|
☑
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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☐
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
|
|
Delaware
|
|
95-3540776
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|
(State or other jurisdiction of
incorporation or organization)
|
|
(I.R.S. Employer
Identification No.)
|
|
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One Amgen Center Drive
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91320-1799
|
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Thousand Oaks
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California
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|
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(Address of principal executive offices)
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(Zip Code)
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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
|
|
Large accelerated filer
|
☑
|
Accelerated filer
|
☐
|
Non-accelerated filer
|
☐
|
|
Smaller reporting company
|
☐
|
Emerging growth company
|
☐
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Page No.
|
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Item 1.
|
||
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||
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||
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||
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||
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||
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Item 2.
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Item 3.
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Item 4.
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Item 1.
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Item 1A.
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Item 2.
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Item 6.
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Item 1.
|
FINANCIAL STATEMENTS
|
|
|
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
|
|
||||
|
|
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
|
|
|
|
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
|
|
|
|
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
|
|
|
|
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
|
|
|
|
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
|
|
|
|
|
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.
|
|
|
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):
|
|
|
|
|
|
|
|
||||||||
|
Weighted-average shares for basic EPS
|
607
|
|
|
656
|
|
|
615
|
|
|
682
|
|
||||
|
Effect of dilutive securities
|
3
|
|
|
4
|
|
|
3
|
|
|
3
|
|
||||
|
Weighted-average shares for diluted EPS
|
610
|
|
|
660
|
|
|
618
|
|
|
685
|
|
||||
|
|
|
|
|
|
|
|
|
||||||||
|
Basic EPS
|
$
|
3.59
|
|
|
$
|
3.50
|
|
|
$
|
6.78
|
|
|
$
|
6.76
|
|
|
Diluted EPS
|
$
|
3.57
|
|
|
$
|
3.48
|
|
|
$
|
6.75
|
|
|
$
|
6.73
|
|
|
Types of securities as of June 30, 2019
|
|
Amortized
cost
|
|
Gross
unrealized
gains
|
|
Gross
unrealized
losses
|
|
Fair
values
|
||||||||
|
U.S. Treasury notes
|
|
$
|
2,709
|
|
|
$
|
10
|
|
|
$
|
(2
|
)
|
|
$
|
2,717
|
|
|
U.S. Treasury bills
|
|
3,497
|
|
|
—
|
|
|
—
|
|
|
3,497
|
|
||||
|
Other government-related debt securities:
|
|
|
|
|
|
|
|
|
||||||||
|
U.S.
|
|
112
|
|
|
—
|
|
|
—
|
|
|
112
|
|
||||
|
Foreign and other
|
|
962
|
|
|
18
|
|
|
(3
|
)
|
|
977
|
|
||||
|
Corporate debt securities:
|
|
|
|
|
|
|
|
|
||||||||
|
Financial
|
|
2,755
|
|
|
19
|
|
|
(1
|
)
|
|
2,773
|
|
||||
|
Industrial
|
|
2,400
|
|
|
14
|
|
|
(6
|
)
|
|
2,408
|
|
||||
|
Other
|
|
558
|
|
|
4
|
|
|
—
|
|
|
562
|
|
||||
|
Residential-mortgage-backed securities
|
|
1,335
|
|
|
2
|
|
|
(4
|
)
|
|
1,333
|
|
||||
|
Other mortgage- and asset-backed securities
|
|
469
|
|
|
—
|
|
|
(6
|
)
|
|
463
|
|
||||
|
Money market mutual funds
|
|
3,886
|
|
|
—
|
|
|
—
|
|
|
3,886
|
|
||||
|
Other short-term interest-bearing securities
|
|
2,389
|
|
|
—
|
|
|
—
|
|
|
2,389
|
|
||||
|
Total interest-bearing securities
|
|
$
|
21,072
|
|
|
$
|
67
|
|
|
$
|
(22
|
)
|
|
$
|
21,117
|
|
|
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 interest-bearing securities
|
|
$
|
29,064
|
|
|
$
|
1
|
|
|
$
|
(341
|
)
|
|
$
|
28,724
|
|
|
Condensed Consolidated Balance Sheets locations
|
|
June 30,
2019 |
|
December 31,
2018 |
||||
|
Cash and cash equivalents
|
|
$
|
4,884
|
|
|
$
|
6,365
|
|
|
Marketable securities
|
|
16,233
|
|
|
22,359
|
|
||
|
Total interest-bearing securities
|
|
$
|
21,117
|
|
|
$
|
28,724
|
|
|
Contractual maturities
|
|
June 30,
2019 |
|
December 31,
2018 |
||||
|
Maturing in one year or less
|
|
$
|
9,872
|
|
|
$
|
17,424
|
|
|
Maturing after one year through three years
|
|
5,730
|
|
|
3,356
|
|
||
|
Maturing after three years through five years
|
|
2,961
|
|
|
5,168
|
|
||
|
Maturing after five years through ten years
|
|
758
|
|
|
885
|
|
||
|
Mortgage- and asset-backed securities
|
|
1,796
|
|
|
1,891
|
|
||
|
Total interest-bearing securities
|
|
$
|
21,117
|
|
|
$
|
28,724
|
|
|
|
|
Less than 12 months
|
|
12 months or more
|
||||||||||||
|
Types of securities as of June 30, 2019
|
|
Fair values
|
|
Unrealized losses
|
|
Fair values
|
|
Unrealized losses
|
||||||||
|
U.S. Treasury notes
|
|
$
|
105
|
|
|
$
|
—
|
|
|
$
|
724
|
|
|
$
|
(2
|
)
|
|
Other government-related debt securities:
|
|
|
|
|
|
|
|
|
||||||||
|
U.S.
|
|
—
|
|
|
—
|
|
|
48
|
|
|
—
|
|
||||
|
Foreign and other
|
|
6
|
|
|
—
|
|
|
115
|
|
|
(3
|
)
|
||||
|
Corporate debt securities:
|
|
|
|
|
|
|
|
|
||||||||
|
Financial
|
|
121
|
|
|
—
|
|
|
320
|
|
|
(1
|
)
|
||||
|
Industrial
|
|
191
|
|
|
(3
|
)
|
|
500
|
|
|
(3
|
)
|
||||
|
Other
|
|
30
|
|
|
—
|
|
|
40
|
|
|
—
|
|
||||
|
Residential-mortgage-backed securities
|
|
93
|
|
|
—
|
|
|
685
|
|
|
(4
|
)
|
||||
|
Other mortgage- and asset-backed securities
|
|
—
|
|
|
—
|
|
|
401
|
|
|
(6
|
)
|
||||
|
Total
|
|
$
|
546
|
|
|
$
|
(3
|
)
|
|
$
|
2,833
|
|
|
$
|
(19
|
)
|
|
|
|
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
|
)
|
|
|
June 30,
2019 |
|
December 31,
2018 |
||||
|
Raw materials
|
$
|
294
|
|
|
$
|
257
|
|
|
Work in process
|
1,788
|
|
|
1,660
|
|
||
|
Finished goods
|
1,094
|
|
|
1,023
|
|
||
|
Total inventories
|
$
|
3,176
|
|
|
$
|
2,940
|
|
|
|
Six months ended
June 30, 2019 |
||
|
Beginning balance
|
$
|
14,699
|
|
|
Currency translation adjustment
|
(10
|
)
|
|
|
Ending balance
|
$
|
14,689
|
|
|
|
June 30, 2019
|
|
December 31, 2018
|
||||||||||||||||||||
|
|
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
|
$
|
12,563
|
|
|
$
|
(7,812
|
)
|
|
$
|
4,751
|
|
|
$
|
12,573
|
|
|
$
|
(7,479
|
)
|
|
$
|
5,094
|
|
|
Licensing rights
|
3,693
|
|
|
(2,174
|
)
|
|
1,519
|
|
|
3,772
|
|
|
(2,032
|
)
|
|
1,740
|
|
||||||
|
Marketing-related rights
|
1,209
|
|
|
(959
|
)
|
|
250
|
|
|
1,297
|
|
|
(1,019
|
)
|
|
278
|
|
||||||
|
Research and development technology rights
|
1,148
|
|
|
(910
|
)
|
|
238
|
|
|
1,148
|
|
|
(872
|
)
|
|
276
|
|
||||||
|
Total finite-lived intangible assets
|
18,613
|
|
|
(11,855
|
)
|
|
6,758
|
|
|
18,790
|
|
|
(11,402
|
)
|
|
7,388
|
|
||||||
|
Indefinite-lived intangible assets:
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
|
In-process research and development
|
55
|
|
|
—
|
|
|
55
|
|
|
55
|
|
|
—
|
|
|
55
|
|
||||||
|
Total other intangible assets
|
$
|
18,668
|
|
|
$
|
(11,855
|
)
|
|
$
|
6,813
|
|
|
$
|
18,845
|
|
|
$
|
(11,402
|
)
|
|
$
|
7,443
|
|
|
Condensed Consolidated Balance Sheets locations
|
|
June 30, 2019
|
||
|
Assets:
|
|
|
||
|
Other assets
|
|
$
|
430
|
|
|
Liabilities:
|
|
|
||
|
Accrued liabilities
|
|
$
|
134
|
|
|
Other noncurrent liabilities
|
|
363
|
|
|
|
Total lease liabilities
|
|
$
|
497
|
|
|
Lease costs
|
|
Three months ended June 30, 2019
|
|
Six months ended
June 30, 2019 |
||||
|
Operating(1)
|
|
$
|
51
|
|
|
$
|
99
|
|
|
Sublease income
|
|
(9
|
)
|
|
(17
|
)
|
||
|
Total net lease costs
|
|
$
|
42
|
|
|
$
|
82
|
|
|
(1)
|
Includes short-term leases and variable lease costs, which were not material for the three and six months ended June 30, 2019.
