UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington D.C. 20549


Form 10-Q


(Mark One)

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

For the quarterly period ended March 31, 20072008

OR

 

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

Commission file number 000-12477


Amgen Inc.

(Exact name of registrant as specified in its charter)


 

Delaware 95-3540776

(State or other jurisdiction of

of incorporation or organization)

 

(I.R.S. Employer

Identification No.)

 

One Amgen Center Drive,

Thousand Oaks, California

 91320-1799
(Address of principal executive offices) (Zip Code)

(805) 447-1000

(Registrant’s (Registrant’s telephone number, including area code)


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  x    No  ¨

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, or a non-accelerated filer.filer, or a smaller reporting company. See definitionthe definitions of “large accelerated filer,” “accelerated filer” and “large accelerated filer”“smaller reporting company” in Rule 12b-2 of the Exchange Act. (Check one):

Large accelerated filer  x    Accelerated filer  ¨    Non-accelerated filer  ¨

Large accelerated filer  xAccelerated filer  ¨Non-accelerated filer  ¨Smaller reporting company  ¨
                                    (Do not  check if a smaller reporting company)

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act)    Yes  ¨    No  x

As of April 16, 2007,May 5, 2008, the registrant had 1,159,644,5241,088,696,087 shares of common stock, $0.0001 par value, outstanding.

 



AMGEN INC.

INDEX

 

      Page No.
PART I        FINANCIAL INFORMATION  

Item 1.

  Financial Statements  1
  Condensed Consolidated Statements of OperationsIncome – Three months ended March 31, 20072008 and 20062007  21
  Condensed Consolidated Balance Sheets – March 31, 20072008 and December 31, 20062007  32
  Condensed Consolidated Statements of Cash Flows – Three months ended March 31, 20072008 and 20062007  43
  Notes to Condensed Consolidated Financial Statements  54

Item 2.

  Management’s Discussion and Analysis of Financial Condition and Results of Operations  1215

Item 4.

  Controls and Procedures  30
34
PART II        OTHER INFORMATION  

Item 1.

  Legal Proceedings  3135

Item 1A.

  Risk Factors  3435

Item 2.

  Unregistered Sales of Equity Securities, Use of Proceeds and Issuer Purchases of Equity Securities  5758

Item 5.

Other Information58

Item 6.

  Exhibits  58
  

Signatures

  59
  

Index to Exhibits

  60

 

i


PART I - FINANCIAL INFORMATION

 

Item 1.FINANCIAL STATEMENTS

The information in this report for the three months ended March 31, 2007 and 2006 is unaudited but includes all adjustments (consisting only of normal recurring accruals, unless otherwise indicated) which Amgen Inc., including its subsidiaries (referred to as “Amgen,” “we,” “our” and “us”), considers necessary for a fair presentation of the results of operations for those periods.

The Condensed Consolidated Financial Statements should be read in conjunction with our Consolidated Financial Statements and the notes thereto contained in our Annual Report on Form 10-K for the year ended December 31, 2006.

Interim results are not necessarily indicative of results for the full fiscal year.

1


AMGEN INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONSINCOME

(In millions, except per share data)

(Unaudited)

 

  Three Months Ended
March 31,
  Three Months Ended
March 31,
 
  2007 2006  2008  2007 

Revenues:

       

Product sales

  $3,565  $3,127  $3,537  $3,565 

Other revenues

   122   90   76   122 
             

Total revenues

   3,687   3,217   3,613   3,687 
             

Operating expenses:

       

Cost of sales (excludes amortization of acquired intangible assets presented below)

   592   552   546   592 

Research and development

   851   655   694   851 

Selling, general and administrative

   770   689   874   770 

Amortization of acquired intangible assets

   74   87   74   74 

Other

   10   —   
             

Total operating expenses

   2,287   1,983   2,198   2,287 
             

Operating income

   1,400   1,234   1,415   1,400 

Interest and other income and (expense), net

   (6)  80   22   (6)
             

Income before income taxes

   1,394   1,314   1,437   1,394 

Provision for income taxes

   283   313   301   283 
             

Net income

  $1,111  $1,001  $1,136  $1,111 
             

Earnings per share:

       

Basic

  $0.95  $0.83  $1.04  $0.95 

Diluted

  $0.94  $0.82  $1.04  $0.94 

Shares used in calculation of earnings per share:

       

Basic

   1,167   1,202   1,089   1,167 

Diluted

   1,177   1,218   1,092   1,177 

See accompanying notes.

2


AMGEN INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(In millions, except per share data)

(Unaudited)

 

  March 31,
2007
 December 31,
2006
   March 31,
2008
 December 31,
2007
 
ASSETS   ASSETS 

Current assets:

      

Cash and cash equivalents

  $1,067  $1,283   $4,324  $2,024 

Marketable securities

   3,770   4,994    4,323   5,127 

Trade receivables, net

   2,157   2,124    2,224   2,101 

Inventories

   2,115   1,903    2,091   2,091 

Other current assets

   1,418   1,408    1,565   1,698 
              

Total current assets

   10,527   11,712    14,527   13,041 

Property, plant, and equipment, net

   6,027   5,921 

Property, plant and equipment, net

   5,949   5,941 

Intangible assets, net

   3,643   3,747    3,271   3,332 

Goodwill

   11,269   11,302    11,347   11,240 

Other assets

   1,104   1,106    1,034   1,085 
              
  $32,570  $33,788   $36,128  $34,639 
              
LIABILITIES AND STOCKHOLDERS’ EQUITY   LIABILITIES AND STOCKHOLDERS’ EQUITY 

Current liabilities:

      

Accounts payable

  $601  $555   $522  $378 

Accrued liabilities

   3,906   4,589    3,432   3,801 

Convertible notes

   —     1,698 

Other long-term debt

   100   100 

Current portion of other long-term debt

   2,000   2,000 
              

Total current liabilities

   4,607   6,942    5,954   6,179 

Deferred tax liabilities

   466   367    381   480 

Convertible notes

   5,080   5,080    5,080   5,080 

Other long-term debt

   2,134   2,134    4,097   4,097 

Other non-current liabilities

   568   301    1,529   934 

Contingencies

      

Stockholders’ equity:

      

Preferred stock; $0.0001 par value; 5 shares authorized; none issued or outstanding

   —     —   

Common stock and additional paid-in capital; $0.0001 par value; 2,750 shares authorized; outstanding - 1,159 shares in 2007 and 1,166 shares in 2006

   24,335   24,155 

Common stock and additional paid-in capital; $0.0001 par value; 2,750 shares authorized; outstanding - 1,088 shares in 2008 and 1,087 shares in 2007

   25,088   24,976 

Accumulated deficit

   (4,638)  (5,203)   (6,031)  (7,160)

Accumulated other comprehensive income

   18   12    30   53 
              

Total stockholders’ equity

   19,715   18,964    19,087   17,869 
              
  $32,570  $33,788   $36,128  $34,639 
              

See accompanying notes.

3


AMGEN INC.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(In millions)

(Unaudited)

 

  Three Months Ended
March 31,
   Three Months Ended
March 31,
 
  2007 2006   2008 2007 

Cash flows from operating activities:

      

Net income

  $1,111  $1,001   $1,136  $1,111 

Depreciation and amortization

   244   219    266   244 

Other items, net

   193   78    16   193 

Changes in operating assets and liabilities:

   

Changes in operating assets and liabilities, net of acquisitions:

   

Trade receivables, net

   (33)  (25)   (93)  (33)

Inventories

   (201)  (2)   18   (201)

Other assets

   (7)  8    35   (7)

Accounts payable

   46   (136)   118   46 

Accrued income taxes

   (270)  373    112   (270)

Deferred revenue

   297   —   

Other accrued liabilities

   (190)  (333)   (323)  (190)
              

Net cash provided by operating activities

   893   1,183    1,582   893 
              

Cash flows from investing activities:

      

Cash restricted for acquisition of Abgenix, Inc.

   —     (2,100)

Purchases of property, plant, and equipment

   (325)  (225)

Purchases of property, plant and equipment

   (170)  (325)

Cash paid for acquisition, net of cash acquired

   (48)  —   

Purchases of marketable securities

   (1,468)  (1,191)

Proceeds from sales of marketable securities

   2,126   2,296 

Proceeds from maturities of marketable securities

   135   251    208   135 

Proceeds from sales of marketable securities

   2,296   344 

Purchases of marketable securities

   (1,191)  (481)

Other

   12   11    49   12 
              

Net cash provided by (used in) investing activities

   927   (2,200)

Net cash provided by investing activities

   697   927 
              

Cash flows from financing activities:

      

Net proceeds from issuance of common stock in connection with equity award programs

   28   138 

Repurchases of common stock

   (537)  (386)   —     (537)

Repayment of convertible notes

   (1,702)  (1)

Proceeds from issuance of convertible notes and related transactions, net

   —     440 

Proceeds from issuance of warrants

   —     774 

Net proceeds from issuance of common stock upon the exercise of employee stock options and in connection with an employee stock purchase plan

   138   89 

Repayment of debt

   —     (1,702)

Other

   65   8    (7)  65 
              

Net cash (used in) provided by financing activities

   (2,036)  924 

Net cash provided by (used in) financing activities

   21   (2,036)
              

Decrease in cash and cash equivalents

   (216)  (93)

Increase (decrease) in cash and cash equivalents

   2,300   (216)

Cash and cash equivalents at beginning of period

   1,283   1,840    2,024   1,283 
              

Cash and cash equivalents at end of period

  $1,067  $1,747   $4,324  $1,067 
              

See accompanying notes.

4


AMGEN INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

March 31, 20072008

(Unaudited)

1. Summary of significant accounting policies

Business

Amgen Inc. is a global biotechnology company that discovers, develops, manufactures and markets human therapeutics based on advances in cellular and molecular biology.

Basis of presentation

The financial information for the three months ended March 31, 20072008 and 20062007 is unaudited but includes all adjustments (consisting of only of normal recurring accruals,adjustments, unless otherwise indicated), which we considerAmgen Inc., including its subsidiaries (referred to as “Amgen,” “the Company,” “we,” “our” or “us”), considers necessary for a fair presentation of the results of operations for those periods. Interim results are not necessarily indicative of results for the full fiscal year.

The condensed consolidated financial statements should be read in conjunction with our consolidated financial statements and the notes thereto contained in our Annual Report on Form 10-K for the year ended December 31, 2007.

Principles of consolidation

The condensed consolidated financial statements include the accounts of Amgen as well as its wholly owned subsidiaries. We do not have any significant interests in any variable interest entities. All material intercompany transactions and balances have been eliminated in consolidation.

Use of estimates

The preparation of condensed consolidated financial statements in conformity with accounting principles generally accepted in the United States (“GAAP”) requires management to make estimates and assumptions that affect the amounts reported in the condensed consolidated financial statements and accompanying notes. Actual results may differ from those estimates.

Inventories

Inventories are stated at the lower of cost or market. Cost, which includes amounts related to materials, labor and overhead, is determined in a manner which approximates the first-in, first-out (“FIFO”) method. Inventories consisted of the following (in millions):

 

  March 31,
2007
  December 31,
2006
  March 31,
2008
  December 31,
2007

Raw materials

  $227  $205  $176  $173

Work in process

   1,259   1,090   1,217   1,246

Finished goods

   629   608   698   672
            
  $2,115  $1,903  $2,091  $2,091
            

5


AMGEN INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS-STATEMENTS (Continued)

 

Intangible assets and goodwillGoodwill

Intangible assets are recorded at cost, less accumulated amortization. Amortization of intangible assets is provided over their estimated useful lives ranging from 5 to 15 years on a straight-line basis (weighted-average amortization period of 14 years at March 31, 2007). Intangible assets primarily consist of acquired product technology rights of $3,030 million, net of accumulated amortization of $1,386 million, which relate to the identifiable intangible assets acquired in connection with the Immunex Corporation (“Immunex”) acquisition in July 2002. Amortization of acquired product technology rights is included in “Amortization of acquired intangible assets” in the Condensed Consolidated Statements of Operations. Intangible assets also include technology used in research and development (“R&D”) with alternative future uses (“acquired R&D technology rights”), primarily the XenoMouse® technology acquired in the Abgenix, Inc. (“Abgenix”) acquisition. Amortization of the acquired R&D technology rights is included in “Research and development” in the Condensed Consolidated Statements of Operations. Amortization of other intangible assets is principally included in “Cost of sales (excludes amortization of acquired intangible assets)” and “Selling, general and administrative” expense in the Condensed Consolidated Statements of Operations. We review our intangible assets for impairment periodically and whenever events or changes in circumstances indicate that the carrying value of an asset may not be recoverable.

Intangible assets subject to amortization

  Weighted-average
amortization period
  March 31,
2007
  December 31,
2006
 

Acquired product technology rights:

     

Developed product technology

  15 years  $2,877  $2,877 

Core technology

  15 years   1,348   1,348 

Trade name

  15 years   190   190 

Acquired R&D technology rights

  5 years   350   350 

Other intangible assets

  11 years   454   454 
           
     5,219   5,219 

Less accumulated amortization

     (1,576)  (1,472)
           
    $3,643  $3,747 
           

Goodwill principally relates to the acquisition of Immunex.Immunex Corporation (“Immunex”). The increase over the balance at December 31, 2007 is related to the goodwill associated with our acquisition of the remaining 51% ownership interest of Dompé Biotec, S.p.A (“Dompé”) on January 4, 2008 (see Note 7, “Acquisition” for further discussion). We perform an impairment test annually and whenever events or changes in circumstances indicate that the carrying amount of goodwill may not be recoverable.

Fair value measurement

The Company adopted the provisions of the Financial Accounting Standards Board’s (“FASB’s”) Statement of Financial Accounting Standards (“SFAS”) No. 157, “Fair Value Measurements” (“SFAS 157”), effective January 1, 2008, for its financial assets and liabilities. The FASB delayed the effective date of SFAS 157 until January 1, 2009, with respect to the fair value measurement requirements for non-financial assets and liabilities that are not remeasured on a recurring basis. Under this standard, fair value is defined as the price that would be received to sell an asset or paid to transfer a liability (i.e., the “exit price”) in an orderly transaction between market participants at the measurement date. The adoption of SFAS 157 did not have a material impact on the Company’s consolidated financial statements.

In determining the fair value of its financial assets and liabilities, the Company uses various valuation approaches. SFAS 157 establishes a hierarchy for inputs used in measuring fair value that maximizes the use of observable inputs and minimizes the use of unobservable inputs by requiring that observable inputs be used when available. Observable inputs are inputs that market participants would use in pricing the asset or liability based on market data obtained from sources independent of the Company. Unobservable inputs are inputs that reflect the Company’s assumptions about the inputs that market participants would use in pricing the asset or liability and are developed based on the best information available in the circumstances. The fair value hierarchy is broken down into three levels based on the source of inputs as follows:

 

Level 1Valuations based on unadjusted quoted prices in active markets for identical assets or liabilities that the Company has the ability to access
Level 2Valuations based on quoted prices for similar assets or liabilities in active markets, quoted prices for identical or similar assets or liabilities in markets that are not active and models for which all significant inputs are observable, either directly or indirectly
Level 3Valuations based on inputs that are unobservable and significant to the overall fair value measurement

6The availability of observable inputs can vary among the various types of financial assets and liabilities. To the extent that the valuation is based on models or inputs that are less observable or unobservable in the market, the determination of fair value requires more judgment. In certain cases, the inputs used to measure fair value may fall into different levels of the fair value hierarchy. In such cases, for financial statement disclosure purposes, the level in the fair value hierarchy within which the fair value measurement is categorized is based on the lowest level input that is significant to the overall fair value measurement.

The Company’s available-for-sale securities, substantially all of which are fixed income investments, are comprised of U.S. Treasury securities, obligations of U.S. government agencies, money market funds, corporate debt securities, other interest bearing securities and publicly traded equity investments. U.S. Treasury securities, money market funds and publicly traded equity investments are valued using quoted market prices with no valuation adjustments applied. Accordingly, these securities are categorized in Level 1. Obligations of U.S. government agencies, corporate debt securities and other interest bearing securities are valued using


AMGEN INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS-STATEMENTS (Continued)

 

quoted market prices of recent transactions or are benchmarked to transactions of very similar securities. When observable price quotations are not available, cash flow models are used to incorporate benchmark yields and issuer spreads. Obligations of U.S. government agencies, corporate debt securities and other interest bearing securities are categorized in Level 2.

Derivatives assets and liabilities include interest rate swaps and foreign currency forward and option contracts. The fair values of these derivatives are determined using models based on market observable inputs, including interest rate curves and both forward and spot prices for foreign currencies. All of these derivative contracts are categorized in Level 2.

The following fair value hierarchy table presents information about each major category of the Company’s financial assets and liabilities measured at fair value on a recurring basis as of March 31, 2008 (in millions):

   Fair value measurement at reporting date using:   
   Quoted prices in
active markets for

identical assets
(Level 1)
  Significant other
observable
inputs

(Level 2)
  Significant
unobservable
inputs

(Level 3)
  Balance as of
March 31, 2008

Assets:

        

Available-for-sale securities

  $4,513  $3,975  $—    $8,488

Derivatives

   —     123   —     123
                

Total

  $4,513  $4,098  $—    $8,611
                

Liabilities:

        

Derivatives

  $—    $118  $—    $118
                

Total

  $—    $118  $—    $118
                

There were no remeasurements to fair value during the three months ended March 31, 2008 of financial assets and liabilities that are not measured at fair value on a recurring basis.

Product sales

Product sales primarily consist of sales of Aranesp® (darbepoetin alfa), EPOGEN® (Epoetin alfa), Neulasta® (pegfilgrastim)/, NEUPOGEN® (Filgrastim) and Enbrel® (etanercept).

Sales of our products are recognized when shipped and title and risk of loss have passed. Product sales are recorded net of accrualsprovisions for estimated rebates, wholesaler chargebacks, discounts and other incentives (collectively “sales incentives”) and returns. Taxes assessed by government authorities on the sales of the Company’s products, primarily in Europe, are excluded from revenues.

We have the exclusive right to sell Epoetin alfa for dialysis, certain diagnostics and all non-human, non-research uses in the United States. We sell Epoetin alfa under the brand name EPOGEN®. We granted to Ortho Pharmaceutical Corporation (which has assigned its rights under the product license agreement to Ortho Biotech Products, L.P.), a subsidiary of Johnson & Johnson (“Johnson & Johnson”J&J”), a license relating to Epoetin alfa for sales in the United States for all human uses except dialysis and diagnostics. This license agreement, which is perpetual, may be terminated for various reasons, including upon mutual agreement of the parties, or default. The parties are required to compensate each other for Epoetin alfa sales that either party makes into the other party’s exclusive market, sometimes referred to as “spillover.” Accordingly, we do not recognize product sales we make into the exclusive market of Johnson & JohnsonJ&J and do recognize the product sales made by Johnson & JohnsonJ&J into our exclusive

AMGEN INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Continued)

market. Sales in our exclusive market are derived from our sales to our customers, as adjusted for spillover. We are employing an arbitrated audit methodology to measure each party’s spillover based on estimates of and subsequent adjustments thereto of third-party data on shipments to end users and their usage.

Research and development costs

Research and development (“R&D&D”) costs which are expensed as incurred areand primarily comprised of costsinclude salaries, benefits and expenses for salariesother staff related costs; facilities and benefits associated with R&D personnel; overhead and occupancy;costs; clinical trial and related clinical manufacturing includingcosts; contract services and other outside costs, process development and quality assurance;costs; information systems and amortization of technology used in R&D with alternative future uses. R&D expenses also includeconsist of internal R&D costs, costs incurred under R&D arrangements with our corporate partners, such costs related toas activities performed on behalf of corporate partners.Kirin-Amgen Inc. (“KA”), and costs associated with collaborative R&D and in-licensing arrangements, including upfront fees and milestones paid to collaboration partners in connection with technologies that have no alternative future use. R&D collaborations resulting in a net payment or reimbursement of R&D costs are recognized as the obligation has been incurred or we become entitled to the cost recovery.

Selling, general and administrative costs

Selling, general and administrative (“SG&A”) expenses are primarily comprised of salaries and benefits associated with sales and marketing, finance, legal and other administrative personnel; outside marketing expenses; overhead and facilities costs and other general and administrative costs.

Earnings per share

Basic earnings per share (“EPS”) is based upon the weighted-average number of common shares outstanding. Diluted EPS is based upon the weighted-average number of common shares and dilutive potential common shares outstanding. Potential common shares outstanding principally include stock options, restricted stock (including restricted stock units) and other equity awards under our employee compensation plans and potential issuance of stock upon the assumed conversion of our 2032 Modified Convertible Notes, 2011 Convertible Notes and 2013 Convertible Notes, as discussed below, and upon the assumed exercise of our warrants using the treasury stock method (collectively “Dilutive Securities”). The convertible note hedges purchased in connection with the issuance of our 2011 Convertible Notes and 2013 Convertible Notes are excluded from the calculation of diluted EPS as their impact is always anti-dilutive.

7Our 2011 Convertible Notes and 2013 Convertible Notes are considered Instrument C securities as defined by Emerging Issues Task Force (“EITF”) Issue No. 90-19 “Convertible Bonds with Issuer Option to Settle for Cash upon Conversion.” Therefore, only the shares of common stock potentially issueable with respect to the excess of the notes’ conversion value over their principal amount, if any, are considered as dilutive potential common shares for purposes of calculating diluted EPS. For the three months ended March 31, 2008 and 2007, the conversion values for our convertible notes were less than the related principal amounts and, accordingly, no shares were assumed to be issued for purposes of computing diluted EPS.


AMGEN INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS-STATEMENTS (Continued)

 

The following table sets forth the computation for basic and diluted EPS (in millions, except per share information):

 

   Three Months Ended
March 31,
   2007  2006

Income (Numerator):

    

Net income for basic EPS

  $1,111  $1,001
        

Shares (Denominator):

    

Weighted-average shares for basic EPS

   1,167   1,202

Effect of Dilutive Securities

   10   16
        

Weighted-average shares for diluted EPS

   1,177   1,218
        

Basic earnings per share

  $0.95  $0.83

Diluted earnings per share

  $0.94  $0.82

Reclassifications

Certain prior period amounts have been reclassified to conform to the current period presentation.

   Three months ended
March 31,
   2008  2007

Income (Numerator):

    

Net income for basic and diluted EPS

  $1,136  $1,111
        

Shares (Denominator):

    

Weighted-average shares for basic EPS

   1,089   1,167

Effect of Dilutive Securities

   3   10
        

Weighted-average shares for diluted EPS

   1,092   1,177
        

Basic EPS

  $1.04  $0.95

Diluted EPS

  $1.04  $0.94

Recent Accounting Pronouncementsaccounting pronouncements

In July 2006,December 2007, the FASB issued SFAS No. 141(R), “Business Combinations” (“SFAS 141(R)”) and SFAS No. 160, “Accounting and Reporting of Noncontrolling Interests in Consolidated Financial Accounting Standards Board (“FASB”) issued FASB Interpretation No. (“FIN”) 48, “Accounting for Uncertainty in Income TaxesStatements – an interpretationamendment of FASB StatementARB No. 109”51 (“FIN 48”SFAS 160”). These standards will significantly change the accounting and reporting for business combination transactions and noncontrolling (minority) interests in consolidated financial statements, including capitalizing at the acquisition date the fair value of acquired in-process research and development (“IPR&D”), and testing for impairment and writing down these assets, if necessary, in subsequent periods during their development. These new standards will be applied prospectively for business combinations that occur on or after January 1, 2009, except that presentation and disclosure requirements of SFAS 160 regarding noncontrolling interests shall be applied retrospectively.

In December 2007, the FASB ratified EITF No. 07-1, “Accounting for Collaborative Agreements” (“EITF 07-1”). EITF 07-1 provides guidance regarding financial statement presentation and disclosure of collaborative arrangements, as defined, which becameincludes arrangements the Company has entered into regarding development and commercialization of products and product candidates. EITF 07-1 is effective for usthe Company as of January 1, 2007. FIN 48 clarifies the accounting for uncertainty in income taxes by prescribing rules for recognition, measurement2009, and classification in our financial statements of tax positions taken orits adoption is not expected to be takenhave a material impact on our consolidated results of operations or financial position.

2. Restructuring

On August 15, 2007, we announced a plan to restructure our worldwide operations in order to improve our cost structure while continuing to make significant R&D investments and build the framework for our future growth. This restructuring plan was primarily the result of regulatory and reimbursement developments that began in 2007 involving erythropoietic stimulating agent (“ESA”) products, including our marketed ESA products Aranesp® and EPOGEN®, and the resulting impact on our operations. Our ESA products have and will continue to face current and future regulatory and reimbursement challenges, including the potential for further revisions to product labels and loss of or restrictions on reimbursement coverage. In addition, the restructuring plan is also, to a tax return.

For tax benefits to be recognized under FIN 48, a tax position must be more-likely-than-not to be sustained upon examination by taxing authorities. The amount recognized is measured aslesser degree, the largest amountresult of benefit that is greater than fifty percent likely of being realized upon ultimate settlement. As of January 1, 2007, the gross amountvarious challenges facing certain of our liabilities for unrecognized tax benefits (“UTBs”) was approximately $945 million and accrued interest related to these UTBs totaled approximately $106 million. Included in the balance is approximately $776 million of UTBs (net of the federal benefit on state taxes) that, if recognized, would affect our annual effective tax rate. The cumulative effect of applying the recognition and measurement provisions upon adoption of FIN 48 was not material.

FIN 48 also provides guidance on the balance sheet classification of liabilities for UTBs as either current or non-current depending on the expected timing of payments. Upon adoption of FIN 48, we reclassified approximately $240 million of UTBs from current income taxes payable to non-current liabilities.

8other products.


AMGEN INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS-STATEMENTS (Continued)

 

InterestThrough March 31, 2008, we have completed a majority of the actions included in our restructuring plan and penaltiesexpect that all remaining actions will be substantially completed in 2008. Key components of our restructuring plan include: (i) worldwide staff reductions aggregating approximately 2,500 positions, (ii) rationalization of our worldwide network of manufacturing facilities in order to gain cost efficiencies while continuing to meet future commercial and clinical demand for our products and product candidates and, to a lesser degree, changes to certain R&D capital projects and (iii) abandoning leases for certain R&D facilities that will not be used in our operations. We currently estimate that $775 million to $825 million of restructuring charges will be incurred in connection with these actions, of which $751 million has been incurred through March 31, 2008. Such cost estimates and amounts incurred to date are net of amounts recoverable from our co-promotion partner, Wyeth.

The following table summarizes the charges (credits) recorded during the three months ended March 31, 2008 related to UTBs are classified as a componentthe restructuring plan by type of activity (in millions):

   Separation
costs
  Asset
impairments
  Other  Total 

Cost of sales (excluding amortization of intangible assets)

  $—    $1  $—    $1 

Research and development

   2   —     —     2 

Selling, general and administrative

   —     —     (1)  (1)

Other

   4   2   4   10 
                 
  $6  $3  $3  $12 
                 

As noted above, since the inception of our provisionrestructuring plan through March 31, 2008, we have incurred $751 million of the estimated $775 million to $825 million of charges expected to be incurred. The charges incurred through March 31, 2008 include $184 million of separation costs, $411 million of asset impairments, $148 million of accelerated depreciation and $8 million of other charges, which primarily include $123 million of loss accruals for income taxes.leases offset by $115 million of cost recoveries from Wyeth.

The following table summarizes the charges and spending relating to the restructuring plan (in millions):

   Separation
costs
  Other  Total 

Restructuring reserves as of January 1, 2008

  $97  $102  $199 

Expense

   6   4   10 

Payments

   (78)   (4)  (82)
             

Restructuring reserves as of March 31, 2008

  $25  $102  $127 
             

The Company records restructuring activities in accordance with SFAS 88,Employers’ Accounting for Settlements and Curtailments of Defined Benefit Pension Plans and for Termination Benefits,SFAS 144,Accounting for the Impairment and Disposal of Long-Lived Assets and SFAS 146,Accounting for Costs Associated with Exit or Disposal Activities.

AMGEN INC.

2.NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Continued)

3. Related party transactions

We own a 50% interest in Kirin-Amgen, Inc. (“KA”),KA, a corporation formed in 1984 with Kirin BreweryHoldings Company, Limited (“Kirin”) for the development and commercialization of certain products based on advanced biotechnology. We account for our interest in KA under the equity method and include our share of KA’s profits or losses in “Selling, general and administrative” in the Condensed Consolidated Statements of Operations.Income. During the three months ended March 31, 20072008 and 2006,2007, our share of KA’s profits was $7$14 million and $12$7 million, respectively. At March 31, 20072008 and December 31, 2006,2007, the carrying value of our equity method investment in KA was $248$306 million and $241$292 million, respectively, and is included in non-current “Other assets” in the Condensed Consolidated Balance Sheets. KA’s revenues consist of royalty income related to its licensed technology rights. All of our rights to manufacture and market certain products including darbepoetin alfa, pegfilgrastim, granulocyte colony-stimulating factor (“G-CSF”) and recombinant human erythropoietin are pursuant to exclusive licenses from KA, which we currently market certain of these products under the brand names Aranesp®, Neulasta®, NEUPOGEN® and EPOGEN®, respectively. KA receives royalty income from us, as well as Kirin, Johnson & JohnsonJ&J and F. Hoffmann-La Roche Ltd. (“Roche”) under separate product license agreements for certain geographic areas outside of the United States. During the three months ended March 31, 20072008 and 2006,2007, KA earned royalties from us of $75 million and $85 million, and $74 million, respectively, whichrespectively. These amounts are included in “Cost of sales (excludes amortization of acquired intangible assets)” in the Condensed Consolidated Statements of Operations.Income. At March 31, 2008, KA owed us $6 million, which was included in “Other current assets” in the Condensed Consolidated Balance Sheets. At December 31, 2007, we owed KA $91 million, which was included in “Accrued liabilities” in the Condensed Consolidated Balance Sheets.

KA’s expenses primarily consist of costs related to R&D activities conducted on its behalf by Amgen and Kirin. KA pays Amgen and Kirin for such services at negotiated rates. During the three months ended March 31, 20072008 and 2006,2007, we earned revenues from KA of $56$32 million and $28$56 million, respectively, for certain R&D activities performed on KA’s behalf, whichbehalf. These amounts are included in “Other revenues” in the Condensed Consolidated Statements of Operations.Income.

3.4. Income taxes

The effective tax rate for the three months ended March 31, 20072008 is different from the statutory rate primarily as a result of indefinitely invested earnings of our foreign operations. We do not provide for U.S. income taxes on undistributed earnings of our controlled foreign corporationsoperations that are intended to be invested indefinitely outside the United States.

One or more of our legal entities file income tax returns in the U.S. federal jurisdiction, various U.S. state jurisdictions and certain foreign jurisdictions. Our income tax returns are routinely audited by the tax authorities in those jurisdictions. Significant disputes can arise with these tax authorities involving issues of the timing and amount of deductions and allocations of income among various tax jurisdictions because of differing interpretations of tax laws and regulations. We are no longer subject to U.S. federal income tax examinations for tax years ending on or before December 31, 20012004 or to California state income tax examinations for tax years ending on or before December 31, 2003.

9During the three months ended March 31, 2008, the gross amount of our unrecognized tax benefits (“UTBs”) increased approximately $100 million as a result of tax positions taken during the current year, and decreased approximately $185 million, net, related to tax positions taken in prior years, primarily as a result of an agreement with the Internal Revenue Service related to certain transfer pricing positions for the years 2005 and 2006. The majority of our UTBs at March 31, 2008, if recognized, would affect our effective tax rate.


AMGEN INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS-STATEMENTS (Continued)

 

The Internal Revenue Service (“IRS”) is currently examining our U.S. income tax returns for the years ended December 31, 2002 through 2004 which is anticipated to be completed in 2007. As of March 31, 2007, the IRS has proposed certain adjustments primarily related to our transfer pricing tax positions. Management is currently evaluating those proposed adjustments to determine if it agrees, but if accepted, the Company does not anticipate that the adjustments would result in a material adverse impact to our consolidated financial position, results of operations or cash flows.

As of January 1, 2007, the gross amount of our liabilities for unrecognized tax benefits was approximately $945 million. Assuming the above noted IRS audit is satisfactorily completed and assuming the application of the proposed adjustments related to our transfer pricing tax positions to subsequent periods, we believe that it is reasonably possible that our liabilities for unrecognized tax benefits may decrease by $350 million to $600 million within the next twelve months.

4.5. Financing arrangements

The following table reflects the carrying value of our long-term borrowings under our various financing arrangements as of March 31, 20072008 and December 31, 20062007 (in millions):

 

  March 31,
2007
  December 31,
2006
  March 31,
2008
  December 31,
2007

0.125% convertible notes due 2011 (2011 Convertible Notes)

  $2,500  $2,500  $2,500  $2,500

0.375% convertible notes due 2013 (2013 Convertible Notes)

   2,500   2,500   2,500   2,500

Zero coupon 30 year modified convertible notes due in 2032 (2032 Modified Convertible Notes)

   80   1,778

Floating rate notes due 2008 (2008 Floating Rate Notes)

   2,000   2,000

5.85% notes due 2017 (2017 Notes)

   1,099   1,099

4.85% notes due 2014 (2014 Notes)

   1,000   1,000   1,000   1,000

4.00% notes due 2009 (2009 Notes)

   999   999   999   999

6.375% notes due 2037 (2037 Notes)

   899   899

Other

   235   235   180   180
            

Total borrowings

   7,314   9,012   11,177   11,177

Less current portion

   100   1,798   2,000   2,000
            

Total non-current debt

  $7,214  $7,214  $9,177  $9,177
            

On March 2, 2007, asApril 17, 2008, we filed a resultshelf registration statement with the Securities and Exchange Commission (“SEC”), which replaced our previous $1.0 billion shelf registration statement, which allows us to issue an unspecified amount of certain holdersdebt securities, common stock, preferred stock, warrants to purchase debt securities, common stock, preferred stock or depository shares, rights to purchase common stock or preferred stock, securities purchase contracts, securities purchase units and depository shares. Under this registration statement, all of the 2032 Modified Convertible Notes exercising their March 1, 2007 put option,securities available for issuance may be offered from time to time with terms to be determined at the time of issuance.

In May 2008, we repurchased $2,253 millionincreased our commercial paper program by $1.3 billion, which provides for unsecured, short-term borrowings of up to an aggregate principal amount of these convertible notes$2.5 billion. We also have a $2.5 billion unsecured revolving credit facility to be used for their then-accreted valuegeneral corporate purposes, including commercial paper backup, which matures in November 2012. No amounts were outstanding under the commercial paper program or credit facility as of $1,702 million in cash, representing approximately 96% of the outstanding balance of these notes. Upon the repurchase of these notes, a pro rata portion, $51 million, of deferred financing and related costs were immediately charged to interest expense during the three months ended March 31, 2007.

10


AMGEN INC.2008.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS—(Continued)

5.6. Stockholders’ equity

Stock repurchase programs

A summary of activity under our stock repurchase programs for the three months ended March 31, 20072008 and 20062007 is as follows (in millions):

 

   2007  2006
   Shares  Dollars  Shares  Dollars

First quarter

  8.8  $537  46.6  $3,374
   2008  2007
   Shares  Dollars  Shares  Dollars

First quarter

  —    $—    8.8  $537

As of March 31, 2007, $6,002 million2008, $6.4 billion was available for stock repurchases under our stockthe $5.0 billion repurchase programs authorized byauthorization received from the Board of Directors.Directors in July 2007 and amounts remaining from the Board of Director’s previous authorization in December 2006. The manner of purchases, the amount we spend, and the number of shares repurchased will vary based on a variety of factors, including the stock price, and blackout periods, in which we are restricted from repurchasing shares, and our credit rating and may include private block purchases as well as market transactions.

Comprehensive incomeAMGEN INC.

