)     $ (897)         $ (3,126)   

 

 
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Equity (Details) (USD $)
In Millions, except Share data, unless otherwise specified
3 Months Ended 6 Months Ended 6 Months Ended
Jun. 30, 2012
Jun. 30, 2011
Jun. 30, 2012
Jun. 30, 2011
Jun. 30, 2012
Common Stock [Member]
Dec. 31, 2011
Common Stock [Member]
Jun. 30, 2011
Common Stock [Member]
Dec. 31, 2010
Common Stock [Member]
Jun. 30, 2012
Other Paid-In Capital [Member]
Jun. 30, 2011
Other Paid-In Capital [Member]
Jun. 30, 2012
Retained Earnings [Member]
Jun. 30, 2011
Retained Earnings [Member]
Jun. 30, 2012
Accumulated Other Comprehensive Loss [Member]
Jun. 30, 2011
Accumulated Other Comprehensive Loss [Member]
Jun. 30, 2012
Treasury Stock [Member]
Jun. 30, 2011
Treasury Stock [Member]
Jun. 30, 2012
Noncontrolling Interests [Member]
Jun. 30, 2011
Noncontrolling Interests [Member]
Stockholders' Equity                                    
Equity, Beginning Balance     $ 56,943 $ 56,805 $ 1,788 $ 1,788 $ 1,788 $ 1,788 $ 40,663 $ 40,701 $ 38,990 $ 37,536 $ (3,132) $ (3,216) $ (23,792) $ (22,433) $ 2,426 $ 2,429
Shares, Beginning Balance     3,577,103,522   3,577,000,000 3,577,000,000 3,577,000,000 3,577,000,000             536,000,000 495,000,000    
Net Income Attributable to Merck & Co., Inc. 1,793 2,024 3,531 3,067             3,531 3,067            
Cash dividends declared on common stock     (2,571) (2,360)             (2,571) (2,360)            
Treasury stock shares purchased     (985) (314)                     (985) (314)    
Treasury stock shares purchased                             26,000,000 9,000,000    
Share-based compensation plans and other     696 287         (113) (44)         809 331    
Share-based compensation plans and other, shares                             (24,000,000) (10,000,000)    
Other comprehensive income 91 394 6 440                 6 440        
Net income attributable to noncontrolling interests 27 30 56 58                         56 58
Distributions attributable to noncontrolling interests     (3) (61)                         (3) (61)
Equity, Ending Balance $ 57,673 $ 57,922 $ 57,673 $ 57,922 $ 1,788 $ 1,788 $ 1,788 $ 1,788 $ 40,550 $ 40,657 $ 39,950 $ 38,243 $ (3,126) $ (2,776) $ (23,968) $ (22,416) $ 2,479 $ 2,426
Shares, Ending Balance 3,577,103,522   3,577,103,522   3,577,000,000 3,577,000,000 3,577,000,000 3,577,000,000             538,000,000 494,000,000    
XML 37 R44.htm IDEA: XBRL DOCUMENT v2.4.0.6
Inventories (Details Textual) (USD $)
Jun. 30, 2012
Dec. 31, 2011
Inventories (Textual) [Abstract]    
Inventories not expected to be sold within one year included in Other assets $ 1,300,000,000 $ 1,300,000,000
Inventories produced in preparation for product launches included in Other Assets $ 169,000,000 $ 127,000,000
XML 38 R30.htm IDEA: XBRL DOCUMENT v2.4.0.6
Pension and Other Postretirement Benefit Plans (Tables)
6 Months Ended
Jun. 30, 2012
Pension and Other Postretirement Benefit Plans [Abstract]  
Components of net cost of defined benefit plans

The Company has defined benefit pension plans covering eligible employees in the United States and in certain of its international subsidiaries. The net cost of such plans consisted of the following components:

 

                                 
    Three Months Ended
June 30,
    Six Months Ended
June 30,
 
($ in millions)         2012                 2011                 2012                 2011        

 

 

 

Service cost

    $ 141      $ 151        $ 283      $ 303   

Interest cost

    166        180        332        359   

Expected return on plan assets

    (244)       (242)       (488)       (485)  

Net amortization

    48        46        96        91   

Termination benefits

                      17   

Curtailments

    (1)       (6)       (1)       (10)  

Settlements

                      (1)  

 

 
      $ 114      $ 136        $ 231      $ 274   

 

 

The Company provides medical, dental and life insurance benefits, principally to its eligible U.S. retirees and similar benefits to their dependents, through its other postretirement benefit plans. The net cost of such plans consisted of the following components:

 

                                 
    Three Months Ended
June 30,
    Six Months Ended
June 30,
 
($ in millions)         2012                 2011                 2012                 2011        

 

 

 

Service cost

    $ 21      $ 28        $ 42      $ 56   

Interest cost

    31        35        62        71   

Expected return on plan assets

    (34)       (36)       (68)       (71)  

Net amortization

    (8)       (6)       (16)       (9)  

Termination benefits

                       

Curtailments

    (2)             (4)        

 

 
      $ 11      $ 25        $ 21      $ 54   

 

 
XML 39 R31.htm IDEA: XBRL DOCUMENT v2.4.0.6
Other (Income) Expense, Net (Tables)
6 Months Ended
Jun. 30, 2012
Other (Income) Expense, Net [Abstract]  
Other (income) expense, net

Other (income) expense, net, consisted of:

 

                                 
    Three Months Ended
June 30,
    Six Months Ended
June 30,
 
($ in millions)         2012                 2011                 2012                 2011        

 

 

 

Interest income

    $ (76)     $ (39)       $ (129)     $ (69)  

Interest expense

    172        170        346        345   

Exchange losses

    13              80        43   

Other, net

    (6)       (11)       (50)       425   

 

 
      $ 103      $ 121        $ 247      $ 744   

 

 
XML 40 R8.htm IDEA: XBRL DOCUMENT v2.4.0.6
Restructuring
6 Months Ended
Jun. 30, 2012
Restructuring [Abstract]  
Restructuring

2.   Restructuring

Merger Restructuring Program

In February 2010, subsequent to the Merck and Schering-Plough Corporation (“Schering-Plough”) merger (the “Merger”), the Company commenced actions under a global restructuring program (the “Merger Restructuring Program”) in conjunction with the integration of the legacy Merck and legacy Schering-Plough businesses. This Merger Restructuring Program is intended to optimize the cost structure of the combined company. In July 2011, the Company announced the latest phase of the Merger Restructuring Program during which the Company expects to reduce its workforce measured at the time of the Merger by an additional 12% to 13% across the Company worldwide. A majority of the workforce reductions in this phase of the Merger Restructuring Program relate to manufacturing (including Animal Health), administrative and headquarters organizations. Previously announced workforce reductions of approximately 17% in earlier phases of the program primarily reflect the elimination of positions in sales, administrative and headquarters organizations, as well as from the sale or closure of certain manufacturing and research and development sites and the consolidation of office facilities. The Company will continue to hire employees in strategic growth areas of the business as necessary. The Company will continue to pursue productivity efficiencies and evaluate its manufacturing supply chain capabilities on an ongoing basis which may result in future restructuring actions.

The Company recorded total pretax restructuring costs of $291 million and $808 million in the second quarter of 2012 and 2011, respectively, and $568 million and $921 million in the first six months of 2012 and 2011, respectively, related to this program. Since inception of the Merger Restructuring Program through June 30, 2012, Merck has recorded total pretax accumulated costs of approximately $5.7 billion and eliminated approximately 20,230 positions comprised of employee separations, as well as the elimination of contractors and vacant positions. The restructuring actions under the Merger Restructuring Program are expected to be substantially completed by the end of 2013, with the exception of certain actions, principally manufacturing-related, which are expected to be substantially completed by 2015. The Company originally estimated the total cumulative pretax costs for this program to be approximately $5.8 billion to $6.6 billion and the Company now expects the cumulative costs to be near the upper end of this range. The Company estimates that approximately two-thirds of the cumulative pretax costs relate to cash outlays, primarily related to employee separation expense. Approximately one-third of the cumulative pretax costs are non-cash, relating primarily to the accelerated depreciation of facilities to be closed or divested.

2008 Global Restructuring Program

In October 2008, Merck announced a global restructuring program (the “2008 Restructuring Program”) to reduce its cost structure, increase efficiency, and enhance competitiveness. As part of the 2008 Restructuring Program, the Company expects to eliminate approximately 7,200 positions — 6,800 active employees and 400 vacancies — across the Company worldwide. Pretax restructuring costs of $(4) million and $1 million were recorded in the second quarter of 2012 and 2011, respectively, and $10 million and $5 million were recorded in the first six months of 2012 and 2011, respectively, related to the 2008 Restructuring Program. Since inception of the 2008 Restructuring Program through June 30, 2012, Merck has recorded total pretax accumulated costs of $1.6 billion and eliminated approximately 6,390 positions comprised of employee separations and the elimination of contractors and vacant positions. The 2008 Restructuring Program was substantially completed in 2011, with the exception of certain manufacturing-related actions, which are expected to be completed by 2015, with the total cumulative pretax costs estimated to be up to $2.0 billion. The Company estimates that two-thirds of the cumulative pretax costs relate to cash outlays, primarily from employee separation expense. Approximately one-third of the cumulative pretax costs are non-cash, relating primarily to the accelerated depreciation of facilities to be closed or divested.

For segment reporting, restructuring charges are unallocated expenses.

The following tables summarize the charges related to Merger Restructuring Program and 2008 Restructuring Program activities by type of cost:

 

                                                                         
    Three Months Ended June 30, 2012         Six Months Ended June 30, 2012  
($ in millions)   Separation
Costs
    Accelerated
Depreciation
    Other     Total          Separation
Costs
    Accelerated
Depreciation
         Other     Total  
                     

Merger Restructuring Program

                                                                       

Materials and production

  $ -     $ 56     $         20     $ 76         $ -     $ 33         $ 37     $ 70  

Marketing and administrative

    -       20       1       21           -       43           2       45  

Research and development

    -       41       -       41           -       82           4       86  

Restructuring costs

    124       -       29       153           304       -           63       367  
      124       117       50       291           304       158           106       568  
                     

2008 Restructuring Program

                                                                       

Materials and production

    -       1       4       5           -       3           11       14  

Restructuring costs

    (13     -       4       (9         (11     -           7       (4
      (13     1       8       (4         (11     3           18       10  
    $         111     $         118     $ 58     $        287         $        293     $        161         $        124     $         578  
   

 

Three Months Ended June 30, 2011

        Six Months Ended June 30, 2011  
($ in millions)   Separation
Costs
    Accelerated
Depreciation
    Other     Total          Separation
Costs
    Accelerated
Depreciation
         Other     Total  
                     

Merger Restructuring Program

                                                                       

Materials and production

  $ -     $ 91     $ 5     $ 96         $ -     $ 152         $ 5     $ 157  

Marketing and administrative

    -       22       1       23           -       45           1       46  

Research and development

    -       38       (22     16           -       80           (19     61  

Restructuring costs

    646       -       27       673           607       -           50       657  
      646       151       11       808           607       277           37       921  
                     

2008 Restructuring Program

                                                                       

Materials and production

    -       4       2       6           -       6           2       8  

Restructuring costs

    (7     -       2       (5         (8     -           5       (3
      (7     4       4       1           (8     6           7       5  
    $ 639     $ 155     $ 15     $ 809         $ 599     $ 283         $ 44     $ 926  

Separation costs are associated with actual headcount reductions, as well as those headcount reductions which were probable and could be reasonably estimated. In the second quarter of 2012 and 2011, approximately 780 positions and 585 positions, respectively, were eliminated under the Merger Restructuring Program. In addition, approximately 60 positions were eliminated in the second quarter of 2011 under the 2008 Restructuring Program. In the first six months of 2012 and 2011, approximately 1,800 positions and 1,335 positions, respectively, were eliminated under the Merger Restructuring Program and approximately 140 positions and 180 positions, respectively, were eliminated under the 2008 Restructuring Program. These position eliminations were comprised of actual headcount reductions and the elimination of contractors and vacant positions.

Accelerated depreciation costs primarily relate to manufacturing, research and administrative facilities and equipment to be sold or closed as part of the programs. Accelerated depreciation costs represent the difference between the depreciation expense to be recognized over the revised useful life of the site, based upon the anticipated date the site will be closed or divested, and depreciation expense as determined utilizing the useful life prior to the restructuring actions. All of the sites have and will continue to operate up through the respective closure dates, and since future cash flows were sufficient to recover the respective book values, Merck was required to accelerate depreciation of the site assets rather than write them off immediately. Site closure dates, particularly related to manufacturing locations, have been and may continue to be adjusted to reflect changes resulting from regulatory or other factors.

Other activity in 2012 and 2011 includes asset abandonment, shut-down and other related costs. Additionally, other activity includes employee-related costs such as curtailment, settlement and termination charges associated with pension and other postretirement benefit plans (see Note 12) and share-based compensation costs.

The following table summarizes the charges and spending relating to Merger Restructuring Program and 2008 Restructuring Program activities for the six months ended June 30, 2012:

 

                                 
($ in millions)   Separation
Costs
    Accelerated
Depreciation
      Other           Total        
         

Merger Restructuring Program

                               

Restructuring reserves January 1, 2012

  $ 1,144     $ -     $ 51     $ 1,195  

Expense

    304       158       106       568  

(Payments) receipts, net

    (634     -       (66     (700

Non-cash activity

    -       (158     (51     (209

Restructuring reserves June 30, 2012 (1)

  $      814     $             -     $           40     $          854  
         

2008 Restructuring Program

                               
         

Restructuring reserves January 1, 2012

  $ 126     $ -     $ -     $ 126  

Expense

    (11     3       18       10  

(Payments) receipts, net

    (15     -       (8     (23

Non-cash activity

    -       (3     (10     (13

Restructuring reserves June 30, 2012 (1)

  $ 100     $ -     $ -     $ 100  

 

(1) 

The cash outlays associated with the Merger Restructuring Program are expected to be substantially completed by the end of 2013 with the exception of certain actions, principally manufacturing-related, which are expected to be substantially completed by 2015. The cash outlays associated with the remaining restructuring reserves for the 2008 Restructuring Program are primarily manufacturing-related and are expected to be completed by the end of 2015.

Legacy Schering-Plough Program

Prior to the Merger, Schering-Plough commenced a Productivity Transformation Program which was designed to reduce and avoid costs and increase productivity. The Company recorded accelerated depreciation costs included in Materials and production costs of $2 million and $7 million for the second quarter of 2012 and 2011, respectively, and $4 million and $16 million for the first six months of 2012 and 2011, respectively. The remaining reserve associated with this program, which is substantially complete, was $18 million at June 30, 2012.

XML 41 R32.htm IDEA: XBRL DOCUMENT v2.4.0.6
Earnings Per Share (Tables)
6 Months Ended
Jun. 30, 2012
Earnings Per Share [Abstract]  
Calculations of earnings per share under the two-class method

The calculations of earnings per share under the two-class method are as follows:

 

                                 
    Three Months Ended
June 30,
    Six Months Ended
June 30,
 
($ and shares in millions except per share amounts)         2012                 2011                 2012                 2011        

 

 

 

Basic Earnings per Common Share

                               

Net income attributable to Merck & Co., Inc.

    $ 1,793     $     2,024         $ 3,531     $         3,067    

Less: Income allocated to participating securities

    1       4         3       8    

 

 

Net income allocated to common shareholders

    $ 1,792     $ 2,020         $ 3,528     $ 3,059    

 

 

 

Average common shares outstanding

    3,041       3,086         3,042       3,085    

 

 
      $ 0.59     $ 0.65         $ 1.16     $ 0.99    

 

 

 

Earnings per Common Share Assuming Dilution

                               

Net income attributable to Merck & Co., Inc.

    $ 1,793     $ 2,024         $ 3,531     $ 3,067    

Less: Income allocated to participating securities

    1       4         3       8    

 

 

Net income allocated to common shareholders

    $ 1,792     $ 2,020         $ 3,528     $ 3,059    

 

 

 

Average common shares outstanding

    3,041       3,086         3,042       3,085    

Common shares issuable (1)

    31       24         32       21    

 

 

Average common shares outstanding assuming dilution

    3,072       3,110         3,074       3,106    

 

 
      $ 0.58     $ 0.65         $ 1.15     $ 0.98    

 

 

 

(1)

Issuable primarily under share-based compensation plans.

