10-Q 1 d400394d10q.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 September 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 October 31, 2012:    3,040,071,937

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

 

 

Sales

     $ 11,488           $ 12,022           $ 35,530         $ 35,753     

 

 

Costs, Expenses and Other

           

Materials and production

     4,137           4,352           12,286           12,695     

Marketing and administrative

     3,063           3,340           9,386           10,029     

Research and development

     1,918           1,954           5,944           6,048     

Restructuring costs

     110           119           473           773     

Equity income from affiliates

     (158)          (161)          (410)          (354)    

Other (income) expense, net

     200           66           446           809     

 

 
     9,270           9,670           28,125           30,000     

 

 

Income Before Taxes

     2,218           2,352           7,405           5,753     

Taxes on Income

     455           628           2,055           904     

 

 

Net Income

     $ 1,763           $ 1,724           $ 5,350           $ 4,849     

Less: Net Income Attributable to Noncontrolling Interests

     34           32           89           89     

 

 

Net Income Attributable to Merck & Co., Inc.

     $ 1,729           $ 1,692           $ 5,261           $ 4,760     

 

 

Basic Earnings per Common Share Attributable to Merck & Co., Inc. Common Shareholders

     $ 0.57           $ 0.55           $ 1.73           $ 1.54     

 

 

Earnings per Common Share Assuming Dilution Attributable to Merck & Co., Inc. Common Shareholders

     $ 0.56           $ 0.55           $ 1.71           $ 1.53     

 

 

Dividends Declared per Common Share

     $ 0.42           $ 0.38           $ 1.26           $ 1.14     

 

 

 

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

 

 

Net Income Attributable to Merck & Co., Inc.

     $ 1,729           $ 1,692           $ 5,261           $ 4,760     

 

 

Other Comprehensive Income Net of Taxes:

           

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

     (143)          60           (99)          (77)    

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

     32           (6)          62           (11)    

Benefit plan net gain and prior service cost, net of amortization

     27           31           45           59     

Cumulative translation adjustment

     170           (22)          84           532     

 

 
     86           63           92           503     

 

 

Comprehensive Income Attributable to Merck & Co., Inc.

     $ 1,815           $ 1,755           $ 5,353           $ 5,263     

 

 

 

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)

 

     September 30, 
2012 
     December 31, 
2011 
 

 

 

Assets

     

Current Assets

     

Cash and cash equivalents

   $ 17,360         $ 13,531     

Short-term investments

     757           1,441     

Accounts receivable (net of allowance for doubtful accounts of $163 in 2012 and $131 in 2011)

     7,952           8,261     

Inventories (excludes inventories of $1,446 in 2012 and $1,379 in 2011 classified in Other assets - see Note 6)

     6,731           6,254     

Deferred income taxes and other current assets

     3,429           3,694     

 

 

Total current assets

     36,229           33,181     

 

 

Investments

     5,560           3,458     

 

 

Property, Plant and Equipment, at cost, net of accumulated depreciation of $17,475 in 2012 and $16,176 in 2011

     15,884           16,297     

 

 

Goodwill

     12,168           12,155     

 

 

Other Intangibles, Net

     30,325           34,302     

 

 

Other Assets

     6,135           5,735     

 

 
   $ 106,301         $ 105,128     

 

 

Liabilities and Equity

     

Current Liabilities

     

Loans payable and current portion of long-term debt

   $ 2,029         $ 1,990     

Trade accounts payable

     1,804           2,023     

Accrued and other current liabilities

     8,923           10,170     

Income taxes payable

     1,512           781     

Dividends payable

     1,315           1,281     

 

 

Total current liabilities

     15,583           16,245     

 

 

Long-Term Debt

     17,571           15,525     

 

 

Deferred Income Taxes and Noncurrent Liabilities

     14,935           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

     40,471           40,663     

Retained earnings

     40,390           38,990     

Accumulated other comprehensive loss

     (3,040)          (3,132)    

 

 
     79,609           78,309     

Less treasury stock, at cost:

     

532,699,267 shares in 2012 and 536,109,713 shares in 2011

     23,862           23,792     

 

 

Total Merck & Co., Inc. stockholders’ equity

     55,747           54,517     

 

 

Noncontrolling Interests

     2,465           2,426     

 

 

Total equity

     58,212           56,943     

 

 
   $ 106,301         $ 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)

 

      Nine Months Ended
  September 30,
 
     2012      2011  

 

 

Cash Flows from Operating Activities

     

Net income

    $ 5,350        $ 4,849     

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

     

Depreciation and amortization

     5,317          5,566     

Intangible asset impairment charges

     176          461     

Equity income from affiliates

     (410)         (354)    

Dividends and distributions from equity affiliates

     181          186     

Deferred income taxes

     (283)         (974)    

Share-based compensation

     257          287     

Other

     (34)         (207)    

Net changes in assets and liabilities

     (2,341)         (664)    

 

 

Net Cash Provided by Operating Activities

     8,213          9,150     

 

 

Cash Flows from Investing Activities

     

Capital expenditures

     (1,176)         (1,120)    

Purchases of securities and other investments

     (6,891)         (4,686)    

Proceeds from sales of securities and other investments

     5,607          4,740     

Dispositions of businesses, net of cash divested

             323     

Acquisitions of businesses, net of cash acquired

             (373)    

Other

     53          (90)    

 

 

Net Cash Used in Investing Activities

     (2,407)         (1,206)    

 

 

Cash Flows from Financing Activities

     

Net change in short-term borrowings

     (280)         1,356     

Proceeds from issuance of debt

     2,504          -     

Payments on debt

     (4)         (1,277)    

Purchases of treasury stock

     (1,439)         (1,359)    

Dividends paid to stockholders

     (3,836)         (3,526)    

Proceeds from exercise of stock options

     1,060          194     

Other

     (54)         (61)    

 

 

Net Cash Used in Financing Activities

     (2,049)         (4,673)    

 

 

Effect of Exchange Rate Changes on Cash and Cash Equivalents

     72          82     

 

 

Net Increase in Cash and Cash Equivalents

     3,829          3,353     

 

 

Cash and Cash Equivalents at Beginning of Year

     13,531          10,900     

 

 

Cash and Cash Equivalents at End of Period

    $      17,360        $      14,253     

 

 

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 also 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 $150 million and $255 million in the third quarter of 2012 and 2011, respectively, and $718 million and $1.2 billion in the first nine months of 2012 and 2011, respectively, related to this program. Since inception of the Merger Restructuring Program through September 30, 2012, Merck has recorded total pretax accumulated costs of approximately $5.8 billion and eliminated approximately 20,750 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 2016. The Company now expects the estimated total cumulative pretax costs for this program to be approximately $7.2 billion to $7.5 billion. The increase from original estimates primarily reflects accelerated depreciation related to additional facility closures identified during the Company’s ongoing assessment of worldwide capacity requirements for its manufacturing, research and administrative facilities subsequent to the Merger, including the recently announced move of the Company’s worldwide headquarters to Summit, New Jersey. The Company estimates that approximately two-thirds of the cumulative pretax costs relate to cash outlays, primarily related to employee separation expense. Approximately

 

- 6 -


Notes to Consolidated Financial Statements (unaudited) (continued)

 

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 $13 million and $20 million were recorded in the third quarter of 2012 and 2011, respectively, and $23 million and $25 million were recorded in the first nine months of 2012 and 2011, respectively, related to the 2008 Restructuring Program. Since inception of the 2008 Restructuring Program through September 30, 2012, Merck has recorded total pretax accumulated costs of $1.6 billion and eliminated approximately 6,400 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 September 30, 2012      Nine Months Ended September 30, 2012  
($ in millions)   

  Separation

Costs

    Accelerated
Depreciation
    Other      Total              Separation
Costs
    Accelerated
Depreciation
     Other      Total        

 

 

Merger Restructuring Program

                    

 

 

Materials and production

    $ -      $ 42      $ 13       $ 55          $ -      $ 75       $ 50       $ 125     

Marketing and administrative

     -        16        3         19           -        59         5         64     

Research and development

     -        (33 (1)      1         (32)          -        49         5         54     

Restructuring costs

     59        -        49         108           363        -         112         475     

 

 
     59        25        66         150           363        183         172         718     

 

 

2008 Restructuring Program

                    

 

 

Materials and production

     -        1        4         5           -        4         15         19     

Marketing and administrative

     -        6        -         6           -        6         -         6     

Restructuring costs

     (1     -        3         2           (12     -         10         (2)    

 

 
     (1     7        7         13           (12     10         25         23     

 

