Item 16. FORM 10-K SUMMARY

Not applicable.

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this Annual Report to be signed on its behalf by the undersigned, thereunto duly authorized.

		AMGEN INC.
		(Registrant)
Date:	February 13, 2019	By:		/S/ DAVID W. MELINE
				David W. Meline
				Executive Vice President and Chief Financial Officer
				(Principal Financial and Accounting Officer)

EXHIBIT 23

CONSENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

We consent to the incorporation by reference in the following Registration Statements:

•	Registration Statement (Form S-8 No. 333-159377) pertaining to the Amgen Inc. 2009 Equity Incentive Plan;

•	Registration Statement (Form S-8 No. 33-39183) pertaining to the Amended and Restated Employee Stock Purchase Plan;

•	Registration Statements (Form S-8 No. 33-39104, as amended by Form S-8 Nos. 333-144581 and 333-216719) pertaining to the Amended and Restated Amgen Retirement and Savings Plan (formerly known as the Amgen Retirement and Savings Plan);

•	Registration Statements (Form S-8 Nos. 33-47605, 333-144580 and 333-216715) pertaining to the Retirement and Savings Plan for Amgen Manufacturing, Limited (formerly known as the Retirement and Savings Plan for Amgen Manufacturing, Inc.);

•	Registration Statements (Form S-8 Nos. 333-81284, 333-177868 and 333-216723) pertaining to the Amgen Nonqualified Deferred Compensation Plan;

•	Registration Statement (Form S-3 No. 333-216060) relating to debt securities, common stock, preferred stock, warrants to purchase debt securities, common stock, preferred stock or depositary shares, rights to purchase common stock or preferred stock, securities purchase contracts, securities purchase units and depositary shares of Amgen Inc. and in the related Prospectus; and

•	Registration Statement (Form S-8 No. 333-176240) pertaining to the Amgen Profit Sharing Plan for Employees in Ireland;

of our reports dated February 13, 2019, with respect to the consolidated financial statements of Amgen Inc. and the effectiveness of internal control over financial reporting of Amgen Inc. included in this Annual Report (Form 10-K) of Amgen Inc. for the year ended December 31, 2018.

/s/ Ernst & Young LLP

Los Angeles, California

February 13, 2019

EXHIBIT 24

POWER OF ATTORNEY

KNOW ALL MEN AND WOMEN BY THESE PRESENTS, that each person whose signature appears below constitutes and appoints David W. Meline, his or her attorney-in-fact, with the power of substitution, for him or her in any and all capacities, to sign any amendments to this Report, and to file the same, with exhibits thereto and other documents in connection therewith, with the Securities and Exchange Commission, hereby ratifying and confirming that said attorney-in-fact, or his or her substitute or substitutes, may do or cause to be done by virtue hereof.

Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the registrant and in the capacities and on the dates indicated:

Signature		Title		Date
/S/ ROBERT A. BRADWAY		Chairman of the Board, Chief Executive Officer and President, and Director (Principal Executive Officer)		2/13/2019
Robert A. Bradway
/S/ DAVID W. MELINE		Executive Vice President and Chief Financial Officer (Principal Financial and Accounting Officer)		2/13/2019
David W. Meline
/S/ WANDA M. AUSTIN		Director		2/13/2019
Wanda M. Austin
/S/ BRIAN J. DRUKER		Director		2/13/2019
Brian J. Druker
/S/ ROBERT A. ECKERT		Director		2/13/2019
Robert A. Eckert
/S/ GREG C. GARLAND		Director		2/13/2019
Greg C. Garland
/S/ FRED HASSAN		Director		2/13/2019
Fred Hassan
/S/ REBECCA M. HENDERSON		Director		2/13/2019
Rebecca M. Henderson
/S/ FRANK C. HERRINGER		Director		2/13/2019
Frank C. Herringer
/S/ CHARLES M. HOLLEY, JR.		Director		2/13/2019
Charles M. Holley, Jr.
/S/ TYLER JACKS		Director		2/13/2019
Tyler Jacks
/S/ ELLEN J. KULLMAN		Director		2/13/2019
Ellen J. Kullman
/S/ RONALD D. SUGAR		Director		2/13/2019
Ronald D. Sugar
/S/ R. SANDERS WILLIAMS		Director		2/13/2019
R. Sanders Williams

Report of Independent Registered Public Accounting Firm

To the Board of Directors and Stockholders of Amgen Inc.

Opinion on the Financial Statements

We have audited the accompanying consolidated balance sheets of Amgen Inc. (the Company) as of December 31, 2018 and 2017, the related consolidated statements of income, comprehensive income, stockholders’ equity and cash flows for each of the three years in the period ended December 31, 2018, and the related notes and the financial statement schedule listed in the Index at Item 15(a)2 (collectively referred to as the “consolidated financial statements”). In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company at December 31, 2018 and 2017, and the results of its operations and its cash flows for each of the three years in the period ended December 31, 2018, in conformity with U.S. generally accepted accounting principles.

We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (PCAOB), the Company’s internal control over financial reporting as of December 31, 2018, based on criteria established in Internal Control-Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (2013 framework) and our report dated February 13, 2019 expressed an unqualified opinion thereon.

Basis for Opinion

These financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s financial statements based on our audits. We are a public accounting firm registered with the PCAOB and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.

We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement, whether due to error or fraud. Our audits included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the financial statements. We believe that our audits provide a reasonable basis for our opinion.

/s/ Ernst & Young LLP

We have served as the Company’s auditor since 1980.

Los Angeles, California

February 13, 2019

F-1

AMGEN INC.

CONSOLIDATED STATEMENTS OF INCOME

Years ended December 31, 2018, 2017 and 2016

(In millions, except per-share data)

	2018				2017				2016
Revenues:
Product sales	$	22,533			$	21,795			$	21,892
Other revenues	1,214				1,054				1,099
Total revenues	23,747				22,849				22,991
Operating expenses:
Cost of sales	4,101				4,069				4,162
Research and development	3,737				3,562				3,840
Selling, general and administrative	5,332				4,870				5,062
Other	314				375				133
Total operating expenses	13,484				12,876				13,197
Operating income	10,263				9,973				9,794
Interest expense, net	1,392				1,304				1,260
Interest and other income, net	674				928				629
Income before income taxes	9,545				9,597				9,163
Provision for income taxes	1,151				7,618				1,441
Net income	$	8,394			$	1,979			$	7,722
Earnings per share:
Basic	$	12.70			$	2.71			$	10.32
Diluted	$	12.62			$	2.69			$	10.24
Shares used in the calculation of earnings per share:
Basic	661				731				748
Diluted	665				735				754

See accompanying notes.

F-2

AMGEN INC.

CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME

Years ended December 31, 2018, 2017 and 2016

(In millions)

	2018				2017				2016
Net income	$	8,394			$	1,979			$	7,722
Other comprehensive (loss) income, net of reclassification adjustments and taxes:
(Losses) gains on foreign currency translation	(141		)		81				(99		)
Gains (losses) on cash flow hedges	247				(288		)		(15		)
(Losses) gains on available-for-sale securities	(185		)		(6		)		122
Other	(2		)		5				1
Other comprehensive (loss) income, net of tax	(81		)		(208		)		9
Comprehensive income	$	8,313			$	1,771			$	7,731

See accompanying notes.

F-3

AMGEN INC.

CONSOLIDATED BALANCE SHEETS

December 31, 2018 and 2017

(In millions, except per-share data)

	2018				2017
ASSETS
Current assets:
Cash and cash equivalents	$	6,945			$	3,800
Marketable securities	22,359				37,878
Trade receivables, net	3,580				3,237
Inventories	2,940				2,834
Other current assets	1,794				1,727
Total current assets	37,618				49,476
Property, plant and equipment, net	4,958				4,989
Intangible assets, net	7,443				8,609
Goodwill	14,699				14,761
Other assets	1,698				2,119
Total assets	$	66,416			$	79,954
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable	$	1,207			$	1,352
Accrued liabilities	7,862				6,516
Current portion of long-term debt	4,419				1,152
Total current liabilities	13,488				9,020
Long-term debt	29,510				34,190
Long-term deferred tax liabilities	864				1,166
Long-term tax liabilities	8,770				9,099
Other noncurrent liabilities	1,284				1,238
Contingencies and commitments
Stockholders’ equity:
Common stock and additional paid-in capital; $0.0001 par value per share; 2,750.0 shares authorized; outstanding—629.6 shares in 2018 and 722.2 shares in 2017	31,246				30,992
Accumulated deficit	(17,977		)		(5,072		)
Accumulated other comprehensive loss	(769		)		(679		)
Total stockholders’ equity	12,500				25,241
Total liabilities and stockholders’ equity	$	66,416			$	79,954

See accompanying notes.

F-4

AMGEN INC.

CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY

Years ended December 31, 2018, 2017 and 2016

(In millions)

	Number of shares of common stock			Common stock and additional paid-in capital				Accumulated deficit				Accumulated other comprehensive loss				Total
Balance as of December 31, 2015	754.0			$	30,649			$	(2,086	)		$	(480	)		$	28,083
Net income	—			—				7,722				—				7,722
Other comprehensive income, net of tax	—			—				—				9				9
Dividends declared on common stock ($4.15 per share)	—			—				(3,120		)		—				(3,120		)
Issuance of common stock in connection with the Company’s equity award programs	3.9			55				—				—				55
Stock-based compensation expense	—			342				—				—				342
Tax impact related to employee stock-based compensation expense	—			(262		)		73				—				(189		)
Repurchases of common stock	(19.7	)		—				(3,027		)		—				(3,027		)
Balance as of December 31, 2016	738.2			30,784				(438		)		(471		)		29,875
Net income	—			—				1,979				—				1,979
Other comprehensive loss, net of tax	—			—				—				(208		)		(208		)
Dividends declared on common stock ($4.77 per share)	—			—				(3,487		)		—				(3,487		)
Issuance of common stock in connection with the Company’s equity award programs	2.5			52				—				—				52
Stock-based compensation expense	—			347				—				—				347
Tax impact related to employee stock-based compensation expense	—			(191		)		—				—				(191		)
Repurchases of common stock	(18.5	)		—				(3,126		)		—				(3,126		)
Balance as of December 31, 2017	722.2			30,992				(5,072		)		(679		)		25,241
Cumulative effect of changes in accounting principles, net of tax	—			—				38				(9		)		29
Net income	—			—				8,394				—				8,394
Other comprehensive loss, net of tax	—			—				—				(81		)		(81		)
Dividends declared on common stock ($5.41 per share)	—			—				(3,482		)		—				(3,482		)
Issuance of common stock in connection with the Company’s equity award programs	1.9			56				—				—				56
Stock-based compensation expense	—			327				—				—				327
Tax impact related to employee stock-based compensation expense	—			(129		)		—				—				(129		)
Repurchases of common stock	(94.5	)		—				(17,855		)		—				(17,855		)
Balance as of December 31, 2018	629.6			$	31,246			$	(17,977	)		$	(769	)		$	12,500

See accompanying notes.

F-5

AMGEN INC.

CONSOLIDATED STATEMENTS OF CASH FLOWS

Years ended December 31, 2018, 2017 and 2016

(In millions)

	2018				2017				2016
Cash flows from operating activities:
Net income	$	8,394			$	1,979			$	7,722
Depreciation and amortization	1,946				1,955				2,105
Stock-based compensation expense	311				329				311
Deferred income taxes	(363		)		(1,330		)		183
Other items, net	386				334				32
Changes in operating assets and liabilities, net of acquisitions:
Trade receivables, net	(378		)		(58		)		(214		)
Inventories	(3		)		133				(80		)
Other assets	35				(24		)		(128		)
Accounts payable	(143		)		424				(44		)
Accrued income taxes, net	(361		)		523				(301		)
Long-term tax liabilities	258				6,681				445
Other liabilities	1,214				231				323
Net cash provided by operating activities	11,296				11,177				10,354
Cash flows from investing activities:
Purchases of marketable securities	(18,741		)		(33,607		)		(28,094		)
Proceeds from sales of marketable securities	28,356				24,240				17,958
Proceeds from maturities of marketable securities	5,412				6,174				2,459
Purchases of property, plant and equipment	(738		)		(664		)		(738		)
Cash acquired in acquisition, net of cash paid	195				(19		)		—
Other	(145		)		(148		)		(243		)
Net cash provided by (used in) investing activities	14,339				(4,024		)		(8,658		)
Cash flows from financing activities:
Net proceeds from issuance of debt	—				4,476				7,318
Repayment of debt	(1,121		)		(4,405		)		(3,725		)
Repurchases of common stock	(17,794		)		(3,160		)		(2,965		)
Dividends paid	(3,507		)		(3,365		)		(2,998		)
Withholding taxes arising from shares withheld for share-based payments	(126		)		(191		)		(260		)
Other	58				51				31
Net cash used in financing activities	(22,490		)		(6,594		)		(2,599		)
Increase (decrease) in cash and cash equivalents	3,145				559				(903		)
Cash and cash equivalents at beginning of year	3,800				3,241				4,144
Cash and cash equivalents at end of year	$	6,945			$	3,800			$	3,241

See accompanying notes.

F-6

AMGEN INC.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

December 31, 2018

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.

Principles of consolidation

The 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 consolidated financial statements in conformity with U.S. generally accepted accounting principles (GAAP) requires management to make estimates and assumptions that affect the amounts reported in the consolidated financial statements and accompanying notes. Actual results may differ from those estimates.

Revenues

Adoption of new revenue recognition standard

In May 2014, the Financial Accounting Standards Board (FASB) issued a new accounting standard that amends the guidance for the recognition of revenue from contracts with customers to transfer goods and services. The FASB subsequently issued additional, clarifying standards to address issues arising from implementation of the new revenue recognition standard. The new revenue recognition standard and clarifying standards require an entity to recognize revenue when control of promised goods or services is transferred to the customer at an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. We adopted this new standard as of January 1, 2018, by applying the modified-retrospective method to those contracts that were not completed as of that date.

The results for reporting periods beginning after January 1, 2018, are presented in accordance with the new standard, although comparative information has not been restated and continues to be reported under the accounting standards and policies in effect for those periods.

Upon adoption, we recorded a net decrease of $25 million to Accumulated deficit due to the cumulative impact of adopting the new standard—with the impact related primarily to the acceleration of deferred revenue, net of related deferred tax impact. The adoption of this new standard had an immaterial impact on our reported total revenues and operating income as compared to what reported amounts would have been under the prior standard, and we expect the impact of adoption in future periods to also be immaterial. Our accounting policies under the new standard were applied prospectively and are described below. See Note 4, Revenues.

Product sales and sales deductions

Revenue from product sales is recognized upon transfer of control of a product to a customer, generally upon delivery, based on an amount that reflects the consideration to which we expect to be entitled, net of accruals for estimated rebates, wholesaler chargebacks, discounts and other deductions (collectively, sales deductions) and returns established at the time of sale.

We analyze the adequacy of our accruals for sales deductions quarterly. Amounts accrued for sales deductions are adjusted when trends or significant events indicate that an adjustment is appropriate. Accruals are also adjusted to reflect actual results. Accruals for sales deductions are based primarily on estimates of the amounts earned or to be claimed on the related sales. These estimates take into consideration current contractual and statutory requirements, specific known market events and trends, internal and external historical data and forecasted customer buying patterns. Sales deductions are substantially product specific and therefore, for any given period, can be affected by the mix of products sold. Included in sales deductions are immaterial net adjustments related to prior-period sales due to changes in estimates. Historically, such amounts have represented less than 1% of the aggregate sales deductions charged against product sales.

F-7

Returns are estimated through comparison of historical return data to their related sales on a production lot basis. Historical rates of return are determined for each product and are adjusted for known or expected changes in the marketplace specific to each product, when appropriate. Historically, sales return provisions have amounted to less than 1% of gross product sales. Changes in estimates for prior-period sales return provisions have historically been immaterial.

Our payment terms vary by types and locations of customers and the products or services offered. Payment terms differ by jurisdiction and customer, but payment is generally required in a term ranging from 30 to 120 days from date of shipment or satisfaction of the performance obligation. For certain products or services and certain customer types, we may require payment before products are delivered or services are rendered to customers.

Indirect taxes collected from customers and remitted to government authorities and that are related to sales of the Company’s products, primarily in Europe, are excluded from revenues.

As a practical expedient, sales commissions are expensed when incurred because the amortization period would have been one year or less. These costs are recorded in Selling, general and administrative expense in the Consolidated Statements of Income.

Other revenues

Other revenues consist primarily of royalty income and corporate partner revenues. Royalties from licensees are based on third-party sales of licensed products and are recorded when the related third-party product sale occurs. Royalty estimates are based on historical and forecasted sales trends. Corporate partner revenues are composed mainly of license fees and milestones earned and our share of commercial profits generated from collaborations. See Arrangements with multiple-performance obligations, discussed below.

Arrangements with multiple-performance obligations

From time to time, we enter into arrangements for the research and development (R&D), manufacture and/or commercialization of products and product candidates. Such arrangements may require us to deliver various rights, services and/or goods, including intellectual property rights/licenses, R&D services, manufacturing services and/or commercialization services. The underlying terms of these arrangements generally provide for consideration to Amgen in the form of nonrefundable upfront license fees, development and commercial performance milestone payments, royalty payments and/or profit sharing.

In arrangements involving more than one performance obligation, each required performance obligation is evaluated to determine whether it qualifies as a distinct performance obligation based on whether (i) the customer can benefit from the good or service either on its own or together with other resources that are readily available and (ii) the good or service is separately identifiable from other promises in the contract. The consideration under the arrangement is then allocated to each separate distinct performance obligation based on its respective relative stand-alone selling price. The estimated selling price of each deliverable reflects our best estimate of what the selling price would be if the deliverable was regularly sold by us on a stand-alone basis or using an adjusted market assessment approach if selling price on a stand-alone basis is not available.

The consideration allocated to each distinct performance obligation is recognized as revenue when control of the related goods or services is transferred. Consideration associated with at-risk substantive performance milestones is recognized as revenue when it is probable that a significant reversal of the cumulative revenue recognized will not occur. We utilize the sales and usage-based royalty exception in arrangements that resulted from the license of intellectual property, recognizing revenues generated from royalties or profit sharing as the underlying sales occur.

Research and development costs

R&D costs are expensed as incurred and include primarily salaries, benefits and other staff-related costs; facilities and overhead costs; clinical trial and related clinical manufacturing costs; contract services and other outside costs; information systems’ costs; and amortization of acquired technology used in R&D with alternative future uses. R&D expenses also include costs and cost recoveries associated with third-party R&D arrangements, including upfront fees and milestones paid to third parties in connection with technologies that had not reached technological feasibility and did not have an alternative future use. Net payment or reimbursement of R&D costs is recognized when the obligations are incurred or as we become entitled to the cost recovery. See Note 9, Collaborations.

Selling, general and administrative costs

Selling, general and administrative (SG&A) costs are composed primarily of salaries, benefits and other staff-related costs associated with sales and marketing, finance, legal and other administrative personnel; facilities and overhead costs; outside marketing, advertising and legal expenses; the U.S. healthcare reform federal excise fee on Branded Prescription Pharmaceutical Manufacturers and Importers; and other general and administrative costs. Advertising costs are expensed as incurred and were $674 million, $620 million and $489 million during the years ended December 31, 2018, 2017 and 2016, respectively. SG&A expenses also include costs and cost recoveries associated with marketing and promotion efforts under certain collaborative

F-8

arrangements. Net payment or reimbursement of SG&A costs is recognized when the obligations are incurred or we become entitled to the cost recovery. See Note 9, Collaborations.

