10-Q 1 y25965e10vq.htm FORM 10-Q FORM 10-Q
Table of Contents

 
UNITED STATES SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
 
Form 10-Q
 
 
     
þ
  QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
    For the quarterly period ended September 30, 2006
OR
o
  TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
    For the quarterly period from           to          
 
Commission file number 1-6571
 
SCHERING-PLOUGH CORPORATION
(Exact name of registrant as specified in its charter)
 
     
New Jersey
  22-1918501
State or other jurisdiction of
incorporation or organization
  (I.R.S. Employer
identification No.)
     
2000 Galloping Hill Road,
Kenilworth, NJ
  07033
Zip Code
(Address of principal executive offices)    
 
Registrant’s telephone number, including area code:
(908) 298-4000
 
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 o
 
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, or a non-accelerated filer. See definition of “accelerated filer and large accelerated filer” in Rule 12b-2 of the Exchange Act.
Large Accelerated Filer þ     Accelerated Filer o     Non-accelerated Filer o
 
Indicate whether the registrant is a shell company (as defined in Rule 12b-2 of the Act).  Yes o     No þ
 
Common Shares Outstanding as of September 30, 2006: 1,482,571,166
 


TABLE OF CONTENTS

PART I. FINANCIAL INFORMATION
Item 1. Financial Statements
SCHERING-PLOUGH CORPORATION AND SUBSIDIARIES STATEMENTS OF CONDENSED CONSOLIDATED OPERATIONS
SCHERING-PLOUGH CORPORATION AND SUBSIDIARIES STATEMENTS OF CONDENSED CONSOLIDATED CASH FLOWS
SCHERING-PLOUGH CORPORATION AND SUBSIDIARIES CONDENSED CONSOLIDATED BALANCE SHEETS
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
Item 3. Quantitative and Qualitative Disclosures about Market Risk
Item 4. Controls and Procedures
PART II. OTHER INFORMATION
Item 1. Legal Proceedings
Item 1A. Risk Factors
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
Item 6. Exhibits
SIGNATURE(S)
EX-10.D.III: SCHERING PLOUGH CORPORATION 2006 STOCK INCENTIVE PLAN
EX-1O.E.XIII: SAVINGS ADVANTAGE PLAN
EX-10.H.III: DIRECTORS COMPENSATION PLAN
EX-10.M.II:OPERATIONS MANAGEMENT TEAM INCENTIVE PLAN
EX-12: COMPUTATION OF RATIO OF EARNINGS TO FIXED CHARGES
EX-15: AWARENESS LETTER
EX-31.1: CERTIFICATION
EX-31.2: CERTIFICATION
EX-32.1: CERTIFICATION
EX-32.2: CERTIFICATION


Table of Contents

 
PART I. FINANCIAL INFORMATION
 
Item 1.   Financial Statements
 
SCHERING-PLOUGH CORPORATION AND SUBSIDIARIES

STATEMENTS OF CONDENSED CONSOLIDATED OPERATIONS
(Unaudited)
(Amounts in millions, except per share figures)
 
                                 
    Three Months
    Nine Months
 
    Ended
    Ended
 
    September 30,     September 30,  
    2006     2005     2006     2005  
 
Net sales
  $ 2,574     $ 2,284     $ 7,944     $ 7,184  
                                 
Cost of sales
    885       775       2,782       2,531  
Selling, general and administrative
    1,158       1,064       3,467       3,261  
Research and development
    536       566       1,557       1,391  
Other (income)/expense, net
    (37 )           (89 )     9  
Special charges
    10       6       90       292  
Equity income from cholesterol joint venture
    (390 )     (215 )     (1,056 )     (605 )
                                 
Income before income taxes
    412       88       1,193       305  
Income tax expense
    103       23       275       162  
                                 
Net income before cumulative effect of a change in accounting principle
    309       65       918       143  
Cumulative effect of a change in accounting principle, net of tax
                22        
                                 
Net income
    309       65       940       143  
                                 
Preferred stock dividends
    22       22       65       65  
                                 
Net income available to common shareholders
  $ 287     $ 43     $ 875     $ 78  
                                 
Diluted earnings per common share:
                               
Earnings available to common shareholders before cumulative effect of a change in accounting principle
  $ 0.19     $ 0.03     $ 0.57     $ 0.05  
Cumulative effect of a change in accounting principle, net of tax
                0.02        
                                 
Diluted earnings per common share
  $ 0.19     $ 0.03     $ 0.59     $ 0.05  
                                 
Basic earnings per common share:
                               
Earnings available to common shareholders before cumulative effect of a change in accounting principle
  $ 0.19     $ 0.03     $ 0.57     $ 0.05  
Cumulative effect of a change in accounting principle, net of tax
                0.02        
                                 
Basic earnings per common share
  $ 0.19     $ 0.03     $ 0.59     $ 0.05  
                                 
Dividends per common share
  $ 0.055     $ 0.055     $ 0.165     $ 0.165  
                                 
 
The accompanying notes are an integral part of these Condensed Consolidated Financial Statements.


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SCHERING-PLOUGH CORPORATION AND SUBSIDIARIES

STATEMENTS OF CONDENSED CONSOLIDATED CASH FLOWS
(Unaudited)
(Amounts in millions)
 
                 
    Nine Months Ended
 
    September 30,  
    2006     2005  
 
Operating Activities:
               
Net income
  $ 940     $ 143  
Cumulative effect of a change in accounting principle, net of tax
    22        
                 
Net income before cumulative effect of a change in accounting principle, net of tax
    918       143  
Adjustments to reconcile net income to net cash provided by operating activities:
               
Payments to U.S. taxing authorities
          (239 )
Non-cash special charges
    66       269  
Depreciation and amortization
    408       362  
Accrued share-based compensation
    120        
Changes in assets and liabilities:
               
Accounts receivable
    (188 )     (344 )
Inventories
    (58 )     (61 )
Prepaid expenses and other assets
    (101 )     233  
Accounts payable and other liabilities
    350       183  
                 
Net cash provided by operating activities
    1,515       546  
                 
Investing Activities:
               
Capital expenditures
    (265 )     (293 )
Dispositions of property and equipment
    8       41  
Purchases of short-term investments
    (4,729 )     (1,795 )
Reduction of short-term investments
    2,573       2,233  
Other, net
    (1 )     (48 )
                 
Net cash (used for)/provided by investing activities
    (2,414 )     138  
                 
Financing Activities:
               
Cash dividends paid to common shareholders
    (243 )     (243 )
Cash dividends paid to preferred shareholders
    (65 )     (65 )
Net change in short-term borrowings
    (1,040 )     (1,208 )
Other, net
    52       51  
                 
Net cash used for financing activities
    (1,296 )     (1,465 )
                 
Effect of exchange rates on cash and cash equivalents
    2       (9 )
                 
Net decrease in cash and cash equivalents
    (2,193 )     (790 )
Cash and cash equivalents, beginning of period
    4,767       4,984  
                 
Cash and cash equivalents, end of period
  $ 2,574     $ 4,194  
                 
 
The accompanying notes are an integral part of these Condensed Consolidated Financial Statements.


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SCHERING-PLOUGH CORPORATION AND SUBSIDIARIES

CONDENSED CONSOLIDATED BALANCE SHEETS
(Unaudited)
(Amounts in millions, except per share figures)
 
                 
    September 30,
    December 31,
 
    2006     2005  
 
ASSETS
Current Assets:
               
Cash and cash equivalents
  $ 2,574     $ 4,767  
Short-term investments
    2,974       818  
Accounts receivable, net
    1,720       1,479  
Inventories
    1,687       1,605  
Deferred income taxes
    379       294  
Prepaid expenses and other current assets
    888       769  
                 
Total current assets
    10,222       9,732  
Property, plant and equipment
    7,233       7,197  
Less accumulated depreciation
    2,880       2,710  
                 
Property, plant and equipment, net
    4,353       4,487  
Goodwill
    204       204  
Other intangible assets, net
    331       365  
Other assets
    577       681  
                 
Total assets
  $ 15,687     $ 15,469  
                 
 
LIABILITIES AND SHAREHOLDERS’ EQUITY
Current Liabilities:
               
Accounts payable
  $ 1,119     $ 1,078  
Short-term borrowings and current portion of long-term debt
    235       1,278  
U.S., foreign and state income tax
    351       213  
Accrued compensation
    664       632  
Other accrued liabilities
    1,532       1,458  
                 
Total current liabilities
    3,901       4,659  
Long-term Liabilities:
               
Long-term debt
    2,413       2,399  
Deferred income tax
    109       117  
Other long-term liabilities
    1,012       907  
                 
Total long-term liabilities
    3,534       3,423  
Commitments and contingent liabilities (Note 15)
               
Shareholders’ Equity:
               
Mandatory convertible preferred shares — $1 par value; issued: 29; $50 per share face value
    1,438       1,438  
Common shares — authorized shares: 2,400, $.50 par value; issued: 2,030
    1,015       1,015  
Paid-in capital
    1,586       1,416  
Retained earnings
    10,103       9,472  
Accumulated other comprehensive income
    (458 )     (516 )
                 
Total
    13,684       12,825  
Less treasury shares: 2006, 547; 2005, 550; at cost
    5,432       5,438  
                 
Total shareholders’ equity
    8,252       7,387  
                 
Total liabilities and shareholders’ equity
  $ 15,687     $ 15,469  
                 
 
The accompanying notes are an integral part of these Condensed Consolidated Financial Statements.


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SCHERING-PLOUGH CORPORATION AND SUBSIDIARIES
 
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
 
1.   Basis of Presentation
 
These unaudited condensed consolidated financial statements of Schering-Plough Corporation and subsidiaries (the Company), included herein have been prepared pursuant to the rules and regulations of the Securities and Exchange Commission (SEC) for reporting on Form 10-Q. Certain information and disclosures normally included in financial statements prepared in accordance with U.S. Generally Accepted Accounting Principles have been condensed or omitted pursuant to such SEC rules and regulations. Certain prior year amounts have been reclassified to conform to the current year presentation. These statements should be read in conjunction with the accounting policies and notes to consolidated financial statements included in the Company’s 2005 10-K.
 
In the opinion of the Company’s management, the financial statements reflect all adjustments necessary for a fair statement of the operations, cash flows and financial position for the interim periods presented.
 
Impact of Recently Issued Accounting Standards
 
In September 2006, the Financial Accounting Standards Board (FASB) issued Statements of Financial Accounting Standard (SFAS) No. 158, “Employers’ Accounting for Defined Benefit Pension and Other Postretirement Plans,” an amendment of FASB Statements No. 87, 88, 106, and 132R. SFAS No. 158 requires an employer to: (a) recognize in its statement of financial position an asset for a plan’s overfunded status and/or a liability for a plan’s underfunded status; (b) measure a plan’s assets and its obligations that determine its funded status as of the end of the employer’s fiscal year (with limited exceptions); and (c) recognize changes in the funded status of a defined benefit postretirement plan in the year in which the changes occur. In accordance with SFAS No. 158, the Company will recognize the funded status of its pension and postretirement benefit plans in its financial statements for the year ending December 31, 2006.
 
In September 2006, the FASB issued SFAS No. 157, “Fair Value Measurements,” which is effective for calendar year companies on January 1, 2008. The Statement defines fair value, establishes a framework for measuring fair value in accordance with Generally Accepted Accounting Principles, and expands disclosures about fair value measurements. The Statement codifies the definition of fair value as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. The standard clarifies the principle that fair value should be based on the assumptions market participants would use when pricing the asset or liability and establishes a fair value hierarchy that prioritizes the information used to develop those assumptions. The Company is currently assessing the potential impacts of implementing this standard.
 
In September 2006, the SEC staff issued Staff Accounting Bulletin (SAB) Topic 1N (SAB 108), “Financial Statements — Considering the Effects of Prior Year Misstatements when Quantifying Misstatements in Current Year Financial Statements,” which is effective for calendar year companies as of December 31, 2006. SAB 108 provides guidance on how prior year misstatements should be taken into consideration when quantifying misstatements in current year financial statements for purposes of determining whether the financial statements are materially misstated. Under this guidance, companies should take into account both the effect of a misstatement on the current year balance sheet as well as the impact upon the current year income statement in assessing the materiality of a current year misstatement. Once a current year misstatement has been quantified, the guidance in SAB Topic 1M, “Financial Statements — Materiality,” (SAB 99) should be applied to determine whether the misstatement is material. The implementation of SAB 108 is not expected to have a material impact on the Company’s financial statements.
 
In July 2006, the FASB issued FASB Interpretation No. 48 (FIN 48), “Accounting for Uncertainty in Income Taxes.” FIN 48 prescribes detailed guidance for the financial statement recognition, measurement and disclosure of uncertain tax positions recognized in an enterprise’s financial statements in accordance with


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SCHERING-PLOUGH CORPORATION AND SUBSIDIARIES
 
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
(Unaudited)

FASB Statement No. 109, “Accounting for Income Taxes.” Tax positions must meet a more-likely-than-not recognition threshold at the effective date to be recognized upon the adoption of FIN 48 and in subsequent periods. FIN 48 will be effective for fiscal years beginning after December 15, 2006 and the provisions of FIN 48 will be applied to all tax positions upon initial adoption of the Interpretation. The cumulative effect of applying the provisions of this Interpretation will be reported as an adjustment to the opening balance of retained earnings upon adoption. The Company is currently evaluating the potential impacts of FIN 48 on its financial statements.
 
2.   Special Charges and Manufacturing Streamlining
 
On June 1, 2006, the Company announced changes to its manufacturing operations in Puerto Rico and New Jersey that will streamline its global supply chain and further enhance the Company’s long-term competitiveness. The Company’s manufacturing operations in Manati, Puerto Rico, are being phased out during 2006 and additional workforce reductions in Las Piedras, Puerto Rico and New Jersey have taken place. In total, the actions taken will result in the elimination of approximately 1,100 positions. Approximately 560 positions have been eliminated as of September 30, 2006.
 
Special Charges
 
Special charges for the three and nine months ended September 30, 2006 totaled $10 million and $90 million, respectively, related to the announced changes in the Company’s manufacturing operations. These charges consisted of $10 million and $35 million of severance for the three and nine months ended September 30, 2006, respectively, and $55 million of fixed asset impairments for the nine months ended September 30, 2006.
 
Special charges for the three months ended September 30, 2005 totaled $6 million primarily related to the consolidation of the Company’s U.S. biotechnology organizations. Special charges for the nine months ended September 30, 2005 totaled $292 million primarily related to an increase of $250 million in litigation reserves for the Massachusetts Investigation. Additional information regarding litigation reserves and matters is also included in Note 15, “Legal, Environmental and Regulatory Matters,” in this 10-Q.
 
Cost of Sales
 
Included in cost of sales for the three months ended September 30, 2006 was $43 million consisting of $41 million of accelerated depreciation and $2 million of other charges related to the announced closure of the Company’s manufacturing facilities in Manati, Puerto Rico. For the nine months ended September 30, 2006, charges related to the Manati closure included in cost of sales totaled $101 million consisting of $45 million of inventory write-offs, $54 million of accelerated depreciation, and $2 million of other charges.


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SCHERING-PLOUGH CORPORATION AND SUBSIDIARIES
 
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
(Unaudited)

The following table summarizes the activities reflected in the Condensed Consolidated Financial Statements for special charges and manufacturing streamlining for the three months ended September 30, 2006:
 
                                                 
    Charges
                               
    Included in
    Special
    Total
    Cash
    Non-Cash
    Accrued
 
    Cost of Sales     Charges     Charges     Payments     Charges     Liability  
    (Dollars in millions)  
 
Accrued liability at June 30, 2006
                                          $ 19  
Severance
  $     $ 10     $ 10     $ (12 )   $       (2 )
Asset impairments
                                   
Accelerated depreciation
    41             41             (41 )      
Inventory write-offs
                                   
Other
    2             2       (2 )            
                                                 
Total
  $ 43     $ 10     $ 53     $ (14 )   $ (41 )        
                                                 
Accrued liability at September 30, 2006
                                          $ 17  
                                                 
 
The following table summarizes the activities reflected in the Condensed Consolidated Financial Statements for special charges and manufacturing streamlining for the nine months ended September 30, 2006:
 
                                                 
    Charges
                               
    Included in
    Special
    Total
    Cash
    Non-Cash
    Accrued
 
    Cost of Sales     Charges     Charges     Payments     Charges     Liability  
    (Dollars in millions)  
 
Accrued liability at January 1, 2006
                                          $  
Severance
  $     $ 35     $ 35     $ (18 )   $       17  
Asset impairments
          55       55             (55 )      
Accelerated depreciation
    54             54             (54 )      
Inventory write-offs
    45             45             (45 )      
Other
    2             2       (2 )            
                                                 
Total
  $ 101     $ 90     $ 191     $ (20 )   $ (154 )        
                                                 
Accrued liability at September 30, 2006
                                          $ 17  
                                                 
 
The Company anticipates incurring from $50 million to $60 million of additional charges related to the announced changes in the Company’s manufacturing operations. Substantially all of these additional charges will be incurred during 2006.
 