Our comprehensive income includesNOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Continued)

7. Acquisition

On January 4, 2008, we completed the acquisition of Dompé, a privately held company that marketed certain of our products in Italy. This cash acquisition was accounted for as a business combination. The purchase price was approximately $162 million, which included the carrying value of our existing 49% ownership in Dompé. The purchase price paid was preliminarily allocated to net income, unrealized gainsassets acquired of approximately $55 million based on their estimated fair values at the acquisition date and losses on our available-for-sale securities and foreign currency forward and option contracts, which qualify and are designated as cash flow hedges, and foreign currency translation adjustments. Duringthe excess of the purchase price over the fair values of net assets acquired of approximately $107 million was assigned to goodwill. The results of Dompé’s operations have been included in the condensed consolidated financial statements commencing January 4, 2008. Pro forma results of operations for the three months ended March 31, 2007 and 2006, total comprehensive income was $1,117 million and $972 million, respectively.2008 assuming the acquisition of Dompé had taken place at the beginning of 2008 would not differ significantly from the actual reported results.

6.8. Contingencies

In the ordinary course of business, we are involved in various legal proceedings and other matters that are complex in nature and have outcomes that are difficult to predict. In accordance with SFAS 5, “Accounting for Contingencies,” we record accruals for such contingencies to the extent that we conclude that it is probable that a liability will be incurred and the amount of the related loss can be reasonably estimated. See Note 10, “Contingencies” to our Consolidated Financial Statements in our Annual Report on Form 10-K for the year ended December 31, 2007 for further discussion of certain of our legal proceedings and other matters.

Certain recent developments concerning our legal proceedings and other matters are discussed below:

Average Wholesale Price Litigation

On March 7, 2008, the Track II defendants reached a tentative class settlement of the in the federal Multi-District Litigation proceeding (“the MDL Proceeding”), captioned In Re: Pharmaceutical Industry Average Wholesale Price Litigation MDL No. 1456 pending in the Massachusetts District Court, which was subsequently amended on April 3, 2008. The tentative Track II settlement relates to claims against numerous defendants including Abbott Laboratories, Inc., Amgen Inc., Aventis Pharmaceuticals Inc., Hoechst Marion Roussel, Baxter Healthcare Corp., Baxter International Inc., Bayer Corporation, Dey, Inc., Fujisawa Healthcare, Inc., Fujisawa USA, Inc., Immunex Corporation, Pharmacia Corporation, Pharmacia & Upjohn LLC (f/k/a Pharmacia & Upjohn, Inc.), Sicor, Inc., Gensia, Inc., Gensia Sicor Pharmaceuticals, Inc., Watson Pharmaceuticals, Inc., and ZLB Behring, L.L.C. A hearing before the Massachusetts District Court was held on April 9, 2008, following which the Massachusetts District Court docketed its preliminarily approval of the proposed settlement and scheduled a fairness hearing for December 16, 2008.

Johnson & Johnson Matters

Arbitration/Demand for Separate BLA

In March 2008, Ortho Biotech Products, L.P., Ortho Biotech Inc., and Ortho-McNeil Pharmaceutical (each a wholly owned subsidiary of Johnson & Johnson, collectively, “Ortho”) and Amgen reached an agreement in principle resolving the claims raised in the arbitration demand.

Ortho Biotech Spillover Arbitration

Ortho Biotech Products, L.P. and Amgen are currently engaged in a joint review of the matters raised in Ortho’s demand and have temporarily stayed the arbitration proceedings to pursue this review.

AMGEN INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Continued)

Roche Matters

Amgen Inc. v. F. Hoffmann-La Roche Ltd., et al (“Roche”).

On February 29, 2008, the U.S. District Court for the District of Massachusetts (the “Court”) entered an Order making a preliminary ruling that the jury’s verdict will stand in all respects and that the parties’ post-trial motions are denied. The Order also preliminarily enjoined Roche, for the life of the patents-in-suit, from infringing the claims of the patents-in-suit found to have been infringed. The February 29, 2008 Order also notified the parties that the Court might modify the preliminary injunction to impose a royalty on Roche along with other conditions in lieu of an injunction. On April 2, 2008, the Court denied Roche’s request for a second extension of time to appeal the preliminary injunction or, in the alternative to modify the injunction to impose a royalty in lieu of the preliminary injunction. On April 9, 2008, Roche filed a Notice of Appeal of the preliminary injunction. Still pending before the Court is Amgen’s motion requesting a permanent injunction upon entry of final judgment that would prevent Roche from commercializing MIRCERA® in the United States during the term of Amgen’s patents which have been found to be infringed by Roche. Roche in turn has requested the Massachusetts District Court’s impose a royalty on future sales of MIRCERA® in the United States in lieu of a permanent injunction.

U.S. International Trade Commission (“ITC”)

On March 19, 2008, the United States Court of Appeals for the Federal Circuit issued a ruling on Amgen’s appeal reversing the ITC’s dismissal of the investigation on jurisdictional grounds and remanding the case for further proceeding to determine if infringement has occurred or will occur and to provide a remedy, if appropriate.

Amgen Inc., et al. v. Ariad Pharmaceuticals, Inc. (“Ariad”)

On January 31, 2008, Ariad agreed to dismiss with prejudice its claims of infringement with respect to U.S. Patent Nos. 6,150,090 and 5,804,374 for any of Amgen’s activities as of the date of the dismissal. The United States District Court for the district of Delaware (the “Delaware District Court”) granted the dismissal with prejudice on February 1, 2008. Both parties filed dispositive motions on April 25, 2008. The Delaware District Court will hold a hearing on the motions on June 19, 2008.

Federal Derivative Litigation – Rosenblum v. Sharer et al

On May 1, 2008, plaintiff in Rosenblum v. Sharer et al filed an amended complaint which removes Dennis Fenton as a defendant and also eliminates the claims for insider selling by defendants. Defendants’ response to the amended complaint is currently due on June 3, 2008.

State Derivative Litigation – Larson v. Sharer et al

In the three state shareholder derivative cases consolidated into one action captionedLarson v. Sharer et al, an amended consolidated complaint was filed on March 13, 2008, adding Anthony Gringeri as a defendant and removing the causes of action for insider selling and misappropriation of information, violation of California Corporations Code Section 25402, and violation of California Corporations Code Section 25403. Defendants’ demurrers and alternative motion to stay this action were filed on April 14, 2008, and are currently scheduled for hearing on June 10, 2008 in the Superior Court of the State of California, Ventura County.

AMGEN INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Continued)

ERISA Litigation

On February 1, 2008, the plaintiffs in the ERISA class action lawsuit ofHarris v. Amgen Inc. et alappealed the decision by the U.S. District Court for the Central District of California to dismiss the claims by both plaintiffs Harris and Ramos to the U.S. Court of Appeals for the 9th Circuit.

Third-party Payors Litigation

On April 8, 2008, the Judicial Panel on Multi-District Litigation granted plaintiffs’ motion in the United Food & Commercial Workers Central Pennsylvania and Regional Health & Welfare Fund v. Amgen Inc. to centralize the five third-party payor lawsuits into one multi-district litigation (“MDL”) case for the purpose of consolidated pretrial proceedings and the five cases are being transferred back to the U.S. District Court for the Central District of California. The cases will be transferred back to the home jurisdictions if and when they are set for trial.

Other

On April 4, 2008, the Attorney General for the State of Louisiana filed a Notice of Dismissal Without Prejudice for the lawsuit filed against Amgen on January 14, 2008 in the Civil District Court for the Parish of Orleans, State of Louisiana.

In the ordinary course of business, we are involved in various legal proceedings and other matters, including those that are tax-related.discussed above. While it is not possible to accurately predict or determine the eventual outcome of these items, we do not believe any suchone or more of these items currently pending willcould have a material adverse effect on our consolidated results of operations, financial position or liquidity, although an adverse resolution in any quarterly or annual reporting period of one or more of these items could have a material impact on the consolidated results of our operations for that period.

11cash flows.


Item 2.MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONOPERATIONS

Forward looking statements

This report and other documents we file with the Securities and Exchange Commission (“SEC”)SEC contain forward looking statements that are based on current expectations, estimates, forecasts and projections about us, our future performance, our business or others on our behalf, our beliefs and our management’s assumptions. In addition, we, or others on our behalf, may make forward looking statements in press releases or written statements, or in our communications and discussions with investors and analysts in the normal course of business through meetings, webcasts, phone calls and conference calls. Words such as “expect,” “anticipate,” “outlook,” “could,” “target,” “project,” “intend,” “plan,” “believe,” “seek,” “estimate,” “should,” “may,” “assume,” “continue,” variations of such words and similar expressions are intended to identify such forward looking statements. These statements are not guarantees of future performance and involve certain risks, uncertainties and assumptions that are difficult to predict. We describe our respective risks, uncertainties and assumptions that could affect the outcome or results of operations in “ItemItem 1A. Risk Factors.Factors.” We have based our forward looking statements on our management’s beliefs and assumptions based on information available to our management at the time the statements are made. We caution you that actual outcomes and results may differ materially from what is expressed, implied or forecast by our forward looking statements. Reference is made in particular to forward looking statements regarding product sales, regulatory activities, clinical trial results, reimbursement, expenses, EPS, liquidity and capital resources and trends. Except as required under the federal securities laws and the rules and regulations of the SEC, we do not have any intention or obligation to update publicly any forward looking statements after the distribution of this report, whether as a result of new information, future events, changes in assumptions or otherwise.

Overview

The following management’s discussionManagement’s Discussion and analysisAnalysis of Financial Condition and Results of Operations (“MD&A”) is intended to assist the reader in understanding Amgen’s business. MD&A is provided as a supplement to, and should be read in conjunction with, our Condensed Consolidated Financial Statementscondensed consolidated financial statements and accompanying notes included in this Quarterly Report on Form 10-Q and our Consolidated Financial Statementsconsolidated financial statements and accompanying notes included in our Annual Report on Form 10-K for the year ended December 31, 2006.2007.

We are a global biotechnology company that discovers, develops, manufactures and markets human therapeutics based on advances in cellular and molecular biology. Our mission is to serve patients. As a science-based, patient-focused organization, we discover and develop innovative therapies to treat grievous illness. We operate in one business segment – human therapeutics. Therefore, our results of operations are discussed on a consolidated basis.

We primarily earn revenues and income and generate cash from sales of human therapeutic products in the areas of supportive cancer care, nephrology inflammation and beginning in the third quarter 2006, in oncology when we received U.S. Food and Drug Administration (“FDA”) approval and launched Vectibix™ (panitumumab), our first cancer therapeutic. For the three months ended March 31, 2007, total revenues were $3.7 billion and net income was $1.1 billion or $0.94 per share. The results of our operations for the three months ended March 31, 2007 reflect the $51 million write-off of deferred financing and related costs resulting from the repayment of the $1.7 billion of convertible debt. As of March 31, 2007, cash, cash equivalents and marketable securities were $4.8

12


billion, of which approximately $3.8 billion was generated from operations in foreign tax jurisdictions and is intended for use outside the United States. The total debt outstanding was $7.3 billion as of March 31, 2007.

inflammation. Our principal products include Aranesp®, EPOGEN®, Neulasta®/, NEUPOGEN® and ENBREL, all of which are sold in the United States. Aranesp® and EPOGEN® stimulate the production of red blood cells to treat anemia and belong to a class of drugs referred to as erythropoiesis-stimulating agents, or ESAs. Aranesp® is used for the treatment of anemia both in supportive cancer care and in nephrology. EPOGEN® is used to treat anemia associated with chronic renal failure (“CRF”). Neulasta® and NEUPOGEN®, which are used in supportive cancer care, selectively stimulate the production of neutrophils, one type of white blood cell that helps the body fight infections. ENBREL is marketed under a co-promotion agreement with Wyeth in the United States and Canada. ENBREL blocks the biologic activity of tumor necrosis factor (“TNF”) by inhibiting TNF, a substance induced in response to inflammatory and immunological responses, such as rheumatoid arthritis and psoriasis. For each of the three months ended March 31, 2008 and 2007, our principal products represented 95% of total worldwide product sales. Our international product sales consist principally of European sales of Aranesp® and, Neulasta®/ and NEUPOGEN®. International product sales represented approximately 19%21% and 18%19% of total product sales for each of the three months ended March 31, 2008 and 2007, respectively. For additional information about our principal products, their

approved indications and 2006, respectively.where they are marketed, see “Item 1. Business – Principal products” in Part I of our Annual Report on Form 10-K for the year ended December 31, 2007.

We operate in a highly regulated industry and various U.S. and foreign regulatory bodies have substantial authority over how we conduct our business. Government authorities in the United States and in other countries regulate the manufacturing and marketing of our products and our ongoing R&D activities. The regulatory environment is evolving and there is increased scrutiny on drug safety and increased authority being granted to regulatory bodies, in particular the U.S. Food and Drug Administration (“FDA”), to assist in ensuring the safety of therapeutic products. Most patients receiving our principal products for approved indications are covered by either government or private payer health care programs. The reimbursement environment is also evolving with greater emphasis on cost containment. Therefore, sales of our principal products and sales growth are and will continue to be affected by the availability and extent of reimbursement from third-party payers, including government and private insurance plans and administration of those programs. For additional information aboutFurther, safety signals or adverse events or results from clinical trials or studies performed by us or by others (including our principal products, their approved indications and where they arelicensees or independent investigators) or from the marketed see “Item 1. Business – Principal products” in Part Iuse of our Annual Report on Form 10-Kproducts may expand safety labeling, restrict the use for the year ended December 31, 2006.our approved products or may result in additional regulatory requirements, such as requiring risk management activities and/or additional or more extensive clinical trials as part of postmarketing commitments (“PMCs”) or a pharmacovigilance program, and may negatively impact worldwide reimbursement for our products.

ForTotal product sales for the three months ended March 31, 2007 and 2006, product sales represented 97% of total revenues, which was mainly comprised of our principal products. During this period, our product sales growth has been primarily driven by sales of2008 decreased 1%, principally due to a decline in U.S. Aranesp® sales, which was substantially offset by an increase in ENBREL sales. In particular, for the three months ended March 31, 2008, U.S. Aranesp® sales declined $249 million, or 38%, Neulastareflecting the negative impact on demand, primarily in the supportive cancer care setting, of ongoing regulatory and reimbursement developments that were principally realized in the second half of 2007. Sales of ENBREL increased $221 million, or 30%, for the three months ended March 31, 2008. This increase includes an initial wholesaler inventory stocking of approximately $120 million resulting from the shift to a wholesaler distribution model. During the three months ended March 31, 2008, ENBREL’s distribution model was converted from primarily being drop shipped directly to pharmacies to a wholesaler distribution model similar to our other products. The increase in ENBREL’s sales also reflects higher demand due to increases in both patients and average net sales price.

Certain of our products, principally our marketed ESA products, face various challenges resulting from regulatory and reimbursement developments. Late in 2006 and throughout 2007, adverse safety results involving ESA products were observed in various studies that were performed by us and by others (including our licensees or independent investigators) that explored the use of ESAs in settings different from those outlined in the FDA approved label, including targeting higher hemoglobin (“Hb”) levels and/or use in non-approved patient populations. The results of these studies culminated in significant regulatory and reimbursement developments affecting the class of ESA products, including Aranesp® and ENBREL, which have benefited primarilyEPOGEN®. For example, in February 2007, following the reported results from segment growth and/or share gains. We believe that maintaining or increasing our segments and share will be more difficult than in previous years since, as discussed below, certain of our principal products face various challenges primarily arising from clinical trial results that led to regulatory activities, including revisions to labeling of certain of our products, coverage and reimbursement reviews, and new competition.

Our anemia products have and are continuing to experience significant regulatory challenges. Various clinical studies by Amgen, including our Anemia of Cancer phase 3 study (the “AoC 103 Study”study”), and third-party studies involving erythropoiesis-stimulating agents (“ESAs”) in off-label uses have recently reported negative safety results. Due to the reported results of our AoC 103 Study, the United States Pharmacopoeia Dispensing Information (“USP DI”) Drug Reference Guides removed Aranesp® for use in the treatment of Anemia of Cancer (“AoC”).AoC. Thereafter, nearly all Medicare contractors have stopped reimbursing for Aranesp® use in AoC patients. Further, on March 9,decreased significantly. In addition, during 2007, based upon data from our AoC 103 Studywe had ongoing discussions with the FDA and other third-party studies,regulatory authorities and meetings with certain of the FDA approved updated safety information, including a boxed warning, inFDA’s advisory panels, namely the prescribing information forOncologic Drugs Advisory Committee (“ODAC”), the class of ESAs, including Aranesp® and EPOGEN®. The label changesCardiovascular-Renal Drug Advisory Committee (“CRDAC”) and the lossDrug Safety and Risk Management Advisory Committee (“DSaRMAC”), regarding the administration of substantially all of the Medicare coverage for Aranesp®our ESA products in AoC could materially impact futurecertain settings. These adverse safety results involving ESA products in various studies and related discussions with regulatory authorities led to several key regulatory and reimbursement developments, including safety-related revisions to ESA product sales, as applicable, for Aranesp® and EPOGEN®. Sales growth slowed for Aranesp®labels in the United States in the latter part of the three months ended March 31,and November 2007. Further, in July 2007, reflecting these developments. Through March 31, 2007, the impact on product sales has been primarily observed in oncology due to the loss of nearly all Medicare coverage in the AoC setting.

However, on April 19, 2007, we announced the results from our “145 study” of Aranesp® in small-cell lung cancer which demonstrated no statistically significant difference in risk of death or in investigator determined progression-free survival. This study had higher initiation and maintenance hemoglobin targets (Hb less than or equal to 13 g/dl) than in the U.S. label. We believe these results contribute to the growing body of evidence on ESA safety when used on label, reinforcing the neutral impact of ESAs on survival in cancer patients suffering from chemotherapy-induced anemia.

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In addition, the outcome of certain future key events could also impact future Aranesp® and EPOGEN® sales as they may influence healthcare provider prescribing behavior, use of our products, regulatory or private healthcare organization medical guidelines and reimbursement practices. For example, the following could impact future Aranesp® sales: On March 14, 2007, shortly after the label changes for all ESAs, the Centers for Medicare and Medicaid Services (“CMS”) issued its National Coverage Decision Memorandum for Use of Erythropoiesis Stimulating Agents in Cancer and Related Neoplastic Conditions (the “Decision Memorandum”). The Decision Memorandum established the ESA reimbursement policy for Medicare and other government beneficiaries who are treated for chemotherapy-induced anemia (“CIA”) with ESAs. We believe that the restrictions in the Decision Memorandum changed the way ESAs are used in clinical practice,

for example, by decreasing the number of treated patients, the average ESA dose and the duration of ESA therapy. These developments have had a material adverse impact on sales of our marketed ESA products, in particular Aranesp® sales in the U.S. supportive cancer care setting. Furthermore, our ESA products continue to face future challenges, including those described below under“ESA Developments” and also the potential for further revisions to product labels and changes to reimbursement. In addition, increased competition, including additional approved indications for existing products, has and will continue to present challenges to certain of our products.

As a result of the challenges facing certain of our products and, in particular, the regulatory and reimbursement developments involving our marketed ESA products that began in 2007 and their resulting impact on our operations, on August 15, 2007, we announced a plan to restructure our worldwide operations in order to improve our cost structure while continuing to make significant R&D investments and build the framework for our future growth. Through March 31, 2008, we have completed a majority of the actions included in our restructuring plan and expect that all remaining actions will be substantially completed in 2008. Key components of our restructuring plan include: (i) worldwide staff reductions aggregating approximately 2,500 positions, (ii) rationalization of our worldwide network of manufacturing facilities in order to gain cost efficiencies while continuing to meet future commercial and clinical demand for our products and product candidates and, to a lesser degree, changes to certain R&D capital projects and (iii) abandoning leases for certain R&D facilities that will not be used in our operations. We currently anticipate that we will incur approximately $775 million to $825 million of restructuring charges in connection with these actions, of which $751 million has been incurred through March 31, 2008.

The following is a discussion of select key developments affecting our business that occurred in 2008 and should be read in conjunction with “Item 1. Business – Key Developments” in Part I of our Annual Report on Form 10-K for the year ended December 31, 2007.

ESA Developments

On January 1, 2008, the CMS’ revisions to its Claims Monitoring Policy: Erythropoietin/darbepoetin alfa usage for beneficiaries with end stage renal disease (“EMP”) became effective which require a 50% reduction in Medicare reimbursement if a patient’s Hb is above 13 grams per deciliter (“g/dL”) for three or more consecutive months. In addition, the EMP reduces the monthly dosing limits to 400,000 international units (“IUs”) of EPOGEN®, from 500,000 IUs, and to 1,200 micrograms (“mcgs”) of Aranesp®, from 1,500 mcgs. We believe that the EMP implementation in January 2008 has significantly impacted physician behavior resulting in declines in dosing trends, however we believe that the pronounced dose declines, which have been observed in the quarter of implementation, will moderate in subsequent quarters, as has been observed with prior years’ EMP changes.

On March 13, 2008, the FDA held a follow-up ODAC panel meeting to discuss cumulative data, including recent study results, on the risks of ESAs when used in the oncology setting. Responding to questions posed by the FDA, the ODAC members discussed (i) continuing to allow the marketing of ESAs for use in the treatment of anemia due to concomitant cancer chemotherapy, (ii) restricting the use of ESAs to only patients with small cell lung cancer, (iii) including a statement that ESA use is not indicated for patients receiving potentially curative treatments, (iv) including a statement that ESA use is not indicated for patients with breast and/or head and neck cancers, (v) requiring the implementation of an informed consent/patient agreement for the treatment of CIA and (vi) restricting the distribution system for oncology patients receiving ESAs. The ODAC is an advisory committee of external experts who advise the FDA about the safety and efficacy of drug products for use in treating cancer patients. This committee is advisory only and FDA officials are not bound to or limited by their recommendations. However, the FDA commonly follows the recommendations of its advisory panels. We are in ongoing discussions with the FDA and, in connection with the available safety data, including the data and study results discussed at the ODAC, the FDA has asked us to (i) propose additional safety-related changes to the labeling for Aranesp® and EPOGEN®, (ii) develop a proposed risk evaluation and mitigation strategy (“REMS”) for Aranesp® and

EPOGEN® and (iii) conduct clinical trials to determine the effects of Aranesp® and EPOGEN® on survival and tumor outcomes. We are in the process of preparing the submissions responsive to the FDA’s recent requests.

On March 7, 2008, we announced that the FDA approved updated safety information, including an updated boxed warning in the labeling information for the class of ESAs, including Aranesp® and EPOGEN®. The updated boxed warning states that ESAs shortened overall survival and/or time-to-tumor progression in clinical studies in patients with breast, non-small cell lung, head and neck, lymphoid and cervical cancers when dosed to a target Hb of greater than or equal to 12 g/dL. In the “Increased Mortality and/or Tumor Progression” warning section of the updated labeling, the interim results of the Preoperative Epirubicin Paclitaxel Aranesp® (“PREPARE”) study in neo-adjuvant breast cancer were added as well as follow up data from the Gynecologic Oncology Group study (“GOG-191 study”) in cervical cancer.

On March 5, 2008, we announced that the European Commission reached its decision to amend the prescribing information (“PI”) for the class of ESAs, including Aranesp®, based on the positive opinion from the European Committee for Medicinal Products for Human Use (“CHMP”) in January 2008. This includes stipulating a uniform target Hb range of 10 g/dL to 12 g/dL with guidance to avoid sustained Hb levels above 12 g/dL. In addition, on May 6, 2008, we announced that the CHMP has requested that we and other ESA marketing authorization holders participate in a closed meeting of the Scientific Advisory Group on Oncology (“SAG-O”) on May 15, 2008. The marketing authorization holders have been asked to provide an overview on studies that have been initiated or conducted since July 2007, as well as any other new data that can help to elucidate recent issues on the impact of ESAs on tumor progression and survival in cancer patients. These data include previously disclosed interim results from the PREPARE study in neoadjuvant breast cancer therapy; follow-up data from the GOG-191 study in cervical cancer, which were published in the February 2008 issue of Gynecologic Oncology; and the February 2008 meta-analysis by Bennett et al, which was published in the Journal of the American Medical Association. Scientific Advisory Groups (“SAGs”) are created by the CHMP to deliver answers, on a consultative basis, to specific questions addressed to them by the CHMP. The CHMP, while taking into account the position expressed by the SAG, remains responsible for its final opinion.

Other Regulatory Developments

On March 17, 2008, we and Wyeth Pharmaceuticals, a division of Wyeth, announced updates to the FDA approved PI for ENBREL in which the U.S. PI now contains a boxed warning relating to the risk of infections, including tuberculosis. This information now in the boxed warning includes additional language regarding screening and monitoring patients for tuberculosis, including patients who tested negative for latent tuberculosis infection.

On May 1, 2008, we announced that the agency had begun reviewing all Medicare policies related to the administration of ESAs in non-renal disease applications as part of a national coverage analysis (“NCA”) which is generally CMS’ first step toward developing a national coverage determination (“NCD”). Generally, a NCD is a national policy statement granting, limiting or excluding Medicare coverage or reimbursement for a specific medical item or service. In addition, the FDA has invitedasked us to participate in a meeting of the OncologicDermatologic and Ophthalmic Drugs Advisory Committee (“ODAC”DODAC”) meeting on May 10, 2007June 18, 2008 to review progress in delineatingdata supporting the effects of ESAs on survival and tumor progression in cancer patients. Further, the European Medicines Agencysupplemental biologic license application (“EMEA”BLA”) has also reported that it is reviewing the safety of ESAs, madesubmitted by us Johnson & Johnson, Shire Pharmaceutical Group plc (“Shire”) and Roche. The following could impact future EPOGEN® sales: CMS has stated thatfor the agency is currently reviewing the Claims Monitoring Policy: Erythropoietin/darbepoetin alfa usage for beneficiaries with end stage renal disease (“EMP”) foruse of ENBREL in treating pediatric patients with end stage renal disease (“ESRD”)chronic moderate to severe plaque psoriasis, who are dialyzed in renal facilities although theyinadequately controlled with topical therapy or who have not yet announced further changes to the EMP. Additionally, onreceived systemic therapy or phototherapy.

On March 12, 2008, the ODAC voted unanimously that the data from our two phase 3 clinical studies evaluating Nplate™ (Romiplostim) for the treatment of thrombocytopenia in immune (idiopathic) thrombocytopenic purpura (“ITP”), which met both primary and secondary endpoints, supports a positive risk/benefit profile for Nplate™. The FDA has required us to submit a REMS as part of our BLA for NplateTM, which extended its Prescription Drug User Fee Act (“PDUFA”) date

from April 23, 2008 to July 23, 2008. As noted above, the ODAC is advisory only and FDA officials are not bound to or limited by their recommendations, however the FDA commonly follows the recommendations of its advisory panels.

In December 2007, Vectibix® (panitumumab) was granted a conditional marketing authorization by the European Commission for the treatment of metastatic carcinoma of the colon or rectum after failure of standard chemotherapy and was launched in several European countries in the first quarter of 2008.

Licensing Developments

In April 12, 2007 after2008, we entered into a review of existing guidelines, the National Kidney Foundationlicense agreement with Kyowa Hakko Kogyo Co., Limited (“NKF”) distributed to the nephrology community a draft of the Kidney Disease Outcomes Quality Initiative (“KDOQI”) Clinical Practice Guideline and Clinical Practice Recommendations for Anemia Management in Chronic Kidney Disease (“proposed KDOQI guidelines”Kyowa Hakko”), which provides us the exclusive rights to develop and commercialize Kyowa Hakko’s humanized monoclonal antibody KW-0761, which is in phase 1 clinical trials, worldwide, except in Japan, Korea, China and Taiwan. We initially acquired rights in all non-oncology indications and may elect to expand the license to include oncology at a later date. In connection with entering into the agreement, we are currently reviewingrecorded a R&D expense in April 2008 for the required $100 million (approximately $62 million, net of tax) up-front payment.

In connection with our efforts to assess the potential impactimprove our cost structure, we refocused our spending on critical R&D and operational priorities and sought greater efficiencies in how we conduct our business, including optimizing on-going clinical trials and trial initiation. These efforts will assist in allowing us to provide continued support of key activities including (i) current and future sales of EPOGEN®. The potential impact of these key events on future sales forpostmarketing studies, including those with respect to our ESA products, Aranesp® and EPOGEN®, as applicable, is highly uncertain; (ii) regulatory affairs, safety and currently not determinable.

Our anemia productscompliance functions; (iii) clinical studies to advance our late-stage pipeline; (iv) the advancement of earlier stage compounds and certain other principal products are also facing a number of competitive challenges as well. Roche is developing a pegylated erythropoietin molecule (“peg-EPO”) product for the United States for which they have filed a biologic license application (“BLA”) with the FDA, which Roche has stated has a Prescription Drug User Fee Act (“PDUFA”) date of May 19, 2007. Roche has announced plans to launch(v) research efforts in the U.S. nephrology segment in 2007, upon regulatory approval, despite our ongoing lawsuitcore areas of oncology, inflammation, bone and their acknowledgment of our U.S. erythropoietin patents. We also expect Roche’s peg-EPO product to be launched in the European Union (“EU”) nephrology segment in 2007 upon regulatory approval.metabolic disorders. Further, in order to continue advancing our expanding pipeline of product candidates and to assist in ensuring that patients around the first quarter of 2007, Shire received approval in the EU for Dynepo™ (Epoetin delta), a competing erythropoietin product. Additionally,world are able to benefit from our future products, we cannot predict with certainty when the first biosimilar products could appear on the market in the EU, however we believe that the first biosimilar erythropoietin products, which would compete with Aranesp®, may be approved in 2007 and could be available in the EU shortly after approval and the first biosimilar G-CSF products, which would compete with Neulasta® and NEUPOGEN®, may be approved sometime in 2007 or early 2008, and could be available in the EU soon thereafter. In addition, ENBREL operates in an extremely competitive environment as evidenced by the number of competitive products, including HUMIRA®, Remicade®, Orencia®, Rituxan®, Raptiva® and Amevive®. Although these competing products have helpedseek partners to grow both the rheumatology and dermatology segments, they have also resulted in ENBREL experiencing share loss in both of these segments.

Further, as a result of safety concerns related to patient survival, we recently announced that we had discontinued Vectibix™ treatmentdevelop selected product candidates in our Panitumumab Advanced Colorectal Cancer Evaluation (“PACCE”) trial, a non-registration-enabling trial evaluating the additionpipeline in certain countries and/or worldwide. We may also divest of Vectibix™ to standard chemotherapy and Avastin®certain less significant marketed products. (bevacizumab) for the treatment of first-line metastatic colorectal cancer. We are in discussions with the FDA with respect to the Vectibix™ label and expect

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that we will add the data from the PACCE trial to the label. The language is still in development, discussions with the FDA are on-going and any label change is subject to FDA approval. The results of the PACCE trial do not influence ongoing registrational studies in combination with chemotherapy in first and second line metastatic colorectal cancer. Further, we continue to be in discussions with the EMEA and the Committee for Medicinal Products for Human Use (“CHMP”) with respect to the approval of Vectibix™ in the EU to treat patients with metastatic colorectal cancer whose disease has progressed on or following all standard chemotherapy regimens. In the event that Amgen should not obtain an initial positive CHMP opinion, we can request re-examination of the CHMP opinion as part of the EU regulatory process.

For the three months ended March 31, 20072008, net income and 2006, operating income was as follows (in millions):

   Three Months
Ended March 31,
    
   2007  2006  Change 

Operating Income

  $1,400  $1,234  13%

Operating income as a percentagediluted earnings per share were $1.1 billion and $1.04, respectively. As of product sales was 39% for both the three months ended March 31, 20072008, cash, cash equivalents and 2006. As a resultmarketable securities were $8.6 billion, of which approximately $4.5 billion was generated from operations in foreign tax jurisdictions and is intended for use in our foreign operations. If these funds are repatriated for use in our U.S. operations, we would be required to pay additional U.S. federal and state income taxes at the impactapplicable marginal tax rates. Our total debt outstanding was $11.2 billion as of recent developments discussed above on Aranesp® and EPOGEN® sales, management has begun taking actions to reduce operating expense growth in order to offset any decline in revenues.March 31, 2008.

We focus our R&D on novel human therapeutics for the treatment of grievous illness. We have substantially expanded our R&D capabilities to manage and execute increasingly larger and more complex clinical trials and to build the capacity to advance more compounds into and through the clinic. In the near term, we expect to see further growth in R&D expense in 2007, but not to the same extent experienced in 2006. For example, the nine “mega-site” trials, which we began in 2006, will continue to require significant time, resources and expense to execute. However, as a result of recent regulatory and reimbursement challenges related to Aranesp® and EPOGEN®, we have been and will continue to assess the optimal level of our R&D investment. To the extent future sales of Aranesp® and EPOGEN®There are negatively impacted as a result of these recent events, we may defer or possibly cancel previously planned clinical trials in order to adjust our R&D investment plans. In order to increase the number of patients available for enrollment for our clinical trials, we have and will continue to open clinical sites and enroll patients in a number of new geographic locations where our experience conducting clinical trials is more limited, including Russia, China, India and some Central and South American countries utilizing third-party contract clinical trial providers.

There arealso many economic and industry-wide factors that affect our business generally and uniquely, including, among others, those relating to increased complexity and cost of R&D due, in part, to greater scrutiny of clinical trials with respect to safety which may lead to fewer treatments being approved by the FDA or other regulatory bodies;bodies and/or safety-related label changes for approved products; increasingly intense competition for marketed products and product candidates; broad reimbursement changes; healthcare provider prescribing behavior, regulatory or private healthcare organization medical guidelines and reimbursement practices; complex and expanding regulatory requirements; and intellectual property protection. See “ItemItem 1. Business”Business in Part I of our Annual Report on Form 10-K for the year ended December 31, 20062007 and “ItemItem 1A. Risk Factors”Factors in Part II herein for further information on these economic and industry-wide factors and their impact and potential impact on our business.

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Reimbursement

Sales of all of our principal products are dependent, in part, on the availability and extent of reimbursement from third-party payers, including governments and private insurance plans. Generally, in Europe and other countries outside the United States, the government sponsored healthcare system is the primary payer of healthcare costs of patients. Governments may regulate access to, prices or reimbursement levels of our products to control costs or to affect levels of use of our products. Worldwide use of our products may be affected by these cost containment pressures and cost shifting from governments and private insurers to healthcare providers or patients in response to ongoing initiatives to reduce or reallocate healthcare expenditures. Further, adverse events or results from clinical trials or studies performed by us or by others or from the marketed use of our drugs may expand safety labeling for our approved products and may negatively impact worldwide reimbursement for our products. On July 30, 2007, the CMS issued its Decision Memorandum and on January 14, 2008, issued changes to its Medicare National Coverage Determinations Manual, effective for claims with dates of service on or after July 30, 2007, with an implementation date of April 7, 2008. A discussion of the Decision Memorandum follows below. (See also “—Item 1A. Risk FactorsOur current products and products in development cannot be sold if we do not gain or maintain regulatory approval of our products and we may be required to perform additional clinical trials or change the labeling of our products or takeconduct other potentially limiting or costly actionsrisk management activities if we or others identify side effects or safety concerns after our products are on the market.” and “—Guidelines and recommendations published by various organizations can reduce the use of our products.products.”)