XML 42 R40.htm IDEA: XBRL DOCUMENT v2.4.0.6
Financial Instruments (Details 1) (USD $)
In Millions, unless otherwise specified
3 Months Ended 6 Months Ended 3 Months Ended 6 Months Ended 3 Months Ended 6 Months Ended 3 Months Ended 6 Months Ended
Jun. 30, 2012
Dec. 31, 2011
Jun. 30, 2012
Commercial paper [Member]
Dec. 31, 2011
Commercial paper [Member]
Jun. 30, 2012
Corporate notes and bonds [Member]
Dec. 31, 2011
Corporate notes and bonds [Member]
Jun. 30, 2012
U.S. government and agency securities [Member]
Dec. 31, 2011
U.S. government and agency securities [Member]
Jun. 30, 2012
Asset-backed securities [Member]
Dec. 31, 2011
Asset-backed securities [Member]
Jun. 30, 2012
Mortgage-backed securities [Member]
Dec. 31, 2011
Mortgage-backed securities [Member]
Jun. 30, 2012
Foreign government bonds [Member]
Dec. 31, 2011
Foreign government bonds [Member]
Jun. 30, 2012
Other debt securities [Member]
Dec. 31, 2011
Other debt securities [Member]
Jun. 30, 2012
Equity securities [Member]
Dec. 31, 2011
Equity securities [Member]
Jun. 30, 2012
Foreign exchange contract [Member]
Derivatives Not Designated as Hedging Instruments [Member]
Jun. 30, 2011
Foreign exchange contract [Member]
Derivatives Not Designated as Hedging Instruments [Member]
Jun. 30, 2012
Foreign exchange contract [Member]
Derivatives Not Designated as Hedging Instruments [Member]
Jun. 30, 2011
Foreign exchange contract [Member]
Derivatives Not Designated as Hedging Instruments [Member]
Jun. 30, 2012
Foreign exchange contract [Member]
Derivatives designated in foreign currency cash flow hedging relationships [Member]
Jun. 30, 2011
Foreign exchange contract [Member]
Derivatives designated in foreign currency cash flow hedging relationships [Member]
Jun. 30, 2012
Foreign exchange contract [Member]
Derivatives designated in foreign currency cash flow hedging relationships [Member]
Jun. 30, 2011
Foreign exchange contract [Member]
Derivatives designated in foreign currency cash flow hedging relationships [Member]
Jun. 30, 2012
Foreign exchange contract [Member]
Derivatives designated in foreign currency net investment hedging relationships [Member]
Jun. 30, 2011
Foreign exchange contract [Member]
Derivatives designated in foreign currency net investment hedging relationships [Member]
Jun. 30, 2012
Foreign exchange contract [Member]
Derivatives designated in foreign currency net investment hedging relationships [Member]
Jun. 30, 2011
Foreign exchange contract [Member]
Derivatives designated in foreign currency net investment hedging relationships [Member]
Jun. 30, 2011
Interest rate swap contract [Member]
Derivatives designated in fair value hedging relationships [Member]
Jun. 30, 2011
Interest rate swap contract [Member]
Derivatives designated in fair value hedging relationships [Member]
Location and pre tax gain or loss amounts for derivatives that are: (i) designated in a fair value hedging relationship, (ii) designated in a cash flow hedging relationship, (iii) designated in a foreign currency net investment hedging relationship and (iv) not designated in a hedging relationship                                                                
Amount of gain recognized in Other (income) expense, net on derivatives                                     $ (279) $ 33 $ (26) $ 349                 $ (126) $ (163)
Amount of loss recognized in Other (income) expense, net on hedged item                                                             126 163
Amount of loss reclassified from AOCI to Sales                                             26 20 53 27            
Amount of (gain) loss recognized in OCI on derivatives                                             (154) 69 (34) 252 86 33 (56) 34    
Amount of gain recognized in Other (income) expense, net on derivatives                                                     (2) (2) (11) (8)    
Available-for-sale investment                                                                
Fair Value 4,954 5,069 220 1,029 2,787 2,032 773 1,021 441 292 271 223 76 72 3 3 383 397                            
Amortized Cost 4,890 5,042 220 1,029 2,759 2,024 772 1,018 439 292 270 223 75 72 1 1 354 383                            
Gross Unrealized Gains 67 37     30 16 1 3 2 1 2 1 1   2 2 29 14                            
Gross Unrealized Losses $ (3) $ (10)     $ (2) $ (8)       $ (1) $ (1) $ (1)                                        
XML 43 R53.htm IDEA: XBRL DOCUMENT v2.4.0.6
Contingencies and Environmental Liabilities (Details Textual 4) (USD $)
In Millions, unless otherwise specified
May 31, 2012
Vytorin ERISA lawsuits [Member]
May 24, 2012
Vytorin ERISA lawsuits [Member]
Jun. 30, 2012
Vytorin shareholder lawsuits [Member]
Loss Contingencies [Line Items]      
Settlement agreement amount $ 12.25 $ 10.40  
Upper limit of directors and officers insurance coverage     $ 250
XML 44 R2.htm IDEA: XBRL DOCUMENT v2.4.0.6
Interim Consolidated Statement of Income (Unaudited) (USD $)
In Millions, except Per Share data, unless otherwise specified
3 Months Ended 6 Months Ended
Jun. 30, 2012
Jun. 30, 2011
Jun. 30, 2012
Jun. 30, 2011
Interim Consolidated Statement of Income [Abstract]        
Sales $ 12,311 $ 12,151 $ 24,041 $ 23,732
Costs, Expenses and Other        
Materials and production 4,112 4,284 8,150 8,343
Marketing and administrative 3,249 3,525 6,322 6,689
Research and development 2,165 1,936 4,026 4,094
Restructuring costs 144 668 363 654
Equity income from affiliates (142) (55) (253) (193)
Other (income) expense, net 103 121 247 744
Total Costs, Expenses and Other 9,631 10,479 18,855 20,331
Income Before Taxes 2,680 1,672 5,186 3,401
Taxes on Income 860 (382) 1,599 276
Net Income 1,820 2,054 3,587 3,125
Less: Net Income Attributable to Noncontrolling Interests 27 30 56 58
Net Income Attributable to Merck & Co., Inc. $ 1,793 $ 2,024 $ 3,531 $ 3,067
Basic Earnings per Common Share Attributable to Merck & Co., Inc. Common Shareholders $ 0.59 $ 0.65 $ 1.16 $ 0.99
Earnings per Common Share Assuming Dilution Attributable to Merck & Co., Inc. Common Shareholders $ 0.58 $ 0.65 $ 1.15 $ 0.98
Dividends Declared per Common Share $ 0.42 $ 0.38 $ 0.84 $ 0.76
XML 45 R45.htm IDEA: XBRL DOCUMENT v2.4.0.6
Other Intangibles (Details Textual) (USD $)
In Millions, unless otherwise specified
3 Months Ended 6 Months Ended
Jun. 30, 2012
Jun. 30, 2011
Jun. 30, 2012
Jun. 30, 2011
Other intangibles (Textual) [Abstract]        
Impairment charges associated with in-process research and development $ 127 $ 19 $ 136 $ 321
Intangible asset impairment charge related to marketed product   $ 118   $ 118
XML 46 R6.htm IDEA: XBRL DOCUMENT v2.4.0.6
Interim Consolidated Statement of Cash Flows (Unaudited) (USD $)
In Millions, unless otherwise specified
6 Months Ended
Jun. 30, 2012
Jun. 30, 2011
Cash Flows from Operating Activities    
Net income $ 3,587 $ 3,125
Adjustments to reconcile net income to net cash provided by operating activities:    
Depreciation and amortization 3,594 3,663
Intangible asset impairment charges 136 439
Equity income from affiliates (253) (193)
Dividends and distributions from equity affiliates 122 121
Deferred income taxes (365) (841)
Share-based compensation 169 200
Other 143 (456)
Net changes in assets and liabilities (2,059) (1,485)
Net Cash Provided by Operating Activities 5,074 4,573
Cash Flows from Investing Activities    
Capital expenditures (762) (689)
Purchases of securities and other investments (4,001) (3,066)
Proceeds from sales of securities and other investments 4,174 2,890
Dispositions of businesses, net of cash divested   323
Acquisitions of businesses, net of cash acquired   (373)
Other 21 (28)
Net Cash Used in Investing Activities (568) (943)
Cash Flows from Financing Activities    
Net change in short-term borrowings 1,637 1,396
Payments on debt (2) (1,265)
Purchases of treasury stock (985) (314)
Dividends paid to stockholders (2,559) (2,351)
Proceeds from exercise of stock options 601 162
Other (3) (57)
Net Cash Used in Financing Activities (1,311) (2,429)
Effect of Exchange Rate Changes on Cash and Cash Equivalents 26 241
Net Increase in Cash and Cash Equivalents 3,221 1,442
Cash and Cash Equivalents at Beginning of Year 13,531 10,900
Cash and Cash Equivalents at End of Period $ 16,752 $ 12,342
XML 47 R59.htm IDEA: XBRL DOCUMENT v2.4.0.6
Share-Based Compensation Plans (Details) (USD $)
In Millions, unless otherwise specified
3 Months Ended 6 Months Ended
Jun. 30, 2012
Jun. 30, 2011
Jun. 30, 2012
Jun. 30, 2011
Amounts of share-based compensation cost recorded in the Consolidated Statement of Income        
Pretax share-based compensation expense $ 93 $ 107 $ 169 $ 200
Income tax benefit (29) (37) (53) (69)
Total share-based compensation expense, net of taxes $ 64 $ 70 $ 116 $ 131
XML 48 R35.htm IDEA: XBRL DOCUMENT v2.4.0.6
Restructuring (Details 1) (USD $)
In Millions, unless otherwise specified
3 Months Ended 6 Months Ended
Jun. 30, 2012
Jun. 30, 2011
Jun. 30, 2012
Jun. 30, 2011
Charges and spending relating to Merger Restructuring Program and 2008 Restructuring Program activities        
Expense $ 287 $ 809 $ 578 $ 926
Accelerated Depreciation [Member]
       
Charges and spending relating to Merger Restructuring Program and 2008 Restructuring Program activities        
Expense 118 155 161 283
2008 Global Restructuring Program [Member]
       
Charges and spending relating to Merger Restructuring Program and 2008 Restructuring Program activities        
Restructuring reserve, beginning balance     126  
Expense (4) 1 10 5
(Payments) receipts, net     (23)  
Non-cash activity     (13)  
Restructuring reserve, ending balance 100   100  
2008 Global Restructuring Program [Member] | Accelerated Depreciation [Member]
       
Charges and spending relating to Merger Restructuring Program and 2008 Restructuring Program activities        
Expense 1 4 3 6
Non-cash activity     (3)  
Merger Restructuring Program [Member]
       
Charges and spending relating to Merger Restructuring Program and 2008 Restructuring Program activities        
Restructuring reserve, beginning balance     1,195  
Expense 291 808 568 921
(Payments) receipts, net     (700)  
Non-cash activity     (209)  
Restructuring reserve, ending balance 854   854  
Merger Restructuring Program [Member] | Accelerated Depreciation [Member]
       
Charges and spending relating to Merger Restructuring Program and 2008 Restructuring Program activities        
Expense 117 151 158 277
Non-cash activity     (158)  
Separation Costs [Member]
       
Charges and spending relating to Merger Restructuring Program and 2008 Restructuring Program activities        
Expense 111 639 293 599
Separation Costs [Member] | 2008 Global Restructuring Program [Member]
       
Charges and spending relating to Merger Restructuring Program and 2008 Restructuring Program activities        
Restructuring reserve, beginning balance     126  
Expense (13) (7) (11) (8)
(Payments) receipts, net     (15)  
Restructuring reserve, ending balance 100   100  
Separation Costs [Member] | Merger Restructuring Program [Member]
       
Charges and spending relating to Merger Restructuring Program and 2008 Restructuring Program activities        
Restructuring reserve, beginning balance     1,144  
Expense 124 646 304 607
(Payments) receipts, net     (634)  
Restructuring reserve, ending balance 814   814  
Other [Member]
       
Charges and spending relating to Merger Restructuring Program and 2008 Restructuring Program activities        
Expense 58 15 124 44
Other [Member] | 2008 Global Restructuring Program [Member]
       
Charges and spending relating to Merger Restructuring Program and 2008 Restructuring Program activities        
Expense 8 4 18 7
(Payments) receipts, net     (8)  
Non-cash activity     (10)  
Other [Member] | Merger Restructuring Program [Member]
       
Charges and spending relating to Merger Restructuring Program and 2008 Restructuring Program activities        
Restructuring reserve, beginning balance     51  
Expense 50 11 106 37
(Payments) receipts, net     (66)  
Non-cash activity     (51)  
Restructuring reserve, ending balance $ 40   $ 40  
XML 49 R65.htm IDEA: XBRL DOCUMENT v2.4.0.6
Taxes on Income (Details) (USD $)
In Millions, unless otherwise specified
1 Months Ended 3 Months Ended 6 Months Ended
Apr. 30, 2011
Jun. 30, 2012
Jun. 30, 2011
Jun. 30, 2012
Jun. 30, 2011
Taxes on Income (Textual) [Abstract]          
Effective tax rate   32.10% (22.80%) 30.80% 8.10%
Litigation charges         $ 500
Net reduction of deferred tax liabilities on intangibles established in purchase accounting due to tax rate changes     230   230
Net payments made to taxing authority for settlement of income tax examination 465        
Canada Revenue Agency (CRA) [Member]
         
Operating Loss Carryforwards [Line Items]          
Additional tax being proposed by Canada Revenue Agency   330   330  
Interest on additional proposed tax   390   390  
IRS [Member]
         
Operating Loss Carryforwards [Line Items]          
Decrease in unrecognized tax benefits resulting from prior period tax positions     $ 700   $ 700
XML 50 R22.htm IDEA: XBRL DOCUMENT v2.4.0.6
Segment Reporting
6 Months Ended
Jun. 30, 2012
Segment Reporting [Abstract]  
Segment Reporting

16.        Segment Reporting

The Company’s operations are principally managed on a products basis and are comprised of four operating segments – Pharmaceutical, Animal Health, Consumer Care and Alliances (which includes revenue and equity income from the Company’s relationship with AZLP). The Animal Health, Consumer Care and Alliances segments are not material for separate reporting and are included in all other in the table below. The Pharmaceutical segment includes human health pharmaceutical and vaccine products marketed either directly by the Company or through joint ventures. Human health pharmaceutical products consist of therapeutic and preventive agents, generally sold by prescription, for the treatment of human disorders. The Company sells these human health pharmaceutical products primarily to drug wholesalers and retailers, hospitals, government agencies and managed health care providers such as health maintenance organizations, pharmacy benefit managers and other institutions. Vaccine products consist of preventive pediatric, adolescent and adult vaccines, primarily administered at physician offices. The Company sells these human health vaccines primarily to physicians, wholesalers, physician distributors and government entities. A large component of pediatric and adolescent vaccines is sold to the U.S. Centers for Disease Control and Prevention Vaccines for Children program, which is funded by the U.S. government. Additionally, the Company sells vaccines to the Federal government for placement into vaccine stockpiles. The Company also has animal health operations that discover, develop, manufacture and market animal health products, including vaccines, which the Company sells to veterinarians, distributors and animal producers. Additionally, the Company has consumer care operations that develop, manufacture and market over-the-counter, foot care and sun care products, which are sold through wholesale and retail drug, food chain and mass merchandiser outlets.

 

Sales of the Company’s products were as follows:

 

                                 
                         Three Months Ended                    
June 30,
                         Six Months Ended                    
June 30,
 
($ in millions)   2012     2011     2012     2011  

 

 

Primary Care and Women’s Health

                               

Cardiovascular

                               

Zetia

    $ 632       $ 592         $ 1,246       $ 1,174    

Vytorin

    445       459         889       939    

Diabetes and Obesity

                               

Januvia

    1,058       779         1,977       1,518    

Janumet

    411       321         802       626    

Respiratory

                               

Singulair

    1,431       1,354         2,771       2,682    

Nasonex

    293       323         668       696    

Clarinex

    140       209         273       364    

Asmanex

    51       47         99       107    

Dulera

    50       25         89       37    

Women’s Health and Endocrine

                               

Fosamax

    186       221         370       429    

NuvaRing

    157       154         303       297    

Follistim AQ

    125       143         241       276    

Implanon

    85       81         161       141    

Cerazette

    72       66         139       125    

Other

                               

Maxalt

    154       131         310       304    

Arcoxia

    117       100         229       214    

Avelox

    44       61         117       167    

Hospital and Specialty

                               

Immunology

                               

Remicade

    518       842         1,037       1,595    

Simponi

    76       75         150       129    

Infectious Disease

                               

Isentress

    398       337         735       629    

PegIntron

    183       154         345       319    

Cancidas

    166       168         311       326    

Victrelis

    126       21         238       22    

Invanz

    110       103         211       189    

Primaxin

    104       136         192       272    

Noxafil

    66       56         125       110    

Oncology

                               

Temodar

    225       234         461       481    

Emend

    145       120         247       207    

Other

                               

Cosopt/Trusopt

    105       122         229       236    

Bridion

    60       47         118       89    

Integrilin

    60       56         113       120    

Diversified Brands

                               

Cozaar/Hyzaar

    337       406         674       832    

Propecia

    100       112         208       218    

Zocor

    96       107         199       234    

Claritin Rx

    48       65         134       186    

Remeron

    66       57         123       117    

Proscar

    55       53         106       113    

Vasotec/Vaseretic

    49       59         102       116    

Vaccines (1)

                               

Gardasil

    324       277         608       490    

ProQuad/M-M-R II/Varivax

    316       291         571       535    

RotaTeq

    142       148         284       272    

Zostavax

    148       122         224       146    

Pneumovax

    101       64         213       143    

Other pharmaceutical (2) 

    985       1,062         2,000       1,957    

 

 

Total Pharmaceutical segment sales

    10,560       10,360         20,642       20,179    

 

 

Other segment sales (3) 

    1,680       1,690         3,273       3,323    

 

 

Total segment sales

    12,240       12,050         23,915       23,502    

 

 

Other (4)

    71       101         126       230    

 

 
      $ 12,311       $ 12,151         $ 24,041       $ 23,732    

 

 

 

(1 ) 

These amounts do not reflect sales of vaccines sold in most major European markets through the Company’s joint venture, Sanofi Pasteur MSD, the results of which are reflected in Equity income from affiliates. These amounts do, however, reflect supply sales to Sanofi Pasteur MSD.

(2 ) 

Other pharmaceutical primarily includes sales of other human health pharmaceutical products not listed separately.

(3 ) 

Reflects other non-reportable segments, including Animal Health and Consumer Care, and revenue from the Company’s relationship with AZLP primarily relating to sales of Nexium. Revenue from AZLP was $223 million and $306 million for the second quarter of 2012 and 2011, respectively, and $409 million and $628 million for the first six months of 2012 and 2011, respectively.

(4 ) 

Other revenues are primarily comprised of miscellaneous corporate revenues, third-party manufacturing sales, sales related to divested products or businesses and supply sales not included in segment results. The declines in other revenues in the second quarter and first six months of 2012 as compared with the same periods of 2011 reflect lower third-party manufacturing sales, which for the year-to-date period were attributable in part to the divestiture of certain manufacturing facilities in the first quarter of 2011.

 

A reconciliation of segment profits to Income before taxes is as follows:

 

                                 
    Three Months Ended
June 30,
    Six Months Ended
June 30,
 
($ in millions)         2012                 2011                 2012                 2011        

 

 

 

Segment profits:

                               

Pharmaceutical segment

    $       6,906      $ 6,443        $ 13,502      $ 12,659   

Other segments

    774        726        1,578        1,517   
   

 

 

 

Total segment profits

    7,680        7,169        15,080        14,176   

Other profits (losses)

    45        34        (28)       (15)  

Unallocated:

                               

Interest income

    76        39        129        69   

Interest expense

    (172)       (170)       (346)       (345)  

Equity income from affiliates

    11        (87)       (9)       (81)  

Depreciation and amortization

    (574)       (623)       (1,135)       (1,194)  

Research and development

    (1,930)       (1,679)       (3,573)       (3,618)  

Amortization of purchase accounting adjustments

    (1,226)       (1,225)       (2,455)       (2,504)  

Restructuring costs

    (144)       (668)       (363)       (654)  

Arbitration settlement charge

                      (500)  

Other unallocated, net

    (1,086)       (1,118)       (2,114)       (1,933)  

 

 
      $ 2,680      $ 1,672        $ 5,186      $ 3,401   

 

 

Segment profits are comprised of segment sales less standard costs and certain operating expenses directly incurred by the segments. For internal management reporting presented to the chief operating decision maker, Merck does not allocate materials and production costs, other than standard costs, the majority of research and development expenses or general and administrative expenses, nor the cost of financing these activities. Separate divisions maintain responsibility for monitoring and managing these costs, including depreciation related to fixed assets utilized by these divisions and, therefore, they are not included in segment profits. In addition, costs related to restructuring activities, as well as the amortization of purchase adjustments are not allocated to segments.

Other profits (losses) are primarily comprised of miscellaneous corporate profits (losses), as well as operating profits (losses) related to third-party manufacturing sales, divested products or businesses and other supply sales.

Other unallocated, net includes expenses from corporate and manufacturing cost centers, product intangible asset impairment charges, gains or losses on sales of businesses and assets and other miscellaneous income or expense items.

XML 51 R36.htm IDEA: XBRL DOCUMENT v2.4.0.6
Restructuring (Details Textual) (USD $)
3 Months Ended 6 Months Ended 3 Months Ended 6 Months Ended 3 Months Ended 6 Months Ended 3 Months Ended 6 Months Ended 1 Months Ended 6 Months Ended 1 Months Ended 6 Months Ended
Jun. 30, 2012
Jun. 30, 2011
Jun. 30, 2012
Jun. 30, 2011
Jun. 30, 2012
2008 Global Restructuring Program [Member]
Person
Jun. 30, 2011
2008 Global Restructuring Program [Member]
Person
Jun. 30, 2012
2008 Global Restructuring Program [Member]
Person
Jun. 30, 2011
2008 Global Restructuring Program [Member]
Person
Dec. 31, 2011
2008 Global Restructuring Program [Member]
Jun. 30, 2012
Merger Restructuring Program [Member]
Person
Jun. 30, 2011
Merger Restructuring Program [Member]
Person
Jun. 30, 2012
Merger Restructuring Program [Member]
Person
Jun. 30, 2011
Merger Restructuring Program [Member]
Person
Dec. 31, 2011
Merger Restructuring Program [Member]
Jun. 30, 2012
Legacy Schering-Plough Program [Member]
Jun. 30, 2011
Legacy Schering-Plough Program [Member]
Jun. 30, 2012
Legacy Schering-Plough Program [Member]
Jun. 30, 2011
Legacy Schering-Plough Program [Member]
Jul. 31, 2011
Minimum [Member]
Merger Restructuring Program [Member]
Jun. 30, 2012
Minimum [Member]
Merger Restructuring Program [Member]
Jun. 30, 2012
Maximum [Member]
2008 Global Restructuring Program [Member]
Jul. 31, 2011
Maximum [Member]
Merger Restructuring Program [Member]
Jun. 30, 2012
Maximum [Member]
Merger Restructuring Program [Member]
Restructuring (Textual) [Abstract]                                              
Additional expected percentage of reduction in total workforce related to Merger Restructuring Program                                     12.00%     13.00%  
Initial expected percentage of reduction in total workforce related to Merger Restructuring Program                       17.00%                      
Cumulative restructuring costs incurred to date since program inception             $ 1,600,000,000         $ 5,700,000,000                      
Positions eliminated since inception of program         6,390   6,390     20,230   20,230                      
Expected cumulative restructuring costs, pre-tax                                       5,800,000,000 2,000,000,000   6,600,000,000
Vacant positions eliminated             400                                
Percentage estimate of cumulative pre tax costs that will result in cash outlays (primarily from employee separation expense)             two-thirds         two-thirds                      
Percentage estimate of cumulative pretax costs that will be non-cash (primarily from accelerated depreciation of facilities)             one-third         one-third                      
Total number of positions expected to be eliminated             7,200                                
Number of active employees expected to be eliminated             6,800                                
Number of positions eliminated           60 140 180   780 585 1,800 1,335                    
Accelerated depreciation for Legacy Schering-Plough Program                             2,000,000 7,000,000 4,000,000 16,000,000          
Restructuring Reserve         100,000,000   100,000,000   126,000,000 854,000,000   854,000,000   1,195,000,000 18,000,000   18,000,000            
Total pre tax restructuring costs $ 287,000,000 $ 809,000,000 $ 578,000,000 $ 926,000,000 $ (4,000,000) $ 1,000,000 $ 10,000,000 $ 5,000,000   $ 291,000,000 $ 808,000,000 $ 568,000,000 $ 921,000,000                    
XML 52 R24.htm IDEA: XBRL DOCUMENT v2.4.0.6
Restructuring (Tables)
6 Months Ended
Jun. 30, 2012
Restructuring [Abstract]  
Charges related to Merger Restructuring Program and 2008 Restructuring Program activities by type of cost

The following tables summarize the charges related to Merger Restructuring Program and 2008 Restructuring Program activities by type of cost:

