AMGN-2013.9.30-10Q
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 10-Q
(Mark One)
|
| |
þ | QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended September 30, 2013
OR
|
| |
¨ | TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
Commission file number 000-12477
Amgen Inc.
(Exact name of registrant as specified in its charter)
|
| | |
Delaware | | 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) |
(805) 447-1000
(Registrant’s telephone number, including area code)
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or Section 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes þ No ¨
Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files). Yes þ No ¨
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See the definitions of “large accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act. (Check one):
|
| | | |
Large accelerated filer þ | Accelerated filer ¨ | Non-accelerated filer ¨ (Do not check if a smaller reporting company) | Smaller reporting company ¨ |
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act) Yes ¨ No þ
As of October 22, 2013, the registrant had 754,126,197 shares of common stock, $0.0001 par value, outstanding.
AMGEN INC.
INDEX
|
| | |
| | Page No. |
| |
Item 1. | | |
| | |
| | |
| | |
| | |
| | |
Item 2. | | |
Item 3. | | |
Item 4. | | |
| |
Item 1. | | |
Item 1A. | | |
Item 5. | OTHER INFORMATION | |
Item 6. | | |
| |
| |
PART I — FINANCIAL INFORMATION
|
| |
Item 1. | FINANCIAL STATEMENTS |
AMGEN INC.
CONDENSED CONSOLIDATED STATEMENTS OF INCOME
(In millions, except per share data)
(Unaudited)
|
| | | | | | | | | | | | | | | |
| Three months ended | | Nine months ended |
| September 30, | | September 30, |
| 2013 | | 2012 | | 2013 | | 2012 |
Revenues: | | | | | | | |
Product sales | $ | 4,647 |
| | $ | 4,201 |
| | $ | 13,393 |
| | $ | 12,302 |
|
Other revenues | 101 |
| | 118 |
| | 272 |
| | 542 |
|
Total revenues | 4,748 |
| | 4,319 |
| | 13,665 |
| | 12,844 |
|
| | | | | | | |
Operating expenses: | | | | | | | |
Cost of sales | 788 |
| | 775 |
| | 2,317 |
| | 2,277 |
|
Research and development | 989 |
| | 880 |
| | 2,834 |
| | 2,442 |
|
Selling, general and administrative | 1,249 |
| | 1,131 |
| | 3,663 |
| | 3,441 |
|
Other | 34 |
| | 110 |
| | 171 |
| | 195 |
|
Total operating expenses | 3,060 |
| | 2,896 |
| | 8,985 |
| | 8,355 |
|
| | | | | | | |
Operating income | 1,688 |
| | 1,423 |
| | 4,680 |
| | 4,489 |
|
| | | | | | | |
Interest expense, net | 257 |
| | 271 |
| | 761 |
| | 762 |
|
Interest and other income, net | 72 |
| | 111 |
| | 332 |
| | 359 |
|
| | | | | | | |
Income before income taxes | 1,503 |
| | 1,263 |
| | 4,251 |
| | 4,086 |
|
| | | | | | | |
Provision for income taxes | 135 |
| | 156 |
| | 191 |
| | 529 |
|
| | | | | | | |
Net income | $ | 1,368 |
| | $ | 1,107 |
| | $ | 4,060 |
| | $ | 3,557 |
|
| | | | | | | |
Earnings per share: | | | | | | | |
Basic | $ | 1.81 |
| | $ | 1.44 |
| | $ | 5.40 |
| | $ | 4.57 |
|
Diluted | $ | 1.79 |
| | $ | 1.41 |
| | $ | 5.31 |
| | $ | 4.51 |
|
| | | | | | | |
Shares used in calculation of earnings per share: | | | | | | | |
Basic | 754 |
| | 771 |
| | 752 |
| | 779 |
|
Diluted | 766 |
| | 783 |
| | 764 |
| | 789 |
|
| | | | | | | |
Dividends paid per share | $ | 0.47 |
| | $ | 0.36 |
| | $ | 1.41 |
| | $ | 1.08 |
|
See accompanying notes.
AMGEN INC.
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME
(In millions)
(Unaudited)
|
| | | | | | | | | | | | | | | |
| Three months ended | | Nine months ended |
| September 30, | | September 30, |
| 2013 | | 2012 | | 2013 | | 2012 |
Net income | $ | 1,368 |
| | $ | 1,107 |
| | $ | 4,060 |
| | $ | 3,557 |
|
Other comprehensive income (loss), net of reclassification adjustments and taxes: | | | | | | | |
Foreign currency translation gains (losses) | 12 |
| | 22 |
| | (36 | ) | | (20 | ) |
Effective portion of cash flow hedges | (84 | ) | | (117 | ) | | 13 |
| | (92 | ) |
Net unrealized gains (losses) on available-for-sale securities | 48 |
| | 88 |
| | (219 | ) | | 85 |
|
Other | (2 | ) | | 3 |
| | (1 | ) | | 3 |
|
Other comprehensive loss, net of tax | (26 | ) | | (4 | ) | | (243 | ) | | (24 | ) |
Comprehensive income | $ | 1,342 |
| | $ | 1,103 |
| | $ | 3,817 |
| | $ | 3,533 |
|
See accompanying notes.
AMGEN INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(In millions, except per share data)
(Unaudited)
|
| | | | | | | |
| September 30, 2013 | | December 31, 2012 |
ASSETS |
Current assets: | | | |
Cash and cash equivalents | $ | 8,281 |
| | $ | 3,257 |
|
Marketable securities | 14,277 |
| | 20,804 |
|
Receivable from sale of investments | 560 |
| | — |
|
Trade receivables, net | 2,670 |
| | 2,518 |
|
Inventories | 2,838 |
| | 2,744 |
|
Other current assets | 2,049 |
| | 1,886 |
|
Total current assets | 30,675 |
| | 31,209 |
|
| | | |
Property, plant and equipment, net | 5,283 |
| | 5,326 |
|
Intangible assets, net | 3,682 |
| | 3,968 |
|
Goodwill | 12,572 |
| | 12,662 |
|
Restricted investments | 3,411 |
| | — |
|
Other assets | 1,450 |
| | 1,133 |
|
Total assets | $ | 57,073 |
| | $ | 54,298 |
|
| | | |
LIABILITIES AND STOCKHOLDERS’ EQUITY |
Current liabilities: | | | |
Accounts payable | $ | 895 |
| | $ | 905 |
|
Accrued liabilities | 3,937 |
| | 4,791 |
|
Current portion of long-term debt | 11 |
| | 2,495 |
|
Total current liabilities | 4,843 |
| | 8,191 |
|
| | | |
Long-term debt | 27,178 |
| | 24,034 |
|
Other noncurrent liabilities | 3,324 |
| | 3,013 |
|
| | | |
Contingencies and commitments |
| |
|
| | | |
Stockholders’ equity: | | | |
Common stock and additional paid-in capital; $0.0001 par value; 2,750.0 shares authorized; outstanding - 754.1 shares in 2013 and 756.3 shares in 2012 | 29,665 |
| | 29,337 |
|
Accumulated deficit | (7,840 | ) | | (10,423 | ) |
Accumulated other comprehensive (loss) income | (97 | ) | | 146 |
|
Total stockholders’ equity | 21,728 |
| | 19,060 |
|
Total liabilities and stockholders’ equity | $ | 57,073 |
| | $ | 54,298 |
|
See accompanying notes.
AMGEN INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(In millions)
(Unaudited)
|
| | | | | | | |
| Nine months ended |
| September 30, |
| 2013 | | 2012 |
Cash flows from operating activities: | | | |
Net income | $ | 4,060 |
| | $ | 3,557 |
|
Depreciation and amortization | 842 |
| | 815 |
|
Stock-based compensation expense | 304 |
| | 271 |
|
Other items, net | 119 |
| | (72 | ) |
Changes in operating assets and liabilities, net of acquisitions: | | | |
Trade receivables, net | (132 | ) | | 198 |
|
Inventories | (71 | ) | | (175 | ) |
Other assets | (174 | ) | | 213 |
|
Accounts payable | 6 |
| | 189 |
|
Accrued income taxes | (483 | ) | | (85 | ) |
Other liabilities | (15 | ) | | 159 |
|
Net cash provided by operating activities | 4,456 |
| | 5,070 |
|
Cash flows from investing activities: | | | |
Purchases of property, plant and equipment | (492 | ) | | (489 | ) |
Cash paid for acquisitions, net of cash acquired | — |
| | (1,990 | ) |
Purchases of marketable securities | (17,878 | ) | | (18,864 | ) |
Proceeds from sales of marketable securities | 15,743 |
| | 12,544 |
|
Proceeds from maturities of marketable securities | 4,846 |
| | 878 |
|
Restriction of investments | (526 | ) | | — |
|
Other | (44 | ) | | (38 | ) |
Net cash provided by (used in) investing activities | 1,649 |
| | (7,959 | ) |
Cash flows from financing activities: | | | |
Repayment of debt | (2,500 | ) | | (102 | ) |
Net proceeds from issuance of debt | 3,074 |
| | 4,933 |
|
Repurchases of common stock | (832 | ) | | (3,390 | ) |
Dividends paid | (1,061 | ) | | (844 | ) |
Net proceeds from issuance of common stock in connection with the Company’s equity award programs | 268 |
| | 1,129 |
|
Other | (30 | ) | | 40 |
|
Net cash (used in) provided by financing activities | (1,081 | ) | | 1,766 |
|
Increase (decrease) in cash and cash equivalents | 5,024 |
| | (1,123 | ) |
Cash and cash equivalents at beginning of period | 3,257 |
| | 6,946 |
|
Cash and cash equivalents at end of period | $ | 8,281 |
| | $ | 5,823 |
|
See accompanying notes.
AMGEN INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
September 30, 2013
(Unaudited)
1. Summary of significant accounting policies
Business
Amgen Inc. (including its subsidiaries, referred to as “Amgen,” “the Company,” “we,” “our” or “us”) is a global biotechnology pioneer that discovers, develops, manufactures and delivers innovative human therapeutics. We operate in one business segment: human therapeutics.
Basis of presentation
The financial information for the three and nine months ended September 30, 2013 and 2012, is unaudited but includes all adjustments (consisting of only normal recurring adjustments, unless otherwise indicated), which Amgen considers necessary for a fair presentation of its condensed consolidated results of operations for those periods. Interim results are not necessarily indicative of results for the full fiscal year.
Prior-period amounts for amortization of certain acquired intangible assets have been reclassified within Operating expenses in our Condensed Consolidated Statements of Income to conform to the current-period presentation.
The condensed consolidated financial statements should be read in conjunction with our consolidated financial statements and the notes thereto contained in our Annual Report on Form 10-K for the year ended December 31, 2012 and in our Quarterly Reports on Form 10-Q for the periods ended March 31, 2013, and June 30, 2013.
Principles of consolidation
The condensed consolidated financial statements include the accounts of Amgen as well as its majority-owned subsidiaries. We do not have any significant interests in any variable interest entities. All material intercompany transactions and balances have been eliminated in consolidation.
Use of estimates
The preparation of condensed consolidated financial statements in conformity with accounting principles generally accepted in the United States (GAAP) requires management to make estimates and assumptions that affect the amounts reported in the condensed consolidated financial statements and accompanying notes. Actual results may differ from those estimates.
Product sales for U.S. federal government stockpiles
Amgen recognizes revenue from the sales of product to the U.S. federal government for stockpile in accordance with Securities and Exchange Commission (SEC) Interpretation, Commission Guidance Regarding Accounting for Sales of Vaccines and Bioterror Countermeasures to the Federal Government for Placement into the Pediatric Vaccine Stockpile or the Strategic National Stockpile (SNS). We recognized $155 million of revenue for NEUPOGEN® (filgrastim) during the three months ended September 30, 2013, for purchases by the government for the SNS. We are contracted to manage this inventory of product until the government requests shipment.
Property, plant and equipment, net
Property, plant and equipment is recorded at historical cost, net of accumulated depreciation and amortization of $6.8 billion and $6.6 billion as of September 30, 2013, and December 31, 2012, respectively.
Restricted investments
We have restricted investments on our Condensed Consolidated Balance Sheet that are owned by ATL Holdings Limited (ATL Holdings), a wholly-owned subsidiary. ATL Holdings is an entity distinct from the Company and its other subsidiaries, with separate assets and liabilities. Because a third party owns Class A preferred shares of ATL Holdings, this entity is required to hold restricted cash or investments. See Note 7, Financing arrangements. On September 30, 2013, $2,881 million of marketable securities, $526 million of cash and cash equivalents and $4 million of related interest receivable were reclassified to Restricted investments on our Condensed Consolidated Balance Sheet.
Comprehensive income
In January 2013, we adopted a new accounting standard that requires additional disclosures regarding amounts that are reclassified out of accumulated other comprehensive income (AOCI). In accordance with the requirements of the standard, the effects of significant reclassifications out of AOCI, by component, on the respective lines in the Condensed Consolidated Statements of Income are presented in Note 8, Stockholders' equity. The standard was required to be applied prospectively beginning January 1, 2013.
Cost savings initiatives
Included in Other operating expenses for the three and nine months ended September 30, 2013, are charges for certain costs savings initiatives of $35 million and $46 million, respectively, compared with $36 million and $106 million for the corresponding periods of the prior year.
2. Business combinations
deCODE Genetics
On December 10, 2012, we acquired all of the outstanding stock of deCODE Genetics (deCODE), a privately held company that is a global leader in human genetics, for total consideration of $401 million in cash. The transaction, which was accounted for as a business combination, provides us with an opportunity to enhance our efforts to identify and validate human disease targets. deCODE's operations, which are not material, have been included in our consolidated financial statements commencing on the acquisition date.
We allocated the consideration to acquire deCODE to finite-lived intangible assets of $465 million comprised of discovery capacity in the genetics of human diseases with an estimated useful life of 10 years, $47 million to goodwill which is not deductible for tax purposes, deferred tax liabilities of $93 million and other net liabilities of $18 million. These amounts reflect adjustments recognized during the nine months ended September 30, 2013, to the acquisition date fair values of assets acquired and liabilities assumed in this acquisition which did not have a material effect on our current or prior period financial statements. These adjustments reduced goodwill by $46 million due primarily to a revision which increased the acquisition date fair value of finite-lived intangible assets by $64 million.
Our accounting for the acquisition is preliminary and will be finalized upon completion of our analysis to determine the acquisition date fair values of certain tax-related items and residual impact on goodwill.
3. Income taxes
The effective tax rates for the three and nine months ended September 30, 2013 were 9.0% and 4.5%, respectively, compared with 12.4% and 12.9% for the corresponding periods of the prior year. The effective rates are different from the federal statutory rates primarily as a result of indefinitely invested earnings of our foreign operations. We do not provide for U.S. income taxes on undistributed earnings of our foreign operations that are intended to be invested indefinitely outside of the United States. In addition, the effective tax rates were reduced by foreign tax credits associated with the Puerto Rico excise tax described below. The effective tax rate for the nine months ended September 30, 2013, was further reduced by two significant events that occurred during the three months ended March 31, 2013. First, we settled our examination with the Internal Revenue Service (IRS) for the years ended December 31, 2007, 2008 and 2009 in which we agreed to certain adjustments proposed by the IRS and remeasured our unrecognized tax benefits (UTBs) accordingly. Second, the American Taxpayer Relief Act of 2012, enacted during the first quarter of 2013, reinstated the federal research and development (R&D) tax credit for 2012 and 2013. Therefore, our effective tax rate for the nine months ended September 30, 2013, includes a benefit for the full-year 2012 R&D tax credit, recorded as a discrete item in the first quarter.
As of January 1, 2011, Puerto Rico began imposing a temporary excise tax on the purchase of goods and services from a related manufacturer in Puerto Rico. The excise tax is imposed on the gross intercompany purchase price of the goods and services and was initially effective for a six-year period beginning in 2011, with the excise tax rate declining in each year (from 4% in 2011 to 1% in 2016). During the three months ended March 31, 2013, the Puerto Rico government enacted an amendment to the excise tax legislation which increased the excise tax rate to a flat 4% effective July 1, 2013 through December 31, 2017. We account for the excise tax as a manufacturing cost that is capitalized in inventory and expensed in cost of sales when the related products are sold. For U.S. income tax purposes, the excise tax results in foreign tax credits that are generally recognized in our provision for income taxes when the excise tax is incurred. Excluding the impact of the Puerto Rico excise tax, our effective tax rates for the three and nine months ended September 30, 2013, would have been 13.8% and 9.8%, respectively, compared with 17.7% and 18.3% for the corresponding periods of the prior year.
