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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 | 95-3540776 | |
(State or other jurisdiction of | (I.R.S. Employer | |
incorporation or organization) | Identification No.) | |
One Amgen Center Drive, | ||
Thousand Oaks, California | 91320-1799 | |
(Address of principal executive offices) | (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 | ||||||||
March 31, | ||||||||
2011 | 2010 | |||||||
Revenues:
|
||||||||
Product sales
|
$ | 3,618 | $ | 3,528 | ||||
Other revenues
|
88 | 64 | ||||||
|
||||||||
Total revenues
|
3,706 | 3,592 | ||||||
|
||||||||
|
||||||||
Operating expenses:
|
||||||||
Cost of
sales (excludes amortization of certain acquired intangible assets presented below)
|
564 | 508 | ||||||
Research and development
|
736 | 646 | ||||||
Selling, general and administrative
|
1,023 | 884 | ||||||
Amortization of certain acquired intangible assets
|
74 | 74 | ||||||
Other
|
16 | (1 | ) | |||||
|
||||||||
Total operating expenses
|
2,413 | 2,111 | ||||||
|
||||||||
|
||||||||
Operating income
|
1,293 | 1,481 | ||||||
|
||||||||
Interest expense, net
|
135 | 145 | ||||||
Interest and other income, net
|
148 | 84 | ||||||
|
||||||||
|
||||||||
Income before income taxes
|
1,306 | 1,420 | ||||||
|
||||||||
Provisions for income taxes
|
181 | 253 | ||||||
|
||||||||
|
||||||||
Net income
|
$ | 1,125 | $ | 1,167 | ||||
|
||||||||
|
||||||||
Earnings per share:
|
||||||||
Basic
|
$ | 1.21 | $ | 1.19 | ||||
Diluted
|
$ | 1.20 | $ | 1.18 | ||||
|
||||||||
Shares used in calculation of earnings per share:
|
||||||||
Basic
|
933 | 982 | ||||||
Diluted
|
941 | 988 |
1
March 31, | December 31, | |||||||
2011 | 2010 | |||||||
ASSETS
|
||||||||
Current assets:
|
||||||||
Cash and cash equivalents
|
$ | 1,266 | $ | 3,287 | ||||
Marketable securities
|
14,092 | 14,135 | ||||||
Trade receivables, net
|
2,517 | 2,335 | ||||||
Inventories
|
2,098 | 2,022 | ||||||
Other current assets
|
1,716 | 1,350 | ||||||
|
||||||||
Total current assets
|
21,689 | 23,129 | ||||||
|
||||||||
Property, plant and equipment, net
|
5,455 | 5,522 | ||||||
Intangible assets, net
|
2,808 | 2,230 | ||||||
Goodwill
|
11,504 | 11,334 | ||||||
Other assets
|
1,258 | 1,271 | ||||||
|
||||||||
Total assets
|
$ | 42,714 | $ | 43,486 | ||||
|
||||||||
|
||||||||
LIABILITIES AND STOCKHOLDERS’ EQUITY
|
||||||||
Current liabilities:
|
||||||||
Accounts payable
|
$ | 832 | $ | 716 | ||||
Accrued liabilities
|
3,334 | 3,366 | ||||||
Current portion of convertible notes
|
83 | 2,488 | ||||||
|
||||||||
Total current liabilities
|
4,249 | 6,570 | ||||||
|
||||||||
Convertible notes
|
2,246 | 2,296 | ||||||
Other long-term debt.
|
8,578 | 8,578 | ||||||
Other non-current liabilities
|
2,657 | 2,098 | ||||||
|
||||||||
Contingencies and commitments
|
||||||||
|
||||||||
Stockholders’ equity:
|
||||||||
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
|
27,376 | 27,299 | ||||||
Accumulated deficit
|
(2,383 | ) | (3,508 | ) | ||||
Accumulated other comprehensive (loss) income
|
(9 | ) | 153 | |||||
|
||||||||
Total stockholders’ equity
|
24,984 | 23,944 | ||||||
|
||||||||
Total liabilities and stockholders’ equity
|
$ | 42,714 | $ | 43,486 | ||||
|
2
Three months ended | ||||||||
March 31, | ||||||||
2011 | 2010 | |||||||
Cash flows from operating activities:
|
||||||||
Net income
|
$ | 1,125 | $ | 1,167 | ||||
Depreciation and amortization
|
273 | 252 | ||||||
Stock-based compensation expense
|
77 | 68 | ||||||
Other items, net
|
14 | 10 | ||||||
Changes in operating assets and liabilities, net of acquisitions:
|
||||||||
Trade receivables, net
|
(181 | ) | (162 | ) | ||||
Inventories
|
(78 | ) | 21 | |||||
Other current assets
|
(62 | ) | (43 | ) | ||||
Accounts payable
|
(38 | ) | 308 | |||||
Accrued income taxes
|
8 | (189 | ) | |||||
Other accrued liabilities
|
(108 | ) | (519 | ) | ||||
|
||||||||
Net cash provided by operating activities
|
1,030 | 913 | ||||||
|
||||||||
|
||||||||
Cash flows from investing activities:
|
||||||||
Purchases of property, plant and equipment
|
(100 | ) | (94 | ) | ||||
Cash paid for acquisitions, net of cash acquired
|
(403 | ) | — | |||||
Purchases of marketable securities
|
(7,203 | ) | (3,160 | ) | ||||
Proceeds from sales of marketable securities
|
6,933 | 2,170 | ||||||
Proceeds from maturities of marketable securities
|
224 | 141 | ||||||
Other
|
(6 | ) | (12 | ) | ||||
|
||||||||
Net cash used in investing activities
|
(555 | ) | (955 | ) | ||||
|
||||||||
|
||||||||
Cash flows from financing activities:
|
||||||||
Repayment of debt
|
(2,500 | ) | — | |||||
Repurchases of common stock
|
(14 | ) | (1,587 | ) | ||||
Net proceeds from issuance of debt
|
— | 989 | ||||||
Net proceeds from issuance of common stock in connection with the Company’s equity award programs
|
16 | 26 | ||||||
Other
|
2 | (4 | ) | |||||
|
||||||||
Net cash used in financing activities
|
(2,496 | ) | (576 | ) | ||||
|
||||||||
|
||||||||
Decrease in cash and cash equivalents
|
(2,021 | ) | (618 | ) | ||||
|
||||||||
Cash and cash equivalents at beginning of period
|
3,287 | 2,884 | ||||||
|
||||||||
|
||||||||
Cash and cash equivalents at end of period
|
$ | 1,266 | $ | 2,266 | ||||
|
3
4
5
2. | Acquisitions |
Cash paid to former shareholders of BioVex
|
$ | 407 | ||
Fair value of contingent consideration obligations
|
190 | |||
|
||||
Total consideration
|
$ | 597 | ||
|
Intangible assets — IPR&D
|
$ | 675 | ||
Goodwill
|
170 | |||
Deferred tax liabilities
|
(246 | ) | ||
Other assets and liabilities acquired, net
|
(2 | ) | ||
|
||||
Total consideration
|
$ | 597 | ||
|
6
7
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 |
8
9
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
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 | ||||
|
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
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 | ||||
|
12
2011 | 2010 | |||||||||||||||
Shares | Dollars | Shares | Dollars | |||||||||||||
First quarter
|
— | $ | — | 29.1 | $ | 1,684 | ||||||||||
|
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 |
13
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
15
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
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 | |||||||
|
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
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
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 | ||||||||||||
|
19
20
21
22
• | 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. |
