e10vq
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 10-Q
(Mark One)
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þ |
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended March 31, 2011
OR
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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)
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Delaware
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95-3540776 |
(State or other jurisdiction of
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(I.R.S. Employer |
incorporation or organization)
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Identification No.) |
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One Amgen Center Drive,
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Thousand Oaks, California
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91320-1799 |
(Address of principal executive offices) |
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(Zip Code) |
(805) 447-1000
(Registrants 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 Section 15(d) of the Securities Exchange Act of 1934 during the preceding 12
months (or for such shorter period that the registrant was required to file such reports), and (2)
has been subject to such filing requirements for the past 90 days. Yes þ No o
Indicate by check mark whether the registrant has submitted electronically and posted on its
corporate Web site, if any, every Interactive Data File required to be submitted and posted
pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months
(or for such shorter period that the registrant was required to submit and post such files). Yes
þ No o
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated
filer, a non-accelerated filer, or a smaller reporting company. See the definitions of large
accelerated filer, accelerated filer and smaller reporting company in Rule 12b-2 of the
Exchange Act. (Check one):
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Large accelerated filer þ
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Accelerated filer o
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Non-accelerated filer o
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Smaller reporting company o |
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(Do not check if a smaller reporting company) |
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Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of
the Act) Yes o No þ
As of April 29, 2011, the registrant had 929,730,507 shares of common stock, $0.0001 par
value, outstanding.
PART I FINANCIAL INFORMATION
Item 1. FINANCIAL STATEMENTS
AMGEN INC.
CONDENSED CONSOLIDATED STATEMENTS OF INCOME
(In millions, except per share data)
(Unaudited)
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Three months ended |
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March 31, |
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2011 |
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2010 |
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Revenues: |
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Product sales |
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$ |
3,618 |
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$ |
3,528 |
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Other revenues |
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88 |
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64 |
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Total revenues |
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3,706 |
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3,592 |
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Operating expenses: |
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Cost of
sales (excludes amortization of certain acquired intangible assets presented below) |
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564 |
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508 |
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Research and development |
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736 |
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646 |
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Selling, general and administrative |
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1,023 |
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884 |
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Amortization of certain acquired intangible assets |
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74 |
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74 |
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Other |
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16 |
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(1 |
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Total operating expenses |
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2,413 |
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2,111 |
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Operating income |
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1,293 |
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1,481 |
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Interest expense, net |
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135 |
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145 |
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Interest and other income, net |
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148 |
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84 |
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Income before income taxes |
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1,306 |
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1,420 |
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Provisions for income taxes |
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181 |
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253 |
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Net income |
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$ |
1,125 |
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$ |
1,167 |
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Earnings per share: |
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Basic |
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$ |
1.21 |
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$ |
1.19 |
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Diluted |
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$ |
1.20 |
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$ |
1.18 |
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Shares used in calculation of earnings per share: |
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Basic |
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933 |
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982 |
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Diluted |
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941 |
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988 |
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See accompanying notes.
1
AMGEN INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(In millions, except per share data)
(Unaudited)
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March 31, |
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December 31, |
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2011 |
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2010 |
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ASSETS |
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Current assets: |
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Cash and cash equivalents |
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$ |
1,266 |
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$ |
3,287 |
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Marketable securities |
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14,092 |
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14,135 |
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Trade receivables, net |
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2,517 |
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2,335 |
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Inventories |
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2,098 |
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2,022 |
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Other current assets |
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1,716 |
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1,350 |
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Total current assets |
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21,689 |
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23,129 |
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Property, plant and equipment, net |
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5,455 |
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5,522 |
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Intangible assets, net |
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2,808 |
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2,230 |
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Goodwill |
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11,504 |
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11,334 |
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Other assets |
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1,258 |
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1,271 |
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Total assets |
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$ |
42,714 |
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$ |
43,486 |
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LIABILITIES AND STOCKHOLDERS EQUITY |
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Current liabilities: |
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Accounts payable |
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$ |
832 |
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$ |
716 |
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Accrued liabilities |
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3,334 |
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3,366 |
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Current portion of convertible notes |
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83 |
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2,488 |
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Total current liabilities |
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4,249 |
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6,570 |
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Convertible notes |
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2,246 |
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2,296 |
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Other long-term debt. |
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8,578 |
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8,578 |
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Other non-current liabilities |
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2,657 |
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2,098 |
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Contingencies and commitments |
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Stockholders equity: |
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Common stock and additional paid-in capital;
$0.0001 par value; 2,750 shares authorized;
outstanding - 933 shares in 2011 and
932 shares in 2010 |
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27,376 |
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27,299 |
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Accumulated deficit |
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(2,383 |
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(3,508 |
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Accumulated other comprehensive (loss) income |
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(9 |
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153 |
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Total stockholders equity |
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24,984 |
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23,944 |
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Total liabilities and stockholders equity |
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$ |
42,714 |
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$ |
43,486 |
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See accompanying notes.
2
AMGEN INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(In millions)
(Unaudited)
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Three months ended |
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March 31, |
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2011 |
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2010 |
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Cash flows from operating activities: |
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Net income |
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$ |
1,125 |
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$ |
1,167 |
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Depreciation and amortization |
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273 |
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252 |
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Stock-based compensation expense |
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77 |
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68 |
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Other items, net |
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14 |
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10 |
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Changes in operating assets and liabilities, net of acquisitions: |
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Trade receivables, net |
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(181 |
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(162 |
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Inventories |
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(78 |
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21 |
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Other current assets |
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(62 |
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(43 |
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Accounts payable |
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(38 |
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308 |
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Accrued income taxes |
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8 |
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(189 |
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Other accrued liabilities |
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(108 |
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(519 |
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Net cash provided by operating activities |
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1,030 |
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913 |
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Cash flows from investing activities: |
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Purchases of property, plant and equipment |
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(100 |
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(94 |
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Cash paid for acquisitions, net of cash acquired |
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(403 |
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Purchases of marketable securities |
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(7,203 |
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(3,160 |
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Proceeds from sales of marketable securities |
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6,933 |
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2,170 |
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Proceeds from maturities of marketable securities |
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224 |
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141 |
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Other |
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(6 |
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(12 |
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Net cash used in investing activities |
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(555 |
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(955 |
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Cash flows from financing activities: |
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Repayment of debt |
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(2,500 |
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Repurchases of common stock |
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(14 |
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(1,587 |
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Net proceeds from issuance of debt |
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989 |
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Net proceeds from issuance of common stock in connection with the Companys equity award programs |
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16 |
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26 |
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Other |
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2 |
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(4 |
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Net cash used in financing activities |
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(2,496 |
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(576 |
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Decrease in cash and cash equivalents |
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(2,021 |
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(618 |
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Cash and cash equivalents at beginning of period |
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3,287 |
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2,884 |
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Cash and cash equivalents at end of period |
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$ |
1,266 |
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$ |
2,266 |
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See accompanying notes.
3
AMGEN INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
March 31, 2011
(Unaudited)
1. Summary of significant accounting policies
Business
Amgen Inc. (including its subsidiaries, referred to as Amgen, the Company, we, our or
us) is a global biotechnology medicines company that discovers, develops, manufactures and
markets medicines for grievous illnesses. We concentrate on innovating novel medicines based on
advances in cellular and molecular biology and we operate in one business segment, human
therapeutics.
Basis of presentation
The financial information for the three months ended March 31, 2011 and 2010 is unaudited but
includes all adjustments (consisting of only normal recurring adjustments, unless otherwise
indicated), which Amgen considers necessary for a fair presentation of its condensed consolidated
results of operations for those periods. Interim results are not necessarily indicative of results
for the full fiscal year.
The condensed consolidated financial statements should be read in conjunction with our
consolidated financial statements and the notes thereto contained in our Annual Report on Form 10-K
for the year ended December 31, 2010.
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.
Revenue recognition for arrangements with multiple-deliverables
From time to time, we enter into arrangements for the research and development (R&D),
manufacture and/or commercialization of products and product candidates. These arrangements may
require us to deliver various rights, services and/or goods across the entire life cycle of a
product or product candidate, including (i) intellectual property rights/license, (ii) R&D
services, (iii) manufacturing services and/or (iv) commercialization services. The underlying terms
of these arrangements generally provide for consideration to Amgen in the form of non-refundable
upfront license payments, R&D and commercial performance milestone payments, cost sharing and/or
royalty payments.
In October 2009, the Financial Accounting Standards Board issued a new accounting standard
which amends the guidance on the accounting for arrangements involving the delivery of more than
one element. This standard addresses the determination of the unit(s) of accounting for
multiple-element arrangements and how the arrangements consideration should be allocated to each
unit of accounting. The Company adopted this new accounting standard on a prospective basis for all
multiple-element arrangements entered into on or after January 1, 2011 and for any multiple-element
arrangements that were entered into prior to January 1, 2011 but materially modified on or after
January 1, 2011.
Pursuant to the new standard, each required deliverable is evaluated to determine if it
qualifies as a separate unit of accounting. For Amgen this determination is generally based on
whether the deliverable has stand-alone value to the customer. The arrangements consideration is
then allocated to each separate unit of accounting based on the relative selling price of each
deliverable. The estimated selling price of each deliverable is determined using the following
hierarchy of values: (i) vendor-specific objective evidence of fair value, (ii) third-party
evidence of selling price, and (iii) best estimate of selling price (BESP). The BESP reflects our
best estimate of what the selling price would be if the deliverable was regularly sold by us on a
stand-alone basis. We expect, in general, to use the BESP for allocating consideration to each
deliverable. In general, the consideration allocated to each unit
4
AMGEN INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Continued)
of accounting is then recognized as the related goods or services are delivered limited to the
consideration that is not contingent upon future deliverables.
For multiple-element arrangements entered into prior to January 1, 2011 and not materially
modified thereafter, we continue to apply our prior accounting policy with respect to such
arrangements. Under this policy, in general, revenue from non-refundable, upfront fees related to
intellectual property rights/licenses where we have continuing involvement is recognized ratably
over the estimated period of ongoing involvement because there is no objective and reliable
evidence of fair value for any undelivered item to allow the delivered item to be considered a
separate unit of accounting. This requirement with respect to the fair value of undelivered items
was eliminated in the newly issued accounting standard. In general, the consideration with respect
to the other deliverables is recognized when the goods or services are delivered.
Under all of our multiple-element arrangements, consideration associated with at risk
substantive performance milestones is recognized as revenue upon the achievement of the related
milestone, as defined in the respective agreements.
The impact of adopting this new accounting standard is dependent on the terms and conditions
of any future arrangement that we may enter into that includes multiple-deliverables, however, its
adoption is not expected to have a material impact on our consolidated results of operations or
financial position. The primary impact of adopting the new accounting standard is expected to be
the earlier recognition of revenue associated with delivering rights to the underlying intellectual
property.
The adoption of this accounting standard did not have a material impact on our condensed
consolidated results of operations or financial position for the three months ended March 31, 2011.
Our consolidated results of operations or financial position for 2010 also would not have been
materially impacted if the accounting standard had been adopted on January 1, 2010.
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
method. Cost also includes the impact of the recently enacted Puerto Rico excise tax related to our
manufacturing operations in Puerto Rico. The Company capitalizes inventories produced in
preparation for product launches when the related product candidates are considered to have a high
probability of regulatory approval and the related costs are expected to be recoverable through the
commercialization of the product. See Note 7, Inventories.
Property, plant and equipment, net
Property, plant and equipment is recorded at historical cost, net of accumulated depreciation
and amortization of $5.3 billion and $5.2 billion as of March 31, 2011 and December 31, 2010,
respectively.
Business combinations
Business combinations are accounted for using the acquisition method of accounting. Under the
acquisition method, assets acquired, including in-process research and development (IPR&D)
projects, and liabilities assumed are recorded at their respective fair values as of the
acquisition date in our condensed consolidated financial statements. The excess of the acquisition
date fair value of consideration over the fair value of the net assets acquired is recorded as
goodwill. Contingent consideration obligations incurred in connection with a business combination
are recorded at their fair values on the acquisition date. We revalue these obligations each
subsequent reporting period until the related contingencies are resolved and record changes in
their fair values in earnings. See Note 2, Acquisitions.
5
AMGEN INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Continued)
On March 4, 2011, we acquired all of the outstanding stock of BioVex Group, Inc. (BioVex), a
privately held biotechnology company developing treatments for cancer and the prevention of
infectious disease, including OncoVEXGM-CSF, a novel oncolytic vaccine in phase 3
clinical development for the treatment of melanoma and head and neck cancer. This transaction,
which was accounted for as a business combination, provides us with an opportunity to expand our efforts to bring novel therapeutics to market. Upon its acquisition, BioVex became a
wholly owned subsidiary of Amgen.
The aggregate acquisition date consideration to acquire BioVex consisted of (in millions):
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Cash paid to former shareholders of BioVex |
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$ |
407 |
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Fair value of contingent consideration obligations |
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190 |
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Total consideration |
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$ |
597 |
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The cash consideration reflects a reduction in the purchase price related to changes in
working capital and excludes amounts that have been and may be paid to the employees of BioVex who
became Amgen employees upon the acquisition, including $7 million paid to settle unvested employee
options to acquire stock in BioVex which we expensed at the acquisition date.
In connection with this acquisition, we are obligated to make additional payments to the
former shareholders of BioVex of up to $575 million contingent upon the achievement of certain
regulatory and sales milestones with regard to OncoVEXGM-CSF, including the filing of a
biologics license application with the U.S. Food and Drug Administration (FDA), the first commercial
sale in each of the United States and the European Union following receipt of marketing approval, which
includes use of the product in specified patient populations, and upon achieving specified levels of
sales. The estimated aggregate fair value of the contingent consideration obligations as of the
acquisition date of $190 million was determined using a combination of valuation techniques. The
contingent consideration obligations to make regulatory milestone payments were valued based on
assumptions regarding the probability of achieving the milestones and making the related payments
with such amounts discounted to present value. The contingent consideration obligations to make
sales milestone payments were valued based on assumptions regarding
the probability of achieving specified
product sales thresholds to determine the required payments with such amounts discounted to present value.
We allocated the total consideration to the acquisition date fair values of assets acquired
and liabilities assumed as follows (in millions):
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Intangible assets IPR&D |
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$ |
675 |
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Goodwill |
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170 |
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Deferred tax liabilities |
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(246 |
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Other assets and liabilities acquired, net |
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(2 |
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Total consideration |
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$ |
597 |
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Intangible assets are composed of the estimated fair value of acquired IPR&D related to
OncoVEXGM-CSF. The estimated fair value was determined using a probability-weighted
income approach, which discounts expected future cash flows to present value. The estimated net
cash flows were discounted to present value using a discount rate of 11%, which is based on the
estimated weighted average cost of capital for companies with characteristics similar to BioVex.