Several of our legal entities file income tax returns in the U.S. federal jurisdiction, various U.S. state jurisdictions and certain foreign jurisdictions. Our income tax returns are routinely audited by the tax authorities in those jurisdictions. Significant
disputes may arise with these tax authorities involving issues of the timing and amount of deductions, the use of tax credits and allocations of income among various tax jurisdictions because of differing interpretations of tax laws and regulations. The U.S. federal income tax examinations for years ended on or before December 31, 2009, and the California state income tax examinations for years ended on or before December 31, 2005, have been completed.
During the three and nine months ended September 30, 2013, the gross amount of our UTBs increased by approximately $85 million and $240 million, respectively, as a result of tax positions taken during the current year. Also, our UTBs decreased by approximately $200 million in the nine months ended September 30, 2013, due to settlement of federal and state tax matters in the first and second quarter. The settlements resulted in recognition of net tax benefits of approximately $195 million for the nine months ended September 30, 2013 including interest, penalties and the federal benefit of state taxes. Substantially all of the UTBs as of September 30, 2013, if recognized, would affect our effective tax rate. As of September 30, 2013, we believe it is reasonably possible that our gross liabilities for UTBs may decrease by approximately $70 million within the succeeding 12 months due to the resolution of state audits.
4. Earnings per share
The computation of basic earnings per share (EPS) is based on the weighted-average number of our common shares outstanding. The computation of diluted EPS is based on the weighted-average number of our common shares outstanding and dilutive potential common shares, which include principally shares that may be issued under: our stock option, restricted stock and performance unit awards, determined using the treasury stock method; and our convertible notes and warrants while outstanding, as discussed below (collectively, “dilutive securities”). The convertible note hedges purchased in connection with the issuance of our convertible notes, which terminated in February 2013, are excluded from the calculation of diluted EPS because their impact is always anti-dilutive.
Prior to the conversion/maturity of our 0.375% 2013 Convertible Notes in February 2013 which were cash settled, the excess of the notes' conversion value, as defined, over their principal amount were considered dilutive potential common shares for purposes of calculating diluted EPS. Warrants sold concurrent with the issuance of our 0.375% 2013 Convertible Notes were cash settled in May 2013. While outstanding, the 0.375% 2013 Convertible Notes and warrants did not have a significant impact on the number of shares used for purposes of computing diluted EPS for any periods presented. See Note 7, Financing arrangements.
The computation for basic and diluted EPS was as follows (in millions, except per share data):
|
| | | | | | | | | | | | | | | |
| Three months ended | | Nine months ended |
| September 30, | | September 30, |
| 2013 | | 2012 | | 2013 | | 2012 |
Income (Numerator): | | | | | | | |
Net income for basic and diluted EPS | $ | 1,368 |
| | $ | 1,107 |
| | $ | 4,060 |
| | $ | 3,557 |
|
| | | | | | | |
Shares (Denominator): | | | | | | | |
Weighted-average shares for basic EPS | 754 |
| | 771 |
| | 752 |
| | 779 |
|
Effect of dilutive securities | 12 |
| | 12 |
| | 12 |
| | 10 |
|
Weighted-average shares for diluted EPS | 766 |
| | 783 |
| | 764 |
| | 789 |
|
| | | | | | | |
Basic EPS | $ | 1.81 |
| | $ | 1.44 |
| | $ | 5.40 |
| | $ | 4.57 |
|
Diluted EPS | $ | 1.79 |
| | $ | 1.41 |
| | $ | 5.31 |
| | $ | 4.51 |
|
For the three and nine months ended September 30, 2013, the number of anti-dilutive shares of our common stock excluded from the computation of diluted EPS were not material. For the three and nine months ended September 30, 2012, there were employee stock-based awards, calculated on a weighted-average basis, to acquire 1 million and 8 million shares of our common stock, respectively, that are not included in the computation of diluted EPS because their impact would have been anti-dilutive.
5. Available-for-sale investments
The amortized cost, gross unrealized gains, gross unrealized losses and estimated fair values of available-for-sale investments by type of security were as follows (in millions):
|
| | | | | | | | | | | | | | | | |
Type of security as of September 30, 2013 | | Amortized cost | | Gross unrealized gains | | Gross unrealized losses | | Estimated fair value |
U.S. Treasury securities | | $ | 6,172 |
| | $ | 5 |
| | $ | (4 | ) | | $ | 6,173 |
|
Other government-related debt securities: | | | | | | | | |
U.S. | | 1,130 |
| | — |
| | (8 | ) | | 1,122 |
|
Foreign and other | | 1,234 |
| | 12 |
| | (38 | ) | | 1,208 |
|
Corporate debt securities: | | | | | | | | |
Financial | | 3,455 |
| | 30 |
| | (25 | ) | | 3,460 |
|
Industrial | | 3,457 |
| | 29 |
| | (28 | ) | | 3,458 |
|
Other | | 335 |
| | 4 |
| | (2 | ) | | 337 |
|
Residential mortgage-backed securities | | 1,410 |
| | 3 |
| | (16 | ) | | 1,397 |
|
Other mortgage- and asset-backed securities | | 1,491 |
| | — |
| | (39 | ) | | 1,452 |
|
Money market mutual funds | | 6,907 |
| | — |
| | — |
| | 6,907 |
|
Total interest-bearing securities | | 25,591 |
| | 83 |
| | (160 | ) | | 25,514 |
|
Equity securities | | 72 |
| | 19 |
| | — |
| | 91 |
|
Total available-for-sale investments | | $ | 25,663 |
| | $ | 102 |
| | $ | (160 | ) | | $ | 25,605 |
|
|
| | | | | | | | | | | | | | | | |
Type of security as of December 31, 2012 | | Amortized cost | | Gross unrealized gains | | Gross unrealized losses | | Estimated fair value |
U.S. Treasury securities | | $ | 4,443 |
| | $ | 15 |
| | $ | — |
| | $ | 4,458 |
|
Other government-related debt securities: | | | | | | | | |
U.S. | | 1,018 |
| | 12 |
| | — |
| | 1,030 |
|
Foreign and other | | 1,549 |
| | 60 |
| | (1 | ) | | 1,608 |
|
Corporate debt securities: | | | | | | | | |
Financial | | 3,266 |
| | 96 |
| | (1 | ) | | 3,361 |
|
Industrial | | 4,283 |
| | 100 |
| | (3 | ) | | 4,380 |
|
Other | | 441 |
| | 11 |
| | — |
| | 452 |
|
Residential mortgage-backed securities | | 1,828 |
| | 9 |
| | (8 | ) | | 1,829 |
|
Other mortgage- and asset-backed securities | | 1,769 |
| | 7 |
| | (9 | ) | | 1,767 |
|
Money market mutual funds | | 2,620 |
| | — |
| | — |
| | 2,620 |
|
Other short-term interest-bearing securities | | 2,186 |
| | — |
| | — |
| | 2,186 |
|
Total interest-bearing securities | | 23,403 |
| | 310 |
| | (22 | ) | | 23,691 |
|
Equity securities | | 52 |
| | 2 |
| | — |
| | 54 |
|
Total available-for-sale investments | | $ | 23,455 |
| | $ | 312 |
| | $ | (22 | ) | | $ | 23,745 |
|
The fair values of available-for-sale investments by classification in the Condensed Consolidated Balance Sheets were as follows (in millions):
|
| | | | | | | | |
Classification in the Condensed Consolidated Balance Sheets | | September 30, 2013 | | December 31, 2012 |
Cash and cash equivalents | | $ | 7,830 |
| | $ | 2,887 |
|
Marketable securities | | 14,277 |
| | 20,804 |
|
Other assets — noncurrent | | 91 |
| | 54 |
|
Restricted investments | | 3,407 |
| | — |
|
Total available-for-sale investments | | $ | 25,605 |
| | $ | 23,745 |
|
Cash and cash equivalents in the table above excludes cash of $451 million and $370 million as of September 30, 2013, and December 31, 2012, respectively. Restricted investments in the table above excludes $4 million of interest receivable related to ATL Holdings as of September 30, 2013.
The fair values of available-for-sale interest-bearing security investments by contractual maturity, except for mortgage- and asset- backed securities that do not have a single maturity date, were as follows (in millions):
|
| | | | | | | | |
Contractual maturity | | September 30, 2013 | | December 31, 2012 |
Maturing in one year or less | | $ | 10,820 |
| | $ | 7,175 |
|
Maturing after one year through three years | | 4,671 |
| | 5,014 |
|
Maturing after three years through five years | | 5,742 |
| | 6,286 |
|
Maturing after five years through ten years | | 1,432 |
| | 1,620 |
|
Mortgage- and asset-backed securities | | 2,849 |
| | 3,596 |
|
Total interest-bearing securities | | $ | 25,514 |
| | $ | 23,691 |
|
For the three months ended September 30, 2013 and 2012, realized gains totaled $24 million and $31 million, respectively, and realized losses totaled $26 million and $11 million, respectively. For the nine months ended September 30, 2013 and 2012, realized gains totaled $142 million and $147 million, respectively, and realized losses totaled $70 million and $41 million, respectively. The cost of securities sold is based on the specific identification method. Substantially all of our available-for-sale investments that were in an unrealized loss position, which totaled $160 million as of September 30, 2013, have been in a continuous unrealized loss position for less than 12 months. These investments had an aggregate fair value of $8.5 billion as of September 30, 2013.
The primary objective of our investment portfolio is to enhance overall returns in an efficient manner while maintaining safety of principal, prudent levels of liquidity and acceptable levels of risk. Our investment policy limits interest-bearing security investments to certain types of debt and money market instruments issued by institutions with primarily investment grade credit ratings and places restrictions on maturities and concentration by asset class and issuer.
We review our available-for-sale investments for other-than-temporary declines in fair value below our cost basis each quarter and whenever events or changes in circumstances indicate that the cost basis of an asset may not be recoverable. This evaluation is based on a number of factors, including the length of time and the extent to which the fair value has been below our cost basis and adverse conditions related specifically to the security, including any changes to the credit rating of the security. As of September 30, 2013, and December 31, 2012, we believe the cost bases for our available-for-sale investments were recoverable in all material respects.
6. Inventories
Inventories consisted of the following (in millions):
|
| | | | | | | |
| September 30, 2013 | | December 31, 2012 |
Raw materials | $ | 218 |
| | $ | 192 |
|
Work in process | 1,807 |
| | 1,723 |
|
Finished goods | 813 |
| | 829 |
|
Total inventories | $ | 2,838 |
| | $ | 2,744 |
|
7. Financing arrangements
The carrying values and the fixed contractual coupon rates of our long-term borrowings were as follows (in millions):
|
| | | | | | | |
| September 30, 2013 | | December 31, 2012 |
0.375% convertible notes due 2013 (0.375% 2013 Convertible Notes) | $ | — |
| | $ | 2,488 |
|
1.875% notes due 2014 (1.875% 2014 Notes) | 1,000 |
| | 1,000 |
|
4.85% notes due 2014 (4.85% 2014 Notes) | 1,000 |
| | 1,000 |
|
2.30% notes due 2016 (2.30% 2016 Notes) | 749 |
| | 749 |
|
2.50% notes due 2016 (2.50% 2016 Notes) | 999 |
| | 999 |
|
2.125% notes due 2017 (2.125% 2017 Notes) | 1,248 |
| | 1,248 |
|
5.85% notes due 2017 (5.85% 2017 Notes) | 1,099 |
| | 1,099 |
|
6.15% notes due 2018 (6.15% 2018 Notes) | 500 |
| | 499 |
|
Master Repurchase Agreement obligation due 2018 | 3,100 |
| | — |
|
4.375% euro-denominated notes due 2018 (4.375% 2018 euro Notes) | 741 |
| | 723 |
|
5.70% notes due 2019 (5.70% 2019 Notes) | 999 |
| | 999 |
|
2.125% euro-denominated notes due 2019 (2.125% 2019 euro Notes) | 910 |
| | 887 |
|
4.50% notes due 2020 (4.50% 2020 Notes) | 300 |
| | 300 |
|
3.45% notes due 2020 (3.45% 2020 Notes) | 898 |
| | 897 |
|
4.10% notes due 2021 (4.10% 2021 Notes) | 998 |
| | 998 |
|
3.875% notes due 2021 (3.875% 2021 Notes) | 1,746 |
| | 1,745 |
|
3.625% notes due 2022 (3.625% 2022 Notes) | 747 |
| | 747 |
|
5.50% pound-sterling-denominated notes due 2026 (5.50% 2026 pound sterling Notes) | 763 |
| | 763 |
|
4.00% pound-sterling-denominated notes due 2029 (4.00% 2029 pound sterling Notes) | 1,118 |
| | 1,117 |
|
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 |
| | 595 |
|
5.15% notes due 2041 (5.15% 2041 Notes) | 2,232 |
| | 2,232 |
|
5.65% notes due 2042 (5.65% 2042 Notes) | 1,244 |
| | 1,244 |
|
5.375% notes due 2043 (5.375% 2043 Notes) | 1,000 |
| | 1,000 |
|
Other notes | 111 |
| | 109 |
|
Total debt | 27,189 |
| | 26,529 |
|
Less current portion | (11 | ) | | (2,495 | ) |
Total noncurrent debt | $ | 27,178 |
| | $ | 24,034 |
|
In connection with the acquisition of Onyx Pharmaceuticals, Inc. (Onyx), we entered into a Master Repurchase Agreement and a Term Loan Credit Facility described below. See Note 12, Subsequent event.
Master Repurchase Agreement
We entered into a Master Repurchase Agreement (Repurchase Agreement) pursuant to which Amgen sold 34,097 Class A preferred shares of one of its wholly-owned subsidiaries, ATL Holdings, to the counterparty on September 30, 2013. The Class A preferred shares have a liquidation preference of $100,000 per share. Pursuant to the Repurchase Agreement, we are obligated to repurchase the Class A preferred shares from the counterparty for the aggregate sale price of $3.1 billion, plus any accrued and unpaid payment obligations described below, on September 28, 2018. The $3.1 billion obligation to repurchase the preferred shares is accounted for as long-term debt on our Condensed Consolidated Balance Sheet. Debt issuance costs of $26 million incurred with respect to this transaction will be amortized over the life of the Repurchase Agreement.
Under the Repurchase Agreement, we are obligated to make payments to the counterparty based on the sale price of the outstanding preferred shares at a floating interest rate based on the London Interbank Offered Rate (LIBOR) plus 1.1%. The Repurchase Agreement contains customary events of default, and we have the right to repurchase all or a portion of the Class A preferred shares at any time prior to September 28, 2018, the required repurchase date for the Class A preferred shares.
Term Loan Credit Facility
On October 1, 2013, we borrowed $5.0 billion under a Term Loan Credit Facility which bears interest at a floating rate based on LIBOR plus additional interest, initially 1%, which can vary based on the credit ratings assigned to our long-term debt by Standard & Poor’s Financial Services LLC (S&P) and Moody’s Investor Service, Inc. (Moody’s). A portion of the principal amount of this debt is to be repaid at the end of each quarter equal to 2.5% of the original amount of the loan, or $125 million, with the balance due on October 1, 2018. The outstanding balance of this loan may be prepaid in whole or in part at any time without penalty. This credit facility includes the same financial covenant as our revolving credit facility with respect to our level of borrowings in relation to our equity, as defined.
Convertible notes
In February 2013, our 0.375% 2013 Convertible Notes matured/converted, and accordingly, the $2.5 billion principal amount was settled in cash. We also elected to pay the note holders who converted their notes $99 million of cash for the conversion value that exceeded the principal amount of the notes, as allowed under the original terms of the notes. As a result of this conversion, we received $99 million of cash from the counterparty to the related convertible note hedge to offset the corresponding payment to the convertible note holders. In addition, on May 1, 2013, warrants to acquire 32 million shares of our common stock at an exercise price of $104.80 originally sold in connection with the issuance of the 0.375% 2013 Convertible Notes were exercised, resulting in a net cash payment of $100 million.
