EX-99.1 2 amgn-20191231xq4ex991.htm EX-99.1 Exhibit


 
 
Exhibit 99.1
amgenlogoa14.jpg
News Release
 

One Amgen Center Drive
Thousand Oaks, CA 91320-1799
Telephone 805-447-1000
www.amgen.com


AMGEN REPORTS FOURTH QUARTER AND FULL YEAR 2019 FINANCIAL RESULTS
 
THOUSAND OAKS, Calif. (Jan. 30, 2020) - Amgen (NASDAQ:AMGN) today announced financial results for the fourth quarter and full year 2019 versus comparable periods in 2018. Key results include:
For the fourth quarter, total revenues decreased 1% to $6.2 billion in comparison to the fourth quarter of 2018, reflecting the impact of biosimilar and generic competition against select products.
Product sales declined 2% globally, while units grew double digits or better for Repatha® (evolocumab), Parsabiv® (etelcalcetide), BLINCYTO® (blinatumomab), Aimovig® (erenumab-aooe), Prolia® (denosumab), Nplate® (romiplostim) and Vectibix® (panitumumab).
For the full year, total revenues decreased 2% to $23.4 billion, with product sales decreasing 1%.
GAAP earnings per share (EPS) decreased 5% to $2.85 in the fourth quarter driven by higher operating expenses, offset partially by lower weighted-average shares outstanding. GAAP EPS increased 2% to $12.88 for the full year driven by lower weighted-average shares outstanding, offset partially by lower operating income.
For the fourth quarter, GAAP operating income decreased 14% to $2.0 billion and GAAP operating margin decreased 4.9 percentage points to 34.8%. For the full year, GAAP operating income decreased 6% to $9.7 billion and GAAP operating margin decreased 1.9 percentage points to 43.6%.
Non-GAAP EPS increased 6% in the fourth quarter to $3.64 and 3% to $14.82 for the full year benefited by lower weighted-average shares outstanding. The increase for the full year was offset partially by lower operating income.
For the fourth quarter, non-GAAP operating income decreased 4% to $2.6 billion and non-GAAP operating margin decreased 0.7 percentage points to 44.6%. For the full year, non-GAAP operating income decreased 6% to $11.2 billion and non-GAAP operating margin decreased 2.4 percentage points to 50.2%.
The Company generated $8.5 billion of free cash flow for the full year versus $10.6 billion in 2018.
2020 total revenues guidance of $25.0-$25.6 billion; EPS guidance of $10.85-$11.65 on a GAAP basis and $14.85-$15.60 on a non-GAAP basis.
"We are entering a period of new product driven revenue growth," said Robert A. Bradway, chairman and chief executive officer. "Heading into 2020, our capital allocation priorities are clear, and we look forward to several important clinical data readouts from our innovative pipeline this year."





AMGEN REPORTS FOURTH QUARTER AND FULL YEAR 2019 FINANCIAL RESULTS
Page 2

$Millions, except EPS, dividends paid per share and percentages
 
Q4'19
 
Q4'18
 
YOY Δ
 
FY'19
 
FY'18
 
YOY Δ
Total Revenues
 
$
6,197

 
$
6,230

 
(1%)
 
$
23,362

 
$
23,747

 
(2%)
GAAP Operating Income
 
$
2,048

 
$
2,382

 
(14%)
 
$
9,674

 
$
10,263

 
(6%)
GAAP Net Income
 
$
1,703

 
$
1,928

 
(12%)
 
$
7,842

 
$
8,394

 
(7%)
GAAP EPS
 
$
2.85

 
$
3.01

 
(5%)
 
$
12.88

 
$
12.62

 
2%
Non-GAAP Operating Income
 
$
2,621

 
$
2,717

 
(4%)
 
$
11,157

 
$
11,857

 
(6%)
Non-GAAP Net Income
 
$
2,174

 
$
2,186

 
(1%)
 
$
9,028

 
$
9,573

 
(6%)
Non-GAAP EPS
 
$
3.64

 
$
3.42

 
6%
 
$
14.82

 
$
14.40

 
3%
Dividends Paid Per Share
 
$
1.45

 
$
1.32

 
10%
 
$
5.80

 
$
5.28

 
10%
References in this release to “non-GAAP” measures, measures presented “on a non-GAAP basis” and to “free cash flow” (computed by subtracting capital expenditures from operating cash flow) refer to non-GAAP financial measures. Adjustments to the most directly comparable GAAP financial measures and other items are presented on the attached reconciliations.