 
    $ 58      $ 32      $          73       $         163          $ 351      $ 193       $         197       $         741     

 

 

 

     Three Months Ended September 30, 2011      Nine Months Ended September 30, 2011  
($ in millions)      Separation
Costs
     Accelerated
Depreciation
    Other     Total              Separation
Costs
    Accelerated
Depreciation
     Other     Total        

 

 

Merger Restructuring Program

                   

 

 

Materials and production

    $ -       $ 81           $ 7      $ 88          $ -      $ 233       $ 12      $ 245     

Marketing and administrative

     -         22        9        31           -        67         10        77     

Research and development

     -         27        1        28           -        107         (18     89     

Restructuring costs

     63         -        45        108           670        -         95        765     

 

 
     63         130        62        255           670        407         99            1,176     

 

 

2008 Restructuring Program

                   

 

 

Materials and production

     -         10        (1     9           -        16         1        17     

Restructuring costs

     5         -        6        11           (3     -         11        8     

 

 
     5         10        5        20           (3     16         12        25     

 

 
    $ 68       $ 140      $          67      $         275          $ 667      $ 423       $         111      $ 1,201     

 

 

 

(1) 

In the third quarter of 2012, the Company recorded an adjustment to accelerated depreciation costs included in research and development expenses revising previously recorded amounts for certain facilities.

Separation costs are associated with actual headcount reductions, as well as those headcount reductions which were probable and could be reasonably estimated. In the third quarter of 2012 and 2011, approximately 525 positions and 1,300 positions, respectively, were eliminated under the Merger Restructuring Program and

 

- 7 -


Notes to Consolidated Financial Statements (unaudited) (continued)

 

approximately 10 and 110 positions, respectively, were eliminated under the 2008 Restructuring Program. In the first nine months of 2012 and 2011, approximately 2,325 positions and 2,635 positions, respectively, were eliminated under the Merger Restructuring Program and approximately 150 positions and 290 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. Anticipated 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 13) 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 nine months ended September 30, 2012:

 

($ in millions)    Separation
Costs
     Accelerated
Depreciation
     Other       Total    

 

 

Merger Restructuring Program

           

 

 

Restructuring reserves January 1, 2012

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

Expense

     363          183          172          718     

(Payments) receipts, net

     (742)                 (131)         (873)    

Non-cash activity

             (183)         (74)         (257)    

 

 

Restructuring reserves September 30, 2012 (1)

   $ 765        $       $ 18        $ 783     

 

 

2008 Restructuring Program

           

 

 

Restructuring reserves January 1, 2012

   $ 126        $       $       $ 126     

Expense

     (12)         10          25          23     

(Payments) receipts, net

     (19)                 (8)         (27)    

Non-cash activity

             (10)         (17)         (27)    

 

 

Restructuring reserves September 30, 2012 (1)

   $ 95        $       $       $ 95     

 

 

 

(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 2016. 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 for the third quarter of 2011 and $4 million and $18 million for the first nine months of 2012 and 2011, respectively. The remaining reserve associated with this program, which is substantially complete, was $17 million at September 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

 

- 8 -


Notes to Consolidated Financial Statements (unaudited) (continued)

 

$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 nine 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

 

- 9 -


Notes to Consolidated Financial Statements (unaudited) (continued)

 

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.

 

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

 

- 10 -


Notes to Consolidated Financial Statements (unaudited) (continued)

 

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 $35 million and $(84) million for the first nine 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 the third quarter of 2011, the Company terminated 11 interest rate swap contracts with a total notional amount of $1.6 billion. These swaps effectively converted $1.6 billion of its fixed-rate notes, with maturity dates ranging from June 2015 to January 2016, to floating-rate instruments. As a result of the third quarter swap terminations, the Company received $113 million in cash, which included $7 million in accrued interest. The corresponding $106 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. In the second quarter of 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 ranging from March 2015 to June 2019, to floating-rate instruments. As a result of the second quarter 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 September 30, 2011, the Company was a party to two pay-floating, receive-fixed interest rate swap contracts with notional amounts of $250 million 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. These 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:

 

          September 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

     $ 163         $ -         $ 4,450           $ 196         $ -         $ 3,727     

Foreign exchange contracts (non-current)

  

Other assets

     350           -           5,637           420           -           4,956     

Foreign exchange contracts (current)

  

Accrued and other current liabilities

     -           48           1,668           -           53           1,718     

Foreign exchange contracts (non-current)

  

Deferred income taxes and noncurrent liabilities

     -           7           426           -           1           104     

 

 
        $ 513         $ 55         $ 12,181           $ 616         $ 54         $ 10,505     

 

 

Derivatives Not Designated as Hedging Instruments

                 

 

 

Foreign exchange contracts (current)

  

Deferred income taxes and other current assets

     $ 55         $ -         $ 4,256           $ 139         $ -         $ 5,306     

Foreign exchange contracts (non-current)

  

Other assets

     18           -           290           -           -           -     

Foreign exchange contracts (current)

  

Accrued and other current liabilities

     -           125           6,129           -           54           5,013     

 

 
        $ 73         $ 125         $ 10,675           $ 139         $ 54         $ 10,319     

 

 
        $ 586         $ 180         $ 22,856           $ 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  
September 30,
      Nine Months Ended  
September 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

   $      $ (40)        $      $ (203)    

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

             40                    203     

Derivatives designated in foreign currency cash flow hedging relationships

       

Foreign exchange contracts

       

Amount of (gain) loss reclassified from AOCI to Sales

    (4)        30          49         57     

Amount of loss (gain) recognized in OCI on derivatives

      236         (70)           202         183     

Derivatives designated in foreign currency net investment hedging relationships

       

Foreign exchange contracts

       

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

    (5)        (1)         (15)        (9)    

Amount of loss (gain) recognized in OCI on derivatives

    54         124          (2)        158     

Derivatives not designated in a hedging relationship

       

Foreign exchange contracts

       

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

    157         (351)         131         (31)    

Amounts of loss recognized in Sales on hedged item

    17         -          17         -     

 

 

 

(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 September 30, 2012, the Company estimates $103 million of pretax net unrealized losses 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:

 

     September 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

       $     3,705          $ 3,650         $ 56       $ (1)          $     2,032       $ 2,024         $ 16       $ (8)    

U.S. government and agency securities

     1,156         1,154         2         -           1,021         1,018         3         -     

Asset-backed securities

     648         644         4         -           292         292         1         (1)    

Mortgage-backed securities

     334         334         2         (2)          223         223         1         (1)    

Commercial paper

     168         168         -         -           1,029         1,029         -         -     

Foreign government bonds

     72         71         1         -           72         72         -         -     

Other debt securities

     -         -         -         -           3         1         2         -     

Equity securities

     420         384         36         -           397         383         14         -     

 

 
       $ 6,503          $ 6,405         $ 101       $ (3)          $ 5,069       $     5,042         $     37       $     (10)    

 

 

Available-for-sale debt securities included in Short-term investments totaled $757 million at September 30, 2012. Of the remaining debt securities, $4.7 billion mature within five years. At September 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 September 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)    September 30, 2012      December 31, 2011  

 

 

Assets

                       

Investments

                       

Corporate notes and bonds

    $       $ 3,705       $ -       $       3,705          $       $ 2,032       $ -       $       2,032     

U.S. government and agency securities

             1,156         -         1,156                   1,021         -         1,021     

Asset-backed securities (1)

             648         -         648                   292         -         292     

Mortgage-backed securities (1)

             334         -         334                   223         -         223     

Commercial paper

             168         -         168                   1,029         -         1,029     

Foreign government bonds

             72         -         72                   72         -         72     

Equity securities

     209          25         -         234           205          22         -         227     

Other debt securities

             -         -         -                   3         -         3     

 

 
     209          6,108         -         6,317           205          4,694         -         4,899     

 

 

Other assets

                       

Securities held for employee compensation

     186          -         -         186           170          -         -         170     

Derivative assets (2)

                       

Purchased currency options

             541         -         541                   613         -         613     

Forward exchange contracts

             45         -         45                   142         -         142     

 

 
             586         -         586                   755         -         755     

 

 

Total assets

    $ 395        $ 6,694       $ -       $ 7,089          $ 375        $ 5,449       $ -       $ 5,824     

 

 

Liabilities

                       

Derivative liabilities (2)

                       

Forward exchange contracts

    $       $ 176       $ -       $ 176          $       $ 107       $ -       $ 107     

Written currency options

             4         -         4                   1         -         1     

 

 

Total liabilities

    $       $ 180       $ -       $ 180          $       $ 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 nine months of 2012. As of September 30, 2012, Cash and cash equivalents of $17.4 billion included $16.6 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 September 30, 2012 was $22.1 billion compared with a carrying value of $19.6 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 50% 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 September 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 19%, 41%, 30% and 10% related to Greece, Italy, Spain and Portugal, respectively. As of September 30, 2012, the Company’s total accounts receivable outstanding for more than one year were approximately $300 million, of which approximately 60% related to accounts receivable in Greece, Italy, Spain and Portugal, mostly comprised of hospital and public sector receivables.