8. Stockholders’ equity
Stock repurchase program
Activity under our stock repurchase program was as follows (in millions):
|
| | | | | | | | | | | | | |
| 2013 | | 2012 |
| Shares | | Dollars | | Shares | | Dollars |
First quarter | 9.1 |
| | $ | 771 |
| | 21.0 |
| | $ | 1,429 |
|
Second quarter | — |
| | — |
| | 17.4 |
| | 1,203 |
|
Third quarter | — |
| | — |
| | 9.7 |
| | 797 |
|
Total stock repurchases | 9.1 |
| | $ | 771 |
| | 48.1 |
| | $ | 3,429 |
|
As of September 30, 2013, $1.6 billion remained available under our Board of Directors-approved stock repurchase program.
Dividends
On December 13, 2012, the Board of Directors declared a quarterly cash dividend of $0.47 per share of common stock, which was paid on March 7, 2013. On March 6, 2013, the Board of Directors declared a quarterly cash dividend of $0.47 per share of common stock, which was paid on June 7, 2013. On July 26, 2013, the Board of Directors declared a quarterly cash dividend of $0.47 per share of common stock, which was paid on September 6, 2013. On October 16, 2013, the Board of Directors declared a quarterly cash dividend of $0.47 per share of common stock, which will be paid on December 6, 2013 to all stockholders of record as of the close of business on November 14, 2013.
Accumulated other comprehensive income
The components of AOCI were as follows (in millions):
|
| | | | | | | | | | | | | | | | | | | |
| Foreign currency translation | | Cash flow hedges | | Available-for-sale securities | | Other | | AOCI |
Balance as of December 31, 2012 | $ | 12 |
| | $ | (35 | ) | | $ | 183 |
| | $ | (14 | ) | | $ | 146 |
|
Foreign currency translation adjustments | (36 | ) | | — |
| | — |
| | — |
| | (36 | ) |
Unrealized gains (losses) | — |
| | (25 | ) | | (32 | ) | | 1 |
| | (56 | ) |
Reclassification adjustments to income | — |
| | 144 |
| | (67 | ) | | — |
| | 77 |
|
Income taxes | 13 |
| | (44 | ) | | 37 |
| | — |
| | 6 |
|
Balance as of March 31, 2013 | (11 | ) | | 40 |
| | 121 |
| | (13 | ) | | 137 |
|
Foreign currency translation adjustments | (39 | ) | | — |
| | — |
| | — |
| | (39 | ) |
Unrealized gains (losses) | — |
| | 53 |
| | (318 | ) | | — |
| | (265 | ) |
Reclassification adjustments to income | — |
| | (18 | ) | | (7 | ) | | — |
| | (25 | ) |
Income taxes | 14 |
| | (13 | ) | | 120 |
| | — |
| | 121 |
|
Balance as of June 30, 2013 | (36 | ) | | 62 |
| | (84 | ) | | (13 | ) | | (71 | ) |
Foreign currency translation adjustments | 18 |
| | — |
| | — |
| | — |
| | 18 |
|
Unrealized gains (losses) | — |
| | 26 |
| | 74 |
| | (2 | ) | | 98 |
|
Reclassification adjustments to income | — |
| | (159 | ) | | 2 |
| | — |
| | (157 | ) |
Income taxes | (6 | ) | | 49 |
| | (28 | ) | | — |
| | 15 |
|
Balance as of September 30, 2013 | $ | (24 | ) | | $ | (22 | ) | | $ | (36 | ) | | $ | (15 | ) | | $ | (97 | ) |
The reclassifications out of AOCI to Net income were as follows (in millions):
|
| | | | | | | | | | |
| | Amounts reclassified out of AOCI | | |
| | Three months ended | | Nine months ended | | |
Components of AOCI | | September 30, 2013 | | September 30, 2013 | | Line item affected in the Statements of Income |
Cash flow hedges: | | | | | | |
Foreign currency contract gains | | $ | 6 |
| | $ | 9 |
| | Product sales |
Cross-currency swap contract gains | | 153 |
| | 25 |
| | Interest and other income, net |
Forward interest rate contract losses | | — |
| | (1 | ) | | Interest expense, net |
| | 159 |
| | 33 |
| | Total before income tax |
| | (59 | ) | | (13 | ) | | Tax (expense)/benefit |
| | $ | 100 |
| | $ | 20 |
| | Net of taxes |
Available-for-sale securities: | | | |
| |
|
Net realized gains (losses) | | $ | (2 | ) | | $ | 72 |
| | Interest and other income, net |
| | 1 |
| | (27 | ) | | Tax (expense)/benefit |
| | $ | (1 | ) | | $ | 45 |
| | Net of taxes |
9. Fair value measurement
To estimate the fair value of our financial assets and liabilities we use valuation approaches within a hierarchy that maximizes the use of observable inputs and minimizes the use of unobservable inputs by requiring that observable inputs be used when available. Observable inputs are inputs that market participants would use in pricing the asset or liability based on market data obtained from sources independent of the Company. Unobservable inputs are inputs that reflect the Company’s assumptions about the inputs that market participants would use in pricing the asset or liability and are developed based on the best information available in the circumstances. The fair value hierarchy is divided into three levels based on the source of inputs as follows:
|
| | |
Level 1 | — | Valuations based on unadjusted quoted prices in active markets for identical assets or liabilities that the Company has the ability to access |
Level 2 | — | Valuations for which all significant inputs are observable, either directly or indirectly, other than level 1 inputs |
Level 3 | — | Valuations based on inputs that are unobservable and significant to the overall fair value measurement |
The availability of observable inputs can vary among the various types of financial assets and liabilities. To the extent that the valuation is based on models or inputs that are less observable or unobservable in the market, the determination of fair value requires more judgment. In certain cases, the inputs used for measuring fair value may fall into different levels of the fair value hierarchy. In such cases, for financial statement disclosure purposes, the level in the fair value hierarchy within which the fair value measurement is categorized is based on the lowest level of input used that is significant to the overall fair value measurement.
The fair value of each major class of the Company’s financial assets and liabilities measured at fair value on a recurring basis was as follows (in millions):
|
| | | | | | | | | | | | | | | | |
| | 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 September 30, 2013, using: | | | | | Total |
Assets: | | | | | | | | |
Available-for-sale investments: | | | | | | | | |
U.S. Treasury securities | | $ | 6,173 |
| | $ | — |
| | $ | — |
| | $ | 6,173 |
|
Other government-related debt securities: | | | | | | | | |
U.S. | | — |
| | 1,122 |
| | — |
| | 1,122 |
|
Foreign and other | | — |
| | 1,208 |
| | — |
| | 1,208 |
|
Corporate debt securities: | | | | | | | | |
Financial | | — |
| | 3,460 |
| | — |
| | 3,460 |
|
Industrial | | — |
| | 3,458 |
| | — |
| | 3,458 |
|
Other | | — |
| | 337 |
| | — |
| | 337 |
|
Residential mortgage-backed securities | | — |
| | 1,397 |
| | — |
| | 1,397 |
|
Other mortgage- and asset-backed securities | | — |
| | 1,452 |
| | — |
| | 1,452 |
|
Money market mutual funds | | 6,907 |
| | — |
| | — |
| | 6,907 |
|
Equity securities | | 91 |
| | — |
| | — |
| | 91 |
|
Derivatives: | | | | | | | | |
Foreign currency contracts | | — |
| | 36 |
| | — |
| | 36 |
|
Cross-currency swap contracts | | — |
| | 133 |
| | — |
| | 133 |
|
Interest rate swap contracts | | — |
| | 13 |
| | — |
| | 13 |
|
Total assets | | $ | 13,171 |
| | $ | 12,616 |
| | $ | — |
| | $ | 25,787 |
|
| | | | | | | | |
Liabilities: | | | | | | | | |
Derivatives: | | | | | | | | |
Foreign currency contracts | | $ | — |
| | $ | 71 |
| | $ | — |
| | $ | 71 |
|
Cross-currency swap contracts | | — |
| | 7 |
| | — |
| | 7 |
|
Interest rate swap contracts |
| — |
|
| 97 |
|
| — |
|
| 97 |
|
Contingent consideration obligations in connection with a business combination | | — |
| | — |
| | 332 |
| | 332 |
|
Total liabilities | | $ | — |
| | $ | 175 |
| | $ | 332 |
| | $ | 507 |
|
|
| | | | | | | | | | | | | | | | |
| | 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, 2012, using: | | | | | Total |
Assets: | | | | | | | | |
Available-for-sale investments: | | | | | | | | |
U.S. Treasury securities | | $ | 4,458 |
| | $ | — |
| | $ | — |
| | $ | 4,458 |
|
Other government-related debt securities: | | | | | | | | |
U.S. | | — |
| | 1,030 |
| | — |
| | 1,030 |
|
Foreign and other | | — |
| | 1,608 |
| | — |
| | 1,608 |
|
Corporate debt securities: | | | | | | | | |
Financial | | — |
| | 3,361 |
| | — |
| | 3,361 |
|
Industrial | | — |
| | 4,380 |
| | — |
| | 4,380 |
|
Other | | — |
| | 452 |
| | — |
| | 452 |
|
Residential mortgage-backed securities | | — |
| | 1,829 |
| | — |
| | 1,829 |
|
Other mortgage- and asset-backed securities | | — |
| | 1,767 |
| | — |
| | 1,767 |
|
Money market mutual funds | | 2,620 |
| | — |
| | — |
| | 2,620 |
|
Other short-term interest-bearing securities | | — |
| | 2,186 |
| | — |
| | 2,186 |
|
Equity securities | | 54 |
| | — |
| | — |
| | 54 |
|
Derivatives: | | | | | | | | |
Foreign currency contracts | | — |
| | 46 |
| | — |
| | 46 |
|
Cross-currency swap contracts | | — |
| | 65 |
| | — |
| | 65 |
|
Total assets | | $ | 7,132 |
| | $ | 16,724 |
| | $ | — |
| | $ | 23,856 |
|
| | | | | | | | |
Liabilities: | | | | | | | | |
Derivatives: | | | | | | | | |
Foreign currency contracts | | $ | — |
| | $ | 59 |
| | $ | — |
| | $ | 59 |
|
Cross-currency swap contracts | | — |
| | 6 |
| | — |
| | 6 |
|
Contingent consideration obligations in connection with a business combination | | — |
| | — |
| | 221 |
| | 221 |
|
Total liabilities | | $ | — |
| | $ | 65 |
| | $ | 221 |
| | $ | 286 |
|
The fair values of our U.S. Treasury securities, money market mutual funds and equity securities are based on quoted market prices in active markets with no valuation adjustment.
Most of our other government-related and corporate debt securities are investment grade with maturity dates of five years or less from the balance sheet date. Our other government-related debt securities portfolio is composed of securities with weighted-average credit ratings of A+ by S&P, AA- or equivalent by Moody's or Fitch, Inc. (Fitch); and our corporate debt securities portfolio has a weighted-average credit rating of A- or equivalent by S&P, BBB+ by Moody's or Fitch. We estimate the fair values of these securities by taking into consideration valuations obtained from third-party pricing services. The pricing services utilize industry standard valuation models, including both income- and market-based approaches, for which all significant inputs are observable, either directly or indirectly, to estimate fair value. These inputs include reported trades of and broker/dealer quotes on the same or similar securities; issuer credit spreads; benchmark securities; and other observable inputs.
Our residential mortgage-, other mortgage- and asset-backed securities portfolio is composed entirely of senior tranches, with credit ratings of AAA by S&P, Moody's or Fitch. We estimate the fair values of these securities by taking into consideration valuations obtained from third-party pricing services. The pricing services utilize industry standard valuation models, including both income- and market-based approaches, for which all significant inputs are observable, either directly or indirectly, to estimate fair value. These inputs include reported trades of and broker/dealer quotes on the same or similar securities; issuer credit spreads; benchmark securities; prepayment/default projections based on historical data; and other observable inputs.
We value our other short-term interest-bearing securities at amortized cost, which approximates fair value given their near term maturity dates.
All of our foreign currency forward and option derivatives contracts have maturities of three years or less and all are with counterparties that have minimum credit ratings of A- or equivalent by S&P, Moody’s or Fitch. We estimated the fair values of these contracts by taking into consideration valuations obtained from a third-party valuation service that utilizes an income-based
industry standard valuation model for which all significant inputs are observable, either directly or indirectly. These inputs include foreign currency rates, LIBOR cash and swap rates and obligor credit default swap rates. In addition, inputs for our foreign currency option contracts also include implied volatility measures. These inputs, where applicable, are at commonly quoted intervals. See Note 10, Derivative instruments.
Our cross-currency swap contracts are with counterparties that have minimum credit ratings of A- or equivalent by S&P, Moody’s or Fitch. We estimated the fair values of these contracts by taking into consideration valuations obtained from a third-party valuation service that utilizes an income-based industry standard valuation model for which all significant inputs are observable either directly or indirectly. These inputs include foreign currency exchange rates, LIBOR, swap rates, obligor credit default swap rates and cross-currency basis swap spreads. See Note 10, Derivative instruments.
Our interest rate swap contracts are with counterparties that have minimum credit ratings of A- or equivalent by S&P, Moody’s or Fitch. We estimated the fair values of these contracts by using an income-based industry standard valuation model for which all significant inputs were observable either directly or indirectly. These inputs included LIBOR, swap rates and obligor credit default swap rates. See Note 10, Derivative instruments.
As a result of our acquisition of BioVex Group, Inc. in March 2011, we are obligated to pay its former shareholders up to $575 million of additional consideration contingent upon achieving up to eight separate regulatory and sales-related milestones with regard to talimogene laherparepvec, which was acquired in the acquisition and is currently in phase 3 clinical development for the treatment of melanoma. The three largest of these potential payments are $125 million each, including the amount due if a Biologics License Application (BLA) is filed with the U.S. Food and Drug Administration (FDA). Potential payments are also due upon the first commercial sale in each of the United States and the European Union (EU) following receipt of marketing approval which includes use of the product in specified patient populations and upon achievement of specified levels of sales within specified periods of time.
These contingent consideration obligations are recorded at their estimated fair values with any changes in fair value recognized in earnings. The fair value measurements of these obligations are based on significant unobservable inputs, including the estimated probabilities and timing of achieving the related regulatory and commercial events in connection with these milestones and, as applicable, estimated annual sales. Significant changes (increases or decreases) in these inputs would result in corresponding changes in the fair values of the contingent consideration obligations.
We revalue these contingent consideration obligations each reporting period until the related contingencies are resolved. We estimate the fair values of these obligations by using a combination of probability-adjusted discounted cash flows, option pricing techniques and a simulation model of expected annual sales. Quarterly, management in our R&D and commercial sales organizations review key assumptions used in the fair value measurements of these obligations. In the absence of any significant changes in key assumptions, the changes in fair values of these contingent consideration obligations reflect the passage of time and changes in our credit risk adjusted rate used to discount obligations to present value. During the three months ended June 30, 2013, there were increases in management's estimates of the probabilities of completing the BLA filing and receiving approval to market talimogene laherparepvec in specified patient populations in the United States and EU. Due primarily to these changes in key assumptions, the estimated aggregate fair value of the contingent consideration obligations increased $111 million during the nine months ended September 30, 2013. There was no change in the estimated aggregate fair value of the contingent consideration obligations during the three months ended September 30, 2013. During the three and nine months ended September 30, 2012, the estimated aggregate fair value of the contingent consideration obligations increased $2 million and $5 million, respectively. Changes in contingent consideration obligations were recorded in Other operating expenses in the Condensed Consolidated Statements of Income.
There have been no transfers of assets or liabilities between the fair value measurement levels, and there were no material remeasurements to fair value during the nine months ended September 30, 2013 and 2012, of assets and liabilities that are not measured at fair value on a recurring basis.
Summary of the fair value of other financial instruments
Cash equivalents
The estimated fair values of cash equivalents approximate their carrying values due to the short-term nature of these financial instruments.