Most patients receiving Aranesp®, Neulasta® and NEUPOGEN® for approved indications are covered by both government andand/or private payer healthcare programs. GovernmentMedicare and Medicaid government healthcare programsprograms’ payment policies for drugs and biologicals are governed bysubject to various laws and regulations. Beginning in January 1, 2005 under the Medicare Prescription Drug Improvement and Modernization Act (the “MMA”) which was enacted into law in December 2003 and became effective January 1, 2005. Since January 1, 2005,, in the physician clinic setting and since January 1, 2006, in the hospital outpatient setting,and dialysis settings, Aranesp®, Neulasta® and NEUPOGEN® have been reimbursed under a Medicare Part B payment methodology that reimburses each product at 106% of its “averageaverage sales price”price (“ASP”) (sometimes referred to as “ASP+6%”). Effective January 1, 2008, Medicare payment in the hospital outpatient setting reimburses each product at 105% of its ASP. ASP is calculated by the manufacturer based on a statutorily defined formula and submitted to CMS. A product’s ASP is calculated on a quarterly basis and therefore may change each quarter. The ASP in effect for a given quarter (the “Current Period”) is based upon certain historical sales and sales incentive data covering a statutorily defined period of time preceding the Current Period. For example, the ASP based payment rate for Aranesp® that will be in effect for the third quarter of 20072008 will be based in part on certain historical sales and sales incentive data for Aranesp® from April 1, 20062007 through March 30, 2007.31, 2008. CMS publishes the ASPs for products in advance of the quarter in which they go into effect. Any changes to the ASP calculation could adversely affect the Medicare reimbursement for our products administered in the physician office and the hospital outpatient setting. Prior to January 1, 2006, Medicare’s hospital outpatient prospective payment system (“OPPS”), which determines payment rates for specified covered outpatient drugs and biologics in the hospital outpatient setting, utilized the average wholesale price (“AWP”) as the basis of Medicare Part B payment for covered outpatient drugs and biologics administered in the hospital outpatient setting. From 2003 to 2005, CMS applied an “equitable adjustment” such that the Aranesp® reimbursement rate was based on the AWP of PROCRIT®, Johnson & Johnson’s recombinant human erythropoietin product marketed in the United States, using a dose conversion ratio. In 2006 and 2007, CMS did not apply an “equitable adjustment” to tie the reimbursement rate for Aranesp® to PROCRIT®. However, CMS has maintained that it reserves the right to apply an “equitable adjustment” to the payment rate for Aranesp® in future years.

In the United States, dialysis providers are primarily reimbursed for EPOGEN® by the federal government through the End Stage Renal Disease (“ESRD ProgramProgram”) of Medicare. The ESRD Program reimburses approved providers for 80% of allowed dialysis costs; the remainder is paid by other sources, including patients, state Medicaid programs, private insurance, and to a lesser extent, state kidney patient programs. The ESRD Program reimbursement ratemethodology is established by federal law and is monitored and implemented by CMS. Effective January 1, 2006, the payment mechanism for separately reimbursed

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dialysis drugs in both free-standing and hospital-based dialysis centers, including EPOGEN® and Aranesp®, is reimbursed by Medicare at ASP+6% using the same payment amounts used in the physician clinic setting. Beginning in the third quarter of 2007, based on its ongoing assessment for payment of Part B drugs, CMS instituted a single payment limit for Epoetin alfa (EPOGEN® and PROCRIT®) in all provider settings. Although we cannot predict the payment levels of EPOGEN® in future quarters or whether Medicare payments for dialysis drugs may be modified by future federal legislation, a decrease in the reimbursement rate for EPOGEN® may have a material adverse effect on our business and results of operations. Any changes to the ASP calculations directly affect the Medicare reimbursement for our products administered in the physician office, dialysis facility and hospital outpatient setting. These calculations are regularly reviewed for completeness and based on such review, we have revised our reported ASPs to reflect calculation changes both

prospectively and retroactively. Partially as a result of our methodology changes, our ASP reimbursement rate for EPOGEN® was reduced for the third quarter of 2007.

Since April 1, 2006, the ESRD ProgramMedicare reimbursement for ESAs administered to dialysis patients has been subject to a revised Hematocrit Measurement Audit Program Memorandum (“HMA-PM”), a Medicare payment review mechanism used by CMS to auditmonitor EPOGEN® and Aranesp® (when used in dialysis) utilization and appropriate hematocrit outcomes of dialysis patients. This policy, the EMP, was further revised, effective OctoberJanuary 1, 2006. The revised EMP provides that2008, requiring a 50% reduction in Medicare reimbursement if a patient’s hemoglobinHb is greater thanabove 13 grams per deciliter, providers are instructedg/dL for three or more consecutive months. In addition, the revised EMP reduces the monthly dosing limits to reduce the patient’s400,000 IUs of EPOGEN®, from 500,000 IUs, and to 1,200 mcgs of Aranesp® dose, from 1,500 mcgs. The implementation of the revised EMP and report this reduction on claims usingESA label changes have led to a coding modifier. If the provider does not reduce the patient’sdecline in EPOGEN® and Aranesp® dose andsales for the provider does not submit medical documentation to support maintaining a patient’s hemoglobin above 13 grams per deciliter, reimbursement will be reducedfirst quarter of 2008 compared to the level it wouldfirst quarter of 2007 primarily due to a decline in both overall utilization and as well as average dosing per patient. We believe that pronounced dose declines, which have been hadobserved in the provider reduced dosage by twenty-five percent.quarter of EMP implementation, will moderate in subsequent quarters, as has been observed with prior years’ EMP changes.

Changes resulting from the MMA, which beginning in 2005 lowered reimbursement for our products, could negatively affect product sales of some of our marketed products. However, we believe that our product sales for 2005, 2006 and 20062007 were not significantly impacted by the reimbursement changes resulting from the MMA. While we cannot accurately predict the impact of any such changes on how, or under what circumstances, healthcare providers will prescribe or administer our products and we cannot estimate the full impact of the MMA on our business, we believe that it is not likely to be significant to our business in 2007. However, additional provisions of the MMA and other regulations affecting reimbursement that have gone or may go into effect could affect our product sales and related sales growth in the future. For example, the MMA required a report to Congress and a demonstration project ofwith regard to a bundled payment system for dialysis, including separately billable drugs and EPOGEN®. The report to Congress was issued on February 20, 2008, but the demonstration project, which was scheduled to start in January 2006, but has been delayed with no announced start date. Bundling initiatives that have been implemented in other healthcare settings have resulted in lower utilization of services that had not previously been a part of the bundled payment. Because CMS is continuing to study bundled payments in the ESRD setting and legislation is possible, we cannot predict what impact a bundled payments system would have on sales of EPOGEN® or Aranesp® used in the treatment of persons receiving outpatient dialysis services.

In addition, in response to CMS considering and rejecting changes to the Medicare Physician Fee Schedule Proposed Rule for 2007, CMS invited comment on the need for future guidance concerning theASP calculation methodology for calculatingaccounting for discounts in multi-product contracts in the ASP of drugs sold under market-based pricing arrangements, including “bundled arrangements,” described by CMS as, for example, when a purchaser’s price for one or more drugs is contingent upon the purchase of other drugs or items. In the2007 Medicare Physician Fee Schedule Final Rule, for 2007, CMS chose not to establish a specific methodology that manufacturers must use for the treatment of bundled price concessions for the purposes of the ASP calculation at this time. However, CMS stated that it may provide more specific guidance in the future through rulemaking, program instruction or other guidance. Further, on December 29, 2006, the Medicare Payment Advisory Commission (“MedPAC”)MedPAC released its second Congressionally-mandated report on December 29, 2006 on the impact of changes in Medicare payments for Part B Drugs specifically recommending that the Secretary of the Department of Health and Human Services clarify ASP reporting requirements “to ensure that ASP calculations allocate discounts to reflect the transaction price for each drug.” Under the ASP system, the Company allocates itswe allocate our discounts based on the prices paid for individual drugs, according to the terms of its contracts with physicians and other purchasers, and we believe that the resulting ASPs reflect the transaction prices for individual drugs. AsReferencing a MedPAC December 2006 report, CMS proposed in the Medicare Physician Fee Schedule Proposed Rule for 2008 revising the methodology for calculating ASP to require the reallocation of price concessions of drugs sold under “bundled arrangements,” described by CMS in part as an arrangement regardless of physical packaging under which the rebate, discount or other price concession is conditioned upon the purchase of the same drug or biological or other drugs or biologicals or some other performance requirement. In the Medicare Physician Fee Schedule Final Rule for 2008, CMS stated that it was not finalizing the proposed regulatory change at this time, based on comments recommending a delay and raising concerns about the proposal. The agency also clarified that in the absence of specific guidance, manufacturers may continue to make “reasonable assumptions” in the calculation of ASP, consistent with the general requirements and the intent of the Medicare statute and regulations and their customary business practices. The agency stated that it will continue to monitor this issue and may provide more specific guidance in the future. Related to this issue, CMS issued a final Medicaid rule on July 6, 2007 that covered a broad range of topics concerning the calculation and use of average manufacturing price (“AMP”) and best price as well as a definition for bundled sales under the Medicaid program. Although it has minor differences, the definition of “bundled sale” under this rule is premature to speculate on howessentially the same as what CMS and other government organizations may react toproposed under the MedPAC’s recommendations, we cannot predict definition of “bundled arrangement” in

the potentialMedicare Physician Fee Schedule Proposed Rule for 2008 but which was not adopted for ASP reporting in the Final Rule for 2008. We continue in the process of evaluating what impact the report mayfinal Medicaid rule will have on our business.

In addition to private payers, since January 1, 2006, ENBREL and Sensipar® (cinacalcet HCl) have been eligible for coverage from the U.S. government under Medicare Part D. Although both ENBREL and

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Sensipar® have received broad formulary placement in 2006 and 2007, Part D formulary placements are made by individual Part D plan sponsors with oversight by CMS and are subject to revision in the future.

Other initiatives reviewing the coverage or reimbursement of our products, including those related to safety, could result in less extensive coverage or lower reimbursement and could negatively affect sales of some of our marketed products. For example, on March 14, 2007, shortly after the March 9, 2007 label changes for all ESAs, CMS announced that the agency had begun reviewing all Medicare policies related to the administration of ESAs in non-renal disease applications as part of a NCAnational coverage analysis (“NCA”) which is generally CMS’ first step toward developing a NCD.national coverage determination (“NCD”). Generally, a NCD is a national policy statement granting, limiting or excluding Medicare coverage or reimbursement for a specific medical item or service. DuringOn May 14, 2007, CMS issued the initialproposed NCD following a review of data and public comments submitted as part of the NCA, which under the MMA, was subject to a 30-day public comment period that ended June 13, 2007. On July 30, 2007, CMS issued its Decision Memorandum which endedwas substantially altered from the proposed NCD. On January 14, 2008, CMS issued changes to its Medicare NCD Manual, adding the ESA Decision Memorandum, effective for claims with dates of service on and after July 30, 2007 with an implementation date of April 13, 2007, we submitted comments to7, 2008. In the Decision Memorandum, CMS which included a detaileddetermined that ESA treatment was not reasonable and thorough review ofnecessary for certain clinical conditions. The Decision Memorandum established the availableESA reimbursement policy for Medicare and other government beneficiaries who are treated for CIA with ESAs. We believe that the restrictions in the Decision Memorandum changed the way ESAs are used in clinical data, noted a series of important considerations and made apractice, for example, by decreasing the number of specific recommendations fortreated patients, the agency to consider in developing a NCD. CMS is required to issue a proposed NCD by September 14, 2007, but could propose a NCD at any time prior to that deadline. Givenaverage ESA dose and the uncertaintyduration of what recommendations a final NCD would consist of, we cannot predict what impact a NCD would haveESA therapy.

We believe this restriction on our business. Following CMS’ announcement that it had begun reviewing all Medicare policies related to the administrationreimbursement of ESAs in non-renal disease applicationsthe Decision Memorandum has had a material adverse effect on March 14, 2007, CMS also stated that the agency is currently reviewinguse, reimbursement and sales of Aranesp®, and our business and results of operations. Additionally, based on our knowledge, although no private payers have implemented the EMPDecision Memorandum to date, many private payers have implemented the restrictions included in the Decision Memorandum. Further, due to difficulties in administering a two-tier medical practice, we believe many healthcare providers have reduced ESA utilization for all of their patients with ESRD who are dialyzed in renal facilities although they have not yet announced further changes toregardless of insurance coverage.

In addition, the EMP. The FDA may also scheduleheld a joint meeting of the Cardio Renal Advisory Committee to reviewCRDAC and the DSaRMAC on September 11, 2007, which evaluated the safety data on ESA use in renal disease. Although CMS has made no announcement of a nephrology focused NCA, any NCD for ESAs in the renal setting, although no public announcement has been made. As a resultwhich may include non-coverage and/or new dosing and treatment restrictions similar to those proposed in Decision Memorandum for treatment of the revisionsanemia in oncology with ESAs, would negatively affect use, reduce reimbursement and current review of the EMP, we cannot predict the potential full impact any revisions to the EMP may have on our business. However, changes reducing reimbursement coverage, could negatively affect product sales of our ESA products.

Further, the Deficit Reduction Act of 2005 (“DRA”) included provisions, which are phased in over time, regarding state collectionproducts and submission of data for the purpose of collecting Medicaid drug rebates from manufacturers for physician-administered drugs. We expect that state compliance with elements of these provisions that become effective in 2007 will increase the level of Medicaid rebates paid by us. We are currently in the process of further evaluating the impact of the DRA and are uncertain as to the potential full impactmay have a material adverse effect on our business. Related to this issue, CMS issued a proposed Medicaid rule on December 18, 2006 that covered a broad rangebusiness and results of topics concerning the calculation and use of AMP and best price as well as a proposed definition for bundled sales under the Medicaid program. We submitted a comment to CMS on the proposed rule which the DRA specifies that CMS issue a final rule no later than July 1, 2007. While we cannot predict the impact of the final rule prior to its issuance, changes reducing reimbursement could negatively affect our business.operations.

Results of Operations

Product sales

For the three months ended March 31, 20072008 and 2006,2007, worldwide product sales and total product sales by geographic region were as follows (in(dollar amounts in millions):

 

18


  Three Months Ended
March 31,
     Three months ended
March 31,
  Change 
  2007  2006  Change   2008  2007  

Aranesp®

  $1,020  $893  14%  $761  $1,020  (25)%

EPOGEN®

   625   604  3%   554   625  (11)%

Neulasta®/NEUPOGEN®

   1,018   896  14%   1,086   1,018  7%

ENBREL

   730   658  11%   951   730  30%

Sensipar®

   105   61  72%   133   105  27%

Vectibix™

   51     n/a 

Vectibix®

   34   51  (33)%

Other

   16   15  7%   18   16  13%
                

Total product sales

  $3,565  $3,127  14%  $3,537  $3,565  (1)%
                

Total U.S.

  $2,884  $2,571  12%  $2,788  $2,884  (3)%

Total International

   681   556  22%   749   681  10%
                

Total product sales

  $3,565  $3,127  14%  $3,537  $3,565  (1)%
                

Product sales are influenced by a number of factors, including demand, third-party reimbursement availability and policies, government programs, regulatory developments or guidelines, clinical trial outcomes, clinical practice, pricing strategies, wholesaler and end-user inventory management practices, patient population, fluctuations in foreign currency exchange rates, new product launches and indications, competitive products, product supply and acquisitions.

Sales growth for the three months ended March 31, 2007 was principally driven by demand for Aranesp®, Neulasta® and ENBREL, which benefited from segment growth and to a lesser degree share gains. InternationalTotal product sales for the three months ended March 31, 20072008 decreased 1%, principally due to a decline in U.S. Aranesp® sales, which was substantially offset by an increase in ENBREL sales. In particular, for the three months ended March 31, 2008, U.S. Aranesp® sales declined $249 million, or 38%, reflecting the negative impact on demand, primarily in the supportive cancer care setting, of ongoing regulatory and reimbursement developments that were principally realized in the second half of 2007. Sales of ENBREL increased $221 million, or 30%, for the three months ended March 31, 2008, which includes an initial wholesaler inventory stocking of approximately $120 million resulting from the shift to a wholesaler distribution model. During the three months ended March 31, 2008, ENBREL’s distribution model was converted from primarily being drop shipped directly to pharmacies to a wholesaler distribution model similar to our other products. The increase in ENBREL sales in the first quarter of 2008 also reflects higher demand due to increases in both patients and average net sales price. Total international product sales for the three months ended March 31, 2008 increased 10% and were favorably impacted by $42$72 million from foreign currency exchange rate changes. Excluding the favorable impact of foreign currency exchange rate changes, international product sales increased 15%decreased 1% over the three months ended March 31, 2006.2007.

Aranesp®

For the three months ended March 31, 20072008 and 2006,2007, total Aranesp® sales by geographic region were as follows (in(dollar amounts in millions):

 

  

Three Months Ended

March 31,

     Three months ended
March 31,
  Change 
  2007    2006  Change   2008  2007  

Aranesp® - U.S.

  $654    $ 596  10%  $405  $654  (38)%

Aranesp® - International

   366     297  23%   356   366  (3)%
                  

Total Aranesp®

  $1,020    $893  14%  $761  $1,020  (25)%
                  

The increasedecrease in U.S. Aranesp® sales for the three months ended March 31, 2007 was driven by2008 reflects the negative impact on demand, due to segment growth and to a lesser degree favorable wholesaler inventory changes. The slowing growth rateprimarily in the United Statessupportive cancer care setting, of physician conformance to ongoing regulatory and reimbursement developments, which were principally realized in the second half of 2007, and a slight decline in our segment share. This decrease in Aranesp® sales was drivenpartially offset by initial customer reactiona slight benefit from a change in accounting estimates related to sales return reserves. The regulatory and reimbursement developments include in particular, (i) the ESA product label changes regarding safety discussed above and the resulting loss of substantially allCMS’ Decision Memorandum issued in July 2007, which significantly restricted Medicare

19


reimbursement for use of Aranesp® in AoC. U.S. sales results forCIA and which we believe has also negatively impacted Aranesp® use in CIA for patients covered by private insurance plans, (ii) the loss of Aranesp® for use in the treatment of AoC and (iii) the March 9, 2007 and November 8, 2007 product safety-related label changes in the United States. During the latter part of the three months ended December 31, 2007 and during the three months ended March 31, 2007 do not fully reflect the significant impact of these developments, which occurred throughout, but primarily2008, Aranesp® sales were relatively stable as we realized only a slight decrease in the latter half, of the first quarter of 2007. underlying demand.

The increasedecrease in international Aranesp® sales for the three months ended March 31, 2007 was also2008 principally drivenreflects continued ESA dosing conservatism and pricing pressures in Europe, partially offset by increased demand due to segment growth and share gains and was favorably impacted by $24 million due to changes in foreign currency exchange rates. It is not clear what the impact of the developments in the United States will have on international Aranesp® sales.rates, which positively impacted sales by approximately $35 million. Excluding the favorable impact of foreign currency exchange rate changes, international Aranesp® sales increased 15% overfor the three months endedmonth period decreased 12%. Through March 31, 2006.2008, biosimilars and other recently introduced marketed products in Europe have not had a significant impact on total international Aranesp® sales.

In addition to the factors mentioned in the “Product sales” section above, future worldwide Aranesp® sales growth will be dependent, in part, on such factors as:

regulatory developments, including those resulting from:

¡

product safety-related label changes occurring on March 7, 2008 in the United States for the class of ESAs, including Aranesp®, as a result of discussions with the FDA regarding safety data from the PREPARE and GOG-191 studies;

¡

pending additional product label changes in the United States for the class of ESAs, including Aranesp®, resulting from the ODAC meeting on March 13, 2008;

¡

product PI changes occurring on March 5, 2008 in Europe for the class of ESAs, including Aranesp®, by the European Commission and the potential for further changes resulting from additional regulatory review;

¡

outcome of the SAG-O meeting on May 15, 2008 to review an overview on studies that have been initiated or conducted since July 2007, as well as any other new data that can help to elucidate recent issues on the impact of ESAs on tumor progression and survival in cancer patients;

¡

future product label changes;

¡

risk management activities undertaken by us or required by the FDA or other regulatory authorities, including a REMS;

reimbursement developments, including those resulting from:

¡

government’s and/or third-party payer’s reaction to recent or future product label changes;

¡

current or future cost containment pressures by third-party payers, including governments and private insurance plans;

our ability to maintain segment share and differentiate Aranesp® from current and potential future competition, including through pricing strategies;

 

adverse events or results from clinical trials or studies performed by us, including our pharmacovigilance clinical trials, or by others (including our licensees or independent investigators), which have and could further impact product safety labeling, and have or could further negatively impact healthcare provider prescribing behavior, use of our product, regulatory or private healthcare organization medical guidelines and reimbursement practices. For example, as discussed in more detail above in the “Overview” section, negative safety results for various studies performed by us and by third-parties, including our AoC 103 Study, involving off-label usage of ESAs have resulted in the following:practices;

-

product safety label changes in the United States for the class of ESAs, including Aranesp® and EPOGEN®, as well as the EMEA’s reported review of the safety of ESAs;

-

discontinued reimbursement for Aranesp® by nearly all Medicare contractors in the treatment of AoC;

-

an FDA ODAC meeting on May 10, 2007 to review progress in delineating the effects of ESAs on survival and tumor progression in cancer patients; and

-

CMS’ March 14, 2007 announced review of all Medicare policies related to the administration of ESAs in non-renal disease applications as part of an NCA;

any or all of which could negatively impact future healthcare provider prescribing behavior, use of our product, regulatory or private healthcare organization medical guidelines and reimbursement practices;

 

governmental or private organization regulations or guidelines relating to the use of our products;

 

reimbursement by third-party payers, including governments and private insurance plans;

an increasingly competitive environment of products or therapies, which in 2007 in the United States could potentially include competition in the nephrology segment from Roche’s peg-EPO product, which Roche has indicated they intend to bring to the U.S. market upon regulatory approval despite our ongoing lawsuit and their acknowledgment of our U.S. erythropoietin patents (see “Item 1. Legal Proceedings – Roche Matters” in Part II herein) and in the EU in 2007 could potentially include Roche’s peg-EPO product,

20


 

biosimilars

an increasingly competitive environment of products or therapies, which have launched in certain countries outside of the United States, for example Roche’s NeoRecormon® and other competing products, such as Shire’speg-EPO product, MIRCERA®, and Shire Pharmaceutical Group Plc’s (“Shire’s”) erythropoietin product, Dynepo® (Epoetin delta), and biosimilar products that have been or are expected to be launched in March 2007;the future; and

 

 

 

our ability to differentiatedevelopment of new treatments for cancer and future chemotherapy treatments. For example, those that are less myelosuppressive may require less Aranesp® from current and potential future competition;;

any or all of which could have a material adverse impact on future sales of Aranesp®.

pricing strategies; and

cost containment pressures from governmentsSee the “Overview” section above and private insurers on healthcare providers.

(See “ItemItem 1A. Risk Factors”Factors in Part II herein for further discussion of certain of the above factors that could impact our future product sales.)

EPOGEN®

For the three months ended March 31, 20072008 and 2006,2007, total EPOGEN® sales were as follows (in(dollar amounts in millions):

 

   Three Months Ended
March 31,
    
   2007  2006  Change 

EPOGEN® - U.S.

  $625  $604  3%
   Three months ended
March 31,
  Change 
   2008  2007  

EPOGEN® - U.S.

  $554  $625  (11)%

ReportedThe decrease in EPOGEN® sales for the three months ended March 31, 2007 increased2008 was primarily driven by a reduction in dose/utilization due to favorableESA label changes and the CMS’ revisions to its EMP, that became effective January 1, 2008, as well as unfavorable wholesaler inventory changes and unfavorable revised estimates of dialysis demand primarily spillover,(primarily spillover) for prior quarters (see Note 1, “SummarySummary of significant accounting policespolicies – Product sales”sales to the Condensed Consolidated Financial Statements for further discussion), and favorable wholesaler inventory changes, partially offset by changes.

We believe that the EMP implementation in customer purchasing patterns versusJanuary 2008 has significantly impacted physician behavior resulting in declines in dosing trends, however we believe that the firstpronounced dose declines, which have been observed in the quarter of theimplementation, will moderate in subsequent quarters, as has been observed with prior year. The ESA product label changes regarding safety discussed above did not significantly impact EPOGEN® sales results for the three months ended March 31, 2007.years’ EMP changes.

In addition to the factors mentioned in the “Product sales” section above, future EPOGEN® sales will be dependent, in part, on such factors as:

 

reimbursement developments, including those resulting from:

¡

changes in healthcare providers’ prescribing behavior resulting in dose declines due to the CMS’ revisions to its EMP, which became effective January 1, 2008;

¡

the federal government’s reaction to recent or future product label changes;

¡

changes in reimbursement rates or changes in the basis for reimbursement by the federal government;

regulatory developments, including those resulting from:

¡

future product label changes;

¡

risk management activities undertaken by us or required by the FDA, including a REMS;

governmental or private organization regulations or guidelines relating to the use of our products, including changes in medical guidelines and legislative actions;

adverse events or results from clinical trials or studies performed by us, including our pharmacovigilance clinical trials, or by others (including our licensees or independent investigators), which have and could further impact product safety labeling, and may negatively impact healthcare provider prescribing behavior, use of our product, regulatory or private healthcare organization medical guidelines and reimbursement practices. For example, as discussed in more detail above in the “Overview” section, negative safety results for various studies performed by us and by third-parties, including our AoC 103 Study, involving off-label usage of ESAs have resulted in the following:

-

product safety label changes in the United States for the class of ESAs, including Aranesp® and EPOGEN®;

-

CMS’ review of the EMP for patients with ESRD who are dialyzed in renal facilities;

-

NKF issuance of proposed KDOQI guidelines;

21


any or all of which could negatively impact future healthcare provider prescribing behavior, use of our product, regulatory or private healthcare organization medical guidelines and reimbursement practices;

governmental or private organization regulations or guidelines relating to the use of our products.

changes in reimbursement rates or a change in the basis for reimbursement by the federal government;

the possibility of competition from Roche’s peg-EPO, which Roche has indicated they plan to launch in the nephrology segment in 2007, upon regulatory approval despite our ongoing lawsuit and their acknowledgment of our U.S. erythropoietin patents (see “Item 1. Legal Proceedings – Roche Matters” in Part II herein);

 

cost containment pressures from the federal government on healthcare providers;

 

pricing strategies; and

 

changes in future patient population growth or dose/utilization;

any or all of which could have a material adverse impact on future sales of EPOGEN®.

EPOGEN® sales could be favorably impacted by underlying demand in the free-standing dialysis centers, which we believe will remain consistent with the annual patient population growth of approximately 3 percent and the lessened impact of conversion to Aranesp® in the U.S. hospital dialysis clinics, which we believe stabilized in mid-2006.

(See “Itemthe “Overview” section above and “Item 1A. Risk Factors”Factors in Part II herein for further discussion of certain of the above factors that could impact our future product sales.)

Neulasta®/NEUPOGEN®

For the three months ended March 31, 20072008 and 2006,2007, total Neulasta®/NEUPOGEN® sales by geographic region were as follows (in(dollar amounts in millions):

 

  Three Months Ended
March 31,
     Three months ended
March 31,
  Change 
  2007    2006  Change   2008  2007  

Neulasta® - U.S.

  $573    $497  15%  $569  $573  (1)%

NEUPOGEN® - U.S.

   204     191  7%   223   204  9%
                  

U.S. Neulasta®/NEUPOGEN® - Total

   777     688  13%   792   777  2%
                  

Neulasta® - International

   146     111  32%   187   146  28%

NEUPOGEN® - International

   95     97  (2)%   107   95  13%
                  

International Neulasta®/NEUPOGEN® - Total

   241     208  16%   294   241  22%
                  

Total Worldwide Neulasta®/NEUPOGEN®

  $1,018    $  896  14%  $1,086  $1,018  7%
                  

The increase in U.S. sales of Neulasta®/NEUPOGEN® sales for the three months ended March 31, 20072008 was primarily driven primarily by higher demand for Neulasta® due to segment growth and to a lesser degree favorableprimarily reflecting increases in average net sales price, partially offset by unfavorable wholesaler inventory changes. Neulasta® segment growth is attributable to an increase in

22


patients in part due to the continued increase of Neulasta® in first-cycle use, as well as higher net sales prices. The increase in international Neulasta®/NEUPOGEN® sales for the three months ended March 31, 2007 was2008 reflects changes in foreign currency exchange rates, which positively impacted first quarter combined international sales by $28 million, as well as increased demand driven by the continued conversion from NEUPOGEN® to Neulasta® and was favorably impacted by $16 million in foreign currency exchange rate changes.. Excluding the favorable impact of foreign currency exchange rate changes, combined international Neulasta®/NEUPOGEN® sales increased 8% over the three months ended March 31, 2006.

For the remainder of 2007, we believe sales growth for Neulasta®/NEUPOGEN® will depend on patient growth and further segment penetration of Neulasta® in the moderate-risk population that would benefit from its use in first and subsequent chemotherapy cycles. NEUPOGEN® competes with Neulasta® in the United States and Europe. Worldwide NEUPOGEN® sales have been adversely impacted by conversion to Neulasta®10%. However, we believe that most of the conversion in the United States and Europe has occurred.

In addition to the factors mentioned in the “Product sales” section above, future worldwide Neulasta®/NEUPOGEN® sales growth will be dependent, in part, on such factors as:

 

penetration of existing segments;

competitive products or therapies, including biosimilar products that have been or may be approved in the European Union (“EU”) sometime in 2008 and be available shortly thereafter. For example, in February 2008, Teva Pharmaceuticals Industries Limited (“Teva”) received a positive opinion from the CHMP for its G-CSF biosimilar product, TevaGrastim®, and is expected to launch in the EU in the second quarter of 2008;

reimbursement by third-party payers, including biosimilar products that may be approved in the EUgovernments and be available shortly thereafter;private insurance plans;

 

adverse events or results from clinical trials or studies performed by us or by others (including our licensees or independent investigators), which maycould expand safety labeling and may negatively impact healthcare provider prescribing behavior, use of our product, regulatory or private healthcare organization medical guidelines and reimbursement practices;

 

governmental or private organization regulations or guidelines relating to the use of our products;

 

reimbursement by third-party payers, including governments and private insurance plans;

cost containment pressures from governments and private insurers on healthcare providers;

 

our ability to minimize healthcare provider distraction from Neulasta®/NEUPOGEN® due to ESA issues;

pricing strategies;

penetration of existing segments;patient growth; and

 

 

 

development of new treatments for cancer and future chemotherapy treatments. For example, those that are less myelosuppressive may require less Neulasta®/NEUPOGEN®, however, other future chemotherapy treatments that are more myelosuppressive, such as dose dense chemotherapy, could require more Neulasta®/NEUPOGEN®.

(See “ItemItem 1A. Risk Factors”Factors in Part II herein for further discussion of certain of the above factors that could impact our future product sales.)

23


ENBREL

For the three months ended March 31, 20072008 and 2006,2007, total ENBREL sales by geographic region were as follows (in(dollar amounts in millions):

 

  Three Months Ended
March 31,
     Three months ended
March 31,
  Change 
  2007  2006  Change   2008  2007  

ENBREL - U.S.

  $693  $629  10%  $904  $693  30%

ENBREL - International

   37   29  28%   47   37  27%
                

Total ENBREL

  $730  $658  11%  $951  $730  30%
                

ENBREL sales growth for the three months ended March 31, 20072008 includes an initial wholesaler inventory stocking of approximately $120 million resulting from the shift to a wholesaler distribution model in the first quarter of 2008. During the three months ended March 31, 2008, ENBREL’s distribution model was driven byconverted from primarily being drop shipped directly to pharmacies to a wholesaler distribution model similar to our other products. We believe that this estimated initial wholesaler inventory stocking is within the expected normal inventory range. The increase in ENBREL sales in the first quarter of 2008 also reflects higher demand due to increases in both patients and average net sales price. While ENBREL continued to maintain a leading position in both rheumatology and dermatology, the sales growth induring the first quarterthree months ended March 31, 2008 was affected by slight share declinedeclines in the United States in both segments versus the first quarter of the prior year2007 due to increased competitive activity.

We believe sales growth for the remainder of 2007 will be principally driven by growth in the rheumatology and dermatology segments.

In addition to the factors mentioned in the “Product sales” section above, future worldwide ENBREL sales growth will be dependent, in part, on such factors as:

 

the effects of competing products or therapies, which may include new indications for existing products and new competitive products coming to market, such as J&J’s CNTO 1275 (ustekinumab) and CNTO 148 (golimumab) and, in part, our ability to differentiate ENBREL based on its safety profile and efficacy;

 

segment growth;recent or future product label changes;

risk management activities undertaken by us or required by the FDA or other regulatory authorities;

growth in the rheumatology and dermatology segments;

outcome of the DODAC meeting on June 18, 2008 to review data supporting the supplemental BLA submitted by us for the use of ENBREL in treating pediatric patients with chronic moderate to

severe plaque psoriasis, who are inadequately controlled with topical therapy or who have received systemic therapy or phototherapy;

the availability, extent and access to reimbursement by government and third-party payers;

 

adverse events or results from clinical trials or studies performed by us or by others (including our licensees or independent investigators), which maycould expand safety labeling and may negatively impact healthcare provider prescribing behavior, use of our product, regulatory or private healthcare organization medical guidelines and reimbursement practices;

 

governmental or private organization regulations or guidelines relating to the use of our products;

 

the availability, extent and access to reimbursement by government and third-party payers;

cost containment pressures from governments and private insurers on healthcare providers;

pricing strategies; and

 

pricing strategies.penetration of existing and new segments, including potential expanded indications.

(See “ItemItem 1A. Risk Factors”Factors in Part II herein for further discussion of certain of the above factors that could impact our future product sales.)

24


Selected operating expenses

The following table summarizes selected operating expenses for the three months ended March 31, 2008 and 2007 and 2006 (in(dollar amounts in millions):

 

  Three Months Ended
March 31,
   Three months ended
March 31,
 Change 
  2007 2006 Change   2008 2007 

Product sales

  $3,565  $3,127  14%  $3,537  $3,565  (1)%

Operating expenses:

        

Cost of sales (excludes amortization of acquired intangible assets)

  $592  $552  7%  $546  $592  (8)%

% of product sales

   17%  18%    15%  17% 

Research and development

  $851  $655  30%  $694  $851  (18)%

% of product sales

   24%  21%    20%  24% 

Selling, general and administrative

  $770  $689  12%  $874  $770  14%

% of product sales

   22%  22%    25%  22% 

Amortization of acquired intangible assets

  $74  $87  (15)%  $74  $74  0%

Other

  $10  $—    100%

Cost of sales

Cost of sales, which excludes the amortization of acquired intangible assets (see “Condensed Consolidated Statements of Operations”Income”), increased 7% fordecreased 8% during the three months ended March 31, 2007. The increase in2008 primarily driven by lower Aranesp® sales volume and reduced product scrap charges partially offset by a higher cost product mix attributable to increased ENBREL sales and a $26 million write-off of a semi-completed manufacturing asset during the three months ended March 31, 2007 was primarily driven by increased sales volumes and the write-off of a semi-completed manufacturing asset that will not be used due to a change in manufacturing strategy largely offset by manufacturing efficiencies.2007.

Research and development

R&D expenses, whichcosts are expensed as incurred areand primarily comprised of costsinclude salaries, benefits and expenses for salariesother staff related costs; facilities and benefits associated with R&D personnel; overhead and occupancy;costs; clinical trial and related clinical manufacturing includingcosts; contract services and other outside costs, process development and quality assurance;costs; information systems and amortization of technology used in R&D with alternative future uses. R&D expenses also includeconsist of internal R&D costs, costs incurred under R&D arrangements with our corporate partners, such costs related toas activities performed on behalf of corporate partners. KA, and costs associated with collaborative R&D and in-licensing arrangements, including upfront fees and milestones paid to collaboration partners in connection with technologies that have no alternative future use. R&D collaborations resulting in a net payment or reimbursement of R&D costs are recognized as the obligation has been incurred or we become entitled to the cost recovery.

R&D expenses increased 30%decreased 18% for the three months ended March 31, 20072008, which was primarily attributable to support the increased number and expensedecreases of mega-trials to advance our late-stage pipeline as well as the continued advancement of earlier stage compounds. During the three months ended March 31, 2007,$64 million in staff-related costs and other expense reductions principally resulting from the previously announced restructuring plan, $36 million from cost recoveries derived from licensing transactions with Daiichi Sankyo Company, Limited and Takeda Pharmaceutical Company Limited (“Takeda”) in Japan and $41 million of clinical trial costs. Clinical trial costs decreased as some of our large clinical trials completed enrollment and manufacturingthe significant costs increased approximately $76 millionassociated with site initiation and $92 million, respectively.patient enrollment are no longer being incurred.