 

                                                                         
    Three Months Ended June 30, 2012         Six Months Ended June 30, 2012  
($ in millions)   Separation
Costs
    Accelerated
Depreciation
    Other     Total          Separation
Costs
    Accelerated
Depreciation
         Other     Total  
                     

Merger Restructuring Program

                                                                       

Materials and production

  $ -     $ 56     $         20     $ 76         $ -     $ 33         $ 37     $ 70  

Marketing and administrative

    -       20       1       21           -       43           2       45  

Research and development

    -       41       -       41           -       82           4       86  

Restructuring costs

    124       -       29       153           304       -           63       367  
      124       117       50       291           304       158           106       568  
                     

2008 Restructuring Program

                                                                       

Materials and production

    -       1       4       5           -       3           11       14  

Restructuring costs

    (13     -       4       (9         (11     -           7       (4
      (13     1       8       (4         (11     3           18       10  
    $         111     $         118     $ 58     $        287         $        293     $        161         $        124     $         578  
   

 

Three Months Ended June 30, 2011

        Six Months Ended June 30, 2011  
($ in millions)   Separation
Costs
    Accelerated
Depreciation
    Other     Total          Separation
Costs
    Accelerated
Depreciation
         Other     Total  
                     

Merger Restructuring Program

                                                                       

Materials and production

  $ -     $ 91     $ 5     $ 96         $ -     $ 152         $ 5     $ 157  

Marketing and administrative

    -       22       1       23           -       45           1       46  

Research and development

    -       38       (22     16           -       80           (19     61  

Restructuring costs

    646       -       27       673           607       -           50       657  
      646       151       11       808           607       277           37       921  
                     

2008 Restructuring Program

                                                                       

Materials and production

    -       4       2       6           -       6           2       8  

Restructuring costs

    (7     -       2       (5         (8     -           5       (3
      (7     4       4       1           (8     6           7       5  
    $ 639     $ 155     $ 15     $ 809         $ 599     $ 283         $ 44     $ 926  
Charges and spending relating to Merger Restructuring Program and 2008 Restructuring Program activities

The following table summarizes the charges and spending relating to Merger Restructuring Program and 2008 Restructuring Program activities for the six months ended June 30, 2012:

 

                                 
($ in millions)   Separation
Costs
    Accelerated
Depreciation
      Other           Total        
         

Merger Restructuring Program

                               

Restructuring reserves January 1, 2012

  $ 1,144     $ -     $ 51     $ 1,195  

Expense

    304       158       106       568  

(Payments) receipts, net

    (634     -       (66     (700

Non-cash activity

    -       (158     (51     (209

Restructuring reserves June 30, 2012 (1)

  $      814     $             -     $           40     $          854  
         

2008 Restructuring Program

                               
         

Restructuring reserves January 1, 2012

  $ 126     $ -     $ -     $ 126  

Expense

    (11     3       18       10  

(Payments) receipts, net

    (15     -       (8     (23

Non-cash activity

    -       (3     (10     (13

Restructuring reserves June 30, 2012 (1)

  $ 100     $ -     $ -     $ 100  

 

(1) 

The cash outlays associated with the Merger Restructuring Program are expected to be substantially completed by the end of 2013 with the exception of certain actions, principally manufacturing-related, which are expected to be substantially completed by 2015. The cash outlays associated with the remaining restructuring reserves for the 2008 Restructuring Program are primarily manufacturing-related and are expected to be completed by the end of 2015.

XML 53 R68.htm IDEA: XBRL DOCUMENT v2.4.0.6
Segment Reporting (Details) (USD $)
In Millions, unless otherwise specified
3 Months Ended 6 Months Ended
Jun. 30, 2012
Jun. 30, 2011
Jun. 30, 2012
Jun. 30, 2011
Sales of the Company's products        
Sales $ 12,311 $ 12,151 $ 24,041 $ 23,732
Primary Care and Women's Health [Member] | Zetia [Member]
       
Sales of the Company's products        
Sales 632 592 1,246 1,174
Primary Care and Women's Health [Member] | Vytorin [Member]
       
Sales of the Company's products        
Sales 445 459 889 939
Primary Care and Women's Health [Member] | Januvia [Member]
       
Sales of the Company's products        
Sales 1,058 779 1,977 1,518
Primary Care and Women's Health [Member] | Janumet [Member]
       
Sales of the Company's products        
Sales 411 321 802 626
Primary Care and Women's Health [Member] | Singulair [Member]
       
Sales of the Company's products        
Sales 1,431 1,354 2,771 2,682
Primary Care and Women's Health [Member] | Nasonex [Member]
       
Sales of the Company's products        
Sales 293 323 668 696
Primary Care and Women's Health [Member] | Clarinex [Member]
       
Sales of the Company's products        
Sales 140 209 273 364
Primary Care and Women's Health [Member] | Asmanex [Member]
       
Sales of the Company's products        
Sales 51 47 99 107
Primary Care and Women's Health [Member] | Dulera [Member]
       
Sales of the Company's products        
Sales 50 25 89 37
Primary Care and Women's Health [Member] | Fosamax [Member]
       
Sales of the Company's products        
Sales 186 221 370 429
Primary Care and Women's Health [Member] | NuvaRing [Member]
       
Sales of the Company's products        
Sales 157 154 303 297
Primary Care and Women's Health [Member] | Follistim AQ [Member]
       
Sales of the Company's products        
Sales 125 143 241 276
Primary Care and Women's Health [Member] | Implanon [Member]
       
Sales of the Company's products        
Sales 85 81 161 141
Primary Care and Women's Health [Member] | Cerazette [Member]
       
Sales of the Company's products        
Sales 72 66 139 125
Primary Care and Women's Health [Member] | Maxalt [Member]
       
Sales of the Company's products        
Sales 154 131 310 304
Primary Care and Women's Health [Member] | Arcoxia [Member]
       
Sales of the Company's products        
Sales 117 100 229 214
Primary Care and Women's Health [Member] | Avelox [Member]
       
Sales of the Company's products        
Sales 44 61 117 167
Hospital and Specialty [Member] | Remicade [Member]
       
Sales of the Company's products        
Sales 518 842 1,037 1,595
Hospital and Specialty [Member] | Simponi [Member]
       
Sales of the Company's products        
Sales 76 75 150 129
Hospital and Specialty [Member] | Isentress [Member]
       
Sales of the Company's products        
Sales 398 337 735 629
Hospital and Specialty [Member] | PegIntron [Member]
       
Sales of the Company's products        
Sales 183 154 345 319
Hospital and Specialty [Member] | Cancidas [Member]
       
Sales of the Company's products        
Sales 166 168 311 326
Hospital and Specialty [Member] | Victrelis [Member]
       
Sales of the Company's products        
Sales 126 21 238 22
Hospital and Specialty [Member] | Invanz [Member]
       
Sales of the Company's products        
Sales 110 103 211 189
Hospital and Specialty [Member] | Primaxin [Member]
       
Sales of the Company's products        
Sales 104 136 192 272
Hospital and Specialty [Member] | Noxafil [Member]
       
Sales of the Company's products        
Sales 66 56 125 110
Hospital and Specialty [Member] | Temodar [Member]
       
Sales of the Company's products        
Sales 225 234 461 481
Hospital and Specialty [Member] | Emend [Member]
       
Sales of the Company's products        
Sales 145 120 247 207
Hospital and Specialty [Member] | Cosopt/Trusopt [Member]
       
Sales of the Company's products        
Sales 105 122 229 236
Hospital and Specialty [Member] | Bridion [Member]
       
Sales of the Company's products        
Sales 60 47 118 89
Hospital and Specialty [Member] | Integrilin [Member]
       
Sales of the Company's products        
Sales 60 56 113 120
Diversified Brands [Member] | Cozaar/Hyzaar [Member]
       
Sales of the Company's products        
Sales 337 406 674 832
Diversified Brands [Member] | Propecia [Member]
       
Sales of the Company's products        
Sales 100 112 208 218
Diversified Brands [Member] | Zocor [Member]
       
Sales of the Company's products        
Sales 96 107 199 234
Diversified Brands [Member] | Claritin Rx [Member]
       
Sales of the Company's products        
Sales 48 65 134 186
Diversified Brands [Member] | Remeron [Member]
       
Sales of the Company's products        
Sales 66 57 123 117
Diversified Brands [Member] | Vasotec/Vaseretic [Member]
       
Sales of the Company's products        
Sales 49 59 102 116
Diversified Brands [Member] | Proscar [Member]
       
Sales of the Company's products        
Sales 55 53 106 113
Vaccines [Member] | Gardasil [Member]
       
Sales of the Company's products        
Sales 324 277 608 490
Vaccines [Member] | ProQuad/M-M-R II/Varivax [Member]
       
Sales of the Company's products        
Sales 316 291 571 535
Vaccines [Member] | RotaTeq [Member]
       
Sales of the Company's products        
Sales 142 148 284 272
Vaccines [Member] | Pneumovax [Member]
       
Sales of the Company's products        
Sales 101 64 213 143
Vaccines [Member] | Zostavax [Member]
       
Sales of the Company's products        
Sales 148 122 224 146
Other pharmaceutical [Member]
       
Sales of the Company's products        
Sales 985 1,062 2,000 1,957
Total Pharmaceutical segment [Member]
       
Sales of the Company's products        
Sales 10,560 10,360 20,642 20,179
Other Segment [Member]
       
Sales of the Company's products        
Sales 1,680 1,690 3,273 3,323
Total Segment [Member]
       
Sales of the Company's products        
Sales 12,240 12,050 23,915 23,502
Other [Member]
       
Sales of the Company's products        
Sales $ 71 $ 101 $ 126 $ 230
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XML 55 R7.htm IDEA: XBRL DOCUMENT v2.4.0.6
Basis of Presentation
6 Months Ended
Jun. 30, 2012
Basis of Presentation [Abstract]  
Basis of Presentation

1.   Basis of Presentation

The accompanying unaudited interim consolidated financial statements of Merck & Co., Inc. (“Merck” or the “Company”) have been prepared pursuant to the rules and regulations for reporting on Form 10-Q. Accordingly, certain information and disclosures required by accounting principles generally accepted in the United States for complete consolidated financial statements are not included herein. These interim statements should be read in conjunction with the audited financial statements and notes thereto included in Merck’s Form 10-K filed on February 28, 2012.

The results of operations of any interim period are not necessarily indicative of the results of operations for the full year. In the Company’s opinion, all adjustments necessary for a fair presentation of these interim statements have been included and are of a normal and recurring nature.

Certain reclassifications have been made to prior year amounts to conform to the current year presentation.

Recently Adopted Accounting Standards

In the first quarter of 2012, the Company retrospectively adopted amended guidance issued by the Financial Accounting Standards Board (the “FASB”) on the presentation of comprehensive income in financial statements. As a result of adopting this standard, the Company has presented a separate Statement of Comprehensive Income. The adoption of this new guidance did not impact the Company’s financial position, results of operations or cash flows.

Recently Issued Accounting Standards

In July 2012, the FASB issued amended guidance that simplifies how an entity tests indefinite-lived intangibles for impairment. The amended guidance will allow companies to first assess qualitative factors to determine whether it is more-likely-than-not that an indefinite-lived intangible asset is impaired as a basis for determining whether it is necessary to perform the quantitative impairment test. The updated guidance is effective for annual and interim impairment tests performed for fiscal years beginning after September 15, 2012, with early adoption permitted. The Company is currently evaluating the impact of adoption on its financial position and results of operations.

XML 56 R3.htm IDEA: XBRL DOCUMENT v2.4.0.6
Interim Consolidated Statement of Comprehensive Income (Unaudited) (USD $)
In Millions, unless otherwise specified
3 Months Ended 6 Months Ended
Jun. 30, 2012
Jun. 30, 2011
Jun. 30, 2012
Jun. 30, 2011
Interim Consolidated Statement of Comprehensive Income [Abstract]        
Net Income Attributable to Merck & Co., Inc. $ 1,793 $ 2,024 $ 3,531 $ 3,067
Other Comprehensive Income Net of Taxes:        
Net unrealized gain (loss) on derivatives, net of reclassifications 102 (30) 44 (137)
Net unrealized gain (loss) on investments, net of reclassifications 1 (4) 30 (5)
Benefit plan net gain (loss) and prior service cost (credit), net of amortization 18 10 18 28
Cumulative translation adjustment (30) 418 (86) 554
Total Other Comprehensive Income Net of Taxes 91 394 6 440
Comprehensive Income Attributable to Merck & Co., Inc. $ 1,884 $ 2,418 $ 3,537 $ 3,507
XML 57 R17.htm IDEA: XBRL DOCUMENT v2.4.0.6
Share-Based Compensation Plans
6 Months Ended
Jun. 30, 2012
Share-Based Compensation Plans [Abstract]  
Share-Based Compensation Plans

11.  Share-Based Compensation Plans

The Company has share-based compensation plans under which employees and non-employee directors may be granted restricted stock units (“RSUs”). In addition, the Company grants options to purchase shares of Company common stock at the fair market value at the time of grant and performance share units (“PSUs”) to certain management-level employees. The Company recognizes the fair value of share-based compensation in net income on a straight-line basis over the requisite service period.

The following table provides amounts of share-based compensation cost recorded in the Consolidated Statement of Income:

 

                                 
      Three Months Ended    
June 30,
        Six Months Ended      
June 30,
 
   

 

 

   

 

 

 

($ in millions)

    2012           2011           2012           2011      

 

 

 

Pretax share-based compensation expense

      $ 93     $ 107           $ 169     $ 200   

Income tax benefit

    (29     (37)        (53     (69)   

 

 

Total share-based compensation expense, net of taxes

      $ 64     $ 70           $ 116     $ 131   

 

 

During the first six months of 2012 and 2011, the Company granted 7 million RSUs with a weighted-average grant date fair value of $39.29 per RSU and 8 million RSUs with a weighted-average grant date fair value of $36.47 per RSU, respectively.

During the first six months of 2012 and 2011, the Company granted 7 million options with a weighted-average exercise price of $39.26 per option and 8 million options with a weighted-average exercise price of $36.55 per option, respectively. The weighted-average fair value of options granted for the first six months of 2012 and 2011 was $5.46 and $5.37 per option, respectively, and was determined using the following assumptions:

 

                 
              Six Months Ended           
June 30,
 
      2012       2011  

 

 

 

Expected dividend yield

    4.4%       4.3%  

Risk-free interest rate

    1.3%       2.6%  

Expected volatility

    25.3%       23.2%  

Expected life (years)

    7.0        7.0   

 

 

At June 30, 2012, there was $555 million of total pretax unrecognized compensation expense related to nonvested stock options, RSU and PSU awards which will be recognized over a weighted-average period of 2.0 years. For segment reporting, share-based compensation costs are unallocated expenses.

 

XML 58 R1.htm IDEA: XBRL DOCUMENT v2.4.0.6
Document and Entity Information
6 Months Ended
Jun. 30, 2012
Jul. 31, 2012
Document and Entity Information [Abstract]    
Entity Registrant Name Merck & Co. Inc.  
Entity Central Index Key 0000310158  
Document Type 10-Q  
Document Period End Date Jun. 30, 2012  
Amendment Flag false  
Document Fiscal Year Focus 2012  
Document Fiscal Period Focus Q2  
Current Fiscal Year End Date --12-31  
Entity Filer Category Large Accelerated Filer  
Entity Common Stock, Shares Outstanding   3,045,632,274
XML 59 R18.htm IDEA: XBRL DOCUMENT v2.4.0.6
Pension and Other Postretirement Benefit Plans
6 Months Ended
Jun. 30, 2012
Pension and Other Postretirement Benefit Plans [Abstract]  
Pension and Other Postretirement Benefit Plans

12.  Pension and Other Postretirement Benefit Plans

The Company has defined benefit pension plans covering eligible employees in the United States and in certain of its international subsidiaries. The net cost of such plans consisted of the following components:

 

                                 
    Three Months Ended
June 30,
    Six Months Ended
June 30,
 
($ in millions)         2012                 2011                 2012                 2011        

 

 

 

Service cost

    $ 141      $ 151        $ 283      $ 303   

Interest cost

    166        180        332        359   

Expected return on plan assets

    (244)       (242)       (488)       (485)  

Net amortization

    48        46        96        91   

Termination benefits

                      17   

Curtailments

    (1)       (6)       (1)       (10)  

Settlements

                      (1)  

 

 
      $ 114      $ 136        $ 231      $ 274   

 

 

The Company provides medical, dental and life insurance benefits, principally to its eligible U.S. retirees and similar benefits to their dependents, through its other postretirement benefit plans. The net cost of such plans consisted of the following components:

 

                                 
    Three Months Ended
June 30,
    Six Months Ended
June 30,
 
($ in millions)         2012                 2011                 2012                 2011        

 

 

 

Service cost

    $ 21      $ 28        $ 42      $ 56   

Interest cost

    31        35        62        71   

Expected return on plan assets

    (34)       (36)       (68)       (71)  

Net amortization

    (8)       (6)       (16)       (9)  

Termination benefits

                       

Curtailments

    (2)             (4)        

 

 
      $ 11      $ 25        $ 21      $ 54   

 

 

In connection with restructuring actions (see Note 2), termination charges for the three and six months ended June 30, 2012 and 2011 were recorded on pension and other postretirement benefit plans related to expanded eligibility for certain employees exiting Merck. Also, in connection with these restructuring actions, curtailments were recorded on pension and other postretirement benefit plans and settlements were recorded on pension plans as reflected in the tables above.

XML 60 R4.htm IDEA: XBRL DOCUMENT v2.4.0.6
Consolidated Balance Sheet (Unaudited) (USD $)
In Millions, unless otherwise specified
Jun. 30, 2012
Dec. 31, 2011
Current Assets    
Cash and cash equivalents $ 16,752 $ 13,531
Short-term investments 698 1,441
Accounts receivable (net of allowance for doubtful accounts of $144 in 2012 and $131 in 2011) 8,152 8,261
Inventories (excludes inventories of $1,490 in 2012 and $1,379 in 2011 classified in Other assets - see Note 6) 6,249 6,254
Deferred income taxes and other current assets 3,788 3,694
Total current assets 35,639 33,181
Investments 4,085 3,458
Property, Plant and Equipment, at cost, net of accumulated depreciation of $17,049 in 2012 and $16,176 in 2011 15,867 16,297
Goodwill 12,158 12,155
Other Intangibles, Net 31,620 34,302
Other Assets 6,156 5,735
Total Assets 105,525 105,128
Current Liabilities    
Loans payable and current portion of long-term debt 3,922 1,990
Trade accounts payable 1,674 2,023
Accrued and other current liabilities 8,917 10,170
Income taxes payable 1,091 781
Dividends payable 1,308 1,281
Total current liabilities 16,912 16,245
Long-Term Debt 15,057 15,525
Deferred Income Taxes and Noncurrent Liabilities 15,883 16,415
Merck & Co., Inc. Stockholders' Equity    
Common stock, $0.50 par value Authorized - 6,500,000,000 shares Issued - 3,577,103,522 shares in 2012 and 2011 1,788 1,788
Other paid-in capital 40,550 40,663
Retained earnings 39,950 38,990
Accumulated other comprehensive loss (3,126) (3,132)
Stockholders' equity before deduction for treasury stock 79,162 78,309
Less treasury stock, at cost: 538,194,526 shares in 2012 and 536,109,713 shares in 2011 23,968 23,792
Total Merck & Co., Inc. stockholders' equity 55,194 54,517
Noncontrolling Interests 2,479 2,426
Total equity 57,673 56,943
Total Liabilities and Stockholders' Equity $ 105,525 $ 105,128
XML 61 R12.htm IDEA: XBRL DOCUMENT v2.4.0.6
Inventories
6 Months Ended
Jun. 30, 2012
Inventories [Abstract]  
Inventories

6.    Inventories

Inventories consisted of:

 

                 
($ in millions)          June 30,       
2012
      December 31,  
2011
 

Finished goods

  $ 1,808     $ 1,983  

Raw materials and work in process

    5,705       5,396  

Supplies

    265       297  

Total (approximates current cost)

    7,778       7,676  

Reduction to LIFO costs

    (39     (43
    $ 7,739     $ 7,633  

Recognized as:

               

Inventories

  $ 6,249     $ 6,254  

Other assets

    1,490       1,379  

Amounts recognized as Other assets are comprised almost entirely of raw materials and work in process inventories. At both June 30, 2012 and December 31, 2011, these amounts included $1.3 billion of inventories not expected to be sold within one year. In addition, these amounts included $169 million and $127 million at June 30, 2012 and December 31, 2011, respectively, of inventories produced in preparation for product launches.