3.   Equity Income from Cholesterol Joint Venture
 
In May 2000, the Company and Merck & Co., Inc. (Merck) entered into two separate sets of agreements to jointly develop and market certain products in the U.S. including (1) two cholesterol-lowering drugs and (2) an allergy/asthma drug. In December 2001, the cholesterol agreements were expanded to include all countries of the world except Japan. In general, the companies agreed that the collaborative activities under these agreements would operate in a virtual joint venture to the maximum degree possible by relying on the respective infrastructures of the two companies. These agreements generally provide for equal sharing of development costs and for co-promotion of approved products by each company.
 
The cholesterol agreements provide for the Company and Merck to jointly develop ezetimibe (marketed as ZETIA in the U.S. and Asia and EZETROL in Europe):
 
i. as a once-daily monotherapy;
 
ii. in co-administration with any statin drug; and


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SCHERING-PLOUGH CORPORATION AND SUBSIDIARIES
 
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
(Unaudited)

iii. as a once-daily fixed-combination tablet of ezetimibe and simvastatin (Zocor), Merck’s cholesterol-modifying medicine. This combination medication (ezetimibe/simvastatin) is marketed as VYTORIN in the U.S. and as INEGY in many international countries.
 
ZETIA/EZETROL (ezetimibe) and VYTORIN/INEGY (the combination of ezetimibe/simvastatin) are approved for use in the U.S. and have been launched in many international markets.
 
The Company utilizes the equity method of accounting in recording its share of activity from the Merck/Schering-Plough cholesterol joint venture. As such, the Company’s net sales do not include the sales of the joint venture. The cholesterol joint venture agreements provide for the sharing of operating income generated by the joint venture based upon percentages that vary by product, sales level and country. In the U.S. market, the Company receives a greater share of profits on the first $300 million of annual ZETIA sales. Above $300 million of annual ZETIA sales, Merck and Schering-Plough (the Partners) generally share profits equally. Schering-Plough’s allocation of the joint venture income is increased by milestones recognized. Further, either Partner’s share of the joint venture’s income from operations is subject to a reduction if the Partner fails to perform a specified minimum number of physician details in a particular country. The Partners agree annually to the minimum number of physician details by country.
 
The Partners bear the costs of their own general sales forces and commercial overhead in marketing joint venture products around the world. In the U.S., Canada, and Puerto Rico, the cholesterol agreements provide for a reimbursement to each Partner for physician details that are set on an annual basis. This reimbursed amount is equal to each Partner’s physician details multiplied by a contractual fixed fee. Schering-Plough reports this reimbursement as part of equity income from the cholesterol joint venture. This amount does not represent a reimbursement of specific, incremental and identifiable costs for the Company’s detailing of the cholesterol products in these markets. In addition, this reimbursement amount is not reflective of the Company’s sales effort related to the joint venture as the Company’s sales force and related costs associated with the joint venture are generally estimated to be higher.
 
During the nine months ended September 30, 2005, the Company recognized milestones of $20 million related to certain European approvals of VYTORIN.
 
Under certain other conditions, as specified in the joint venture agreements with Merck, the Company could earn additional milestones totaling $105 million.
 
Costs of the joint venture that the Partners contractually share are a portion of manufacturing costs, specifically identified promotion costs (including direct-to-consumer advertising and direct and identifiable out-of-pocket promotion) and other agreed upon costs for specific services such as market support, market research, market expansion, a specialty sales force and physician education programs.
 
Certain specified research and development expenses are generally shared equally by the Partners.
 
The unaudited financial information below presents summarized combined financial information for the Merck/Schering-Plough Cholesterol Partnership for the three and nine months ended September 30, 2006 and 2005:
 
                                 
    Three Months
    Nine Months
 
    Ended
    Ended
 
    September 30,     September 30,  
    2006     2005     2006     2005  
    (Dollars in millions)  
 
Net sales
  $ 1,028     $ 630     $ 2,795     $ 1,679  
Cost of sales
    47       32       132       99  
Income from operations
    698       340       1,789       814  


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SCHERING-PLOUGH CORPORATION AND SUBSIDIARIES
 
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
(Unaudited)

Amounts related to physician details, among other expenses, that are invoiced by Schering-Plough and Merck in the U.S., Canada and Puerto Rico are deducted from income from operations of the Partnership.
 
Schering-Plough’s share of the Partnership’s income from operations for the three and nine months ended September 30, 2006 was $343 million and $920 million, respectively, and $169 million and $465 million, respectively, for the three and nine months ended September 30, 2005. In the U.S. market, Schering-Plough receives a greater share of income from operations on the first $300 million of annual ZETIA sales.
 
The following unaudited information provides a summary of the components of the Company’s equity income from the cholesterol joint venture for the three and nine months ended September 30, 2006 and 2005:
 
                                 
    Three Months
    Nine Months
 
    Ended
    Ended
 
    September 30,     September 30,  
    2006     2005     2006     2005  
    (Dollars in millions)  
 
Schering-Plough’s share of income from operations
  $ 343     $ 169     $ 920     $ 465  
Contractual reimbursement to Schering-Plough for physician details
    44       52       127       141  
Elimination of intercompany profit and other, net
    3       (6 )     9       (1 )
                                 
Total equity income from cholesterol joint venture
  $ 390     $ 215     $ 1,056     $ 605  
                                 
 
Equity income from the joint venture excludes any profit arising from transactions between the Company and the joint venture until such time as there is an underlying profit realized by the joint venture in a transaction with a party other than the Company or Merck.
 
Due to the virtual nature of the cholesterol joint venture, the Company incurs substantial costs, such as selling, general and administrative costs, that are not reflected in equity income and are borne by the overall cost structure of the Company. These costs are reported on their respective line items in the Statements of Condensed Consolidated Operations. The cholesterol agreements do not provide for any jointly owned facilities and, as such, products resulting from the joint venture are manufactured in facilities owned by either the Company or Merck.
 
The allergy/asthma agreements provide for the joint development and marketing by the Partners of a once-daily, fixed-combination tablet containing CLARITIN and Singulair. Singulair is Merck’s once-daily leukotriene receptor antagonist for the treatment of asthma and seasonal allergic rhinitis. In January 2002, the Merck/Schering-Plough respiratory joint venture reported on results of Phase III clinical trials of a fixed-combination tablet containing CLARITIN and Singulair and at that time concluded that this Phase III study did not demonstrate sufficient added benefits in the treatment of seasonal allergic rhinitis. Although the CLARITIN and Singulair combination tablet does not have approval in any country, Phase III clinical development is ongoing.
 
4.   Share-Based Compensation
 
Prior to January 1, 2006, the Company accounted for its stock compensation arrangements using the intrinsic value method, which followed the recognition and measurement principles of APB Opinion No. 25, “Accounting for Stock Issued to Employees” and the related Interpretations. Prior to 2006, no stock-based employee compensation cost was reflected in net income, other than for the Company’s deferred stock units, as stock options granted under all other plans had an exercise price equal to the market value of the underlying common stock on the date of grant.


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SCHERING-PLOUGH CORPORATION AND SUBSIDIARIES
 
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
(Unaudited)

The Company adopted Statement of Financial Accounting Standards No. 123 (Revised 2004), “Share-Based Payment” (SFAS 123R), effective January 1, 2006. SFAS 123R requires companies to recognize compensation expense in an amount equal to the fair value of all share-based payments granted to employees. The Company elected the modified prospective transition method and therefore adjustments to prior periods were not required as a result of adopting SFAS 123R. Under this method, the provisions of SFAS 123R apply to all awards granted after the date of adoption and to any unrecognized expense of awards unvested at the date of adoption based on the grant date fair value. SFAS 123R also amends SFAS No. 95, “Statement of Cash Flows,” to require that excess tax benefits that had been reflected as operating cash flows be reflected as financing cash flows.
 
In the second quarter of 2006, the 2006 Stock Incentive Plan (the 2006 Plan) was approved by the Company’s shareholders. Under the terms of the 2006 Plan, 92 million of the Company’s authorized common shares may be granted as stock options or awarded as deferred stock units to officers and certain employees of the Company through December 2011. As of September 30, 2006, 76 million options and deferred stock units remain available for future year grants under the 2006 Plan.
 
The Company intends to utilize unissued authorized shares to satisfy stock option exercises and for the issuance of deferred stock units.
 
For grants issued to retirement eligible employees prior to the adoption of SFAS 123R, the Company recognized compensation costs over the stated vesting period of the stock option or deferred stock unit with acceleration of any unrecognized compensation costs upon the retirement of the employee. Upon adoption of SFAS 123R, the Company recognizes compensation costs on all share-based grants made on or after January 1, 2006 over the service period, which is the earlier of the employees retirement eligibility date or the service period of the award.
 
Implementation of SFAS 123R
 
In the first quarter of 2006, the Company recognized a benefit to income of $22 million for the cumulative effect of a change in accounting principle related to two long-term compensation plans required to be accounted for as liability plans under SFAS 123R.
 
Tax benefits recognized related to stock-based compensation and related cash flow impacts were not material during the three and nine months ended September 30, 2006 as the Company is in a U.S. Net Operating Loss position.
 
Stock Options
 
Stock options are granted to employees at exercise prices equal to the fair market value of the Company’s stock at the dates of grant. Stock options, under the 2006 Plan, generally vest over three years and have a term of seven years. Certain options granted under previous plans vest over longer periods ranging from three to nine years and have a term of 10 years. Compensation costs for all stock options are recognized over the requisite service period for each separately vesting portion of the stock option award. Expense is recognized, net of estimated forfeitures, over the vesting period of the options using an accelerated method. Expense recognized for the three and nine months ended September 30, 2006 was approximately $16 million and $43 million, respectively.


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SCHERING-PLOUGH CORPORATION AND SUBSIDIARIES
 
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
(Unaudited)

The weighted-average assumptions used in the Black-Scholes option-pricing model for the three and nine months ended September 30, 2006 and 2005 were as follows:
 
                                 
    Three Months
    Nine Months
 
    Ended
    Ended
 
    September 30,     September 30,  
    2006     2005     2006     2005  
 
Dividend yield
    1.1 %     1.7 %     1.1 %     1.7 %
Volatility
    24.0 %     31.5 %     25.7 %     32.1 %
Risk-free interest rate
    5.0 %     4.1 %     5.0 %     4.1 %
Expected term of options (in years)
    4.5       7.0       4.5       7.0  
 
Dividend yields are based on historical dividend yields. Expected volatilities are based on historical volatilities of the Company’s common stock. The risk-free interest rate is based on the U.S. Treasury yield curve in effect at the time of grant for periods corresponding with the expected life of the options. The expected term of options represents the weighted average period of time that options granted are expected to be outstanding giving consideration to vesting schedules and the Company’s historical exercise patterns.
 
The amount of cash received from the exercise of stock options for the three and nine months ended September 30, 2006 was $20 million and $52 million, respectively. The amount of cash received for the three and nine months ended September 30, 2005 was $22 million and $50 million, respectively.
 
Stock-based compensation prior to January 1, 2006 was determined using the intrinsic value method. The following table provides supplemental information for the three and nine months ended September 30, 2005 as if stock-based compensation had been computed under SFAS 123:
 
                 
    Three Months
    Nine Months
 
    Ended
    Ended
 
    September 30,
    September 30,
 
    2005     2005  
    (Dollars in millions except
 
    per share figures)  
 
Net income available to common shareholders, as reported
  $ 43     $ 78  
Add back: Expense included in reported net income for deferred stock units
    25       66  
Deduct: Pro forma expense as if both stock options and deferred stock units were charged against net income available to common shareholders in accordance with SFAS 123
    (55 )     (139 )
                 
Pro forma net income available to common shareholders using the fair value method
  $ 13     $ 5  
                 
Diluted earnings per common share:
               
Diluted earnings per common share, as reported
  $ 0.03     $ 0.05  
Pro forma diluted earnings per common share using the fair value method
    0.01       0.00  
Basic earnings per common share:
               
Basic earnings per common share, as reported
  $ 0.03     $ 0.05  
Pro forma basic earnings per common share using the fair value method
    0.01       0.00  


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SCHERING-PLOUGH CORPORATION AND SUBSIDIARIES
 
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
(Unaudited)

Summarized information about stock options outstanding and exercisable at September 30, 2006 is as follows:
 
                                         
    Outstanding     Exercisable  
          Weighted-
    Weighted-
          Weighted-
 
    Number
    Average
    Average
    Number
    Average
 
    of
    Remaining
    Exercise
    of
    Exercise
 
Exercise Price Range
  Options     Term in Years     Price     Options     Price  
    (In thousands)                 (In thousands)        
 
Under $20
    46,647       6.6     $ 18.22       28,132     $ 18.03  
$20 to $30
    9,892       8.5       20.83       3,462       20.99  
$30 to $40
    15,256       3.4       36.57       15,200       36.60  
Over $40
    14,736       3.5       46.36       14,556       46.33  
                                         
      86,531                       61,350          
                                         
 
The weighted-average fair value of stock options granted for the three and nine months ended September 30, 2006 was $5.24 and $5.22, respectively. The weighted-average fair value of stock options granted for the three and nine months ended September 30, 2005 was $6.98 and $7.04, respectively. The intrinsic value of stock options exercised was $3 million and $12 million for the three and nine months ended September 30, 2006, respectively. The intrinsic value of stock options exercised was $9 million and $21 million for the three and nine months ended September 30, 2005, respectively. The total fair value of options vested during the three and nine months ended September 30, 2006 was $2 million and $70 million, respectively. The total fair value of options vested during the three and nine-months ended September 30, 2005 was $17 million and $67 million, respectively.
 
As of September 30, 2006, the total remaining unrecognized compensation cost related to non-vested stock options amounted to $61 million, which will be amortized over the weighted-average remaining requisite service period of 2.1 years.
 
The following table summarizes stock option activities over the nine months ended September 30, 2006 under the current and prior plans:
 
                 
          Weighted-
 
    Number
    Average
 
    of
    Exercise
 
    Options     Price  
    (In thousands)        
 
Outstanding at January 1, 2006
    82,484     $ 27.00  
Granted
    9,638       19.24  
Exercised
    (3,268 )     15.90  
Canceled or expired
    (2,323 )     27.24  
                 
Outstanding, ending balance
    86,531       26.55  
                 
Exercisable at September 30, 2006
    61,350     $ 29.51  
                 
 
The aggregate intrinsic value of stock options outstanding at September 30, 2006 was $194 million. The aggregate intrinsic value of stock options currently exercisable at September 30, 2006 was $119 million. Intrinsic value for stock options is calculated based on the exercise price of the underlying awards and the quoted price of the Company’s common stock as of the reporting date.


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SCHERING-PLOUGH CORPORATION AND SUBSIDIARIES
 
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
(Unaudited)

The following table summarizes nonvested stock option activity over the nine months ended September 30, 2006 under the current and prior plans:
 
                 
          Weighted-
 
    Number
    Average
 
    of
    Fair
 
    Options     Value  
    (In thousands)        
 
Nonvested at January 1, 2006
    28,022     $ 6.41  
Granted
    9,638       5.22  
Vested
    (11,150 )     6.30  
Forfeited
    (1,329 )     5.93  
                 
Nonvested at September 30, 2006
    25,181     $ 6.03  
                 
 
Deferred Stock Units
 
The fair value of deferred stock units is determined based on the number of shares granted and the quoted price of the Company’s common stock at the date of grant. Deferred stock units generally vest at the end of three years provided the employee remains in the service of the Company. Expense is recognized on a straight-line basis over the vesting period. Deferred stock units are payable in an equivalent number of common shares. Expense recognized for the three and nine months ended September 30, 2006 was $28 million and $84 million, respectively. Expense recognized for the three and nine months ended September 30, 2005 was $25 million and $66 million, respectively.
 