Stock-based compensation

We have stock-based compensation plans under which various types of equity-based awards are granted, including restricted stock units (RSUs), performance units and stock options. The fair values of RSUs and stock option awards, which are subject only to service conditions with graded vesting, are recognized as compensation expense, generally on a straight-line basis over the service period, net of estimated forfeitures. The fair values of performance unit awards are recognized as compensation expense, generally on a straight-line basis from the grant date to the end of the performance period. See Note 5, Stock-based compensation.

Income taxes

We provide for income taxes based on pretax income and applicable tax rates in the various jurisdictions in which we operate. Significant judgment is required in determining our provision for income taxes and income tax assets and liabilities, including evaluating uncertainties in the application of accounting principles and complex tax laws. Deferred income taxes are recorded for the expected tax consequences of temporary differences between the bases of assets and liabilities, as well as for loss and tax credit carryforwards for financial reporting purposes and amounts recognized for income tax purposes. We record a valuation allowance to reduce our deferred tax assets to the amount of future tax benefit that is more likely than not to be realized.

We recognize the tax benefit from an uncertain tax position only if it is more likely than not that the tax position will be sustained upon examination by the taxing authorities based on the technical merits of the position. The tax benefit recognized in the consolidated financial statements for a particular tax position is based on the largest benefit that is more likely than not to be realized. The amount of unrecognized tax benefits (UTBs) is adjusted as appropriate for changes in facts and circumstances, such as significant amendments to existing tax law, new regulations or interpretations by the taxing authorities, new information obtained during a tax examination, or resolution of an examination. We recognize both accrued interest and penalties, where appropriate, related to UTBs in income tax expense. See Note 7, Income taxes.

Business combinations

Business combinations are accounted for using the acquisition method of accounting. Under the acquisition method, assets acquired, including in-process research and development (IPR&D) projects, and liabilities assumed are recorded at their respective fair values as of the acquisition date in our consolidated financial statements. The excess of the fair value of consideration transferred over the fair value of the net assets acquired is recorded as goodwill. Contingent consideration obligations incurred in connection with a business combination (including the assumption of an acquiree’s liability arising from a business combination it consummated prior to our acquisition) are recorded at their fair values on the acquisition date and remeasured at their fair values each subsequent reporting period until the related contingencies are resolved. The resulting changes in fair values are recorded in earnings. See Note 3, Business combinations, and Note 18, Fair value measurement.

Cash equivalents

We consider cash equivalents to be only those investments that are highly liquid, readily convertible to cash and which mature within three months from the date of purchase.

Interest-bearing securities

We consider our interest-bearing securities investment portfolio available-for-sale, and accordingly, these investments are recorded at fair value, with unrealized gains and losses recorded in Accumulated other comprehensive income (loss) (AOCI). Investments with maturities beyond one year may be classified as short-term marketable securities in the Consolidated Balance Sheets due to their highly liquid nature and because they represent the Company’s investments that are available for current operations. See Note 11, Investments, and Note 18, Fair value measurement.

Inventories

Inventories are stated at the lower of cost or net realizable value. Cost, which includes amounts related to materials, labor and overhead, is determined in a manner that approximates the first-in, first-out method. Net realizable value is the estimated selling price in the ordinary course of business less reasonably predictable costs of completion, disposal and transportation. See Note 12, Inventories.

Derivatives

We recognize all of our derivative instruments as either assets or liabilities at fair value in the Consolidated Balance Sheets. The accounting for changes in the fair value of a derivative instrument depends on whether the derivative has been formally designated and qualifies as part of a hedging relationship under the applicable accounting standards and, further, on the type of

F-9

hedging relationship. For derivatives formally designated as hedges, we assess both at inception and quarterly thereafter, whether the hedging derivatives are highly effective in offsetting changes in either the fair value or cash flows of the hedged item. Our derivatives that are not designated and do not qualify as hedges are adjusted to fair value through current earnings. See Note 18, Fair value measurement, and Note 19, Derivative instruments.

Property, plant and equipment, net

Property, plant and equipment is recorded at historical cost, net of accumulated depreciation, amortization and, if applicable, impairment charges. We review our property, plant and equipment assets for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Depreciation is provided over the assets’ useful lives on a straight-line basis. Leasehold improvements are amortized on a straight-line basis over the shorter of their estimated useful lives or lease terms. See Note 13, Property, plant and equipment.

Goodwill and other intangible assets

Finite-lived intangible assets are recorded at cost, net of accumulated amortization, and, if applicable, impairment charges. Amortization of finite-lived intangible assets is provided over their estimated useful lives on a straight-line basis or based on the pattern in which economic benefits are consumed, if reliably determinable. We review our finite-lived intangible assets for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. See Note 14, Goodwill and other intangible assets.

The fair values of IPR&D projects acquired in a business combination that are not complete are capitalized and accounted for as indefinite-lived intangible assets until completion or abandonment of the related R&D efforts. Upon successful completion of the project, the capitalized amount is amortized over its estimated useful life. If a project is abandoned, all remaining capitalized amounts are written off immediately. There are often major risks and uncertainties associated with IPR&D projects as we are required to obtain regulatory approvals in order to be able to market the resulting products. Such approvals require completing clinical trials that demonstrate a product candidate is safe and effective. Consequently, the eventual realized value of the acquired IPR&D project may vary from its fair value at the date of acquisition, and IPR&D impairment charges may occur in future periods.

Capitalized IPR&D projects are tested for impairment annually and whenever events or changes in circumstances indicate that the carrying amount may not be recoverable. We consider various factors for potential impairment, including the current legal and regulatory environment and the competitive landscape. Adverse clinical trial results, significant delays in obtaining marketing approval, the inability to bring a product to market and the introduction or advancement of competitors’ products could result in partial or full impairment of the related intangible assets.

We perform an impairment test of goodwill annually and whenever events or changes in circumstances indicate that the carrying amount may not be recoverable. To date, an impairment of goodwill has not been recorded. See Note 14, Goodwill and other intangible assets.

Contingencies

In the ordinary course of business, we are involved in various legal proceedings, government investigations and other matters that are complex in nature and have outcomes that are difficult to predict. Certain of these proceedings are discussed in Note 20, Contingencies and commitments. 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.

Foreign currency translation

The net assets of international subsidiaries whose local currencies have been determined to be the functional currencies are translated into U.S. dollars using current exchange rates. The U.S. dollar effects that arise from translating net assets of these subsidiaries at changing rates are recognized in AOCI. The earnings of these subsidiaries are translated into U.S. dollars using average exchange rates.

Other recently adopted pronouncements

In January 2016, the FASB issued a new accounting standard that amends the accounting and disclosures of financial instruments, including a provision requiring that equity investments (except for investments accounted for under the equity method of accounting) be measured at fair value, with changes in fair value recognized in current earnings. With the exception of equity investments that were previously accounted for at cost, a modified-retrospective approach was used to reflect the cumulative-effect of adoption as an adjustment to Accumulated deficit as of the beginning of the fiscal year. The new standard will be applied prospectively to investments currently that were previously accounted for at cost. Upon adoption, on January 1, 2018, we recorded

F-10

an immaterial adjustment to Accumulated deficit from AOCI, which represented the net unrealized gain on all equity investments with readily determinable fair values as of December 31, 2017. The impact that this new standard has on our consolidated statements of income after adoption will depend on changes in fair values of equity securities in our portfolio in the future. See Note 11, Investments.

In October 2016, the FASB issued a new accounting standard that amends the income tax accounting guidance for intra-entity transfers of assets other than inventory. The new standard requires that entities recognize the income tax consequences of an intercompany transfer of an asset, other than inventory, in the period the transfer occurs. The current exception to defer the recognition of any tax impact on intercompany transfers of inventory until the inventory is sold to a third party remains unaffected. We adopted this standard as of January 1, 2018, and will apply it to any transaction occurring on or after the adoption date. The adoption of this standard did not have a material impact on our consolidated financial statements; however, the impact on our consolidated financial statements in future periods will depend on the facts and circumstances of future transactions.

In January 2017, the FASB issued a new accounting standard that changes the definition of a business to assist entities with the evaluation of when a set of assets acquired or disposed of should be considered a business. The new standard requires that an entity evaluate whether substantially all of the fair value of the gross assets acquired is concentrated in a single identifiable asset or group of similar identifiable assets; if so, the set of assets would not be considered a business. The new standard also requires that a business include at least one substantive process, and it narrows the definition of outputs. We adopted this standard as of January 1, 2018. Adoption of this new standard may result in more transactions being accounted for as asset acquisitions versus business combinations; however, the impact on our consolidated financial statements in future periods will depend on the facts and circumstances of future transactions.

In August 2017, the FASB issued a new accounting standard that amends the accounting and reporting of hedging activities, which we elected to adopt early during the second quarter of 2018. Among its provisions, the new standard (i) eliminates the separate measurement and reporting of hedge ineffectiveness and (ii) permits an entity to recognize in earnings the initial fair value of an excluded component of a hedging instrument’s fair value under a systematic and rational method over the life of the derivative instrument. In accordance with the transition provisions of the new standard, the separate measurement of ineffectiveness for our cash flow hedging instruments existing as of the date of adoption is required to be eliminated through a cumulative-effect adjustment to Accumulated deficit as of January 1, 2018, the beginning of the fiscal year. In addition, certain provisions in the guidance require modifications to existing presentation and disclosure requirements on a prospective basis. The adoption of this standard did not have a material impact on our consolidated financial statements. See Note 19, Derivative instruments.

Other recent accounting pronouncements

In February 2016, the FASB issued a new accounting standard that amends the guidance for the accounting and disclosure of leases. This new standard requires that lessees recognize on the balance sheet the assets and liabilities that arise from leases, including leases classified as operating leases under current GAAP, and disclose qualitative and quantitative information about leasing arrangements. The new standard requires a modified-retrospective approach to adoption and is effective for interim and annual periods beginning on January 1, 2019. In July 2018, the FASB further amended this standard to allow for a new transition method that offers the option to use the effective date as the date of initial application. We intend to elect this alternative transition method and therefore will not adjust comparative-period financial information. In addition, we intend to elect the package of practical expedients permitted under the transition guidance of the new standard to not reassess prior conclusions related to contracts that are or that contain leases, lease classification and initial direct costs. We do not expect that this standard will have a material impact on our Consolidated Statements of Income. The primary effect of adoption will be the requirement to record the present value of lease liabilities for current operating leases and corresponding right-of-use (ROU) assets. Upon adoption, we estimate we will have additional liabilities ranging from $400 million to $450 million with corresponding ROU assets of a similar amount for lease agreements in effect as of December 31, 2018. The actual impact will depend on our lease portfolio at the time of adoption. We are currently finalizing the implementation of the lease accounting information system, documenting processes, and establishing internal controls to properly track, record and account for our lease portfolio. The new standard also provides practical expedients for the ongoing accounting. We also currently expect to elect the practical expedient to not separate lease and nonlease components for most of our asset classes.

In June 2016, the FASB issued a new accounting standard that amends the guidance for measuring and recording credit losses on financial assets measured at amortized cost by replacing the incurred-loss model with an expected-loss model. Accordingly, these financial assets will be presented at the net amount expected to be collected. This new standard also requires that credit losses related to available-for-sale debt securities be recorded as an allowance through net income rather than reducing the carrying amount under the current, other-than-temporary-impairment model. The new standard is effective for interim and annual periods beginning on January 1, 2020, but may be adopted earlier, beginning on January 1, 2019. With certain exceptions, adjustments are to be applied using a modified-retrospective approach by reflecting adjustments through a cumulative-effect impact on retained earnings as of the beginning of the fiscal year of adoption. We are currently evaluating the impact that this new standard will have on our consolidated financial statements.

2. Restructuring

In 2014, we initiated a restructuring plan to invest in continuing innovation and the launch of our new pipeline molecules, while improving our cost structure. As part of the plan, we closed facilities in Washington State and Colorado and are reducing the number of buildings we occupy at our headquarters in Thousand Oaks, California, as well as at other locations. We completed the activities associated with this restructuring plan in 2018.

Through December 31, 2018, we incurred $548 million of separation costs and other headcount-related costs for staff reductions and $261 million of net asset-related charges, which consist primarily of asset impairments, accelerated depreciation and other related costs resulting from the consolidation of our worldwide facilities. During the years ended December 31, 2018, 2017 and 2016, we incurred restructuring costs of $12 million, $88 million and $37 million, respectively. As of December 31, 2018 and 2017, the restructuring liabilities were not significant.

3. Business combinations

Kirin-Amgen, Inc.

During the first quarter of 2018, we acquired the remaining 50% ownership of Kirin-Amgen, Inc. (K-A), from Kirin Holdings Company, Limited (Kirin), making K-A a wholly owned subsidiary of Amgen. Upon its acquisition, K-A’s operations have been included in our consolidated financial statements commencing on the share acquisition date. The acquisition relieved Amgen of future royalty obligations to K-A.

Prior to the share acquisition date, we owned 50% of K-A and accounted for our interest in K-A by using the equity method of accounting. See Note 10, Related party transactions.

The transaction was accounted for as a step acquisition of a business in which we were required to remeasure our existing 50% ownership interest at fair value. In addition, we were required to effectively settle our preexisting relationship with K-A, which resulted in a loss. Together the gain on the remeasurement of our existing ownership interest and the loss from the settlement of the preexisting relationship resulted in a net gain of $80 million, which was recorded in Interest and other income, net, in the Consolidated Statements of Income.

The primary means of consideration for this transaction was a payment of $780 million in cash. The aggregate share acquisition date consideration to acquire the remaining 50% ownership in K-A and the fair value of Amgen’s preacquisition investment consisted of the following (in millions):

		Amounts
Total cash paid to Kirin		$	780
Fair value of contingent consideration obligation		45
Loss on settlement of preexisting relationship		(168		)
Total consideration transferred to acquire K-A		657
Fair value of Amgen’s investment in K-A		825
Total acquisition date fair value		$	1,482

F-11

In connection with this acquisition, we are obligated to make single-digit royalty payments to Kirin contingent upon sales of brodalumab. The estimated fair value of this contingent consideration obligation was $45 million as of the share acquisition date.

The fair values of assets acquired and liabilities assumed consisted of cash of $977 million, licensing rights of $470 million, deferred tax liabilities of $102 million, other assets and liabilities of $131 million and goodwill of $6 million. The estimated fair value of acquired licensing rights was determined by using a probability-weighted-income approach, which discounts expected future cash flows to present value by using a discount rate that represents the estimated rate that market participants would use to value the assets. The projected cash flows were based on certain assumptions, including estimates of future revenues and expenses and the time and resources needed to maintain the assets through commercialization. The licensing rights will be amortized over a weighted-average period of four years by using the straight-line method. The excess of the share acquisition date consideration over the fair values assigned to the assets acquired and the liabilities assumed of $6 million was recorded as goodwill, which is not deductible for tax purposes. The $131 million in other assets and liabilities represents primarily receivables for royalties earned by K-A but not yet received, offset partially by payables representing R&D expenses incurred but not yet reimbursed by K-A.

Pro forma results of operations for this acquisition have not been presented because this acquisition is not material to our consolidated results of operations.

4. Revenues

We operate in one business segment: human therapeutics. Therefore, results of our operations are reported on a consolidated basis for purposes of segment reporting, consistent with internal management reporting. Revenues by product and by geographic area, based on customers’ locations, are presented below. Rest-of-world (ROW) revenues relate to products that are sold principally in Europe.

Revenues were as follows (in millions):

		Year ended December 31, 2018
		US				ROW				Total
Enbrel® (etanercept)		$	4,807			$	207			$	5,014
Neulasta® (pegfilgrastim)		3,866				609				4,475
Prolia® (denosumab)		1,500				791				2,291
Aranesp® (darbepoetin alfa)		942				935				1,877
XGEVA® (denosumab)		1,338				448				1,786
Sensipar® / Mimpara® (cinacalcet)		1,436				338				1,774
EPOGEN® (epoetin alfa)		1,010				—				1,010
Other products		2,530				1,776				4,306
Total product sales(1)		17,429				5,104				22,533
Other revenues		929				285				1,214
Total revenues(2)		$	18,358			$	5,389			$	23,747

F-12

		Year ended December 31, 2017
		US				ROW				Total
ENBREL		$	5,206			$	227			$	5,433
Neulasta®		3,931				603				4,534
Aranesp®		1,114				939				2,053
Prolia®		1,272				696				1,968
Sensipar® / Mimpara®		1,374				344				1,718
XGEVA®		1,157				418				1,575
EPOGEN®		1,096				—				1,096
Other products		1,981				1,437				3,418
Total product sales(1)		17,131				4,664				21,795
Other revenues		898				156				1,054
Total revenues(2)		$	18,029			$	4,820			$	22,849

		Year ended December 31, 2016
		US				ROW				Total
ENBREL		$	5,719			$	246			$	5,965
Neulasta®		3,925				723				4,648
Aranesp®		1,082				1,011				2,093
Prolia®		1,049				586				1,635
Sensipar® / Mimpara®		1,240				342				1,582
XGEVA®		1,115				414				1,529
EPOGEN®		1,282				—				1,282
Other products		1,913				1,245				3,158
Total product sales(1)		17,325				4,567				21,892
Other revenues		1,001				98				1,099
Total revenues(2)		$	18,326			$	4,665			$	22,991

---

(1)	Hedging gains and losses, which are included in product sales, were not material for the years ended December 31, 2018 and 2017. For the year ended December 31, 2016, hedging gains were $308 million.

(2)	Prior-period amounts are not adjusted under the modified-retrospective method of adoption of the new revenue recognition accounting standard.

F-13

5. Stock-based compensation

Our Amended and Restated 2009 Equity Incentive Plan (the Amended 2009 Plan) authorizes for issuance to employees of Amgen, employees of Amgen subsidiaries and nonemployee members of our Board of Directors shares of our common stock pursuant to grants of equity-based awards, including RSUs, stock options and performance units. The pool of shares available under the Amended 2009 Plan is reduced by one share for each stock option granted and by 1.9 shares for other types of awards granted, including RSUs and performance units (full-value awards). In general, if any shares subject to an award granted under the Amended 2009 Plan expire or become forfeited, terminated or canceled without the issuance of shares, the shares subject to such awards are added back into the authorized pool on the same basis that they were removed. In addition, under the Amended 2009 Plan, shares withheld to pay for minimum statutory tax obligations with respect to full-value awards are added back into the authorized pool on the basis of 1.9 shares. As of December 31, 2018, the Amended 2009 Plan provides for future grants and/or issuances of up to 32 million shares of our common stock. Stock-based awards under our employee compensation plans are made with newly issued shares reserved for this purpose.

The following table reflects the components of stock-based compensation expense recognized in our Consolidated Statements of Income (in millions):

	Years ended December 31,
	2018				2017				2016
RSUs	$	165			$	174			$	177
Performance units	117				133				123
Stock options	29				22				11
Total stock-based compensation expense, pretax	311				329				311
Tax benefit from stock-based compensation expense	(67		)		(118		)		(112		)
Total stock-based compensation expense, net of tax	$	244			$	211			$	199

Restricted stock units and stock options

Eligible employees generally receive an annual grant of RSUs and, for certain executive-level employees, stock options, with the size and type of award generally determined by the employee’s salary grade and performance level. In 2016, we reinstated the practice of granting stock options to eligible employees annually, which had been suspended from 2012 through 2015. In addition, certain management and professional-level employees typically receive RSU grants upon commencement of employment. Nonemployee members of our Board of Directors also receive an annual grant of RSUs.

Our RSU and stock option grants provide for accelerated or continued vesting in certain circumstances as defined in the plans and related grant agreements, including upon death, disability, termination in connection with a change in control and the retirement of employees who meet certain service and/or age requirements. RSUs and stock options generally vest in equal amounts on the second, third and fourth anniversaries of the grant date. RSUs accrue dividend equivalents, which are typically payable in shares, only when and to the extent the underlying RSUs vest and are issued to the recipient.

