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þ | QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
o | TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
Delaware
(State or other jurisdiction of incorporation or organization) |
95-3540776
(I.R.S. Employer Identification No.) |
|
One Amgen Center Drive,
Thousand Oaks, California (Address of principal executive offices) |
91320-1799 (Zip Code) |
Large accelerated filer þ | Accelerated filer o | Non-accelerated filer o | Smaller reporting company o | |||
(Do not check if a smaller reporting company) |
i
Three months ended | Six months ended | |||||||||||||||
June 30, | June 30, | |||||||||||||||
2011 | 2010 | 2011 | 2010 | |||||||||||||
Revenues:
|
||||||||||||||||
Product sales
|
$ | 3,893 | $ | 3,613 | $ | 7,511 | $ | 7,141 | ||||||||
Other revenues
|
66 | 191 | 154 | 255 | ||||||||||||
|
||||||||||||||||
Total revenues
|
3,959 | 3,804 | 7,665 | 7,396 | ||||||||||||
|
||||||||||||||||
|
||||||||||||||||
Operating expenses:
|
||||||||||||||||
Cost of sales (excludes amortization of certain
acquired intangible assets presented below)
|
602 | 553 | 1,166 | 1,061 | ||||||||||||
Research and development
|
819 | 675 | 1,555 | 1,321 | ||||||||||||
Selling, general and administrative
|
1,130 | 986 | 2,153 | 1,870 | ||||||||||||
Amortization of certain acquired intangible assets
|
73 | 73 | 147 | 147 | ||||||||||||
Other
|
3 | — | 19 | (1 | ) | |||||||||||
|
||||||||||||||||
Total operating expenses
|
2,627 | 2,287 | 5,040 | 4,398 | ||||||||||||
|
||||||||||||||||
|
||||||||||||||||
Operating income
|
1,332 | 1,517 | 2,625 | 2,998 | ||||||||||||
|
||||||||||||||||
Interest expense, net
|
122 | 147 | 257 | 292 | ||||||||||||
Interest and other income, net
|
129 | 94 | 277 | 178 | ||||||||||||
|
||||||||||||||||
|
||||||||||||||||
Income before income taxes
|
1,339 | 1,464 | 2,645 | 2,884 | ||||||||||||
|
||||||||||||||||
Provision for income taxes
|
169 | 262 | 350 | 515 | ||||||||||||
|
||||||||||||||||
|
||||||||||||||||
Net income
|
$ | 1,170 | $ | 1,202 | $ | 2,295 | $ | 2,369 | ||||||||
|
||||||||||||||||
|
||||||||||||||||
Earnings per share:
|
||||||||||||||||
Basic
|
$ | 1.26 | $ | 1.25 | $ | 2.47 | $ | 2.44 | ||||||||
Diluted
|
$ | 1.25 | $ | 1.25 | $ | 2.45 | $ | 2.43 | ||||||||
|
||||||||||||||||
Shares used in calculation of earnings per share:
|
||||||||||||||||
Basic
|
927 | 959 | 930 | 970 | ||||||||||||
Diluted
|
935 | 964 | 938 | 976 |
1
June 30, | December 31, | |||||||
2011 | 2010 | |||||||
ASSETS
|
||||||||
Current assets:
|
||||||||
Cash and cash equivalents
|
$ | 5,998 | $ | 3,287 | ||||
Marketable securities
|
13,174 | 14,135 | ||||||
Trade receivables, net
|
2,713 | 2,335 | ||||||
Inventories
|
2,230 | 2,022 | ||||||
Other current assets
|
1,366 | 1,350 | ||||||
|
||||||||
Total current assets
|
25,481 | 23,129 | ||||||
|
||||||||
Property, plant and equipment, net
|
5,516 | 5,522 | ||||||
Intangible assets, net
|
2,782 | 2,230 | ||||||
Goodwill
|
11,794 | 11,334 | ||||||
Other assets
|
1,363 | 1,271 | ||||||
|
||||||||
Total assets
|
$ | 46,936 | $ | 43,486 | ||||
|
||||||||
|
||||||||
LIABILITIES AND STOCKHOLDERS’ EQUITY
|
||||||||
Current liabilities:
|
||||||||
Accounts payable
|
$ | 870 | $ | 716 | ||||
Accrued liabilities
|
3,629 | 3,366 | ||||||
Current portion of convertible notes
|
83 | 2,488 | ||||||
|
||||||||
Total current liabilities
|
4,582 | 6,570 | ||||||
|
||||||||
Convertible notes
|
2,279 | 2,296 | ||||||
Other long-term debt
|
11,568 | 8,578 | ||||||
Other non-current liabilities
|
2,893 | 2,098 | ||||||
|
||||||||
Contingencies and commitments
|
||||||||
|
||||||||
Stockholders’ equity:
|
||||||||
Common stock and additional paid-in capital;
$0.0001 par value; 2,750 shares authorized;
outstanding - 924 shares in 2011 and
932 shares in 2010
|
27,514 | 27,299 | ||||||
Accumulated deficit
|
(1,945 | ) | (3,508 | ) | ||||
Accumulated other comprehensive income
|
45 | 153 | ||||||
|
||||||||
Total stockholders’ equity
|
25,614 | 23,944 | ||||||
|
||||||||
Total liabilities and stockholders’ equity
|
$ | 46,936 | $ | 43,486 | ||||
|
2
Six months ended | ||||||||
June 30, | ||||||||
2011 | 2010 | |||||||
Cash flows from operating activities:
|
||||||||
Net income
|
$ | 2,295 | $ | 2,369 | ||||
Depreciation and amortization
|
534 | 503 | ||||||
Stock-based compensation expense
|
174 | 166 | ||||||
Other items, net
|
(36 | ) | 72 | |||||
Changes in operating assets and liabilities, net of acquisitions:
|
||||||||
Trade receivables, net
|
(369 | ) | (99 | ) | ||||
Inventories
|
(194 | ) | 120 | |||||
Other current assets
|
51 | (129 | ) | |||||
Accounts payable
|
121 | 148 | ||||||
Accrued income taxes
|
25 | (297 | ) | |||||
