UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington D.C. 20549


Form 10-Q


(Mark One)

(Mark One)

x

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

For the quarterly period ended March 31, 2007

OR

 

¨

For the quarterly period ended September 30, 2006

OR

o

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

Commission file number 000-12477


Amgen Inc.

(Exact name of registrant as specified in its charter)


Delaware

Delaware95-3540776

(State or other jurisdiction

of incorporation or organization)

(I.R.S. Employer

Identification No.)

incorporation or organization)

Identification No.)

One Amgen Center Drive,

Thousand Oaks, California

91320-1799

(Address of principal executive offices)

(Zip Code)

(805) 447-1000

(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  o¨

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

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

Accelerated filer o

Non-accelerated filer o

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

As of October 20, 2006,April 16, 2007, the registrant had 1,166,518,4561,159,644,524 shares of common stock, $0.0001 par value, outstanding.

 





AMGEN INC.

INDEX

Page No.

PART I FINANCIAL INFORMATION

PART I

FINANCIAL INFORMATION

Item 1.

Item 1.

Financial Statements

1

Condensed Consolidated Statements of Operations –
Three and nine months ended September 30,March 31, 2007 and 2006 and 2005

2

Condensed Consolidated Balance Sheets –
September 30, 2006 March 31, 2007 and December 31, 20052006

3

Condensed Consolidated Statements of Cash Flows –
Nine Three months ended September 30,March 31, 2007 and 2006 and 2005

4

Notes to Condensed Consolidated Financial Statements

5

Item 2.

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

20

12

Item 4.   

Item 4.

Controls and Procedures

39

30

PART II

OTHER INFORMATION

Item 1.

Legal Proceedings

40

31

Item 1A.

Risk Factors

43

34

Item 2.

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

63

57

Item 6.

Exhibits

64

58

Signatures

65

59

Index to Exhibits

66

60

 

i





PART I - FINANCIAL INFORMATION

Item 1.                   Financial Statements

Item 1.FINANCIAL STATEMENTS

The information in this report for the three and nine months ended September 30,March 31, 2007 and 2006 and 2005 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, 2005.2006.

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


1


AMGEN INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(In millions, except per share data)

(Unaudited)

 

 

Three Months Ended

 

Nine Months Ended

 

 

 

September 30,

 

September 30,

 

 

 

2006

 

2005

 

2006

 

2005

 

Revenues:

 

 

 

 

 

 

 

 

 

Product sales

 

$

3,503

 

$

3,047

 

$

10,121

 

$

8,854

 

Other revenues

 

109

 

107

 

312

 

305

 

Total revenues

 

3,612

 

3,154

 

10,433

 

9,159

 

 

 

 

 

 

 

 

 

 

 

Operating expenses:

 

 

 

 

 

 

 

 

 

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

 

489

 

552

 

1,534

 

1,571

 

Research and development

 

872

 

562

 

2,315

 

1,653

 

Selling, general and administrative

 

807

 

656

 

2,336

 

1,879

 

Write-off of acquired in-process research and development

 

 

 

1,101

 

 

Amortization of acquired intangible assets

 

122

 

86

 

296

 

260

 

Legal settlements

 

 

 

 

49

 

Total operating expenses

 

2,290

 

1,856

 

7,582

 

5,412

 

 

 

 

 

 

 

 

 

 

 

Operating income

 

1,322

 

1,298

 

2,851

 

3,747

 

 

 

 

 

 

 

 

 

 

 

Interest and other income and (expense), net

 

39

 

14

 

140

 

10

 

 

 

 

 

 

 

 

 

 

 

Income before income taxes

 

1,361

 

1,312

 

2,991

 

3,757

 

 

 

 

 

 

 

 

 

 

 

Provision for income taxes

 

259

 

345

 

874

 

907

 

 

 

 

 

 

 

 

 

 

 

Net income

 

$

1,102

 

$

967

 

$

2,117

 

$

2,850

 

 

 

 

 

 

 

 

 

 

 

Earnings per share:

 

 

 

 

 

 

 

 

 

Basic

 

$

0.94

 

$

0.78

 

$

1.79

 

$

2.30

 

Diluted

 

$

0.94

 

$

0.77

 

$

1.77

 

$

2.26

 

 

 

 

 

 

 

 

 

 

 

Shares used in calculation of earnings per share:

 

 

 

 

 

 

 

 

 

Basic

 

1,167

 

1,233

 

1,181

 

1,238

 

Diluted

 

1,178

 

1,249

 

1,194

 

1,263

 

 

   Three Months Ended
March 31,
   2007  2006

Revenues:

   

Product sales

  $3,565  $3,127

Other revenues

   122   90
        

Total revenues

   3,687   3,217
        

Operating expenses:

   

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

   592   552

Research and development

   851   655

Selling, general and administrative

   770   689

Amortization of acquired intangible assets

   74   87
        

Total operating expenses

   2,287   1,983
        

Operating income

   1,400   1,234

Interest and other income and (expense), net

   (6)  80
        

Income before income taxes

   1,394   1,314

Provision for income taxes

   283   313
        

Net income

  $1,111  $1,001
        

Earnings per share:

   

Basic

  $0.95  $0.83

Diluted

  $0.94  $0.82

Shares used in calculation of earnings per share:

   

Basic

   1,167   1,202

Diluted

   1,177   1,218

See accompanying notes.


2


AMGEN INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(In millions, except per share data)

(Unaudited)

 

 

September 30,

 

December 31,

 

 

 

2006

 

2005

 

ASSETS

 

 

 

 

 

Current assets:

 

 

 

 

 

Cash and cash equivalents

 

$

1,291

 

$

1,840

 

Marketable securities

 

4,490

 

3,415

 

Trade receivables, net

 

2,124

 

1,769

 

Inventories

 

1,711

 

1,258

 

Other current assets

 

1,040

 

953

 

Total current assets

 

10,656

 

9,235

 

 

 

 

 

 

 

Property, plant, and equipment, net

 

5,673

 

5,038

 

Intangible assets, net

 

3,819

 

3,742

 

Goodwill

 

11,206

 

10,495

 

Other assets

 

1,232

 

787

 

 

 

$

32,586

 

$

29,297

 

 

 

 

 

 

 

LIABILITIES AND STOCKHOLDERS’ EQUITY

 

 

 

 

 

Current liabilities:

 

 

 

 

 

Accounts payable

 

$

569

 

$

596

 

Accrued liabilities

 

3,946

 

2,999

 

Convertible notes

 

1,773

 

 

Total current liabilities

 

6,288

 

3,595

 

 

 

 

 

 

 

Deferred tax liabilities

 

1,079

 

1,163

 

Convertible notes

 

5,000

 

1,759

 

Other long-term debt

 

2,233

 

2,198

 

Other non-current liabilities

 

265

 

131

 

 

 

 

 

 

 

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 - 1,166 shares in 2006 and 1,224 shares in 2005

 

23,500

 

23,561

 

Accumulated deficit

 

(5,789

)

(3,132

)

Accumulated other comprehensive income

 

10

 

22

 

Total stockholders’ equity

 

17,721

 

20,451

 

 

 

$

32,586

 

$

29,297

 

 

   March 31,
2007
  December 31,
2006
 
ASSETS   

Current assets:

   

Cash and cash equivalents

  $1,067  $1,283 

Marketable securities

   3,770   4,994 

Trade receivables, net

   2,157   2,124 

Inventories

   2,115   1,903 

Other current assets

   1,418   1,408 
         

Total current assets

   10,527   11,712 

Property, plant, and equipment, net

   6,027   5,921 

Intangible assets, net

   3,643   3,747 

Goodwill

   11,269   11,302 

Other assets

   1,104   1,106 
         
  $32,570  $33,788 
         
LIABILITIES AND STOCKHOLDERS’ EQUITY   

Current liabilities:

   

Accounts payable

  $601  $555 

Accrued liabilities

   3,906   4,589 

Convertible notes

   —     1,698 

Other long-term debt

   100   100 
         

Total current liabilities

   4,607   6,942 

Deferred tax liabilities

   466   367 

Convertible notes

   5,080   5,080 

Other long-term debt

   2,134   2,134 

Other non-current liabilities

   568   301 

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 

Accumulated deficit

   (4,638)  (5,203)

Accumulated other comprehensive income

   18   12 
         

Total stockholders’ equity

   19,715   18,964 
         
  $32,570  $33,788 
         

See accompanying notes.


3


AMGEN INC.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(In millions)

(Unaudited)

 

 

Nine Months Ended

 

 

 

September 30,

 

 

 

2006

 

2005

 

Cash flows from operating activities:

 

 

 

 

 

Net income

 

$

2,117

 

$

2,850

 

Write-off of acquired in-process research and development

 

1,101

 

 

Depreciation and amortization

 

763

 

623

 

Stock-based compensation expense

 

330

 

76

 

Tax benefits related to employee stock-based compensation

 

52

 

247

 

Other items, net

 

(177

)

(73

)

Cash provided by (used in) changes in operating assets and liabilities:

 

 

 

 

 

Trade receivables, net

 

(355

)

(203

)

Inventories

 

(378

)

(171

)

Other assets

 

(26

)

2

 

Accounts payable

 

(11

)

(10

)

Accrued income taxes

 

326

 

194

 

Other accrued liabilities

 

405

 

247

 

Net cash provided by operating activities

 

4,147

 

3,782

 

 

 

 

 

 

 

Cash flows from investing activities:

 

 

 

 

 

Cash paid for acquisition of Abgenix, Inc., net of cash acquired

 

(1,888

)

 

Purchases of property, plant, and equipment

 

(834

)

(602

)

Proceeds from maturities of marketable securities

 

858

 

519

 

Proceeds from sales of marketable securities

 

2,052

 

9,373

 

Purchases of marketable securities

 

(3,981

)

(9,028

)

Other

 

(136

)

41

 

Net cash (used in) provided by investing activities

 

(3,929

)

303

 

 

 

 

 

 

 

Cash flows from financing activities:

 

 

 

 

 

Repurchases of common stock (see Notes 5 and 6)

 

(1,755

)

(3,194

)

Repayment of debt assumed in Abgenix, Inc. acquisition

 

(653

)

 

Repayment of convertible notes

 

 

(1,175

)

Proceeds from issuance of convertible notes and related transactions, net (see Note 5)

 

440

 

 

Proceeds from issuance of warrants (see Note 5)

 

774

 

 

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

 

367

 

924

 

Other

 

60

 

(15

)

Net cash used in financing activities

 

(767

)

(3,460

)

 

 

 

 

 

 

(Decrease) increase in cash and cash equivalents

 

(549

)

625

 

 

 

 

 

 

 

Cash and cash equivalents at beginning of period

 

1,840

 

1,526

 

 

 

 

 

 

 

Cash and cash equivalents at end of period

 

$

1,291

 

$

2,151

 

 

   Three Months Ended
March 31,
 
   2007  2006 

Cash flows from operating activities:

   

Net income

  $1,111  $1,001 

Depreciation and amortization

   244   219 

Other items, net

   193   78 

Changes in operating assets and liabilities:

   

Trade receivables, net

   (33)  (25)

Inventories

   (201)  (2)

Other assets

   (7)  8 

Accounts payable

   46   (136)

Accrued income taxes

   (270)  373 

Other accrued liabilities

   (190)  (333)
         

Net cash provided by operating activities

   893   1,183 
         

Cash flows from investing activities:

   

Cash restricted for acquisition of Abgenix, Inc.

   —     (2,100)

Purchases of property, plant, and equipment

   (325)  (225)

Proceeds from maturities of marketable securities

   135   251 

Proceeds from sales of marketable securities

   2,296   344 

Purchases of marketable securities

   (1,191)  (481)

Other

   12   11 
         

Net cash provided by (used in) investing activities

   927   (2,200)
         

Cash flows from financing activities:

   

Repurchases of common stock

   (537)  (386)

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 

Other

   65   8 
         

Net cash (used in) provided by financing activities

   (2,036)  924 
         

Decrease in cash and cash equivalents

   (216)  (93)

Cash and cash equivalents at beginning of period

   1,283   1,840 
         

Cash and cash equivalents at end of period

  $1,067  $1,747 
         

See accompanying notes.

4





AMGEN INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

September 30, 2006March 31, 2007

(Unaudited)

1. Summary of significant accounting policies

Business

Amgen 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 and nine months ended September 30,March 31, 2007 and 2006 and 2005 is unaudited but includes all adjustments (consisting only of normal recurring accruals, unless otherwise indicated), which we consider 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.

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)(“FIFO”) method. Inventories consisted of the following (in millions):

 

September 30,

 

December 31,

 

 

 

2006

 

2005

 

Raw materials

 

$

200

 

$

145

 

Work in process

 

1,054

 

758

 

Finished goods

 

457

 

355

 

 

 

$

1,711

 

$

1,258

 

 


   March 31,
2007
  December 31,
2006

Raw materials

  $227  $205

Work in process

   1,259   1,090

Finished goods

   629   608
        
  $2,115  $1,903
        

5


AMGEN INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS- (Continued)

Intangible assets and goodwill

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 September 30, 2006)March 31, 2007). Intangible assets primarily consist of acquired product technology rights of $3,177$3,030 million, net of accumulated amortization of $1,238$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 accompanying Condensed Consolidated Statements of Operations. Intangible assets also include technology used in research and development (“R&D”) with alternative future uses specifically(“acquired R&D technology rights”), primarily the XenoMouse®XenoMouse® technology acquired in the Abgenix, Inc. (“Abgenix”) acquisition (see Note 8, “Abgenix, Inc. acquisition”).acquisition. Amortization of the XenoMouse®acquired R&D technology rights is included in “Research and development” in the accompanyingCondensed 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. During the three months ended September 30, 2006, we recognized a $49 million impairment charge related to a non-Enbrel® related intangible asset previously acquired in the Immunex acquisition, which is included in “Amortization of acquired intangible assets” in the accompanying Condensed Consolidated Statements of Operations.

 

Weighted-average

 

September 30,

 

December 31,

 

Intangible assets subject to amortization

 

amortization period

 

2006

 

2005

 

Acquired product technology rights:

 

 

 

 

 

 

 

Developed product technology

 

15 years

 

$

2,877

 

$

3,077

 

Core technology

 

15 years

 

1,348

 

1,348

 

Trade name

 

15 years

 

190

 

190

 

XenoMouse® technology

 

5 years

 

320

 

 

Other intangible assets

 

11 years

 

454

 

335

 

 

 

 

 

5,189

 

4,950

 

Less accumulated amortization

 

 

 

(1,370

)

(1,208

)

 

 

 

 

$

3,819

 

$

3,742

 

 

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. The increase over the balance at December 31, 2005 is due to the goodwill associated with the Abgenix acquisition on April 1, 2006 (see Note 8, “Abgenix, Inc. acquisition”) net of the decrease primarily due to tax benefits realized upon exercise of Immunex related stock options during the nine months ended September 30, 2006. We perform an impairment test annually and whenever events or changes in circumstances indicate that the carrying amount of goodwill may not be recoverable.


6


AMGEN INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS- (Continued)

Product sales

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

Sales of our products are recognized when shipped and title and risk of loss have passed. Product sales are recorded net of accruals 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®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”), 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 & Johnson and do recognize the product sales made by Johnson & Johnson into our exclusive 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, are primarily comprised of costs for:and expenses for salaries and benefits associated with R&D personnel,personnel; overhead and occupancy,occupancy; clinical trial and related clinical manufacturing, including contract services and other outside costs, process development and quality assurance,assurance; information systems and amortization of technology used in R&D with alternative future uses. R&D expenses also include such costs related to activities performed on behalf of corporate partners.

Acquired in-process research and development

The fair value of acquired in-process R&D (“IPR&D”) projects and technologies which have no alternative future use and which have not reached technological feasibility at the date of acquisition are immediately expensed. In the second quarter of 2006 we expensed $1,101 million of acquired IPR&D related to the Abgenix acquisition (see Note 8, “Abgenix, Inc. acquisition”). Acquired IPR&D is considered part of total R&D expense.

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 stock optioncompensation plans and potential issuancesissuance of stock under


our other equity incentive plans and underupon the assumed conversion of our 2032 Modified Convertible Notes, 2011 Convertible Notes, 2013 Convertible Notes and underupon the assumed exercise of our warrants using the treasury stock method (collectively “Dilutive Securities”). Potential common shares also include common stock to be issued upon conversionThe convertible note hedges purchased in connection with the issuance of our 20322011 Convertible Notes underand 2013 Convertible Notes are excluded from the if-converted method. For further information regarding our convertible notes and warrants (see Note 5, “Financing arrangements”).calculation of diluted EPS as their impact is always anti-dilutive.

7


AMGEN INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS- (Continued)

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

 

 

Three Months Ended

 

Nine Months Ended

 

 

 

September 30,

 

September 30,

 

 

 

2006

 

2005

 

2006

 

2005

 

Income (Numerator):

 

 

 

 

 

 

 

 

 

Net income for basic EPS

 

$

1,102

 

$

967

 

$

2,117

 

$

2,850

 

Adjustment for interest expense on 2032 Convertible Notes, net of tax

 

 

 

 

6

 

Net income for diluted EPS, after assumed conversion

 

$

1,102

 

$

967

 

$

2,117

 

$

2,856

 

 

 

 

 

 

 

 

 

 

 

Shares (Denominator):

 

 

 

 

 

 

 

 

 

Weighted-average shares for basic EPS

 

1,167

 

1,233

 

1,181

 

1,238

 

Effect of Dilutive Securities

 

11

 

15

 

13

 

12

 

Effect of 2032 Convertible Notes, after assumed conversion

 

 

1

 

 

13

 

Weighted-average shares for diluted EPS

 

1,178

 

1,249

 

1,194

 

1,263

 

 

 

 

 

 

 

 

 

 

 

Basic earnings per share

 

$

0.94

 

$

0.78

 

$

1.79

 

$

2.30

 

Diluted earnings per share

 

$

0.94

 

$

0.77

 

$

1.77

 

$

2.26

 

 

   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.

Recent Accounting Pronouncements

Effective January 1, 2006, we adopted the fair value recognition provisions of Statement of Financial Accounting Standards (“SFAS”) No. 123(R), “Share-Based Payment,” using the modified-prospective-transition method. See Note 2, “Employee stock-based payments” for further discussion regarding this accounting pronouncement.

In JuneJuly 2006, the Financial Accounting Standards Board (“FASB”) issued FASB Interpretation No. (“FIN”) 48, “Accounting for Uncertainty in Income Taxes – an interpretation of FASB Statement No. 109” (“FIN 48”), which became effective for fiscal years beginning after December 15, 2006.us as of January 1, 2007. FIN 48 clarifies the accounting for uncertainty in income taxes by prescribing rules for recognition, measurement classification and disclosureclassification in our financial statements of tax positions taken or expected to be taken in a tax return. We are currently evaluating the provisions in

For tax benefits to be recognized under FIN 48, but have not yet determined its expected impact on us. We plana tax position must be more-likely-than-not to adopt this new standard onbe sustained upon examination by taxing authorities. 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.


Reclassifications

Certain prior period amounts have been reclassified2007, the gross amount of our liabilities for unrecognized tax benefits (“UTBs”) was approximately $945 million and accrued interest related to conform tothese UTBs totaled approximately $106 million. Included in the current period presentation.

2.             Employee stock-based payments

We have employee compensation plans under which various typesbalance is approximately $776 million of stock-based instruments are granted. These instruments, as more fully described below, principally include stock options, restricted stock (including restricted stock units) and performance units. AsUTBs (net of September 30, 2006, these plans provide for future grants and/or issuancesthe federal benefit on state taxes) that, if recognized, would affect our annual effective tax rate. The cumulative effect of up to approximately 43 million shares of common stock to our employees. Stock-based awards under our employee compensation plans are made with newly issued shares reserved for this purpose.