Summarized information about deferred stock units outstanding at September 30, 2006 is as follows:
 
                         
    Outstanding  
          Weighted-
       
    Number of
    Average
    Weighted-
 
    Deferred Stock
    Remaining
    Average
 
Deferred Stock Unit Price Range
  Units     Term in Years     Fair Value  
    (In thousands)              
 
Under $18
    1,310       1.0     $ 17.32  
$18 to $20
    9,050       2.0       18.95  
$20 to $22
    6,435       1.6       20.71  
Over $22
    347       0.4       34.48  
                         
      17,142                  
                         
 
The weighted-average fair value of deferred stock units granted was $20.38 and $19.24 for the three and nine months ended September 30, 2006, respectively. The weighted-average fair value of deferred stock units granted for the three and nine months ended September 30, 2005 was $20.76 and $20.67, respectively. The total fair value of deferred stock units vested during the three and nine months ended September 30, 2006 was $3 million and $4 million, respectively. The total fair value of deferred stock units vested during the three and nine months ended September 30, 2005 was $1 million and $7 million, respectively.
 
As of September 30, 2006, the total remaining unrecognized compensation cost related to deferred stock units amounted to $206 million, which will be amortized over the weighted-average remaining requisite service period of 2.1 years.


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SCHERING-PLOUGH CORPORATION AND SUBSIDIARIES
 
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
(Unaudited)

The following table summarizes deferred stock unit activity over the nine months ended September 30, 2006 under the current and prior plans:
 
                 
    Number
       
    of Nonvested
    Weighted-
 
    Deferred
    Average
 
    Stock Units     Fair Value  
    (In thousands)        
 
Nonvested at January 1, 2006
    11,416     $ 20.12  
Granted
    6,606       19.24  
Vested
    (219 )     18.84  
Forfeited
    (661 )     20.09  
                 
Nonvested at September 30, 2006
    17,142     $ 19.80  
                 
 
Incentive Plans
 
The Company has two compensation plans that are classified as liability plans under SFAS 123R as the ultimate cash payout of these plans will be based on the Company’s stock performance as compared to the stock performance of a peer group. Upon adoption of SFAS 123R on January 1, 2006, the Company recognized a cumulative income effect of a change in accounting principle of $22 million in order to recognize the liability plans at fair value. Income or expense amounts related to these liability plans are based on the change in fair value at each reporting date. Fair value for the plans were estimated using a lattice valuation model using expected volatility assumptions and other assumptions appropriate for determining fair value. The amount recognized, other than the impact of the cumulative effect of a change in accounting principle, in the Statements of Condensed Consolidated Operations for the three and nine months ended September 30, 2006 related to these liability awards was not material.
 
As of September 30, 2006, the total remaining unrecognized compensation cost related to the incentive plans amounted to $32 million, which will be amortized over the weighted-average remaining requisite service period of 2.0 years. This amount will vary each reporting period based on changes in fair value.
 
5. Other (Income)/Expense, Net
 
The components of other (income)/expense, net are as follows:
 
                                 
    Three Months
    Nine Months
 
    Ended
    Ended
 
    September 30,     September 30,  
    2006     2005     2006     2005  
    (Dollars in millions)  
 
Interest cost incurred
  $ 44     $ 41     $ 142     $ 133  
Less: amount capitalized on construction
    4       5       11       11  
                                 
Interest expense
    40       36       131       122  
Interest income
    (77 )     (45 )     (214 )     (118 )
Foreign exchange losses
          2       6       6  
Other, net
          7       (12 )     (1 )
                                 
Total other (income)/expense, net
  $ (37 )   $     $ (89 )   $ 9  
                                 
 
During the third quarter of 2006, the Company participated in a healthcare refinancing program adopted by a local government fiscal authority in a major European market. As of September 30, 2006, the Company


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SCHERING-PLOUGH CORPORATION AND SUBSIDIARIES
 
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
(Unaudited)

has transferred $28 million of its trade accounts receivables owned by a foreign subsidiary to a third-party financial institution without recourse. The transfer of trade accounts receivable qualified as sales of accounts receivable under SFAS No. 140, “Accounting for Transfers and Servicing of Financial Assets and Extinguishments of Liabilities.” For the three and nine months ended September 30, 2006, the loss on the transfer of these trade accounts receivable is immaterial and included in interest expense. Cash flows from the transaction are included in the change in accounts receivable in operating activities.
 
6.   Income Taxes
 
At December 31, 2005, the Company had approximately $1.5 billion of U.S. Net Operating Losses (U.S. NOLs) for tax purposes available to offset future U.S. taxable income through 2024. The Company generated an additional U.S. NOL during the nine months ended September 30, 2006.
 
The Company’s tax provisions for the three and nine months ended September 30, 2006 and 2005 primarily relate to foreign taxes and do not include any benefit related to U.S. NOLs. The Company maintains a valuation allowance on its net U.S. deferred tax assets, including the benefit of U.S. NOLs, as management cannot conclude that it is more likely than not the benefit of U.S. net deferred tax assets can be realized.
 
7.   Retirement Plans and Other Post-Retirement Benefits
 
The Company has defined benefit pension plans covering eligible employees in the U.S. and certain foreign countries. The Company also provides post-retirement health care benefits to its eligible U.S. retirees and their dependents.
 
The components of net pension expense were as follows:
 
                                 
    Three Months
    Nine Months
 
    Ended
    Ended
 
    September 30,     September 30,  
    2006     2005     2006     2005  
    (Dollars in millions)  
 
Service cost
  $ 30     $ 26     $ 89     $ 80  
Interest cost
    28       28       85       93  
Expected return on plan assets
    (28 )     (29 )     (85 )     (97 )
Amortization, net
    12       8       33       29  
Termination benefits
          2             5  
Settlement
    2             4        
                                 
Net pension expense
  $ 44     $ 35     $ 126     $ 110  
                                 
 
The components of other post-retirement benefits expense were as follows:
 
                                 
    Three Months
    Nine Months
 
    Ended
    Ended
 
    September 30,     September 30,  
    2006     2005     2006     2005  
    (Dollars in millions)  
 
Service cost
  $ 5     $ 4     $ 13     $ 11  
Interest cost
    7       7       20       18  
Expected return on plan assets
    (3 )     (4 )     (10 )     (11 )
Amortization, net
    1             3       1  
                                 
Net other post-retirement benefits expense
  $ 10     $ 7     $ 26     $ 19  
                                 


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SCHERING-PLOUGH CORPORATION AND SUBSIDIARIES
 
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
(Unaudited)

For the three and nine months ended September 30, 2006, the Company contributed $49 million and $89 million, respectively, to its retirement plans. The Company expects to contribute approximately $20 million to its retirement plans in the remainder of 2006.
 
8.   Earnings Per Common Share
 
The following table reconciles the components of the basic and diluted earnings per common share (EPS) computations:
 
                                 
    Three Months
    Nine Months
 
    Ended
    Ended
 
    September 30,     September 30,  
    2006     2005     2006     2005  
    (Dollars and shares in millions)  
 
EPS Numerator:
                               
Net income before cumulative effect of a change in accounting principle and preferred stock dividends
  $ 309     $ 65     $ 918     $ 143  
                                 
Add: Cumulative effect of a change in accounting principle, net of tax
                22        
Less: Preferred stock dividends
    22       22       65       65  
                                 
Net income available to common shareholders
  $ 287     $ 43     $ 875     $ 78  
                                 
EPS Denominator:
                               
Weighted average shares outstanding for basic EPS
    1,482       1,477       1,481       1,476  
Dilutive effect of options and deferred stock units
    10       10       8       7  
                                 
Average shares outstanding for diluted EPS
    1,492       1,487       1,489       1,483  
                                 
 
The equivalent common shares issuable under the Company’s stock incentive plans which were excluded from the computation of diluted EPS because their effect would have been antidilutive were 51 million for the three and nine months ended September 30, 2006, and 33 million and 38 million for the three and nine months ended September 30, 2005, respectively. Also, at September 30, 2006 and 2005, 65 million and 68 million, respectively, of common shares obtainable upon conversion of the Company’s 6 percent Mandatory Convertible Preferred Stock were excluded from the computation of diluted earnings per share because their effect would have been antidilutive.
 
9.   Comprehensive Income
 
Comprehensive income is comprised of the following:
 
                                 
    Three Months
    Nine Months
 
    Ended
    Ended
 
    September 30,     September 30,  
    2006     2005     2006     2005  
    (Dollars in millions)  
 
Net income
  $ 309     $ 65     $ 940     $ 143  
Foreign currency translation adjustment
    9       1       56       (123 )
Unrealized gain on investments available for sale, net of tax
    6       1       2        
                                 
Total comprehensive income
  $ 324     $ 67     $ 998     $ 20  
                                 


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SCHERING-PLOUGH CORPORATION AND SUBSIDIARIES
 
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
(Unaudited)

10.   Inventories

 
Inventories consisted of the following:
 
                 
    September 30,
    December 31,
 
    2006     2005  
    (Dollars in millions)  
 
Finished products
  $ 700     $ 665  
Goods in process
    731       614  
Raw materials and supplies
    256       326  
                 
Total inventories
  $ 1,687     $ 1,605  
                 
 
11.   Other Intangible Assets
 
The components of other intangible assets, net are as follows:
 
                                                 
    September 30, 2006     December 31, 2005  
    Gross
                Gross
             
    Carrying
    Accumulated
          Carrying
    Accumulated
       
    Amount     Amortization     Net     Amount     Amortization     Net  
    (Dollars in millions)  
 
Patents and licenses
  $ 581     $ 359     $ 222     $ 579     $ 329     $ 250  
Trademarks and other
    166       57       109       166       51       115  
                                                 
Total other intangible assets
  $ 747     $ 416     $ 331     $ 745     $ 380     $ 365  
                                                 
 
These intangible assets are amortized on the straight-line method over their respective useful lives. The residual value of intangible assets is estimated to be zero. Amortization expenses for the three and nine months ended September 30, 2006 were $12 million and $36 million, respectively, and $12 million and $37 million for the three and nine months ended September 30, 2005, respectively. Annual amortization expenses related to these intangible assets for the years 2007 to 2012 is expected to be approximately $50 million.
 
12.   Short-Term Borrowings
 
Short-term borrowings primarily consist of bank loans and commercial paper. Short-term borrowings at September 30, 2006 and December 31, 2005 totaled $235 million and $1.3 billion, respectively.
 
The Company entered into a $575 million credit facility during the fourth quarter of 2005 for the purposes of funding repatriations under the American Jobs Creation Act of 2004. As of September 30, 2006, the outstanding balance under this facility was paid in full and the facility has been terminated.
 
13.   Segment Data
 
The Company has three reportable segments: Prescription Pharmaceuticals, Consumer Health Care and Animal Health. The segment sales and profit data that follow are consistent with the Company’s current management reporting structure. The Prescription Pharmaceuticals segment discovers, develops, manufactures and markets human pharmaceutical products. The Consumer Health Care segment develops, manufactures and markets over-the-counter, foot care and sun care products, primarily in the U.S. The Animal Health segment discovers, develops, manufactures and markets animal health products.


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SCHERING-PLOUGH CORPORATION AND SUBSIDIARIES
 
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
(Unaudited)

Net sales by segment:
 
                                 
    Three Months
    Nine Months
 
    Ended
    Ended
 
    September 30,     September 30,  
    2006     2005     2006     2005  
    (Dollars in millions)  
 
Prescription Pharmaceuticals
  $ 2,087     $ 1,840     $ 6,350     $ 5,660  
Consumer Health Care
    259       235       918       895  
Animal Health
    228       209       676       629  
                                 
Consolidated net sales
  $ 2,574     $ 2,284     $ 7,944     $ 7,184  
                                 
 
Profit by segment:
 
                                 
    Three Months
    Nine Months
 
    Ended
    Ended
 
    September 30,     September 30,  
    2006     2005     2006     2005  
    (Dollars in millions)  
 
Prescription Pharmaceuticals
  $ 355     $ 93     $ 1,074     $ 507  
Consumer Health Care
    74       55       237       225  
Animal Health
    36       33       106       89  
Corporate and other, including net interest income of $37 and $83, respectively, in 2006, and net interest income/(expense) of $9 and $(4), respectively, in 2005
    (53 )     (93 )     (224 )     (516 )
                                 
Income before income taxes
  $ 412     $ 88     $ 1,193     $ 305  
                                 
 
Schering-Plough’s net sales do not include sales of VYTORIN and ZETIA that are marketed in the partnership with Merck, as the Company accounts for this joint venture under the equity method of accounting (see Note 3, “Equity Income From Cholesterol Joint Venture,” for additional information). The Prescription Pharmaceuticals segment includes equity income from the cholesterol joint venture.
 
“Corporate and other” includes interest income and expense, foreign exchange gains and losses, headquarters expenses, special charges and other miscellaneous items. The accounting policies used for segment reporting are the same as those described in Note 1, “Summary of Significant Accounting Policies,” in the Company’s 2005 10-K.
 
For the three and nine months ended September 30, 2006, “Corporate and other” included special charges of $10 million and $90 million, respectively, related to the changes to the Company’s manufacturing operations in the U.S. and Puerto Rico announced in June 2006, all of which related to the Prescription Pharmaceuticals segment (see Note 2, “Special Charges and Manufacturing Streamlining,” for additional information).
 
For the three and nine months ended September 30, 2005, “Corporate and other” included special charges of $6 million and $292 million, respectively, primarily related to an increase in litigation reserves for the Massachusetts Investigation (see Note 15, “Legal, Environmental and Regulatory Matters,” for additional information) with the majority of the remaining amount related to charges as a result of the consolidation of the Company’s U.S. biotechnology organizations. Special charges for the nine months ended September 30, 2005 is estimated to be as follows: Prescription Pharmaceuticals — $288 million, Consumer Health Care — $1 million, Animal Health — $1 million and Corporate and other — $2 million.


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SCHERING-PLOUGH CORPORATION AND SUBSIDIARIES
 
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
(Unaudited)

Sales of products comprising 10 percent or more of the Company’s U.S. or international sales for the three or nine months ended September 30, 2006, were as follows:
 
                                 
    Three Months
    Nine Months
 
    Ended
    Ended
 
    September 30, 2006     September 30, 2006  
    Amount     Percentage     Amount     Percentage  
    (Dollars in millions)     (%)     (Dollars in millions)     (%)  
 
U.S.
                               
NASONEX
    153       15       441       14  
OTC CLARITIN
    92       9       303       10  
International
                               
REMICADE
    317       21       902       19  
PEG-INTRON
    155       10       477       10  
 
The Company does not disaggregate assets on a segment basis for internal management reporting and, therefore, such information is not presented.
 
14.   Consent Decree
 
In May 2002, the Company agreed with the FDA to the entry of a Consent Decree to resolve issues related to compliance with current Good Manufacturing Practices (cGMP) at certain of the Company’s facilities in New Jersey and Puerto Rico (the “Consent Decree” or the “Decree”).
 
In summary, the Decree required the Company to make payments totaling $500 million in two equal installments of $250 million, which were paid in 2002 and 2003. In addition, the Decree required the Company to complete revalidation programs for manufacturing processes used to produce bulk active pharmaceutical ingredients and finished drug products at the covered facilities, as well as to implement a comprehensive cGMP Work Plan for each such facility. The Decree required the foregoing to be completed in accordance with strict schedules, and provided for possible imposition of additional payments in the event the Company did not adhere to the approved schedules. Final completion of the work was made subject to certification by independent experts, whose certifications were in turn made subject to FDA acceptance.
 
Although the Company has reported to the FDA that it has completed both the revalidation programs and the cGMP Work Plan, third party certification of the Work Plan is still pending. It is possible that the third party expert may not certify the completion of a Work Plan Significant Step or that the FDA may disagree with the expert’s certification. In such an event, it is possible that FDA may assess additional payments as permitted under the Decree, and as described in more detail below.
 
In general, the cGMP Work Plan contained 212 Significant Steps whose timely and satisfactory completion are subject to payments of $15 thousand per business day for each deadline missed. These payments may not exceed $25 million for 2002, and $50 million for each of the years 2003, 2004 and 2005. These payments are subject to an overall cap of $175 million. The Company would expense any such additional payments assessed under the Decree if and when incurred.
 