This is comparable to the estimated internal rate of return on BioVex operations and represents the
rate that market participants would use to value the intangible assets. The projected cash flows
from OncoVEXGM-CSF were based on certain key assumptions, including estimates of future
revenue and expenses taking into account the stage of development of OncoVEXGM-CSF at
the acquisition date, the time and resources needed to complete development and the probabilities
of obtaining marketing approval from the FDA and other regulatory agencies. IPR&D intangible assets
acquired in a business combination are considered to be indefinite-lived until the completion or
abandonment of the associated R&D efforts.
The excess of the acquisition date consideration over the fair values assigned to the assets
acquired and the liabilities assumed of $170 million was recorded as goodwill, which is not
deductible for tax purposes. Goodwill is primarily attributable to the deferred tax consequences of
acquired IPR&D recorded for financial statement purposes.
The amounts initially recorded for acquired IPR&D intangible assets and tax-related
liabilities are preliminary. The amounts will be finalized upon collection of the appropriate information with respect to the BioVex intercompany
arrangements related to the acquired IPR&D and the tax impacts thereof.
BioVex is included in our condensed consolidated financial statements commencing on the
acquisition date. Pro forma supplemental condensed consolidated financial information assuming the
acquisition occurred on January 1, 2011 and 2010 is not provided as the impact would not be
material to our condensed consolidated results of operations.
6
AMGEN INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Continued)
3. Income taxes
The effective tax rates for the three months ended March 31, 2011 and 2010 are different from
the statutory rates primarily as a result of indefinitely invested earnings of our foreign
operations. We do not provide for U.S. income taxes on undistributed earnings of our foreign
operations that are intended to be invested indefinitely outside the United States. The effective
tax rate for the three months ended March 31, 2011 was further reduced by foreign tax credits
associated with the new Puerto Rico excise tax.
Commencing January 1, 2011, Puerto Rico imposes a temporary excise tax on the purchase of
goods and services from a related manufacturer in Puerto Rico. This excise tax is currently
scheduled to expire in 2016. We account for the excise tax as a manufacturing cost that is
capitalized in inventory and expensed in cost of sales when the related products are sold. For U.S.
income tax purposes, a significant portion of the excise tax results in tax credits that are
recognized in our provision for income taxes when the excise tax is paid. Our effective tax rate
for the three months ended March 31, 2011 without the impact of the tax credits associated with the
new Puerto Rico excise tax would have been 18.8%.
One or more of our legal entities file income tax returns in the U.S. federal jurisdiction,
various U.S. state jurisdictions and certain foreign jurisdictions. Our income tax returns are
routinely audited by the tax authorities in those jurisdictions. Significant disputes may arise
with these tax authorities involving issues of the timing and amount of deductions, the use of tax
credits and allocations of income among various tax jurisdictions because of differing
interpretations of tax laws and regulations. We are no longer subject to U.S. federal income tax
examinations for years ended on or before December 31, 2006 or to California state income tax
examinations for years ended on or before December 31, 2003.
The Internal Revenue Service (IRS) is currently examining our U.S. income tax returns for the
years ended December 31, 2007, 2008 and 2009. As of March 31, 2011, the Company and the IRS have
agreed to certain transfer pricing adjustments for the year ended December 31, 2009 and the Company
has, accordingly, adjusted its liability for unrecognized tax benefits (UTBs) as discussed below.
The remainder of this examination is expected to be completed in 2012.
During the three months ended March 31, 2011, the gross amount of our UTBs increased by
approximately $72 million as a result of tax positions taken during the current year. During the
three months ended March 31, 2011, the gross amount of our UTBs decreased by approximately $201
million as a result of resolving certain transfer pricing matters related to prior years.
Substantially all of the UTBs as of March 31, 2011, if recognized, would affect our effective tax
rate.
7
AMGEN INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Continued)
4. Earnings per share
The computation of basic earnings per share (EPS) is based upon the weighted-average number of
our common shares outstanding. The computation of diluted EPS is based upon the weighted-average
number of our common shares and dilutive potential common shares outstanding. Dilutive potential
common shares outstanding, determined using the treasury stock method, principally include: shares
that may be issued under our stock option, restricted stock and performance unit awards; our 2011
Convertible Notes and 2013 Convertible Notes, as discussed below; and our outstanding warrants
(collectively dilutive securities). The convertible note hedges purchased in connection with the
issuance of our convertible notes are excluded from the calculation of diluted EPS as their impact
is always anti-dilutive.
Upon conversion of our 2011 Convertible Notes (while they were outstanding) and 2013
Convertible Notes, the principal amount would be settled in cash and the excess of the conversion
value, as defined, over the principal amount may be settled in cash and/or shares of our common
stock. Therefore, only the shares of our common stock potentially issuable with respect to the
excess of the notes conversion value over their principal amount, if any, are considered as
dilutive potential common shares for purposes of calculating diluted EPS.
The following table sets forth the computation for basic and diluted EPS (in millions, except
per share data):
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
|
March 31, |
|
|
|
2011 |
|
|
2010 |
|
Income (Numerator): |
|
|
|
|
|
|
|
|
Net income for basic and diluted EPS |
|
$ |
1,125 |
|
|
$ |
1,167 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares (Denominator): |
|
|
|
|
|
|
|
|
Weighted-average shares for basic EPS |
|
|
933 |
|
|
|
982 |
|
Effect of dilutive securities |
|
|
8 |
|
|
|
6 |
|
|
|
|
|
|
|
|
Weighted-average shares for diluted EPS |
|
|
941 |
|
|
|
988 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic EPS |
|
$ |
1.21 |
|
|
$ |
1.19 |
|
Diluted EPS |
|
$ |
1.20 |
|
|
$ |
1.18 |
|
For the three months ended March 31, 2011 and 2010, there were employee stock options,
calculated on a weighted average basis, to purchase 39 million and 40 million shares of our common
stock, respectively, with exercise prices greater than the average market prices of our common
stock for these periods that are not included in the computation of diluted EPS as their impact
would have been anti-dilutive. In addition, shares of our common stock which may be issued upon
exercise of our warrants are not included in the computation of diluted EPS for any of the periods
presented above as their impact would have been anti-dilutive.
8
AMGEN INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Continued)
5. Cost savings initiatives
Manufacturing operations at Fremont, California
As part of continuing efforts to optimize our network of manufacturing facilities and improve
cost efficiencies, on January 18, 2011, we entered into an agreement whereby Boehringer Ingelheim
(BI) agreed to acquire all of our rights in and substantially all assets at our manufacturing
operations located in Fremont, California. The transaction was approved by Amgens Board of
Directors in December 2010 and closed in March 2011. In connection with the closing of this
transaction, BI has or will assume our obligations under the facilitys operating lease agreements
and has entered into an agreement to manufacture certain quantities of our marketed product
Vectibix®, for us at this facility through December 31, 2012 (the supply agreement).
Due to the lack of sufficient initial investment by BI in the acquisition of this facility and
our ongoing involvement with these operations, the transaction did not meet the accounting
requirements to be treated as a sale involving real estate. As a result, the related assets will
continue to be carried on our Condensed Consolidated Balance Sheet.
We considered this transaction with BI to be a potential indicator of impairment and,
accordingly, we performed an impairment analysis of the carrying values of the related fixed assets
as of December 31, 2010. Based on this analysis, we determined that no future economic benefit
would be received from a manufacturing line at the facility that had not yet been completed. As a
result, we wrote off its entire carrying value, which aggregated $118 million for the three months
ended December 31, 2010.
The carrying values of the remaining fixed assets, aggregating approximately $133 million,
were determined to be fully recoverable. However, as a result of this transaction, we reduced the
estimated remaining useful lives of these fixed assets to coincide with the period covered by the
supply agreement. During the three months ended March 31, 2011, we recorded incremental
depreciation in excess of what otherwise would have been recorded of approximately $10 million.
This amount is included in Cost of sales (excludes amortization of certain acquired intangible
assets presented below) in the Condensed Consolidated Statement of Income. In addition, due to the
assignment to BI of the obligations under certain of the facilitys operating leases in March 2011,
we recorded a charge of approximately $11 million in the three months ended March 31, 2011 with
respect to the lease period beyond the end of the supply agreement. This amount is recorded in
Cost of sales (excludes amortization of certain acquired intangible assets presented below) in
the Condensed Consolidated Statement of Income.
Other
As part of continuing efforts to improve cost efficiencies in our manufacturing operations,
we also recorded certain charges aggregating $16 million during the three months ended March 31,
2011, which are included in Other in the Condensed Consolidated Statement of Income.
9
AMGEN INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Continued)
6. Available-for-sale investments
The fair values of available-for-sale investments by type of security, contractual maturity
and classification in the Condensed Consolidated Balance Sheets were as follows (in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross |
|
|
Gross |
|
|
Estimated |
|
|
|
Amortized |
|
|
unrealized |
|
|
unrealized |
|
|
fair |
|
Type of security as of March 31, 2011 |
|
cost |
|
|
gains |
|
|
losses |
|
|
value |
|
U.S. Treasury securities |
|
$ |
3,573 |
|
|
$ |
7 |
|
|
$ |
(23 |
) |
|
$ |
3,557 |
|
Other government related debt securities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Obligations of U.S. government agencies and FDIC guaranteed bank debt |
|
|
1,660 |
|
|
|
13 |
|
|
|
(2 |
) |
|
|
1,671 |
|
Foreign and other |
|
|
796 |
|
|
|
14 |
|
|
|
|
|
|
|
810 |
|
Corporate debt securities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Financial |
|
|
2,957 |
|
|
|
55 |
|
|
|
(11 |
) |
|
|
3,001 |
|
Industrial |
|
|
3,131 |
|
|
|
72 |
|
|
|
(6 |
) |
|
|
3,197 |
|
Other |
|
|
352 |
|
|
|
10 |
|
|
|
(1 |
) |
|
|
361 |
|
Mortgage and asset backed securities |
|
|
1,498 |
|
|
|
4 |
|
|
|
(7 |
) |
|
|
1,495 |
|
Money market mutual funds |
|
|
1,075 |
|
|
|
|
|
|
|
|
|
|
|
1,075 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total debt securities |
|
|
15,042 |
|
|
|
175 |
|
|
|
(50 |
) |
|
|
15,167 |
|
Equity securities |
|
|
52 |
|
|
|
|
|
|
|
(4 |
) |
|
|
48 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
15,094 |
|
|
$ |
175 |
|
|
$ |
(54 |
) |
|
$ |
15,215 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross |
|
|
Gross |
|
|
Estimated |
|
|
|
Amortized |
|
|
unrealized |
|
|
unrealized |
|
|
fair |
|
Type of security as of December 31, 2010 |
|
cost |
|
|
gains |
|
|
losses |
|
|
value |
|
U.S. Treasury securities |
|
$ |
5,044 |
|
|
$ |
50 |
|
|
$ |
(14 |
) |
|
$ |
5,080 |
|
Other government related debt securities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Obligations of U.S. government agencies
and FDIC guaranteed bank debt |
|
|
2,158 |
|
|
|
51 |
|
|
|
(1 |
) |
|
|
2,208 |
|
Foreign and other |
|
|
837 |
|
|
|
16 |
|
|
|
(1 |
) |
|
|
852 |
|
Corporate debt securities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Financial |
|
|
2,252 |
|
|
|
53 |
|
|
|
(9 |
) |
|
|
2,296 |
|
Industrial |
|
|
2,441 |
|
|
|
71 |
|
|
|
(5 |
) |
|
|
2,507 |
|
Other |
|
|
307 |
|
|
|
10 |
|
|
|
(1 |
) |
|
|
316 |
|
Mortgage and asset backed securities |
|
|
841 |
|
|
|
5 |
|
|
|
(5 |
) |
|
|
841 |
|
Money market mutual funds |
|
|
3,030 |
|
|
|
|
|
|
|
|
|
|
|
3,030 |
|
Other short-term interest bearing securities |
|
|
147 |
|
|
|
|
|
|
|
|
|
|
|
147 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total debt securities |
|
|
17,057 |
|
|
|
256 |
|
|
|
(36 |
) |
|
|
17,277 |
|
Equity securities |
|
|
50 |
|
|
|
|
|
|
|
(2 |
) |
|
|
48 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
17,107 |
|
|
$ |
256 |
|
|
$ |
(38 |
) |
|
$ |
17,325 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
10
AMGEN INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Continued)
|
|
|
|
|
|
|
|
|
|
|
March 31, |
|
|
December 31, |
|
Contractual maturity |
|
2011 |
|
|
2010 |
|
Maturing in one year or less |
|
$ |
1,713 |
|
|
$ |
4,118 |
|
Maturing after one year through three years |
|
|
7,049 |
|
|
|
6,736 |
|
Maturing after three years through five years |
|
|
5,367 |
|
|
|
5,812 |
|
Maturing after five years |
|
|
1,038 |
|
|
|
611 |
|
|
|
|
|
|
|
|
Total debt securities |
|
|
15,167 |
|
|
|
17,277 |
|
Equity securities |
|
|
48 |
|
|
|
48 |
|
|
|
|
|
|
|
|
|
|
$ |
15,215 |
|
|
$ |
17,325 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
March 31, |
|
|
December 31, |
|
Classification in the Condensed Consolidated Balance Sheets |
|
2011 |
|
|
2010 |
|
Cash and cash equivalents |
|
$ |
1,266 |
|
|
$ |
3,287 |
|
Marketable securities |
|
|
14,092 |
|
|
|
14,135 |
|
Other assets noncurrent |
|
|
48 |
|
|
|
48 |
|
|
|
|
|
|
|
|
|
|
|
15,406 |
|
|
|
17,470 |
|
Less cash |
|
|
(191 |
) |
|
|
(145 |
) |
|
|
|
|
|
|
|
|
|
$ |
15,215 |
|
|
$ |
17,325 |
|
|
|
|
|
|
|
|
For the three months ended March 31, 2011 and 2010, realized gains totaled $89 million and $21
million, respectively, and realized losses totaled $8 million and $2 million, respectively. The
cost of securities sold is based on the specific identification method.
The primary objective of our investment portfolio is to enhance overall returns in an
efficient manner while maintaining safety of principal, prudent levels of liquidity and acceptable
levels of risk. Our investment policy limits debt security investments to certain types of debt and
money market instruments issued by institutions with primarily investment grade credit ratings and
places restrictions on maturities and concentration by type and issuer.
We review our available-for-sale investments for other-than-temporary declines in fair value
below our cost basis each quarter and whenever events or changes in circumstances indicate that the
cost basis of an asset may not be recoverable. This evaluation is based on a number of factors,
including the length of time and extent to which the fair value has been below our cost basis and
adverse conditions related specifically to the security, including any changes to the credit rating
of the security by a rating agency. As of March 31, 2011 and December 31, 2010, we believe the cost
bases for our available-for-sale investments were recoverable in all material respects.