Prior to January 1, 2006, we accounted for our employee stock-based compensation underapplying the recognition and measurement principlesprovisions upon adoption of Accounting Principles Board Opinion (“APB”) No. 25, “Accounting for Stock Issued to Employees,” and related interpretations, as permitted by SFAS No. 123, “Accounting for Stock-Based Compensation.” Under the recognition principles of APB No. 25, compensation expense related to restricted stock and performance unitsFIN 48 was recognized in our financial statements. However, APB No. 25 generally did not require the recognition of compensation expense for our stock options because the exercise price of these instruments was generally equal to the market value of the underlying common stockmaterial.

FIN 48 also provides guidance on the datebalance sheet classification of grant, and the related number of shares granted were fixed at that point in time.

Effective January 1, 2006, we adopted the fair value recognition provisions of SFAS No. 123(R), “Share-Based Payment.” In addition to recognizing compensation expense related to restricted stock and performance units, SFAS No. 123(R) also requires us to recognize compensation expense related to the estimated fair value of stock options. We adopted SFAS No. 123(R) using the modified-prospective-transition method. Under that transition method, compensation expense recognized subsequent to adoption includes: (a) compensation costliabilities for all share-based payments granted prior to, but not yet vestedUTBs as of January 1, 2006, basedeither current or non-current depending on the values estimated in accordance with the original provisionsexpected timing of SFAS No. 123, and (b) compensation cost for all share-based payments granted subsequent to January 1, 2006, based on the grant-date fair values estimated in accordance with the provisions of SFAS No. 123(R). Consistent with the modified-prospective-transition method, our results of operations for prior periods have not been adjusted to reflect the adoption of SFAS 123(R).

As a result of recognizing compensation expense for stock options pursuant to the provisions of SFAS No. 123(R), our income before income taxes for the three and nine months ended September 30, 2006, was $50 million and $179 million lower, respectively, and our net income was $36 million and $124 million lower, respectively, than if we had continued to account for stock options under APB No. 25. In addition, both basic and diluted earnings per share for the three and nine months ended September 30, 2006 were $0.03 and $0.11 lower, respectively, than if we had continued to account for stock options under APB No. 25.


The following table reflects the components of stock-based compensation expense recognized in our Condensed Consolidated Statements of Operations for the three and nine months ended September 30, 2006 and 2005 (amounts in millions):

 

 

Three Months Ended

 

Nine Months Ended

 

 

 

September 30,

 

September 30,

 

 

 

2006

 

2005

 

2006

 

2005

 

Stock options

 

$

50

 

$

 

$

179

 

$

 

Restricted stock

 

17

 

13

 

42

 

35

 

Performance units

 

34

 

13

 

109

 

41

 

Total stock-based compensation expense, pre-tax

 

101

 

26

 

330

 

76

 

Tax benefit from stock-based compensation expense

 

(29

)

(8

)

(103

)

(23

)

Total stock-based compensation expense, net of tax

 

$

72

 

$

18

 

$

227

 

$

53

 

The above table does not reflect any stock option compensation for the three and nine months ended September 30, 2005 as we generally did not record stock option expense under APB No. 25, as previously discussed. The following table illustrates the effect on net income and earnings per share for the three and nine months ended September 30, 2005 if we had applied the fair value recognition provisions to our stock options as provided under SFAS No. 123 (in millions, except per share information):

 

Three Months Ended

 

Nine Months Ended

 

 

 

September 30, 2005

 

September 30, 2005

 

Net income

 

$

967

 

$

2,850

 

Stock-based compensation, net of tax

 

(46

)

(183

)

Pro forma net income

 

$

921

 

$

2,667

 

 

 

 

 

 

 

Earnings per share:

 

 

 

 

 

Basic

 

$

0.78

 

$

2.30

 

Impact of stock option expense

 

(0.03

)

(0.15

)

Basic - pro forma

 

$

0.75

 

$

2.15

 

 

 

 

 

 

 

Diluted

 

$

0.77

 

$

2.26

 

Impact of stock option expense

 

(0.03

)

(0.14

)

Diluted - pro forma

 

$

0.74

 

$

2.12

 

For purposes of this pro forma disclosure, the fair values of stock options were estimated using the Black-Scholes option valuation model and amortized to expense over the options’ vesting periods.


Employee stock option and restricted stock grants

Several of our equity-based compensation plans provide for grants of stock options to employees. The option exercise price is set at the closing price of our common stock on the date of grant, and the related number of shares granted is fixed at that point in time. These plans also provide for grants of restricted stock. Grants of these equity instruments generally vest/have restrictions which lapse over a three to five year period. In addition, stock option awards expire seven years from the date of grant. Eligible employees generally receive a grant of stock options and/or restricted stock annually with the number of shares and type of instrument generally determined by the employee’s salary grade and performance level. In addition, certain management and professional level employees typically receive a stock option grant upon commencement of employment. These stock-based plans provide for accelerated vesting/lapse of restrictions if there is a change in control as defined in the plans.

We use the Black-Scholes option valuation model to estimate the grant date fair value of employee stock options. The expected volatility reflects the consideration of the implied volatility in our publicly traded instruments during the period the option is granted. We believe implied volatility in these instruments is more indicative of expected future volatility than the historical volatility in the price of our common stock. Upon the adoption of SFAS No. 123(R) the expected life of the option is estimated using the “simplified” method as provided in Securities and Exchange Commission Staff Accounting Bulletin No. 107. Under this method, the expected life equals the arithmetic average of the vesting term and the original contractual term of the option. Prior to adoption of SFAS No. 123(R), we used historical data to estimate the expected life of the options. The risk-free interest rates for periods within the expected life of the option are based on the U.S. Treasury yield curve in effect during the period the options were granted.payments. Upon adoption of SFAS No. 123(R),FIN 48, we began using historical datareclassified approximately $240 million of UTBs from current income taxes payable to estimate forfeiture rates applied to the gross amount of expense determined using the option valuation model. Prior to adoption of SFAS No. 123(R), we recognized forfeitures as they occurred. There was no material impact upon adoption of SFAS No. 123(R) between these methods of accounting for forfeitures. The weighted-average assumptions used to estimate the fair value of the stock options using the Black-Scholes option valuation model were as follows for the nine months ended September 30:non-current liabilities.

 

2006

 

2005

 

Fair value of common stock

 

$

71.05

 

$

61.40

 

Fair value of stock options granted

 

$

21.84

 

$

17.93

 

Risk-free interest rate

 

4.8%

 

4.0%

 

Expected life (in years)

 

4.8

 

5.1

 

Expected volatility

 

24.3%

 

23.6%

 

Expected dividend yield

 

0%

 

0%

 


Stock option information with respect to our stock-based compensation plans during the nine months ended September 30, 2006 is as follows (options and dollars in millions, except per share amounts):

 

 

 

 

 

 

Weighted-

 

 

 

 

 

 

 

Weighted-

 

average

 

 

 

 

 

 

 

average

 

remaining

 

Aggregate

 

 

 

 

 

exercise

 

contractual

 

intrinsic

 

 

 

Options

 

price

 

life (Yrs)

 

value

 

Balance unexercised at December 31, 2005

 

67.6

 

$

56.03

 

 

 

 

 

Granted

 

10.3

 

$

71.04

 

 

 

 

 

Assumed from Abgenix (including 1.4 vested)

 

1.9

 

$

33.79

 

 

 

 

 

Exercised

 

(8.0

)

$

36.80

 

 

 

 

 

Forfeited/expired

 

(2.2

)

$

56.66

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance unexercised at September 30, 2006

 

69.6

 

$

59.86

 

3.9

 

$

837

 

 

 

 

 

 

 

 

 

 

 

Vested or expected to vest at September 30, 2006

 

66.0

 

$

59.55

 

3.9

 

$

812

 

 

 

 

 

 

 

 

 

 

 

Exercisable at September 30, 2006

 

41.8

 

$

56.83

 

3.0

 

$

619

 

 

The total intrinsic value of options exercised during the three and nine months ended September 30, 2006 was $43 million and $260 million, respectively.8

The fair values of shares of restricted stock are determined based on the closing price of Amgen common stock on the grant dates. Information regarding our restricted stock during the nine months ended September 30, 2006 is as follows (shares in millions):


AMGEN INC.

 

 

 

Weighted-

 

 

 

 

 

average

 

 

 

 

 

grant date

 

Nonvested shares

 

Shares

 

fair value

 

Nonvested at December 31, 2005

 

2.8

 

$

58.90

 

Granted

 

2.3

 

$

71.56

 

Vested

 

(0.8

)

$

59.23

 

Forfeited

 

(0.2

)

$

62.25

 

 

 

 

 

 

 

Nonvested at September 30, 2006

 

4.1

 

$

65.68

 

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS- (Continued)

 

The total fair value of shares of restricted stock that vested during the threeInterest and nine months ended September 30, 2006 was $4 million and $55 million, respectively.

As of September 30, 2006, there was $563 million of total unrecognized compensation costpenalties related to nonvested awards of both stock options and shares of restricted stock. That cost is expected to be recognized over a weighted-average period of 1.5 years. For stock option and restricted stock awards subject to graded vesting that were issued after January 1, 2006, we recognize compensation cost on a straight-line basis over the service period for the entire award.

12




Performance award program

Beginning in 2004, certain management-level employees receive annual grants of performance units. A performance unit gives the recipient the right to receive common stock that is contingent upon achievement of specified pre-established performance goals over a three-year performance period. The performance goals are based upon both Amgen’s standalone performance and its performance compared to other benchmark companies, in each case with respect to compound annual growth rates for revenue and earnings per share, as defined in the program. Performance units are assigned a unit value based on the fair market value of Amgen common stock on the grant date. The ultimate level of attainment of performance goals is determined at the end of the performance period and expressed as a percentage (within a range of 0% to 225%). This percentage is multiplied by the number of performance units initially granted and by the initial value per unit to determine the aggregate dollar value of the award. The aggregate dollar value is then divided by the average closing price of Amgen common stock during a specified period following the performance period to determine the number of shares of common stock payable to the recipient.

Because the first performance period for these instruments ends on December 31, 2006, no performance units have yet vested and no common stock has been issued to any recipient. As of September 30, 2006, there was $165 million of total estimated unrecognized compensation cost related to performance units that is expected to be recognized over a weighted-average period of 1.0 year.

Under APB No. 25, the estimated amounts owed for grants of performance units were classified in stockholders’ equity, but upon adoption of SFAS 123(R), these amountsUTBs are classified as liabilities. Accordingly, on January 1, 2006, a reclassification was made from stockholders’ equity to liabilities (current and non-current) totaling $104 million.component of our provision for income taxes.

3.2. Related party transactions

We own a 50% interest in Kirin-Amgen, Inc. (“KA”), a corporation formed in 1984 with Kirin Brewery 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. During the three and nine months ended September 30,March 31, 2007 and 2006, our share of KA’s profits were $15was $7 million and $43 million, respectively. During the three and nine months ended September 30, 2005, our share of KA’s profits were $13 million and $43$12 million, respectively. At September 30, 2006March 31, 2007 and December 31, 2005,2006, the carrying value of our equity method investment in KA was $223$248 million and $180$241 million, respectively, and is included in non-current other assets“Other assets” in the accompanying 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 erythropoietin,darbepoetin alfa, pegfilgrastim, granulocyte colony-stimulating factor (“G-CSF”), darbepoetin alfa and pegfilgrastimrecombinant human erythropoietin are pursuant to exclusive licenses from KA, which we currently


market certain of these products under the brand names EPOGEN®Aranesp®, NEUPOGEN®Neulasta®, Aranesp®NEUPOGEN® and Neulasta®EPOGEN®, respectively. KA receives royalty income from us, as well as Kirin, Johnson & Johnson and F. Hoffmann-La Roche LtdLtd. (“Roche”) under separate product license agreements for certain geographic areas outside of the United States. During the three and nine months ended September 30,March 31, 2007 and 2006, KA earned royalties from us of $82$85 million and $238$74 million, respectively. During the three and nine months ended September 30, 2005, KA earned royalties from us of $72 million and $215 million, respectively. These amountsrespectively, which are included in “Cost of sales (excludes amortization of acquired intangible assets)” in the Condensed Consolidated Statements of Operations.

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 and nine months ended September 30,March 31, 2007 and 2006, we earned revenues from KA of $35$56 million and $98$28 million, respectively, for certain R&D activities performed on KA’s behalf. During the three and nine months ended September 30, 2005, we earned revenues from KA of $34 million and $81 million, respectively. These amountsbehalf, which are included in “Other revenues” in the accompanying Condensed Consolidated Statements of Operations.

4.3. Income taxes

The tax ratesrate for the three and nine months ended September 30, 2006 areMarch 31, 2007 is different from the statutory rate primarily as a result of the favorable resolution of prior year federal and state audits and indefinitely invested earnings of our foreign operations. In addition, the tax rate for the nine months ended September 30, 2006 was impacted by the write-off of non-deductible acquired IPR&D in connection with the acquisition of Abgenix. The favorable impact of prior year tax matters recognized in the three months ended September 30, 2006 amounted to approximately $60 million, or $0.05 per diluted share. We do not provide for U.S. income taxes on undistributed earnings of our controlled foreign operationscorporations 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 Internal Revenue Service and various state and foreign tax authorities.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 periodically evaluateare no longer subject to U.S. federal income tax examinations for tax years ending on or before December 31, 2001 or to California state income tax examinations for tax years ending on or before December 31, 2003.

9


AMGEN INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS- (Continued)

The Internal Revenue Service (“IRS”) is currently examining our exposures associated withU.S. income tax filingreturns 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. WhileManagement 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 positions comply with applicable laws, we record liabilities based upon estimates offor unrecognized tax benefits may decrease by $350 million to $600 million within the ultimate outcomes of these matters.


next twelve months.

5.4. Financing arrangements

The following table reflects the carrying value of our long-term borrowings under our various financing arrangements as of September 30, 2006March 31, 2007 and December 31, 20052006 (in millions):

 

 

September 30,

 

December 31,

 

 

 

2006

 

2005

 

0.125% convertible notes due 2011 (2011 Convertible Notes)

 

$

2,500

 

$

 

0.375% convertible notes due 2013 (2013 Convertible Notes)

 

2,500

 

 

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

 

1,753

 

1,739

 

4.85% notes due 2014 (2014 Notes)

 

1,000

 

1,000

 

4.00% notes due 2009 (2009 Notes)

 

999

 

998

 

6.5% debt securities due 2007 (2007 Notes)

 

100

 

100

 

8.1% notes due 2097 (Century Notes)

 

100

 

100

 

Non-interest bearing note due 2013 (acquired Abgenix note)

 

34

 

 

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

 

20

 

20

 

Total borrowings

 

9,006

 

3,957

 

Less current portion

 

1,773

 

 

Total non-current debt

 

$

7,233

 

$

3,957

 

 

   March 31,
2007
  December 31,
2006

0.125% convertible notes due 2011 (2011 Convertible Notes)

  $2,500  $2,500

0.375% convertible notes due 2013 (2013 Convertible Notes)

   2,500   2,500

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

   80   1,778

4.85% notes due 2014 (2014 Notes)

   1,000   1,000

4.00% notes due 2009 (2009 Notes)

   999   999

Other

   235   235
        

Total borrowings

   7,314   9,012

Less current portion

   100   1,798
        

Total non-current debt

  $7,214  $7,214
        

2011 and 2013 Convertible Notes

In February 2006, we issued $2.5 billion principal amountOn March 2, 2007, as a result of convertible notes due in 2011 (the “2011 Convertible Notes”) and $2.5 billion principal amountcertain holders of convertible notes due in 2013 (the “2013 Convertible Notes”) in a private placement. The 2011the 2032 Modified Convertible Notes and the 2013 Convertible Notes were issued at par and pay interest at a rate of 0.125% and 0.375%, respectively. The 2011 Convertible Notes and the 2013 Convertible Notes may be convertible based on an initial conversion rate of 12.5247 shares and 12.5814 shares, respectively, per $1,000exercising their March 1, 2007 put option, we repurchased $2,253 million aggregate principal amount of notes (which represents an initial conversion price of approximately $79.84 and $79.48 per share, respectively). These conversion rates will be adjusted if we make specified types of distributions or enter into certain other transactions in respect to our common stock. The 2011 Convertible Notes and the 2013 Convertible Notes may only be converted: 1) during any calendar quarter beginning after June 30, 2006 if the closing price of our common stock exceeds 130% of the respective conversion price per share during a defined period at the end of the previous quarter, 2) if we make specified distributions to holders of our common stock or specified corporate transactions occur, or 3) one month prior to the respective maturity date. Upon conversion, a holder would receive the conversion value equal to the conversion rate multiplied by the volume weighted average price of our common stock during a specified period following the conversion date. The conversion value will be paid in: 1) cash equal to the lesser of the principal amount of the note or the conversion value, as defined, and 2) to the extent the conversion value exceeds the principal amount of the note, shares of our common stock, cash or a combination of common stock and cash, at our option (the “excess conversion value”). In addition, upon a change in control, as defined, the holders may require us to purchase for cash all or a portion of their notes for 100% of the principal amount of the notes plus accrued and unpaid interest, if any. Debt issuance costs totaled approximately $88 million and are being amortized over the life of the notes.


In connection with issuance of these convertible notes a totalfor their then-accreted value of $3.0 billion of our common stock was repurchased under our stock repurchase program. Also concurrent with the issuance$1,702 million in cash, representing approximately 96% of the 2011 Convertible Notes and the 2013 Convertible Notes, we purchased convertible note hedges in private transactions. The convertible note hedges allow us to receive sharesoutstanding balance of our common stock and/or cash from the counterparties to the transactions equal to the amounts of common stock and/or cash related to the excess conversion value that we would issue and/or pay to the holders of the 2011 Convertible Notes and the 2013 Convertible Notes upon conversion. These transactions will terminate at the earlier of the maturity dates of the related notes or the first day none of the related notes remain outstanding due to conversion or otherwise. The cost of the convertible note hedges aggregated approximately $1.5 billion. The net proceeds received from the issuance of the 2011 and 2013 Convertible Notes,these notes. Upon the repurchase of our common stock and the purchase of the convertible note hedges was $440 million.

Also concurrent with the issuance of the 2011 Convertible Notes and the 2013 Convertible Notes, we sold warrants to acquire shares of our common stock at an exercise price of $107.90 per share in a private placement. Pursuant to these transactions, warrants for approximately 31.3 million shares of our common stock may be settled in May 2011 and warrants for approximately 31.5 million shares of our common stock may be settled in May 2013 (the “settlement dates”). If the average price of our common stock during a defined period ending on or about the respective settlement dates exceeds the exercise price of the warrants, the warrants will be settled, at our option, in cash or shares of our common stock. Proceeds received from the issuance of the warrants totaled approximately $774 million.

Because we have the choice of settling the convertible note hedges and warrants in cash or shares of our stock, and these contracts meet all of the applicable criteria for equity classification as outlined in EITF No. 00-19, “Accounting for Derivative Financial Instruments Indexed to, and Potentially Settled in, a Company’s Own Stock,” the cost of the convertible note hedges and net proceeds from the sale of the warrants are classified in stockholders’ equity. In addition, because both of these contracts are classified in stockholders’ equity and are indexed to our own common stock, they are not accounted for as derivatives under SFAS No. 133, “Accounting for Derivative Instruments and Hedging Activities.”