Other accrued liabilities
|
(35 | ) | (376 | ) | ||||
|
||||||||
Net cash provided by operating activities
|
2,566 | 2,477 | ||||||
|
||||||||
|
||||||||
Cash flows from investing activities:
|
||||||||
Purchases of property, plant and equipment
|
(223 | ) | (271 | ) | ||||
Cash paid for acquisitions, net of cash acquired
|
(701 | ) | — | |||||
Purchases of marketable securities
|
(13,207 | ) | (7,607 | ) | ||||
Proceeds from sales of marketable securities
|
14,019 | 5,246 | ||||||
Proceeds from maturities of marketable securities
|
408 | 290 | ||||||
Other
|
(5 | ) | (48 | ) | ||||
|
||||||||
Net cash provided by (used in) investing activities
|
291 | (2,390 | ) | |||||
|
||||||||
|
||||||||
Cash flows from financing activities:
|
||||||||
Repayment of debt
|
(2,500 | ) | — | |||||
Repurchases of common stock
|
(745 | ) | (2,300 | ) | ||||
Net proceeds from issuance of debt
|
2,973 | 989 | ||||||
Other
|
126 | 52 | ||||||
|
||||||||
Net cash used in financing activities
|
(146 | ) | (1,259 | ) | ||||
|
||||||||
|
||||||||
Increase (decrease) in cash and cash equivalents
|
2,711 | (1,172 | ) | |||||
|
||||||||
Cash and cash equivalents at beginning of period
|
3,287 | 2,884 | ||||||
|
||||||||
|
||||||||
Cash and cash equivalents at end of period
|
$ | 5,998 | $ | 1,712 | ||||
|
3
4
5
Cash paid to former shareholders of BioVex
|
$ | 407 | ||
Fair value of contingent consideration obligations
|
190 | |||
|
||||
Total consideration
|
$ | 597 | ||
|
6
Intangible assets — IPR&D
|
$ | 675 | ||
Goodwill
|
170 | |||
Deferred tax liabilities
|
(246 | ) | ||
Other assets and liabilities acquired, net
|
(2 | ) | ||
|
||||
Total consideration
|
$ | 597 | ||
|
7
8
Three months ended | Six months ended | |||||||||||||||
June 30, | June 30, | |||||||||||||||
2011 | 2010 | 2011 | 2010 | |||||||||||||
Income (Numerator):
|
||||||||||||||||
Net income for basic and diluted EPS
|
$ | 1,170 | $ | 1,202 | $ | 2,295 | $ | 2,369 | ||||||||
|
||||||||||||||||
|
||||||||||||||||
Shares (Denominator):
|
||||||||||||||||
Weighted-average shares for basic EPS
|
927 | 959 | 930 | 970 | ||||||||||||
Effect of dilutive securities
|
8 | 5 | 8 | 6 | ||||||||||||
|
||||||||||||||||
Weighted-average shares for diluted EPS
|
935 | 964 | 938 | 976 | ||||||||||||
|
||||||||||||||||
|
||||||||||||||||
Basic EPS
|
$ | 1.26 | $ | 1.25 | $ | 2.47 | $ | 2.44 | ||||||||
Diluted EPS
|
$ | 1.25 | $ | 1.25 | $ | 2.45 | $ | 2.43 |
9
10
Gross | Gross | Estimated | ||||||||||||||
Amortized | unrealized | unrealized | fair | |||||||||||||
Type of security as of June 30, 2011 | cost | gains | losses | value | ||||||||||||
U.S. Treasury securities
|
$ | 2,896 | $ | 13 | $ | (2 | ) | $ | 2,907 | |||||||
Other government related debt securities:
|
||||||||||||||||
Obligations
of U.S. government agencies and FDIC guaranteed bank debt
|
1,537 | 22 | — | 1,559 | ||||||||||||
Foreign and other
|
795 | 17 | — | 812 | ||||||||||||
Corporate debt securities:
|
||||||||||||||||
Financial
|
2,887 | 61 | (4 | ) | 2,944 | |||||||||||
Industrial
|
2,963 | 77 | (4 | ) | 3,036 | |||||||||||
Other
|
342 | 12 | — | 354 | ||||||||||||
Mortgage and asset backed securities
|
1,541 | 7 | (4 | ) | 1,544 | |||||||||||
Money market mutual funds
|
5,677 | — | — | 5,677 | ||||||||||||
Other short-term interest bearing securities
|
157 | — | — | 157 | ||||||||||||
|
||||||||||||||||
Total debt security investments
|
18,795 | 209 | (14 | ) | 18,990 | |||||||||||
Equity securities
|
52 | — | (5 | ) | 47 | |||||||||||
|
||||||||||||||||
|
$ | 18,847 | $ | 209 | $ | (19 | ) | $ | 19,037 | |||||||
|
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 security investments
|
17,057 | 256 | (36 | ) | 17,277 | |||||||||||
Equity securities
|
50 | — | (2 | ) | 48 | |||||||||||
|
||||||||||||||||
|
$ | 17,107 | $ | 256 | $ | (38 | ) | $ | 17,325 | |||||||
|
11
June 30, | December 31, | |||||||
Classification in the Condensed Consolidated Balance Sheets | 2011 | 2010 | ||||||
Cash and cash equivalents
|
$ | 5,816 | $ | 3,142 | ||||
Marketable securities
|
13,174 | 14,135 | ||||||
Other assets — noncurrent
|
47 | 48 | ||||||
|
||||||||
|
$ | 19,037 | $ | 17,325 | ||||
|
June 30, | December 31, | |||||||
Contractual maturity | 2011 | 2010 | ||||||
Maturing in one year or less
|
$ | 6,609 | $ | 4,118 | ||||
Maturing after one year through three years
|
6,138 | 6,736 | ||||||
Maturing after three years through five years
|
5,168 | 5,812 | ||||||
Maturing after five years
|
1,075 | 611 | ||||||
|
||||||||
Total debt security investments
|
$ | 18,990 | $ | 17,277 | ||||
|
June 30, | December 31, | |||||||
2011 | 2010 | |||||||
Raw materials
|
$ | 157 | $ | 128 | ||||
Work in process
|