7. Inventories
Inventories consisted of the following (in millions):
|
|
|
|
|
|
|
|
|
|
|
March 31, |
|
|
December 31, |
|
|
|
2011 |
|
|
2010 |
|
Raw materials |
|
$ |
135 |
|
|
$ |
128 |
|
Work in process |
|
|
1,445 |
|
|
|
1,382 |
|
Finished goods |
|
|
518 |
|
|
|
512 |
|
|
|
|
|
|
|
|
|
|
$ |
2,098 |
|
|
$ |
2,022 |
|
|
|
|
|
|
|
|
11
8. Financing arrangements
The following table reflects the carrying values and the fixed contractual coupon rates of our
borrowings under our various financing arrangements (dollar amounts in millions):
|
|
|
|
|
|
|
|
|
|
|
March 31, |
|
|
December 31, |
|
|
|
2011 |
|
|
2010 |
|
0.125% convertible notes due 2011 (2011 Convertible Notes) |
|
$ |
|
|
|
$ |
2,488 |
|
0.375% convertible notes due 2013 (2013 Convertible Notes) |
|
|
2,246 |
|
|
|
2,213 |
|
5.85% notes due 2017 (2017 Notes) |
|
|
1,099 |
|
|
|
1,099 |
|
4.85% notes due 2014 (2014 Notes) |
|
|
1,000 |
|
|
|
1,000 |
|
5.70% notes due 2019 (2019 Notes) |
|
|
998 |
|
|
|
998 |
|
6.40% notes due 2039 (2039 Notes) |
|
|
996 |
|
|
|
996 |
|
6.375% notes due 2037 (2037 Notes) |
|
|
899 |
|
|
|
899 |
|
3.45% notes due October 2020 (October 2020 Notes) |
|
|
897 |
|
|
|
897 |
|
5.75% notes due 2040 (2040 Notes) |
|
|
696 |
|
|
|
696 |
|
4.95% notes due 2041 (2041 Notes) |
|
|
595 |
|
|
|
595 |
|
6.15% notes due 2018 (2018 Notes) |
|
|
499 |
|
|
|
499 |
|
6.90% notes due 2038 (2038 Notes) |
|
|
499 |
|
|
|
499 |
|
4.50% notes due March 2020 (March 2020 Notes) |
|
|
300 |
|
|
|
300 |
|
Other notes including our zero coupon convertible notes |
|
|
183 |
|
|
|
183 |
|
|
|
|
|
|
|
|
Total borrowings |
|
|
10,907 |
|
|
|
13,362 |
|
Less current portion |
|
|
(83 |
) |
|
|
(2,488 |
) |
|
|
|
|
|
|
|
Total non-current debt |
|
$ |
10,824 |
|
|
$ |
10,874 |
|
|
|
|
|
|
|
|
The holders of our zero coupon convertible notes due in 2032 have the right to put the
debt to us for repayment on March 1, 2012. Accordingly the debt is classified as a current
liability as of March 31, 2011.
Debt repayments
In February 2011, the 2011 Convertible Notes became due, and we repaid the $2.5 billion
aggregate principal amount. As these convertible notes were cash settleable, the debt and equity
components of these notes were bifurcated and accounted for separately. The discounted carrying
value of the debt component resulting from the bifurcation was accreted back to the principal
amount over the period the notes were outstanding. The total aggregate amount repaid, including the
amount related to the debt discount of $643 million resulting from the bifurcation, is included in
Cash flows from financing activities in the Condensed Consolidated Statements of Cash Flows.
Shelf registration statement
In March 2011, we filed a shelf registration statement with the Securities and Exchange
Commission (SEC) to replace an existing shelf registration statement that was scheduled to expire
in April 2011. This shelf registration allows us to issue an unspecified amount of: debt
securities; common stock; preferred stock; warrants to purchase debt securities, common stock,
preferred stock or depository shares; rights to purchase common stock or preferred stock;
securities purchase contracts; securities purchase units; and depository shares. Under this
registration statement, all of the securities available for issuance may be offered from time to
time with terms to be determined at the time of issuance. This shelf registration expires in March
2014.
12
AMGEN INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Continued)
9. Stockholders equity
Stock repurchase program
The following table is a summary of activity under our stock repurchase program (in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2011 |
|
|
2010 |
|
|
|
Shares |
|
|
Dollars |
|
|
Shares |
|
|
Dollars |
|
First quarter |
|
|
|
|
|
$ |
|
|
|
|
29.1 |
|
|
$ |
1,684 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
In December 2009, the Board of Directors authorized us to repurchase up to an additional $5.0
billion of our common stock of which a total of $2.2 billion remains available as of March 31,
2011. In addition, in April 2011, the Board of Directors authorized us to repurchase up to an
additional $5.0 billion of our common stock.
10. Fair value measurement
We use various valuation approaches in determining the fair value of our financial assets and
liabilities within a hierarchy that maximizes the use of observable inputs and minimizes the use of
unobservable inputs by requiring that observable inputs be used when available. Observable inputs
are inputs that market participants would use in pricing the asset or liability based on market
data obtained from sources independent of the Company. Unobservable inputs are inputs that reflect
the Companys assumptions about the inputs that market participants would use in pricing the asset
or liability and are developed based on the best information available in the circumstances. The
fair value hierarchy is broken down into three levels based on the source of inputs as follows:
|
|
|
|
|
Level 1
|
|
|
|
Valuations based on unadjusted quoted prices in active markets for identical assets or liabilities that the Company
has the ability to access |
|
|
|
|
|
Level 2
|
|
|
|
Valuations for which all significant inputs are observable, either directly or indirectly, other than level 1 inputs |
|
|
|
|
|
Level 3
|
|
|
|
Valuations based on inputs that are unobservable and significant to the overall fair value measurement |
The availability of observable inputs can vary among the various types of financial assets and
liabilities. To the extent that the valuation is based on models or inputs that are less observable
or unobservable in the market, the determination of fair value requires more judgment. In certain
cases, the inputs used to measure fair value may fall into different levels of the fair value
hierarchy. In such cases, for financial statement disclosure purposes, the level in the fair value
hierarchy within which the fair value measurement is categorized is based on the lowest level of
input used that is significant to the overall fair value measurement.
The following fair value hierarchy tables present information about each major class of the
Companys financial assets and liabilities measured at fair value on a recurring basis (in
millions):
13
AMGEN INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Continued)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Quoted prices in |
|
|
Significant |
|
|
Significant |
|
|
|
|
|
active markets for |
|
|
other observable |
|
|
unobservable |
|
|
|
Fair value measurement |
|
identical assets |
|
|
inputs |
|
|
inputs |
|
|
|
as of March 31, 2011 using: |
|
(Level 1) |
|
|
(Level 2) |
|
|
(Level 3) |
|
|
Total |
Assets: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Available-for-sale securities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S. Treasury securities |
|
$ |
3,557 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
3,557 |
|
Other government related debt securities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Obligations of U.S. government agencies
and FDIC guaranteed bank debt |
|
|
|
|
|
|
1,671 |
|
|
|
|
|
|
|
1,671 |
|
Foreign and other |
|
|
|
|
|
|
810 |
|
|
|
|
|
|
|
810 |
|
Corporate debt securities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Financial |
|
|
|
|
|
|
3,001 |
|
|
|
|
|
|
|
3,001 |
|
Industrial |
|
|
|
|
|
|
3,197 |
|
|
|
|
|
|
|
3,197 |
|
Other |
|
|
|
|
|
|
361 |
|
|
|
|
|
|
|
361 |
|
Mortgage and asset backed securities |
|
|
|
|
|
|
1,495 |
|
|
|
|
|
|
|
1,495 |
|
Money market mutual funds |
|
|
1,075 |
|
|
|
|
|
|
|
|
|
|
|
1,075 |
|
Equity securities |
|
|
48 |
|
|
|
|
|
|
|
|
|
|
|
48 |
|
Derivatives: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign currency contracts |
|
|
|
|
|
|
57 |
|
|
|
|
|
|
|
57 |
|
Interest rate swap contracts |
|
|
|
|
|
|
160 |
|
|
|
|
|
|
|
160 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total assets |
|
$ |
4,680 |
|
|
$ |
10,752 |
|
|
$ |
|
|
|
$ |
15,432 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Derivatives: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign currency contracts |
|
$ |
|
|
|
$ |
189 |
|
|
$ |
|
|
|
$ |
189 |
|
Interest rate swap contracts |
|
|
|
|
|
|
12 |
|
|
|
|
|
|
|
12 |
|
Contingent consideration obligations in
connection with a business combination |
|
|
|
|
|
|
|
|
|
|
190 |
|
|
|
190 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total liabilities |
|
$ |
|
|
|
$ |
201 |
|
|
$ |
190 |
|
|
$ |
391 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Quoted prices in |
|
|
Significant |
|
|
Significant |
|
|
|
|
|
active markets for |
|
|
other observable |
|
|
unobservable |
|
|
|
Fair value measurement |
|
identical assets |
|
|
inputs |
|
|
inputs |
|
|
|
as of December 31, 2010 using: |
|
(Level 1) |
|
|
(Level 2) |
|
|
(Level 3) |
|
|
Total |
Assets: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Available-for-sale securities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S. Treasury securities |
|
$ |
5,080 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
5,080 |
|
Other government related debt securities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Obligations of U.S. government agencies
and FDIC guaranteed bank debt |
|
|
|
|
|
|
2,208 |
|
|
|
|
|
|
|
2,208 |
|
Foreign and other |
|
|
|
|
|
|
852 |
|
|
|
|
|
|
|
852 |
|
Corporate debt securities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Financial |
|
|
|
|
|
|
2,296 |
|
|
|
|
|
|
|
2,296 |
|
Industrial |
|
|
|
|
|
|
2,507 |
|
|
|
|
|
|
|
2,507 |
|
Other |
|
|
|
|
|
|
316 |
|
|
|
|
|
|
|
316 |
|
Mortgage and asset backed securities |
|
|
|
|
|
|
841 |
|
|
|
|
|
|
|
841 |
|
Money market mutual funds |
|
|
3,030 |
|
|
|
|
|
|
|
|
|
|
|
3,030 |
|
Other short-term interest bearing securities |
|
|
|
|
|
|
147 |
|
|
|
|
|
|
|
147 |
|
Equity securities |
|
|
48 |
|
|
|
|
|
|
|
|
|
|
|
48 |
|
Derivatives: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign currency contracts |
|
|
|
|
|
|
154 |
|
|
|
|
|
|
|
154 |
|
Interest rate swap contracts |
|
|
|
|
|
|
195 |
|
|
|
|
|
|
|
195 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total assets |
|
$ |
8,158 |
|
|
$ |
9,516 |
|
|
$ |
|
|
|
$ |
17,674 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Derivatives: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign currency contracts |
|
$ |
|
|
|
$ |
103 |
|
|
$ |
|
|
|
$ |
103 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total liabilities |
|
$ |
|
|
|
$ |
103 |
|
|
$ |
|
|
|
$ |
103 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
14
AMGEN INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Continued)
The fair value of our U.S. Treasury securities, money market mutual funds and equity
securities are based on quoted market prices in active markets with no valuation adjustment.
Substantially all of our other government related and corporate debt securities are investment
grade with maturity dates of five years or less. Our other government related debt securities
portfolio is comprised of securities with a weighted average credit rating of AAA or equivalent
by Standard and Poors (S&P), Moodys Investors Services, Inc. (Moodys) or Fitch, Inc. (Fitch),
and our corporate debt securities portfolio has a weighted average credit rating of A or
equivalent by S&P, Moodys or Fitch. We estimate the fair value of these securities taking into
consideration valuations obtained from third-party pricing services. The pricing services utilize
industry standard valuation models, including both income and market based approaches, for which
all significant inputs are observable, either directly or indirectly, to estimate fair value. These
inputs include reported trades and broker/dealer quotes of the same or similar securities, issuer
credit spreads, benchmark securities and other observable inputs.
Our mortgage and asset backed securities portfolio is comprised entirely of senior tranches,
with a credit rating of AAA or equivalent by S&P, Moodys or Fitch. We estimate the fair value of
these securities taking into consideration valuations obtained from third-party pricing services.
The pricing services utilize industry standard valuation models, including both income and market
based approaches, for which all significant inputs are observable, either directly or indirectly,
to estimate fair value. These inputs include reported trades and broker/dealer quotes of the same
or similar securities, issuer credit spreads, benchmark securities, prepayment/default projections
based on historical data and other observable inputs.
We value our other short-term interest bearing securities at amortized cost which approximates
fair value given their near term maturity dates.
Substantially all of our foreign currency forward and option derivatives contracts have
maturities of three years or less and all are entered into with counterparties that have a minimum
credit rating of A- or equivalent by S&P, Moodys or Fitch. We estimate the fair value of these
contracts taking into consideration valuations obtained from a third-party valuation service that
utilizes an income-based industry standard valuation model for which all significant inputs are
observable, either directly or indirectly. These inputs include quoted foreign currency spot rates,
forward points, London Interbank Offered Rate (LIBOR) and swap curves and obligor credit default
swap rates. In addition, inputs for our foreign currency option contracts also include implied
volatility measures. These inputs, where applicable, are at commonly quoted intervals. As of March
31, 2011 and December 31, 2010, we had open foreign currency forward contracts with notional
amounts of $3.4 billion and $3.2 billion, respectively, and open foreign currency option contracts
with notional amounts of $300 million and $398 million, respectively, that were primarily
Euro-based and were designated as cash flow hedges. In addition, as of March 31, 2011 and December
31, 2010, we had $788 million and $670 million, respectively, of open foreign currency forward
contracts to reduce exposure to fluctuations in value of certain assets and liabilities denominated
in foreign currencies that were primarily Euro-based and that were not designated as hedges. (See
Note 11, Derivative instruments.)
Our interest rate swap contracts are entered into with counterparties that have a minimum
credit rating of A- or equivalent by S&P, Moodys or Fitch. We estimate the fair value of these
contracts using an income-based industry standard valuation model for which all significant inputs
are observable either directly or indirectly. These inputs include LIBOR and swap curves and
obligor credit default swap rates. We had interest rate swap agreements with an aggregate notional
amount of $3.6 billion as of March 31, 2011 and December 31, 2010 that were designated as fair
value hedges. (See Note 11, Derivative instruments.)
Contingent consideration obligations in connection with a business combination were incurred
as a result of our acquisition of BioVex in March 2011. The fair value measurements of contingent
consideration obligations are based on significant unobservable inputs, and accordingly, such
amounts are considered Level 3 measurements. There was no material change in the fair values of
these obligations from the acquisition date through March 31, 2011. For a description of the
valuation methodology and related assumptions used to estimate the fair values of the contingent
consideration obligations, see Note 2, Acquisitions.
There have been no transfers of assets or liabilities between the fair value measurement
levels and there were no material remeasurements to fair value during the three months ended March
31, 2011 and 2010 of assets and liabilities that are not measured at fair value on a recurring
basis.
