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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
(Mark One)
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the quarterly period ended June 30, 2019
or
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
Commission File Number: 001-37702
Amgen Inc.
(Exact name of registrant as specified in its charter)
Delaware
 
95-3540776
(State or other jurisdiction of
incorporation or organization)
 
(I.R.S. Employer
Identification No.)
 
 
One Amgen Center Drive
 
91320-1799
Thousand Oaks
 
California
 
(Address of principal executive offices)
 
(Zip Code)
(805) 447-1000
(Registrant’s telephone number, including area code)

Securities registered pursuant to Section 12(b) of the Act:
Title of each class
Trading Symbol(s)
Name of each exchange on which registered
Common stock, $0.0001 par value
AMGN
The NASDAQ Global Select Market
1.250% Senior Notes Due 2022
AMGN22
New York Stock Exchange
2.00% Senior Notes Due 2026
AMGN26
New York Stock Exchange
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or Section 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes  No 
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes  No 
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large accelerated filer
Accelerated filer
Non-accelerated filer
Smaller reporting company
Emerging growth company
 
 
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes
No 
As of July 24, 2019, the registrant had 599,701,222 shares of common stock, $0.0001 par value, outstanding.



AMGEN INC.
INDEX
 
 
Page No.
Item 1.
 
 
 
 
 
 
Item 2.
Item 3.
Item 4.
Item 1.
Item 1A.
Item 2.
Item 6.

i


PART I — FINANCIAL INFORMATION 
Item 1.
FINANCIAL STATEMENTS
AMGEN INC.
CONDENSED CONSOLIDATED STATEMENTS OF INCOME
(In millions, except per-share data)
(Unaudited)

 
Three months ended
June 30,
 
Six months ended
June 30,
 
2019
 
2018
 
2019
 
2018
Revenues:
 
 
 
 
 
 
 
Product sales
$
5,574

 
$
5,679

 
$
10,860

 
$
11,022

Other revenues
297

 
380

 
568

 
591

Total revenues
5,871

 
6,059

 
11,428

 
11,613

 
 
 
 
 
 
 
 
Operating expenses:
 
 
 
 
 
 
 
Cost of sales
1,012

 
1,024

 
2,067

 
1,968

Research and development
924

 
869

 
1,803

 
1,629

Selling, general and administrative
1,260

 
1,353

 
2,414

 
2,480

Other
(3
)
 
(19
)
 
(6
)
 
(22
)
Total operating expenses
3,193

 
3,227

 
6,278

 
6,055

 
 
 
 
 
 
 
 
Operating income
2,678

 
2,832

 
5,150

 
5,558

 
 
 
 
 
 
 
 
Interest expense, net
332

 
347

 
675

 
685

Interest and other income, net
218

 
162

 
403

 
393

 
 
 
 
 
 
 
 
Income before income taxes
2,564

 
2,647

 
4,878

 
5,266

 
 
 
 
 
 
 
 
Provision for income taxes
385

 
351

 
707

 
659

 
 
 
 
 
 
 
 
Net income
$
2,179

 
$
2,296

 
$
4,171

 
$
4,607

 
 
 
 
 
 
 
 
Earnings per share:
 
 
 
 
 
 
 
Basic
$
3.59

 
$
3.50

 
$
6.78

 
$
6.76

Diluted
$
3.57

 
$
3.48

 
$
6.75

 
$
6.73

 
 
 
 
 
 
 
 
Shares used in calculation of earnings per share:
 
 
 
 
 
 
 
Basic
607

 
656

 
615

 
682

Diluted
610

 
660

 
618

 
685


See accompanying notes.