Restricted stock units

The grant date fair value of an RSU equals the closing price of our common stock on the grant date, as RSUs accrue dividend equivalents during their vesting period. The weighted-average grant date fair values of RSUs granted during the years ended December 31, 2018, 2017 and 2016, were $179.18, $163.99 and $156.76, respectively.

The following table summarizes information regarding our RSUs:

	Year ended December 31, 2018
	Units (in millions)			Weighted-average grant date fair value
Balance nonvested at December 31, 2017	3.4			$	155.11
Granted	1.2			$	179.18
Vested	(1.2	)		$	142.82
Forfeited	(0.3	)		$	163.36
Balance nonvested at December 31, 2018	3.1			$	168.11

F-14

The total grant date fair values of RSUs that vested during the years ended December 31, 2018, 2017 and 2016, were $167 million, $182 million and $193 million, respectively.

As of December 31, 2018, there was $304 million of unrecognized compensation cost related to nonvested restricted stock units and unvested stock options, which is expected to be recognized over a weighted-average period of 1.7 years.

Stock options

The exercise price of stock options is set as the closing price of our common stock on the grant date, and the related number of shares granted is fixed at that point in time. Awards expire 10 years from the date of grant. We use the Black–Scholes option valuation model to estimate the grant date fair value of stock options.

The weighted-average assumptions used in the option valuation model and the resulting weighted-average grant date fair values of stock options granted were as follows:

	Years ended December 31,
	2018				2017				2016
Closing price of our common stock on grant date	$	177.46			$	162.60			$	156.35
Expected volatility (average of implied and historical volatility)	24.6		%		22.7		%		24.3		%
Expected life (in years)	5.8				5.8				5.8
Risk-free interest rate	2.8		%		2.1		%		1.5		%
Expected dividend yield	2.9		%		2.8		%		2.6		%
Fair value of stock options granted	$	34.60			$	27.54			$	27.55

The following table summarizes information regarding our stock options:

	Year ended December 31, 2018
	Options (in millions)			Weighted- average exercise price				Weighted- average remaining contractual life (in years)		Aggregate intrinsic value (in millions)
Balance unexercised at December 31, 2017	4.0			$	127.08
Granted	1.2			$	177.46
Exercised	(0.5	)		$	76.68
Expired/forfeited	(0.3	)		$	163.79
Balance unexercised at December 31, 2018	4.4			$	143.57			7.0		$	225
Vested or expected to vest at December 31, 2018	4.2			$	142.09			6.9		$	220
Exercisable at December 31, 2018	1.2			$	84.01			3.3		$	135

The total intrinsic values of options exercised during the years ended December 31, 2018, 2017 and 2016, were $53 million, $60 million and $102 million, respectively. The actual tax benefits realized from tax deductions from option exercises during the years ended December 31, 2018, 2017 and 2016, were $12 million, $21 million and $37 million, respectively.

Performance units

Certain management-level employees also receive annual grants of performance units, which give the recipient the right to receive common stock that is contingent upon achievement of specified preestablished goals over the performance period, which is generally three years. The performance goals for the units granted during the years ended December 31, 2018, 2017 and 2016, which are accounted for as equity awards, are based on (i) Amgen’s stockholder return compared with a comparator group of companies, which are considered market conditions and are therefore reflected in the grant date fair values of the units, and (ii) Amgen’s stand-alone financial performance measures, which are considered performance conditions. The expense recognized for awards is based on the grant date fair value of a unit multiplied by the number of units expected to be earned with respect to the related performance conditions, net of estimated forfeitures. Depending on the outcome of these performance goals, a recipient may ultimately earn a number of units greater or less than the number of units granted. Shares of our common stock are issued on a one-for-one basis for each performance unit earned. In general, performance unit awards vest at the end of the performance period. The performance award program provides for accelerated or continued vesting in certain circumstances as defined in the plan, including upon death, disability, a change in control and retirement of employees who meet certain service and/or age

F-15

requirements. Performance units accrue dividend equivalents that are typically payable in shares only when and to the extent the underlying performance units vest and are issued to the recipient, including with respect to market and performance conditions that affect the number of performance units earned.

We use a payout simulation model to estimate the grant date fair value of performance units. The weighted-average assumptions used in this model and the resulting weighted-average grant date fair values of performance units granted were as follows:

	Years ended December 31,
	2018				2017				2016
Closing price of our common stock on grant date	$	177.93			$	162.60			$	156.35
Volatility	23.8		%		25.9		%		25.8		%
Risk-free interest rate	2.6		%		1.4		%		0.9		%
Fair value of units granted	$	189.21			$	178.87			$	170.56

The payout simulation model assumes correlations of returns of the stock prices of our common stock and the common stocks of the comparator groups of companies and stock price volatilities of the comparator groups of companies to simulate stockholder returns over the performance periods and their resulting impact on the payout percentages based on the contractual terms of the performance units.

As of December 31, 2018 and 2017, 2.0 million and 2.2 million performance units were outstanding with weighted-average grant date fair values of $180.12 and $177.16 per unit, respectively. During the year ended December 31, 2018, 0.8 million performance units with a weighted-average grant date fair value of $189.21 were granted, and 0.2 million performance units with a weighted-average grant date fair value of $177.95 were forfeited.

The total fair values of performance units that vested during the years ended December 31, 2018, 2017 and 2016 were $133 million, $219 million and $347 million, respectively, based on the number of performance units earned multiplied by the closing stock price of our common stock on the last day of the performance period.

As of December 31, 2018, there was $131 million of unrecognized compensation cost, which is expected to be recognized over a weighted-average period of one year.

6. Defined contribution plan

The Company has defined contribution plans to which employees of the Company and participating subsidiaries may defer compensation for income tax purposes. Participants are eligible to receive matching contributions based on their contributions, in addition to other Company contributions. Defined contribution plan expenses were $173 million, $196 million and $174 million for the years ended December 31, 2018, 2017 and 2016, respectively.

7. Income taxes

On December 22, 2017, the United States enacted major tax reform legislation, Public Law No. 115-97, commonly referred to as the Tax Cuts and Jobs Act (2017 Tax Act). The 2017 Tax Act imposes a repatriation tax on accumulated earnings of foreign subsidiaries, imposes a current tax on certain foreign earnings and lowers the general corporate income tax rate to 21%. In December 2017, the SEC staff issued Staff Accounting Bulletin No. 118, which allows us to record provisional amounts during a measurement period not to extend beyond one year of the enactment date. We have completed our accounting for the tax effects of the 2017 Tax Act, including the repatriation tax, the net deferred tax remeasurement and the impact on our UTBs. None of the adjustments we made to our provisional amounts were material to our consolidated financial statements.

Income before income taxes included the following (in millions):

	Years ended December 31,
	2018				2017				2016
Domestic	$	4,856			$	4,436			$	4,478
Foreign	4,689				5,161				4,685
Total income before income taxes	$	9,545			$	9,597			$	9,163

F-16

The provision for income taxes included the following (in millions):

	Years ended December 31,
	2018				2017				2016
Current provision:
Federal	$	1,270			$	8,615			$	984
State	17				5				65
Foreign	227				275				176
Total current provision	1,514				8,895				1,225
Deferred (benefit) provision:
Federal	(317		)		(1,120		)		372
State	(7		)		—				(69		)
Foreign	(39		)		(157		)		(87		)
Total deferred (benefit) provision	(363		)		(1,277		)		216
Total provision for income taxes	$	1,151			$	7,618			$	1,441

Deferred income taxes reflect the tax effect of temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes, tax credit carryforwards and the tax effects of net operating loss (NOL) carryforwards. Significant components of our deferred tax assets and liabilities were as follows (in millions):

	December 31,
	2018				2017
Deferred income tax assets:
NOL and credit carryforwards	$	810			$	812
Accrued expenses	428				362
Expenses capitalized for tax	185				155
Stock-based compensation	95				99
Other	174				154
Total deferred income tax assets	1,692				1,582
Valuation allowance	(509		)		(497		)
Net deferred income tax assets	1,183				1,085
Deferred income tax liabilities:
Acquired intangible assets	(1,509		)		(1,748		)
Debt	(184		)		(184		)
Other	(267		)		(240		)
Total deferred income tax liabilities	(1,960		)		(2,172		)
Total deferred income taxes, net	$	(777	)		$	(1,087	)

Valuation allowances are provided to reduce the amounts of our deferred tax assets to an amount that is more likely than not to be realized based on an assessment of positive and negative evidence, including estimates of future taxable income necessary to realize future deductible amounts.

The valuation allowance increased in 2018 due primarily to the Company’s expectation that some state R&D credits will not be utilized.

As of December 31, 2018, we had $20 million of federal tax credit carryforwards available to reduce future federal income taxes and have provided no valuation allowance for those federal tax credit carryforwards. The federal tax credit carryforwards expire between 2026 and 2035. We had $556 million of state tax credit carryforwards available to reduce future state income taxes and have provided a valuation allowance for $444 million of those state tax credit carryforwards. A portion of the state credits for which no valuation allowance has been provided will expire between 2022 and 2024.

F-17

As of December 31, 2018, we had $145 million of federal NOL carryforwards available to reduce future federal income taxes and have provided a valuation allowance for $6 million of those federal NOL carryforwards. The federal NOL carryforwards, for which no valuation allowance has been provided, expire between 2020 and 2035. We had $287 million of state NOL carryforwards available to reduce future state income taxes and have provided a valuation allowance for $263 million of those state NOL carryforwards. The state NOLs for which no valuation allowance has been provided expire between 2019 and 2032. We had $1.8 billion of foreign NOL carryforwards available to reduce future foreign income taxes and have provided a valuation allowance for $485 million of those foreign NOL carryforwards. For the foreign NOLs with no valuation allowance provided, $620 million has no expiry; and the remainder will expire between 2019 and 2024.

The reconciliations of the total gross amounts of UTBs (excluding interest, penalties, foreign tax credits and the federal tax benefit of state taxes related to UTBs) were as follows (in millions):

	Years ended December 31,
	2018				2017				2016
Beginning balance	$	2,953			$	2,543			$	2,114
Additions based on tax positions related to the current year	173				447				425
Additions based on tax positions related to prior years	13				1				18
Reductions for tax positions of prior years	(17		)		(5		)		(7		)
Reductions for expiration of statute of limitations	—				(5		)		—
Settlements	(61		)		(28		)		(7		)
Ending balance	$	3,061			$	2,953			$	2,543

Substantially all of the UTBs as of December 31, 2018, if recognized, would affect our effective tax rate. During the year ended December 31, 2018, we effectively settled various examinations with state tax authorities for prior tax years. As a result of these developments, we remeasured our UTBs accordingly.

Interest and penalties related to UTBs are included in our provision for income taxes. During the years ended December 31, 2018, 2017 and 2016, we recognized $137 million, $56 million and $125 million, respectively, of interest and penalties through the income tax provision in the Consolidated Statements of Income. As of December 31, 2018 and 2017, accrued interest and penalties associated with UTBs were $469 million and $332 million, respectively.

The reconciliations between the federal statutory tax rate applied to income before income taxes and our effective tax rate were as follows:

	Years ended December 31,
	2018			2017			2016
Federal statutory tax rate	21.0	%		35.0	%		35.0	%
2017 Tax Act, net repatriation tax	—	%		70.7	%		—	%
Foreign earnings	(4.3	)%		(15.8	)%		(15.5	)%
2017 Tax Act, net deferred tax remeasurement	—	%		(6.9	)%		—	%
Credits, Puerto Rico Excise Tax	(2.5	)%		(2.2	)%		(2.3	)%
2017 Tax Act, net impact on intercompany sales	(1.8	)%		—	%		—	%
Interest on uncertain tax positions	1.2	%		0.6	%		0.5	%
Credits, primarily federal R&D	(0.8	)%		(0.6	)%		(0.7	)%
Share-based payments	(0.2	)%		(0.7	)%		(1.3	)%
Other, net	(0.5	)%		(0.7	)%		—	%
Effective tax rate	12.1	%		79.4	%		15.7	%

The effective tax rate for the year ended December 31, 2018 differs from the federal statutory rate due primarily to impacts of the jurisdictional mix of income and expenses. The effective tax rate for 2017 differs from the federal statutory rate primarily as a result of the 2017 Tax Act. The effective tax rate for 2016 differs from the federal statutory rate primarily as a result of indefinitely invested earnings of our foreign operations. Substantially all of the benefit to our effective tax rate from foreign earnings results from the Company’s operations conducted in Puerto Rico, a territory of the United States that is treated as a foreign

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jurisdiction for U.S. tax purposes and is subject to tax incentive grants through 2035; these earnings are also subject to U.S. tax at a reduced 10.5% rate.

The U.S. territory of Puerto Rico imposes an excise tax on the gross intercompany purchase price of goods and services from our manufacturer in Puerto Rico. The rate of 4% is effective through December 31, 2027. 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.

Income taxes paid during the years ended December 31, 2018, 2017 and 2016, were $1.9 billion, $1.5 billion and $1.1 billion, respectively.

One or more of our legal entities file income tax returns in the U.S. federal jurisdiction, various U.S. state jurisdictions and certain foreign jurisdictions. Our income tax returns are routinely examined by the tax authorities in those jurisdictions. Significant disputes may arise with authorities involving issues of the timing and amount of deductions, the use of tax credits and allocations of income and expenses among various tax jurisdictions because of differing interpretations of tax laws, regulations and the interpretation of the relevant facts. As previously disclosed, we received a Revenue Agent Report (RAR) from the Internal Revenue Service (IRS) for the years 2010, 2011 and 2012. The RAR proposes to make significant adjustments that relate primarily to the allocation of profits between certain of our entities in the United States and the U.S. territory of Puerto Rico. In November 2017, we received a modified RAR that revised the IRS’s calculation but continued to propose substantial adjustments. We disagree with the proposed adjustments and are pursuing resolution with the IRS administrative appeals office, which currently has jurisdiction over the matter. If we deem necessary, we will vigorously contest the proposed adjustments through the judicial process. Final resolution of this complex matter is not likely within the next 12 months and could have a material impact on our consolidated financial statements. We believe our accrual for income tax liabilities is appropriate based on past experience, interpretations of tax law, and judgments about potential actions by tax authorities; however, due to the complexity of the provision for income taxes, the ultimate resolution of any tax matters may result in payments greater or less than amounts accrued. We are no longer subject to U.S. federal income tax examinations for years ended on or before December 31, 2009. In addition, we are currently under examination by a number of other state and foreign tax jurisdictions.

8. 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 primarily shares that may be issued under our stock option, restricted stock and performance unit award programs, as determined by using the treasury stock method (collectively, dilutive securities).

The computations for basic and diluted EPS were as follows (in millions, except per-share data):

	Years ended December 31,
	2018				2017				2016
Income (Numerator):
Net income for basic and diluted EPS	$	8,394			$	1,979			$	7,722
Shares (Denominator):
Weighted-average shares for basic EPS	661				731				748
Effect of dilutive securities	4				4				6
Weighted-average shares for diluted EPS	665				735				754
Basic EPS	$	12.70			$	2.71			$	10.32
Diluted EPS	$	12.62			$	2.69			$	10.24

For each of the three years ended December 31, 2018, the number of antidilutive employee stock-based awards excluded from the computation of diluted EPS was not significant.

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9. Collaborations

A collaborative arrangement is a contractual arrangement that involves a joint operating activity. Such arrangements involve two or more parties that are both (i) active participants in the activity and (ii) exposed to significant risks and rewards dependent on the commercial success of the activity.

From time to time, we enter into collaborative arrangements for the R&D, manufacture and/or commercialization of products and/or product candidates. These collaborations generally provide for nonrefundable upfront license fees, development and commercial-performance milestone payments, cost sharing, royalty payments and/or profit sharing. Our collaboration arrangements are performed with no guarantee of either technological or commercial success, and each is unique in nature. See Note 1, Summary of significant accounting policies, for additional discussion of revenues recognized for these types of arrangements. Operating expenses for costs incurred pursuant to these arrangements are reported in their respective expense line items in the consolidated statements of income, net of any payments due to or reimbursements due from our collaboration partners, with such reimbursements being recognized at the time the party becomes obligated to pay. Our significant arrangements are discussed below.

Novartis AG

In April 2017, we expanded our existing migraine collaboration with Novartis AG (Novartis). In the United States, Amgen and Novartis jointly develop and collaborate on the commercialization of Aimovig® (erenumab-aooe). Amgen, as the principal, recognizes product sales of Aimovig® in the United States, shares U.S. commercialization costs with Novartis and pays Novartis a significant royalty on net sales in the United States. Novartis holds global co-development rights and exclusive commercial rights outside the United States and Japan for Aimovig® and other specified migraine programs. Novartis pays Amgen double-digit royalties on net sales of the products in the Novartis exclusive territories and funds a portion of global R&D expenses. In addition, Novartis will make a payment to Amgen of up to $100 million if certain commercial and expenditure thresholds are achieved with respect to Aimovig® in the United States. Amgen manufactures and supplies Aimovig® worldwide.

The migraine collaboration will continue for the commercial lives of the products unless terminated in accordance with its terms.

During the year ended December 31, 2018, net costs paid to Novartis for migraine products were $44 million and were recorded primarily in Selling, general and administrative expense in the Consolidated Statements of Income. During the years ended December 31, 2017 and 2016, net costs recovered from Novartis for the migraine products were $124 million and $33 million, respectively, and were recorded primarily in Research and development expense in the Consolidated Statements of Income. During the year ended December 31, 2018, royalties due to Novartis for the migraine products were $43 million and were recorded in Cost of sales in the Consolidated Statements of Income. As a result of certain regulatory and commercial events, we received milestone payments from Novartis of $295 million and $60 million during the years ended December 31, 2018 and 2017, respectively, which were recorded in Other revenues in the Consolidated Statements of Income.

UCB

We are in a collaboration with UCB for the development and commercialization of EVENITYTM (romosozumab). Under our collaboration, UCB has the rights to lead commercialization for EVENITYTM for all indications in Europe, China (excluding Hong Kong) and Brazil. All other territories have been allocated to Amgen. Generally, development costs and future worldwide commercialization profits and losses related to the collaboration after accounting for expenses are shared equally. The collaboration agreement will continue in effect unless terminated earlier in accordance with its terms. During the years ended December 31, 2018, 2017 and 2016, net costs recovered from UCB were not material and were recorded primarily in Research and development expense in the Consolidated Statements of Income.

Bayer HealthCare Pharmaceuticals Inc.

We are in a collaboration with Bayer HealthCare Pharmaceuticals Inc. (Bayer) to jointly develop and commercialize Nexavar® (sorafenib) worldwide, except in Japan. The rights to develop and market Nexavar® in Japan are reserved to Bayer. Nexavar® is currently marketed and sold in more than 100 countries around the world for the treatment of unresectable liver cancer and advanced kidney cancer. In the United States, Nexavar® is also approved for the treatment of patients with locally recurrent or metastatic, progressive, differentiated thyroid carcinoma refractory to radioactive iodine treatment.

In 2015, we amended the terms of our collaboration agreement with Bayer, which terminated the co-promotion agreement in the United States and transferred all U.S. operational responsibilities to Bayer, including commercial and medical affairs activities. Prior to the termination of the co-promotion agreement, we co-promoted Nexavar® with Bayer and shared equally in the profits or losses in the United States. In lieu of this profit share, Bayer now pays Amgen a royalty on U.S. sales of Nexavar® at a percentage rate in the high 30s. Amgen no longer contributes sales force personnel or medical liaisons to support Nexavar®

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in the United States. There are no changes to the global R&D or non-U.S. profit share arrangements in the original agreement, as discussed below.

In all countries outside the United States, excluding Japan, Bayer manages all commercialization activities and incurs all of the sales and marketing expenditures and mutually agreed R&D expenses, for which we continue to reimburse Bayer for half. In these countries, we continue to receive 50% of net profits on sales of Nexavar® after deducting certain Bayer-related costs.