Borrowings
We estimated the fair values of our long-term notes (Level 2) by taking into consideration indicative prices obtained from a third-party financial institution that utilizes industry standard valuation models, including both income- and market-based approaches, for which all significant inputs are observable either directly or indirectly. These inputs include reported trades of and
broker/dealer quotes on the same or similar securities; credit spreads; benchmark yields; foreign currency exchange rates, as applicable; and other observable inputs. As of September 30, 2013, and December 31, 2012, the aggregate fair values of our long-term debt were $28.3 billion and $29.9 billion, respectively, and the carrying values were $27.2 billion and $26.5 billion, respectively.
10. Derivative instruments
The Company is exposed to foreign currency exchange rate and interest rate risks related to its business operations. To reduce our risks related to these exposures, we utilize or have utilized certain derivative instruments, including foreign currency forward, foreign currency option, cross-currency swap, forward interest rate and interest rate swap contracts. We do not use derivatives for speculative trading purposes.
Cash flow hedges
We are exposed to possible changes in the values of certain anticipated foreign currency cash flows resulting from changes in foreign currency exchange rates, associated primarily with our euro-denominated international product sales. Increases and decreases in the cash flows associated with our international product sales due to movements in foreign currency exchange rates are offset partially by the corresponding increases and decreases in our international operating expenses resulting from these foreign currency exchange rate movements. To further reduce our exposure to foreign currency exchange rate fluctuations on our international product sales, we enter into foreign currency forward and option contracts to hedge a portion of our projected international product sales primarily over a three-year time horizon, with, at any given point in time, a higher percentage of nearer-term projected product sales being hedged than in successive periods. As of September 30, 2013, and December 31, 2012, we had open foreign currency forward contracts with notional amounts of $3.8 billion and $3.7 billion, respectively, and open foreign currency option contracts with notional amounts of $210 million and $200 million, respectively. These foreign currency forward and option contracts, primarily euro based, have been designated as cash flow hedges, and accordingly, the effective portions of the unrealized gains and losses on these contracts are reported in AOCI in the Condensed Consolidated Balance Sheets and reclassified to earnings in the same periods during which the hedged transactions affect earnings.
To hedge our exposure to foreign currency exchange rate risk associated with certain of our long-term notes denominated in foreign currencies, we entered into cross-currency swap contracts. Under the terms of these contracts, we paid euros/pounds sterling and received U.S. dollars for the notional amounts at the inception of the contracts, and we exchange interest payments based on these notional amounts at fixed rates over the lives of the contracts in which we pay U.S. dollars and receive euros/pounds sterling. In addition, we will pay U.S. dollars to and receive euros/pounds sterling from the counterparties at the maturities of the contracts for these same notional amounts. The terms of these contracts correspond to the related hedged notes, effectively converting the interest payments and principal repayment on these notes from euros/pounds sterling to U.S. dollars. These cross-currency swap contracts have been designated as cash flow hedges, and accordingly, the effective portions of the unrealized gains and losses on these contracts are reported in AOCI and reclassified to earnings in the same periods during which the hedged debt affects earnings. The notional amounts and interest rates of our cross-currency swaps are as follows (notional amounts in millions):
|
| | | | | | | | | | | | | | |
| | 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 | % | | $ | 748 |
| | 5.8 | % |
4.00% 2029 pound sterling Notes | | £ | 700 |
| | 4.00 | % | | $ | 1,122 |
| | 4.3 | % |
In connection with the anticipated issuance of long-term fixed-rate debt, we occasionally enter into forward interest rate contracts in order to hedge the variability in cash flows due to changes in the applicable Treasury rate between the time we enter into these contracts and the time the related debt is issued. Gains and losses on such contracts, which are designated as cash flow hedges, are reported in AOCI and amortized into earnings over the lives of the associated debt issuances.
The effective portion of the unrealized gain/(loss) recognized in other comprehensive income for our derivative instruments designated as cash flow hedges was as follows (in millions):
|
| | | | | | | | | | | | | | | | |
| | Three months ended | | Nine months ended |
| | September 30, | | September 30, |
Derivatives in cash flow hedging relationships | | 2013 | | 2012 | | 2013 | | 2012 |
Foreign currency contracts | | $ | (137 | ) | | $ | (127 | ) | | $ | (16 | ) | | $ | (25 | ) |
Cross-currency swap contracts | | 163 |
| | 38 |
| | 70 |
| | 11 |
|
Forward interest rate contracts | | — |
| | — |
| | — |
| | (7 | ) |
Total | | $ | 26 |
| | $ | (89 | ) | | $ | 54 |
| | $ | (21 | ) |
The location in the Condensed Consolidated Statements of Income and the effective portion of the gain/(loss) reclassified out of AOCI into earnings for our derivative instruments designated as cash flow hedges were as follows (in millions):
|
| | | | | | | | | | | | | | | | | | |
| | | | Three months ended | | Nine months ended |
| | | | September 30, | | September 30, |
Derivatives in cash flow hedging relationships | | Statements of Income location | | 2013 | | 2012 | | 2013 | | 2012 |
Foreign currency contracts | | Product sales | | $ | 6 |
| | $ | 38 |
| | $ | 9 |
| | $ | 67 |
|
Cross-currency swap contracts | | Interest and other income, net | | 153 |
| | 58 |
| | 25 |
| | 54 |
|
Forward interest rate contracts | | Interest expense, net | | — |
| | — |
| | (1 | ) | | (1 | ) |
Total | | | | $ | 159 |
| | $ | 96 |
| | $ | 33 |
| | $ | 120 |
|
No portions of our cash flow hedge contracts are excluded from the assessment of hedge effectiveness, and the gains and losses on the ineffective portions of these hedging instruments were not material for the three and nine months ended September 30, 2013 and 2012. As of September 30, 2013, the amounts expected to be reclassified out of AOCI into earnings over the next 12 months are approximately $20 million of net losses on our foreign currency and cross-currency swap contracts and approximately $1 million of losses on forward interest rate contracts.
Fair value hedges
To achieve a desired mix of fixed and floating interest rates on our long-term debt, we entered into interest rate swap contracts, which qualified and were designated as fair value hedges. The terms of these interest rate swap contracts corresponded to the related hedged debt instruments and effectively converted a fixed interest rate coupon to a floating LIBOR-based coupon over the lives of the respective notes. Due to historically low interest rates, during the three months ended June 30, 2012, we terminated our interest rate swap contracts with an aggregate notional amount of $3.6 billion with respect to our 4.85% 2014 Notes, 5.85% 2017 Notes, 6.15% 2018 Notes and 5.70% 2019 Notes with rates that ranged from LIBOR plus 0.3% to LIBOR plus 2.6%.
During the three months ended March 31, 2013, we entered into interest rate swap contracts with an aggregate notional amount of $2.5 billion with respect to our 3.875% 2021 Notes and our 3.625% 2022 Notes. During the three months ended June 30, 2013, we entered into interest rate swap contracts with an aggregate notional amount of $1.9 billion with respect to our 3.45% 2020 Notes and our 4.10% 2021 Notes. The contracts have rates that range from three-month LIBOR plus 1.1% to three-month LIBOR plus 2.0%.
For derivative instruments that are designated and qualify as fair value hedges, the unrealized gain or loss on the derivative resulting from the change in fair value during the period as well as the offsetting unrealized loss or gain of the hedged item resulting from the change in fair value during the period attributable to the hedged risk is recognized in current earnings. For the three and nine months ended September 30, 2013, we included the unrealized losses on the hedged debt of $7 million and gains of $84 million, respectively, in the same line item, Interest expense, net, in the Condensed Consolidated Statements of Income, as the offsetting unrealized gains of $7 million and losses of $84 million, respectively, on the related interest rate swap contracts. For the nine months ended September 30, 2012, we included the unrealized losses on the hedged debt of $20 million in the same line item, Interest expense, net, in the Condensed Consolidated Statements of Income, as the offsetting unrealized gains of $20 million on the related interest rate swap contracts.
Derivatives not designated as hedges
We enter into foreign currency forward contracts that are not designated as hedging transactions to reduce our exposure to foreign currency fluctuations of certain assets and liabilities denominated in foreign currencies. These exposures are hedged on a month-to-month basis. As of September 30, 2013, and December 31, 2012, the total notional amounts of these foreign currency forward contracts were $694 million and $629 million, respectively.
The location in the Condensed Consolidated Statements of Income and the amount of gain/(loss) recognized in earnings for our derivative instruments not designated as hedging instruments were as follows (in millions):
|
| | | | | | | | | | | | | | | | | | |
| | | | Three months ended | | Nine months ended |
| | | | September 30, | | September 30, |
Derivatives not designated as hedging instruments | | Statements of Income location | | 2013 | | 2012 | | 2013 | | 2012 |
Foreign currency contracts | | Interest and other income, net | | $ | 15 |
| | $ | 3 |
| | $ | 10 |
| | $ | 13 |
|
The fair values of derivatives included in the Condensed Consolidated Balance Sheets were as follows (in millions):
|
| | | | | | | | | | | | |
| | Derivative assets | | Derivative liabilities |
September 30, 2013 | | 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 | | $ | 133 |
| | Accrued liabilities/ Other noncurrent liabilities | | $ | 7 |
|
Foreign currency contracts | | Other current assets/ Other noncurrent assets | | 36 |
| | Accrued liabilities/ Other noncurrent liabilities | | 71 |
|
Interest rate swap contracts | | Other current assets/ Other noncurrent assets | | 13 |
| | Accrued liabilities/ Other noncurrent liabilities | | 97 |
|
Total derivatives designated as hedging instruments | | | | 182 |
| | | | 175 |
|
Derivatives not designated as hedging instruments: | | | | | | | | |
Foreign currency contracts | | Other current assets | | — |
| | Accrued liabilities | | — |
|
Total derivatives not designated as hedging instruments | | | | — |
| | | | — |
|
Total derivatives | | | | $ | 182 |
| | | | $ | 175 |
|
|
| | | | | | | | | | | | |
| | Derivative assets | | Derivative liabilities |
December 31, 2012 | | 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 | | $ | 65 |
| | Accrued liabilities/ Other noncurrent liabilities | | $ | 6 |
|
Foreign currency contracts | | Other current assets/ Other noncurrent assets | | 45 |
| | Accrued liabilities/ Other noncurrent liabilities | | 58 |
|
Total derivatives designated as hedging instruments | | | | 110 |
| | | | 64 |
|
Derivatives not designated as hedging instruments: | | | | | | | | |
Foreign currency contracts | | Other current assets | | 1 |
| | Accrued liabilities | | 1 |
|
Total derivatives not designated as hedging instruments | | | | 1 |
| | | | 1 |
|
Total derivatives | | | | $ | 111 |
| | | | $ | 65 |
|
Our derivative contracts that were in liability positions as of September 30, 2013, contain certain credit-risk-related contingent provisions that would be triggered if: (i) we were to undergo a change in control and (ii) our or the surviving entity’s creditworthiness deteriorates, which is generally defined as having either a credit rating that is below investment grade or a materially weaker creditworthiness after the change in control. If these events were to occur, the counterparties would have the right, but not the obligation, to close the contracts under early-termination provisions. In such circumstances, the counterparties could request immediate settlement of these contracts for amounts that approximate the then current fair values of the contracts. In addition, our derivative contracts are not subject to any type of master netting arrangement, and amounts due to or from a counterparty under these contracts may only be offset against other amounts due to or from the same counterparty if an event of default or termination, as defined, were to occur.
The cash flow effects of our derivatives contracts for the nine months ended September 30, 2013 and 2012, are included within Net cash provided by operating activities in the Condensed Consolidated Statements of Cash Flows.
11. Contingencies and commitments
Contingencies
In the ordinary course of business, we are involved in various legal proceedings and other matters, including those discussed in this Note, that are complex in nature and have outcomes that are difficult to predict. See Note 18, Contingencies and commitments to our consolidated financial statements in our Annual Report on Form 10-K for the year ended December 31, 2012, and Note 11, Contingencies and commitments to our condensed consolidated financial statements in our Quarterly Reports on Form 10-Q for the periods ended March 31, 2013 and June 30, 2013 for further discussion of certain of our legal proceedings and other matters.
We record accruals for loss contingencies to the extent that we conclude that it is probable that a liability has been incurred and the amount of the related loss can be reasonably estimated. We evaluate, on a quarterly basis, developments in legal proceedings and other matters that could cause an increase or decrease in the amount of the liability that has been accrued previously.
Our legal proceedings range from cases brought by a single plaintiff to class actions with thousands of putative class members. These legal proceedings, as well as other matters, involve various aspects of our business and a variety of claims (including but not limited to patent infringement, marketing, pricing and trade practices and securities law), some of which present novel factual allegations and/or unique legal theories. In each of the matters described in this filing, in Note 18 to our consolidated financial statements in our Annual Report on Form 10-K for the year ended December 31, 2012, or in Note 11 to our condensed consolidated financial statements in our Quarterly Reports on Form 10-Q for the periods ended March 31, 2013, and June 30, 2013, plaintiffs seek an award of a not-yet-quantified amount of damages or an amount that is not material. In addition, a number of the matters pending against us are at very early stages of the legal process (which in complex proceedings of the sort faced by us often extend for several years). As a result, none of the matters described in these filings have progressed sufficiently through discovery and/or development of important factual information and legal issues to enable us to estimate a range of possible loss, if any, or such amounts are not material. While it is not possible to accurately predict or determine the eventual outcomes of these items, an adverse determination in one or more of these items currently pending could have a material adverse effect on our consolidated results of operations, financial position or cash flows.
Certain recent developments concerning our legal proceedings and other matters are discussed below:
Sandoz Patent Litigation
As previously disclosed, Sandoz, Inc. filed a complaint against Amgen and Hoffman-La Roche, Inc. (Roche) alleging that U.S. Patent Nos. 8,063,182 and 8,163,522 are invalid and seeking a declaratory judgment of non-infringement, invalidity and unenforceability of the '182 and '522 patents. On August 16, 2013, Amgen and Roche filed a motion to dismiss Sandoz’s complaint for lack of subject matter jurisdiction. A hearing on the motion to dismiss is set for November 15, 2013.
Onyx Litigation
Between August 28, 2013 and September 16, 2013, nine plaintiffs filed purported class action lawsuits against Onyx, its directors, Amgen and Arena Acquisition Company, and unnamed “John Doe” defendants in connection with Amgen’s acquisition of Onyx. Seven of those purported class actions were brought in the Superior Court of the State of California for the County of San Mateo, captioned Lawrence I. Silverstein and Phil Rosen v. Onyx Pharmaceuticals, Inc., et al. (August 28, 2013) (“Silverstein”), Laura Robinson v. Onyx Pharmaceuticals, Inc., et al. (originally filed in the Superior Court for the County of San Francisco on August 28, 2013, and re-filed in the Superior Court for the County of San Mateo on August 29, 2013) (“Robinson”), John Solak v. Onyx Pharmaceuticals, Inc., et al. (August 30, 2013), Louisiana Municipal Police Employees’ Retirement System and Hubert Chow v. Onyx Pharmaceuticals, Inc., et al. (September 3, 2013) (“Louisiana Municipal”), Laurine Jonopulos v. Onyx Pharmaceuticals, Inc., et al. (September 4, 2013) (“Jonopulos”), Clifford G. Martin v. Onyx Pharmaceuticals, Inc., et al. (September 9, 2013) (“Martin”) and Merrill L. Magowan v. Onyx Pharmaceuticals, Inc. et al. (September 9, 2013) (“Magowan”). The eighth and ninth purported class actions were brought in the Court of Chancery of the State of Delaware, captioned Mark D. Smilow, IRA v. Onyx Pharmaceuticals Inc., et al. (August 29, 2013) and William L. Fitzpatric v. Onyx Pharmaceuticals, Inc., et al. (September 16, 2013) (“Fitzpatric”). On September 5, 2013, the plaintiff in the John Solak case filed a request for dismissal of the case without prejudice. On September 10, 2013, the plaintiff in the Mark D. Smilow, IRA case filed a notice and proposed order of voluntary dismissal of the case without prejudice. On September 10, 2013, plaintiffs in the Silverstein and Louisiana Municipal cases filed an amended complaint alleging substantially the same claims and seeking substantially the same relief as in their individual purported class action lawsuits. Each of the lawsuits alleges that the Onyx director defendants breached their fiduciary duties to Onyx shareholders, and that the other defendants aided and abetted such breaches, by seeking to sell Onyx through an allegedly unfair process and for an unfair price and on unfair terms. The Magowan and Fitzpatric complaints and the amended complaint filed in the Silverstein and Louisiana Municipal cases also allege that the individual defendants breached their fiduciary duties with respect to the contents of the tender offer solicitation material. Each of the lawsuits seeks, among other things, equitable relief that would enjoin the consummation of the proposed merger, rescission of the merger agreement (to the extent it has already been implemented), and attorneys’ fees and costs, and certain of the lawsuits seek other relief. The Silverstein, Robinson, Louisiana Municipal and Jonopulos cases were designated as “complex” and assigned to the Honorable Marie S. Weiner, who subsequently entered an order consolidating the Silverstein, Robinson, Louisiana Municipal, Jonopulos, Martin and Magowan cases.