During the third quarter of 2012, the Company collected approximately $60 million of accounts receivable from the government of Portugal, which pertained to accounts receivable outstanding from 2011 and prior. 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 September 30, 2012 and December 31, 2011, the Company had received cash collateral of $313

 

- 15 -


Notes to Consolidated Financial Statements (unaudited) (continued)

 

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 September 30, 2012 or December 31, 2011.

 

6.

Inventories

Inventories consisted of:

 

($ in millions)   

  September 30,  

2012

   

  December 31,    

2011    

 

 

 

Finished goods

   $ 1,952      $ 1,983     

Raw materials and work in process

     5,971        5,396     

Supplies

     264        297     

 

 

Total (approximates current cost)

     8,187        7,676     

Reduction to LIFO costs

     (10     (43)    

 

 
   $ 8,177      $ 7,633     

 

 

Recognized as:

    

Inventories

   $ 6,731      $ 6,254     

Other assets

     1,446        1,379     

 

 

Amounts recognized as Other assets are comprised almost entirely of raw materials and work in process inventories. At both September 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 $191 million and $127 million at September 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 third quarter of 2012 and 2011, the Company recorded $40 million and $22 million, respectively, and during the first nine months of 2012 and 2011, recorded $176 million and $343 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 subsequently deemed to have no alternative use in the period. Certain of the charges in 2011 were also attributable to compounds that were out-licensed to a third party for consideration that was less than the related asset’s carrying value. Also, during the first nine months 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    
September 30,
         Nine Months Ended    
September 30,
 
($ in millions)         2012               2011                2012               2011       

 

 

AstraZeneca LP

     $ 134           $ 141             $ 387           $ 318      

Other (1)

     24             20            23             36      

 

 
     $          158           $            161             $          410           $            354      

 

 

 

(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

 

- 16 -


Notes to Consolidated Financial Statements (unaudited) (continued)

 

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 Nexium and Prilosec. 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
September 30,
     Nine Months Ended
September 30,
 
($ in millions)       2012      2011           2012      2011    

 

 

Sales

   $         1,232          $         1,124          $         3,424          $         3,460      

Materials and production costs

     561            464            1,520            1,524      

Other expense, net

     204            357            936            1,004      

 

 

Income before taxes (1)

   $ 467          $ 303          $ 968          $ 932      

 

 

 

(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.

Johnson & Johnson°Merck Consumer Pharmaceuticals Company

In September 2011, Merck sold its 50% interest in the Johnson & Johnson°Merck Consumer Pharmaceuticals Company (“JJMCP”) joint venture to J&J. The venture between Merck and J&J was formed in 1989 to develop, manufacture, market and distribute certain over-the-counter consumer products in the United States and Canada. Merck received a one-time payment of $175 million and recognized a pretax gain of $136 million in the third quarter of 2011 reflected in Other (income) expense, net. The partnership assets also included a manufacturing facility.

 

9.

Long-Term Debt

In September 2012, the Company closed an underwritten public offering of $2.5 billion senior unsecured notes consisting of $1.0 billion aggregate principle amount of 1.1% notes due 2018, $1.0 billion aggregate principle amount of 2.4% notes due 2022 and $500 million aggregate principle amount of 3.6% notes due 2042. Interest on the notes is payable semi-annually. The notes of each series are redeemable in whole or in part at any time at the Company’s option at varying redemption prices. Proceeds from the notes will be used for general corporate purposes, including making contributions to the Company’s pension plans and the repayment of outstanding commercial paper and upcoming debt maturities.

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.

 

10.

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

 

- 17 -


Notes to Consolidated Financial Statements (unaudited) (continued)

 

(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 are no U.S. Vioxx Product Liability Lawsuits currently scheduled for trial in 2012, and none scheduled for 2013. 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. On October 15, 2012, the parties executed a settlement agreement to resolve the litigation. The Company established a reserve of $39 million in the third quarter of 2012 in connection with that settlement agreement, which is the minimum amount that the Company is required to pay under the agreement. The agreement is subject to court approval and certain other conditions.

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.

 

- 18 -


Notes to Consolidated Financial Statements (unaudited) (continued)

 

Merck has also been named as a defendant in several lawsuits brought by state Attorneys General. 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.

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. On April 10, 2012, plaintiffs filed a motion for class certification. Briefing is ongoing. 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 (the “KBC 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. On September 15, 2012, defendants answered the complaints in all individual actions other than the KBC Lawsuit; on the same day, defendants moved to dismiss the complaint in the KBC Lawsuit on statute of limitations grounds. The motion to dismiss in the KBC Lawsuit is fully briefed and pending before the court. Discovery is currently proceeding in the individual securities lawsuits together with discovery in the class action.

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.

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.

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 and 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.

 

- 19 -


Notes to Consolidated Financial Statements (unaudited) (continued)

 

In November 2011, the Company announced that it had reached a resolution with federal and state authorities regarding this matter, pending court approval. On April 19, 2012, the U.S. District Court for the District of Massachusetts accepted the resolution and thereafter the Company made the payments noted above.

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. The Company has established a reserve with respect to the Canada Settlement Agreement and with respect to certain other Vioxx Product Liability Lawsuits, including the Missouri matter discussed above. 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 September 30, 2012, approximately 4,005 cases, which include approximately 4,580 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 1,215 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 2,785 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 955 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. Plaintiff and Merck subsequently entered into a confidential stipulation as to the amount of plaintiff’s damages that enabled Merck to appeal the underlying judgment, and Merck filed its appeal in the Boles case on October 18, 2012. 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. Plaintiffs have filed an appeal in two of the cases – Graves v. Merck and Secrest v. Merck.

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 was set for trial on October 15, 2012, but plaintiff dismissed the case and refiled it in the Fosamax ONJ MDL. 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

 

- 20 -


Notes to Consolidated Financial Statements (unaudited) (continued)

 

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 September 30, 2012, approximately 255 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. Plaintiffs have filed an appeal in both cases.

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 640 cases were pending in the Fosamax Femur Fracture MDL as of September 30, 2012. A Case Management Order has been entered that requires the parties to review 40 cases (later reduced to 33 cases). Judge Joel Pisano has selected four cases from that group 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, which will be Glynn v. Merck.

As of September 30, 2012, approximately 1,740 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. Judge Higbee has set March 4, 2013 as the date for the first trial of the New Jersey state Femur Fracture cases. On September 27, 2012, Judge Higbee selected the Unanski v. Merck and Su v. Merck cases to be tried jointly beginning on the March 4, 2013 trial date.

As of September 30, 2012, approximately 380 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 September 30, 2012, there were approximately 1,220 NuvaRing cases. Of these cases, approximately 1,030 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 185 are pending in coordinated discovery proceedings in the Bergen County Superior Court of New Jersey before Judge Brian R. Martinotti. Five additional cases are pending in various other state courts.

 

- 21 -


Notes to Consolidated Financial Statements (unaudited) (continued)

 

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 20 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 expert discovery has been completed in those first trial pool cases. Certain replacement trial pool cases remain in fact discovery.

The Company has filed motions related to the admissibility of expert testimony and motions for summary judgment. Following the completion of briefing, the Company expects substantive hearings on those motions to take place in late 2012 or early 2013. 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 September 30, 2012, approximately 265 lawsuits involving a total of approximately 415 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 various federal courts 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.

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, as amended. On March 1, 2012, defendants filed a motion for summary judgment. On September 25, 2012, the court granted lead plaintiffs’ amended motion for class certification and denied defendants’ motion for summary judgment. On October 9, 2012, Merck filed a petition for leave to appeal the class certification decision to the Third Circuit Court of Appeals, which lead plaintiffs opposed on October 19, 2012. The petition for interlocutory review is pending before the Third Circuit. A trial date has been set by the district court for March 4, 2013.