15
AMGEN INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Continued)
Summary of the fair value of other financial instruments
Short-term assets and liabilities
The estimated fair values of cash equivalents, accounts receivable and accounts payable
approximate their carrying values due to the short-term nature of these financial instruments.
Borrowings
We estimate the fair value of our convertible notes using an income-based industry standard
valuation model for which all significant inputs are observable either directly or indirectly,
including benchmark yields adjusted for our credit risk (Level 2). The fair values of our
convertible notes exclude their equity components and represent only the liability components of
these instruments as their equity components are included in Common stock and additional paid-in
capital in the Condensed Consolidated Balance Sheets. We estimate the fair value of our other
long-term notes taking into consideration indicative prices obtained from a third party financial
institution that utilizes industry standard valuation models, including both income and market
based approaches, for which all significant inputs are observable, either directly or indirectly.
These inputs include reported trades and broker/dealer quotes of the same or similar securities,
credit spreads, benchmark yields and other observable inputs (Level 2). The following tables
present the carrying values and estimated fair values of our borrowings (in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
March 31, 2011 |
|
|
December 31, 2010 |
|
|
|
Carrying value |
|
|
Fair value |
|
|
Carrying value |
|
|
Fair value |
|
2011 Convertible Notes |
|
$ |
|
|
|
$ |
|
|
|
$ |
2,488 |
|
|
$ |
2,501 |
|
2013 Convertible Notes |
|
|
2,246 |
|
|
|
2,480 |
|
|
|
2,213 |
|
|
|
2,479 |
|
2017 Notes |
|
|
1,099 |
|
|
|
1,245 |
|
|
|
1,099 |
|
|
|
1,280 |
|
2014 Notes |
|
|
1,000 |
|
|
|
1,094 |
|
|
|
1,000 |
|
|
|
1,101 |
|
2019 Notes |
|
|
998 |
|
|
|
1,107 |
|
|
|
998 |
|
|
|
1,139 |
|
2039 Notes |
|
|
996 |
|
|
|
1,089 |
|
|
|
996 |
|
|
|
1,149 |
|
2037 Notes |
|
|
899 |
|
|
|
974 |
|
|
|
899 |
|
|
|
1,027 |
|
October 2020 Notes |
|
|
897 |
|
|
|
836 |
|
|
|
897 |
|
|
|
857 |
|
2040 Notes |
|
|
696 |
|
|
|
699 |
|
|
|
696 |
|
|
|
734 |
|
2041 Notes |
|
|
595 |
|
|
|
546 |
|
|
|
595 |
|
|
|
564 |
|
2018 Notes |
|
|
499 |
|
|
|
568 |
|
|
|
499 |
|
|
|
584 |
|
2038 Notes |
|
|
499 |
|
|
|
591 |
|
|
|
499 |
|
|
|
607 |
|
March 2020 Notes |
|
|
300 |
|
|
|
307 |
|
|
|
300 |
|
|
|
311 |
|
Other notes including our zero coupon debt |
|
|
183 |
|
|
|
204 |
|
|
|
183 |
|
|
|
214 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
10,907 |
|
|
$ |
11,740 |
|
|
$ |
13,362 |
|
|
$ |
14,547 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
16
AMGEN INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Continued)
11. Derivative instruments
The Company is exposed to risks related to its business operations, certain of which are
managed through derivative instruments. The risks that we manage by using derivative instruments
are foreign exchange rate risk and interest rate risk. We use financial instruments including
foreign currency forward, foreign currency option, forward interest rate and interest rate swap
contracts to reduce our risk to these exposures. We do not use derivatives for speculative trading
purposes.
We recognize all of our derivative instruments as either assets or liabilities at fair value
in the Condensed Consolidated Balance Sheets (see Note 10, Fair value measurement). The accounting
for changes in the fair value of a derivative instrument depends on whether it has been formally
designated and qualifies as part of a hedging relationship under the applicable accounting
standards and, further, on the type of hedging relationship. For derivatives formally designated as
hedges, we assess both at inception and quarterly thereafter, whether the hedging derivatives are
highly effective in offsetting changes in either the fair value or cash flows of the hedged item.
Our derivatives that are not designated and do not qualify as hedges are adjusted to fair value
through current earnings.
Cash flow hedges
We are exposed to possible changes in values of certain anticipated foreign currency cash
flows resulting from changes in foreign currency exchange rates, associated primarily with our
international product sales denominated in Euros. Increases or decreases in the cash flows
associated with our international product sales due to movements in foreign currency exchange rates
are partially offset by the corresponding increases and decreases in our international operating
expenses resulting from these foreign currency exchange rate movements. To further reduce our
exposure to foreign currency exchange rate fluctuations on our international product sales, we
enter into foreign currency forward and option contracts to hedge a portion of our projected
international product sales primarily over a three-year time horizon with, at any given point in
time, a higher percentage of nearer term projected product sales being hedged than successive
periods. As of March 31, 2011 and December 31, 2010, we had open foreign currency forward contracts
with notional amounts of $3.4 billion and $3.2 billion, respectively, and open foreign currency
option contracts with notional amounts of $300 million and $398 million, respectively. These
foreign currency forward and option contracts, primarily Euro-based, have been designated as cash
flow hedges, and accordingly, the effective portion of the unrealized gains and losses on these
contracts are reported in Accumulated Other Comprehensive Income (AOCI) in the Condensed
Consolidated Balance Sheets and reclassified to earnings in the same periods during which the
hedged transactions affect earnings.
In connection with the anticipated issuance of long-term fixed-rate debt, we occasionally
enter into forward interest rate contracts in order to hedge the variability in cash flows due to
changes in the applicable Treasury rate between the time we enter into these contracts and the time
the related debt is issued. Gains and losses on such contracts, which are designated as cash flow
hedges, are reported in AOCI and amortized into earnings over the lives of the associated debt
issuances.
The following table reflects the effective portion of the unrealized gain/(loss) recognized in
Other Comprehensive Income for our cash flow hedge contracts (in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
|
|
|
|
|
March 31, |
|
Derivatives in cash flow hedging relationships |
|
|
2011 |
|
|
2010 |
|
Foreign currency contracts |
|
|
|
|
|
$ |
(197 |
) |
|
$ |
175 |
|
Forward interest rate contracts |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
|
|
|
|
$ |
(197 |
) |
|
$ |
175 |
|
|
|
|
|
|
|
|
|
|
|
|
The following table reflects the location in the Condensed Consolidated Statements of Income and the effective portion of the loss reclassified from AOCI into earnings for our cash flow hedge contracts (in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
|
|
|
|
|
March 31, |
|
Derivatives in cash flow hedging relationships |
|
Statements of Income location |
|
|
2011 |
|
|
2010 |
|
Foreign currency contracts |
|
Product sales |
|
$ |
(8 |
) |
|
$ |
(6 |
) |
Forward interest rate contracts |
|
Interest expense, net |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
|
|
|
|
$ |
(8 |
) |
|
$ |
(6 |
) |
|
|
|
|
|
|
|
|
|
|
|
17
AMGEN INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Continued)
No portions of our cash flow hedge contracts are excluded from the assessment of hedge
effectiveness and the ineffective portions of these hedging instruments were approximately $1
million of expense and approximately $1 million of income for the three months ended March 31, 2011
and 2010, respectively. As of March 31, 2011, the amounts expected to be reclassified from AOCI
into earnings over the next 12 months are approximately $104 million of losses on foreign currency
forward and option contracts and approximately $1 million of losses on forward interest rate
contracts.
Fair value hedges
To achieve a desired mix of fixed and floating interest rate debt, we have entered into
interest rate swap agreements, which qualify and have been designated as fair value hedges. The
terms of these interest rate swap agreements correspond to the related hedged debt instruments and
effectively convert a fixed interest rate coupon to a floating LIBOR-based coupon over the lives of
the respective notes. The rates on these swaps range from LIBOR plus 0.3% to LIBOR plus 2.6%. We
had interest rate swap agreements with aggregate notional amounts of $3.6 billion as of March 31,
2011 and December 31, 2010. The interest rate swap agreements as of March 31, 2011 and December 31,
2010 were for our notes due in 2014, 2017, 2018 and 2019. For derivative instruments that are
designated and qualify as a fair value hedge, the unrealized gain or loss on the derivative
resulting from the change in fair value during the period as well as the offsetting unrealized loss
or gain of the hedged item resulting from the change in fair value during the period attributable
to the hedged risk are recognized in current earnings. For the three months ended March 31, 2011
and 2010, we included the unrealized gain on the hedged debt of $47 million and the unrealized loss
on the hedged debt of $17 million, respectively, in the same line item, Interest expense, net in
the Condensed Consolidated Statements of Income, as the offsetting unrealized loss of $47 million
and the unrealized gain of $17 million, respectively, on the related interest rate swap agreements.
Derivatives not designated as hedges
We enter into foreign currency forward contracts to reduce our exposure to foreign currency
fluctuations of certain assets and liabilities denominated in foreign currencies which are not
designated as hedging transactions. These exposures are hedged on a month-to-month basis. As of
March 31, 2011 and December 31, 2010, the total notional amounts of these foreign currency forward
contracts, primarily Euro-based, were $788 million and $670 million, respectively.
The following table reflects the location in the Condensed Consolidated Statements of Income
and the amount of gain/(loss) recognized in earnings for the derivative instruments not designated
as hedging instruments (in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
|
|
|
|
|
March 31, |
|
Derivatives not designated as hedging instruments |
|
Statements of Income location |
|
|
2011 |
|
|
2010 |
|
Foreign currency contracts |
|
Interest and other income, net |
|
$ |
(51 |
) |
|
$ |
23 |
|
|
|
|
|
|
|
|
|
|
|
|
18
AMGEN INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Continued)
The following tables reflect the fair values of both derivatives designated as hedging
instruments and not designated as hedging instruments included in the Condensed Consolidated
Balance Sheets as of March 31, 2011 and December 31, 2010 (in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Derivative assets |
|
|
Derivative liabilities |
|
March 31, 2011 |
|
Balance Sheet location |
|
|
Fair value |
|
|
Balance Sheet location |
|
|
Fair value |
|
Derivatives designated as hedging
instruments: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest rate swap contracts |
|
Other current assets/Other non-current assets |
|
$ |
160 |
|
|
Accrued liabilities/Other non-current liabilities |
|
$ |
12 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign currency contracts |
|
Other current assets/Other non-current assets |
|
|
57 |
|
|
Accrued liabilities/Other non-current liabilities |
|
|
189 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total derivatives
designated as hedging
instruments |
|
|
|
|
|
|
217 |
|
|
|
|
|
|
|
201 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Derivatives not designated
as hedging instruments: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign currency contracts |
|
Other current assets |
|
|
|
|
|
Accrued liabilities |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total derivatives not
designated as hedging
instruments |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total derivatives |
|
|
|
|
|
$ |
217 |
|
|
|
|
|
|
$ |
201 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Derivative assets |
|
|
Derivative liabilities |
|
December 31, 2010 |
|
Balance Sheet location |
|
|
Fair value |
|
|
Balance Sheet location |
|
|
Fair value |
|
Derivatives designated as hedging
instruments: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest rate swap contracts |
|
Other current assets/Other non-current assets |
|
$ |
195 |
|
|
Accrued liabilities/Other non-current liabilities |
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign currency contracts |
|
Other current assets/Other non-current assets |
|
|
154 |
|
|
Accrued liabilities/Other non-current liabilities |
|
|
103 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total derivatives designated
as hedging instruments |
|
|
|
|
|
|
349 |
|
|
|
|
|
|
|
103 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Derivatives not designated as
hedging instruments: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign currency contracts |
|
Other current assets |
|
|
|
|
|
Accrued liabilities |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total derivatives not
designated as hedging
instruments |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total derivatives |
|
|
|
|
|
$ |
349 |
|
|
|
|
|
|
$ |
103 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Our derivative contracts that were in a liability position as of March 31, 2011 contain
certain credit risk related contingent provisions that are triggered if (i) we were to undergo a
change in control and (ii) our or the surviving entitys creditworthiness deteriorates, which is
generally defined as having either a credit rating that is below investment grade or a materially
weaker creditworthiness after the change in control. If these events were to occur, the
counterparties would have the right, but not the obligation, to close the contracts under early
termination provisions. In such circumstances, the counterparties could request immediate
settlement of these contracts for amounts that approximate the then current fair values of the
contracts.
The cash flow effects of our derivatives contracts are included within Net cash provided by
operating activities in the Condensed Consolidated Statements of Cash Flows.
19
12. Contingencies and commitments
In the ordinary course of business, we are involved in various legal proceedings and other
matters, including those discussed in this Note, which are complex in nature and have outcomes that
are difficult to predict. We record accruals for such contingencies to the extent that we conclude
that it is probable that a liability will be incurred and the amount of the related loss can be
reasonably estimated. While it is not possible to accurately predict or determine the eventual
outcome of these items, one or more of these items currently pending could have a material adverse
effect on our consolidated results of operations, financial position or cash flows.
Certain of our legal proceedings and other matters are discussed below:
Roche U.S. International Trade Commission Complaint
On March 11, 2011, the U.S. International Trade Commission issued an order to show cause why
the investigation should not be terminated without a determination of violation or by way of
consent order in view of the resolution of the U.S. District Court for the District of
Massachusetts proceedings. In response, on April 21, 2011, the parties filed a joint response
requesting termination of the investigation on the basis of a proposed Consent Order and
Stipulation.
Teva Matters
Sensipar® Abbreviated New Drug Application Litigation
On April 19, 2011, Teva Pharmaceuticals USA, Inc., Teva Pharmaceutical Industries Ltd. and
Barr Laboratories, Inc. filed an unopposed motion for voluntary dismissal of their appeal. On
April 20, 2011, the U.S. Court of Appeals for the Federal Circuit granted the motion and dismissed
the appeal.
Simonian v. Amgen Inc.
On April 12, 2011, Amgen and Mr. Simonian reached a settlement and the U.S. District Court for
the Northern District of Illinois dismissed the case with prejudice.
Average Wholesale Price Litigation
Plaintiffs continue to file for extensions for the final approval hearing of the Track II
settlement due to continued deficiencies in executing notices, and the final approval hearing is
currently scheduled for June 13, 2011.
Birch v. Sharer, et al.
On February 24, 2011, plaintiff filed a notice of appeal with the California State Appellate
Court. The schedule for briefing the appeal has not yet been set.
Third-Party Payers Litigation
No appeal was filed with the U.S. Supreme Court by the plaintiffs and the deadline for doing
so has passed.
Qui Tam Actions
On April 26, 2011, the Massachusetts District Court changed the trial date to be set for the
running trial list starting on October 3, 2011.