25


Selling, general and administrative

Selling, general and administrative (“SG&A”)&A expenses are primarily comprised of salaries and benefits associated with sales and marketing, finance, legal and other administrative personnel; outside marketing expenses; overhead and occupancyfacilities costs and other general and administrative costs. SG&A increased 12% forFor the three months ended March 31, 2007,2008, the 14% increase in SG&A is primarily reflecting thedriven by higher Wyeth profit share relatedexpense due to ENBREL. Duringhigher ENBREL sales, which accounted for approximately three quarters of the increase. For the three months ended March 31, 2008 and 2007, outside marketing expenses in support of our principal products, includingthe Wyeth profit share related to ENBREL, increased byexpense as a percentage of total SG&A, was approximately $60 million.one third and 30%, respectively.

Amortization of acquired intangible assets

Amortization of acquired intangible assets relates to the acquired product technology rights acquired in connection with the Immunex acquisition.

Other

As discussed in Note 2, “Restructuring” to the Condensed Consolidated Financial Statements, on August 15, 2007, we announced plans to restructure our worldwide operations in order to improve our cost structure while continuing to make significant R&D investments and build the framework for our future growth. As a result of this restructuring plan, we recorded the following charges during the three months ended March 31, 2008: (i) staff separation costs of $4 million, (ii) asset impairment charges of $2 million and (iii) other charges of $4 million.

Interest and other income and (expense), net

Interest and other income and (expense), net for the three months ended March 31, 20072008 was $22 million of income compared to $6 million of expense compared to $80 million of income for the three months ended March 31, 2006. The decrease was principally attributable2007. This change is primarily due to the rebalancing of investments in our marketable securities portfolio which resulted in net realized gains of approximately $30 million during the three months ended March 31, 2008 and the write-off of $51 million of deferred financing and related costs in March 2007 resulting from the repayment of thecertain of our convertible debt, and lowerpartially offset by the incremental interest income.expense of approximately $53 million related to the $4.0 billion of debt issued in May 2007.

Income taxes

Our effective tax rate for the three months ended March 31, 20072008 was 20.3%21.0%, compared with 23.8%20.3% for the same period last year. OurThe increase in our effective tax rate for the three months ended March 31, 2008 compared to the three months ended March 31, 2007 has decreasedwas primarily due to anthe expiration of the federal research and experimentation tax credit (“R&E Credit”) on December 31, 2007, partially offset by a proportionate increase in the amount of foreign earnings intended to be invested indefinitely outside of the United States and the reinstatement of the federal research and experimentation (R&E) credit in the fourth quarter of 2006. The R&E credit expired at December 31, 2005, and was not available for the three months ended March 31, 2006. The rate for the three months ended March 31, 2007 also decreased duerelative to the absence of a one-time taxable dividend that was received in the three months ended March 31, 2006. As permitted in Accounting Principles Board Opinion (“APB”) No. 23, “Accounting for Income Taxes – Special Areas,” we do not provide for U.S. income taxes on undistributed earnings of our foreign operations that are intended to be invested indefinitely outside the United States.total pretax income.

See Note 3, “Income taxes”4, “Income taxes to the Condensed Consolidated Financial Statements for further discussion.

Recent and proposed accounting pronouncements

In July 2006,December 2007, the FASB issued FIN 48,SFAS No. 141(R), “Business Combinations” and SFAS No. 160, “Accounting and Reporting of Noncontrolling Interests in Consolidated Financial Statements – an amendment of ARB No. 51”. These standards will significantly change the accounting and reporting for business combination transactions and noncontrolling (minority) interests in consolidated financial statements, including capitalizing at the acquisition date the fair value of acquired IPR&D, and testing for impairment and writing down these assets, if necessary, in subsequent periods during their development. These new standards will be applied prospectively for business combinations that occur on or after January 1, 2009, except that presentation and disclosure requirements of SFAS 160 regarding noncontrolling interests shall be applied retrospectively.

In December 2007, the FASB ratified EITF No. 07-1, “Accounting for Collaborative Agreements”. EITF 07-1 provides guidance regarding financial statement presentation and disclosure of collaborative arrangements, as defined, which becameincludes arrangements we have entered into regarding development and commercialization of products and product candidates. EITF 07-1 is effective for us as of January 1, 2007. FIN 48 clarifies2009, and its adoption is not expected to have a material impact on our condensed consolidated results of operations or financial position.

In August 2007, the FASB exposed for public comment a proposed FASB Staff Position (“FSP”) that would change the method of accounting for uncertaintyconvertible debt securities that require or permit settlement in income taxes by prescribing rules for recognition, measurementcash either in whole or in part upon conversion (“cash settled convertible debt securities”), which includes our convertible debt securities, and classification in our financial statements of tax positions taken or expectedwould require the proposed method to be takenretrospectively applied. During its March 2008 deliberations, the FASB affirmed the proposed method of accounting and decided to delay the effective date of the final FSP for calendar year end companies like us to the first quarter of 2009. The FASB currently indicates that it expects to take a final vote on and, if approved, issue the final FSP in the second quarter of 2008. Under this proposed method of accounting, the debt and equity components of our convertible debt securities would be bifurcated and accounted for separately in a tax return.

For tax benefitsmanner that would result in recognizing interest on these securities at effective rates more comparable to be recognized under FIN 48, a tax position must be more-likely-than-not to be sustained upon examination by taxing authorities.what we would have incurred had we issued nonconvertible debt with otherwise similar terms. The amount recognized is measured as the largest amount of benefit that is greater than fifty percent likely of being realized upon ultimate settlement. As of January 1, 2007, the gross amountequity component of our liabilities for UTBs was approximately $945 million, and accrued interest related to these UTBs totaled approximately $106 million. Includedconvertible debt securities would be included in the balance is approximately $776 millionpaid-in-capital section of UTBs (netstockholders’ equity on our Consolidated Balance Sheet and, accordingly, the initial carrying values of these debt securities would be reduced. Our net income for financial reporting purposes would be reduced by recognizing the accretion of the federal benefitreduced carrying values of our convertible debt securities to their face amounts as additional non-cash interest expense. Therefore, if the FASB issues the final FSP to change the method of accounting for cash settled convertible debt securities as described above, it would have a material adverse impact on state taxes)our past and future reported financial results. We cannot predict any other changes in GAAP that if

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recognized,may be made which would affect accounting for convertible debt securities and which could have an adverse impact on our annual effective tax rate. The cumulative effect of applying the recognition and measurement provisions upon adoption of FIN 48 was not material.past or future reported financial results.

FIN 48 also provides guidance on the balance sheet classification of liabilities for UTBs as either current or non-current depending on the expected timing of payments. Upon adoption of FIN 48, we reclassified approximately $240 million of UTBs from current income taxes payable to non-current liabilities.

Financial Condition, Liquidity and Capital Resources

The following table summarizes selected financial data (in millions):

 

  March 31,
2007
  December 31,
2006
  March 31,
2008
  December 31,
2007

Cash, cash equivalents and marketable securities

  $4,837  $6,277  $8,647  $7,151

Total assets

   32,570   33,788   36,128   34,639

Current debt

   100   1,798   2,000   2,000

Non-current debt

   7,214   7,214   9,177   9,177

Stockholders’ equity

   19,715   18,964   19,087   17,869

We believe that existing funds, cash generated from operations and existing sources of and access to financing are adequate to satisfy our working capital, capital expenditure and debt service requirements for the foreseeable future, as well as to support our stock repurchase programs and other business initiatives, including acquisitions and licensing activities. However,We have $2.0 billion of floating rate notes due in order to provide for greater financial flexibilityNovember 2008 and liquidity, we are currently reviewing additional borrowing opportunities. We would expectexploring alternatives to use any proceeds raised by such borrowing primarily for purchases of shares under our stock repurchase program and for general corporate purposes, including capital expenditures, other working capital needs and other business initiatives.refinance opportunistically.

Cash, cash equivalents and marketable securities

Of the total cash, cash equivalents and marketable securities at March 31, 2007,2008, approximately $3.8$4.5 billion was generated from operations in foreign tax jurisdictions and is intended for use outside the United States.in our foreign operations. If these funds are repatriated for use in our U.S. operations, substantial additional taxes on certain of these amounts willwe would be required to be paid.pay additional U.S. federal and state income taxes at the applicable marginal tax rates.

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Financing arrangements

The following table reflects the carrying value of our long-term borrowings under our various financing arrangements as of March 31, 20072008 and December 31, 20062007 (in millions):

 

  March 31,
2007
  December 31,
2006
  March 31,
2008
  December 31,
2007

0.125% convertible notes due 2011 (2011 Convertible Notes)

  $2,500  $2,500  $2,500  $2,500

0.375% convertible notes due 2013 (2013 Convertible Notes)

   2,500   2,500   2,500   2,500

Zero coupon 30 year modified convertible notes due in 2032 (2032 Modified Convertible Notes)

   80   1,778

Floating rate notes due 2008 (2008 Floating Rate Notes)

   2,000   2,000

5.85% notes due 2017 (2017 Notes)

   1,099   1,099

4.85% notes due 2014 (2014 Notes)

   1,000   1,000   1,000   1,000

4.00% notes due 2009 (2009 Notes)

   999   999   999   999

6.375% notes due 2037 (2037 Notes)

   899   899

Other

   235   235   180   180
            

Total borrowings

   7,314   9,012   11,177   11,177

Less current portion

   100   1,798   2,000   2,000
            

Total non-current debt

  $7,214  $7,214  $9,177  $9,177
            

On April 17, 2008, we filed a shelf registration statement with the SEC, which replaced our previous $1.0 billion shelf registration statement, which allows us to issue an unspecified amount of debt securities, common stock, preferred stock, warrants to purchase debt securities, common stock, preferred stock or

depository shares, rights to purchase common stock or preferred stock, securities purchase contracts, securities purchase units and depository shares. Under this registration statement, all of the securities available for issuance may be offered from time to time with terms to be determined at the time of issuance.

In May 2008, we increased our commercial paper program by $1.3 billion, which provides for unsecured, short-term borrowings of up to an aggregate of $2.5 billion. We also have a $2.5 billion unsecured revolving credit facility to be used for general corporate purposes, including commercial paper backup, which matures in November 2012. No amounts were outstanding under the commercial paper program or credit facility as of March 31, 2008.

Certain of our financing arrangements contain non-financial covenants and as of March 31, 2007,2008 we were in compliance with all applicable covenants. None of our financing arrangements contain any financial covenants. Our outstanding convertible notes, our outstanding long-term senior notes and our outstanding long-term debtnotes are all rated A2 by Moody’s and A+“A+” with a negative outlook by Standard & Poor’s. Poor’s, “A2” under review for possible downgrade by Moody’s Investors Service, Inc. and “A” with a stable outlook by Fitch, Inc.

See Note 4, “Financing arrangements” to our Condensed Consolidated Financial StatementsRecent and proposed accounting pronouncements for furthera discussion of potential future impacts to the transactions during the quarter ended March 31, 2007 and “Note 5, Financing arrangements” in Part IV ofaccounting for our Annual Report on Form 10-K for the year ended December 31, 2006 for additional discussion of each of our financing arrangements.convertible debt.

Cash flows

The following table summarizes our cash flow activity (in millions):

 

   Three months ended
March 31,
 
   2007  2006 

Net cash provided by operating activities

  $893  $1,183 

Net cash provided by (used in) investing activities

   927   (2,200)

Net cash (used in) provided by financing activities

   (2,036)  924 
   Three months ended
March 31,
 
   2008  2007 

Net cash provided by operating activities

  $1,582  $893 

Net cash provided by investing activities

   697   927 

Net cash provided by (used in) financing activities

   21   (2,036)

Operating

Cash provided by operating activities has been and is expected to continue to be our primary recurring source of funds. Cash provided by operating activities during the three months ended March 31, 2007 decreased from the prior year three months ended2008 increased primarily due to increaseda decrease in disbursements from the timing of payments in the ordinarynormal course of business partially offset by higher receipts from customers. (Seeand the receipt of $300 million for an upfront milestone payment related to our licensing agreement with Takeda, which is included in the “Changes in deferred revenue” in the Condensed Consolidated Statements of Cash Flows.)

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Investing

Capital expenditures totaled $325$170 million during the three months ended March 31, 2007,2008, compared with $225$325 million during the same period last year. The capital expenditures during the three months ended March 31, 2008 were primarily associated with manufacturing capacity expansions in Puerto Rico and Fremont, other site developments and investment in our global enterprise resource planning (“ERP”) system. The capital expenditures during the three months ended March 31, 2007 were primarily associated with ongoing manufacturing capacity and site expansions in Puerto Rico and other locations and investment in our global enterprise resource planning (“ERP”) system.

Capital expenditures for the three months ended March 31, 2006 were primarily associated with ongoing manufacturing and site expansion in Puerto Rico, manufacturing expansion in Colorado, site development in Rhode Island and Thousand Oaks and costs associated with implementing our ERP system.

We currently estimate 20072008 spending on capital projects and equipment to be similar to the prior year as we continue to increase our manufacturing operations globally and proceed with the implementation of our ERP system. The most significant of these expenditures are expected to be incurred with the further expansion of the Puerto Rico bulk manufacturing, formulation, fill and finish facilities.approximately $900 million.

Financing

On March 2, 2007, as a result of certain holders of the 2032 Modified Convertible Notes exercising their March 1, 2007 put option, we repurchased $2,253 million aggregate principal amount of Convertible Notes at their then-accreted value for $1,702 million in cash, or approximately 96%, of the outstanding balance of these notes.

During the three months ended March 31, 2008, we did not repurchase any shares of our common stock. During the three months ended March 31, 2007, and 2006, we repurchased 8.8 million and 46.6 million shares of our common stock respectively, at a total cost of $537 million and $3,374 million, respectively.million. As of March 31, 2007,2008, we had $6,002 million$6.4 billion available for stock repurchases under our stockthe $5.0 billion repurchase programs authorized byauthorization received from the Board of Directors.Directors in July 2007 and amounts remaining from the Board of Director’s previous authorization in December 2006. The manner of purchases, amounts we spend and the number of shares repurchased will vary based on a variety of factors including the stock price, and blackout periods, in which we are restricted from repurchasing shares, and our credit rating and may include private block purchases as well as market transactions. Repurchases under our stock repurchase programs reflect, in

part, our confidence in the long-term value of Amgen common stock. Additionally, we believe that it is an effective way of returning cash to our stockholders.

For additional information regarding our stock repurchase program, see Part II – Other Information, “ItemItem 2. Unregistered Sales of Equity Securities, Use of Proceeds and Issuer Purchases of Equity Securities.Securities in Part II herein.

We receive cash from the exercise of employee stock options and proceeds from the sale of stock pursuant to the employee stock purchase plan.stock. Employee stock option exercises and proceeds from the sale of stock by us pursuant to the employee stock purchase plan provided $138$28 million and $89$138 million of cash during the three months ended March 31, 20072008 and 2006,2007, respectively. Proceeds from the exercise of employee stock options will vary from period to period based upon, among other factors, fluctuations in the market value of our stock relative to the exercise price of such options.

On March 2, 2007, as a result of holders of substantially all of our outstanding 2032 Modified Convertible Notes exercising their March 1, 2007 put option, we purchased $2.3 billion aggregate principal amount, or the majority of the then outstanding convertible notes at their then-accreted value for $1.7 billion in cash.

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Item 4.CONTROLS AND PROCEDURES

We maintain “disclosure controls and procedures,” as such term is defined under Exchange Act Rule 13a-15(e), that are designed to ensure that information required to be disclosed in Amgen’s Exchange Act reports is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms, and that such information is accumulated and communicated to Amgen’s management, including its Chief Executive Officer and Chief Financial Officer, as appropriate, to allow timely decisions regarding required disclosures. In designing and evaluating the disclosure controls and procedures, Amgen’s management recognized that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives and in reaching a reasonable level of assurance Amgen’s management necessarily was required to apply its judgment in evaluating the cost-benefit relationship of possible controls and procedures. We have carried out an evaluation under the supervision and with the participation of our management, including Amgen’s Chief Executive Officer and Chief Financial Officer, of the effectiveness of the design and operation of Amgen’s disclosure controls and procedures. Based upon their evaluation and subject to the foregoing, the Chief Executive Officer and Chief Financial Officer concluded that our disclosure controls and procedures were effective as of March 31, 2007.2008.

The Company isManagement determined that, as of March 31, 2008, there were no changes in the process of implementing an ERP system using SAP applications, which involves migrating the Company’s legacy financial, supply chain and human resource systems and users worldwide to a common SAP platform. In January 2007, the Company implemented the ERP system in its European operations. The implementation of this phase of the project has involved changes to certainour internal controlscontrol over financial reporting which the Company believes were material. In connection with this, we reviewed the design and operating effectiveness of key controls over financial reporting affected by the new system for the quarter ended March 31, 2007. There were no other changes that occurred during the firstfiscal quarter of 2007then ended that have materially affected, or are reasonably likely to materially affect, the Company’sour internal control over financial reporting.

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PART II - OTHER INFORMATION

 

Item 1.LEGAL PROCEEDINGS

Certain ofSee Note 8, “Contingences” to the Condensed Consolidated Financial Statements for a discussion which is limited to certain recent developments concerning our legal proceedings are reportedproceedings. This discussion should be read in conjunction with Note 10, “Contingencies” to our Consolidated Financial Statements in Part IV of our Annual Report on Form 10-K for the year ended December 31, 2006 and below. While it is not possible to accurately predict or determine the eventual outcome of these items, we do not believe any such items currently pending will have a material adverse effect on our consolidated financial position or liquidity, although an adverse resolution in any quarterly or annual reporting period of one or more of these items could have a material impact on the consolidated results of our operations for that period.

Transkaryotic Therapies (“TKT”) and Aventis Litigation

On March 22, 2007, Amgen filed a Petition for a Writ of Certiorari with the U.S. Supreme Court.

Average Wholesale Price Litigation

In the Multi-District Litigation (the “MDL”) Proceeding, on April 2, 2007, the judge granted in part and denied in part Defendants’, which includes Amgen and Immunex together with other pharmaceutical manufacturers, motions to dismiss the consolidated New York counties case. On April 5, 2007, the County of Orange, New York filed an AWP complaint in the United States District Court for the Southern District of New York and a notice of related action was filed with the Judicial Panel on Multidistrict Litigation in Boston, Massachusetts. Amgen and Immunex were served with the complaint on April 23, 2007.

Robert J. Swanson v. TAP Pharmaceutical Products, Inc., et. al.

The case remains stayed and another status conference is scheduled for July 30, 2007.

State of Alaska v. Abbott Laboratories, Inc., et. al.

A hearing on Defendants’, which includes Amgen and Immunex together with other pharmaceutical manufacturers, motions to dismiss is scheduled for May 9, 2007.

IUOE, Local 68 v. AstraZenaca, PLC, et al.

A hearing on Defendants’, which includes Amgen and Immunex together with other pharmaceutical manufacturers, motions to dismiss was held on April 5, 2007 in which Defendants’ motions were denied.

Roche Matters

Amgen Inc. v. F. Hoffmann-La Roche Ltd., et al.

On March 5, 2007, we and F. Hoffman-La Roche Ltd., Roche Diagnostics GmbH, and Hoffmann-La Roche, Inc. (collectively, “Roche”) filed opening briefs setting forth respective proposals for the United States District Court for the District of Massachusetts’ (the “District Court”) construction of the claims of the patents. On March 7, 2007, the United States Court of Appeals for the

31


Federal Circuit dismissed Ortho’s appeal as requested in the parties’ stipulation. On March 19, 2007, the parties filed their responsive briefs with respect to construction of the patent claims. On March 30, 2007, the District Court dismissed Roche’s counterclaim II related to alleged sham litigation and affirmative defense XII relating to equitable estoppel and denied the motion to dismiss Roche’s remaining counterclaims and affirmative defenses. The District Court also stated that the case would be tried by a jury so long as Roche’s antitrust counterclaims remain in the case. On April 2, 2007, Roche filed its Amended Answer and Counterclaims pursuant to the District Court’s March 30 Order. On April 16, 2007, Amgen filed its Answer to Roche’s Amended Answer and Counterclaims. On April 17, 2007, the District Court held a Markman Hearing during which the parties presented their proposed constructions of the claims of the patents-in-suit. The District Court announced its working-construction of many of the claim terms in dispute during the April 17, 2007 hearing, but has not yet issued a written decision with respect to claim construction.

Amgen Inc., et. al. v. Ariad Pharmaceuticals, Inc. (“Ariad”)

On March 27, 2007, the United States District Court for the District of Delaware (the “Delaware District Court”) denied Ariad’s renewed Motion to Dismiss for Failure to Name Indispensable Parties or in the alternative to Transfer. On April 13, 2007, Amgen, Immunex, Amgen USA Inc. and Amgen Manufacturing, Limited (the “Amgen Entities”) filed an Amended Complaint for Declaratory Judgment of Invalidity and Non-infringement against Ariad and the Whitehead Institute for Biomedical Research (the “Whitehead Institute”). On April 13, 2007, Ariad, the Whitehead Institute, Massachusetts Institute of Technology (“MIT”) and The President and Fellows of Harvard College (“Harvard”) filed an Answer to Amgen’s Amended Complaint and a Counterclaim against the Amgen Entities and Wyeth for patent infringement. On April 13, 2007, Ariad, the Whitehead Institute, MIT and Harvard also filed a Complaint in the Delaware District Court against Amgen and Wyeth for patent infringement of the U.S. Patent Number 6,410,516 (the “‘516 patent”).

Other

On March 20, 2007, Amgen received a letter from Chairmen Dingell and Stupak of the House Subcommittee on Oversight & Investigation, Committee on Energy & Commerce. The letter posed questions around ESA studies, promotion of ESAs, communications with the FDA and sales to physicians. Amgen has cooperated fully and submitted its response on April 18, 2007.

On April 17, 2007, a class action shareholder litigation suit was filed against Amgen Inc., Kevin W. Sharer, Willard H. Dere, Richard D. Nanula, Dennis M. Fenton, Roger M. Perlmutter, Brian M. McNamee, George J. Morrow, Edward V. Fritzky, Gilbert S. Omenn and Franklin P. Johnson, Jr., (the “Federal Defendants”) in the United States District Court for the Central District of California (the “California Central District Court”). The complaint alleges that Amgen and these officers and directors made false statements that resulted in a fraudulent scheme and course of business operated as a fraud or deceit on purchasers of Amgen publicly traded securities in that: (i) it temporarily deceived the investing public regarding Amgen’s prospects and business; (ii) it artificially inflated the prices of Amgen’s publicly traded securities; and (iii) it caused plaintiff and other members of the Class to purchase Amgen publicly traded securities at inflated prices. The complaint also makes off-label marketing allegations. Amgen was served with the complaint on April 20, 2007. A second shareholder complaint was filed against the Federal Defendants on May 1, 2007, also in the California Central District Court. The complaint alleges that, throughout the class period, Federal Defendants failed to disclose material adverse facts about the Company’s marketing of Aranesp® and EPOGEN®. Specifically, defendants failed to disclose or indicate the following: (i) that Amgen was improperly

 

32


marketing Aranesp® and EPOGEN® for off-label uses; and (ii) that the defendants were aware of the negative results of studies which showed more cancer reoccurrences and an increased number of patient deaths in studies that tested Aranesp®. This suit, as well as additional related securities suits, if filed, will be consolidated into a master complaint in the California Central District Court. Also on May 1, 2007, a third shareholder complaint was filed in California Central District Court. The complaint alleges that the Federal Defendants made false statements that resulted in a fraudulent scheme and course of business operated as a fraud or deceit on purchasers of Amgen publicly traded securities in that: (i) it temporarily deceived the investing public regarding Amgen’s prospects and business; (ii) it artificially inflated the prices of Amgen’s publicly traded securities; and (iii) it caused plaintiff and other members of the Class to purchase Amgen publicly traded securities at inflated prices. The complaint also makes off-label marketing allegations. In the three shareholder complaints, plaintiffs seek class certification, compensatory damages, legal fees and other relief deemed proper.

Further on May 1, 2007, two shareholder derivative complaints were filed in Superior Court of the State of California, Ventura County and name Amgen Inc., Kevin W. Sharer, George J. Morrow, Dennis M. Fenton, Brian M. McNamee, Roger M. Perlmutter, David Baltimore, Gilbert S. Omenn, Judith C. Pelham, Frederick W. Gluck, Jerry D. Choate, J. Paul Reason, Frank J. Biondi, Jr., Leonard D. Schaeffer, Frank C. Herringer, Richard D. Nanula, Willard H. Dere, Edward V. Fritzky, Franklin P. Johnson, Jr. and Donald B. Rice as defendants (the “State Defendants”). The complaints allege that the State Defendants breached their fiduciary duties, wasted corporate assets, were unjustly enriched and violated the California Corporations Code. Plaintiffs allege that the State Defendants failed to disclose and/or misrepresented results of Aranesp® clinical studies, marketed both Aranesp® and EPOGEN® for off-label uses and that these actions or inactions as well as the Amgen market strategy caused damage to the Company resulting in several inquiries, investigations and lawsuits that are costly to defend. The complaints also allege insider trading by the State Defendants. Plaintiffs seek treble damages based on various causes of action, reformed corporate governance, equitable and/or injunctive relief, restitution, disgorgement of profits, benefits and other compensation, and legal costs.

Additionally, on May 7, 2007, a third shareholder derivative complaint was filed in the California Central District Court and named Amgen Inc., Kevin W. Sharer, George J. Morrow, Dennis M. Fenton, Brian M. McNamee, Roger M. Perlmutter, David Baltimore, Gilbert S. Omenn, Judith C. Pelham, Frederick W. Gluck, Jerry D. Choate, J. Paul Reason, Frank J. Biondi, Jr., Leonard D. Schaeffer, Frank C. Herringer, Richard D. Nanula, Edward V. Fritzky and Franklin P. Johnson, Jr. as defendants. The complaint alleges the same claims and requests the same relief as in the shareholder derivative complaints filed in the Superior Court of the State of California, Ventura County, described above.

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Item 1A.RISK FACTORS

This report and other documents we file with the SEC contain forward looking statements that are based on current expectations, estimates, forecasts and projections about us, our future performance, our business or others on our behalf, our beliefs and our management’s assumptions. These statements are not guarantees of future performance and involve certain risks, uncertainties, and assumptions that are difficult to predict. You should carefully consider the risks and uncertainties facing our business. The risks described below are not the only ones facing us. Our business is also subject to the risks that affect many other companies, such as employment relations, general economic conditions, geopolitical events and international operations. Further, additional risks not currently known to us or that we currently believe are immaterial also may impair our business, operations, liquidity and stock price materially and adversely.

Our current products and products in development cannot be sold if we do not gain or maintain regulatory approval of our products and we may be required to perform additional clinical trials or change the labeling of our products or conduct other potentially limiting or costly risk management activities if we or others identify side effects or safety concerns after our products are on the market.

We and certain of our licensees and partners conduct research, preclinical testing and clinical trials for our product candidates and marketed products for both their existing indications as well as for new and/or expanded indications. In addition, we manufacture and contract manufacture, and certain of our licensees and partners manufacture our products and product candidates, price, sell, distribute and market or co-market our products for their approved indications. These activities are subject to extensive regulation by numerous state and federal governmental authorities in the United States, such as the FDA and CMS, as well as in foreign countries, such as the European Agency for the Evaluation of Medicinal Products (“EMEA”) in European countries, Canada and Australia. Currently, we are required in the United States and in foreign countries to obtain approval from those countries’ regulatory authorities before we can manufacture (or have our third-party manufacturers produce), market and sell our products in those countries. The FDA and other U.S. and foreign regulatory agencies have substantial authority to fail to approve commencement of, suspend or terminate clinical trials, require additional testing, delay or withhold registration and marketing approval, mandate product withdrawals and require changes in labeling (including eliminating certain therapeutic indications) of our products. On September 27, 2007, President Bush signed into law the Food and Drug Administration Amendments Act of 2007 (the “FDAAA”), significantly adding to the FDA’s authority including allowing the FDA to (i) require sponsors of marketed products to conduct post-approval clinical studies to assess a known serious risk, signals of serious risk or to identify an unexpected serious risk; (ii) mandate labeling changes to products, at any point in a product’s lifecycle, based on new safety information and (iii) require sponsors to implement a REMS for a product which could include a medication guide, patient package insert, a communication plan to healthcare providers, or other elements as the FDA deems are necessary to assure safe use of the drug, which could include imposing certain restrictions on distribution or use of a product. Failure to comply with the new requirements, if imposed on a sponsor by the FDA under the FDAAA, could result in significant civil monetary penalties. Further, regulatory agencies could change existing, or promulgate new, regulations at any time which may affect our ability to obtain or maintain approval of our existing or future products or require significant additional costs to obtain or maintain such approvals.

In our experience, obtaining regulatory approval has been and continues to be increasingly difficult and costly and takes many years, and after it is obtained remains costly to maintain. With the occurrence of a

number of high profile safety events with certain pharmaceutical products, regulatory authorities, and in particular the FDA, members of Congress, the U.S. Government Accountability Office (“GAO”), Congressional committees, private health/science foundations and organizations, medical professionals, including physicians and investigators, and the general public are increasingly concerned about potential or perceived safety issues associated with pharmaceutical and biological products, whether under study for initial approval or already marketed. For example, we have received letters from both the House Subcommittee on Oversight and Investigation, Committee on Energy and Commerce and the United States Senate Committee on Finance with inquiries with respect to our ESA studies, promotions of our ESAs and other products, rebates and contracting strategies and our pharmacovigilance program, to which we have fully cooperated by submitting our responses and meeting with Congressional staff. To the extent that there is resulting legislation or changes in CMS or FDA policy or regulatory activity as a result of Congressional concerns, such changes could have a material or adverse effect on the use of our ESA products.

As a result of this increasing concern, potential or perceived safety signals and safety concerns, from clinical trials, use by the market or other sources, are receiving greater scrutiny, which may lead to fewer treatments being approved by the FDA or other regulatory bodies, revised labeling of an approved product or a class of products for safety reasons, potentially including a boxed warning or additional limitations on the use of approved products in specific therapeutic areas (until additional clinical trials can be designed and completed), mandated PMCs, pharmacovigilance programs for approved products or requirement of risk management activities (including a REMS) related to the promotion and sale of a product. In addition, significant concerns about the safety and effectiveness of our products could ultimately lead to the revocation of marketing approval by therapeutic area, or in total, which would have a material adverse effect on the use, sales and reimbursement of the affected products and on our business and results of operations. (See “–Our sales depend on payment and reimbursement from third-party payers, and, to the extent that reimbursement for our products is reduced, this could negatively impact the utilization of our products.”)

Certain specific labeling or label changes of approved products or product candidates may be necessary or required for a number of reasons, including: the identification of actual or theoretical safety or efficacy concerns by regulatory agencies, the discovery of significant problems with a similar product that implicates an entire class of products, subsequent concerns about the sufficiency of the data or studies underlying the label or changes to the underlying safety/efficacy analysis related to results from clinical trials performed by us or others. In addition, before or after any of our products are approved for commercial use, regulatory bodies could decide that the product labels need to include certain warning language as part of an evolving label change to a particular class of products. For example, in March and November 2007 and in March 2008, the labels of the class of ESA products, including Aranesp® and EPOGEN®, were updated to include revised boxed warnings, restrictions on the use of ESAs in specific therapeutic areas and other safety-related product labeling changes. We continue to be in discussion with the FDA to complete further revisions to our ESA labels. (See “–The potential future labeling changes or risk management activities including those discussed at the March 13, 2008 ODAC meeting may adversely impact the use, sales and reimbursement of our ESAs.”) On March 17, 2008, we and Wyeth announced updates to the FDA approved PI for ENBREL in which the U.S. PI now contains a boxed warning relating to the risk of infections, including tuberculosis. This information now in the boxed warning includes additional language regarding screening and monitoring patients for tuberculosis, including patients who tested negative for latent tuberculosis infection. Additionally, on May 1, 2008, we announced that the FDA has asked us to participate in a meeting of the DODAC on June 18, 2008 to review data supporting the supplemental BLA submitted by us for the use of ENBREL in treating pediatric patients with chronic moderate to severe plaque psoriasis, who are inadequately controlled with topical therapy or who have received systemic therapy or phototherapy. Although we cannot predict what action, if any, the FDA may take or require of us or what recommendations may arise from the DODAC meeting, a recommendation by the DODAC not to approve the new indication or any further revisions to the ENBREL label could have a negative impact on the use and sales of ENBREL. Additionally, the FDA previously instituted a class label change for the class of ESAs to add information about pure red cell aplasia (“PRCA”) to the adverse event profile section and for the boxed warning in the PI of the label described above. A revision of product labeling or the regulatory actions described above could be required even if there is no clearly established connection between the product and the safety or efficacy concerns that have been raised. Also in October 2007, we announced that we and the FDA

adopted changes to the U.S. PI for Vectibix® based on the results of the Panitumumab Advanced Colorectal Cancer Evaluation (“PACCE”) trial highlighting to clinicians the greater risk seen when Vectibix® is combined with Avastin® and the specific chemotherapy used in the PACCE trial to treat patients with first-line metastatic colorectal cancer (“mCRC”). Vectibix®is not indicated for the first-line treatment of mCRC and the new safety information applies to an unapproved use of Vectibix®.

In addition, if we or others identify safety concerns before approval of the product or after a product is on the market, the regulatory agencies such as the FDA or EMEA may impose risk management activities upon us at substantial costs and/or may require additional or more extensive clinical trials as part of a pharmacovigilance program of our product, or for approval of a new indication, any of which could have a negative affect on our ability to launch the product candidate and could have a material adverse effect on sales of the affected products and on our business and results of operations. For example, the FDA required us to submit a REMS as part of the BLA for NplateTM which extended its PDUFA date from April 23 to July 23, 2008. Regulatory agencies such as the FDA could also require us to engage in risk management activities, including a REMS, which could modify or restrict our existing promotional activities, restrict or encumber the ability of healthcare providers to prescribe, dispense or use our products or limit patient access to our products. In addition to our ESA products, we have ongoing PMC studies for substantially all of our marketed products other than Sensipar®. These clinical trials must be conducted by us to maintain regulatory approval and marketing authorization. For example, we have agreed with the FDA to a robust pharmacovigilance program to continue to study the safety surrounding the use of ESAs in certain cancer indications. (See “–The potential future labeling changes or risk management activities including those discussed at the March 13, 2008 ODAC meeting may adversely impact the use, sales and reimbursement of our ESAs.”) Additionally, the approvals of Vectibix® in both the United States and EU were conditioned on us conducting additional clinical trials of the use of Vectibix® as a therapy in treating mCRC. If results from mandated clinical trials as part of a PMC or pharmacovigilance program are negative or any risk management activities resulted in decreased use of our products, it could have a material adverse effect on sales of the affected products and on our business and results of operations.

Substantially all of our marketed products are currently approved in the United States and most are approved in Europe and in other foreign countries for specific uses. However, later discovery of unknown problems with our products could result in the regulatory activities described above or even the potential withdrawal of the product in certain therapeutic areas or certain product presentations, or completely, from the market. If new medical data suggests an unacceptable safety risk or previously unidentified side-effects, we may voluntarily withdraw, or regulatory authorities may mandate we withdraw such product in certain therapeutic areas, or completely recall a product presentation from the market for some period or permanently. For example in 2006, we initiated a voluntary recall of the Neulasta® SureClick™ pre-filled pen in Europe because of the potential risk to patients of receiving an incomplete dose and we conducted a voluntary wholesaler recall of a limited number of lots of ENBREL as a result of a small number of reports of missing, detached or loose rubber caps on the needleless syringe filled with diluent liquid by a third-party contract manufacturer and packaged with the vials of ENBREL. Although there have been no observable adverse event trends associated with the Neulasta® SureClick™ pre-filled pen or with the reports of missing, detached or loose rubber caps on the needleless syringe packaged with the ENBREL vials, we may experience the same or other problems in the future resulting in broader product recalls or adverse event trends. Additionally, if other parties (including our licensees, such as J&J and Wyeth, or independent investigators) fail to effectively report to regulatory agencies side effects or other safety concerns that occur from their use of our products in clinical trials or studies or from marketed use, regulatory approval may be withdrawn for a product for the therapeutic area in question, or completely, or other risk management activities may be imposed by regulators.