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, as amended. 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. On September 25, 2012, the court granted lead plaintiffs’ amended motion for class certification and denied defendants’ motions for summary judgment. On October 9, 2012, Schering-Plough and the underwriter defendants filed separate petitions for leave to appeal the class certification decision to the Third Circuit Court of Appeals, which lead plaintiffs opposed on October 19, 2012. The petitions for interlocutory review are pending before the Third Circuit. A trial date has been set by the district court for March 4, 2013.

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

 

- 22 -


Notes to Consolidated Financial Statements (unaudited) (continued)

 

Merck in the District of New Jersey, and all of those lawsuits were consolidated under the caption In re Merck & Co., Inc. Vytorin ERISA Litigation. A consolidated amended complaint was filed in February 2009, and named as defendants Merck and various current and former members of the Company’s Board of Directors. The plaintiffs alleged 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 fairness hearing on final approval of the settlement for September 25, 2012. Following the fairness hearing, the court granted plaintiffs’ motion for final approval of the settlement agreement on September 28, 2012. On October 26, 2012, the court entered an order and final judgment which, among other things, provides broad releases with prejudice. 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 the plan of allocation approved by the court.

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.

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, Oklahoma, and Mississippi. The Company and/or certain of its subsidiaries continue to be defendants in cases brought by six states.

The Company is also appealing the recommendation of a court-appointed Special Master that Merck be reinstated 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

 

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Notes to Consolidated Financial Statements (unaudited) (continued)

 

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 has filed a petition for certiorari with the U.S. Supreme Court seeking review of the Third Circuit’s reversal of summary judgment.

Nexium Anti-Trust Litigation

In September 2012, the Company and certain of its subsidiaries were among the defendants named in a putative class action lawsuit brought on behalf of direct purchasers of Nexium in federal court in New Jersey. The lawsuit alleges violations of federal antitrust law arising from settlements reached by and among the defendants to resolve certain patent litigation relating to the entry of generic esomeprazole on the U.S. market. Specifically, the plaintiffs contend that these settlements had the effect of impermissibly delaying the entry of generic esomeprazole in the United States and extending the monopoly power of Nexium, leading to higher average market prices. The Company denies any wrongdoing and intends to defend the lawsuit, which bears the caption Value Drug Company and Burlington Drug Co. Inc., et al. v. AstraZeneca PLC, et al.

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, Emend for Injection, Nasonex, Nexium, 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 products acquired through mergers and acquisitions, 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.

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 Teva Parenteral Medicines, Inc. (“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

 

- 24 -


Notes to Consolidated Financial Statements (unaudited) (continued)

 

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, whichever may occur earlier.

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. In September 2012, 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 Zetia. The lawsuit automatically stays FDA approval of Sandoz’s ANDA until February 2015 or until an adverse court decision, if any, whichever may occur earlier.

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 September 30, 2012 and December 31, 2011 of approximately $240 million represents the

 

- 25 -


Notes to Consolidated Financial Statements (unaudited) (continued)

 

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.

 

11.

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.

     -                 -        4,760        -        -        -           -        4,760     

Cash dividends declared on common stock

     -                 -        (3,533     -        -        -           -        (3,533)    

Treasury stock shares purchased

     -                 -        -        -        41        (1,359)          -        (1,359)    

Share-based compensation plans and other

     -                 16        -        -        (11     377           -        393     

Other comprehensive income

     -                 -        -        503        -        -           -        503     

Net income attributable to noncontrolling interests

     -                 -        -        -        -        -           89        89     

Distributions attributable to noncontrolling interests

     -                 -        -        -        -        -           (62     (62)    

 

 

Balance September 30, 2011

     3,577       $ 1,788        $ 40,717      $ 38,763      $ (2,713     525      $ (23,415)        $ 2,456      $ 57,596     

 

 

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.

     -                 -        5,261        -        -        -           -        5,261     

Cash dividends declared on common stock

     -                 -        (3,861     -        -        -           -        (3,861)    

Treasury stock shares purchased

     -                 -        -        -        36        (1,439)          -        (1,439)    

Share-based compensation plans and other

     -                 (192     -        -        (39     1,369           -        1,177     

Other comprehensive income

     -                 -        -        92        -        -           -        92     

Net income attributable to noncontrolling interests

     -                 -        -        -        -        -           89        89     

Distributions attributable to noncontrolling interests

     -                 -        -        -        -        -           (50     (50)    

 

 

Balance September 30, 2012

     3,577       $ 1,788        $ 40,471      $ 40,390      $ (3,040     533      $ (23,862)        $ 2,465      $ 58,212     

 

 

 

- 26 -


Notes to Consolidated Financial Statements (unaudited) (continued)

 

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

     (77)         (11)         59          532          503     

 

 

Balance at September 30, 2011

   $ (36)       $ 20        $ (1,984)       $ (713)            $ (2,713)    

 

 

Balance January 1, 2012

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

Other comprehensive (loss) income

     (99)         62          45          84          92     

 

 

Balance at September 30, 2012

   $ (95)       $ 83        $ (2,301)       $ (727)            $ (3,040)    

 

 

Included in cumulative translation adjustment are pretax gains of approximately $393 million for the first nine months of 2011 relating to translation impacts of intangible assets recorded in conjunction with the Merger.

 

12.

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    
September 30,
         Nine Months Ended    
September 30,
 
($ in millions)    2012          2011          2012           2011    

 

 

Pretax share-based compensation expense

     $ 88          $ 86           $ 257          $ 287     

Income tax benefit

     (28)           (30)          (81)           (99)    

 

 

Total share-based compensation expense, net of taxes

     $ 60          $ 56           $ 176          $ 188     

 

 

During the first nine months of 2012 and 2011, the Company granted 7 million RSUs with a weighted-average grant date fair value of $39.38 per RSU and 8 million RSUs with a weighted-average grant date fair value of $36.44 per RSU, respectively.

During the first nine months of 2012 and 2011, the Company granted 7 million options with a weighted-average exercise price of $39.39 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 nine months of 2012 and 2011 was $5.47 and $5.37 per option, respectively, and was determined using the following assumptions:

 

         Nine Months Ended    
September 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     

 

 

 

- 27 -


Notes to Consolidated Financial Statements (unaudited) (continued)

 

At September 30, 2012, there was $449 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 1.8 years. For segment reporting, share-based compensation costs are unallocated expenses.

 

13.

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      
September 30,
           Nine Months Ended      
September 30,
 
($ in millions)    2012          2011        2012          2011    

 

 

Service cost

     $   133          $ 158           $ 416          $ 461     

Interest cost

     162            182           494            541     

Expected return on plan assets

         (239)                 (243)              (727)                 (728)    

Net amortization

     48            58           144            149     

Termination benefits

     4            15           13            32     

Curtailments

     (4)           (6)          (5)           (16)    

Settlements

     -            -           -            (1)    

 

 
     $ 104          $ 164           $ 335          $ 438     

 

 

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      
September 30,
           Nine Months Ended      
September 30,
 
($ in millions)    2012          2011        2012          2011    

 

 

Service cost

     $ 22          $ 27           $ 64          $ 83     

Interest cost

     31            35           93            106     

Expected return on plan assets

           (34)                   (35)              (102)                 (106)    

Net amortization

     (9)           (4)          (25)           (13)    

Termination benefits

     5            5           10            11     

Curtailments

     (2)           (1)          (6)           -     

 

 
     $ 13          $ 27           $ 34          $ 81     

 

 

In connection with restructuring actions (see Note 2), termination charges for the three and nine months ended September 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.

The Company expects to contribute approximately $1.75 billion to its defined benefit pension plans during 2012.

 

- 28 -


Notes to Consolidated Financial Statements (unaudited) (continued)

 

14.

Other (Income) Expense, Net

Other (income) expense, net, consisted of:

 

         Three Months Ended    
September 30,
         Nine Months Ended    
September 30,
 
($ in millions)    2012       2011       2012      2011    

 

 

Interest income

     $         (47)       $             (32)          $             (177)          $             (102)    

Interest expense

     178          176           524           522     

Exchange losses

     50          59           130           102     

Other, net

     19          (137)          (31)         287     

 

 
     $ 200        $ 66           $ 446           $ 809     

 

 

As a result of significant collections of accounts receivable in Spain (see Note 5), the Company recognized incremental interest income of approximately $35 million in the first nine 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 third quarter and first nine months of 2011 includes a $136 million gain on the disposition of the Company’s interest in the JJMCP joint venture. In addition, Other, net for the first nine 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 nine months ended September 30, 2012 and 2011 was $583 million and $261 million, respectively, which excludes commitment fees. Interest paid for the nine months ended September 30, 2011 is net of $288 million received by the Company from the termination of certain interest rate swap contracts during the period (see Note 5).