On February 11, 2011, the states of New York, Massachusetts, California, Illinois and Indiana,
on behalf of the states of Georgia and New Mexico, and the relator filed reply briefs and oral
argument was heard by the U.S. Court of Appeals for the First Circuit on April 6, 2011. On April
11, 2011, the U.S. District Court for the District of Massachusetts heard summary judgment
arguments on the fourth amended complaint from Amgen, Integrated Nephrology Network and the
relator.
20
Other
In March 2011, the U.S. Attorneys Office of the Western District of Washington informed Amgen
that the subject matter of its investigation would be transferred to the U.S. Attorneys Office of
the Eastern District of New York.
13. Subsequent events
In April 2011, we announced our acquisition of Laboratorio Quimico Farmaceutico Bergamo Ltda
(Bergamo), a privately-held Brazilian pharmaceutical company, for approximately $215 million in
cash. Bergamo is a leading supplier of medicines to the hospital sector in Brazil with capabilities
in oncology medicines. The company has approximately 400 staff, a portfolio of marketed products
and manufacturing facilities in the state of Sao Paulo, Brazil. Upon its acquisition, Bergamo
became a wholly owned subsidiary of Amgen. This acquisition will provide us with direct access to
the Brazilian pharmaceutical market. This transaction will be accounted for as a business
combination and included in our condensed consolidated financial statements commencing on the
acquisition date.
Pro forma supplemental condensed consolidated financial information for Amgen including the
results of Bergamo assuming an acquisition date of January 1, 2011 and 2010 is not provided as the
impact to our condensed consolidated results of operations would not be material, either
individually or when aggregated with the acquisition of BioVex (see Note 2, Acquisitions).
21
Item 2. MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
Forward looking statements
This report and other documents we file with the SEC contain forward looking statements that
are based on current expectations, estimates, forecasts and projections about us, our future
performance, our business or others on our behalf, our beliefs and our managements 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. Such words
as expect, anticipate, outlook, could, target, project, intend, plan, believe,
seek, estimate, should, may, assume, and continue, as well as 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 in Part II herein. We have based our
forward looking statements on our managements beliefs and assumptions based on information
available to our management at the time the statements are made. We caution you that actual
outcomes and results may differ materially from what is expressed, implied or forecast by our
forward looking statements. Reference is made in particular to forward looking statements regarding
product sales, regulatory activities, clinical trial results, reimbursement, expenses, EPS,
liquidity and capital resources and trends, including use of capital. 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 Managements Discussion and Analysis of Financial Condition and Results of
Operations (MD&A) is intended to assist the reader in understanding Amgens business. MD&A is
provided as a supplement to, and should be read in conjunction with, our Annual Report on Form 10-K
for the year ended December 31, 2010. Our results of operations discussed in MD&A are presented in
conformity with GAAP.
Amgen Inc. (including its subsidiaries, referred to as Amgen, the Company, we, our or
us) is the worlds largest independent biotechnology medicines company. We discover, develop,
manufacture and market medicines for grievous illnesses. We focus solely on human therapeutics and
concentrate on innovating novel medicines based on advances in cellular and molecular biology. Our
mission is to serve patients. We operate in one business segment human therapeutics. Therefore,
our results of operations are discussed on a consolidated basis.
Currently, we market primarily recombinant protein therapeutics in supportive cancer care,
nephrology and inflammation. Our principal products are: Aranesp® (darbepoetin alfa) and
EPOGEN® (Epoetin alfa), erythropoiesis-stimulating agents (ESAs); Neulasta®
(pegfilgrastim); NEUPOGEN® (Filgrastim); and Enbrel® (etanercept), all of
which are sold in the United States. We market ENBREL under a collaboration agreement with Pfizer
Inc. (Pfizer) in the United States and Canada. Our international product sales consist principally
of European sales of Aranesp®, Neulasta® and NEUPOGEN®. For the
three months ended March 31, 2011 and 2010, our principal products represented 89% and 92% of
worldwide product sales, respectively. Our other marketed products include
Sensipar®/Mimpara® (cinacalcet), Vectibix® (panitumumab),
Nplate® (romiplostim), Prolia® (denosumab) and XGEVA (denosumab).
22
Significant developments
The following is a list of selected significant developments that occurred to date during 2011
affecting our business:
ESAs
|
|
|
We continue to work closely with the FDA to finalize ESA labeling changes that could
further limit ESA treatment in chronic kidney disease (CKD) patients both on dialysis and
not on dialysis. |
|
|
|
The Centers for Medicare & Medicaid Services Final Rule on Bundling
in Dialysis became effective on January 1, 2011 and provides a single payment for all dialysis
services, including drugs that were previously reimbursed separately (except for oral
drugs without intravenous equivalents for which the bundling rules have been postponed).
Substantially all dialysis providers in the United States opted into the bundled payment
system in its entirety on January 1, 2011. As expected, the bundled payment system has
decreased dose utilization of EPOGEN®, and this decrease has had a material
adverse impact on our EPOGEN® sales. |
|
|
|
In 2010 and in early 2011, the Centers for Medicare & Medicaid Services (CMS) engaged in a number of activities to examine
the use of ESAs in certain patients with kidney disease, including holding a March 2010
meeting of the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC),
opening a National Coverage Analysis (NCA) in June 2010 to examine the use of ESAs to
manage anemia in patients with CKD and dialysis-related anemia, as well as holding another
MEDCAC meeting in January 2011 to review the impact of ESA use on renal transplant graft
survival. On March 16, 2011, CMS issued a Proposed Decision Memorandum (PDM) as part of
its ongoing NCA proposing that a National Coverage Determination (NCD) not be issued at
that time. CMS solicited public comments on their proposal and indicated that they would
respond to these comments and conclude the NCA process on or before June 16, 2011, but CMS
could propose an NCD at any time prior to that deadline. |
The above factors, individually or in combination, may have a material adverse impact on future
sales of our ESA products.
Prolia®
|
|
|
We estimate that the large majority of Prolia® usage to date has been
through the buy and bill process under Medicare Part B. However, we believe that primary
care physicians may have a preference to write a prescription for Prolia® and
utilize the pharmacy benefit, most frequently the prescription drug benefit under Medicare
Part D. We are in the process of securing Part D coverage with what we believe to be
affordable patient co-pays and prior authorizations consistent with product labeling. |
Vectibix®
|
|
|
On March 18, 2011, we received notice that the Committee for Medicinal Products for
Human Use of the European Medicines Agency (EMA) has adopted a negative opinion for
Amgens application to extend the marketing authorization in Europe for
Vectibix® to include its use in combination with chemotherapy for the treatment
of patients with wild-type KRAS metastatic colorectal cancer. On March 30, 2011, we
announced we had submitted a request to the EMA for a re-examination of the negative
opinion. |
Pipeline
|
|
|
On March 30, 2011, we along with our partner Takeda Pharmaceutical Company
Limited/Millennium Pharmaceuticals announced top-line results from the MONET1 pivotal
phase 3 trial evaluating motesanib administered in combination with paclitaxel and
carboplatin in 1,090 patients with advanced non-squamous non-small cell lung cancer. The
trial did not meet its primary objective of demonstrating an improvement in overall
survival. |
23
Dividend and Stock Repurchases
|
|
|
On April 20, 2011, the Board of Directors approved a dividend policy related to our common
stock and authorized us to repurchase up to an additional $5.0 billion of our common
stock. We expect to announce our initial quarterly dividend in connection with our second quarter
of 2011 earnings announcement. |
Acquisition
|
|
|
On March 4, 2011, we acquired BioVex, a privately held biotechnology company developing
treatments for cancer and the prevention of infectious disease, including
OncoVEXGM-CSF, a novel oncolytic vaccine in phase 3 clinical development for
the treatment of melanoma and head and neck cancer. Under the terms of this transaction,
we paid $407 million in cash and incurred contingent consideration obligations to make up
to $575 million in additional payments upon the achievement of certain regulatory and
sales milestones with regard to OncoVEXGM-CSF. The aggregate fair value as of
the acquisition date of these contingent consideration obligations was $190 million. These
obligations are revalued each subsequent reporting period until the underlying
contingencies are resolved, with any resulting changes in their fair values recorded in
earnings. In connection with the acquisition, we also recorded intangible assets of $675
million with respect to the IPR&D project for OncoVEXGM-CSF. The addition of
this IPR&D project to our ongoing clinical development programs is not anticipated to
materially increase our ongoing R&D expenses. For a more detailed description of this
transaction, see Note 2, Acquisitions to our condensed consolidated financial statements. |
24
Selected Financial Data
The following table presents selected financial data (amounts in millions, except percentages
and per share data):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
|
|
|
|
March 31, |
|
|
|
|
|
|
2011 |
|
|
2010 |
|
|
Change |
Product sales: |
|
|
|
|
|
|
|
|
|
|
|
|
U.S. |
|
$ |
2,778 |
|
|
$ |
2,677 |
|
|
|
4 |
% |
International |
|
|
840 |
|
|
|
851 |
|
|
|
(1 |
)% |
|
|
|
|
|
|
|
|
|
|
|
Total product sales |
|
|
3,618 |
|
|
|
3,528 |
|
|
|
3 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Other revenues |
|
|
88 |
|
|
|
64 |
|
|
|
38 |
% |
|
|
|
|
|
|
|
|
|
|
|
Total revenues |
|
$ |
3,706 |
|
|
$ |
3,592 |
|
|
|
3 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses |
|
$ |
2,413 |
|
|
$ |
2,111 |
|
|
|
14 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating income |
|
$ |
1,293 |
|
|
$ |
1,481 |
|
|
|
(13 |
)% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income |
|
$ |
1,125 |
|
|
$ |
1,167 |
|
|
|
(4 |
)% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted EPS |
|
$ |
1.20 |
|
|
$ |
1.18 |
|
|
|
2 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted shares |
|
|
941 |
|
|
|
988 |
|
|
|
(5 |
)% |
The following discusses certain key changes in our results of operations for the three
months ended March 31, 2011 as well as our financial condition as of March 31, 2011.
Our results of operations for the three months ended March 31, 2011 were impacted by a new
excise tax in Puerto Rico. Commencing January 1, 2011, Puerto Rico imposes a temporary excise tax
on the purchase of goods and services from a related manufacturer in Puerto Rico. This tax is
currently scheduled to expire in 2016. We account for the excise tax as a manufacturing cost that
is capitalized in inventory and expensed in cost of sales when the related products are sold. For
U.S. income tax purposes, a significant portion of the excise tax results in tax credits that are
recognized in our provision for income taxes when the excise tax is paid. This excise tax will
have a significant adverse impact on our cost of sales and a significant favorable impact on our
provision for income taxes. In addition, the overall impact of the excise tax will vary period to
period as a result of the timing difference between recognizing the expense and the applicable tax
credit. For the three months ended March 31, 2011, operating expenses were adversely impacted by
$13 million and the provision for income taxes was favorably impacted by $67 million as a result of
this excise tax.
The increase in U.S. product sales for the three months ended March 31, 2011 was driven
primarily by increases in sales of Neulasta®/NEUPOGEN®,
ENBREL, XGEVA and Prolia®, offset partially by
decreases in sales of EPOGEN® and Aranesp®.
International product sales decreased slightly for the three months ended March 31, 2011 driven by
decreases in Aranesp® and Neulasta®/NEUPOGEN® sales, largely
offset by increases in sales of our other marketed products.
The increase in operating expenses for the three months ended March 31, 2011 was driven
primarily by higher SG&A costs of $139 million and higher R&D costs of
$90 million.
The decrease in net income for the three months ended March 31, 2011 was due primarily to
lower operating income offset partially by higher net realized gains on investments and a lower
effective income tax rate, due primarily to higher tax credits in 2011 associated with the new
Puerto Rico excise tax.
The increase in diluted EPS for the three months ended March 31, 2011 was due to the reduction
in the number of shares used in the calculation of diluted EPS, offset partially by the reduction
in net income. The decrease in the number of shares used in the computation of diluted EPS reflects
the impact of our stock repurchase program. Due to the timing difference noted above associated
with the new Puerto Rico excise tax, our diluted EPS for the first quarter of 2011 were favorably
impacted by approximately $0.06.
25
As of March 31, 2011, our cash, cash equivalents and marketable securities totaled $15.4
billion and total debt outstanding was $10.9 billion. Of our total cash, cash equivalents and
marketable securities balances as of March 31, 2011, approximately $13.6 billion was generated from
operations in foreign tax jurisdictions and is intended to be invested indefinitely outside of the
United States. Under current tax laws, if these funds were repatriated for use in our U.S.
operations, we would be required to pay additional U.S. federal and state income taxes at the
applicable marginal tax rates.
Product sales
Worldwide product sales were as follows (dollar amounts in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
|
|
|
|
March 31, |
|
|
|
|
|
|
2011 |
|
|
2010 |
|
|
Change |
Aranesp® |
|
$ |
580 |
|
|
$ |
627 |
|
|
|
(7 |
)% |
EPOGEN® |
|
|
535 |
|
|
|
623 |
|
|
|
(14 |
)% |
Neulasta®/NEUPOGEN® |
|
|
1,232 |
|
|
|
1,179 |
|
|
|
4 |
% |
ENBREL |
|
|
875 |
|
|
|
804 |
|
|
|
9 |
% |
Sensipar®/Mimpara® |
|
|
187 |
|
|
|
179 |
|
|
|
4 |
% |
Vectibix® |
|
|
75 |
|
|
|
67 |
|
|
|
12 |
% |
Nplate® |
|
|
65 |
|
|
|
49 |
|
|
|
33 |
% |
Prolia® |
|
|
27 |
|
|
|
|
|
|
|
|
|
XGEVA |
|
|
42 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total product sales |
|
$ |
3,618 |
|
|
$ |
3,528 |
|
|
|
3 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total U.S. |
|
$ |
2,778 |
|
|
$ |
2,677 |
|
|
|
4 |
% |
Total International |
|
|
840 |
|
|
|
851 |
|
|
|
(1 |
)% |
|
|
|
|
|
|
|
|
|
|
|
Total product sales |
|
$ |
3,618 |
|
|
$ |
3,528 |
|
|
|
3 |
% |
|
|
|
|
|
|
|
|
|
|
|
Product sales are influenced by a number of factors, some of which may impact sales of
certain of our existing products more significantly than others. For a list of certain of these
factors, see Results of Operations Product Sales in our Annual Report on Form 10-K for the year
ended December 31, 2010.
Aranesp®
Total Aranesp® sales by geographic region were as follows (dollar amounts in
millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
|
|
|
|
March 31, |
|
|
|
|
|
|
2011 |
|
|
2010 |
|
|
Change |
Aranesp® U.S. |
|
$ |
250 |
|
|
$ |
268 |
|
|
|
(7 |
)% |
Aranesp® International |
|
|
330 |
|
|
|
359 |
|
|
|
(8 |
)% |
|
|
|
|
|
|
|
|
|
|
|
Total Aranesp® |
|
$ |
580 |
|
|
$ |
627 |
|
|
|
(7 |
)% |
|
|
|
|
|
|
|
|
|
|
|
The decrease in U.S. Aranesp® sales for the three months ended March 31, 2011
was due principally to a mid-teens percentage point decrease in unit demand, offset partially by an
increase in the average net sales price. This sales decrease reflects an overall decline in the
segment.