|
|
Maturity dates
|
|
Operating leases
|
||
|
Remaining six months ending December 31, 2019
|
|
$
|
69
|
|
|
2020
|
|
152
|
|
|
|
2021
|
|
132
|
|
|
|
2022
|
|
73
|
|
|
|
2023
|
|
62
|
|
|
|
Thereafter
|
|
48
|
|
|
|
Total lease payments(1)
|
|
536
|
|
|
|
Less imputed interest
|
|
(39
|
)
|
|
|
Present value of lease liabilities
|
|
$
|
497
|
|
|
(1)
|
Includes future rental commitments for abandoned leases of $200 million. We expect to receive total future rental income of $158 million related to noncancelable subleases for abandoned facilities.
|
|
|
|
Three months ended June 30, 2019
|
|
Six months ended
June 30, 2019 |
||||
|
Cash paid for amounts included in the measurement of lease liabilities:
|
|
|
|
|
||||
|
Operating cash flows from operating leases
|
|
$
|
39
|
|
|
$
|
73
|
|
|
ROU assets obtained in exchange for lease obligations:
|
|
|
|
|
||||
|
Operating leases
|
|
$
|
46
|
|
|
$
|
54
|
|
|
|
June 30,
2019 |
|
December 31,
2018 |
||||
|
5.70% notes due 2019 (5.70% 2019 Notes)
|
$
|
—
|
|
|
$
|
1,000
|
|
|
1.90% notes due 2019 (1.90% 2019 Notes)
|
—
|
|
|
700
|
|
||
|
Floating Rate Notes due 2019
|
—
|
|
|
550
|
|
||
|
2.20% notes due 2019 (2.20% 2019 Notes)
|
—
|
|
|
1,400
|
|
||
|
2.125% €675 million notes due 2019 (2.125% 2019 euro Notes)
|
768
|
|
|
774
|
|
||
|
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)
|
1,422
|
|
|
1,433
|
|
||
|
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)
|
717
|
|
|
713
|
|
||
|
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)
|
853
|
|
|
860
|
|
||
|
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)
|
603
|
|
|
606
|
|
||
|
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)
|
889
|
|
|
893
|
|
||
|
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 bond discounts, premiums and issuance costs, net
|
(882
|
)
|
|
(896
|
)
|
||
|
Fair value adjustments
|
295
|
|
|
(53
|
)
|
||
|
Total carrying value of debt
|
30,614
|
|
|
33,929
|
|
||
|
Less current portion
|
(2,816
|
)
|
|
(4,419
|
)
|
||
|
Total long-term debt
|
$
|
27,798
|
|
|
$
|
29,510
|
|
|
|
2019
|
|
2018
|
||||||||||
|
|
Shares *
|
|
Dollars
|
|
Shares
|
|
Dollars
|
||||||
|
First quarter
|
15.9
|
|
|
$
|
3,031
|
|
|
56.4
|
|
|
$
|
10,787
|
|
|
Second quarter
|
13.1
|
|
|
2,349
|
|
|
18.2
|
|
|
3,190
|
|
||
|
Total stock repurchases
|
28.9
|
|
|
$
|
5,380
|
|
|
74.6
|
|
|
$
|
13,977
|
|
|
|
Foreign
currency
translation
|
|
Cash flow
hedges
|
|
Available-for-sale
securities
|
|
Other
|
|
AOCI
|
||||||||||
|
Balance as of December 31, 2018
|
$
|
(670
|
)
|
|
$
|
241
|
|
|
$
|
(338
|
)
|
|
$
|
(2
|
)
|
|
$
|
(769
|
)
|
|
Foreign currency translation adjustments
|
(13
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(13
|
)
|
|||||
|
Unrealized gains
|
—
|
|
|
30
|
|
|
218
|
|
|
—
|
|
|
248
|
|
|||||
|
Reclassification adjustments to income
|
—
|
|
|
28
|
|
|
4
|
|
|
—
|
|
|
32
|
|
|||||
|
Income taxes
|
—
|
|
|
(13
|
)
|
|
(1
|
)
|
|
—
|
|
|
(14
|
)
|
|||||
|
Balance as of March 31, 2019
|
(683
|
)
|
|
286
|
|
|
(117
|
)
|
|
(2
|
)
|
|
(516
|
)
|
|||||
|
Foreign currency translation adjustments
|
(4
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(4
|
)
|
|||||
|
Unrealized (losses) gains
|
—
|
|
|
(96
|
)
|
|
161
|
|
|
—
|
|
|
65
|
|
|||||
|
Reclassification adjustments to income
|
—
|
|
|
(36
|
)
|
|
2
|
|
|
—
|
|
|
(34
|
)
|
|||||
|
Other
|
—
|
|
|
—
|
|
|
—
|
|
|
6
|
|
|
6
|
|
|||||
|
Income taxes
|
—
|
|
|
28
|
|
|
(10
|
)
|
|
—
|
|
|
18
|
|
|||||
|
Balance as of June 30, 2019
|
$
|
(687
|
)
|
|
$
|
182
|
|
|
$
|
36
|
|
|
$
|
4
|
|
|
$
|
(465
|
)
|
|
|
|
Three months ended June 30,
|
|
|
||||||
|
Components of AOCI
|
|
2019
|
|
2018
|
|
Condensed Consolidated
Statements of Income locations
|
||||
|
Cash flow hedges:
|
|
|
|
|
|
|
||||
|
Foreign currency contract gains (losses)
|
|
$
|
22
|
|
|
$
|
(20
|
)
|
|
Product sales
|
|
Cross-currency swap contract gains (losses)
|
|
14
|
|
|
(298
|
)
|
|
Interest and other income, net
|
||
|
|
|
36
|
|
|
(318
|
)
|
|
Income before income taxes
|
||
|
|
|
(8
|
)
|
|
68
|
|
|
Provision for income taxes
|
||
|
|
|
$
|
28
|
|
|
$
|
(250
|
)
|
|
Net income
|
|
Available-for-sale securities:
|
|
|
|
|
|
|
||||
|
Net realized losses
|
|
$
|
(2
|
)
|
|
$
|
(115
|
)
|
|
Interest and other income, net
|
|
|
|
—
|
|
|
1
|
|
|
Provision for income taxes
|
||
|
|
|
$
|
(2
|
)
|
|
$
|
(114
|
)
|
|
Net income
|
|
|
|
Six months ended June 30,
|
|
|
||||||
|
Components of AOCI
|
|
2019
|
|
2018
|
|
Condensed Consolidated
Statements of Income locations
|
||||
|
Cash flow hedges:
|
|
|
|
|
|
|
||||
|
Foreign currency contract gains (losses)
|
|
$
|
36
|
|
|
$
|
(54
|
)
|
|
Product sales
|
|
Cross-currency swap contract losses
|
|
(28
|
)
|
|
(134
|
)
|
|
Interest and other income, net
|
||
|
|
|
8
|
|
|
(188
|
)
|
|
Income before income taxes
|
||
|
|
|
(2
|
)
|
|
40
|
|
|
Provision for income taxes
|
||
|
|
|
$
|
6
|
|
|
$
|
(148
|
)
|
|
Net income
|
|
Available-for-sale securities:
|
|
|
|
|
|
|
||||
|
Net realized losses
|
|
$
|
(6
|
)
|
|
$
|
(249
|
)
|
|
Interest and other income, net
|
|
|
|
—
|
|
|
2
|
|
|
Provision for income taxes
|
||
|
|
|
$
|
(6
|
)
|
|
$
|
(247
|
)
|
|
Net income
|
|
Level 1
|
—
|
Valuations based on unadjusted quoted prices in active markets for identical assets or liabilities that the Company has the ability to access
|
|
Level 2
|
—
|
Valuations for which all significant inputs are observable either directly or indirectly—other than Level 1 inputs
|
|
Level 3
|
—
|
Valuations based on inputs that are unobservable and significant to the overall fair value measurement
|
|
|
|
Quoted prices in
active markets for identical assets (Level 1) |
|
Significant
other observable
inputs
(Level 2)
|
|
Significant
unobservable
inputs
(Level 3)
|
|
|
||||||||
|
|
|
|
|
|
|
|||||||||||
|
Fair value measurement as of June 30, 2019, using:
|
|
|
|
|
Total
|
|||||||||||
|
Assets:
|
|
|
|
|
|
|
|
|
||||||||
|
Interest-bearing securities:
|
|
|
|
|
|
|
|
|
||||||||
|
U.S. Treasury notes
|
|
$
|
2,717
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
2,717
|
|
|
U.S. Treasury bills
|
|
3,497
|
|
|
—
|
|
|
—
|
|
|
3,497
|
|
||||
|
Other government-related debt securities:
|
|
|
|
|
|
|
|
|
||||||||
|
U.S.