 

15.

Taxes on Income

The effective tax rates of 20.5% and 27.8% for the third quarter and first nine months of 2012 and 26.7% and 15.7% for the third quarter and first nine 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 third quarter and first nine months of 2012 also reflect the favorable impacts of a tax settlement with the Canada Revenue Agency (the “CRA”) as discussed below and the realization of foreign tax credits. The effective tax rate for the first nine months of 2011 also reflects the net favorable impact relating to the settlement of Merck’s 2002-2005 federal income tax audit as discussed below, 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, as well as the unfavorable impact of the $500 million charge related to the resolution of the arbitration proceeding with J&J.

As previously disclosed, the Canada Revenue Agency (the “CRA”) had 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. In the third quarter of 2012, Merck and the CRA reached a settlement that calls for Merck to pay additional Canadian tax of approximately $65 million. The Company’s unrecognized tax benefits related to these matters exceeded the settlement amount and therefore the Company recorded a net $112 million tax provision benefit in the third quarter of 2012. A portion of the taxes paid is expected to be creditable for U.S. tax purposes. The Company had previously established reserves for these matters. The resolution of these matters did not have a material effect on the Company’s results of operations, financial position or liquidity.

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.

 

- 29 -


Notes to Consolidated Financial Statements (unaudited) (continued)

 

16.

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                          Nine Months Ended            
     September 30,      September 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.

     $ 1,729       $ 1,692           $ 5,261       $ 4,760     

Less: Income allocated to participating securities

     -         3           4         12     

 

 

Net income allocated to common shareholders

     $       1,729       $        1,689           $       5,257       $        4,748     

 

 

Average common shares outstanding

     3,045         3,070           3,043         3,079     

 

 
     $ 0.57       $ 0.55           $ 1.73       $ 1.54     

 

 

Earnings per Common Share Assuming Dilution

           

Net income attributable to Merck & Co., Inc.

     $ 1,729       $ 1,692           $ 5,261       $ 4,760     

Less: Income allocated to participating securities

     -         3           4         12     

 

 

Net income allocated to common shareholders

     $ 1,729       $ 1,689           $ 5,257       $ 4,748     

 

 

Average common shares outstanding

     3,045         3,070           3,043         3,079     

Common shares issuable (1)

     34         21           34         23     

 

 

Average common shares outstanding assuming dilution

     3,079         3,091           3,077         3,102     

 

 
     $ 0.56       $ 0.55           $ 1.71       $ 1.53     

 

 

 

(1) 

Issuable primarily under share-based compensation plans.

For the three months ended September 30, 2012 and 2011, 97 million and 170 million, respectively, and for the first nine months of 2012 and 2011, 111 million and 170 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.

 

17.

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. 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.

 

- 30 -


Notes to Consolidated Financial Statements (unaudited) (continued)

 

Sales of the Company’s products were as follows:

 

     Three Months Ended      Nine Months Ended  
     September 30,      September 30,  
($ in millions)    2012      2011      2012      2011  

 

 

Primary Care and Women’s Health

           

Cardiovascular

           

Zetia

     $ 645         $ 614           $ 1,891         $ 1,788     

Vytorin

     423         469           1,312         1,407     

Diabetes and Obesity

           

Januvia

     975         846           2,952         2,364     

Janumet

     405         350           1,207         977     

Respiratory

           

Singulair

     602         1,336           3,373         4,018     

Nasonex

     292         266           960         962     

Clarinex

     64         128           337         492     

Asmanex

     42         42           141         149     

Dulera

     52         22           140         59     

Women’s Health and Endocrine

           

Fosamax

     152         215           522         644     

NuvaRing

     156         159           459         455     

Follistim AQ

     111         129           352         404     

Implanon

     93         80           254         220     

Cerazette

     64         74           202         199     

Other

           

Maxalt

     166         156           476         460     

Arcoxia

     109         108           338         321     

Avelox

     30         59           146         227     

Hospital and Specialty

           

Immunology

           

Remicade

     490         561           1,527         2,156     

Simponi

     86         74           236         203     

Infectious Disease

           

Isentress

     399         343           1,133         972     

PegIntron

     165         163           510         482     

Cancidas

     163         150           474         476     

Victrelis

     149         31           387         53     

Invanz

     118         107           329         296     

Primaxin

     109         124           301         397     

Noxafil

     66         61           191         171     

Oncology

           

Temodar

     227         223           688         704     

Emend

     111         98           358         305     

Other

           

Cosopt/Trusopt

     102         124           331         360     

Bridion

     68         52           186         141     

Integrilin

     48         53           160         172     

Diversified Brands

           

Cozaar/Hyzaar

     295         404           969         1,236     

Propecia

     104         112           312         330     

Zocor

     86         110           285         345     

Claritin Rx

     47         55           181         240     

Remeron

     52         65           175         181     

Proscar

     55         58           160         171     

Vasotec/Vaseretic

     42         57           144         173     

Vaccines (1)

           

Gardasil

     581         445           1,189         935     

ProQuad/M-M-R II/Varivax

     396         391           967         927     

RotaTeq

     150         184           433         457     

Zostavax

     202         108           426         254     

Pneumovax

     160         133           372         276     

Other pharmaceutical (2)

     1,023         1,015           3,031         2,975     

 

 

Total Pharmaceutical segment sales

     9,875         10,354           30,517         30,534     

 

 

Other segment sales (3)

     1,556         1,586           4,830         4,908     

 

 

Total segment sales

     11,431         11,940           35,347         35,442     

 

 

Other (4)

     57         82           183         311     

 

 
     $               11,488         $               12,022           $               35,530         $               35,753     

 

 

 

(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 $255 million and $299 million for the third quarter of 2012 and 2011, respectively, and $664 million and $928 million for the first nine 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 third quarter and first nine 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.

 

 

- 31 -


Notes to Consolidated Financial Statements (unaudited) (continued)

 

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

 

               Three Months Ended           
September 30,
               Nine Months Ended           
September 30,
 
($ in millions)    2012      2011      2012      2011  

 

 

Segment profits:

           

Pharmaceutical segment

     $ 6,265           $ 6,355           $ 19,767           $ 19,014     

Other segments

     819           783           2,397           2,300     
  

 

 

 

Total segment profits

     7,084           7,138           22,164           21,314     

Other (losses) profits

     (4)          5           (32)          (9)    

Unallocated:

           

Interest income

     47           32           177           102     

Interest expense

     (178)          (176)          (524)          (522)    

Equity income from affiliates

     (5)          (1)          (14)          (82)    

Depreciation and amortization

     (486)          (619)          (1,620)          (1,814)    

Research and development

     (1,689)          (1,712)          (5,263)          (5,330)    

Amortization of purchase accounting adjustments

     (1,232)          (1,284)          (3,687)          (3,788)    

Restructuring costs

     (110)          (119)          (473)          (773)    

Arbitration settlement charge

     -           -           -           (500)    

Other unallocated, net

     (1,209)          (912)          (3,323)          (2,845)    

 

 
     $         2,218           $         2,352           $         7,405           $         5,753     

 

 

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 accounting adjustments are not allocated to segments.

Other (losses) profits 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.

 

- 32 -


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

Singulair Patent Expiries

The patent that provided U.S. market exclusivity for Singulair (montelukast sodium) expired in August 2012 and the Company is experiencing a significant and rapid decline in U.S. Singulair sales and the Company expects the decline to continue. 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.

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 $37 million and $39 million was recorded as a reduction to revenue in the third quarter of 2012 and 2011, respectively, and $113 million and $109 million for the first nine 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 $37 million for the third quarter of 2012 and 2011, respectively, and $143 million and $122 million for the first nine 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.

Operating Results

Sales

Worldwide sales were $11.5 billion for the third quarter of 2012, a decline of 4% compared with the third quarter of 2011. The revenue decline in the third quarter was driven primarily by lower sales of Singulair. As noted above, the patent that provided U.S. market exclusivity for Singulair expired in August 2012 and the Company is experiencing a significant and rapid decline in U.S. Singulair sales. Foreign exchange unfavorably affected global sales performance by 4% for the third quarter of 2012. The revenue decline in the third quarter also reflects lower sales of Cozaar (losartan potassium), Hyzaar (losartan potassium hydrochlorothiazide), Remicade, Clarinex (desloratadine), Fosamax (alendronate sodium) and Vytorin (ezetimibe/simvastatin). These declines were partially offset by growth in Gardasil [human papillomavirus quadrivalent (types 6, 11, 16 and 18) vaccine, recombinant], Januvia (sitagliptin), Victrelis (boceprevir), Zostavax [Zoster Vaccine Live], Isentress (raltegravir) and Janumet (sitagliptin/metformin HCI).