Product Sales Performance

Total product sales decreased 2% for the fourth quarter of 2019 versus the fourth quarter of 2018. Product sales decreased 1% for the full year driven by lower net selling price, offset partially by higher unit demand.

Prolia sales increased 15% for the fourth quarter and 17% for the full year driven by higher unit demand.

EVENITY® (romosozumab-aqqg) launched in 2019, generating sales of $85 million in the fourth quarter and $189 million for the full year.

Repatha sales increased 26% for the fourth quarter and 20% for the full year driven primarily by higher unit demand, offset partially by net selling price.

Aimovig sales increased 3% for the fourth quarter driven by higher unit demand, offset partially by unfavorable changes in accounting estimates. Full year sales grew 157% driven primarily by unit demand.

Parsabiv sales increased 49% for the fourth quarter and 88% for the full year driven primarily by higher unit demand, offset partially by net selling price.

Otezla® (apremilast) was acquired on Nov. 21, 2019, and generated $178 million in sales for the period.

Enbrel® (etanercept) sales increased 2% for the fourth quarter and 4% for the full year driven primarily by favorable changes in accounting estimates and higher net selling price, offset partially by lower unit demand.

AMGEVITA (adalimumab) generated $71 million of sales in the fourth quarter and $215 million for the full year.

KYPROLIS® (carfilzomib) sales increased 6% for the fourth quarter and 8% for the full year driven by higher unit demand.






AMGEN REPORTS FOURTH QUARTER AND FULL YEAR 2019 FINANCIAL RESULTS
Page 3

XGEVA® (denosumab) sales increased 7% for the fourth quarter and 8% for the full year driven primarily by higher unit demand and, to a lesser extent, higher net selling price.

Vectibix sales increased 8% for the fourth quarter and the full year driven by higher unit demand.

Nplate sales increased 15% for the fourth quarter and 11% for the full year driven primarily by higher unit demand.

BLINCYTO sales increased 27% for the fourth quarter and 36% for the full year driven by higher unit demand.

KANJINTI™* (trastuzumab-anns) generated $103 million of sales in the fourth quarter and $226 million for the full year.

MVASI™* (bevacizumab-awwb) generated $84 million of sales in the fourth quarter and $127 million for the full year.

Neulasta® (pegfilgrastim) sales decreased 43% for the fourth quarter and 28% for the full year driven by the impact of biosimilar competition on unit demand and lower net selling price.

NEUPOGEN® (filgrastim) sales decreased 17% for the fourth quarter driven by the impact of competition on unit demand. Sales decreased 28% for the full year driven by the impact of competition on unit demand and lower net selling price.

EPOGEN® (epoetin alfa) sales decreased 20% for the fourth quarter driven by lower net selling price and unit demand. Sales decreased 14% for the full year driven primarily by lower net selling price.

Aranesp® (darbepoetin alfa) sales decreased 10% for the fourth quarter driven by the impact of competition on unit demand and lower net selling price as well as unfavorable changes in inventory. Sales decreased 8% for the full year driven primarily by the impact of competition of unit demand.

Sensipar/Mimpara® (cinacalcet) sales decreased 76% for the fourth quarter and 69% for the full year driven by the impact of generic competition on unit demand.

* Registered in the United States.







AMGEN REPORTS FOURTH QUARTER AND FULL YEAR 2019 FINANCIAL RESULTS
Page 4

Product Sales Detail by Product and Geographic Region
$Millions, except percentages
 
Q4'19
 
Q4'18
 
YOY Δ
 
 
US
 
ROW
 
TOTAL
 
TOTAL
 
TOTAL
Prolia®
 
$
499

 
$
253

 
$
752

 
$
655

 
15%
EVENITY®
 
27

 
58

 
85

 

 
*
Repatha®
 
117

 
83

 
200

 
159

 
26%
Aimovig®
 
98

 

 
98

 
95

 
3%
Parsabiv®
 
156

 
23

 
179

 
120

 
49%
Otezla®
 
139

 
39

 
178

 