2032 Convertible Notes and 2032 Modified Convertible Notes

In 2002, we issued zero coupon, 30 year convertible notes (“2032 Convertible Notes”). In March 2005, certain of these notes, a pro rata portion, $51 million, of deferred financing and related costs were repurchased at their then accreted value, for cash, in accordance with their terms. Subsequently, inimmediately charged to interest expense during the three months ended March and August, of 2005, we modified the terms of substantially all of the remaining 2032 Convertible Notes (“2032 Modified Convertible Notes”). Pursuant to the terms of the 2032 Convertible Notes and 2032 Modified Convertible Notes, as amended, holders of such notes may require us to purchase on specific dates all or some of their notes generally for cash. The next specified date when holders can require us to repurchase some or all of their notes at their then accreted value is on March 1,31, 2007. Accordingly, the notes are classified as current liabilities in the accompanying Condensed Consolidated Balance Sheet as of September 30, 2006.


10


6.AMGEN INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS—(Continued)

5. Stockholders’ equity

Stock repurchase programprograms

A summary of activity under our stock repurchase programprograms for the ninethree months ended September 30,March 31, 2007 and 2006 and 2005 is as follows (in millions):

 

2006

 

2005

 

 

 

Shares

 

Dollars

 

Shares

 

Dollars

 

First quarter

 

46.7

 

$

3,374

 

26.8

 

$

1,675

 

Second quarter

 

13.0

 

876

 

12.1

 

750

 

Third quarter

 

7.3

 

505

 

9.5

 

769

 

Total

 

67.0

 

$

4,755

 

48.4

 

$

3,194

 

 

   2007  2006
   Shares  Dollars  Shares  Dollars

First quarter

  8.8  $537  46.6  $3,374

As of September 30, 2006, $1,784March 31, 2007, $6,002 million was available for stock repurchases under our stock repurchase programprograms authorized by the Board of Directors in December 2005. Directors. 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 may include private block purchases as well as market transactions.

Stockholder Rights Agreement

On July 11, 2006, Amgen’s board of directors voted unanimously to terminate our preferred stock rights plan. The plan was originally scheduled to expire on December 12, 2010, but was amended to accelerate the expiration date to July 31, 2006.

Comprehensive income

Our comprehensive income includes net income, unrealized gains 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. During the three and nine months ended September 30,March 31, 2007 and 2006, total comprehensive income was $1,128$1,117 million and $2,105 million, respectively. During the three and nine months ended September 30, 2005, total comprehensive income was $953 million and $2,864$972 million, respectively.

7.6. Contingencies

In the ordinary course of business, we are involved in various legal proceedings and other matters, including those that are tax-related. 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.


8.             Abgenix, Inc. acquisition

On April 1, 2006, we acquired all of the outstanding common stock of Abgenix, a company that specialized in the discovery, development and manufacture of human therapeutic antibodies. We paid cash consideration of $22.50 per share in this transaction that was accounted for as a business combination. Additionally, we issued 1.9 million stock options in exchange for Abgenix stock options assumed in the acquisition, 1.4 million of which were vested at the date of acquisition. The purchase price was as follows (in millions):

Cash paid for shares

 

$

2,103

 

Other, principally fair value of vested options assumed

 

92

 

Total

 

$

2,195

 

 

The purchase price was preliminarily allocated to all of the tangible and intangible assets acquired, including acquired IPR&D, and liabilities assumed based on their estimated fair values at the acquisition date. The excess of the purchase price over the fair values of assets and liabilities acquired was assigned to goodwill. The following table summarizes the estimated fair values at the acquisition date (in millions):11

In-process research and development

 

$

1,101

 

Identifiable intangible asset

 

320

 

Cash

 

252

 

Deferred tax assets, net

 

258

 

Property, plant and equipment

 

220

 

Other assets

 

76

 

Liabilities, principally convertible debt

 

(762

)

Goodwill

 

730

 

Net assets acquired

 

$

2,195

 

The preliminary estimated fair values of IPR&D, the identifiable intangible asset and property, plant and equipment were determined with the assistance of an independent valuation firm. The estimated fair values of the intangible assets were determined based upon discounted after-tax cash flows adjusted for the probabilities of successful development and commercialization. The final determination of the purchase price allocation is expected to be completed as soon as practicable. The identifiable intangible asset consists of Abgenix’s XenoMouse® technology that has alternative future uses in our R&D activities and will be amortized over its 5-year estimated useful life. The amount preliminarily allocated to IPR&D was immediately expensed in the Condensed


Consolidated Statement of Operations during the three months ended June 30, 2006 (see Note 1, “Summary of significant accounting policies – Acquired in process-research and development”). The results of Abgenix’s operations have been included in the Condensed Consolidated Financial Statements commencing April 1, 2006. Pro forma results of operations for the three and nine months ended September 30, 2006 assuming the acquisition of Abgenix had taken place at the beginning of 2006 would not differ significantly from actual reported results.

9.             Subsequent events

On October 24, 2006, we completed the acquisition of Avidia, Inc. (“Avidia”). Avidia was a privately held biopharmaceutical company focused on the discovery and development of a new class of human therapeutic known as Avimer™ proteins. Pursuant to the merger agreement, we paid in cash approximately $290 million, net of cash acquired and our existing equity stake in Avidia, and may be subject to pay additional amounts upon the achievement of certain future events. Avidia’s operations will be included in our Condensed Consolidated Financial Statements commencing October 24, 2006. In connection with the acquisition, which will be accounted for as a business combination, we will expense the estimated fair value of Avidia’s acquired IPR&D during the three months ended December 31, 2006. The purchase price allocation has not been finalized at this time.

19




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

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

Forward looking statements

This report and other documents we file with the Securities and Exchange Commission (“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 “Item 1A. Risk 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, earnings per share (“EPS”),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 discussion and analysis (“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 Statements and accompanying notes included in this Quarterly Report on Form 10-Q and our Consolidated Financial Statements and accompanying notes included in our Annual Report on Form 10-K for the year ended December 31, 2005.2006.

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 inflammation, nephrology and supportive cancer care. Also,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, however we do not expect product sales of Vectibix™ to be significant for the remainder of 2006.therapeutic. For the three and nine months ended September 30, 2006,March 31, 2007, total revenues were $3.6$3.7 billion and $10.4 billion, respectively. For the three and nine months ended September 30, 2006, net income was $1.1 billion and $2.1 billion, respectively, or


$0.94 $0.94 per share and $1.77 per share, respectively.share. The results of our operations for the nine months ended September 30, 2006 reflect the $1.1 billion write-off of acquired in-process research and development (“IPR&D”) costs associated with the Abgenix, Inc. (“Abgenix”) acquisition recorded in the three months ended June 30, 2006.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 September 30, 2006,March 31, 2007, cash, cash equivalents and marketable securities were $5.8 $4.8

12


billion, of which approximately $4.7$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 $9.0$7.3 billion as of September 30, 2006.March 31, 2007.

Our principal products include Aranesp® (darbepoetin alfa)Aranesp®, EPOGEN® (Epoetin alfa)EPOGEN®, Neulasta® (pegfilgrastim)Neulasta®/NEUPOGEN® (Filgrastim)NEUPOGEN® and Enbrel® (etanercept).ENBREL, all of which are sold in the United States. ENBREL is marketed under a co-promotion agreement with Wyeth in the United States and Canada. For additional information about our principal products, their approved indicationsOur international product sales consist principally of European sales of Aranesp® and 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, 2005. For the three and nine months ended September 30, 2006 and 2005,Neulasta®/NEUPOGEN®. International product sales represented 97%approximately 19% and 18% of total revenues. Over the last several years, our product sales growth has been primarily driven by salesfor each of Aranesp®, ENBRELthe three months ended March 31, 2007 and Neulasta®, which have benefited primarily from share gains and/or segment growth. We expect these products to continue to drive year over year sales growth for the remainder of 2006. However, we expect that maintaining or increasing share will be more of a challenge than in previous years as we operate in an increasingly competitive environment and we have experienced share loss with ENBREL. Going forward, we will focus on growing our segments, including increasing our penetration in the therapeutic areas in which our products are used, while also continuing to focus on segment share. Our principal products have attained significant sales levels, and for certain of our products, in a relatively short period of time. As a result, although we have experienced significant year over year sales growth, in the near term we expect our product sales growth to be lower than that achieved in the past several years. Furthermore, various factors can influence sales growth on a sequential quarterly basis, such as wholesaler and end-user inventory management practices and fluctuations in foreign exchange rates. For example, wholesaler buying patterns in advance of holidays may result in higher sequential quarterly sales growth for the quarters ending June 30 and December 31.

2006, respectively. Most patients receiving our principal products for approved indications are covered by either government or private payer health care programs. Beginning in the first quarterTherefore, sales of 2006, ENBREL and Sensipar® (cinacalcet HCl) also became eligible for coverage from the U.S. Government under Medicare Program Part D. Therefore, our principal product salesproducts 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 payer reimbursement policies. While we believe thatinsurance plans and administration of those programs. For additional information about our product sales for 2005principal products, their approved indications and the nine months ended September 30, 2006 have not been nor,where they are marketed, see “Item 1. Business – Principal products” in Part I of our Annual Report on Form 10-K for the remainder of 2006, are expected to be significantly impacted by the reimbursement changes resulting from the Medicare Prescription Drug Improvement and Modernization Act (or the “Medicare Modernization Act” (“MMA”)) enacted in 2005, 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. See “Reimbursement” below for further information.year ended December 31, 2006.

International product sales represented approximately 18% of total product sales for each of the three and nine month periods ended September 30, 2006 and 2005. Our international product sales consist principally of European sales of Aranesp® and Neulasta®/NEUPOGEN® and were favorably impacted by approximately $16 million forFor the three months ended September 30,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 of Aranesp®, Neulasta® and ENBREL, which have benefited primarily from foreign currency changes but were unfavorably impactedsegment 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 approximately $39 million (see “ResultsAmgen, including our Anemia of Operations” discussion below)Cancer phase 3 study (the “AoC 103 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”). Thereafter, nearly all Medicare contractors have stopped reimbursing for Aranesp® use in AoC patients. Further, on March 9, 2007, based upon data from our AoC 103 Study and other third-party studies, the FDA approved updated safety information, including a boxed warning, in the prescribing information for the nineclass of ESAs, including Aranesp® and EPOGEN®. The label changes and the loss of substantially all of the Medicare coverage for Aranesp® in AoC could materially impact future product sales, as applicable, for Aranesp® and EPOGEN®. Sales growth slowed for Aranesp® in the United States in the latter part of the three months ended September 30, 2006. March 31, 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.

13


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”) 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 invited us to participate in the Oncologic Drugs Advisory Committee (“ODAC”) meeting on May 10, 2007 to review progress in delineating the effects of ESAs on survival and tumor progression in cancer patients. Further, the European Medicines Agency (“EMEA”) has also reported that it is reviewing the safety of ESAs, made by us, Johnson & Johnson, Shire Pharmaceutical Group plc (“Shire”) and Roche. The following could impact future EPOGEN® sales: CMS has stated that the agency is currently reviewing the Claims Monitoring Policy: Erythropoietin/darbepoetin alfa usage for beneficiaries with end stage renal disease (“EMP”) for patients with end stage renal disease (“ESRD”) who are dialyzed in renal facilities although they have not yet announced further changes to the EMP. Additionally, on April 12, 2007 after a review of existing guidelines, the National Kidney Foundation (“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”), which we are currently reviewing to assess the potential impact on future sales of EPOGEN®. The potential impact of these key events on future sales for Aranesp® and EPOGEN®, as applicable, is highly uncertain and currently not determinable.

Our anemia products 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 in the U.S. nephrology segment in 2007, upon regulatory approval, despite our ongoing lawsuit 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. Further, in the first quarter of 2007, Shire received approval in the EU for Dynepo™ (Epoetin delta), a competing erythropoietin product. Additionally, 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 helped to grow both the positiverheumatology and negative impacts that movementsdermatology segments, they have also resulted in foreign exchange rates have on our


ENBREL experiencing share loss in both of these segments.

international product sales are mitigated, in part, by the natural, opposite impact these exchange rate movements have on our international operating expenses andFurther, as a result of safety concerns related to patient survival, we recently announced that we had discontinued Vectibix™ treatment in our foreign currency hedging activities. Our hedging activities seekPanitumumab Advanced Colorectal Cancer Evaluation (“PACCE”) trial, a non-registration-enabling trial evaluating the addition of Vectibix™ to offsetstandard chemotherapy and Avastin® (bevacizumab) for the impact, both positivetreatment of first-line metastatic colorectal cancer. We are in discussions with the FDA with respect to the Vectibix™ label and negative, expect

14


that foreign exchange rate changes may have on our net income. As such,we will add the impactdata from the PACCE trial to our netthe 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 operations from changesthe PACCE trial do not influence ongoing registrational studies in foreign currency exchange ratescombination 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 been largely mitigated.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 and nine months ended September 30,March 31, 2007 and 2006, and 2005, operating income was as follows:follows (in millions):

(Amounts in millions)

 

Three Months Ended
September 30,

 

 

 

Nine Months Ended
September 30,

 

 

 

 

 

2006

 

2005

 

Change

 

2006

 

2005

 

Change

 

Operating Income

 

$

1,322

 

$

1,298

 

2%

 

$

2,851

 

$

3,747

 

(24)%

 

 

   Three Months
Ended March 31,
    
   2007  2006  Change 

Operating Income

  $1,400  $1,234  13%

Operating income as a percentage of product sales was 38% and 43%39% for both the three months ended September 30, 2006March 31, 2007 and 2005, respectively. The2006. As a result of the impact 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 operating income as a percentage of product sales for the three months ended September 30, 2006 compared to the three months ended September 30, 2005 primarily reflects the increase in research and development (“R&D”) expenses. For the nine months ended September 30, 2006 and 2005, operating income as a percentage of product sales was 28% and 42%, respectively. The decline in operating income for the nine month period ended September 30, 2006 largely reflects the write-off of acquired IPR&D of $1.1 billion in connection with the Abgenix acquisition.revenues.

We focus our R&D on novel human therapeutics for the treatment of grievous illness. We have substantially expanded and will need to continue to significantly expand our clinical development resources, including human capital,R&D capabilities to manage and execute increasingly larger and more complex clinical trials. Throughout 2006,trials and to build the capacity to advance more compounds into and through the clinic. In the near term, we haveexpect to see further growth in R&D expense in 2007, but not to the same extent experienced a significant increase in the number, size, duration and complexity of our clinical trials, in particular with respect to denosumab, our late-stage investigational product for osteoporosis and metastatic bone cancer.2006. For example, testing denosumabthe nine “mega-site” trials, which we began in the osteoporosis setting requires large clinical trials, substantial2006, will continue to require significant time, and resources to recruit patients and significant expense to execute. We have begun nine “mega-site” trials (involving 200 or more sites) in 2006 to support denosumab and our other late-stage programs. (Two additional “mega-site” trials associated with our late-stage program for AMG 706, specifically the Phase 3 studies in first line breast cancer and first line non-small cell lung cancer, previously expected to begin in the fourth quarter of 2006 have been delayed subject to additional Phase 1 and 2 data and protocol modificationsHowever, as a result of observing an increased frequency of cholecystitis, inflammation ofrecent regulatory and reimbursement challenges related to Aranesp® and EPOGEN®, we have been and will continue to assess the gall bladder, in patients treated with this late stage product candidate. See “Item 1A. Risk Factors in Part II herein — Before we commercialize and sell anyoptimal level of our product candidates,R&D investment. To the extent future sales of Aranesp® and EPOGEN® are negatively impacted as a result of these recent events, we must conductmay defer or possibly cancel previously planned clinical trials in humans; if we failorder to adequately manage these trials we may not be able to sell future products andadjust our sales could be adversely affected.”) To execute our clinical trial programs, we need to continue to accelerate the growth of our development organization and associated R&D support organizations, implement new management structures and approaches and increase dependence on third-party contract clinical trial providers. Further,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.


On April 1, 2006, we paid shareholders of Abgenix $22.50 in cash per common share for a total value of approximately $2.1 billion to acquire all of the shares and assumed Abgenix’s outstanding debt with a fair value of approximately $686 million. Abgenix specialized in the discovery, development and manufacture of human therapeutic antibodies and was our co-development partner for Vectibix™ (panitumumab). The results of Abgenix’s operations have been included in our Condensed Consolidated Financial Statements commencing April 1, 2006.

On October 24, 2006, we completed our acquisition of Avidia, Inc (“Avidia”). Pursuant to the merger agreement, we paid in cash approximately $290 million, net of cash acquired and our existing equity stake in Avidia, and may be subject to pay additional amounts upon the achievement of certain future events. Avidia focused on the discovery and development of a new class of human therapeutic known as Avimer™ proteins. The transaction provides Amgen with Avidia’s lead product candidate, an inhibitor of interleukin 6 (IL-6) for the treatment of inflammation and autoimmune diseases, which is in Phase 1 clinical trials.

There are many economic and industry-wide factors that affect our business generally and uniquely, including, among others, those relating to broad reimbursement changes, increased complexity and cost of R&D andue, 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; increasingly competitive environmentintense competition for our currently marketed products and product candidates including the expected introduction of biosimilar products in Europe,candidates; broad reimbursement changes; complex and expanding regulatory requirementsrequirements; and intellectual property protection. See “Item 1. Business” in Part I of our Annual Report on Form 10-K for the year ended December 31, 20052006 and “Item 1A. Risk Factors” in Part II herein for further information on these economic and industry-wide factors and their impact and potential impact on our business.

15


Reimbursement

InSales of all of our principal products are dependent, in part, on the United States, dialysis providers are primarily reimbursed for EPOGEN® by the federal government through the End Stage Renal Disease Program (“ESRD Program”)availability and extent of Medicare. The ESRD Program reimburses approved providers for 80% of allowed dialysis costs; the remainder is paid by other sources,reimbursement from third-party payers, including patients, state Medicaid programs,governments and 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 the Centers for Medicare & Medicaid Services (“CMS”). Most patients receiving Aranesp®, Neulasta® and NEUPOGEN® for approved indications are covered by both government and private payer health care programs. Since January 1, 2006, ENBREL and Sensipar® are 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.plans. Generally, in Europe and other countries outside the U.S.,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.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 health carehealthcare providers in response to ongoing initiatives to reduce health carehealthcare expenditures. Therefore, sales of allFurther, adverse events or results from clinical trials or studies performed by us or by others or from the marketed use of our principaldrugs 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 dependent, in part, on the availabilitymarket. and extent“—Guidelines and recommendations published by various organizations can reduce the use of reimbursement from third-party payers, including governmentsour products.”)

Most patients receiving Aranesp®, Neulasta® and NEUPOGEN® for approved indications are covered by both government and private insurance plans.


The MMApayer healthcare programs. Government healthcare programs are governed by the Medicare Prescription Drug Improvement and Modernization Act (the “MMA”) which was enacted into law in December 2003 and implementedbecame effective January 1, 2005. Changes resulting from the MMA, which lowered reimbursement for our products, could negatively affect product sales of some of our marketed products. We believe that our product sales for 2005 and the nine months ended September 30, 2006, have not been nor, for the remainder of 2006, are expected to be significantly impacted by the reimbursement changes resulting from the MMA. We believe this was, in part, due to the effects of CMS’ oncology demonstration project (the “2005 Demonstration Project”) on sales of our products used in supportive cancer care, especially Aranesp®. Furthermore, we believe this was also, in part, due to increased reimbursement rates to physicians from CMS for services associated with drug administration. The 2005 Demonstration Project, which provided financial incentives to physicians for collecting and reporting oncology patient survey data, expired on December 31, 2005. In November 2005, CMS announced a new demonstration project (the “2006 Demonstration Project”) that uses different criteria for how patients with cancer are evaluated and treated and that is targeted at approximately half of the funding originally targeted for the 2005 Demonstration Project. The final rule for the 2006 Medicare Physician Fee Schedule Payment Final Rule issued in November 2005 reduced payments for physician services in 2006 by approximately 4.4% on average, although legislation eliminated this reduction for 2006. The Medicare Physician Fee Schedule Payment Final Rule for 2007 issued in November 2006 and effective January 1, 2007, reduces payments for physician services in 2007 by approximately 5.0% on average. It is uncertain whether legislation will eliminate this reduction in 2007 or if payments for physician services will again be reduced after 2007. Because we cannot accurately predict the impact of any such changes on how, or under what circumstances, healthcare providers will prescribe or administer our products, we cannot estimate the full impact of the MMA on our business. 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.