The agreement with Bayer will terminate at the later of the date when patents expire that were issued in connection with product candidates discovered under the agreement or on the last day that we or Bayer market or sell products commercialized under the agreement anywhere in the world. Patents related to Nexavar® begin to expire in 2020.

During the years ended December 31, 2018, 2017 and 2016, Amgen recorded Nexavar® net profits of $164 million, $161 million and $167 million, respectively, which were recognized as Other revenues in the Consolidated Statements of Income. During the years ended December 31, 2018, 2017 and 2016, Amgen recorded royalty income of $91 million, $133 million and $137 million, respectively, in Other revenues in the Consolidated Statements of Income, pursuant to the 2015 amendment to the collaboration agreement. Net R&D expenses related to the agreement were not material for the years ended December 31, 2018, 2017 and 2016.

Other

In addition to the collaborations discussed above, we have various others that are not individually significant to our business at this time. Pursuant to the terms of those agreements, we may be required to pay or we may receive additional amounts upon the achievement of various development and commercial milestones, which in the aggregate could be significant. We may also incur or have reimbursed to us significant R&D costs if the related product candidate were to advance to late-stage clinical trials. In addition, if any products related to these collaborations are approved for sale, we may be required to pay or we may receive significant royalties on future sales. The payment of these amounts, however, is contingent upon the occurrence of various future events, which have a high degree of uncertainty of occurrence.

10. Related party transactions

As of December 31, 2017, we owned a 50% interest in K-A, a corporation formed in 1984 with Kirin for the development and commercialization of certain products based on advanced biotechnology. All of our rights to manufacture and market certain products including pegfilgrastim, filgrastim, darbepoetin alfa, recombinant human erythropoietin and romiplostim are pursuant to exclusive licenses from K-A, which we currently market under the brand names Neulasta®, NEUPOGEN® (filgrastim)/GRANULOKINE®, Aranesp®, EPOGEN® and Nplate® (romiplostim), respectively. During the first quarter of 2018, we acquired the remaining 50% ownership of K-A from Kirin, making K-A a wholly owned subsidiary of Amgen. The transaction was accounted for as a business combination. K-A’s results of operations are now included in our consolidated financial statements, and as a result, transactions between us and K-A are eliminated in consolidation. See Note 3, Business combinations. License agreements with Kirin and Johnson & Johnson (J&J) remain in place.

Prior to the share acquisition, we accounted for our interest in K-A using the equity method and included our share of K-A’s profits or losses in Selling, general and administrative expense in the Consolidated Statements of Income. Our share of K-A’s profits was insignificant for the period January 1, 2018 through the 2018 share acquisition date. For the years ended December 31, 2017 and 2016, our share of K-A’s profits was $68 million and $58 million, respectively. The carrying value of our equity method investment in K-A was $570 million as of December 31, 2017, and is included in Other assets in the Consolidated Balance Sheets.

K-A’s revenues consist of royalty income related to its licensed technology rights. Prior to the share acquisition, K-A received royalty income from us. K-A also received and continues to receive royalty income from Kirin and J&J under separate product license contracts for certain geographic areas outside the United States. Royalties earned by K-A from us were insignificant for the period January 1, 2018 through the 2018 share acquisition date. During the years ended December 31, 2017 and 2016, K-A earned royalties from us of $221 million and $239 million, respectively. These amounts are included in Cost of sales in the Consolidated Statements of Income.

K-A’s expenses consist primarily of costs related to R&D activities conducted on its behalf by us through the 2018 share acquisition and by Kirin. Payment for these services is based on negotiated rates. Revenues from K-A for certain R&D activities performed on K-A’s behalf were insignificant for the period January 1, 2018 through the 2018 share acquisition date. During the years ended December 31, 2017 and 2016, we earned revenues from K-A of $28 million and $31 million, respectively, for certain R&D activities performed on K-A’s behalf. These amounts were recognized as Other revenues in the Consolidated Statements of

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Income. Cost recoveries from K-A recorded during the period January 1, 2018 through the 2018 share acquisition date and the years ended December 31, 2017 and 2016, were insignificant. These amounts are included in Research and development expense in the Consolidated Statements of Income.

As of December 31, 2017, we owed K-A $80 million, which is included in Accrued liabilities in the Consolidated Balance Sheets.

11. Investments

Available-for-sale investments

The amortized cost, gross unrealized gains, gross unrealized losses and fair values of available-for-sale investments by type of security were as follows (in millions):

Types of securities as of December 31, 2018		Amortized cost				Gross unrealized gains				Gross unrealized losses				Fair values
U.S. Treasury notes		$	2,710			$	—			$	(47	)		$	2,663
U.S. Treasury bills		8,191				—				—				8,191
Other government-related debt securities:
U.S.		112				—				(2		)		110
Foreign and other		972				1				(41		)		932
Corporate debt securities:
Financial		2,778				—				(81		)		2,697
Industrial		2,603				—				(99		)		2,504
Other		583				—				(21		)		562
Residential-mortgage-backed securities		1,458				—				(36		)		1,422
Other mortgage- and asset-backed securities		483				—				(14		)		469
Money market mutual funds		5,659				—				—				5,659
Other short-term interest-bearing securities		3,515				—				—				3,515
Total available-for-sale investments		$	29,064			$	1			$	(341	)		$	28,724

Types of securities as of December 31, 2017		Amortized cost				Gross unrealized gains				Gross unrealized losses				Fair values
U.S. Treasury notes		$	8,313			$	1			$	(72	)		$	8,242
Other government-related debt securities:
U.S.		225				—				(2		)		223
Foreign and other		2,415				18				(11		)		2,422
Corporate debt securities:
Financial		10,089				17				(34		)		10,072
Industrial		9,688				34				(52		)		9,670
Other		1,393				3				(6		)		1,390
Residential-mortgage-backed securities		2,198				—				(30		)		2,168
Other mortgage- and asset-backed securities		2,312				—				(15		)		2,297
Money market mutual funds		3,245				—				—				3,245
Other short-term interest-bearing securities		1,440				—				—				1,440
Total interest-bearing securities		41,318				73				(222		)		41,169
Equity securities		135				14				—				149
Total available-for-sale investments		$	41,453			$	87			$	(222	)		$	41,318

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The fair values of available-for-sale investments by location in the Consolidated Balance Sheets were as follows (in millions):

		December 31,
Consolidated Balance Sheets locations		2018				2017
Cash and cash equivalents		$	6,365			$	3,291
Marketable securities		22,359				37,878
Other assets		—				149
Total available-for-sale investments		$	28,724			$	41,318

Cash and cash equivalents in the above table excludes bank account cash of $580 million and $509 million as of December 31, 2018 and 2017, respectively. Other assets as of December 31, 2017, consisted of equity securities, which are no longer classified as available-for-sale.

As a result of the adoption of the new accounting standard related to the classification and measurement of financial instruments on January 1, 2018, equity investments (except for investments accounted for under the equity method of accounting) are now measured at fair value, with changes in fair value recognized in earnings. These investments were previously measured at fair value, with changes in fair value recognized in AOCI. Accordingly, these securities are no longer classified as available-for-sale and their presentation is not comparable to the presentation as of December 31, 2017. See Equity securities, discussed below, and Note 1, Summary of significant accounting policies.

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):

		December 31,
Contractual maturities		2018				2017
Maturing in one year or less		$	17,424			$	6,733
Maturing after one year through three years		3,356				12,820
Maturing after three years through five years		5,168				13,836
Maturing after five years through ten years		885				3,263
Maturing after ten years		—				52
Mortgage- and asset-backed securities		1,891				4,465
Total interest-bearing securities		$	28,724			$	41,169

For the years ended December 31, 2018, 2017 and 2016, realized gains on interest-bearing securities were $29 million, $147 million and $304 million, respectively, and realized losses on interest-bearing securities were $394 million, $213 million and $367 million, respectively. Realized gains and losses on interest-bearing securities are recorded in Interest and other income, net, in the Consolidated Statements of Income. The cost of securities sold is based on the specific-identification method.

F-23

The fair values and gross unrealized losses of available-for-sale investments in an unrealized loss position aggregated by type and length of time that the securities have been in a continuous loss position were as follows (in millions):

		Less than 12 months								12 months or more
Types of securities as of December 31, 2018		Fair values				Unrealized losses				Fair values				Unrealized losses
U.S. Treasury notes		$	1,219			$	(21	)		$	1,444			$	(26	)
Other government-related debt securities:
U.S.		—				—				110				(2		)
Foreign and other		631				(31		)		240				(10		)
Corporate debt securities:
Financial		1,968				(59		)		718				(22		)
Industrial		1,898				(81		)		529				(18		)
Other		529				(20		)		28				(1		)
Residential-mortgage-backed securities		576				(14		)		840				(22		)
Other mortgage- and asset-backed securities		17				—				451				(14		)
Total		$	6,838			$	(226	)		$	4,360			$	(115	)

		Less than 12 months								12 months or more
Types of securities as of December 31, 2017		Fair values				Unrealized losses				Fair values				Unrealized losses
U.S. Treasury notes		$	7,728			$	(70	)		$	195			$	(2	)
Other government-related debt securities:
U.S.		188				(1		)		34				(1		)
Foreign and other		1,163				(9		)		115				(2		)
Corporate debt securities:
Financial		5,928				(28		)		462				(6		)
Industrial		5,760				(43		)		612				(9		)
Other		868				(4		)		117				(2		)
Residential-mortgage-backed securities		1,838				(24		)		276				(6		)
Other mortgage- and asset-backed securities		1,777				(12		)		250				(3		)
Total		$	25,250			$	(191	)		$	2,061			$	(31	)

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 it 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. The 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, as well as adverse conditions related specifically to the security such as any changes to the credit rating of the security and the intent to sell or whether we will more likely than not be required to sell the security before recovery of its amortized cost basis. Our assessment of whether a security is other-than-temporarily impaired could change in the future based on new developments or changes in assumptions related to that particular security. As of December 31, 2018, unrealized losses on available-for-sale investments were due primarily to higher interest rates on that date than at the time the securities were purchased. As of December 31, 2018 and 2017, we believe the cost bases for our available-for-sale investments were recoverable in all material respects.

F-24

Equity securities

We held investments in equity securities with readily determinable fair values of $176 million and $149 million as of December 31, 2018 and 2017, respectively, which are included in Other assets in the Consolidated Balance Sheets. As a result of the adoption of the new accounting standard related to the classification and measurement of financial instruments on January 1, 2018, equity investments (except for investments accounted for under the equity method of accounting) are now measured at fair value, with changes in fair value recognized in earnings. These investments were previously measured at fair value, with changes in fair value recognized in AOCI. Accordingly, these securities are no longer classified as available-for-sale and their presentation is not comparable to the presentation as of December 31, 2017. See Available-for-sale investments, discussed above, and Note 1, Summary of significant accounting policies. Gains and losses recognized on equity securities with readily determinable fair values, including gains and losses recognized on sales, were not material for the years ended December 31, 2018, 2017 and 2016.

We held investments in equity securities without readily determinable fair values of $222 million and $95 million as of December 31, 2018 and 2017, respectively, which are included in Other assets in the Consolidated Balance Sheets. Adjustments to the carrying values of these securities were not material for the years ended December 31, 2018, 2017 and 2016.

Limited partnership investments

We held limited partnership investments of $285 million and $213 million as of December 31, 2018 and 2017, respectively, which are included in Other assets in the Consolidated Balance Sheets. These investments are measured by using the net asset values of the underlying investments as a practical expedient. These investments are typically redeemable only through distributions upon liquidation of the underlying assets. As of December 31, 2018, unfunded additional commitments to be made during the next several years for these investments were not material. Gains and losses recognized on our limited partnership investments were not material for the years ended December 31, 2018, 2017 and 2016.

12. Inventories

Inventories consisted of the following (in millions):

	December 31,
	2018				2017
Raw materials	$	257			$	232
Work in process	1,660				1,668
Finished goods	1,023				934
Total inventories	$	2,940			$	2,834

13. Property, plant and equipment

Property, plant and equipment consisted of the following (dollar amounts in millions):

			December 31,
	Useful life (in years)		2018				2017
Land	—		$	265			$	283
Buildings and improvements	10-40		3,616				3,507
Manufacturing equipment	8-12		2,418				2,372
Laboratory equipment	8-12		1,174				1,179
Capitalized software	3-5		1,124				1,150
Other	3-15		3,204				3,254
Construction in progress	—		953				834
Property, plant and equipment, gross			12,754				12,579
Less accumulated depreciation and amortization			(7,796		)		(7,590		)
Property, plant and equipment, net			$	4,958			$	4,989

F-25

During the years ended December 31, 2018, 2017 and 2016, we recognized depreciation and amortization expense associated with our property, plant and equipment of $630 million, $604 million and $619 million, respectively.

Geographic information

Certain geographic information with respect to property, plant and equipment, net (long-lived assets), was as follows (in millions):

	December 31,
	2018				2017
United States	$	2,373			$	2,349
Puerto Rico	1,476				1,527
ROW	1,109				1,113
Total property, plant and equipment, net	$	4,958			$	4,989

14. Goodwill and other intangible assets

Goodwill

The changes in the carrying amounts of goodwill were as follows (in millions):

	Years ended December 31,
	2018				2017
Beginning balance	$	14,761			$	14,751
Addition from K-A acquisition	6				—
Currency translation adjustments	(68		)		10
Ending balance	$	14,699			$	14,761

Other intangible assets

Other intangible assets consisted of the following (in millions):

	December 31,
	2018												2017
	Gross carrying amounts				Accumulated amortization				Other intangible assets, net				Gross carrying amounts				Accumulated amortization				Other intangible assets, net
Finite-lived intangible assets:
Developed-product-technology rights	$	12,573			$	(7,479	)		$	5,094			$	12,589			$	(6,796	)		$	5,793
Licensing rights	3,772				(2,032		)		1,740				3,275				(1,601		)		1,674
Marketing-related rights	1,297				(1,019		)		278				1,319				(920		)		399
R&D technology rights	1,148				(872		)		276				1,161				(804		)		357
Total finite-lived intangible assets	18,790				(11,402		)		7,388				18,344				(10,121		)		8,223
Indefinite-lived intangible assets:
IPR&D	55				—				55				386				—				386
Total other intangible assets	$	18,845			$	(11,402	)		$	7,443			$	18,730			$	(10,121	)		$	8,609

F-26

Developed-product-technology rights consist of rights related to marketed products acquired in business combinations. Licensing rights consist primarily of contractual rights acquired in business combinations to receive future milestone, royalty and profit-sharing payments; capitalized payments to third parties for milestones related to regulatory approvals to commercialize products; and upfront payments associated with royalty obligations for marketed products. Licensing rights increased in 2018 due to the K-A share acquisition. See Note 3, Business combinations. Marketing-related rights assets consist primarily of rights related to the sale and distribution of marketed products. R&D technology rights consist of technology used in R&D with alternative future uses.

IPR&D consists of R&D projects acquired in a business combination that are not complete at the time of acquisition due to remaining technological risks and/or lack of receipt of required regulatory approvals. During 2018, we discontinued the internal development of a non-key program, resulting in an impairment charge of $330 million, which was recognized in Other operating expenses in the Consolidated Statements of Income and included in Other items, net, in the Consolidated Statements of Cash Flows.

All IPR&D projects have major risks and uncertainties associated with the timely and successful completion of the development and commercialization of product candidates, including our ability to confirm safety and efficacy based on data from clinical trials, our ability to obtain necessary regulatory approvals and our ability to successfully complete these tasks within budgeted costs. We are not permitted to market a human therapeutic without obtaining regulatory approvals, and such approvals require the completion of clinical trials that demonstrate that a product candidate is safe and effective. In addition, the availability and extent of coverage and reimbursement from third-party payers, including government healthcare programs and private insurance plans as well as competitive product launches, affect the revenues a product can generate. Consequently, the eventual realized value, if any, of acquired IPR&D projects may vary from their estimated fair values. We review IPR&D projects for impairment annually, whenever events or changes in circumstances indicate that the carrying amounts may not be recoverable and upon the establishment of technological feasibility or regulatory approval.

During the years ended December 31, 2018, 2017 and 2016, we recognized amortization expenses associated with our finite-lived intangible assets of $1.3 billion, $1.3 billion and $1.5 billion, respectively. Amortization of intangible assets is included primarily in Cost of sales in the Consolidated Statements of Income. The total estimated amortization expenses for our finite-lived intangible assets for each of the next five years are $1.3 billion, $1.2 billion, $1.0 billion, $0.9 billion and $0.9 billion in 2019, 2020, 2021, 2022 and 2023, respectively.

15. Accrued liabilities

Accrued liabilities consisted of the following (in millions):

	December 31,
	2018				2017
Sales deductions	$	3,170			$	2,247
Employee compensation and benefits	1,001				816
Dividends payable	914				953
Sales returns reserve	535				455
Other	2,242				2,045
Total accrued liabilities	$	7,862			$	6,516

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16. Financing arrangements

Our borrowings consisted of the following (in millions):

	December 31,
	2018				2017
6.15% notes due 2018 (6.15% 2018 Notes)	$	—			$	500
4.375% €550 million notes due 2018 (4.375% 2018 euro Notes)	—				653
5.70% notes due 2019 (5.70% 2019 Notes)	1,000				1,000
1.90% notes due 2019 (1.90% 2019 Notes)	700				700
Floating Rate Notes due 2019	550				550
2.20% notes due 2019 (2.20% 2019 Notes)	1,400				1,400
2.125% €675 million notes due 2019 (2.125% 2019 euro Notes)	774				810
4.50% notes due 2020 (4.50% 2020 Notes)	300				300
2.125% notes due 2020 (2.125% 2020 Notes)	750				750
Floating Rate Notes due 2020	300				300
2.20% notes due 2020 (2.20% 2020 Notes)	700				700
3.45% notes due 2020 (3.45% 2020 Notes)	900				900
4.10% notes due 2021 (4.10% 2021 Notes)	1,000				1,000
1.85% notes due 2021 (1.85% 2021 Notes)	750				750
3.875% notes due 2021 (3.875% 2021 Notes)	1,750				1,750
1.25% €1,250 million notes due 2022 (1.25% 2022 euro Notes)	1,433				1,501
2.70% notes due 2022 (2.70% 2022 Notes)	500				500
2.65% notes due 2022 (2.65% 2022 Notes)	1,500				1,500
3.625% notes due 2022 (3.625% 2022 Notes)	750				750
0.41% CHF700 million bonds due 2023 (0.41% 2023 Swiss franc Bonds)	713				719
2.25% notes due 2023 (2.25% 2023 Notes)	750				750
3.625% notes due 2024 (3.625% 2024 Notes)	1,400				1,400
3.125% notes due 2025 (3.125% 2025 Notes)	1,000				1,000
2.00% €750 million notes due 2026 (2.00% 2026 euro Notes)	860				901
2.60% notes due 2026 (2.60% 2026 Notes)	1,250				1,250
5.50% £475 million notes due 2026 (5.50% 2026 pound sterling Notes)	606				642
3.20% notes due 2027 (3.20% 2027 Notes)	1,000				1,000
4.00% £700 million notes due 2029 (4.00% 2029 pound sterling Notes)	893				946
6.375% notes due 2037 (6.375% 2037 Notes)	552				552
6.90% notes due 2038 (6.90% 2038 Notes)	291				291
6.40% notes due 2039 (6.40% 2039 Notes)	466				466
5.75% notes due 2040 (5.75% 2040 Notes)	412				412
4.95% notes due 2041 (4.95% 2041 Notes)	600				600
5.15% notes due 2041 (5.15% 2041 Notes)	974				974
5.65% notes due 2042 (5.65% 2042 Notes)	487				487
5.375% notes due 2043 (5.375% 2043 Notes)	261				261
4.40% notes due 2045 (4.40% 2045 Notes)	2,250				2,250
4.563% notes due 2048 (4.563% 2048 Notes)	1,415				1,415
4.663% notes due 2051 (4.663% 2051 Notes)	3,541				3,541
Other notes due 2097	100				100
Unamortized discounts, premiums, issuance costs and fair value adjustments, net	(949		)		(929		)
Total carrying value of debt	33,929				35,342
Less current portion	(4,419		)		(1,152		)
Total long-term debt	$	29,510			$	34,190

There are no material differences between the effective interest rates and coupon rates of any of our borrowings, except for the 4.563% 2048 Notes and the 4.663% 2051 Notes, which have effective interest rates of 6.3% and 5.6%, respectively.