1,553 | 1,382 | ||||||
Finished goods
|
520 | 512 | ||||||
|
||||||||
|
$ | 2,230 | $ | 2,022 | ||||
|
12
June 30, | December 31, | |||||||
2011 | 2010 | |||||||
0.125% convertible notes due 2011 (2011 Convertible Notes)
|
$ | — | $ | 2,488 | ||||
0.375% convertible notes due 2013 (2013 Convertible Notes)
|
2,279 | 2,213 | ||||||
5.65% notes due 2042 (2042 Notes)
|
1,244 | — | ||||||
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 | ||||||
4.10% notes due 2021 (2021 Notes)
|
997 | — | ||||||
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 | ||||||
2.30% notes due 2016 (2016 Notes)
|
748 | — | ||||||
5.75% notes due 2040 (2040 Notes)
|
697 | 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
|
13,930 | 13,362 | ||||||
Less current portion
|
(83 | ) | (2,488 | ) | ||||
|
||||||||
Total non-current debt
|
$ | 13,847 | $ | 10,874 | ||||
|
13
2011 | 2010 | |||||||||||||||
Shares | Dollars | Shares | Dollars | |||||||||||||
First quarter
|
— | $ | — | 29.1 | $ | 1,684 | ||||||||||
Second quarter
|
12.9 | 732 | 10.3 | 616 | ||||||||||||
|
||||||||||||||||
|
12.9 | $ | 732 | 39.4 | $ | 2,300 | ||||||||||
|
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 |
14
Quoted prices in | Significant | Significant | ||||||||||||||
active markets for | other observable | unobservable | ||||||||||||||
Fair value measurement | identical assets | inputs | inputs | |||||||||||||
as of June 30, 2011 using: | (Level 1) | (Level 2) | (Level 3) | Total | ||||||||||||
Assets:
|
||||||||||||||||
Available-for-sale securities:
|
||||||||||||||||
U.S. Treasury securities
|
$ | 2,907 | $ | — | $ | — | $ | 2,907 | ||||||||
Other government related debt securities:
|
||||||||||||||||
Obligations of U.S. government agencies
and FDIC guaranteed bank debt
|
— | 1,559 | — | 1,559 | ||||||||||||
Foreign and other
|
— | 812 | — | 812 | ||||||||||||
Corporate debt securities:
|
||||||||||||||||
Financial
|
— | 2,944 | — | 2,944 | ||||||||||||
Industrial
|
— | 3,036 | — | 3,036 | ||||||||||||
Other
|
— | 354 | — | 354 | ||||||||||||
Mortgage and asset backed securities
|
— | 1,544 | — | 1,544 | ||||||||||||
Money market mutual funds
|
5,677 | — | — | 5,677 | ||||||||||||
Other short-term interest bearing securities
|
— | 157 | — | 157 | ||||||||||||
Equity securities
|
47 | — | — | 47 | ||||||||||||
Derivatives:
|
||||||||||||||||
Foreign currency contracts
|
— | 50 | — | 50 | ||||||||||||
Interest rate swap contracts
|
— | 232 | — | 232 | ||||||||||||
|
||||||||||||||||
Total assets
|
$ | 8,631 | $ | 10,688 | $ | — | $ | 19,319 | ||||||||
|
||||||||||||||||
|
||||||||||||||||
Liabilities:
|
||||||||||||||||
Derivatives:
|
||||||||||||||||
Foreign currency contracts
|
$ | — | $ | 170 | $ | — | $ | 170 | ||||||||
Contingent consideration obligations in
connection with a business combination
|
— | — | 192 | 192 | ||||||||||||
|
||||||||||||||||
Total liabilities
|
$ | — | $ | 170 | $ | 192 | $ | 362 | ||||||||
|
||||||||||||||||
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 | ||||||||
|
15
16
17
Three months ended | Six months ended | |||||||||||||||
June 30, | June 30, | |||||||||||||||
Derivatives in cash flow hedging relationships | 2011 | 2010 | 2011 | 2010 | ||||||||||||
Foreign currency contracts
|
$ | (21 | ) | $ | 224 | $ | (218 | ) | $ | 399 | ||||||
Forward interest rate contracts
|
— | — | — | — | ||||||||||||
|
||||||||||||||||
Total
|
$ | (21 | ) | $ | 224 | $ | (218 | ) | $ | 399 | ||||||
|
Three months ended | Six months ended | |||||||||||||||||
June 30, | June 30, | |||||||||||||||||
Derivatives in cash flow hedging relationships | Statements of Income location | 2011 | 2010 | 2011 | 2010 | |||||||||||||
Foreign currency contracts
|
Product sales | $ | (33 | ) | $ | 21 | $ | (41 | ) | $ | 15 | |||||||
Forward interest rate contracts
|
Interest expense, net | — | — | — | — | |||||||||||||
|
||||||||||||||||||
Total
|
$ | (33 | ) | $ | 21 | $ | (41 | ) | $ | 15 | ||||||||
|
18
Three months ended | Six months ended | |||||||||||||||||
Derivatives not designated as | June 30, | June 30, | ||||||||||||||||
hedging instruments | Statements of Income location | 2011 | 2010 | 2011 | 2010 | |||||||||||||
Foreign currency contracts
|
Interest and other income, net. | $ | (9 | ) | $ | 53 | $ | (60 | ) | $ | 76 | |||||||
Derivative assets | Derivative liabilities | |||||||||||
June 30, 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
|
$ | 232 |
Accrued liabilities/Other
non-current liabilities
|
$ | — | ||||||
Foreign currency contracts
|
Other current assets/Other
non-current assets
|
50 |
Accrued
liabilities/Other non-current liabilities
|
170 | ||||||||
|
||||||||||||
Total derivatives designated as hedging
instruments