The main components of the MMA that affect our currently marketed products are as follows:

·                  Through 2004, the Average Wholesale Price (“AWP”) mechanism was the basis of Medicare Part B payment for covered outpatient drugs and biologics. Since January 1, 2005, in the physician clinic setting Aranesp®and since January 1, 2006, in the hospital outpatient setting, Aranesp®, Neulasta®Neulasta® and NEUPOGEN® are beingNEUPOGEN® have been reimbursed under a Medicare Part B payment methodology that reimburses each product at 106% of its “average sales price” (“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®Aranesp® that will be in effect for the firstthird quarter of 2007 will be based in part on certain historical sales and sales incentive data for Aranesp®Aranesp® from OctoberApril 1, 20052006 through SeptemberMarch 30, 2006.2007. CMS publishes the ASPs for products in advance of the quarter in which they go into effect. The ASPsAny changes to the ASP calculation could adversely affect the Medicare reimbursement for Aranesp® and Neulasta® trended downward during the first three quarters of 2005, began to stabilize during the fourth quarter of 2005 and have remained relatively stable in 2006.

·                  Since August 1, 2006, physiciansour products administered in the physician clinic setting have hadoffice and the choice between purchasing and billing for specific drugs under the ASP+6% system or obtaining those drugs from vendors selected by CMS under the “competitive acquisition program” (“CAP”). We believe CAP is unlikelyhospital outpatient setting. Prior to have a significant impact on our business.


·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 AWPthe average wholesale price (“AWP”) as the basis of Medicare Part B payment for reimbursementcovered outpatient drugs and biologics administered in 2005. CMS’the hospital outpatient setting. From 2003 to 2005, reimbursement rate, as in 2003 and 2004, continued the application ofCMS applied an “equitable adjustment” such that the 2005 Aranesp®Aranesp® reimbursement rate was based on the AWP of PROCRIT®. For 2005,PROCRIT®, Johnson & Johnson’s recombinant human erythropoietin product marketed in the reimbursement rate for Aranesp® was 83% of the AWP for PROCRIT®, down from 88% of the AWP for PROCRIT® in 2004, withUnited States, using a dose conversion ratio of 330 U PROCRIT® to 1 mcg Aranesp®, the same ratio as 2004. Effective January 1,ratio. In 2006 the OPPS system changed from an AWP based reimbursement system to a system based on ASP. This change affects Aranesp®, Neulasta® and NEUPOGEN® when administered in the hospital outpatient setting. The OPPS rule for 2006 based reimbursement for non-pass through products such as Aranesp®, Neulasta® and NEUPOGEN® on ASP+6% using the same payment amounts as used in the physician clinic setting and2007, CMS did not apply an “equitable adjustment” to tie the reimbursement rate for Aranesp®Aranesp® to PROCRIT® using a dose conversion ratio. In the OPPS final rule for 2007,PROCRIT®. However, CMS states that it will not apply an “equitable adjustment” to the payment rate for Aranesp® in 2007, and will, as in 2006, reimburse hospitals for the costs associated with administering specific Medicare-covered outpatient drugs and biologicals (such as Aranesp®, Neulasta® and NEUPOGEN®) at ASP+6%. CMS noted in the 2005 final rule and has maintained that it reserves the right to apply an “equitable adjustment” to the payment rate for Aranesp®Aranesp® in future years.

·                  Pursuant to final rules issued by CMS on November 3, 2004, Medicare reimbursementIn the United States, dialysis providers are primarily reimbursed for EPOGEN® used in the dialysis setting for calendar year 2005 changed from the previous rate in 2004 of $10 per 1,000 Units to $9.76 per 1,000 Units, in 2005, a rate based upon an average acquisition cost for 2003 determinedEPOGEN® by the Officefederal government through the ESRD Program of Medicare. The ESRD Program reimburses approved providers for 80% of allowed dialysis costs; the Inspector General (“OIG”)remainder is paid by other sources, including patients, state Medicaid programs, private insurance, and adjusted for price inflation based on the Producer Price Index for pharmaceutical products. Pursuant to the CMS final rules, the difference between the 2004a lesser extent, state kidney patient programs. The ESRD Program reimbursement rates for all drugs separately billed outside the dialysis composite rate (including EPOGEN®)is established by federal law and the 2005 reimbursement rates for such drugs was added to the composite rate that dialysis providers receive for dialysis treatment. Pursuant to the Medicare Physician Fee Schedule Payment Final Rule for 2006, effectiveis monitored and implemented by CMS. Effective January 1, 2006, the payment mechanism for separately reimbursed

16


dialysis drugs in both freestandingfree-standing and hospital-based dialysis centers, including EPOGEN®EPOGEN® and Aranesp®Aranesp®, is reimbursed by Medicare at ASP+6% using the same payment amounts used in the physician clinic settingsetting. Since April 1, 2006, the ESRD Program reimbursement has been subject to a revised Hematocrit Measurement Audit Program Memorandum (“HMA-PM”), a Medicare payment review mechanism used by CMS to audit EPOGEN® and calculated quarterlyAranesp® (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 same manner as describedpatient’s EPOGEN® and Aranesp® dose and report this reduction on 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, under the Medicare Part B payment methodology. CMS publishes the ASPscould negatively affect product sales of some of our marketed products. However, we believe that our product sales for products in advance of the quarter in which they go into effect. Based upon the2005 and 2006 final rule,were not significantly impacted by the reimbursement rate for EPOGEN® for 2006 decreasedchanges resulting from the reimbursement rate in 2005. In the Medical Physician Fee Schedule Payment Final Rule for 2007, CMS continues the 2006 payment mechanism of ASP+6% for EPOGEN® and other separately reimbursed dialysis drugs in both freestanding and hospital-based dialysis centers. BecauseMMA. While we cannot accurately predict the extent to which this reimbursement will impact of any such changes on how, or under what circumstances, healthcare providers will prescribe or administer EPOGEN®,our products and we cannot estimate the full impact of the ASP+6% reimbursement rateMMA on our EPOGEN® product sales. However,business, we believe that it hasis not been and is unlikelylikely 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, and 2007.


Thebut 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, addressed several new topics regarding the ASP payment methodology. In the proposed rule, 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. AnyFurther, on December 29, 2006, the Medicare Payment Advisory Commission (“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® (cinacalcet HCl) have been eligible for coverage from the U.S. government under Medicare Part D. Although both ENBREL and

17


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 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 ASP calculation could adversely affectEMP. The FDA may also schedule a meeting of the Medicare reimbursement for our products administeredCardio Renal Advisory Committee to review the use of ESAs in the physician office and the hospital outpatient setting.

In addition, on November 9, 2005, CMS released a revision to the Hematocrit Measurement Audit Program Memorandum (“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. The new policy, Claims Monitoring Policy: Erythropoietin/darbepoetin alfa usage for beneficiaries with end stage renal disease (“Claims Monitoring Policy”), became effective April 1, 2006 and was further revised effective October 1, 2006. The revised Claims Monitoring Policy 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 claims using a coding modifier. If the provider does not reduce the patient’s EPOGEN® and Aranesp® dose and there issetting although no medical documentation to support the higher dosage, reimbursement will be reduced to the level it would havepublic announcement has been had the provider reduced dosage by twenty-five percent. Based on our preliminary evaluation, we do not expect the Claims Monitoring Policy to have a negative impact on EPOGEN® and Aranesp® sales and given the importance of EPOGEN® and Aranesp® for maintaining the quality of care for dialysis patients, we do not expect that the policy will substantially impact the utilization of EPOGEN® and Aranesp®. However, given the recent revisions, we are currently in the process of further evaluating the Claims Monitoring Policy.made. As a result of the revisions and current review of the EMP, we cannot predict the potential full impact of this final guidanceany 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 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 a result we cannot predictto 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.

Results of Operations

Product sales

For the three and nine months ended September 30,March 31, 2007 and 2006, and 2005, worldwide product sales and total product sales by geographic region were as follows:follows (in millions):

(Amounts in millions)

 

Three Months Ended

 

 

 

Nine Months Ended

 

 

 

 

 

September 30,

 

 

 

September 30,

 

 

 

 

 

2006

 

2005

 

Change

 

2006

 

2005

 

Change

 

Aranesp®

 

$

1,067

 

$

840

 

27%

 

$

3,015

 

$

2,400

 

26%

 

EPOGEN®

 

633

 

599

 

6%

 

1,850

 

1,829

 

1%

 

Neulasta®/NEUPOGEN®

 

998

 

882

 

13%

 

2,899

 

2,576

 

13%

 

Enbrel®

 

705

 

668

 

6%

 

2,087

 

1,899

 

10%

 

Sensipar®

 

83

 

43

 

93%

 

223

 

106

 

110%

 

Other

 

17

 

15

 

13%

 

47

 

44

 

7%

 

Total product sales

 

$

3,503

 

$

3,047

 

15%

 

$

10,121

 

$

8,854

 

14%

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Total U.S.

 

$

2,864

 

$

2,504

 

14%

 

$

8,296

 

$

7,267

 

14%

 

Total International

 

639

 

543

 

18%

 

1,825

 

1,587

 

15%

 

Total product sales

 

$

3,503

 

$

3,047

 

15%

 

$

10,121

 

$

8,854

 

14%

 

 

18


   Three Months Ended
March 31,
    
   2007  2006  Change 

Aranesp®

  $1,020  $893  14%

EPOGEN®

   625   604  3%

Neulasta®/NEUPOGEN®

   1,018   896  14%

ENBREL

   730   658  11%

Sensipar®

   105   61  72%

Vectibix™

   51     n/a 

Other

   16   15  7%
          

Total product sales

  $3,565  $3,127  14%
          

Total U.S.

  $2,884  $2,571  12%

Total International

   681   556  22%
          

Total product sales

  $3,565  $3,127  14%
          

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 and nine months ended September 30, 2006March 31, 2007 was principally driven by demand for Aranesp®Aranesp®, Neulasta®Neulasta® and ENBREL.ENBREL, which benefited from segment growth and to a lesser degree share gains. International product sales growth for the three months ended March 31, 2007 were favorably impacted by approximately $16$42 million from foreign currency exchange rate changes. Excluding the favorable impact of foreign currency exchange rate changes, but were unfavorably impacted by approximately $39 million forinternational product sales increased 15% over the ninethree months ended September 30,March 31, 2006.

We expect Aranesp®, Neulasta® and ENBREL to continue to drive year over year sales growth forAranesp®

For the remainder of 2006. However, we expect that maintaining or increasing share will be more of a challenge than in previous years as we operate in an increasingly competitive environment and we have experienced share loss with ENBREL. Going forward, we will focus on growing our segments, including increasing our penetration in the therapeutic areas in which our products are used, while also continuing to focus on segment share.

While we believe that our product sales for 2005 and the ninethree months ended September 30,March 31, 2007 and 2006, have not been nor, for the remainder of 2006, are expected to be significantly impactedtotal Aranesp® sales by the reimbursement changes resulting from the MMA implemented in 2005, 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 additional information on reimbursement and its impact on our business, see “Reimbursement” above.geographic region were as follows (in millions):


Aranesp®

(Amounts in millions)

 

Three Months Ended

 

 

 

Nine Months Ended

 

 

 

 

 

September 30,

 

 

 

September 30,

 

 

 

 

 

2006

 

2005

 

Change

 

2006

 

2005

 

Change

 

Aranesp® - U.S.

 

$

720

 

$

542

 

33%

 

$

2,029

 

$

1,525

 

33%

 

Aranesp® - International

 

347

 

298

 

16%

 

986

 

875

 

13%

 

Total Aranesp®

 

$

1,067

 

$

840

 

27%

 

$

3,015

 

$

2,400

 

26%

 

 

   

Three Months Ended

March 31,

    
   2007    2006  Change 

Aranesp® - U.S.

  $654    $ 596  10%

Aranesp® - International

   366     297  23%
            

Total Aranesp®

  $1,020    $893  14%
            

The increase in U.S. Aranesp®Aranesp® sales for the three and nine months ended September 30, 2006March 31, 2007 was primarily driven by demand reflecting bothdue to segment growth and share gains.to a lesser degree favorable wholesaler inventory changes. The slowing growth rate in the United States was driven by initial customer reaction to the ESA product label changes regarding safety discussed above and the resulting loss of substantially all Medicare

19


reimbursement for Aranesp® in AoC. U.S. sales results for Aranesp® for the three months ended March 31, 2007 do not fully reflect the significant impact of these developments, which occurred throughout, but primarily in the latter half, of the first quarter of 2007. The increase in international Aranesp®Aranesp® sales for the three and nine months ended September 30, 2006March 31, 2007 was also principally driven by demand. International sales for the nine months ended September 30, 2006 were unfavorablyincreased demand due to segment growth and share gains and was favorably impacted by $27$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. Excluding the favorable impact of foreign currency exchange rate changes, international Aranesp® sales increased 15% over the three months ended March 31, 2006.

ForIn addition to the remainder of 2006, we believe that Aranesp®factors mentioned in the “Product sales” section above, future worldwide Aranesp® sales growth will be driven primarily by increased demand due to both segment growth and continued share gains. Further, sales of Aranesp® have been and may continue to be benefited by its use in U.S. hospital dialysis clinics to treat anemia associated with chronic renal failure instead of EPOGEN®, however, we believe this conversion stabilized as of June 30, 2006. In addition, we believe future worldwide Aranesp® sales growth will also be dependent, in part, on such factors as:

adverse events or results from clinical trials or studies performed by us or by others 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 third-party payers (including governmentsus 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®, 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 insurance plans); cost containment pressures from governmentshealthcare organization medical guidelines and private insurers on health care providers; reimbursement practices;

governmental or private organization regulations or guidelines relating to the use of our products; government programs; penetration of existing

reimbursement by third-party payers, including governments and new segments, including potential new indications; patient population growth; the effects of pricing strategies; private insurance plans;

an increasingly competitive environment of competitive products or therapies, including biosimilar productswhich in Europe;2007 in the developmentUnited 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 new treatments for cancer;our U.S. erythropoietin patents (see “Item 1. Legal Proceedings – Roche Matters” in Part II herein) and changes in foreign currency exchange rates (seethe EU in 2007 could potentially include Roche’s peg-EPO product,

20


biosimilars and other competing products, such as Shire’s erythropoietin product launched in March 2007;

our ability to differentiate Aranesp® from current and potential future competition;

pricing strategies; and

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

(See “Item 1A. Risk FactorsFactors” in Part II herein — Ourfor further discussion of certain of the above factors that impact our product sales.)

EPOGEN®

For the three months ended March 31, 2007 and 2006, total EPOGEN® 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.”).were as follows (in millions):

EPOGEN®

(Amounts in millions)

 

Three Months Ended

 

 

 

Nine Months Ended

 

 

 

 

 

September 30,

 

 

 

September 30,

 

 

 

 

 

2006

 

2005

 

Change

 

2006

 

2005

 

Change

 

EPOGEN® - U.S.

 

$

633

 

$

599

 

6%

 

$

1,850

 

$

1,829

 

1%

 

 

   Three Months Ended
March 31,
    
   2007  2006  Change 

EPOGEN® - U.S.

  $625  $604  3%

Reported EPOGEN®EPOGEN® sales for the three months ended September 30, 2006March 31, 2007 increased primarily due to favorable year over yearrevised estimates of dialysis demand, primarily spillover, for prior quarters (see Note 1, “Summary of significant accounting polices – Product sales” to the Condensed Consolidated Financial Statements for further discussion), and favorable wholesaler inventory changes, and underlying demand in the freestanding dialysis clinics. These increases were partially offset by year over year increasedchanges in customer purchasing patterns versus the first quarter of the 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.

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

adverse events or results from clinical trials or studies performed by us or by others which have and could further impact product safety labeling and may negatively impact healthcare provider prescribing behavior, use of Aranesp®our product, regulatory or private healthcare organization medical guidelines and reimbursement practices. For example, as discussed in more detail above in the hospital setting. Reported EPOGEN® sales“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 nine months ended September 30, 2006 increased modestly primarily duefollowing:

-

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 increased demand in the freestanding dialysis centers largely offset by the increased use of Aranesp® in the hospital setting. We believe that conversion to Aranesp® in the hospital setting stabilized as of June 30, 2006.our products.


We believe EPOGEN® should experience sales growth for the remainder of 2006 primarily as a result of patient population growth and the stabilization of conversion to Aranesp® in the U.S. hospital dialysis clinics. On an annual basis, we believe demand for EPOGEN® in the freestanding dialysis clinics, which account for a majority of EPOGEN® sales, remains consistent with an estimated annual patient population growth of 3-4 percent. Dialysis patients receiving treatment for anemia associated with end stage renal disease with EPOGEN® are covered primarily under medical programs provided by the federal government. Therefore, going forward, we believe EPOGEN® sales growth will further depend on changes in reimbursement rates or a change in the basis for reimbursement by the federal government. We believe EPOGEN® sales growth will also be dependent,government;

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

cost containment pressures from the federal government on health care providershealthcare providers;

pricing strategies; and the effects of pricing strategies (see

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 “Item 1A. Risk FactorsFactors” in Part II herein — 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.”). We recently entered into a five-year sole sourcing and supply agreement with an affiliate of Fresenius Medical Care North America, Inc. (“Fresenius”), on its behalf and on behalffurther discussion of certain of its affiliates, to purchase,the above factors that impact our product sales.)

Neulasta®/NEUPOGEN®

For the three months ended March 31, 2007 and we have agreed to supply, all of Fresenius’ commercial requirements for erythropoietic stimulating proteins for use in managing the anemia of its hemodialysis patients in the United States and Puerto Rico, based on forecasts provided2006, total Neulasta®/NEUPOGEN® sales by Fresenius and subject to the terms and conditions of the agreement.geographic region were as follows (in millions):

Neulasta®/NEUPOGEN®

(Amounts in millions)

 

Three Months Ended

 

 

 

Nine Months Ended

 

 

 

 

 

September 30,

 

 

 

September 30,

 

 

 

 

 

2006

 

2005

 

Change

 

2006

 

2005

 

Change

 

Neulasta® - U.S.

 

$

560

 

$

475

 

18%

 

$

1,636

 

$

1,381

 

18%

 

NEUPOGEN® - U.S.

 

212

 

205

 

3%

 

609

 

595

 

2%

 

U.S. Neulasta®/NEUPOGEN® - Total

 

772

 

680

 

14%

 

2,245

 

1,976

 

14%

 

Neulasta® - International

 

130

 

102

 

27%

 

363

 

284

 

28%

 

NEUPOGEN® - International

 

96

 

100

 

(4)%

 

291

 

316

 

(8)%

 

International Neulasta®/NEUPOGEN® - Total

 

226

 

202

 

12%

 

654

 

600

 

9%

 

Total Worldwide Neulasta®/NEUPOGEN®

 

$

998

 

$

882

 

13%

 

$

2,899

 

$

2,576

 

13%

 

 

   Three Months Ended
March 31,
    
   2007    2006  Change 

Neulasta® - U.S.

  $573    $497  15%

NEUPOGEN® - U.S.