If regulatory authorities determine that we or our licensees or partners conducting R&D activities on our behalf have not complied with regulations in the R&D of a product candidate, new indication for an existing product or information to support a current indication, then they may not approve the product candidate or new indication or maintain approval of the current indication in its current form or at all, and we will not be able to market and sell it. If we were unable to market and sell our products or product candidates, our business and results of operations would be materially and adversely affected. Additionally, safety signals

or adverse events or results from clinical trials or studies performed by us or by others (including our licensees or independent investigators) from the marketed use of our drugs that resulted in revised safety labeling or restrictions on the use of our approved products could negatively impact healthcare provider prescribing behavior, use of our products, regulatory or private health organization medical guidelines and reimbursement for our products all of which would have a material adverse effect on our business and results of operations. (SeeOur sales depend on payment and reimbursement from third-party payers, and, to the extent that reimbursement for our products is reduced, this could negatively impact the utilization of our products.” and “– Guidelines and recommendations published by various organizations can reduce the use of our products.”)

The potential future labeling changes or risk management activities including those discussed at the March 13, 2008 ODAC meeting may adversely impact the use, sales and reimbursement of our ESAs.

On March 9, 2007, based upon data from our AoC 103 Study, J&J’s Correction of Hemoglobin and Outcomes in Renal Insufficiency (“CHOIR”) study, and preliminary data from the third-party investigator Danish Head and Neck Cancer (“DAHANCA”) 10 Study, among others, the FDA approved updated safety information, including a boxed warning, in the PI for the class of ESAs, including Aranesp® and EPOGEN®. On May 10, 2007, the ODAC held a panel meeting to discuss the safety/efficacy profile of ESA use in oncology. Responding to questions posed by the FDA, the ODAC recommended that more restrictions be added to ESA labels and that additional clinical trials be conducted by companies with currently approved ESAs, including us, although no specific restrictions or studies were recommended at the ODAC meeting. The committee is advisory and FDA officials are not bound to or limited by its recommendations. However, the FDA has commonly followed the recommendations of its advisory panels. The FDA also held a joint meeting of the CRDAC and the DSaRMAC on September 11, 2007, which evaluated the safety data on ESA use in renal disease.

On November 8, 2007, in recognition of the input from the May 2007 ODAC and September 2007 joint CRDAC/DSaRMAC meetings, we announced additional updates to the Aranesp® and EPOGEN®/PROCRIT® package inserts which reflected ongoing interactions with the FDA regarding the safety and benefit/risk profile of ESAs. The changes to the ESA labels included modifications to the boxed warnings which included language with respect to renal failure which stated that “patients experienced greater risks for death and serious cardiovascular events when administered ESAs to target higher versus lower hemoglobin levels (13.5 vs. 11.3 g/dL; 14 vs. 10 g/dL) in two clinical studies. Individualize dosing to achieve and maintain hemoglobin levels within the range of 10 to 12 g/dL.” Additional language was also added to the INDICATIONS AND USAGE section, and the WARNINGS section and clarification of the Hb range for CRF patients was added in the DOSAGE AND ADMINISTRATION section. On March 7, 2008, we announced that the FDA approved updated safety information, including the boxed warning in the labeling information for the class of ESAs, including Aranesp® and EPOGEN®. The updated boxed warning states that ESAs shortened overall survival and/or time-to-tumor progression in clinical studies in patients with breast, non-small cell lung, head and neck, lymphoid and cervical cancers when dosed to a target Hb of greater than or equal to 12 g/dL. In the “Increased Mortality and/or Tumor Progression” warning section of the updated labeling, the interim results of the PREPARE study in neo-adjuvant breast cancer were added as well as follow up data from the GOG-191 study in cervical cancer.

On March 13, 2008, the FDA held a follow-up ODAC panel meeting to discuss cumulative data, including recent study results, on the risks of ESAs when used in the oncology setting. Although not required, the FDA has and will likely continue to take into consideration the recommendations by the ODAC in its ongoing discussions with us regarding our ESAs. Responding to questions posed by the FDA, the fourteen ODAC members voted as follows:

FDA Questions to the Committee

  Yes  No  

Abstention

Considering all the available data on the benefit and risks of ESAs in the treatment of anemia due to concomitant cancer chemotherapy, do you recommend that these products continue to be marketed for that indication?

  13  1  

Should the current indication be modified to restrict use only to patients with small cell lung cancer?

  6  8  

Should the current indication be modified to include a statement that ESA use is not indicated for patients receiving potentially curative treatments?

  11  2  1

Should the current indication be modified to include a statement that ESA use is not indicated for patients with breast and/or head and neck cancers?

  9  5  

Should the FDA require the implementation of an informed consent/patient agreement for the treatment of chemotherapy induced anemia?

  8  5  1

Should the FDA mandate a restricted distribution system for oncology patients receiving ESAs?*

  1  10  2

* Only thirteen votes cast.

We are in ongoing discussions with the FDA, and in connection with available safety data, including the data and study results discussed at the ODAC, the FDA has asked us to (i) propose additional safety-related changes to the labeling for Aranesp® and EPOGEN®, (ii) develop a proposed REMS for Aranesp® and EPOGEN® and (iii) conduct clinical trials to determine the effects of Aranesp® and EPOGEN® on survival and tumor outcomes. We are in the process of preparing the submissions responsive to the FDA’s requests and although we cannot predict what final label revisions or risk management activities the FDA may require of us based upon the recommendations from the ODAC meeting, further revisions to the labels for Aranesp® and EPOGEN® and/or risk management activities could have a material adverse impact on the reimbursement, use and sales of our ESA products, which would have a material adverse effect on our business and results of operations. (See “–Our current products and products in development cannot be sold if we do not gain or maintain regulatory approval of our products and we may be required to perform additional clinical trials or change the labeling of our products or conduct other potentially limiting or costly risk management activities if we or others identify side effects or safety concerns after our products are on the market”and “–Our sales depend on payment and reimbursement from third-party payers, and, to the extent that reimbursement for our products is reduced, this could negatively impact the utilization of our products.”)

In addition, we continue to work with the FDA to finalize protocols for large placebo-controlled randomized studies that will formally evaluate overall survival and progression free survival endpoints in patients treated according to the U.S. approved package insert. The addition of these clinical trials to our pharmacovigilance program and any additional clinical trials required by the FDA could result in substantial additional expense, additional label restrictions, or the loss of regulatory approval for an approved indication and may have a material adverse effect on our business and results of operations. Additionally, any negative results from such trials could materially affect the extent of approvals, the use, reimbursement and sales of our ESA products. (See “–Before we commercialize and sell any of our product candidates or existing products for new indications, we must conduct clinical trials in humans; if we fail to adequately manage these trials we may not be able to sell future products and our sales could be adversely affected.”)

On March 5, 2008, we announced that the European Commission reached its decision to amend the PI for the class of ESAs, including Aranesp®, based on the positive opinion from the CHMP in January 2008, which was consistent with the EMEA’s October 23, 2007 press release stipulating a uniform target Hb range for all ESAs of 10 g/dL to 12 g/dL with guidance to avoid sustained Hb levels above 12 g/dL. Following the March 13, 2008 ODAC, we have continued to share additional ESA safety data with the EMEA as it has become available. In addition, on May 6, 2008, we announced that the CHMP has requested that we and other ESA marketing authorization holders

participate in a closed meeting of the SAG-O on May 15, 2008. The marketing authorization holders have been asked to provide an overview on studies that have been initiated or conducted since July 2007, as well as any other new data that can help to elucidate recent issues on the impact of ESAs on tumor progression and survival in cancer patients. These data include previously disclosed interim results from the PREPARE study in neoadjuvant breast cancer therapy; follow-up data from the GOG-191 study in cervical cancer, which were published in the February 2008 issue of Gynecologic Oncology; and the February 2008 meta-analysis by Bennett et al, which was published in the Journal of the American Medical Association. SAGs are created by the CHMP to deliver answers, on a consultative basis, to specific questions addressed to them by the CHMP. The CHMP, while taking into account the position expressed by the SAG, remains responsible for its final opinion. Should the CHMP and EMEA add additional safety labeling to the class of ESAs based upon the SAG-O meeting, the reimbursement, use and sales of Aranesp® in Europe could be materially adversely affected.

Before we commercialize and sell any of our product candidates or existing products for new indications, we must conduct clinical trials in humans; if we fail to adequately manage these trials we may not be able to sell future products and our sales could be adversely affected.

Before we can sell any products, we must conduct clinical trials which demonstrate that our product candidates are safe and effective for use in humans for the indications sought or our existing products are safe and effective for use in humans in new indications sought. Additionally, we may be required to conduct additional trials as a condition of the approval of our label or as a result of perceived or existing safety concerns. The results of these clinical trials are used as the basis to obtain regulatory approval from regulatory authorities such as the FDA. Clinical trials are experiments conducted using our product candidates in human patients having the diseases or medical conditions we are trying to address. Conducting clinical trials is a complex, time-consuming and expensive process. We are required to conduct clinical trials using an appropriate number of trial sites and patients to support the product label claims we are seeking or to support our existing label. The length of time, number of trial sites and patients required for clinical trials vary substantially according to the type, complexity, novelty and intended use of the product candidate or the extent of the safety concerns, post-marketing issues and/or exposure to patients and therefore, we may spend several years and incur substantial expense in completing certain trials. Our ability to complete our clinical trials in a timely fashion depends in large part on a number of key factors including protocol design, regulatory and institutional review board approval, availability of clinical study material and the rate of patient enrollment in clinical trials. Patient enrollment is a function of several factors, including the size and location of the patient population, enrollment criteria and competition with other clinical trials for eligible patients. As such, there may be limited availability of patients who meet the criteria for certain clinical trials. Delays in planned clinical trials can result in increased development costs, delays in regulatory approvals, associated delays in product candidates reaching the market and revisions to existing product labels. In addition, in order to increase the number of patients available for enrollment for our clinical trials, we have and will continue to open clinical sites and enroll patients in a number of new geographic locations where our experience conducting clinical trials is more limited, including Russia, China, India and some Central and South American countries either through utilization of third-party contract clinical trial providers entirely or in combination with local staff. Conducting clinical trials in locations where we have limited experience requires substantial time and resources to identify and understand the unique regulatory environments of individual countries. If we fail to adequately manage the design, execution and regulatory aspects of our large, complex and regulatory diverse clinical trials, our clinical trials and corresponding regulatory approvals may be delayed or we may fail to gain approval for our product candidates altogether or could lose our ability to market existing products in certain therapeutic areas or altogether. If we are unable to market and sell our product candidates or are unable to obtain approvals in the timeframe needed to execute our product strategies, our business and results of operations would be materially adversely affected. Additional information on our clinical trials can be found on our website at (http://www.amgen.com). (This website address is not intended to function as a hyperlink, and the information contained on our website is not intended to be a part of this filing.)

Patients may also suffer adverse medical events or side effects in the course of our, our licensees, partners or independent investigator’s clinical trials of our products or product candidates that may delay the clinical program, require additional or longer trials to gain approval, prohibit regulatory approval of our

product candidates or additional indications for our currently approved products, or may render the product candidate commercially unfeasible or limit our ability to market existing products in certain therapeutic areas or at all. For example, as a result of observing an increased frequency of cholecystitis, inflammation of the gall bladder, in patients treated with our late-stage product candidate motesanib diphosphate, we delayed our phase 3 trial in first-line non-small cell lung cancer (“NSCLC”), which was previously expected to begin in the fourth quarter of 2006, until the second half of 2007. Clinical trials must be designed based on the current standard of medical care. However in certain diseases, such as cancer, the standard of care is evolving rapidly. In these diseases, the duration of time needed to complete certain clinical trials may result in the design of such clinical trials being based on an out of date standard of medical care, limiting the utility and application of such trials. Of course, even if we successfully manage our clinical trials, we may not obtain favorable clinical trial results and may not be able to obtain regulatory approval for new product candidates, product label extensions or maintenance of our current labels on this basis. Further, clinical trials conducted by others, including our licensees, partners or independent investigators, may result in unfavorable clinical trials results that may call into question the safety of our products in off-label or on label uses that may result in label restrictions and/or additional trials.

In connection with our efforts to improve our cost structure, we refocused our spending on critical R&D and operational priorities and sought greater efficiencies in how we conduct our business, including optimizing ongoing clinical trials and trial initiation. These efforts will assist in allowing us to provide continued support of key activities including (i) current and future postmarketing studies, including those with respect to our ESA products, Aranesp® and EPOGEN®; (ii) regulatory affairs, safety and compliance functions; (iii) clinical studies to advance our late-stage pipeline; (iv) the advancement of earlier stage compounds and (v) research efforts in the core areas of oncology, inflammation, bone and metabolic disorders. To the extent future sales are negatively affected as a result of additional regulatory and reimbursement developments or other challenges, we may be required to further adjust our R&D investment plans. Such actions could result in delays in obtaining approval or reductions in the number of indications and market potential of our product candidates. We also partner certain portions and/or geographic regions of our pipeline to preserve opportunities that may result in sharing the positive economic results with another party. For example, in the first quarter of 2008 we completed a collaboration with Takeda for up to thirteen clinical molecules from our pipeline.

Our sales depend on payment and reimbursement from third-party payers, and, to the extent that reimbursement for our products is reduced, this could negatively impact the utilization of our products.

Sales of all of our principal products are dependent, in part, on the availability and extent of reimbursement from third-party payers, including governments and private insurance plans. Generally, in Europe and other countries outside the United States, the government sponsored healthcare system is the primary payer of healthcare costs of patients. Governments may regulate access to, prices or reimbursement levels of our products to control costs or to affect levels of use of our products. Worldwide use of our products may be affected by these cost containment pressures and cost shifting from governments and private insurers to healthcare providers or patients in response to ongoing initiatives to reduce or reallocate healthcare expenditures. Further, adverse events or results from clinical trials or studies performed by us or by others or from the marketed use of our drugs may expand safety labeling for our approved products and may negatively impact worldwide reimbursement for our products. On July 30, 2007, the CMS issued its Decision Memorandum and on January 14, 2008, issued changes to its Medicare National Coverage Determinations Manual, effective for claims with dates of service on or after July 30, 2007, with an implementation date of April 7, 2008. A discussion of the Decision Memorandum follows below. (See also “–Our current products and products in development cannot be sold if we do not gain or maintain regulatory approval of our products and we may be required to perform additional clinical trials or change the labeling of our products or conduct other potentially limiting or costly risk management activities if we or others identify side effects or safety concerns after our products are on the market.” and “–Guidelines and recommendations published by various organizations can reduce the use of our products.”)

Most patients receiving Aranesp®, Neulasta® and NEUPOGEN® for approved indications are covered by government and/or private payer healthcare programs. Medicare and Medicaid government healthcare

programs’ payment policies for drugs and biologicals are subject to various laws and regulations. Beginning in January 1, 2005 under the MMA, in the physician clinic setting and January 1, 2006, in the hospital outpatient and dialysis settings, Aranesp®, Neulasta® and NEUPOGEN® have been reimbursed under a Medicare Part B payment methodology that reimburses each product at 106% of its ASP (sometimes referred to as “ASP+6%”). Effective January 1, 2008, Medicare payment in the hospital outpatient setting reimburses each product at 105% of its ASP. ASP is calculated by the manufacturer based on a statutorily defined formula and submitted to CMS. A product’s ASP is calculated on a quarterly basis and therefore may change each quarter. The ASP in effect for a given quarter (the “Current Period”) is based upon certain historical sales and sales incentive data covering a statutorily defined period of time preceding the Current Period. For example, the ASP based payment rate for Aranesp® that will be in effect for the third quarter of 2008 will be based in part on certain historical sales and sales incentive data for Aranesp® from April 1, 2007 through March 31, 2008. CMS publishes the ASPs for products in advance of the quarter in which they go into effect.

In the United States, dialysis providers are primarily reimbursed for EPOGEN® by the federal government through the ESRD Program of Medicare. The ESRD Program reimburses approved providers for 80% of allowed dialysis costs; the remainder is paid by other sources, including patients, state Medicaid programs, private insurance, and to a lesser extent, state kidney patient programs. The ESRD Program reimbursement methodology is established by federal law and is monitored and implemented by CMS. Effective January 1, 2006, the payment mechanism for separately reimbursed dialysis drugs in both free-standing and hospital-based dialysis centers, including EPOGEN® and Aranesp®, is reimbursed by Medicare at ASP+6% using the same payment amounts used in the physician clinic setting. Beginning in the third quarter of 2007, based on its ongoing assessment for payment of Part B drugs, CMS instituted a single payment limit for Epoetin alfa (EPOGEN® and PROCRIT®) in all provider settings. Although we cannot predict the payment levels of EPOGEN® in future quarters or whether Medicare payments for dialysis drugs may be modified by future federal legislation, a decrease in the reimbursement rate for EPOGEN® may have a material adverse effect on our business and results of operations. Any changes to the ASP calculations directly affect the Medicare reimbursement for our products administered in the physician office, dialysis facility and hospital outpatient setting. These calculations are regularly reviewed for completeness and based on such review, we have revised our reported ASPs to reflect calculation changes both prospectively and retroactively. Partially as a result of our methodology changes, our ASP reimbursement rate for EPOGEN® was reduced for the third quarter of 2007.

Since April 1, 2006, the Medicare reimbursement for ESAs administered to dialysis patients has been subject to a revised HMA-PM, a Medicare payment review mechanism used by CMS to monitor EPOGEN® and Aranesp® utilization and appropriate hematocrit outcomes of dialysis patients. This policy, the EMP, was revised, effective January 1, 2008, requiring a 50% reduction in Medicare reimbursement if a patient’s Hb is above 13 g/dL for three or more consecutive months. In addition, the revised EMP reduces the monthly dosing limits to 400,000 IUs of EPOGEN®, from 500,000 IUs, and to 1,200 mcgs of Aranesp®, from 1,500 mcgs. The implementation of the revised EMP and ESA label changes have led to a decline in EPOGEN® sales for the first quarter of 2008 compared to the first quarter of 2007 primarily due to a decline in both overall utilization and as well as average dosing per patient. We believe that pronounced dose declines, which have been observed in the quarter of EMP implementation, will moderate in subsequent quarters, as has been observed with prior years’ EMP changes. However, further reductions in utilization or declining doses of EPOGEN®as a result of the revised EMP will have a material adverse effect on the sales of EPOGEN® and our business and results of operations.

Changes resulting from the MMA, which beginning in 2005 lowered reimbursement for our products, could negatively affect product sales of some of our marketed products. However, we believe that our product sales for 2005, 2006 and 2007 were not significantly impacted by the reimbursement changes resulting from the MMA. However, additional provisions of the MMA and other regulations affecting reimbursement that have gone or may go into effect could affect our product sales in the future. For example, the MMA required a report to Congress and a demonstration project with regard to a bundled payment system for dialysis, including separately billable drugs and EPOGEN®. The report to Congress was issued on February 20, 2008, but the demonstration project, which was scheduled to start in January 2006, has been delayed with no announced start

date. Bundling initiatives that have been implemented in other healthcare settings have resulted in lower utilization of services that had not previously been a part of the bundled payment. Because CMS is continuing to study bundled payments in the ESRD setting and legislation is possible, we cannot predict what impact a bundled payments system would have on sales of EPOGEN® or Aranesp® used in the treatment of persons receiving outpatient dialysis services.

In addition, in response to CMS considering and rejecting changes to the ASP calculation methodology for accounting for discounts in multi-product contracts in the 2007 Medicare Physician Fee Schedule Final Rule, MedPAC released its second Congressionally-mandated report on December 29, 2006 on the impact of changes in Medicare payments for Part B Drugs specifically recommending that the Secretary of the Department of Health and Human Services clarify ASP reporting requirements “to ensure that ASP calculations allocate discounts to reflect the transaction price for each drug.” Under the ASP system, we allocate our discounts based on the prices paid for individual drugs, according to the terms of its contracts with physicians and other purchasers, and we believe that the resulting ASPs reflect the transaction prices for individual drugs. Referencing a MedPAC December 2006 report, CMS proposed in the Medicare Physician Fee Schedule Proposed Rule for 2008 revising the methodology for calculating ASP to require the reallocation of price concessions of drugs sold under “bundled arrangements,” described by CMS in part as an arrangement regardless of physical packaging under which the rebate, discount or other price concession is conditioned upon the purchase of the same drug or biological or other drugs or biologicals or some other performance requirement. In the Medicare Physician Fee Schedule Final Rule for 2008, CMS stated that it was not finalizing the proposed regulatory change at this time, based on comments recommending a delay and raising concerns about the proposal. The agency also clarified that in the absence of specific guidance, manufacturers may continue to make “reasonable assumptions” in the calculation of ASP, consistent with the general requirements and the intent of the Medicare statute and regulations and their customary business practices. The agency stated that it will continue to monitor this issue and may provide more specific guidance in the future. Related to this issue, CMS issued a final Medicaid rule on July 6, 2007 that covered a broad range of topics concerning the calculation and use of AMP and best price as well as a definition for bundled sales under the Medicaid program. Although it has minor differences, the definition of “bundled sale” under this rule is essentially the same as what CMS proposed under the definition of “bundled arrangement” in the Medicare Physician Fee Schedule Proposed Rule for 2008 but which was not adopted for ASP reporting in the Final Rule for 2008. We continue in the process of evaluating what impact the final Medicaid rule will have on our business.

Other initiatives reviewing the coverage or reimbursement of our products, including those related to safety, could result in less extensive coverage or lower reimbursement and could negatively affect sales of some of our marketed products. For example, on March 14, 2007, shortly after the March 9, 2007 label changes for all ESAs, CMS announced that the agency had begun reviewing all Medicare policies related to the administration of ESAs in non-renal disease applications as part of a NCA which is generally CMS’ first step toward developing a NCD. Generally, a NCD is a national policy statement granting, limiting or excluding Medicare coverage or reimbursement for a specific medical item or service. On May 14, 2007, CMS issued the proposed NCD following a review of data and public comments submitted as part of the NCA, which under the MMA, was subject to a 30-day public comment period that ended June 13, 2007. On July 30, 2007, CMS issued its Decision Memorandum which was substantially altered from the proposed NCD. On January 14, 2008, CMS issued changes to its Medicare NCD Manual, adding the ESA Decision Memorandum, effective for claims with dates of service on and after July 30, 2007 with an implementation date of April 7, 2008. In the Decision Memorandum, CMS determined that ESA treatment was not reasonable and necessary for certain clinical conditions. The Decision Memorandum established the ESA reimbursement policy for Medicare and other government beneficiaries who are treated for CIA with ESAs. We believe that the restrictions in the Decision Memorandum changed the way ESAs are used in clinical practice, for example, by decreasing the number of treated patients, the average ESA dose and the duration of ESA therapy.

We believe this restriction on reimbursement of ESAs in the Decision Memorandum has had and may continue to have a material adverse effect on the use, reimbursement and sales of Aranesp®, and our business and results of operations. Additionally, based on our knowledge, although no private payers have implemented the Decision Memorandum to date, many private payers have implemented the restrictions

included in the Decision Memorandum. Further, due to difficulties in administering a two-tier medical practice, we believe many healthcare providers have reduced ESA utilization for all of their patients regardless of insurance coverage. While we cannot fully predict the further impact of the Decision Memorandum on how, or under what circumstances, healthcare providers will prescribe or administer our ESAs, it had a significant impact to our business in 2007 and believe that it may continue to impact us in 2008.

In addition, the FDA held a joint meeting of the CRDAC and the DSaRMAC on September 11, 2007, which evaluated the safety data on ESA use in renal disease. Although CMS has made no announcement of a nephrology focused NCA, any NCD for ESAs in the renal setting, which may include non-coverage and/or new dosing and treatment restrictions similar to those proposed in Decision Memorandum for treatment of anemia in oncology with ESAs, would negatively affect use, reduce reimbursement and coverage, negatively affect product sales of our ESA products and may have a material adverse effect on our business and results of operations.

If, and when, reimbursement rates or availability for our marketed products changes adversely or if we fail to obtain adequate reimbursement for our current or future products, healthcare providers may limit how much or under what circumstances they will prescribe or administer them, which could reduce the use of our products or cause us to reduce the price of our products. This could result in lower product sales, which could have a material adverse effect on us and our results of operations. For example, the use of EPOGEN® in the United States in connection with treatment for ESRD is funded primarily by the U.S. federal government. In early 1997, CMS, formerly known as Healthcare Financing Administration (“HCFA”), instituted a reimbursement change for EPOGEN®, which materially and adversely affected our EPOGEN® sales until the policies were revised. In addition, following the update to the ESA labels and associated revisions in compendia, nearly all Medicare contractors dropped reimbursement for Aranesp® for anemia of cancer. (See “–Guidelines and recommendations published by various organizations can reduce the use of our products.”) Also, we believe the increasing emphasis on cost-containment initiatives in the United States, Europe and other countries has and will continue to put pressure on the price and usage of our products, which may adversely impact product sales. Further, when a new therapeutic product is approved, the governmental and/or private coverage and reimbursement for that product is uncertain and a failure to demonstrate clear clinical and/or comparative value associated with the use of a new therapeutic product as compared to existing therapeutic products or practices may result in inadequate or no reimbursement. We cannot predict the availability or amount of reimbursement for our approved products or product candidates, including those at a late stage of development, and current reimbursement policies for marketed products may change at any time. Sales of all our products are and will be affected by government and private payer reimbursement policies. Reduction in reimbursement for our products could have a material adverse effect on our product sales and results of operations.

If our intellectual property positions are challenged, invalidated, circumvented or expire, or if we fail to prevail in present and future intellectual property litigation, our business could be adversely affected.

The patent positions of pharmaceutical and biotechnology companies can be highly uncertain and often involve complex legal, scientific and factual questions. To date, there has emerged no consistent policy regarding breadth of claims allowed in such companies’ patents. Third parties may challenge, invalidate or circumvent our patents and patent applications relating to our products, product candidates and technologies. In addition, our patent positions might not protect us against competitors with similar products or technologies because competing products or technologies may not infringe our patents. For certain of our product candidates, there are third parties who have patents or pending patentspatent applications that they may claim prevent us from commercializing these product candidates in certain territories. Patent disputes are frequent, costly and can preclude or delay commercialization of products. We are currently, and in the future may be, involved in patent litigation. However, a patent dispute or litigation may not discourage a potential violator from bringing the product that is alleged to infringe to market and we may be subject to competition during certain periods of litigation. For example, with the October 23, 2007, jury verdict in the U.S. Federal District Court in Boston and the Court’s rulings on various pre-trial and post-trial motions, F. Hoffmann-La Roche is developingLtd., Roche Diagnostics GmbH, and Hoffmann-La Roche, Inc. (collectively, “Roche”) was found to infringe a peg-EPO for which they havetotal of ten claims from

four of Amgen’s EPO patents. Roche filed a BLA with the FDA for their peg-EPO product and whichon November 14, 2007 the FDA approved MIRCERA® for the treatment of anemia associated with CRF including patients on dialysis and patients not on dialysis. We are now requesting the Court make permanent the preliminary injunction currently in place that prohibits Roche has stated has a PDUFA date of May 19, 2007. On November 8, 2005, we filed a lawsuit against Roche for patent infringement of sixfrom commercializing its peg-EPO product in the United States in violation of our U.S. patents. In addition, onaffirmed patent rights. On April 11, 2006, we filed a complaint with9, 2008, Roche appealed the U.S. International Trade Commission (“ITC”) requesting that the ITC institute an investigation of Roche’s importation of peg-EPO.preliminary injunction. This lawsuit and matter is described in “Item 1. Legal Proceedings —Note 10 “Contingencies – Roche Matters.MattersAccording to Roche’s public statements, they expect to launch the moleculeConsolidated Financial Statements in the U.S. nephrology segmentour 2007 Form 10-K and are updated as required in 2007, upon regulatory approval, despite our ongoing lawsuit and their acknowledgement of our U.S. erythropoietin patents.subsequently filed Form 10-Qs. (See “—“–Our marketed products face substantial competition and other companies may discover, develop, acquire or commercialize products before or more successfully than we do.do.”) Further, under the Hatch-Waxman Act, products approved by the FDA under a new drug application (“NDA”) may be the subject of patent litigation with generic competitors before the five year period of data exclusivity provided for under the Hatch-Waxman Act has expired and prior to the expiration of the patent term of product. If we lose or settle current or future litigations at certain stages or entirely, we could be subject to competition and/or significant liabilities; required to enter into third-party licenses for the infringed product or technology;technology or required to cease using the technology or product in dispute. In addition, we cannot guarantee that such licenses will be available on terms acceptable to us, or at all.

Our success depends in part on our ability to obtain and defend patent rights and other intellectual property rights that are important to the commercialization of our products and product candidates. We have filed applications for a number of patents and have been granted patents or obtained rights relating to erythropoietin, natural and recombinant G-CSF, darbepoetin alfa, pegfilgrastim, etanercept, cinacalcet HCl, panitumumab and our other products and potential products. We market our erythropoietin, recombinant G-CSF, darbepoetin alfa, pegfilgrastim, etanercept, cinacalcet HCl and panitumumab products as EPOGEN® (Epoetin alfa), NEUPOGEN®

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(Filgrastim), Aranesp® (darbepoetin alfa), Neulasta® (pegfilgrastim), Enbrel® (etanercept), Sensipar®/Mimpara® (cinacalcet HCl) and Vectibix™Vectibix® (panitumumab), respectively. With respect to our material patents, we have had a number of G-CSF patent expiries in the United States. In addition, we have had one principal erythropoietin patent expiry in the EU and our principal European patent relating to G-CSF has expired.

Product

General Subject Matter

Expiration
Epoetin alfaU.S.— Process of making erythropoietin8/15/2012
— Product claims to erythropoietin8/20/2013
— Pharmaceutical compositions of erythropoietin8/20/2013
— Cells that make certain levels of erythropoietin5/26/2015
darbepoetin alfaEurope(1)— Glycosylation analogs of erythropoietin proteins10/12/2010
— Glycosylation analogs of erythropoietin proteins8/16/2014
FilgrastimU.S.— G-CSF polypeptides12/3/2013
— Methods of treatment using G-CSF polypeptides12/10/2013
pegfilgrastimU.S.— Pegylated G-CSF10/20/2015
Europe(1)— Pegylated G-CSF2/8/2015
etanerceptU.S.— Methods of treating TNF — dependent inflammatory response9/5/2009
— TNFR proteins and pharmaceutical compositions9/5/2009
— TNFR DNA vectors, cells and processes for making proteins10/23/2012
panitumumabU.S.— Human monoclonal antibodies to epidermal growth factor receptor (“EGFr”)5/5/2017
cinacalcet HClU.S.(2)— Calcium receptor-active molecules12/14/2016
— Calcium receptor-active molecules12/14/2016
— Calcium receptor-active molecules12/14/2016
— Calcium receptor-active molecules10/23/2015
Europe(1)— Calcium receptor-active molecules10/23/2015

(1)

In some cases these European patents may also be entitled to supplemental protection in one or more countries in Europe and the length of any such extension will vary country by country.

(2)

An application for patent term extension has been submitted and is currently pending in the United States.

We also have been granted or obtained rights to patents in Europe relating to erythropoietin; G-CSF; pegfilgrastim (pegylated G-CSF); etanercept; two relating to darbepoetin alfa; hyperglycosylated erythropoietic proteins; and cinacalcet HCl. Our principal European patent relating to erythropoietin expired on December 12, 2004 and our principal European patent relating to G-CSF expired on August 22, 2006. We believe that asAs these patents have expired, othersome companies couldhave and we believe others may receive approval for and market follow-on biologics or biosimilar products (as they are generally known in the EU) and other products to compete with these products in the EU presenting additional competition to our products. (See “— O“–urOur marketed products face substantial competition and other companies may discover, develop, acquire or commercialize products before or more successfully than we do.do.”) Although we cannot predict with certainty when the first biosimilar products could appear on the market in the EU, we expect that the first biosimilar G-CSF product may be approved in the EU some

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time in 2007 or early 2008 and could be available shortly thereafter, and that it would compete with Neulasta® and NEUPOGEN®. While we do not market EPOGEN® in Europe as this right belongs to Johnson & Johnson (through KA), we do market Aranesp® in the EU, which competes with Johnson & Johnson’s EPREX® product, Roche’s NeoRecormon® product and others’ erythropoietin products. We expect that biosimilar erythropoietin products may be approved in the EU in 2007 and could be available in the EU shortly after approval. In the first quarter of 2007, Shire received approval in the EU for Dynepo™ (Epoetin delta), a competing erythropoietin product. In addition, Roche is developing its peg-EPO product which, upon regulatory approval, we expect they will launch in the EU nephrology segment in 2007. Although, we cannot predict whether or to what extent the entry of biosimilar products or other competing products would impact future Aranesp®, Neulasta® or NEUPOGEN® sales in the EU, biosimilar products or other products that effectively compete with our products could reduce sales which could have a material adverse affect on our results of operations.

In 2006, the EMEA developed and issued final regulatory guidelines related to the development and approval of biosimilar products. The final guidelines included clinical trial guidance for certain biosimilar products including erythropoietins and G-CSFs, which guidance recommends that applicants seeking approval of such biosimilar products conduct fairly extensive pharmacodynamic, toxicological, clinical safety studies and a pharmacovigilance program. In the United States, there currently is no legal approval pathway for follow-on biologics. A number of events would need to occur before these products could enter the market, including passage of legislation by Congress to create a new approval pathway and promulgation of associated regulations and guidance by the FDA. During this current Congressional session, several members of Congress expressed interest in the issue, a number of bills have been introduced, and the House and Senate have held hearings. It is unknown what type of regulatory framework, what legal provisions, and what timeframes for guidance development any final legislation would contain. Until such legislation is created, we cannot predict when follow-on biologics could appear in the United States.

Before we commercializeWe may experience difficulties, delays or unexpected costs and sell any ofnot achieve or maintain anticipated cost savings from our product candidates, we must conduct clinical trials in humans; if we fail to adequately manage these trials we may not be able to sell future products and our sales could be adversely affected.recently announced restructuring plan.

Before we can sell any products, we must conduct clinical trials which demonstrate that our product candidates are safe and effective for use in humans for the indications sought. The results of these clinical trials are used as the basis to obtain regulatory approval from government authorities such as the FDA. Clinical trials are experiments conducted using our product candidates in human patients having the diseases or medical conditions we are trying to address. Conducting clinical trials is a complex, time-consuming and expensive process. We are required to conduct clinical trials using an appropriate number of trial sites and patients to support the product label claims we are seeking. The length of time, number of trial sites and patients required for clinical trials vary substantially according to the type, complexity, novelty and intended use of the product candidate and therefore, we may spend as much as several years completing certain trials. Our ability to complete our clinical trials in a timely fashion depends in large part on a number of key factors including protocol design, regulatory and institutional review board approval and the rate of patient enrollment in clinical trials. Patient enrollment is a function of several factors, including the size and location of the patient population, enrollment criteria and competition with other clinical trials for eligible patients. As such, there may be limited availability of patients who meet the criteria for certain clinical trials. Delays in planned clinical trials can result in increased development costs, delays in regulatory approvals and associated delays in product candidates reaching the market.