1


AMGEN INC.
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME
(In millions)
(Unaudited)

 
Three months ended
June 30,
 
Six months ended
June 30,
 
2019
 
2018
 
2019
 
2018
Net income
$
2,179

 
$
2,296

 
$
4,171

 
$
4,607

Other comprehensive income (loss), net of reclassification adjustments and taxes:
 
 
 
 
 
 
 
Losses on foreign currency translation
(4
)
 
(111
)
 
(17
)
 
(82
)
(Losses) gains on cash flow hedges
(104
)
 
223

 
(59
)
 
229

Gains (losses) on available-for-sale securities
153

 
9

 
374

 
(334
)
Other
6

 

 
6

 
2

Other comprehensive income (loss), net of taxes
51

 
121

 
304

 
(185
)
Comprehensive income
$
2,230

 
$
2,417

 
$
4,475

 
$
4,422


See accompanying notes.

2


AMGEN INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(In millions, except per-share data)

 
June 30,
2019
 
December 31,
2018
 
(Unaudited)
 
 
ASSETS
Current assets:
 
 
 
Cash and cash equivalents
$
5,525

 
$
6,945

Marketable securities
16,233

 
22,359

Trade receivables, net
3,801

 
3,580

Inventories
3,176

 
2,940

Other current assets
2,011

 
1,794

Total current assets
30,746

 
37,618

 
 
 
 
Property, plant and equipment, net
4,882

 
4,958

Intangible assets, net
6,813

 
7,443

Goodwill
14,689

 
14,699

Other assets
2,243

 
1,698

Total assets
$
59,373

 
$
66,416

 
 
 
 
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
 
 
 
Accounts payable
$
1,001

 
$
1,207

Accrued liabilities
6,805

 
7,862

Current portion of long-term debt
2,816

 
4,419

Total current liabilities
10,622

 
13,488

 
 
 
 
Long-term debt
27,798

 
29,510

Long-term deferred tax liabilities
763

 
864

Long-term tax liabilities
7,861

 
8,770

Other noncurrent liabilities
1,535

 
1,284

 
 
 
 
Contingencies and commitments

 

 
 
 
 
Stockholders’ equity:
 
 
 
Common stock and additional paid-in capital; $0.0001 par value; 2,750.0 shares authorized; outstanding — 602.1 shares in 2019 and 629.6 shares in 2018
31,313

 
31,246

Accumulated deficit
(20,054
)
 
(17,977
)
Accumulated other comprehensive loss
(465
)
 
(769
)
Total stockholders’ equity
10,794

 
12,500

Total liabilities and stockholders’ equity
$
59,373

 
$
66,416


See accompanying notes.

3


AMGEN INC.
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY
(In millions, except per-share data)
(Unaudited)

 
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, 2018
629.6

 
$
31,246

 
$
(17,977
)
 
$
(769
)
 
$
12,500

Net income

 

 
1,992

 

 
1,992

Other comprehensive income, net of taxes

 

 

 
253

 
253

Dividends declared on common stock ($1.45 per share)

 

 
(879
)
 

 
(879
)
Issuance of common stock in connection with the Company’s equity award programs
0.7

 
6

 

 

 
6

Stock-based compensation expense

 
64

 

 

 
64

Tax impact related to employee stock-based compensation expense

 
(73
)
 

 

 
(73
)
Repurchases of common stock
(15.9
)
 

 
(3,031
)
 

 
(3,031
)
Balance as of March 31, 2019
614.4

 
31,243

 
(19,895
)
 
(516
)
 
10,832

Net income

 

 
2,179

 

 
2,179

Other comprehensive income, net of taxes

 

 

 
51

 
51

Issuance of common stock in connection with the Company’s equity award programs
0.8

 
23

 

 

 
23

Stock-based compensation expense

 
97

 

 

 
97

Tax impact related to employee stock-based compensation expense

 
(50
)
 

 

 
(50
)
Repurchases of common stock
(13.1
)
 

 
(2,349
)
 

 
(2,349
)
Other

 

 
11

 

 
11

Balance as of June 30, 2019
602.1

 
$
31,313

 
$
(20,054
)
 
$
(465
)
 
$
10,794


See accompanying notes.



