   204     191  7%
            

U.S. Neulasta®/NEUPOGEN® - Total

   777     688  13%
            

Neulasta® - International

   146     111  32%

NEUPOGEN® - International

   95     97  (2)%
            

International Neulasta®/NEUPOGEN® - Total

   241     208  16%
            

Total Worldwide Neulasta®/NEUPOGEN®

  $1,018    $  896  14%
            

The increase in U.S. Neulasta®Neulasta®/NEUPOGEN®NEUPOGEN® sales for the three and nine months ended September 30, 2006March 31, 2007 was driven primarily by demand for Neulasta®. In addition,Neulasta® due to segment growth and to a lesser degree favorable wholesaler inventory changes. Neulasta® segment growth is attributable to an increase in

22


patients in part due to the continued increase of Neulasta®in demand for Neulasta® for the three and nine months ended September 30, 2006 also includes the impact of a 2 percent U.S. price increase in April 2006. U.S. demand for Neulasta® continued to benefit from a product label extension based on clinical data demonstrating the value of first cycle


utilization in moderate-high risk chemotherapy regimens.first-cycle use, as well as higher net sales prices. The increase in international Neulasta®Neulasta®/NEUPOGEN®NEUPOGEN® sales for the three and nine months ended September 30, 2006March 31, 2007 was driven primarily by demand for Neulasta®. International sales for the nine months ended September 30, 2006 were unfavorablycontinued conversion 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 2006,2007, we believe sales growth for Neulasta®Neulasta®/NEUPOGEN®NEUPOGEN® will continue todepend on patient growth and further segment penetration of Neulasta® in the moderate-risk population that would benefit from a Neulasta® label extension based on clinical data demonstratingits use in first and subsequent chemotherapy cycles. NEUPOGEN® competes with Neulasta® in the valueUnited States and Europe. Worldwide NEUPOGEN® sales have been adversely impacted by conversion to Neulasta®. However, we believe that most of first cycle utilizationthe conversion in moderate-high risk chemotherapy regimes. the United States and Europe has occurred.

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

competitive products or therapies, including biosimilar products that may be approved in the EU and be available shortly thereafter;

adverse events or results from clinical trials or studies performed by us or by others which may expand safety labeling and may negatively impact healthcare provider prescribing behavior, use of our product, regulatory or private healthcare organization medical guidelines and reimbursement by third-party payers (including governments and private insurance plans); cost containment pressures from governments and private insurers on health care providers; practices;

governmental or private organization regulations or guidelines relating to the use of our products; government programs (see

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

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

pricing strategies;

penetration of existing segments; 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 “Item 1A. Risk FactorsFactors” in Part II herein — 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 utilizationfurther discussion of our products.”); penetration of existing segments; patient population growth; the effects of pricing strategies; competitive products or therapies, including biosimilar products in Europe; changes in foreign currency exchange rates and the development of new treatments for cancer. Future chemotherapy treatments 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®. NEUPOGEN® competes with Neulasta® in the United States and Europe. U.S. and International NEUPOGEN® sales have been adversely impacted by conversion to Neulasta®. However, we believe that mostcertain of the conversion inabove factors that impact our product sales.)

23


ENBREL

For the United States has occurred. In Europe, we have been actively converting NEUPOGEN® patients to Neulasta®, emphasizing its less frequent dosing requirementsthree months ended March 31, 2007 and 2006, total ENBREL sales by geographic region were as compared to NEUPOGEN®. While conversion of NEUPOGEN® patients to Neulasta® in Europe is still occurring, we believe that this conversion has mainly stabilized.follows (in millions):

ENBREL

(Amounts in millions)

 

Three Months Ended

 

 

 

Nine Months Ended

 

 

 

 

 

September 30,

 

 

 

September 30,

 

 

 

 

 

2006

 

2005

 

Change

 

2006

 

2005

 

Change

 

ENBREL - U.S.

 

$

669

 

$

641

 

4%

 

$

1,983

 

$

1,825

 

9%

 

ENBREL - International

 

36

 

27

 

33%

 

104

 

74

 

41%

 

Total ENBREL

 

$

705

 

$

668

 

6%

 

$

2,087

 

$

1,899

 

10%

 

 

   Three Months Ended
March 31,
    
   2007  2006  Change 

ENBREL - U.S.

  $693  $629  10%

ENBREL - International

   37   29  28%
          

Total ENBREL

  $730  $658  11%
          

ENBREL sales growth for the three and nine months ended September 30, 2006March 31, 2007 was driven by demand. For the three months ended September 30, 2006, growth was primarily driven by demand due to increases in the Rheumatology segment. In addition, the increase in demand for the threeboth patients and nine months ended September 30, 2006 also includes the impact of a 4.9 percent U.S. price increase that went into effect May 1, 2006.net sales price. While ENBREL continued to maintain a leading position in both rheumatology and dermatology, we have experiencedthe sales growth in the first quarter was affected by slight share lossdecline in the United States in both segments versus the first quarter of the prior year over year. ENBREL sales growth has been affected in 2006 by slowing segment growth in dermatology and bydue to increased competitive activities in both segments.

30




activity.

We believe sales growth for the remainder of 20062007 will be principally driven by growth ofin the rheumatology segment. Going forward,and dermatology segments.

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

the effects of competing products or therapies; therapies and, in part, our ability to differentiate ENBREL based on safety and efficacy;

segment growth; the availability

adverse events or results from clinical trials or studies performed by us or by others which may expand safety labeling and extentmay negatively impact healthcare provider prescribing behavior, use of our product, regulatory or private healthcare organization medical guidelines and reimbursement by government and third-party payers; cost containment pressures from governments and private insurers on health care providers; practices;

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

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

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

pricing strategies (seestrategies.

(See “Item 1A. Risk FactorsFactors” in Part II herein – Our sales depend on payment and reimbursement from third-party payers, and, tofor further discussion of certain of the extentabove factors that reimbursement forimpact our products is reduced, this could negatively impact the utilization of our products.”product sales.).

24


Selected operating expenses

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

 

Three Months Ended

 

 

 

Nine Months Ended

 

 

 

 

 

September 30,

 

 

 

September 30,

 

 

 

 

 

2006

 

2005

 

Change

 

2006

 

2005

 

Change

 

Product sales

 

$

3,503

 

$

3,047

 

15%

 

$

10,121

 

$

8,854

 

14%

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

Cost of sales (excludes amortization of acquired intangible assets)

 

$

489

 

$

552

 

(11)%

 

$

1,534

 

$

1,571

 

(2)%

 

% of product sales

 

14%

 

18%

 

 

 

15%

 

18%

 

 

 

Research and development

 

$

872

 

$

562

 

55%

 

$

2,315

 

$

1,653

 

40%

 

% of product sales

 

25%

 

18%

 

 

 

23%

 

19%

 

 

 

Selling, general and administrative

 

$

807

 

$

656

 

23%

 

$

2,336

 

$

1,879

 

24%

 

% of product sales

 

23%

 

22%

 

 

 

23%

 

21%

 

 

 

Write-off of acquired in-process research and development

 

$

 

$

 

 

 

$

1,101

 

$

 

 

 

Amortization of acquired intangible assets

 

$

122

 

$

86

 

 

 

$

296

 

$

260

 

 

 

 

   Three Months Ended
March 31,
    
   2007  2006  Change 

Product sales

  $3,565  $3,127  14%

Operating expenses:

    

Cost of sales (excludes amortization of acquired intangible assets)

  $592  $552  7%

% of product sales

   17%  18% 

Research and development

  $851  $655  30%

% of product sales

   24%  21% 

Selling, general and administrative

  $770  $689  12%

% of product sales

   22%  22% 

Amortization of acquired intangible assets

  $74  $87  (15)%

Cost of sales

Cost of sales, which excludes the amortization of acquired intangible assets (see “Condensed Consolidated Statements of Operations”), decreased 11%increased 7% for the three months and 2% for the nine months ended September 30, 2006, respectively. The decrease in the three months ended September 30, 2006 was primarily driven by lower royalty expenses, a favorable product mix and, to a lesser extent, production efficiencies. Royalty expenses were lower in the three months ended September 30, 2006 due to the expiration of certain contractual royalty obligations on Neulasta® and NEUPOGEN® sales and the acquisition of certain royalty rights on sales of ENBREL and European Union Neulasta® and NEUPOGEN® sales. The moderate decrease in costs of sales for the nine months ended September 30, 2006 was primarily due to cost savings from lower royalty expenses, a favorable product mix and production efficiencies largely offset by higher manufacturing costs during the three months ended March 31, 2006.


2007. The increase in 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.

Research and development

R&D expenses, which are expensed as incurred, are primarily comprised of costs and expenses for:for salaries and benefits associated with R&D personnel,personnel; overhead and occupancy,occupancy; clinical trial and related clinical manufacturing, including contract services and other outside costs, process development and quality assurance,assurance; information systems and amortization of technology used in R&D with alternative future uses. R&D expenses also include such costs related to activities performed on behalf of corporate partners. R&D expenses increased 55% and 40%, respectively,30% for the three and nine months ended September 30, 2006March 31, 2007 primarily driven by higher staff-related costs and increased funding to support clinical trials for our late stage programs, including higher clinical materialthe increased number and manufacturing costs. In addition, R&D costs for the three and nine months ended September 30, 2006, include approximately $21 million and $78 million, respectively, in stock option expense, which was not reflected in our Consolidated Results of Operations prior to January 1, 2006 (see “Recent accounting pronouncements” below) and approximately $16 million and $32 million, respectively, in non-cash amortization expense of mega-trials to advance our late-stage pipeline as well as the intangible asset, XenoMouse® technology, acquired in the Abgenix acquisition.continued advancement of earlier stage compounds. During the three months ended September 30, 2006,March 31, 2007, staff-related costs including stock option compensation, and clinical trial and clinical manufacturing costs increased approximately $139$76 million and $121 million, respectively. During the nine months ended September 30, 2006, staff-related costs, including stock option compensation, and clinical trial and clinical manufacturing costs increased approximately $347 million and $246$92 million, respectively.

25


Selling, general and administrative

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 occupancy costs;costs and other general and administrative costs. SG&A increased 23% and 24%12% for the three and nine months ended September 30, 2006,March 31, 2007, primarily reflecting higher staff levels and additional infrastructure costs, primarily associated with our Global Enterprise Resource Planning (ERP) system,the Wyeth profit share related to support our growing organization. In addition, SG&A costs for the three and nine months ended September 30, 2006 include approximately $25 million and $96 million, respectively, in stock option expense, which was not reflected in our Consolidated Results of Operations prior to January 1, 2006 (see “Recent accounting pronouncements” below).ENBREL. During the three months ended September 30, 2006, staff-related costs, including stock option compensation, and additional infrastructure costs increased over the three months ended September 30, 2005 by approximately $109 million and $12 million, respectively. In addition, we incurred $6 million in higher legal costs associated with ongoing litigation and $46 million in increasedMarch 31, 2007 outside marketing expenses in support of our principal products, including the Wyeth profit share related to ENBREL. During the nine months ended September 30, 2006, staff-related costs, including stock option compensation, and additional infrastructure costs increased over the nine months ended September 30, 2005 by $312 million and $35 million, respectively. In addition, we incurred $41 million in higher legal costs associated with ongoing litigation and $111 million in increased outside marketing expenses in support of our principal products, including the Wyeth profit share related to ENBREL, for the nine month period.increased by approximately $60 million.

Write-off of acquired in-process research and development

The fair value of acquired IPR&D projects and technologies which have no alternative future use and which have not reached technological feasibility at the date of acquisition are immediately expensed. In the second quarter of 2006 we expensed $1,101 million of acquired IPR&D related to the Abgenix acquisition. Acquired IPR&D is considered part of total R&D expense.


Amortization of acquired intangible assets

Amortization of acquired intangible assets relates to the acquired productsproduct technology rights acquired in connection with the Immunex Corporation (“Immunex”) acquisition. This amortization also included $49 million for the three and nine months ended September 30, 2006 related to the impairment of a non-Enbrel® related intangible asset previously acquired in the Immunex acquisition.

Legal settlements

During the nine months ended September 30, 2005, we settled certain legal matters, primarily related to a patent legal proceeding, and recorded an expense of $49 million, net of amounts previously accrued.

Interest and other income and (expense), net

Interest and other income and (expense), net for the three months ended September 30, 2006March 31, 2007 was $39$6 million of incomeexpense compared to $14$80 million of income for the three months ended September 30, 2005. Interest and other income (expense), net for the nine months ended September 30, 2006March 31, 2006. The decrease was $140 million of income compared to $10 million of income for the nine months ended September 30, 2005. These increases were principally attributable to an increase inthe write-off of $51 million of deferred financing and related costs resulting from the repayment of the convertible debt and lower interest income.

Income taxes

Our effective tax rates for the three and nine months ended September 30, 2006 were 19.0% and 29.2%, respectively, compared with 26.3% and 24.2%, respectively, for the same periods last year. The decrease in our effective tax rate for the three months ended September 30, 2006 asMarch 31, 2007 was 20.3%, compared towith 23.8% for the three months ended September 30, 2005 was primarily due to the favorable resolution of prior year federal and state audits and an increase in the amount of earnings intended to be invested indefinitely outside of the United States, partially offset by the expiration of the federal research and experimentation (“R&E”) credit in 2005.same period last year. Our effective tax rate for the ninethree months ended September 30, 2006 as compared to the nine months ended September 30, 2005March 31, 2007 has increaseddecreased primarily due to the write-off of acquired IPR&D costs in connection with the acquisition of Abgenix, and to a lesser degree, the expiration of the federal R&E credit in 2005. The increase in the rates for the nine months ended September 30, 2006 was partially offset by an increase in the amount of foreign earnings intended to be invested indefinitely outside of the United States.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 due 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.

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

Recent accounting pronouncements

On January 1,In July 2006, we adopted Statement of Financial Accounting Standards (“SFAS”) No. 123(R), “Share-Based Payment.” SFAS No. 123(R) requiresthe FASB issued FIN 48, which became effective for us to account for our stock options using a fair-value-based method as described in such statement and recognize the resulting compensation expense in our financial statements. Prior to January 1, 2006, we accounted for our employee stock options using the intrinsic value method under APB No. 25, “Accounting for Stock Issued to


Employees” and related interpretations, as permitted by SFAS No. 123, “Accounting for Stock-Based Compensation,” which generally did not result in any employee stock option expense. We adopted SFAS No. 123(R) using the modified-prospective-transition method. Under this transition method, compensation expense recognized subsequent to adoption includes: (a) compensation cost for all share-based payments granted prior to, but not yet vested as of January 1, 2006, based on the values estimated in accordance with the original provisions of SFAS No. 123, and (b) compensation cost for all share-based payments granted subsequent to January 1, 2006, based on the grant-date fair values estimated in accordance with the provisions of SFAS No. 123(R). The modified-prospective-transition method did not require recognition of related compensation expense in our financial statements for prior periods. Comparability, therefore, of the current period financial statements to prior periods has been and will be impacted.

The adoption of SFAS No. 123(R) will have a material impact on our results of operations for 2006. The actual annual stock option expense in 2006 is dependent on a number of factors including the number of stock options granted, our common stock price and related expected volatility and other inputs utilized in estimating the fair value of the stock options at the time of grant. As a result of recognizing compensation expense for stock options pursuant to the provisions of SFAS No. 123(R), our income before income taxes for the three and nine months ended September 30, 2006, was$50 million and $179million lower, respectively, and our net income was $36 million and $124 million lower, respectively, than if we had continued to account for stock options under APB No. 25. In addition, both basic and diluted earnings per share for the three and nine months ended September 30, 2006 were $0.03 and $0.11 lower, respectively, than if we had continued to account for stock options under APB No. 25. We expect the impact of stock option expense to be in the range of $0.12 to $0.14 per share in 2006 compared to $0.19 for 2005 (see Note 2, “Employee stock-based payments” in the Condensed Consolidated Financial Statements). The estimated annual impact of stock option expense for 2006 is less than the corresponding pro forma expense amount for 2005 principally due to a reduction in the number of stock options granted in recent years in favor of a combination of other equity awards. Other equity awards are comprised principally of restricted stock and performance units. Pre-tax stock-based compensation expense relating to these other equity awards for the three months ended September 30, 2006 and September 30, 2005 were $51 million and $26 million, respectively. As of September 30, 2006, there was $563 million of total unrecognized compensation cost related to unvested stock options and shares of restricted stock that is expected to be recognized over the weighted-average period of 1.5 years and $165 million of total unrecognized compensation cost related to performance units that is expected to be recognized over the weighted-average period of 1.0 year.

In June 2006, the Financial Accounting Standards Board (“FASB”) issued FASB Interpretation No. (“FIN”) 48, “Accounting for Uncertainty in Income Taxes,” effective for fiscal years beginning after December 15, 2006.2007. FIN 48 clarifies the accounting for uncertainty in income taxes by prescribing rules for recognition, measurement classification and disclosureclassification in our financial statements of tax positions taken or expected to be taken in a tax return. We are currently evaluating the provisions in

For tax benefits to be recognized under FIN 48, but have not yet determined its expected impact on us. We plana tax position must be more-likely-than-not to adopt this new standard onbe sustained upon examination by taxing authorities. 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.


2007, the gross amount of our liabilities for 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

26


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.

Financial Condition, Liquidity and Capital Resources

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

 

September 30,

 

December 31,

 

 

 

2006

 

2005

 

Cash, cash equivalents, restricted cash, and marketable securities

 

$

5,781

 

$

5,255

 

Total assets

 

32,586

 

29,297

 

Current debt

 

1,773

 

 

Non-current debt

 

7,233

 

3,957

 

Stockholders’ equity

 

17,721

 

20,451

 

 

   March 31,
2007
  December 31,
2006

Cash, cash equivalents and marketable securities

  $4,837  $6,277

Total assets

   32,570   33,788

Current debt

   100   1,798

Non-current debt

   7,214   7,214

Stockholders’ equity

   19,715   18,964

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 programprograms and other business initiatives, including acquisitions and licensing activities. However, in order to provide for greater financial flexibility and liquidity, we may raiseare currently reviewing additional borrowing opportunities. We would expect 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 from time to time by accessing both publicexpenditures, other working capital needs and private markets.other business initiatives.

Cash, cash equivalents and marketable securities

Of the total cash, cash equivalents and marketable securities at September 30, 2006,March 31, 2007, approximately $4.7$3.8 billion was generated from operations in foreign tax jurisdictions and is intended for use outside the United States. If these funds are repatriated for use in our U.S. operations, substantial additional taxes on certain of these amounts will be required to be paid.

27


Financing arrangements

In February 2006, we issued $2.5 billion principal amount of convertible notes due in 2011 (the “2011 Convertible Notes”) and $2.5 billion principal amount of convertible notes due in 2013 (the “2013 Convertible Notes”) in a private placement. The 2011 Convertible Notes andfollowing table reflects the 2013 Convertible Notes were issued at par and pay interest at a rate of 0.125% and 0.375%, respectively. The 2011 Convertible Notes and the 2013 Convertible Notes may be convertible based on an initial conversion rate of 12.5247 shares and 12.5814 shares, respectively, per $1,000 principal amount of notes (which represents an initial conversion price of approximately $79.84 and $79.48 per share, respectively). The 2011 Convertible Notes and the 2013 Convertible Notes may only be converted: 1) during any calendar quarter beginning after June 30, 2006 if the closing pricecarrying value of our common stock exceeds 130% of the respective conversion price per share during a defined period at the end of the previous quarter, 2) if we make specified distributions to holders of our common stock or specified corporate transactions occur, or 3) one month prior to the respective maturity date. Upon conversion, a holder would receive: 1) cash equal to the lesser of the principal amount of the note or the conversion value, as defined, and 2) to the extent the conversion value exceeds the principal amount of the note, shares of our common stock, cash or a combination of common stock and cash, at our option (the “excess conversion value”). In addition, upon a change in control, as defined, the holders may require us to purchase for cash all or a portion of their notes for 100% of the principal amount of the notes plus accrued and unpaid interest, if any. Debt issuance costs totaled approximately $88 million and are being amortized over the life of the notes. Moody’s and Standard & Poor’s rate our outstanding convertible notes A2 and A+, respectively.