Federal Securities Litigation - In re Amgen Inc. Securities Litigation
The trial date for this securities class action lawsuit pending against Amgen has been set by the U.S. District Court for the Central District of California for June 1, 2015.
Government Investigations and Qui Tam Actions
As previously disclosed, Amgen accrued an immaterial amount to resolve the last remaining Original Qui Tam Action (as defined in Note 18, Contingencies and commitments to our consolidated financial statements in our Annual Report on Form 10-K for the year ended December 31, 2012). In September 2013, the U.S. District Court for the Eastern District of New York granted the government’s motion to dismiss the complaint of the relator plaintiffs based on prosecutorial discretion.
12. Subsequent event
On October 1, 2013, we completed our acquisition of Onyx, a publicly held biopharmaceutical company engaged in the development and commercialization of innovative therapies for improving the lives of people with cancer, which became a wholly owned subsidiary of Amgen. This transaction, which was accounted for as a business combination, provides us with an important and growing multiple myeloma franchise, with Kyprolis® (carfilzomib) for Injection already approved in the United States, and with oprozomib being evaluated in clinical trials for patients with hematologic malignancies. In addition, Onyx has collaborations with Bayer HealthCare Pharmaceuticals, Inc., for two of Bayer’s marketed oncology products: Nexavar® (sorafenib) tablets, for which Onyx and Bayer have a profit-sharing relationship, and Stivarga® (regorafenib) tablets, for which Onyx receives sales-based royalties from Bayer. Onyx also has a collaboration with Pfizer related to palbociclib, an oncology product being developed by Pfizer for which Onyx will receive sales-based royalties.
The net cash consideration to acquire Onyx totaled approximately $9.7 billion which equals a price of $125 per share of common stock.
Given the timing of the closing of this transaction, we are currently in the process of valuing the assets acquired and liabilities assumed in the business combination. As a result, we are not yet able to provide the amounts to be recognized as of the acquisition date for the major classes of assets acquired and liabilities assumed and other related disclosures. We will include this and other related information in our 2013 Annual Report on Form 10-K.
We financed the transaction with approximately $1.6 billion cash on hand, $3.1 billion in bank debt issued on September 30, 2013, and $5.0 billion in bank debt issued on October 1, 2013. See Note 7, Financing arrangements.
|
| |
Item 2. | MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS |
Forward-looking statements
This report and other documents we file with the SEC contain forward-looking statements that are based on current expectations, estimates, forecasts and projections about us, our future performance, our business, our beliefs and our management’s assumptions. In addition, we, or others on our behalf, may make forward-looking statements in press releases or written statements or in our communications and discussions with investors and analysts in the normal course of business through meetings, webcasts, phone calls and conference calls. Such words as “expect,” “anticipate,” “outlook,” “could,” “target,” “project,” “intend,” “plan,” “believe,” “seek,” “estimate,” “should,” “may,” “assume,” and “continue,” as well as variations of such words and similar expressions, are intended to identify such forward-looking statements. These statements are not guarantees of future performance and involve certain risks, uncertainties and assumptions that are difficult to predict. We describe our respective risks, uncertainties and assumptions that could affect the outcome or results of operations in Part I, Item 1A, of our Annual Report on Form 10-K for the fiscal year ended December 31, 2012. We have based our forward-looking statements on our management’s beliefs and assumptions based on information available to our management at the time the statements are made. We caution you that actual outcomes and results may differ materially from what is expressed, implied or forecast by our forward-looking statements. Reference is made in particular to forward-looking statements regarding product sales, regulatory activities, clinical trial results, reimbursement, expenses, EPS, liquidity and capital resources, trends and planned dividends and stock repurchases. Except as required under the federal securities laws and the rules and regulations of the SEC, we do not have any intention or obligation to update publicly any forward-looking statements after the distribution of this report, whether as a result of new information, future events, changes in assumptions or otherwise.
Overview
The following Management’s Discussion and Analysis of Financial Condition and Results of Operations (MD&A) is intended to assist the reader in understanding Amgen’s business. MD&A is provided as a supplement to, and should be read in conjunction with, our Annual Report on Form 10-K for the year ended December 31, 2012 and our Quarterly Reports on Form 10-Q for the periods ended March 31, 2013, and June 30, 2013. Our results of operations discussed in MD&A are presented in conformity with GAAP.
Amgen discovers, develops, manufactures, and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new science's promise by bringing safe, effective medicines from lab to manufacturing plant to patient. Amgen therapeutics have changed the practice of medicine, helping people around the world in the fight against serious illnesses. With a deep and broad pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people's lives. Amgen operates in one business segment: human therapeutics. Therefore, our results of operations are discussed on a consolidated basis.
Currently, we market primarily recombinant protein therapeutics for supportive cancer care, inflammation, nephrology and bone disease. Our principal products are Neulasta® (pegfilgrastim), NEUPOGEN® (filgrastim), Enbrel® (etanercept), XGEVA® (denosumab), Prolia® (denosumab) and our erythropoiesis-stimulating agents: Aranesp® (darbepoetin alfa) and EPOGEN® (epoetin alfa). Our product sales outside the United States consist principally of sales in Europe. For the three and nine months ended September 30, 2013, our principal products represented 89% and 88% of worldwide product sales, respectively, compared with 89% for the corresponding periods of the prior year. Our other marketed products include principally Sensipar®/Mimpara® (cinacalcet), Vectibix® (panitumumab) and Nplate® (romiplostim).
Significant developments
Following is a summary of selected significant developments affecting our business that have occurred since June 30, 2013. For additional developments or for a more comprehensive discussion of certain developments discussed below, see our Annual Report on Form 10-K for the year ended December 31, 2012 and our Quarterly Reports on Form 10-Q for the periods ended March 31, 2013, and June 30, 2013.
Acquisition
| |
• | In October 2013, we acquired Onyx, a biopharmaceutical company engaged in the development and commercialization of innovative therapies for improving the lives of people with cancer. Onyx has an important and growing multiple myeloma franchise, with Kyprolis® (carfilzomib) for Injection already approved in the United States, and with oprozomib being evaluated in clinical trials for patients with hematologic malignancies. In addition, Onyx has collaborations with Bayer HealthCare Pharmaceuticals, Inc., for two of Bayer’s marketed oncology products: Nexavar® (sorafenib) tablets, for which Onyx and Bayer have a profit-sharing relationship, and Stivarga® (regorafenib) tablets, for which Onyx receives sales-based royalties from Bayer. Onyx also has a collaboration with Pfizer related to palbociclib, an oncology product being developed by Pfizer for which Onyx will receive sales-based royalties. See Note 12, Subsequent event to the condensed consolidated financial statements. |
We believe there is a significant opportunity to grow Kyprolis®. Ongoing studies to support and extend the position of Kyprolis® in multiple myeloma include:
| |
• | The FOCUS trial, which could support the EU filing for the indication of relapsed/refractory multiple myeloma, is expected to read out in the first half of 2014. |
| |
• | The ASPIRE trial is the confirmatory trial for full U.S. approval as well as a registration-enabling study for relapsed multiple myeloma in the United States and the EU. The Independent Data Monitoring Committee review of interim analysis is projected to occur in the first half of 2014. |
| |
• | The ENDEAVOR trial compares Kyprolis® with Velcade® (bortezomib) in patients with relapsed multiple myeloma who have received one to three prior therapies. |
| |
• | The CLARION trial compares Kyprolis® with Velcade® in patients with newly diagnosed multiple myeloma. |
Products/Pipeline
Vectibix®
| |
• | In September 2013, we presented results from the phase 3 ASPECCT ('763) trial comparing Vectibix® with Erbitux® (cetuximab) for the treatment of wild-type KRAS metastatic colorectal cancer in patients who have not responded to chemotherapy. The study met its primary endpoint, demonstrating that panitumumab was non-inferior to cetuximab for overall survival. In Europe, the ASPECCT trial is a Specific Obligation for Vectibix® as part of the European Medicine Agency's conditional marketing authorization. |
Trebananib
| |
• | In October 2013, we announced that the primary analysis of the event-driven overall survival secondary endpoint from the ongoing pivotal phase 3 study in recurrent ovarian cancer (TRINOVA-1) is projected to occur in the second half of 2014. |
| |
• | In October 2013, we announced that enrollment has been closed in a phase 3 study in recurrent ovarian cancer (TRINOVA-2) due to DOXIL® (doxorubicin HCl liposome injection) supply issues. |
| |
• | In October 2013, we discussed that enrollment will be reduced in the phase 3 study in first-line ovarian cancer (TRINOVA-3) while maintaining the integrity of the primary endpoint (progression-free survival). |
Evolocumab (AMG 145)
| |
• | In October 2013, we announced that all of the pivotal lipid lowering studies of evolocumab have completed enrollment and that data are expected in the first quarter of 2014. |
Brodalumab
| |
• | In October 2013, we announced that all phase 3 studies in subjects with psoriasis have completed enrollment and that data are expected in 2014. |
Ivabradine
| |
• | In August 2013, we obtained the commercial rights in the United States to Servier's novel oral drug ivabradine. Ivabradine is approved in the EU for chronic heart failure and stable angina in patients with elevated heart rates, as well as approved in more than 100 other countries, excluding the United States. |
Biosimilars
| |
• | In October 2013, we announced that we commenced a pivotal study in subjects with psoriasis for our biosimilar Humira® (adalimumab). |
Selected financial information
The following is an overview of our results of operations (in millions, except percentages and per share data):
|
| | | | | | | | | | | | | | | | | | | | | |
| Three months ended | | | | Nine months ended | | |
| September 30, | | | | September 30, | | |
| 2013 | | 2012 | | Change | | 2013 | | 2012 | | Change |
Product sales: | | | | | | | | | | | |
U.S. | $ | 3,625 |
| | $ | 3,248 |
| | 12 | % | | $ | 10,358 |
| | $ | 9,500 |
| | 9 | % |
Rest-of-the-world (ROW) | 1,022 |
| | 953 |
| | 7 | % | | 3,035 |
| | 2,802 |
| | 8 | % |
Total product sales | 4,647 |
| | 4,201 |
| | 11 | % | | 13,393 |
| | 12,302 |
| | 9 | % |
Other revenues | 101 |
| | 118 |
| | (14 | )% | | 272 |
| | 542 |
| | (50 | )% |
Total revenues | $ | 4,748 |
| | $ | 4,319 |
| | 10 | % | | $ | 13,665 |
| | $ | 12,844 |
| | 6 | % |
Operating expenses | $ | 3,060 |
| | $ | 2,896 |
| | 6 | % | | $ | 8,985 |
| | $ | 8,355 |
| | 8 | % |
Operating income | $ | 1,688 |
| | $ | 1,423 |
| | 19 | % | | $ | 4,680 |
| | $ | 4,489 |
| | 4 | % |
Net income | $ | 1,368 |
| | $ | 1,107 |
| | 24 | % | | $ | 4,060 |
| | $ | 3,557 |
| | 14 | % |
Diluted EPS | $ | 1.79 |
| | $ | 1.41 |
| | 27 | % | | $ | 5.31 |
| | $ | 4.51 |
| | 18 | % |
Diluted shares | 766 |
| | 783 |
| | (2 | )% | | 764 |
| | 789 |
| | (3 | )% |
The increases in global product sales for the three and nine months ended September 30, 2013, were driven by ENBREL, Neulasta®, XGEVA® and Prolia®. Product sales included a $155-million order for NEUPOGEN® from the U.S. government in the third quarter. Product sales for the nine months ended September 30, 2013, also included a positive adjustment of $164 million to previous years' estimates for managed Medicaid rebates based on recent claims experience. In the United States, we pay rebates to the states for our products that are covered and reimbursed by state Medicaid programs. One of the provisions of the Affordable Care Act—a U.S. healthcare reform law that became effective in 2010—was the extension of the Medicaid drug rebate program to patients in Medicaid managed care insurance plans for whom rebates were not previously required. As we sell product, we estimate the amount of Medicaid rebate that will be paid by us based on the product sold, contractual terms, estimated patient population, historical experience and wholesaler inventory levels, and we accrue these rebates in the period the related sale is recorded. We then adjust the rebate accruals as more information becomes available and to reflect actual claims experience. Estimating such rebates is complicated, in part, due to the limited availability of actual claims data as a result of the time delay between the date of sale and the actual settlement of the liability, which can take more than one year.
Other revenues for the three months ended September 30, 2013, decreased slightly. The decrease in other revenues for the nine months ended September 30, 2013, was due primarily to revenue recognized in the prior year related to changes in our motesanib collaboration with Takeda and milestone payments received in the prior year from AstraZeneca and Astellas Pharma Inc.
The increases in operating expenses for the three and nine months ended September 30, 2013, were driven primarily by R&D and Selling, general & administrative (SG&A) spending.
Net income for the three months ended September 30, 2013, increased due primarily to higher operating income. The increase in net income for the nine months ended September 30, 2013, was due primarily to a lower effective income tax rate driven by tax benefits recognized in the first quarter as well as higher operating income.
The increases in diluted EPS for the three and nine months ended September 30, 2013, were driven primarily by an increase in net income and, to a lesser extent, by the favorable impact of our stock repurchase program in 2012 and the first quarter of 2013, which reduced the number of shares used to compute diluted EPS. We did not repurchase any shares during the second or third quarter of 2013.
Results of operations
Product sales
Worldwide product sales were as follows (dollar amounts in millions):
|
| | | | | | | | | | | | | | | | | | | | | |
| Three months ended | | | | Nine months ended | | |
| September 30, | | | | September 30, | | |
| 2013 | | 2012 | | Change | | 2013 | | 2012 | | Change |
Neulasta®/NEUPOGEN® | $ | 1,601 |
| | $ | 1,355 |
| | 18 | % | | $ | 4,383 |
| | $ | 4,046 |
| | 8 | % |
ENBREL | 1,155 |
| | 1,079 |
| | 7 | % | | 3,351 |
| | 3,075 |
| | 9 | % |
Aranesp® | 449 |
| | 497 |
| | (10 | )% | | 1,441 |
| | 1,551 |
| | (7 | )% |
EPOGEN® | 491 |
| | 491 |
| | — | % | | 1,428 |
| | 1,462 |
| | (2 | )% |
XGEVA® | 261 |
| | 201 |
| | 30 | % | | 733 |
| | 533 |
| | 38 | % |
Prolia® | 178 |
| | 110 |
| | 62 | % | | 508 |
| | 318 |
| | 60 | % |
Other products | 512 |
| | 468 |
| | 9 | % | | 1,549 |
| | 1,317 |
| | 18 | % |
Total product sales | $ | 4,647 |
| | $ | 4,201 |
| | 11 | % | | $ | 13,393 |
| | $ | 12,302 |
| | 9 | % |
Future sales of our products are influenced by a number of factors, some of which may impact sales of certain of our products more significantly than others. Such factors are discussed below and in the Overview, Item 1. Business — Marketed Products, Item 1A. Risk Factors and Item 7 — Product Sales in our Annual Report on Form 10-K for the year ended December 31, 2012.