• | 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. |
• | 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 Amgen’s 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. |
• | 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
• | 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. |
• | On March 4, 2011, we acquired BioVex, a privately held biotechnology company developing treatments for cancer and the prevention of infectious disease, including OncoVEX GM-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 OncoVEX GM-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 OncoVEX GM-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
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 | )% |
25
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 | % | ||||||
|
Three months ended | ||||||||||||
March 31, | ||||||||||||
2011 | 2010 | Change | ||||||||||
Aranesp
®
— U.S.
|
$ | 250 | $ | 268 | (7 | )% | ||||||
Aranesp
®
— International
|
330 | 359 | (8 | )% | ||||||||
|
||||||||||||
Total Aranesp
®
|
$ | 580 | $ | 627 | (7 | )% | ||||||
|
26
• | 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. |
Three months ended | ||||||||||||
March 31, | ||||||||||||
2011 | 2010 | Change | ||||||||||
EPOGEN
®
— U.S.
|
$ | 535 | $ | 623 | (14 | )% | ||||||
|
• | 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: |
- | CMS’s 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. |
27
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 | % | ||||||
|
Three months ended | ||||||||||||
March 31, | ||||||||||||
2011 | 2010 | Change | ||||||||||
ENBREL — U.S.
|
$ | 821 | $ | 754 | 9 | % | ||||||
ENBREL — Canada
|
54 | 50 | 8 | % | ||||||||
|
||||||||||||
Total ENBREL
|
$ | 875 | $ | 804 | 9 | % | ||||||
|
28
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 | % | ||||||
|
29
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 | % |
30
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 | % |
31
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 |
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 | ) |
32
• | 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. |
33
34
35
36
Amgen Inc.
(Registrant) |
||||
Date: May 10, 2011 | By: | /s/ Jonathan M. Peacock | ||
Jonathan M. Peacock | ||||
Executive Vice President
and Chief Financial Officer |
38
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
|
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.)
|
|
|
|
|
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 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.)
|
|
|
|
|
4.20
|
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.)
|
|
|
|
|
4.21
|
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.)
|
|
|
|
|
4.22
|
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.)
|
|
|
|
|
4.23
|
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.)
|
|
|
|
|
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.)
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|
|
|
|
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.)
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|
|
|
|
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.)
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|
|
|
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).
|
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|
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|
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.)
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|
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|
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.)
|
|
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|
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.)
|
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|
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.)
|
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|
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|
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.)
|
|
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|
|
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.)
|
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|
|
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.)
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|
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.)
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|
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.)
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|
|
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.)
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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.)
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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.)
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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.)
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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.)
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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.)
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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.)
|
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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.)
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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.)
|
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|
|
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.)
|
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|
|
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.)
|
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|
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.)
|
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|
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.)
|
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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.
|
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32**
|
Section 1350 Certifications.
|
|
|
|
|
101.INS**
|
XBRL Instance Document.
|
|
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|
|
101.SCH**
|
XBRL Taxonomy Extension Schema Document.
|
|
|
|
|
101.CAL**
|
XBRL Taxonomy Extension Calculation Linkbase Document.
|
|
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|
|
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) |
43
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 |
---|