 

- 33 -


Global sales for the first nine months of 2012 were $35.5 billion, a decrease of 1% compared with the same period in 2011. Foreign exchange unfavorably affected global sales performance by 3% for the first nine months of 2012. The sales decline in the year-to-date period was driven primarily by lower sales of Singulair, Remicade, Cozaar, Hyzaar, Clarinex, Fosamax, Primaxin (imipenem and cilastatin sodium), and Vytorin, as well as by lower revenue from the Company’s relationship with AstraZeneca LP (“AZLP”). These declines were largely offset by higher sales of Januvia, Victrelis, Gardasil, Janumet, Zostavax, Isentress, Zetia (ezetimibe), Pneumovax [pneumococcal vaccine polyvalent], and higher sales of the Company’s animal health products.

While several of the Company’s brands experienced positive volume growth trends in the European Union (the “EU”) in the first nine months 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 and mandatory switches to generic 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 nine months of 2012 and the Company anticipates 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
September 30,
     Nine Months Ended
September 30,
 
($ in millions)    2012      2011      2012      2011  

 

 

Primary Care and Women’s Health

           

Cardiovascular

           

Zetia

     $ 645         $ 614           $ 1,891         $ 1,788     

Vytorin

     423         469           1,312         1,407     

Diabetes and Obesity

           

Januvia

     975         846           2,952         2,364     

Janumet

     405         350           1,207         977     

Respiratory

           

Singulair

     602         1,336           3,373         4,018     

Nasonex

     292         266           960         962     

Clarinex

     64         128           337         492     

Asmanex

     42         42           141         149     

Dulera

     52         22           140         59     

Women’s Health and Endocrine

           

Fosamax

     152         215           522         644     

NuvaRing

     156         159           459         455     

Follistim AQ

     111         129           352         404     

Implanon

     93         80           254         220     

Cerazette

     64         74           202         199     

Other

           

Maxalt

     166         156           476         460     

Arcoxia

     109         108           338         321     

Avelox

     30         59           146         227     

Hospital and Specialty

           

Immunology

           

Remicade

     490         561           1,527         2,156     

Simponi

     86         74           236         203     

Infectious Disease

           

Isentress

     399         343           1,133         972     

PegIntron

     165         163           510         482     

Cancidas

     163         150           474         476     

Victrelis

     149         31           387         53     

Invanz

     118         107           329         296     

Primaxin

     109         124           301         397     

Noxafil

     66         61           191         171     

Oncology

           

Temodar

     227         223           688         704     

Emend

     111         98           358         305     

Other

           

Cosopt/Trusopt

     102         124           331         360     

Bridion

     68         52           186         141     

Integrilin

     48         53           160         172     

Diversified Brands

           

Cozaar/Hyzaar

     295         404           969         1,236     

Propecia

     104         112           312         330     

Zocor

     86         110           285         345     

Claritin Rx

     47         55           181         240     

Remeron

     52         65           175         181     

Proscar

     55         58           160         171     

Vasotec/Vaseretic

     42         57           144         173     

Vaccines (1)

           

Gardasil

     581         445           1,189         935     

ProQuad/M-M-R II/Varivax

     396         391           967         927     

RotaTeq

     150         184           433         457     

Zostavax

     202         108           426         254     

Pneumovax

     160         133           372         276     

Other pharmaceutical (2)

     1,023         1,015           3,031         2,975     

 

 

Total Pharmaceutical segment sales

     9,875         10,354           30,517         30,534     

 

 

Other segment sales (3)

     1,556         1,586           4,830         4,908     

 

 

Total segment sales

     11,431         11,940           35,347         35,442     

 

 

Other (4)

     57         82           183         311     

 

 
     $                 11,488         $                 12,022           $                 35,530         $                 35,753     

 

 

 

(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 $255 million and $299 million for the third quarter of 2012 and 2011, respectively, and $664 million and $928 million for the first nine 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 third quarter and first nine 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 $1.3 billion and $1.5 billion for the three months ended September 30, 2012 and 2011, respectively, and $4.3 billion and $4.0 billion for the nine months ended September 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 (also marketed as Ezetrol outside the United States), a cholesterol-absorption inhibitor, were $645 million in the third quarter of 2012, an increase of 5% compared with the third quarter of 2011, and were $1.9 billion for the first nine months of 2012, an increase of 6% compared with the same period in 2011. Foreign exchange unfavorably affected global sales performance by 4% and 2% in the third quarter and first nine months of 2012, respectively. The sales increases reflect positive performance in the United States due to pricing, as well as volume growth in Japan, partially offset by volume declines in the United States and Europe. Sales of Vytorin (marketed outside the United States as Inegy), a combination product containing the active ingredients of both Zetia and Zocor (simvastatin), were $423 million and $1.3 billion in the third quarter and first nine months of 2012, respectively, representing declines of 10% and 7%, respectively, compared with the same periods in 2011. Foreign exchange unfavorably affected global sales performance by 6% and 4% in the third quarter and first nine 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 certain 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 $975 million in the third quarter of 2012, an increase of 15% compared with the third quarter of 2011, due primarily to volume growth in the United States and Japan. Worldwide sales of Januvia were $3.0 billion for the first nine months of 2012, representing an increase of 25% compared with the same period of 2011, reflecting volume growth both in international markets, as well as in the United States.

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 $405 million for the third quarter of 2012 and $1.2 billion for the first nine months of 2012, representing increases of 16% and 24%, respectively, compared with the same periods of 2011, reflecting volume growth in the United States, the emerging markets and Europe.

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.

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

 

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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 $602 million for the third quarter of 2012 and $3.4 billion for the first nine months of 2012, declines of 55% and 16%, respectively, compared with the same periods of 2011, driven primarily by lower sales in United States. Revenue declines in Europe, Canada and the emerging markets also contributed to Singulair sales declines during the quarter and year-to-date period. The patent that provided U.S. market exclusivity for Singulair expired on August 3, 2012. Accordingly, the Company is experiencing a significant and rapid decline in U.S. Singulair sales and the Company expects the decline to continue. U.S. sales of Singulair declined 72% to $249 million in the third quarter of 2012 compared with the third quarter of 2011. 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 $292 million for the third quarter of 2012, an increase of 10% compared with the third quarter of 2011, reflecting increases in the United States and volume growth in Japan. Worldwide sales of Nasonex were $960 million for the first nine months of 2012, comparable to the same period of 2011, driven largely by price in the United States, offset by price declines in Europe and lower volumes in Japan. Foreign exchange unfavorably affected global sales performance by 4% and 2% for the third quarter and first nine months of 2012, respectively. 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 10 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 $64 million for the third quarter of 2012 and $337 million for the first nine months of 2012, declines of 50% and 32%, respectively, compared with the same periods of 2011, reflecting lower volumes in Europe and the United States as a result of generic competition. As previously disclosed, by virtue of litigation settlements, certain generic manufacturers were 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. The Company anticipates that U.S. sales of Clarinex will continue to be negatively impacted in the fourth quarter 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 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 $152 million for the third quarter of 2012 and $522 million for the first nine months of 2012, representing declines of 29% and 19%, 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 $156 million for the third quarter of 2012, a decline of 2% compared with the third quarter of 2011, and $459 million for the first nine months of 2012, an increase of 1% compared with the same period of 2011. Foreign

 

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exchange negatively affected sales performance by 6% and 4% for the third quarter and first nine months of 2012, respectively. Sales performance in both periods reflects volume growth in the emerging markets.

Global sales of Follistim AQ (follitropin beta injection) (marketed in most countries outside the United States as Puregon), a biological fertility treatment, were $111 million for the third quarter of 2012 and $352 million for the first nine months of 2012, declines of 14% and 13%, respectively, compared with the same periods of 2011, driven largely by volume declines in Europe. Puregon lost market exclusivity in the EU in August 2009. Foreign exchange unfavorably affected global sales performance by 6% and 3% for the third quarter and first nine 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/17ß-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 conducting an additional clinical study requested by the FDA and plans to update the application in the future.