|
282 | 170 | ||||||||||
|
||||||||||||
Derivatives not designated as hedging
instruments:
|
||||||||||||
Foreign currency contracts
|
Other current assets | — | Accrued liabilities | — | ||||||||
|
||||||||||||
Total derivatives not designated as
hedging instruments
|
— | — | ||||||||||
|
||||||||||||
Total derivatives
|
$ | 282 | $ | 170 | ||||||||
|
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 | ||||||||
|
19
20
21
Item 2. | MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS |
22
• | On June 24, 2011, we announced that the FDA had approved changes to the labels for the use of ESAs, including Aranesp ® and EPOGEN ® , in patients with chronic kidney disease (CKD). While the previous label language specified a hemoglobin target range of 10-12 grams per deciliter (g/dL) for CKD patients on dialysis as well as those not on dialysis, the modified labeling provides separate treatment guidance for these two populations. For patients on dialysis, who constitute the majority of CKD patients receiving ESA treatment, the new label advises physicians to initiate ESA therapy when the hemoglobin level is less than 10 g/dL and to reduce or interrupt the dose when the hemoglobin approaches or exceeds 11 g/dL. We refer in this report to these ESA label changes as the “June 2011 ESA label changes.” |
• | On June 16, 2011, the Centers for Medicare & Medicaid Services (CMS) issued a Final Decision Memorandum (FDM) as part of its National Coverage Analysis (NCA) for ESAs in nephrology. In the FDM, CMS determined that it would not issue a national coverage determination (NCD) at that time for ESAs for treatment of anemia in adults with CKD, and that it would instead monitor the use of ESAs through the end stage renal disease (ESRD) bundled payment system and its other policy avenues. | ||
• | On July 1, 2011, CMS released a proposed rule to update various provisions of its bundled payment system for dialysis services and the related ESRD Quality Incentive Program (QIP). Among the changes proposed by CMS for payment year 2013 is the elimination of one of the QIP’s quality measures which tracks the percent of a provider’s Medicare patients with a hemoglobin level below 10 g/dL. This quality measure was included by CMS in the QIP’s initial payment year, 2012 in part to provide a disincentive to providers/facilities to under-treat patients for anemia, particularly in light of the implementation of the new bundled payment system for dialysis services. CMS indicated that its proposed removal of this quality measure from the QIP was being done in response to the June 2011 ESA label changes. The proposed change to the QIP is subject to a 60-day public comment period, following which CMS is expected to issue a final rule on the QIP and also on its other proposed changes to the bundled payment system. |
23
• | On May 17, 2011, we announced results of a pivotal phase 3 trial (‘147) in 1,432 men with castrate-resistant prostate cancer that has not yet spread to bone. The data showed that XGEVA ® significantly improved median bone metastasis-free survival by 4.2 months, a risk reduction of 15%, compared with placebo (29.5 versus 25.2 months, respectively; hazard ratio (HR) 0.85; 95% confidence interval (CI): 0.73, 0.98; P=0.028). XGEVA ® also significantly delayed the time to first bone metastases by 3.7 months compared with placebo (HR 0.84; 95% CI: 0.71, 0.98; P=0.032; risk reduction of 16%). XGEVA ® also reduced the risk of bone metastases that were symptomatic by 33% (HR 0.67; 95% CI: 0.49, 0.92; P=0.01). Overall survival was similar between groups (HR 1.01; 95% CI: 0.85, 1.20; P=0.91), and the HR for progression-free survival was 0.89 (95% CI: 0.78, 1.02, P=0.093). In the ‘147 trial, adverse events and serious adverse events were relatively similar between the XGEVA ® and placebo arms. Hypocalcemia and osteonecrosis of the jaw (ONJ) were reported with increased frequencies in the XGEVA ® treated patients. The yearly rate of ONJ in the XGEVA ® arm was similar to prior XGEVA ® trial results. Back pain was the most common adverse event reported in the XGEVA ® arm of the trial. | ||
• | On June 27, 2011, based on this ‘147 trial, we announced the submission of a supplemental BLA to the FDA to expand the indication for XGEVA ® to treat men with castrate-resistant prostate cancer to reduce the risk of developing bone metastases. If approved, XGEVA ® would be the first therapy licensed to prevent or delay the spread of cancer to the bone. | ||