XML 62 R11.htm IDEA: XBRL DOCUMENT v2.4.0.6
Financial Instruments
6 Months Ended
Jun. 30, 2012
Financial Instruments [Abstract]  
Financial Instruments

5.   Financial Instruments

Derivative Instruments and Hedging Activities

The Company manages the impact of foreign exchange rate movements and interest rate movements on its earnings, cash flows and fair values of assets and liabilities through operational means and through the use of various financial instruments, including derivative instruments.

A significant portion of the Company’s revenues and earnings in foreign affiliates is exposed to changes in foreign exchange rates. The objectives and accounting related to the Company’s foreign currency risk management program, as well as its interest rate risk management activities are discussed below.

Foreign Currency Risk Management

The Company has established revenue hedging, balance sheet risk management and net investment hedging programs to protect against volatility of future foreign currency cash flows and changes in fair value caused by volatility in foreign exchange rates.

The objective of the revenue hedging program is to reduce the potential for longer-term unfavorable changes in foreign exchange rates to decrease the U.S. dollar value of future cash flows derived from foreign currency denominated sales, primarily the euro and Japanese yen. To achieve this objective, the Company will hedge a portion of its forecasted foreign currency denominated third-party and intercompany distributor entity sales that are expected to occur over its planning cycle, typically no more than three years into the future. The Company will layer in hedges over time, increasing the portion of third-party and intercompany distributor entity sales hedged as it gets closer to the expected date of the forecasted foreign currency denominated sales, such that it is probable the hedged transaction will occur. The portion of sales hedged is based on assessments of cost-benefit profiles that consider natural offsetting exposures, revenue and exchange rate volatilities and correlations, and the cost of hedging instruments. The hedged anticipated sales are a specified component of a portfolio of similarly denominated foreign currency-based sales transactions, each of which responds to the hedged currency risk in the same manner. The Company manages its anticipated transaction exposure principally with purchased local currency put options, which provide the Company with a right, but not an obligation, to sell foreign currencies in the future at a predetermined price. If the U.S. dollar strengthens relative to the currency of the hedged anticipated sales, total changes in the options’ cash flows offset the decline in the expected future U.S. dollar equivalent cash flows of the hedged foreign currency sales. Conversely, if the U.S. dollar weakens, the options’ value reduces to zero, but the Company benefits from the increase in the U.S. dollar equivalent value of the anticipated foreign currency cash flows.

In connection with the Company’s revenue hedging program, a purchased collar option strategy may be utilized. With a purchased collar option strategy, the Company writes a local currency call option and purchases a local currency put option. As compared to a purchased put option strategy alone, a purchased collar strategy reduces the upfront costs associated with purchasing puts through the collection of premium by writing call options. If the U.S. dollar weakens relative to the currency of the hedged anticipated sales, the purchased put option value of the collar strategy reduces to zero and the Company benefits from the increase in the U.S. dollar equivalent value of its anticipated foreign currency cash flows, however this benefit would be capped at the strike level of the written call.If the U.S. dollar strengthens relative to the currency of the hedged anticipated sales, the written call option value of the collar strategy reduces to zero and the changes in the purchased put cash flows of the collar strategy would offset the decline in the expected future U.S. dollar equivalent cash flows of the hedged foreign currency sales.

The Company may also utilize forward contracts in its revenue hedging program. If the U.S. dollar strengthens relative to the currency of the hedged anticipated sales, the increase in the fair value of the forward contracts offsets the decrease in the expected future U.S. dollar cash flows of the hedged foreign currency sales. Conversely, if the U.S. dollar weakens, the decrease in the fair value of the forward contracts offsets the increase in the value of the anticipated foreign currency cash flows.

The fair values of these derivative contracts are recorded as either assets (gain positions) or liabilities (loss positions) in the Consolidated Balance Sheet. Changes in the fair value of derivative contracts are recorded each period in either current earnings or Other comprehensive income (“OCI”), depending on whether the derivative is designated as part of a hedge transaction and, if so, the type of hedge transaction. For derivatives that are designated as cash flow hedges, the effective portion of the unrealized gains or losses on these contracts is recorded in Accumulated other comprehensive income (“AOCI”) and reclassified into Sales when the hedged anticipated revenue is recognized. The hedge relationship is highly effective and hedge ineffectiveness has been de minimis. For those derivatives which are not designated as cash flow hedges, unrealized gains or losses are recorded in Sales each period. The cash flows from these contracts are reported as operating activities in the Consolidated Statement of Cash Flows. The Company does not enter into derivatives for trading or speculative purposes.

The primary objective of the balance sheet risk management program is to mitigate the exposure of foreign currency denominated net monetary assets of foreign subsidiaries where the U.S. dollar is the functional currency from the effects of volatility in foreign exchange. In these instances, Merck principally utilizes forward exchange contracts, which enable the Company to buy and sell foreign currencies in the future at fixed exchange rates and economically offset the consequences of changes in foreign exchange from the monetary assets. Merck routinely enters into contracts to offset the effects of exchange on exposures denominated in developed country currencies, primarily the euro and Japanese yen. For exposures in developing country currencies, the Company will enter into forward contracts to partially offset the effects of exchange on exposures when it is deemed economical to do so based on a cost-benefit analysis that considers the magnitude of the exposure, the volatility of the exchange rate and the cost of the hedging instrument. The Company will also minimize the effect of exchange on monetary assets and liabilities by managing operating activities and net asset positions at the local level.

Monetary assets and liabilities denominated in a currency other than the functional currency of a given subsidiary are remeasured at spot rates in effect on the balance sheet date with the effects of changes in spot rates reported in Other (income) expense, net. The forward contracts are not designated as hedges and are marked to market through Other (income) expense, net. Accordingly, fair value changes in the forward contracts help mitigate the changes in the value of the remeasured assets and liabilities attributable to changes in foreign currency exchange rates, except to the extent of the spot-forward differences. These differences are not significant due to the short-term nature of the contracts, which typically have average maturities at inception of less than one year.

The Company also uses forward exchange contracts to hedge its net investment in foreign operations against movements in exchange rates. The forward contracts are designated as hedges of the net investment in a foreign operation. The Company hedges a portion of the net investment in certain of its foreign operations and measures ineffectiveness based upon changes in spot foreign exchange rates. The effective portion of the unrealized gains or losses on these contracts is recorded in foreign currency translation adjustment within OCI, and remains in AOCI until either the sale or complete or substantially complete liquidation of the subsidiary. The cash flows from these contracts are reported as investing activities in the Consolidated Statement of Cash Flows.

Foreign exchange risk is also managed through the use of foreign currency debt. The Company’s senior unsecured euro-denominated notes have been designated as, and are effective as, economic hedges of the net investment in a foreign operation. Accordingly, foreign currency transaction gains or losses due to spot rate fluctuations on the euro-denominated debt instruments are included in foreign currency translation adjustment within OCI. Included in the cumulative translation adjustment are pretax gains (losses) of $92 million and $(178) million for the first six months of 2012 and 2011, respectively, from the euro-denominated notes.

 

Interest Rate Risk Management

The Company may use interest rate swap contracts on certain investing and borrowing transactions to manage its net exposure to interest rate changes and to reduce its overall cost of borrowing. The Company does not use leveraged swaps and, in general, does not leverage any of its investment activities that would put principal capital at risk.

In June 2011, the Company terminated nine interest rate swap contracts with a total notional amount of $3.5 billion. These swaps effectively converted $3.5 billion of its fixed-rate notes, with maturity dates varying from March 2015 to June 2019, to floating rate instruments. As a result of the swap terminations, the Company received $175 million in cash, which included $36 million in accrued interest. The corresponding $139 million basis adjustment of the debt associated with the terminated swap contracts was deferred and is being amortized as a reduction of interest expense over the respective term of the notes. The cash flows from these contracts are reported as operating activities in the Consolidated Statement of Cash Flows.

At June 30, 2011, the Company was a party to 13 pay-floating, receive-fixed interest rate swap contracts with notional amounts of $1.9 billion in the aggregate designated as fair value hedges of fixed-rate notes in which the notional amounts match the amount of the hedged fixed-rate notes. The interest rate swap contracts were designated hedges of the fair value changes in the notes attributable to changes in the benchmark London Interbank Offered Rate (“LIBOR”) swap rate. The fair value changes in the notes attributable to changes in the benchmark interest rate were recorded in interest expense and offset by the fair value changes in the swap contracts. The Company terminated certain of these interest rate swap contracts in the third quarter of 2011 and the remaining interest rate swap contracts matured in the fourth quarter of 2011. The cash flows from these contracts are reported as operating activities in the Consolidated Statement of Cash Flows.

Presented in the table below is the fair value of derivatives segregated between those derivatives that are designated as hedging instruments and those that are not designated as hedging instruments:

 

                                                     
        June 30,2012     December 31, 2011  
        Fair Value of Derivative     U.S. Dollar     Fair Value of Derivative     U.S. Dollar  

($ in millions)

  Balance Sheet Caption     Asset       Liability       Notional       Asset       Liability       Notional  

Derivatives Designated as Hedging Instruments

  

Foreign exchange contracts (current)

 

Deferred income taxes and other current assets

    $ 279     $ -     $ 5,005       $ 196     $ -     $ 3,727  

Foreign exchange contracts (non-current)

 

Other assets

    470       -       5,177       420       -       4,956  

Foreign exchange contracts (current)

 

Accrued and other current liabilities

    -       13       411       -       53       1,718  

Foreign exchange contracts (non-current)

 

Deferred income taxes and noncurrent liabilities

    -       7       436       -       1       104  
          $ 749     $ 20     $ 11,029       $ 616     $ 54     $ 10,505  

Derivatives Not Designated as Hedging Instruments

  

Foreign exchange contracts (current)

 

Deferred income taxes and other current assets

    $ 100     $ -     $ 4,511       $ 139     $ -     $ 5,306  

Foreign exchange contracts (non-current)

 

Other assets

    35       -       339       -       -       -  

Foreign exchange contracts (current)

 

Accrued and other current liabilities

    -       28       3,740       -       54       5,013  
          $ 135     $ 28     $ 8,590       $ 139     $ 54     $ 10,319  
          $ 884     $ 48     $ 19,619       $ 755     $ 108     $ 20,824  

 

The table below provides information on the location and pretax gain or loss amounts for derivatives that are: (i) designated in a fair value hedging relationship, (ii) designated in a cash flow hedging relationship, (iii) designated in a foreign currency net investment hedging relationship and (iv) not designated in a hedging relationship:

 

                                     
          Three Months Ended      
June 30,
              Six Months Ended      
June 30,
 
($ in millions)         2012                 2011                     2012                 2011        

 

 

Derivatives designated in fair value hedging relationships

                                   

 

Interest rate swap contracts

                                   

Amount of gain recognized in Other (income) expense, net on derivatives

    $       -     $       (126)           $       -     $       (163)  

Amount of loss recognized in Other (income) expense, net on hedged item

    -       126            -       163   
           

Derivatives designated in foreign currency cash flow hedging relationships

                                   

 

Foreign exchange contracts

                                   

Amount of loss reclassified from AOCI to Sales

    26       20            53       27   

Amount of (gain) loss recognized in OCI on derivatives

    (154     69            (34     252   
           

Derivatives designated in foreign currency net investment hedging relationships

                                   

 

Foreign exchange contracts

                                   

Amount of gain recognized in Other (income) expense, net on derivatives (1)

    (2     (2)           (11     (8)  

Amount of loss (gain) recognized in OCI on derivatives

    86       33            (56     34   
           

Derivatives not designated in a hedging relationship

                                   

 

Foreign exchange contracts

                                   

Amount of (gain) loss recognized in Other (income) expense, net on derivatives (2)

    (279     33            (26     349   

 

 

 

(1) 

There was no ineffectiveness on the hedge. Represents the amount excluded from hedge effectiveness testing.

(2) 

These derivative contracts mitigate changes in the value of remeasured foreign currency denominated monetary assets and liabilities attributable to changes in foreign currency exchange rates.

At June 30, 2012, the Company estimates $2 million of pretax net unrealized gains on derivatives maturing within the next 12 months that hedge foreign currency denominated sales over that same period will be reclassified from AOCI to Sales. The amount ultimately reclassified to Sales may differ as foreign exchange rates change. Realized gains and losses are ultimately determined by actual exchange rates at maturity.

Investments in Debt and Equity Securities

Information on available-for-sale investments is as follows:

 

                                                                     
    June 30, 2012         December 31, 2011  
    Fair     Amortized     Gross Unrealized         Fair     Amortized     Gross Unrealized  
($ in millions)   Value     Cost     Gains     Losses         Value     Cost     Gains     Losses  

 

       

 

 

 

 

Corporate notes and bonds

  $ 2,787     $ 2,759     $ 30     $ (2)         $ 2,032     $ 2,024     $ 16     $ (8)  

U.S. government and agency securities

    773       772       1                 1,021       1,018       3        

Asset-backed securities

    441       439       2                 292       292       1       (1)  

Mortgage-backed securities

    271       270       2       (1)           223       223       1       (1)  

Commercial paper

    220       220       -                 1,029       1,029       -        

Foreign government bonds

    76       75       1                 72       72       -        

Other debt securities

    3       1       2                 3       1       2        

Equity securities

    383       354       29                 397       383       14        

 

 
    $ 4,954     $ 4,890     $ 67     $ (3)         $ 5,069     $ 5,042     $ 37     $ (10)  

 

 

Available-for-sale debt securities included in Short-term investments totaled $698 million at June 30, 2012. Of the remaining debt securities, $3.4 billion mature within five years. At June 30, 2012, there were no debt securities pledged as collateral.

 

Fair Value Measurements

Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. The Company uses a fair value hierarchy which maximizes the use of observable inputs and minimizes the use of unobservable inputs when measuring fair value. There are three levels of inputs used to measure fair value with Level 1 having the highest priority and Level 3 having the lowest:

Level 1 - Quoted prices (unadjusted) in active markets for identical assets or liabilities.

Level 2 - Observable inputs other than Level 1 prices, such as quoted prices for similar assets or liabilities, or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities.

Level 3 - Unobservable inputs that are supported by little or no market activity. Level 3 assets are those whose values are determined using pricing models, discounted cash flow methodologies, or similar techniques with significant unobservable inputs, as well as instruments for which the determination of fair value requires significant judgment or estimation. The Company had no Level 3 assets at June 30, 2012 or December 31, 2011.

If the inputs used to measure the financial assets and liabilities fall within more than one level described above, the categorization is based on the lowest level input that is significant to the fair value measurement of the instrument.

Financial Assets and Liabilities Measured at Fair Value on a Recurring Basis

Financial assets and liabilities measured at fair value on a recurring basis are summarized below:

 

                                                                     
    Fair Value Measurements Using         Fair Value Measurements Using  
     Quoted Prices
In Active
Markets for
 Identical Assets 
(Level 1)
    Significant
Other
Observable
Inputs
(Level 2)
    Significant
Unobservable
Inputs
(Level 3)
    Total          Quoted Prices
In Active
Markets for
 Identical Assets 
(Level 1)
    Significant
Other
Observable
Inputs
(Level 2)
    Significant
Unobservable
Inputs
(Level 3)
    Total  
($ in millions)   June 30, 2012          December 31, 2011  

Assets

                                                                   

Investments

                                                                   

Corporate notes and bonds

  $ -     $ 2,787     $ -     $ 2,787         $ -     $ 2,032     $ -     $ 2,032  

U.S. government and agency securities

    -       773       -       773           -       1,021       -       1,021  

Asset-backed securities (1)

    -       441       -       441           -       292       -       292  

Mortgage-backed securities (1)

    -       271       -       271           -       223       -       223  

Commercial paper

    -       220       -       220           -       1,029       -       1,029  

Foreign government bonds

    -       76       -       76           -       72       -       72  

Equity securities

    203       9       -       212           205       22       -       227  

Other debt securities

    -       3       -       3           -       3       -       3  
      203       4,580       -       4,783           205       4,694       -       4,899  
                   

Other assets

                                                                   

Securities held for employee compensation

    171       -       -       171           170       -       -       170  
                                                                     

Derivative assets (2)

                                                                   

Purchased currency options

    -       763       -       763           -       613       -       613  

Forward exchange contracts

    -       121       -       121           -       142       -       142  
      -       884       -       884           -       755       -       755  

Total assets

  $           374     $      5,464     $             -     $      5,838         $           375     $      5,449     $             -     $      5,824  
                   

Liabilities

                                                                   

Derivative liabilities (2)

                                                                   

Forward exchange contracts

  $ -     $ 48     $ -     $ 48         $ -     $ 107     $ -     $ 107  

Written currency options

    -       -       -       -           -       1       -       1  

Total liabilities

  $ -     $ 48     $ -     $ 48         $ -     $ 108     $ -     $ 108  

 

(1) 

Primarily all of the asset-backed securities are highly-rated (Standard & Poor’s rating of AAA and Moody’s Investors Service rating of Aaa), secured primarily by credit card, auto loan, and home equity receivables, with weighted-average lives of primarily 5 years or less. Mortgage-backed securities represent AAA-rated securities issued or unconditionally guaranteed as to payment of principal and interest by U.S. government agencies.

(2) 

The fair value determination of derivatives includes the impact of the credit risk of counterparties to the derivatives and the Company’s own credit risk, the effects of which were not significant.

 

There were no transfers between Level 1 and Level 2 during the first six months of 2012. As of June 30, 2012, Cash and cash equivalents of $16.8 billion included $15.9 billion of cash equivalents (which would be considered Level 2 in the fair value hierarchy).

Other Fair Value Measurements

Some of the Company’s financial instruments, such as cash and cash equivalents, receivables and payables, are reflected in the balance sheet at carrying value, which approximates fair value due to their short-term nature.

The estimated fair value of loans payable and long-term debt (including current portion) at June 30, 2012 was $21.2 billion compared with a carrying value of $19.0 billion and at December 31, 2011 was $19.5 billion compared with a carrying value of $17.5 billion. Fair value was estimated using recent observable market prices and would be considered Level 2 in the fair value hierarchy.

Concentrations of Credit Risk

On an ongoing basis, the Company monitors concentrations of credit risk associated with corporate and government issuers of securities and financial institutions with which it conducts business. Credit exposure limits are established to limit a concentration with any single issuer or institution. Cash and investments are placed in instruments that meet high credit quality standards, as specified in the Company’s investment policy guidelines. Approximately 40% of the Company’s cash and cash equivalents are invested in five highly rated money market funds.

The majority of the Company’s accounts receivable arise from product sales in the United States and Europe and are primarily due from drug wholesalers and retailers, hospitals, government agencies, managed health care providers and pharmacy benefit managers. The Company monitors the financial performance and credit worthiness of its customers so that it can properly assess and respond to changes in their credit profile. The Company also continues to monitor economic conditions, including the volatility associated with international sovereign economies, and associated impacts on the financial markets and its business, taking into consideration the global economic downturn and the sovereign debt issues in certain European countries. The Company continues to monitor the credit and economic conditions within Greece, Spain, Italy and Portugal, among other members of the EU. These economic conditions, as well as inherent variability of timing of cash receipts, have resulted in, and may continue to result in, an increase in the average length of time that it takes to collect accounts receivable outstanding. As such, time value of money discounts have been recorded for those customers for which collection of accounts receivable is expected to be in excess of one year. The Company does not expect to have write-offs or adjustments to accounts receivable which would have a material adverse effect on its financial position, liquidity or results of operations.

At June 30, 2012, the Company’s accounts receivable in Greece, Italy, Spain and Portugal totaled approximately $1.0 billion. Of this amount, hospital and public sector receivables were approximately $700 million in the aggregate, of which approximately 16%, 38%, 28% and 18% related to Greece, Italy, Spain and Portugal, respectively. As of June 30, 2012, the Company’s total accounts receivable outstanding for more than one year were approximately $200 million, of which approximately 70% related to accounts receivable in Greece, Italy, Spain and Portugal, mostly comprised of hospital and public sector receivables.

During the second quarter of 2012, the Company collected approximately $500 million of accounts receivable in connection with the Spanish government’s debt stabilization/stimulus plan. In addition, in the second and first quarters of 2012, the Company completed non-recourse factorings of approximately $120 million and $110 million, respectively, of hospital and public sector accounts receivable in Italy.

As previously disclosed, the Company received zero coupon bonds from the Greek government in settlement of 2007-2009 receivables related to certain government sponsored institutions. The Company had recorded impairment charges to reduce the bonds to fair value. During 2011, the Company sold a portion of these bonds and the remainder was sold during the first quarter of 2012.

Derivative financial instruments are executed under International Swaps and Derivatives Association master agreements. The master agreements with several of the Company’s financial institution counterparties also include credit support annexes. These annexes contain provisions that require collateral to be exchanged depending on the value of the derivative assets and liabilities, the Company’s credit rating, and the credit rating of the counterparty. As of June 30, 2012 and December 31, 2011, the Company had received cash collateral of $539 million and $327 million, respectively, from various counterparties and the obligation to return such collateral is recorded in Accrued and other current liabilities. The Company had not advanced any cash collateral to counterparties as of June 30, 2012 or December 31, 2011.