Other

Global sales of Maxalt (rizatriptan benzoate), a product for the acute treatment of migraine, were $166 million for the third quarter of 2012, an increase of 7% compared with the third quarter of 2011, and were $476 million for the first nine months of 2012, an increase of 3% compared with the first nine months of 2011, reflecting favorable pricing in the United States, 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, declined 13% to $490 million for the third quarter of 2012 compared with the third quarter of 2011 reflecting declines in Europe. Foreign exchange unfavorably affected global sales performance by 13% in the third quarter of 2012. Sales of Remicade declined 29% to $1.5 billion for the first nine months of 2012 compared with the same period 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 the first nine months of 2012 as compared with the same period in 2011 reflects these changes. In the Retained Territories, Remicade sales declined 5% in the first nine months of 2012, which reflects an 8% unfavorable effect from foreign exchange. Sales of Simponi, a once-monthly subcutaneous treatment for certain inflammatory diseases, were $86 million in the third quarter of 2012 compared with $74 million in the third quarter of 2011 due to continued uptake since launch. Sales of Simponi were $236 million for the first nine

 

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months of 2012 compared with $203 million for the first nine months of 2011. In the Retained Territories, sales of Simponi grew 35% in the first nine months of 2012 due in part to ongoing launches. In July 2012, a submission was made to the European Medicines Agency requesting approval of Simponi for 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 $399 million in the third quarter of 2012, an increase of 16% compared with the third quarter of 2011, and were $1.1 billion in the first nine months of 2012, an increase of 17% compared with the first nine months of 2011, primarily reflecting volume growth in the United States and, for the year-to-date period, growth in Latin America and the Eastern Europe, Middle East and Africa region. Foreign exchange unfavorably affected global sales performance by 7% and 4% in the third quarter and first nine months of 2012, respectively.

Worldwide sales of PegIntron (peginterferon alpha-2b), a treatment for chronic hepatitis C, were $165 million for the third quarter of 2012, an increase of 1% compared with the third quarter of 2011, and were $510 million for the first nine months of 2012, an increase of 6% compared with the same period in 2011. Foreign exchange unfavorably affected global sales performance by 7% and 4% for the third quarter and first nine months of 2012, respectively. Sales performance in the first nine months of 2012 reflects volume growth and favorable pricing in the United States and volume growth in the Eastern Europe, Middle East and Africa region, partially offset by volume declines in Japan.

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 64 countries and has launched in 31 of those markets. Sales of Victrelis were $149 million and $31 million for the third quarter of 2012 and 2011, respectively, and $387 million and $53 million for the first nine months of 2012 and 2011, respectively.

Sales of Primaxin, an anti-bacterial product, were $109 million in the third quarter of 2012, a decline of 12% compared with the third quarter of 2011, primarily due to volume declines in the United States and Europe, partially offset by increases in certain emerging markets. Sales of Primaxin were $301 million for the first nine months of 2012, a decline of 24% compared with the same period of 2011, primarily reflecting volume declines in the United States, Europe, Latin America and 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 $227 million for the third quarter of 2012, an increase of 2% compared with the third quarter of 2011, and were $688 million for the first nine months of 2012, representing a decline of 2% compared with the same period of 2011. Foreign exchange unfavorably affected global sales performance by 4% and 2% for the third quarter and first nine months of 2012, respectively. Sales performance primarily reflects 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 $111 million in the third quarter of 2012, an increase of 12% compared with the third quarter of 2011, and were $358 million for the first nine months of 2012, an increase of 17% compared with the first nine months of 2011. Foreign exchange unfavorably affected global sales performance by 6% and 3% for the third quarter and first nine months of 2012, respectively. Sales performance in both periods primarily reflects volume growth in the United States, as well as in the emerging markets. In addition, higher volumes in Japan also contributed to sales growth in the first nine months of 2012.

 

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Other

Worldwide sales of ophthalmic products Cosopt (dorzolamide hydrochloride-timolol maleate ophthalmic solution) and Trusopt (dorzolamide hydrochloride ophthalmic solution) were $102 million in the third quarter of 2012, a decline of 18% compared with the third quarter of 2011, and were $331 million for the first nine months of 2012, a decrease of 8% 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 6% and 4% for the third quarter and first nine 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 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 $68 million and $52 million for the third quarter of 2012 and 2011, respectively, and were $186 million and $141 million for the first nine months of 2012 and 2011, respectively. Sugammadex 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 $39 million and $34 million in the third quarter of 2012 and 2011, respectively, and were $123 million and $80 million for the first nine months of 2012 and 2011, respectively. Merck continues to focus on building the brand awareness of Saphris in the United States. If increasing the brand awareness in the United States 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 the value of the Saphris/Sycrest intangible asset, which had a carrying value of approximately $570 million at September 30, 2012. If the Saphris/Sycrest intangible asset is determined to be impaired, the impairment 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 27% in the third quarter of 2012 and 22% in the first nine 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 international markets have expired. Accordingly, the Company is experiencing significant declines in Cozaar and Hyzaar sales and the Company expects the declines to continue.

 

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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.

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 31% in the third quarter of 2012 to $581 million and rose 27% to $1.2 billion for the first nine months of 2012 reflecting growth in the United States driven by greater uptake in males, and growth in the emerging markets, particularly in Latin America and the Asia Pacific region. In addition, the launch in Japan 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 dysplasias 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 resulted in supply constraints for ProQuad, 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, became available for ordering in October 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 $283 million for the third quarter of 2012 compared with $290 million for the third quarter of 2011 and were $675 million for the first nine months of 2012 compared with $640 million for the first nine months of 2011. The sales increase in the first nine months of 2012 was driven primarily by 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 $111 million for the third quarter of 2012 compared with $102 million for the third quarter of 2011 and were $292 million for the first nine months of 2012 compared with $251 million for the first nine months of 2011 driven primarily by 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 $150 million in the third quarter of 2012, a decline of 19% compared with the third quarter of 2011, due primarily to lower public sector sales in the United States, as well as lower sales in the emerging markets. Sales for the first nine months of 2012 were $433 million, a decline of 5% compared with the first nine months of 2011, largely reflecting lower public sector sales in the United States, partially offset by volume growth in the emerging markets.

Merck’s sales of Zostavax, a vaccine to help prevent shingles (herpes zoster) in adults 50 years of age and older, were $202 million in the third quarter of 2012 as compared with $108 million in the third quarter of 2011 and were $426 million in the first nine months of 2012 compared with $254 million in the first nine months of 2011. Sales performance in the third quarter and first nine months of 2012 reflects a positive response to supply availability and increased promotional efforts in the United States. The Company experienced supply issues in 2011. No broad international launches or immunization programs are currently planned for 2012.

Merck’s sales of Pneumovax, a vaccine to help prevent pneumococcal disease, grew 20% to $160 million in the third quarter of 2012 and increased 35% to $372 million in the first nine months of 2012 compared with the same periods of 2011. Sales growth in both periods was driven primarily by positive performance in the United

 

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States due to higher volumes and favorable pricing. In addition, higher sales in Japan contributed to sales growth for the first nine months of 2012.

Merck’s adult formulation of Vaqta [Hepatitis A Vaccine, Inactivated], a vaccine against hepatitis A which was experiencing supply issues, became available in the third quarter of 2012.

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 $815 million for the third quarter of 2012, a decline of 1% compared with the third quarter of 2011. Foreign exchange unfavorably affected global sales performance by 8% in the third quarter of 2012. Sales of Animal Health products for the first nine months of 2012 were $2.5 billion, an increase of 5% compared with the same period in 2011, which reflects a 5% unfavorable effect from foreign exchange. Excluding the impact of foreign exchange, sales performance in both periods reflects growth in cattle, poultry and companion animal products. In addition, higher sales of swine products also contributed to sales growth for the first nine months of 2012.