 
*
Enbrel® 
 
1,306

 
40

 
1,346

 
1,315

 
2%
AMGEVITA™
 

 
71

 
71

 
11

 
*
KYPROLIS®
 
171

 
95

 
266

 
251

 
6%
XGEVA®
 
366

 
123

 
489

 
456

 
7%
Vectibix®
 
80

 
102

 
182

 
168

 
8%
Nplate®
 
125

 
85

 
210

 
182

 
15%
BLINCYTO®
 
50

 
30

 
80

 
63

 
27%
KANJINTI™
 
79

 
24

 
103

 
23

 
*
MVASI™
 
79

 
5

 
84

 

 
*
Neulasta®
 
583

 
82

 
665

 
1,169

 
(43%)
NEUPOGEN®
 
41

 
21

 
62

 
75

 
(17%)
EPOGEN®
 
210

 

 
210

 
264

 
(20%)
Aranesp®
 
180

 
247

 
427

 
474

 
(10%)
Sensipar®/Mimpara®
 
36

 
71

 
107

 
448

 
(76%)
Other**
 
27

 
60

 
87

 
73

 
19%
Total product sales
 
$
4,369

 
$
1,512

 
$
5,881

 
$
6,001

 
(2%)
 
 
 
 
 
 
 
 
 
 
 
* Change in excess of 100%
 
 
 
 
 
 
 
 
 
 
** Other includes GENSENTA, Bergamo, Corlanor® and IMLYGIC®.





AMGEN REPORTS FOURTH QUARTER AND FULL YEAR 2019 FINANCIAL RESULTS
Page 5

$Millions, except percentages
 
FY'19
 
FY'18
 
YOY Δ
 
 
US
 
ROW
 
TOTAL
 
TOTAL
 
TOTAL
Prolia®
 
$
1,772

 
$
900

 
$
2,672

 
$
2,291

 
17%
EVENITY®
 
42

 
147

 
189

 

 
*
Repatha®
 
376

 
285

 
661

 
550

 
20%
Aimovig®
 
306

 

 
306

 
119

 
*
Parsabiv®
 
550

 
80

 
630

 
336

 
88%
Otezla®
 
139

 
39

 
178

 

 
*
Enbrel® 
 
5,050

 
176

 
5,226

 
5,014

 
4%
AMGEVITA™
 

 
215

 
215

 
11

 
*
KYPROLIS®
 
654

 
390

 
1,044

 
968

 
8%
XGEVA®
 
1,457

 
478

 
1,935

 
1,786

 
8%
Vectibix®
 
316

 
428

 
744

 
691

 
8%
Nplate®
 
480

 
315

 
795

 
717

 
11%
BLINCYTO®
 
176

 
136

 
312

 
230

 
36%
KANJINTI™
 
118

 
108

 
226

 
44

 
*
MVASI™
 
121

 
6

 
127

 

 
*
Neulasta®
 
2,814

 
407

 
3,221

 
4,475

 
(28%)
NEUPOGEN®
 
178

 
86

 
264

 
365

 
(28%)
EPOGEN®
 
867

 

 
867

 
1,010

 
(14%)
Aranesp®
 
758

 
971

 
1,729

 
1,877

 
(8%)
Sensipar®/Mimpara®
 
252

 
299

 
551

 
1,774

 
(69%)
Other**
 
105

 
207

 
312

 
275

 
13%
Total product sales
 
$
16,531

 
$
5,673

 
$
22,204

 
$
22,533

 
(1%)
 
 
 
 
 
 
 
 
 
 
 
* Change in excess of 100%
 
 
 
 
 
 
 
 
 
 
** Other includes GENSENTA, Bergamo, IMLYGIC® and Corlanor®.
Operating Expense, Operating Margin and Tax Rate Analysis
On a GAAP basis:
Total Operating Expenses increased 8% in the fourth quarter and 2% for the full year. Cost of Sales margin increased 3 percentage points in the fourth quarter driven primarily by amortization of intangible assets acquired in the Otezla acquisition. For the full year, Cost of Sales margin increased 1.4 percentage points driven primarily by unfavorable product mix and amortization of intangible assets acquired in the Otezla acquisition, offset partially by lower royalties and lower manufacturing costs. Research & Development (R&D) expenses increased 11% in the fourth quarter and 10% for the full year driven by higher spending in research and early pipeline in support of our oncology programs. The full year was offset partially by lower spend in support of marketed programs. Selling, General & Administrative (SG&A) expenses decreased 3% in the fourth quarter driven by lower spend for launched and marketed products and lower general and administrative expenses, offset partially by Otezla commercial-related expenses. For the full year, SG&A expenses decreased 3% driven by lower general and administrative expenses, the end of certain amortization of intangible assets in 2018 and lower spend for launched and marketed products, offset partially by Otezla commercial-related expenses. Other expenses increased in the fourth quarter driven primarily by restructuring costs in 2019. For the full year, other operating expenses decreased driven primarily by an impairment charge in 2018 of an intangible asset.





