þ | QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
¨ | TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
Delaware | 95-3540776 | |
(State or other jurisdiction of incorporation or organization) | (I.R.S. Employer Identification No.) | |
One Amgen Center Drive, Thousand Oaks, California | 91320-1799 | |
(Address of principal executive offices) | (Zip Code) |
Large accelerated filer þ | Accelerated filer ¨ | Non-accelerated filer ¨ (Do not check if a smaller reporting company) | Smaller reporting company ¨ |
Page No. | ||
Item 1. | ||
Item 2. | ||
Item 3. | ||
Item 4. | ||
Item 1. | ||
Item 1A. | ||
Item 2. | UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS | |
Item 6. | ||
Item 1. | FINANCIAL STATEMENTS |
Three months ended | Six months ended | ||||||||||||||
June 30, | June 30, | ||||||||||||||
2015 | 2014 | 2015 | 2014 | ||||||||||||
Revenues: | |||||||||||||||
Product sales | $ | 5,225 | $ | 4,949 | $ | 10,099 | $ | 9,305 | |||||||
Other revenues | 145 | 231 | 304 | 396 | |||||||||||
Total revenues | 5,370 | 5,180 | 10,403 | 9,701 | |||||||||||
Operating expenses: | |||||||||||||||
Cost of sales | 1,089 | 1,081 | 2,122 | 2,171 | |||||||||||
Research and development | 964 | 1,018 | 1,858 | 2,045 | |||||||||||
Selling, general and administrative | 1,160 | 1,136 | 2,186 | 2,159 | |||||||||||
Other | 81 | 43 | 139 | 60 | |||||||||||
Total operating expenses | 3,294 | 3,278 | 6,305 | 6,435 | |||||||||||
Operating income | 2,076 | 1,902 | 4,098 | 3,266 | |||||||||||
Interest expense, net | 277 | 282 | 529 | 541 | |||||||||||
Interest and other income, net | 198 | 138 | 304 | 237 | |||||||||||
Income before income taxes | 1,997 | 1,758 | 3,873 | 2,962 | |||||||||||
Provision for income taxes | 344 | 211 | 597 | 342 | |||||||||||
Net income | $ | 1,653 | $ | 1,547 | $ | 3,276 | $ | 2,620 | |||||||
Earnings per share: | |||||||||||||||
Basic | $ | 2.18 | $ | 2.04 | $ | 4.30 | $ | 3.46 | |||||||
Diluted | $ | 2.15 | $ | 2.01 | $ | 4.26 | $ | 3.41 | |||||||
Shares used in calculation of earnings per share: | |||||||||||||||
Basic | 760 | 759 | 761 | 758 | |||||||||||
Diluted | 768 | 768 | 769 | 768 | |||||||||||
Dividends paid per share | $ | 0.79 | $ | 0.61 | $ | 1.58 | $ | 1.22 |
Three months ended | Six months ended | ||||||||||||||
June 30, | June 30, | ||||||||||||||
2015 | 2014 | 2015 | 2014 | ||||||||||||
Net income | $ | 1,653 | $ | 1,547 | $ | 3,276 | $ | 2,620 | |||||||
Other comprehensive income (loss), net of reclassification adjustments and taxes: | |||||||||||||||
Foreign currency translation gains (losses) | 18 | 7 | (155 | ) | (1 | ) | |||||||||
Effective portion of cash flow hedges | (115 | ) | (25 | ) | 63 | (23 | ) | ||||||||
Net unrealized (losses) gains on available-for-sale securities | (108 | ) | 21 | 32 | 61 | ||||||||||
Other | — | — | — | 1 | |||||||||||
Other comprehensive (loss) income, net of tax | (205 | ) | 3 | (60 | ) | 38 | |||||||||
Comprehensive income | $ | 1,448 | $ | 1,550 | $ | 3,216 | $ | 2,658 |
June 30, 2015 | December 31, 2014 | ||||||
ASSETS | |||||||
Current assets: | |||||||
Cash and cash equivalents | $ | 3,795 | $ | 3,731 | |||
Marketable securities | 26,198 | 23,295 | |||||
Trade receivables, net | 2,779 | 2,546 | |||||
Inventories | 2,567 | 2,647 | |||||
Other current assets | 2,397 | 2,494 | |||||
Total current assets | 37,736 | 34,713 | |||||
Property, plant and equipment, net | 5,050 | 5,223 | |||||
Intangible assets, net | 11,988 | 12,693 | |||||
Goodwill | 14,723 | 14,788 | |||||
Other assets | 1,712 | 1,592 | |||||
Total assets | $ | 71,209 | $ | 69,009 | |||
LIABILITIES AND STOCKHOLDERS’ EQUITY | |||||||
Current liabilities: | |||||||
Accounts payable | $ | 934 | $ | 1,212 | |||
Accrued liabilities | 4,707 | 5,296 | |||||
Current portion of long-term debt | 1,250 | 500 | |||||
Total current liabilities | 6,891 | 7,008 | |||||
Long-term debt | 30,702 | 30,215 | |||||
Long-term deferred tax liability | 3,227 | 3,461 | |||||
Other noncurrent liabilities | 2,905 | 2,547 | |||||
Contingencies and commitments | |||||||
Stockholders’ equity: | |||||||
Common stock and additional paid-in capital; $0.0001 par value; 2,750.0 shares authorized; outstanding - 759.1 shares in 2015 and 760.4 shares in 2014 | 30,464 | 30,410 | |||||
Accumulated deficit | (2,912 | ) | (4,624 | ) | |||
Accumulated other comprehensive loss | (68 | ) | (8 | ) | |||
Total stockholders’ equity | 27,484 | 25,778 | |||||
Total liabilities and stockholders’ equity | $ | 71,209 | $ | 69,009 |
Six months ended | |||||||
June 30, | |||||||
2015 | 2014 | ||||||
Cash flows from operating activities: | |||||||
Net income | $ | 3,276 | $ | 2,620 | |||
Depreciation and amortization | 1,043 | 1,024 | |||||
Stock-based compensation expense | 160 | 199 | |||||
Deferred income taxes | (126 | ) | 108 | ||||
Other items, net | (228 | ) | (107 | ) | |||
Changes in operating assets and liabilities, net of acquisitions: | |||||||
Trade receivables, net | (199 | ) | — | ||||
Inventories | 196 | 40 | |||||
Other assets | 85 | (11 | ) | ||||
Accounts payable | (269 | ) | 125 | ||||
Accrued income taxes | 369 | (131 | ) | ||||
Other liabilities | (164 | ) | (498 | ) | |||
Net cash provided by operating activities | 4,143 | 3,369 | |||||
Cash flows from investing activities: | |||||||
Purchases of property, plant and equipment | (251 | ) | (345 | ) | |||
Proceeds from sale of property, plant and equipment | 226 | — | |||||
Cash paid for acquisitions, net of cash acquired | — | (115 | ) | ||||
Purchases of marketable securities | (13,530 | ) | (15,593 | ) | |||
Proceeds from sales of marketable securities | 8,021 | 9,137 | |||||
Proceeds from maturities of marketable securities | 2,500 | 3,295 | |||||
Change in restricted investments | — | 533 | |||||
Other | (277 | ) | (135 | ) | |||
Net cash used in investing activities | (3,311 | ) | (3,223 | ) | |||
Cash flows from financing activities: | |||||||
Net proceeds from issuance of debt | 3,464 | 4,476 | |||||
Repayment of debt | (2,150 | ) | (3,355 | ) | |||
Repurchases of common stock | (940 | ) | — | ||||
Dividends paid | (1,201 | ) | (923 | ) | |||
Net proceeds from issuance of common stock in connection with the Company’s equity award programs | 52 | 99 | |||||
Settlement of contingent consideration obligation | (225 | ) | — | ||||
Other | 232 | 104 | |||||
Net cash (used in) provided by financing activities | (768 | ) | 401 | ||||
Increase in cash and cash equivalents | 64 | 547 | |||||
Cash and cash equivalents at beginning of period | 3,731 | 3,805 | |||||
Cash and cash equivalents at end of period | $ | 3,795 | $ | 4,352 |
Three months ended June 30, 2015 | ||||||||||||||||||||
Separation costs | Asset impairments | Accelerated depreciation | Other | Total | ||||||||||||||||
Cost of sales | $ | — | $ | — | $ | 13 | $ | 2 | $ | 15 | ||||||||||
Research and development | — | — | 7 | 11 | 18 | |||||||||||||||
Selling, general and administrative | — | — | 5 | 15 | 20 | |||||||||||||||
Other | 7 | — | — | 3 | 10 | |||||||||||||||
Total | $ | 7 | $ | — | $ | 25 | $ | 31 | $ | 63 |
Six months ended June 30, 2015 | ||||||||||||||||||||
Separation costs | Asset impairments | Accelerated depreciation | Other | Total | ||||||||||||||||
Cost of sales | $ | — | $ | — | $ | 26 | $ | 3 | $ | 29 | ||||||||||
Research and development | — | — | 21 | 14 | 35 | |||||||||||||||
Selling, general and administrative | — | — | 6 | 18 | 24 | |||||||||||||||
Other | 55 | — | — | 12 | 67 | |||||||||||||||
Total | $ | 55 | $ | — | $ | 53 | $ | 47 | $ | 155 |
During the six months ended June 30, 2015 | |||||||||||
Separation costs | Other | Total | |||||||||
Restructuring liabilities as of December 31, 2014 | $ | 221 | $ | 23 | $ | 244 | |||||
Expense | 56 | 39 | 95 | ||||||||
Payments | (145 | ) | (35 | ) | (180 | ) | |||||
Restructuring liabilities as of June 30, 2015 | $ | 132 | $ | 27 | $ | 159 |
Three months ended | Six months ended | ||||||||||||||
June 30, | June 30, | ||||||||||||||
2015 | 2014 | 2015 | 2014 | ||||||||||||
Income (Numerator): | |||||||||||||||
Net income for basic and diluted EPS | $ | 1,653 | $ | 1,547 | $ | 3,276 | $ | 2,620 | |||||||
Shares (Denominator): | |||||||||||||||
Weighted-average shares for basic EPS | 760 | 759 | 761 | 758 | |||||||||||
Effect of dilutive securities | 8 | 9 | 8 | 10 | |||||||||||
Weighted-average shares for diluted EPS | 768 | 768 | 769 | 768 | |||||||||||
Basic EPS | $ | 2.18 | $ | 2.04 | $ | 4.30 | $ | 3.46 | |||||||
Diluted EPS | $ | 2.15 | $ | 2.01 | $ | 4.26 | $ | 3.41 |
Type of security as of June 30, 2015 | Amortized cost | Gross unrealized gains | Gross unrealized losses | Estimated fair value | ||||||||||||
U.S. Treasury securities | $ | 3,604 | $ | 14 | $ | (8 | ) | $ | 3,610 | |||||||
Other government-related debt securities: | ||||||||||||||||
U.S. | 551 | 1 | (1 | ) | 551 | |||||||||||
Foreign and other | 1,718 | 19 | (14 | ) | 1,723 | |||||||||||
Corporate debt securities: | ||||||||||||||||
Financial | 7,425 | 22 | (21 | ) | 7,426 | |||||||||||
Industrial | 7,657 | 27 | (55 | ) | 7,629 | |||||||||||
Other | 830 | 3 | (4 | ) | 829 | |||||||||||
Residential mortgage-backed securities | 1,498 | 7 | (8 | ) | 1,497 | |||||||||||
Other mortgage- and asset-backed securities | 2,053 | 1 | (40 | ) | 2,014 | |||||||||||
Money market mutual funds | 2,951 | — | — | 2,951 | ||||||||||||
Other short-term interest-bearing securities | 1,284 | — | — | 1,284 | ||||||||||||
Total interest-bearing securities | 29,571 | 94 | (151 | ) | 29,514 | |||||||||||
Equity securities | 97 | 82 | (4 | ) | 175 | |||||||||||
Total available-for-sale investments | $ | 29,668 | $ | 176 | $ | (155 | ) | $ | 29,689 |
Type of security as of December 31, 2014 | Amortized cost | Gross unrealized gains | Gross unrealized losses | Estimated fair value | ||||||||||||
U.S. Treasury securities | $ | 3,632 | $ | 22 | $ | (8 | ) | $ | 3,646 | |||||||
Other government-related debt securities: | ||||||||||||||||
U.S. | 530 | 1 | (3 | ) | 528 | |||||||||||
Foreign and other | 1,572 | 21 | (24 | ) | 1,569 | |||||||||||
Corporate debt securities: | ||||||||||||||||
Financial | 6,036 | 21 | (16 | ) | 6,041 | |||||||||||
Industrial | 6,394 | 23 | (66 | ) | 6,351 | |||||||||||
Other | 650 | 3 | (4 | ) | 649 | |||||||||||
Residential mortgage-backed securities | 1,708 | 4 | (10 | ) | 1,702 | |||||||||||
Other mortgage- and asset-backed securities | 1,837 | — | (41 | ) | 1,796 | |||||||||||
Money market mutual funds | 3,004 | — | — | 3,004 | ||||||||||||
Other short-term interest-bearing securities | 1,302 | — | — | 1,302 | ||||||||||||
Total interest-bearing securities | 26,665 | 95 | (172 | ) | 26,588 | |||||||||||
Equity securities | 98 | 48 | (2 | ) | 144 | |||||||||||
Total available-for-sale investments | $ | 26,763 | $ | 143 | $ | (174 | ) | $ | 26,732 |
Classification in the Condensed Consolidated Balance Sheets | June 30, 2015 | December 31, 2014 | ||||||
Cash and cash equivalents | $ | 3,316 | $ | 3,293 | ||||
Marketable securities | 26,198 | 23,295 | ||||||
Other assets — noncurrent | 175 | 144 | ||||||
Total available-for-sale investments | $ | 29,689 | $ | 26,732 |
Contractual maturity | June 30, 2015 | December 31, 2014 | ||||||
Maturing in one year or less | $ | 4,701 | $ | 4,936 | ||||
Maturing after one year through three years | 8,712 | 6,829 | ||||||
Maturing after three years through five years | 8,900 | 7,840 | ||||||
Maturing after five years through ten years | 3,468 | 3,267 | ||||||
Maturing after ten years | 222 | 218 | ||||||
Mortgage- and asset-backed securities | 3,511 | 3,498 | ||||||
Total interest-bearing securities | $ | 29,514 | $ | 26,588 |
Less than 12 months | 12 months or greater | |||||||||||||||
Type of security as of June 30, 2015 | Fair value | Unrealized losses | Fair value | Unrealized losses | ||||||||||||
U.S. Treasury securities | $ | 1,522 | $ | (7 | ) | $ | 30 | $ | (1 | ) | ||||||
Other government-related debt securities: | ||||||||||||||||
U.S. | 275 | (1 | ) | 20 | — | |||||||||||
Foreign and other | 701 | (12 | ) | 71 | (2 | ) | ||||||||||
Corporate debt securities: | ||||||||||||||||