In connection with the issuance of these convertible notes, a total of $3.0 billion of our common stock was repurchasedlong-term borrowings under our stock repurchase program. Also concurrent with the issuance of the 2011 Convertible Notes and the 2013 Convertible Notes, we purchased convertible note hedges in private transactions. The convertible note hedges allow us to receive shares of our common stock and/or cash from the counterparties to the transactions equal to the amounts of common stock and/or cash related to the excess conversion value that we would pay to the holders of the 2011 Convertible Notes and the 2013 Convertible Notes upon conversion. These transactions will terminate the earlier of the maturity dates of the related notes or the first day none of the related notes remain outstanding due to conversion or otherwise. The cost of the convertible note hedges, which aggregated approximately $1.5 billion, was recorded as a reduction of equity. The net proceeds from the issuance of the 2011 and 2013 Convertible Notes, the repurchase of common stock and the purchase of the convertible note hedges was $440 million.

Also concurrent with the issuance of the 2011 Convertible Notes and the 2013 Convertible Notes, we sold warrants to acquire shares of our common stock at an exercise price of $107.90 per share in a private placement. Pursuant to these transactions, warrants for approximately 31.3 million shares of our common stock may be settled in May 2011 and warrants for approximately 31.5 million shares of our common stock may be settled in May 2013 (the “settlement dates”). If the average price of our common stock during a defined period ending on or about the respective settlement dates exceeds the exercise price of the warrants, the warrants will be settled, at our option, in cash or shares of our common stock. Proceeds received from the issuance of the warrants totaled approximately $774 million.

As of September 30, 2006 we had zero coupon convertible notes due in 2032 with an accreted value of $1.8 billion outstanding and having an aggregate face amount of $2.36 billion and yield to maturity of 1.125%. The holders of these convertible notes may require us to purchase, generally for cash, all or a portion of their convertible notes on specified dates (the “Put Option”), at a price equal to the original issuance price plus the accrued original issue discount through the purchase date. The next available Put Option date is on March 1, 2007. Accordingly, the convertible notes were classified as current liabilities in the accompanying Condensed Consolidated Balance Sheetvarious financing arrangements as of September 30, 2006. Moody’sMarch 31, 2007 and Standard & Poor’s rate our outstanding convertible notes A2 and A+, respectively.December 31, 2006 (in millions):

As of September 30, 2006 we had $2.0 billion of long-term notes outstanding. These long-term notes consisted of: 1) $1.0 billion of notes that bear interest at a fixed rate of 4.0% and mature in 2009, and 2) $1.0 billion of notes that bear interest at a fixed rate of 4.85% and mature in 2014. Moody’s and Standard & Poor’s rate our outstanding long-term senior notes A2 and A+, respectively.

As of September 30, 2006, we had $234 million of additional long-term debt securities outstanding. These long-term debt securities consisted of: 1) $100 million of debt securities that bear interest at a fixed rate of 6.5% and mature in 2007 under a $500 million debt shelf registration statement (the “$500 Million Shelf”), 2) $100 million of debt securities that bear interest at a fixed rate of 8.1% and mature in 2097, and 3) $34 million in notes due in 2013 with an effective rate of 5.35% assumed in the Abgenix acquisition. Our outstanding long-term debt is rated A2 by Moody’s and A+ by Standard & Poor’s. Under the $500 Million Shelf, all of the remaining $400 million of debt securities available for issuance may be offered from time to time under our medium-term note program with terms to be determined at the time of issuance.


We have a $1.0 billion unsecured revolving credit facility to be used for general corporate purposes, including commercial paper support, which matures in November 2010. Additionally, we have a commercial paper program, which provides for unsecured, short-term borrowings of up to an aggregate of $1.2 billion. No amounts were outstanding under the credit facility or commercial paper program as of September 30, 2006.

We have a $1.0 billion shelf registration statement (the “$1 Billion Shelf”) which allows us to issue debt securities, common stock and associated preferred share purchase rights, preferred stock, warrants to purchase debt securities, common stock or preferred stock, securities purchase contracts, securities purchase units and depositary shares. The $1 Billion Shelf was established to provide for further financial flexibility and the securities available for issuance may be offered from time to time with terms to be determined at the time of issuance. As of September 30, 2006, no securities had been issued under the $1 Billion Shelf.

   March 31,
2007
  December 31,
2006

0.125% convertible notes due 2011 (2011 Convertible Notes)

  $2,500  $2,500

0.375% convertible notes due 2013 (2013 Convertible Notes)

   2,500   2,500

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

   80   1,778

4.85% notes due 2014 (2014 Notes)

   1,000   1,000

4.00% notes due 2009 (2009 Notes)

   999   999

Other

   235   235
        

Total borrowings

   7,314   9,012

Less current portion

   100   1,798
        

Total non-current debt

  $7,214  $7,214
        

Certain of our financing arrangements contain non-financial covenants and as of September 30, 2006,March 31, 2007, we were in compliance with all applicable covenants. Our outstanding convertible notes, our outstanding long-term senior notes and our outstanding long-term debt are all rated A2 by Moody’s and A+ by Standard & Poor’s. See Note 4, “Financing arrangements” to our Condensed Consolidated Financial Statements for further discussion of the transactions during the quarter ended March 31, 2007 and “Note 5, Financing arrangements” in Part IV of our Annual Report on Form 10-K for the year ended December 31, 2006 for additional discussion of each of our financing arrangements.

Cash flows

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

 

Nine months ended September 30,

 

 

 

2006

 

2005

 

Net cash provided by operating activities

 

$

4,147

 

$

3,782

 

Net cash (used in) provided by investing activities

 

(3,929

)

303

 

Net cash used in financing activities

 

(767

)

(3,460

)

 

   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 

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 ninethree months ended September 30, 2006 increasedMarch 31, 2007 decreased from the prior year nine month periodthree months ended due to higher cash receiptsincreased disbursements from customers driven by the growth in product sales and the timing of payments in the ordinary course of business.business partially offset by higher receipts from customers. (See Condensed Consolidated Statements of Cash Flows).Flows.)

Investing

On April, 1, 2006, we completed our acquisition of Abgenix and paid $2.1 billion in cash to the shareholders of Abgenix to acquire all outstanding shares. In addition, we acquired $252 million in cash, and subsequent to the completion of the acquisition, we paid off $653 million of convertible debt assumed in this transaction.28


Investing

Capital expenditures totaled $834$325 million during the ninethree months ended September 30, 2006,March 31, 2007, compared with $602$225 million during the same period last year. The capital expenditures during the ninethree months ended September 30, 2006March 31, 2007 were primarily associated with ongoing manufacturing capacity and site expansions in Ireland, Puerto Rico and other locations and costs associated with


investment in our global enterprise resource planning (“ERP”) system.

implementing our ERP system. The capitalCapital expenditures duringfor the ninethree months ended September 30, 2005March 31, 2006 were primarily associated with ongoing manufacturing and site expansion in Puerto Rico, andmanufacturing expansion in Colorado, and site development in Rhode Island and Thousand Oaks and other locations.costs associated with implementing our ERP system.

We currently estimate 20062007 spending on capital projects and equipment to be in excess of $1 billionsimilar to the prior year as we continue to increase our manufacturing and R&D 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 the start of engineering and construction of a new process development, bulk manufacturing, formulation, fill and finish facility in Ireland, the expansion of R&D operations at existing sites in the United States and the United Kingdom and construction of a new development center in Uxbridge, United Kingdom..

Financing

On October 24, 2006,March 2, 2007, as a result of certain holders of the 2032 Modified Convertible Notes exercising their March 1, 2007 put option, we completed our acquisitionrepurchased $2,253 million aggregate principal amount of Avidia and paid $290Convertible Notes at their then-accreted value for $1,702 million in cash, netor approximately 96%, of cash acquiredthe outstanding balance of these notes.

During the three months ended March 31, 2007 and our existing equity stake in Avidia. In addition, we may be subject to pay additional amounts upon the achievement of certain future events.

Financing

In February 2006, we issued $5.0 billion convertible notes, of which $2.5 billion pay interest at 0.125% and are due in 2011 and $2.5 billion pay interest at 0.375% and are due in 2013. In connection with the issuance of these convertible notes, a total of $3.0 billion of our common stock was repurchased under our stock repurchase program. Also concurrent with the issuance of these convertible notes, we purchased convertible note hedges at a cost of approximately $1.5 billion. The net proceeds received from the issuance of the 2011 and 2013 Convertible Notes, the repurchase of common stock and the purchase of the convertible note hedges was $440 million. Also concurrent with the issuance of the convertible notes, we sold 62.8 million warrants to acquire shares of our common stock for proceeds of $774 million, 31.3 million of which may be settled in May 2011 and 31.5 million of which may be settled in May 2013. For further information on these transactions, see “Financing arrangements” above.

During the nine months ended September 30, 2006 and 2005, we repurchased 67.08.8 million and 48.446.6 million shares of our common stock, respectively, at a total cost of $4,755$537 million and $3,194$3,374 million, respectively. As of September 30, 2006,March 31, 2007, we had $1,784$6,002 million available for stock repurchases under our stock repurchase programprograms authorized by the Board of Directors. The manner of purchases, amountamounts 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 may include private block purchases as well as market transactions. Repurchases under our stock repurchase programprograms 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, Item“Item 2. Unregistered Sales of Equity Securities, Use of Proceeds and Issuer Purchases of Equity Securities.

On March 2, 2005, as a result of certain holders of the zero coupon convertible notes due in 2032 exercising their March 1, 2005 Put Option, we repurchased $1.59 billion aggregate principal amount or approximately 40% of the then outstanding convertible notes at their then-accreted value for $1,175 million in cash.


We receive cash from the exercise of employee stock options and proceeds from the sale of stock pursuant to the employee stock purchase plan. Employee stock option exercises and proceeds from the sale of stock by us pursuant to the employee stock purchase plansplan provided $367$138 million and $924$89 million of cash during the ninethree months ended September 30,March 31, 2007 and 2006, and 2005, 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.

29


Item 4.            Controls and Procedures

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 September 30, 2006.March 31, 2007.

Further, management determined that, asThe Company is in the process of September 30, 2006, thereimplementing 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 certain internal controls 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 in our internal control over financial reporting that occurred during the fiscalfirst quarter then endedof 2007 that have materially affected, or are reasonably likely to materially affect, ourthe Company’s internal control over financial reporting.

39




30


PART II - - OTHER INFORMATION

Item 1.            Legal Proceedings

Item 1.LEGAL PROCEEDINGS

Certain of our legal proceedings are reported in our Annual Report on Form 10-K for the year ended December 31, 2005, with material developments since that report described in our Quarterly Reports on Form 10-Q for the quarters ended March 31, 2006 and June 30, 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 August 17, 2006,March 22, 2007, Amgen filed a combined petitionPetition for panel rehearing and rehearing en banca Writ of Certiorari with the United States Court of Appeals for the Federal Circuit regarding the claim construction with respect to claim 1 of the U.S. Patent No. 5,955,422 (the “‘422 Patent”).Supreme Court.

Israel Bio-Engineering Project Litigation (“IBEP”)

The United States Court of Appeals for the Federal Circuit held oral argument on October 4, 2006.

Average Wholesale Price Litigation

In the Multi-District Litigation (the “MDL”) Proceeding, on September 12, 2006, a hearing beforeApril 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 was held on plaintiffs’ motion for class certification as to the Phase II defendants, which includeMassachusetts. Amgen and Immunex Corporation (“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 April 2,July 30, 2007.

Commonwealth of Pennsylvania v. TAP Pharmaceutical Products, Inc. et. al.

On October 11, 2006, the case was removed to the United States District Court for the Eastern District of Pennsylvania.

State of Wisconsin v. Amgen Inc., et. al.

On October 11, 2006, the case was removed to the United States District Court for the Western District of Wisconsin.

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


On October 11, 2006, the case was removedA hearing on Defendants’, which includes Amgen and Immunex together with other pharmaceutical manufacturers, motions to the United States District Courtdismiss is scheduled for the Middle District of Alabama. On November 3, 2006, the case was remanded to the Circuit Court of Montgomery County, Alabama.May 9, 2007.

People of State of IllinoisIUOE, Local 68 v. Abbott Laboratories, Inc., et. al

On October 11, 2006, the case was removed to United States District Court for the Northern District of Illinois.

County of Erie v. Abbott Laboratories, Inc.,AstraZenaca, PLC, et al.

On September 7, 2006, the court granted in part,A hearing on Defendants’, which includes Amgen and denied in part defendants’Immunex together with other pharmaceutical manufacturers, motions to dismiss. Immunex’s motion to dismiss was granted. Amgen’s motion to dismiss washeld on April 5, 2007 in which Defendants’ motions were denied. On October 11, 2006, the case was removed to United States District Court for the Western District of New York.

Roche Matters

State of MississippiAmgen Inc. v. Abbott Laboratories, Inc.F. Hoffmann-La Roche Ltd., et al.

On October 11, 2006, the case was removed to United States District CourtMarch 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 Northern District of Mississippi.

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

On October 10, 2006, the case removed to the United States District Court for the District of MassachusettsMassachusetts’ (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 willaffirmative 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 transferred intotried by a jury so long as Roche’s antitrust counterclaims remain in the MDL proceeding.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.

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

 On October 6, 2006, the Attorney General of the state of Alaska filed a complaint naming Amgen and Immunex, along with several other pharmaceutical manufacturers, as defendants in the litigation. The complaint was filed with the Alaska Superior Court in Anchorage, Alaska. Amgen was served with the complaint filed on October 19, 2006. Immunex has yet to be served.

County of Schenectady v. Abbott Laboratories,Ariad Pharmaceuticals, Inc., et al.

On August 21, 2006, Immunex was served with the complaint and on August 24, 2006, Amgen was served with the complaint filed in the Supreme Court of New York, Schenectady County. On October 11, 2006, the case was removed to United States District Court for the Northern District of New York.

County of Oswego v.Abbott Laboratories, Inc., et al. (“Ariad”)

On August 21, 2006, Immunex was served with the complaint and on August 24, 2006, Amgen was served with the complaint filed in the Supreme Court of New York, Oswego County. On October 11, 2006, the case was removed to United States District Court for the Northern District of New York.


Johnson & Johnson Matters

Arbitration/Demand for Separate BLA

From September 11-15, 2006, a final arbitration hearing was held before the arbitration panel in Chicago, Illinois. Closing arguments have been scheduled for November 29, 2006.

Ortho Biotech Litigation

On SeptemberMarch 27, 2006, closing arguments were held on Ortho Biotech’s motion for preliminary injunction in Trenton, New Jersey before2007, the United States District Court for the District of New Jersey.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”).

Roche MattersOther

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

On OctoberMarch 20, 2006,2007, Amgen received a letter from Chairmen Dingell and Stupak of the U.S.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 Massachusetts denied F. Hoffman-La Roche Ltd., Roche Diagnostics GmbHCalifornia (the “California Central District Court”). The complaint alleges that Amgen and Hoffman-La Roche, Inc.’s (collectively, “Roche”) motionthese 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 dismiss based upon lack of subject matter jurisdiction and denied Ortho Biotech’s motion to intervenepurchase 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 lawsuit. On October 23, 2006, a scheduling conferenceCalifornia 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 heldimproperly

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 which the judge set September 2007 as the target date for the trial to commence.  On November 6, 2006, Roche filed an answer to the complaint in which Roche deniesstudies that they infringe the patents-in-suit, assert legal and equitable defenses and counterclaims including non-infringement, patent invalidity, patent unenforceability, patent misuse,tested Aranesp®. This suit, as well as accusingadditional 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 violating stateAmgen’s publicly traded securities; and federal antitrust(iii) it caused plaintiff and unfair competition law.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.

U.S. International Trade Commission

On August 31, 2006,Further on May 1, 2007, two shareholder derivative complaints were filed in Superior Court of the U.S. International Trade CommissionState 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 “Commission”“State Defendants”) adopted. The complaints allege that the Administrative Law Judge’s summary determination terminatingState Defendants breached their fiduciary duties, wasted corporate assets, were unjustly enriched and violated the investigationCalifornia 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 clinical trial exemption to patent infringement liability under 35 U.S.C. 271(e)(1). On October 11, 2006,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 a petition for reviewin the Superior Court of the Commission’s decision with the United States CourtState of Appeals for the Federal Circuit.California, Ventura County, described above.

Amgen Inc., et. al. v. Ariad Pharmaceuticals, Inc.

On September 11, 2006, the U.S. District Court for the District of Delaware denied Ariad Pharmaceuticals, Inc.’s (“Ariad”) motion to dismiss for lack of subject matter jurisdiction and denied without prejudice Ariad’s motion to dismiss for failure to name indispensable parties. On September 25, 2006, Ariad filed a motion seeking certification for interlocutory appeal of the Court’s denial of Ariad’s Motion to Dismiss for lack of subject matter jurisdiction. On October 5, 2006, Ariad filed a renewed motion to dismiss for failure to name indispensable parties. The Court heard oral argument on these motions on November 3, 2006 and granted Ariad’s motion seeking certification for an interlocutory appeal. The Court denied without prejudice Ariad’s renewed motion to dismiss and motion to transfer.33



Item 1A.RISK FACTORS

Item 1A.         Risk Factors

The following itemsThis report and other documents we file with the SEC contain forward looking statements that are representativebased 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 thefuture performance and involve certain risks, uncertainties and assumptions that couldare 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 the outcome of the forward looking statementsmany other companies, such as employment relations, general economic conditions, geopolitical events and actual results could beinternational 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 different.and adversely.

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 patents 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, F. Hoffmann-La Roche Ltd (“Roche”) is developing a pegylated erythropoietin molecule that, according to Roche’s public statements,peg-EPO for which they expect to bring tohave filed a BLA with the U.S. market despite their acknowledgementFDA and which Roche has stated has a PDUFA date of our U.S. erythropoietin patents.May 19, 2007. On November 8, 2005, we filed a lawsuit against Roche for patent infringement of six of our U.S. patents. This lawsuit is described in “Item 3. Legal Proceedings – Amgen Inc. v. F. Hoffmann-La Roche Ltd., et al.” in our Form 10-K for the year ended December 31, 2005, and updated in “Item 1. Legal Proceedings – Roche Matters” above. In addition, on April 11, 2006, we filed a complaint with the U.S. International Trade Commission (ITC)(“ITC”) requesting that the ITC institute an investigation of Roche’s importation of pegylated recombinant human erythropoietin.peg-EPO. This lawsuit and matter is described in “Item 1. Legal Proceedings Roche Matters.” Further,According to Roche’s public statements, they expect to launch the molecule in the U.S. nephrology segment in 2007, upon regulatory approval, despite our ongoing lawsuit and their acknowledgement of our U.S. erythropoietin patents. (See “—Our marketed products face substantial competition and other companies may discover, develop, acquire or commercialize products before or more successfully than we are currently involved in an ongoing patent infringement lawsuit against Transkaryotic Therapies, Inc. (“TKT”do.) and Aventis with respect to our erythropoietin patents. If we lose or settle current or future litigations at certain stages or entirely, we could be:be subject to competition and/or significant liabilities; required to enter into third-party licenses for the infringed product or 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 granulocyte-colony stimulating factors or 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 etanerceptpanitumumab products as EPOGEN®EPOGEN® (Epoetin alfa), NEUPOGEN® NEUPOGEN®

34


(Filgrastim), Aranesp®Aranesp® (darbepoetin alfa), Neulasta®Neulasta® (pegfilgrastim) and Enbrel®, Enbrel® (etanercept), Sensipar®/Mimpara® (cinacalcet HCl) and Vectibix™ (panitumumab), respectively. Our material patents are set forth below. With respect to our material patents, we have had a number of G-CSF patent expiries in the United States andStates. In addition, we have had one expiry in the European Union (the “EU”) and oneprincipal erythropoietin patent expiry in the EU.