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Patients may also suffer adverse medical events or side effects in the course of our clinical trials that may delay or prohibit regulatory approval of our product candidates or additional indications for our currently approved products, or may render the product candidate commercially infeasible. Additionally, adverse events or results from clinical trials or studies performed by us or by others may expand safety labeling for our approved products and may negatively impact healthcare provider prescribing behavior, use of our products, regulatory or private healthcare organization medical guidelines and reimbursement of our products. (See “—Our current products and products in development cannot be sold if we do not gain or maintain regulatory approval of our products and we may be required to perform additional clinical trials or change the labeling of our products or take other potentially limiting or costly actions if we or others identify side effects after our products are on the market.”;Our sales depend on payment and reimbursement from third-party payers, and, to the extent that reimbursement for our products is reduced, this could negatively impact the utilization of our products.”; and “—Guidelines and recommendations published by various organizations can reduce the use of our products.”) For example, as a result of observing an increased frequency of cholecystitis, inflammation of the gall bladder, in patients treated with our late-stage product candidate motesanib diphosphate, we delayed our phase 3 “mega-site” trial (involving 200 or more sites) in first line non-small cell lung cancer, which was previously expected to begin in the fourth quarter of 2006, until the second half of 2007. Clinical trials must be designed based on the current standard of medical care. However in certain diseases, such as cancer, the standard of care is evolving rapidly. In these diseases, the duration of time needed to complete certain clinical trials may result in the design of such clinical trials being based on an out of date standard of medical care, limiting the utility and application of such trials. Of course, even if we successfully manage our clinical trials, we may not obtain favorable clinical trial results and may not be able to obtain regulatory approval on this basis.

We have substantially expanded our R&D capabilities to manage and execute increasingly larger and more complex clinical trials and to build the capacity to advance more compounds into and through the clinic. In the near term, we expect to see further growth in R&D expense in 2007, but not to the same extent experienced in 2006. For example, the nine “mega-site” trials which we began in 2006 will continue to require significant time, resources and expense to execute. However, as a result of recent developments and, in particular the regulatory and reimbursement challenges relatedchanges to Aranesp®our marketed ESA products, on August 15, 2007, we announced a plan to restructure our worldwide operations in order to improve our cost structure while continuing to make significant R&D investments and EPOGEN®,build the framework for our future growth. As part of the restructuring plan, we have beenreduced staff, made changes to certain capital projects and will continue to assess the optimal level of our R&D investment. For example, we recently announced that after discussions with the FDA we have decided not to file for approval of motesanib diphosphate in refractory thyroid cancer until there is more clarity on what a regulatory filing package would constitute for that indication. To the extent future sales of Aranesp® and EPOGEN® are negatively impacted asclosed certain production operations. As a result of these recent events,our restructuring plan, we expect to reduce costs beginning in 2008. Our ability to achieve and maintain anticipated savings is dependent upon various future developments, some of which are beyond our control. We may deferalso not realize or possibly cancel previously planned clinical trialsmaintain, in orderfull or in part, the anticipated benefits and savings from our restructuring efforts due to adjust our R&D investment plans. Such actions could delay obtaining approvalunforeseen difficulties, delays or reduce the number of indications and market potential of our product candidates. In order to increase the number of patients available for enrollment for our clinical trials, we have and will continue to open clinical sites and enroll patients in a number of new geographic locations where our experience conducting clinical trials is more limited, including Russia, China, India and some Central and South American countries utilizing third-party contract clinical trial providers. Conducting clinical trials in locations where we have limited experience requires substantial time and resources to identify and understand the unique regulatory environments of individual countries. If we fail to adequately manage our increasingly larger, more complex and regulatory diverse clinical trials, our clinical trials and corresponding regulatory approvals may be delayed or we may fail to gain approval for our product candidates altogether.unexpected costs. If we are unable to market and sellachieve or maintain the anticipated savings or benefits to our product candidates or are unable to obtain approvalsbusiness in the timeframe needed to execute our product strategies,expected time frame or other unforeseen events occur, our business and results of operations wouldmay be materially adversely affected. Additional informationFurther, if we were to experience additional changes to our business, we may face further restructuring and/or reorganization activities in the future.

In addition, our reduction of staff was completed through a combination of a voluntary transition program and an involuntary reduction in force. In order to be successful and build our framework for future growth, we must continue to execute and deliver on our clinical trials can be found on our website at

37core business initiatives with fewer human resources


(http://www.amgen.com). (This website address is not intended to function as a hyperlink, and the information contained on our website is not intended to be a partlosses of this filing.)

Our current productsintellectual capital. We must also attract, retain and products in development cannot be sold if we do not gain or maintain regulatory approval of our productsmotivate key employees including highly qualified management, scientific, manufacturing and we may be required to perform additional clinical trials or change the labeling of our products or take other potentially limiting or costly actions if we or others identify side effects after our products are on the market.

We and certain of our licensors and partners conduct research, preclinical testing and clinical trials for our product candidates. In addition, we manufacture and contract manufacture and certain of our licensors and partners manufacture our product candidates. We also manufacture and contract manufacture, price, sell, distribute and market or co-market our products for their approved indications. These activities are subject to extensive regulation by numerous state and federal governmental authorities in the United States, such as the FDA and CMS, as well as in foreign countries, including European countries, Canada, Australia and Japan. Currently, we are required in the United States and in foreign countries to obtain approval from those countries’ regulatory authorities before we can manufacture (or have our third-party manufacturers produce), market and sell our products in those countries. The FDA and other U.S. and foreign regulatory agencies have substantial authority to fail to approve commencement of, suspend or terminate clinical trials, require additional testing, delay or withhold registrationsales and marketing approval, mandate product withdrawals and require changes in labeling ofpersonnel who are critical to our products.

In our experience, obtaining regulatory approval is costly and takes many years, and after it is obtained, remains costly to maintain. With the occurrence of a number of high profile safety events with certain pharmaceutical products such as Vioxx® and Bextra®, regulatory authorities, members of Congress, the Government Accountability Office (“GAO”), private health/science foundations and organizations, medical professionals, including physicians and investigators, and the general public are increasingly concerned about potential or perceived safety issues associated with pharmaceutical and biological products, whether under study for initial approval or already marketed. As a result, safety signals from clinical trials or other sources are receiving greater scrutiny which may lead to fewer treatments being approved by the FDA or other regulatory bodies, termination of clinical trials before completion or longer or additional clinical trials that may result in substantial additional expense. (See “—Before we commercialize and sell any of our product candidates, we must conduct clinical trials in humans; if we fail to adequately manage these trials webusiness. We may not be able to sell future products and our sales could be adversely affected.”)

Adverse eventsattract, retain or results from clinical trials or studies performed by us or by others or from the marketed use of our drugs may expand safety labeling for our approved products and may negatively impact healthcare provider prescribing behavior, use of our products, regulatory or private health organization medical guidelines and reimbursement for our products. (See “—Guidelines and recommendations published by various organizations can reduce the use of our products.” and “Our sales depend on payment and reimbursement from third-party payers, and, to the extent that reimbursement for our products is reduced, this could negatively impact the utilization of our products.”) For example on March 9, 2007, based upon data from our AoC 103 Study, Johnson & Johnson’s Correction of Hemoglobin and Outcomes In Renal Insufficiency (“CHOIR”) study, and preliminary data from the third-party investigator Danish Head and Neck Cancer (DAHANCA) 10 Study, among others, the FDA approved updated safety information, including a boxed warning, in the prescribing information for the class of ESAs, including Aranesp® and EPOGEN®. The new boxed warning notes that ESAs, when administered to target a hemoglobin of greater than 12 g/dL: i) increased the risk for death and serious cardiovascular events; ii) shortened time to tumor progression in patients

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with advanced head and neck cancer receiving radiation therapy; and iii) shortened overall survival and increased deaths attributed to disease progression at four months in patients with metastatic breast cancer receiving chemotherapy. Physicians were advised in the boxed warning to use the lowest dose of ESAs that will gradually increase the hemoglobin concentration to the lowest level sufficient to avoid the need for red blood cell transfusions, and not to exceed 12 g/dL. The EMEA has also reported that it is reviewing the safety of ESAs, made by us, Johnson & Johnson, Shire and Roche. Further, the FDA has invited us to participate at the May 10, 2007, meeting of the ODAC. It is our understanding that the ODAC will review progress made by us and others in delineating the effects of ESAs on survival and tumor progression in cancer patients. We are uncertain as to what will result from the ODAC meeting and cannot predict what, if any impact, the meeting may have on our business. In addition, we recently announced that we had discontinued Vectibix™ treatment in our PACCE trial, a non-registration-enabling trial evaluating the addition of Vectibix™ to standard chemotherapy and Avastin® (bevacizumab) for the treatment of first-line metastatic colorectal cancer. The PACCE trial investigated a treatment regimen that used dual biologics combined with oxaliplatin- or irinotecan-based chemotherapy. The decision to discontinue Vectibix™ treatment in the trial was based on a preliminary review of data from a pre-planned interim efficacy analysis, which revealed a statistically significant difference in progression-free survival in favor of the control arm. An unplanned analysis of overall survival also demonstrated a statistically significant difference favoring the control arm. We had previously informed investigators and regulatory authorities about safety information from a planned interim safety analysis of the PACCE trial, which showed an increased incidence of grade 3 severe events of diarrhea, dehydration and infections in the Vectibix™-treated patients and additionally an increased incidence of pulmonary embolism was observed in patients who received Vectibix™ compared with those who did not. We are in discussions with the FDA with respect to the Vectibix™ label and expect that we will add the data from the PACCE trial to the label. The language is still in development, discussions with the FDA are on-going and any label change is subject to FDA approval. Further, we continue to be in discussions with EMEA and the CHMP with respect to the approval of Vectibix™ in the EU to treat patients with metastatic colorectal cancer whose disease has progressed on or following all standard chemotherapy regimens. In the event that Amgen should not obtain an initial positive CHMP opinion, we can request re-examination of the CHMP opinion as part of the EU regulatory process.

Substantially all of our marketed products are currently approved in the United States and most are approved in Europe and in other foreign countries for specific uses. However, later discovery of unknown problems with our products could result in restrictions on the sale or use of such products, including potential withdrawal of the product from the market. If new medical data suggests an unacceptable safety risk or previously unidentified side-effects, we may voluntarily withdraw, or regulatory authorities may mandate the withdrawal of, such product from the market for some period or permanently. For example, we previously initiated a voluntary recall of the Neulasta® SureClick™ pre-filled pen in Europe because of the potential risk to patients of receiving an incomplete dose and we have previously conducted a voluntary wholesaler recall of a limited number of lots of ENBREL as a result of a small number of reports of missing, detached or loose rubber caps on the needle-less syringe filled with diluent liquid by a third-party contract manufacturer and packaged with the vials of ENBREL. Although there have been no observable adverse event trends associated with the Neulasta® SureClick™ pre-filled pen or with the reports of missing, detached or loose rubber caps with the needle-less syringe packaged with the ENBREL vials, we may experience the same or other problemsmotivate qualified employees in the future resulting in broader product recalls or adverse event trends. Further, regulatory agencies could change existing, or promulgate new, regulations at any time whichand our inability to do so may adversely affect our ability to obtain or maintain approval of our existing or future products or require significant additional costs to obtain or maintain such approvals.

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If we or others identify side effects or other safety concerns before or after any of our products are on the market, or if manufacturing problems occur, regulatory approval may be withdrawn, reformulation of our products may be required or other risk management activities may be imposed by regulators, additional clinical trials may be required, changes in labeling of our products and changes to or re-approvals of our manufacturing facilities may be required, any of which could have a material adverse effect on sales of the affected products and on our business and results of operations. Regulatory agencies such as the FDA could require us to engage in risk management activities which could modify or restrict our existing promotional activities, restrict or encumber the ability of healthcare providers to prescribe, dispense or use our products or limit patient access to our products. Certain specific labeling or label changes may be necessary for a number of reasons, including: the identification of actual or theoretical safety or efficacy concerns by regulatory agencies or the discovery of significant problems with a similar product that implicates an entire class of products or subsequent concerns about the sufficiency of the data or studies underlying the label. Before any of our products are approved for commercial use, regulatory bodies could decide that the product label include certain warning language as part of an evolving label change to a particular class of products. For example, the Vectibix™ prescribing information includes a boxed warning from the FDA on dermatologic toxicities and severe infusion reactions as part of an evolving FDA labeling to the anti-EGFr class. In addition, after any of our products are approved for commercial use, we or regulatory bodies could decide, and have in the past decided, that changes to our product labeling are required. For example, the FDA has instituted a class label change for the three ESAs marketed in the United States to add information about pure red cell aplasia (“PRCA”) to the adverse event profile section and for the boxed warning in the prescribing information of the label described above.

Any significant concerns raised about the safety or efficacy of our products could also result in the need to reformulate those products, to conduct additional clinical trials, to make changes to our manufacturing processes or to seek re-approval of our manufacturing facilities. Significant concerns about the safety and effectiveness of a product could ultimately lead to the revocation of its marketing approval. The labeling of a new product, a revision of product labeling or the regulatory actions described above could be required even if there is no clearly established connection between the product and the safety or efficacy concerns that have been raised. If the labeling of a new product, a revision of product labeling or the regulatory actions described above resulted in decreased use of our products, it could have a material adverse effect on sales of the affected products and on our business and results of operations.

In addition, if regulatory authorities determine that we or our licensor or partner conducting R&D activities on our behalf have not complied with regulations in the R&D of a product candidate, new indication or information to support a current indication, then they may not approve the product candidate and we will not be able to market and sell it. If we were unable to market and sell our products or product candidates, our business and results of operations would be materially and adversely affected.

Our sales depend on payment and reimbursement from third-party payers, and, to the extent that reimbursement for our products is reduced, this could negatively impact the utilization of our products.

Sales of all of our principal products are dependent, in part, on the availability and extent of reimbursement from third-party payers, including governments and private insurance plans. Generally, in Europe and other countries outside the United States, the government sponsored healthcare system is the primary payer of healthcare costs of patients. Governments may regulate access to, prices or reimbursement levels of our products to control costs or to affect levels of use of our products. Worldwide use of our products may be affected by these cost containment pressures

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and cost shifting from governments and private insurers to healthcare providers in response to ongoing initiatives to reduce healthcare expenditures. Further, adverse events or results from clinical trials or studies performed by us or by others or from the marketed use of our drugs may expand safety labeling for our approved products and may negatively impact worldwide reimbursement for our products. (See also “—Our current products and products in development cannot be sold if we do not gain or maintain regulatory approval of our products and we may be required to perform additional clinical trials or change the labeling of our products or take other potentially limiting or costly actions if we or others identify side effects after our products are on the market.” and “—Guidelines and recommendations published by various organizations can reduce the use of our products.”)

Most patients receiving Aranesp®, Neulasta® and NEUPOGEN® for approved indications are covered by both government and private payer healthcare programs. Government healthcare programs are governed by the MMA, which was enacted into law in December 2003 and became effective January 1, 2005. Since January 1, 2005, in the physician clinic setting and since January 1, 2006, in the hospital outpatient setting, Aranesp®, Neulasta® and NEUPOGEN® have been reimbursed under a Medicare Part B payment methodology that reimburses each product at 106% of its ASP (sometimes referred to as “ASP+6%”). ASP is calculated by the manufacturer based on a statutorily defined formula and submitted to CMS. A product’s ASP is calculated on a quarterly basis and therefore may change each quarter. The ASP in effect for a given quarter (the “Current Period”) is based upon certain historical sales and sales incentive data covering a statutorily defined period of time preceding the Current Period. For example, the ASP for Aranesp® that will be in effect for the third quarter of 2007 will be based in part on certain historical sales and sales incentive data for Aranesp® from April 1, 2006 through March 30, 2007. CMS publishes the ASPs for products in advance of the quarter in which they go into effect. Any changes to the ASP calculation could adversely affect the Medicare reimbursement for our products administered in the physician office and the hospital outpatient setting. Prior to January 1, 2006, Medicare’s hospital OPPS, which determines payment rates for specified covered outpatient drugs and biologics in the hospital outpatient setting, utilized the AWP as the basis of Medicare Part B payment for covered outpatient drugs and biologics administered in the hospital outpatient setting. From 2003 to 2005, CMS applied an “equitable adjustment” such that the Aranesp® reimbursement rate was based on the AWP of PROCRIT®, Johnson & Johnson’s recombinant human erythropoietin product marketed in the United States, using a dose conversion ratio. In 2006 and 2007, CMS did not apply an “equitable adjustment” to tie the reimbursement rate for Aranesp® to PROCRIT®. However, CMS has maintained that it reserves the right to apply an “equitable adjustment” to the payment rate for Aranesp® in future years.

In the United States, dialysis providers are primarily reimbursed for EPOGEN® by the federal government through the ESRD Program of Medicare. The ESRD Program reimburses approved providers for 80% of allowed dialysis costs; the remainder is paid by other sources, including patients, state Medicaid programs, private insurance, and to a lesser extent, state kidney patient programs. The ESRD Program reimbursement rate is established by federal law and is monitored and implemented by CMS. Effective January 1, 2006, the payment mechanism for separately reimbursed dialysis drugs in both free-standing and hospital-based dialysis centers, including EPOGEN® and Aranesp®, is reimbursed by Medicare at ASP+6% using the same payment amounts used in the physician clinic setting. Since April 1, 2006, the ESRD Program reimbursement has been subject to a revised HMA-PM, a Medicare payment review mechanism used by CMS to audit EPOGEN® and Aranesp® (when used in dialysis) utilization and appropriate hematocrit outcomes of dialysis patients. This policy, EMP, was further revised effective October 1, 2006. The revised EMP provides that if a patient’s hemoglobin is greater than 13 grams per deciliter, providers are instructed to reduce the patient’s EPOGEN® and Aranesp® dose and report this reduction on

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claims using a coding modifier. If the provider does not reduce the patient’s EPOGEN® and Aranesp® dose and the provider does not submit medical documentation to support maintaining a patient’s hemoglobin above 13 grams per deciliter, reimbursement will be reduced to the level it would have been had the provider reduced dosage by twenty-five percent.

Changes resulting from the MMA, which beginning in 2005 lowered reimbursement for our products, could negatively affect product sales of some of our marketed products. However, we believe that our product sales for 2005 and 2006 were not significantly impacted by the reimbursement changes resulting from the MMA. While we cannot accurately predict the impact of any such changes on how, or under what circumstances, healthcare providers will prescribe or administer our products and we cannot estimate the full impact of the MMA on our business, we believe that it is not likely to be significant to our business in 2007. However, additional provisions of the MMA and other regulations affecting reimbursement that have gone or may go into effect could affect our product sales and related sales growth in the future. For example, the MMA required a demonstration project of a bundled payment system for dialysis, including separately billable drugs and EPOGEN®. The demonstration project was scheduled to start in January 2006, but has been delayed with no announced start date. Bundling initiatives that have been implemented in other healthcare settings have resulted in lower utilization of services that had not previously been a part of the bundled payment. Because CMS is continuing to study bundled payments in the ESRD setting, we cannot predict what impact a bundled payments system would have on sales of EPOGEN® or Aranesp® used in the treatment of persons receiving outpatient dialysis services. In addition, in the Medicare Physician Fee Schedule Proposed Rule for 2007, CMS invited comment on the need for future guidance concerning the methodology for calculating the ASP of drugs sold under market-based pricing arrangements, including “bundled arrangements,” described by CMS as, for example, when a purchaser’s price for one or more drugs is contingent upon the purchase of other drugs or items. In the Medicare Physician Fee Schedule Final Rule for 2007, CMS chose not to establish a specific methodology that manufacturers must use for the treatment of bundled price concessions for the purposes of the ASP calculation at this time. However, CMS stated that it may provide more specific guidance in the future through rulemaking, program instruction or other guidance. Further, on December 29, 2006, the MedPAC released its second Congressionally-mandated report on the impact of changes in Medicare payments for Part B Drugs specifically recommending that the Secretary of the Department of Health and Human Services clarify ASP reporting requirements “to ensure that ASP calculations allocate discounts to reflect the transaction price for each drug.” Under the ASP system, the Company allocates its discounts based on the prices paid for individual drugs, according to the terms of its contracts with physicians and other purchasers, and we believe that the resulting ASPs reflect the transaction prices for individual drugs. As it is premature to speculate on how CMS and other government organizations may react to the MedPAC’s recommendations, we cannot predict the potential impact the report may have on our business.

In addition to private payers, since January 1, 2006, ENBREL and Sensipar® have been eligible for coverage from the U.S. government under Medicare Part D. Although both ENBREL and Sensipar® have received broad formulary placement in 2006 and 2007, Part D formulary placements are made by individual Part D plan sponsors with oversight by CMS and are subject to revision in the future.

Other initiatives reviewing the coverage or reimbursement of our products, including those related to safety, could result in less extensive coverage or lower reimbursement and could negatively affect sales of some of our marketed products. For example, on March 14, 2007, shortly after the label changes for all ESAs, CMS announced that the agency had begun reviewing all Medicare policies related to the administration of ESAs in non-renal disease applications as part of a NCA, which is

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generally CMS’ first step toward developing a NCD. Generally, a NCD is a national policy statement granting, limiting or excluding Medicare coverage or reimbursement for a specific medical item or service. During the initial comment period which ended on April 13, 2007, we submitted comments to CMS which included a detailed and thorough review of the available clinical data, noted a series of important considerations and made a number of specific recommendations for the agency to consider in developing a NCD. CMS is required to issue a proposed NCD by September 14, 2007, but could propose a NCD at any time prior to that deadline. Given the uncertainty of what recommendations a final NCD would consist of, we cannot predict what impact a NCD would have on our business. Following CMS’ announcement that it had begun reviewing all Medicare policies related to the administration of ESAs in non-renal disease applications on March 14, 2007, CMS also stated that the agency is currently reviewing the EMP for patients with ESRD who are dialyzed in renal facilities although they have not yet announced further changes to the EMP. The FDA may also schedule a meeting of the Cardio Renal Advisory Committee to review the use of ESAs in the renal setting although no public announcement has been made. As a result of the revisions and current review of the EMP, we cannot predict the potential full impact any revisions to the EMP may have on our business. However, changes reducing reimbursement coverage could negatively affect product sales of our ESA products.

Further, the DRA of 2005 included provisions, which are phased in over time, regarding state collection and submission of data for the purpose of collecting Medicaid drug rebates from manufacturers for physician-administered drugs. We expect that state compliance with elements of these provisions that become effective in 2007 will increase the level of Medicaid rebates paid by us. We are currently in the process of further evaluating the impact of the DRA and are uncertain as to the potential full impact on our business. Related to this issue, CMS issued a proposed Medicaid rule on December 18, 2006 that covered a broad range of topics concerning the calculation and use of AMP and best price as well as a proposed definition for bundled sales under the Medicaid program. We submitted a comment to CMS on the proposed rule which the DRA specifies that CMS issue a final rule no later than July 1, 2007. While we cannot predict the impact of the final rule prior to its issuance, changes reducing reimbursement could negatively affect our business.

If, and when, reimbursement rates or availability for our marketed products changes adversely or if we fail to obtain adequate reimbursement for our current or future products, healthcare providers may limit how much or under what circumstances they will prescribe or administer them, which could reduce the use of our products or cause us to reduce the price of our products. This could result in lower product sales, which could have a material adverse effect on us and our results of operations. For example, the use of EPOGEN® in the United States in connection with treatment for end stage renal disease is funded primarily by the U.S. federal government. In early 1997, CMS, formerly known as Healthcare Financing Administration (“HCFA”), instituted a reimbursement change for EPOGEN®, which materially and adversely affected our EPOGEN® sales until the policies were revised and in 2007, following the update to the ESA labels, nearly all Medicare contractors dropped reimbursement for Aranesp® for anemia of cancer. (See “—Guidelines and recommendations published by various organizations can reduce the use of our products.”) Also, we believe the increasing emphasis on cost-containment initiatives in the United States, Europe and other countries has and will continue to put pressure on the price and usage of our products, which may adversely impact product sales. Further, when a new therapeutic product is approved, the governmental and/or private coverage and reimbursement for that product is uncertain and a failure to demonstrate clear economic value associated with the use of a new therapeutic product as compared to existing therapeutic products or practices may result in inadequate or no reimbursement. We cannot predict the availability or amount of reimbursement for our approved products or product candidates, including those at a late stage of development, and current

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reimbursement policies for marketed products may change at any time. Sales of all our products are and will be affected by government and private payer reimbursement policies. Reduction in reimbursement for our products could have a material adverse effect on our product sales and results of operations.

Guidelines and recommendations published by various organizations can reduce the use of our products.

Government agencies promulgate regulations and guidelines directly applicable to us and to our products. However, professional societies, practice management groups, insurance carriers, physicians, private health/science foundations and organizations involved in various diseases from time to time may also publish guidelines or recommendations to healthcare providers, administrators and payers, and patient communities. Recommendations of government agencies or these other groups/organizations may relate to such matters as usage, dosage, route of administration and use of related therapies and reimbursement of our products by government and private payers. (See “—“–Our sales depend on payment and reimbursement from third-party payers, and, to the extent that reimbursement for our products is reduced, this could negatively impact the utilization of our products.products.”) Organizations like these have in the past made recommendations about our products. Recommendations or guidelines that are followed by patients and healthcare providers could result in decreased use and/or dosage of our products. Some examples of agency and organizational guidelines include:

 

On April 12, 2007 the NKF distributed to the nephrology community the draft of the KDOQI Clinical Practice Guideline and Clinical Practice Recommendations for Anemia Management in Chronic Kidney Disease. The draft guideline was open for comments from the community until April 30, 2007 prior to being finalized and published. The NKF’s Anemia Working Group initiated a review of the existing guidelines following recent clinical developments, such as the publication of the results of the CHOIR and other trials. In the proposed guideline, the group recommends what factors should be considered in selecting a Hb target and states that the selected Hb target should generally be in the range 11.0 to 12.0 g/dL. Like others in the nephrology community, we are currently reviewing the new guideline and cannot predict what impact the revised guideline will have on our business but anticipate that CMS will likely consider the KDOQI guidelines as it undertakes its review of the EMP.

On August 30, 2007, the National Kidney Foundation (the “NKF”) distributed to the nephrology community final updated Kidney Disease Outcomes Quality Initiative (“KDOQI”) clinical practice guidelines and clinical practice recommendations for anemia in chronic kidney disease (“CKD”). The NKF’s Anemia Work Group conducted an extensive review of results from 26 new and existing randomized controlled trials, comparing the risks and benefits of a range of Hb therapeutic targets in CKD patients. Based on this review, the NKF-KDOQI™ Anemia Work Group recommended in their 2007 Update to the NKF-KDOQI™ Anemia Management Guidelines that physicians target Hb in the range of 11 g/dL to 12 g/dL, and also stipulated that the target not be above 13 g/dL. Like others in the nephrology community, we continue to monitor the impact the updated guidelines have had and will have on physician utilization and dosage of EPOGEN® and Aranesp®.

 

 

 

The GAO issued a report on December 5, 2006 recommending that ESRD drugs and biologics, including EPOGEN®, be bundled into the Medicare dialysis composite payment rate. This recommendation is similar to the ones made by MedPAC and CMS. A day after the GAO report was released, the House Ways and Means Committee held a hearing that focused on EPOGEN®, including discussion of the delay in the MMA mandated bundled payment demonstration, and the GAO report and recommendation. However, Congress did not take legislative action in 2006 toFuture Medicare reform legislation may require bundling. Nevertheless, we expect the policy debate around a bundled payment systemfor all dialysis services, including but not limited to ESAs, other drugs and labs common in ESRD to continue in 2007.dialysis.

 

 

 

On February 2, 2007, following the reported results from our AoC 103 Study, the USP DI Drug Reference Guides removed Aranesp® for use in the treatment of AoC. Thereafter, nearly all Medicare contractors stopped reimbursing for Aranesp® use in AoC patients.decreased significantly throughout 2007.

Any recommendations or guidelines that result in decreased use, dosage or reimbursement of our products could adversely affect our product sales and operating results materially. In addition,

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the perception by the investment community or stockholders that such recommendations or guidelines will result in decreased use and dosage of our products could adversely affect the market price for our common stock.

We may not be able to develop commercial products.

We intend to continue an aggressive research and development program.to make significant R&D investments. Successful product development in the biotechnology industry is highly uncertain, and very few R&D projects produce a commercial product. Product candidates or new indications for existing products (collectively, “product candidates”) that appear promising

in the early phases of development, such as in early human clinical trials, may fail to reach the market for a number of reasons, such as:

 

the product candidate did not demonstrate acceptable clinical trial results even though it demonstrated positive preclinical trial results

 

the product candidate was not effective or more effective than currently available therapies in treating a specified condition or illness

 

the product candidate had harmful side effects in humans or animals

 

the necessary regulatory bodies, such as the FDA, did not approve our product candidate for an intended use

 

the product candidate was not economical for us to manufacture and commercialize

 

other parties have or may have proprietary rights to our product candidate, such as patent rights, and will not let us sell it on reasonable terms, or at all

 

the product candidate is not cost effective in light of existing therapeutics

 

we and certain of our licensorslicensees, partners or partnersindependent investigators may fail to effectively conduct clinical development or clinical manufacturing activities

 

the regulatory pathway to approval for product candidates is uncertain or not well-defined

We recentlyFor example, we announced that after discussions with the FDA we have decided not to file for approval of motesanib diphosphate in refractory thyroid cancer until there is more clarity on what would constitute an appropriate regulatory filing package for that indication. We believe that the safety concerns around our ESAs expressed by the FDA must be addressed to the agency’s satisfaction before new indications or expanded labeling of our ESA products will likely be approved.

Further, several of our product candidates have failed or been discontinued at various stages in the product development process, including, but not limited to, Brain Derived Neurotrophic Factor (“BDNF”), Megakaryocyte Growth and Development Factor (“MGDF”) and Glial Cell Lined-Derived Neurotrophic Factor (“GDNF”). For example, in 1997, we announced the failure of BDNF for the treatment of amyotrophic lateral sclerosis, or Lou Gehrig’s Disease, because the product candidate, when administered by injection, did not produce acceptable clinical results for a specific use after a phase 3 trial, even though BDNF had progressed successfully through preclinical and earlier clinical trials. In addition, in 1998, we discontinued development of MGDF, a novel platelet growth factor, at the phase 3 trial stage after several people in platelet donation trials developed low platelet counts and neutralizing antibodies. Also, in June 2004, we announced that the phase 2 study of GDNF for

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the treatment of advanced Parkinson’s disease did not meet the primary study endpoint upon completion of nine months of the double-blind treatment phase of the study even though a small phase 1 pilot investigator-initiated open-label study over a three year period appeared to result in improvements for advanced Parkinson’s disease patients. Subsequently, in the fall of 2004 we discontinued clinical development of GDNF in patients with advanced Parkinson’s disease after several patients in the phase 2 study developed neutralizing antibodies and new preclinical data showed that GDNF caused irreversible damage to the area of the brain critical to movement control and coordination. On February 11, 2005, we confirmed our previous decision to halt clinical trials and, as a part of that decision and based on thorough scientific review, we also concluded that we will not provide GDNF to the 48 patients who participated in clinical trials that were terminated in the fall of 2004. Of course, there may be other factors that prevent us from marketing a product. We cannot guarantee we will be able to produce or manufacture commercially successful products. (See “—“–Difficulties, disruptions or delays in manufacturing or failure to comply with manufacturing regulations may limit supply

of our products and limit our product sales.”; “—“– Our current products and products in development cannot be sold if we do not gain or maintain regulatory approval of our products and we may be required to perform additional clinical trials or change the labeling of our products or takeconduct other potentially limiting or costly actionsrisk management activities if we or others identify side effects or safety concerns after our products are on the market.; and “—“– Before we commercialize and sell any of our product candidates or existing products for new indications, we must conduct clinical trials in humans; if we fail to adequately manage these trials we may not be able to sell future products and our sales could be adversely affected.”)

Our business may be impactedaffected by government investigations or litigation.

We and certain of our subsidiaries are involved in legal proceedings relating to various patent matters, government investigations, our business operations, government requests for information and other legal proceedings that arise from time to time in the ordinary course of our business. Matters required to be disclosed by us are set forth in “Item 1. Legal Proceedings”Note 10, “Contingencies” to the Consolidated Financial Statements in our 2007 Form 10-K and are updated as required in subsequently filed Form 10-Qs. Litigation is inherently unpredictable, and the outcome can result in excessive verdicts and/or injunctive relief that affects how we operate our business. Consequently, it is possible that we could, in the future, incur judgments or enter into settlements of claims for monetary damages or change the way we operate our business, which could have a material adverse effect on our results of operations, (in the case of monetary damages, in the period in which such damages are incurred).financial position or cash flows.

The federal government, state governments and private payers are investigating, and many have filed actions against numerous pharmaceutical and biotechnology companies, including Amgen and Immunex, now a wholly owned subsidiary of ours, alleging that the reporting of prices for pharmaceutical products has resulted in false and overstated AWP,average wholesale price (“AWP”), which in turn is alleged to have improperly inflated the reimbursement paid by Medicare beneficiaries, insurers, state Medicaid programs, medical plans and other payers to healthcare providers who prescribed and administered those products. A number of these actions have been brought against us and/or Immunex. Additionally, a number of states have pending investigations regarding our Medicaid drug pricing practices and the U.S. Departments of Justice and Health and Human Services have requested that Immunex produce documents relating to pricing issues. Further, certain state government entity plaintiffs in some of these AWP cases are also alleging that companies, including ours, were not reporting their “best price” to the states under the Medicaid program. These cases and investigations are described in “Item 1. Legal Proceedings —Note 10, “Contingencies – Average Wholesale Price Litigation”Litigation” to the Consolidated Financial Statements in our 2007 Form 10-K and are updated as required in subsequentsubsequently filed Form 10-Qs. Other states and agencies could initiate investigations of our pricing practices. A decision adverse to our interests on these actions and/or investigations could

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result in substantial economic damages and could have a material adverse effect on our results of operations, financial position or cash flows in the period in which such liabilities are incurred.

We may be required to defend lawsuits or pay damages for product liability claims.

Product liability is a major risk in testing and marketing biotechnology and pharmaceutical products. We may face substantial product liability exposure in human clinical trials and for products that we sell after regulatory approval. Product liability claims, regardless of their merits, could be costly and divert management’s attention, and adversely affect our reputation and the demand for our products. Amgen and Immunex have been named as defendants in product liability actions for certain of our products.

Our revenues may fluctuate and our operating results are subject to fluctuations and these fluctuations could cause financial results to be below expectations and our stock price is volatile, which could adversely affect your investment.

Our revenues and operating results may fluctuate from period to period for a number of reasons, some of which we cannot control. For example, primarily as a result of various regulatory and reimbursement developments involving ESA products that began in 2007, our anemia product sales, in particular sales of Aranesp®, for 2007 were materially adversely impacted. Even a relatively small revenue shortfall may cause

financial results for a period to be below our expectations or projections as some of our operating expenses are fixed in the short term and cannot be reduced within a short period of time to offset reductions in revenue. Further, primarily as a result of the various regulatory and reimbursement developments impacting ESA products, on August 15, 2007, we announced a plan to restructure our worldwide operations in order to improve our cost structure. As of March 31, 2008, we have incurred approximately $751 million of the current estimated $775 million to $825 million in charges in connection with this restructuring plan. Our operating results have and will continue to fluctuate and be adversely impacted as a result of these restructuring charges. (See “–We may experience difficulties, delays or unexpected costs and not achieve or maintain anticipated cost savings from our recently announced restructuring plan.”) In addition, in the event that the actual restructuring charges exceed our latest estimate, this may cause our operating results for a period to be below our expectations or projections. As a result of the above or other challenges, including the outcomes from the March 13, 2008 ODAC meeting and continuing label revisions to our ESAs, our revenues and operating results and, in turn, our stock price may be subject to significant fluctuations. Changes in credit ratings issued by nationally recognized statistical ratings organizations could adversely affect our cost of financing and have an adverse effect on the market price of our securities. Additionally, our stock price, like that of other biotechnology companies, is volatile. For example, in the fifty-two weeks prior to March 31, 2008, the trading price of our common stock has ranged from a high of $65.10 per share to a low of $39.97 per share.