Neulasta®/NEUPOGEN®
Total Neulasta®/NEUPOGEN® sales by geographic region were as follows (dollar amounts in millions):
|
| | | | | | | | | | | | | | | | | | | | | |
| Three months ended | | | | Nine months ended | | |
| September 30, | | | | September 30, | | |
| 2013 | | 2012 | | Change | | 2013 | | 2012 | | Change |
Neulasta®— U.S. | $ | 905 |
| | $ | 824 |
| | 10 | % | | $ | 2,629 |
| | $ | 2,432 |
| | 8 | % |
Neulasta®— ROW | 230 |
| | 220 |
| | 5 | % | | 665 |
| | 666 |
| | — | % |
Total Neulasta® | 1,135 |
| | 1,044 |
| | 9 | % | | 3,294 |
| | 3,098 |
| | 6 | % |
NEUPOGEN®— U.S. | 409 |
| | 249 |
| | 64 | % | | 918 |
| | 756 |
| | 21 | % |
NEUPOGEN®— ROW | 57 |
| | 62 |
| | (8 | )% | | 171 |
| | 192 |
| | (11 | )% |
Total NEUPOGEN® | 466 |
| | 311 |
| | 50 | % | | 1,089 |
| | 948 |
| | 15 | % |
Total Neulasta®/NEUPOGEN® | $ | 1,601 |
| | $ | 1,355 |
| | 18 | % | | $ | 4,383 |
| | $ | 4,046 |
| | 8 | % |
The increase in global Neulasta® sales for the three months ended September 30, 2013, was driven by an increase in the average net sales price. The increase in global Neulasta® sales for the nine months ended September 30, 2013, was driven by an increase in the average net sales price, offset partially by a decline in units.
The increases in global NEUPOGEN® sales for the three and nine months ended September 30, 2013, were driven by a $155-million order from the U.S. government. Excluding the special order, sales for the three and nine months ended September 30, 2013, reflected decreases in unit demand, offset partially by increases in the average net sales price.
Our outstanding material U.S. patents for filgrastim (NEUPOGEN®) expire in December 2013. We expect to face competition in the United States beginning in the fourth quarter of 2013, which may have a material adverse impact over time on sales of NEUPOGEN® and Neulasta®.
ENBREL
Total ENBREL sales by geographic region were as follows (dollar amounts in millions):
|
| | | | | | | | | | | | | | | | | | | | | |
| Three months ended | | | | Nine months ended | | |
| September 30, | | | | September 30, | | |
| 2013 | | 2012 | | Change | | 2013 | | 2012 | | Change |
ENBREL — U.S. | $ | 1,073 |
| | $ | 1,012 |
| | 6 | % | | $ | 3,136 |
| | $ | 2,881 |
| | 9 | % |
ENBREL — Canada | 82 |
| | 67 |
| | 22 | % | | 215 |
| | 194 |
| | 11 | % |
Total ENBREL | $ | 1,155 |
| | $ | 1,079 |
| | 7 | % | | $ | 3,351 |
| | $ | 3,075 |
| | 9 | % |
The increases in ENBREL sales for the three and nine months ended September 30, 2013, were driven primarily by increases in the average net sales price, offset partially by slight unit declines.
Aranesp®
Total Aranesp® sales by geographic region were as follows (dollar amounts in millions):
|
| | | | | | | | | | | | | | | | | | | | | |
| Three months ended | | | | Nine months ended | | |
| September 30, | | | | September 30, | | |
| 2013 | | 2012 | | Change | | 2013 | | 2012 | | Change |
Aranesp® — U.S. | $ | 171 |
| | $ | 178 |
| | (4 | )% | | $ | 567 |
| | $ | 595 |
| | (5 | )% |
Aranesp® — ROW | 278 |
| | 319 |
| | (13 | )% | | 874 |
| | 956 |
| | (9 | )% |
Total Aranesp® | $ | 449 |
| | $ | 497 |
| | (10 | )% | | $ | 1,441 |
| | $ | 1,551 |
| | (7 | )% |
The decreases in global Aranesp® sales for the three and nine months ended September 30, 2013, were driven by a decline in units and we expect sales to continue trending slightly downward.
EPOGEN®
Total EPOGEN® sales were as follows (dollar amounts in millions):
|
| | | | | | | | | | | | | | | | | | | | | |
| Three months ended | | | | Nine months ended | | |
| September 30, | | | | September 30, | | |
| 2013 | | 2012 | | Change | | 2013 | | 2012 | | Change |
EPOGEN® — U.S. | $ | 491 |
| | $ | 491 |
| | — | % | | $ | 1,428 |
| | $ | 1,462 |
| | (2 | )% |
EPOGEN® sales for the three months ended September 30, 2013, were flat. EPOGEN® sales for the nine months ended September 30, 2013, declined 2%.
The Centers for Medicare & Medicaid Services was directed to reduce the dialysis services and the related end stage renal disease payment bundle amount effective January 1, 2014, under the American Taxpayer Relief Act enacted in January 2013. This change may have an adverse impact on EPOGEN® sales. A final ruling is expected in November.
XGEVA® and Prolia®
Total XGEVA® and total Prolia® sales by geographic region were as follows (dollar amounts in millions):
|
| | | | | | | | | | | | | | | | | | | | | |
| Three months ended | | | | Nine months ended | | |
| September 30, | | | | September 30, | | |
| 2013 | | 2012 | | Change | | 2013 | | 2012 | | Change |
XGEVA® — U.S. | $ | 194 |
| | $ | 171 |
| | 13 | % | | $ | 561 |
| | $ | 466 |
| | 20 | % |
XGEVA® — ROW | 67 |
| | 30 |
| | * |
| | 172 |
| | 67 |
| | * |
|
Total XGEVA® | 261 |
| | 201 |
| | 30 | % | | 733 |
| | 533 |
| | 38 | % |
Prolia® — U.S. | 109 |
| | 68 |
| | 60 | % | | 314 |
| | 197 |
| | 59 | % |
Prolia® — ROW | 69 |
| | 42 |
| | 64 | % | | 194 |
| | 121 |
| | 60 | % |
Total Prolia® | 178 |
| | 110 |
| | 62 | % | | 508 |
| | 318 |
| | 60 | % |
Total XGEVA®/Prolia® | $ | 439 |
| | $ | 311 |
| | 41 | % | | $ | 1,241 |
| | $ | 851 |
| | 46 | % |
* Change in excess of 100%
The increases in global XGEVA® and Prolia® sales for the three and nine months ended September 30, 2013, were driven by unit growth reflecting increased segment share.
Sequentially, global XGEVA® sales increased 5% in the quarter ended September 30, 2013, compared with the quarter ended June 30, 2013, reflecting increased segment share. Global Prolia® sales decreased 5% during that same period, impacted by seasonality.
Other products
Other product sales by geographic region were as follows (dollar amounts in millions):
|
| | | | | | | | | | | | | | | | | | | | | |
| Three months ended | | | | Nine months ended | | |
| September 30, | | | | September 30, | | |
| 2013 | | 2012 | | Change | | 2013 | | 2012 | | Change |
Sensipar® — U.S. | $ | 183 |
| | $ | 172 |
| | 6 | % | | $ | 540 |
| | $ | 462 |
| | 17 | % |
Sensipar®/Mimpara® — ROW | 76 |
| | 71 |
| | 7 | % | | 242 |
| | 232 |
| | 4 | % |
Vectibix® — U.S. | 32 |
| | 30 |
| | 7 | % | | 90 |
| | 92 |
| | (2 | )% |
Vectibix® — ROW | 75 |
| | 58 |
| | 29 | % | | 197 |
| | 176 |
| | 12 | % |
Nplate® — U.S. | 58 |
| | 53 |
| | 9 | % | | 175 |
| | 157 |
| | 11 | % |
Nplate® — ROW | 48 |
| | 38 |
| | 26 | % | | 132 |
| | 110 |
| | 20 | % |
Other — ROW | 40 |
| | 46 |
| | (13 | )% | | 173 |
| | 88 |
| | 97 | % |
Total other products | $ | 512 |
| | $ | 468 |
| | 9 | % | | $ | 1,549 |
| | $ | 1,317 |
| | 18 | % |
Total U.S. — other products | $ | 273 |
| | $ | 255 |
| | 7 | % | | $ | 805 |
| | $ | 711 |
| | 13 | % |
Total ROW — other products | 239 |
| | 213 |
| | 12 | % | | 744 |
| | 606 |
| | 23 | % |
Total other products | $ | 512 |
| | $ | 468 |
| | 9 | % | | $ | 1,549 |
| | $ | 1,317 |
| | 18 | % |
Operating expenses
Operating expenses were as follows (dollar amounts in millions):
|
| | | | | | | | | | | | | | | | | | | | | |
| Three months ended | | | | Nine months ended | | |
| September 30, | | | | September 30, | | |
| 2013 | | 2012 | | Change | | 2013 | | 2012 | | Change |
Cost of sales | $ | 788 |
| | $ | 775 |
| | 2 | % | | $ | 2,317 |
| | $ | 2,277 |
| | 2 | % |
% of product sales | 17.0 | % | | 18.4 | % | | | | 17.3 | % | | 18.5 | % | | |
Research and development | $ | 989 |
| | $ | 880 |
| | 12 | % | | $ | 2,834 |
| | $ | 2,442 |
| | 16 | % |
% of product sales | 21.3 | % | | 20.9 | % | | | | 21.2 | % | | 19.9 | % | | |
Selling, general and administrative | $ | 1,249 |
| | $ | 1,131 |
| | 10 | % | | $ | 3,663 |
| | $ | 3,441 |
| | 6 | % |
% of product sales | 26.9 | % | | 26.9 | % | | | | 27.4 | % | | 28.0 | % | | |
Other | $ | 34 |
| | $ | 110 |
| | (69 | )% | | $ | 171 |
| | $ | 195 |
| | (12 | )% |
Cost of sales
Cost of sales decreased to 17.0% and 17.3% of product sales for the three and nine months ended September 30, 2013, respectively, driven by lower royalties and higher average net sales prices, offset partially by changes in product mix. The excise tax imposed by Puerto Rico on the gross intercompany purchase price of goods and services from our manufacturer in Puerto Rico also slightly contributed to the decreases as the tax rate declined from 4.0% in 2011 to 3.75% in 2012 and 2.75% in 2013. However, changes to the law have increased the rate effective July 1, 2013, back to 4.0%.
Excluding the impact of the excise tax, cost of sales would have been 15.0% and 15.4% of product sales for the three and nine months ended September 30, 2013, respectively, compared with 16.4% and 16.5% for the corresponding periods of the prior year.
See Note 3, Income taxes, to the condensed consolidated financial statements for further discussion of the Puerto Rico excise tax.
Research and development
The increase in R&D expenses for the three months ended September 30, 2013, was driven primarily by increased costs associated with supporting later-stage clinical programs of $133 million, particularly evolocumab and the $50 million upfront payment to Servier for the U.S. rights to ivabradine. These expenses were offset partially by reduced expenses associated with marketed product support of $24 million. Expenses related to Discovery Research and Translational Sciences activities were flat compared with the prior year.
The increase in R&D expenses for the nine months ended September 30, 2013, was driven primarily by increased costs associated with supporting later-stage clinical programs of $364 million, including evolocumab, and increases in Discovery Research and Translational Sciences activities of $65 million. These expenses were offset partially by reduced expenses associated with marketed product support of $37 million.
Selling, general and administrative
The increases in SG&A expenses for the three and nine months ended September 30, 2013, were driven by higher ENBREL profit share expenses of $46 million and $154 million, respectively; as well as $39 million and $88 million, respectively, related primarily to favorable changes to the estimated U.S. healthcare reform federal excise fee in the prior year.
Under our ENBREL collaboration agreement, we currently pay Pfizer a percentage of annual gross profits on our ENBREL sales in the United States and Canada attributable to all approved indications for ENBREL on a scale that increases as gross profits increase; however, we maintain a majority share of ENBREL profits. For the three and nine months ended September 30, 2013, expenses associated with the ENBREL profit share were $432 million and $1,235 million, respectively, compared with $386 million and $1,081 million for the corresponding periods of the prior year. After expiration of the co-promotion term on October 31, 2013, we will be required to pay Pfizer residual royalties on a declining percentage of net Enbrel sales in the United States and Canada of 12% through October 31, 2014, 11% through October 31, 2015 and 10% through October 31, 2016.
Other
Other operating expenses for the three and nine months ended September 30, 2013, included certain charges related to our cost savings initiatives, primarily severance, of $35 million and $46 million, respectively.
Based on analysis of the results from the phase 3 trial for talimogene laherparepvec in melanoma, which met its primary endpoint, there were increases in management's estimates of the probabilities of completing the BLA filing and receiving approval to market talimogene laherparepvec in specified patient populations in the United States and the EU. Due primarily to these changes in key assumptions, the estimated aggregate fair value of the contingent consideration obligations increased during the nine months ended September 30, 2013, by $111 million and was recorded in Other operating expenses.
Other operating expenses for the three and nine months ended September 30, 2012, included certain charges related to our cost savings initiatives of $36 million and $106 million, due primarily to lease abandonment expenses, and legal proceedings charges of $53 million and $65 million, respectively.
Non-operating expenses/income and income taxes
Non-operating expenses/income and income taxes were as follows (dollar amounts in millions):
|
| | | | | | | | | | | | | | | |
| Three months ended | | Nine months ended |
| September 30, | | September 30, |
| 2013 | | 2012 | | 2013 | | 2012 |
Interest expense, net | $ | 257 |
| | $ | 271 |
| | $ | 761 |
| | $ | 762 |
|
Interest and other income, net | $ | 72 |
| | $ | 111 |
| | $ | 332 |
| | $ | 359 |
|
Provision for income taxes | $ | 135 |
| | $ | 156 |
| | $ | 191 |
| | $ | 529 |
|
Effective tax rate | 9.0 | % | | 12.4 | % | | 4.5 | % | | 12.9 | % |
Interest expense, net
The decrease in interest expense, net for the three months ended September 30, 2013, was due primarily to the settlement of the 0.375% 2013 Convertible Notes in February 2013, offset partially by financing fees paid in association with the acquisition of Onyx. Interest expense, net for the nine months ended September 30, 2013, was essentially flat as the decrease resulting from the settlement of our 0.375% 2013 Convertible Notes was offset by increases resulting from the higher average debt balance on other outstanding debt and financing fees paid in association with the acquisition of Onyx.
Interest and other income, net
The decrease in interest and other income, net for the three months ended September 30, 2013, was due primarily to higher net gains on sales of investments recognized in the prior year and lower portfolio investment returns. The decrease in interest and other income, net for the nine months ended September 30, 2013, was due primarily to higher net gains on sales of investments recognized in the prior year.
Income taxes
Our effective tax rates for the three and nine months ended September 30, 2013, were 9.0% and 4.5%, respectively, compared with 12.4% and 12.9% for the corresponding periods of the prior year. The decrease in our effective tax rate for the three months ended September 30, 2013, was due primarily to the current year reinstatement of the federal R&D tax credit and changes in the jurisdictional mix of income and expenses in 2013.
For the nine months ended September 30, 2013, the effective tax rate was reduced by two significant events that occurred during the three months ended March 31, 2013. First, the rate was reduced by the federal and state tax impacts of the settlement of our examination with the IRS related to years ended December 31, 2007, 2008 and 2009. The settlement resulted in a net tax benefit of approximately $185 million. Second, the rate was reduced by the reinstatement of the federal R&D tax credit for 2012 and 2013. The retroactive extension of the federal R&D tax credit for 2012 resulted in a net tax benefit of approximately $60 million.
Excluding the impact of the Puerto Rico excise tax, our effective tax rates for the three and nine months ended September 30, 2013, would have been 13.8% and 9.8%, respectively, compared with 17.7% and 18.3% for the corresponding periods of the prior year.
See Note 3, Income taxes, to the condensed consolidated financial statements for further discussion.