XML 63 R23.htm IDEA: XBRL DOCUMENT v2.4.0.6
Basis of Presentation (Policies)
6 Months Ended
Jun. 30, 2012
Basis of Presentation [Abstract]  
Recently Adopted Accounting Standards

Recently Adopted Accounting Standards

In the first quarter of 2012, the Company retrospectively adopted amended guidance issued by the Financial Accounting Standards Board (the “FASB”) on the presentation of comprehensive income in financial statements. As a result of adopting this standard, the Company has presented a separate Statement of Comprehensive Income. The adoption of this new guidance did not impact the Company’s financial position, results of operations or cash flows.

Recently Issued Accounting Standards

Recently Issued Accounting Standards

In July 2012, the FASB issued amended guidance that simplifies how an entity tests indefinite-lived intangibles for impairment. The amended guidance will allow companies to first assess qualitative factors to determine whether it is more-likely-than-not that an indefinite-lived intangible asset is impaired as a basis for determining whether it is necessary to perform the quantitative impairment test. The updated guidance is effective for annual and interim impairment tests performed for fiscal years beginning after September 15, 2012, with early adoption permitted. The Company is currently evaluating the impact of adoption on its financial position and results of operations.

Contingencies and Legal Defense Costs

Legal defense costs expected to be incurred in connection with a loss contingency are accrued when probable and reasonably estimable.

XML 64 R19.htm IDEA: XBRL DOCUMENT v2.4.0.6
Other (Income) Expense, Net
6 Months Ended
Jun. 30, 2012
Other (Income) Expense, Net [Abstract]  
Other (Income) Expense, Net

13.  Other (Income) Expense, Net

Other (income) expense, net, consisted of:

 

                                 
    Three Months Ended
June 30,
    Six Months Ended
June 30,
 
($ in millions)         2012                 2011                 2012                 2011        

 

 

 

Interest income

    $ (76)     $ (39)       $ (129)     $ (69)  

Interest expense

    172        170        346        345   

Exchange losses

    13              80        43   

Other, net

    (6)       (11)       (50)       425   

 

 
      $ 103      $ 121        $ 247      $ 744   

 

 

 

As a result of significant collections of accounts receivable in Spain during the second quarter (see Note 5), the Company recognized incremental interest income of approximately $35 million in the second quarter and first six months of 2012 for accelerated accretion of time value of money discounts related to these receivables. Other, net (as presented in the table above) for the first six months of 2011 reflects a $500 million charge related to the resolution of the arbitration proceeding involving the Company’s rights to market Remicade and Simponi (see Note 4), as well as a $127 million gain on the sale of certain manufacturing facilities and related assets. Interest paid for the six months ended June 30, 2012 and 2011 was $324 million and $194 million, respectively, which excludes commitment fees. Interest paid for the six months ended June 30, 2011 is net of $175 million received by the Company from the termination of certain interest rate swap contracts during the period (see Note 5).

XML 65 R15.htm IDEA: XBRL DOCUMENT v2.4.0.6
Contingencies and Environmental Liabilities
6 Months Ended
Jun. 30, 2012
Contingencies and Environmental Liabilities [Abstract]  
Contingencies and Environmental Liabilities

9.    Contingencies and Environmental Liabilities

The Company is involved in various claims and legal proceedings of a nature considered normal to its business, including product liability, intellectual property, and commercial litigation, as well as additional matters such as antitrust actions and environmental matters. Except for the Vioxx Litigation and the ENHANCE Litigation (each as defined below) for which separate assessments are provided in this Note, in the opinion of the Company, it is unlikely that the resolution of these matters will be material to the Company’s financial position, results of operations or cash flows.

Given the preliminary nature of the litigation discussed below, including the Vioxx Litigation and the ENHANCE Litigation, and the complexities involved in these matters, the Company is unable to reasonably estimate a possible loss or range of possible loss for such matters until the Company knows, among other factors, (i) what claims, if any, will survive dispositive motion practice, (ii) the extent of the claims, including the size of any potential class, particularly when damages are not specified or are indeterminate, (iii) how the discovery process will affect the litigation, (iv) the settlement posture of the other parties to the litigation and (v) any other factors that may have a material effect on the litigation.

The Company records accruals for contingencies when it is probable that a liability has been incurred and the amount can be reasonably estimated. These accruals are adjusted periodically as assessments change or additional information becomes available. For product liability claims, a portion of the overall accrual is actuarially determined and considers such factors as past experience, number of claims reported and estimates of claims incurred but not yet reported. Individually significant contingent losses are accrued when probable and reasonably estimable. Legal defense costs expected to be incurred in connection with a loss contingency are accrued when probable and reasonably estimable.

The Company’s decision to obtain insurance coverage is dependent on market conditions, including cost and availability, existing at the time such decisions are made. The Company has evaluated its risks and has determined that the cost of obtaining product liability insurance outweighs the likely benefits of the coverage that is available and as such, has no insurance for certain product liabilities effective August 1, 2004.

Vioxx Litigation

Product Liability Lawsuits

As previously disclosed, Merck is a defendant in approximately 100 federal and state lawsuits (the “Vioxx Product Liability Lawsuits”) alleging personal injury or economic loss as a result of the purchase or use of Vioxx. Most of the remaining cases are coordinated in a multidistrict litigation in the U.S. District Court for the Eastern District of Louisiana (the “Vioxx MDL”) before Judge Eldon E. Fallon.

There is one U.S. Vioxx Product Liability Lawsuit currently scheduled for trial in 2012. Merck has previously disclosed the outcomes of several Vioxx Product Liability Lawsuits that were tried prior to 2012. All post-trial appeals have been resolved.

There are pending in various U.S. courts putative class actions purportedly brought on behalf of individual purchasers or users of Vioxx seeking reimbursement for alleged economic loss. In the Vioxx MDL proceeding, approximately 30 such class actions remain. In June 2010, Merck moved to strike the class claims or for judgment on the pleadings regarding the master complaint, which includes the above-referenced cases, and briefing on that motion was completed in September 2010. The Vioxx MDL court heard oral argument on Merck’s motion in October 2010 and took it under advisement.

In 2008, a Missouri state court certified a class of Missouri plaintiffs seeking reimbursement for out-of-pocket costs relating to Vioxx. The Vioxx MDL court issued an order in April 2012 enjoining the Missouri plaintiffs from offering any evidence that does not sufficiently exclude damages attributable to claims already settled through the prior personal injury and third-party payor settlements and from executing any judgment obtained through admission of such evidence. The Missouri plaintiffs have appealed that decision to the U.S. Court of Appeals for the Fifth Circuit, which has set an expedited briefing schedule on plaintiffs’ appeal. Trial has been rescheduled for November 1, 2012, in light of the appeal. In Indiana, plaintiffs filed a motion to certify a class of Indiana Vioxx purchasers in a case pending before the Circuit Court of Marion County, Indiana. That case has been dormant for several years. In April 2010, a Kentucky state court denied Merck’s motion for summary judgment and certified a class of Kentucky plaintiffs seeking reimbursement for out-of-pocket costs relating to Vioxx. The trial court subsequently entered an amended class certification order in January 2011. Merck appealed that order to the Kentucky Court of Appeals and, on February 10, 2012, the Kentucky Court of Appeals reversed the trial court’s amended class certification order and denied certification. The plaintiff has petitioned the Kentucky Supreme Court to review the Court of Appeals’ order. Merck opposed the petition, and the Kentucky Supreme Court has not yet ruled.

Merck has also been named as a defendant in several lawsuits brought by, or on behalf of, government entities. Six of these suits are being brought by state Attorneys General and one has been brought on behalf of a county. All of these actions except for an action brought by the Kentucky Attorney General are in the Vioxx MDL proceeding. These actions allege that Merck misrepresented the safety of Vioxx. These suits seek recovery for expenditures on Vioxx by government-funded health care programs, such as Medicaid, and/or penalties for alleged Consumer Fraud Act violations. Judge Fallon remanded the Kentucky case to state court on January 3, 2012. Merck’s petition to appeal that decision to the U.S. Court of Appeals for the Fifth Circuit was denied. The lawsuit brought by the county is a putative class action filed by Santa Clara County, California on behalf of all similarly situated California counties. Merck moved for judgment on the pleadings in the case brought by Santa Clara County in September 2011. The court granted Merck’s motion on March 20, 2012, but gave the county leave to file an amended complaint.

Shareholder Lawsuits

As previously disclosed, in addition to the Vioxx Product Liability Lawsuits, various putative class actions and individual lawsuits under federal securities laws and state laws have been filed against Merck and various current and former officers and directors (the “Vioxx Securities Lawsuits”). The Vioxx Securities Lawsuits are coordinated in a multidistrict litigation in the U.S. District Court for the District of New Jersey before Judge Stanley R. Chesler, and have been consolidated for all purposes. In August 2011, Judge Chesler granted in part and denied in part Merck’s motion to dismiss the Fifth Amended Class Action Complaint in the consolidated securities action. Among other things, the claims based on statements made on or after the voluntary withdrawal of Vioxx on September 30, 2004 have been dismissed. In October 2011, defendants answered the Fifth Amended Class Action Complaint. Discovery is currently proceeding in accordance with the court’s scheduling order.

 

As previously disclosed, several individual securities lawsuits filed by foreign institutional investors also are consolidated with the Vioxx Securities Lawsuits. In October 2011, plaintiffs filed amended complaints in each of the pending individual securities lawsuits. Also in October 2011, a new individual securities lawsuit was filed in the District of New Jersey by several foreign institutional investors; that case is also consolidated with the Vioxx Securities Lawsuits. On January 20, 2012, defendants filed motions to dismiss in one of the individual lawsuits (the “ABP Lawsuit”). Briefing on the motions to dismiss was completed on March 26, 2012. On August 1, 2012, Judge Chesler granted in part and denied in part the motions to dismiss the ABP Lawsuit. Among other things, certain alleged misstatements and omissions were dismissed as inactionable and all state law claims were dismissed in full. By stipulation and order, defendants are not required to respond to the complaints in the remaining individual securities lawsuits until on or about September 15, 2012.

Insurance

The Company has Directors and Officers insurance coverage applicable to the Vioxx Securities Lawsuits with remaining stated upper limits of approximately $175 million. As a result of the previously disclosed insurance arbitration, additional insurance coverage for these claims should also be available, if needed, under upper-level excess policies that provide coverage for a variety of risks. There are disputes with the insurers about the availability of some or all of the Company’s insurance coverage for these claims and there are likely to be additional disputes. The amounts actually recovered under the policies discussed in this paragraph may be less than the stated upper limits.

Investigations

As previously disclosed, Merck received subpoenas from the Department of Justice (the “DOJ”) requesting information related to Merck’s research, marketing and selling activities with respect to Vioxx in a federal health care investigation under criminal statutes. As previously disclosed, in March 2009, Merck received a letter from the U.S. Attorney’s Office for the District of Massachusetts identifying it as a target of the grand jury investigation regarding Vioxx. In 2010, the Company established a $950 million reserve (the “Vioxx Liability Reserve”) in connection with the anticipated resolution of the DOJ’s investigation.

In November 2011, the Company announced that it had reached a resolution with federal and state authorities regarding this matter, pending court approval. Under civil settlement agreements signed with the United States and individually with 44 states and the District of Columbia, Merck paid approximately two-thirds of the Vioxx Liability Reserve to resolve civil allegations related to Vioxx. As a result, the United States and the participating states have released Merck from civil liability related to the government’s allegations regarding the sale and promotion of Vioxx. The Company also has agreed to plead guilty to one count of misdemeanor misbranding of Vioxx under the Federal Food, Drug, and Cosmetic Act by promoting the drug for the treatment of rheumatoid arthritis prior to the approval of that indication by the U.S. Food and Drug Administration (the “FDA”) in April 2002. The Company paid a fine of approximately one-third of the Vioxx Liability Reserve to the federal government as part of the plea agreement.

In December 2011, the U.S. District Court for the District of Massachusetts conducted a hearing with regard to the resolution. During that hearing, the parties advised the court as to the nature of the resolution and the core documents comprising the resolution. On April 19, 2012, the court accepted the resolution and thereafter the Company made the payments noted above.

International Lawsuits

As previously disclosed, in addition to the lawsuits discussed above, Merck has been named as a defendant in litigation relating to Vioxx in Australia, Brazil, Canada, Europe and Israel (collectively, the “Vioxx Foreign Lawsuits”). As previously disclosed, the Company has entered into an agreement to resolve all claims related to Vioxx in Canada. The agreement is pending approval by courts in Canada’s provinces.

Reserves

The Company believes that it has meritorious defenses to the remaining Vioxx Product Liability Lawsuits, Vioxx Securities Lawsuits and Vioxx Foreign Lawsuits (collectively, the “Vioxx Lawsuits”) and will vigorously defend against them. In view of the inherent difficulty of predicting the outcome of litigation, particularly where there are many claimants and the claimants seek indeterminate damages, the Company is unable to predict the outcome of these matters and, at this time, cannot reasonably estimate the possible loss or range of loss with respect to the remaining Vioxx Lawsuits. As previously disclosed, the Company has a reserve with respect to the Canada Settlement Agreement. The Company also has an immaterial remaining reserve relating to the Vioxx investigation discussed above for the non-participating states with which litigation is continuing. The Company has established no other liability reserves with respect to the Vioxx Litigation. Unfavorable outcomes in the Vioxx Litigation could have a material adverse effect on the Company’s financial position, liquidity and results of operations.

 

Other Product Liability Litigation

Fosamax

As previously disclosed, Merck is a defendant in product liability lawsuits in the United States involving Fosamax (the “Fosamax Litigation”). As of June 30, 2012, approximately 3,615 cases, which include approximately 4,175 plaintiff groups, had been filed and were pending against Merck in either federal or state court, including one case which seeks class action certification, as well as damages and/or medical monitoring. In approximately 1,200 of these actions, plaintiffs allege, among other things, that they have suffered osteonecrosis of the jaw (“ONJ”), generally subsequent to invasive dental procedures, such as tooth extraction or dental implants and/or delayed healing, in association with the use of Fosamax. In addition, plaintiffs in approximately 2,415 of these actions generally allege that they sustained femur fractures and/or other bone injuries (“Femur Fractures”) in association with the use of Fosamax.

Cases Alleging ONJ and/or Other Jaw Related Injuries

In August 2006, the Judicial Panel on Multidistrict Litigation (the “JPML”) ordered that certain Fosamax product liability cases pending in federal courts nationwide should be transferred and consolidated into one multidistrict litigation (the “Fosamax ONJ MDL”) for coordinated pre-trial proceedings. The Fosamax ONJ MDL has been transferred to Judge John Keenan in the U.S. District Court for the Southern District of New York. As a result of the JPML order, approximately 950 of the cases are before Judge Keenan. In the first Fosamax ONJ MDL trial, Boles v. Merck, the Fosamax ONJ MDL court declared a mistrial because the eight person jury could not reach a unanimous verdict. The Boles case was retried in June 2010 and resulted in a verdict in favor of the plaintiff in the amount of $8 million. Merck filed post-trial motions seeking judgment as a matter of law or, in the alternative, a new trial. In October 2010, the court denied Merck’s post-trial motions but sua sponte ordered a remittitur reducing the verdict to $1.5 million. Plaintiff rejected the remittitur ordered by the court and requested a new trial on damages, which is scheduled to take place on September 18, 2012. Merck intends to appeal the verdict in Boles after the new trial on damages has concluded. Three other cases have been tried to verdict in the Fosamax ONJ MDL. Defense verdicts in favor of Merck were returned in each of those three cases.

In February 2011, Judge Keenan ordered that there will be two further bellwether trials conducted in the Fosamax ONJ MDL. Spano v. Merck and Jellema v. Merck were selected by the court to be tried in 2012, but each case was dismissed by the plaintiffs. On March 28, 2012, the court selected Scheinberg v. Merck as the next case to be tried and set the trial date for January 14, 2013.

Outside the Fosamax ONJ MDL, in Florida, Carballo v. Merck has been set for trial on October 15, 2012 and Anderson v. Merck has been set for trial on January 14, 2013.

In addition, in July 2008, an application was made by the Atlantic County Superior Court of New Jersey requesting that all of the Fosamax cases pending in New Jersey be considered for mass tort designation and centralized management before one judge in New Jersey. In October 2008, the New Jersey Supreme Court ordered that all pending and future actions filed in New Jersey arising out of the use of Fosamax and seeking damages for existing dental and jaw-related injuries, including ONJ, but not solely seeking medical monitoring, be designated as a mass tort for centralized management purposes before Judge Carol E. Higbee in Atlantic County Superior Court. As of June 30, 2012, approximately 240 ONJ cases were pending against Merck in Atlantic County, New Jersey. In July 2009, Judge Higbee entered a Case Management Order (and various amendments thereto) setting forth a schedule that contemplates completing fact and expert discovery in an initial group of cases to be reviewed for trial. In February 2011, the jury in Rosenberg v. Merck, the first trial in the New Jersey coordinated proceeding, returned a verdict in Merck’s favor. In April 2012, the jury in Sessner v. Merck, the second case tried in New Jersey, also returned a verdict in Merck’s favor.

In California, the parties are reviewing the claims of two plaintiffs in the Carrie Smith, et al. v. Merck case and the claims in Pedrojetti v. Merck. The cases of one or more of these plaintiffs are expected to be tried in 2013.

Discovery is ongoing in the Fosamax ONJ MDL litigation, the New Jersey coordinated proceeding, and the remaining jurisdictions where Fosamax cases are pending. The Company intends to defend against these lawsuits.

Cases Alleging Femur Fractures

In March 2011, Merck submitted a Motion to Transfer to the JPML seeking to have all federal cases alleging Femur Fractures consolidated into one multidistrict litigation for coordinated pre-trial proceedings. The Motion to Transfer was granted in May 2011, and all federal cases involving allegations of Femur Fracture have been or will be transferred to a multidistrict litigation in the District of New Jersey (the “Fosamax Femur Fracture MDL”). As a result of the JPML order, approximately 510 cases were pending in the Fosamax Femur Fracture MDL as of June 30, 2012. A Case Management Order has been entered that requires the parties to review 40 cases (later reduced to 33 cases) with a fact discovery deadline of July 31, 2012 and an expert discovery deadline of November 28, 2012. Judge Joel Pisano has selected four cases to be tried as the initial bellwether cases in the Fosamax Femur Fracture MDL and has set an April 8, 2013 trial date for the first bellwether case.

As of June 30, 2012, approximately 1,535 cases alleging Femur Fractures have been filed in New Jersey state court and are pending before Judge Higbee in Atlantic County Superior Court. The parties have selected an initial group of 30 cases to be reviewed through fact discovery. Plaintiffs subsequently dismissed or advised that they will dismiss seven of the cases that were selected and discovery in the remaining cases is continuing. Judge Higbee has set March 4, 2013 as the date for the first trial of the New Jersey state Femur Fracture cases.

As of June 30, 2012, approximately 350 cases alleging Femur Fractures have been filed in California state court. A petition was filed seeking to coordinate all Femur Fracture cases filed in California state court before a single judge in Orange County, California. The petition was granted and Judge Steven Perk is now presiding over the coordinated proceedings. No scheduling order has yet been entered.

Additionally, there are nine Femur Fracture cases pending in other state courts. A trial date has been set for August 12, 2013 for the Barnes case pending in Alabama state court.

Discovery is ongoing in the Fosamax Femur Fracture MDL and in state courts where Femur Fracture cases are pending and the Company intends to defend against these lawsuits.

NuvaRing

As previously disclosed, beginning in May 2007, a number of complaints were filed in various jurisdictions asserting claims against the Company’s subsidiaries Organon USA, Inc., Organon Pharmaceuticals USA, Inc., Organon International (collectively, “Organon”), and the Company arising from Organon’s marketing and sale of NuvaRing, a combined hormonal contraceptive vaginal ring. The plaintiffs contend that Organon and Schering-Plough, among other things, failed to adequately design and manufacture NuvaRing and failed to adequately warn of the alleged increased risk of venous thromboembolism (“VTE”) posed by NuvaRing, and/or downplayed the risk of VTE. The plaintiffs seek damages for injuries allegedly sustained from their product use, including some alleged deaths, heart attacks and strokes. The majority of the cases are currently pending in a federal multidistrict litigation (the “NuvaRing MDL”) venued in Missouri and in a coordinated proceeding in New Jersey state court.

As of June 30, 2012, there were approximately 1,100 NuvaRing cases. Of these cases, approximately 950 are or will be pending in the NuvaRing MDL in the U.S. District Court for the Eastern District of Missouri before Judge Rodney Sippel, and approximately 135 are pending in coordinated discovery proceedings in the Bergen County Superior Court of New Jersey before Judge Brian R. Martinotti. Six additional cases are pending in various other state courts.