Under the terms of the Decree, provided that the FDA has not notified the Company of a significant violation of FDA law, regulations, or the Decree in the five-year period since the Decree’s entry, May 2002 through May 2007, the Company may petition the court to have the Decree dissolved and the FDA will not oppose the Company’s petition.


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SCHERING-PLOUGH CORPORATION AND SUBSIDIARIES
 
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
(Unaudited)

15. Legal, Environmental and Regulatory Matters
 
Background
 
The Company is involved in various claims, investigations and legal proceedings.
 
The Company records a liability for contingencies when it is probable that a liability has been incurred and the amount can be reasonably estimated. The Company adjusts its liabilities for contingencies to reflect the current best estimate of probable loss or minimum liability as the case may be. Where no best estimate is determinable, the Company records the minimum amount within the most probable range of its liability. Expected insurance recoveries have not been considered in determining the amounts of recorded liabilities for environmental-related matters.
 
If the Company believes that a loss contingency is reasonably possible, rather than probable, or the amount of loss cannot be estimated, no liability is recorded. However, where a liability is reasonably possible, disclosure of the loss contingency is made.
 
The Company reviews the status of all claims, investigations and legal proceedings on an ongoing basis, including related insurance coverages. From time to time, the Company may settle or otherwise resolve these matters on terms and conditions management believes are in the best interests of the Company. Resolution of any or all claims, investigations and legal proceedings, individually or in the aggregate, could have a material adverse effect on the Company’s results of operations, cash flows or financial condition. In addition, resolution of matters described under Investigations could involve injunctive or administrative remedies that would adversely impact the business such as exclusion from government reimbursement programs, which in turn would have a material adverse impact on the business, future financial condition, cash flows and results of operations.
 
Except for the matters discussed in the remainder of this Note, the recorded liabilities for contingencies at September 30, 2006, and the related expenses incurred during the three and nine months ended September 30, 2006, were not material. In the opinion of management, based on the advice of legal counsel, the ultimate outcome of these matters, except matters discussed in the remainder of this Note, will not have a material impact on the Company’s results of operations, cash flows or financial condition.
 
Patent Matters
 
DR. SCHOLL’S FREEZE AWAY Patent.  On July 26, 2004, OraSure Technologies filed an action in the U.S. District Court for the Eastern District of Pennsylvania alleging patent infringement by Schering-Plough HealthCare Products by its sale of DR. SCHOLL’S FREEZE AWAY wart removal product. The complaint seeks a permanent injunction and unspecified damages, including treble damages.
 
Investigations
 
Massachusetts Investigation.  On August 29, 2006, the Company announced it had reached an agreement with the U.S. Attorney’s Office for the District of Massachusetts and the U.S. Department of Justice to settle the previously disclosed investigation involving the Company’s sales, marketing and clinical trial practices and programs (the “Massachusetts Investigation”) (see “Massachusetts Investigation” in Part I, Item 3, “Legal Proceedings” of the 2005 10-K).
 
The agreement provides for an aggregate settlement amount of $435 million and is subject to court approval. Under the agreement, Schering Sales Corporation, a subsidiary of the Company, will plead guilty to one count of conspiracy to make false statements to the government and pay a criminal fine of $180 million, and the Company will pay $255 million to resolve civil aspects of the investigation. In connection with the settlement, the Company signed an addendum to an existing corporate integrity agreement with the Office of


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SCHERING-PLOUGH CORPORATION AND SUBSIDIARIES
 
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
(Unaudited)

Inspector General of the U.S. Department of Health and Human Services. The addendum will not affect the Company’s ongoing business with any customers, including the federal government.
 
As previously disclosed, the Company had recorded a liability of $500 million related to the Massachusetts Investigation, the investigations described below under “AWP Investigations” and the litigation by certain states described below under “AWP Litigation.” The settlement amount of $435 million relates only to the Massachusetts Investigation. The AWP investigations and litigation are ongoing.
 
AWP Investigations.  The Company continues to respond to existing and new investigations by the Department of Health and Human Services, the Department of Justice and several states into industry and Company practices regarding average wholesale price (AWP). These investigations relate to whether the AWP used by pharmaceutical companies for certain drugs improperly exceeds the average prices paid by providers and, as a consequence, results in unlawful inflation of certain government drug reimbursements that are based on AWP. The Company is cooperating with these investigations. The outcome of these investigations could include the imposition of substantial fines, penalties and injunctive or administrative remedies.
 
NITRO-DUR Investigation.  In August 2003, the Company received a civil investigative subpoena issued by the Office of Inspector General of the U.S. Department of Health and Human Services, seeking documents concerning the Company’s classification of NITRO-DUR for Medicaid rebate purposes, and the Company’s use of nominal pricing and bundling of product sales. The Company is cooperating with the investigation. It appears that the subpoena is one of a number addressed to pharmaceutical companies concerning an inquiry into issues relating to the payment of government rebates.
 
Pricing Matters
 
AWP Litigation.  The Company continues to respond to existing and new litigation by certain states and private payors into industry and Company practices regarding average wholesale price (AWP). These litigations relate to whether the AWP used by pharmaceutical companies for certain drugs improperly exceeds the average prices paid by providers and, as a consequence, results in unlawful inflation of certain reimbursements for drugs by state programs and private payors that are based on AWP. The complaints allege violations of federal and state law, including fraud, Medicaid fraud and consumer protection violations, among other claims. In the majority of cases, the plaintiffs are seeking class certifications. In some cases, classes have been certified. The outcome of these litigations could include substantial damages, the imposition of substantial fines, penalties and injunctive or administrative remedies.
 
Securities and Class Action Litigation
 
Federal Securities Litigation.  Following the Company’s announcement that the FDA had been conducting inspections of the Company’s manufacturing facilities in New Jersey and Puerto Rico and had issued reports citing deficiencies concerning compliance with current Good Manufacturing Practices, several lawsuits were filed against the Company and certain named officers. These lawsuits allege that the defendants violated the federal securities law by allegedly failing to disclose material information and making material misstatements. Specifically, they allege that the Company failed to disclose an alleged serious risk that a new drug application for CLARINEX would be delayed as a result of these manufacturing issues, and they allege that the Company failed to disclose the alleged depth and severity of its manufacturing issues. These complaints were consolidated into one action in the U.S. District Court for the District of New Jersey, and a consolidated amended complaint was filed on October 11, 2001, purporting to represent a class of shareholders who purchased shares of Company stock from May 9, 2000 through February 15, 2001. The complaint seeks compensatory damages on behalf of the class. The Court certified the shareholder class on October 10, 2003. Discovery is ongoing.


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SCHERING-PLOUGH CORPORATION AND SUBSIDIARIES
 
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
(Unaudited)

Shareholder Derivative Actions.  Two lawsuits were filed in the U.S. District Court for the District of New Jersey, against the Company, certain officers, directors and a former director seeking damages on behalf of the Company, including disgorgement of trading profits made by defendants allegedly obtained on the basis of material non-public information. The complaints allege a failure to disclose material information and breach of fiduciary duty by the directors, relating to the FDA inspections and investigations into the Company’s pricing practices and sales, marketing and clinical trials practices. These lawsuits are shareholder derivative actions that purport to assert claims on behalf of the Company. The two shareholder derivative actions pending in the U.S. District Court for the District of New Jersey were consolidated into one action on August 20, 2001, which is in its very early stages.
 
ERISA Litigation.  On March 31, 2003, the Company was served with a putative class action complaint filed in the U.S. District Court in New Jersey alleging that the Company, retired Chairman, CEO and President Richard Jay Kogan, the Company’s Employee Savings Plan (Plan) administrator, several current and former directors, and certain corporate officers (Messrs. LaRosa and Moore) breached their fiduciary obligations to certain participants in the Plan. The complaint seeks damages in the amount of losses allegedly suffered by the Plan. The complaint was dismissed on June 29, 2004. The plaintiffs appealed. On August 19, 2005, the U.S. Court of Appeals for the Third Circuit reversed the dismissal by the District Court and the matter has been remanded back to the District Court for further proceedings.
 
K-DUR Antitrust Litigation.  K-DUR is Schering-Plough’s long-acting potassium chloride product supplement used by cardiac patients. Following the commencement of the FTC administrative proceeding described below, alleged class action suits were filed in federal and state courts on behalf of direct and indirect purchasers of K-DUR against Schering-Plough, Upsher-Smith, Inc. (Upsher-Smith) and ESI Lederle, Inc. (Lederle). These suits claim violations of federal and state antitrust laws, as well as other state statutory and common law causes of action. These suits seek unspecified damages. Discovery is ongoing.
 
Antitrust Matters
 
K-DUR.  Schering-Plough had settled patent litigation with Upsher-Smith and Lederle, which had related to generic versions of K-DUR for which Lederle and Upsher Smith had filed Abbreviated New Drug Applications (ANDAs). On April 2, 2001, the FTC started an administrative proceeding against Schering-Plough, Upsher-Smith and Lederle alleging anti-competitive effects from those settlements. The administrative law judge issued a decision that the patent litigation settlements complied with the law in all respects and dismissed all claims against the Company. The FTC Staff appealed that decision to the full Commission. The full Commission reversed the decision of the administrative law judge ruling that the settlements did violate the antitrust laws. The full Commission issued a cease and desist order imposing various injunctive restraints. The federal court of appeals set aside the Commission ruling and vacated the cease and desist order. On August 29, 2005, the FTC filed a petition seeking a hearing by the U.S. Supreme Court. The Supreme Court denied the petition on June 26, 2006.
 
Pending Administrative Obligations
 
In connection with the settlement of an investigation with the U.S. Department of Justice and the U.S. Attorney’s Office for the Eastern District of Pennsylvania, the Company entered into a five-year corporate integrity agreement (CIA). The Company signed an addendum to the CIA in connection with the settlement of the Massachusetts Investigation. As disclosed in Note 14, “Consent Decree,” the Company is subject to obligations under a Consent Decree with the FDA. Failure to comply with the obligations under the CIA or the Consent Decree can result in financial penalties.


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SCHERING-PLOUGH CORPORATION AND SUBSIDIARIES
 
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
(Unaudited)

Other Matters
 
Biopharma Contract Dispute.  Biopharma S.r.l. filed a claim in the Civil Court of Rome on July 21, 2004 (docket No. 57397/2004, 9th Chamber) against certain Schering-Plough subsidiaries. The Complaint alleges that the Company did not fulfill its duties under distribution and supply agreements between Biopharma and a Schering-Plough subsidiary for distribution by Schering-Plough of generic products manufactured by Biopharma to hospitals and to pharmacists in France. This matter was settled with no material impact on the Company’s financial statements and the claim was withdrawn on July 19, 2006.
 
Tax Matters
 
In October 2001, IRS auditors asserted that two interest rate swaps that the Company entered into with an unrelated party should be recharacterized as loans from affiliated companies, resulting in additional tax liability for the 1991 and 1992 tax years. In September 2004, the Company made payments to the IRS in the amount of $194 million for income tax and $279 million for interest. The Company filed refund claims for the tax and interest with the IRS in December 2004. Following the IRS’s denial of the Company’s claims for a refund, the Company filed suit in May 2005 in the U.S. District Court for the District of New Jersey for refund of the full amount of the tax and interest. This refund litigation is currently in the discovery phase. The Company’s tax reserves were adequate to cover the above mentioned payments.
 
Environmental
 
The Company has responsibilities for environmental cleanup under various state, local and federal laws, including the Comprehensive Environmental Response, Compensation and Liability Act, commonly known as Superfund. At several Superfund sites (or equivalent sites under state law), the Company is alleged to be a potentially responsible party (PRP). The Company believes that it is remote at this time that there is any material liability in relation to such sites. The Company estimates its obligations for cleanup costs for Superfund sites based on information obtained from the federal Environmental Protection Agency (EPA), an equivalent state agency and/or studies prepared by independent engineers, and on the probable costs to be paid by other PRPs. The Company records a liability for environmental assessments and/or cleanup when it is probable a loss has been incurred and the amount can be reasonably estimated.


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REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
 
To the Board of Directors and Shareholders of Schering-Plough Corporation:
 
We have reviewed the accompanying condensed consolidated balance sheet of Schering-Plough Corporation and subsidiaries (the “Corporation”) as of September 30, 2006, and the related statements of condensed consolidated operations for the three and nine-month periods ended September 30, 2006 and 2005, and the statements of condensed consolidated cash flows for the nine-month periods ended September 30, 2006 and 2005. These interim financial statements are the responsibility of the Corporation’s management.
 
We conducted our reviews in accordance with the standards of the Public Company Accounting Oversight Board (United States). A review of interim financial information consists principally of applying analytical procedures and making inquiries of persons responsible for financial and accounting matters. It is substantially less in scope than an audit conducted in accordance with the standards of the Public Company Accounting Oversight Board (United States), the objective of which is the expression of an opinion regarding the financial statements taken as a whole. Accordingly, we do not express such an opinion.
 
Based on our reviews, we are not aware of any material modifications that should be made to such condensed consolidated interim financial statements for them to be in conformity with accounting principles generally accepted in the United States of America.
 
We have previously audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States), the consolidated balance sheet of Schering-Plough Corporation and subsidiaries as of December 31, 2005, and the related statements of consolidated operations, stockholders’ equity, and cash flows for the year then ended (not presented herein); and in our report dated February 28, 2006, we expressed an unqualified opinion on those consolidated financial statements. In our opinion, the information set forth in the accompanying condensed consolidated balance sheet as of December 31, 2005 is fairly stated, in all material respects, in relation to the consolidated balance sheet from which it has been derived.
 
As discussed in Note 4 to the condensed consolidated financial statements, effective January 1, 2006, the Corporation adopted Statement of Financial Accounting Standards No. 123 (Revised 2004), “Share-Based Payment”.
 
/s/  Deloitte & Touche LLP
 
Parsippany, New Jersey
October 26, 2006


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Item 2.   Management’s Discussion and Analysis of Financial Condition and Results of Operations
 
EXECUTIVE OVERVIEW
 
Overview of the Company
 
Schering-Plough (the Company) discovers, develops, manufactures and markets medical therapies and treatments to enhance human health. The Company also markets leading consumer brands in the over-the-counter (OTC), foot care and sun care markets and operates a global animal health business.
 
As a research-based pharmaceutical company, a core strategy of Schering-Plough is to invest substantial funds in scientific research with the goal of creating therapies and treatments with important medical and commercial value. Consistent with this core strategy, the Company has been increasing its investment in research and development, and this trend is expected to continue at historic levels or greater. Research and development activities focus on mechanisms to treat serious diseases. There is a high rate of failure inherent in such research and, as a result, there is a high risk that the funds invested in research programs will not generate financial returns. This risk profile is compounded by the fact that this research has a long investment cycle. To bring a pharmaceutical compound from the discovery phase to the commercial phase may take a decade or more.
 
There are two sources of new products: products acquired through acquisition and licensing arrangements, and products in the Company’s late-stage research pipeline. With respect to acquisitions and licensing, there are limited opportunities for obtaining or licensing critical late-stage products, and these limited opportunities typically require substantial amounts of funding. The Company competes for these opportunities against companies often with greater financial resources. Accordingly, it may be challenging for the Company to acquire or license critical late-stage products that will have a positive material financial impact.
 
The Company supports commercialized products with manufacturing, sales and marketing efforts. The Company is also moving forward with additional investments to enhance its infrastructure and business, including capital expenditures for the development process, where products are moved from the drug discovery pipeline to markets, information technology systems, and post-marketing studies and monitoring.
 
Earlier this decade, the Company experienced a number of business, regulatory, and legal challenges. In April 2003, the Board of Directors named Fred Hassan as the new Chairman of the Board and Chief Executive Officer of Schering-Plough Corporation. Under his leadership, a new leadership team was recruited and a six- to eight-year, five-phase Action Agenda was formulated with the goal of stabilizing, repairing and turning around the Company. A year after entering the third phase of the Action Agenda, the Turnaround phase, in October 2006, the Company announced it entered the fourth phase of the Action Agenda — Build the Base.
 
As discussed in more detail in Note 15, “Legal, Environmental and Regulatory Matters,” and Part II, Item 1, “Legal Proceedings,” on August 29, 2006, the Company announced it had reached an agreement with the U.S. Attorney’s Office for the District of Massachusetts and the U.S. Department of Justice to settle the previously disclosed Massachusetts Investigation (see “Massachusetts Investigation” in Part I, Item 3, “Legal Proceedings,” of the Company’s 2005 10-K for additional information). The agreement provides for an aggregate settlement of $435 million and is subject to court approval. The Company believes the settlement of the Massachusetts Investigation will not have a material adverse effect on the Company’s results of operations, financial condition or its business.
 