Financial | 3,539 | (20 | ) | 156 | (1 | ) | ||||||||||
Industrial | 4,364 | (51 | ) | 307 | (4 | ) | ||||||||||
Other | 358 | (4 | ) | 24 | — | |||||||||||
Residential mortgage-backed securities | 464 | (3 | ) | 305 | (5 | ) | ||||||||||
Other mortgage- and asset-backed securities | 1,020 | (11 | ) | 401 | (29 | ) | ||||||||||
Equity securities | — | — | 2 | (4 | ) | |||||||||||
Total | $ | 12,243 | $ | (109 | ) | $ | 1,316 | $ | (46 | ) |
Less than 12 months | 12 months or greater | |||||||||||||||
Type of security as of December 31, 2014 | Fair value | Unrealized losses | Fair value | Unrealized losses | ||||||||||||
U.S. Treasury securities | $ | 1,770 | $ | (7 | ) | $ | 171 | $ | (1 | ) | ||||||
Other government-related debt securities: | ||||||||||||||||
U.S. | 160 | — | 178 | (3 | ) | |||||||||||
Foreign and other | 514 | (14 | ) | 159 | (10 | ) | ||||||||||
Corporate debt securities: | ||||||||||||||||
Financial | 3,150 | (14 | ) | 158 | (2 | ) | ||||||||||
Industrial | 3,931 | (62 | ) | 222 | (4 | ) | ||||||||||
Other | 354 | (4 | ) | 5 | — | |||||||||||
Residential mortgage-backed securities | 614 | (4 | ) | 413 | (6 | ) | ||||||||||
Other mortgage- and asset-backed securities | 1,071 | (8 | ) | 561 | (33 | ) | ||||||||||
Equity securities | 5 | (2 | ) | — | — | |||||||||||
Total | $ | 11,569 | $ | (115 | ) | $ | 1,867 | $ | (59 | ) |
June 30, 2015 | December 31, 2014 | ||||||
Raw materials | $ | 221 | $ | 198 | |||
Work in process | 1,320 | 1,551 | |||||
Finished goods | 1,026 | 898 | |||||
Total inventories | $ | 2,567 | $ | 2,647 |
Six months ended June 30, | |||||||
2015 | 2014 | ||||||
Beginning balance | $ | 14,788 | $ | 14,968 | |||
Goodwill related to acquisitions of businesses(1) | — | (128 | ) | ||||
Currency translation adjustments | (65 | ) | 4 | ||||
Ending balance | $ | 14,723 | $ | 14,844 |
(1) | Composed of goodwill recognized on the acquisition dates of business combinations and subsequent adjustments to these amounts resulting from changes to the acquisition date fair values of net assets acquired in the business combinations recorded during their respective measurement periods. |
June 30, 2015 | December 31, 2014 | ||||||||||||||||||||||
Gross carrying amount | Accumulated amortization | Intangible assets, net | Gross carrying amount | Accumulated amortization | Intangible assets, net | ||||||||||||||||||
Finite-lived intangible assets: | |||||||||||||||||||||||
Developed product technology rights | $ | 10,796 | $ | (4,568 | ) | $ | 6,228 | $ | 10,826 | $ | (4,155 | ) | $ | 6,671 | |||||||||
Licensing rights | 3,283 | (847 | ) | 2,436 | 3,236 | (696 | ) | 2,540 | |||||||||||||||
R&D technology rights | 1,143 | (600 | ) | 543 | 1,167 | (569 | ) | 598 | |||||||||||||||
Marketing-related rights | 1,222 | (582 | ) | 640 | 1,241 | (512 | ) | 729 | |||||||||||||||
Total finite-lived intangible assets | 16,444 | (6,597 | ) | 9,847 | 16,470 | (5,932 | ) | 10,538 | |||||||||||||||
Indefinite-lived intangible assets: | |||||||||||||||||||||||
In-process research and development | 2,141 | — | 2,141 | 2,155 | — | 2,155 | |||||||||||||||||
Total identifiable intangible assets | $ | 18,585 | $ | (6,597 | ) | $ | 11,988 | $ | 18,625 | $ | (5,932 | ) | $ | 12,693 |
June 30, 2015 | December 31, 2014 | ||||||
2.30% notes due 2016 (2.30% 2016 Notes) | $ | 750 | $ | 749 | |||
2.50% notes due 2016 (2.50% 2016 Notes) | 1,000 | 1,000 | |||||
Floating Rate Notes due 2017 | 600 | 600 | |||||
1.25% notes due 2017 (1.25% 2017 Notes) | 849 | 849 | |||||
2.125% notes due 2017 (2.125% 2017 Notes) | 1,249 | 1,249 | |||||
5.85% notes due 2017 (5.85% 2017 Notes) | 1,100 | 1,100 | |||||
6.15% notes due 2018 (6.15% 2018 Notes) | 500 | 500 | |||||
Term Loan due 2018 | 2,225 | 4,375 | |||||
4.375% euro-denominated notes due 2018 (4.375% 2018 euro Notes) | 615 | 668 | |||||
Floating Rate Notes due 2019 | 250 | 250 | |||||
2.20% notes due 2019 (2.20% 2019 Notes) | 1,398 | 1,398 | |||||
5.70% notes due 2019 (5.70% 2019 Notes) | 999 | 999 | |||||
2.125% euro-denominated notes due 2019 (2.125% 2019 euro Notes) | 750 | 814 | |||||
4.50% notes due 2020 (4.50% 2020 Notes) | 300 | 300 | |||||
2.125% notes due 2020 (2.125% 2020 Notes) | 749 | — | |||||
3.45% notes due 2020 (3.45% 2020 Notes) | 898 | 898 | |||||
4.10% notes due 2021 (4.10% 2021 Notes) | 998 | 998 | |||||
3.875% notes due 2021 (3.875% 2021 Notes) | 1,747 | 1,747 | |||||
2.70% notes due 2022 (2.70% 2022 Notes) | 499 | — | |||||
3.625% notes due 2022 (3.625% 2022 Notes) | 747 | 747 | |||||
3.625% notes due 2024 (3.625% 2024 Notes) | 1,398 | 1,398 | |||||
3.125% notes due 2025 (3.125% 2025 Notes) | 995 | — | |||||
5.50% pound-sterling-denominated notes due 2026 (5.50% 2026 pound sterling Notes) | 742 | 735 | |||||
4.00% pound-sterling-denominated notes due 2029 (4.00% 2029 pound sterling Notes) | 1,086 | 1,076 | |||||
6.375% notes due 2037 (6.375% 2037 Notes) | 899 | 899 | |||||
6.90% notes due 2038 (6.90% 2038 Notes) | 499 | 499 | |||||
6.40% notes due 2039 (6.40% 2039 Notes) | 996 | 996 | |||||
5.75% notes due 2040 (5.75% 2040 Notes) | 697 | 697 | |||||
4.95% notes due 2041 (4.95% 2041 Notes) | 596 | 596 | |||||
5.15% notes due 2041 (5.15% 2041 Notes) | 2,233 | 2,233 | |||||
5.65% notes due 2042 (5.65% 2042 Notes) | 1,245 | 1,245 | |||||
5.375% notes due 2043 (5.375% 2043 Notes) | 1,000 | 1,000 | |||||
4.40% notes due 2045 (4.40% 2045 Notes) | 1,243 | — | |||||
Other notes | 100 | 100 | |||||
Total debt | 31,952 | 30,715 | |||||
Less current portion | (1,250 | ) | (500 | ) | |||
Total noncurrent debt | $ | 30,702 | $ | 30,215 |
2015 | 2014 | ||||||||||||
Shares | Dollars | Shares | Dollars | ||||||||||
First quarter | 2.9 | $ | 451 | — | $ | — | |||||||
Second quarter | 3.3 | 515 | — | — | |||||||||
Total stock repurchases | 6.2 | $ | 966 | — | $ | — |
Foreign currency translation | Cash flow hedges | Available-for-sale securities | Other | AOCI | |||||||||||||||
Balance as of December 31, 2014 | $ | (264 | ) | $ | 290 | $ | (19 | ) | $ | (15 | ) | $ | (8 | ) | |||||
Foreign currency translation adjustments | (184 | ) | — | — | — | (184 | ) | ||||||||||||
Unrealized gains | — | 168 | 188 | — | 356 | ||||||||||||||
Reclassification adjustments to income | — | 114 | 35 | — | 149 | ||||||||||||||
Income taxes | 11 | (104 | ) | (83 | ) | — | (176 | ) | |||||||||||
Balance as of March 31, 2015 | $ | (437 | ) | $ | 468 | $ | 121 | $ | (15 | ) | $ | 137 | |||||||
Foreign currency translation adjustments | 24 | — | — | — | 24 | ||||||||||||||
Unrealized gains (losses) | — | 44 | (180 | ) | — | (136 | ) | ||||||||||||
Reclassification adjustments to income | — | (226 | ) | 9 | — | (217 | ) | ||||||||||||
Income taxes | (6 | ) | 67 | 63 | — | 124 | |||||||||||||
Balance as of June 30, 2015 | $ | (419 | ) | $ | 353 | $ | 13 | $ | (15 | ) | $ | (68 | ) |
Amounts reclassified out of AOCI | ||||||||||
Components of AOCI | Three months ended June 30, 2015 | Three months ended June 30, 2014 | Line item affected in the Statements of Income | |||||||
Cash flow hedges: | ||||||||||
Foreign currency contract gains | $ | 91 | $ | — | Product sales | |||||
Cross-currency swap contract gains | 136 | 48 | Interest and other income, net | |||||||
Forward interest rate contract losses | (1 | ) | — | Interest expense | ||||||
226 | 48 | Total before income tax | ||||||||
(81 | ) | (18 | ) | Tax expense | ||||||
$ | 145 | $ | 30 | Net of taxes | ||||||
Available-for-sale securities: | ||||||||||
Net realized (losses) gains | $ | (9 | ) | $ | 40 | Interest and other income, net | ||||
3 | (15 | ) | Tax benefit/(expense) | |||||||
$ | (6 | ) | $ | 25 | Net of taxes |
Amounts reclassified out of AOCI | ||||||||||
Components of AOCI | Six months ended June 30, 2015 | Six months ended June 30, 2014 | Line item affected in the Statements of Income | |||||||
Cash flow hedges: | ||||||||||
Foreign currency contract gains | $ | 160 | $ | — | Product sales | |||||
Cross-currency swap contract (losses) gains | (47 | ) | 62 | Interest and other income, net | ||||||
Forward interest rate contract losses | (1 | ) | — | Interest expense | ||||||
112 | 62 | Total before income tax | ||||||||
(40 | ) | (23 | ) | Tax expense | ||||||
$ | 72 | $ | 39 | Net of taxes | ||||||
Available-for-sale securities: | ||||||||||
Net realized (losses) gains | $ | (44 | ) | $ | 42 | Interest and other income, net | ||||
16 | (16 | ) | Tax benefit/(expense) | |||||||
$ | (28 | ) | $ | 26 | Net of taxes |
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 |
Quoted prices in active markets for identical assets (Level 1) | Significant other observable inputs (Level 2) | Significant unobservable inputs (Level 3) | ||||||||||||||
Fair value measurement | ||||||||||||||||
as of June 30, 2015, using: | Total | |||||||||||||||
Assets: | ||||||||||||||||
Available-for-sale investments: | ||||||||||||||||
U.S. Treasury securities | $ | 3,610 | $ | — | $ | — | $ | 3,610 | ||||||||
Other government-related debt securities: | ||||||||||||||||
U.S. | — | 551 | — | 551 | ||||||||||||
Foreign and other | — | 1,723 | — | 1,723 | ||||||||||||
Corporate debt securities: | ||||||||||||||||
Financial | — | 7,426 | — | 7,426 | ||||||||||||
Industrial | — | 7,629 | — | 7,629 | ||||||||||||
Other | — | 829 | — | 829 | ||||||||||||
Residential mortgage-backed securities | — | 1,497 | — | 1,497 | ||||||||||||
Other mortgage- and asset-backed securities | — | 2,014 | — | 2,014 | ||||||||||||
Money market mutual funds | 2,951 | — | — | 2,951 | ||||||||||||
Other short-term interest-bearing securities | — | 1,284 | — | 1,284 | ||||||||||||
Equity securities | 175 | — | — | 175 | ||||||||||||
Derivatives: | ||||||||||||||||
Foreign currency contracts | — | 238 | — | 238 | ||||||||||||
Cross-currency swap contracts | — | 22 | — | 22 | ||||||||||||
Interest rate swap contracts | — | 50 | — | 50 | ||||||||||||
Total assets | $ | 6,736 | $ | 23,263 | $ | — | $ | 29,999 | ||||||||
Liabilities: | ||||||||||||||||
Derivatives: | ||||||||||||||||
Foreign currency contracts | $ | — | $ | 7 | $ | — | $ | 7 | ||||||||
Cross-currency swap contracts | — | 80 | — | 80 | ||||||||||||
Interest rate swap contracts | — | 24 | — | 24 | ||||||||||||
Contingent consideration obligations in connection with business combinations | — | — | 215 | 215 | ||||||||||||
Total liabilities | $ | — | $ | 111 | $ | 215 | $ | 326 |
Quoted prices in active markets for identical assets (Level 1) | Significant other observable inputs (Level 2) | Significant unobservable inputs (Level 3) | ||||||||||||||
Fair value measurement | ||||||||||||||||
as of December 31, 2014, using: | Total | |||||||||||||||
Assets: | ||||||||||||||||
Available-for-sale investments: | ||||||||||||||||
U.S. Treasury securities | $ | 3,646 | $ | — | $ | — | $ | 3,646 | ||||||||
Other government-related debt securities: | ||||||||||||||||
U.S. | — | 528 | — | 528 | ||||||||||||
Foreign and other | — | 1,569 | — | 1,569 | ||||||||||||
Corporate debt securities: | ||||||||||||||||
Financial | — | 6,041 | — | 6,041 | ||||||||||||
Industrial | — | 6,351 | — | 6,351 | ||||||||||||
Other | — | 649 | — | 649 | ||||||||||||
Residential mortgage-backed securities | — | 1,702 | — | 1,702 | ||||||||||||
Other mortgage- and asset-backed securities | — | 1,796 | — | 1,796 | ||||||||||||
Money market mutual funds | 3,004 | — | — | 3,004 | ||||||||||||
Other short-term interest-bearing securities | — | 1,302 | — | 1,302 | ||||||||||||
Equity securities | 144 | — | — | 144 | ||||||||||||
Derivatives: | ||||||||||||||||
Foreign currency contracts | — | 360 | — | 360 | ||||||||||||
Cross-currency swap contracts | — | 32 | — | 32 | ||||||||||||
Interest rate swap contracts | — | 46 | — | 46 | ||||||||||||
Total assets | $ | 6,794 | $ | 20,376 | $ | — | $ | 27,170 | ||||||||
Liabilities: | ||||||||||||||||
Derivatives: | ||||||||||||||||
Foreign currency contracts | $ | — | $ | 4 | $ | — | $ | 4 | ||||||||
Cross-currency swap contracts | — | 12 | — | 12 | ||||||||||||
Interest rate swap contracts | — | 26 | — | 26 | ||||||||||||
Contingent consideration obligations in connection with business combinations | — | — | 215 | 215 | ||||||||||||
