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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 September 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 October 23, 2019, the registrant had 594,183,541 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.



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
September 30,
 
Nine months ended
September 30,
 
2019
 
2018
 
2019
 
2018
Revenues:
 
 
 
 
 
 
 
Product sales
$
5,463

 
$
5,510

 
$
16,323

 
$
16,532

Other revenues
274

 
394

 
842

 
985

Total revenues
5,737

 
5,904

 
17,165

 
17,517

 
 
 
 
 
 
 
 
Operating expenses:
 
 
 
 
 
 
 
Cost of sales
1,036

 
1,037

 
3,103

 
3,005

Research and development
1,001

 
926

 
2,804

 
2,555

Selling, general and administrative
1,223

 
1,293

 
3,637

 
3,773

Other
1

 
325

 
(5
)
 
303

Total operating expenses
3,261

 
3,581

 
9,539

 
9,636

 
 
 
 
 
 
 
 
Operating income
2,476

 
2,323

 
7,626

 
7,881

 
 
 
 
 
 
 
 
Interest expense, net
313

 
355

 
988

 
1,040

Interest and other income, net
114

 
126

 
517

 
519

 
 
 
 
 
 
 
 
Income before income taxes
2,277

 
2,094

 
7,155

 
7,360

 
 
 
 
 
 
 
 
Provision for income taxes
309

 
235

 
1,016

 
894

 
 
 
 
 
 
 
 
Net income
$
1,968

 
$
1,859

 
$
6,139

 
$
6,466

 
 
 
 
 
 
 
 
Earnings per share:
 
 
 
 
 
 
 
Basic
$
3.29

 
$
2.88

 
$
10.08

 
$
9.67

Diluted
$
3.27

 
$
2.86

 
$
10.01

 
$
9.61

 
 
 
 
 
 
 
 
Shares used in calculation of earnings per share:
 
 
 
 
 
 
 
Basic
599

 
645

 
609

 
669

Diluted
602

 
649

 
613

 
673


See accompanying notes.

1


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

 
Three months ended
September 30,
 
Nine months ended
September 30,
 
2019
 
2018
 
2019
 
2018
Net income
$
1,968

 
$
1,859

 
$
6,139

 
$
6,466

Other comprehensive income (loss), net of reclassification adjustments and taxes:
 
 
 
 
 
 
 
Losses on foreign currency translation
(39
)
 
(71
)
 
(56
)
 
(153
)
Gains on cash flow hedges
86

 
41

 
27

 
270

Gains (losses) on available-for-sale securities
30

 
97

 
404

 
(237
)
Other

 
(3
)
 
6

 
(1
)
Other comprehensive income (loss), net of taxes
77

 
64

 
381

 
(121
)
Comprehensive income
$
2,045

 
$
1,923

 
$
6,520

 
$
6,345


See accompanying notes.

2


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

 
September 30,
2019
 
December 31,
2018
 
(Unaudited)
 
 
ASSETS
Current assets:
 
 
 
Cash and cash equivalents
$
11,415

 
$
6,945

Marketable securities
9,438

 
22,359

Trade receivables, net
3,606

 
3,580

Inventories
3,243

 
2,940

Other current assets
3,349

 
1,794

Total current assets
31,051

 
37,618

 
 
 
 
Property, plant and equipment, net
4,901

 
4,958

Intangible assets, net
6,702

 
7,443

Goodwill
14,705

 
14,699

Other assets
2,176

 
1,698

Total assets
$
59,535

 
$
66,416

 
 
 
 
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
 
 
 
Accounts payable
$
1,005

 
$
1,207

Accrued liabilities
7,683

 
7,862

Current portion of long-term debt
2,049

 
4,419

Total current liabilities
10,737

 
13,488

 
 
 
 
Long-term debt
27,742

 
29,510

Long-term deferred tax liabilities
665

 
864

Long-term tax liabilities
7,921

 
8,770

Other noncurrent liabilities
1,543

 
1,284

 
 
 
 
Contingencies and commitments

 

 
 
 
 
Stockholders’ equity:
 
 
 
Common stock and additional paid-in capital; $0.0001 par value; 2,750.0 shares authorized; outstanding — 596.2 shares in 2019 and 629.6 shares in 2018
31,451

 
31,246

Accumulated deficit
(20,136
)
 
(17,977
)
Accumulated other comprehensive loss
(388
)
 
(769
)
Total stockholders’ equity
10,927

 
12,500

Total liabilities and stockholders’ equity
$
59,535

 
$
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

Net income

 

 
1,968

 

 
1,968

Other comprehensive income, net of taxes

 

 

 
77

 
77

Dividends declared on common stock ($1.45 per share)

 

 
(880
)
 

 
(880
)
Issuance of common stock in connection with the Company’s equity award programs
0.3

 
37

 

 

 
37

Stock-based compensation expense

 
108

 

 

 
108

Tax impact related to employee stock-based compensation expense

 
(7
)
 

 

 
(7
)
Repurchases of common stock
(6.2
)
 

 
(1,170
)
 

 
(1,170
)
Balance as of September 30, 2019
596.2

 
$
31,451

 
$
(20,136
)
 
$
(388
)
 
$
10,927


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

Net income

 

 
1,859

 

 
1,859

Other comprehensive income, net of taxes

 

 

 
64

 
64

Dividends declared on common stock ($1.32 per share)

 

 
(867
)
 

 
(867
)
Issuance of common stock in connection with the Company’s equity award programs
0.2

 
13

 

 

 
13

Stock-based compensation expense

 
94

 

 

 
94

Tax impact related to employee stock-based compensation expense

 
(10
)
 

 

 
(10
)
Repurchases of common stock
(8.7
)
 

 
(1,713
)
 

 
(1,713
)
Balance as of September 30, 2018
640.5

 
$
31,145

 
$
(15,987
)
 
$
(809
)
 
$
14,349


See accompanying notes.