Pursuant to orders of Judge Sippel in the NuvaRing MDL, the parties originally selected a pool of more than 20 cases to prepare for trial and that pool has since been narrowed to eight cases from which the first trials in the NuvaRing MDL will be selected. Pursuant to Judge Martinotti’s order in the New Jersey proceeding, the parties selected 10 trial pool cases to be prepared for trial and the first trial is expected to commence in February 2013. The parties have completed fact discovery in the originally selected trial pool cases in each jurisdiction and the Company anticipates expert discovery to be completed in those first trial pool cases by the summer of 2012. Certain replacement trial pool cases remain in fact discovery. Moreover, on January 31, 2012, the parties in the New Jersey coordinated proceeding selected an additional 10 trial pool cases for completion of fact discovery.

The Company anticipates filing motions related to the admissibility of expert testimony beginning in the summer of 2012 and continuing through the fall with status conferences to be held in each coordinated proceeding following the completion of briefing to discuss the timing of hearings related to the motions. The Company expects substantive hearings on those motions to take place in late 2012. The Company anticipates that status conferences will be held in each coordinated proceeding following rulings on the substantive evidentiary motions to determine a methodology for selecting the first cases to be tried. The Company intends to defend against these lawsuits.

Propecia/Proscar

As previously disclosed, Merck is a defendant in product liability lawsuits in the United States involving Propecia and/or Proscar. As of June 30, 2012, approximately 200 lawsuits involving a total of approximately 325 plaintiffs (in a few instances spouses are joined in the suits) who allege that they have experienced persistent sexual side effects following cessation of treatment with Propecia and/or Proscar have been filed against Merck. The lawsuits, which are in their early stages, are pending in federal courts in New Jersey, Washington, Washington D.C., Florida, Illinois, Colorado, Missouri and Ohio, and in state court in New Jersey. The federal lawsuits have been consolidated for pretrial purposes in a federal MDL before Judge John Gleeson of the Eastern District of New York. The matters pending in state court in New Jersey have been consolidated before Judge Jessica Mayer in Middlesex County. The Company intends to defend against these lawsuits.

Governmental Proceedings

As publicly disclosed, on June 21, 2012, the U.S. District Court for the Eastern District of Pennsylvania unsealed a complaint that has been filed against the Company under the federal False Claims Act by two former employees alleging, among other things, that the Company defrauded the U.S. government by falsifying data in connection with a clinical study conducted on the mumps component of the Company’s M-M-R II vaccine. The complaint alleges the fraud took place between 1999 and 2001. The U.S. government had the right to participate in and take over the prosecution of this lawsuit, but has advised the Company that it will decline to exercise that right. Thus, the two former employees are pursuing the lawsuit without the involvement of the U.S. government. The Company intends to defend against this lawsuit.

Vytorin/Zetia Litigation

As previously disclosed, in April 2008, a Merck shareholder filed a putative class action lawsuit in federal court which has been consolidated in the District of New Jersey with another federal securities lawsuit under the caption In re Merck & Co., Inc. Vytorin Securities Litigation. An amended consolidated complaint was filed in October 2008 and named as defendants Merck; Merck/Schering-Plough Pharmaceuticals, LLC; and certain of the Company’s current and former officers and directors. The complaint alleges that Merck delayed releasing unfavorable results of the ENHANCE clinical trial regarding the efficacy of Vytorin and that Merck made false and misleading statements about expected earnings, knowing that once the results of the ENHANCE study were released, sales of Vytorin would decline and Merck’s earnings would suffer. In December 2008, Merck and the other defendants moved to dismiss this lawsuit on the grounds that the plaintiffs failed to state a claim for which relief can be granted. In September 2009, the court denied defendants’ motion to dismiss. In June 2011, lead plaintiffs filed a motion for leave to further amend the consolidated complaint, which was granted on February 7, 2012. On February 9, 2012, plaintiffs filed a second amended consolidated complaint, which defendants answered on February 23, 2012. In February 2012, the parties completed briefing on lead plaintiffs’ motion for class certification. That motion is now pending before the court. On March 1, 2012, defendants filed a motion for summary judgment. That motion is now fully briefed and pending before the court.

There is a similar consolidated, putative class action securities lawsuit pending in the District of New Jersey, filed by a Schering-Plough shareholder against Schering-Plough and its former Chairman, President and Chief Executive Officer, Fred Hassan, under the caption In re Schering-Plough Corporation/ENHANCE Securities Litigation. The amended consolidated complaint was filed in September 2008 and names as defendants Schering-Plough; Merck/Schering-Plough Pharmaceuticals; certain of the Company’s current and former officers and directors; and underwriters who participated in an August 2007 public offering of Schering-Plough’s common and preferred stock. In December 2008, Schering-Plough and the other defendants filed motions to dismiss this lawsuit on the grounds that the plaintiffs failed to state a claim for which relief can be granted. In September 2009, the court denied defendants’ motions to dismiss. In February 2012, the parties completed briefing on lead plaintiffs’ motion for class certification. That motion is now pending before the court. On March 1, 2012, the Schering-Plough defendants filed a motion for partial summary judgment and the underwriter defendants filed a motion for summary judgment. Those motions are now fully briefed and pending before the court.

As previously disclosed, in April 2008, a member of a Merck ERISA plan filed a putative class action lawsuit against Merck and certain of the Company’s current and former officers and directors alleging they breached their fiduciary duties under ERISA. Since that time, there have been other similar ERISA lawsuits filed against Merck in the District of New Jersey, and all of those lawsuits have been consolidated under the caption In re Merck & Co., Inc. Vytorin ERISA Litigation. A consolidated amended complaint was filed in February 2009, and names as defendants Merck and various current and former members of the Company’s Board of Directors. The plaintiffs allege that the ERISA plans’ investment in Merck stock was imprudent because Merck’s earnings were dependent on the commercial success of its cholesterol drug Vytorin, and defendants knew or should have known that the results of a scientific study would cause the medical community to turn to less expensive drugs for cholesterol management. On May 24, 2012, the plaintiffs filed an unopposed motion for preliminary approval of settlement, conditional certification of a settlement class, approval of the class notice, and scheduling of a final fairness hearing. The court granted that motion on June 22, 2012 and scheduled a hearing on final approval of the settlement for September 25, 2012. Pursuant to the settlement agreement, Merck’s insurers have paid $10.4 million into a settlement fund which (after enumerated costs, fees, and awards are withdrawn) will be allocated to members of the settlement class according to a plan of allocation to be approved by the court. The settlement agreement provides that, in exchange for such consideration, the plaintiffs and settlement class members will issue broad releases with prejudice.

There was a similar consolidated, putative class action ERISA lawsuit pending in the District of New Jersey, filed by a member of a Schering-Plough ERISA plan against Schering-Plough and certain of its then-current and former officers and directors, alleging they breached their fiduciary duties under ERISA, bearing the caption In re Schering-Plough Corp. ENHANCE ERISA Litigation. The consolidated amended complaint was filed in October 2009 and named as defendants Schering-Plough, various then-current and former members of Schering-Plough’s Board of Directors and then-current and former members of committees of Schering-Plough’s Board of Directors. On February 10, 2012, the plaintiffs filed an executed class action settlement agreement and preliminary approval order. The court signed the preliminary approval order on February 16, 2012, and held a final fairness hearing on May 30, 2012. On May 31, 2012, the court issued an opinion, order, and final judgment. Among other things, the final judgment dismissed this action with prejudice, provided releases to the defendants, and approved the settlement agreement pursuant to which Merck’s insurers have paid $12.25 million into a settlement fund.

Discovery in the lawsuits referred to in this section (collectively, the “ENHANCE Litigation”) has concluded. The Company believes that it has meritorious defenses to the ENHANCE Litigation and intends to vigorously defend against these lawsuits. The Company is unable to predict the outcome of these matters and at this time cannot reasonably estimate the possible loss or range of loss with respect to the ENHANCE Litigation. Unfavorable outcomes resulting from the ENHANCE Litigation could have a material adverse effect on the Company’s financial position, liquidity and results of operations.

Insurance

The Company has Directors and Officers insurance coverage applicable to the Vytorin shareholder lawsuits brought by legacy Schering-Plough shareholders with stated upper limits of approximately $250 million, which is currently being used to partially fund the Company’s legal fees. There are disputes with the insurers about the availability of some or all of the Company’s insurance coverage for these claims and there are likely to be additional disputes. The amounts actually recovered under the policies discussed in this paragraph may be less than the stated limits. The Company also has Fiduciary and other insurance for the Vytorin ERISA lawsuits which funded the costs of the two ERISA settlements discussed above.

Commercial Litigation

AWP Litigation

As previously disclosed, the Company and/or certain of its subsidiaries remain defendants in cases brought by various states alleging manipulation by pharmaceutical manufacturers of Average Wholesale Prices (“AWP”), which are sometimes used by public and private payors in calculating provider reimbursement levels. The outcome of these lawsuits could include substantial damages, the imposition of substantial fines and penalties and injunctive or administrative remedies.

Since the start of 2012, the Company has settled certain AWP cases brought by the states of Alabama, Alaska, Kansas, Kentucky, Louisiana, and Mississippi. The Company and/or certain of its subsidiaries continue to be defendants in cases brought by six states.

A motion has also been filed to reinstate the Company as a defendant in a putative class action in New Jersey State court which alleges on behalf of third-party payers and individuals that manufacturers inflated drug prices by manipulation of AWPs and other means. This case was dismissed against the Company without prejudice in 2007.

K-DUR Antitrust Litigation

As previously disclosed, in June 1997 and January 1998, Schering-Plough settled patent litigation with Upsher-Smith, Inc. (“Upsher-Smith”) and ESI Lederle, Inc. (“Lederle”), respectively, relating to generic versions of K-DUR, Schering-Plough’s long-acting potassium chloride product supplement used by cardiac patients, for which Lederle and Upsher-Smith had filed Abbreviated New Drug Applications (“ANDAs”). Following the commencement of an administrative proceeding by the U.S. Federal Trade Commission (the “FTC”) in 2001 alleging anti-competitive effects from those settlements (which has been resolved in Schering-Plough’s favor), putative class and non-class action suits were filed on behalf of direct and indirect purchasers of K-DUR against Schering-Plough, Upsher-Smith and Lederle and were consolidated in a multi-district litigation in the U.S. District Court for the District of New Jersey. These suits claimed violations of federal and state antitrust laws, as well as other state statutory and common law causes of action, and sought unspecified damages. In April 2008, the indirect purchasers voluntarily dismissed their case. In March 2010, the District Court granted summary judgment to the defendants on the remaining lawsuits and dismissed the matter in its entirety. However, in July 2012, the Third Circuit Court of Appeals reversed the District Court’s judgment and remanded the case for further proceedings. At the same time, the Third Circuit upheld a December 2008 decision by the District Court to certify certain direct purchaser plaintiffs’ claims as a class action. The Company intends to seek further judicial review.

Coupon Litigation

Since March 2012, a number of private health plans have filed separate putative class action lawsuits against the Company alleging that Merck’s coupon programs injured health insurers by reducing beneficiary co-payment amounts, thereby allegedly causing beneficiaries to purchase higher-priced drugs than they otherwise would have purchased and increasing the insurers’ reimbursement costs. The actions, which were filed in U.S. District Court for the District of New Jersey and the Southern District of Illinois, seek damages and injunctive relief barring the Company from issuing coupons that would reduce beneficiary co-pays on behalf of putative nationwide classes of health insurers. Similar actions relating to manufacturer coupon programs have been filed against several other pharmaceutical manufacturers in a variety of federal courts. The Company intends to defend against these lawsuits.

Patent Litigation

From time to time, generic manufacturers of pharmaceutical products file ANDAs with the FDA seeking to market generic forms of the Company’s products prior to the expiration of relevant patents owned by the Company. To protect its patent rights, the Company may file patent infringement lawsuits against such generic companies. Certain products of the Company (or marketed via agreements with other companies) currently involved in such patent infringement litigation in the United States include: AzaSite, Cancidas, Emend for Injection, Nasonex, Nexium, Noxafil, Vytorin and Zetia. Similar lawsuits defending the Company’s patent rights may exist in other countries. The Company intends to vigorously defend its patents, which it believes are valid, against infringement by generic companies attempting to market products prior to the expiration of such patents. As with any litigation, there can be no assurance of the outcomes, which, if adverse, could result in significantly shortened periods of exclusivity for these products and, with respect to legacy Schering-Plough products, potentially significant intangible asset impairment charges.

AzaSite — In May 2011, a patent infringement suit was filed in the United States against Sandoz Inc. (“Sandoz”) in respect of Sandoz’s application to the FDA seeking pre-patent expiry approval to market a generic version of AzaSite. The lawsuit automatically stays FDA approval of Sandoz’s ANDA until October 2013 or until an adverse court decision, if any, whichever may occur earlier.

Cancidas — In November 2009, a patent infringement lawsuit was filed in the United States against Teva Parenteral Medicines, Inc. (“TPM”) in respect of TPM’s application to the FDA seeking pre-patent expiry approval to sell a generic version of Cancidas. That lawsuit has been dismissed with no rights granted to TPM. Also, in March 2010, a patent infringement lawsuit was filed in the United States against Sandoz in respect of Sandoz’s application to the FDA seeking pre-patent expiry approval to sell a generic version of Cancidas. In April 2012, the parties entered into a settlement agreement allowing Sandoz to sell a generic version of Cancidas commencing on August 28, 2017.

Emend for Injection — In May 2012, a patent infringement lawsuit was filed in the United States against Sandoz in respect of Sandoz’s application to the FDA seeking pre-patent expiry approval to market a generic version of Emend for Injection. The lawsuit automatically stays FDA approval of Sandoz’s ANDA until July 2015 or until an adverse court decision, if any, whichever may occur earlier. In June 2012, a patent infringement lawsuit was filed in the United States against Accord Healthcare, Inc. US, Accord Healthcare, Inc. and Intas Pharmaceuticals Ltd (collectively, “Intas”) in respect of Intas’ application to the FDA seeking pre-patent expiry approval to market a generic version of Emend for Injection. The lawsuit automatically stays FDA approval of Intas’ ANDA until July 2015 or until an adverse court decision, if any, whichever may occur earlier.

Integrilin — In February 2009, a patent infringement lawsuit was filed (jointly with Millennium Pharmaceuticals, Inc.) in the United States against TPM in respect of TPM’s application to the FDA seeking approval to sell a generic version of Integrilin prior to the expiry of the last to expire listed patent. In October 2011, the parties entered a settlement agreement allowing TPM to sell a generic version of Integrilin beginning June 2, 2015.

Nasonex — In December 2009, a patent infringement suit was filed in the United States against Apotex Corp. (“Apotex”) in respect of Apotex’s application to the FDA seeking pre-patent expiry approval to market a generic version of Nasonex. A trial in this matter was held in April 2012. A decision was issued on June 15, 2012, holding that the Merck patent covering mometasone furoate monohydrate was valid, but that it was not infringed by Apotex’s proposed product. The finding of non-infringement is under appeal.

Nexium — Patent infringement lawsuits were brought (jointly with AstraZeneca) in the United States against the following generic companies: Ranbaxy Laboratories Ltd., IVAX Pharmaceuticals, Inc. (later acquired by Teva Pharmaceuticals, Inc. (“Teva”)), Dr. Reddy’s Laboratories, Sandoz, Lupin Ltd., Hetero Drugs Limited Unit III (“Hetero”) and Torrent Pharmaceuticals Ltd. in response to each generic company’s application seeking pre-patent expiry approval to sell a generic version of Nexium. Settlements have been reached in each of these lawsuits, the terms of which provide that the respective generic company may bring a generic version of esomeprazole product to market on May 27, 2014. In addition, a patent infringement lawsuit was also filed (jointly with AstraZeneca) in February 2010 in the United States against Sun Pharma Global Fze (“Sun Pharma”) in respect of its application to the FDA seeking pre-patent expiry approval to sell a generic version of Nexium IV, which lawsuit was settled with an agreement which provides that Sun Pharma will be entitled to bring its generic esomeprazole IV product to market in the United States on January 1, 2014. Finally, additional patent infringement lawsuits have been filed (jointly with AstraZeneca) in the United States against Hamni USA, Inc. (“Hamni”) and Mylan Laboratories Limited (“Mylan Labs”) related to their applications to the FDA seeking pre-patent expiry approval to sell generic versions of Nexium. The Hamni and Mylan Labs applications to the FDA remain stayed until May 2013 and August 2014, respectively, or until earlier adverse court decisions, if any.

 

Noxafil — In May 2011, a patent infringement suit was filed in the United States against Sandoz in respect of Sandoz’s application to the FDA seeking pre-patent expiry approval to market a generic version of Noxafil. In May 2012, Sandoz withdrew its challenge to Merck’s Noxafil patents and the lawsuit has been dismissed.

NuvaRing — In February 2011, a patent infringement suit was brought against Merck in the International Trade Commission (the “ITC”) by Femina Pharma Incorporated (“Femina”) in respect of the product NuvaRing. The complaint alleged that NuvaRing infringes a patent owned by Femina. Femina’s ITC complaint sought an exclusion order against the importation of NuvaRing into the United States. A hearing began in the ITC proceeding on January 17, 2012 and on January 18, 2012 Femina withdrew its complaint and terminated the action. In addition, in November 2011, Femina brought a patent infringement lawsuit against Merck in the Eastern District of Virginia asserting that NuvaRing infringes the same patent. That case was stayed pending the outcome of the ITC proceeding. In April 2012, Femina voluntarily withdrew its lawsuit.

Propecia — In December 2010, a patent infringement lawsuit was filed in the United States against Hetero in respect of Hetero’s application to the FDA seeking pre-patent expiry approval to sell a generic version of Propecia. In March 2011, the Company settled this lawsuit with Hetero by agreeing to allow Hetero to sell a generic 1 mg finasteride product beginning on July 1, 2013. By virtue of a previous litigation settlement agreement, another generic manufacturer has been given the right to enter the U.S. market in January 2013.

Temodar — In July 2007, a patent infringement action was filed (jointly with Cancer Research Technologies, Limited (“CRT”)) in the United States against Barr Laboratories (“Barr”) (later acquired by Teva) in respect of Barr’s application to the FDA seeking pre-patent expiry approval to sell a generic version of Temodar. In January 2010, the court issued a decision finding the CRT patent unenforceable on grounds of prosecution laches and inequitable conduct. In November 2010, the appeals court issued a decision reversing the trial court’s finding. In December 2010, Barr filed a petition seeking a rehearing en banc of the appeal, which petition was denied. In June 2011, Barr filed a petition for review by the U.S. Supreme Court, which was denied. By virtue of an agreement that Barr not launch a product during the appeal process, the Company has agreed that Barr can launch a product in August 2013.

In September 2010, a patent infringement lawsuit was filed (jointly with CRT) in the United States against Sun Pharmaceutical Industries Inc. (“Sun”) in respect of Sun’s application to the FDA seeking pre-patent expiry approval to sell a generic version of Temodar. The lawsuit automatically stayed FDA approval of Sun’s ANDA until February 2013 or until an adverse court decision, if any, whichever may occur earlier. In November 2010, a patent infringement lawsuit was filed (jointly with CRT) in the United States against Accord HealthCare Inc. (“Accord”) in respect of its application to the FDA seeking pre-patent expiry approval to sell a generic version of Temodar. The lawsuit automatically stayed FDA approval of Accord’s application until April 13, 2013 or until an adverse court decision, if any, whichever may occur earlier. The Company and CRT entered into agreements with Sun and Accord to stay the respective lawsuits pending the outcome of the U.S. Supreme Court appeal process in the Barr lawsuit. In light of the U.S. Supreme Court’s denial of Barr’s petition, Sun and Accord withdrew their challenges to the Temodar patent and the respective lawsuits have been withdrawn.

Vytorin — In December 2009, a patent infringement lawsuit was filed in the United States against Mylan Pharmaceuticals, Inc. (“Mylan”) in respect of Mylan’s application to the FDA seeking pre-patent expiry approval to sell a generic version of Vytorin. A trial against Mylan jointly in respect of Zetia and Vytorin was conducted in December 2011. In April 2012, the court issued a decision finding the patent valid and enforceable. Accordingly, Mylan’s ANDA will not be approvable until April 25, 2017. Mylan has appealed that decision. In February 2010, a patent infringement lawsuit was filed in the United States against Teva in respect of Teva’s application to the FDA seeking pre-patent expiry approval to sell a generic version of Vytorin. In July 2011, the patent infringement lawsuit was dismissed and Teva agreed not to sell generic versions of Zetia or Vytorin until the Company’s exclusivity rights expire on April 25, 2017, except in certain circumstances. In August 2010, a patent infringement lawsuit was filed in the United States against Impax Laboratories Inc. (“Impax”) in respect of Impax’s application to the FDA seeking pre-patent expiry approval to sell a generic version of Vytorin. An agreement was reached with Impax to stay the lawsuit pending the outcome of the lawsuit with Mylan. In October 2011, a patent infringement lawsuit was filed in the United States against Actavis Inc. (“Actavis”) in respect to Actavis’ application to the FDA seeking pre-patent expiry approval to sell a generic version of Vytorin. An agreement was reached with Actavis to stay the lawsuit pending the outcome of the lawsuit with Mylan.