The Company’s financial situation continues to improve, as discussed below. The Company’s cholesterol franchise products, VYTORIN and ZETIA, are the primary drivers of this improvement. ZETIA is the Company’s novel cholesterol absorption inhibitor. VYTORIN is the combination of ZETIA and Zocor, Merck & Co., Inc.’s (Merck) statin medication. These two products have been launched through a joint venture between the Company and Merck. ZETIA (ezetimibe), marketed in Europe as EZETROL, is marketed for use either by itself or together with statins for the treatment of elevated cholesterol levels. VYTORIN (ezetimibe/simvastatin), marketed as INEGY internationally, has been launched in more than 35 countries and ZETIA/EZETROL in more than 80 countries.


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The Company currently expects its cholesterol franchise to continue to grow in 2007. The financial commitment to compete in the cholesterol-reduction market is shared with Merck and profits from the sales of VYTORIN and ZETIA are also shared with Merck. The operating results of the joint venture with Merck are recorded using the equity method of accounting. Outside of the joint venture with Merck, in the Japanese market, Bayer Healthcare will co-market the Company’s cholesterol-absorption inhibitor, ZETIA, upon approval. Due to a backlog of new drug applications in Japan, the Company cannot precisely predict the timing of this approval.
 
The cholesterol-reduction market is the single largest pharmaceutical category in the world. VYTORIN and ZETIA are competing in this market, and on a combined basis, these products have continued to grow in terms of market share during 2006. As a franchise, the two products combined have captured more than 15 percent of total prescriptions in the U.S. cholesterol management market (based on September 2006 IMS data).
 
During 2005 and 2006, the Company’s results of operations and cash flows have been driven significantly by the performance of VYTORIN and ZETIA. As a result, the Company’s ability to generate profits is predominantly dependent upon the performance of the VYTORIN and ZETIA cholesterol franchise, which dependence is expected to continue for some time. For the three and nine months ended September 30, 2006, equity income from the cholesterol joint venture was $390 million and $1.1 billion, respectively, and net income available to common shareholders was $287 million and $875 million, respectively. Additional information regarding the joint venture with Merck is also included in Note 3, “Equity Income from Cholesterol Joint Venture,” in this 10-Q. Although it is expected that operating cash flow and existing cash and short-term investments will fund the Company’s operations for the intermediate term, as discussed in more detail below, future cash flows are also dependent upon the performance of VYTORIN and ZETIA. The Company must generate profits and cash flows to maintain and enhance its infrastructure and business as discussed above.
 
Sales of VYTORIN and ZETIA may be impacted by the introduction of new innovative competing treatments and generic versions of existing products. Currently, the U.S. cholesterol lowering market is adjusting to the entry into the market of generic forms of cholesterol products. The Company cannot reasonably predict what effect the introduction of generic forms of cholesterol management products may have on VYTORIN and ZETIA, although the decisions of government entities, managed care groups and other groups concerning formularies and reimbursement policies could potentially negatively impact the dollar size and/or growth of the cholesterol management market, including VYTORIN and ZETIA. A material change in the sales or market share of VYTORIN and ZETIA would have a significant impact on the Company’s operations and cash flow.
 
REMICADE is prescribed for the treatment of immune-mediated inflammatory disorders such as rheumatoid arthritis, early rheumatoid arthritis, psoriatic arthritis, Crohn’s disease, ankylosing spondylitis, plaque psoriasis and ulcerative colitis. REMICADE is the Company’s second largest marketed pharmaceutical product line (after the cholesterol franchise). This product is licensed from and manufactured by Centocor, Inc., a Johnson & Johnson company. The Company has the exclusive marketing rights to this product outside of the U.S., Japan, and certain Asian markets. During 2005, the Company exercised an option under its contract with Centocor for license rights to develop and commercialize golimumab, a fully human monoclonal antibody, in the same territories as REMICADE. Golimumab is currently in Phase III trials. The Company had previously disclosed the difference of opinion between the parties as to the expiration date of Schering-Plough’s rights to golimumab and their collaboration in resolving this matter. In August 2006, the Company received clarification through arbitration that its rights to market golimumab will extend to 15 years after the first commercial sale in its territories, but Centocor has appealed the clarification.
 
As is typical in the pharmaceutical industry, the Company licenses manufacturing, marketing and/or distribution rights to certain products to others, and also manufactures, markets and/or distributes products owned by others pursuant to licensing and joint venture arrangements. Any time that third parties are involved, there are additional factors relating to the third party and outside the control of the Company that may create


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positive or negative impacts on the Company. VYTORIN, ZETIA and REMICADE are subject to such arrangements and are key to the Company’s current business and financial performance.
 
In addition, any potential strategic alternatives may be impacted by the change of control provisions in those arrangements, which could result in VYTORIN and ZETIA being acquired by Merck or REMICADE reverting back to Centocor. The change in control provision relating to VYTORIN and ZETIA is included in the contract with Merck, filed as Exhibit 10(q) to the Company’s 10-K, and the change of control provision relating to REMICADE is contained in the contract with Centocor, filed as Exhibit 10(u) to the Company’s 10-K.
 
Current State of the Business
 
Net sales in the third quarter of 2006 were $2.6 billion or 13 percent higher than the third quarter of 2005. As discussed below, the sales increase was driven primarily by the growth of REMICADE, NASONEX, and TEMODAR.
 
The Company had net income available to common shareholders of $287 million and $875 million, respectively, for the three and nine months ended September 30, 2006 as compared to $43 million and $78 million for the three and nine months ended September 30, 2005, respectively. The net income available to common shareholders for the three and nine months ended September 30, 2006 included charges totaling approximately $53 million and $191 million, respectively, related to the announced actions to streamline the Company’s manufacturing operations and a favorable impact of $60 million from the reversal of previously accrued rebate amounts for a U.S. Government pharmaceutical program (the TRICARE Retail Pharmacy Program) that the U.S. Federal Court of Appeals ruled pharmaceutical manufacturers are not obligated to pay. The nine months ended September 30, 2006 included an income item of $22 million resulting from the cumulative effect of a change in accounting principle, net of tax, related to the implementation of SFAS 123R related to stock-based compensation. For the three and nine months ended September 30, 2005, net income available to common shareholders included special charges of $6 million and $292 million, respectively (see Note 2, “Special Charges and Manufacturing Streamlining,” for additional information).
 
Many of the Company’s manufacturing sites operate below capacity. The Company’s manufacturing sites subject to the Consent Decree remained open while the Company was performing its revalidation and cGMP Work Plan obligations under decree. However, the Consent Decree work placed significant additional controls on production and release of products from these sites, which increased costs and slowed production and led to a reduction in the product mix at the sites. Further, the Company’s research and development operations were negatively impacted by the Consent Decree because these operations share common facilities with the manufacturing operations. Although certain costs, such as those associated with third party certifications, are decreasing as the Company goes through the process of certifying the Work Plan, other financial impacts will continue, such as the costs of the new processes that will continue to be used and the reduced product mix and volumes at the sites.
 
Pursuant to the Company’s continuing work to enhance long-term competitiveness, on June 1, 2006, the Company announced plans to close manufacturing facilities in Manati, Puerto Rico and additional changes to its manufacturing operations in Puerto Rico and New Jersey that will streamline its global supply chain (see Note 2, “Special Charges and Manufacturing Streamlining,” and Discussion of Operating Results for additional information).
 
The Company continually reviews the business, including manufacturing operations, to identify actions that will enhance long-term competitiveness. However, the Company’s manufacturing cost base is relatively fixed, and actions to significantly reduce the Company’s manufacturing infrastructure involve complex issues. As a result, shifting products between manufacturing plants can take many years due to construction and regulatory requirements, including revalidation and registration requirements. The Company continues to review the carrying value of manufacturing assets for indications of impairment. Future events and decisions may lead to additional asset impairments or related costs.


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During 2005, the Company repatriated approximately $9.4 billion of previously unremitted foreign earnings at a reduced tax rate as provided by the American Jobs Creation Act of 2004 (AJCA). Repatriating funds under the AJCA benefited the Company by allowing the Company to fund U.S. cash needs while preserving U.S. NOLs.
 
DISCUSSION OF OPERATING RESULTS
 
Net Sales
 
A significant portion of net sales is made to major pharmaceutical and health care products distributors and major retail chains in the U.S. Consequently, net sales and quarterly growth comparisons may be affected by fluctuations in the buying patterns of major distributors, retail chains and other trade buyers. These fluctuations may result from seasonality, pricing, wholesaler buying decisions or other factors.
 
Consolidated net sales for the three months ended September 30, 2006 totaled $2.6 billion, an increase of $290 million or 13 percent, including a favorable impact of 2 percent from foreign exchange and a $47 million favorable impact related to the reversal of previously accrued rebate amounts for a U.S. Government pharmaceutical program (the TRICARE Retail Pharmacy Program) that the U.S. Federal Court of Appeals ruled pharmaceutical manufacturers are not obligated to pay, as compared with the same period in 2005. For the nine months ended September 30, 2006, consolidated net sales totaled $7.9 billion, an increase of $760 million or 11 percent, including an unfavorable impact of 2 percent from foreign exchange, as compared to the same period in 2005.
 
Net sales for the three and nine months ended September 30, 2006 and 2005 were as follows:
 
                                                 
    Three Months Ended
    Nine Months Ended
 
    September 30,     September 30,  
                Increase
                Increase
 
    2006     2005     (Decrease)     2006     2005     (Decrease)  
    (Dollars in millions)     (%)     (Dollars in millions)     (%)  
 
PRESCRIPTION PHARMACEUTICALS(a)
  $ 2,087     $ 1,840       13     $ 6,350     $ 5,660       12  
REMICADE
    317       237       34       902       691       31  
NASONEX
    221       170       30       691       552       25  
PEG-INTRON
    206       185       11       629       537       17  
TEMODAR
    179       152       18       513       428       20  
CLARINEX/AERIUS
    171       157       9       557       507       10  
INTEGRILIN
    82       86       (5 )     244       244        
CLARITIN Rx
    74       76       (2 )     279       287       (3 )
REBETOL
    72       82       (12 )     237       237        
AVELOX
    63       41       55       201       159       26  
INTRON A
    57       72       (21 )     180       220       (18 )
CAELYX
    52       46       14       156       135       15  
SUBUTEX
    51       44       14       152       148       2  
ELOCON
    36       34       6       108       113       (4 )
CIPRO
    28       41       (32 )     86       114       (24 )
Other Pharmaceutical
    478       417       15       1,415       1,288       10  
CONSUMER HEALTH CARE
    259       235       10       918       895       3  
OTC(b)
    138       129       7       440       453       (3 )
Foot Care
    92       85       8       270       258       5  
Sun Care
    29       21       38       208       184       13  
ANIMAL HEALTH
    228       209       9       676       629       7  
                                                 
CONSOLIDATED NET SALES(a)
  $ 2,574     $ 2,284       13     $ 7,944     $ 7,184       11  
                                                 


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(a) Included in 2006 sales is approximately $47 million resulting from the reversal of previously accrued rebate amounts for the TRICARE Retail Pharmacy Program that the U.S. Federal Court of Appeals ruled pharmaceutical manufacturers are not obligated to pay.
 
(b) Includes OTC CLARITIN net sales of $95 million and $92 million in the third quarter of 2006 and 2005, respectively, and $318 million and $340 million for the nine months ended September 30, 2006 and 2005, respectively.
 
International net sales of REMICADE, for the treatment of immune-mediated inflammatory disorders such as rheumatoid arthritis, early rheumatoid arthritis, psoriatic arthritis, Crohn’s disease, ankylosing spondylitis, plaque psoriasis and ulcerative colitis, were up $80 million or 34 percent to $317 million in the third quarter of 2006, and $211 million or 31 percent to $902 million for the nine months ended September 30, 2006, as compared to the same periods in 2005, primarily due to expanded indications and continued market growth. In January 2006, REMICADE was approved for the additional indication of ulcerative colitis in Europe. In October 2006, REMICADE received an approval for label upgrade by the European Commission for use as a second-line therapy from a third-line therapy for patients with Crohn’s disease. During 2006, competitive products for the indications referred to above have been introduced.
 
Global net sales of NASONEX nasal spray, a once-daily corticosteroid nasal spray for allergies, rose 30 percent to $221 million in the third quarter and 25 percent to $691 million for the nine months ended September 30, 2006. Third quarter U.S. sales climbed 41 percent to $153 million and international sales climbed 11 percent to $68 million, as the product captured greater market share versus the 2005 periods. A generic form of Flonase (fluticasone propionate) was approved in 2006 and may unfavorably impact the corticosteroid nasal spray market.
 
Global net sales of PEG-INTRON Powder for Injection, a pegylated interferon product for treating hepatitis C, increased 11 percent to $206 million in the third quarter and 17 percent to $629 million in the nine months ended September 30, 2006 versus the 2005 periods, due to higher U.S. sales and a sales increase in Japan. PEG-INTRON sales in Japan are expected to decline in the fourth quarter of 2006 and in 2007 as new patient enrollment moderates.
 
Global net sales of TEMODAR capsules, a treatment for certain types of brain tumors, increased $27 million or 18 percent to $179 million in the third quarter and $85 million or 20 percent to $513 million in the nine months ended September 30, 2006 versus the same periods in 2005 due to increased utilization for treating newly diagnosed glioblastoma multiforme (GBM), which is the most prevalent form of brain cancer. The growth rates for TEMODAR may moderate going forward, as significant market penetration has already been achieved in the treatment of GBM, especially in the U.S. In Japan, TEMODAR has been granted approval to treat malignant glioma.
 
Global net sales of CLARINEX (marketed as AERIUS in many countries outside the U.S.), for the treatment of seasonal outdoor allergies and year-round indoor allergies, increased 9 percent to $171 million in the third quarter, and 10 percent to $557 million in the nine months ended September 30, 2006, as compared to the same periods in 2005. Sales outside the U.S. rose 15 percent to $73 million in the third quarter and 14 percent to $293 million in the nine months ended September 30, 2006, as compared to 2005 periods, due to increased demand.
 
Global net sales of INTEGRILIN injection, a glycoprotein platelet aggregation inhibitor for the treatment of patients with acute coronary syndrome, which is sold primarily in the U.S. by Schering-Plough, decreased 5 percent to $82 million in the third quarter of 2006 and were flat at $244 million for the nine months ended September 30, 2006, as compared to the same periods in 2005, due to a contracting market.
 
International net sales of prescription CLARITIN decreased 2 percent to $74 million in the third quarter of 2006 and 3 percent to $279 million in the nine months ended September 30, 2006, as compared to the same periods in 2005. Sales in 2005 reflected an unusually severe allergy season in Japan.
 
Global net sales of REBETOL capsules, for use in combination with INTRON A or PEG-INTRON for treating hepatitis C, decreased 12 percent to $72 million in the third quarter of 2006 as compared to the third


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quarter of 2005. Net sales of this product were flat at $237 million for the nine months ended September 30, 2006, as compared to the same period in 2005. The decrease in sales in the third quarter of 2006 was due to lower sales in Europe resulting from increased competition and lower sales in Japan reflecting government mandated price reductions. Sales of REBETOL in Japan are expected to decline due to the moderation of hepatitis C patient enrollments in Japan. Sales of REBETOL going forward will continue to be impacted by government mandated price reductions in Japan.
 
Net sales of AVELOX, a fluoroquinolone antibiotic for the treatment of certain respiratory and skin infections, sold in the U.S. by Schering-Plough as a result of the Company’s license agreement with Bayer, increased $22 million or 55 percent to $63 million in the third quarter of 2006 and $42 million or 26 percent to $201 million in the nine months ended September 30, 2006, as compared to the 2005 periods, due to market share growth and new indications.
 
Global net sales of INTRON A injection, for chronic hepatitis B and C and other antiviral and anticancer indications, decreased 21 percent to $57 million in the third quarter of 2006 and 18 percent to $180 million for the nine months ended September 30, 2006, as compared to the same periods in 2005, due primarily to the conversion to PEG-INTRON for treating hepatitis C in Japan and melanoma in the U.S.
 