• | On July 15, 2011, we announced that the European Commission (EC) granted marketing authorization for XGEVA ® for the prevention of skeletal-related events (pathological fracture, radiation to bone, spinal cord compression or surgery to bone) in adults with bone metastases from solid tumors. The timing of reimbursement authority approval of pricing in individual EU countries will vary by country, which could follow the EC approval by many months. The EC also granted XGEVA ® an additional year of data and market exclusivity in the EU since the indication was considered new for denosumab and based on the significant clinical benefit of XGEVA ® in comparison with existing therapies. |
• | On June 24, 2011, we announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion recommending that Vectibix ® be approved for use in the EU in first-line in combination with FOLFOX and in second-line in combination with FOLFIRI in patients who have received first-line fluoropyrimidine-based chemotherapy (excluding irinotecan) for patients with wild-type KRAS metastatic colorectal cancer (mCRC). | ||
• | On July 29, 2011, we announced that we received Complete Response Letters from the FDA on the first- and second-line mCRC supplemental BLAs. The FDA did not ask for new clinical studies, but requested an updated safety analysis and additional analyses of the overall survival data in the ‘181 and ‘203 studies, using more mature data sets. The FDA has also informed us that approval for the first- and second-line indications will also be contingent upon approval of the companion diagnostic device being developed in collaboration with QIAGEN N.V., which identifies a patient’s KRAS gene status. Amgen is reviewing the Complete Response Letters and will work with the FDA to determine the appropriate next steps regarding these applications. |
• | On July 29, 2011, we announced our decision to terminate the current OncoVEX GM-CSF phase 3 trial in patients with squamous cell carcinoma of the head and neck (SCCHN) to permit significant modification of clinical trial design mandated by the changing therapeutic landscape for patients with SCCHN. The phase 3 trial in patients with malignant melanoma is ongoing. |
• | On July 28, 2011, the Board of Directors declared a quarterly cash dividend of $0.28 per share of common stock. This dividend will be paid on September 8, 2011 to all stockholders of record as of the close of business on August 18, 2011. |
24
Three months ended | Six months ended | |||||||||||||||||||||||
June 30, | June 30, | |||||||||||||||||||||||
2011 | 2010 | Change | 2011 | 2010 | Change | |||||||||||||||||||
Product sales:
|
||||||||||||||||||||||||
U.S.
|
$ | 2,975 | $ | 2,787 | 7 | % | $ | 5,753 | $ | 5,464 | 5 | % | ||||||||||||
International
|
918 | 826 | 11 | % | 1,758 | 1,677 | 5 | % | ||||||||||||||||
|
||||||||||||||||||||||||
Total product sales
|
3,893 | 3,613 | 8 | % | 7,511 | 7,141 | 5 | % | ||||||||||||||||
|
||||||||||||||||||||||||
Other revenues
|
66 | 191 | (65 | )% | 154 | 255 | (40 | )% | ||||||||||||||||
|
||||||||||||||||||||||||
Total revenues
|
$ | 3,959 | $ | 3,804 | 4 | % | $ | 7,665 | $ | 7,396 | 4 | % | ||||||||||||
|
||||||||||||||||||||||||
|
||||||||||||||||||||||||
Operating expenses
|
$ | 2,627 | $ | 2,287 | 15 | % | $ | 5,040 | $ | 4,398 | 15 | % | ||||||||||||
|
||||||||||||||||||||||||
Operating income
|
$ | 1,332 | $ | 1,517 | (12 | )% | $ | 2,625 | $ | 2,998 | (12 | )% | ||||||||||||
|
||||||||||||||||||||||||
Net income
|
$ | 1,170 | $ | 1,202 | (3 | )% | $ | 2,295 | $ | 2,369 | (3 | )% | ||||||||||||
|
||||||||||||||||||||||||
Diluted EPS
|
$ | 1.25 | $ | 1.25 | — | $ | 2.45 | $ | 2.43 | 1 | % | |||||||||||||
|
||||||||||||||||||||||||
Diluted shares
|
935 | 964 | (3 | )% | 938 | 976 | (4 | )% |
25
Three months ended | Six months ended | |||||||||||||||||||||||
June 30, | June 30, | |||||||||||||||||||||||
2011 | 2010 | Change | 2011 | 2010 | Change | |||||||||||||||||||
Aranesp
®
|
$ | 585 | $ | 603 | (3 | )% | $ | 1,165 | $ | 1,230 | (5 | )% | ||||||||||||
EPOGEN
®
|
543 | 657 | (17 | )% | 1,078 | 1,280 | (16 | )% | ||||||||||||||||
Neulasta
®
/NEUPOGEN
®
|
1,326 | 1,174 | 13 | % | 2,558 | 2,353 | 9 | % | ||||||||||||||||
ENBREL
|
956 | 877 | 9 | % | 1,831 | 1,681 | 9 | % | ||||||||||||||||
Sensipar
®
/Mimpara
®
|
199 | 172 | 16 | % | 386 | 351 | 10 | % | ||||||||||||||||
Vectibix
®
|
81 | 72 | 13 | % | 156 | 139 | 12 | % | ||||||||||||||||
Nplate
®
|
75 | 55 | 36 | % | 140 | 104 | 35 | % | ||||||||||||||||
Prolia
®
|
44 | 3 | — | 71 | 3 | — | ||||||||||||||||||
XGEVA
®
|
73 | — | — | 115 | — | — | ||||||||||||||||||
Other
|
11 | — | — | 11 | — | — | ||||||||||||||||||
|
||||||||||||||||||||||||
Total product sales
|
$ | 3,893 | $ | 3,613 | 8 | % | $ | 7,511 | $ | 7,141 | 5 | % | ||||||||||||
|
||||||||||||||||||||||||
|
||||||||||||||||||||||||
Total U.S.