5


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

 
Nine months ended
September 30,
 
2019
 
2018
Cash flows from operating activities:
 
 
 
Net income
$
6,139

 
$
6,466

Depreciation, amortization and other
1,504

 
1,456

Deferred income taxes
(172
)
 
(294
)
Other items, net
169

 
636

Changes in operating assets and liabilities, net of acquisitions:
 
 
 
Trade receivables, net
(63
)
 
(234
)
Inventories
(101
)
 
(93
)
Other assets
(269
)
 
(110
)
Accounts payable
(196
)
 
(311
)
Accrued income taxes, net
(128
)
 
(384
)
Long-term tax liabilities
(262
)
 
204

Other liabilities
15

 
766

Net cash provided by operating activities
6,636

 
8,102

Cash flows from investing activities:
 
 
 
Purchases of marketable securities
(9,062
)
 
(12,617
)
Proceeds from sales of marketable securities
3,019

 
28,059

Proceeds from maturities of marketable securities
18,441

 
3,881

Cash paid, net of cash acquired
(177
)
 
197

Purchases of property, plant and equipment
(430
)
 
(513
)
Other
(119
)
 
(31
)
Net cash provided by investing activities
11,672

 
18,976

Cash flows from financing activities:
 
 
 
Repayment of debt
(4,514
)
 
(500
)
Repurchases of common stock
(6,608
)
 
(15,670
)
Dividends paid
(2,649
)
 
(2,667
)
Other
(67
)
 
(85
)
Net cash used in financing activities
(13,838
)
 
(18,922
)
Increase in cash and cash equivalents
4,470

 
8,156

Cash and cash equivalents at beginning of period
6,945

 
3,800

Cash and cash equivalents at end of period
$
11,415

 
$
11,956


See accompanying notes.

6


AMGEN INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
September 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 nine months ended September 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 Reports on Form 10-Q for the periods ended March 31, 2019 and June 30, 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 $8.2 billion and $7.8 billion as of September 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 9, 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. 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 have substantially completed our impact assessment and do not currently anticipate a material impact on our condensed consolidated financial statements.
2. Business combinations
Nuevolution AB
On July 15, 2019, we acquired all of the outstanding stock of Nuevolution AB (Nuevolution), a publicly traded, Denmark-based biotechnology company with a leading small-molecule-drug discovery platform, for total consideration of $183 million in cash. The transaction, which was accounted for as a business combination, expands our ability to discover novel small molecules against difficult-to-drug targets and with greater speed and efficiency. Nuevolution’s operations, which are not material, have been included in our condensed consolidated financial statements commencing on the acquisition date.
We allocated the consideration to acquire Nuevolution to finite-lived intangible assets of $150 million, comprised primarily of technology rights for a drug discovery platform with an estimated useful life of 10 years; goodwill of $26 million, which is not tax deductible; deferred tax liabilities of $22 million; and other net assets of $29 million.
The estimated fair values of intangible assets were determined primarily using a probability-weighted income approach, which discounts expected future cash flows to present value by using a discount rate that represents the estimated rate that market participants would use to value the intangible assets.
Our accounting for this acquisition is preliminary and will be finalized upon completion of our analysis to determine the acquisition date fair values of certain assets acquired, tax-related items and the residual impact on goodwill.
Otezla® 
On August 25, 2019, we entered into an agreement with Celgene Corporation (Celgene) in connection with Celgene’s previously announced merger with Bristol-Myers Squibb Company (BMS) to acquire worldwide rights to Otezla® (apremilast), the only oral, nonbiologic treatment for psoriasis and psoriatic arthritis, and certain related assets and liabilities for $13.4 billion. We expect to fund the purchase price with cash. The transaction is expected to close by the end of 2019.

8


3. 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.
Revenues were as follows (in millions):
 
 
Three months ended September 30,
 
 
2019
 
2018
 
 
US
 
ROW
 
Total
 
US
 
ROW
 
Total
Enbrel® (etanercept)
 
$
1,323

 
$
43

 
$
1,366

 
$
1,242

 
$
50

 
$
1,292

Neulasta® (pegfilgrastim)
 
619

 
92

 
711

 
897

 
154

 
1,051

Prolia® (denosumab)
 
425

 
205

 
630

 
354

 
178

 
532

XGEVA® (denosumab)
 
356

 
120

 
476

 
323

 
110

 
433

Aranesp® (darbepoetin alfa)
 
204

 
248

 
452

 
248

 
229

 
477

KYPROLIS® (carfilzomib)
 
163

 
103

 
266

 
142

 
90

 
232

EPOGEN® (epoetin alfa)
 
215

 

 
215

 
252

 

 
252

Sensipar®/Mimpara® (cinacalcet)
 
38

 
71

 
109

 
330

 
79

 
409

Other products
 
686

 
552

 
1,238

 
472

 
360

 
832

Total product sales(1)
 
$
4,029

 
$
1,434

 
5,463

 
$
4,260

 
$
1,250

 
5,510

Other revenues
 
 
 
 
 
274

 
 
 
 
 
394

Total revenues
 
 
 
 
 
$
5,737

 
 
 
 
 
$
5,904

 
 
Nine months ended September 30,
 
 
2019
 
2018
 
 
US
 
ROW
 
Total
 
US
 
ROW
 
Total
ENBREL
 
$
3,744

 
$
136

 
$
3,880

 
$
3,544

 
$
155

 
$
3,699

Neulasta®
 
2,231

 
325

 
2,556

 
2,854

 
452

 
3,306

Prolia®
 
1,273

 
647