The decrease in international Aranesp® sales for the three months ended March 31,
2011 was due principally to decreases in both unit demand and the average net sales price,
reflecting an overall decline in the segment.
26
Future Aranesp® sales will depend, in part, on the factors as set forth in our
Annual Report on Form 10-K for the year ended December 31, 2010 and such factors as:
|
|
|
regulatory developments, including: |
|
- |
|
product label changes, including those that we are working with the FDA to finalize
that could further limit ESA treatment in CKD patients both on dialysis and not on
dialysis; |
|
- |
|
the ongoing compliance requirements for our ESA risk evaluation and mitigation
strategy;
|
|
|
|
reimbursement developments, including the potential imposition of an NCD or other
developments resulting from the NCA opened by CMS in June 2010 and the associated MEDCAC
meetings; and |
|
|
|
development of new protocols, tests and/or treatments for cancer and/or new
chemotherapy treatments or alternatives to chemotherapy that may have reduced and may
continue to reduce the use of chemotherapy in some patients. |
Certain of the above factors, individually or in combination, could have a material adverse impact on future sales of
Aranesp®.
EPOGEN®
Total EPOGEN® sales were as follows (dollar amounts in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
|
|
|
|
March 31, |
|
|
|
|
|
|
2011 |
|
|
2010 |
|
|
Change |
EPOGEN® U.S. |
|
$ |
535 |
|
|
$ |
623 |
|
|
|
(14 |
)% |
|
|
|
|
|
|
|
|
|
|
|
The decrease in EPOGEN® sales for the three months ended March 31, 2011 was
due primarily to a decline in unit demand, offset slightly by an increase in the average net sales
price. The decrease in unit demand reflects a decrease in dose utilization as healthcare providers
continued to implement new dose regimens in connection with the implementation of the bundled
payment system, offset slightly by patient population growth.
Future EPOGEN® sales will depend, in part, on the factors as set forth in our
Annual Report on Form 10-K for the year ended December 31, 2010 and such factors as:
|
|
|
product label changes, including those that we are working with the FDA to finalize
that could further limit ESA treatment in CKD patients both on dialysis and not on
dialysis; |
|
|
|
reimbursement developments, including those resulting from: |
|
- |
|
CMSs Final Rule on Bundling in Dialysis; |
|
- |
|
Other CMS activities, including the potential imposition of an NCD or other
developments resulting from the NCA opened by CMS in June 2010 and the associated MEDCAC
meetings; |
|
|
|
changes in dose fluctuations as healthcare providers continue to refine their treatment
practices in accordance with approved labeling; and |
|
|
|
adoption of alternative therapies or development of new modalities to treat anemia
associated with chronic renal failure. |
Certain of the above factors, individually or in combination, could have a material adverse impact on future sales of
EPOGEN®.
27
Neulasta®/NEUPOGEN®
Total Neulasta®/NEUPOGEN® sales by geographic region were as follows
(dollar amounts in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
|
|
|
|
March 31, |
|
|
|
|
|
|
2011 |
|
|
2010 |
|
|
Change |
Neulasta® U.S. |
|
$ |
710 |
|
|
$ |
637 |
|
|
|
11 |
% |
NEUPOGEN® U.S. |
|
|
220 |
|
|
|
225 |
|
|
|
(2 |
)% |
|
|
|
|
|
|
|
|
|
|
|
U.S. Neulasta®/NEUPOGEN® Total |
|
|
930 |
|
|
|
862 |
|
|
|
8 |
% |
|
|
|
|
|
|
|
|
|
|
|
Neulasta® International |
|
|
226 |
|
|
|
226 |
|
|
|
|
|
NEUPOGEN® International |
|
|
76 |
|
|
|
91 |
|
|
|
(16 |
)% |
|
|
|
|
|
|
|
|
|
|
|
International Neulasta®/NEUPOGEN® Total |
|
|
302 |
|
|
|
317 |
|
|
|
(5 |
)% |
|
|
|
|
|
|
|
|
|
|
|
Total Neulasta®/NEUPOGEN® |
|
$ |
1,232 |
|
|
$ |
1,179 |
|
|
|
4 |
% |
|
|
|
|
|
|
|
|
|
|
|
The increase in combined U.S. sales of Neulasta®/NEUPOGEN® for the
three months ended March 31, 2011 was driven primarily by an increase in the average net sales
price and, to a lesser extent, an increase in unit demand.
The decrease in combined Neulasta®/NEUPOGEN® international sales for the
three months ended March 31, 2011 was driven primarily by a decline in NEUPOGEN® sales
as a result of biosimilar competition, offset partially by growth in Neulasta® sales
due, in part, to continued conversion of NEUPOGEN® to Neulasta®.
Future Neulasta®/NEUPOGEN® sales will depend, in part, on the factors as
set forth in our Annual Report on Form 10-K for the year ended December 31, 2010.
ENBREL
Total ENBREL sales by geographic region were as follows (dollar amounts in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
|
|
|
|
March 31, |
|
|
|
|
|
|
2011 |
|
|
2010 |
|
|
Change |
ENBREL U.S. |
|
$ |
821 |
|
|
$ |
754 |
|
|
|
9 |
% |
ENBREL Canada |
|
|
54 |
|
|
|
50 |
|
|
|
8 |
% |
|
|
|
|
|
|
|
|
|
|
|
Total ENBREL |
|
$ |
875 |
|
|
$ |
804 |
|
|
|
9 |
% |
|
|
|
|
|
|
|
|
|
|
|
The increase in ENBREL sales for the three months ended March 31, 2011 was driven
primarily by an increase in the average net sales price and, to a lesser extent, an
increase in unit demand. This increase reflects segment growth, offset partially by share declines.
ENBREL continues to maintain a leading position in both the rheumatology and dermatology segments.
Future ENBREL sales will depend, in part, on the factors as set forth in our Annual Report on
Form 10-K for the year ended December 31, 2010.
28
Other products
Other product sales by geographic region were as follows (dollar amounts in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
|
|
|
|
March 31, |
|
|
|
|
|
|
2011 |
|
|
2010 |
|
|
Change |
Sensipar® U.S. |
|
$ |
116 |
|
|
$ |
117 |
|
|
|
(1 |
)% |
Sensipar® (Mimpara®) International |
|
|
71 |
|
|
|
62 |
|
|
|
15 |
% |
Vectibix® U.S. |
|
|
30 |
|
|
|
25 |
|
|
|
20 |
% |
Vectibix® International |
|
|
45 |
|
|
|
42 |
|
|
|
7 |
% |
Nplate® U.S. |
|
|
37 |
|
|
|
28 |
|
|
|
32 |
% |
Nplate® International |
|
|
28 |
|
|
|
21 |
|
|
|
33 |
% |
Prolia® U.S. |
|
|
17 |
|
|
|
|
|
|
|
|
|
Prolia® International |
|
|
10 |
|
|
|
|
|
|
|
|
|
XGEVA U.S. |
|
|
42 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total other products |
|
$ |
396 |
|
|
$ |
295 |
|
|
|
34 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total U.S. |
|
$ |
242 |
|
|
$ |
170 |
|
|
|
42 |
% |
Total International |
|
|
154 |
|
|
|
125 |
|
|
|
23 |
% |
|
|
|
|
|
|
|
|
|
|
|
Total other products |
|
$ |
396 |
|
|
$ |
295 |
|
|
|
34 |
% |
|
|
|
|
|
|
|
|
|
|
|
Future sales of our other products will depend, in part, on the factors as set forth in
our Annual Report on Form 10-K for the year ended December 31, 2010.
29
Selected operating expenses
The following table presents selected operating expenses (dollar amounts in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
|
|
|
|
March 31, |
|
|
|
|
|
|
2011 |
|
|
2010 |
|
|
Change |
Cost of sales |
|
$ |
564 |
|
|
$ |
508 |
|
|
|
11 |
% |
% of product sales |
|
|
15.6 |
% |
|
|
14.4 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
$ |
736 |
|
|
$ |
646 |
|
|
|
14 |
% |
% of product sales |
|
|
20.3 |
% |
|
|
18.3 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Selling, general and administrative |
|
$ |
1,023 |
|
|
$ |
884 |
|
|
|
16 |
% |
% of product sales |
|
|
28.3 |
% |
|
|
25.1 |
% |
|
|
|
|
Cost of sales
Cost of sales, which excludes the amortization of certain acquired intangible assets,
increased to 15.6% of product sales for the three months ended March 31, 2011, driven primarily by
higher bulk material cost, certain expenses related to actions to improve cost efficiencies and the
new excise tax associated with our manufacturing operations in Puerto Rico, offset partially by
higher average net sales prices and lower royalties.
Research and development
The increase in R&D expenses for the three months ended March 31, 2011 was attributable
primarily to: $46 million of higher clinical trial costs, reflecting our strategic decision to
invest in late stage clinical trials, including AMG 386 and AMG 479, and to augment support for
marketed products; and $28 million of higher staff related costs, primarily in support of
international expansion and discovery research.
Selling, general and administrative
The increase in SG&A expenses for the three months ended March 31, 2011 was due primarily to
certain expenses that did not occur in the same period last year,
including the U.S. Healthcare Reform Excise Fee of $39 million and promotional costs of $39 million,
due primarily to the launches of Prolia® and XGEVA. This increase was also
driven by $30 million of higher ENBREL profit share expense, under our collaboration agreement with
Pfizer, due to increased ENBREL sales. For the three months ended March 31, 2011 and 2010,
excluding expenses associated with the ENBREL profit share of $299 million and $269 million,
respectively, SG&A expenses increased 18%.
Under our collaboration agreement, we currently pay Pfizer a percentage of annual gross
profits on our ENBREL sales in the United States and Canada attributable to all approved
indications for ENBREL on a scale that increases as gross profits increase; however, we maintain a
majority share of ENBREL profits. After expiration of the agreement in the fourth quarter of 2013,
we will be required to pay Pfizer a declining percentage of annual net ENBREL sales in the United
States and Canada for three years, ranging from 12% to 10%. The amounts of such payments are
anticipated to be significantly less than what would be owed based on the terms of the current
ENBREL profit share.
30
Non-operating expenses/income and provisions for income taxes
The following table presents non-operating expenses/income and the provisions for income taxes
(dollar amounts in millions):
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
|
March 31, |
|
|
|
2011 |
|
|
2010 |
|
Interest expense, net |
|
$ |
135 |
|
|
$ |
145 |
|
Interest and other income, net |
|
$ |
148 |
|
|
$ |
84 |
|
Provisions for income taxes |
|
$ |
181 |
|
|
$ |
253 |
|
Effective income tax rate |
|
|
13.9 |
% |
|
|
17.8 |
% |
Interest expense, net
Included in interest expense, net for the three months ended March 31, 2011 and 2010 is the
impact of non-cash interest expense of $44 million and $65 million, respectively, resulting from
the change in the accounting for our convertible debt effective January 1, 2009.
Interest and other income, net
The increase in interest and other income, net for the three months ended March 31, 2011 was
due primarily to higher net realized gains on investments of $61 million.
Income taxes
Our effective tax rate for the three months ended March 31, 2011 was 13.9% compared to 17.8%
for the corresponding period of the prior year. The decrease in our effective tax rate was due
primarily to higher tax credits in 2011 associated with the new Puerto Rico excise tax and the
federal R&D credit, offset partially by the inclusion of the non-deductible U.S. Healthcare Reform
Excise Fee in 2011 and changes in revenue and expense mix. Our effective tax rate for the three
months ended March 31, 2011 without the impact of the tax credits associated with the new Puerto
Rico excise tax would have been 18.8%.
See Note 3, Income taxes to the condensed consolidated financial statements for further
discussion.
31
Financial Condition, Liquidity and Capital Resources
The following table summarizes selected financial data (in millions):
|
|
|
|
|
|
|
|
|
|
|
March 31, |
|
|
December 31, |
|
|
|
2011 |
|
|
2010 |
|
Cash, cash equivalents and marketable securities |
|
$ |
15,358 |
|
|
$ |
17,422 |
|
Total assets |
|
|
42,714 |
|
|
|
43,486 |
|
Current debt |
|
|
83 |
|
|
|
2,488 |
|
Non-current debt |
|
|
10,824 |
|
|
|
10,874 |
|
Stockholders equity |
|
|
24,984 |
|
|
|
23,944 |
|
On April 20, 2011,
the Board of Directors approved a dividend policy related to our common stock. We expect to announce our
initial quarterly dividend in connection with our second quarter of 2011 earnings announcement. In addition
to the planned dividend, the Company intends to continue to return cash to stockholders through share repurchases.
Both our plans to pay dividends and opportunistically repurchase stock reflect our confidence in the future cash
flows of our business. Repurchases under our stock repurchase program also reflect our confidence in the long-term
value of our common stock. The amount we spend and the number of shares repurchased will vary based on a number of
factors including the stock price, dividend payments and blackout periods in which we are restricted from
repurchasing shares, and the manner of purchases may include private block purchases as well as market
transactions. As of March 31, 2011, we had $2.2 billion
remaining under the Board of Directors previous stock repurchase authorization, and on April 20, 2011, the Board of Directors authorized us to
repurchase up to an additional $5.0 billion of our common stock. Whether and when we declare dividends or
repurchase stock, the size of any dividend and the amount of stock we repurchase could be affected by a number
of factors. See Item 1A. Risk Factors There can be no assurance that we will continue to
declare cash dividends or repurchase stock in Part II hereof.
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, dividend and
debt service requirements for the foreseeable future. In addition, we plan to opportunistically
pursue our stock repurchase program and other business initiatives, including acquisitions and
licensing activities. We anticipate that our liquidity needs can be met through a variety of
sources, including cash provided by operating activities, sale of marketable securities, borrowings
through commercial paper and/or our syndicated credit facility and access to other debt markets and
equity markets.
Certain of our financing arrangements contain non-financial covenants and we were in
compliance with all applicable covenants as of March 31, 2011. None of our financing arrangements
contain any financial covenants.
Cash flows
The following table summarizes our cash flow activity (in millions):
|
|
|
|
|
|
|
|
|
|
|
Three months ended March 31, |
|
|
|
2011 |
|
|
2010 |
|
Net cash provided by operating activities |
|
$ |
1,030 |
|
|
$ |
913 |
|
Net cash used in investing activities |
|
|
(555 |
) |
|
|
(955 |
) |
Net cash used in financing activities |
|
|
(2,496 |
) |
|
|
(576 |
) |
Operating
Cash provided by operating activities has been and is expected to continue to be our primary
recurring source of funds. Cash provided by operating activities during the three months ended
March 31, 2011 increased due primarily to the timing and amounts of payments to tax authorities
offset partially by the impact of increased inventory related expenditures.