Under the terms of all of our outstanding notes—including debt exchange issuances, discussed below, and except our Other notes due 2097—in the event of a change-in-control triggering event we may be required to purchase all or a portion of these debt securities at prices equal to 101% of the principal amounts of the notes plus accrued and unpaid interest. In addition, all of our outstanding notes—except our floating-rate notes, 0.41% 2023 Swiss franc Bonds and Other notes due 2097—may be redeemed at any time at our option—in whole or in part—at the principal amounts of the notes being redeemed plus accrued and unpaid

F-28

interest and make-whole amounts, which are defined by the terms of the notes. Certain of the redeemable notes do not require the payment of make-whole amounts if redeemed during a specified period of time immediately prior to the maturity of the notes. Such time periods range from one to six months prior to maturity.

Debt issuances

We did not issue any debt or debt securities during the year ended December 31, 2018. We issued debt and debt securities in various offerings during the years ended December 31, 2017 and 2016 as follows:

•	In 2017, we issued $4.5 billion principal amount of notes, consisting of the Floating Rate Notes due 2019, the 1.90% 2019 Notes, the Floating Rate Notes due 2020, the 2.20% 2020 Notes, the 2.65% 2022 Notes and the 3.20% 2027 Notes.

•

In 2016, we issued $6.7 billion principal amount of notes, consisting of the 1.85% 2021 Notes, the 1.25% 2022 euro Notes, the 0.41% 2023 Swiss franc Bonds, the 2.25% 2023 Notes, the 2.00% 2026 euro Notes and the 2.60% 2026 Notes and $1.0 billion of the 4.40% 2045 Notes. We received a $79 million premium on the 4.40% 2045 Notes. In addition, we borrowed $605 million under a short-term floating-rate loan.

As of December 31, 2018, we have a commercial paper program that allows us to issue up to $2.5 billion of unsecured commercial paper to fund our working-capital needs. During the year ended December 31, 2017, we issued and repaid an aggregate of $12.3 billion of commercial paper and had a maximum outstanding balance of $1.5 billion under our commercial paper program. During the years ended December 31, 2018 and 2016, we did not issue any commercial paper. No commercial paper was outstanding as of December 31, 2018 or 2017.

Debt repayments

In 2018, we repaid $1.1 billion of debt, including the $500 million aggregate principal amount of the 6.15% 2018 Notes and the €550 million aggregate principal amount of the 4.375% 2018 Notes revalued at $621 million upon maturity. In 2017, we repaid $4.4 billion of debt, including the $605 million short-term floating-rate loan, the $1.25 billion aggregate principal amount of the 2.125% 2017 Notes, the $600 million aggregate principal amount of the Floating Rate Notes due 2017, the $850 million aggregate principal amount of the 1.25% 2017 Notes and the $1.1 billion aggregate principal amount of the 5.85% 2017 Notes. In 2016, we repaid $3.7 billion of debt, including the remaining $1.975 billion of principal on a term loan credit facility, the $750 million aggregate principal amount of the 2.30% 2016 Notes and the $1.0 billion aggregate principal amount of the 2.50% 2016 Notes.

Debt exchange

During 2016, we completed a private offering to exchange portions of certain outstanding senior notes due 2037 through 2043 (collectively, the Old Notes), for new senior notes, consisting of principal amounts of $1.4 billion of 4.563% 2048 Notes and $3.5 billion of 4.663% 2051 Notes (collectively, the New Notes).

The New Notes bear lower fixed-coupon rates while requiring higher principal repayments on extended maturity dates compared with the Old Notes that were exchanged. There were no other significant changes to the terms between the Old Notes and the New Notes. The exchange was accounted for as a debt modification, and there were no cash payments to or cash receipts from the noteholders as a result of the exchange. Existing deferred financing costs associated with the Old Notes as well as discounts associated with the New Notes aggregating $801 million are being accreted over the term of the New Notes and recorded as Interest expense, net, in the Consolidated Statements of Income. Transaction costs of $24 million incurred for the exchange were expensed immediately in Interest and other income, net, in the Consolidated Statements of Income.

Interest rate swaps

To achieve a desired mix of fixed-rate and floating-rate debt, we entered into interest rate swap contracts that effectively converted fixed-rate interest coupons for certain of our debt issuances to floating London Interbank Offered Rate (LIBOR)-based coupons over the lives of the respective notes. These interest rate swap contracts qualified and are designated as fair value hedges.

F-29

The effective interest rates on notes for which we have entered into interest rate swap contracts and the related notional amounts of these contracts were as follows (dollar amounts in millions):

				December 31,
				2018				2017
Notes		Effective interest rates		Notional amounts
2.20% 2019 Notes		LIBOR + 0.6%		$	1,400			$	1,400
3.45% 2020 Notes		LIBOR + 1.1%		900				900
4.10% 2021 Notes		LIBOR + 1.7%		1,000				1,000
3.875% 2021 Notes		LIBOR + 2.0%		1,750				1,750
3.625% 2022 Notes		LIBOR + 1.6%		750				750
3.625% 2024 Notes		LIBOR + 1.4%		1,400				1,400
3.125% 2025 Notes		LIBOR + 0.9%		1,000				1,000
2.600% 2026 Notes		LIBOR + 0.3%		1,250				1,250
4.663% 2051 Notes		LIBOR + 0.0%		1,500				—
Total notional amounts				$	10,950			$	9,450

Cross-currency swaps

In order 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. The terms of these contracts effectively convert the interest payments and principal repayment on our 2.125% 2019 euro Notes, 1.25% 2022 euro Notes, 0.41% 2023 Swiss franc Bonds, 2.00% 2026 euro Notes, 5.50% 2026 pound sterling Notes and 4.00% 2029 pound sterling Notes from euros, pounds sterling and Swiss francs to U.S. dollars. These cross-currency swap contracts have been designated as cash flow hedges. For information regarding the terms of these contracts, see Note 19, Derivative instruments.

Shelf registration statements and other facilities

In 2014, we entered into a $2.5 billion syndicated, unsecured, revolving credit agreement, which is available for general corporate purposes or as a liquidity backstop to our commercial paper program. The commitments under the revolving credit agreement may be increased by up to $500 million with the agreement of the banks. Each bank that is a party to the agreement has an initial commitment term of five years. We extended this term by one year during 2016 and may extend the term for an additional year with the agreement of the banks. Annual commitment fees for this agreement are 0.09% of the unused portion of the facility based on our current credit rating. Generally, we would be charged interest at LIBOR plus 1% for any amounts borrowed under this facility. As of December 31, 2018 and 2017, no amounts were outstanding under this facility.

In 2017, we filed a shelf registration statement with the SEC that allows us to issue unspecified amounts of debt securities; common stock; preferred stock; warrants to purchase debt securities, common stock, preferred stock or depositary shares; rights to purchase common stock or preferred stock; securities purchase contracts; securities purchase units; and depositary shares. Under this shelf registration statement, all of the securities available for issuance may be offered from time to time with terms to be determined at the time of issuance. This shelf registration statement expires in February 2020.

Certain of our financing arrangements contain nonfinancial covenants. In addition, our revolving credit agreement includes a financial covenant, which was modified during 2018. The modified covenant requires that we maintain a specified minimum interest coverage ratio of (i) the sum of consolidated net income, interest expense, provision for income taxes, depreciation expense, amortization expense, unusual or nonrecurring charges and other noncash items (Consolidated EBITDA) to (ii) Consolidated Interest expense, each as defined and described in the amended credit agreement. We were in compliance with all applicable covenants under these arrangements as of December 31, 2018.

F-30

Contractual maturities of debt obligations

The aggregate contractual maturities of all borrowings due subsequent to December 31, 2018, are as follows (in millions):

Maturity dates		Amounts
2019		$	4,424
2020		2,950
2021		3,500
2022		4,183
2023		1,463
Thereafter		18,358
Total		$	34,878

Interest costs

Interest costs are expensed as incurred except to the extent such interest is related to construction in progress, in which case interest is capitalized. Interest costs capitalized for the years ended December 31, 2018, 2017 and 2016, were not material. Interest paid, including the ongoing impact of interest rate and cross-currency swap contracts, during the years ended December 31, 2018, 2017 and 2016, was $1.5 billion, $1.3 billion and $1.2 billion, respectively.

17. Stockholders’ equity

Stock repurchase program

Activity under our stock repurchase program, on a trade date basis, was as follows (in millions):

	Years ended December 31,
	2018							2017							2016
	Shares *			Dollars				Shares			Dollars				Shares			Dollars
First quarter	56.4			$	10,787			3.4			$	555			4.7			$	690
Second quarter	18.2			3,190				6.2			1,006				3.9			591
Third quarter	8.7			1,713				4.4			769				4.4			747
Fourth quarter	11.1			2,165				4.5			796				6.7			999
Total stock repurchases	94.5			$	17,855			18.5			$	3,126			19.7			$	3,027

• Total shares do not add due to rounding.

In January, April and December 2018, our Board of Directors increased the amount authorized under our stock repurchase program by $10.0 billion, $5.0 billion and $3.6 billion, respectively. Repurchase activity for the year ended December 31, 2018, included 52.1 million shares of our common stock acquired under a tender offer at an aggregate cost of $10.0 billion. As of December 31, 2018, $5.1 billion remained available under our stock repurchase program.

Dividends

Our Board of Directors declared quarterly dividends per share of $1.32, $1.15 and $1.00, which were paid in each of the four quarters of 2018, 2017, and 2016, respectively.

Historically, we have declared dividends in December of each year, which were paid in the first quarter of the following fiscal year, and in March, July and October, which were paid in the second, third and fourth quarters, respectively, of the same fiscal year. Additionally, on December 7, 2018, the Board of Directors declared a quarterly cash dividend of $1.45 per share of common stock, which will be paid on March 8, 2019, to all stockholders of record as of the close of business on February 15, 2019.

F-31

Accumulated other comprehensive income (loss)

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, 2015	$	(511	)		$	297			$	(260	)		$	(6	)		$	(480	)
Foreign currency translation adjustments	(93		)		—				—				—				(93		)
Unrealized (losses) gains	—				(176		)		63				—				(113		)
Reclassification adjustments to income	—				139				61				—				200
Other	—				—				—				1				1
Income taxes	(6		)		22				(2		)		—				14
Balance as of December 31, 2016	(610		)		282				(138		)		(5		)		(471		)
Foreign currency translation adjustments	77				—				—				—				77
Unrealized gains (losses)	—				192				(46		)		—				146
Reclassification adjustments to income	—				(638		)		41				—				(597		)
Other	—				—				—				5				5
Income taxes	4				158				(1		)		—				161
Balance as of December 31, 2017	(529		)		(6		)		(144		)		—				(679		)
Cumulative effect of change in accounting principle, net of tax(1)	—				—				(9		)		—				(9		)
Foreign currency translation adjustments	(141		)		—				—				—				(141		)
Unrealized gains (losses)	—				61				(556		)		—				(495		)
Reclassification adjustments to income	—				262				365				—				627
Other	—				—				—				(2		)		(2		)
Income taxes	—				(76		)		6				—				(70		)
Balance as of December 31, 2018	$	(670	)		$	241			$	(338	)		$	(2	)		$	(769	)

---

(1)	See Note 1, Summary of significant accounting policies, for additional information regarding the adoption on January 1, 2018, of the new accounting standard related to the classification and measurement of financial instruments and the related cumulative effect from the change in accounting principle.

With respect to the table above, income tax expenses or benefits for unrealized gains and losses and the related reclassification adjustments to income for cash flow hedges were a $21 million expense and $55 million expense in 2018, a $68 million expense and $226 million benefit in 2017 and a $68 million benefit and $46 million expense in 2016, respectively. Income tax expenses or benefits for unrealized gains and losses and the related reclassification adjustments to income for available-for-sale securities were a $9 million benefit and $3 million expense for 2018, a $9 million expense and $8 million benefit in 2017 and a $9 million benefit and $11 million expense in 2016, respectively.

F-32

Reclassifications out of AOCI and into earnings were as follows (in millions):

		Years ended December 31,
Components of AOCI		2018				2017				2016				Consolidated Statements of Income locations
Cash flow hedges:
Foreign currency contract (losses) gains		$	(21	)		$	65			$	308			Product sales
Cross-currency swap contract (losses) gains		(241		)		574				(446		)		Interest and other income, net
Forward interest rate contract losses		—				(1		)		(1		)		Interest expense, net
		(262		)		638				(139		)		Income before income taxes
		55				(226		)		46				Provision for income taxes
		$	(207	)		$	412			$	(93	)		Net income
Available-for-sale securities:
Net realized losses		$	(365	)		$	(41	)		$	(61	)		Interest and other income, net
		3				(8		)		11				Provision for income taxes
		$	(362	)		$	(49	)		$	(50	)		Net income

Other

In addition to common stock, our authorized capital includes 5 million shares of preferred stock, $0.0001 par value. As of December 31, 2018 and 2017, no shares of preferred stock were issued or outstanding.

18. 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 an 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 an 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.

F-33

The fair values of each major class of the Company’s financial assets and liabilities measured at fair value on a recurring basis were as follows (in millions):

Fair value measurement as of December 31, 2018, using:		Quoted prices in active markets for identical assets (Level 1)				Significant other observable inputs (Level 2)				Significant unobservable inputs (Level 3)				Total
Assets:
Interest-bearing securities:
U.S. Treasury notes		$	2,663			$	—			$	—			$	2,663
U.S. Treasury bills		8,191				—				—				8,191
Other government-related debt securities:
U.S.		—				110				—				110
Foreign and other		—				932				—				932
Corporate debt securities:
Financial		—				2,697				—				2,697
Industrial		—				2,504				—				2,504
Other		—				562				—				562
Residential-mortgage-backed securities		—				1,422				—				1,422
Other mortgage- and asset-backed securities		—				469				—				469
Money market mutual funds		5,659				—				—				5,659
Other short-term interest-bearing securities		—				3,515				—				3,515
Equity securities		176				—				—				176
Derivatives:
Foreign currency contracts		—				182				—				182
Cross-currency swap contracts		—				170				—				170
Interest rate swap contracts		—				56				—				56
Total assets		$	16,689			$	12,619			$	—			$	29,308
Liabilities:
Derivatives:
Foreign currency contracts		$	—			$	26			$	—			$	26
Cross-currency swap contracts		—				401				—				401
Interest rate swap contracts		—				149				—				149
Contingent consideration obligations		—				—				72				72
Total liabilities		$	—			$	576			$	72			$	648

F-34

Fair value measurement as of December 31, 2017, using:		Quoted prices in active markets for identical assets (Level 1)				Significant other observable inputs (Level 2)				Significant unobservable inputs (Level 3)				Total
Assets:
Interest-bearing securities:
U.S. Treasury notes		$	8,242			$	—			$	—			$	8,242
Other government-related debt securities:
U.S.		—				223				—				223
Foreign and other		—				2,422				—				2,422
Corporate debt securities:
Financial		—				10,072				—				10,072
Industrial		—				9,670				—				9,670
Other		—				1,390				—				1,390
Residential-mortgage-backed securities		—				2,168				—				2,168
Other mortgage- and asset-backed securities		—				2,297				—				2,297
Money market mutual funds		3,245				—				—				3,245
Other short-term interest-bearing securities		—				1,440				—				1,440
Equity securities		149				—				—				149
Derivatives:
Foreign currency contracts		—				6				—				6
Cross-currency swap contracts		—				270				—				270
Interest rate swap contracts		—				10				—				10
Total assets		$	11,636			$	29,968			$	—			$	41,604
Liabilities:
Derivatives:
Foreign currency contracts		$	—			$	204			$	—			$	204
Cross-currency swap contracts		—				220				—				220
Interest rate swap contracts		—				61				—				61
Contingent consideration obligations		—				—				69				69
Total liabilities		$	—			$	485			$	69			$	554

Interest-bearing and equity securities

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 and have 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– or equivalent by Standard & Poor’s Financial Services LLC (S&P), Moody’s Investors Service, Inc. (Moody’s) or Fitch Ratings, Inc. (Fitch); and our corporate debt securities portfolio has weighted-average credit ratings of A– or equivalent by Fitch and BBB + or equivalent by S&P or Moody’s. We estimate the fair values of these securities by taking into consideration valuations obtained from third-party pricing services. The pricing services use 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. The 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 use 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. The inputs include reported trades of and broker-dealer quotes on the same or similar securities; issuer credit spreads; benchmark securities; prepayment or default projections based on historical data; and other observable inputs.

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We value our other short-term interest-bearing securities at amortized cost, which approximates fair value given their near-term maturity dates.

Derivatives

All of our foreign currency forward and option derivative 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 estimate the fair values of these contracts by taking into consideration valuations obtained from a third-party valuation service that uses 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 and obligor credit default swap rates. In addition, inputs for our foreign currency option contracts include implied volatility measures. These inputs, where applicable, are at commonly quoted intervals. See Note 19, 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 estimate the fair values of these contracts by taking into consideration valuations obtained from a third-party valuation service that uses 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 19, 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 estimate the fair values of these contracts by using an income-based industry-standard valuation model for which all significant inputs are observable either directly or indirectly. These inputs include LIBOR, swap rates and obligor credit default swap rates. See Note 19, Derivative instruments.

Contingent consideration obligations

As a result of our business acquisitions, we have incurred contingent consideration obligations, as discussed below. The contingent consideration obligations are recorded at their fair values by using probability-adjusted discounted cash flows, and we revalue these obligations each reporting period until the related contingencies have been resolved. The fair value measurements of these obligations are based on significant unobservable inputs related to licensing rights and product candidates acquired in business combinations, and are reviewed quarterly by management in our R&D and commercial sales organizations. These inputs include, as applicable, estimated probabilities and the timing of achieving specified regulatory and commercial milestones as well as estimated annual sales. Significant changes that increase or decrease the probabilities of achieving the related regulatory and commercial events or that shorten or lengthen the time required to achieve such events or that increase or decrease estimated annual sales would result in corresponding increases or decreases in the fair values of the obligations, as applicable. Changes in the fair values of contingent consideration obligations are recognized in Other operating expenses in the Consolidated Statements of Income.

Changes in the carrying amounts of contingent consideration obligations were as follows (in millions):

	Years ended December 31,
	2018				2017				2016
Beginning balance	$	69			$	179			$	188
Addition from K-A acquisition	45				—				—
Net changes in valuations	(42		)		(110		)		(9		)
Ending balance	$	72			$	69			$	179

As a result of our acquisition of K-A in 2018, we are obligated to make single-digit royalty payments to Kirin contingent upon sales of brodalumab. See Note 3, Business combinations.

As a result of our acquisition of Dezima in 2015, we are obligated to pay its former shareholders up to $1.25 billion of additional consideration contingent upon achieving certain development and sales-related milestones and low single-digit royalties on net product sales above a certain threshold for AMG 899, an IPR&D asset. The fair values of the contingent consideration obligations had an aggregate value of $110 million at acquisition. During 2017, we decided to discontinue the internal development of AMG 899 and accordingly, reduced from $116 million to zero the related contingent consideration liabilities and recognized an impairment charge of $400 million on the IPR&D asset in Other operating expenses in the Consolidated Statements of Income. The remeasurement of these liabilities and the impairment charge are included in Other items, net, in the Consolidated Statements of Cash Flows.