International net sales of CAELYX, for the treatment of ovarian cancer, metastatic breast cancer and Kaposi’s sarcoma, increased 14 percent to $52 million in the third quarter and 15 percent to $156 million in the nine months ended September 30, 2006, as compared to the same periods in 2005, largely as a result of increased use in treating ovarian and breast cancer.
 
International net sales of SUBUTEX tablets, for the treatment of opiate addiction, increased 14 percent to $51 million in the third quarter of 2006 and 2 percent to $152 million in the nine months ended September 30, 2006, as compared to the same periods in 2005, due to success against generic competition.
 
Global net sales of ELOCON cream, a medium-potency topical steroid, increased $2 million to $36 million in the third quarter and decreased $5 million to $108 million for the nine months ended September 30, 2006, as compared to the same periods in 2005, reflecting generic competition introduced in the U.S. during the first quarter of 2005. Generic competition is expected to continue to adversely affect sales of this product.
 
Net sales of CIPRO, a fluoroquinolone antibiotic for the treatment of certain respiratory, skin, urinary tract and other infections, sold in the U.S. by Schering-Plough as a result of the Company’s license agreement with Bayer, decreased 32 percent to $28 million in the third quarter of 2006 and 24 percent to $86 million in the nine months ended September 30, 2006, as compared to the same periods in 2005, due to market share erosion from branded and generic competition.
 
Other pharmaceutical net sales include a large number of lower sales volume prescription pharmaceutical products. Several of these products are sold in limited markets outside the U.S., and many are multiple source products no longer protected by patents. These products include treatments for respiratory, cardiovascular, dermatological, infectious, oncological and other diseases.
 
Global net sales of Consumer Health Care products, which include OTC, foot care and sun care products, increased $24 million or 10 percent to $259 million in the third quarter and $23 million or 3 percent to $918 million for the nine months ended September 30, 2006, as compared to the same periods in 2005, primarily reflecting increased sales of COPPERTONE CONTINUOUS SPRAY sun care products and DR. SCHOLL’S and other foot care products. Sales of sun care products grew $8 million or 38 percent to $29 million in the third quarter of 2006 and $24 million or 13 percent to $208 million for the nine months ended September 30, 2006. Sales of OTC CLARITIN increased 4 percent to $95 million in the third quarter of 2006 and decreased 7 percent to $318 million in the nine months ended September 30, 2006, as compared to the same periods in 2005. OTC CLARITIN sales growth in the third quarter of 2006 reflected growth in sales of CLARITIN products that do not contain pseudoephedrine (PSE) tempered by the continued adverse impact on retail sales of CLARITIN-D due to restrictions on the retail sale of OTC products containing PSE. In addition, OTC CLARITIN continues to face competition from private label and branded loratadine.


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The Company sells numerous non-prescription upper respiratory products which contain PSE, a FDA-approved ingredient for the relief of nasal congestion. The Company’s annual North American sales of non-prescription upper respiratory products that contain PSE totaled approximately $277 million in 2005 and $51 million and $175 million for the three and nine months ended September 30, 2006, respectively, down 17 percent in the third quarter and 22 percent for the nine months ended September 30, 2006, as compared to $61 million and $224 million, respectively, for the same periods in 2005. These products include all CLARITIN-D products as well as some DRIXORAL, CORICIDIN and CHLOR-TRIMETON products. The Company understands that PSE has been used in the illicit manufacture of methamphetamine, a dangerous and addictive drug. For some time, many states, Canada and Mexico have enacted regulations concerning the non-prescription sale of products containing PSE. In March 2006, the U.S. federal government enacted the Combat Meth Epidemic Act that requires retailers to place non-prescription PSE containing products behind the counter or away from customers’ direct access and places other administrative restrictions on the purchase of these products. The Company continues to monitor developments in this area and is working to mitigate further negative impact on operations or financial results. These regulations do not relate to the sale of prescription products, such as CLARINEX-D products, that contain PSE.
 
Global net sales of Animal Health products increased 9 percent in the third quarter of 2006 to $228 million and 7 percent to $676 million in the nine months ended September 30, 2006, as compared to the same periods in 2005. The increased sales reflected growth of core brands across most geographic and species areas, led by higher sales of companion animal products. The sales growth included a favorable impact from foreign exchange of 2 percent in the third quarter of 2006. The sales growth for the nine months ended September 30, 2006 was tempered by an unfavorable impact from foreign exchange of 2 percent.
 
Costs, Expenses and Equity Income
 
A summary of costs, expenses and equity income for the three and nine months ended September 30, 2006 and 2005 is as follows:
 
                                                 
    Three Months Ended
    Nine Months Ended
 
    September 30,     September 30,  
                Increase
                Increase
 
    2006     2005     (Decrease)     2006     2005     (Decrease)  
    (Dollars in millions)     (%)     (Dollars in millions)     (%)  
 
Cost of sales
  $ 885     $ 775       14     $ 2,782     $ 2,531       10  
Selling, general and administrative (SG&A)
    1,158       1,064       9       3,467       3,261       6  
Research and development (R&D)
    536       566       (5 )     1,557       1,391       12  
Other (income)/expense, net
    (37 )           N/M       (89 )     9       N/M  
Special charges
    10       6       66       90       292       (69 )
Equity income from cholesterol joint venture(a)
    (390 )     (215 )     81       (1,056 )     (605 )     75  
 
 
N/M — Not a meaningful percentage.
 
(a) Included in 2006 equity income from cholesterol joint venture is approximately $13 million resulting from the reversal of previously accrued rebate amounts for the TRICARE Retail Pharmacy Program.
 
Substantially all the sales of cholesterol products are not included in the Company’s net sales. The results of these sales are reflected in equity income from cholesterol joint venture. In addition, due to the virtual nature of the joint venture, the Company incurs substantial selling, general and administrative expenses that are not captured in equity income but are included in the Company’s Statements of Condensed Consolidated Operations. As a result, the Company’s gross margin, and ratios of SG&A expenses and R&D expenses as a percentage of net sales do not reflect the impact of the joint venture’s operating results.


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Gross Margin
 
Gross margin for the three months ended September 30, 2006 was 65.6 percent as compared to 66.0 percent in the third quarter of 2005, reflecting the negative impact of $43 million of costs associated with manufacturing changes included in cost of sales (see Note 2, “Special Charges and Manufacturing Streamlining,” for additional information) partially offset by the reversal of the previously accrued rebate amounts for the TRICARE Retail Pharmacy Program. Gross margin for the nine months ended September 30, 2006 was 65.0 percent as compared to 64.8 percent in the same period in 2005. This increase in gross margin was primarily due to increased sales of higher margin products and supply chain efficiency improvements including cost savings from the manufacturing streamlining. These favorable items were partially offset by the costs associated with the manufacturing changes and royalties for INTEGRILIN.
 
Selling, General and Administrative
 
Selling, general and administrative expenses (SG&A) were $1.2 billion in the third quarter of 2006 and $3.5 billion in the nine months ended September 30, 2006, an increase of 9 percent and 6 percent, respectively, as compared to the same periods in 2005. The increase reflects ongoing investments in emerging markets and field support for new launches as well as higher promotional spending.
 
Research and Development
 
Research and development (R&D) spending decreased 5 percent to $536 million in the third quarter of 2006 and increased 12 percent to $1.6 billion for the nine months ended September 30, 2006 as compared to the same periods in 2005. The decrease in R&D spending in the third quarter of 2006 was due to a $124 million charge in the third quarter of 2005 resulting from the Company’s exercise of its rights to develop and commercialize golimumab. The decrease was offset by higher costs associated with clinical trials and to support the Company’s pipeline. Generally, changes in R&D spending reflect fluctuations due to the timing of internal research efforts and research collaborations with various partners to discover and develop a steady flow of innovative products.
 
The Company believes it has a strong early development pipeline across a wide-range of therapeutic areas with 17 compounds now approaching or in Phase I development. As the Company continues to develop the later phase growth-drivers of the pipeline (e.g., Thrombin Receptor Antagonist, golimumab, vicriviroc and HCV protease inhibitor), the Company anticipates an approximate doubling of annual patient enrollment in clinical trials over the next 2-4 years as compared to 2005 levels.
 
As a result, the Company expects R&D spending to reflect the progression of the Company’s early-stage pipeline and increased clinical trial activity. To maximize the Company’s chances for the successful development of new products, the Company began a Development Excellence initiative in 2005 to build talent and critical mass, create a uniform level of excellence and deliver on high-priority programs within R&D. In 2006, the Company began a Global Clinical Harmonization Program to maximize and globalize the quality of clinical trial execution and pharmacovigilance processes.
 
Other (Income)/Expense, Net
 
The Company had other income, net, of $37 million in the third quarter of 2006 and $89 million for the nine months ended September 30, 2006, as compared to $0 and $9 million of other expense, net, for the three and nine months ended September 30, 2005, respectively, due primarily to higher interest rates earned in 2006 on larger overall balances of cash equivalents and short-term investments.
 
Special Charges and Manufacturing Streamlining
 
On June 1, 2006, the Company announced changes to its manufacturing operations in Puerto Rico and New Jersey that will streamline its global supply chain and further enhance the Company’s long-term competitiveness. The Company’s manufacturing operations in Manati, Puerto Rico, will be phased out during 2006 and additional workforce reductions in Las Piedras, Puerto Rico, and New Jersey will take place. In


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total, the actions taken will result in the elimination of approximately 1,100 positions. Approximately 560 positions have been eliminated as of September 30, 2006 with the majority of the remaining positions expected to be eliminated by year-end 2006. Total expenses associated with these actions are expected to be in the range of $240 million to $250 million. The Company expects these actions to result in annual savings of approximately $100 million in 2007 and thereafter.
 
Special Charges
 
Special charges for the three and nine months ended September 30, 2006 totaled $10 million and $90 million, respectively, related to the announced changes in the Company’s manufacturing operations. These charges consisted of $10 million and $35 million of severance for the three and nine months ended September 30, 2006 and $55 million of fixed asset impairments for the nine months ended September 30, 2006.
 
Special charges for the three months ended September 30, 2005 totaled $6 million primarily related to the consolidation of the Company’s U.S. biotechnology organization. Special charges for the nine months ended September 30, 2005 totaled $292 million primarily related to an increase in litigation reserves for the Massachusetts Investigation. On August 29, 2006, the Company announced it had reached an agreement with the U.S. Attorney’s Office for District of Massachusetts and the U.S. Department of Justice to settle the previously disclosed Massachusetts Investigation. The agreement is subject to court approval. Additional information regarding litigation reserves and matters is also included in Note 15, “Legal, Environmental and Regulatory Matters,” in this 10-Q.
 
Cost of Sales
 
Included in cost of sales for the third quarter of 2006 was $43 million consisting of $41 million of accelerated depreciation and $2 million of other charges related to the announced closure of the Company’s manufacturing facilities in Manati, Puerto Rico. For the nine months ended September 30, 2006, the charges included in cost of sales totaled $101 million consisting of $45 million of inventory write-offs, $54 million of accelerated depreciation and $2 million of other charges.
 
The following table summarizes the activities in the accounts reflected in the Condensed Consolidated Financial Statements for special charges and manufacturing streamlining for the three months ended September 30, 2006:
 
                                                 
    Charges
                      Non-
       
    Included in
    Special
    Total
    Cash
    Cash
    Accrued
 
    Cost of Sales     Charges     Charges     Payments     Charges     Liability  
    (Dollars in millions)  
 
Accrued liability at June 30, 2006
                                          $ 19  
Severance
  $     $ 10     $ 10     $ (12 )   $       (2 )
Asset impairments
                                   
Accelerated depreciation
    41             41             (41 )      
Inventory write-offs
                                   
Other
    2             2       (2 )            
                                                 
Total
  $ 43     $ 10     $ 53     $ (14 )   $ (41 )        
                                                 
Accrued liability at September 30, 2006
                                          $ 17  
                                                 


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The following table summarizes the activities in the accounts reflected in the Condensed Consolidated Financial Statements for special charges and manufacturing streamlining for the nine months ended September 30, 2006:
 
                                                 
    Charges
                      Non-
       
    Included in
    Special
    Total
    Cash
    Cash
    Accrued
 
    Cost of Sales     Charges     Charges     Payments     Charges     Liability  
    (Dollars in millions)  
 
Accrued liability at January 1, 2006
                                          $  
Severance
  $     $ 35     $ 35     $ (18 )   $       17  
Asset impairments
          55       55             (55 )      
Accelerated depreciation
    54             54             (54 )      
Inventory write-offs
    45             45             (45 )      
Other
    2             2       (2 )            
                                                 
Total
  $ 101     $ 90     $ 191     $ (20 )   $ (154 )        
                                                 
Accrued liability at September 30, 2006
                                          $ 17  
                                                 
 
The Company anticipates incurring from $50 million to $60 million of additional charges related to the announced changes in the Company’s manufacturing operations. Substantially all of these additional charges will be incurred during 2006. Special charges are anticipated to be in the range of $10 million to $20 million, consisting primarily of severance. Accelerated depreciation of approximately $40 million, related to the phase-out of the remaining manufacturing operations in Manati, will be charged to cost of sales.
 
Equity Income from Cholesterol Joint Venture
 
Global cholesterol franchise sales, which include sales made by the Company and the cholesterol joint venture with Merck of VYTORIN and ZETIA, totaled $1.0 billion and $2.8 billion during the three and nine months ended September 30, 2006, respectively, as compared to $622 million and $1.6 billion for the three and nine months ended September 30, 2005, respectively. As a franchise, the two products combined have captured more than 15 percent of total prescriptions in the U.S. cholesterol management market (based on September 2006 IMS data). VYTORIN has been launched in more than 35 countries, including the U.S. in August 2004. ZETIA has been launched in more than 80 countries.
 
The Company utilizes the equity method of accounting for the joint venture. Sharing of income from operations is based upon percentages that vary by product, sales level and country. The Company’s allocation of joint venture income is increased by milestones earned. Merck and Schering-Plough (the Partners) bear the costs of their own general sales forces and commercial overhead in marketing joint venture products around the world. In the U.S., Canada and Puerto Rico, the joint venture reimburses each Partner for a pre-defined amount of physician details that are set on an annual basis. The Company reports this reimbursement as part of equity income from the cholesterol joint venture. This reimbursement does not represent a reimbursement of specific, incremental and identifiable costs for the Company’s detailing of the cholesterol products in these markets. In addition, this reimbursement amount is not reflective of Schering-Plough’s sales effort related to the joint venture as Schering-Plough’s sales force and related costs associated with the joint venture are generally estimated to be higher.
 
Costs of the joint venture that the Partners contractually share are a portion of manufacturing costs, specifically identified promotion costs (including direct-to-consumer advertising and direct and identifiable out-of-pocket promotion) and other agreed upon costs for specific services such as market support, market research, market expansion, a specialty sales force and physician education programs.
 
Certain specified research and development expenses are generally shared equally by the Partners.
 
Equity income from cholesterol joint venture totaled $390 million and $1.1 billion in the third quarter and the nine months ended September 30, 2006, respectively, as compared to $215 million and $605 million, respectively, for the same periods in 2005. The increase in equity income reflected the strong sales


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performance for VYTORIN and ZETIA during the three and nine months ended September 30, 2006. Included in equity income from cholesterol joint venture is approximately $13 million resulting from the reversal of previously accrued rebate amounts for the TRICARE Retail Pharmacy Program.
 
During the nine months ended September 30, 2005, the Company recognized a milestone of $20 million for financial reporting purposes. This milestone related to certain European approvals of VYTORIN (ezetimibe/simvastatin) in the first quarter of 2005. This amount is included in equity income.
 
Under certain other conditions, as specified in the joint venture agreements with Merck, the Company could earn additional milestones totaling $105 million.
 
In addition to the milestone recognized in the first nine months of 2005, the Company’s equity income in the first nine months of 2006 and 2005 was favorably impacted by the proportionally greater share of income allocated from the joint venture on the first $300 million of annual ZETIA sales.
 
It should be noted that the Company incurs substantial selling, general and administrative and other costs, which are not reflected in equity income from the cholesterol joint venture and instead are included in the overall cost structure of the Company.
 