32
Investing
Cash used in investing activities during the three months ended March 31, 2011
was primarily for the acquisition of BioVex, net of cash acquired of $403 million, and for the three months ended March 31, 2010
was primarily for net purchases of marketable securities of $849 million. Capital expenditures during the three months ended March 31, 2011 and 2010
totaled $100 million and $94 million, respectively. Capital expenditures during the three months ended March 31,
2011 and 2010 were associated primarily with manufacturing capacity expansions in Puerto Rico and
other site developments. We currently estimate 2011 spending on capital projects and equipment to
be approximately $600 million.
Financing
In February 2011, the 2011 Convertible Notes became due and we repaid the $2.5 billion
aggregate principal amount. See Note 8, Financing arrangements to the condensed consolidated financial statements for a
further discussion of our long-term borrowings.
During the three months ended March 31, 2011, we did not repurchase any shares of our common
stock. However, we had a net cash outflow of $14 million related to the settlement of shares of our
common stock repurchased during the three months ended December 31, 2010. During the three months
ended March 31, 2010, we repurchased 29.1 million shares of our common stock at a total cost of
$1.7 billion, of which $1.6 billion represented a net cash outflow in the period.
Summary of Critical Accounting Policies
A
discussion of our critical accounting policies is presented in
Part II, Item 7 of our Annual Report on Form 10-K for
the year ended December 31, 2010 and is supplemented with the
accounting policy discussed below.
Valuation of assets and liabilities in connection with business combinations
We have acquired and continue to acquire intangible assets in connection with business
combinations. These intangible assets consist primarily of technology associated with currently
marketed human therapeutic products and IPR&D product candidates. Discounted cash flow models are
typically used to determine the fair values of these intangible assets for purposes of allocating
consideration paid to the net assets acquired in a business combination. These models require the
use of significant estimates and assumptions, including, but not limited to:
|
|
|
determining the timing and expected costs to complete in-process projects taking into
account the stage of completion at the acquisition date; |
|
|
|
projecting the probability and timing of obtaining marketing approval from the FDA and
other regulatory agencies for product candidates; |
|
|
|
estimating future net cash flows from product sales resulting from completed products
and in-process projects; and |
|
|
|
developing appropriate discount rates to calculate the present values of the cash
flows. |
Significant estimates and assumptions are also required to determine the acquisition date fair
values of contingent consideration obligations incurred in connection with a business combination.
In addition, we must revalue these obligations each subsequent reporting period until the related
contingencies are resolved and record changes in their fair values in earnings. The acquisition
date fair values of contingent consideration obligations incurred in the acquisition of BioVex were
determined using a combination of valuation techniques. Significant estimates and assumptions
required for these valuations included, but were not limited to, the probability of achieving
regulatory milestones, product sales projections under various scenarios and discount rates
used to calculate the present value of the required payments. These estimates and assumptions are required to be
updated in order to revalue these contingent consideration obligations each reporting
period. Accordingly, subsequent changes in underlying facts and circumstances could result in changes in these
estimates and assumptions, which could have a material impact on the estimated
future fair values of these obligations.
We believe the fair values used to record intangible assets acquired and contingent
consideration obligations incurred in connection with business combinations are based upon
reasonable estimates and assumptions given the facts and circumstances as of the related
valuation dates.
33
Item 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
Information
about our market risk is disclosed in
Part II, Item 7A of our Annual Report on Form 10-K for the fiscal year ended December 31, 2010 and
is incorporated herein by reference. There have been no material
changes for the three months ended March 31, 2011 to the
information provided in Part II, Item 7A of our Annual Report on Form 10-K for the
fiscal year ended December 31, 2010.
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 Amgens
Exchange Act reports is recorded, processed, summarized and reported within the time periods
specified in the SECs rules and forms, and that such information is accumulated and communicated
to Amgens 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, Amgens 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, Amgens
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 Amgens Chief Executive Officer
and Chief Financial Officer, of the effectiveness of the design and operation of Amgens disclosure
controls and procedures. Based upon their evaluation and subject to the foregoing, the Chief
Executive Officer and Chief Financial Officer concluded that our disclosure controls and procedures
were effective as of March 31, 2011.
Management determined that, as of March 31, 2011, there were no changes in our internal
control over financial reporting that occurred during the fiscal quarter then ended that have
materially affected, or are reasonably likely to materially affect, our internal control over
financial reporting.
34
PART II OTHER INFORMATION
Item 1. LEGAL PROCEEDINGS
See Note 12, Contingencies and commitments to the condensed consolidated financial statements
for a discussion which is limited to certain recent developments concerning our legal proceedings.
These discussions should be read in conjunction with Note 19, Contingencies and commitments to our
consolidated financial statements in Part IV of our Annual Report on Form 10-K for the year ended
December 31, 2010.
Item 1A. RISK FACTORS
This report and other documents we file with the SEC contain forward looking statements that
are based on current expectations, estimates, forecasts and projections about us, our future
performance, our business or others on our behalf, our beliefs and our managements assumptions.
These statements are not guarantees of future performance and involve certain risks, uncertainties
and assumptions that are difficult to predict. You should carefully consider the risks and
uncertainties facing our business. We have described the primary risks relating to our business in
our Annual Report on Form 10-K for the fiscal year ended December 31, 2010 and periodically update
those risks for material developments. These risks are not the only ones facing us. Our business is
also subject to the risks that affect many other companies, such as employment relations, general
economic conditions, geopolitical events and international operations. Further, additional risks
not currently known to us or that we currently believe are immaterial also may impair our business,
operations, liquidity and stock price materially and adversely.
Below, we are providing, in supplemental form, the material changes to our risk factors that
occurred during the past quarter. Our risk factors disclosed in Part I, Item 1A, of our Annual
Report on Form 10-K for the fiscal year ended December 31, 2010 provide additional disclosure and
context for these supplemental risks for the first quarter 2011 and are incorporated herein by
reference.
Our sales depend on coverage and reimbursement from third-party payers.
On March 16, 2011, CMS issued a PDM as part of its ongoing NCA for the treatment of CKD and
dialysis-related anemia. In the PDM, CMS proposed that an NCD not be issued at that time. CMS
solicited public comments on their proposal and indicated that they would respond to these comments
and conclude the NCA process on or before June 16, 2011, but the conclusion may or may not be
consistent with the PDM and CMS could still propose an NCD at some point in the future. Changes to
the ESA label could affect CMSs decision as to whether to proceed with an NCD or the contents of
such NCD, and may also lead to other changes in reimbursement policies or practices, including
CMSs End Stage Renal Disease Quality Improvement Program (ESRD QIP) and/or bundled payment system
for dialysis treatment.
Our current products and products in development cannot be sold if we do not maintain or gain
regulatory approval.
We continue to work closely with the FDA to finalize ESA labeling changes that could further
limit ESA treatment in CKD patients both on dialysis and not on dialysis.
Our ESA products continue to be under review and receive scrutiny by regulatory authorities.
We continue to work closely with the FDA to finalize ESA labeling changes that could further
limit ESA treatment in CKD patients both on dialysis and not on dialysis. We also continue to
cooperate with CMS in determining appropriate coverage and reimbursement for our ESAs. On March 16,
2011, CMS issued a PDM as part of its ongoing NCA for the treatment of CKD and dialysis-related
anemia. In the PDM, CMS proposed that an NCD not be issued at that time. CMS solicited public
comments on their proposal and indicated that they would respond to these comments and conclude the
NCA process on or before June 16, 2011, but the conclusion may or
may not be consistent with the PDM and CMS could still propose an NCD
at some point in the future. Changes to the ESA label could affect CMSs decision as to whether to proceed with an NCD or the
contents of such NCD, and may also lead to other changes in reimbursement policies or practices,
including CMSs ESRD QIP and/or bundled payment system for dialysis treatment.
Our business may be affected by litigation and government investigations.
In March 2011, the U.S. Attorneys Office of the Western District of Washington informed Amgen
that the subject matter of its investigation would be transferred to the U.S. Attorneys Office of
the Eastern District of New York.
35
There can be no assurance that we will continue to declare cash dividends or repurchase stock.
On April 20, 2011, our Board of Directors
adopted a dividend policy pursuant to which the Company would pay quarterly dividends on our common stock, and increased
the total authorization for repurchases of our common stock to $7.2 billion. Whether we continue and the
amount and timing of such dividends and/or stock repurchases are subject to capital availability and periodic
determinations by our Board of Directors that cash dividends and/or stock repurchases are in the best interest
of our stockholders and are in compliance with all respective laws and agreements of the Company applicable to
the declaration and payment of cash dividends and the repurchase of stock. Future dividends and stock repurchases,
their timing and amount, as well as the relative allocation of cash between dividends and stock repurchases, may be
affected by, among other factors: our views on potential future capital requirements for strategic transactions,
including acquisitions; debt service requirements; our credit rating; changes to applicable tax laws or corporate
laws; and changes to our business model. In addition, the amount we spend and the number of shares we are able to
repurchase under our stock repurchase program may further be affected by a number of other factors, including the
stock price and blackout periods in which we are restricted from repurchasing shares. Our dividend payments and/or
stock repurchases may change from time to time, and we cannot provide assurance that we will continue to declare
dividends and/or repurchase stock in any particular amounts or at all. A reduction in or elimination of our
dividend payments and/or stock repurchases could have a negative effect on our stock price.
36
Item 6. EXHIBITS
Reference is made to the Index to Exhibits included herein.
37
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly
caused this Quarterly Report to be signed on its behalf by the undersigned, thereunto duly authorized.
|
|
|
|
|
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Amgen Inc.
(Registrant)
|
|
Date: May 10, 2011 |
By: |
/s/ Jonathan M. Peacock
|
|
|
|
Jonathan M. Peacock |
|
|
|
Executive Vice President
and Chief Financial Officer |
|
38
AMGEN INC.
INDEX TO EXHIBITS
|
|
|
Exhibit No. |
|
Description |
2.1*
|
|
Agreement and Plan of Merger, dated as of January 24, 2011,
among BioVex Group, Inc., BioVex Limited, Amgen Inc.,
Andromeda Acquisition Corp. and Forbion 1 Management B.V. as
the Stockholders Agent (with certain confidential information
deleted therefrom). |
|
|
|
2.2*
|
|
First Amendment to the Agreement and Plan of Merger, dated as
of March 3, 2011, by and among BioVex Group, Inc., BioVex
Limited, Amgen Inc., Andromeda Acquisition Corp. and Forbion 1
Management B.V. as the Stockholders Agent (with certain
confidential information deleted therefrom). |
|
|
|
3.1
|
|
Restated Certificate of Incorporation (As Restated December 6,
2005). (Filed as an exhibit to Form 10-K for the year ended
December 31, 2005 on March 10, 2006 and incorporated herein by
reference.) |
|
|
|
3.2
|
|
Certificate of Amendment of the Restated Certificate of
Incorporation (As Amended May 24, 2007). (Filed as an exhibit
to Form 10-Q for the quarter ended June 30, 2007 on August 9,
2007 and incorporated herein by reference.) |
|
|
|
3.3
|
|
Certificate of Correction of the Restated Certificate of
Incorporation (As Corrected May 24, 2007). (Filed as an
exhibit to Form 10-Q for the quarter ended June 30, 2007 on
August 9, 2007 and incorporated herein by reference.) |
|
|
|
3.4
|
|
Certificate of Elimination of the Certificate of Designations
of the Series A Junior Participating Preferred Stock (As
Eliminated December 10, 2008). (Filed as an exhibit to Form
10-K for the year ended December 31, 2008 on February 27, 2009
and incorporated herein by reference.) |
|
|
|
3.5
|
|
Certificate of Amendment of the Restated Certificate of
Incorporation (As Amended May 11, 2009). (Filed as an exhibit
to Form 10-Q for the quarter ended June 30, 2009 on August 10,
2009 and incorporated herein by reference.) |
|
|
|
3.6
|
|
Certificate of Correction of the Restated Certificate of
Incorporation (As Corrected May 11, 2009). (Filed as an
exhibit to Form 10-Q for the quarter ended June 30, 2009 on
August 10, 2009 and incorporated herein by reference.) |
|
|
|
3.7
|
|
Certificate of Correction of the Restated Certificate of
Incorporation (As Corrected May 13, 2010). (Filed as an
exhibit to Form 10-Q for the quarter ended June 30, 2010 on
August 9, 2010.) |
|
|
|
3.8
|
|
Amended and Restated Bylaws of Amgen Inc. (As Amended and
Restated October 6, 2009). (Filed as an exhibit to Form 8-K
filed on October 7, 2009 and incorporated herein by
reference.) |
|
|
|
4.1
|
|
Form of stock certificate for the common stock, par value
$.0001 of the Company. (Filed as an exhibit to Form 10-Q for
the quarter ended March 31, 1997 on May 13, 1997 and
incorporated herein by reference.) |
|
|
|
4.2
|
|
Form of Indenture, dated January 1, 1992. (Filed as an exhibit
to Form S-3 Registration Statement filed on December 19, 1991
and incorporated herein by reference.) |
|
|
|
4.3
|
|
Agreement of Resignation, Appointment and Acceptance dated
February 15, 2008. (Filed as an exhibit to Form 10-K for the
year ended December 31, 2007 on February 28, 2008 and
incorporated herein by reference.) |
|
|
|
4.4
|
|
Two Agreements of Resignation, Appointment and Acceptance in
the same form as the previously filed Exhibit 4.3 hereto are
omitted pursuant to instruction 2 to Item 601 of Regulation
S-K. Each of these agreements, which are dated December 15,
2008, replaces the current trustee under the agreements listed
as Exhibits 4.9 and 4.15, respectively, with Bank of New York
Mellon. Amgen Inc. hereby agrees to furnish copies of these
agreements to the Securities and Exchange Commission upon
request. |
|
|
|
4.5
|
|
First Supplemental Indenture, dated February 26, 1997. (Filed
as an exhibit to Form 8-K on March 14, 1997 and incorporated
herein by reference.) |
|
|
|
4.6
|
|
8-1/8% Debentures due April 1, 2097. (Filed as an exhibit to
Form 8-K filed on April 8, 1997 and incorporated herein by
reference.) |
|
|
|
4.7
|
|
Officers Certificate, dated as of January 1, 1992, as
supplemented by the First Supplemental Indenture, dated as of
February 26, 1997, 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
|
|
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
|
|
Indenture, dated as of March 1, 2002. (Filed as an exhibit to
Form 8-K on March 1, 2002 and incorporated herein by
reference.) |
|
|
|
4.10
|
|
First Supplemental Indenture, dated March 2, 2005. (Filed as
an exhibit to Form 8-K filed on March 4, 2005 and incorporated
herein by reference.) |
39
|
|
|
Exhibit No. |
|
Description |
4.11
|
|
Indenture, dated as of August 4, 2003. (Filed as an exhibit to
Form S-3 Registration Statement on August 4, 2003 and
incorporated herein by reference.) |
|
|
|
4.12
|
|
Form of 4.85% Senior Notes due 2014. (Filed as an exhibit to
Form 8-K on November 19, 2004 and incorporated herein by
reference.) |
|
|
|
4.13
|
|
Officers Certificate, dated November 18, 2004, including
forms of the 4.00% Senior Notes due 2009 and 4.85% Senior
Notes due 2014. (Filed as an exhibit to Form 8-K on November
19, 2004 and incorporated herein by reference.) |
|
|
|
4.14
|
|
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.) |
|
|
|
4.15
|
|
Indenture, dated as of May 6, 2005. (Filed as an exhibit to
Form 8-K on May 6, 2005 and incorporated herein by reference.) |
|
|
|
4.16
|
|
Indenture, dated as of February 17, 2006 and First
Supplemental Indenture, dated as of June 8, 2006 (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.) |
|
|
|
4.17
|
|
Indenture, dated as of February 17, 2006 and First
Supplemental Indenture, dated as of June 8, 2006 (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.) |
|
|
|
4.18
|
|
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.) |
|
|
|
4.19
|
|
Officers Certificate of Amgen Inc. dated as of May 30, 2007,
including forms of the Companys Senior Floating Rate Notes
due 2008, 5.85% Senior Notes due 2017 and 6.375% Senior Notes
due 2037. (Filed as an exhibit to Form 8-K on May 30, 2007 and
incorporated herein by reference.) |
|
|
|
4.20
|
|
Officers Certificate of Amgen Inc. dated as of May 23, 2008,
including forms of the Companys 6.15% Senior Notes due 2018
and 6.90% Senior Notes due 2038. (Filed as exhibit to Form 8-K
on May 23, 2009 and incorporated herein by reference.) |
|
|
|
4.21
|
|
Officers Certificate of Amgen Inc. dated as of January 16,
2009, including forms of the Companys 5.70% Senior Notes due
2019 and 6.40% Senior Notes due 2039. (Filed as exhibit to
Form 8-K on January 16, 2009 and incorporated herein by
reference.) |
|
|
|
4.22
|
|
Officers Certificate of Amgen Inc. dated as of March 12,
2010, including forms of the Companys 4.50% Senior Notes due
2020 and 5.75% Senior Notes due 2040. (Filed as exhibit to
Form 8-K on March 15, 2010 and incorporated herein by
reference.) |
|
|
|
4.23
|
|
Officers Certificate of Amgen Inc., dated as of September 16,
2010, including forms of the Companys 3.45% Senior Notes due
2020 and 4.95% Senior Notes due 2041. (Filed as an exhibit to
Form 8-K on September 17, 2010 and incorporated herein by
reference.) |
|
|
|
10.1+
|
|
Amgen Inc. 2009 Equity Incentive Plan. (Filed as Appendix A to
Amgen Inc.s Proxy Statement on March 26, 2009 and
incorporated herein by reference.) |
|
|
|
10.2+*
|
|
Form of Stock Option Agreement for the Amgen Inc. 2009 Equity
Incentive Plan. (As Amended on March 2, 2011.) |
|
|
|
10.3+*
|
|
Form of Restricted Stock Unit Agreement for the Amgen Inc.