|
$ | 2,975 | $ | 2,787 | 7 | % | $ | 5,753 | $ | 5,464 | 5 | % | ||||||||||||
Total International
|
918 | 826 | 11 | % | 1,758 | 1,677 | 5 | % | ||||||||||||||||
|
||||||||||||||||||||||||
Total product sales
|
$ | 3,893 | $ | 3,613 | 8 | % | $ | 7,511 | $ | 7,141 | 5 | % | ||||||||||||
|
Three months ended | Six months ended | |||||||||||||||||||||||
June 30, | June 30, | |||||||||||||||||||||||
2011 | 2010 | Change | 2011 | 2010 | Change | |||||||||||||||||||
Aranesp
®
— U.S.
|
$ | 241 | $ | 267 | (10 | )% | $ | 491 | $ | 535 | (8 | )% | ||||||||||||
Aranesp
®
— International
|
344 | 336 | 2 | % | 674 | 695 | (3 | )% | ||||||||||||||||
|
||||||||||||||||||||||||
Total Aranesp
®
|
$ | 585 | $ | 603 | (3 | )% | $ | 1,165 | $ | 1,230 | (5 | )% | ||||||||||||
|
26
• | reimbursement developments, including CMS’s proposed changes related to the QIP, if implemented as currently proposed; and | ||
• | regulatory developments, including the June 2011 ESA label changes. |
Three months ended | Six months ended | |||||||||||||||||||||||
June 30, | June 30, | |||||||||||||||||||||||
2011 | 2010 | Change | 2011 | 2010 | Change | |||||||||||||||||||
EPOGEN
®
— U.S.
|
$ | 543 | $ | 657 | (17 | )% | $ | 1,078 | $ | 1,280 | (16 | )% | ||||||||||||
|
• | reimbursement developments, including CMS’s proposed changes related to the QIP, if implemented as currently proposed; and | ||
• | regulatory developments, including the June 2011 ESA label changes. |
27
Three months ended | Six months ended | |||||||||||||||||||||||
June 30, | June 30, | |||||||||||||||||||||||
2011 | 2010 | Change | 2011 | 2010 | Change | |||||||||||||||||||
Neulasta
®
— U.S.
|
$ | 769 | $ | 643 | 20 | % | $ | 1,479 | $ | 1,280 | 16 | % | ||||||||||||
NEUPOGEN
®
— U.S.
|
230 | 225 | 2 | % | 450 | 450 | — | |||||||||||||||||
|
||||||||||||||||||||||||
U.S. Neulasta
®
/NEUPOGEN
®
— Total
|
999 | 868 | 15 | % | 1,929 | 1,730 | 12 | % | ||||||||||||||||
|
||||||||||||||||||||||||
Neulasta
®
— International
|
246 | 218 | 13 | % | 472 | 444 | 6 | % | ||||||||||||||||
NEUPOGEN
®
— International
|
81 | 88 | (8 | )% | 157 | 179 | (12 | )% | ||||||||||||||||
|
||||||||||||||||||||||||
International Neulasta
®
/NEUPOGEN
®
— Total
|
327 | 306 | 7 | % | 629 | 623 | 1 | % | ||||||||||||||||
|
||||||||||||||||||||||||
Total Neulasta
®
/NEUPOGEN
®
|
$ | 1,326 | $ | 1,174 | 13 | % | $ | 2,558 | $ | 2,353 | 9 | % | ||||||||||||
|
Three months ended | Six months ended | |||||||||||||||||||||||
June 30, | June 30, | |||||||||||||||||||||||
2011 | 2010 | Change | 2011 | 2010 | Change | |||||||||||||||||||
ENBREL
— U.S.
|
$ | 894 | $ | 819 | 9 | % | $ | 1,715 | $ | 1,573 | 9 | % | ||||||||||||
ENBREL — Canada
|
62 | 58 | 7 | % | 116 | 108 | 7 | % | ||||||||||||||||
|
||||||||||||||||||||||||
Total ENBREL
|
$ | 956 | $ | 877 | 9 | % | $ | 1,831 | $ | 1,681 | 9 | % | ||||||||||||
|
28
Three months ended | Six months ended | |||||||||||||||||||||||
June 30, | June 30, | |||||||||||||||||||||||
2011 | 2010 | Change | 2011 | 2010 | Change | |||||||||||||||||||
Sensipar
®
— U.S.
|
$ | 124 | $ | 112 | 11 | % | $ | 240 | $ | 229 | 5 | % | ||||||||||||
Sensipar
®
(Mimpara
®
) — International
|
75 | 60 | 25 | % | 146 | 122 | 20 | % | ||||||||||||||||
Vectibix
®
— U.S.
|
31 | 29 | 7 | % | 61 | 54 | 13 | % | ||||||||||||||||
Vectibix
®
— International
|
50 | 43 | 16 | % | 95 | 85 | 12 | % | ||||||||||||||||
Nplate
®
— U.S.
|
40 | 32 | 25 | % | 77 | 60 | 28 | % | ||||||||||||||||
Nplate
®
— International
|
35 | 23 | 52 | % | 63 | 44 | 43 | % | ||||||||||||||||
Prolia
®
— U.S.
|
30 | 3 | — | 47 | 3 | — | ||||||||||||||||||
Prolia
®
— International
|
14 | — | — | 24 | — | — | ||||||||||||||||||
XGEVA
®
— U.S.
|
73 | — | — | 115 | — | — | ||||||||||||||||||
Other — International
|
11 | — | — | 11 | — | — | ||||||||||||||||||
|
||||||||||||||||||||||||
Total other products
|
$ | 483 | $ | 302 | 60 | % | $ | 879 | $ | 597 | 47 | % | ||||||||||||
|
||||||||||||||||||||||||
|
||||||||||||||||||||||||
Total U.S.