Total liabilities | $ | — | $ | 42 | $ | 215 | $ | 257 |
Three months ended June 30, | Six months ended June 30, | ||||||||||||||
2015 | 2014 | 2015 | 2014 | ||||||||||||
Beginning balance | $ | 215 | $ | 596 | $ | 215 | $ | 595 | |||||||
Net changes in valuation | — | 14 | — | 15 | |||||||||||
Ending balance | $ | 215 | $ | 610 | $ | 215 | $ | 610 |
Foreign currency | U.S. dollars | |||||||||||||
Hedged notes | Notional amount | Interest rate | Notional amount | Interest rate | ||||||||||
2.125% 2019 euro Notes | € | 675 | 2.125 | % | $ | 864 | 2.6 | % | ||||||
5.50% 2026 pound sterling Notes | £ | 475 | 5.50 | % | $ | 747 | 6.0 | % | ||||||
4.00% 2029 pound sterling Notes | £ | 700 | 4.00 | % | $ | 1,111 | 4.5 | % |
Three months ended | Six months ended | |||||||||||||||
June 30, | June 30, | |||||||||||||||
Derivatives in cash flow hedging relationships | 2015 | 2014 | 2015 | 2014 | ||||||||||||
Foreign currency contracts | $ | (99 | ) | $ | (13 | ) | $ | 293 | $ | — | ||||||
Cross-currency swap contracts | 143 | 21 | (81 | ) | 25 | |||||||||||
Total | $ | 44 | $ | 8 | $ | 212 | $ | 25 |
Three months ended | Six months ended | |||||||||||||||||
June 30, | June 30, | |||||||||||||||||
Derivatives in cash flow hedging relationships | Statements of Income location | 2015 | 2014 | 2015 | 2014 | |||||||||||||
Foreign currency contracts | Product sales | $ | 91 | $ | — | $ | 160 | $ | — | |||||||||
Cross-currency swap contracts | Interest and other income, net | 136 | 48 | (47 | ) | 62 | ||||||||||||
Forward interest rate contracts | Interest expense, net | (1 | ) | — | (1 | ) | — | |||||||||||
Total | $ | 226 | $ | 48 | $ | 112 | $ | 62 |
Three months ended | Six months ended | |||||||||||||||||
June 30, | June 30, | |||||||||||||||||
Derivatives not designated as hedging instruments | Statements of Income location | 2015 | 2014 | 2015 | 2014 | |||||||||||||
Foreign currency contracts | Interest and other income, net | $ | 20 | $ | (14 | ) | $ | (9 | ) | $ | (12 | ) |
Derivative assets | Derivative liabilities | |||||||||||
June 30, 2015 | Balance Sheet location | Fair value | Balance Sheet location | Fair value | ||||||||
Derivatives designated as hedging instruments: | ||||||||||||
Cross-currency swap contracts | Other current assets/ Other noncurrent assets | $ | 22 | Accrued liabilities/ Other noncurrent liabilities | $ | 80 | ||||||
Foreign currency contracts | Other current assets/ Other noncurrent assets | 234 | Accrued liabilities/ Other noncurrent liabilities | 3 | ||||||||
Interest rate swap contracts | Other current assets/ Other noncurrent assets | 50 | Accrued liabilities/ Other noncurrent liabilities | 24 | ||||||||
Total derivatives designated as hedging instruments | 306 | 107 | ||||||||||
Derivatives not designated as hedging instruments: | ||||||||||||
Foreign currency contracts | Other current assets | 4 | Accrued liabilities | 4 | ||||||||
Total derivatives not designated as hedging instruments | 4 | 4 | ||||||||||
Total derivatives | $ | 310 | $ | 111 |
Derivative assets | Derivative liabilities | |||||||||||
December 31, 2014 | Balance Sheet location | Fair value | Balance Sheet location | Fair value | ||||||||
Derivatives designated as hedging instruments: | ||||||||||||
Cross-currency swap contracts | Other current assets/ Other noncurrent assets | $ | 32 | Accrued liabilities/ Other noncurrent liabilities | $ | 12 | ||||||
Foreign currency contracts | Other current assets/ Other noncurrent assets | 356 | Accrued liabilities/ Other noncurrent liabilities | — | ||||||||
Interest rate swap contracts | Other current assets/ Other noncurrent assets | 46 | Accrued liabilities/ Other noncurrent liabilities | 26 | ||||||||
Total derivatives designated as hedging instruments | 434 | 38 | ||||||||||
Derivatives not designated as hedging instruments: | ||||||||||||
Foreign currency contracts | Other current assets | 4 | Accrued liabilities | 4 | ||||||||
Total derivatives not designated as hedging instruments | 4 | 4 | ||||||||||
Total derivatives | $ | 438 | $ | 42 |
Item 2. | MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS |
• | In June 2015, the Company discussed the data supporting the BLA for the treatment of high cholesterol with the FDA's Endocrinologic and Metabolic Drugs Advisory Committee. A majority of the Committee recommended approval of Repatha™ for the treatment of high cholesterol in multiple high-risk patient populations, and were unanimously in favor of approval for the treatment of homozygous familial hypercholesterolemia. FDA advisory committees review marketed and investigational human drug products, including safety and effectiveness data, and make recommendations to the FDA. These committees are advisory and FDA officials are not bound to or limited by its recommendations, although the FDA has commonly followed the recommendations of its advisory panels. The FDA PDUFA target action date for our BLA is August 27, 2015. |
• | In July 2015, we announced that the European Commission granted marketing authorization for Repatha™ for the treatment of high cholesterol, as an adjunct to diet: |
◦ | In combination with statins or other lipid-lowering therapies in patients unable to control their low-density lipoprotein cholesterol with maximum tolerated statin doses, or |
◦ | Alone or in combination with other lipid-lowering therapies in patients who are statin intolerant or for whom a statin is contraindicated. |
• | In May 2015, we announced that we commenced termination of our participation in the co-development and commercialization of brodalumab with AstraZeneca. The decision was based on events of suicidal ideation and behavior in the brodalumab program. |
• | In July 2015, we announced that we initiated phase 3 studies in episodic migraine. |
• | In July 2015, we announced that we submitted a supplemental New Drug Application (sNDA) to the FDA for Kyprolis® to seek an expanded indication for the treatment of patients with relapsed multiple myeloma, who have received at least one prior therapy, based on data from the global phase 3 ENDEAVOR (RandomizEd, OpeN Label, Phase 3 Study of Carfilzomib Plus DExamethAsone Vs Bortezomib Plus DexamethasOne in Patients With Relapsed Multiple Myeloma) trial. |
• | In July 2015, we announced that the FDA approved the sNDA for Kyprolis® in combination with Revlimid® (lenalidomide) and dexamethasone for the treatment of patients with multiple myeloma who have received one to three prior lines of therapy, based on the phase 3 ASPIRE (CArfilzomib, Lenalidomide, and DexamethaSone versus Lenalidomide and Dexamethasone for the treatment of PatIents with Relapsed Multiple MyEloma) trial. |
• | In June 2015, we announced that the phase 3 study evaluating the treatment effect of adjuvant Prolia® therapy in postmenopausal women with early hormone receptor positive breast cancer receiving aromatase inhibitor therapy, met its primary endpoint. |
• | In April 2015, the Cellular, Tissue and Gene Therapies Advisory Committee and the Oncologic Drugs Advisory Committee of the FDA jointly reviewed our talimogene laherparepvec BLA, with a majority voting that talimogene laherparepvec has a favorable risk-benefit profile for the treatment of injectable regionally or distantly metastatic melanoma. The FDA PDUFA target action date for our BLA is October 27, 2015. |
• | In June 2015, we announced that the phase 3 study evaluating Vectibix® and best supportive care met its primary endpoint. |
Three months ended | Six months ended | ||||||||||||||||||||
June 30, | June 30, | ||||||||||||||||||||
2015 | 2014 | Change | 2015 | 2014 | Change | ||||||||||||||||
Product sales: | |||||||||||||||||||||
U.S. | $ | 4,105 | $ | 3,758 | 9 | % | $ | 7,876 | $ | 7,047 | 12 | % | |||||||||
Rest of the world (ROW) | 1,120 | 1,191 | (6 | )% | 2,223 | 2,258 | (2 | )% | |||||||||||||
Total product sales | 5,225 | 4,949 | 6 | % | 10,099 | 9,305 | 9 | % | |||||||||||||
Other revenues | 145 | 231 | (37 | )% | 304 | 396 | (23 | )% | |||||||||||||
Total revenues | $ | 5,370 | $ | 5,180 | 4 | % | $ | 10,403 | $ | 9,701 | 7 | % | |||||||||
Operating expenses | $ | 3,294 | $ | 3,278 | — | % | $ | 6,305 | $ | 6,435 | (2 | )% | |||||||||
Operating income | $ | 2,076 | $ | 1,902 | 9 | % | $ | 4,098 | $ | 3,266 | 25 | % | |||||||||
Net income | $ | 1,653 | $ | 1,547 | 7 | % | $ | 3,276 | $ | 2,620 | 25 | % | |||||||||
Diluted EPS | $ | 2.15 | $ | 2.01 | 7 | % | $ | 4.26 | $ | 3.41 | 25 | % | |||||||||
Diluted shares | 768 | 768 | — | % | 769 | 768 | — | % |
Three months ended | Six months ended | ||||||||||||||||||||
June 30, | June 30, | ||||||||||||||||||||
2015 | 2014 | Change | 2015 | 2014 | Change | ||||||||||||||||
Neulasta®/NEUPOGEN® | $ | 1,414 | $ | 1,429 | (1 | )% | $ | 2,794 | $ | 2,808 | — | % | |||||||||
ENBREL | 1,348 | 1,243 | 8 | % | 2,464 | 2,231 | 10 | % | |||||||||||||
XGEVA® | 331 | 299 | 11 | % | 671 | 578 | 16 | % | |||||||||||||
Prolia® | 340 | 264 | 29 | % | 612 | 460 | 33 | % | |||||||||||||
EPOGEN® | 491 | 512 | (4 | )% | 1,025 | 974 | 5 | % | |||||||||||||
Aranesp® | 479 | 517 | (7 | )% | 959 | 977 | (2 | )% | |||||||||||||
Sensipar®/Mimpara® | 344 | 298 | 15 | % | 678 | 568 | 19 | % | |||||||||||||
Other products | 478 | 387 | 24 | % | 896 | 709 | 26 | % | |||||||||||||
Total product sales | $ | 5,225 | $ | 4,949 | 6 | % | $ | 10,099 | $ | 9,305 | 9 | % |
Three months ended | Six months ended | ||||||||||||||||||||
June 30, | June 30, | ||||||||||||||||||||
2015 | 2014 | Change | 2015 | 2014 | Change | ||||||||||||||||
Neulasta®— U.S. | $ | 953 | $ | 895 | 6 | % | $ | 1,875 | $ | 1,747 | 7 | % | |||||||||
Neulasta®— ROW | 205 | 238 | (14 | )% | 417 | 476 | (12 | )% | |||||||||||||
Total Neulasta® | 1,158 | 1,133 | 2 | % | 2,292 | 2,223 | 3 | % | |||||||||||||
NEUPOGEN®— U.S. | 191 | 214 | (11 | )% | 372 | 428 | (13 | )% | |||||||||||||
NEUPOGEN®— ROW | 65 | 82 | (21 | )% | 130 | 157 | (17 | )% | |||||||||||||
Total NEUPOGEN® | 256 | 296 | (14 | )% | 502 | 585 | (14 | )% | |||||||||||||
Total Neulasta®/NEUPOGEN® | $ | 1,414 | $ | 1,429 | (1 | )% | $ | 2,794 | $ | 2,808 | — | % |
Three months ended | Six months ended | ||||||||||||||||||||
June 30, | June 30, | ||||||||||||||||||||
2015 | 2014 | Change | 2015 | 2014 | Change | ||||||||||||||||
ENBREL — U.S. | $ | 1,280 | $ | 1,171 | 9 | % | $ | 2,332 | $ | 2,095 | 11 | % | |||||||||
ENBREL — Canada | 68 | 72 | (6 | )% | 132 | 136 | (3 | )% | |||||||||||||
Total ENBREL | $ | 1,348 | $ | 1,243 | 8 | % | $ | 2,464 | $ | 2,231 | 10 | % |
Three months ended | Six months ended | ||||||||||||||||||||
June 30, | June 30, | ||||||||||||||||||||
2015 | 2014 | Change | 2015 | 2014 | Change | ||||||||||||||||
XGEVA® — U.S. | $ | 234 | $ | 207 | 13 | % | $ | 479 | $ | 407 | 18 | % | |||||||||
XGEVA® — ROW | 97 | 92 | 5 | % | 192 | 171 | 12 | % | |||||||||||||
Total XGEVA® | 331 | 299 | 11 | % | 671 | 578 | 16 | % | |||||||||||||
Prolia® — U.S. | 215 | 159 | 35 | % | 385 | 278 | 38 | % | |||||||||||||
Prolia® — ROW | 125 | 105 | 19 | % | 227 | 182 | 25 | % | |||||||||||||
Total Prolia® | 340 | 264 | 29 | % | 612 | 460 | 33 | % | |||||||||||||
Total XGEVA®/Prolia® | $ | 671 | $ | 563 | 19 | % | $ | 1,283 | $ | 1,038 | 24 | % |
Three months ended | Six months ended | ||||||||||||||||||||
June 30, | June 30, | ||||||||||||||||||||
2015 | 2014 | Change | 2015 | 2014 | Change | ||||||||||||||||
EPOGEN® — U.S. | $ | 491 | $ | 512 | (4 | )% | $ | 1,025 | $ | 974 | 5 | % |
Three months ended | Six months ended | ||||||||||||||||||||
June 30, | June 30, | ||||||||||||||||||||
2015 | 2014 | Change | 2015 | 2014 | Change | ||||||||||||||||
Aranesp® — U.S. | $ | 223 | $ | 223 | — | % | $ | 412 | $ | 400 | 3 | % | |||||||||
Aranesp® — ROW | 256 | 294 | (13 | )% | 547 | 577 | (5 | )% | |||||||||||||
Total Aranesp® | $ | 479 | $ | 517 | (7 | )% | $ | 959 | $ | 977 | (2 | )% |
Three months ended | Six months ended | ||||||||||||||||||||
June 30, | June 30, | ||||||||||||||||||||
2015 | 2014 | Change | 2015 | 2014 | Change | ||||||||||||||||
Sensipar® — U.S. | $ | 261 | $ | 204 | 28 | % | $ | 502 | $ | 382 | 31 | % | |||||||||