2009 Equity Incentive Plan. (As Amended on March 2, 2011.) |
|
|
|
10.4+
|
|
Amgen Inc. 2009 Performance Award Program. (As Amended and
Restated on December 4, 2009.) (Filed as an exhibit to Form
10-K for the year ended December 31, 2009 on March 1, 2010 and
incorporated herein by reference.) |
|
|
|
10.5+*
|
|
Form of Performance Unit Agreement for the Amgen Inc. 2009
Performance Award Program. (As Amended on March 2, 2011.) |
|
|
|
10.6+
|
|
Amgen Inc. 2009 Director Equity Incentive Program. (Filed as
an exhibit to Form 8-K on May 8, 2009 and incorporated herein
by reference.) |
|
|
|
10.7+
|
|
Form of Grant of Non-Qualified Stock Option Agreement and
Restricted Stock Unit Agreement for the Amgen Inc. 2009
Director Equity Incentive Program. (Filed as an exhibit to
Form 8-K on May 8, 2009 and incorporated herein by reference.) |
|
|
|
10.8+
|
|
Amgen Supplemental Retirement Plan. (As Amended and Restated
effective January 1, 2009.) (Filed as an exhibit to Form 10-Q
for the quarter ended September 30, 2008 on November 7, 2008
and incorporated herein by reference.) |
|
|
|
10.9+*
|
|
Amendment and Restatement of the Amgen Change of Control
Severance Plan. (As Amended and Restated effective December 9,
2010 and subsequently amended effective March 2, 2011.) |
40
|
|
|
Exhibit No. |
|
Description |
10.10+
|
|
Amgen Inc. Executive Incentive Plan. (As Amended and Restated
effective January 1, 2009.) (Filed as an exhibit to Form 10-Q
for the quarter ended September 30, 2008 on November 7, 2008
and incorporated herein by reference.) |
|
|
|
10.11+
|
|
Amgen Inc. Executive Nonqualified Retirement Plan. (As Amended
and Restated effective January 1, 2009.) (Filed as an exhibit
to Form 10-Q for the quarter ended September 30, 2008 on
November 7, 2008 and incorporated herein by reference.) |
|
|
|
10.12+
|
|
First Amendment to the Amgen Inc. Executive Nonqualified
Retirement Plan. (Filed as an exhibit to Form 10-Q for the
quarter ended June 30, 2010 on August 9, 2010 and incorporated
herein by reference.) |
|
|
|
10.13+
|
|
Amgen Nonqualified Deferred Compensation Plan. (As Amended and
Restated effective January 1, 2009.) (Filed as an exhibit to
Form 10-Q for the quarter ended September 30, 2008 on November
7, 2008 and incorporated herein by reference.) |
|
|
|
10.14+
|
|
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.) |
|
|
|
10.15+
|
|
Agreement between Amgen Inc. and Mr. Jonathan M. Peacock,
dated July 5, 2010. (Filed as an exhibit to Form 10-Q for the
quarter ended September 30, 2010 on November 8, 2010 and
incorporated herein by reference.) |
|
|
|
10.16
|
|
Consulting Agreement, effective February 1, 2011, between
Amgen Inc. and Mr. George Morrow. (Filed as an exhibit to Form
8-K on October 22, 2010 and incorporated herein by reference). |
|
|
|
10.17
|
|
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.) |
|
|
|
10.18
|
|
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.) |
|
|
|
10.19
|
|
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.) |
|
|
|
10.20
|
|
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.) |
|
|
|
10.21
|
|
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.) |
|
|
|
10.22
|
|
Amendment No. 13 to the Shareholders Agreement, dated June
28, 2007 (with certain confidential information deleted
therefrom). (Filed as an exhibit to Form 10-Q for the quarter
ended June 30, 2007 on August 9, 2007 and incorporated herein
by reference.) |
|
|
|
10.23
|
|
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.) |
|
|
|
10.24
|
|
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.) |
|
|
|
10.25
|
|
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.) |
|
|
|
10.26
|
|
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.) |
|
|
|
10.27
|
|
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, |
41
|
|
|
Exhibit No. |
|
Description |
|
|
1998, Amendment
No. 3 to Kirin-Amgen, Inc. / Amgen G-CSF European License
Agreement, dated October 20, 1988, and 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.) |
|
|
|
10.28
|
|
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.) |
|
|
|
10.29
|
|
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 incorporated herein by reference.) |
|
|
|
10.30
|
|
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.) |
|
|
|
10.31
|
|
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.) |
|
|
|
10.32
|
|
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.) |
|
|
|
10.33
|
|
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.) |
|
|
|
10.34
|
|
Confirmation of OTC Warrant Transaction, dated February 14,
2006, to Amgen Inc. from Merrill Lynch International for
warrants expiring in 2013. (Filed as an exhibit to Form 10-K
for the year ended December 31, 2005 on March 10, 2006 and
incorporated herein by reference.) |
|
|
|
10.35
|
|
Collaboration Agreement, dated July 11, 2007, between Amgen
Inc. and Daiichi Sankyo Company (with certain confidential
information deleted therefrom). (Filed as an exhibit to Form
10-Q for the quarter ended September 30, 2007 on November 9,
2007 and incorporated herein by reference.) |
|
|
|
10.36
|
|
Credit Agreement, dated November 2, 2007, among Amgen Inc.,
with Citicorp USA, Inc., as administrative agent, Barclays
Bank PLC, as syndication agent, Citigroup Global Markets, Inc.
and Barclays Capital, as joint lead arrangers and joint book
runners, and the other banks party thereto. (Filed as an
exhibit to Form 8-K filed on November 2, 2007 and incorporated
herein by reference.) |
|
|
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10.37
|
|
Amendment No. 1, dated May 18, 2009, to the Credit Agreement
dated November 2, 2007, among Amgen Inc., with Citicorp USA,
Inc., as administrative agent, Barclays Bank PLC, as
syndication agent, Citigroup Global Markets, Inc. and Barclays
Capital, as joint lead arrangers and joint book runners, and
the other banks party thereto. (Filed as an exhibit to Form
10-Q for the quarter ended June 30, 2009 on August 10, 2009
and incorporated herein by reference.) |
|
|
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10.38
|
|
Multi-product License Agreement with Respect to Japan between
Amgen Inc. and Takeda Pharmaceutical Company Limited dated
February 1, 2008 (with certain confidential information
deleted therefrom). (Filed as an exhibit to Form 10-Q for the
quarter ended March 31, 2008 on May 12, 2008 and incorporated
herein by reference.) |
|
|
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10.39
|
|
License Agreement for motesanib diphosphate between Amgen Inc.
and Takeda Pharmaceutical Company Limited dated February 1,
2008 (with certain confidential information deleted
therefrom). (Filed as an exhibit to Form 10-Q for the quarter
ended March 31, 2008 on May 12, 2008 and incorporated herein
by reference.) |
|
|
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10.40
|
|
Supply Agreement between Amgen Inc. and Takeda Pharmaceutical
Company Limited dated February 1, 2008 (with certain
confidential information deleted therefrom). (Filed as an
exhibit to Form 10-Q for the quarter ended March 31, 2008 on
May 12, 2008 and incorporated herein by reference.) |
|
|
|
10.41
|
|
Sale and Purchase Agreement between Amgen Inc. and Takeda
Pharmaceutical Company Limited dated February 1, 2008 (with
certain confidential information deleted therefrom). (Filed as
an exhibit to Form 10-Q for the quarter ended March 31, 2008
on May 12, 2008 and incorporated herein by reference.) |
|
|
|
10.42
|
|
Master Services Agreement, dated October 22, 2008, between
Amgen Inc. and International Business |
42
|
|
|
Exhibit No. |
|
Description |
|
|
Machines Corporation
(with certain confidential information deleted therefrom).
(Filed as an exhibit to Form 10-K for the year ended December
31, 2008 on February 27, 2009 and incorporated herein by
reference.) |
|
|
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10.43
|
|
Amendment, dated December 11, 2009, to Master Services
Agreement, dated October 22, 2009, between Amgen Inc. and
International Business Machines Corporation (with certain
confidential information deleted therefrom). (Filed as an
exhibit to Form 10-K for the year ended December 31, 2009 on
March 1, 2010 and incorporated herein by reference.) |
|
|
|
10.44
|
|
Amendment Number 6, dated September 23, 2010, to Master
Services Agreement, dated October 22, 2009, between Amgen Inc.
and International Business Machines Corporation (with certain
confidential information deleted therefrom). (Filed as an
exhibit to Form 10-Q for the quarter ended September 30, 2010
on November 8, 2010 and incorporated herein by reference.) |
|
|
|
10.45
|
|
Integrated Facilities Management Services Agreement, dated
February 4, 2009 between Amgen Inc. and Jones Lang LaSalle
Americas, Inc. (with certain confidential information deleted
therefrom). (Filed as an exhibit to Form 10-K for the year
ended December 31, 2008 on February 27, 2009 and incorporated
herein by reference.) |
|
|
|
10.46
|
|
Collaboration Agreement dated July 27, 2009 between Amgen Inc.
and Glaxo Group Limited, a wholly-owned subsidiary of
GlaxoSmithKline plc (with certain confidential information
deleted therefrom). (Filed as an exhibit to Form 10-Q for the
quarter ended September 30, 2009 on November 6, 2009 and
incorporated herein by reference.) |
|
|
|
10.47
|
|
Expansion Agreement dated July 27, 2009 between Amgen Inc. and
Glaxo Group Limited, a wholly-owned subsidiary of
GlaxoSmithKline plc (with certain confidential information
deleted therefrom). (Filed as an exhibit to Form 10-Q for the
quarter ended September 30, 2009 on November 6, 2009 and
incorporated herein by reference.) |
|
|
|
10.48
|
|
Amendment Number 1, dated September 20, 2010, to Expansion
Agreement dated July 27, 2009 between Amgen Inc. and Glaxo
Group Limited, a wholly-owned subsidiary of GlaxoSmithKline
plc (with certain confidential information deleted therefrom).
(Filed as an exhibit to Form 10-Q for the quarter ended
September 30, 2010 on November 8, 2010 and incorporated herein
by reference.) |
|
|
|
10.49
|
|
Underwriting Agreement, dated March 12, 2010, by and among the
Company and Banc of America Securities LLC, Barclays Capital
Inc. and Morgan Stanley & Co. Incorporated, as representatives
of the several underwriters named therein. (Filed as an
exhibit to Form 8-K on March 15, 2010 and incorporated herein
by reference.) |
|
|
|
10.50
|
|
Underwriting Agreement, dated September 13, 2010, by and among
the Company and Citigroup Global Markets Inc., Goldman, Sachs
& Co. and Morgan Stanley & Co. Incorporated, as
representatives of the several underwriters named therein.
(Filed as an exhibit to Form 8-K on September 17, 2010 and
incorporated herein by reference.) |
|
|
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31*
|
|
Rule 13a-14(a) Certifications. |
|
|
|
32**
|
|
Section 1350 Certifications. |
|
|
|
101.INS**
|
|
XBRL Instance Document. |
|
|
|
101.SCH**
|
|
XBRL Taxonomy Extension Schema Document. |
|
|
|
101.CAL**
|
|
XBRL Taxonomy Extension Calculation Linkbase Document. |
|
|
|
101.LAB**
|
|
XBRL Taxonomy Extension Label Linkbase Document. |
|
|
|
101.PRE**
|
|
XBRL Taxonomy Extension Presentation Linkbase Document. |
|
|
|
101.DEF**
|
|
XBRL Taxonomy Extension Definition Linkbase. |
|
|
|
(* = 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)
43