EU and our principal European patent relating to G-CSF has expired.

 

Product

General Subject Matter

Expiration

Epoetin alfa

U.S.

— Process of making erythropoietin

8/15/2012

— Product claims to erythropoietin

8/20/2013

— Pharmaceutical compositions of erythropoietin

8/20/2013

— Cells that make certain levels of erythropoietin

5/26/2015

darbepoetin alfa

Europe(1)

Europe(1)

— Glycosylation analogs of erythropoietin proteins

10/12/2010

— Glycosylation analogs of erythropoietin proteins

8/16/2014

Filgrastim

U.S.

— G-CSF polypeptides

12/3/2013

— Methods of treatment using G-CSF polypeptides

12/10/2013

pegfilgrastim

U.S.

— Pegylated G-CSF

10/20/2015

Europe(1)

Europe(1)

— Pegylated G-CSF

2/8/2015

etanercept

U.S.

— Methods of treating TNF — dependent disease

inflammatory response

9/5/2009

— TNFR proteins and pharmaceutical compositions

9/5/2009

— TNFR DNA vectors, cells and processes for making proteins

10/23/2012
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)

10/23/2012An application for patent term extension has been submitted and is currently pending in the United States.


(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.

We also have been granted or obtained rights to patents in Europe relating to:to erythropoietin; G-CSF; pegfilgrastim (pegylated G-CSF); etanercept; two relating to darbepoetin alfa; and hyperglycosylated erythropoietic proteins.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 as these patents have expired, other companies could receive approval for and market follow-on biologics or biosimilar products (as they are generally known in the EU) to compete with these products in the EU;EU presenting additional competition to our products. (See “—Our Our marketed products face substantial competition and other companies may discover, develop, acquire or commercialize products before or more successfully than we do.”) While we do not market EPOGEN® in Europe as this right belongs to Johnson & Johnson (through Kirin Amgen, Inc. (“KA”)), we do market Aranesp® in the EU, which competes with Johnson & Johnson’s EPREX® product, Roche’s Neorecormon® product and others’ erythropoietin products. 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 addition, based on an announcement bythe first quarter of 2007, Shire Pharmaceuticals Group plc (“Shire”)received approval in the EU for Dynepo™ (Epoetin delta), we expect that a competing erythropoietin product. In addition, Roche is developing its peg-EPO product manufactured by Shire, may appear on the marketwhich, upon regulatory approval, we expect they will launch in the EU nephrology segment in 2007. We also expect thatAlthough, we cannot predict whether or to what extent the firstentry of biosimilar G-CSF product may be approvedproducts or other competing products would impact future Aranesp®, Neulasta® or NEUPOGEN® sales in the EU, as early as third quarter of 2007 andbiosimilar products or other products that it wouldeffectively compete with Neulasta® and our products could reduce sales which could have a material adverse affect on our results of operations.NEUPOGEN®.

In 2006, the European Medicines Agency (“EMEA”)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 granulocyte-colony stimulating factors,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. Although,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 whether or to what extent the entry of biosimilar products would impact future Aranesp®, Neulasta® or NEUPOGEN® saleswhen follow-on biologics could appear in the EU, biosimilar or other products that effectively compete with our products could reduce sales which could have a material adverse affect on our results of operations.


United States.

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 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. The results of these clinical trials are used as the basis to obtain regulatory approval from government authorities such as the U.S. Food and Drug Administration (“FDA”).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 timely 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 AMG 706,motesanib diphosphate, we recently announced that two ofdelayed our phase 3 “mega-site” trialstrial (involving 200 or more sites) associated with the AMG 706 program, specifically the Phase 3 study in first line breast cancer and first line non-small cell lung cancer, which was previously expected to begin in the fourth quarter of 2006, have been delayed subject to additional Phase 1 and 2 data and protocol modifications. Additionally, clinicaluntil 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.

The number, size, durationWe have substantially expanded our R&D capabilities to manage and complexity of ourexecute increasingly larger and more complex clinical trials has increased and we expect will continue to increase significantly for 2006, in particular with respectbuild the capacity to denosumab, our late-stage investigational product for osteoporosisadvance more compounds into and metastatic bone cancer. Due tothrough the number of large-scale clinical trials initiated this year,clinic. In the near term, we expect to see further accelerated growth in research and developmentR&D expense in 2006 as compared2007, but not to 2005.the same extent experienced in 2006. For example, testing denosumabthe nine “mega-site” trials which we began in the osteoporosis setting requires large clinical trials, substantial2006 will continue to require significant time, and resources to recruit patients and significant expense to execute. WeHowever, as a result of recent regulatory and reimbursement challenges related to Aranesp® and EPOGEN®, we have begun nine “mega-site”been 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 as a result of these recent events, we may defer or possibly cancel previously planned clinical trials in 2006order to support denosumabadjust our R&D investment plans. Such actions could delay obtaining approval or reduce the number of indications and our other late-stage programs. To execute our clinical trial programs, we need to accelerate the growthmarket potential of our development organization, implement new management structures and approaches and increase dependence on third-party contract clinical trial providers. Further,product candidates. In order to increase the number of patients available for enrollment for our clinical trials, we are planning, with the assistance of third-party contract clinical trial providers,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 the increasing number, sizeour increasingly larger, more complex and complexity of ourregulatory 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. 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

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(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.)

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.

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 registration and marketing approval, mandate product withdrawals and require changes in labeling of 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 we may not be able to sell future products and our sales could be adversely affected.”)

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 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 problems 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 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.

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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 materially.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.”) 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.

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. 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 to require bundling. Nevertheless, we expect the policy debate around a bundled payment system in ESRD to continue in 2007.

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.

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. Successful product development in the biotechnology industry is highly uncertain, and very few research and developmentR&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 companies or peopleparties 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 licensors or partners may fail to effectively conduct clinical development or clinical manufacturing activities

Several

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

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 would constitute an appropriate regulatory filing package for that indication.

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

45


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 labelinvestigator-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 take other potentially limiting or costly actions if we or others identify side effects after our products are on the market.”; and “—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 we may not be able to sell future products and our sales could be adversely affected.”)

Our sales depend on paymentbusiness may be impacted by government investigations or litigation.

We and reimbursement from third-party payers, and, to the extent that reimbursement for our products is reduced, this could negatively impact the utilizationcertain of our products.

Insubsidiaries 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 United States, dialysis providersordinary course of our business. Matters required to be disclosed by us are primarily reimbursed for EPOGEN® by the federal government through the End Stage Renal Disease Program (“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 the Centers for Medicare & Medicaid Services (“CMS”). Most patients receiving Aranesp®, Neulasta® and NEUPOGEN® for approved indications are covered by both government and private payer health care programs. Since January 1, 2006, ENBREL and Sensipar® are eligible for coverage from the U.S. government under Medicare Part D. Although both ENBREL and Sensipar® have received broad formulary placementset forth in 2006 and 2007, Part D formulary placements are made by individual Part D plan sponsors with oversight by CMS“Item 1. Legal Proceedings” and are subject to revisionupdated as required in the future.Generally, in Europe and other countries outside the U.S., the government sponsored healthcare systemsubsequently filed Form 10-Qs. Litigation is the primary payer of healthcare costs of patients. Governments may regulate access to, prices or reimbursement levels of our products to control costs. Worldwide use of our products may be affected by these cost containment pressures and cost shifting from governments and private insurers to health care providers in response to ongoing initiatives to reduce health care expenditures. Therefore, 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.

The Medicare Prescription Drug Improvement and Modernization Act (or the “Medicare Modernization Act” (“MMA”)) was enacted into law in December 2003 and implemented January 1, 2005. Changes resulting from the MMA, which lowered reimbursement for our products, could negatively affect product sales of some of our marketed products. We believe that our product sales for 2005inherently unpredictable, and the nine months ended September 30, 2006, have not been nor, for the remainder of 2006,


are expected to be significantly impacted by the reimbursement changes resulting from the MMA. We believe this was,outcome can result in part, due to the effects of CMS’ oncology demonstration project (the “2005 Demonstration Project”) on sales of our products used in supportive cancer care, especially Aranesp®. Furthermore,excessive verdicts and/or injunctive relief that affects how we believe this was also, in part, due to increased reimbursement rates to physicians from CMS for services associated with drug administration. The 2005 Demonstration Project, which provided financial incentives to physicians for collecting and reporting oncology patient survey data, expired on December 31, 2005. In November 2005, CMS announced a new demonstration project (the “2006 Demonstration Project”) that uses different criteria for how patients with cancer are evaluated and treated and that is targeted at approximately half of the funding originally targeted for the 2005 Demonstration Project. The final rule for the 2006 Medicare Physician Fee Schedule Payment Final Rule issued in November 2005 reduced payments for physician services in 2006 by approximately 4.4% on average, although legislation eliminated this reduction for 2006. The Medicare Physician Fee Schedule Payment Final Rule for 2007 issued in November 2006 and effective January 1, 2007, reduces payments for physician services in 2007 by approximately 5.0% on average. It is uncertain whether legislation will eliminate this reduction in 2007 or if payments for physician services will again be reduced after 2007. Because we cannot accurately predict the impact of any such changes on how, or under what circumstances, healthcare providers will prescribe or administer our products, we cannot estimate the full impact of the MMA onoperate our business. However, additional provisions of the MMA and other regulations affecting reimbursementConsequently, it is possible that have gone or may go into effectwe could, affect our product sales and related sales growth in the future.

The main components of the MMA that affect our currently marketed products are as follows:

·                  Through 2004, the Average Wholesale Price (“AWP”) mechanism was the basis of Medicare Part B payment for covered outpatient drugs and biologics. Since January 1, 2005, in the physician clinic setting, Aranesp®, Neulasta® and NEUPOGEN® are being reimbursed under a Medicare Part B payment methodology that reimburses each product at 106% of its “average sales price” (“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 first quarter of 2007 will be based in part on certain historical sales and sales incentive data for Aranesp® from October 1, 2005 through September 30, 2006. CMS publishes the ASPs for products in advance of the quarter in which they go into effect. The ASPs for Aranesp® and Neulasta® trended downward during the first three quarters of 2005, began to stabilize during the fourth quarter of 2005 and have remained relatively stable in 2006.

·                  Since August 1, 2006, physicians in the physician clinic setting have had the choice between purchasing and billing for specific drugs under the ASP+6% system or obtaining those drugs from vendors selected by CMS under the “competitive acquisition program” (“CAP”). We believe CAP is unlikely to have a significant impact on our business.

·                  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 AWP as the basis for reimbursement in 2005. CMS’


2005 reimbursement rate, as in 2003 and 2004, continued the application of an “equitable adjustment” such that the 2005 Aranesp® reimbursement rate was based on the AWP of PROCRIT®. For 2005, the reimbursement rate for Aranesp® was 83% of the AWP for PROCRIT®, down from 88% of the AWP for PROCRIT® in 2004, with a dose conversion ratio of 330 U PROCRIT® to 1 mcg Aranesp®, the same ratio as 2004. Effective January 1, 2006, the OPPS system changed from an AWP based reimbursement system to a system based on ASP. This change affects Aranesp®, Neulasta® and NEUPOGEN® when administered in the hospital outpatient setting. The OPPS rule for 2006 based reimbursement for non-pass through products such as Aranesp®, Neulasta® and NEUPOGEN® on ASP+6% using the same payment amounts as used in the physician clinic setting and did not apply an “equitable adjustment” to tie the reimbursement rate for Aranesp® to PROCRIT® using a dose conversion ratio. In the OPPS final rule for 2007, CMS states that it will not apply an “equitable adjustment” to the payment rate for Aranesp® in 2007, and will, as in 2006, reimburse hospitals for the costs associated with administering specific Medicare-covered outpatient drugs and biologicals (such as Aranesp®, Neulasta® and NEUPOGEN®) at ASP+6%. CMS noted in the 2005 final rule and has maintained that it reserves the right to apply an “equitable adjustment” to the payment rate for Aranesp® in future years.

·                  Pursuant to final rules issued by CMS on November 3, 2004, Medicare reimbursement for EPOGEN® used in the dialysis setting for calendar year 2005 changed from the previous rate in 2004 of $10 per 1,000 Units to $9.76 per 1,000 Units, in 2005, a rate based upon an average acquisition cost for 2003 determined by the Office of the Inspector General (“OIG”) and adjusted for price inflation based on the Producer Price Index for pharmaceutical products. Pursuant to the CMS final rules, the difference between the 2004 reimbursement rates for all drugs separately billed outside the dialysis composite rate (including EPOGEN®) and the 2005 reimbursement rates for such drugs was added to the composite rate that dialysis providers receive for dialysis treatment. Pursuant to the Medicare Physician Fee Schedule Payment Final Rule for 2006, effective January 1, 2006, the payment mechanism for separately reimbursed dialysis drugs in both freestanding 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 and calculated quarterly in the same manner as described above for our products under the Medicare Part B payment methodology. CMS publishes the ASPs for products in advance of the quarter in which they go into effect. Based upon the 2006 final rule, the reimbursement rate for EPOGEN® for 2006 decreased from the reimbursement rate in 2005. In the Medical Physician Fee Schedule Payment Final Rule for 2007, CMS continues the 2006 payment mechanism of ASP+6% for EPOGEN® and other separately reimbursed dialysis drugs in both freestanding and hospital-based dialysis centers. Because we cannot accurately predict the extent to which this reimbursement will impact how, or under what circumstances, healthcare providers will prescribe or administer EPOGEN®, we cannot estimate the full impact of the ASP+6% reimbursement rate on our EPOGEN® product sales. However, we believe that it has not been and is unlikely to be significant in 2006 and 2007.


The Medicare Physician Fee Schedule Proposed Rule for 2007 addressed several new topics regarding the ASP payment methodology. In the proposed rule, 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 instructionincur judgments or other guidance. Any changes toenter into settlements of claims for monetary damages or change the ASP calculation could adversely affect the Medicare reimbursement forway we operate our products administered in the physician office and the hospital outpatient setting.

In addition, on November 9, 2005, CMS released a revision to the Hematocrit Measurement Audit Program Memorandum (“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. The new policy, Claims Monitoring Policy: Erythropoietin/darbepoetin alfa usage for beneficiaries with end stage renal disease (“Claims Monitoring Policy”), became effective April 1, 2006 and was further revised effective October 1, 2006. The revised Claims Monitoring Policy 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 claims using a coding modifier. If the provider does not reduce the patient’s EPOGEN® and Aranesp® dose and there is no medical documentation to support the higher dosage, reimbursement will be reduced to the level it would have been had the provider reduced dosage by twenty-five percent. Based on our preliminary evaluation, we do not expect the Claims Monitoring Policy to have a negative impact on EPOGEN® and Aranesp® sales and given the importance of EPOGEN® and Aranesp® for maintaining the quality of care for dialysis patients, we do not expect that the policy will substantially impact the utilization of EPOGEN® and Aranesp®. However, given the recent revisions, we are currently in the process of further evaluating the Claims Monitoring Policy. As a result, we cannot predict the potential full impact of this final guidance on our business.

Further, the Deficit Reduction Act of 2005 (“DRA”) 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 as a result we cannot predict the potential full impact on 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, health care 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,business, which could have a material adverse effect on us and our results of operations. For example,operations (in the usecase of EPOGEN®monetary damages, in the United Statesperiod in connection with treatmentwhich such damages are incurred).

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 end stage renal diseasepharmaceutical products has resulted in false and overstated AWP, which in turn is funded primarilyalleged 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. federal government. In early 1997, CMS, formerly knownDepartments 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 — Average Wholesale Price Litigation” and are updated as Healthcare Financing Administration (“HCFA”), instituted a reimbursement change for EPOGEN®, which materiallyrequired in subsequent Form 10-Qs. Other states and adversely affected our EPOGEN® sales until the policies were revised. 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 usageagencies could initiate investigations of our products, which may adversely impact product sales. Further, when a new therapeutic product is approved, the governmentalpricing practices. A decision adverse to our interests on these actions and/or private coverage and reimbursement for that product is uncertain and a failure to demonstrate clear economic value associated with the use of


investigations could

a new therapeutic product as compared to existing therapeutic products or practices may

46


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,substantial economic damages 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.operations 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.

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 aan 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 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 derived from biological sources, including mammalian tissues, bovine serum and human serum albumin, or HSA. We are investigating alternatives to certain biological sources and alternative manufacturing processes that do not require the use of certain biologically-sourced raw materials as

47


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 in the manufacture of our products could

51




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.

Our current products and products in development cannot be sold if we do not maintain regulatory approval of our products and we may be required to perform additional clinical trials or change the labeling of our products 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 terminate clinical trials, require additional testing, delay or withhold registration and marketing approval, mandate product withdrawals and require changes in labeling of 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), 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. As a result, clinical trials may receive greater scrutiny with respect to safety. Any safety concerns may result in the FDA or other regulatory authorities requiring 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 we may not be able to sell future products and our sales could be adversely affected.”) In addition, if regulatory authorities determine that we or our licensor or partner conducting research and development activities on our behalf have not complied with regulations in the research and development of a product candidate, 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.

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 initiated a voluntary recall of the Neulasta® SureClickTM 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 ® SureClickTM pen or with the reports of missing detached or loose rubber caps, we may experience the same or other problems 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 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.

If we or others identify side effects before or after any of our products are on the market, or if manufacturing problems occur, regulatory approval may be withdrawn and reformulation of our products, additional clinical trials, 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. Certain labels 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; 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 VectibixTM (panitumumab) prescribing information includes warning language from the FDA on dermatologic toxicities and severe infusion reactions as part of an evolving FDA labeling to the anti-epidermal growth factor receptor (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 also instituted a class label change for the three recombinant erythropoiesis stimulating proteins (ESPs) marketed in the U.S. The label change to the class, which included EPOGEN® and Aranesp®, added information about pure red cell aplasia (PRCA) to the adverse event profile section to the three ESP product labels in the U.S. 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.

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. 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 take other potentially limiting or costly actions if we or others identify side effects after our products are on the market.”) We currently manufacture our products and product candidates at our


manufacturing facilities located in Thousand Oaks and Fremont, California, Boulder and Longmont, Colorado, West Greenwich, Rhode Island and Juncos, Puerto RicoRico. (See “—We 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.”). 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™ and plan to use contract manufacturers to produce a number of our late stagelate-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.”) 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 patient prescriptions, primarily due to variation in the expected production yield from Boehringer Ingelheim Pharma KG (“BI 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 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 located in Puerto


Rico, 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 full production capacity over the next few years, expand 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 of our new plant in Ireland; 2) construction, qualification and licensure of new formulation, fill and finish facilities at our Puerto Rico site; and 3)2) expansion of existing bulk protein facilities at our Puerto Rico site including the licensure of our Puerto Rico plant for production of Aranesp® and EPOGEN®darbepoetin bulk drug substance.substance and increased production of pegfilgrastim and Filgrastim bulk drug substance; 3) construction, qualification and licensure of our new process bulk and formulation, fill and finish plant in Ireland.

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 VectibixTMVectibix™. 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.

49


We 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®EPOGEN®, Aranesp®Aranesp®, Neulasta®Neulasta® and NEUPOGEN®NEUPOGEN® and some formulation, fill and finish operations for ENBREL 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 aan 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 had evidence of adverse trends in the microbial bioburden of the production environment that reduced the production output. 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.”)