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As a result of our acquisition of BioVex Group Inc. in 2011, we are obligated to pay its former shareholders up to $325 million upon achieving separate regulatory and sales-related milestones with regard to IMLYGIC® (talimogene laherparepvec) if certain sales thresholds are met within specified periods of time.

During the years ended December 31, 2018 and 2017, there were no transfers of assets or liabilities between fair value measurement levels. During the years ended December 31, 2018 and 2017, there were no material remeasurements to the fair values of assets and liabilities that are not measured at fair value on a recurring basis, except with respect to the IPR&D asset discussed above and in Note 14, Goodwill and other intangible assets.

Summary of the fair values of other financial instruments

Cash equivalents

The fair values of cash equivalents approximate their carrying values due to the short-term nature of such financial instruments.

Borrowings

We estimated the fair values of our borrowings by using Level 2 inputs. As of December 31, 2018 and 2017, the aggregate fair values of our borrowings were $35.0 billion and $38.6 billion, respectively, and the carrying values were $33.9 billion and $35.3 billion, respectively.

19. 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 such exposures, we use or have used 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.

During 2018, we adopted early a new accounting standard that amends the accounting and reporting of hedging activities. Certain required disclosures have been made on a prospective basis in accordance with the guidance of the standard. See Note 1, Summary of significant accounting policies.

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 corresponding increases and decreases in the cash flows from our international operating expenses resulting from these foreign currency exchange rate movements. To further reduce our exposure to foreign currency exchange rate fluctuations with regard to 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 December 31, 2018, 2017 and 2016, we had foreign currency forward contracts with notional amounts of $4.5 billion, $4.6 billion and $3.4 billion, respectively, and foreign currency option contracts with notional amounts of $21 million, $74 million and $608 million, respectively. We have designated these foreign currency forward and foreign currency option contracts, which are primarily euro based, as cash flow hedges. Accordingly, we report the unrealized gains and losses on these contracts in AOCI in the Consolidated Balance Sheets, and we reclassify them to Product sales in the Consolidated Statements of Income 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 debt denominated in foreign currencies, we enter into cross-currency swap contracts. Under the terms of such contracts, we paid euros, pounds sterling and Swiss francs and received U.S. dollars for the notional amounts at the inception of the contracts; and based on these notional amounts, we exchange interest payments at fixed rates over the lives of the contracts by paying U.S. dollars and receiving euros, pounds sterling and Swiss francs. In addition, we will pay U.S. dollars to and receive euros, pounds sterling and Swiss francs from the counterparties at the maturities of the contracts for these same notional amounts. The terms of these contracts correspond to the related hedged debt, thereby effectively converting the interest payments and principal repayment on the debt from euros, pounds sterling and Swiss francs to U.S. dollars. We have designated these cross-currency swap contracts as cash flow hedges. Accordingly, the unrealized gains and losses on these contracts are reported in AOCI in the Consolidated Balance Sheets and

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reclassified to Interest and other income, net, in the Consolidated Statements of Income in the same periods during which the hedged debt affects earnings.

The notional amounts and interest rates of our cross-currency swaps as of December 31, 2018, were as follows (notional amounts in millions):

		Foreign currency							U.S. dollars
Hedged notes		Notional amounts				Interest rates			Notional amounts				Interest rates
2.125% 2019 euro Notes		€	675			2.1	%		$	864			2.6	%
1.25% 2022 euro Notes		€	1,250			1.3	%		$	1,388			3.2	%
0.41 % 2023 Swiss franc Bonds		CHF	700			0.4	%		$	704			3.4	%
2.00% 2026 euro Notes		€	750			2.0	%		$	833			3.9	%
5.50% 2026 pound sterling Notes		£	475			5.5	%		$	747			6.0	%
4.00% 2029 pound sterling Notes		£	700			4.0	%		$	1,111			4.5	%

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 U.S. Treasury rate between the time we enter into these contracts and the time the related debt is issued. Gains and losses on forward interest rate contracts, which are designated as cash flow hedges, are recognized in AOCI in the Consolidated Balance Sheets and are amortized into Interest expense, net, in the Consolidated Statements of Income over the lives of the associated debt issuances. Amounts recognized in connection with forward interest rate swaps during the year ended December 31, 2018, and amounts expected to be recognized during the subsequent 12 months are not material.

The unrealized gains and losses recognized in AOCI for our derivative instruments designated as cash flow hedges were as follows (in millions):

				Years ended December 31,
Derivatives in cash flow hedging relationships				2018				2017				2016
Foreign currency contracts				$	348			$	(402	)		$	115
Cross-currency swap contracts				(287		)		581				(281		)
Forward interest rate contracts				—				13				(10		)
Total unrealized gains (losses)				$	61			$	192			$	(176	)

The locations in the Consolidated Statements of Income and the gains and losses reclassified out of AOCI and into earnings for our derivative instruments designated as cash flow hedges were as follows (in millions):

				Years ended December 31,
Derivatives in cash flow hedging relationships		Consolidated Statements of Income locations		2018				2017				2016
Foreign currency contracts		Product sales		$	(21	)		$	65			$	308
Cross-currency swap contracts		Interest and other income, net		(241		)		574				(446		)
Forward interest rate contracts		Interest expense, net		—				(1		)		(1		)
Total realized (losses) gains				$	(262	)		$	638			$	(139	)

No portions of our cash flow hedge contracts were excluded from the assessment of hedge effectiveness. As of December 31, 2018, the amount expected to be reclassified out of AOCI and into earnings during the next 12 months is $110 million of net losses on our foreign currency and cross-currency swap contracts.

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Fair value hedges

To achieve a desired mix of fixed-rate and floating-rate debt, we entered into interest rate swap contracts that qualified for and were designated as fair value hedges. These interest rate swap contracts effectively convert fixed-rate coupons to floating-rate LIBOR-based coupons over the terms of the related hedge contracts. During the year ended December 31, 2018, we entered into $1.5 billion of interest rate swaps. As of December 31, 2018 and 2017, we had interest rate swap contracts with aggregate notional amounts of $10.95 billion and $9.45 billion, respectively, that hedge certain of our long-term debt issuances. See Note 16, Financing arrangements—Interest rate swaps.

For interest rate swap contracts that qualify for and are designated as fair value hedges, we recognize in Interest expense, net, in the Consolidated Statements of Income, 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. If a hedging relationship involving an interest rate swap contract is terminated, the gain or loss realized on contract termination is recorded as an adjustment to the carrying value of the debt and amortized into Interest expense, net, over the remaining life of the previously hedged debt.

Net unrealized gains and losses on our outstanding interest rate swap contracts were as follows (in millions):

		Years ended December 31,
Derivatives in fair value hedging relationships		2018				2017				2016
Net unrealized losses recognized on interest rate swap contracts		$	(42	)		$	(85	)		$	(34	)
Net unrealized gains recognized on related hedged debt		$	42			$	85			$	34

The hedged liabilities and related cumulative-basis adjustments for fair value hedges of those liabilities were recorded in the Consolidated Balance Sheets as follows (in millions):

		Carrying amounts of hedged liabilities(1)								Cumulative amounts of fair value hedging adjustments related to the carrying amounts of the hedged liabilities(2)
		December 31,								December 31,
Consolidated Balance Sheets locations		2018				2017				2018				2017
Current portion of long-term debt		$	2,396			$	500			$	(3	)		$	23
Long-term debt		$	9,361			$	10,516			$	(50	)		$	(11	)

---

(1)	Current portion of long-term debt includes $1.0 billion and $500 million of carrying value with discontinued hedging relationships as of December 31, 2018 and 2017, respectively. Long-term debt includes $137 million and $1.1 billion of carrying value with discontinued hedging relationships as of December 31, 2018 and 2017, respectively.

(2)	Current portion of long-term debt includes $3 million and $23 million of hedging adjustments on discontinued hedging relationships as of December 31, 2018 and 2017, respectively. Long-term debt includes $37 million and $40 million of hedging adjustments on discontinued hedging relationships as of December 31, 2018 and 2017, respectively.

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The following table summarizes the amounts recorded in income and expense line items and the effects thereon from fair value and cash flow hedging, including discontinued hedging relationships (in millions):

		Year ended December 31, 2018
		Product sales				Interest and other income, net				Interest (expense), net
Total amounts recorded in income and (expense) line items presented in the Consolidated Statements of Income		$	22,533			$	674			$	(1,392	)
The effects of cash flow and fair value hedging:
Losses on cash flow hedging relationships reclassified out of AOCI:
Foreign currency contracts		$	(21	)
Cross-currency swap contracts						$	(241	)
Gains (losses) on fair value hedging relationships—interest rate swap agreements:
Hedged items(1)										$	65
Derivatives designated as hedging instruments										$	(42	)

---

(1)	The amounts include benefits of $23 million related to the amortization of the cumulative amount of fair value hedging adjustments included in the carrying amount of the hedged debt for discontinued hedging relationships for the year ended December 31, 2018.

Derivatives not designated as hedges

To reduce our exposure to foreign currency fluctuations of certain assets and liabilities denominated in foreign currencies, we enter into foreign currency forward contracts that are not designated as hedging transactions. These exposures are hedged on a month-to-month basis. As of December 31, 2018, 2017 and 2016, the total notional amounts of these foreign currency forward contracts were $737 million, $757 million and $666 million, respectively. The fair values of these derivatives as of December 31, 2018 and 2017, were not material.

The location in the Consolidated Statements of Income and the amounts of gains (losses) recognized in earnings for our derivative instruments not designated as hedging instruments were as follows (in millions):

				Years ended December 31,
Derivatives not designated as hedging instruments		Consolidated Statements of Income location		2018				2017				2016
Foreign currency contracts		Interest and other income, net		$	34			$	24			$	(56	)

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The fair values of derivatives included in the Consolidated Balance Sheets were as follows (in millions):

		Derivative assets						Derivative liabilities
December 31, 2018		Consolidated Balance Sheets locations		Fair values				Consolidated Balance Sheets locations		Fair values
Derivatives designated as hedging instruments:
Foreign currency contracts		Other current assets/ Other assets		$	181			Accrued liabilities/ Other noncurrent liabilities		$	26
Cross-currency swap contracts		Other current assets/ Other assets		170				Accrued liabilities/ Other noncurrent liabilities		401
Interest rate swap contracts		Other current assets/ Other assets		56				Accrued liabilities/ Other noncurrent liabilities		149
Total derivatives designated as hedging instruments				407						576
Derivatives not designated as hedging instruments:
Foreign currency contracts		Other current assets		1				Accrued liabilities		—
Total derivatives not designated as hedging instruments				1						—
Total derivatives				$	408					$	576
		Derivative assets						Derivative liabilities
December 31, 2017		Consolidated Balance Sheets locations		Fair values				Consolidated Balance Sheets locations		Fair values
Derivatives designated as hedging instruments:
Foreign currency contracts		Other current assets/ Other assets		$	6			Accrued liabilities/ Other noncurrent liabilities		$	204
Cross-currency swap contracts		Other current assets/ Other assets		270				Accrued liabilities/ Other noncurrent liabilities		220
Interest rate swap contracts		Other current assets/ Other assets		10				Accrued liabilities/ Other noncurrent liabilities		61
Total derivatives designated as hedging instruments				$	286					$	485

Our derivative contracts that were in liability positions as of December 31, 2018, 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 either to or from a counterparty under the contracts may be offset against other amounts due either to or from the same counterparty only if an event of default or termination, as defined, were to occur.

The cash flow effects of our derivative contracts are included within Net cash provided by operating activities in the Consolidated Statements of Cash Flows.

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20. Contingencies and commitments

Contingencies

In the ordinary course of business, we are involved in various legal proceedings, government investigations and other matters that are complex in nature and have outcomes that are difficult to predict. See Part I, Item 1A. Risk Factors—Our business may be affected by litigation and government investigations. We describe our legal proceedings and other matters that are significant or that we believe could become significant in this footnote.

We record accruals for loss contingencies to the extent that we conclude 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 involve various aspects of our business and a variety of claims, some of which present novel factual allegations and/or unique legal theories. In each of the matters described in this filing in which we could incur a liability, our opponents 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 we face often extend for several years. As a result, none of the matters described in this filing in which we could incur a liability have progressed sufficiently through discovery and/or the 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. In addition, while some of the matters described in this filing do not present circumstances in which we could incur a liability (such as some matters involving our claims that others have infringed our patents and in which such others have not asserted counterclaims against us), such matters nevertheless have the potential to significantly impact our business. While it is not possible to accurately predict or determine the eventual outcomes of these matters, an adverse determination in one or more of these matters 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:

Sensipar® (cinacalcet) Abbreviated New Drug Application (ANDA) Patent Litigation

Amgen Inc. v. Aurobindo Pharma Ltd. et al.

Beginning in September 2016, Amgen filed 14 separate lawsuits in the U.S. District Court for the District of Delaware (the Delaware District Court) for infringement of our U.S. Patent No. 9,375,405 (the ’405 Patent) against a number of manufacturers of purported generic versions of our Sensipar® product. In February 2017, the Delaware District Court consolidated these 14 lawsuits into a single case, Amgen Inc. v. Aurobindo Pharma Ltd. et al. The ’405 Patent is entitled “Rapid Dissolution Formulation of a Calcium Receptor-Active Compound” and expires in 2026. All defendants responding to the complaint denied infringement and sought judgment that the ’405 Patent is invalid and/or not infringed. Between September and November of 2017, Amgen filed, and the Delaware District Court signed, stipulated dismissals of the lawsuit against Micro Labs Ltd. and Micro Labs USA, Inc., and the lawsuit against Apotex Inc. and Apotex Corp. (collectively, Apotex), as well as consent judgments filed by Amgen and each of (1) Sun Pharma Global FZE, Sun Pharmaceutical Industries, Ltd. and Sun Pharmaceutical Industries, Inc. (collectively, Sun), (2) Ajanta Pharma Limited and Ajanta Pharma USA, Inc., (3) Hetero USA Inc., Hetero Labs Ltd. and Hetero Labs Ltd. Unit V and (4) Breckenridge Pharmaceutical, Inc. (Breckenridge). Each consent judgment stipulated to an entry of judgment of infringement and validity of the ’405 Patent and an injunction prohibiting the manufacture, use, sale, offer to sell, importation of, or distribution into the United States of the respective defendant’s cinacalcet product during the term of the ’405 Patent unless specifically authorized pursuant to the confidential settlement agreement.

In June 2017, Amgen filed four additional lawsuits in the Delaware District Court for infringement of the ’405 Patent against additional defendants. These defendants also responded to the complaint denying infringement and seeking a declaration of noninfringement and invalidity of the ’405 Patent. One of these lawsuits was subsequently consolidated into Amgen Inc. v. Aurobindo Pharma Ltd. et al. and the remaining three of these lawsuits were consolidated into a separate single case, Amgen Inc. v. Alkem et al. (see below).

On March 5, 2018, the Delaware District Court commenced trial on the infringement claims and defenses in the Amgen Inc. v. Aurobindo Pharma Ltd. et al. consolidated lawsuit against the defendants that remained in the lawsuit, collectively consisting of (1) Aurobindo Pharma Ltd. and Aurobindo Pharma USA, Inc. (collectively, Aurobindo), (2) Watson Laboratories, Inc. and Actavis Pharma, Inc. (collectively, Watson), (3) Amneal Pharmaceuticals LLC, Amneal Pharmaceuticals of New York, LLC and Amneal Pharmaceuticals Co. India Private Limited, (4) Zydus Pharmaceuticals (USA) Inc. and Cadila Healthcare Ltd. (collectively, Zydus) and (5) Piramal Healthcare UK Limited (Piramal).

Just prior to trial, the Delaware District Court signed consent judgments filed by Amgen and each of Cipla Limited and Cipla USA, Inc. (collectively, Cipla) and Strides Pharma Global PTE Limited and Strides Pharma, Inc. (collectively, Strides), and in

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March 2018 the Delaware District Court signed a consent judgment filed by Amgen and Aurobindo. In each consent judgment, the parties stipulated to an entry of judgment of infringement and validity of the ’405 Patent and an injunction prohibiting the manufacture, use, sale, offer to sell, importation of, or distribution into the United States of the applicable defendant’s cinacalcet product during the term of the ’405 Patent unless specifically authorized pursuant to the applicable confidential settlement agreement. Just prior to trial, the Delaware District Court also entered orders dismissing each of Dr. Reddy’s Laboratories, Ltd. and Dr. Reddy’s Laboratories, Inc. (collectively, Dr. Reddy’s), and Mylan Pharmaceuticals Inc. and Mylan Inc. (collectively, Mylan), on stipulations between Amgen and such parties, respectively, subject to the terms of confidential settlement agreements.

On July 27, 2018, the Delaware District Court issued a trial order finding on the infringement claims and defenses in the Amgen Inc. v. Aurobindo Pharma Ltd. et al. consolidated lawsuit that Zydus infringes the ’405 Patent and that Amneal Pharmaceuticals LLC and Amneal Pharmaceuticals of New York, LLC (collectively, Amneal), Piramal and Watson do not infringe the ’405 Patent. On August 24, 2018, the Delaware District Court issued an order dismissing, without prejudice, the invalidity counterclaims of Amneal, Piramal and Watson and entered judgment of noninfringement of the ’405 Patent in favor of Amneal, Piramal and Watson. On September 20, 2018, Amgen filed a notice of appeal to the Federal Circuit Court. On October 9, 2018, the Delaware District Court dismissed, without prejudice, the invalidity counterclaims of Zydus and entered judgment of infringement of the ’405 Patent by Zydus in favor of Amgen, including an order that the effective date of the U.S. Food and Drug Administration (FDA) approval of Zydus’ generic version of Sensipar® shall be no earlier than the expiry date of our ’405 Patent. On October 11, 2018, Zydus filed a notice of appeal to the U.S. Court of Appeals for the Federal Circuit (the Federal Circuit Court) and on October 24, 2018, the Federal Circuit Court consolidated the appeals of Zydus and Amgen.

In December 2018, the FDA approved Watson’s generic version of Sensipar® and Watson’s parent company, Teva Pharmaceutical Industries Ltd. (Teva), began selling its product at-risk notwithstanding that the appeals were pending at the Federal Circuit Court. On January 2, 2019, Amgen, Watson and Teva entered into a settlement agreement in which Teva agreed to stop selling its generic product until the mid-year 2021, or earlier under certain circumstances, and to pay Amgen an undisclosed amount. On January 9, 2019, Watson and Amgen filed a motion asking the Delaware District Court to vacate its final judgment of noninfringement as to Watson and to enter a proposed consent judgment of infringement and validity of the ’405 Patent and an injunction prohibiting the making, having made, using, selling, offering to sell, or distributing Watson’s cinacalcet product in the United States, or importing Watson’s cinacalcet product into the United States, consistent with the confidential settlement agreement. On January 11, 2019, the Federal Circuit Court stayed the pending appeal as to Watson in order for the Delaware District Court to rule on the motion of Watson and Amgen. On January 18, 2019 and January 23, 2019, respectively, Cipla and Sun filed oppositions to the motion of Watson and Amgen.

On January 8, 2019, Cipla filed a separate lawsuit in the Delaware District Court against Amgen seeking a declaration that provisions of its settlement agreement with Amgen have been triggered by Teva’s at-risk launch of Watson’s generic version of Sensipar®, giving Cipla a right to market its own generic version under its settlement agreement. Cipla’s complaint also alleges antitrust violations by Amgen. The portions of the complaint covering Cipla’s settlement agreement were filed with the court under seal and remain confidential.

Amgen Inc. v. Alkem et al.