AMGEN REPORTS FOURTH QUARTER AND FULL YEAR 2019 FINANCIAL RESULTS
Page 6

Operating Margin decreased 4.9 percentage points in the fourth quarter to 34.8% driven primarily by the Otezla acquisition, and decreased 1.9 percentage points for the full year to 43.6%.
Tax Rate increased 2.3 percentage points in the fourth quarter and 2.1 percentage points for the full year due primarily to a prior-year tax benefit associated with intercompany sales under U.S. corporate tax reform.

On a non-GAAP basis:
Total Operating Expenses increased 2% in the fourth quarter and 3% for the full year. Cost of Sales margin decreased 0.2 percentage points in the fourth quarter. For the full year, Cost of Sales margin increased 0.5 percentage points driven primarily by unfavorable product mix, offset partially by lower royalties and lower manufacturing costs. R&D expenses increased 11% for the fourth quarter and 10% for the full year driven by higher spending in research and early pipeline in support of our oncology programs. The full year was offset partially by lower spend in support of marketed programs. SG&A expenses decreased 2% in the fourth quarter driven by lower spend for launched and marketed products and lower general and administrative expenses, offset partially by Otezla commercial-related expenses. For the full year, SG&A expenses decreased 2% driven by lower general and administrative expenses and lower spend for launched and marketed products, offset partially by Otezla commercial-related expenses.
Operating Margin decreased 0.7 percentage points to 44.6% in the fourth quarter, and decreased 2.4 percentage points to 50.2% for the full year.
Tax Rate increased 1.6 percentage points in the fourth quarter and 1.5 percentage points for the full year due primarily to a prior-year tax benefit associated with intercompany sales under U.S. corporate tax reform.
$Millions, except percentages
 
GAAP
 
Non-GAAP
 
 
Q4'19
 
Q4'18
 
YOY Δ
 
Q4'19
 
Q4'18
 
YOY Δ
Cost of Sales
 
$
1,253

 
$
1,096

 
14%
 
$
790

 
$
819

 
(4%)
% of product sales
 
21.3
%
 
18.3
%
 
3 pts.
 
13.4
%
 
13.6
%
 
(0.2) pts.
Research & Development
 
$
1,312

 
$
1,182

 
11%
 
$
1,285

 
$
1,162

 
11%
% of product sales
 
22.3
%
 
19.7
%
 
2.6 pts.
 
21.9
%
 
19.4
%
 
2.5 pts.
Selling, General & Administrative
 
$
1,513

 
$
1,559

 
(3%)
 
$
1,501

 
$
1,532

 
(2%)
% of product sales
 
25.7
%
 
26.0
%
 
(0.3) pts.
 
25.5
%
 
25.5
%
 
0.0 pts.
Other
 
$
71

 
$
11

 
*
 
$

 
$

 
—%
Total Operating Expenses
 
$
4,149

 
$
3,848

 
8%
 
$
3,576

 
$
3,513

 
2%
 
 
 
 
 
 
 
 
 
 
 
 
 
Operating Margin
 
 
 
 
 
 
 
 
 
 
 
 
operating income as % of product sales
 
34.8
%
 
39.7
%
 
(4.9) pts.
 
44.6
%
 
45.3
%
 
(0.7) pts.
 
 
 
 
 
 
 
 
 
 
 
 
 
Tax Rate
 
14.1
%
 
11.8
%
 
2.3 pts.
 
14.9
%
 
13.3
%
 
1.6 pts.
 