Provision for Income Taxes
 
Tax expense was $103 million and $275 million for the three and nine months ended September 30, 2006, respectively. Tax expense for the three and nine months ended September 30, 2005 was $23 million and $162 million, respectively. The income tax expense primarily related to foreign taxes and does not include any benefit related to U.S. Net Operating Losses (U.S. NOLs). The Company maintains a valuation allowance on its net U.S. deferred tax assets, including the benefit of U.S. NOLs, as management cannot conclude that it is more likely than not that the benefit of U.S. net deferred tax assets can be realized.
 
At December 31, 2005, the Company had approximately $1.5 billion of U.S. NOLs. The Company generated an additional U.S. NOL during the nine months ended September 30, 2006.
 
Net Income Available to Common Shareholders
 
Net income available to common shareholders includes the deduction of preferred stock dividends of $22 million in each three-month period of 2006 and 2005. The preferred stock dividends related to the issuance of the 6 percent Mandatory Convertible Preferred Stock in August 2004. In addition, net income available to common shareholders for the three and nine months ended September 30, 2006 included charges totaling $53 million and $191 million, respectively, related to actions to streamline the Company’s manufacturing operations and a $60 million favorable impact resulting from the reversal of previously accrued rebate amounts for the TRICARE Retail Pharmacy Program. The nine months ended September 30, 2006 included an income item of $22 million resulting from the cumulative effect of a change in accounting principle, net of tax, related to the implementation of SFAS 123R related to stock-based compensation. For the three and nine months ended September 30, 2005, net income available to common shareholders included special charges of $6 million and $292 million, respectively, (see Note 2, “Special Charges and Manufacturing Streamlining,” for additional information).
 
LIQUIDITY AND FINANCIAL RESOURCES
 
Discussion of Cash Flow
 
                 
    Nine Months
 
    Ended
 
    September 30,  
    2006     2005  
    (Dollars in millions)  
 
Cash flow from operating activities
  $ 1,515     $ 546  
Cash flow from investing activities
    (2,414 )     138  
Cash flow from financing activities
    (1,296 )     (1,465 )


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Net cash provided by operating activities for the nine months ended September 30, 2006 was $1.5 billion, an increase of $969 million, as compared to the same period of 2005. The increase primarily resulted from higher net income in 2006. As disclosed in Note 15, “Legal, Environmental and Regulatory Matters,” and Part II, Item 1, “Legal Proceedings,” the Company has reached an agreement with the U.S. Attorney’s Office for the District of Massachusetts and the U.S. Department of Justice to settle the previously disclosed Massachusetts Investigation for an aggregate amount of $435 million. The agreement is subject to court approval. The Company currently expects that these settlement payments will be made over the next several quarters.
 
Net cash used for investing activities during the nine months ended September 30, 2006 was $2.4 billion primarily related to the net purchase of short-term investments of $2.2 billion and $265 million of capital expenditures. Net cash provided by investing activities for the nine months ended September 30, 2005 was $138 million primarily related to net reductions in short-term investments of $438 million and proceeds from sales of property and equipment of $41 million offset by $293 million of capital expenditures and the purchase of intangible assets of $48 million.
 
Net cash used for financing activities in the nine months ended September 30, 2006 and 2005 was $1.3 billion and $1.5 billion, respectively. Uses of cash for financing activities for the nine months ended September 30, 2006 and 2005 included the payment of dividends on common and preferred shares of $308 million in each period, and the repayment of short-term borrowings of $1.0 billion and $1.2 billion, respectively.
 
As the Company’s financial situation continues to improve, the Company is moving forward with additional investments to enhance its infrastructure and business. This includes expected capital expenditures of approximately $300 million over the next several years for a pharmaceutical sciences center. The center will allow the Company to streamline and integrate the Company’s drug development process, where products are moved from the drug discovery pipeline to market. There will be additional related expenditures to upgrade equipment and staffing for the center.
 
Total cash, cash equivalents and short-term investments less total debt was approximately $2.9 billion at September 30, 2006. Cash generated from operations and available cash and short-term investments are expected to provide the Company with the ability to fund cash needs for the intermediate term.
 
Borrowings and Credit Facilities
 
The Company has outstanding $1.25 billion aggregate principal amount of 5.3 percent senior unsecured notes due 2013 and $1.15 billion aggregate principal amount of 6.5 percent senior unsecured notes due 2033. As previously disclosed, the interest rates payable on the notes are subject to adjustment and have been adjusted as discussed below.
 
On July 14, 2004, Moody’s lowered its rating on the notes to Baa1. Accordingly, the interest payable on each note increased 25 basis points effective December 1, 2004. Therefore, on December 1, 2004, the interest rate payable on the notes due 2013 increased from 5.3 percent to 5.55 percent, and the interest rate payable on the notes due 2033 increased from 6.5 percent to 6.75 percent. This adjustment to the interest rate payable on the notes increased the Company’s interest expense by approximately $6 million annually. The interest rate payable on a particular series of notes will return to 5.3 percent and 6.5 percent, respectively, and the rate adjustment provisions will permanently cease to apply if, following a downgrade by either Moody’s or S&P below A3 or A−, respectively, the notes are subsequently rated above Baa1 by Moody’s and BBB+ by S&P.
 
The Company has a $1.5 billion credit facility with a syndicate of banks. This facility matures in May 2009 and requires the Company to maintain a total debt to total capital ratio of no more than 60 percent. This credit line is available for general corporate purposes and is considered as support to the Company’s commercial paper borrowings. Borrowings under this credit facility may be drawn by the U.S. parent company or by its wholly-owned international subsidiaries when accompanied by a parent guarantee. This facility does not require compensating balances, however, a nominal commitment fee is paid. As of September 30, 2006, no borrowings were outstanding under this facility.


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In addition to the above credit facility, the Company entered into a $575 million credit facility during the fourth quarter of 2005 for the purposes of funding repatriations under the American Jobs Creation Act of 2004. As of September 30, 2006, the outstanding balance under this facility was paid in full and the facility has been terminated.
 
At September 30, 2006 and December 31, 2005, short-term borrowings, including the amount borrowed under the credit facilities mentioned above, totaled $235 million and $1.3 billion, respectively, including outstanding commercial paper of $151 million and $298 million, respectively. The short-term credit ratings discussed below have not significantly affected the Company’s ability to issue or rollover its outstanding commercial paper borrowings at this time. However, the Company believes the ability of commercial paper issuers, such as the Company, with one or more short-term credit ratings of P-2 from Moody’s, A-2 from S&P and/or F2 from Fitch to issue or rollover outstanding commercial paper can, at times, be less than that of companies with higher short-term credit ratings. In addition, the total amount of commercial paper capacity available to these issuers is typically less than that of higher-rated companies. The Company’s sizable lines of credit with commercial banks as well as cash and short-term investments held by U.S. and international subsidiaries serve as alternative sources of liquidity and to support its commercial paper program.
 
The Company’s current unsecured senior credit ratings and outlook are as follows:
 
             
Senior Unsecured Credit Ratings
  Long-term   Short-term   Outlook
 
Moody’s Investors Service
  Baa1   P-2   Stable
Standard and Poor’s
  A−   A-2   Stable
Fitch Ratings
  A−   F-2   Stable
 
The Company’s credit ratings could decline below their current levels. The impact of such decline could reduce the availability of commercial paper borrowing and would increase the interest rate on the Company’s short and long-term debt. As discussed above, the Company believes that existing cash, short-term investments and cash generated from operations will allow the Company to fund its cash needs for the intermediate term.
 
  6 Percent Mandatory Convertible Preferred Stock
 
In August 2004, the Company issued 28,750,000 shares of 6 percent mandatory convertible preferred stock with a face value of $1.44 billion. The preferred stock will automatically convert into between 2.2451 and 2.7840 common shares of the Company depending on the average closing price of the Company’s common shares over a period immediately preceding the mandatory conversion date of September 14, 2007, as defined in the prospectus. This preferred stock is described in more detail in Note 14, “Shareholders’ Equity” under Item 8,” Financial Statements and Supplementary Data,” in the 2005 10-K.
 
REGULATORY AND COMPETITIVE ENVIRONMENT IN WHICH THE COMPANY OPERATES
 
The Company is subject to the jurisdiction of various national, state and local regulatory agencies. These regulations are described in more detail in Part I, Item I, “Business,” of the 2005 10-K.
 
Regulatory compliance is complex, as regulatory standards (including Good Clinical Practices, Good Laboratory Practices and Good Manufacturing Practices) vary by jurisdiction and are constantly evolving.
 
Regulatory compliance is costly. Regulatory compliance also impacts the timing needed to bring new drugs to market and to market drugs for new indications. Further, failure to comply with regulations can result in delays in the approval of drugs, seizure or recall of drugs, suspension or revocation of the authority necessary for the production and sale of drugs, fines and other civil or criminal sanctions.
 
Regulatory compliance, and the cost of compliance failures, can have a material impact on the Company’s results of operations, its cash flows or financial condition.
 
Since 2002, the Company has been working under a U.S. FDA Consent Decree to resolve issues involving the Company’s compliance with current Good Manufacturing Practices (cGMP) at certain of its manufacturing sites in New Jersey and Puerto Rico. See details in Note 14, “Consent Decree,” in this 10-Q.


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Under the terms of the Consent Decree, the Company made payments totaling $500 million during 2002 and 2003. As of the end of 2005, the Company has completed the revalidation programs for bulk active pharmaceutical ingredients and finished drug products, as well as all 212 Significant Steps of the cGMP Work Plan, in accordance with the schedules required by the Consent Decree. The Company’s completion of the cGMP Work Plan is currently pending certification by a third party expert, whose certification is in turn subject to acceptance by the FDA. Under the terms of the Decree, provided that the FDA has not notified the Company of a significant violation of FDA law, regulations, or the Decree in the five-year period since the Decree’s entry, May 2002 through May 2007, the Company may petition the court to have the Decree dissolved and FDA will not oppose the Company’s petition.
 
The Company engages in clinical trial research in many countries around the world. These clinical trial research activities must comply with stringent regulatory standards and are subject to inspection by U.S., EU, and local country regulatory authorities. Failure to comply with current Good Clinical Practices or other applicable laws or regulations can result in delays in approval of clinical trials, suspension of ongoing clinical trials, delays in approval of marketing authorizations, criminal sanctions against the Company and/or responsible individuals, and changes in the conditions of marketing authorizations for the Company’s products.
 
The Company is subject to pharmacovigilance reporting requirements in many countries and other jurisdictions, including the U.S., the EU and the EU member states. The requirements differ from jurisdiction to jurisdiction, but all include requirements for reporting adverse events that occur while a patient is using a particular drug, in order to alert the manufacturer of the drug and the governmental agency to potential problems.
 
During 2003, pharmacovigilance inspections by officials of the British and French medicines agencies conducted at the request of the European Medicines Agency (EMEA) cited serious deficiencies in reporting processes. The Company has continued to work on its long-term action plan to rectify the deficiencies and has provided regular updates to the EMEA.
 
During the fourth quarter of 2005, local UK and EMEA regulatory authorities conducted a follow up inspection to assess the Company’s implementation of its action plan. In the first quarter of 2006, these authorities also inspected the U.S.-based components of the Company’s pharmacovigilance system. The inspectors acknowledged that progress had been made since 2003, but also continued to note significant concerns with the quality systems supporting the Company’s pharmacovigilance processes. Similarly, in a follow up inspection of the Company’s clinical trial practices in the UK, inspectors identified issues with respect to the Company’s management of clinical trials and related pharmacovigilance practices.
 
The Company intends to continue upgrading skills, processes and systems in clinical practices and pharmacovigilance. The Company remains committed to accomplish this work and to invest significant resources in this area. Further, in February 2006, the Company began the Global Clinical Harmonization Program for building clinical excellence (in trial design, execution and tracking), which will strengthen the Company’s scientific and compliance rigor on a global basis.
 
The Company does not know what action, if any, the EMEA or national authorities will take in response to the inspections. Possible actions include further inspections, demands for improvements in reporting systems, criminal sanctions against the Company and/or responsible individuals and changes in the conditions of marketing authorizations for the Company’s products.
 
Recently, clinical trials and post-marketing surveillance of certain marketed drugs of competitors’ within the industry have raised safety concerns that have led to recalls, withdrawals or adverse labeling of marketed products. In addition, these situations have raised concerns among some prescribers and patients relating to the safety and efficacy of pharmaceutical products in general. Company personnel have regular, open dialogue with the FDA and other regulators and review product labels and other materials on a regular basis and as new information becomes known.
 
Following this wake of recent product withdrawals of other companies and other significant safety issues, health authorities such as the FDA, the EMEA and the PMDA have increased their focus on safety, when assessing the benefit/risk balance of drugs. Some health authorities appear to have become more cautious


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when making decisions about approvability of new products or indications and are re-reviewing select products which are already marketed, adding further to the uncertainties in the regulatory processes. There is also greater regulatory scrutiny, especially in the United States, on advertising and promotion and in particular direct-to-consumer advertising.
 
Similarly, major health authorities, including the FDA, EMEA and PMDA, have also increased collaboration amongst themselves, especially with regard to the evaluation of safety and benefit/risk information. Media attention has also increased. In the current environment, a health authority regulatory action in one market, such as a safety labeling change, may have regulatory, prescribing and marketing implications in other markets to an extent not previously seen.
 
Some health authorities, such as the PMDA in Japan, have publicly acknowledged a significant backlog in workload due to resource constraints within their agency. This backlog has caused long regulatory review times for new indications and products, including the initial approval of ZETIA in Japan, and has added to the uncertainty in predicting approval timelines in these markets. While the PMDA has committed to correcting the backlog, it is expected to continue for the foreseeable future.
 
In 2005, the FDA issued a Final Rule removing the essential use designation for albuterol CFC products. The removal of this designation requires that all CFC albuterol products, including the Company’s PROVENTIL CFC, be removed from the market no later than December 31, 2008. This will necessitate a transition in the marketplace from albuterol CFC (PROVENTIL) to albuterol HFA (PROVENTIL HFA) no later than the end of 2008. It is difficult to predict what impact this transition will have on the albuterol marketplace and the Company’s products, but the Company currently intends to transition sooner than 2008.
 
These and other uncertainties inherent in government regulatory approval processes, including, among other things, delays in approval of new products, formulations or indications, may also affect the Company’s operations. The effect of regulatory approval processes on operations cannot be predicted.
 
The Company has nevertheless achieved a significant number of important regulatory approvals since 2004, including approvals for VYTORIN, CLARINEX D-24, CLARINEX REDITABS, CLARINEX D-12 and new indications for TEMODAR and NASONEX. Other significant approvals since 2004 include ASMANEX DPI (Dry Powder for Inhalation) in the U.S., NOXAFIL in the EU, Australia and the U.S., PEG-INTRON in Japan and new indications for REMICADE. The Company also has a number of significant regulatory submissions filed in major markets awaiting approval.
 
As described more specifically in Note 15, “Legal, Environmental and Regulatory Matters,” in this 10-Q, the pricing, sales and marketing programs and arrangements, and related business practices of the Company and other participants in the health care industry are under increasing scrutiny from federal and state regulatory, investigative, prosecutorial and administrative entities. These entities include the Department of Justice and its U.S. Attorney’s Offices, the Office of Inspector General of the Department of Health and Human Services, the FDA, the Federal Trade Commission (FTC) and various state Attorneys General offices. Many of the health care laws under which certain of these governmental entities operate, including the federal and state anti-kickback statutes and statutory and common law false claims laws, have been construed broadly by the courts and permit the government entities to exercise significant discretion. In the event that any of those governmental entities believes that wrongdoing has occurred, one or more of them could institute civil or criminal proceedings, which, if instituted and resolved unfavorably, could subject the Company to substantial fines, penalties and injunctive or administrative remedies, including exclusion from government reimbursement programs. The Company also cannot predict whether any investigations will affect its marketing practices or sales. Any such result could have a material adverse impact on the Company’s results of operations, cash flows, financial condition, or its business.
 
In the U.S., many of the Company’s pharmaceutical products are subject to increasingly competitive pricing as managed care groups, institutions, government agencies and other groups seek price discounts. In the U.S. market, the Company and other pharmaceutical manufacturers are required to provide statutorily defined rebates to various government agencies in order to participate in Medicaid, the veterans’ health care program and other government-funded programs.


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In most international markets, the Company operates in an environment of government mandated cost-containment programs. Several governments have placed restrictions on physician prescription levels and patient reimbursements, emphasized greater use of generic drugs and enacted across-the-board price cuts as methods to control costs. For example, Japan generally enacts biennial price reductions and this occurred again in April 2006. Pricing actions will occur in 2006 in certain major European markets.
 