As stated above, Amgen filed four lawsuits in June 2017 for infringement of the ’405 Patent. In December 2017, the lawsuits filed against (1) Alkem Laboratories Ltd. (Alkem), (2) Lupin Ltd. and Lupin Pharmaceuticals, Inc. (collectively, Lupin) and (3) Macleods Pharmaceuticals Ltd. and Macleods Pharma USA, Inc. (collectively, Macleods) were consolidated into a separate single case, Amgen Inc. v. Alkem et al. In each of those three lawsuits, all defendants responded to the complaint denying infringement and seeking a declaration of noninfringement and invalidity of the ’405 Patent; Macleods’ response also included a counterclaim alleging sham litigation in violation of the Sherman Antitrust Act, which Amgen has denied and which the Delaware District Court stayed pending resolution of the patent claims.

In March 2018, the Delaware District Court signed a consent judgment filed by Amgen and Macleods in which the parties stipulated to an entry of judgment of infringement and validity of the ’405 Patent and an injunction prohibiting the manufacture, use, sale, offer to sell, importation of, or distribution into the United States of Macleods’ cinacalcet product during the term of the ’405 Patent unless specifically authorized pursuant to the confidential settlement agreement. In April 2018, the Delaware District Court also entered orders respectively dismissing Lupin and Alkem on stipulations between the parties, subject to the terms of confidential settlement agreements.

Other Sensipar® ANDA Patent Litigation

In December 2017, Amgen filed four additional lawsuits in the Delaware District Court for infringement of the ’405 Patent against (1) Watson, (2) Teva Pharmaceuticals, USA, Inc., (3) Barr Laboratories, Inc. and (4) Torrent Pharma Inc. and Torrent Pharmaceuticals Ltd. These lawsuits were distinct from the suits consolidated into Amgen Inc. v. Aurobindo Pharma Ltd. et al., and all four additional suits were subsequently dismissed by agreement between Amgen and the respective defendants.

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In June 2018, Amgen filed a lawsuit in the Delaware District Court against Accord Healthcare, Inc. (Accord) and Intas Pharmaceuticals Ltd. (Intas) for infringement of the ’405 Patent. Amgen seeks an order making any FDA approval of these defendants’ generic version of Sensipar® effective no earlier than the expiration of the ’405 Patent. On September 18, 2018, Accord denied infringement of the ’405 Patent and alleged that the patent is invalid. On September 20, 2018, Intas was dismissed from the Delaware District Court lawsuit without prejudice by joint stipulation of the parties. On February 1, 2019, Accord filed a motion for summary judgment of noninfringement. Trial is scheduled to begin June 15, 2020.

On September 7, 2018, Amgen filed a lawsuit in the Delaware District Court for infringement of the ’405 Patent against Emcure Pharmaceuticals Ltd., Heritage Pharmaceuticals Inc. and Heritage Pharma Labs Inc. In December 2018, the Delaware District Court entered an order dismissing all defendants on a stipulation between the parties, subject to the terms of a confidential settlement agreement.

KYPROLIS® (carfilzomib) ANDA Patent Litigation

Beginning in October 2016, our subsidiary Onyx Therapeutics, Inc. (Onyx Therapeutics), filed four separate lawsuits in the Delaware District Court against: (1) Cipla, (2) Sagent Pharmaceuticals, Inc. (Sagent), (3) Breckenridge and (4) Fresenius Kabi, USA LLC, Fresenius Kabi USA, Inc., Fresenius Pharmaceuticals Holding, Inc. and Fresenius Kabi Oncology Limited, each for infringing U.S. Patent Nos. 7,232,818 (the ’818 Patent), 7,417,042 (the ’042 Patent), 7,491,704 (the ’704 Patent), 7,737,112 (the ’112 Patent), 8,129,346 (the ’346 Patent), 8,207,125 (the ’125 Patent), 8,207,126 (the ’126 Patent), 8,207,127 (the ’127 Patent) and 8,207,297 (the ’297 Patent). By joint stipulation of the parties, Fresenius Pharmaceuticals Holding, Inc. and Fresenius Kabi Oncology Limited were subsequently dismissed from the lawsuit against them. In October and November 2016, Onyx Therapeutics also filed four separate lawsuits in the Delaware District Court against: (1) MSN Laboratories Private Limited and MSN Pharmaceuticals, Inc. (collectively, MSN), (2) Dr. Reddy’s, (3) Qilu Pharma, Inc. and Qilu Pharmaceutical Co. Ltd. (collectively, Qilu) and (4) Apotex, each for infringing the ’112 Patent; and a separate lawsuit against InnoPharma, Inc. (InnoPharma) for infringement of the ’042, ’112 and ’297 Patents. In April 2017, Onyx Therapeutics filed a separate lawsuit in the Delaware District Court against Teva Pharmaceuticals USA, Inc. and Teva Pharmaceutical Industries Ltd. for infringement of the ’818, ’042, ’704, ’112, ’346, ’125, ’126, ’127 and ’297 Patents. The Delaware District Court has consolidated these ten lawsuits for purposes of discovery into a single case, Onyx Therapeutics, Inc. v. Cipla Limited., et al.

In August 2017, Onyx Therapeutics filed additional lawsuits in the Delaware District Court against InnoPharma for infringement of the ’818, ’704, ’346, ’125, ’126 and ’127 Patents; and against Apotex and Qilu for infringement of the ’818, ’042, ’704, ’346, ’125, ’126, ’127 and ’297 Patents. On September 14, 2017, the Delaware District Court consolidated these three additional lawsuits for purposes of discovery into the existing consolidated case.

In September 2017, by joint stipulation of the parties, Teva Pharmaceutical Industries Ltd. was dismissed from the suit against it, leaving Teva Pharmaceuticals USA, Inc., as the remaining defendant in that litigation.

In November 2017, Onyx Therapeutics filed a lawsuit in the Delaware District Court against Aurobindo Pharma USA, Inc. (Aurobindo) for infringement of the ’818, ’042, ’704, ’112, ’346, ’125, ’126, ’127 and ’297 Patents. In December 2017, Onyx Therapeutics filed additional lawsuits in the Delaware District Court against Dr. Reddy’s for infringement of the ’818, ’042, ’704, ’346, ’125, ’126, ’127 and ’297 Patents, and against MSN for infringement of the ’112 Patent. In January 2018, Onyx Therapeutics filed a lawsuit in the Delaware District Court against Apotex for infringement of the ’818, ’042, ’704, ’112, ’346, ’125, ’126, ’127 and ’297 Patents.

In February 2018, Qilu and Teva Pharmaceuticals USA, Inc. were each dismissed from the applicable lawsuits by joint stipulation of the parties. On February 7, 2018, the Delaware District Court also consolidated for purposes of discovery the lawsuit against Aurobindo into the existing consolidated case, Onyx Therapeutics, Inc. v. Cipla Limited, et al. On March 20, 2018, the Delaware District Court entered a stipulation between the parties providing Aurobindo a covenant not to sue on the ’818,’704,’346 and ’297 Patents.

On February 15, 2018, Onyx Therapeutics filed a lawsuit in the Delaware District Court against Breckenridge for patent infringement, and subsequently amended the complaint on March 9, 2018 to assert infringement of the ’042, ’112, ’125, ’126 and ’127 Patents. On April 20, 2018, Onyx Therapeutics filed a lawsuit in the Delaware District Court against Cipla for patent infringement of the ’042, ’112, ’125, ’126 and ’127 Patents.

The lawsuits filed between 2016-2018 are based on ANDAs that seek approval to market generic versions of KYPROLIS® before expiration of the asserted patent or patents. In each lawsuit, Onyx Therapeutics seeks an order of the Delaware District Court making any FDA approval of the respective defendant’s ANDA effective no earlier than the expiration of the applicable patents. Responses to the complaints have been filed by all defendants alleging invalidity and, in certain instances, noninfringement of the patents.

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During April 2018, the Delaware District Court entered orders on stipulations between Onyx Therapeutics and each of Apotex, Dr. Reddy’s and Sagent, respectively, that each defendant infringes the ’042, ’112, ’125, ’126 and ’127 Patents, and that Onyx Therapeutics will not assert patent infringement of the ’818, ’704, ’346 and ’297 Patents against certain of the respective defendants’ ANDA applications and products. During May, June and July of 2018, the Delaware District Court entered orders on stipulations between Onyx Therapeutics and each of Fresenius Kabi, USA LLC and Fresenius Kabi USA, Inc. (collectively, Fresenius), Breckenridge, Aurobindo, Cipla and Innopharma, respectively, that each defendant infringes the ’042, ’112, ’125, ’126 and ’127 Patents. Onyx Therapeutics had previously provided those defendants a covenant that it would not assert patent infringement of the ’818,’704,’346 and ’297 Patents against certain of the respective defendants’ ANDA applications and products. On June 4, 2018, the Delaware District Court also entered an order on a stipulation between Onyx Therapeutics and MSN that MSN infringes the ’112 Patent.

In December 2018, Apotex, Dr. Reddy’s, Fresenius, InnoPharma, Sagent, Breckenridge, Aurobindo and Cipla amended their responses to the complaints to add the defense of unclean hands and to seek declarations of unenforceability of the asserted patents based on allegations of inequitable conduct. In January 2019, MSN amended its responses to the complaints to add the defense of unclean hands. Trial in the consolidated case is scheduled to commence on May 6, 2019.

On January 11, 2019, Onyx Therapeutics filed a separate lawsuit in the Delaware District Court against Breckenridge for infringing the ’042, ’112 and ’125 Patents in connection with its ANDA that seeks approval to market generic versions of KYPROLIS® before expiration of those patents. Onyx Therapeutics seeks an order from the Delaware District Court making any FDA approval of Breckenridge’s ANDA effective no earlier than the expiration of the applicable patents.

Sandoz ENBREL (etanercept) Patent Litigation

On February 26, 2016, two affiliates of Amgen Inc. (Immunex Corporation and Amgen Manufacturing, Limited (AML) (collectively, Amgen)), along with Hoffmann-La Roche Inc. (Roche), filed a lawsuit in the U.S. District Court for the District of New Jersey (the New Jersey District Court) against Sandoz Inc., Sandoz International GmbH and Sandoz GmbH (collectively, Sandoz). This lawsuit stems from Sandoz’s submission of an application for FDA licensure of an etanercept product as biosimilar to Amgen’s ENBREL. Amgen and Roche have asserted infringement of five patents: U.S. Patent Nos. 8,063,182 (the ’182 Patent); 8,163,522 (the ’522 Patent); 7,915,225; 8,119,605; and 8,722,631 (the ’631 Patent). By their complaint, Amgen and Roche seek an injunction to prohibit Sandoz from commercializing its biosimilar etanercept product in the United States prior to the expiry of such patents. Responses have been filed by all Sandoz defendants denying infringement and/or asserting that the patents at issue are invalid. On August 11, 2016, and subject to the terms of a confidential stipulation, the New Jersey District Court entered a preliminary injunction prohibiting Sandoz from making, using, importing, selling or offering for sale Sandoz’s etanercept product. On August 30, 2016, the FDA approved Sandoz’s ErelziTM, a biosimilar to ENBREL.

On September 14, 2017, Amgen filed a motion for summary judgment that Sandoz infringed claim 1 of the ’631 Patent and, on October 23, 2017, Sandoz filed its brief in opposition to the motion.

On September 10, 2018, the New Jersey District Court entered an order that the making, using, offering to sell or selling in the United States, or the importation into the United States by Sandoz of Sandoz’s biosimilar etanercept product infringes the ’182 Patent and the ’522 Patent. The New Jersey District Court held a bench trial from September 11, 2018, to September 25, 2018, focusing on Sandoz’s challenges to the validity of these patents. Closing arguments were heard on November 19, 2018, and the parties await the court’s verdict.

NEUPOGEN® (filgrastim) / Neulasta® (pegfilgrastim) Patent Litigation

Adello NEUPOGEN® Patent Litigation

On March 8, 2018, Amgen Inc. and AML (collectively, Amgen) filed a lawsuit in the New Jersey District Court against Adello Biologics, LLC (Adello). This lawsuit stems from Adello’s submission of an application for FDA licensure of a filgrastim product as biosimilar to Amgen’s NEUPOGEN®. Amgen has asserted infringement of 17 of our patents. Amgen seeks an injunction to prohibit Adello from commercializing its biosimilar filgrastim product in the United States prior to the expiry of these patents. On May 17, 2018, Adello responded to Amgen’s lawsuit for patent infringement, denying infringement and seeking judgment that the patents-in-suit are invalid and not infringed.

On October 3, 2018, Amgen filed a first amended complaint in the New Jersey District Court adding as defendants Amneal Pharmaceuticals LLC and Amneal Pharmaceuticals, Inc. (collectively, Amneal) and reducing the number of patents-in-suit from 17 to 4: U.S. Patent Nos. 8,940,878 (the ’878 Patent); 8,952,138 (the ’138 Patent); 9,643,997 (the ’997 Patent); and 9,856,287 (the ’287 Patent). On October 17, 2018, Adello responded to the first amended complaint, seeking judgment that our patents-in-suit are not infringed by Adello’s biosimilar filgrastim product and that our patents are invalid. On December 5, 2018, Amneal filed a motion to dismiss the claims against it for failure to state a claim and for lack of subject-matter jurisdiction.

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Apotex NEUPOGEN® / Neulasta® Patent Litigation

On August 7, 2018, Amgen filed a lawsuit in the U.S. District Court for the Southern District of Florida against Apotex for infringement of the ’287 Patent in accordance with the patent provisions of the Biologics Price Competition and Innovation Act (BPCIA). This lawsuit stems from Apotex’s submissions of applications for FDA licensure of a pegfilgrastim product as biosimilar to Amgen’s Neulasta® and a filgrastim product as biosimilar to Amgen’s NEUPOGEN®. By its complaint, Amgen seeks, among other remedies, an injunction prohibiting Apotex from infringing the ’287 Patent. On December 10, 2018, Apotex filed a motion to dismiss the complaint for failure to state a claim. A hearing on the motion to dismiss is scheduled for March 15, 2019.

On October 1, 2018, Apotex and Adello Biologics, LLC filed a petition in the U.S. Patent and Trademark Office requesting that the Patent Trial and Appeal Board (PTAB) institute post grant review proceedings on the ’287 Patent. On January 23, 2019, Amgen filed a patent owner’s preliminary response.

On February 17, 2017, the PTAB of the U.S. Patent and Trademark Office granted Apotex’s petition to institute an inter partes review (IPR) of the ’138 Patent, challenging claims of the ’138 Patent as unpatentable. On May 22, 2017, Amgen filed its response and oral argument was held before the PTAB on December 13, 2017. The PTAB issued a final decision on the IPR of the ’138 Patent holding all but one claim of the ’138 Patent as unpatentable. On March 16, 2018, Apotex filed a request for rehearing on the PTAB’s finding that this one claim is patentable.

Coherus Neulasta® Patent Litigation

On May 10, 2017, Amgen filed a lawsuit in the Delaware District Court against Coherus BioSciences, Inc. (Coherus) for infringement of our U.S. Patent No. 8,273,707 (the ’707 Patent). This lawsuit stems from Coherus’ submission of an application for FDA licensure of a pegfilgrastim product as biosimilar to Amgen’s Neulasta® under the BPCIA. By its complaint, Amgen seeks, among other remedies, an injunction prohibiting Coherus from infringing the ’707 Patent. On March 26, 2018, the Delaware District Court granted Coherus’ motion to dismiss Amgen’s complaint for failure to state a claim and final judgment was entered dismissing Amgen’s complaint on April 18, 2018. On May 17, 2018, Amgen appealed the judgment to the Federal Circuit Court. On November 2, 2018, the FDA approved Coherus’ UDENYCATM, a biosimilar to Neulasta®, which was subsequently launched in January 2019.

We are also engaged in a separate lawsuit in which we have alleged that Coherus and others misappropriated our confidential information and trade secrets through hiring of former Amgen employees and that they have used such information to develop and market UDENYCATM. Trial is scheduled to begin on April 22, 2019.

Mylan Neulasta® Patent Litigation

On September 22, 2017, Amgen Inc. and AML (collectively, Amgen) filed a lawsuit in the District Court for the Western District of Pennsylvania (the Pennsylvania Western District Court) against Mylan Inc., Mylan Pharmaceuticals Inc., Mylan GmbH, and Mylan N.V. (collectively, Mylan) for infringement of our ’707 Patent and the ’997 Patent. This lawsuit stems from Mylan’s submission of an application for FDA licensure of a pegfilgrastim product as biosimilar to Amgen’s Neulasta® under the BPCIA. By its complaint, Amgen seeks, among other remedies, an injunction prohibiting Mylan from infringing the ’707 and ’997 Patents. On November 22, 2017, Mylan answered the complaint, denying patent infringement and alleging that the patents are invalid. On April 6, 2018, Mylan filed a motion for judgment on the pleadings of noninfringement of our ’707 Patent, which was denied by the court without prejudice on November 15, 2018. On June 4, 2018, the FDA approved Mylan’s Fulphila®, a biosimilar to Neulasta®, which was subsequently launched in July 2018. On November 20, 2018, the Pennsylvania Western District Court issued a claim construction opinion and order. On January 23 and 30, 2019, Mylan filed a renewed motion for judgment on the pleadings of noninfringement of the ’707 Patent and a motion for summary judgment of noninfringement of the ’997 Patent, respectively.

Pfizer NEUPOGEN® Patent Litigation

On July 18, 2018, Amgen Inc. and AML (collectively, Amgen) filed a lawsuit in the Delaware District Court against Pfizer Inc. and Hospira Inc. (collectively, Pfizer). This lawsuit stems from Pfizer’s submission of an application for FDA licensure of a filgrastim product as biosimilar to Amgen’s NEUPOGEN®. Amgen has asserted infringement of the ’997 Patent and seeks, among other remedies, injunctive relief to prohibit Pfizer from infringing the ’997 Patent. On July 20, 2018, the FDA approved Pfizer’s NIVESTYMTM, a biosimilar to NEUPOGEN®, which was subsequently launched in October 2018.

On August 9, 2018, Pfizer answered the complaint and counterclaimed seeking a declaration that Pfizer does not infringe Amgen’s ’997 Patent and that the patent is invalid. Trial is scheduled to commence on June 15, 2020.

Sandoz NEUPOGEN® Patent Litigation

On October 24, 2014, Amgen Inc. and AML (collectively, Amgen) filed a lawsuit in the U.S. District Court for the Northern District of California (the California Northern District Court) against Sandoz Inc., Sandoz International GmbH and Sandoz GmbH

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(collectively, Sandoz) for infringement of our U.S. Patent No. 6,162,427 (the ’427 Patent) and various state law claims. The lawsuit stems from Sandoz filing an application for FDA licensure of a filgrastim product as biosimilar to NEUPOGEN® under the BPCIA, while having deliberately failed to comply with the BPCIA’s disclosure requirement to Amgen as the reference product sponsor. By its complaint, Amgen seeks, among other remedies, an injunction to cease Sandoz’s unauthorized reliance on Amgen’s Biologics License Application (BLA) for filgrastim and an injunction to prevent infringement of the ’427 Patent.

On March 19, 2015, the California Northern District Court issued an order dismissing with prejudice Amgen’s state law claims and entered judgment in favor of Sandoz Inc. on its cross-motion for partial judgment on the pleadings. The order also denied Amgen’s motion for a preliminary injunction, as well as Amgen’s motion for partial judgment on the pleadings. On a joint motion of the parties, on March 25, 2015, the California Northern District Court entered final judgment on the claims and counterclaims decided by the court’s March 19 order. The remaining patent infringement claim, counterclaim and defenses were stayed by the court pending appeal. On March 25, 2015, Amgen appealed both the judgment in favor of Sandoz Inc. and the denial of Amgen’s motion for preliminary injunction to the Federal Circuit Court. On May 5, 2015, the Federal Circuit Court entered an injunction prohibiting Sandoz Inc. from marketing, selling, offering for sale, or importing into the United States Sandoz’s FDA-approved Zarxio® biosimilar product until the Federal Circuit Court resolved the appeal.