|
|
—
|
|
|
112
|
|
|
—
|
|
|
112
|
|
||||
|
Foreign and other
|
|
—
|
|
|
977
|
|
|
—
|
|
|
977
|
|
||||
|
Corporate debt securities:
|
|
|
|
|
|
|
|
|
||||||||
|
Financial
|
|
—
|
|
|
2,773
|
|
|
—
|
|
|
2,773
|
|
||||
|
Industrial
|
|
—
|
|
|
2,408
|
|
|
—
|
|
|
2,408
|
|
||||
|
Other
|
|
—
|
|
|
562
|
|
|
—
|
|
|
562
|
|
||||
|
Residential-mortgage-backed securities
|
|
—
|
|
|
1,333
|
|
|
—
|
|
|
1,333
|
|
||||
|
Other mortgage- and asset-backed securities
|
|
—
|
|
|
463
|
|
|
—
|
|
|
463
|
|
||||
|
Money market mutual funds
|
|
3,886
|
|
|
—
|
|
|
—
|
|
|
3,886
|
|
||||
|
Other short-term interest-bearing securities
|
|
—
|
|
|
2,389
|
|
|
—
|
|
|
2,389
|
|
||||
|
Equity securities
|
|
287
|
|
|
—
|
|
|
—
|
|
|
287
|
|
||||
|
Derivatives:
|
|
|
|
|
|
|
|
|
||||||||
|
Foreign currency contracts
|
|
—
|
|
|
205
|
|
|
—
|
|
|
205
|
|
||||
|
Cross-currency swap contracts
|
|
—
|
|
|
150
|
|
|
—
|
|
|
150
|
|
||||
|
Interest rate swap contracts
|
|
—
|
|
|
258
|
|
|
—
|
|
|
258
|
|
||||
|
Total assets
|
|
$
|
10,387
|
|
|
$
|
11,630
|
|
|
$
|
—
|
|
|
$
|
22,017
|
|
|
|
|
|
|
|
|
|
|
|
||||||||
|
Liabilities:
|
|
|
|
|
|
|
|
|
||||||||
|
Derivatives:
|
|
|
|
|
|
|
|
|
||||||||
|
Foreign currency contracts
|
|
$
|
—
|
|
|
$
|
15
|
|
|
$
|
—
|
|
|
$
|
15
|
|
|
Cross-currency swap contracts
|
|
—
|
|
|
515
|
|
|
—
|
|
|
515
|
|
||||
|
Contingent consideration obligations
|
|
—
|
|
|
—
|
|
|
63
|
|
|
63
|
|
||||
|
Total liabilities
|
|
$
|
—
|
|
|
$
|
530
|
|
|
$
|
63
|
|
|
$
|
593
|
|
|
|
|
Quoted prices in
active markets for
identical assets
(Level 1)
|
|
Significant
other observable
inputs
(Level 2)
|
|
Significant
unobservable
inputs
(Level 3)
|
|
|
||||||||
|
|
|
|
|
|
|
|||||||||||
|
Fair value measurement as of December 31, 2018, using:
|
|
|
|
|
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
|
|
|
|
|
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
|
%
|
|
|
|
Three months ended
June 30, |
|
Six months ended
June 30, |
||||||||||||
|
Derivatives in cash flow hedging relationships
|
|
2019
|
|
2018
|
|
2019
|
|
2018
|
||||||||
|
Foreign currency contracts
|
|
$
|
(16
|
)
|
|
$
|
281
|
|
|
$
|
69
|
|
|
$
|
192
|
|
|
Cross-currency swap contracts
|
|
(80
|
)
|
|
(315
|
)
|
|
(135
|
)
|
|
(77
|
)
|
||||
|
Total unrealized (losses) gains
|
|
$
|
(96
|
)
|
|
$
|
(34
|
)
|
|
$
|
(66
|
)
|
|
$
|
115
|
|
|
|
|
Carrying amounts of hedged liabilities(1)
|
|
Cumulative amounts of fair value hedging adjustments related to the carrying amounts of the hedged liabilities(2)
|
||||||||||||
|
Condensed Consolidated Balance Sheets locations
|
|
June 30, 2019
|
|
December 31, 2018
|
|
June 30, 2019
|
|
December 31, 2018
|
||||||||
|
Current portion of long-term debt
|
|
$
|
—
|
|
|
$
|
2,396
|
|
|
$
|
—
|
|
|
$
|
(3
|
)
|
|
Long-term debt
|
|
$
|
9,712
|
|
|
$
|
9,361
|
|
|
$
|
295
|
|
|
$
|
(50
|
)
|
|
(1)
|
Current portion of long-term debt includes $1.0 billion of carrying value with discontinued hedging relationships as of December 31, 2018. Long-term debt includes $136 million and $137 million of carrying value with discontinued hedging relationships as of June 30, 2019 and December 31, 2018, respectively.
|
|
(2)
|
Current portion of long-term debt includes $3 million of hedging adjustments on discontinued hedging relationships as of December 31, 2018. Long-term debt includes $36 million and $37 million of hedging adjustments on discontinued hedging relationships as of June 30, 2019 and December 31, 2018, respectively.
|
|
|
|
Three months ended June 30, 2019
|
|
Six months ended June 30, 2019
|
||||||||||||||||||||
|
|
|
Product sales
|
|
Interest and other income, net
|
|
Interest (expense), net
|
|
Product sales
|
|
Interest and other income, net
|
|
Interest (expense), net
|
||||||||||||
|
Total amounts recorded in income and (expense) line items presented in the Condensed Consolidated Statements of Income
|
|
$
|
5,574
|
|
|
$
|
218
|
|
|
$
|
(332
|
)
|
|
$
|
10,860
|
|
|
$
|
403
|
|
|
$
|
(675
|
)
|
|
The effects of cash flow and fair value hedging:
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
|
Gains (losses) on cash flow hedging relationships reclassified out of AOCI:
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
|
Foreign currency contracts
|
|
$
|
22
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
36
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
Cross-currency swap contracts
|
|
$
|
—
|
|
|
$
|
14
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
(28
|
)
|
|
$
|
—
|
|
|
(Losses) gains on fair value hedging relationships—interest rate swap agreements:
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
|
Hedged items(1)
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
(218
|
)
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
(348
|
)
|
|
Derivatives designated as hedging instruments
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
218
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
351
|
|
|
|
|
Three months ended June 30, 2018
|
|
Six months ended June 30, 2018
|
||||||||||||||||||||
|
|
|
Product sales
|
|
Interest and other income, net
|
|
Interest (expense), net
|
|
Product sales
|
|
Interest and other income, net
|
|
Interest (expense), net
|
||||||||||||
|
Total amounts recorded in income and (expense) line items presented in the Condensed Consolidated Statements of Income
|
|
$
|
5,679
|
|
|
$
|
162
|
|
|
$
|
(347
|
)
|
|
$
|
11,022
|
|
|
$
|
393
|
|
|
$
|
(685
|
)
|
|
The effects of cash flow and fair value hedging:
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
|
Losses on cash flow hedging relationships reclassified out of AOCI:
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
|
Foreign currency contracts
|
|
$
|
(20
|
)
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
(54
|
)
|
|
$
|
—
|
|
|
$
|
—
|
|
|
Cross-currency swap contracts
|
|
$
|
—
|
|
|
$
|
(298
|
)
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
(134
|
)
|
|
$
|
—
|
|
|
Gains (losses) on fair value hedging relationships—interest rate swap agreements:
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
|
Hedged items(1)
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
58
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
230
|
|
|
Derivatives designated as hedging instruments
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
(51
|
)
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
(215
|
)
|
|
(1)
|
Gains (losses) on hedged items do not completely offset (losses) gains on the related designated hedging instruments due to amortization of the cumulative amounts of fair value hedging adjustments included in the carrying amount of the hedged debt for discontinued hedging relationships.