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 $451 million for the third quarter of 2012, an increase of 7% compared with the third quarter of 2011, and were $1.6 billion for the first nine months of 2012, an increase of 5% compared with the first nine months of 2011. Sales growth in both periods reflects higher sales of Dr. Scholl’s and Coppertone. Higher sales of MiraLAX and Claritin also contributed to revenue growth in the first nine months of 2012. Revenue growth in the year-to-date period was 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 also 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 $150 million and $255 million in the third quarter of 2012 and 2011, respectively, and $718 million and $1.2 billion in the first nine 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 2016. The Company now expects the estimated total cumulative pretax costs for this program to be approximately $7.2 billion to $7.5 billion. The increase from original estimates primarily reflects accelerated depreciation related to additional facility closures identified during the Company’s ongoing assessment of worldwide capacity requirements for its manufacturing, research and administrative facilities subsequent to the Merger, including the recently announced move of the Company’s worldwide headquarters to Summit, New Jersey. 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

 

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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 $13 million and $20 million were recorded in the third quarter of 2012 and 2011, respectively, and $23 million and $25 million were recorded in the first nine 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 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 third quarter of 2012, a decline of 5% compared with the third quarter of 2011, and were $12.3 billion for the first nine months of 2012, a decline of 3% compared with the first nine months of 2011. Costs in the third quarter of 2012 and 2011 include $1.2 billion and $1.3 billion, respectively, and for each of the first nine months of 2012 and 2011 include $3.7 billion, of expenses for the amortization of intangible assets recognized in connection with mergers and acquisitions. Costs in the first nine months of 2011 also include an intangible asset impairment charge of $118 million. The Company may recognize additional non-cash impairment charges in the future related to product intangibles that were measured at fair value and capitalized in connection with mergers and acquisitions and such charges could be material. Also included in materials and production costs were costs associated with restructuring activities which amounted to $60 million and $99 million in the third quarter of 2012 and 2011, respectively, and $148 million and $280 million in the first nine 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 64.0% in the third quarter of 2012 compared with 63.8% in the third quarter of 2011 and was 65.4% in the first nine months of 2012 compared with 64.5% in the first nine months of 2011. The amortization of intangible assets, impairment charges and restructuring charges noted above had an unfavorable effect on gross margin of 11.2 and 11.5 percentage points for the third quarter of 2012 and 2011, respectively, and 10.8 and 11.8 percentage points for the first nine months of 2012 and 2011, respectively. Excluding these impacts, the gross margins in 2012 as compared with the same periods of 2011 declined reflecting the significant decline in Singulair sales as a result of the loss of U.S. market exclusivity, partially offset by improvements resulting from other changes in product mix and lower costs due to manufacturing efficiencies. The Company anticipates that gross margin will continue to be negatively affected by the Singulair U.S. patent expiry and by the Singulair patent expiry in major European markets in 2013.

Marketing and Administrative

Marketing and administrative expenses were $3.1 billion in the third quarter of 2012, a decline of 8% compared with the third quarter of 2011, and were $9.4 billion in the first nine months of 2012, a decrease of 6% compared with the first nine months of 2011. The declines were due to the favorable impact of foreign exchange, a decline in promotion costs and lower selling costs resulting from restructuring activities. Expenses for the third quarter of 2012 and 2011 include restructuring costs of $25 million and $31 million, respectively, and for the first nine months of 2012 and 2011 include $70 million and $77 million, respectively, related primarily 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 $68 million and $57 million of acquisition-related costs in the third quarter of 2012 and 2011, respectively, and $183 million and $192 million for the first nine months of 2012 and 2011, respectively, consisting largely of integration costs.

 

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Research and Development

Research and development expenses were $1.9 billion for the third quarter of 2012, a decline of 2% compared with the third quarter of 2011, and were $5.9 billion for the first nine months of 2012, a decrease of 2% compared with the first nine 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 in each of the third quarter of 2012 and the third quarter of 2011, and were $3.3 billion and $3.4 billion in the first nine 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 $798 million and $800 million in the aggregate for the third quarter of 2012 and 2011, respectively, and $2.4 billion and $2.3 billion for the first nine months of 2012 and 2011, respectively. Research and development expenses in 2012 and 2011 were favorably affected by cost savings resulting from restructuring activities.

Research and development expenses also include in-process research and development (“IPR&D”) impairment charges and research and development related restructuring charges. During the third quarter of 2012 and 2011, the Company recorded $40 million and $22 million, respectively, and for the first nine months of 2012 and 2011, recognized $176 million and $343 million, respectively, of IPR&D impairment charges primarily for programs that had previously been deprioritized and were subsequently deemed to have no alternative use during the period. Certain of the charges in 2011 were also attributable to compounds that were out-licensed to a third party for consideration that was less than the related asset’s carrying value. 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 $(32) million and $28 million in the third quarter of 2012 and 2011, respectively, and $54 million and $89 million in the first nine months of 2012 and 2011, respectively. In the third quarter of 2012, the Company recorded an adjustment to accelerated depreciation costs included in research and development expenses revising previously recorded amounts for certain facilities. Included in research and development expenses in the first nine 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 $110 million and $473 million for the third quarter and first nine months of 2012, nearly all of which related to the Merger Restructuring Program. Restructuring costs were $119 million and $773 million for the third quarter and first nine 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 535 positions in the third quarter of 2012, of which 525 related to the Merger Restructuring Program and 10 related to the 2008 Restructuring Program. During the first nine months of 2012, Merck eliminated approximately 2,475 positions of which 2,325 related to the Merger Restructuring Program and 150 related to the 2008 Restructuring Program. For the third quarter of 2011, Merck eliminated 1,510 positions of which 1,300 related to the Merger Restructuring Program, 110 related to the 2008 Restructuring Program and 100 related to a legacy Schering-Plough program. During the first nine months of 2011, Merck eliminated approximately 3,025 positions of which 2,635 related to the Merger Restructuring Program, 290 related to the 2008 Restructuring Program and 100 related to the legacy Schering-Plough 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 $158 million in the third quarter of 2012 compared with $161 million in the third quarter of 2011 and $410 million for the first nine months of 2012 compared with $354 million in the first nine months of 2011. The increase in the first nine months of 2012 largely reflects higher equity income from AZLP. (See “Selected Joint Venture and Affiliate Information” below.)

 

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Other (Income) Expense, Net

Other (income) expense, net was $200 million of expense in the third quarter of 2012 compared with $66 million of expense in the third quarter of 2011. The third quarter of 2011 includes a $136 million gain on the divestiture of the Company’s interest in the Johnson & Johnson°Merck Consumer Pharmaceuticals Company (“JJMCP”) joint venture (see Note 8 to the interim consolidated financial statements). Other (income) expense, net was $446 million of expense in the first nine months of 2012 compared with $809 million of expense in the first nine months of 2011. Included in other (income) expense, net during the first nine 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 the $136 million gain on the divestiture of the Company’s interest in the JJMCP joint venture noted above, and a $127 million gain on the sale of certain manufacturing facilities and related assets.

Segment Profits

     Three Months Ended
September 30,
     Nine Months Ended
September 30,
 
($ in millions)    2012      2011      2012      2011  

 

 

Pharmaceutical segment profits

     $         6,265        $         6,355          $         19,767        $         19,014    

Other non-reportable segment profits

     819          783          2,397          2,300    

Other

     (4,866)         (4,786)         (14,759)         (15,561)   

 

 

Income before income taxes

     $ 2,218        $ 2,352          $ 7,405        $ 5,753    

 

 

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, a gain on the divestiture of the Company’s interest in the JJMCP joint venture, 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 declined 1% in the third quarter of 2012, driven primarily by the effects of the loss of U.S. market exclusivity for Singulair. Pharmaceutical segment profits increased 4% in first nine months of 2012 driven largely by lower operating expenses, partially offset by the effects of the loss of U.S. market exclusivity for Singulair.

Taxes on Income

The effective tax rates of 20.5% and 27.8% for the third quarter and first nine months of 2012 and 26.7% and 15.7% for the third quarter and first nine 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 third quarter and first nine months of 2012 also reflect the favorable impacts of a tax settlement with the Canada Revenue Agency (the “CRA”) and the realization of foreign tax credits. The effective tax rate for the first nine months of 2011 also reflects the net favorable impact of approximately $700 million relating to the settlement of Merck’s 2002-2005 federal income tax audit, 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, as well as the unfavorable 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 $1.7 billion for the third quarter of 2012 compared with $1.7 billion for the third quarter of 2011 and $5.3 billion for the first nine months of 2012 compared with $4.8 billion for the first nine months of 2011. Earnings per common share assuming dilution attributable to Merck & Co., Inc. common shareholders (“EPS”) for the third quarter of 2012 were $0.56 compared with $0.55 in the third quarter of 2011 and were $1.71 for the first nine months of 2012 compared with $1.53 for the first nine months of

 

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2011. Net income and EPS were up slightly in the third quarter of 2012 as compared with the third quarter of 2011 due primarily to lower marketing and administrative expenses, lower restructuring costs and the favorable impact of tax items, largely offset by the effects of the loss of U.S. market exclusivity for Singulair in 2012, as well as the gain recognized in 2011 on the divestiture of the Company’s interest in the JJMCP joint venture. The increases in net income and EPS in the first nine months of 2012 as compared with the same period in 2011 were primarily due to lower marketing and administrative expenses, lower restructuring costs, lower intangible asset impairment charges and the arbitration settlement charge recorded in 2011, partially offset by the eff