Our revenues, operating results and stock price may be affected by a number of factors, such as:

adverse developments regarding the safety or efficacy of our products

changes in the government’s or private payers’ reimbursement policies or prescribing guidelines for our products

inability to maintain regulatory approval of marketed products or manufacturing facilities

actual or anticipated clinical trial results of ours or our licensees, partners or independent investigators

business development or licensing activities

product development or other business announcements by us or our competitors

regulatory matters or actions, such as label changes or risk management activities

lower than expected demand for our products or a change in product mix either or both of which may result in less than optimal utilization of our manufacturing facilities and the potential to incur excess capacity or impairment charges

changes in our product pricing strategies

changes in wholesaler buying patterns

increased competition from new or existing products

fluctuations in foreign currency exchange rates

announcements in the scientific and research community

intellectual property and legal matters

actual or anticipated product supply constraints

broader economic, industry and market trends unrelated to our performance

pronouncements and rule changes by applicable standards authorities that change the manner in which we account for certain transactions

Of course, there may be other factors that affect our revenues, operating results and stock price in any given period. In addition, if our revenues, earnings or other financial results in any period fail to meet the investment community’s expectations, there could be an immediate adverse impact on our stock price.

We rely on single third-party suppliers for some of our raw materials, medical devices and components; if these third-parties fail to supply these items, we may be unable to supply our products.

Certain raw materials necessary for commercial manufacturing and formulation of our products are provided by single-source unaffiliated third-party suppliers. Also, certain medical devices and components necessary for formulation, fill and finish of our products are provided by single-source unaffiliated third-party suppliers. Certain of these raw materials, medical devices and components are the proprietary products of these unaffiliated third-party suppliers and, in some cases, such proprietary products are specifically cited in our drug application with the FDA so that they must be obtained from that specific sole source and could not be obtained from another supplier unless and until the FDA approved that other supplier. We would be unable to obtain these raw materials, medical devices or components for an indeterminate period of time if these third-party single-source suppliers were to cease or interrupt production or otherwise fail to supply these materials or products to us for any reason, including:

 

regulatory requirements or action by the FDA or others

 

adverse financial developments at or affecting the supplier

 

unexpected demand for or shortage of raw materials, medical devices or components

 

labor disputes or shortages, including the effects of an avian or pandemic flu outbreak, or otherwise

 

failure to comply with our quality standards which results in quality failures, product contamination and/or recall

These events could adversely affect our ability to satisfy demand for our products, which could adversely affect our product sales and operating results materially. For example, we have experienced shortages in certain components necessary for the formulation, fill and finish of certain of our products in our Puerto Rico facility without impact on our ability to supply these products. However, we may experience these or other shortages in the future resulting in delayed shipments, supply constraints and/or stock-outs of our products.

Also, certain of the raw materials required in the commercial manufacturing and the formulation of our products are sourced from other countries and/or derived from biological sources, including mammalian tissues, bovine serum and HSA.human serum albumin (“HSA”). We are also investigating alternatives to certain biological sources and alternative manufacturing processes that do not require the use of certain biologically-sourced raw materials as

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such raw materials may be subject to contamination and/or recall. Also, some countries in which we market our products may restrict the use of certain biologically derived substances in the manufacture of drugs. A material shortage, contamination, recall and/or restriction of the use of certain biologically derived substances or other raw materials, which may be sourced from other countries, used in the manufacture of our products could adversely impact or disrupt our commercial manufacturing of our products or could result in a mandated withdrawal of our products from the market. This could adversely affect our ability to satisfy demand for our products, which could adversely affect our product sales and operating results materially. Further, any disruptions or delays by us or by third-party suppliers or partners in converting to alternatives to certain biological sources and alternative manufacturing processes or our ability to gain

regulatory approval for the alternative materials and manufacturing processes could increase our associated costs or result in the recognition of an impairment in the carrying value of certain related assets, which could have a material and adverse affect on our results of operations.

Difficulties, disruptions or delays in manufacturing or failure to comply with manufacturing regulations may limit supply of our products and limit our product sales.

We currently manufacture and market all our principal products, and we plan to manufacture and market many of our potential products.product candidates. Manufacturing biologic human therapeutic products is difficult, complex and highly regulated. (See “—“–Our current products and products in development cannot be sold if we do not gain or maintain regulatory approval of our products and we may be required to perform additional clinical trials or change the labeling of our products or takeconduct other potentially limiting or costly actionsrisk management activities if we or others identify side effects or safety concerns after our products are on the market.market.”) We currently manufacture our products and product candidates at our manufacturing facilities located in Thousand Oaks and Fremont, California,California; Boulder and Longmont, Colorado,Colorado; West Greenwich, Rhode IslandIsland; Bothell, Washington and Juncos, Puerto Rico. (See “—“–We manufacture and formulate, fill and finish substantially all our products at our Puerto Rico manufacturing facility; if significant natural disasters or production failures occur at this facility, we may not be able to supply these products.products.”) Additionally, we currently use third-party contract manufacturers to produce or assist in the production of ENBREL and Sensipar®/Mimpara® and in the formulation, fill and finish of Vectibix™Vectibix® and plan to use contract manufacturers to produce a number of our late-stage product candidates. (See “—“–We are dependent on third parties for a significant portion of our bulk supply and the formulation, fill and finish of ENBREL.ENBREL.”) Our ability to adequately and timely manufacture and supply our products is dependent on the uninterrupted and efficient operation of our facilities which is impacted by many manufacturing variables including:

 

availability or contamination of raw materials and components used in the manufacturing process, particularly those for which we have no other source or supplier

 

facility capacity of our facilities or those of our contract manufacturers

 

facility contamination by microorganisms or viruses

 

labor disputes or shortages, including the effects of an avian or pandemic flu outbreak or otherwise

 

compliance with regulatory requirements

 

changes in forecasts of future demand

 

timing and actual number of production runs

 

production success rates and bulk drug yields

 

timing and outcome of product quality testing

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If we have problems in one or more of these or other manufacturing variables, we may experience delayed shipments, supply constraints, stock-outs and/or recalls of our products. For example, in the second quarter of 2002, the prior co-marketers with respect to ENBREL experienced a brief period where no ENBREL was available to fill new patient prescriptions, primarily due to variation in the expected production yield from Boehringer Ingelheim Pharma KG (“BI Pharma”).Pharma. If we are at any time unable to provide an uninterrupted supply of our products to patients, we may lose patients, physicians may elect to prescribe competing therapeutics instead of our products, and sales of our products will be adversely affected, which could materially and adversely affect our product sales and results of operations.

We manufacture and contract manufacture, price, sell, distribute and market or co-market our products for their approved indications. These activities are subject to extensive regulation by numerous state and federal

governmental authorities in the United States, such as the FDA and CMS, as well as in foreign countries, including European countries, Canada, Australia and Japan. Although we have obtained regulatory approval for our marketed products, these products and our manufacturing processes and those of our third-party contract manufacturers must undergo a potentially lengthy FDA or other regulatory approval process and are subject to continued review by the FDA and other regulatory authorities. It can take longer than five years to build and license a new manufacturing plant and it can take longer than three years to qualify and license a new contract manufacturer. In order to maintain adequate supply, to keep up with growing demand for our products, mitigate risks associated with the vast majority of our formulation, fill and finish operations locatedbeing performed in Puerto Rico,a single facility and to adequately prepare to launch a number of our late-stage product candidates, we must successfully implement a number of manufacturing projects on schedule, operate our facilities at nearly fullappropriate production capacity over the next few years, expandcontinue our use of third-party contract manufacturers build inventory of our bulk and finished products and maintain a state of regulatory compliance. Key manufacturing projects include: 1) construction, qualification and licensure(i) expansion of new formulation, fill and finish facilities at our Puerto Rico site; 2) expansion of existing bulk protein facilities at our Puerto Rico site includingfor the licensureproduction of our Puerto Rico plant for production of darbepoetin bulk drug substance and increased production of pegfilgrastim and Filgrastim bulk drug substance; 3)late-stage product candidate denosumab; (ii) construction, qualification and licensure of a new formulation and filling facility at our new process bulkPuerto Rico site and formulation, fill and finish plant in Ireland.(iii) expansion of our Fremont, California facility to support future product launches.

If regulatory authorities determine that we or our third-party contract manufacturers or third-party service providers have violated regulations or if they restrict, suspend or revoke our prior approvals, they could prohibit us from manufacturing our products or conducting clinical trials or selling our marketed products until we or our third-party contract manufacturers or third-party service providers comply, or indefinitely. Because our third-party contract manufacturers and third-party service providers are subject to FDA and foreign regulatory authorities, alternative qualified third-party contract manufacturers and service providers may not be available on a timely basis or at all. For example, we are dependent upon a single FDA approved third-party contract manufacturer for the formulation, fill and finish of Vectibix™. If we or our third-party contract manufacturers and third-party service providers cease or interrupt production or if our third-party contract manufacturers and third-party service providers fail to supply materials, products or services to us for any reason, we may experience delayed shipments, supply constraints, stock-outs and/or recalls of our products. If we are unable to manufacture, market and sell our products, our business and results of operations would be materially and adversely affected.

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We manufacture and formulate, fill and finish substantially all our products at our Puerto Rico manufacturing facility; if significant natural disasters or production failures occur at this facility, we may not be able to supply these products.

We currently perform all of the formulation, fill and finish for EPOGEN®, Aranesp®, Neulasta® and NEUPOGEN® and, some formulation, fill and finish operations for ENBREL, and all of the bulk manufacturing for Aranesp®, Neulasta® and NEUPOGEN® at our manufacturing facility in Juncos, Puerto Rico. Our global supply of these products is significantly dependent on the uninterrupted and efficient operation of this facility. Additionally, to keep up with the growing demand for our products, we are operating this facility at nearly full production capacity. A number of factors could adversely affect our formulation, fill and finish operations, including:

 

power failures

 

breakdown, failure or substandard performance of equipment

 

improper installation or operation of equipment

 

labor disputes or shortages, including the effects of an avian or pandemic flu outbreak or otherwise

 

inability of third-party suppliers to provide raw materials and components

 

natural or other disasters, including hurricanes

 

failures to comply with regulatory requirements, including those of the FDA

For example, this facility in Puerto Rico has experienced manufacturing component shortages and has hadthere was evidence of adverse trends in the microbial bioburden of the production environment that reduced the production output.output in the past. Although these experiences in Puerto Rico have not impacted our ability to supply product in the past, the same or other problems may result in our being unable to supply these products, which could adversely affect our product sales and operating results materially. Although we have obtained limited insurance to protect against certain business interruption losses, there can be no assurance that such coverage will be adequate or that such coverage will continue to remain available on acceptable terms, if at all. The extent of the coverage of our insurance could limit our ability to mitigate for lost sales and could result in such losses adversely affecting our product sales and operating results materially. (See “—“–Difficulties, disruptions or delays in manufacturing or failure to comply with manufacturing regulations may limit supply of our products and limit our product sales.sales.”)

We are dependent on third parties for a significant portion of our bulk supply and the formulation, fill and finish of ENBREL.

Under a collaboration and global supply agreement, we and Wyeth share the total worldwide bulk supply of ENBREL produced by our Rhode Island manufacturing facility, BI Pharma’s manufacturing facility in Germany and Wyeth’s manufacturing facility in Ireland. Our ENBREL supply forecasts rely on certain assumptions of how much ENBREL each of these manufacturing facilities is expected to produce. If any of these manufacturing facilities are unable to produce in accordance with our or Wyeth’s expectations, the worldwide supply of ENBREL could be adversely affected materially. In such cases, we may be required to allocate supply for Wyeth’s benefit. To the extent that there is a shortfall in worldwide production, our supply of ENBREL could be adversely affected. Additionally, the costs associated with a shortfall or failure in production of ENBREL would be borne by both parties.

We currently produce a substantial portion of the annual ENBREL supply at our Rhode Island manufacturing facilities.facility. However, we also depend on third parties for a significant portion of our ENBREL bulk supply as well as for some of the formulation, fill and finish of ENBREL that we manufacture. BI Pharma is our third-party contract manufacturer of ENBREL bulk drug; accordingly, our U.S. and Canadian supply of ENBREL is currently significantly dependent on BI Pharma’s production schedule for ENBREL. We would be unable to produce ENBREL in sufficient quantities to substantially offset shortages in BI Pharma’s scheduled production if BI Pharma or other third-party contract manufacturers used for the formulation, fill and finish of ENBREL bulk drug were to cease or interrupt production or services or otherwise fail to supply materials, products or services to us for any reason, including due to labor shortages or disputes, regulatory requirements or action or

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contamination of product lots or product recalls. For example, in the second quarter of 2002, the prior co-marketers with respect to ENBREL experienced a brief period where no ENBREL was available to fill new patient prescriptions, primarily due to variation in the expected production yield from BI Pharma. We cannot guarantee that an alternative third-party contract manufacturer would be available on a timely basis or at all. This in turn could materially reduce our ability to satisfy demand for ENBREL, which could materially and adversely affect our operating results.

Among the factors that could affect our actual supply of ENBREL at any time include, without limitation, BI Pharma’s and theour Rhode Island facilities’facility’s bulk drug production scheduling. For example, BI Pharma does not produce ENBREL continuously; rather, it produces the bulk drug substance through a series of periodic campaigns throughout the year. Our Rhode Island manufacturing facilities arefacility is currently dedicated to ENBREL production. The amount of commercial inventory available to us at any time depends on a variety of factors, including the timing and actual number of BI Pharma’s production runs, the actual number of runs at our Rhode Island manufacturing facilities,facility, and, for either the Rhode Island or BI Pharma facilities, the level of production yields and success rates, the timing and outcome of product quality testing and the amount of formulation, fill and finish capacity. We are also dependent on third-parties for some formulation, fill and finish of ENBREL bulk drug substance manufactured at our Rhode Island facilities.facility. If third-party formulation, fill and finish manufacturers are unable to provide sufficient capacity or are otherwise unable to provide services to us, the supply of ENBREL could be adversely affected materially.

Under a collaboration and global supply agreement, the Company and Wyeth share the total worldwide bulk supply of ENBREL produced by Amgen’s Rhode Island manufacturing facilities, BI Pharma’s manufacturing facility in Germany and Wyeth’s manufacturing facility in Ireland. Our ENBREL supply forecasts rely on certain assumptions of how much ENBREL each of these manufacturing facilities is expected to produce. If any of these manufacturing facilities are unable to produce in accordance with our or Wyeth’s expectations, the worldwide supply of ENBREL could be adversely affected materially. In such cases, we may be required to allocate supply for Wyeth’s benefit. To the extent that there is a shortfall in worldwide production expectations, our supply of ENBREL could be adversely affected. Additionally, the costs associated with a shortfall or failure in production of ENBREL would be borne by both parties.

Our marketed products face substantial competition and other companies may discover, develop, acquire or commercialize products before or more successfully than we do.

We operate in a highly competitive environment. Our products compete with other products or treatments for diseases for which our products may be indicated. For example, ENBREL competes in certain circumstances with products marketed by Johnson & Johnson,J&J, Abbott Laboratories (“Abbott”), Biogen IDEC Inc., Genentech, Bristol-MeyersInc., Bristol-Myers Squibb Corporation, Novartis AG and Sanofi-Aventis, as well as the generic drug methotrexate, and may face competition from other potential therapies being developed.developed, including J&J’s CNTO 1275 (ustekinumab). Additionally, on January 18, 2008, Abbott announced it had received approval from the FDA to market HUMIRA® as a treatment for adult patients with moderate to severe chronic plaque psoriasis. HUMIRA® will now compete with ENBREL in both the rheumatology and dermatology segments. While ENBREL continues to maintain a leading position in both rheumatology and dermatology, it has experienced and continues to experience share loss to competitors. Additionally, AranespVectibix® competes with products marketed by Johnson & Johnson, our oncology therapeutic in the United States and the EU andto treat patients with products marketed by Roche in the EU. Also,mCRC, competes with Imclone’s Erbitux®. Additionally, Aranesp® faces competitioncompetes or will potentially compete in the EU from Dynepo™, a competing erythropoietin product marketed by Shire and may face competition from Roche’s peg-EPO, which may receive approval in the EU and be launched later this year. Aranesp® and EPOGEN® may also face competition in the U.S. from Roche’s peg-EPO for which they have filed a BLA with the FDA and which Roche has stated has a PDUFA date of May 19, 2007. According to Roche’s public statements, they expect to launch the molecule in the U.S. nephrology segment in 2007, upon regulatory approval, despite ourwith:

 

51


Product

Company

Countries

Timing for Launch

EPREX®J&JEULaunched in 1988
Neorecormon®RocheEULaunched in 1993
Dynepo™ShireGermany, UKLaunched in 2007
Biosimilar ErythropoietinSandoz with co-marketers Hexal and MediceGermany, UK
Others
Launched in 2007
2008
Biosimilar ErythropoietinHospira/StadaGermany, UK2008
Others2008
peg-EPO/MIRCERA®RocheGermany, UKLaunched in 2007

Netherlands, Austria,

Sweden, Switzerland

2008

ongoing lawsuit and their acknowledgement of our U.S. erythropoietin patents. (See “—If our intellectual property positions are challenged, invalidated, circumvented or expire, or if we fail to prevail in present and future intellectual property litigation, our business could be adversely affected.”) In addition, Astellas/FibroGenseveral companies are developing potentially competing therapies. For example, Affymax Inc./Takeda are co-developing, an erythropoietic small molecule and Affymax is developingHematide™, an erythropoietin mimetic for the treatment of anemia. Vectibix™, our recently launched oncology therapeutic in the U.S. to treat patients with metastatic colorectal cancer, competes with Imclone’s Erbitux®. Further, if our currently marketed products are approved for new uses, or if we sell new products, or our competitors get new or expanded indications, we may face new, additional competition that we do not face today. Further, adverse clinical developments for our current products could limit our ability to compete. (See “—“–Our current products and products in development cannot be sold if we do not gain or maintain regulatory approval of our products and we may be required to perform additional clinical trials or change the labeling of our products or takeconduct other potentially limiting or costly actionsrisk management activities if we or others identify side effects or safety concerns after our products are on the market.market.”) Our products may compete against products that have lower prices, equivalent or superior performance, are easier to administer or that are otherwise competitive with our products.

Our principal European patent relating to erythropoietin expired on December 12, 2004 and our principal European patent relating to G-CSF expired on August 22, 2006. We believe that asAs these patents have expired, some companies have and other companies couldmay receive approval for and market biosimilar or other products to compete with our products in the EU, presenting additional competition to our products. Although we cannot predict with certainty when the first G-CSF biosimilar products could appear on the market in the EU, with the February 21, 2008 positive opinion from the CHMP, we expect that the first biosimilar G-CSF product maywill be approved some time in 2007 or earlythe second quarter of 2008 and could be available shortly thereafter, and that it would compete with Neulasta® and NEUPOGEN®. While we do not market EPOGENFor example, in February 2008, Teva received a positive opinion from the CHMP for its G-CSF biosimilar product, TevaGrastim® in Europe as this right belongs, which is expected to Johnson & Johnson (through KA), we do market Aranesp® in the EU, which competes with Johnson & Johnson’s EPREX® product, Roche’s NeoRecormon® product and others’ erythropoietin products. In addition, Roche is developing its peg-EPO product which, upon regulatory approval, we expect they will launch in the EU nephrology segment in 2007. We believe that biosimilar erythropoietin products may be approved in the EU in 2007 and could be available in the EU shortly after approval.second quarter of 2008. We cannot predict whether or to what extent the entry of biosimilar products or other competing products wouldwill impact future Aranesp®, Neulasta® or NEUPOGEN® sales in the EU. Our inability to compete effectively could reduce sales which could have a material adverse affecteffect on our results of operations.

In 2006, the EMEA developed and issued final regulatory guidelines related to the development and approval of biosimilar products. The final guidelines included clinical trial guidance for certain biosimilar products including erythropoietins and G-CSFs, which guidance recommends that applicants seeking approval of such biosimilar products conduct fairly extensive pharmacodynamic, toxicological, clinical safety studies and a pharmacovigilance program. In the United States, there currently is no legal approval pathway for follow-on biologics.the approval of BLAs for biosimilars. A number of events would need to occur before these products could enter the market, including passage of legislation by Congress to create a new approval pathway and, depending on the specific provisions of any such legislation, promulgation of associated regulations andor guidance by the FDA. During this current Congressional session,In 2007, several members of Congress expressed interest in the issue, a number of bills have beenwere introduced, the House of Representatives and the Senate held hearings on biosimilars, and the Senate Committee on HELP voted on legislation in June 2007. In 2008, additional legislation was introduced in the House and Senate have held hearings.of Reprsentatives. To date, however, no final legislation has been considered or passed in either chamber of Congress. Given the continuing interest of Congress in the issue, it is possible but not likely that legislation on biosimilars will be finalized this year. It is unknown what type of regulatory framework, what legal provisions, and what timeframes for issuance of regulations or guidance development any final legislation would contain. Until such legislation is created, we cannot predict when follow-on biologicsbiosimilars could appear in the United States.

Certain of our competitors, including biotechnology and pharmaceutical companies, market products or are actively engaged in R&D in areas where we have products or where we are

52


developing product candidates or new indications for existing products. In the future, we expect that our products will compete with new drugs currently in development, drugs approved for other indications that may be approved for the same indications as those of our products and drugs approved for other indications that are used off-label. Large pharmaceutical corporations may have greater clinical, research, regulatory, manufacturing, marketing, financial and human resources than we do. In addition, some of our competitors may have technical or competitive advantages over us for the development of technologies and processes. These resources may make it difficult for us to compete with them to successfully discover, develop and market new products and for our current products to compete with new products or new product indications that these competitors may bring to market. Business combinations among our competitors may also increase competition and the resources available to our competitors.

We have grown rapidly,must build the framework for our future growth, and if we fail to adequately manage that growthexecute on our initiatives our business could be adversely impacted.affected.

We have had an aggressive growth plan that has included substantialAs a result of developments in 2007 and, increasing investments in researchparticular the regulatory and development, sales and marketing and facilities. Wereimbursement changes to our ESA products, on August 15, 2007, we announced a plan to continuerestructure our worldwide operations in order to grow, however givenimprove our cost structure while continuing to make significant R&D investments and build the recent challenges around ESAs,framework for our plan hasfuture growth. We face a number of risks, some of which we cannot completely control. For example:

 

we will need to manage complexities associated with a largerlarge and more geographically diverse organization

 

we will need to manage and execute larger, morelarge, complex and increasingly global clinical trials

we will need to monitor and make strategic expense management reduction decisions to effectively offset any decline in revenues

 

we will need to significantly expand our sales and marketing resources to launch our late-stage product candidatescandidate, denosumab

 

we will need to accurately anticipate demand for the products we manufacture and maintain adequate manufacturing capacity for both commercial and clinical supply

we will needhave and continue to start up our new manufacturing facilities and enter into and manage new third-party contract manufacturing arrangements, while operating our existing manufacturing facilities at near or full capacity

we are implementingimplement an enterprise resource planningERP system to support our increasingly complex business and business processes and such implementation is costly and carries substantial operations risk, including loss of data or information, unanticipated increases in costs, disruption of operations or business interruption

Of course, there may be other risks and we cannot guarantee that we will be able to successfully manage these or other risks. If we fail to manageexecute on our growthinitiatives in these ways or others, such failure could result in a material adverse affecteffect on our business and results of operations.

53


Concentration of sales at certain of our wholesaler distributors and consolidation of free-standing dialysis clinic businesses may negatively impact our bargaining power and profit margins.

The substantial majority of our U.S. product sales are made to three pharmaceutical product wholesaler distributors, AmerisourceBergen Corporation, Cardinal Health, Inc. and McKesson Corporation. These distributors, in turn, sell our products to their customers, which include physicians or their clinics, dialysis centers, hospitals and pharmacies. One of these products, EPOGEN®, is primarily sold to free-standing dialysis clinics, which have recently experienced significant consolidation. Two organizations, DaVita Inc. and Fresenius Medical Care North America, Inc. (“Fresenius”) own or manage a large a number of the outpatient dialysis facilities located in the United States and account for a significant majority of all EPOGEN® sales in the free-standing dialysis clinic setting. In October 2006, we entered into a five-year sole sourcing and supply agreement with an affiliate of Fresenius, on its behalf and on behalf of certain of its affiliates, to purchase, and we have agreed to supply, all of Fresenius’ commercial requirements for erythropoietic stimulating proteinsESAs for use in managing the anemia of its hemodialysis patients in the United States and Puerto Rico, based on forecasts provided by Fresenius and subject to the terms and conditions of the agreement.

ThisThese entities’ purchasing leverage has increased due to this concentration and consolidation has increased these entities’ purchasing leverage andwhich may put pressure on our pricing by their potential ability to extract price discounts on our products or fees for other services, correspondingly negatively impacting our bargaining position and profit margins. The results of these developments may have a material adverse effect on our product sales and results of operations.

Our marketing of ENBREL will beis dependent in part upon Wyeth.

Under a co-promotion agreement, the Companywe and Wyeth market and sell ENBREL in the United States and Canada. A management committee comprised of an equal number of representatives from us and Wyeth is responsible for overseeing the marketing and sales of ENBREL including strategic planning, the approval of an annual marketing plan, product pricing and the establishment of a brand team. The brand team, with equal representation from us and Wyeth, prepares and implements the annual marketing plan, which includes a minimum level of financial and sales personnel commitment from each party, and is responsible for all sales activities. If Wyeth fails to market ENBREL effectively deliver on its marketing commitments to us or if the Companywe and Wyeth fail to coordinate our efforts effectively, our sales of ENBREL may be adversely affected materially.

Our revenues may fluctuate and our operating results are subject to fluctuations and these fluctuations could cause financial results to be below expectations and our stock price is volatile, which could adversely affect your investment.

Our operating results may fluctuate from period to period for a number of reasons. In budgeting our operating expenses for the foreseeable future, we assume that revenues will continue to grow; however, some of our operating expenses are fixed in the short term and cannot be reduced within a short period of time to offset unplanned or unexpected reductions in revenue. Because of this, even a relatively small revenue shortfall may cause a period’s results to be below our expectations or projections. A revenue shortfall could arise from any number of factors, some of which we cannot control. For example, as our ESAs and certain other principal products are facing a number of regulatory, reimbursement and competitive challenges, our revenues and operating results and, in turn, our stock price may be subject to significant fluctuations. Additionally, our stock price, like that of other biotechnology companies, is volatile. For example, in the fifty-two weeks prior to March 31, 2007, the trading price of our common stock has ranged from a high of $76.50 per share to a low of $55.72 per share.

54


Our revenues, operating results and stock price may be affected by a number of factors, such as:

adverse developments regarding the safety or efficacy of our products

changes in the government’s or private payers’ reimbursement policies or prescribing guidelines for our products

inability to maintain regulatory approval of marketed products or manufacturing facilities

actual or anticipated clinical trial results of ours or other companies and organizations

actual or anticipated product supply constraints

business development or licensing activities

product development or other business announcements by us or our competitors

regulatory matters or actions

changes in our product pricing strategies

lower than expected demand for our products

changes in wholesaler buying patterns

increased competition from new or existing products

fluctuations in foreign currency exchange rates

announcements in the scientific and research community

intellectual property and legal matters

broader economic, industry and market trends unrelated to our performance

pronouncements and rule changes by applicable standards authorities that change the manner in which we account for certain transactions

Of course, there may be other factors that affect our revenues in any given period. In addition, if our revenues, earnings or other financial results in any period fail to meet the investment community’s expectations, there could be an immediate adverse impact on our stock price.

Our corporate compliance program cannot guarantee that we are in compliance with all potentially applicable U.S. federal and state regulations and all potentially applicable foreign regulations.

The development, manufacturing, distribution, pricing, sales, marketing and reimbursement of our products, together with our general operations, isare subject to extensive federal and state regulation in the United States and to extensive regulation in foreign countries. (See “—“ –Our current products and products in development cannot be sold if we do not gain or maintain regulatory approval of our

55


products and we may be required to perform additional clinical trials or change the labeling of our products or takeconduct other potentially limiting or costly actionsrisk management activities if we or others identify side effects or safety concerns after our products are on the market.market.” and “—“ –Difficulties, disruptions or delays in manufacturing or failure to comply with manufacturing regulations may limit supply of our products and limit our product sales.sales.”) While we have developed and instituted a corporate compliance program, based on what we believe to be current best practices, we cannot assureguarantee you that we, our employees, our consultants or our contractors are or will be in compliance with all potentially applicable U.S. federal and state regulations and/or laws or all

potentially applicable foreign regulations and/or laws. If we fail to comply with any of these regulations and/or laws, a range of actions could result, including, but not limited to, the termination of clinical trials, the failure to approve a product candidate, restrictions on our products or manufacturing processes, including withdrawal of our products from the market, significant fines, exclusion from government healthcare programs or other sanctions or litigation.

The accounting method for our convertible debt securities may be subject to change.

A convertible debt security providing for net share and/or cash settlement of the conversion value and meeting specified requirements under Emerging Issues Task Force (“EITF”)EITF Issue No. 00-19, “AccountingAccounting for Derivative Financial Instruments Indexed to, and Potentially Settled in, a Company’s Own Stock,including our outstanding convertible debt securities, is accounted for by recognizing interest expense atcurrently classified in its stated coupon rate. For purposesentirety as debt. No portion of computing diluted earnings per share, any shares issuable upon conversionthe carrying value of such a security related to the conversion option indexed to our stock is computed usingclassified as equity. In addition, interest expense is recognized at the treasury stock method.stated coupon rate. The effectcoupon rate of the treasury stock method is that the shares potentially issuable upon conversion ofinterest for convertible debt securities, including our convertible debt securities, that meet these specified requirements are not included in the calculation of our earnings per share exceptis typically lower than what an issuer would be required to the extent that the conversion value of such securities exceeds their principal amount, in which event they are treatedpay for earnings per share purposes as us having issued the number of shares of our common stock necessary to settle the conversion.nonconvertible debt with otherwise similar terms.

The EITF is reviewingconsidered in 2007 whether the accounting method for net shareconvertible debt securities that require or permit settlement in cash either in whole or in part upon conversion (“cash settled convertible securitiesdebt securities”) should be changed. The EITF is consideringchanged, but was unable to reach a consensus and discontinued deliberations on this issue. Subsequently, in July 2007, the FASB voted unanimously to reconsider the current accounting for cash settled convertible debt securities, which includes our convertible debt securities. In August 2007, the FASB exposed for public comment a proposed FSP that would change the method forof accounting for net share settled convertiblesuch securities under whichand would require the proposed method to be retrospectively applied. During its March 2008 deliberations, the FASB affirmed the proposed method of accounting and decided to delay the effective date of the final FSP for calendar year end companies like us to the first quarter of 2009. The FASB currently indicates that it expects to take a final vote on and, if approved, issue the final FSP in the second quarter of 2008. Under this proposed method of accounting, the debt and equity components of the securityour convertible debt securities would be bifurcated and accounted for separately.separately in a manner that would result in recognizing interest on these securities at effective rates more comparable to what we would have incurred had we issued nonconvertible debt with otherwise similar terms. The effectequity component of this proposal is that the equity componentour convertible debt securities would be included in the paid-in-capital section of stockholders’ equity on an issuer’s balance sheetour Consolidated Balance Sheet and, accordingly, the initial carrying valuevalues of the convertiblethese debt securities would be reduced. NetOur net income for financial reporting purposes attributable to our common stockholders would be lowerreduced by recognizing the accretion of the reduced carrying valuevalues of theour convertible debt securitysecurities to itstheir face amountamounts as additional non-cash interest expense. The diluted earnings per share calculation would continueTherefore, if the FASB issues the final FSP to be calculated based onchange the treasury stock method.

We cannot predict the outcomemethod of the EITF deliberations and whether the EITF will require that net shareaccounting for cash settled convertible debt securities and their relatedas described above, it would have a material adverse impact on earnings per share, be accounted for under the existing method, the proposed method described above or some other method,our past and when any change would be implemented or whether it would be implemented retroactively or prospectively.future reported financial results.

We also cannot predict any other changes in GAAP that may be made affectingwhich would affect accounting for convertible debt securities. Any change in the accounting method for convertible debt securities and which could have an adverse impact on our past or future reported financial results. These impacts could adversely affect the trading price of our common stock and in turn negatively impact the trading price of the notes.

56


Continual manufacturing process improvement efforts may result in the carrying value of certain existing manufacturing facilities or other assets becoming impaired.impaired or other related charges being incurred.

In connection with our ongoingcontinuous process improvement activities, associated with products we manufacture,evaluate our processes and procedures in order to identify opportunities to achieve greater efficiencies in how we continually investconduct our business in order to reduce costs. In particular, we evaluate our various manufacturing practices and related processes with the objective of increasingto increase production yields andand/or success rates as well as capacity utilization to gain increased cost efficiencies and capacity utilization. We are investigating alternative manufacturing processes that do not require the use of certain biologically-sourced raw materials. The development or implementation of such processes could result in changes to or redundancies with our existing manufacturing operations.efficiencies. Depending on the timing and outcomes of these efforts and our other estimates and assumptions regarding future product sales,process improvement initiatives, the carrying value of certain manufacturing facilities or other assets may not be fully recoverable and could result in the recognition of an impairment incharges and/or the carrying value at the time that such effects are identified. The potential recognition of impairment in the carrying value,other related charges. The recognition of such charges, if any, could have a material and adverse affect on our results of operations.

Item 2.UNREGISTERED SALES OF EQUITY SECURITIES, USE OF PROCEEDS AND ISSUER PURCHASES OF EQUITY SECURITIES

During the three months ended March 31, 2007,2008, we had two outstanding stock repurchase programs. The manner of purchases, the amount we spend and the number of shares repurchased will vary based on a variety of factors including the stock price, and blackout periods, in which we are restricted from repurchasing shares, and our credit rating and may include private block purchases as well as market transactions. Repurchases under our stock repurchase programs reflect, in part, our confidence in the long-term value of Amgen common stock. Additionally, we believe that it is an effective way of returning cash to our stockholders. A summary of our repurchase activity for the three months ended March 31, 20072008 is as follows:

 

   Total Number
of Shares
Purchased
  Average
Price Paid
per Share
  Total Number
of Shares
Purchased as Part
of Publicly
Announced Programs
  Maximum $ Value
that May Yet Be
Purchased Under the
Programs (1)

January 1 - January 31

  —    $—    —    $6,539,425,046

February 1 - February 28

  542,073   69.39  539,100   6,502,011,624

March 1 - March 31

  8,301,223   60.48  8,262,400   6,002,394,552
          
  8,843,296(2)  61.02  8,801,500(2) 
          

   Total number
of shares
purchased
  Average
price paid
per share
  Total number of
shares purchased

as part of publicly
announced programs
  Maximum $ value
that may yet be
purchased under the
programs(1)

January 1 - January 31

  —    $—    —    $6,439,425,117

February 1 - February 29

  2,993   46.56  —     6,439,425,117

March 1 - March 31

  35,158   45.48  —     6,439,425,117
          
  38,151(2)  45.56  —  (2) 
          

(1)

In December 2006, the Board of Directors authorized us to repurchase up to $5.0 billion of common stock. In July 2007, the Board of Directors authorized us to repurchase up to an additional $5.0 billion of common stock.

(2)

The difference between total number of shares purchased and the total number of shares purchased as part of publicly announced programs is due to shares of common stock withheld by us for the payment of taxes upon vesting of certain employees’ restricted stock.

 

Item 5.OTHER INFORMATION

57

In May 2008, we increased our commercial paper program by $1.3 billion, which provides for unsecured, short-term borrowings of up to an aggregate of $2.5 billion. We also have a $2.5 billion unsecured revolving credit facility to be used for general corporate purposes, including commercial paper backup, which matures in November 2012. No amounts were outstanding under the commercial paper program or credit facility as of March 31, 2008.


Item 6.EXHIBITS

(a) Reference is made to the Index to Exhibits included herein.