Sensipar®/Mimpara® — ROW | 83 | 94 | (12 | )% | 176 | 186 | (5 | )% | |||||||||||||
Total Sensipar®/Mimpara® | $ | 344 | $ | 298 | 15 | % | $ | 678 | $ | 568 | 19 | % |
Three months ended | Six months ended | ||||||||||||||||||||
June 30, | June 30, | ||||||||||||||||||||
2015 | 2014 | Change | 2015 | 2014 | Change | ||||||||||||||||
Vectibix® — U.S. | $ | 52 | $ | 36 | 44 | % | $ | 99 | $ | 75 | 32 | % | |||||||||
Vectibix® — ROW | 108 | 96 | 13 | % | 183 | 160 | 14 | % | |||||||||||||
Nplate® — U.S. | 73 | 62 | 18 | % | 151 | 124 | 22 | % | |||||||||||||
Nplate® — ROW | 52 | 56 | (7 | )% | 100 | 107 | (7 | )% | |||||||||||||
Kyprolis® — U.S. | 112 | 75 | 49 | % | 209 | 137 | 53 | % | |||||||||||||
Kyprolis® — ROW | 7 | 3 | * | 18 | 9 | 100 | % | ||||||||||||||
Other — U.S. | 20 | — | N/A | 35 | — | N/A | |||||||||||||||
Other — ROW | 54 | 59 | (8 | )% | 101 | 97 | 4 | % | |||||||||||||
Total other products | $ | 478 | $ | 387 | 24 | % | $ | 896 | $ | 709 | 26 | % | |||||||||
Total U.S. — other products | $ | 257 | $ | 173 | 49 | % | $ | 494 | $ | 336 | 47 | % | |||||||||
Total ROW — other products | 221 | 214 | 3 | % | 402 | 373 | 8 | % | |||||||||||||
Total other products | $ | 478 | $ | 387 | 24 | % | $ | 896 | $ | 709 | 26 | % |
Three months ended | Six months ended | ||||||||||||||||||||
June 30, | June 30, | ||||||||||||||||||||
2015 | 2014 | Change | 2015 | 2014 | Change | ||||||||||||||||
Cost of sales | $ | 1,089 | $ | 1,081 | 1 | % | $ | 2,122 | $ | 2,171 | (2 | )% | |||||||||
% of product sales | 20.8 | % | 21.8 | % | 21.0 | % | 23.3 | % | |||||||||||||
% of total revenues | 20.3 | % | 20.9 | % | 20.4 | % | 22.4 | % | |||||||||||||
Research and development | $ | 964 | $ | 1,018 | (5 | )% | $ | 1,858 | $ | 2,045 | (9 | )% | |||||||||
% of product sales | 18.4 | % | 20.6 | % | 18.4 | % | 22.0 | % | |||||||||||||
% of total revenues | 18.0 | % | 19.7 | % | 17.9 | % | 21.1 | % | |||||||||||||
Selling, general and administrative | $ | 1,160 | $ | 1,136 | 2 | % | $ | 2,186 | $ | 2,159 | 1 | % | |||||||||
% of product sales | 22.2 | % | 23.0 | % | 21.6 | % | 23.2 | % | |||||||||||||
% of total revenues | 21.6 | % | 21.9 | % | 21.0 | % | 22.3 | % | |||||||||||||
Other | $ | 81 | $ | 43 | 88 | % | $ | 139 | $ | 60 | * |
Three months ended | Six months ended | ||||||||||||||
June 30, | June 30, | ||||||||||||||
2015 | 2014 | 2015 | 2014 | ||||||||||||
Interest expense, net | $ | 277 | $ | 282 | $ | 529 | $ | 541 | |||||||
Interest and other income, net | $ | 198 | $ | 138 | $ | 304 | $ | 237 | |||||||
Provision for income taxes | $ | 344 | $ | 211 | $ | 597 | $ | 342 | |||||||
Effective tax rate | 17.2 | % | 12.0 | % | 15.4 | % | 11.5 | % |
June 30, 2015 | December 31, 2014 | ||||||
Cash, cash equivalents and marketable securities | $ | 29,993 | $ | 27,026 | |||
Total assets | $ | 71,209 | $ | 69,009 | |||
Current portion of long-term debt | $ | 1,250 | $ | 500 | |||
Long-term debt | $ | 30,702 | $ | 30,215 | |||
Stockholders’ equity | $ | 27,484 | $ | 25,778 |
Six months ended June 30, | |||||||
2015 | 2014 | ||||||
Net cash provided by operating activities | $ | 4,143 | $ | 3,369 | |||
Net cash used in investing activities | $ | (3,311 | ) | $ | (3,223 | ) | |
Net cash (used in) provided by financing activities | $ | (768 | ) | $ | 401 |
Item 3. | QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK |
Item 4. | CONTROLS AND PROCEDURES |
Item 1. | LEGAL PROCEEDINGS |
Item 1A. | RISK FACTORS |
• | revised or restrictive labeling for our products, or the potential for restrictive labeling that may result in our decision not to commercialize a product candidate; |
• | requirement of risk management activities or other regulatory agency compliance actions related to the promotion and sale of our products; |
• | mandated post-marketing commitments or pharmacovigilance programs for our approved products; |
• | product recalls of our approved products; |
• | revocation of approval for our products from the market completely, or within particular therapeutic areas or patient types; |
• | increased timelines or delays in being approved by the FDA or other regulatory bodies; and/or |
• | fewer treatments or product candidates being approved by regulatory bodies. |
Item 2. | UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS |
Total number of shares purchased | Average price paid per share | Total number of shares purchased as part of publicly announced program | Maximum dollar value that may yet be purchased under the program(1) | ||||||||||
April 1 - April 30 | 532,300 | $ | 160.76 | 532,300 | $ | 3,310,258,090 | |||||||
May 1 - May 31 | 1,027,900 | 159.15 | 1,027,900 | 3,146,663,762 | |||||||||
June 1 - June 30 | 1,694,000 | 156.74 | 1,694,000 | 2,881,142,334 | |||||||||
3,254,200 | $ | 158.16 | 3,254,200 |
(1) | In October 2014, our Board of Directors authorized an increase that resulted in a total of $4.0 billion available under the stock repurchase program. |
Item 6. | EXHIBITS |
Amgen Inc. | ||||
(Registrant) | ||||
Date: | August 5, 2015 | By: | /S/ DAVID W. MELINE | |
David W. Meline | ||||
Executive Vice President and Chief Financial Officer |
Exhibit No. | Description | |
3.1 | Restated Certificate of Incorporation of Amgen Inc. (As Restated March 6, 2013.) (Filed as an exhibit to Form 10-Q for the quarter ended March 31, 2013 on May 3, 2013 and incorporated herein by reference.) | |
3.2 | Amended and Restated Bylaws of Amgen Inc. (As Amended and Restated March 6, 2013). (Filed as an exhibit to Form 8-K on March 6, 2013 and incorporated herein by reference.) | |
3.3 | First Amendment to the Amended and Restated Bylaws of Amgen Inc. (As Amended and Restated March 6, 2013). (Filed as an exhibit to Form 8-K on October 16, 2013 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 | First Supplemental Indenture, dated February 26, 1997. (Filed as an exhibit to Form 8-K on March 14, 1997 and incorporated herein by reference.) | |
4.5 | 8-1/8% Debentures due April 1, 2097. (Filed as an exhibit to Form 8-K on April 8, 1997 and incorporated herein by reference.) | |
4.6 | Officer's Certificate of Amgen Inc., dated January 1, 1992, as supplemented by the First Supplemental Indenture, dated 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 on April 8, 1997 and incorporated herein by reference.) | |
4.7 | Indenture, dated August 4, 2003. (Filed as an exhibit to Form S-3 Registration Statement on August 4, 2003 and incorporated herein by reference.) | |
4.8 | 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.) | |
4.9 | Officers' Certificate of Amgen Inc., dated 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.) | |
4.10 | Officers' Certificate of Amgen Inc., dated 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.) | |
4.11 | Officers' Certificate of Amgen Inc., dated 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.) | |
4.12 | Officers' Certificate of Amgen Inc., dated 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.) | |
4.13 | Officers' Certificate of Amgen Inc., dated 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.) | |
4.14 | Officers' Certificate of Amgen Inc., dated 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.) | |
4.15 | Officers' Certificate of Amgen Inc., dated November 10, 2011, including forms of the Company's 1.875% Senior Notes due 2014, 2.50% Senior Notes due 2016, 3.875% Senior Notes due 2021 and 5.15% Senior Notes due 2041. (Filed as an exhibit to Form 8-K on November 10, 2011 and incorporated herein by reference.) | |
Exhibit No. | Description | |
4.16 | Officers' Certificate of Amgen Inc., dated December 5, 2011, including forms of the Company's 4.375% Senior Notes due 2018 and 5.50% Senior Notes due 2026. (Filed as an exhibit to Form 8-K on December 5, 2011 and incorporated herein by reference.) | |
4.17 | Officers' Certificate of Amgen Inc., dated May 15, 2012, including forms of the Company's 2.125% Senior Notes due 2017, 3.625% Senior Notes due 2022 and 5.375% Senior Notes due 2043. (Filed as an exhibit to Form 8-K on May 15, 2012 and incorporated herein by reference.) | |
4.18 | Officers' Certificate of Amgen Inc., dated September 13, 2012, including forms of the Company's 2.125% Senior Notes due 2019 and 4.000% Senior Notes due 2029. (Filed as an exhibit to Form 8-K on September 13, 2012 and incorporated herein by reference.) | |
4.19 | Indenture, dated May 22, 2014, between Amgen Inc. and The Bank of New York Mellon Trust Company, N.A., as Trustee. (Filed as an exhibit to Form 8-K on May 22, 2014 and incorporated herein by reference.) | |
4.20 | Officers' Certificate of Amgen Inc., dated May 22, 2014, including forms of the Company's Senior Floating Rate Notes due 2017, Senior Floating Rate Notes due 2019, 1.250% Senior Notes due 2017, 2.200% Senior Notes due 2019 and 3.625% Senior Notes due 2024. (Filed as an exhibit to Form 8-K on May 22, 2014 and incorporated herein by reference.) | |
4.21 | Officer’s Certificate of Amgen Inc., dated May 1, 2015, including forms of the Company’s 2.125% Senior Notes due 2020, 2.700% Senior Notes due 2022, 3.125% Senior Notes due 2025 and 4.400% Senior Notes. 9Add due 2045. (Filed as an exhibit on Form 8-K on May 1, 2015 and incorporated herein by reference.) | |
10.1+ | Amgen Inc. Amended and Restated 2009 Equity Incentive Plan. (Filed as Appendix C to the Definitive Proxy Statement on Schedule 14A on April 8, 2013 and incorporated herein by reference.) | |
10.2+ | First Amendment to Amgen Inc. Amended and Restated 2009 Equity Incentive Plan, effective March 4, 2015. (Filed as an exhibit to Form 10-Q for the quarter ended March 31, 2015 on April 27, 2015 and incorporated herein by reference.) | |
10.3+ | Form of Stock Option Agreement for the Amgen Inc. Amended and Restated 2009 Equity Incentive Plan. (As Amended on March 6, 2013.) (Filed as an exhibit to Form 10-Q for the quarter ended March 31, 2013 on May 3, 2013 and incorporated herein by reference.) | |
10.4+* | Form of Restricted Stock Unit Agreement for the Amgen Inc. Amended and Restated 2009 Equity Incentive Plan. (As Amended on May 14, 2015.) | |
10.5+ | Amgen Inc. 2009 Performance Award Program. (As Amended on December 13, 2013.) (Filed as an exhibit to Form 10-K for the year ended December 31, 2013 on February 24, 2014 and incorporated herein by reference.) | |
10.6+* | Form of Performance Unit Agreement for the Amgen Inc. 2009 Performance Award Program. (As Amended on May 14, 2015). | |
10.7+ | Amgen Inc. 2009 Director Equity Incentive Program. (As Amended on March 6, 2013.) (Filed as an exhibit to Form 10-Q for the quarter ended March 31, 2013 on May 3, 2013 and incorporated herein by reference.) | |
10.8+ | Form of Grant of Non-Qualified Stock Option 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.) | |
10.9+ | Form of Restricted Stock Unit Agreement for the Amgen Inc. 2009 Director Equity Incentive Program. (As Amended on March 6, 2013.) (Filed as an exhibit to Form 10-Q for the quarter ended March 31, 2013 on May 3, 2013 and incorporated herein by reference.) | |
10.10+ | Amgen Inc. Supplemental Retirement Plan. (As Amended and Restated effective October 16, 2013.) (Filed as an exhibit to Form 10-K for the year ended December 31, 2013 on February 24, 2014 and incorporated herein by reference.) | |
10.11+ | 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.) | |
10.12+ | 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.) | |
10.13+ | First Amendment to the Amgen Inc. Executive Incentive Plan, effective December 13, 2012. (Filed as an exhibit to Form 10-K for the year ended December 31, 2012 on February 27, 2013 and incorporated herein by reference.) | |
Exhibit No. | Description | |
10.14+ | 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.) | |
10.15+ | First Amendment to the Amgen Inc. Executive Nonqualified Retirement Plan, effective July 21, 2010. (Filed as an exhibit to Form 10-Q for the quarter ended June 30, 2010 on August 9, 2010 and incorporated herein by reference.) | |