Financial condition, liquidity and capital resources
Selected financial data was as follows (in millions):
|
| | | | | | | |
| September 30, 2013 | | December 31, 2012 |
Cash, cash equivalents and marketable securities | $ | 22,558 |
| | $ | 24,061 |
|
Receivable from sale of investments | 560 |
| | — |
|
Restricted investments | 3,411 |
| | — |
|
Total assets | 57,073 |
| | 54,298 |
|
Current portion of long-term debt | 11 |
| | 2,495 |
|
Long-term debt | 27,178 |
| | 24,034 |
|
Stockholders’ equity | 21,728 |
| | 19,060 |
|
The Company intends to continue to return capital to stockholders through the payment of cash dividends, reflecting our confidence in the future cash flows of our business. Whether and when we declare dividends and the size of any dividend could be affected by a number of factors. (See our Annual Report on Form 10-K for the year ended December 31, 2012, Item 1A. Risk Factors—There can be no assurance that we will continue to declare cash dividends or repurchase stock.) In December 2012, March 2013 and July 2013, the Board of Directors declared quarterly cash dividends of $0.47 per share of common stock, which were paid on March 7, June 7 and September 6, 2013, respectively. On October 16, 2013, the Board of Directors declared a quarterly cash dividend of $0.47 per share of common stock, which will be paid on December 6, 2013. During the nine months ended September 30, 2013, we repurchased 9.1 million shares of our common stock at an aggregate cost of $771 million at an average price of $85.03 per share. As of September 30, 2013, $1.6 billion remained available under our stock repurchase program; however, we do not expect to make any significant repurchases of our common stock during the remainder of 2013, 2014 and 2015.
We entered into a Repurchase Agreement pursuant to which Amgen sold 34,097 Class A preferred shares of one of its wholly-owned subsidiaries, ATL Holdings, to a counterparty on September 30, 2013. Pursuant to the Repurchase Agreement, we are obligated to repurchase the Class A preferred shares from the counterparty on or before September 28, 2018, for the aggregate sale price of $3.1 billion. Under the Repurchase Agreement, which is accounted for as long-term debt, we are obligated to make payments to the counterparty based on the sale price of the outstanding preferred shares at a floating interest rate of LIBOR plus 1.1%.
On October 1, 2013, we borrowed $5.0 billion under a Term Loan Credit Facility which bears interest at a floating rate based on LIBOR plus additional interest, initially 1%, which can vary based on the credit ratings assigned to our long-term debt by S&P and Moody’s. A portion of the principal amount of this debt is to be repaid at the end of each quarter equal to 2.5% of the original amount of the loan, or $125 million, with the balance due on October 1, 2018. This credit facility includes the same financial covenant as our revolving credit facility with respect to our level of borrowings in relation to our equity, as defined. For a discussion of the Repurchase Agreement and the Term Loan Credit Facility, see Note 7, Financing arrangements to the condensed consolidated financial statements.
The $8.1 billion of proceeds received under the Repurchase Agreement and the Term Loan Credit Facility and additional available cash was used to purchase Onyx on October 1, 2013. See Note 12, Subsequent event to the condensed consolidated financial statements.
In February 2013, our 0.375% 2013 Convertible Notes matured/converted, and accordingly, the $2.5 billion principal amount was settled in cash. We also elected to pay the note holders who converted their notes $99 million of cash for the excess conversion value, as allowed under the original terms of the notes, which was offset by our receipt of the same amount of cash from the counterparty to the related convertible note hedge. In addition, in May 2013, warrants to acquire 32 million shares of our common stock at an exercise price of $104.80 originally sold in connection with the issuance of the 0.375% 2013 Convertible Notes were exercised resulting in a net cash payment of $100 million. See Note 7, Financing arrangements, to the condensed consolidated financial statements for a discussion of these transactions.
We believe that existing funds, cash generated from operations and existing sources of and access to financing are adequate, for the foreseeable future, to satisfy: our needs for working capital; capital expenditure and debt service requirements; our plans to pay dividends; and other business initiatives we may strategically pursue, including acquisitions and licensing activities. We anticipate that our liquidity needs can be met through a variety of sources, including cash provided by operating activities, sales of marketable securities, borrowings through commercial paper and/or syndicated credit facilities and access to other domestic and foreign debt markets and equity markets. With respect to our U.S. operations, we believe that existing funds intended for use in the United States; cash generated from our U.S. operations, including intercompany payments and receipts; and existing sources
of and access to financing (collectively referred to as U.S. funds) are adequate to continue to meet our U.S. obligations (including our plans to pay dividends with U.S. funds) for the foreseeable future. See our Annual Report on Form 10-K for the year ended December 31, 2012, Item 1A. Risk Factors – Global economic conditions may negatively affect us and may magnify certain risks that affect our business.
A significant portion of our operating cash flows is dependent on the timing of payments from our customers located in the United States and, to a lesser extent, our customers outside the United States, which include government-owned or -supported healthcare providers (government healthcare providers). Payments from these government healthcare providers are dependent in part on the economic stability and creditworthiness of their applicable country. Historically, some payments from a number of European government healthcare providers have extended beyond the contractual terms of sale, and regional economic uncertainty continues. In particular, credit and economic conditions in Southern Europe, particularly in Spain, Italy, Greece and Portugal, continue to adversely impact the timing of collections of our trade receivables in this region. As of September 30, 2013, accounts receivable in these four countries totaled $453 million, of which $352 million was past due. Although economic conditions in this region may continue to affect the average length of time it takes to collect payments, to date we have not incurred any significant losses related to these receivables; and the timing of payments in these countries has not had nor is it currently expected to have a material adverse impact on our overall operating cash flows. However, if government funding for healthcare were to become unavailable in these countries or if significant adverse adjustments to past payment practices were to occur, we might not be able to collect the entire balance of these receivables. We will continue working closely with these customers, monitoring the economic situation and taking appropriate actions as necessary.
Of our total cash, cash equivalents, marketable securities, receivable from sale of investments and restricted investments balances totaling $26.5 billion as of September 30, 2013, approximately $20.0 billion was generated from operations in foreign tax jurisdictions and is intended to be invested indefinitely outside of the United States. Under current tax laws, if these funds were repatriated for use in our U.S. operations, we would be required to pay additional U.S. federal and state income taxes at the applicable marginal tax rates.
Certain of our financing arrangements contain non-financial covenants. In addition, our revolving credit agreement includes a financial covenant with respect to the level of our borrowings in relation to our equity, as defined. We were in compliance with all applicable covenants under these arrangements as of September 30, 2013.
Cash flows
Our cash flow activities were as follows (in millions):
|
| | | | | | | |
| Nine months ended September 30, |
| 2013 | | 2012 |
Net cash provided by operating activities | $ | 4,456 |
| | $ | 5,070 |
|
Net cash provided by (used in) investing activities | 1,649 |
| | (7,959 | ) |
Net cash (used in) provided by financing activities | (1,081 | ) | | 1,766 |
|
Operating
Cash provided by operating activities has been and is expected to continue to be our primary recurring source of funds. Cash provided by operating activities during the nine months ended September 30, 2013, decreased due primarily to the receipt of $397 million of cash in the prior year period in connection with the termination of interest rate swap agreements and the timing of receipts from customers, including the impact of $197 million received under a government-funded program in Spain during the prior year period.
Investing
Cash provided by investing activities during the nine months ended September 30, 2013, was due primarily to net sales of marketable securities of $2.7 billion, offset partially by a restriction of investments of $526 million and capital expenditures of $492 million. Cash used in investing activities during the nine months ended September 30, 2012, was due primarily to net purchases of marketable securities of $5.4 billion, acquisitions of businesses, net of cash acquired of $2.0 billion and capital expenditures of $489 million. Capital expenditures during the nine months ended September 30, 2013 and 2012 were associated primarily with manufacturing capacity expansions in Ireland and Puerto Rico, as well as other site developments. We currently estimate 2013 spending on capital projects and equipment to be approximately $700 million.
Financing
Cash used in financing activities during the nine months ended September 30, 2013, was due primarily to the cash settlement of the $2.5 billion principal amount of the 0.375% 2013 Convertible Notes which matured/converted, repurchases of our common stock of $832 million and the payment of dividends of $1.1 billion, offset partially by the net proceeds from issuance of debt of $3.1 billion and net proceeds from issuance of common stock in connection with the Company's equity award programs of $268 million.
Cash provided by financing activities during the nine months ended September 30, 2012, was due primarily to the net proceeds from issuance of long-term debt of $4.9 billion and the net proceeds from issuance of common stock in connection with the Company's equity award programs of $1.1 billion, offset partially by repurchases of our common stock of $3.4 billion and the payment of dividends of $844 million.
See Note 7, Financing arrangements, and Note 8, Stockholders’ equity, to the condensed consolidated financial statements for further discussion.
Critical accounting policies
The preparation of our condensed consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and the notes to the financial statements. Some of those judgments can be subjective and complex, and therefore, actual results could differ materially from those estimates under different assumptions or conditions. A summary of our critical accounting policies is presented in Part II, Item 7, of our Annual Report on Form 10-K for the year ended December 31, 2012. There have been no material changes to our critical accounting policies during the nine months ended September 30, 2013.
|
| |
Item 3. | QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK |
Information about our market risk is disclosed in Part II, Item 7A, of our Annual Report on Form 10-K for the fiscal year ended December 31, 2012, and is incorporated herein by reference. Except as discussed below, there have been no material changes during the nine months ended September 30, 2013, to the information provided in Part II, Item 7A, of our Annual Report on Form 10-K for the fiscal year ended December 31, 2012.
Interest rate sensitive financial instruments
To achieve a desired mix of fixed and floating rate debt, we entered into interest rate swap contracts with aggregate notional amounts of $2.5 billion and $1.9 billion during the three months ended March 31, 2013 and June 30, 2013, respectively, for an aggregate notional amount of $4.4 billion in contracts outstanding as of September 30, 2013. These derivative contracts qualify and have been designated for accounting purposes as fair value hedges and effectively convert a fixed rate interest coupon to a floating rate LIBOR-based coupon over the remaining lives of the hedged notes. A hypothetical 100 basis point increase in interest rates relative to interest rates at September 30, 2013, would have resulted in a reduction in fair value of approximately $310 million on our interest rate swap contracts on this date and would not result in a material effect on the related income or cash flows in the ensuing year.
|
| |
Item 4. | CONTROLS AND PROCEDURES |
We maintain “disclosure controls and procedures,” as such term is defined under Exchange Act Rule 13a-15(e), that are designed to ensure that information required to be disclosed in Amgen’s Exchange Act reports is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms, and that such information is accumulated and communicated to Amgen’s management, including its Chief Executive Officer and Chief Financial Officer, as appropriate, to allow timely decisions regarding required disclosures. In designing and evaluating the disclosure controls and procedures, Amgen’s management recognized that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives and, in reaching a reasonable level of assurance, Amgen’s management necessarily was required to apply its judgment in evaluating the cost-benefit relationship of possible controls and procedures. We have carried out an evaluation under the supervision and with the participation of our management, including Amgen’s Chief Executive Officer and Chief Financial Officer, of the effectiveness of the design and operation of Amgen’s disclosure controls and procedures. Based upon their evaluation and subject to the foregoing, the Chief Executive Officer and Chief Financial Officer concluded that our disclosure controls and procedures were effective as of September 30, 2013.
Management determined that, as of September 30, 2013, there were no changes in our internal control over financial reporting that occurred during the fiscal quarter then ended that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
PART II — OTHER INFORMATION
See Note 11, Contingencies and commitments, to the condensed consolidated financial statements included in our Quarterly Reports on Form 10-Q for the periods ended September 30, 2013, June 30, 2013, and March 31, 2013, for discussions that are limited to certain recent developments concerning our legal proceedings. Those discussions should be read in conjunction with Note 18, Contingencies and commitments, to our consolidated financial statements in Part IV of our Annual Report on Form 10-K for the year ended December 31, 2012.
This report and other documents we file with the SEC contain forward-looking statements that are based on current expectations, estimates, forecasts and projections about us, our future performance, our business, our beliefs and our management’s assumptions. These statements are not guarantees of future performance and involve certain risks, uncertainties and assumptions that are difficult to predict. You should carefully consider the risks and uncertainties facing our business. We have described in our Annual Report on Form 10-K for the fiscal year ended December 31, 2012, the primary risks related to our business and periodically update those risks for material developments. Those risks are not the only ones facing us. Our business is also subject to the risks that affect many other companies, such as employment relations, general economic conditions, geopolitical events and international operations. Further, additional risks not currently known to us or that we currently believe are immaterial may in the future materially and adversely affect our business, operations, liquidity and stock price.
Below, we are providing, in supplemental form, the material changes to our risk factors that occurred during the past quarter. Our risk factors disclosed in Part I, Item 1A, of our Annual Report on Form 10-K for the fiscal year ended December 31, 2012, provide additional disclosure and context for these supplemental risks and are incorporated herein by reference.
Our efforts to acquire other companies or products and to integrate their operations may not be successful, and may result in costs, delays or failures to realize the benefits of the transactions.
We have an ongoing process of evaluating potential merger, acquisition, partnering and in-license opportunities that we expect will contribute to our future growth and expand our geographic footprint, product offerings and/or our R&D pipeline. For example, on October 1, 2013, we acquired Onyx, a biopharmaceutical company with several currently marketed products as well as pipeline candidates going through the development process. Acquisitions may result in unanticipated costs, delays or other operational or financial problems related to integrating the acquired company and business with our company, which may result in the diversion of our management's attention from other business issues and opportunities. Failures or difficulties in integrating the operations of the businesses that we acquire, including their personnel, technology, compliance programs, financial systems, distribution and general business operations and procedures, while preserving important R&D, distribution, marketing, promotion and other relationships, may affect our ability to grow and may result in our incurring asset impairment or restructuring charges.
|
| |
Item 5. | OTHER INFORMATION |
As previously disclosed, on August 24, 2013, the Company entered into a Repurchase Agreement with Bank of America, N.A. (BANA), pursuant to which the Company subsequently sold to BANA 34,097 shares of Class A Preferred Stock (the Purchased Securities) of its wholly owned subsidiary ATL Holdings for an aggregate purchase price of $3.1 billion in cash. Under the Repurchase Agreement, the Company is obligated to repurchase from BANA, and BANA is obligated to resell to the Company, the Purchased Securities on the repurchase date, which is scheduled to be the date occurring five years after the initial sale of the Purchased Securities, for an aggregate repurchase price equal to the aggregate purchase price paid by BANA for such Purchased Securities (plus any accrued and unpaid interest equivalent). In connection with the Repurchase Agreement, the Company entered into an ancillary agreement (the Ancillary Agreement) with BANA, which contains a number of representations and covenants of the Company, including agreements by the Company intended to maintain the status of ATL Holdings as an entity distinct from the Company and its other subsidiaries. The material terms of the Repurchase Agreement and the Ancillary Agreement were disclosed in the Company’s current report on Form 8-K filed on August 26, 2013 (the August 26th 8-K).
On October 28, 2013, BANA transferred by novation to SMBC Repo Pass-Thru Trust 2013-1, an affiliate of Sumitomo Mitsui Banking Corporation, (SMBC) all of its rights and obligations under the Repurchase Agreement and the Ancillary Agreement related to the portion of the Purchased Securities represented by 10,230 shares of Class A Preferred Stock of ATL Holdings (the SMBC Novated Purchased Securities). To effect the novation, the Company entered into a novation agreement (the SMBC Novation Agreement) with BANA and SMBC, and a new master repurchase agreement (the SMBC Repo Agreement) and a new ancillary agreement (the SMBC Ancillary Agreement) with SMBC related to the SMBC Novated Purchased Securities and otherwise on terms substantially identical to the Repurchase Agreement and Ancillary Agreement, respectively. BANA transferred the SMBC Novated Purchased Securities to SMBC as part of the novation.
On October 29, 2013, BANA transferred by novation to HSBC Bank USA, N.A. (HSBC) all of its rights and obligations under the Repurchase Agreement and the Ancillary Agreement related to the portion of the Purchased Securities represented by 6,660 shares of Class A Preferred Stock of ATL Holdings (the HSBC Novated Purchased Securities). To effect the novation, the Company entered into a novation agreement (the HSBC Novation Agreement) with BANA and HSBC, and a new master repurchase agreement (the HSBC Repo Agreement) and a new ancillary agreement (the HSBC Ancillary Agreement) with HSBC related to the HSBC Novated Purchased Securities and otherwise on terms substantially identical to the Repurchase Agreement and Ancillary Agreement, respectively. BANA transferred the HSBC Novated Purchased Securities to HSBC as part of the novation.