|
$ | 298 | $ | 176 | 69 | % | $ | 540 | $ | 346 | 56 | % | ||||||||||||
Total International
|
185 | 126 | 47 | % | 339 | 251 | 35 | % | ||||||||||||||||
|
||||||||||||||||||||||||
Total other products
|
$ | 483 | $ | 302 | 60 | % | $ | 879 | $ | 597 | 47 | % | ||||||||||||
|
29
Three months ended | Six months ended | |||||||||||||||||||||||
June 30, | June 30, | |||||||||||||||||||||||
2011 | 2010 | Change | 2011 | 2010 | Change | |||||||||||||||||||
Cost of sales
|
$ | 602 | $ | 553 | 9 | % | $ | 1,166 | $ | 1,061 | 10 | % | ||||||||||||
% of product sales
|
15.5 | % | 15.3 | % | 15.5 | % | 14.9 | % | ||||||||||||||||
Research and development
|
$ | 819 | $ | 675 | 21 | % | $ | 1,555 | $ | 1,321 | 18 | % | ||||||||||||
% of product sales
|
21.0 | % | 18.7 | % | 20.7 | % | 18.5 | % | ||||||||||||||||
Selling, general and administrative
|
$ | 1,130 | $ | 986 | 15 | % | $ | 2,153 | $ | 1,870 | 15 | % | ||||||||||||
% of product sales
|
29.0 | % | 27.3 | % | 28.7 | % | 26.2 | % |
30
Three months ended | Six months ended | |||||||||||||||
June 30, | June 30, | |||||||||||||||
2011 | 2010 | 2011 | 2010 | |||||||||||||
Interest expense, net
|
$ | 122 | $ | 147 | $ | 257 | $ | 292 | ||||||||
Interest and other income, net
|
$ | 129 | $ | 94 | $ | 277 | $ | 178 | ||||||||
Provisions for income taxes
|
$ | 169 | $ | 262 | $ | 350 | $ | 515 | ||||||||
Effective tax rate
|
12.6 | % | 17.9 | % | 13.2 | % | 17.9 | % |
31
June 30, | December 31, | |||||||
2011 | 2010 | |||||||
Cash, cash equivalents and marketable securities
|
$ | 19,172 | $ | 17,422 | ||||
Total assets
|
46,936 | 43,486 | ||||||
Current debt
|
83 | 2,488 | ||||||
Non-current debt
|
13,847 | 10,874 | ||||||
Stockholders’ equity
|
25,614 | 23,944 |
32
Six months ended June 30, | ||||||||
2011 | 2010 | |||||||
Net cash provided by operating activities
|
$ | 2,566 | $ | 2,477 | ||||
Net cash provided by (used in) investing activities
|
291 | (2,390 | ) | |||||
Net cash used in financing activities
|
(146 | ) | (1,259 | ) |
33
• | 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. |
34
Item 3. | QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK |
Item 4. | CONTROLS AND PROCEDURES |
35
Item 1. | LEGAL PROCEEDINGS |
Item 1A. | RISK FACTORS |
36
37
38
Item 2. | UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS |
Total number of | Maximum $ value | |||||||||||||||
Total number | Average | shares purchased | that may yet be | |||||||||||||
of shares | price paid | as part of publicly | purchased under the | |||||||||||||
purchased | per share | announced programs | programs (1) | |||||||||||||
April 1 - April 30
|
6,926,000 | $ | 56.01 | 6,926,000 | $ | 6,775,473,148 | ||||||||||
May 1 - May 31
|
5,940,129 | 57.86 | 5,940,129 | 6,431,749,468 | ||||||||||||
June 1 - June 30
|
— | — | — | 6,431,749,468 | ||||||||||||
|
||||||||||||||||
|
12,866,129 | 56.87 | 12,866,129 | |||||||||||||
|
(1) | In December 2009, the Board of Directors authorized us to repurchase up to $5.0 billion of our common stock, and in April 2011, the Board of Directors authorized us to repurchase up to an additional $5.0 billion of our common stock. A total of $6.4 billion remained available as of June 30, 2011. |
Item 5. | OTHER INFORMATION |
Item 6. | EXHIBITS |
39
Amgen Inc.
(Registrant) |
||||
Date: August 8, 2011 | By: | /s/ Jonathan M. Peacock | ||
Jonathan M. Peacock | ||||
Executive Vice President
and Chief Financial Officer |
40
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). (Filed as an
exhibit to Form 10-Q for the quarter ended March 31, 2011 on May 10, 2011 and incorporated
herein by reference.)
|
|
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). (Filed as an exhibit to Form 10-Q for the quarter ended March 31, 2011 on May 10,
2011 and incorporated herein by reference.)
|
|
3.1 |
Restated Certificate of Incorporation (As Restated December 6, 2005). (Filed as an exhibit to
Form 10-K for the year ended December 31, 2005 on March 10, 2006 and incorporated herein by
reference.)
|
|
3.2 |
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 |
Officer’s 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.)
|
41
Exhibit No. | Description | |
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.)
|
|
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 0.375% 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.)
|
|
4.17 |
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.)
|
|
4.18 |
Officers’ Certificate of Amgen Inc. dated as of May 30, 2007, including forms of the Company’s
Senior Floating Rate Notes due 2008, 5.85% Senior Notes due 2017 and 6.375% Senior Notes due
2037. (Filed as an exhibit to Form 8-K on May 30, 2007 and incorporated herein by reference.)
|
|
4.19 |
Officers’ Certificate of Amgen Inc. dated as of May 23, 2008, including forms of the Company’s
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.)
|
|
4.20 |
Officers’ Certificate of Amgen Inc. dated as of January 16, 2009, including forms of the
Company’s 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.)