4


AMGEN INC.
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY
(In millions, except per-share data)
(Unaudited)


 
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, 2017
722.2

 
$
30,992

 
$
(5,072
)
 
$
(679
)
 
$
25,241

Cumulative effect of changes in accounting principles, net of taxes

 

 
38

 
(9
)
 
29

Net income

 

 
2,311

 

 
2,311

Other comprehensive loss, net of taxes

 

 

 
(306
)
 
(306
)
Dividends declared on common stock ($1.32 per share)

 

 
(877
)
 

 
(877
)
Issuance of common stock in connection with the Company’s equity award programs
0.6

 
5

 

 

 
5

Stock-based compensation expense

 
61

 

 

 
61

Tax impact related to employee stock-based compensation expense

 
(57
)
 

 

 
(57
)
Repurchases of common stock
(56.4
)
 

 
(10,787
)
 

 
(10,787
)
Balance as of March 31, 2018
666.4

 
31,001

 
(14,387
)
 
(994
)
 
15,620

Net income

 

 
2,296

 

 
2,296

Other comprehensive income, net of taxes

 

 

 
121

 
121

Issuance of common stock in connection with the Company’s equity award programs
0.8

 
19

 

 

 
19

Stock-based compensation expense

 
93

 

 

 
93

Tax impact related to employee stock-based compensation expense

 
(65
)
 

 

 
(65
)
Repurchases of common stock
(18.2
)
 

 
(3,190
)
 

 
(3,190
)
Other

 

 
15

 

 
15

Balance as of June 30, 2018
649.0

 
$
31,048

 
$
(15,266
)
 
$
(873
)
 
$
14,909


See accompanying notes.


5


AMGEN INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(In millions)
(Unaudited)

 
Six months ended
June 30,
 
2019
 
2018
Cash flows from operating activities:
 
 
 
Net income
$
4,171

 
$
4,607

Depreciation, amortization and other
996

 
955

Deferred income taxes
(70
)
 
(114
)
Other items, net
32

 
181

Changes in operating assets and liabilities, net of acquisition:
 
 
 
Trade receivables, net
(228
)
 
(348
)
Inventories
(118
)
 
(135
)
Other assets
(158
)
 
(232
)
Accounts payable
(205
)
 
(329
)
Accrued income taxes, net
(257
)
 
(314
)
Long-term tax liabilities
(322
)
 
134

Other liabilities
(582
)
 
424

Net cash provided by operating activities
3,259

 
4,829

Cash flows from investing activities:
 
 
 
Purchases of marketable securities
(7,250
)
 
(6,733
)
Proceeds from sales of marketable securities
217

 
23,723

Proceeds from maturities of marketable securities
13,617

 
993

Cash acquired in acquisition, net of cash paid

 
197

Purchases of property, plant and equipment
(260
)
 
(342
)
Other
(24
)
 
6

Net cash provided by investing activities
6,300

 
17,844

Cash flows from financing activities:
 
 
 
Repayment of debt
(3,650
)
 
(500
)
Repurchases of common stock
(5,447
)
 
(13,941
)
Dividends paid
(1,781
)
 
(1,816
)
Other
(101
)
 
(85
)
Net cash used in financing activities
(10,979
)
 
(16,342
)
(Decrease) increase in cash and cash equivalents
(1,420
)
 
6,331

Cash and cash equivalents at beginning of period
6,945

 
3,800

Cash and cash equivalents at end of period
$
5,525

 
$
10,131


See accompanying notes.