10.16+ | Amgen Nonqualified Deferred Compensation Plan. (As Amended and Restated effective October 16, 2013.) (Filed as an exhibit to Form 10-K for the year ended December 31, 2013 on February 24, 2014 and incorporated herein by reference.) | |
10.17+ | Agreement between Amgen Inc. and David W. Meline, effective July 21, 2014. (Filed as an exhibit to Form 10-Q for the quarter ended September 30, 2014 on October 29, 2014 and incorporated herein by reference.) | |
10.18+* | Agreement between Amgen Inc. and Jonathan Graham, dated May 11, 2015. | |
10.19 | 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.) | |
10.20 | 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.) | |
10.21 | 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.) | |
10.22 | 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.) | |
10.23 | Amendment No. 13 to the Shareholders' Agreement, dated June 28, 2007 (portions of the exhibit have been omitted pursuant to a request for confidential treatment). (Filed as an exhibit to Form 10-Q for the quarter ended June 30, 2007 on August 9, 2007 and incorporated herein by reference.) | |
10.24 | Amendment No. 14 to the Shareholders' Agreement, dated March 26, 2014. (Filed as an exhibit to Form 10-Q for the quarter ended March 31, 2014 on April 30, 2014 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, 1998, Amendment No. 3 to Kirin-Amgen, Inc. / Amgen G-CSF European License Agreement, dated October 20, 1988, and Amendment No. 4 to Kirin-Amgen, Inc. / Amgen G-CSF European License Agreement, dated December 29, 1989, between Kirin-Amgen, Inc. and Amgen Inc. (Filed as exhibits to Form 10-K for the year ended December 31, 2000 on March 7, 2001 and incorporated herein by reference.) | |
10.28 | Amended and Restated Promotion Agreement, dated December 16, 2001, by and among Immunex Corporation, American Home Products Corporation and Amgen Inc. (portions of the exhibit have been omitted pursuant to a request for confidential treatment). (Filed as an exhibit to Amendment No. 1 to Form S-4 Registration Statement on March 22, 2002 and incorporated herein by reference.) | |
10.29 | Description of Amendment No. 1 to Amended and Restated Promotion Agreement, effective July 8, 2003, among Wyeth, Amgen Inc. and Immunex Corporation (portions of the exhibit have been omitted pursuant to a request for confidential treatment). (Filed as an exhibit to Form 10-K for the year ended December 31, 2003 on March 11, 2004 and incorporated herein by reference.) | |
Exhibit No. | Description | |
10.30 | Description of Amendment No. 2 to Amended and Restated Promotion Agreement, effective April 20, 2004, by and among Wyeth, Amgen Inc. and Immunex Corporation. (Filed as an exhibit to Amendment No. 1 to Form S-4 Registration Statement on June 29, 2004 and incorporated herein by reference.) | |
10.31 | Amendment No. 3 to Amended and Restated Promotion Agreement, effective January 1, 2005, by and among Wyeth, Amgen Inc. and Immunex Corporation (portions of the exhibit have been omitted pursuant to a request for confidential treatment). (Filed as an exhibit to Form 10-Q for the quarter ended March 31, 2005 on May 4, 2005 and incorporated herein by reference.) | |
10.32 | Amended and Restated Credit Agreement, dated July 30, 2014, among Amgen Inc., the Banks therein named, Citibank, N.A., as administrative agent, and JPMorgan Chase Bank, N.A., as syndication agent (Filed as an exhibit to Form 8-K on July 30, 2014 and incorporated herein by reference.) | |
10.33 | Collaboration and License Agreement between Amgen Inc. and Celltech R&D Limited dated May 10, 2002 (portions of the exhibit have been omitted pursuant to a request for confidential treatment) and Amendment No. 1, effective June 9, 2003, to Collaboration and License Agreement between Amgen Inc. and Celltech R&D Limited (portions of the exhibit have been omitted pursuant to a request for confidential treatment). (Filed as an exhibit to Form 10-K/A for the year ended December 31, 2012 on July 31, 2013 and incorporated herein by reference.) | |
10.34 | Sourcing and Supply Agreement, dated November 15, 2011, by and between Amgen USA Inc, a wholly owned subsidiary of Amgen Inc., and DaVita Inc. (portions of the exhibit have been omitted pursuant to a request for confidential treatment). (Filed as an exhibit to Form 10-K for the year ended December 31, 2011 on February 29, 2012 and incorporated herein by reference.) | |
10.35 | Amendment Number 1 to Sourcing and Supply Agreement, effective January 1, 2013, by and between Amgen USA Inc., a wholly owned subsidiary of Amgen Inc., and DaVita Healthcare Partners Inc. f/k/a DaVita Inc. (portions of the exhibit have been omitted pursuant to a request for confidential treatment). (Filed as an exhibit to Form 10-K for the year ended December 31, 2012 on February 27, 2013 and incorporated herein by reference.) | |
10.36 | Collaboration Agreement dated March 30, 2012 by and between Amgen Inc. and AstraZeneca Collaboration Ventures, LLC, a wholly owned subsidiary of AstraZeneca Pharmaceuticals LP (portions of the exhibit have been omitted pursuant to a request for confidential treatment). (Filed as an exhibit to Form 10-Q for the quarter ended March 31, 2012 on May 8, 2012 and incorporated herein by reference.) | |
10.37 | Amendment No. 1 to Collaboration Agreement, dated October 1, 2014, by and among Amgen Inc., AstraZeneca Collaboration Ventures, LLC and AstraZeneca Pharmaceuticals LP (portions of the exhibit have been omitted pursuant to a request for confidential treatment). (Filed as an exhibit to Form 10-K for the year ended December 31, 2014 on February 19, 2015 and incorporated herein by reference.) | |
10.38 | Collaboration Agreement, dated April 22, 1994, by and between Bayer Corporation (formerly Miles, Inc.) and Onyx Pharmaceuticals, Inc. (Filed as an exhibit to Form 10-Q for the quarter ended March 31, 2011 by Onyx Pharmaceuticals, Inc. on May 10, 2011 and incorporated herein by reference.) | |
10.39 | Amendment to Collaboration Agreement, dated April 24, 1996, by and between Bayer Corporation and Onyx Pharmaceuticals, Inc. (Filed as an exhibit to Form 10-Q for the quarter ended March 31, 2006 by Onyx Pharmaceuticals, Inc. on May 10, 2006 and incorporated herein by reference.) | |
10.40 | Amendment to Collaboration Agreement, dated February 1, 1999, by and between Bayer Corporation and Onyx Pharmaceuticals, Inc. (Filed as an exhibit to Form 10-Q for the quarter ended March 31, 2006 by Onyx Pharmaceuticals, Inc. on May 10, 2006 and incorporated herein by reference.) | |
10.41 | Settlement Agreement and Release, dated October 11, 2011, by and between Bayer Corporation, Bayer AG, Bayer HealthCare LLC and Bayer Pharma AG and Onyx Pharmaceuticals, Inc. (Filed as an exhibit to Form 10-K for the year ended December 31, 2011 by Onyx Pharmaceuticals, Inc. on February 27, 2012 and incorporated herein by reference.) | |
10.42 | Fourth Amendment to Collaboration Agreement, dated October 11, 2011, by and between Bayer Corporation and Onyx Pharmaceuticals, Inc. (Filed as an exhibit to Form 10-K for the year ended December 31, 2011 by Onyx Pharmaceuticals, Inc. on February 27, 2012 and incorporated herein by reference.) | |
10.43* | Side Letter Regarding Collaboration Agreement, dated May 29, 2015, by and between Bayer HealthCare LLC and Onyx Pharmaceuticals, Inc. | |
10.44 | Commitment Letter, dated August 24, 2013, among Amgen Inc., Bank of America, N.A., Merrill Lynch, Pierce, Fenner & Smith Incorporated, JPMorgan Chase Bank, N.A., J.P. Morgan Securities LLC and Barclays Bank PLC. (Filed as an exhibit to Form 8-K on August 26, 2013 and incorporated herein by reference.) | |
Exhibit No. | Description | |
10.45 | Master Repurchase Agreement, dated August 24, 2013, between Amgen Inc. and Bank of America, N.A. (Filed as an exhibit to Form 8-K on August 26, 2013 and incorporated herein by reference.) | |
10.46 | Master Repurchase Agreement, dated October 28, 2013, between Amgen Inc. and SMBC Repo Pass-Thru Trust, 2013-1. (Filed as an exhibit to Form 10-Q for the quarter ended September 30, 2013 on October 29, 2013 and incorporated herein by reference.) | |
10.47 | Master Repurchase Agreement, dated October 29, 2013, between Amgen Inc. and HSBC Bank USA, N.A. (Filed as an exhibit to Form 10-Q for the quarter ended September 30, 2013 on October 29, 2013 and incorporated herein by reference.) | |
10.48 | Term Loan Facility Credit Agreement, dated September 20, 2013, among Amgen Inc., the Banks therein named, Bank of America, N.A., as Administrative Agent, and Barclays Bank PLC and JPMorgan Chase Bank, N.A., as Syndication Agents. (Filed as an exhibit to Form 8-K on September 20, 2013 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. | |
101.DEF* | XBRL Taxonomy Extension Definition Linkbase Document. | |
101.LAB* | XBRL Taxonomy Extension Label Linkbase Document. | |
101.PRE* | XBRL Taxonomy Extension Presentation Linkbase Document. |
Plan: | Amgen Inc. Amended and Restated 2009 Equity Incentive Plan, as amended and/or restated from time to time |
Grant Price: | $________ |
Vesting Date: | Means the vesting date indicated in the Vesting Schedule |
Vesting Schedule: | Means the schedule of vesting set forth under Vesting Details |
Vesting Details: | Means the presentation (tabular or otherwise) of the Vesting Date and the quantity of Shares vesting |
a. | General. Subject to the terms and conditions of this Agreement, on each Vesting Date, the Number of Units indicated on the Vesting Schedule shall vest, provided that you have remained continuously and actively employed with the Company or an Affiliate (as defined in the Plan) through each applicable Vesting Date, unless (i) [your employment has terminated due to your Voluntary Termination (as defined in paragraph (d) of this Section I below) ]*2, [(ii)] you experience a Qualified Termination (as defined below), or (iii)[(ii)] as otherwise determined by the Company in the exercise of its discretion as provided in paragraph (f) of this Section I. The Units represent an unfunded, unsecured promise by the Company to deliver Shares. Only whole Shares shall be issued upon vesting of the Units, and the Company shall be under no obligation to issue any fractional Shares to you. If your employment with the Company or an Affiliate is terminated for any reason or for no reason, including if your active employment is terminated by the Company or an Affiliate without Cause (as defined below), or in the event of any other termination of your active employment caused directly or indirectly by the Company or an Affiliate, except as otherwise provided in paragraphs (b), (c), [(d), ]*(1) (e) or (f) of this Section I below, your unvested Units shall automatically expire and terminate on the date of termination of your active employment. Notwithstanding anything herein to the contrary, the Vesting Schedule may be accelerated (by notice in writing) by the Company in its sole discretion at any time during the term of the Units. In addition, if not prohibited by local law, vesting may be suspended by the Company in its sole discretion during a leave of absence as provided from time to time according to Company policies and practices. |
b. | Permanent and Total Disability. Notwithstanding the provisions in paragraph (a) above, if your employment with the Company or an Affiliate terminates due to your Permanent and Total Disability (as defined below), then the vesting of Units granted under this Agreement shall be accelerated, subject to your execution of a general release and waiver in a form provided by the Company, to vest as of the day immediately preceding such termination of your employment with respect to all Units granted hereunder, except that if the Units were granted in the calendar year in which such termination occurs, the Units shall be accelerated to vest with respect to a number of Units equal to the number of Units subject to this Agreement multiplied by a fraction, the numerator of which is the number of complete months you remained continuously and actively employed during such calendar year, and the denominator of which is twelve (12). |