|
|
|
|
Derivative assets
|
|
Derivative liabilities
|
||||||||
|
June 30, 2019
|
|
Condensed Consolidated
Balance Sheets locations
|
|
Fair values
|
|
Condensed Consolidated
Balance Sheets locations |
|
Fair values
|
||||
|
Derivatives designated as hedging instruments:
|
|
|
|
|
|
|
|
|
||||
|
Foreign currency contracts
|
|
Other current assets/ Other assets
|
|
$
|
203
|
|
|
Accrued liabilities/ Other noncurrent liabilities
|
|
$
|
15
|
|
|
Cross-currency swap contracts
|
|
Other current assets/ Other assets
|
|
150
|
|
|
Accrued liabilities/ Other noncurrent liabilities
|
|
515
|
|
||
|
Interest rate swap contracts
|
|
Other current assets/ Other assets
|
|
258
|
|
|
Accrued liabilities/ Other noncurrent liabilities
|
|
—
|
|
||
|
Total derivatives designated as hedging instruments
|
|
|
|
611
|
|
|
|
|
530
|
|
||
|
Derivatives not designated as hedging instruments:
|
|
|
|
|
|
|
|
|
||||
|
Foreign currency contracts
|
|
Other current assets
|
|
2
|
|
|
Accrued liabilities
|
|
—
|
|
||
|
Total derivatives not designated as hedging instruments
|
|
|
|
2
|
|
|
|
|
—
|
|
||
|
Total derivatives
|
|
|
|
$
|
613
|
|
|
|
|
$
|
530
|
|
|
|
|
Derivative assets
|
|
Derivative liabilities
|
||||||||
|
December 31, 2018
|
|
Condensed Consolidated
Balance Sheets locations
|
|
Fair values
|
|
Condensed 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
|
|
|
Item 2.
|
MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
|
|
•
|
In June 2019, we and UCB, our global collaboration partner in the development of EVENITYTM, announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a negative opinion on the Marketing Authorization Application for EVENITYTM for the treatment of severe osteoporosis. In July 2019, UCB submitted a written notice to the EMA requesting a reexamination of the CHMP opinion.
|
|
•
|
In July 2019, we and Novartis discontinued investigating AMG 520 / CNP520, a small-molecule inhibitor of beta-site amyloid precursor protein-cleaving enzyme-1 (BACE), for the prevention of Alzheimer’s disease.
|
|
•
|
In July 2019, we announced that the FDA has set a December 14, 2019 Biosimilar User Fee Act target action date for the Biologics License Application of ABP 710, a biosimilar candidate to REMICADE®.
|
|
•
|
In June 2019, we and Allergan plc (Allergan) announced that the FDA approved KANJINTITM for all approved indications of the reference product Herceptin® (trastuzumab) for the treatment of HER2-overexpressing adjuvant and metastatic breast cancer and HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. In July 2019, we and Allergan announced the launch of KANJINTITM in the United States.
|
|
•
|
In July 2019, we and Allergan announced the launch of MVASITM in the United States.
|
|
|
Three months ended
June 30, |
|
|
|
Six months ended
June 30, |
|
|
||||||||||||||
|
|
2019
|
|
2018
|
|
Change
|
|
2019
|
|
2018
|
|
Change
|
||||||||||
|
Product sales
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||
|
U.S.
|
$
|
4,142
|
|
|
$
|
4,367
|
|
|
(5
|
)%
|
|
$
|
8,133
|
|
|
$
|
8,514
|
|
|
(4
|
)%
|
|
ROW
|
1,432
|
|
|
1,312
|
|
|
9
|
%
|
|
2,727
|
|
|
2,508
|
|
|
9
|
%
|
||||
|
Total product sales
|
5,574
|
|
|
5,679
|
|
|
(2
|
)%
|
|
10,860
|
|
|
11,022
|
|
|
(1
|
)%
|
||||
|
Other revenues
|
297
|
|
|
380
|
|
|
(22
|
)%
|
|
568
|
|
|
591
|
|
|
(4
|
)%
|
||||
|
Total revenues
|
$
|
5,871
|
|
|
$
|
6,059
|
|
|
(3
|
)%
|
|
$
|
11,428
|
|
|
$
|
11,613
|
|
|
(2
|
)%
|
|
Operating expenses
|
$
|
3,193
|
|
|
$
|
3,227
|
|
|
(1
|
)%
|
|
$
|
6,278
|
|
|
$
|
6,055
|
|
|
4
|
%
|
|
Operating income
|
$
|
2,678
|
|
|
$
|
2,832
|
|
|
(5
|
)%
|
|
$
|
5,150
|
|
|
$
|
5,558
|
|
|
(7
|
)%
|
|
Net income
|
$
|
2,179
|
|
|
$
|
2,296
|
|
|
(5
|
)%
|
|
$
|
4,171
|
|
|
$
|
4,607
|
|
|
(9
|
)%
|
|
Diluted EPS
|
$
|
3.57
|
|
|
$
|
3.48
|
|
|
3
|
%
|
|
$
|
6.75
|
|
|
$
|
6.73
|
|
|
—
|
%
|
|
Diluted shares
|
610
|
|
|
660
|
|
|
(8
|
)%
|
|
618
|
|
|
685
|
|
|
(10
|
)%
|
||||
|
|
Three months ended
June 30, |
|
|
|
Six months ended
June 30, |
|
|
||||||||||||||
|
|
2019
|
|
2018
|
|
Change
|
|
2019
|
|
2018
|
|
Change
|
||||||||||
|
ENBREL — U.S.
|
$
|
1,315
|
|
|
$
|
1,252
|
|
|
5
|
%
|
|
$
|
2,421
|
|
|
$
|
2,302
|
|
|
5
|
%
|
|
ENBREL — Canada
|
48
|
|
|
50
|
|
|
(4
|
)%
|
|
93
|
|
|
105
|
|
|
(11
|
)%
|
||||
|
Total ENBREL
|
$
|
1,363
|
|
|
$
|
1,302
|
|
|
5
|
%
|
|
$
|
2,514
|
|
|
$
|
2,407
|
|
|
4
|
%
|
|
|
Three months ended
June 30, |
|
|
|
Six months ended
June 30, |
|
|
||||||||||||||
|
|
2019
|
|
2018
|
|
Change
|
|
2019
|
|
2018
|
|
Change
|
||||||||||
|
Neulasta®— U.S.
|
$
|
719
|
|
|
$
|
948
|
|
|
(24
|
)%
|
|
$
|
1,612
|
|
|
$
|
1,957
|
|
|
(18
|
)%
|
|
Neulasta®— ROW
|
105
|
|
|
152
|
|
|
(31
|
)%
|
|
233
|
|
|
298
|
|
|
(22
|
)%
|
||||
|
Total Neulasta®
|
$
|
824
|
|
|
$
|
1,100
|
|
|
(25
|
)%
|
|
$
|
1,845
|
|
|
$
|
2,255
|
|
|
(18
|
)%
|
|
|
Three months ended
June 30, |
|
|
|
Six months ended
June 30, |
|
|
||||||||||||||
|
|
2019
|
|
2018
|
|
Change
|
|
2019
|
|
2018
|
|
Change
|
||||||||||
|
Prolia® — U.S.