Zetia — In March 2007, a patent infringement lawsuit was filed in the United States against Glenmark Pharmaceuticals Inc., USA and its parent corporation (collectively, “Glenmark”) in respect of Glenmark’s application to the FDA seeking pre-patent expiry approval to sell a generic version of Zetia. In May 2010, Glenmark agreed to a settlement by virtue of which Glenmark will be permitted to launch its generic product in the United States on December 12, 2016, subject to receiving final FDA approval. In June 2010, a patent infringement lawsuit was filed in the United States against Mylan in respect of Mylan’s application to the FDA seeking pre-patent expiry approval to sell a generic version of Zetia. A trial against Mylan jointly in respect of Zetia and Vytorin was conducted in December 2011. In April 2012, the court issued a decision finding the patent valid and enforceable. Accordingly, Mylan’s ANDA will not be approvable until April 25, 2017. Mylan has appealed that decision. In September 2010, a patent infringement lawsuit was filed in the United States against Teva in respect of Teva’s application to the FDA seeking pre-patent expiry approval to sell a generic version of Zetia. In July 2011, the patent infringement lawsuit was dismissed without any rights granted to Teva.

Other Litigation

There are various other pending legal proceedings involving the Company, principally product liability and intellectual property lawsuits. While it is not feasible to predict the outcome of such proceedings, in the opinion of the Company, either the likelihood of loss is remote or any reasonably possible loss associated with the resolution of such proceedings is not expected to be material to the Company’s financial position, results of operations or cash flows either individually or in the aggregate.

Legal Defense Reserves

Legal defense costs expected to be incurred in connection with a loss contingency are accrued when probable and reasonably estimable. Some of the significant factors considered in the review of these legal defense reserves are as follows: the actual costs incurred by the Company; the development of the Company’s legal defense strategy and structure in light of the scope of its litigation; the number of cases being brought against the Company; the costs and outcomes of completed trials and the most current information regarding anticipated timing, progression, and related costs of pre-trial activities and trials in the associated litigation. The amount of legal defense reserves as of June 30, 2012 and December 31, 2011 of approximately $250 million and $240 million, respectively, represents the Company’s best estimate of the minimum amount of defense costs to be incurred in connection with its outstanding litigation; however, events such as additional trials and other events that could arise in the course of its litigation could affect the ultimate amount of legal defense costs to be incurred by the Company. The Company will continue to monitor its legal defense costs and review the adequacy of the associated reserves and may determine to increase the reserves at any time in the future if, based upon the factors set forth, it believes it would be appropriate to do so.

Environmental Matters

The Company and its subsidiaries are parties to a number of proceedings brought under the Comprehensive Environmental Response, Compensation and Liability Act, commonly known as Superfund, and other federal and state equivalents. These proceedings seek to require the operators of hazardous waste disposal facilities, transporters of waste to the sites and generators of hazardous waste disposed of at the sites to clean up the sites or to reimburse the government for cleanup costs. The Company has been made a party to these proceedings as an alleged generator of waste disposed of at the sites. In each case, the government alleges that the defendants are jointly and severally liable for the cleanup costs. Although joint and several liability is alleged, these proceedings are frequently resolved so that the allocation of cleanup costs among the parties more nearly reflects the relative contributions of the parties to the site situation. The Company’s potential liability varies greatly from site to site. For some sites the potential liability is de minimis and for others the final costs of cleanup have not yet been determined. While it is not feasible to predict the outcome of many of these proceedings brought by federal or state agencies or private litigants, in the opinion of the Company, such proceedings should not ultimately result in any liability which would have a material adverse effect on the financial position, results of operations, liquidity or capital resources of the Company. The Company has taken an active role in identifying and providing for these costs and such amounts do not include any reduction for anticipated recoveries of cleanup costs from former site owners or operators or other recalcitrant potentially responsible parties.

As previously disclosed, approximately 2,200 plaintiffs have filed an amended complaint against Merck and 12 other defendants in U.S. District Court, Eastern District of California asserting claims under the Clean Water Act, the Resource Conservation and Recovery Act, as well as negligence and nuisance. The suit seeks damages for personal injury, diminution of property value, medical monitoring and other alleged real and personal property damage associated with groundwater, surface water and soil contamination found at the site of a former Merck subsidiary in Merced, California. Certain of the other defendants in this suit have settled with plaintiffs regarding some or all aspects of plaintiffs’ claims. This lawsuit is proceeding in a phased manner. A jury trial commenced in February 2011 during which a jury was asked to make certain factual findings regarding whether contamination moved off-site to any areas where plaintiffs could have been exposed to such contamination and, if so, when, where and in what amounts. Defendants in this “Phase 1” trial included Merck and three of the other original 12 defendants. In March 2011, the Phase 1 jury returned a mixed verdict, finding in favor of Merck and the other defendants as to some, but not all, of plaintiffs’ claims. Specifically, the jury found that contamination from the site did not enter or affect plaintiffs’ municipal water supply wells or any private domestic wells. The jury found, however, that plaintiffs could have been exposed to contamination via air emissions prior to 1994, as well as via surface water in the form of storm drainage channeled into an adjacent irrigation canal, including during a flood in April 2006. In response to post-trial motions by Merck and other defendants, on September 7, 2011, the court entered an order setting aside a part of the Phase 1 jury’s findings that had been in favor of plaintiffs. Specifically, the court held that plaintiffs could not have been exposed to any contamination in surface or flood water during the April 2006 flood or, in fact, at any time later than 1991. Merck’s motion for reconsideration of the remainder of the jury’s Phase I verdict that was adverse to Merck was denied. Following the retirement of the judge handling this case, on September 21, 2011, the case was assigned to Judge David O. Carter of the U.S. District Court for the Central District of California. Judge Carter selected 10 plaintiffs whose claims would be reviewed and, depending on the outcome of Merck’s anticipated summary judgment motions, possibly tried in early 2013. Plaintiffs subsequently withdrew the claim of one of those 10 plaintiffs, leaving nine whose claims may proceed to trial. The court has dismissed the claims of 1,083 of the plaintiffs in this action whose claims were precluded by aspects of the Phase I jury findings and the court’s subsequent orders.

XML 66 R60.htm IDEA: XBRL DOCUMENT v2.4.0.6
Share-Based Compensation Plans (Details 1)
6 Months Ended
Jun. 30, 2012
Jun. 30, 2011
Assumptions used to determine weighted-average fair value of options granted    
Expected dividend yield 4.40% 4.30%
Risk-free interest rate 1.30% 2.60%
Expected volatility 25.30% 23.20%
Expected life (years) 7 years 7 years
XML 67 R13.htm IDEA: XBRL DOCUMENT v2.4.0.6
Other Intangibles
6 Months Ended
Jun. 30, 2012
Other Intangibles [Abstract]  
Other Intangibles

7.    Other Intangibles

In connection with mergers and acquisitions, the Company measures the fair value of marketed products and research and development pipeline programs and capitalizes these amounts. During the second quarter of 2012 and 2011, the Company recorded $127 million and $19 million, respectively, and during the first six months of 2012 and 2011, recorded $136 million and $321 million, respectively, of in-process research and development (“IPR&D”) impairment charges within Research and development expenses primarily for pipeline programs that had previously been deprioritized and were deemed to have no alternative use in the period. Also, during the second quarter of 2011, the Company recorded an intangible asset impairment charge of $118 million within Materials and production costs related to a marketed product. The Company may recognize additional non-cash impairment charges in the future related to other pipeline programs or marketed products and such charges could be material.

XML 68 R14.htm IDEA: XBRL DOCUMENT v2.4.0.6
Joint Ventures and Other Equity Method Affiliates
6 Months Ended
Jun. 30, 2012
Joint Ventures and Other Equity Method Affiliates [Abstract]  
Joint Ventures and Other Equity Method Affiliates

8.    Joint Ventures and Other Equity Method Affiliates

Equity income from affiliates reflects the performance of the Company’s joint ventures and other equity method affiliates and was comprised of the following:

 

                                     
   

    Three Months Ended    

June 30,

       

    Six Months Ended    

June 30,

 
($ in millions)   2012     2011          2012     2011  

AstraZeneca LP

  $ 140       $ 44         $ 253     $ 177  

Other (1)

    2         11           -       16  
    $ 142       $ 55         $ 253     $ 193  

 

(1 ) 

Includes results from Sanofi Pasteur MSD.

AstraZeneca LP

In 1998, Merck and Astra completed the restructuring of the ownership and operations of their existing joint venture whereby Merck acquired Astra’s interest in KBI Inc. (“KBI”) and contributed KBI’s operating assets to a new U.S. limited partnership, Astra Pharmaceuticals L.P. (the “Partnership”), in exchange for a 1% limited partner interest. Astra contributed the net assets of its wholly owned subsidiary, Astra USA, Inc., to the Partnership in exchange for a 99% general partner interest. The Partnership, renamed AstraZeneca LP (“AZLP”) upon Astra’s 1999 merger with Zeneca Group Plc, became the exclusive distributor of the products for which KBI retained rights.

In June 2012, Merck and AstraZeneca amended the 1998 option agreement which gave AstraZeneca the option to buy Merck’s common stock interest in KBI and, through it, Merck’s interest in Nexium and Prilosec as well as AZLP. The updated agreement eliminates AstraZeneca’s option to acquire Merck’s interest in KBI in 2012 and provides AstraZeneca a new option to acquire Merck’s interest in KBI in June 2014. As a result of the amended agreement, Merck will continue to record supply sales and equity income from the partnership for the remainder of 2012 and 2013. In 2014, AstraZeneca has the option to purchase Merck’s interest in KBI based in part on the value of Merck’s interest in Prilosec and Nexium. AstraZeneca’s option is exercisable between March 1, 2014 and April 30, 2014. If AstraZeneca chooses to exercise this option, the closing date is expected to be June 30, 2014. Under the amended agreement, AstraZeneca will make a payment to Merck upon closing of $327 million, reflecting an estimate of the fair value of Merck’s interest in Nexium and Prilosec. This portion of the exercise price is subject to a true-up in 2018 based on actual sales from closing in 2014 to June 2018. The exercise price will also include an additional amount equal to a multiple of ten times Merck’s average 1% annual profit allocation in the partnership for the three-years prior to exercise. The Company believes that it is likely that AstraZeneca will exercise its option in 2014.

Summarized financial information for AZLP is as follows:

 

                                     
    Three Months Ended         Six Months Ended  
    June 30,         June 30,  
($ in millions)   2012     2011          2012     2011  

Sales

  $ 1,150     $           1,181         $ 2,192     $           2,336  

Materials and production costs

    520       516           959       1,061  

Other expense, net

    350       345           732       646  

Income before taxes (1)

  $ 280     $ 320         $ 501     $ 629  

 

(1) 

Merck’s partnership returns from AZLP are generally contractually determined and are not based on a percentage of income from AZLP, other than with respect to Merck’s 1% limited partnership interest.

XML 69 R16.htm IDEA: XBRL DOCUMENT v2.4.0.6
Equity
6 Months Ended
Jun. 30, 2012
Equity [Abstract]  
Equity

10.  Equity

 

                                                                         
                            Accumulated                          
                Other           Other                 Non-        
    Common Stock          Paid-In            Retained       Comprehensive     Treasury Stock     Controlling        
($ and shares in millions)   Shares      Par Value       Capital     Earnings     Loss     Shares     Cost       Interests     Total  

 

Balance January 1, 2011

    3,577     $ 1,788       $ 40,701       $ 37,536     $ (3,216)       495       $     (22,433)      $ 2,429       $       56,805    

Net income attributable to
Merck & Co., Inc.

    -       -         -         3,067       -         -         -          -         3,067    

Cash dividends declared on common stock

    -       -         -         (2,360     -         -         -          -         (2,360)   

Treasury stock shares purchased

    -       -         -         -       -         9         (314)        -         (314)   

Share-based compensation plans and other

    -       -         (44)       -       -         (10)       331          -         287    

Other comprehensive income

    -       -         -         -       440         -         -          -         440    

Net income attributable to noncontrolling interests

    -       -         -         -       -         -         -          58         58    

Distributions attributable to noncontrolling interests

    -       -         -         -       -         -         -          (61)        (61)   

 

 

Balance June 30, 2011

    3,577     $ 1,788       $ 40,657       $ 38,243     $ (2,776)       494     $ (22,416)      $ 2,426       $ 57,922    

 

 

 

Balance January 1, 2012

    3,577     $ 1,788       $ 40,663       $ 38,990     $ (3,132)       536       $ (23,792)      $ 2,426       $ 56,943    

Net income attributable to
Merck & Co., Inc.

    -       -         -         3,531       -         -         -          -         3,531    

Cash dividends declared on common stock

    -       -         -         (2,571     -         -         -          -         (2,571)   

Treasury stock shares purchased

    -       -         -         -       -         26         (985)        -         (985)   

Share-based compensation plans and other

    -       -         (113)       -       -         (24)       809          -         696    

Other comprehensive income

    -       -         -         -       6         -         -          -         6    

Net income attributable to noncontrolling interests

    -       -         -         -       -         -         -          56         56    

Distributions attributable to noncontrolling interests

    -       -         -         -       -         -         -          (3)        (3)   

 

 

Balance June 30, 2012

    3,577     $ 1,788       $ 40,550       $ 39,950     $ (3,126)       538       $ (23,968)      $ 2,479       $ 57,673    

 

 

In connection with the 1998 restructuring of Astra Merck Inc., the Company assumed $2.4 billion par value preferred stock with a dividend rate of 5% per annum, which is carried by KBI and included in Noncontrolling interests on the Consolidated Balance Sheet. If AstraZeneca exercises its option to acquire Merck’s interest in AZLP (see Note 8), this preferred stock obligation will be retired.

 

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

 

                                         
($ in millions)       Derivatives         Investments           Employee
Benefit 
Plans
        Cumulative
    Translation
    Adjustment
    Accumulated 
Other 
Comprehensive 
Loss 
 

 

 

 

Balance January 1, 2011

  $ 41      $ 31      $ (2,043)     $ (1,245)         $     (3,216)   

Other comprehensive (loss) income

    (137)       (5)       28        554        440    

 

 

Balance at June 30, 2011

  $ (96)     $ 26      $ (2,015)     $ (691)         $ (2,776)   

 

 

 

Balance January 1, 2012

  $     $ 21      $ (2,346)     $ (811)         $ (3,132)   

Other comprehensive income (loss)

    44        30        18        (86)       6    

 

 

Balance at June 30, 2012

  $ 48      $ 51      $ (2,328)     $ (897)         $ (3,126)   

 

 

Included in cumulative translation adjustment are pretax gains of approximately $340 million for the first six months of 2011 relating to translation impacts of intangible assets recorded in conjunction with the Merger.

XML 70 R64.htm IDEA: XBRL DOCUMENT v2.4.0.6
Other (income) Expense, Net (Details Textual) (USD $)
In Millions, unless otherwise specified
6 Months Ended
Jun. 30, 2012
Jun. 30, 2011
Other Income Expense Net (Textual) [Abstract]    
Gain on sale of manufacturing facilities and related assets   $ 127
Litigation charges   500
Interest paid 324 194
Cash received from interest rate swap termination   175
Accelerated accretion of time value of money discounts $ 35  
XML 71 R66.htm IDEA: XBRL DOCUMENT v2.4.0.6
Earnings per Share (Details) (USD $)
In Millions, except Per Share data, unless otherwise specified
3 Months Ended 6 Months Ended
Jun. 30, 2012
Jun. 30, 2011
Jun. 30, 2012
Jun. 30, 2011
Basic Earnings per Common Share        
Net Income Attributable to Merck & Co., Inc. $ 1,793 $ 2,024 $ 3,531 $ 3,067
Less: Income allocated to participating securities 1 4 3 8
Net income allocated to common shareholders 1,792 2,020 3,528 3,059
Average common shares outstanding 3,041 3,086 3,042 3,085
Basic Earnings per Common Share Attributable to Merck & Co., Inc. Common Shareholders $ 0.59 $ 0.65 $ 1.16 $ 0.99
Earnings per Common Share Assuming Dilution        
Net Income Attributable to Merck & Co., Inc. 1,793 2,024 3,531 3,067
Less: Income allocated to participating securities 1 4 3 8
Net income allocated to common shareholders $ 1,792 $ 2,020 $ 3,528 $ 3,059
Average common shares outstanding 3,041 3,086 3,042 3,085
Common shares issuable 31 24 32 21
Average common shares outstanding assuming dilution 3,072 3,110 3,074 3,106
Earnings per Common Share Assuming Dilution Attributable to Merck & Co., Inc. Common Shareholders $ 0.58 $ 0.65 $ 1.15 $ 0.98
XML 72 R63.htm IDEA: XBRL DOCUMENT v2.4.0.6
Other (income) Expense, Net (Details) (USD $)
In Millions, unless otherwise specified
3 Months Ended 6 Months Ended
Jun. 30, 2012
Jun. 30, 2011
Jun. 30, 2012
Jun. 30, 2011
Other (income) expense, net        
Interest income $ (76) $ (39) $ (129) $ (69)
Interest expense 172 170 346 345
Exchange losses 13 1 80 43
Other, net (6) (11) (50) 425
Other (income) expense, net $ 103 $ 121 $ 247 $ 744
XML 73 R34.htm IDEA: XBRL DOCUMENT v2.4.0.6
Restructuring (Details) (USD $)
In Millions, unless otherwise specified
3 Months Ended 6 Months Ended
Jun. 30, 2012
Jun. 30, 2011
Jun. 30, 2012
Jun. 30, 2011
Charges related to Merger Restructuring Program and 2008 Restructuring Program activities by type of cost        
Materials and production $ 4,112 $ 4,284 $ 8,150 $ 8,343
Marketing and administrative 3,249 3,525 6,322 6,689
Research and development 2,165 1,936 4,026 4,094
Restructuring costs 144 668 363 654
Charges 287 809 578 926
Accelerated Depreciation [Member]
       
Charges related to Merger Restructuring Program and 2008 Restructuring Program activities by type of cost        
Charges 118 155 161 283
Separation Costs [Member]
       
Charges related to Merger Restructuring Program and 2008 Restructuring Program activities by type of cost        
Charges 111 639 293 599
Other [Member]
       
Charges related to Merger Restructuring Program and 2008 Restructuring Program activities by type of cost        
Charges 58 15 124 44
2008 Global Restructuring Program [Member]
       
Charges related to Merger Restructuring Program and 2008 Restructuring Program activities by type of cost        
Materials and production 5 6 14 8
Restructuring costs (9) (5) (4) (3)
Charges (4) 1 10 5
2008 Global Restructuring Program [Member] | Accelerated Depreciation [Member]
       
Charges related to Merger Restructuring Program and 2008 Restructuring Program activities by type of cost        
Materials and production 1 4 3 6
Charges 1 4 3 6
2008 Global Restructuring Program [Member] | Separation Costs [Member]
       
Charges related to Merger Restructuring Program and 2008 Restructuring Program activities by type of cost        
Restructuring costs (13) (7) (11) (8)
Charges (13) (7) (11) (8)
2008 Global Restructuring Program [Member] | Other [Member]
       
Charges related to Merger Restructuring Program and 2008 Restructuring Program activities by type of cost        
Materials and production 4 2 11 2
Restructuring costs 4 2 7 5
Charges 8 4 18 7
Merger Restructuring Program [Member]
       
Charges related to Merger Restructuring Program and 2008 Restructuring Program activities by type of cost        
Materials and production 76 96 70 157
Marketing and administrative 21 23 45 46
Research and development 41 16 86 61
Restructuring costs 153 673 367 657
Charges 291 808 568 921
Merger Restructuring Program [Member] | Accelerated Depreciation [Member]
       
Charges related to Merger Restructuring Program and 2008 Restructuring Program activities by type of cost        
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Marketing and administrative 20 22 43 45
Research and development 41 38 82 80
Charges 117 151 158 277
Merger Restructuring Program [Member] | Separation Costs [Member]
       
Charges related to Merger Restructuring Program and 2008 Restructuring Program activities by type of cost        
Restructuring costs 124 646 304 607
Charges 124 646 304 607
Merger Restructuring Program [Member] | Other [Member]
       
Charges related to Merger Restructuring Program and 2008 Restructuring Program activities by type of cost        
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Marketing and administrative 1 1 2 1
Research and development   (22) 4 (19)
Restructuring costs 29 27 63 50
Charges $ 50 $ 11 $ 106 $ 37
XML 74 R51.htm IDEA: XBRL DOCUMENT v2.4.0.6
Contingencies and Environmental Liabilities (Details Textual 2) (NuvaRing [Member])
Jun. 30, 2012
LegalMatter
Loss Contingencies [Line Items]  
Loss contingency, pending claims number 1,100
Federal [Member] | NuvaRing MDL [Member]
 
Loss Contingencies [Line Items]  
Loss contingency, pending claims number 950
Initial number of cases selected for review 20
Subsequent number of cases selected for review 8
Other state court [Member]
 
Loss Contingencies [Line Items]  
Loss contingency, pending claims number 6
NuvaRing New Jersey state court [Member]
 
Loss Contingencies [Line Items]  
Loss contingency, pending claims number 135
Initial number of cases selected for review 10
Subsequent number of cases selected for review 10
XML 75 R21.htm IDEA: XBRL DOCUMENT v2.4.0.6
Earnings per Share
6 Months Ended
Jun. 30, 2012
Earnings Per Share [Abstract]  
Earnings Per Share

15.  Earnings Per Share

The Company calculates earnings per share pursuant to the two-class method, which is an earnings allocation formula that determines earnings per share for common stock and participating securities according to dividends declared and participation rights in undistributed earnings. Under this method, all earnings (distributed and undistributed) are allocated to common shares and participating securities based on their respective rights to receive dividends. RSUs and certain PSUs granted before December 31, 2009 to certain management level employees participate in dividends on the same basis as common shares and such dividends are nonforfeitable by the holder. As a result, these RSUs and PSUs meet the definition of a participating security. For RSUs and PSUs issued on or after January 1, 2010, dividends declared during the vesting period are payable to the employees only upon vesting and therefore such RSUs and PSUs do not meet the definition of a participating security.