58


SIGNATURES

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

 

 Amgen Inc.
 (Registrant)
Date:

May 9, 200712, 2008

 By: 

/s/ ROBERT A. BRADWAY

  Robert A. Bradway
  

Executive Vice President

and Chief Financial Officer

59


AMGEN INC.

INDEX TO EXHIBITS

 

Exhibit

No.

  

Description

3.1

  Restated Certificate of Incorporation (As Restated December 6, 2005). (Filed as an exhibit to Form 10-K for the year ended December 31, 2005 on March 10, 2006 and incorporated herein by reference.)

3.2

Certificate of Amendment of the Restated Certificate of Incorporation (As Amended May 24, 2007). (Filed as an exhibit to Form 10-Q for the quarter ended June 30, 2007 on August 9, 2007 and incorporated herein by reference.)

3.3      

Certificate of Correction of the Restated Certificate of Incorporation (As Corrected May 24, 2007). (Filed as an exhibit to Form 10-Q for the quarter ended June 30, 2007 on August 9, 2007 and incorporated herein by reference.)

3.4      

  Amended and Restated Bylaws of Amgen Inc. (As Amended and Restated February 14, 2007). (Filed as an exhibit to Form 8-K filed on February 20, 2007 and incorporated herein by reference.)

3.5      

Amendment to Amended and Restated Bylaws of Amgen Inc. (Filed as an exhibit to Form 10-Q for the quarter ended June 30, 2007 on August 9, 2007 and incorporated herein by reference.)

4.1

  Form of stock certificate for the common stock, par value $.0001 of the Company. (Filed as an exhibit to Form 10-Q for the quarter ended March 31, 1997 on May 13, 1997 and incorporated herein by reference.)

4.2

  Form of Indenture, dated January 1, 1992, between Amgen Inc. and Citibank N.A.1992. (Filed as an exhibit to Form S-3 Registration Statement filed on December 19, 1991 and incorporated herein by reference.)

4.3

  6.50% Notes Due December 1, 2007.Agreement of Resignation, Appointment and Acceptance dated February 15, 2008. (Filed as an exhibit to Form 8-K filed10-K for the year ended December 31, 2007 on December 5, 1997February 28, 2008 and incorporated herein by reference.)

4.4

  First Supplemental Indenture, dated February 26, 1997, between Amgen Inc. and Citibank, N.A.1997. (Filed as an exhibit to Form 8-K on March 14, 1997 and incorporated herein by reference.)

4.5

Officer’s Certificate, dated as of January 1, 1992, as supplemented by the First Supplemental Indenture, dated as of February 26, 1997, each between Amgen Inc. and Citibank, N.A., establishing a series of securities entitled “6.50% Notes Due December 1, 2007” (Filed as an exhibit to Form 8-K filed on December 5, 1997 and incorporated herein by reference.)
  4.6

  8-1/8% Debentures due April 1, 2097. (Filed as an exhibit to Form 8-K filed on April 8, 1997 and incorporated herein by reference.)
  4.7

4.6      

  Officer’s Certificate, dated as of January 1, 1992, as supplemented by the First Supplemental Indenture, dated as of February 26, 1997, each between Amgen Inc. and Citibank, N.A., establishing a series of securities entitled “8 1/8% Debentures due April 1, 2097.” (Filed as an exhibit to Form 8-K filed on April 8, 1997 and incorporated herein by reference.)
  4.8

4.7      

  Form of Liquid Yield Option™ Note due 2032. (Filed as an exhibit to Form 8-K on March 1, 2002 and incorporated herein by reference.)
  4.9

4.8      

  Indenture, dated as of March 1, 2002, between Amgen Inc. and LaSalle Bank National Association.2002. (Filed as an exhibit to Form 8-K on March 1, 2002 and incorporated herein by reference.)
  4.10

4.9      

  First Supplemental Indenture, dated March 2, 2005, between Amgen Inc. and LaSalle Bank National Association.2005. (Filed as an exhibit to Form 8-K filed on March 4, 2005 and incorporated herein by reference.)
  4.11

4.10    

  Indenture, dated as of August 4, 2003, between Amgen Inc. and JPMorgan Chase Bank.2003. (Filed as an exhibit to Form S-3 Registration Statement on August 4, 2003 and incorporated herein by reference.)
  4.12

4.11    

  Form of 4.00% Senior Note due 2009. (Filed as an exhibit to Form 8-K on November 19,

60


2004 and incorporated herein by reference.)
  4.13

4.12    

  Form of 4.85% Senior Notes due 2014. (Filed as an exhibit to Form 8-K on November 19, 2004 and incorporated herein by reference.)
  4.14

4.13    

  Officers’ Certificate, dated November 18, 2004, including forms of the 4.00% Senior Notes due 2009 and 4.85% Senior Notes due 2014. (Filed as an exhibit to Form 8-K on November 19, 2004 and incorporated herein by reference.)
  4.15

4.14    

  Registration Rights Agreement, dated as of November 18, 2004, among Amgen Inc. and Morgan Stanley & Co. Incorporated and Merrill Lynch, Pierce, Fenner & Smith Incorporated. (Filed as an exhibit to Form 8-K on November 19, 2004 and incorporated herein by reference.)
  4.16

4.15    

  Form of Zero Coupon Convertible Note due 2032. (Filed as an exhibit to Form 8-K on May 6, 2005

and incorporated herein by reference.)
  4.17

4.16    

  Indenture, dated as of May 6, 2005, between Amgen Inc. and LaSalle Bank National Association.2005. (Filed as an exhibit to Form 8-K on May 6, 2005 and incorporated herein by reference.)
  4.18

4.17    

  Indenture, dated as of February 17, 2006 and First Supplemental Indenture, dated as of June 8, 2006 between Amgen Inc. and JPMorgan Chase Bank, N.A, as trustee (including form of 0.125% Convertible Senior Note due 2011). (Filed as exhibit to Form 10-Q for the quarter ended June 30, 2006 on August 9, 2006 and incorporated herein by reference).
  4.19

4.18    

  Indenture, dated as of February 17, 2006 and First Supplemental Indenture, dated as of June 8, 2006 between Amgen Inc. and JPMorgan Chase Bank, N.A., as trustee (including form of 0.375% Convertible Senior Note due 2013). (Filed as exhibit to Form 10-Q for the quarter ended June 30, 2006 on August 9, 2006 and incorporated herein by reference).
  4.20

4.19    

  Registration Rights Agreement, dated as of February 17, 2006, among Amgen Inc. and Merrill Lynch, Pierce, Fenner & Smith Incorporated, Morgan Stanley & Co. Incorporated, Citigroup Global Markets Inc., JPMorgan Securities Inc., Lehman Brothers Inc., Bear, Stearns & Co. Inc., Credit Suisse Securities (USA) LLC. (Filed as an exhibit to Form 8-K on February 21, 2006 and incorporated herein by reference.)
  4.21

4.20    

  Corporate Commercial Paper - Master Note between and among Amgen Inc., as Issuer, Cede & Co., as Nominee of The Depository Trust Company, and Citibank, N.A., as Paying Agent. (Filed as an exhibit to Form 10-Q for the quarter ended March 31, 1998 on May 13, 1998 and incorporated herein by reference.)
  4.22

4.21    

  The instruments defining the rights of holders of the long-term debt securities of Abgenix, Inc. and its subsidiaries are omitted pursuant to section (b)(4)(iii)(A) of Item 601 of Regulation S-K. Amgen Inc. hereby agrees to furnish copies of these instruments to the Securities and Exchange Commission upon request.
10.1+

4.22    

  Officers’ Certificate of Amgen Inc. dated as of May 30, 2007, including forms of the Company’s Senior Floating Rate Notes due 2008, 5.85% Senior Notes due 2017 and 6.375% Senior Notes due 2037. (Filed as an exhibit to Form 8-K on May 30, 2007 and incorporated herein by reference).

4.23    

Registration Rights Agreement, dated as of May 30, 2007, among Amgen Inc. and Morgan Stanley & Co. Incorporated, Merrill Lynch, Pierce, Fenner & Smith Incorporated, Barclays Capital Inc., Credit Suisse Securities (USA) LLC, Goldman, Sachs & Co., Citigroup Global Markets Inc., J.P. Morgan Securities Inc. and Lehman Brothers Inc. (Filed as an exhibit to Form 8-K on May 30, 2007 and incorporated herein by reference).

10.1+    

Amgen Inc. Amended and Restated 1991 Equity Incentive Plan (As Amended and Restated December 5, 2005) and Forms of Stock Option Grant Agreements and Restricted Stock Unit Agreements.. (Filed as exhibits to Form 8-K on December 8, 2005 and incorporated herein by reference.)

10.2+

  Amgen Inc. Director Equity Incentive Program (As Amended and Restated December 6, 2005) and Forms of Stock Option Grant AgreementsAgreement and Restricted Stock Unit Agreements.Agreement for the Amgen Inc. Amended and Restated 1991 Equity Incentive Plan. (Filed as exhibitsan exhibit to Form 8-K10-K for the year ended December 31, 2007 on December 8, 2005February 28, 2008 and incorporated herein by reference.)

10.3+

Amgen Inc. Amended and Restated Director Equity Incentive Program (As Amended and Restated December 10, 2007) and forms of Stock Option Grant Agreement and Restricted Stock Unit Agreement for the Amgen Inc. Amended and Restated Director Equity Incentive Program. (Filed as an exhibit to Form 10-K for the year ended December 31, 2007 on February 28, 2008 and incorporated herein by reference.)

10.4+    

  Amgen Inc. Amended and Restated 1997 Equity Incentive Plan (As Amended and Restated December 5, 2005) and Forms of Stock Option Grant Agreements and Restricted Stock Unit Agreements. (Filed as exhibits to Form 8-K on December 8, 2005 and incorporated herein by reference.)
10.4+

10.5+    

  Amended and Restated 1999 Equity Incentive Plan (As Amended and Restated of December 5, 2005) and Forms of Stock Option Grant Agreements. (Filed as exhibits to Form 8-K on December 8, 2005 and incorporated herein by reference.)
10.5+

10.6+    

  Amgen Inc. Amended and Restated 1999 Incentive Stock Plan (As Amended and

61


Restated April 1, 2006). (Filed as an exhibit to Form S-8 on April 3, 2006 and incorporated herein by reference.)
10.6+

10.7+    

  Amgen Inc. Amended and Restated Employee Stock Purchase Plan. (Filed as an exhibit to Form 10-Q for the quarter ended June 30, 2000 on August 1, 2000 and incorporated herein by reference.)
10.7+

10.8+    

  First Amendment to the Amgen Inc. Amended and Restated Employee Stock Purchase Plan (As Amended and Restated July 12, 2005). (Filed as an exhibit to Form 8-K on July 14, 2005 and

incorporated herein by reference.)
10.8+

10.9+    

Second Amendment to the Amgen Inc. Amended and Restated Employee Stock Purchase Plan (As Amended and Restated July 12, 2005). (Filed as an exhibit to Form 10-K for the year ended December 31, 2007 on February 28, 2008 and incorporated herein by reference.)

10.10+  

  Amgen Supplemental Retirement Plan (As Amended and Restated January 1, 2005). (Filed as an exhibit to Form 8-K on October 12, 2004 and incorporated herein by reference.)
10.9+

10.11+  

  First Amendment to the Amgen Supplemental Retirement Plan (As Amended and Restated January 1, 2005). (Filed as an exhibit to Form 8-K on October 20, 2005 and incorporated herein by reference.)
10.10+

10.12+  

  Second Amendment to the Amgen Supplemental Retirement Plan (As Amended and Restated July 1, 2006). (Filed as an exhibit to Form 8-K on May 16, 2006 and incorporated herein by reference.)
10.11+

10.13+  

  Third Amendment to the Amgen Supplemental Retirement Plan (As Amended and Restated January 1, 2007)2005). (Filed as an exhibit to Form 10-K for the year ended December 31, 2006 on February 28, 2007 and incorporated herein by reference.)
10.12+

10.14+  

Fourth Amendment to the Amgen Supplemental Retirement Plan (As Amended and Restated January 1, 2005). (Filed as an exhibit to Form 10-Q for the quarter ended September 30, 2007 on November 9, 2007 and incorporated herein by reference.)

10.15+*

Fifth Amendment to the Amgen Supplemental Retirement Plan (As Amended and Restated January 1, 2005).

10.16+  

  Amgen Inc. Change of Control Severance Plan. (Filed as an exhibit to Form 10-K for the year ended December 31, 1998 on March 16, 1999 and incorporated herein by reference.)
10.13+

10.17+  

  First Amendment to Amgen Inc. Change of Control Severance Plan (As Amended May 10, 2000). (Filed as an exhibit to Form 10-Q for the quarter ended June 30, 2000 on August 1, 2000 and incorporated herein by reference.)
10.14+

10.18+  

  Second Amendment to the Amgen Inc. Change in Control Severance Plan (As Amended October 16, 2001). (Filed as an exhibit to Form 10-Q for the quarter ended September 30, 2001 on October 26, 2001 and incorporated herein by reference.)
10.15+

10.19+  

  Third Amendment to the Amgen Inc. Change of Control Severance Plan (As Amended January 1, 2004). (Filed as an exhibit to Form 10-K for the year ended December 31, 2004 on March 9, 2005 and incorporated herein by reference.)
10.16+

10.20+  

  Fourth Amendment to the Amgen Inc. Change of Control Severance Plan (As Amended June 1, 2004). (Filed as an exhibit to Form 10-K for the year ended December 31, 2004 on March 9, 2005 and incorporated herein by reference.)
10.17+

10.21+  

  Fifth Amendment to the Amgen Inc. Change of Control Severance Plan (As Amended December 6, 2004). (Filed as an exhibit to Form 8-K on December 9, 2004 and incorporated herein by reference.)
10.18+

10.22+  

  Sixth Amendment to the Amgen Inc. Change of Control Severance Plan (As Amended May 10, 2006). (Filed as an exhibit to Form 8-K on May 16, 2006 and incorporated herein by reference.)
10.19+

10.23+  

  Seventh Amendment to the Amgen Inc. Change of Control Severance Plan (As Amended October 4, 2006). (Filed as exhibit to Form 8-K on October 6, 2006 and incorporated herein by reference).
10.20+

10.24+  

  EightEighth Amendment to the Amgen Inc. Change of Control Severance Plan (As Amended December 15, 2006). (Filed as an exhibit to Form 10-K for the year ended December 31, 2006 on February 28, 2007 and incorporated herein by reference).
10.21+

10.25+  

  Amgen Inc. Executive Incentive Plan. (Filed as Annex G to Amendment No. 1 to Form S-4 Registration Statement on March 22, 2002 and incorporated herein by reference.)
10.22+

10.26+  

  First Amendment to the Amgen Inc. Executive Incentive Plan (As Amended December 6, 2004). (Filed as an exhibit to Form 8-K on December 9, 2004 and incorporated herein by

62


refersence. reference.)
10.23+

10.27+  

  Amgen Inc. Executive Nonqualified Retirement Plan. (Filed as an exhibit to Form 10-K for the year ended December 31, 2001 on February 26, 2002 and incorporated herein by reference.)
10.24+

10.28+  

First Amendment to the Amgen Inc. Executive Nonqualified Retirement Plan. (Filed as an exhibit to Form 10-Q for the quarter ended September 30, 2007 on November 9, 2007 and incorporated herein by reference.)

10.29+  

  Amgen Nonqualified Deferred Compensation Plan (As Amended and Restated effective January 1, 2005). (Filed as an exhibit to Form 8-K on October 12, 2004 and incorporated herein by reference.)
10.25+

10.30+  

  First Amendment to the Amgen Nonqualified Deferred Compensation Plan (As Amended and Restated January 1, 2005). (Filed as an exhibit to Form 8-K on October 20, 2005 and incorporated

herein by reference.)
10.26+

10.31+  

  Second Amendment to the Amgen Nonqualified Deferred Compensation Plan (As Amended and Restated January 1, 2005). (Filed as an exhibit to Form 8-K on November 22, 2005 and incorporated herein by reference.)
10.27+

10.32+  

  Third Amendment to the Amgen Nonqualified Deferred Compensation Plan (As Amended and Restated January 1, 2005). (Filed as an exhibit to Form 10-K for the year ended December 31, 2006 on February 28, 2007 and incorporated herein by reference.)
10.28+

10.33+  

Fourth Amendment to the Amgen Nonqualified Deferred Compensation Plan (As Amended and Restated January 1, 2005). (Filed as an exhibit to Form 10-Q for the quarter ended September 30, 2007 on November 9, 2007 and incorporated herein by reference.)

10.34+  

Fifth Amendment to the Amgen Nonqualified Deferred Compensation Plan (As Amended and Restated January 1, 2005). (Filed as an exhibit to Form 10-K for the year ended December 31, 2007 on February 28, 2008 and incorporated herein by reference.)

10.35+*

  Amended and Restated Amgen Inc. Performance Award Program (As Amended and Restated December 5, 2005). (Filed as an exhibit to Form 8-K on December 8, 2005March 21, 2008) and incorporated herein by reference.)form of Performance Unit Agreement.
10.29+Form of Performance Unit Agreement to the Amended and Restated Amgen Inc. Performance Award Program (As Amended and Restated December 5, 2005). (Filed as an exhibit to Form 8-K on December 8, 2005 and incorporated herein by reference.)
10.30+Amgen Inc. Amended and Restated 1987 Directors’ Stock Option Plan. (Filed as an exhibit to Form 10-K for the year ended December 31, 1996 on March 24, 1997 and incorporated herein by reference.)
10.31+

10.36+  

  2002 Special Severance Pay Plan for Amgen Employees. (Filed as an exhibit to Form 10-Q for the quarter ended June 30, 2002 on August 13, 2002 and incorporated herein by reference.)
10.32+

10.37+  

  Agreement, dated March 2, 2001, between Amgen Inc. and Mr. George J. Morrow. (Filed as an exhibit to Form 10-Q for the quarter ended March 31, 2001 on May 14, 2001 and incorporated herein by reference.)
10.33+

10.38+  

  Agreement, dated March 2, 2001 between Amgen Inc. and Dr. Roger M. Perlmutter, M.D., Ph.D. (Filed as an exhibit to Form 10-Q for the quarter ended March 31, 2001 on May 14, 2001 and incorporated herein by reference.)
10.34+

10.39+  

  Agreement, dated May 2, 2001, between Amgen Inc. and Mr. Brian McNamee. (Filed as an exhibit to Form 10-Q for the quarter ended June 30, 2001 on July 27, 2001 and incorporated herein by reference.)
10.35+

10.40+  

  Restricted Stock Purchase Agreement, dated March 3, 2003, between Amgen Inc. and Brian M. McNamee. (Filed as an exhibit to Form 10-Q for the quarter ended June 30, 2003 on July 30, 2003 and incorporated herein by reference.)
10.36+

10.41+  

  Agreement, dated May 14, 2001, between Amgen Inc. and Mr. Richard Nanula. (Filed as an exhibit to Form 10-Q for the quarter ended June 30, 2001 on July 27, 2001 and incorporated herein by reference.)
10.37+

10.42+  

  Promissory Note, dated June 27, 2001, of Mr. Richard Nanula. (Filed as an exhibit to Form 10-Q for the quarter ended June 30, 2001 on July 27, 2001 and incorporated herein by reference.)
10.38+

10.43+  

Amendment to Promissory Note, dated August 31, 2007 to Promissory Note, dated June 27, 2001, of Mr. Richard Nanula. (Filed as an exhibit to Form 10-Q for the quarter ended September 30, 2007 on November 9, 2007 and incorporated herein by reference.)

10.44+  

  Agreement, dated February 11, 2004, between Amgen Inc. and David J. Scott. (Filed as an exhibit to Form 10-K for the year ended December 31, 2003 on March 11, 2004 and incorporated herein by reference.)
10.39+Restricted Stock Purchase Agreement, dated December 6, 2004, between Amgen Inc. and

10.45    

63


Dennis M. Fenton. (Filed as an exhibit to Form 10-K for the year ended December 31, 2005 on March 10, 2006 and incorporated herein by reference.)
10.40  Product License Agreement, dated September 30, 1985, and Technology License Agreement, dated, September 30, 1985 between Amgen and Ortho Pharmaceutical Corporation. (Filed as an exhibit to Form 10-Q for the quarter ended June 30, 2000 on August 1, 2000 and incorporated herein by reference.)
10.41

10.46    

  Shareholders’ Agreement, dated May 11, 1984, among Amgen, Kirin Brewery Company, Limited and Kirin-Amgen, Inc. (Filed as an exhibit to Form 10-K for the year ended December 31, 2000 on March 7, 2001 and incorporated herein by reference.)
10.42

10.47    

  Amendment No. 1 dated March 19, 1985, Amendment No. 2 dated July 29, 1985 (effective July 1, 1985), and Amendment No. 3, dated December 19, 1985, to the Shareholders’ Agreement dated May 11, 1984. (Filed as an exhibit to Form 10-Q for the quarter ended June 30, 2000 on August 1, 2000 and incorporated herein by reference.)
10.43

10.48    

  Amendment No. 4 dated October 16, 1986 (effective July 1, 1986), Amendment No. 5 dated December 6, 1986 (effective July 1, 1986), Amendment No. 6 dated June 1, 1987, Amendment No. 7 dated July 17, 1987 (effective April 1, 1987), Amendment No. 8 dated May 28, 1993 (effective November 13, 1990), Amendment No. 9 dated December 9, 1994 (effective June 14, 1994), Amendment No. 10

effective March 1, 1996, and Amendment No. 11 effective March 20, 2000 to the Shareholders’ Agreement, dated May 11, 1984. (Filed as exhibits to Form 10-K for the year ended December 31, 2000 on March 7, 2001 and incorporated herein by reference.)
10.44

10.49    

  Amendment No. 12 to the Shareholders’ Agreement, dated January 31, 2001. (Filed as an exhibit to Form 10-Q for the quarter ended June 30, 2005 on August 8, 2005 and incorporated herein by reference.)
10.45

10.50    

Amendment No. 13 to the Shareholders’ Agreement, dated June 28, 2007 (with certain confidential information deleted therefrom). (Filed as an exhibit to Form 10-Q for the quarter ended June 30, 2007 on August 9, 2007 and incorporated herein by reference.)

10.51    

  Product License Agreement, dated September 30, 1985, and Technology License Agreement, dated September 30, 1985, between Kirin-Amgen, Inc. and Ortho Pharmaceutical Corporation. (Filed as an exhibit to Form 10-Q for the quarter ended June 30, 2000 on August 1, 2000 and incorporated herein by reference.)
10.46

10.52    

  Research, Development Technology Disclosure and License Agreement: PPO, dated January 20, 1986, by and between Kirin Brewery Co., Ltd. and Amgen Inc. (Filed as an exhibit to Amendment No. 1 to Form S-1 Registration Statement on March 11, 1986 and incorporated herein by reference.)
10.47

10.53    

  Amendment Agreement, dated June 30, 1988, to Research, Development, Technology Disclosure and License Agreement: GM-CSF dated March 31, 1987, between Kirin Brewery Company, Limited and Amgen Inc. (Filed as an exhibit to Form 8 amending the Quarterly Report on Form 10-Q for the quarter ended June 30, 1988 on August 25, 1988 and incorporated herein by reference.)
10.48

10.54    

  Assignment and License Agreement, dated October 16, 1986 (effective July 1, 1986, between Amgen and Kirin-Amgen, Inc. (Filed as an exhibit to Form 10-K for the year ended December 31, 2000 on March 7, 2001 and incorporated herein by reference.)
10.49

10.55    

  G-CSF United States License Agreement, dated June 1, 1987 (effective July 1, 1986), Amendment No. 1, dated October 20, 1988, and Amendment No. 2, dated October 17, 1991 (effective November 13, 1990), between Kirin-Amgen, Inc. and Amgen Inc. (Filed as exhibits to Form 10-K for the year ended December 31, 2000 on March 7, 2001 and incorporated herein by reference.)
10.50

10.56    

  G-CSF European License Agreement, dated December 30, 1986, between Kirin-Amgen and Amgen, Amendment No. 1 to Kirin-Amgen, Inc. / Amgen G-CSF European License Agreement, dated June 1, 1987, Amendment No. 2 to Kirin-Amgen, Inc. / Amgen G-CSF European License Agreement, dated March 15, 1998, Amendment No. 3 to Kirin-Amgen, Inc. / Amgen G-CSF European License Agreement, dated October 20, 1988, and

64


Amendment No. 4 to Kirin-Amgen, Inc. / Amgen G-CSF European License Agreement, dated December 29, 1989, between Kirin-Amgen, Inc. and Amgen Inc. (Filed as exhibits to Form 10-K for the year ended December 31, 2000 on March 7, 2001 and incorporated herein by reference.)
10.51

10.57    

  ENBRELEnbrel® Supply Agreement among Immunex Corporation, American Home Products Corporation and Boehringer Ingelheim Pharma KG, dated as of November 5, 1998 (with certain confidential information deleted therefrom). (Filed as an exhibit to the Immunex Corporation Annual Report on Form 10-K for the year ended December 31, 1998 on March 23, 1998 and incorporated herein by reference.)
10.52

10.58    

  Amendment No. 1 to the ENBRELEnbrel® Supply Agreement, dated June 27, 2000, among Immunex Corporation, American Home Products Corporation and Boehringer Ingelheim Pharma KG, (with certain confidential information deleted therefrom). (Filed as an exhibit to the Immunex Corporation Form 10-Q for the quarter ended June 30, 2000 on August 11, 2000 and incorporated herein by reference.)
10.53

10.59    

  Amendment No. 2 to the ENBRELEnbrel® Supply Agreement, dated June 3, 2002, among Immunex Corporation, Wyeth (formerly known as American Home Products Corporation) and Boehringer Ingelheim Pharma KG (with certain confidential information deleted therefrom). (Filed as an exhibit to Form 10-Q for the quarter ended June 30, 2002 on August 13, 2002 and incorporated herein by reference.)
10.54

10.60    

  Amendment No. 3 to the ENBRELEnbrel® Supply Agreement, dated December 18, 2002, among Immunex Corporation, Wyeth (formerly, “American Home Products Corporation”) and Boehringer Ingelheim Pharma KG (with certain confidential information deleted therefrom). (Filed as an exhibit to Form 10-K for the year ended December 31, 2002 on March 10, 2003 and incorporated herein by reference.)

10.55

10.61    

  Amendment No. 4 to the ENBRELEnbrel® Supply Agreement, dated May 21, 2004, among Immunex Corporation, Wyeth (formerly, “American Home Products Corporation”) and Boehringer Ingelheim Pharma KG. (Filed as an exhibit to Form 10-Q for the quarter ended June 30, 2005 on August 8, 2005 and incorporated herein by reference.)
10.56

10.62    

  Amendment No. 5 to the ENBRELEnbrel® Supply Agreement, dated August 30, 2005, among Immunex Corporation, Wyeth (formerly, “American Home Products Corporation”) and Boehringer Ingelheim Pharma KG. (Filed as an exhibit to Form 10-Q for the quarter ended September 30, 2005 on November 9, 2005 and incorporated herein by reference.)
10.57

10.63    

Amendment No. 6 to the Enbrel®Supply Agreement, dated November 27, 2007, among Immunex Corporation, Wyeth (formerly, “American Home Products Corporation”) and Boehringer Ingelheim Pharma KG (with certain confidential information deleted therefrom) (Filed as an exhibit to Form 10-K for the year ended December 31, 2007 on February 28, 2008 and incorporated herein by reference.)

10.64    

  Agreement Regarding Governance and Commercial Matters, dated December 16, 2001, by and among American Home Products Corporation, American Cyanamid Company and Amgen Inc. (with certain confidential information deleted therefrom). (Filed as an exhibit to Amendment No. 1 to Form S-4 Registration Statement on March 22, 2002 and incorporated herein by reference.)
10.58Asset Purchase Agreement dated May 2, 2002, by and between Immunex Corporation and Schering Aktiengesellschaft (with certain confidential information deleted therefrom). (Filed as an exhibit to Form 10-Q for the quarter ended June 30, 2002 on August 13, 2002 and incorporated herein by reference.)
10.59Amendment No. 1 dated as of June 25, 2002 and Amendment No. 2 dated as of July 17, 2002 to the Asset Purchase Agreement dated as of September 25, 2002, by and between Immunex Corporation and Schering Aktiengesellschaft. (Filed as an exhibit to Form 10-Q for the quarter ended June 30, 2002 on August 13, 2002 and incorporated herein by reference.)
10.60

10.65    

  Amended and Restated Promotion Agreement, dated as of December 16, 2001, by and among Immunex Corporation, American Home Products Corporation and Amgen Inc. (with certain confidential information deleted therefrom). (Filed as an exhibit to Amendment No. 1 to Form S-4 Registration Statement on March 22, 2002 and

65


incorporated herein by reference.)
10.61

10.66    

  Description of Amendment No. 1 to Amended and Restated Promotion Agreement, effective as of July 8, 2003, among Wyeth, Amgen Inc. and Immunex Corporation, (with certain confidential information deleted therefrom). (Filed as an exhibit to Form 10-K for the year ended December 31, 2003 on March 11, 2004 and incorporated herein by reference.)
10.62

10.67    

  Description of Amendment No. 2 to Amended and Restated Promotion Agreement, effective as of April 20, 2004, by and among Wyeth, Amgen Inc. and Immunex Corporation. (Filed as an exhibit to Form S-4/A on June 29, 2004 and incorporated herein by reference.)
10.63

10.68    

  Amendment No. 3 to Amended and Restated Promotion Agreement, effective as of January 1, 2005, by and among Wyeth, Amgen Inc. and Immunex Corporation (with certain confidential information deleted therefrom). (Filed as an exhibit to Form 10-Q for the quarter ended March 31, 2005 on May 4, 2005 and incorporated herein by reference.)
10.64Credit Agreement, dated as of July 16, 2004, among Amgen Inc., the Banks therein named, Citibank N.A., as Issuing Bank, Citicorp USA, Inc., as Administrative Agent, and Barclays Bank PLC, as Syndication Agent. (Filed as an exhibit to Form 10-Q for the quarter ended June 30, 2004 on August 6, 2004 and incorporated herein by reference.)
10.65First Amendment dated as of December 6, 2005, to the Credit Agreement dated as of July 16, 2004, among Amgen Inc., the Banks therein named, Citibank N.A., as Issuing Bank, Citicorp USA, Inc, as Administrative Agent, and Barclays Bank PLC, as Syndication Agent. (Filed as an exhibit to Form 8-K dated and filed on December 8, 2005 and incorporated herein by reference.)
10.66

10.69    

  Purchase Agreement, dated as of November 15, 2004, among Amgen Inc. and Morgan Stanley & Co. Incorporated and Merrill Lynch, Pierce, Fenner & Smith Incorporated, as representatives of the several initial purchasers. (Filed as an exhibit to Form 8-K on November 19, 2004 and incorporated herein by reference.)
10.67

10.70    

  Purchase Agreement, dated as of February 14, 2006, among Amgen Inc., Merrill Lynch, Pierce, Fenner & Smith Incorporated, Morgan Stanley & Co. Incorporated, Citigroup Global Markets Inc., JPMorganJP Morgan Securities, Inc., Lehman Brothers Inc, Bear, Stearns & Co. Inc., Credit Suisse Securities (USA) LLC. (Filed as an exhibit to Form 8-K on February 21, 2006 and incorporated herein by reference.)
10.68

10.71    

  Confirmation of OTC Convertible Note Hedge related to 2011 Notes, dated February 14, 2006, to Amgen Inc. from Merrill Lynch International related to the 0.125% Convertible Senior Notes Due 2011. (Filed as an exhibit to Form 10-K for the year ended December 31, 2005 on March 10, 2006 and incorporated herein by reference.)
10.69

10.72    

  Confirmation of OTC Convertible Note Hedge related to 2013 Notes, dated February 14, 2006, to Amgen Inc. from Merrill Lynch International related to 0.375% Convertible Senior Notes Due 2013. (Filed as an exhibit to Form 10-K for the year ended December 31, 2005 on March 10, 2006 and incorporated herein by reference.)
10.70

10.73    

  Confirmation of OTC Convertible Note Hedge related to 2011 Notes, dated February 14, 2006, to Amgen Inc. from Morgan Stanley & Co. International Limited related to the 0.125% Convertible Senior Notes Due 2011 Notes. (Filed as an exhibit to Form 10-K for the year ended December 31, 2005 on March 10, 2006 and incorporated herein by reference.)
10.71

10.74    

  Confirmation of OTC Warrant Transaction, dated February 14, 2006, to Amgen Inc. from Merrill Lynch International for warrants expiring in 2011. (Filed as an exhibit to Form 10-K for the year ended December 31, 2005 on March 10, 2006 and incorporated herein by reference.)

66


reference.)
10.72

10.75    

  Confirmation of OTC Warrant Transaction, dated February 14, 2006, to Amgen Inc. from Merrill Lynch International for warrants expiring in 2013. (Filed as an exhibit to Form 10-K for the year ended December 31, 2005 on March 10, 2006 and incorporated herein by reference.)
10.73

10.76    

  Confirmation of OTC Warrant Transaction, dated February 14, 2006, to Amgen Inc. from Morgan Stanley & Co. International Limited for warrants maturing in 2011. (Filed as an exhibit to Form 10-K for the year ended December 31, 2005 on March 10, 2006 and incorporated herein by reference.)
10.74

10.77    

  Purchase Agreement, dated February 16, 2006, between Amgen Inc. and Citigroup Global Markets Inc. (Filed as an exhibit to Form 10-K for the year ended December 31, 2005 on March 10, 2006 and incorporated herein by reference.)

10.78    

Purchase Agreement, dated May 24, 2007, among Amgen Inc., Morgan Stanley & Co. Incorporated, Merrill Lynch, Pierce, Fenner & Smith Incorporated and the Initial Purchasers Names in Schedule A thereof. (Filed as an exhibit to Form 10-Q for the quarter ended June 30, 2007 on August 9, 2007 and incorporated herein by reference.)

10.79    

Purchase Agreement, dated May 29, 2007, between Amgen Inc. and Merrill Lynch International. (Filed as an exhibit to Form 10-Q for the quarter ended June 30, 2007 on August 9, 2007 and incorporated herein by reference.)

10.80    

Collaboration Agreement, dated July 11, 2007, between Amgen Inc. and Daiichi Sankyo Company (with certain confidential information deleted therefrom). (Filed as an exhibit to Form 10-Q for the quarter ended September 30, 2007 on November 9, 2007 and incorporated herein by reference.)

10.81    

Credit Agreement, dated November 2, 2007, among Amgen Inc., with Citicorp USA, Inc., as administrative agent, Barclays Bank PLC, as syndication agent, Citigroup Global Markets, Inc. and Barclays Capital, as joint lead arrangers and joint book runners, and the other banks party thereto. (Filed as an exhibit to Form 8-K filed on November 2, 2007 and incorporated herein by reference).

10.82*  

Multi-product License Agreement with Respect to Japan between Amgen Inc. and Takeda Pharmaceutical Company Limited dated February 1, 2008 (with certain confidential information deleted therefrom).

10.83*  

License Agreement for motesanib diphosphate between Amgen Inc. and Takeda Pharmaceutical Company Limited dated February 1, 2008 (with certain confidential information deleted therefrom).

10.84*  

Supply Agreement between Amgen Inc. and Takeda Pharmaceutical Company Limited dated February 1, 2008 (with certain confidential information deleted therefrom).

10.85*  

Sale and Purchase Agreement between Amgen Inc. and Takeda Pharmaceutical Company Limited dated February 1, 2008 (with certain confidential information deleted therefrom).

31*

  Rule 13a-14(a) Certifications.

32**

  Section 1350 Certifications.

(* = filed herewith)

(*= filed herewith)

(** = furnished herewith and not “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended)

(**= furnished herewith and not “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended)

(+ = management contract or compensatory plan or arrangement.)

(+= management contract or compensatory plan or arrangement.)

 

6766