|
$
|
458
|
|
|
$
|
396
|
|
|
16
|
%
|
|
$
|
848
|
|
|
$
|
716
|
|
|
18
|
%
|
|
Prolia® — ROW
|
240
|
|
|
214
|
|
|
12
|
%
|
|
442
|
|
|
388
|
|
|
14
|
%
|
||||
|
Total Prolia®
|
$
|
698
|
|
|
$
|
610
|
|
|
14
|
%
|
|
$
|
1,290
|
|
|
$
|
1,104
|
|
|
17
|
%
|
|
|
Three months ended
June 30, |
|
|
|
Six months ended
June 30, |
|
|
||||||||||||||
|
|
2019
|
|
2018
|
|
Change
|
|
2019
|
|
2018
|
|
Change
|
||||||||||
|
XGEVA® — U.S.
|
$
|
379
|
|
|
$
|
339
|
|
|
12
|
%
|
|
$
|
735
|
|
|
$
|
671
|
|
|
10
|
%
|
|
XGEVA® — ROW
|
120
|
|
|
113
|
|
|
6
|
%
|
|
235
|
|
|
226
|
|
|
4
|
%
|
||||
|
Total XGEVA®
|
$
|
499
|
|
|
$
|
452
|
|
|
10
|
%
|
|
$
|
970
|
|
|
$
|
897
|
|
|
8
|
%
|
|
|
Three months ended
June 30, |
|
|
|
Six months ended
June 30, |
|
|
||||||||||||||
|
|
2019
|
|
2018
|
|
Change
|
|
2019
|
|
2018
|
|
Change
|
||||||||||
|
Aranesp® — U.S.
|
$
|
192
|
|
|
$
|
241
|
|
|
(20
|
)%
|
|
$
|
374
|
|
|
$
|
466
|
|
|
(20
|
)%
|
|
Aranesp® — ROW
|
244
|
|
|
231
|
|
|
6
|
%
|
|
476
|
|
|
460
|
|
|
3
|
%
|
||||
|
Total Aranesp®
|
$
|
436
|
|
|
$
|
472
|
|
|
(8
|
)%
|
|
$
|
850
|
|
|
$
|
926
|
|
|
(8
|
)%
|
|
|
Three months ended
June 30, 2019 |
|
|
|
Six months ended
June 30, |
|
|
||||||||||||||
|
|
2019
|
|
2018
|
|
Change
|
|
2019
|
|
2018
|
|
Change
|
||||||||||
|
KYPROLIS® — U.S.
|
$
|
166
|
|
|
$
|
151
|
|
|
10
|
%
|
|
$
|
320
|
|
|
$
|
288
|
|
|
11
|
%
|
|
KYPROLIS® — ROW
|
101
|
|
|
112
|
|
|
(10
|
)%
|
|
192
|
|
|
197
|
|
|
(3
|
)%
|
||||
|
Total KYPROLIS®
|
$
|
267
|
|
|
$
|
263
|
|
|
2
|
%
|
|
$
|
512
|
|
|
$
|
485
|
|
|
6
|
%
|
|
|
Three months ended
June 30, |
|
|
|
Six months ended
June 30, |
|
|
||||||||||||||
|
|
2019
|
|
2018
|
|
Change
|
|
2019
|
|
2018
|
|
Change
|
||||||||||
|
EPOGEN® — U.S.
|
$
|
223
|
|
|
$
|
250
|
|
|
(11
|
)%
|
|
$
|
442
|
|
|
$
|
494
|
|
|
(11
|
)%
|
|
|
Three months ended
June 30, |
|
|
|
Six months ended
June 30, |
|
|
||||||||||||||
|
|
2019
|
|
2018
|
|
Change
|
|
2019
|
|
2018
|
|
Change
|
||||||||||
|
Sensipar® — U.S.
|
$
|
43
|
|
|
$
|
330
|
|
|
(87
|
)%
|
|
$
|
178
|
|
|
$
|
739
|
|
|
(76
|
)%
|
|
Sensipar®/Mimpara® — ROW
|
79
|
|
|
90
|
|
|
(12
|
)%
|
|
157
|
|
|
178
|
|
|
(12
|
)%
|
||||
|
Total Sensipar®/Mimpara®
|
$
|
122
|
|
|
$
|
420
|
|
|
(71
|
)%
|
|
$
|
335
|
|
|
$
|
917
|
|
|
(63
|
)%
|
|
|
Three months ended
June 30, |
|
|
|
Six months ended
June 30, |
|
|
||||||||||||||
|
|
2019
|
|
2018
|
|
Change
|
|
2019
|
|
2018
|
|
Change
|
||||||||||
|
Nplate®— U.S.
|
$
|
122
|
|
|
$
|
107
|
|
|
14
|
%
|
|
236
|
|
|
219
|
|
|
8
|
%
|
||
|
Nplate®— ROW
|
79
|
|
|
72
|
|
|
10
|
%
|
|
154
|
|
|
139
|
|
|
11
|
%
|
||||
|
Vectibix®— U.S.
|
79
|
|
|
68
|
|
|
16
|
%
|
|
157
|
|
|
143
|
|
|
10
|
%
|
||||
|
Vectibix®— ROW
|
117
|
|
|
105
|
|
|
11
|
%
|
|
209
|
|
|
199
|
|
|
5
|
%
|
||||
|
Parsabiv® — U.S.
|
148
|
|
|
66
|
|
|
*
|
|
|
257
|
|
|
102
|
|
|
*
|
|
||||
|
Parsabiv® — ROW
|
20
|
|
|
7
|
|
|
*
|
|
|
37
|
|
|
12
|
|
|
*
|
|
||||
|
Repatha®— U.S.
|
91
|
|
|
98
|
|
|
(7
|
)%
|
|
174
|
|
|
182
|
|
|
(4
|
)%
|
||||
|
Repatha®— ROW
|
61
|
|
|
50
|
|
|
22
|
%
|
|
119
|
|
|
89
|
|
|
34
|
%
|
||||
|
NEUPOGEN®— U.S.
|
55
|
|
|
63
|
|
|
(13
|
)%
|
|
105
|
|
|
128
|
|
|
(18
|
)%
|
||||
|
NEUPOGEN®— ROW
|
20
|
|
|
39
|
|
|
(49
|
)%
|
|
43
|
|
|
77
|
|
|
(44
|
)%
|
||||
|
BLINCYTO® — U.S.
|
39
|
|
|
34
|
|
|
15
|
%
|
|
79
|
|
|
64
|
|
|
23
|
%
|
||||
|
BLINCYTO® — ROW
|
39
|
|
|
26
|
|
|
50
|
%
|
|
68
|
|
|
45
|
|
|
51
|
%
|
||||
|
Aimovig® — U.S.
|
83
|
|
|
2
|
|
|
*
|
|
|
142
|
|
|
2
|
|
|
*
|
|
||||
|
Biosimilars — ROW
|
82
|
|
|
2
|
|
|
*
|
|
|
137
|
|
|
2
|
|
|
*
|
|
||||
|
EVENITYTM — U.S.
|
3
|
|
|
—
|
|
|
*
|
|
|
3
|
|
|
—
|
|
|
*
|
|
||||
|
EVENITYTM— ROW
|
25
|
|
|
—
|
|
|
*
|
|
|
42
|
|
|
—
|
|
|
*
|
|
||||
|
Other — U.S.