|
|
4.21 |
Officers’ Certificate of Amgen Inc. dated as of March 12, 2010, including forms of the
Company’s 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.)
|
|
4.22 |
Officers’ Certificate of Amgen Inc., dated as of September 16, 2010, including forms of the
Company’s 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.)
|
|
4.23 |
Officers’ Certificate of Amgen Inc., dated as of June 30, 2011, including forms of the
Company’s 2.30% Senior Notes due 2016, 4.10% Senior Notes due 2021 and 5.65% Senior Notes due
2042. (Filed as an exhibit to Form 8-K on June 30, 2011 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.) (Filed as an exhibit to Form 10-Q for the quarter ended March 31, 2011 on May
10, 2011 and incorporated herein by reference.)
|
|
10.3+ |
Form of Restricted Stock Unit Agreement for the Amgen Inc. 2009 Equity Incentive Plan. (As
Amended on March 2, 2011.) (Filed as an exhibit to Form 10-Q for the quarter ended March 31,
2011 on May 10, 2011 and incorporated herein by reference.)
|
|
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.) (Filed as an exhibit to Form 10-Q for the quarter ended March 31,
2011 on May 10, 2011 and incorporated herein by reference.)
|
|
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.)
|
42
Exhibit No. | Description | |
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+* |
First Amendment to the Amgen Supplemental Retirement Plan, effective April 11, 2011.
|
|
10.10+ |
Amended and Restated Amgen Change of Control Severance Plan. (As Amended and Restated
effective December 9, 2010 and subsequently amended effective March 2, 2011.) (Filed as an
exhibit to Form 10-Q for the quarter ended March 31, 2011 on May 10, 2011 and incorporated
herein by reference.)
|
|
10.11+ |
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.)
|
|
10.12+ |
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.)
|
|
10.13+ |
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.)
|
|
10.14+ |
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.)
|
|
10.15+* |
First Amendment to the Amgen Nonqualified Deferred Compensation Plan, effective April 11, 2011.
|
|
10.16+ |
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.)
|
|
10.17+ |
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.)
|
|
10.18 |
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).
|
|
10.19 |
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.)
|
|
10.20 |
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.)
|
|
10.21 |
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.)
|
|
10.22 |
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.)
|
|
10.23 |
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.)
|
|
10.24 |
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.)
|
|
10.25 |
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.)
|
|
10.26 |
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.)
|
43
Exhibit No. | Description | |
10.27 |
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.)
|
|
10.28 |
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.)
|
|
10.29 |
G-CSF European License Agreement, dated December 30, 1986, between Kirin-Amgen and Amgen,
Amendment No. 1 to Kirin-Amgen, Inc. / Amgen G-CSF European License Agreement, dated June 1,
1987, Amendment No. 2 to Kirin-Amgen, Inc. / Amgen G-CSF European License Agreement, dated
March 15, 1998, Amendment No. 3 to Kirin-Amgen, Inc. / Amgen G-CSF European License Agreement,
dated October 20, 1988, and 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.)
|
|
10.30 |
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.)
|
|
10.31 |
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.)
|
|
10.32 |
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.)
|
|
10.33 |
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.)
|
|
10.34 |
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.)
|
|
10.35 |
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.)
|
|
10.36 |
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.)
|
|
10.37 |
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.)
|
|
10.38 |
Credit Agreement, dated November 2, 2007, among Amgen Inc., with Citicorp USA, Inc., as
administrative agent, Barclays Bank PLC, as syndication agent, Citigroup Global Markets, Inc.
and Barclays Capital, as joint lead arrangers and joint book runners, and the other banks
party thereto. (Filed as an exhibit to Form 8-K filed on November 2, 2007 and incorporated
herein by reference.)
|
|
10.39 |
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.)
|
|
10.40 |
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.)
|
44
Exhibit No. | Description | |
10.41 |
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.)
|
|
10.42 |
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.)
|
|
10.43 |
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.)
|
|
10.44 |
Master Services Agreement, dated October 22, 2008, 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, 2008 on February 27, 2009
and incorporated herein by reference.)
|
|
10.45 |
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.)
|
|
10.46 |
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.)
|
|
10.47* |
Integrated Facilities Management Services Agreement, dated February 4, 2009 between Amgen Inc.
and Jones Lang LaSalle Americas, Inc. (with certain confidential information deleted
therefrom) (Previously filed as an exhibit to Form 10-K for the year ended December 31, 2008
on February 27, 2009.), as amended by Amendment Number 1 dated March 31, 2010, Amendment Number
2 dated May 12, 2011 (as corrected by the Letter Agreement), and Letter Agreement dated July
19, 2011 (with certain confidential information deleted therefrom).
|
|
10.48 |
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.)
|
|
10.49 |
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.)
|
|
10.50 |
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.)
|
|
10.51 |
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.)
|
|
10.52 |
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.)
|
|
10.53 |
Underwriting Agreement, dated June 27, 2011, by and among the Company and Barclays Capital
Inc., Merrill Lynch, Pierce, Fenner & Smith Incorporated and Morgan Stanley & Co. LLC, as
representatives of the several underwriters named therein. (Filed as an exhibit to Form 8-K on
June 30, 2011 and incorporated herein by reference.)
|
|
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.
|
45
Exhibit No. | Description | |
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) |
46
No information found
* THE VALUE IS THE MARKET VALUE AS OF THE LAST DAY OF THE QUARTER FOR WHICH THE 13F WAS FILED.
FUND | NUMBER OF SHARES | VALUE ($) | PUT OR CALL |
---|
DIRECTORS | AGE | BIO | OTHER DIRECTOR MEMBERSHIPS |
---|
No information found
Price
Yield
Owner | Position | Direct Shares | Indirect Shares |
---|