On July 21, 2015, the Federal Circuit Court affirmed the California Northern District Court’s dismissal of Amgen’s state law claims concluding that the only remedies available for a biosimilar applicant’s failure to provide its BLA by the statutory deadline is to bring a patent infringement claim and seek those patent remedies provided by the statute. The Federal Circuit Court also concluded that a biosimilar applicant must give 180-day advance notice of first commercial marketing after the FDA has licensed the biosimilar product. Accordingly, the Federal Circuit Court entered an order that its previously entered injunction be extended through September 2, 2015 (180 days from Sandoz Inc.’s notice given after FDA approval).

In 2016, Sandoz filed a petition for certiorari with the U.S. Supreme Court and Amgen filed a conditional cross-petition for certiorari. Both petitions were granted and on June 12, 2017, the U.S. Supreme Court reversed the Federal Circuit Court ruling that a biosimilar applicant must wait to give the 180-day advance notice of first commercial marketing until after the FDA has licensed the biosimilar product, holding that such notice can be given either before or after the FDA approval. The U.S. Supreme Court also vacated the Federal Circuit Court’s decision that the only remedy available when a biosimilar applicant refuses to provide its BLA is to bring a patent infringement claim. The U.S. Supreme Court agreed with the Federal Circuit Court that there is no remedy under federal law for failing to make the disclosure but remanded the case to the Federal Circuit Court to determine whether California law would treat noncompliance with such requirement as unlawful and, if so, to determine whether the BPCIA pre-empts any additional remedy available under state law and whether Sandoz forfeited any pre-emption defense. On December 14, 2017, the Federal Circuit Court affirmed the California Northern District Court’s dismissal of Amgen’s state law claims, holding that the BPCIA pre-empts state law remedies for a biosimilar applicant’s failure to comply with the BPCIA’s disclosure requirement.

Following the California Northern District Court’s September 8, 2015 lift of the stay of the case, the parties continued to litigate the remaining patent infringement claim, counterclaim and defenses. On October 15, 2015, Amgen filed a first supplemental and amended complaint adding to the lawsuit Sandoz’s infringement of the ’878 Patent, which covers methods of purifying proteins. On September 13, 2017, by joint stipulation of the parties, the California Northern District Court dismissed from the case the parties’ respective claims and counterclaims related to the ’427 Patent. On October 25, 2017, Sandoz filed motions for summary judgment of noninfringement of the ’878 Patent and for summary judgment regarding damages. On December 19, 2017, the California Northern District Court granted Sandoz’s summary judgment of noninfringement. Sandoz’s motion for summary judgment regarding damages was denied as moot. On January 8, 2018, the California Northern District Court entered judgment of noninfringement of the ’878 and ’427 Patents and dismissed without prejudice Sandoz’s counterclaims of invalidity of the ’878 and ’427 Patents. On February 5, 2018, Amgen appealed the judgment to the Federal Circuit Court. A hearing on the appeal has been scheduled for March 4, 2019.

Sandoz Neulasta® Patent Litigation

On May 12, 2016, Amgen filed a lawsuit in the California Northern District Court against Sandoz and Lek Pharmaceuticals d.d. for infringement of the ’878 Patent and U.S. Patent No. 5,824,784 (the ’784 Patent) in accordance with the patent provisions of the BPCIA. The lawsuit stems from Sandoz filing an application for FDA licensure of a pegfilgrastim product as biosimilar to Neulasta®. On June 23, 2016, Sandoz responded to the complaint, denying infringement and seeking judgment that the patents-in-suit are invalid and/or not infringed. On December 7, 2016, by joint stipulation of the parties, the California Northern District Court dismissed from the case all claims and counterclaims related to the ’784 Patent. On October 25, 2017, Sandoz filed motions for summary judgment of noninfringement of the ’878 Patent and for summary judgment regarding damages. On December 19, 2017, the California Northern District Court granted Sandoz’s summary judgment of noninfringement of the ’878 Patent. Sandoz’s motion for summary judgment regarding damages was denied as moot. On January 8, 2018, the California Northern District Court entered judgment of noninfringement of the ’878 Patent and dismissed without prejudice Sandoz’s counterclaims of invalidity of the ’878 Patent. On February 5, 2018, Amgen appealed the judgment to the Federal Circuit Court. A hearing on the appeal has been scheduled for March 4, 2019.

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PCSK9 Antibody Patent Litigation

U.S. Patent Litigation-Sanofi/Regeneron

On October 17, 2014, Amgen initiated a series of lawsuits in the Delaware District Court against Sanofi, Aventisub LLC, formerly doing business as Aventis Pharmaceuticals Inc., and Regeneron Pharmaceuticals, Inc. (Regeneron) for patent infringement. On December 15, 2014, these lawsuits were consolidated by the Delaware District Court into a single case against Sanofi, Sanofi-Aventis U.S. LLC and Aventisub LLC, formerly doing business as Aventis Pharmaceuticals Inc. (collectively, Sanofi) and Regeneron, addressing seven of our patents: U.S. Patent Nos. 8,563,698; 8,829,165 (the ’165 Patent); 8,859,741 (the ’741 Patent); 8,871,913; 8,871,914; 8,883,983; and 8,889,834. These patents describe and claim monoclonal antibodies to proprotein convertase subtilisin/kexin type 9 (PCSK9). By its complaints, Amgen seeks an injunction to prevent the infringing manufacture, use and sale of Sanofi and Regeneron’s alirocumab, a monoclonal antibody targeting PCSK9. On January 29, 2016, the Delaware District Court granted Amgen’s motion to amend the complaint to add AML and Amgen USA Inc. as plaintiffs and to add the allegation that defendants’ infringement of Amgen’s patents is willful.

On February 22, 2016, the Delaware District Court entered a stipulated order finding alirocumab and the drug product containing it, PRALUENT®, infringe certain of Amgen’s patents, including claims 2, 7, 9, 15, 19 and 29 of the ’165 Patent and claim 7 of the ’741 Patent. On March 18, 2016, the Delaware District Court entered judgment in favor of Amgen following a five-day jury trial and a unanimous jury verdict that these patent claims from the ’165 Patent and the ’741 Patent are all valid. On January 3, 2017, the Delaware District Court denied Sanofi and Regeneron’s post-trial motions seeking a new trial and for judgment as a matter of law, and on January 5, 2017, granted Amgen’s motion for a permanent injunction prohibiting the infringing manufacture, use, sale, offer for sale or import of alirocumab in the United States.

On January 12, 2017, Sanofi and Regeneron filed an appeal of the judgment and the permanent injunction to the Federal Circuit Court. On February 8, 2017, following a motion by Sanofi and Regeneron, the Federal Circuit Court entered a stay of the permanent injunction during the pendency of the appeal. On October 5, 2017, the Federal Circuit Court reversed in part the judgment of the Delaware District Court and remanded for a new trial two of Sanofi and Regeneron’s patent validity defenses (failure to meet the law’s requirements for patentability of written description and enablement of the claimed inventions), and affirmed the Delaware District Court’s judgment of infringement of claims 2, 7, 9, 15, 19 and 29 of the ’165 Patent and claim 7 of the ’741 Patent and patent validity on Sanofi and Regeneron’s third patent validity defense (finding that the claimed inventions were not obvious to a person of ordinary skill in the field of the patents). The Federal Circuit Court also vacated and remanded for further consideration by the Delaware District Court the permanent injunction. On July 23, 2018, Amgen filed a petition for certiorari with the U.S. Supreme Court seeking review of the Federal Circuit Court’s conclusion that the judgment affirming the validity of Amgen’s patents was based, in part, on an erroneous application of the law of written description. On January 7, 2019, the Supreme Court denied Amgen’s petition for certiorari.

On remand from the appellate court, the Delaware District Court scheduled a new trial to begin on February 19, 2019 on Sanofi and Regeneron’s challenges to the validity of our patents based on lack of written description and enablement of the claimed inventions. Consideration of damages and injunctive relief will follow, as appropriate. The court also entered judgment on the pleadings for Sanofi and Regeneron on Amgen’s claim of willful infringement.

Patent Disputes in the International Region

On February 24, 2016, the European Patent Office (EPO) granted European Patent No. 2,215,124 (EP 2,215,124) to Amgen. This patent describes and claims monoclonal antibodies to PCSK9 and methods of treatment. On February 24, 2016, Sanofi filed an opposition to the patent in the EPO seeking to invalidate it. In November 2016, Sanofi-Aventis Deutschland GmbH, Sanofi-Aventis Groupe S.A. and Sanofi Winthrop Industrie S.A. filed a joint opposition against Amgen’s patent, and each of Eli Lilly and Company, Regeneron and Strawman Ltd. also filed oppositions to Amgen’s patent. Following a three-day hearing, on November 30, 2018, the EPO confirmed the validity of Amgen’s EP 2,215,124.

We are also involved in and expect future involvement in additional disputes regarding our PCSK9 patents in other jurisdictions and regions, including matters filed against us and that we have filed in the United Kingdom, Germany, France and Japan.

Hospira EPOGEN® (epoetin alfa) Patent Litigation

On September 18, 2015, Amgen filed a lawsuit in the Delaware District Court against Hospira, Inc. (Hospira), a subsidiary of Pfizer, for infringement of Amgen’s U.S. Patent Nos. 5,856,298 (the ’298 Patent) and 5,756,349 (the ’349 Patent) in accordance with the patent provisions of the BPCIA and for a declaration that Hospira has failed to comply with certain requirements of the BPCIA. This lawsuit stems from the submission by Hospira under the BPCIA of an application for FDA licensure of an epoetin product as biosimilar to Amgen’s EPOGEN®. By its complaint, Amgen seeks, among other remedies, an injunction prohibiting Hospira from using or selling infringing cells and/or product manufactured during the ’298 or the ’349 Patent terms and enjoining

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Hospira from commencing commercial marketing of any biosimilar epoetin product until a date that is at least 180 days after Hospira provides legally effective notice to Amgen.

On August 19, 2016, Hospira responded to the complaint denying patent infringement and any violation of the BPCIA and seeking judgment that the patents-in-suit are invalid and not infringed by Hospira. On January 23, 2017, the Delaware District Court entered an order construing the claims of the ’349 and ’298 Patents and holding that two claims of the ’298 Patent are invalid for failure to properly narrow the claim on which they depend.

On September 22, 2017, after a five-day trial, the jury returned a verdict finding the ’298 Patent valid and infringed by Hospira and the ’349 Patent not infringed. The jury awarded Amgen $70 million in damages for Hospira’s infringement. On October 23, 2017, Hospira moved for judgment as a matter of law of noninfringement and invalidity of the ’298 Patent or, in the alternative, for reduction of the damage award or a new trial on the ’298 Patent.

On May 15, 2018, the FDA approved Hospira’s RETACRIT®, a biosimilar to EPOGEN®, which was subsequently launched on November 14, 2018.

On August 27, 2018, the Delaware District Court denied Hospira’s October 23, 2017, motion and entered final judgment on September 11, 2018. On October 3, 2018, Hospira filed a notice of appeal to the Federal Circuit Court and on October 15, 2018, Amgen filed a notice of cross-appeal.

Litigation relating to our Biosimilar Products

MVASITM (bevacizumab-awwb) Patent Litigation

On October 6 and October 18, 2017, Genentech, Inc. (Genentech) and City of Hope filed separate lawsuits in the Delaware District Court respectively alleging Amgen’s infringement of (i) 24 of the 27 patents listed by Genentech in the BPCIA exchange and (ii) 25 of the same 27 patents, in each case by Amgen’s submission for FDA licensure of MVASITM as biosimilar to Genentech’s Avastin® (bevacizumab), and for non-compliance with certain provisions of the BPCIA. On December 6, 2017, Genentech and City of Hope amended their complaints to allege that Amgen will also infringe newly issued U.S. Patent No. 9,795,672. On April 17, 2018, the Delaware District Court granted Amgen’s motion to dismiss certain claims by Genentech and City of Hope that Amgen had not complied with the BPCIA.

Amgen responded to the complaints on May 1 and June 5, 2018, respectively, denying patent infringement and any violation of the BPCIA and seeking judgment that the patents-in-suit are invalid, unenforceable and/or not infringed by Amgen. On May 22 and June 19, 2018, respectively, Genentech and City of Hope moved to dismiss from each case all of Amgen’s counterclaims and certain of Amgen’s defenses.

On August 31, 2018, in accordance with the scheduling order issued by the Delaware District Court, Genentech and City of Hope reduced the number of asserted patents in each lawsuit to 8, asserting the same patents in each case. On October 22, 2018, the two cases were consolidated by the court. Trial is scheduled to begin on July 13, 2020.

KANJINTITM (trastuzumab) Patent Litigation

On June 21, 2018, Genentech and City of Hope filed a lawsuit in the Delaware District Court alleging Amgen’s infringement of 37 patents by Amgen’s submission of an application for FDA licensure of KANJINTITM, Amgen’s biosimilar version of Genentech’s Herceptin® (trastuzumab). On July 19, 2018, Genentech, City of Hope and Amgen filed a joint stipulation to dismiss certain of the patents from the lawsuit and Genentech and City of Hope filed an amended complaint narrowing its allegations of infringement to 18 of the 37 patents. Among other remedies, Genentech and City of Hope seek injunctive relief prohibiting patent infringement.

On August 23, 2018, Genentech and City of Hope moved to dismiss Amgen’s unenforceability counterclaims and affirmative defense. On November 7, 2018, in accordance with the scheduling order issued by the Delaware District Court, Genentech and City of Hope reduced the number of asserted patents from 18 to 10. On January 17, 2019, Genentech and the City of Hope filed a second amended complaint that removed one of the remaining 10 asserted patents and added a different patent. Trial is scheduled to begin on or after December 9, 2019.

AMJEVITATM (adalimumab-atto) / AMGEVITATM Patent Litigation

On January 24, 2019, Coherus filed a lawsuit in the Delaware District Court that the formulation of AMJEVITATM infringes three patents: U.S. Patent Nos. 10,155,039; 10,159,732; and 10,159,733. By its complaint, Coherus seeks, among other remedies, injunctive relief prohibiting patent infringement.

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Amgen has also been sued in a number of European countries by Fresenius Kabi Deutschland GmbH (Fresenius), alleging that AMGEVITATM infringes various patents of Fresenius and seeking, among other remedies, injunctive relief prohibiting patent infringement.

U.S. Attorney’s Office for the District of Massachusetts-Patient Assistance Investigation

Amgen, together with other companies in our industry, has received inquiries from the U.S. Attorney’s Office for the District of Massachusetts relating to support of charitable 501(c)(3) organizations that provide financial assistance to Medicare patients. Amgen is cooperating with this ongoing inquiry.

Commitments

Lease commitments

We lease certain facilities and equipment related primarily to administrative, R&D, sales and marketing activities under noncancelable operating leases that expire through 2029. The following table summarizes the minimum future rental commitments under noncancelable operating leases as of December 31, 2018 (in millions):

	Amounts
2019	$	164
2020	126
2021	113
2022	64
2023	56
Thereafter	46
Total minimum operating lease commitments	$	569

Included in the table above are future rental commitments for abandoned leases in the amount of $222 million. There were no material charges for lease abandonments related to the restructuring plan that commenced in 2014. See Note 2, Restructuring. We expect to receive total future rental income of $203 million relating to noncancelable subleases of abandoned facilities. Rental expenses on operating leases for the years ended December 31, 2018, 2017 and 2016, were $166 million, $159 million and $134 million, respectively.

U.S. repatriation tax commitments

Under the 2017 Tax Act, we elected to pay the repatriation tax related primarily to our prior indefinitely invested earnings of our foreign operations in eight annual installments. See Note 7, Income taxes. The following table summarizes the remaining scheduled repatriation tax payments as of December 31, 2018 (in millions):

	Amounts
2019	$	586
2020	586
2021	586
2022	586
2023	1,099
Thereafter	3,296
Total remaining U.S. repatriation tax commitments	$	6,739

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21. Major customers

In the United States, we sell primarily to pharmaceutical wholesale distributors that we utilize as the principal means of distributing our products to healthcare providers. Outside the United States, we sell principally to healthcare providers and/or pharmaceutical wholesale distributors depending on the distribution practice in each country. We monitor the financial condition of our larger customers and limit our credit exposure by setting credit limits and, in certain circumstances, by requiring letters of credit or obtaining credit insurance.

We had product sales to three customers, each of them accounting for more than 10% of total revenues for each of the years ended December 31, 2018, 2017 and 2016. For the year ended December 31, 2018, on a combined basis, these customers accounted for 84% and 98% of total gross revenues and U.S. gross product sales, respectively, as shown in the following table. Certain information with respect to these customers was as follows (dollar amounts in millions):

	Years ended December 31,
	2018				2017				2016
AmerisourceBergen Corporation:
Gross product sales	$	12,091			$	10,742			$	10,100
% of total gross revenues	33		%		31		%		31		%
% of U.S. gross product sales	39		%		37		%		38		%
McKesson Corporation:
Gross product sales	$	11,434			$	10,625			$	9,710
% of total gross revenues	31		%		30		%		30		%
% of U.S. gross product sales	35		%		35		%		34		%
Cardinal Health, Inc.:
Gross product sales	$	7,475			$	7,049			$	6,520
% of total gross revenues	20		%		20		%		20		%
% of U.S. gross product sales	24		%		24		%		24		%

As of December 31, 2018 and 2017, amounts due from these three customers each exceeded 10% of gross trade receivables and accounted for 76% and 75%, respectively, of net trade receivables on a combined basis. As of December 31, 2018 and 2017, 23% and 25%, respectively, of trade receivables, net, were due from customers located outside the United States—primarily in Europe. Our total allowance for doubtful accounts as of December 31, 2018 and 2017 was not material.

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22. Quarterly financial data (unaudited)

The following tables summarize the Company’s unaudited financial data on a quarterly basis. The sum of the quarterly earnings (loss) per-share amounts may not equal the amount reported for the full year because per-share amounts are computed independently for each quarter and for the full year based on respective weighted-average shares outstanding and dilutive securities.

Quarterly financial data is summarized as follows (in millions, except per-share data):

	2018 Quarters ended
	December 31				September 30				June 30				March 31
Product sales	$	6,001			$	5,510			$	5,679			$	5,343
Gross profit from product sales	$	4,905			$	4,473			$	4,655			$	4,399
Net income	$	1,928			$	1,859			$	2,296			$	2,311
Earnings per share:
Basic	$	3.04			$	2.88			$	3.50			$	3.27
Diluted	$	3.01			$	2.86			$	3.48			$	3.25
	2017 Quarters ended
	December 31				September 30				June 30				March 31
Product sales	$	5,569			$	5,453			$	5,574			$	5,199
Gross profit from product sales	$	4,510			$	4,463			$	4,550			$	4,203
Net (loss) income	$	(4,264	)		$	2,021			$	2,151			$	2,071
(Loss) earnings per share:
Basic	$	(5.89	)		$	2.78			$	2.93			$	2.81
Diluted(1)	$	(5.89	)		$	2.76			$	2.91			$	2.79

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(1)	During periods of net loss, diluted loss per share is equal to basic loss per share because the antidilutive effect of potential common shares is disregarded.

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SCHEDULE II

AMGEN INC.

VALUATION AND QUALIFYING ACCOUNTS

Years ended December 31, 2018, 2017 and 2016

(In millions)

Allowance for doubtful accounts		Balance at beginning of period				Additions charged to costs and expenses				Other additions				Deductions				Balance at end of period
Year ended December 31, 2018		$	51			$	1			$	—			$	4			$	48
Year ended December 31, 2017		$	51			$	4			$	—			$	4			$	51
Year ended December 31, 2016		$	55			$	11			$	—			$	15			$	51

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