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

We currently produce a substantial portion of annual ENBREL supply at our Rhode Island manufacturing facilities. 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

50


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 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 the Rhode Island facilities’ 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 are 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, 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. 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, wethe 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 Centocor, Inc., Johnson & Johnson, Abbott, Laboratories, Biogen, IDEC Inc., Genentech, Inc., Pfizer Inc.,Bristol-Meyers Squibb, Novartis Corp. and Sanofi-Aventis, as well as the generic drug methotrexate, and may face competition from other potential therapies being developed. 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, Aranesp®Aranesp® competes with products marketed by Johnson & Johnson in the United States and the EU and with products marketed by Roche in the EU. Also, Aranesp® may faceAranesp® faces competition in the EU from anotherDynepo™, a competing erythropoietin product producedmarketed by Shire and may face competition from Roche’s peg-EPO, which may receive approval in 2007. Aranesp®the EU and EPOGEN®be launched later this year. Aranesp® and EPOGEN® may also face competition in the U.S. from Roche’s pegylated erythropoietin molecule that, accordingpeg-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 bring tolaunch the molecule in the U.S. marketnephrology segment in 2007, upon regulatory approval, despite our

51


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, VectibixTMAstellas/FibroGen are co-developing an erythropoietic small molecule and Affymax is developing 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, will competecompetes with Imclone’s Erbitux.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 take other potentially limiting or costly actions if we or others identify side effects after our products are on the 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 as these patents have expired, other companies could receive approval for and market biosimilar products to compete with our products in the EU, presenting additional competition to our products. 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. 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 some 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. 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. We also expect thatcannot predict whether or to what extent the firstentry of biosimilar G-CSF product may be approved as early as third quarterproducts or other competing products would impact future Aranesp®, Neulasta® or NEUPOGEN® sales in the EU. Our inability to compete effectively could reduce sales which could have a material adverse affect on our results of 2007 and that it would compete with Neulasta® and NEUPOGEN®. 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 granulocyte-colony stimulating factors,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. WeIn 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 whether or to what extent the entry of biosimilar products would impact future Aranesp®, Neulasta® or NEUPOGEN® saleswhen follow-on biologics could appear in the EU. Our inability to compete effectively could reduce sales which could have a material adverse affect on our results of operations.


United States.

Certain of our competitors, including biotechnology and pharmaceutical companies, market products or are actively engaged in research and developmentR&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, and if we fail to adequately manage that growth our business could be adversely impacted.

We have had an aggressive growth plan that has included substantial and increasing investments in research and development, sales and marketing and facilities. We plan to continue to grow, andhowever given the recent challenges around ESAs, our plan has a number of risks, some of which we cannot completely control. For example:

·we need to generate higher revenues to cover a higher level of operating expenses, and our ability to do so may depend on factors that we do not control

·we need to attract and retain highly qualified management, scientific, manufacturing and sales and marketing personnel, including the planned hiring of approximately 1,000 new staff into our research and development organizations and a significant number of new personnel to support our manufacturing operations in 2006

·we will need to assimilate new staff members and we will need to manage complexities associated with a larger faster growing and more geographically diverse organization

·

we will need to significantly expand our clinical development resources to manage and execute larger, more complex and increasingly global largerclinical trials

we will need to monitor and more complex clinical trialsmake 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 a number of late-stage product candidates close in time

·

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 need to start up and operate a number ofour new manufacturing facilities and enter into and manage new third-party contract manufacturing arrangements, which may result in temporary inefficiencies and higher costswhile operating our existing manufacturing facilities at near or full capacity

·

we are implementing an enterprise resource planning 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 manage our growth in these ways or others, such failure could result in a material adverse affect on our business and results of operations.

53


Concentration of sales at certain of our wholesaler distributors and consolidation of freestandingfree-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 clinics, dialysis centers, hospitals and pharmacies. One of these products, EPOGEN®EPOGEN®, is primarily sold to freestandingfree-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 number of the outpatient dialysis facilities located in the United States and account for a significant majority of all EPOGEN®EPOGEN® sales in the freestandingfree-standing dialysis clinic setting. We recentlyIn 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 proteins 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.

This concentration and consolidation has increased these entities’ purchasing leverage and 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 be dependent in part upon Wyeth.

Under a co-promotion agreement, wethe Company 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 or if wethe Company and Wyeth fail to coordinate our efforts effectively, our sales of ENBREL may be adversely affected materially.


Our businessrevenues may be impacted by government investigations or litigation.

Wefluctuate and certain of our subsidiariesoperating results are involved in legal proceedings relatingsubject to various patent matters, government investigations, our business operations, government requests for informationfluctuations and other legal proceedings that arise from time to time in the ordinary course of our business. Matters requiredthese fluctuations could cause financial results to be disclosed by us are set forth in “Item 3. Legal Proceedings” in Form 10-K for the year ended December 31, 2005,below expectations 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).

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 Corporation (“Immunex”), now a wholly owned subsidiary of ours, alleging that the reporting of prices for pharmaceutical products has resulted in false and overstated 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 health care 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, are not reporting their “best price” to the states under the Medicaid program. These cases and investigations are described in “Item 3. Legal Proceedings - Average Wholesale Price Litigation” in Form 10-K for the year ended December 31, 2005, and are updated as required in subsequent 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 result in substantial economic damages and could have a material adverse effect on our results of operations 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.

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, private health/science foundations and organizations involved in various diseases from time to time may also publish guidelines or recommendations to the health care 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. Organizations like these have in the past made recommendations about our products. Recommendations or guidelines that are followed by patients and health care providers could result in decreased use of our products. Some examples of government agency guidelines include:

·The Agency for Healthcare Research and Quality (“AHRQ”) issued a report on May 23, 2006 on erythropoietic stimulating proteins (“ESPs”) used in cancer treatment, comparing the effectiveness of Aranesp® and PROCRIT®. In its report, AHRQ concluded that there was no clinically significant difference in the two products’ efficacy in the chemotherapy-induced anemia setting. Although we do not believe Aranesp® sales will be significantly impacted by the release of this report, payers may use the report’s findings to modify coverage and reimbursement for ESPs used for treatment of chemotherapy-induced anemia, including Aranesp®, and use of this product could be affected.

·The Government Accountability Office (GAO) is conducting a study with the expected goal of developing recommendations on bundling ESRD drugs and biologicals into a composite rate. Amgen expects that the GAO recommendations resulting from this study will be consistent with earlier GAO studies recommending a fully prospective payment bundle of services and drugs. If the recommendations are implemented, these policies could adversely impact Medicare reimbursement for EPOGEN® and Aranesp® in the dialysis setting.

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

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 September 30, 2006,March 31, 2007, the trading price of our common stock has ranged from a high of $84.50$76.50 per share to a low of $63.52$55.72 per share.

54


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

·                  changes in reimbursement policies or medical practices

·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, is 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 take other potentially limiting or costly actions if we or others identify side effects after our products are on the 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.”) While we have developed and instituted a corporate compliance program based on what we believe to be current best practices, we cannot assure you that we, our employees, our consultants or our employeescontractors 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.

Our revenuesThe accounting method for our convertible debt securities may fluctuate,be subject to change.

A convertible debt security providing for net share settlement of the conversion value and meeting specified requirements under Emerging Issues Task Force (“EITF”) Issue No. 00-19, “Accounting for Derivative Financial Instruments Indexed to, and Potentially Settled in, a Company’s Own Stock,” is accounted for by recognizing interest expense at its stated coupon rate. For purposes of computing diluted earnings per share, any shares issuable upon conversion of such a security is computed using the treasury stock method. The effect of the treasury stock method is that the shares potentially issuable upon conversion of our convertible debt securities that meet these specified requirements are not included in the calculation of our earnings per share except to the extent that the conversion value of such securities exceeds their principal amount, in which event they are treated for earnings per share purposes as us having issued the number of shares of our common stock necessary to settle the conversion.

The EITF is reviewing whether the accounting method for net share settled convertible securities should be changed. The EITF is considering a proposed method for accounting for net share settled convertible securities under which the debt and equity components of the security would be bifurcated and accounted for separately. The effect of this fluctuation could causeproposal is that the equity component would be included in the paid-in-capital section of stockholders’ equity on an issuer’s balance sheet and, accordingly, the initial carrying value of the convertible securities would be reduced. Net income for financial resultsreporting purposes attributable to our common stockholders would be lower by recognizing accretion of the reduced carrying value of the convertible debt security to its face amount as additional interest expense. The diluted earnings per share calculation would continue to be below expectations.calculated based on the treasury stock method.

Our operating resultsWe cannot predict the outcome of the EITF deliberations and whether the EITF will require that net share settled convertible securities, and their related impact on earnings per share, be accounted for under the existing method, the proposed method described above or some other method, and when any change would be implemented or whether it would be implemented retroactively or prospectively.

We also cannot predict any other changes in GAAP that may fluctuate from period to periodbe made affecting accounting for a number of reasons. In budgetingconvertible debt securities. Any change in the accounting method for convertible debt securities could have an adverse impact on our operating expenses forpast or future reported financial results. These impacts could adversely affect the foreseeable future, we assume that revenues will continue to grow; however, sometrading price of our operating expenses are fixedcommon stock and in turn negatively impact the short term. 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, we may face:

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

·inability to maintain regulatory approval of marketed products or manufacturing facilities

·changes in our product pricing strategies

·lower than expected demand for our products

·inability to provide adequate supply of our products


·changes in wholesaler buying patterns

·increased competition from new or existing products

·fluctuations in foreign currency exchange rates

Of course, there may be other factors that affect our revenues in any given period. Similarly if investors or the investment community are uncertain about our financial performance for a given period, our stocktrading price could also be adversely impacted.

We may not realize all of the anticipated benefits of our merger with Abgenix, Inc.notes.

On April 1, 2006, we completed our acquisition of Abgenix for approximately $2.1 billion in cash plus the assumption of debt. The acquisition provides us with full ownership of VectibixTM, eliminates a tiered royalty on denosumab, one of our most important advanced pipeline products, as well as provides us with Abgenix’s manufacturing plant. The success of the merger will depend, in part, on our ability to realize the anticipated growth opportunities from integrating the businesses. The integration of two independent companies is a complex, costly and time-consuming process. We cannot assure you that the integration of Abgenix with us will result in the realization of the full post-merger benefits anticipated by us.

56


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

In connection with our ongoing process improvement activities associated with products we manufacture, we continually invest in our various manufacturing practices and related processes with the objective of increasing production yields and success rates 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. Depending on the timing and outcomes of these efforts and our other estimates and assumptions regarding future product sales, the carrying value of certain manufacturing facilities or other assets may not be fully recoverable and could result in the recognition of an impairment in the carrying value at the time that such effects are identified. The potential recognition of impairment in the carrying value, 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

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

During the three months ended September 30, 2006,March 31, 2007, we had onetwo outstanding stock repurchase program.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 may include private block purchases as well as market transactions. Repurchases under our stock repurchase programprograms 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 September 30, 2006March 31, 2007 is as follows:


 

 

 

 

 

 

 

Total Number

 

 

 

 

 

 

 

 

 

of Shares

 

Maximum $ Value

 

 

 

Total Number

 

Average

 

Purchased as Part

 

that May Yet Be

 

 

 

of Shares

 

Price Paid

 

of Publicly

 

Purchased Under the

 

 

 

Purchased

 

per Share

 

Announced Programs

 

Programs (1)

 

July 1 - July 31

 

2,595,235

 

$

69.38

 

2,594,700

 

$

2,109,191,167

 

August 1 - August 31

 

4,736,640

 

$

68.85

 

4,718,167

 

$

1,784,315,317

 

September 1 - September 30

 

759

 

$

69.13

 

 

$

1,784,315,317

 

Total

 

7,332,634

(2)

$

69.03

 

7,312,867

(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

  —    $—    —    $6,539,425,046

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) 
          

(1)          In December 2005,
(1)In December 2006, the Board authorized us to repurchase up to $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.

(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.57


Item 6.            Exhibits

Item 6.EXHIBITS

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

64




58


SIGNATURESSIGNATURES

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, 2007By:

Amgen Inc.

/s/ ROBERT A. BRADWAY

(Registrant)

Robert A. Bradway

Date:

November 9, 2006

By:

/s/ RICHARD D. NANULA

Richard D. Nanula

Executive Vice President

and Chief Financial Officer

 


59


AMGEN INC.

INDEX TO EXHIBITS

Exhibit No.

Description

  3.1

2.1

Agreement and Plan of Merger, dated as of September 28, 2006, among Amgen Inc., Aviator Merger Sub, Inc., Avidia, Inc. and Alloy Ventures, Inc., in its capacity as a Stockholders’ Agent thereunder. (Filed as an exhibit to Form 8-K filed on October 2, 2006 and incorporated herein by reference).

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

  3.2

Amended and Restated Bylaws of Amgen Inc. (As Amended and Restated May 10, 2006)February 14, 2007). (Filed as an exhibit to Form 8-K filed on March 13, 2006February 20, 2007 and incorporated herein by reference.)

4.1

  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

  4.2

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

4.3

  4.3

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.)

4.4

  4.4

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

4.5

  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

  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

  4.7

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

  4.8

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

  4.9

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

4.10

  4.10

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

4.11

Registration Rights Agreement, dated as of March 1, 2002, between Amgen Inc. and Merrill Lynch, Pierce, Fenner & Smith Incorporated. (Filed as an exhibit to Form 8-K on


March 1, 2002 and incorporated herein by reference.)

  4.11

4.12

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

4.13

  4.12

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.)

4.14

  4.13

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.)

4.15

  4.14

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.)

4.16

  4.15

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.)

4.17

  4.16

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.)

4.18

  4.17

Indenture, dated as of May 6, 2005, between Amgen Inc. and LaSalle Bank National Association. (Filed as an exhibit to Form 8-K on May 6, 2005 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 0.125% 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).

4.20

  4.19

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).

4.21

  4.20

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.)

4.22

  4.21

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.)

4.23

  4.22

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

10.1+

+

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 an exhibitexhibits to Form 8-K on December 8, 2005 and incorporated herein by reference.)

10.2

10.2+

+

Amgen Inc. Director Equity Incentive Program (As Amended and Restated December 6, 2005) and Forms of Stock Option Grant Agreements and Restricted Stock Unit Agreements for the Amended and Restated 1991 Equity Incentive Plan (As Amended and Restated December 5, 2005).Agreements. (Filed as an exhibitexhibits to Form 8-K on December 8, 2005 and incorporated herein by reference.)


10.3

+

Amgen Inc. Director Equity Incentive Program (As Amended and Restated December 6, 2005). (Filed as an exhibit to Form 8-K on December 8, 2005 and incorporated herein by reference.)

10.4

+

Forms of Stock Option Grant Agreements and Restricted Stock Unit Agreements for the Amgen Inc. Director Equity Incentive Plan. (Filed as an exhibit to Form 8-K on December 8, 2005 and incorporated herein by reference.)

10.3+

10.5

+

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 an exhibitexhibits to Form 8-K on December 8, 2005 and incorporated herein by reference.)

10.6

+

Forms of Stock Option Grant Agreements and Restricted Stock Unit Agreements for the Amended and Restated 1997 Equity Incentive Plan (As Amended and Restated December 5, 2005). (Filed as an exhibit to Form 8-K on December 8, 2005 and incorporated herein by reference.)

10.4+

10.7

+

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

10.8

10.5+

+

Forms of Stock Option Grant Agreements forAmgen Inc. Amended and Restated 1999 Equity Incentive Stock Plan (As Amended and

61


Restated December 5, 2005)April 1, 2006). (Filed as an exhibit to Form 8-KS-8 on December 8, 2005April 3, 2006 and incorporated herein by reference.)

10.9

10.6+

+

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.)

10.10

10.7+

+

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.)

10.11

+

Amgen Retirement and Savings Plan (As Amended and Restated January 1, 2006). (Filed as an exhibit to Form 8-K on October 20, 2005 and incorporated herein by reference.)

10.8+

10.12

+

First Amendment to the Amgen Retirement and Savings Plan (As Amended and Restated January 1, 2006). (Filed as an exhibit to Form 8-K on May 16, 2006 and incorporated herein by reference.)

10.13

+

Second Amendment to the Amgen Retirement and Savings Plan (As Amended and Restated January 1, 2006). (Filed as an exhibit to Form 8-K on July 14, 2006 and incorporated herein by reference).

10.14

+

Third Amendment to the Amgen Retirement and Savings Plan (As Amended and Restated January 1, 2006). (Filed as an exhibit to Form 8-K on September 15, 2006 and incorporated herein by reference).

10.15

+

Fourth Amendment to the Amgen Retirement and Savings Plan (As Amended and Restated January 1, 2006). (Filed as an exhibit to Form 8-K on October 6, 2006 and incorporated herein by reference).

10.16

+

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.)

10.17

10.9+

+

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.)

10.18

10.10+

+

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.)

10.19

10.11+

+

Third Amendment to the Amgen Supplemental Retirement Plan (As Amended and Restated January 1, 2007). (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+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.)


10.20

10.13+

+

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.)

10.21

10.14+

+

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.)

10.22

10.15+

+

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.)

10.23

10.16+

+

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.)

10.24

10.17+

+

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.)

10.25

10.18+

+

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.)

10.26

10.19+

+

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).

10.27

10.20+

+

Eight 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+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.)

10.28

10.22+

+

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 reference.)

62


10.29

+

refersence.)

10.23+

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.)

10.30

10.24+

+

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.)

10.31

10.25+

+

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.)

10.32

10.26+

+

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+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+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.)

10.33

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.)

10.34

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.)

10.35

10.31+

+

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.)

10.36

10.32+

+

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.)


10.37

10.33+

+

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.)

10.38

+

Promissory Note, dated June 29, 2001, of Dr. Roger M. Perlmutter. (Filed as an exhibit to Form 10-Q for the quarter ended June 30, 2001 on July 27, 2001 and incorporated herein by reference.)

10.34+

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.)

10.40

10.35+

+

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.)

10.41

10.36+

+

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.)

10.42

10.37+

+

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.)

10.43

10.38+

+

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.)

10.44

10.39+

+

Restricted Stock Purchase Agreement, dated December 6, 2004, between Amgen Inc. and

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.)

10.45

+

Amgen Inc. Amended and Restated 1996 Incentive Stock Plan (As Amended and Restated April 1, 2006). (Filed as an exhibit to Form S-8 on April 3, 2006 and incorporated herein by reference.)

10.40

10.46

+

Amgen Inc. Amended and Restated 1999 Incentive Stock Plan (As Amended and Restated April 1, 2006). (Filed as an exhibit to Form S-8 on April 3, 2006 and incorporated herein by reference.)

10.47

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.)

10.48

10.41

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.)

10.49

10.42

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.)

10.50

10.43

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.)

10.51

10.44

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.)

10.52

10.45

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.)

10.53

10.46

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.)

10.54

10.47

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.)

10.55

10.48

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.)

10.56

10.49

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.)

10.57

10.50

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.)

10.58

10.51

ENBREL®

ENBREL® 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.)

10.59

10.52

Amendment No. 1 to the ENBREL®ENBREL® 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.)

10.60

10.53

Amendment No. 2 to the ENBREL®ENBREL® 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.)

10.61

10.54

Amendment No. 3 to the ENBREL®ENBREL® 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.)

10.62

10.55

Amendment No. 4 to the ENBREL®ENBREL® 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.)

10.63

10.56

Amendment No. 5 to the ENBREL®ENBREL® 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.)

10.64

10.57

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.)

10.65

10.58

Asset 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.)

10.66

10.59

Amendment 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.)

10.67

10.60

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.)

10.68

10.61

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.)

10.69

10.62

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.)

10.70

10.63

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.)

10.71

10.64

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 10-Q for the quarter ended June 30, 2004 on August 6, 2004 and incorporated herein by reference.)

10.72

10.65

First Amendment dated as of December 6, 2004,2005, 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.)

10.73

10.66

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.)

10.74

10.67

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., 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.)

10.75

10.68

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.)

10.76

10.69

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.)

10.77

10.70

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.)

10.78

10.71

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


10.79

reference.)

10.72Confirmation 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.)

10.80

10.73

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.)

10.81

10.74

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.)

31*

31*

Rule 13a-14(a) Certifications.

32**

Section 1350 Certifications.


(* = filed herewith)

(** = 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.)

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67