|
27
|
|
|
22
|
|
|
23
|
%
|
|
50
|
|
|
41
|
|
|
22
|
%
|
||||
|
Other — ROW
|
52
|
|
|
49
|
|
|
6
|
%
|
|
90
|
|
|
93
|
|
|
(3
|
)%
|
||||
|
Total other products
|
$
|
1,142
|
|
|
$
|
810
|
|
|
41
|
%
|
|
$
|
2,102
|
|
|
$
|
1,537
|
|
|
37
|
%
|
|
Total U.S. — other products
|
$
|
647
|
|
|
$
|
460
|
|
|
41
|
%
|
|
$
|
1,203
|
|
|
$
|
881
|
|
|
37
|
%
|
|
Total ROW — other products
|
495
|
|
|
350
|
|
|
41
|
%
|
|
899
|
|
|
656
|
|
|
37
|
%
|
||||
|
Total other products
|
$
|
1,142
|
|
|
$
|
810
|
|
|
41
|
%
|
|
$
|
2,102
|
|
|
$
|
1,537
|
|
|
37
|
%
|
|
|
Three months ended
June 30, |
|
|
|
Six months ended
June 30, |
|
|
||||||||||||||
|
|
2019
|
|
2018
|
|
Change
|
|
2019
|
|
2018
|
|
Change
|
||||||||||
|
Operating expenses:
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||
|
Cost of sales
|
$
|
1,012
|
|
|
$
|
1,024
|
|
|
(1
|
)%
|
|
$
|
2,067
|
|
|
$
|
1,968
|
|
|
5
|
%
|
|
% of product sales
|
18.2
|
%
|
|
18.0
|
%
|
|
|
|
19.0
|
%
|
|
17.9
|
%
|
|
|
||||||
|
% of total revenues
|
17.2
|
%
|
|
16.9
|
%
|
|
|
|
18.1
|
%
|
|
16.9
|
%
|
|
|
||||||
|
Research and development
|
$
|
924
|
|
|
$
|
869
|
|
|
6
|
%
|
|
$
|
1,803
|
|
|
$
|
1,629
|
|
|
11
|
%
|
|
% of product sales
|
16.6
|
%
|
|
15.3
|
%
|
|
|
|
16.6
|
%
|
|
14.8
|
%
|
|
|
||||||
|
% of total revenues
|
15.7
|
%
|
|
14.3
|
%
|
|
|
|
15.8
|
%
|
|
14.0
|
%
|
|
|
||||||
|
Selling, general and administrative
|
$
|
1,260
|
|
|
$
|
1,353
|
|
|
(7
|
)%
|
|
$
|
2,414
|
|
|
$
|
2,480
|
|
|
(3
|
)%
|
|
% of product sales
|
22.6
|
%
|
|
23.8
|
%
|
|
|
|
22.2
|
%
|
|
22.5
|
%
|
|
|
||||||
|
% of total revenues
|
21.5
|
%
|
|
22.3
|
%
|
|
|
|
21.1
|
%
|
|
21.4
|
%
|
|
|
||||||
|
Other
|
$
|
(3
|
)
|
|
$
|
(19
|
)
|
|
(84
|
)%
|
|
$
|
(6
|
)
|
|
$
|
(22
|
)
|
|
(73
|
)%
|
|
|
Three months ended
June 30, |
|
Six months ended
June 30, |
||||||||||||
|
|
2019
|
|
2018
|
|
2019
|
|
2018
|
||||||||
|
Interest expense, net
|
$
|
332
|
|
|
$
|
347
|
|
|
$
|
675
|
|
|
$
|
685
|
|
|
Interest and other income, net
|
$
|
218
|
|
|
$
|
162
|
|
|
$
|
403
|
|
|
$
|
393
|
|
|
Provision for income taxes
|
$
|
385
|
|
|
$
|
351
|
|
|
$
|
707
|
|
|
$
|
659
|
|
|
Effective tax rate
|
15.0
|
%
|
|
13.3
|
%
|
|
14.5
|
%
|
|
12.5
|
%
|
||||
|
|
June 30,
2019 |
|
December 31,
2018 |
||||
|
Cash, cash equivalents and marketable securities
|
$
|
21,758
|
|
|
$
|
29,304
|
|
|
Total assets
|
$
|
59,373
|
|
|
$
|
66,416
|
|
|
Current portion of long-term debt
|
$
|
2,816
|
|
|
$
|
4,419
|
|
|
Long-term debt
|
$
|
27,798
|
|
|
$
|
29,510
|
|
|
Stockholders’ equity
|
$
|
10,794
|
|
|
$
|
12,500
|
|
|
|
Six months ended
June 30, |
||||||
|
|
2019
|
|
2018
|
||||
|
Net cash provided by operating activities
|
$
|
3,259
|
|
|
$
|
4,829
|
|
|
Net cash provided by investing activities
|
$
|
6,300
|
|
|
$
|
17,844
|
|
|
Net cash used in financing activities
|
$
|
(10,979
|
)
|
|
$
|
(16,342
|
)
|
|
Item 3.
|
QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
|
|
Item 4.
|
CONTROLS AND PROCEDURES
|
|
Item 1.
|
LEGAL PROCEEDINGS
|
|
Item 1A.
|
RISK FACTORS
|
|
Item 2.
|
UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
|
|
Period
|
|
Total number
of shares
purchased
|
|
Average
price paid
per share (1)
|
|
Total number
of shares purchased
as part of publicly announced program
|
|
Maximum dollar
value that may
yet be purchased
under the program(2)
|
||||||
|
April 1 - 30
|
|
5,910,200
|
|
|
$
|
186.39
|
|
|
5,910,200
|
|
|
$
|
981,408,982
|
|
|
May 1 - 31
|
|
4,457,100
|
|
|
$
|
170.96
|
|
|
4,457,100
|
|
|
$
|
5,219,445,027
|
|
|
June 1 - 30
|
|
2,718,800
|
|
|
$
|
178.60
|
|
|
2,718,800
|
|
|
$
|
4,733,865,620
|
|
|
Total
|
|
13,086,100
|
|
|
$
|
179.51
|
|
|
13,086,100
|
|
|
|
||
|
(1)
|
Average price paid per share includes related expenses.
|
|
(2)
|
In May 2019, our Board of Directors increased the amount authorized under our stock repurchase program by an additional $5.0 billion.
|
|
Item 6.
|
EXHIBITS
|
|
Exhibit No.
|
|
Description
|
|
3.1
|
|
Restated Certificate of Incorporation of Amgen Inc. (As Restated March 6, 2013.) (Filed as an exhibit to Form 10-Q for the quarter ended March 31, 2013 on May 3, 2013 and incorporated herein by reference.)
|
|
|
|
|
|
3.2
|
|
Amended and Restated Bylaws of Amgen Inc. (As Amended and Restated February 15, 2016.) (Filed as an exhibit to Form 8-K on February 17, 2016 and incorporated herein by reference.)
|
|
|
|
|
|
4.1
|
|
Form of stock certificate for the common stock, par value $.0001 of the Company. (Filed as an exhibit to Form 10-Q for the quarter ended March 31, 1997 on May 14, 1997 and incorporated herein by reference.)
|
|
|
|
|
|
4.2
|
|
Form of Indenture, dated January 1, 1992. (Filed as an exhibit to Form S-3 Registration Statement filed on December 19, 1991 and incorporated herein by reference.)
|
|
|
|
|
|
4.3
|
|
Agreement of Resignation, Appointment and Acceptance dated February 15, 2008. (Filed as an exhibit to Form 10-K for the year ended December 31, 2007 on February 28, 2008 and incorporated herein by reference.)
|
|
|
|
|
|
4.4
|
|
First Supplemental Indenture, dated February 26, 1997. (Filed as an exhibit to Form 8-K on March 14, 1997 and incorporated herein by reference.)
|
|
|
|
|
|
4.5
|
|
8-1/8% Debentures due April 1, 2097. (Filed as an exhibit to Form 8-K on April 8, 1997 and incorporated herein by reference.)
|
|
|
|
|
|
4.6
|
|
Officer’s Certificate of Amgen Inc., dated April 8, 1997, establishing a series of securities entitled “8 1/8% Debentures due April 1, 2097.” (Filed as an exhibit to Form 8-K on April 8, 1997 and incorporated herein by reference.)
|
|
|
|
|
|
4.7
|
|
Indenture, dated August 4, 2003. (Filed as an exhibit to Form S-3 Registration Statement on August 4, 2003 and incorporated herein by reference.)
|
|
|
|
|
|
4.8
|
|
Corporate Commercial Paper - Master Note between and among Amgen Inc., as Issuer, Cede & Co., as Nominee of The Depository Trust Company, and Citibank, N.A., as Paying Agent. (Filed as an exhibit to Form 10-Q for the quarter ended March 31, 1998 on May 13, 1998 and incorporated herein by reference.)
|
|
|
|
|
|
4.9
|
|
Officers’ Certificate of Amgen Inc., dated May 30, 2007, including forms of the Company’s Senior Floating Rate Notes due 2008, 5.85% Senior Notes due 2017 and 6.375% Senior Notes due 2037. (Filed as an exhibit to Form 8-K on May 30, 2007 and incorporated herein by reference.)
|
|
|
|
|
|
4.10
|
|
Officers’ Certificate of Amgen Inc., dated May 23, 2008, including forms of the Company’s 6.15% Senior Notes due 2018 and 6.90% Senior Notes due 2038. (Filed as exhibit to Form 8-K on May 23, 2008 and incorporated herein by reference.)
|
|
|
|
|
|
4.11
|
|
Officers’ Certificate of Amgen Inc., dated January 16, 2009, including forms of the Company’s 5.70% Senior Notes due 2019 and 6.40% Senior Notes due 2039. (Filed as exhibit to Form 8-K on January 16, 2009 and incorporated herein by reference.)