6


AMGEN INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
June 30, 2019
(Unaudited)
1. Summary of significant accounting policies
Business
Amgen Inc. (including its subsidiaries, referred to as “Amgen,” “the Company,” “we,” “our” or “us”) is a global biotechnology pioneer that discovers, develops, manufactures and delivers innovative human therapeutics. We operate in one business segment: human therapeutics.
Basis of presentation
The financial information for the three and six months ended June 30, 2019 and 2018, is unaudited but includes all adjustments (consisting of only normal, recurring adjustments unless otherwise indicated), which Amgen considers necessary for a fair presentation of its condensed consolidated results of operations for those periods. Interim results are not necessarily indicative of results for the full fiscal year.
The condensed consolidated financial statements should be read in conjunction with our consolidated financial statements and the notes thereto contained in our Annual Report on Form 10-K for the year ended December 31, 2018, and with our condensed consolidated financial statements and the notes thereto contained in our Quarterly Report on Form 10-Q for the period ended March 31, 2019.
Principles of consolidation
The condensed consolidated financial statements include the accounts of Amgen as well as its majority-owned subsidiaries. We do not have any significant interests in any variable interest entities. All material intercompany transactions and balances have been eliminated in consolidation.
Use of estimates
The preparation of condensed consolidated financial statements in conformity with U.S. generally accepted accounting principles (GAAP) requires management to make estimates and assumptions that affect the amounts reported in the condensed consolidated financial statements and accompanying notes. Actual results may differ from those estimates.
Property, plant and equipment, net
Property, plant and equipment is recorded at historical cost, net of accumulated depreciation and amortization of $8.1 billion and $7.8 billion as of June 30, 2019 and December 31, 2018, respectively.
Leases
Adoption of new lease standard
In February 2016, the Financial Accounting Standards Board (FASB) issued a new accounting standard that amends the guidance for the accounting and disclosure of leases. This new standard requires that lessees recognize the assets and liabilities that arise from leases on the balance sheet, including leases classified as operating leases, and that they disclose qualitative and quantitative information about leasing arrangements. The FASB subsequently issued additional amendments to address issues arising from the implementation of the new lease standard. We adopted this standard as of January 1, 2019, using the modified-retrospective method. This approach provides a method for recording existing leases at adoption. We used the adoption date as our date of initial application, and thus comparative-period financial information is not presented for periods prior to the adoption date. In addition, we elected the package of practical expedients permitted under the transition guidance within the new standard, which, among other things, allowed us to carry forward the historical lease classification.
Adoption of the new standard resulted in total lease liabilities of $510 million and right-of-use (ROU) assets of $439 million as of January 1, 2019. The difference between the initial lease liabilities and the ROU assets is related primarily to previously existing lease liabilities. The standard did not materially impact our Condensed Consolidated Statements of Income and had no impact on our Condensed Consolidated Statements of Cash Flows. Our accounting policies under the new standard are described below. See Note 8, Leases.

7


Lease recognition
At inception of a contract, we determine whether an arrangement is or contains a lease. For all leases, we determine the classification as either operating or financing. Operating leases are included in Other assets, Accrued liabilities and Other noncurrent liabilities in our Condensed Consolidated Balance Sheets.
ROU assets represent our right to use an underlying asset for the lease term, and lease liabilities represent our obligation to make lease payments under the lease. Lease recognition occurs at the commencement date, and lease liability amounts are based on the present value of lease payments made during the lease term. Our lease terms may include options to extend or terminate the lease when it is reasonably certain that we will exercise that option. Because most of our leases do not provide information to determine an implicit interest rate, we use our incremental borrowing rate in determining the present value of lease payments. ROU assets also include any lease payments made prior to the commencement date and exclude lease incentives received. Operating lease expense is recognized on a straight-line basis over the lease term.
We have lease agreements with both lease and nonlease components, which are generally accounted for together as a single lease component. In addition, for certain vehicle and equipment leases, we apply a portfolio approach to determine the lease term and discount rate.
Other recent accounting pronouncements
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 by 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. 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 condensed consolidated financial statements.
2. 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 primarily in Europe.

8


Revenues were as follows (in millions):
 
 
Three months ended June 30,
 
 
2019
 
2018
 
 
US
 
ROW
 
Total
 
US
 
ROW
 
Total
Enbrel® (etanercept)
 
$
1,315

 
$
48

 
$
1,363

 
$
1,252

 
$
50

 
$
1,302

Neulasta® (pegfilgrastim)
 
719

 
105

 
824

 
948

 
152

 
1,100

Prolia® (denosumab)
 
458

 
240

 
698

 
396

 
214

 
610

XGEVA® (denosumab)
 
379

 
120

 
499

 
339

 
113

 
452

Aranesp® (darbepoetin alfa)
 