Since the Company is unable to predict the final form and timing of any future domestic or international governmental or other health care initiatives, including the passage of laws permitting the importation of pharmaceuticals into the U.S., their effect on operations and cash flows cannot be reasonably estimated. Similarly, the effect on operations and cash flows of decisions of government entities, managed care groups and other groups concerning formularies and pharmaceutical reimbursement policies cannot be reasonably estimated.
 
The Company cannot predict what net effect the Medicare prescription drug benefit will have on markets and sales. The new Medicare Drug Benefit (Medicare Part D), which took effect January 1, 2006, offers voluntary prescription drug coverage, subsidized by Medicare, to over 40 million Medicare beneficiaries through competing private prescription drug plans (PDPs) and Medicare Advantage (MA) plans. Many of the Company’s leading drugs are already covered under Medicare Part B (e.g., TEMODAR, INTEGRILIN and INTRON A). Medicare Part B provides payment for physician services which can include prescription drugs administered along with other physician services. The manner in which drugs are reimbursed under Medicare Part B may limit the Company’s ability to offer larger price concessions or make large price increases on these drugs. Other Schering-Plough drugs have a relatively small portion of their sales to the Medicare population (e.g., CLARINEX and the hepatitis C franchise). The Company could experience expanded utilization of VYTORIN and ZETIA and new drugs in the Company’s R&D pipeline.
 
The market for pharmaceutical products is competitive. The Company’s operations may be affected by technological advances of competitors, industry consolidation, patents granted to competitors, competitive combination products, new products of competitors, new information from clinical trials of marketed products or post-marketing surveillance and generic competition as the Company’s products mature. In addition, patent positions are increasingly being challenged by competitors, and the outcome can be highly uncertain. An adverse result in a patent dispute can preclude commercialization of products or negatively affect sales of existing products. The effect on operations of competitive factors and patent disputes cannot be predicted.
 
OUTLOOK
 
Despite changes that may occur in the cholesterol reduction market as new generic products enter the market, the Company anticipates that sales from the cholesterol joint venture will grow in 2007. The Company expects lower sales of hepatitis C franchise products in Japan in the fourth quarter and in 2007 as patient enrollments continue to moderate.
 
It is anticipated that the actions taken to streamline the Company’s manufacturing operations will result in annual cost savings of approximately $100 million in 2007 and thereafter.
 
The Company anticipates that R&D expenses will continue to increase faster than net sales in the fourth quarter of 2006, but will depend on the timing of studies and the success of trials now underway. These trials include those for the Thrombin Receptor Antagonist, golimumab, vicriviroc, the Hepatitis Protease Inhibitor and the combination treatment for asthma containing ASMANEX and FORADIL.
 
As the Company continues to move forward in the Action Agenda, additional investments are anticipated to enhance the infrastructure in areas such as clinical development, pharmacovigilance and information technology.
 
Certain factors, including those set forth in Part II, Item 1A, “Risk Factors” of the Company’s 10-Q for the second quarter of 2006, could cause actual results to differ materially from the forward-looking statements in this section.


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IMPACT OF RECENTLY ISSUED ACCOUNTING STANDARDS
 
In September 2006, the Financial Accounting Standards Board (FASB) issued Statements of Financial Accounting Standard (SFAS) No. 158, “Employers’ Accounting for Defined Benefit Pension and Other Postretirement Plans,” an amendment of FASB Statements No. 87, 88, 106, and 132R. SFAS No. 158 requires an employer to: (a) recognize in its statement of financial position an asset for a plan’s overfunded status and/or a liability for a plan’s underfunded status; (b) measure a plan’s assets and its obligations that determine its funded status as of the end of the employer’s fiscal year (with limited exceptions); and (c) recognize changes in the funded status of a defined benefit postretirement plan in the year in which the changes occur. In accordance with SFAS No. 158, the Company will recognize the funded status of its pension and postretirement benefit plans in its financial statements for the year ending December 31, 2006.
 
In September 2006, the FASB issued SFAS No. 157, “Fair Value Measurements,” which is effective for calendar year companies on January 1, 2008. The Statement defines fair value, establishes a framework for measuring fair value in accordance with Generally Accepted Accounting Principles, and expands disclosures about fair value measurements. The Statement codifies the definition of fair value as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. The standard clarifies the principle that fair value should be based on the assumptions market participants would use when pricing the asset or liability and establishes a fair value hierarchy that prioritizes the information used to develop those assumptions. The Company is currently assessing the potential impacts of implementing this standard.
 
In September 2006, the SEC staff issued Staff Accounting Bulletin (SAB) Topic 1N (SAB 108), “Financial Statements — Considering the Effects of Prior Year Misstatements when Quantifying Misstatements in Current Year Financial Statements,” which is effective for calendar year companies as of December 31, 2006. SAB 108 provides guidance on how prior year misstatements should be taken into consideration when quantifying misstatements in current year financial statements for purposes of determining whether the financial statements are materially misstated. Under this guidance, companies should take into account both the effect of a misstatement on the current year balance sheet as well as the impact upon the current year income statement in assessing the materiality of a current year misstatement. Once a current year misstatement has been quantified, the guidance in SAB Topic 1M, “Financial Statements — Materiality,” (SAB 99) should be applied to determine whether the misstatement is material. The implementation of SAB 108 is not expected to have a material impact on the Company’s financial statements.
 
In July 2006, the FASB issued FASB Interpretation No. 48 (FIN 48), “Accounting for Uncertainty in Income Taxes.” FIN 48 prescribes detailed guidance for the financial statement recognition, measurement and disclosure of uncertain tax positions recognized in an enterprise’s financial statements in accordance with FASB Statement No. 109, “Accounting for Income Taxes.” Tax positions must meet a more-likely-than-not recognition threshold at the effective date to be recognized upon the adoption of FIN 48 and in subsequent periods. FIN 48 will be effective for fiscal years beginning after December 15, 2006 and the provisions of FIN 48 will be applied to all tax positions upon initial adoption of the Interpretation. The cumulative effect of applying the provisions of this Interpretation will be reported as an adjustment to the opening balance of retained earnings upon adoption. The company is currently evaluating the potential impacts of FIN 48 on its financial statements.
 
CRITICAL ACCOUNTING POLICIES
 
Refer to “Management’s Discussion and Analysis of Operations and Financial Condition” in the Company’s 2005 10-K for disclosures regarding the Company’s critical accounting policies.
 
Rebates, Discounts and Returns
 
The Company’s rebate accruals for Federal and State governmental programs at September 30, 2006 and 2005 were $256 million and $311 million, respectively. Commercial discounts, returns and other rebate accruals at September 30, 2006 and 2005 were $292 million and $279 million, respectively. These accruals are established in the period the related revenue was recognized resulting in a reduction to sales and the


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establishment of liabilities, which are included in total current liabilities, or in the case of returns and other receivable adjustments, an allowance provided against accounts receivable.
 
In the case of the governmental rebate programs, the Company’s payments involve interpretation of relevant statutes and regulations. These interpretations are subject to challenges and changes in interpretive guidance by governmental authorities. The result of such a challenge or change could affect whether the estimated governmental rebate amounts are ultimately sufficient to satisfy the Company’s obligations.
 
The following summarizes the activity in the accounts related to accrued rebates, sales returns and discounts for the nine months ended September 30, 2006 and 2005:
 
                 
    Nine Months
 
    Ended
 
    September 30,  
    2006     2005  
 
Accrued Rebates/Returns/Discounts, Beginning of Period
  $ 522     $ 537  
                 
Provision for Rebates, current year
    363       375  
Adjustments to prior-year estimates(1)
    (54 )      
Payments
    (313 )     (332 )
                 
      (4 )     43  
                 
Provision for Returns, current year
    123       125  
Adjustments to prior-year estimates
    (8 )      
Returns
    (88 )     (133 )
                 
      27       (8 )
                 
Provision for Discounts, current year
    426       309  
Adjustments to prior-year estimates
           
Discounts granted
    (423 )     (291 )
                 
      3       18  
                 
Accrued Rebates/Returns/Discounts, End of Period
  $ 548     $ 590  
                 
 
 
(1) For the nine months ended September 30, 2006, the adjustments to prior-year estimates for rebates include amounts resulting from the reversal of the accrued rebate amounts made in 2005 and 2004 for the TRICARE Retail Pharmacy Program that the U.S. Federal Court of Appeals ruled pharmaceutical manufacturers are not obligated to pay.
 
In formulating and recording the above accruals, management utilizes assumptions and estimates that include historical experience, wholesaler data, the projection of market conditions and forecasted product demand amounts. Based on a sensitivity analysis prepared by management, a reasonable possible change in these assumptions and estimates would not have a material impact on the Company’s results of operations.
 
DISCLOSURE NOTICE
 
Cautionary Statements Under the Private Securities Litigation Reform Act of 1995
 
Management’s Discussion and Analysis of Financial Condition and Results of Operations and other sections of this report and other written reports and oral statements made from time to time by the Company may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements do not relate strictly to historical or current facts and are based on current expectations or forecasts of future events. You can identify these forward-looking statements by their use of words such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “forecast,” “project,” “intend,” “plan,” “potential,” “will,” and other similar words and terms. In particular, forward-looking statements include statements relating to future actions, ability to access the capital markets, prospective products or product


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approvals, timing and conditions of regulatory approvals, patent and other intellectual property protection, future performance or results of current and anticipated products, sales efforts, research and development programs, estimates of rebates, discounts and returns, expenses and programs to reduce expenses, the cost of and savings from reductions in work force, the outcome of contingencies such as litigation and investigations, growth strategy and financial results.
 
Actual results may vary materially from the Company’s forward-looking statements and there are no guarantees about the performance of Schering-Plough’s stock or business. Schering-Plough does not assume the obligation to update any forward-looking statement. A number of risks and uncertainties could cause results to differ from forward-looking statements, including market forces, economic factors, product availability, patent and other intellectual property protection, current and future branded, generic or over-the-counter competition, the regulatory process, and any developments following regulatory approval, among other uncertainties. For further details of these and other risks and uncertainties that may impact forward-looking statements, see Schering-Plough’s Securities and Exchange Commission filings, including the risks and uncertainties set forth in Part II, Item 1A, “Risk Factors,” of the Company’s 10-Q for the second quarter of 2006.
 
Item 3.   Quantitative and Qualitative Disclosures about Market Risk
 
The Company is exposed to market risk primarily from changes in foreign currency exchange rates and, to a lesser extent, from interest rates and equity prices. Refer to “Management’s Discussion and Analysis of Operations and Financial Condition” in the Company’s 2005 10-K for additional information.
 
Item 4.   Controls and Procedures
 
Management, including the chief executive officer and the chief financial officer, has evaluated the Company’s disclosure controls and procedures as of the end of the quarterly period covered by this 10-Q and has concluded that the Company’s disclosure controls and procedures are effective. They also concluded that there were no changes in the Company’s internal control over financial reporting that occurred during the Company’s most recent fiscal quarter that have materially affected, or are reasonably likely to materially affect, the Company’s internal control over financial reporting.
 
As part of the changing business environment in which the Company operates, the Company is replacing and upgrading a number of information systems. This process will be ongoing for several years. In connection with these changes, as part of the Company’s management of both internal control over financial reporting and disclosure controls and procedures, management has concluded that the new systems are at least as effective with respect to those controls as the prior systems.
 
PART II. OTHER INFORMATION
 
Item 1.   Legal Proceedings
 
Material pending legal proceedings involving the Company are described in Item 3, “Legal Proceedings,” of the 2005 10-K. The following discussion is limited to material developments to previously reported proceedings and new legal proceedings, which the Company, or any of its subsidiaries, became a party during the quarter ended September 30, 2006, or subsequent thereto, but before the filing of this report. This section should be read in conjunction with Part I, Item 3, “Legal Proceedings” of the 2005 10-K and Part II, Item 1, “Legal Proceedings” of the 10-Q for the second quarter of 2006.
 
Investigations
 
Massachusetts Investigation.  On August 29, 2006, the Company announced it had reached an agreement with the U.S. Attorney’s Office for the District of Massachusetts and the U.S. Department of Justice to settle the previously disclosed investigation involving the Company’s sales, marketing and clinical trial practices and programs (the “Massachusetts Investigation”) (see “Massachusetts Investigation” in Part I, Item 3, “Legal Proceedings” of the 2005 10-K).


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The agreement provides for an aggregate settlement amount of $435 million and is subject to court approval. Under the agreement, Schering Sales Corporation, a subsidiary of the Company, will plead guilty to one count of conspiracy to make false statements to the government and pay a criminal fine of $180 million, and the Company will pay $255 million to resolve civil aspects of the investigation. In connection with the settlement, the Company signed an addendum to an existing corporate integrity agreement with the Office of Inspector General of the U.S. Department of Health and Human Services. The addendum will not affect the Company’s ongoing business with any customers, including the federal government.
 
As previously disclosed, the Company had recorded a liability of $500 million related to the Massachusetts Investigation, the AWP investigations and AWP litigation by certain states (see “AWP Investigations” and the litigation by certain states described under “AWP Litigation” in Part I, Item 3, “Legal Proceedings” of the 2005 10-K). The settlement amount of $435 million relates only to the Massachusetts Investigation. The AWP investigations and litigation are ongoing.
 
Item 1A.   Risk Factors
 
There are no material changes from the risk factors set forth in Part II, Item 1A, “Risk Factors” of the Company’s 10-Q for the second quarter of 2006. Please refer to that section for disclosures regarding the risks and uncertainties related to the Company’s business.
 
Item 2.   Unregistered Sales of Equity Securities and Use of Proceeds
 
This table provides information with respect to purchases by the Company of its common shares during the third quarter of 2006.
 
                                 
                Total Number of
    Maximum Number
 
                Shares Purchased as
    of Shares that May
 
          Average
    Part of Publicly
    yet be Purchased
 
    Total Number of
    Price Paid
    Announced Plans or
    Under the Plans or
 
Period
  Shares Purchased     per Share     Programs     Programs  
 
July 1, 2006 through July 31, 2006
    13,838 (1)   $ 19.03       N/A       N/A  
August 1, 2006 through August 31, 2006
    12,448 (1)   $ 20.42       N/A       N/A  
September 1, 2006 through September 30, 2006
    39,922 (1)   $ 20.99       N/A       N/A  
Total July 1, 2006 through September 30, 2006
    66,208 (1)   $ 20.47       N/A       N/A  
 
 
(1) All of the shares included in the table above were repurchased pursuant to the Company’s stock incentive program and represent shares delivered to the Company by option holders for payment of the exercise price and tax withholding obligations in connection with stock options and stock awards.


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Item 6.   Exhibits
 
         
Exhibit
       
Number
 
Description
 
Location
 
10(d)(iii)
  Schering-Plough Corporation 2006 Stock Incentive Plan (as amended and restated effective May 19, 2006 with amendments through September 19, 2006).*   Attached.
10(e)(xiii)
  Savings Advantage Plan (as amended and restated effective June 1, 2006).*   Attached.
10(h)(iii)
  Schering-Plough Corporation Directors Compensation Plan (as amended and restated effective June 1, 2006 with amendments through September 19, 2006).*   Attached.
10(m)(ii)
  Operations Management Team Incentive Plan (as amended and restated effective June 26, 2006).*   Attached.
12
  Computation of Ratio of Earnings to Fixed Charges.   Attached.
15
  Awareness letter.   Attached.
31.1
  Sarbanes-Oxley Act of 2002, Section 302 Certification for Chairman of the Board and Chief Executive Officer.   Attached.
31.2
  Sarbanes-Oxley Act of 2002, Section 302 Certification for Executive Vice President and Chief Financial Officer.   Attached.
32.1
  Sarbanes-Oxley Act of 2002, Section 906 Certification for Chairman of the Board and Chief Executive Officer.   Attached.
32.2
  Sarbanes-Oxley Act of 2002, Section 906 Certification for Executive Vice President and Chief Financial Officer.   Attached.
 
 
* Compensatory plan, contract or arrangement.


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SIGNATURE(S)
 
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
 
SCHERING-PLOUGH CORPORATION
(Registrant)
 
  By 
/s/  STEVEN H. KOEHLER

Steven H. Koehler
Vice President and Controller
(Duly Authorized Officer
and Chief Accounting Officer)
 
Date: October 27, 2006


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