|
|
|
|
|
|
4.12
|
|
Officers’ Certificate of Amgen Inc., dated March 12, 2010, including forms of the Company’s 4.50% Senior Notes due 2020 and 5.75% Senior Notes due 2040. (Filed as exhibit to Form 8-K on March 12, 2010 and incorporated herein by reference.)
|
|
|
|
|
|
4.13
|
|
Officers’ Certificate of Amgen Inc., dated September 16, 2010, including forms of the Company’s 3.45% Senior Notes due 2020 and 4.95% Senior Notes due 2041. (Filed as an exhibit to Form 8-K on September 17, 2010 and incorporated herein by reference.)
|
|
|
|
|
|
4.14
|
|
Officers’ Certificate of Amgen Inc., dated June 30, 2011, including forms of the Company’s 2.30% Senior Notes due 2016, 4.10% Senior Notes due 2021 and 5.65% Senior Notes due 2042. (Filed as an exhibit to Form 8-K on June 30, 2011 and incorporated herein by reference.)
|
|
|
|
|
|
4.15
|
|
Officers’ Certificate of Amgen Inc., dated November 10, 2011, including forms of the Company’s 1.875% Senior Notes due 2014, 2.50% Senior Notes due 2016, 3.875% Senior Notes due 2021 and 5.15% Senior Notes due 2041. (Filed as an exhibit to Form 8-K on November 10, 2011 and incorporated herein by reference.)
|
|
|
|
|
|
4.16
|
|
Officers’ Certificate of Amgen Inc., dated December 5, 2011, including forms of the Company’s 4.375% Senior Notes due 2018 and 5.50% Senior Notes due 2026. (Filed as an exhibit to Form 8-K on December 5, 2011 and incorporated herein by reference.)
|
|
|
|
|
|
10.7+
|
|
Form of Performance Unit Agreement for the Amgen Inc. 2009 Performance Award Program. (As Amended on December 7, 2018.) (Filed as an exhibit to Form 10-K for the year ended December 31, 2018 on February 13, 2019 and incorporated herein by reference.)
|
|
|
|
|
|
10.8+
|
|
Amgen Inc. 2009 Director Equity Incentive Program. (As Amended on October 24, 2017.) (Filed as an exhibit to Form 10-K for the year ended December 31, 2017 on February 13, 2018 and incorporated herein by reference.)
|
|
|
|
|
|
10.9+
|
|
Form of Grant of Non-Qualified Stock Option Agreement for the Amgen Inc. 2009 Director Equity Incentive Program. (Filed as an exhibit to Form 8-K on May 8, 2009 and incorporated herein by reference.)
|
|
|
|
|
|
10.10+
|
|
Form of Restricted Stock Unit Agreement for the Amgen Inc. 2009 Director Equity Incentive Program. (As Amended on October 24, 2017.) (Filed as an exhibit to Form 10-K for the year ended December 31, 2017 on February 13, 2018 and incorporated herein by reference.)
|
|
|
|
|
|
10.11+
|
|
Form of Cash-Settled Restricted Stock Unit Agreement for the Amgen 2009 Director Equity Incentive Program. (Filed as an exhibit to Form 10-K for the year ended December 31, 2017 on February 13, 2018 and incorporated herein by reference.)
|
|
|
|
|
|
10.12+
|
|
Amgen Inc. Supplemental Retirement Plan. (As Amended and Restated effective October 16, 2013.) (Filed as an exhibit to Form 10-K for the year ended December 31, 2013 on February 24, 2014 and incorporated herein by reference.)
|
|
|
|
|
|
10.13+
|
|
First Amendment to the Amgen Inc. Supplemental Retirement Plan, effective October 14, 2016. (Filed as an exhibit to Form 10-Q for the quarter ended September 30, 2016 on October 28, 2016 and incorporated herein by reference.)
|
|
|
|
|
|
10.14+
|
|
Amended and Restated Amgen Change of Control Severance Plan. (As Amended and Restated effective December 9, 2010 and subsequently amended effective March 2, 2011.) (Filed as an exhibit to Form 10-Q for the quarter ended March 31, 2011 on May 10, 2011 and incorporated herein by reference.)
|
|
|
|
|
|
10.15+
|
|
Amgen Inc. Executive Incentive Plan. (As Amended and Restated effective January 1, 2009.) (Filed as an exhibit to Form 10-Q for the quarter ended September 30, 2008 on November 7, 2008 and incorporated herein by reference.)
|
|
|
|
|
|
10.16+
|
|
First Amendment to the Amgen Inc. Executive Incentive Plan, effective December 13, 2012. (Filed as an exhibit to Form 10-K for the year ended December 31, 2012 on February 27, 2013 and incorporated herein by reference.)
|
|
|
|
|
|
10.17+
|
|
Second Amendment to the Amgen Inc. Executive Incentive Plan, effective January 1, 2017. (Filed as an exhibit to Form 10-Q for the quarter ended March 31, 2017 on April 27, 2017 and incorporated herein by reference.)
|
|
|
|
|
|
10.18+
|
|
Amgen Nonqualified Deferred Compensation Plan. (As Amended and Restated effective October 16, 2013.) (Filed as an exhibit to Form 10-K for the year ended December 31, 2013 on February 24, 2014 and incorporated herein by reference.)
|
|
|
|
|
|
10.19+
|
|
First Amendment to the Amgen Nonqualified Deferred Compensation Plan, effective October 14, 2016. (Filed as an exhibit to Form 10-Q for the quarter ended September 30, 2016 on October 28, 2016 and incorporated herein by reference.)
|
|
|
|
|
|
10.20+
|
|
Agreement between Amgen Inc. and David W. Meline, effective July 21, 2014. (Filed as an exhibit to Form 10-Q for the quarter ended September 30, 2014 on October 29, 2014 and incorporated herein by reference.)
|
|
|
|
|
|
10.21+
|
|
Agreement between Amgen Inc. and Jonathan Graham, dated May 11, 2015. (Filed as an exhibit to Form 10-Q/A for the quarter ended June 30, 2015 on August 6, 2015 and incorporated herein by reference.)
|
|
|
|
|
|
10.22+
|
|
Agreement between Amgen Inc. and Lori Johnston, dated October 25, 2016. (Filed as an exhibit to Form 10-K for the year ended December 31, 2016 on February 14, 2017 and incorporated herein by reference.)
|
|
|
|
|
|
10.23+
|
|
Agreement between Amgen Inc. and Murdo Gordon, dated July 25, 2018. (Filed as an exhibit to Form 10-Q for the quarter ended September 30, 2018 on October 31, 2018 and incorporated herein by reference.)
|
|
|
|
|
|
10.24
|
|
Amended and Restated Credit Agreement, dated July 30, 2014, among Amgen Inc., the Banks therein named, Citibank, N.A., as administrative agent, and JPMorgan Chase Bank, N.A., as syndication agent (the “Credit Agreement”). (Filed as an exhibit to Form 8-K on July 30, 2014 and incorporated herein by reference.)
|
|
|
|
|
|
10.25
|
|
Amendment No. 1 to the Credit Agreement, dated March 9, 2018, among Amgen Inc., the Banks therein named, and Citibank, N.A., as administrative agent. (Filed as an exhibit to Form 10-Q for the quarter ended March 31, 2018 on April 25, 2018 and incorporated herein by reference.)
|
|
|
|
|
|
10.26
|
|
Collaboration and License Agreement between Amgen Inc. and Celltech R&D Limited dated May 10, 2002 (portions of the exhibit have been omitted pursuant to a request for confidential treatment) and Amendment No. 1, effective June 9, 2003, to Collaboration and License Agreement between Amgen Inc. and Celltech R&D Limited (portions of the exhibit have been omitted pursuant to a request for confidential treatment). (Filed as an exhibit to Form 10-K/A for the year ended December 31, 2012 on July 31, 2013 and incorporated herein by reference.)
|
|
|
|
|
|
10.27
|
|
Amendment No. 2 to Collaboration and License Agreement, effective November 14, 2016, between Amgen Inc. and Celltech R&D Limited (portions of the exhibit have been omitted pursuant to a request for confidential treatment). (Filed as an exhibit to Form 10-K for the year ended December 31, 2016 on February 14, 2017 and incorporated herein by reference.)