192

 
244

 
436

 
241

 
231

 
472

KYPROLIS® (carfilzomib)
 
166

 
101

 
267

 
151

 
112

 
263

EPOGEN® (epoetin alfa)
 
223

 

 
223

 
250

 

 
250

Sensipar®/Mimpara® (cinacalcet)
 
43

 
79

 
122

 
330

 
90

 
420

Other products
 
647

 
495

 
1,142

 
460

 
350

 
810

Total product sales(1)
 
$
4,142

 
$
1,432

 
5,574

 
$
4,367

 
$
1,312

 
5,679

Other revenues
 
 
 
 
 
297

 
 
 
 
 
380

Total revenues
 
 
 
 
 
$
5,871

 
 
 
 
 
$
6,059

 
 
Six months ended June 30,
 
 
2019
 
2018
 
 
US
 
ROW
 
Total
 
US
 
ROW
 
Total
ENBREL
 
$
2,421

 
$
93

 
$
2,514

 
$
2,302

 
$
105

 
$
2,407

Neulasta®
 
1,612

 
233

 
1,845

 
1,957

 
298

 
2,255

Prolia®
 
848

 
442

 
1,290

 
716

 
388

 
1,104

XGEVA®
 
735

 
235

 
970

 
671

 
226

 
897

Aranesp®
 
374

 
476

 
850

 
466

 
460

 
926

KYPROLIS®
 
320

 
192

 
512

 
288

 
197

 
485

EPOGEN®
 
442

 

 
442

 
494

 

 
494

Sensipar®/Mimpara®
 
178

 
157

 
335

 
739

 
178

 
917

Other products
 
1,203

 
899

 
2,102

 
881

 
656

 
1,537

Total product sales(1)
 
$
8,133

 
$
2,727

 
10,860

 
$
8,514

 
$
2,508

 
11,022

Other revenues
 
 
 
 
 
568

 
 
 
 
 
591

Total revenues
 
 
 
 
 
$
11,428

 
 
 
 
 
$
11,613

____________ 
(1) 
Hedging gains and losses, which are included in product sales, were not material for the three and six months ended June 30, 2019 and 2018.
3. Income taxes
The effective tax rates for the three and six months ended June 30, 2019, were 15.0% and 14.5%, respectively, compared with 13.3% and 12.5%, respectively, for the corresponding periods of the prior year.
The increase in our effective tax rates for the three and six months ended June 30, 2019, was due primarily to a prior-year tax benefit associated with intercompany sales under U.S. corporate tax reform. The effective tax rates differ from the federal statutory rate primarily as a result of foreign earnings from the Company’s operations conducted in Puerto Rico, a territory of the United States that is treated as a foreign jurisdiction for U.S. tax purposes and that is subject to tax incentive grants through 2035; these earnings are subject to U.S. tax at a reduced 10.5% rate.

9


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.
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 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 and regulations and the interpretations 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 condensed 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.
During the three and six months ended June 30, 2019, the gross amounts of our unrecognized tax benefits (UTBs) increased $60 million and $110 million, respectively, as a result of tax positions taken during the current year. Substantially all of the UTBs as of June 30, 2019, if recognized, would affect our effective tax rate.
4. Earnings per share
The computation of basic earnings per share (EPS) is based on the weighted-average number of our common shares outstanding. The computation of diluted EPS is based on the weighted-average number of our common shares outstanding and dilutive potential common shares, which include primarily shares that may be issued under our stock option, restricted stock and performance unit award programs (collectively, dilutive securities), as determined by using the treasury stock method.
The computations for basic and diluted EPS were as follows (in millions, except per-share data):
 
Three months ended
June 30,
 
Six months ended
June 30,
 
2019
 
2018
 
2019
 
2018
Income (Numerator):
 
 
 
 
 
 
 
Net income for basic and diluted EPS
$
2,179

 
$
2,296

 
$
4,171

 
$
4,607

 
 
 
 
 
 
 
 
Shares (Denominator):