c. | Death. Notwithstanding the provisions in paragraph (a) above, if your employment with the Company or an Affiliate terminates due to your death, then the vesting of Units granted under this Agreement shall be accelerated to vest as of the day immediately preceding your death with respect to all Units granted hereunder, except that if the Units were granted in the calendar year in which your death occurs the Units shall be accelerated to vest with respect to a number of Units equal to the number of Units subject to this Agreement multiplied by a fraction, the numerator of which is the number of complete months you remained continuously and actively employed during such calendar year, and the denominator of which is twelve (12). |
d. | [Retirement. Notwithstanding the provisions in paragraph (a) above, if you terminate your employment with the Company or an Affiliate due to your voluntary termination (and such voluntary termination is not the result of Permanent and Total Disability (as defined below)) after you are at least sixty-five (65) years of age, or after you are at least fifty-five (55) years of age and have been an employee of the Company and/or an Affiliate for at least ten (10) years in the aggregate as determined by the Company in its sole discretion according to Company policies and practices as in effect from time to time (“Voluntary Termination”), then the Units will vest pursuant to the Vesting Schedule without regard to the termination of employment prior to the Vesting Date, subject to your execution of a general release and waiver in a form provided by the Company, with respect to all Units granted hereunder; provided, however, that if the Units were granted in the calendar year in which the Voluntary Termination occurs, the Units will vest pursuant to the Vesting Schedule provided in the Award Notice only with respect to a number of Units equal to the number of Units subject to this Agreement multiplied by a fraction, the numerator of which is the number of complete months you remained continuously and actively employed during such calendar year, and the denominator of which is twelve (12); notwithstanding the definition of Voluntary Termination set forth above, if the Company receives an opinion of counsel that there has been a legal judgment and/or legal development in your jurisdiction that would likely result in the favorable treatment upon Voluntary Termination described above being deemed unlawful and/or discriminatory, then the Committee will not apply the favorable treatment described above.][Reserved]*3 |
e. | Qualified Termination after a Change of Control. Notwithstanding the provisions in paragraph (a) above, in the event of a Qualified Termination (as defined below), then, to the extent permitted by applicable law, the vesting of Units granted under this Agreement shall be accelerated to vest as of the day immediately prior to the Qualified Termination. |
f. | Continued Vesting. Notwithstanding the provisions in paragraph (a) above, the Company may in its sole discretion at any time during the term of this Agreement, in writing, otherwise provide that the Units will vest pursuant to the Vesting Schedule without regard to the termination of employment prior to the Vesting Date, subject to any terms and conditions that the Company may determine. |
(a) | if you are an employee who participates in the Change of Control Plan (as defined below), your termination of employment within two (2) years following a Change of Control (i) by the Company other than for Cause, Disability (as defined below), or as a result of your death or (ii) by you for Good Reason (as defined in the Change of Control Plan); or |
(b) | if you are an employee who does not participate in the Change of Control Plan or the Change of Control Plan is no longer in effect, your termination of employment within two (2) years following a Change of Control by the Company other than for Cause, Disability (as defined below), or as a result of your death; |
a. | the terms and conditions of this Agreement, including Appendix A, are deemed modified to the extent necessary or advisable to comply with applicable foreign laws or facilitate the administration of the Plan; |
b. | if applicable, the effectiveness of your award of Units is conditioned upon its compliance with any applicable foreign laws, regulations, rules or local governmental regulatory exemption and subject to receipt of any required foreign regulatory approvals; |
c. | to the extent necessary to comply with applicable foreign laws, the payment of any earned Units shall be made in cash or Common Stock, at the Company’s election; and |
d. | the Company may take any other action, before or after an award of Units is made, that it deems advisable to obtain approval or comply with any necessary local governmental regulatory exemptions or approvals. |
(1) | Your participation in the Plan does not constitute an acquired right. |
(2) | The Plan and your participation in the Plan are offered by Amgen Inc. on a wholly discretionary basis. |
(3) | Your participation in the Plan is voluntary. |
(4) | Amgen Inc. and its Affiliates are not responsible for any decrease in the value of the Units granted and/or Shares issued under the Plan. |
(1) | Su participación en el Plan de ninguna manera constituye un derecho adquirido. |
(2) | El Plan y su participación en el mismo son ofrecidos por Amgen Inc. de forma completamente discrecional. |
(3) | Su participación en el Plan es voluntaria. |
(4) | Amgen Inc. y sus Afiliados no son responsables de ninguna disminución en el valor de Unidades o de las Acciones Comunes emitidas mediante el Plan. |
Plan: | Amgen Inc. Amended and Restated 2009 Equity Incentive Plan, as amended and/or restated from time to time |
Program | Amgen Inc. 2009 Performance Award Program, as amended and/or restated from time to time |
Resolutions: | The Resolutions of the Compensation and Management Development Committee of the Board of Directors of Amgen Inc., adopted on _____________, regarding the Amgen Inc. 2009 Performance Award Program, as amended from time to time |
Performance Period: | The Performance Period beginning on ____, 20__ and ending on _______, 20__ |
Vesting Date: | Means the vesting date indicated in the Vesting Schedule |
Vesting Schedule: | Means the schedule of vesting set forth under Vesting Details |
Vesting Details: | Means the presentation (tabular or otherwise) of the Vesting Date and the quantity of Shares vesting. |
(1) | Your participation in the Plan and the Program do not constitute an acquired right. |
(2) | The Plan and your participation in the Plan and the Program are offered by Amgen Inc. on a wholly discretionary basis. |
(3) | Your participation in the Plan and the Program is voluntary. |
(4) | Amgen Inc. and its Affiliates are not responsible for any decrease in the value of any Shares issued with respect to the Award. |
(1) | Su participación en el Plan y en el Programa de ninguna manera constituye un derecho adquirido. |
(2) | Su participación en Plan y en el Programa son ofrecidos por Amgen Inc. de forma completamente discrecional. |
(3) | Su participación en el Plan y en el Programa es voluntaria. |
(4) | Amgen Inc. y sus Afiliados no son responsables de ninguna disminución en el valor de las Acciones Comunes emitidas mediante el Plan. |
1. | Report to work at Amgen or another location to which you are required to travel and perform the regular duties of your employment. |
2. | Contact the Amgen Benefits Center at 1-800-97AMGEN, to enroll within 31 days of your hire date. |
3. | Meet all other eligibility requirements under the plan. |
/s/ Jonathan P. Graham | 5/19/2015 | |
Signature of Acceptance | Date | |
XXXX | ||
Last 4 Digits of Social Security Number (For Identification Purposes) | ||
Last 4 Digits of Government ID (If No Social Security Number) |
A) | Complete, date and sign the Amgen Proprietary Information and Inventions Agreement and return it with your signed offer letter. |
B) | Sign and date the Amgen New Staff Member Letter and Certification and return it with your signed offer letter. |
C) | Date and sign the enclosed Mutual Agreement to Arbitrate Claims and return it with your signed offer letter. |
D) | You will be required to provide Amgen with proof of your identity and eligibility for employment per requirements of the Immigration Reform and Control Act of 1986 within 3 (three) days of hire. Information pertaining to this Act and required proof are enclosed. |
E) | For California non-exempt staff only, sign and date the Notice To Employee, Labor Code 2810.5 |
• | Carefully read the Company’s Proprietary Information and Inventions Agreement (“PIIA”) that you have executed, and make sure that you understand your obligations under the terms of the PIIA. If you have any questions, please contact Human Resources. |
• | You may not bring any material to the Company from third parties in hard copy, in electronic format or in any other form. Nor should you use any such material in your work for the Company. |
• | Prior to commencing any work for the Company, conduct a search of your personal computer(s), email accounts, and any other electronic storage devices you possess, as well as any files you maintain in hard copy, for information or materials belonging to your Prior Employers. You are instructed to make appropriate arrangements to return any such information or materials belonging to your Prior Employers, consistent with any obligations you have to the Prior Employers. |
• | Do not disclose to or provide the Company with any customer lists you obtained from or during your employment with your Prior Employers. When interacting with doctors or other members of the healthcare industry with whom you may have had contact while working for your Prior Employers, clearly indicate to such persons that you are an Amgen staff member, and focus on the Company’s products rather than using or discussing information related to your prior employment. |
• | If you have any doubts regarding whether you may take, disclose, upload, access, or use any information in your possession, you must err on the side of not taking, disclosing, uploading, accessing or using the information. |
• | Do not begin any work for the Company before your employment with your Prior Employers has officially ended. |
• | After commencing work for the Company, do not request that any employee of your Prior Employers provide you with, or take any other steps to obtain, any information or property of your Prior Employers. |
• | Under no circumstances are you permitted to connect to a Company computer any electronic storage device containing information or property relating to your Prior Employers. Likewise, in performing work for the Company, you are not permitted to use, disclose, access or upload any such information or property. If you discover that any confidential, proprietary, or trade secret information or property of your Prior Employers has been uploaded to any Company computer or email system(s), immediately inform Human Resources. |
• | The Company may monitor and/or conduct an audit of your use of Company computer systems, and you should not have any expectation of privacy in data sent, stored or received on any Company systems. See the Company’s Use of Company Systems and Internet Conduct Policy for further details. |
• | Disclose and identify below all agreements relating to your Prior Employers that may affect your eligibility to become employed by and/or to perform work for the Company, including any non-competition agreement(s), agreements relating to the solicitation of employees or customers, or other restrictive agreements (collectively, “Restrictive Agreements”), regardless of whether you believe these agreements are enforceable, apply to your potential employment with the Company, or have expired, and provide a copy to Human Resources. If “none,” please so indicate. Do not leave blank. |
Name of Agreement | Employer | Date signed | ||||
None | 5/19/2015 | |||||