|
|
|
|
|
|
10.28*
|
|
|
|
|
|
|
|
10.29
|
|
Collaboration Agreement, dated April 22, 1994, by and between Bayer Corporation (formerly Miles, Inc.) and Onyx Pharmaceuticals, Inc. (Filed as an exhibit to Form 10-Q for the quarter ended March 31, 2011 by Onyx Pharmaceuticals, Inc. on May 10, 2011 and incorporated herein by reference.)
|
|
|
|
|
|
10.30
|
|
Amendment to Collaboration Agreement, dated April 24, 1996, by and between Bayer Corporation and Onyx Pharmaceuticals, Inc. (Filed as an exhibit to Form 10-Q for the quarter ended March 31, 2006 by Onyx Pharmaceuticals, Inc. on May 10, 2006 and incorporated herein by reference.)
|
|
|
|
|
|
10.31
|
|
Amendment to Collaboration Agreement, dated February 1, 1999, by and between Bayer Corporation and Onyx Pharmaceuticals, Inc. (Filed as an exhibit to Form 10-Q for the quarter ended March 31, 2006 by Onyx Pharmaceuticals, Inc. on May 10, 2006 and incorporated herein by reference.)
|
|
|
|
|
|
10.32
|
|
Settlement Agreement and Release, dated October 11, 2011, by and between Bayer Corporation, Bayer AG, Bayer HealthCare LLC and Bayer Pharma AG and Onyx Pharmaceuticals, Inc. (Filed as an exhibit to Form 10-K for the year ended December 31, 2011 by Onyx Pharmaceuticals, Inc. on February 27, 2012 and incorporated herein by reference.)
|
|
|
|
|
|
10.33
|
|
Fourth Amendment to Collaboration Agreement, dated October 11, 2011, by and between Bayer Corporation and Onyx Pharmaceuticals, Inc. (Filed as an exhibit to Form 10-K for the year ended December 31, 2011 by Onyx Pharmaceuticals, Inc. on February 27, 2012 and incorporated herein by reference.)
|
|
|
|
|
|
10.34
|
|
Side Letter Regarding Collaboration Agreement, dated May 29, 2015, by and between Bayer HealthCare LLC and Onyx Pharmaceuticals, Inc. (Filed as an exhibit to Form 10-Q for the quarter ended June 30, 2015 on August 5, 2015 and incorporated herein by reference.)
|
|
|
|
|
|
10.35
|
|
Sourcing and Supply Agreement, dated January 6, 2017, by and between Amgen USA Inc., a wholly owned subsidiary of Amgen Inc., and DaVita Inc. (portions of the exhibit have been omitted pursuant to a request for confidential treatment). (Filed as an exhibit to Form 10-Q for the quarter ended March 31, 2017 on April 27, 2017 and incorporated herein by reference.)
|
|
|
|
|
|
10.36
|
|
Exclusive License and Collaboration Agreement, dated August 28, 2015, by and between Amgen Inc. and Novartis Pharma AG (portions of the exhibit have been omitted pursuant to a request for confidential treatment). (Filed as an exhibit to Form 10-Q for the quarter ended June 30, 2017 on July 26, 2017 and incorporated herein by reference.)
|
|
|
|
|
|
10.37
|
|
Amendment No. 1 to the Exclusive License and Collaboration Agreement, dated April 21, 2017, by and between Amgen Inc. and Novartis Pharma AG (portions of the exhibit have been omitted pursuant to a request for confidential treatment). (Filed as an exhibit to Form 10-Q for the quarter ended June 30, 2017 on July 26, 2017 and incorporated herein by reference.)
|
|
|
|
|
|
10.38
|
|
Amendment No. 2 to the Exclusive License and Collaboration Agreement, dated April 21, 2017, by and between Amgen Inc. and Novartis Pharma AG (portions of the exhibit have been omitted pursuant to a request for confidential treatment). (Filed as an exhibit to Form 10-Q for the quarter ended June 30, 2017 on July 26, 2017 and incorporated herein by reference.)
|
|
|
|
|
|
10.39
|
|
Collaboration Agreement, dated April 21, 2017, by and between Amgen Inc. and Novartis Pharma AG (portions of the exhibit have been omitted pursuant to a request for confidential treatment). (Filed as an exhibit to Form 10-Q for the quarter ended June 30, 2017 on July 26, 2017 and incorporated herein by reference.)
|
|
|
|
|
|
10.40
|
|
Amendment No. 1 to the Collaboration Agreement, dated March 20, 2018, by and between Novartis Pharma AG and Amgen Inc. (portions of the exhibit have been omitted pursuant to a request for confidential treatment). (Filed as an exhibit to Form 10-Q for the quarter ended March 31, 2018 on April 25, 2018 and incorporated herein by reference.)
|
|
|
|
|
|
31*
|
|
|
|
|
|
|
|
32**
|
|
|
|
|
|
|
|
101.INS
|
|
XBRL Instance Document - The instance document does not appear in the interactive data file because its XBRL tags are embedded within the inline XBRL document.
|
|
|
|
|
|
101.SCH*
|
|
XBRL Taxonomy Extension Schema Document.
|
|
|
|
|
|
101.CAL*
|
|
XBRL Taxonomy Extension Calculation Linkbase Document.
|
|
|
|
|
|
101.DEF*
|
|
XBRL Taxonomy Extension Definition Linkbase Document.
|
|
|
|
|
|
101.LAB*
|
|
XBRL Taxonomy Extension Label Linkbase Document.
|
|
|
|
|
|
101.PRE*
|
|
XBRL Taxonomy Extension Presentation Linkbase Document.
|
|
|
|
Amgen Inc.
|
||
|
|
|
(Registrant)
|
||
|
|
|
|
|
|
|
Date:
|
July 30, 2019
|
By:
|
|
/S/ DAVID W. MELINE
|
|
|
|
|
|
David W. Meline
|
|
|
|
|
|
Executive Vice President and Chief Financial Officer
|
|
|
|
|
|
(Principal Financial and Accounting Officer)
|
|
Re:
|
Romosozumab
|
|
/s/ Murdo Gordon
|
|
/s/ David W. Meline
|
|
/s/ Mark Glyn Hardy
|
|
1.
|
I have reviewed this Quarterly Report on Form 10-Q of Amgen Inc.;
|
|
2.
|
Based on my knowledge, this quarterly report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this quarterly report;
|
|
3.
|
Based on my knowledge, the financial statements, and other financial information included in this quarterly report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this quarterly report;
|
|
4.
|
The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
|
|
(a)
|
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this quarterly report is being prepared;
|
|
(b)
|
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
|
|
(c)
|
Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this quarterly report based on such evaluation; and
|
|
(d)
|
Disclosed in this quarterly report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
|
|
5.
|
The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
|
|
(a)
|
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
|
|
(b)
|
Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
|
|
Date: July 30, 2019
|
/s/ ROBERT A. BRADWAY
|
|
|
Robert A. Bradway
|
|
|
Chairman of the Board,
|
|
|
Chief Executive Officer and President
|
|
1.
|
I have reviewed this Quarterly Report on Form 10-Q of Amgen Inc.;
|
|
2.
|
Based on my knowledge, this quarterly report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this quarterly report;
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3.
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Based on my knowledge, the financial statements, and other financial information included in this quarterly report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this quarterly report;
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4.
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The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
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(a)
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Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this quarterly report is being prepared;
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(b)
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Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
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(c)
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Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this quarterly report based on such evaluation; and
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(d)
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Disclosed in this quarterly report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
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5.
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The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
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(a)
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All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
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(b)
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Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
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Date: July 30, 2019
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/s/ DAVID W. MELINE
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David W. Meline
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Executive Vice President and Chief Financial Officer
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(i)
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the accompanying Quarterly Report on Form 10-Q of the Company for the period ended June 30, 2019 (the “Report”) fully complies with the requirements of Section 13(a) or Section 15(d), as applicable, of the Securities Exchange Act of 1934, as amended; and
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(ii)
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information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
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Date: July 30, 2019
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/s/ ROBERT A. BRADWAY
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Robert A. Bradway
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Chairman of the Board,
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Chief Executive Officer and President
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(i)
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the accompanying Quarterly Report on Form 10-Q of the Company for the period ended June 30, 2019 (the “Report”) fully complies with the requirements of Section 13(a) or Section 15(d), as applicable, of the Securities Exchange Act of 1934, as amended; and
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(ii)
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information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
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Date: July 30, 2019
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/s/ DAVID W. MELINE
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David W. Meline
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Executive Vice President and Chief Financial Officer
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