The foregoing summaries of the SMBC Novation Agreement, the SMBC Repo Agreement, the SMBC Ancillary Agreement, the HSBC Novation Agreement, the HSBC Repo Agreement and the HSBC Ancillary Agreement do not purport to be complete and are subject to, and qualified in their entirety by, the full text of the agreements. The SMBC Repo Agreement and the HSBC Repo Agreement are filed herewith as Exhibits 10.61 and 10.62, respectively, which are incorporated herein by reference. The material terms of the SMBC Novation Agreement and the HSBC Novation Agreement are substantially the same as the form of novation agreement included as an exhibit to the Repurchase Agreement, and the material terms of the SMBC Ancillary Agreement and the HSBC Ancillary Agreement are substantially the same as the form of ancillary agreement included as an exhibit to the Repurchase Agreement. The Repurchase Agreement was filed as an exhibit to the August 26th 8-K and is incorporated herein by reference.
Reference is made to the Index to Exhibits included herein.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this Quarterly Report to be signed on its behalf by the undersigned, thereunto duly authorized.
|
| | | | |
| | Amgen Inc. |
| | (Registrant) |
| | | |
Date: | October 29, 2013 | By: | | /s/ Jonathan M. Peacock |
| | | | Jonathan M. Peacock |
| | | | Executive Vice President and Chief Financial Officer |
AMGEN INC.
INDEX TO EXHIBITS
|
| | |
Exhibit No. | | Description |
2.1 | | Agreement and Plan of Merger, dated as of August 24, 2013, by and among Onyx Pharmaceuticals, Inc., Amgen Inc. and Arena Acquisition Company. (Filed as an exhibit to Form 8-K on August 26, 2013 and incorporated herein by reference.) |
| | |
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, dated as of January 1, 1992, as supplemented by the First Supplemental Indenture, dated as of February 26, 1997, establishing a series of securities entitled “8 1/8% Debentures due April 1, 2097.” (Filed as an exhibit to Form 8-K on April 8, 1997 and incorporated herein by reference.) |
| | |
4.7 | | Indenture, dated as of August 4, 2003. (Filed as an exhibit to Form S-3 Registration Statement on August 4, 2003 and incorporated herein by reference.) |
| | |
4.8 | | Officers' Certificate, dated November 18, 2004, including forms of the 4.00% Senior Notes due 2009 and 4.85% Senior Notes due 2014. (Filed as an exhibit to Form 8-K on November 19, 2004 and incorporated herein by reference.) |
| | |
4.9 | | 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.) |
| | |
4.10 | | Officers' Certificate of Amgen Inc., dated as of May 30, 2007, including forms of the Company's Senior Floating Rate Notes due 2008, 5.85% Senior Notes due 2017 and 6.375% Senior Notes due 2037. (Filed as an exhibit to Form 8-K on May 30, 2007 and incorporated herein by reference.) |
| | |
4.11 | | Officers' Certificate of Amgen Inc., dated as of May 23, 2008, including forms of the Company's 6.15% Senior Notes due 2018 and 6.90% Senior Notes due 2038. (Filed as exhibit to Form 8-K on May 23, 2009 and incorporated herein by reference.) |
| | |
4.12 | | Officers' Certificate of Amgen Inc., dated as of January 16, 2009, including forms of the Company's 5.70% Senior Notes due 2019 and 6.40% Senior Notes due 2039. (Filed as exhibit to Form 8-K on January 16, 2009 and incorporated herein by reference.) |
| | |
4.13 | | Officers' Certificate of Amgen Inc., dated as of March 12, 2010, including forms of the Company's 4.50% Senior Notes due 2020 and 5.75% Senior Notes due 2040. (Filed as exhibit to Form 8-K on March 15, 2010 and incorporated herein by reference.) |
| | |
4.14 | | Officers' Certificate of Amgen Inc., dated as of September 16, 2010, including forms of the Company's 3.45% Senior Notes due 2020 and 4.95% Senior Notes due 2041. (Filed as an exhibit to Form 8-K on September 17, 2010 and incorporated herein by reference.) |
| | |
|
| | |
Exhibit No. | | Description |
4.15 | | Officers' Certificate of Amgen Inc., dated as of June 30, 2011, including forms of the Company's 2.30% Senior Notes due 2016, 4.10% Senior Notes due 2021 and 5.65% Senior Notes due 2042. (Filed as an exhibit to Form 8-K on June 30, 2011 and incorporated herein by reference.) |
| | |
4.16 | | Officers' Certificate of Amgen Inc., dated as of 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.) |
| | |
4.17 | | Officers' Certificate of Amgen Inc., dated as of 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.) |
| | |
4.18 | | Officers' Certificate of Amgen Inc., dated as of 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.) |
| | |
4.19 | | Officers' Certificate of Amgen Inc., dated as of 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.) |
| | |
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+ | | Form of Stock Option Agreement for the Amgen Inc. 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.) |
| | |
10.3+ | | Form of Restricted Stock Unit Agreement for the Amgen Inc. 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+ | | Amgen Inc. 2009 Performance Award 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.) |
| | |
10.5+ | | Form of Performance Unit Agreement for the Amgen Inc. 2009 Performance Award 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.) |
| | |
10.6+ | | 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.) |
| | |
10.7+ | | 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.) |
| | |
10.8+ | | 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.) |
| | |
10.9+ | | Amgen Inc. Supplemental Retirement Plan. (As Amended and Restated effective January 1, 2009.) (Filed as an exhibit to Form 10-Q for the quarter ended September 30, 2008 on November 7, 2008 and incorporated herein by reference.) |
| | |
10.10+ | | First Amendment to the Amgen Inc. Supplemental Retirement Plan, effective April 11, 2011. (Filed as an exhibit to Form 10-Q for the quarter ended June 30, 2011 on August 8, 2011 and incorporated herein by reference.) |
| | |
10.11+ | | Second Amendment to the Amgen Inc. Supplemental Retirement Plan, effective October 12, 2011. (Filed as an exhibit to Form 10-K for the year ended December 31, 2011 on February 29, 2012 and incorporated herein by reference.) |
| | |
10.12+ | | Third Amendment to the Amgen Inc. Supplemental Retirement Plan, effective January 1, 2012. (Filed as an exhibit to Form 10-K for the year ended December 31, 2011 on February 29, 2012 and incorporated herein by reference.) |
| | |
10.13+ | | Fourth Amendment to the Amgen Inc. Supplemental Retirement Plan, effective June 18, 2012. (Filed as an exhibit to Form 10-Q for the quarter ended June 30, 2012 on August 8, 2012 and incorporated herein by reference.) |
| | |
10.14+ | | Fifth Amendment to the Amgen Inc. Supplemental Retirement Plan, effective August 27, 2012. (Filed as an exhibit to Form 10-Q for the quarter ended September 30, 2012 on November 6, 2012 and incorporated herein by reference.) |
| | |
|
| | |
Exhibit No. | | Description |
10.15+ | | 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.) |
| | |
10.16+ | | 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.) |
| | |
10.17+ | | 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.) |
| | |
10.18+ | | 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.) |
| | |
10.19+ | | 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.) |
| | |
10.20+ | | Amgen Nonqualified Deferred Compensation Plan. (As Amended and Restated effective January 1, 2009.) (Filed as an exhibit to Form 10-Q for the quarter ended September 30, 2008 on November 7, 2008 and incorporated herein by reference.) |
| | |
10.21+ | | First Amendment to the Amgen Nonqualified Deferred Compensation Plan, effective April 11, 2011. (Filed as an exhibit to Form 10-Q for the quarter ended June 30, 2011 on August 8, 2011 and incorporated herein by reference.) |
| | |
10.22+ | | Second Amendment to the Amgen Nonqualified Deferred Compensation Plan, effective October 12, 2011. (Filed as an exhibit to Form 10-K for the year ended December 31, 2011 on February 29, 2012 and incorporated herein by reference.) |
| | |
10.23+ | | Third Amendment to the Amgen Nonqualified Deferred Compensation Plan, effective June 18, 2012. (Filed as an exhibit to Form 10-Q for the quarter ended June 30, 2012 on August 8, 2012 and incorporated herein by reference.) |
| | |
10.24+ | | Fourth Amendment to the Amgen Nonqualified Deferred Compensation Plan, effective August 27, 2012. (Filed as an exhibit to Form 10-Q for the quarter ended September 30, 2012 on November 6, 2012 and incorporated herein by reference.) |
| | |
10.25+ | | Agreement between Amgen Inc. and Mr. Jonathan M. Peacock, dated July 5, 2010. (Filed as an exhibit to Form 10-Q for the quarter ended September 30, 2010 on November 8, 2010 and incorporated herein by reference.) |
| | |
10.26+ | | Agreement between Amgen Inc. and Mr. Anthony C. Hooper, dated October 12, 2011. (Filed as an exhibit to Form 10-K for the year ended December 31, 2011 on February 29, 2012 and incorporated herein by reference.) |
| | |
10.27+ | | Consulting Services Agreement, entered into as of January 25, 2013, by and between Amgen Inc. and Fabrizio Bonanni. (Filed as an exhibit to Form 10-Q for the quarter ended March 31, 2013 on May 3, 2013 and incorporated herein by reference.) |
| | |
10.28+ | | Restricted Stock Unit Agreement, dated April 27, 2012, between Amgen Inc. and Kevin W. Sharer. (Filed as an exhibit to Form 10-Q for the quarter ended June 30, 2012 on August 8, 2012 and incorporated herein by reference.) |
| | |
10.29+ | | Performance Unit Agreement, dated April 27, 2012, between Amgen Inc. and Kevin W. Sharer. (Filed as an exhibit to Form 10-Q for the quarter ended June 30, 2012 on August 8, 2012 and incorporated herein by reference.) |
| | |
10.30 | | Product License Agreement, dated September 30, 1985, and Technology License Agreement, dated, September 30, 1985 between Amgen and Ortho Pharmaceutical Corporation. (Filed as an exhibit to Form 10-Q for the quarter ended June 30, 2000 on August 1, 2000 and incorporated herein by reference.) |
| | |
10.31 | | 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.) |
| | |
10.32 | | 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.) |
|
| | |
Exhibit No. | | Description |
10.33 | | 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.) |
| | |
10.34 | | 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.) |
| | |
10.35 | | 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.) |
| | |
10.36 | | Product License Agreement, dated September 30, 1985, and Technology License Agreement, dated September 30, 1985, between Kirin-Amgen, Inc. and Ortho Pharmaceutical Corporation. (Filed as an exhibit to Form 10-Q for the quarter ended June 30, 2000 on August 1, 2000 and incorporated herein by reference.) |
| | |
10.37 | | Research, Development Technology Disclosure and License Agreement: PPO, dated January 20, 1986, by and between Kirin Brewery Co., Ltd. and Amgen Inc. (Filed as an exhibit to Amendment No. 1 to Form S-1 Registration Statement on March 11, 1986 and incorporated herein by reference.) |
| | |
10.38 | | 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.) |
| | |
10.39 | | 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.) |
| | |
10.40 | | 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.) |
| | |
10.41 | | Amended and Restated Promotion Agreement, dated as of 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.) |
| | |
10.42 | | Description of Amendment No. 1 to Amended and Restated Promotion Agreement, effective as of 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.) |
| | |
10.43 | | Description of Amendment No. 2 to Amended and Restated Promotion Agreement, effective as of April 20, 2004, by and among Wyeth, Amgen Inc. and Immunex Corporation. (Filed as an exhibit to Amendment No. 1 to Form S-4 Registration Statement on June 29, 2004 and incorporated herein by reference.) |
| | |
10.44 | | Amendment No. 3 to Amended and Restated Promotion Agreement, effective as of 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.) |
| | |
10.45 | | Credit Agreement, dated as of December 2, 2011, among Amgen Inc., with Citibank, N.A., as administrative agent, JPMorgan Chase Bank, N.A., as syndication agent, Citigroup Global Markets Inc. and J.P. Morgan Securities LLC as joint lead arrangers and joint book runners, and the other banks party thereto. (Filed as an exhibit to Form 8-K on December 2, 2011 and incorporated herein by reference.) |
| | |
10.46 | | 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 as of 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.) |
| | |
|
| | |
Exhibit No. | | Description |
10.47 | | Integrated Facilities Management Services Agreement, dated February 4, 2009, between Amgen Inc. and Jones Lang LaSalle Americas, Inc. (portions of the exhibit have been omitted pursuant to a request for confidential treatment) (Previously filed as an exhibit to Form 10-K for the year ended December 31, 2008 on February 27, 2009.), as amended by Amendment Number 1 dated March 31, 2010 (portions of the exhibit have been omitted pursuant to a request for confidential treatment), Amendment Number 2 dated May 12, 2011 (as corrected by the Letter Agreement) (portions of the exhibit have been omitted pursuant to a request for confidential treatment), and Letter Agreement dated July 19, 2011. (Filed as an exhibit to Form 10-Q for the quarter ended June 30, 2011 on August 8, 2011 and incorporated herein by reference.) |
| | |
10.48 | | Amendment Number 3, dated July 1, 2011, to the Integrated Facilities Management Services Agreement, dated February 4, 2009, between Amgen Inc. and Jones Lang LaSalle Americas, Inc. (Filed as an exhibit to Form 10-Q for the quarter ended September 30, 2011 on November 4, 2011 and incorporated herein by reference.) |
| | |
10.49 | | Amendment Number 4, dated March 20, 2013, to the Integrated Facilities Management Services Agreement, dated February 4, 2009, between Amgen Inc. and Jones Lang LaSalle Americas, Inc. (Filed as an exhibit to Form 10-Q for the quarter ended March 31, 2013 on May 3, 2013 and incorporated herein by reference.) |
| | |
10.50* | | Amendment Number 5, entered into as of September 1, 2013, to the Integrated Facilities Management Services Agreement, dated February 4, 2009, between Amgen Inc. and Jones Lang LaSalle Americas, Inc. |
| | |
10.51 | | Collaboration Agreement dated July 27, 2009 between Amgen Inc. and Glaxo Group Limited, a wholly owned subsidiary of GlaxoSmithKline plc (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 September 30, 2009 on November 6, 2009 and incorporated herein by reference.) |
| | |
10.52 | | Amendment Number 1, dated as of January 24, 2012, to Collaboration Agreement dated July 27, 2009 between Amgen Inc. and Glaxo Group Limited, a wholly owned subsidiary of GlaxoSmithKline plc. (Filed as an exhibit to Form 10-K for the year ended December 31, 2012 on February 27, 2013 and incorporated herein by reference.) |
| | |
10.53 | | Expansion Agreement dated July 27, 2009 between Amgen Inc. and Glaxo Group Limited, a wholly owned subsidiary of GlaxoSmithKline plc (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 September 30, 2009 on November 6, 2009 and incorporated herein by reference.) |
| | |
10.54 | | Amendment Number 1, dated September 20, 2010, to Expansion Agreement dated July 27, 2009 between Amgen Inc. and Glaxo Group Limited, a wholly owned subsidiary of GlaxoSmithKline plc (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 September 30, 2010 on November 8, 2010 and incorporated herein by reference.) |
| | |
10.55 | | Amendment Number 2, dated as of January 24, 2012, to Expansion Agreement dated July 27, 2009 between Amgen Inc. and Glaxo Group Limited, a wholly owned subsidiary of GlaxoSmithKline plc. (Filed as an exhibit to Form 10-K for the year ended December 31, 2012 on February 27, 2013 and incorporated herein by reference.) |
| | |
10.56 | | 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.) |
| | |
10.57 | | Amendment Number 1 to Sourcing and Supply Agreement, effective as of 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.) |
| | |
10.58 | | 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.) |
| | |
10.59 | | 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.) |
| | |
10.60 | | 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.) |
| | |
10.61* | | Master Repurchase Agreement, dated October 28, 2013, between Amgen Inc. and SMBC Repo Pass-Thru Trust, 2013-1. |
|
| | |
Exhibit No. | | Description |
10.62* | | Master Repurchase Agreement, dated October 29, 2013, between Amgen Inc. and HSBC Bank USA, N.A. |
| | |
10.63 | | Term Loan Facility Credit Agreement, dated as of September 20, 2013, among Amgen Inc., the Banks therein named, Bank of America, N.A., as Administrative Agent, and Barclays Bank PLC and JP Morgan 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. |
____________________________
(* = filed herewith)
(** = furnished herewith and not “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended)
(+ = management contract or compensatory plan or arrangement)