• | If you are subject to an agreement not to solicit employees of your Prior Employers, you should refrain from doing so. You should specifically inform Human Resources if you are subject to such an agreement. If you are subject to such an agreement and a former colleague contacts you about employment opportunities with the Company, please contact Human Resources for assistance. |
• | Do not use any email account (including Company email accounts), text messages, Instant Messaging, or any other method of written communication to store or discuss any proprietary, confidential or trade secret information or other property belonging to your Prior Employers. |
• | Immediately inform Human Resources if you are contacted in any manner by any former employer regarding your work for Amgen and/or any non-competition agreements, agreements that relate to the solicitation of employees or customers, or any other restrictive agreements you entered into in connection with any Prior Employers. |
1. | The amount of the Bonus is described in the offer letter (as may be amended) that was provided separately to me. |
2. | The Bonus will generally be paid to me as follows: |
• | After thirty (30) days following my start date with Amgen, I will be paid $1,000,000.00 as an advance. This amount will be earned only after I complete two years of employment with Amgen. The Bonus is intended to facilitate my acceptance of employment with Amgen and my continued employment with Amgen for a period of at least two years. Amgen is providing me with the Bonus with the expectation that I will not resign my employment during this two-year period. |
• | $1,000,000.00 to be paid on or about the first anniversary of your start date. I understand that if I am not employed by Amgen on this date, I have not earned any portion of this amount. |
3. | I understand and agree that I am an at-will employee and that I am free to resign at any time and Amgen is free to terminate my employment, with or without cause, at any time. Nevertheless, I understand that if I resign my employment with Amgen before I complete two years of employment, I have not earned any portion of the Bonus amount. Therefore, I agree to repay Amgen for the gross amount of my Bonus advance if I resign my employment for any reason within 24 months from my hire date at Amgen. I also agree that in the event of such a resignation, the amount to be reimbursed shall be due in full and payable by me immediately in cash (i.e., by check, wire transfer, or similar immediate payment) without further notice or demand by Amgen. |
4. | Generally, a sign-on/retention bonus is considered ordinary wage income to the recipient. I understand that Amgen will report to appropriate federal and state taxing authorities all income that Amgen considers to be subject to taxation and will withhold appropriate taxes in accordance with federal and state regulations. I understand that it is my obligation to declare all income and pay all taxes owed on such income, if any. |
5. | I understand that this agreement shall be governed by the law of the State of California. |
6. | Nothing in this Agreement will be construed as an employment contract or to guarantee me employment at Amgen for any fixed term. I understand that my employment at Amgen is at will. |
7. | The provisions of this agreement are severable. If any part is found to be unenforceable, all other provisions shall remain fully valid and enforceable. |
I agree: | Amgen Inc: | |||
/s/ Jonathan P. Graham | /s/ Trent Hamilton | |||
Signature of Staff Member | Signature of Authorized Representative | |||
/s/ Jonathan P. Graham | Director Human Resources | |||
Print Name of Staff Member | Title of Representative | |||
XXX | 5/22/2015 | |||
Last 4 Digits of Social Security Number (For Identification Purposes) | Date | |||
Last 4 Digits of Government ID (If No Social Security Number) | ||||
5/19/2015 | ||||
Date |
1. | The relocation benefits to be provided to me are outlined in the Amgen Relocation Policy that applies to staff members at my Global Career Framework (“GCF”) level. |
2. | I will obtain relocation benefits from Amgen by following the procedures outlined in the Amgen Relocation Policy that applies to staff members at my GCF level. |
3. | I understand that I may obtain an estimate of my relocation costs from Amgen/Amgen’s third-party relocation vendor and that the actual cost of my relocation may be more or less than the estimate I am provided. I further understand that I can obtain detailed information about the actual services and costs being incurred during my relocation by contacting Amgen or Amgen’s third-party relocation vendor. |
4. | The relocation benefits are to facilitate my move as a result of my decision to accept an offer of employment with Amgen. I acknowledge that the cost of these benefits is not required to be reimbursed to me as a matter of law under California Labor Code section 2802 or any similar statute. |
5. | Amgen provides the relocation benefits with the expectation that I will not in the short term resign my employment. While, as an at-will employee, I am free to resign at any time, I agree to reimburse Amgen for the gross amount of the cost of the relocation benefits (according to the schedule below) if I resign my employment for any reason within 730 days of my start date with Amgen. Upon my resignation, the amount to be reimbursed shall be immediately due and payable by me without further notice or demand. The schedule for reimbursement is as follows: |
Days Since Start Date | % of Gross Cost of Relocation Benefits to be Reimbursed to Amgen |
0 to 365 days | 100 % |
366- 450 days | 75 % |
451 - 540 days | 50 % |
541 - 730 days | 25 % |
Over 730 days | 0 % |
6. | I understand that Amgen will report to federal and state taxing agencies all income that Amgen considers to be subject to taxation. I understand that it is my obligation to declare all income and pay all taxes owed on such income, if any. |
7. | In the event that I fail to make a reimbursement required by this agreement and Amgen initiates proceedings to recover such reimbursement, the prevailing party in such a suit shall be awarded its reasonable costs and attorney’s fees. |
8. | I understand that this agreement shall be governed by the law of the State of California. |
9. | Nothing in this agreement will be construed as an employment contract or to guarantee me employment at Amgen for any fixed term. I understand that my employment at Amgen is at will. Nor does this agreement guarantee me reimbursement of any particular relocation expenses. I understand that reimbursement is governed by the Amgen Relocation Policy and that I must comply with the procedures in that policy. |
10. | The provisions of this agreement are severable. If any part is found to be unenforceable, all other provisions shall remain fully valid and enforceable. |
I agree: | Amgen Inc: | |||
/s/ Jonathan P. Graham | /s/ Trent Hamilton | |||
Signature of Staff Member | Signature of Authorized Representative | |||
Jonathan P. Graham | Director Human Resources | |||
Print Name of Staff Member | Title of Representative | |||
XXX | 5/22/2015 | |||
Last 4 Digits of Social Security Number (For Identification Purposes) | Date | |||
Last 4 Digits of Government ID (If No Social Security Number) | ||||
5/19/2015 | ||||
Date |
a. | The Parties hereby agree that, notwithstanding anything to the contrary in the Collaboration Agreement, during the U.S. Royalty Term (as defined below), Bayer shall have exclusive authority and control over the commercialization of the Collaboration Products in the United States (including control over when and how to discontinue commercialization of the Collaboration Products in the United States, provided, however, that, if Bayer elects to discontinue commercialization of the Collaboration Products in the United States, Onyx shall have the right to assume exclusive authority and control over the commercialization of the Collaboration Products in the United States and, in such event, the Parties would promptly agree upon a transition plan). In exercising such authority and control, Bayer shall use the level of efforts and resources (including the promptness with which such efforts and resources would be applied) commonly used by Bayer with respect to a product of commercial potential |
b. | The Parties hereby agree that the Executive Committee shall develop a plan for, and manage, the orderly termination of the co-promotion activities and arrangements contemplated in the Co-Promotion Agreement on commercially reasonable terms, provided, however, that all such co-promotion activities and arrangements shall be fully terminated on or before the Termination Date. |
c. | The Parties hereby acknowledge and agree that (i) neither Onyx nor Bayer is a “Breaching Party” under the Co-Promotion Agreement and the provisions of Section 10.5(c) of the Co-Promotion Agreement shall not apply to the termination of the Co-Promotion Agreement, (ii) the termination of the Co-Promotion Agreement as set forth herein shall not release or operate to discharge either Party from any liability or obligation that may have accrued prior to the Termination Date, and (iii) from and after the Termination Date, the Co-Promotion Collaboration Product (as defined in the Co-Promotion Agreement) shall (x) cease to be a Co-Promoted Product and a Co-Promotion Product and (y) not be deemed a Royalty-Bearing Product under the Collaboration Agreement. |
d. | The Parties hereby acknowledge and agree that, from the date hereof until the Termination Date, the terms of the Co-Promotion Agreement, including, without limitation, the terms of Article VIII of the Co-Promotion Agreement (Economics of Co-Promotion; Profit Sharing), remain in full force and effect. For clarity, the Parties hereby further acknowledge and agree that each Party shall bear its own costs and expenses required to implement the terms of this Agreement (including severance costs related to personnel) and any such costs and expenses shall not be considered Allowable Co-Promotion Expenses or otherwise shared by the Parties. |
e. | Bayer shall use Commercially Reasonable Efforts to obtain, at its own expense and in a timely manner, any U.S. Regulatory Approvals that are required by applicable law to remove the Onyx name and/or logo from the Collaboration Products’ label, promotional materials and other materials that utilize as of the date hereof the Onyx name and/or logo . Upon Bayer’s request, Onyx shall provide Bayer reasonable assistance with obtaining such U.S. Regulatory Approvals, provided that Bayer shall reimburse Onyx for its reasonable out-of-pocket expenses in connection therewith. |
f. | The Parties hereby agree that, as has been the agreed-upon practice of the Parties under the Collaboration Agreement, for purposes of the Parties’ prospective arrangements set forth in this letter, the United States shall refer to the fifty (50) states of the United States of America and the District of Columbia, but shall exclude territories and possessions thereof. For the avoidance of doubt, the United States territories and possessions other than the fifty (50) states and the District of Columbia shall be treated for all purposes hereunder in an equivalent manner to any country worldwide other than the United States and compensation for sales of Collaboration Products in such territories and possessions shall be governed by Section 16.1 of the Collaboration Agreement. |