 

The calculations of earnings per share under the two-class method are as follows:

 

                                 
    Three Months Ended
June 30,
    Six Months Ended
June 30,
 
($ and shares in millions except per share amounts)         2012                 2011                 2012                 2011        

 

 

 

Basic Earnings per Common Share

                               

Net income attributable to Merck & Co., Inc.

    $ 1,793     $     2,024         $ 3,531     $         3,067    

Less: Income allocated to participating securities

    1       4         3       8    

 

 

Net income allocated to common shareholders

    $ 1,792     $ 2,020         $ 3,528     $ 3,059    

 

 

 

Average common shares outstanding

    3,041       3,086         3,042       3,085    

 

 
      $ 0.59     $ 0.65         $ 1.16     $ 0.99    

 

 

 

Earnings per Common Share Assuming Dilution

                               

Net income attributable to Merck & Co., Inc.

    $ 1,793     $ 2,024         $ 3,531     $ 3,067    

Less: Income allocated to participating securities

    1       4         3       8    

 

 

Net income allocated to common shareholders

    $ 1,792     $ 2,020         $ 3,528     $ 3,059    

 

 

 

Average common shares outstanding

    3,041       3,086         3,042       3,085    

Common shares issuable (1)

    31       24         32       21    

 

 

Average common shares outstanding assuming dilution

    3,072       3,110         3,074       3,106    

 

 
      $ 0.58     $ 0.65         $ 1.15     $ 0.98    

 

 

 

(1)

Issuable primarily under share-based compensation plans.

For the three months ended June 30, 2012 and 2011, 107 million and 138 million, respectively, and for the first six months of 2012 and 2011, 112 million and 173 million, respectively, of common shares issuable under share-based compensation plans were excluded from the computation of earnings per common share assuming dilution because the effect would have been antidilutive.

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Inventories (Tables)
6 Months Ended
Jun. 30, 2012
Inventories [Abstract]  
Inventories

Inventories consisted of:

 

                 
($ in millions)          June 30,       
2012
      December 31,  
2011
 

Finished goods

  $ 1,808     $ 1,983  

Raw materials and work in process

    5,705       5,396  

Supplies

    265       297  

Total (approximates current cost)

    7,778       7,676  

Reduction to LIFO costs

    (39     (43
    $ 7,739     $ 7,633  

Recognized as:

               

Inventories

  $ 6,249     $ 6,254  

Other assets

    1,490       1,379  
XML 77 R49.htm IDEA: XBRL DOCUMENT v2.4.0.6
Contingencies and Environmental Liabilities (Details Textual) (USD $)
In Millions, unless otherwise specified
6 Months Ended 12 Months Ended 6 Months Ended
Jun. 30, 2011
Jun. 30, 2012
Vioxx MDL Litigation [Member]
LegalMatter
Jun. 30, 2012
Vioxx Investigations [Member]
Location
Dec. 31, 2010
Vioxx Investigations [Member]
Jun. 30, 2012
Vioxx Securities Lawsuits [Member]
LegalMatter
Loss Contingencies [Line Items]          
Litigation charges $ (500)     $ 950  
Number of cases settled or dismissed         1
Loss contingency, pending claims number   100      
Number of class actions remaining   30      
Number of lawsuits scheduled for trial current fiscal year   1      
Number of suits brought on by Attorneys General   6      
Number of suits brought on by County   1      
Number of states the Company signed settlement agreements with     44    
Upper limit of directors and officers insurance coverage         $ 175
Approximate percent of reserve that will be paid to resolve civil allegations     67.00%    
Approximate percent of reserve that will be paid to federal government     33.00%    
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Financial Instruments (Details 2) (USD $)
In Millions, unless otherwise specified
Jun. 30, 2012
Dec. 31, 2011
Assets    
Fair Value $ 4,954 $ 5,069
Derivative assets 884 755
Total assets 5,838 5,824
Liabilities    
Derivative liabilities 48 108
Commercial paper [Member]
   
Assets    
Fair Value 220 1,029
Corporate notes and bonds [Member]
   
Assets    
Fair Value 2,787 2,032
U.S. government and agency securities [Member]
   
Assets    
Fair Value 773 1,021
Asset-backed securities [Member]
   
Assets    
Fair Value 441 292
Mortgage-backed securities [Member]
   
Assets    
Fair Value 271 223
Foreign government bonds [Member]
   
Assets    
Fair Value 76 72
Equity securities [Member]
   
Assets    
Fair Value 383 397
Other debt securities [Member]
   
Assets    
Fair Value 3 3
Fair Value, Measurements, Recurring [Member]
   
Assets    
Investments 4,783 4,899
Securities held for employee compensation 171 170
Purchased currency options 763 613
Derivative assets 884 755
Liabilities    
Total liabilities 48 108
Fair Value, Measurements, Recurring [Member] | Commercial paper [Member]
   
Assets    
Fair Value 220 1,029
Fair Value, Measurements, Recurring [Member] | Foreign exchange contract [Member]
   
Assets    
Derivative assets 121 142
Liabilities    
Derivative liabilities 48 107
Fair Value, Measurements, Recurring [Member] | Written currency options [Member]
   
Liabilities    
Derivative liabilities   1
Fair Value, Measurements, Recurring [Member] | Corporate notes and bonds [Member]
   
Assets    
Fair Value 2,787 2,032
Fair Value, Measurements, Recurring [Member] | U.S. government and agency securities [Member]
   
Assets    
Fair Value 773 1,021
Fair Value, Measurements, Recurring [Member] | Asset-backed securities [Member]
   
Assets    
Fair Value 441 292
Fair Value, Measurements, Recurring [Member] | Mortgage-backed securities [Member]
   
Assets    
Fair Value 271 223
Fair Value, Measurements, Recurring [Member] | Foreign government bonds [Member]
   
Assets    
Fair Value 76 72
Fair Value, Measurements, Recurring [Member] | Equity securities [Member]
   
Assets    
Fair Value 212 227
Fair Value, Measurements, Recurring [Member] | Other debt securities [Member]
   
Assets    
Fair Value 3 3
Quoted Prices In Active Markets for Identical Assets (Level 1) [Member]
   
Assets    
Total assets 374 375
Quoted Prices In Active Markets for Identical Assets (Level 1) [Member] | Fair Value, Measurements, Recurring [Member]
   
Assets    
Investments 203 205
Securities held for employee compensation 171 170
Quoted Prices In Active Markets for Identical Assets (Level 1) [Member] | Fair Value, Measurements, Recurring [Member] | Equity securities [Member]
   
Assets    
Fair Value 203 205
Significant Other Observable Inputs (Level 2) [Member]
   
Assets    
Total assets 5,464 5,449
Significant Other Observable Inputs (Level 2) [Member] | Fair Value, Measurements, Recurring [Member]
   
Assets    
Investments 4,580 4,694
Purchased currency options 763 613
Derivative assets 884 755
Liabilities    
Total liabilities 48 108
Significant Other Observable Inputs (Level 2) [Member] | Fair Value, Measurements, Recurring [Member] | Commercial paper [Member]
   
Assets    
Fair Value 220 1,029
Significant Other Observable Inputs (Level 2) [Member] | Fair Value, Measurements, Recurring [Member] | Foreign exchange contract [Member]
   
Assets    
Derivative assets 121 142
Liabilities    
Derivative liabilities 48 107
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Liabilities    
Derivative liabilities   1
Significant Other Observable Inputs (Level 2) [Member] | Fair Value, Measurements, Recurring [Member] | Corporate notes and bonds [Member]
   
Assets    
Fair Value 2,787 2,032
Significant Other Observable Inputs (Level 2) [Member] | Fair Value, Measurements, Recurring [Member] | U.S. government and agency securities [Member]
   
Assets    
Fair Value 773 1,021
Significant Other Observable Inputs (Level 2) [Member] | Fair Value, Measurements, Recurring [Member] | Asset-backed securities [Member]
   
Assets    
Fair Value 441 292
Significant Other Observable Inputs (Level 2) [Member] | Fair Value, Measurements, Recurring [Member] | Mortgage-backed securities [Member]
   
Assets    
Fair Value 271 223
Significant Other Observable Inputs (Level 2) [Member] | Fair Value, Measurements, Recurring [Member] | Foreign government bonds [Member]
   
Assets    
Fair Value 76 72
Significant Other Observable Inputs (Level 2) [Member] | Fair Value, Measurements, Recurring [Member] | Equity securities [Member]
   
Assets    
Fair Value 9 22
Significant Other Observable Inputs (Level 2) [Member] | Fair Value, Measurements, Recurring [Member] | Other debt securities [Member]
   
Assets    
Fair Value 3 3
Significant Unobservable Inputs (Level 3) [Member]
   
Assets    
Total assets      
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Assets    
Fair Value      
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Assets    
Fair Value      
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Assets    
Fair Value      
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Consolidated Balance Sheet (Unaudited) (Parenthetical) (USD $)
In Millions, except Share data, unless otherwise specified
Jun. 30, 2012
Dec. 31, 2011
Consolidated Balance Sheet [Abstract]    
Allowance for doubtful accounts $ 144 $ 131
Inventories classified in other assets 1,490 1,379
Accumulated depreciation $ 17,049 $ 16,176
Common stock, par value $ 0.50 $ 0.50
Common stock, shares authorized 6,500,000,000 6,500,000,000
Common stock, shares issued 3,577,103,522 3,577,103,522
Treasury stock, shares 538,194,526 536,109,713
XML 80 R10.htm IDEA: XBRL DOCUMENT v2.4.0.6
Collaborative Arrangements
6 Months Ended
Jun. 30, 2012
Collaborative Arrangements [Abstract]  
Collaborative Arrangements

4.   Collaborative Arrangements

The Company continues its strategy of establishing external alliances to complement its substantial internal research capabilities, including research collaborations, licensing preclinical and clinical compounds and technology platforms to drive both near- and long-term growth. The Company supplements its internal research with a licensing and external alliance strategy focused on the entire spectrum of collaborations from early research to late-stage compounds, as well as new technologies across a broad range of therapeutic areas. These arrangements often include upfront payments and royalty or profit share payments, contingent upon the occurrence of certain future events linked to the success of the asset in development, as well as expense reimbursements or payments to the third party.

Cozaar/Hyzaar

In 1989, Merck and E.I. duPont de Nemours and Company (“DuPont”) agreed to form a long-term research and marketing collaboration to develop a class of therapeutic agents for high blood pressure and heart disease, discovered by DuPont, called angiotensin II receptor antagonists, which include Cozaar and Hyzaar. In return, Merck provided DuPont marketing rights in the United States and Canada to its prescription medicines, Sinemet and Sinemet CR (the Company has since regained global marketing rights to Sinemet and Sinemet CR). Pursuant to a 1994 agreement with DuPont, the Company has an exclusive licensing agreement to market Cozaar and Hyzaar in return for royalties and profit share payments to DuPont. The patents that provided market exclusivity in the United States and in a number of major European markets for Cozaar and Hyzaar expired in 2010.

Remicade/Simponi

In 1998, a subsidiary of Schering-Plough entered into a licensing agreement with Centocor Ortho Biotech Inc. (“Centocor”), a Johnson & Johnson (“J&J”) company, to market Remicade, which is prescribed for the treatment of inflammatory diseases. In 2005, Schering-Plough’s subsidiary exercised an option under its contract with Centocor for license rights to develop and commercialize Simponi, a fully human monoclonal antibody. The Company had exclusive marketing rights to both products outside the United States, Japan and certain other Asian markets. In December 2007, Schering-Plough and Centocor revised their distribution agreement regarding the development, commercialization and distribution of both Remicade and Simponi, extending the Company’s rights to exclusively market Remicade to match the duration of the Company’s exclusive marketing rights for Simponi. In addition, Schering-Plough and Centocor agreed to share certain development costs relating to Simponi’s auto-injector delivery system. On October 6, 2009, the European Commission approved Simponi as a treatment for rheumatoid arthritis and other immune system disorders in two presentations – a novel auto-injector and a prefilled syringe. As a result, the Company’s marketing rights for both products extend for 15 years from the first commercial sale of Simponi in the European Union (the “EU”) following the receipt of pricing and reimbursement approval within the EU. In April 2011, Merck and J&J reached an agreement to amend the agreement governing the distribution rights to Remicade and Simponi. Under the terms of the amended distribution agreement, Merck relinquished marketing rights for Remicade and Simponi to J&J in territories including Canada, Central and South America, the Middle East, Africa and Asia Pacific effective July 1, 2011. Merck retained exclusive marketing rights throughout Europe, Russia and Turkey (the “Retained Territories”). In addition, beginning July 1, 2011, all profits derived from Merck’s exclusive distribution of the two products in the Retained Territories are being equally divided between Merck and J&J. J&J also received a one-time payment from Merck of $500 million in April 2011, which the Company recorded as a charge to Other (income) expense, net in the first quarter of 2011.

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Equity (Details Textual) (USD $)
6 Months Ended
Jun. 30, 2012
Jun. 30, 2011
Equity (Textual) [Abstract]    
Par value preferred stock obligation assumed in connection with the 1998 restructuring of Astra Merck Inc $ 2,400,000,000  
Preferred stock assumed with Astra Merck Inc. dividend per annum 5.00%  
Cumulative translation gains (losses) relating to translation impact of intangible assets   $ 340,000,000
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Segment Reporting (Details 1) (USD $)
In Millions, unless otherwise specified
3 Months Ended 6 Months Ended
Jun. 30, 2012
Jun. 30, 2011
Jun. 30, 2012
Jun. 30, 2011
Reconciliation of segment profits to Income Before Taxes        
Income Before Taxes $ 2,680 $ 1,672 $ 5,186 $ 3,401
Interest income 76 39 129 69
Interest expense (172) (170) (346) (345)
Equity income from affiliates 142 55 253 193
Depreciation and amortization     (3,594) (3,663)
Research and development (2,165) (1,936) (4,026) (4,094)
Restructuring costs (144) (668) (363) (654)
Arbitration settlement charge       (500)
Pharmaceutical segment [Member]
       
Reconciliation of segment profits to Income Before Taxes        
Income Before Taxes 6,906 6,443 13,502 12,659
Other Segment [Member]
       
Reconciliation of segment profits to Income Before Taxes        
Income Before Taxes 774 726 1,578 1,517
Total segment [Member]
       
Reconciliation of segment profits to Income Before Taxes        
Income Before Taxes 7,680 7,169 15,080 14,176
Other profits (losses) [Member]
       
Reconciliation of segment profits to Income Before Taxes        
Income Before Taxes 45 34 (28) (15)
Unallocated: [Member]
       
Reconciliation of segment profits to Income Before Taxes        
Interest income 76 39 129 69
Interest expense (172) (170) (346) (345)
Equity income from affiliates 11 (87) (9) (81)
Depreciation and amortization (574) (623) (1,135) (1,194)
Research and development (1,930) (1,679) (3,573) (3,618)
Amortization of purchase accounting adjustments (1,226) (1,225) (2,455) (2,504)
Restructuring costs (144) (668) (363) (654)
Arbitration settlement charge       (500)
Other unallocated, net $ (1,086) $ (1,118) $ (2,114) $ (1,933)
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Joint Ventures and Other Equity Method Affiliates (Tables)
6 Months Ended
Jun. 30, 2012
Joint Ventures and Other Equity Method Affiliates [Abstract]  
Equity income from affiliates

Equity income from affiliates reflects the performance of the Company’s joint ventures and other equity method affiliates and was comprised of the following:

 

                                     
   

    Three Months Ended    

June 30,

       

    Six Months Ended    

June 30,

 
($ in millions)   2012     2011          2012     2011  

AstraZeneca LP

  $ 140       $ 44         $ 253     $ 177  

Other (1)

    2         11           -       16  
    $ 142       $ 55         $ 253     $ 193  

 

(1 ) 

Includes results from Sanofi Pasteur MSD.

Summarized financial information for AZLP

Summarized financial information for AZLP is as follows:

 

                                     
    Three Months Ended         Six Months Ended  
    June 30,         June 30,  
($ in millions)   2012     2011          2012     2011  

Sales

  $ 1,150     $           1,181         $ 2,192     $           2,336  

Materials and production costs

    520       516           959       1,061  

Other expense, net

    350       345           732       646  

Income before taxes (1)

  $ 280     $ 320         $ 501     $ 629  

 

(1) 

Merck’s partnership returns from AZLP are generally contractually determined and are not based on a percentage of income from AZLP, other than with respect to Merck’s 1% limited partnership interest.

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Collaborative Arrangements (Details) (USD $)
In Millions, unless otherwise specified
1 Months Ended
Apr. 30, 2011
Oct. 31, 2009
Collaborative Arrangements (Textual) [Abstract]    
Extended marketing rights for both products (Remicade and Simponi)   15 years
Arbitration settlement payment $ 500  
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Taxes on Income
6 Months Ended
Jun. 30, 2012
Taxes on Income [Abstract]  
Taxes on Income

14.  Taxes on Income

The effective tax rates of 32.1% and 30.8% for the second quarter and first six months of 2012 and (22.8)% and 8.1% for the second quarter and first six months of 2011 reflect the impacts of acquisition-related costs and restructuring costs, partially offset by the beneficial impact of foreign earnings. In addition, the effective tax rates for the second quarter and first six months of 2011 also reflect a net favorable impact relating to the settlement of Merck’s 2002-2005 federal income tax audit as discussed below, as well as the net favorable impact of certain foreign and state tax rate changes that resulted in a net $230 million reduction of deferred tax liabilities on intangibles established in purchase accounting. In addition, the effective tax rate for the first six months of 2011 also reflects the impact of the $500 million charge related to the resolution of the arbitration proceeding with J&J.

In April 2011, the Internal Revenue Service (the “IRS”) concluded its examination of Merck’s 2002-2005 federal income tax returns and as a result the Company was required to make net payments of approximately $465 million. The Company’s unrecognized tax benefits for the years under examination exceeded the adjustments related to this examination period and therefore the Company recorded a net $700 million tax provision benefit in the second quarter of 2011. This net benefit reflects the decrease of unrecognized tax benefits for the years under examination partially offset by increases to the unrecognized tax benefits for years subsequent to the examination period as a result of this settlement. The Company disagrees with the IRS treatment of one issue raised during this examination and is appealing the matter through the IRS administrative process.

As previously disclosed, the Canada Revenue Agency (the “CRA”) has proposed adjustments for 1999 and 2000 relating to intercompany pricing matters and, in July 2011, the CRA issued assessments for other miscellaneous audit issues for tax years 2001-2004. These adjustments would increase Canadian tax due by approximately $330 million plus approximately $390 million of interest through June 30, 2012. The Company disagrees with the positions taken by the CRA and believes they are without merit. The Company continues to contest the assessments through the CRA appeals process. The CRA is expected to prepare similar adjustments for later years. Management believes that resolution of these matters will not have a material effect on the Company’s financial position or liquidity.