a. | Royalty. Bayer shall pay to Onyx non-refundable, non-creditable royalties equal to thirty-nine percent (39%) of Net Sales of all Collaboration Products in the United States during the U.S. Royalty Term. Any sales of Collaboration Products in the United States by or on behalf of Bayer, its Affiliates, licensees and/or sublicensees shall be treated hereunder as if such sales were made by Bayer. If Bayer grants licenses to its Affiliates or Third Parties to make or sell Collaboration Products in the United States, it shall include an obligation for such parties to account for and report Net Sales of Collaboration Products on the same basis as if such sales were made by Bayer, and Bayer shall pay royalties to Onyx under this letter as if the Net Sales of such Collaboration Products by such Affiliates and Third Parties were Net Sales of Bayer. Notwithstanding the foregoing, if during the U.S. Royalty Term, a Third Party receives marketing authorization for and commences commercial sale of a Generic Product (as defined below) in the United States, then royalties payable to Onyx with respect to Net Sales of the applicable Collaboration Product in the United States shall be reduced to nineteen and one half percent (19.5%) beginning on the first day of the first full calendar quarter following the date of first sale of the Generic Product in which Net Sales of the applicable Collaboration Product in the United States in such calendar quarter decrease by more than fifty percent (50%) from the Net Sales of such Collaboration Product in the United States in the calendar quarter immediately preceding the first sale of such Generic Product. For the purposes of this provision, a “Generic Product” shall mean, with respect to a Collaboration Product, any pharmaceutical product in the United States that: (i) contains the same active pharmaceutical ingredient as the Collaboration Product; (ii) is approved by the FDA in reliance, in whole or in part, on the prior Drug Approval of such Collaboration Product (e.g., pursuant to 21 U.S.C. 355(b)(2), an abbreviated new drug application (ANDA) pursuant to 21 U.S.C. §355(j), a separate NDA, compendia listing, other Drug Approval Application or otherwise, including foreign equivalents of the foregoing); (iii) has one or more Governmental or Regulatory Authority-approved indications in the United States equivalent to the Governmental or Regulatory Authority-approved indication for such Product in the United States; (iv) is bioequivalent to such Collaboration Product as determined by the FDA; and (v) is sold in the United States by a Third Party that (a) is not a licensee or sublicensee of Bayer or its Affiliates or any of their licensees or sublicensees, (b) has not obtained such product from a chain of distribution including Bayer, its Affiliates or any of their licensees or sublicensees, and (c) is not otherwise authorized by Bayer or any of its Affiliates, licensees, sublicensees or distributors to sell such product. |
b. | U.S. Royalty Term. Royalties shall be paid under this Paragraph 3 during the period from the Termination Date until the date of the termination or expiration, as the case may be, of the Collaboration Agreement in accordance with its terms (such period, the “U.S. Royalty Term”). |
c. | Royalty Reports and Payments. Within ten (10) days following the end of each calendar quarter during the U.S. Royalty Term, Bayer shall provide Onyx with a report estimating Net Sales of the Collaboration Products in the United States for such calendar quarter. Within thirty (30) days following the end of each calendar quarter during the U.S. Royalty Term, Bayer shall provide Onyx with a report containing the following information for such calendar quarter: (i) the amount of gross sales of Collaboration Products in the United States, (ii) an itemized calculation of Net Sales in the United States showing deductions permitted in the definition of “Net Sales,” and (iii) the calculation of the royalty payment due on such sales pursuant to Paragraph 3.a hereof. Bayer shall pay to Onyx all amounts due to Onyx pursuant |
d. | Books and Records. During the U.S. Royalty Term, Bayer shall, and shall cause its Affiliates, licensees and sublicensees to, keep complete and accurate books and records that disclose the total United States sales and Net Sales of Collaboration Products in the United States, the number of units of Collaboration Products sold in the United States, and all matters relating to those sales that are relevant for the purposes of determining the royalties due to Onyx hereunder. During the U.S. Royalty Term, Bayer shall, and shall cause its Affiliates to, (i) maintain such books and records in sufficient detail to calculate all amounts payable hereunder and to verify compliance with Bayer’s obligations under this letter, and (ii) retain such books and records until the later of (a) five (5) years after the end of the period to which such books and records pertain, and (b) the expiration of the applicable tax statute of limitation (or any extensions thereof), or for such longer period as may be required by applicable laws. |
e. | Other Royalty Terms. The Parties hereby acknowledge and agree that the terms of Sections 4.4 (Mode of Payment), 4.5 (Taxes), 4.6 (Interest on Late Payments), 4.7 (Audit), 4.8 (Audit Dispute) and 4.9 (Confidentiality) of the Agreement Regarding Regorafenib, dated as of October 11, 2011, by and between the Parties, are incorporated herein mutatis mutantis such that these provisions apply to sales of Collaboration Products in the United States during the U.S. Royalty Term and the royalties payable to Onyx under this Paragraph 3 in connection therewith. |
a. | Governance. Notwithstanding anything set forth in the Collaboration Agreement, from and after the Termination Date, the Parties shall only be required to constitute the Alliance Steering Committee (the “ASC”), the Executive Committee (the “EC”), the Joint Project Committee (the “JPC”) and any subcommittee as either the ASC or EC shall decide by unanimous written consent. For the avoidance of doubt, neither the ASC, EC or JPC shall have any responsibility with respect to, or the right to approve, U.S. marketing activities. |
b. | Global Development. Except as expressly set forth in this letter, nothing in this letter is intended to modify or otherwise alter the provisions of the Collaboration Agreement with respect to ongoing and / or future global clinical development of the Collaboration Compounds including provisions related to the sharing of costs and expenses and decision-making. Global clinical development projects refer to those development projects approved by the EC and managed globally even if such development projects may benefit the United States. For clarity, the Parties hereby acknowledge and agree that (i) the ongoing pediatric program is considered a global clinical development project for the purposes of this provision and (ii) the ongoing Phase 4 clinical studies in the United States are not considered global clinical development projects and Bayer shall be solely responsible for all costs and expenses relating thereto. |
c. | Separate Development Program. The Parties hereby acknowledge and agree that, effective as of the Termination Date, Sections 1.86, 1.87 and 12.5 of the Collaboration Agreement are hereby deleted in their entirety and shall no longer be of any force or effect. |
d. | Co-Promotion Right. The Parties acknowledge and agree that, effective as of the Termination Date, Sections 13.4, 13.5, 13.6, 13.7, 13.8, 13.9, 13.10 and 13.11 of the Collaboration Agreement are hereby deleted in their entirety and shall no longer be of any force or effect. |
e. | Notice. The addresses to which notices to Bayer pursuant to Section 28.7 of the Collaboration Agreement shall be addressed shall be: |
f. | Term and Termination. The Parties acknowledge and agree that Section 24.1(c) of the Collaboration Agreement is hereby deleted in its entirety and replaced with the following: “the last date on which any Party or its Affiliates, licensees or sublicensees markets or sells any Collaboration Product anywhere in the world.” |
1. | I have reviewed this Quarterly Report on Form 10-Q of Amgen Inc.; |
2. | Based on my knowledge, this quarterly report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this quarterly report; |
3. | Based on my knowledge, the financial statements, and other financial information included in this quarterly report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this quarterly report; |
4. | The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have: |
(a) | Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this quarterly report is being prepared; |
(b) | Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles; |
(c) | Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this quarterly report based on such evaluation; and |
(d) | Disclosed in this quarterly report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and |
5. | The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions): |
(a) | All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and |
(b) | Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting. |
Date: August 5, 2015 | /s/ ROBERT A. BRADWAY |
Robert A. Bradway | |
Chairman of the Board, | |
Chief Executive Officer and President |
1. | I have reviewed this Quarterly Report on Form 10-Q of Amgen Inc.; |
2. | Based on my knowledge, this quarterly report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this quarterly report; |
3. | Based on my knowledge, the financial statements, and other financial information included in this quarterly report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this quarterly report; |
4. | The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have: |
(a) | Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this quarterly report is being prepared; |
(b) | Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles; |
(c) | Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this quarterly report based on such evaluation; and |
(d) | Disclosed in this quarterly report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and |
5. | The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions): |
(a) | All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and |
(b) | Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting. |
Date: August 5, 2015 | /s/ DAVID W. MELINE |
David W. Meline | |
Executive Vice President and Chief Financial Officer |
(i) | the accompanying Quarterly Report on Form 10-Q of the Company for the period ended June 30, 2015 (the “Report”) fully complies with the requirements of Section 13(a) or Section 15(d), as applicable, of the Securities Exchange Act of 1934, as amended; and |
(ii) | information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company. |
Dated: August 5, 2015 | /s/ ROBERT A. BRADWAY |
Robert A. Bradway | |
Chairman of the Board, | |
Chief Executive Officer and President |
(i) | the accompanying Quarterly Report on Form 10-Q of the Company for the period ended June 30, 2015 (the “Report”) fully complies with the requirements of Section 13(a) or Section 15(d), as applicable, of the Securities Exchange Act of 1934, as amended; and |
(ii) | information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company. |
Dated: August 5, 2015 | /s/ DAVID W. MELINE |
David W. Meline | |
Executive Vice President and Chief Financial Officer |
Available-for-sale investments (Fair Values by Contractual Maturity) (Details) - USD ($) $ in Millions |
Jun. 30, 2015 |
Dec. 31, 2014 |
---|---|---|
Fair values of available-for-sale debt security investments by contractual maturity | ||
Maturing in one year or less | $ 4,701 | $ 4,936 |
Maturing after one year through three years | 8,712 | 6,829 |
Maturing after three years through five years | 8,900 | 7,840 |
Maturing after five years through ten years | 3,468 | 3,267 |
Maturing after ten years | 222 | 218 |
Mortgage- and asset-backed securities | 3,511 | 3,498 |
Total available-for-sale investments | 29,689 | 26,732 |
Total interest-bearing securities [Member] | ||
Fair values of available-for-sale debt security investments by contractual maturity | ||
Total available-for-sale investments | $ 29,514 | $ 26,588 |
Stockholders' equity (Share Repurchase Program) (Details) - USD ($) shares in Millions, $ in Millions |
3 Months Ended | 6 Months Ended | ||||
---|---|---|---|---|---|---|
Jun. 30, 2015 |
Mar. 31, 2015 |
Jun. 30, 2014 |
Mar. 31, 2014 |
Jun. 30, 2015 |
Jun. 30, 2014 |
|
Equity [Abstract] | ||||||
Stock repurchased, Shares | 3.3 | 2.9 | 0.0 | 0.0 | 6.2 | 0.0 |
Stock repurchased | $ 515 | $ 451 | $ 0 | $ 0 | $ 966 | $ 0 |
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