 
 
 
 
 
 
 
 
 
 
 
 
* Change in excess of 100%
 
 
 
 
 
 
 
 
 
 
 
 
pts: percentage points
 
 
 
 
 
 
 
 
 
 
 
 





AMGEN REPORTS FOURTH QUARTER AND FULL YEAR 2019 FINANCIAL RESULTS
Page 7

$Millions, except percentages
 
GAAP
 
Non-GAAP
 
 
FY'19
 
FY'18
 
YOY Δ
 
FY'19
 
FY'18
 
YOY Δ
Cost of Sales
 
$
4,356

 
$
4,101

 
6%
 
$
3,065

 
$
3,001

 
2%
% of product sales
 
19.6
%
 
18.2
%
 
1.4 pts.
 
13.8
%
 
13.3
%
 
0.5 pts.
Research & Development
 
$
4,116

 
$
3,737

 
10%
 
$
4,027

 
$
3,657

 
10%
% of product sales
 
18.5
%
 
16.6
%
 
1.9 pts.
 
18.1
%
 
16.2
%
 
1.9 pts.
Selling, General & Administrative
 
$
5,150

 
$
5,332

 
(3%)
 
$
5,113

 
$
5,232

 
(2%)
% of product sales
 
23.2
%
 
23.7
%
 
(0.5) pts.
 
23.0
%
 
23.2
%
 
(0.2) pts.
Other
 
$
66

 
$
314

 
(79%)
 
$

 
$

 
—%
Total Operating Expenses
 
$
13,688

 
$
13,484

 
2%
 
$
12,205

 
$
11,890

 
3%
 
 
 
 
 
 
 
 
 
 
 
 
 
Operating Margin
 
 
 
 
 
 
 
 
 
 
 
 
operating income as % of product sales
 
43.6
%
 
45.5
%
 
(1.9) pts.
 
50.2
%
 
52.6
%
 
(2.4) pts.
 
 
 
 
 
 
 
 
 
 
 
 
 
Tax Rate
 
14.2
%
 
12.1
%
 
2.1 pts.
 
15.0
%
 
13.5
%
 
1.5 pts.
 
 
 
 
 
 
 
 
 
 
 
 
 
pts: percentage points
 
 
 
 
 
 
 
 
 
 
 
 
Cash Flow and Balance Sheet
The Company generated $2.3 billion of free cash flow in the fourth quarter of 2019 versus $3.0 billion in the fourth quarter of 2018 due primarily to timing of tax payments. The Company generated $8.5 billion of free cash flow for the full year 2019 versus $10.6 billion in 2018 due primarily to unfavorable changes in working capital, an advanced tax deposit and lower net income.
The Company’s fourth quarter 2019 dividend of $1.45 per share was declared on Oct. 22, 2019, and was paid on Dec. 6, 2019, to all stockholders of record as of Nov. 15, 2019, representing a 10% increase from the fourth quarter of 2018. The Company's first quarter 2020 dividend of $1.60 per share declared on Dec. 11, 2019, will be paid on March 6, 2020, to all stockholders of record as of Feb. 14, 2020, representing a 10% increase from that paid in each of the previous four quarters of 2019.
During the fourth quarter of 2019, the Company repurchased 5.1 million shares of common stock at a total cost of $1.1 billion. For the full year, the Company repurchased 40.2 million shares of common stock at a total cost of $7.6 billion. At the end of the fourth quarter, the Company had $6.5 billion remaining under its stock repurchase authorization.
$Billions, except shares
 
Q4'19
 
Q4'18
 
YOY Δ
 
 
FY'19
 
FY'18
 
YOY Δ
 
Operating Cash Flow
 
$
2.5

 
$
3.2

 
$
(0.7
)
 
 
$
9.2

 
$
11.3

 
$
(2.1
)
 
Capital Expenditures
 
0.2

 
0.2

 
0.0

 
 
0.6

 
0.7

 
(0.1
)
 
Free Cash Flow
 
2.3

 
3.0

 
(0.6
)
 
 
8.5

 
10.6

 
(2.0
)
 
Dividends Paid
 
0.9

 
0.8

 
0.0

 
 
3.5

 
3.5

 
0.0

 
Share Repurchases
 
1.1

 
2.2

 
(1.1
)
 
 
7.6

 
17.9

 
(10.2
)
 
Average Diluted Shares (millions)
 
598

 
640

 
(42
)
 
 
609

 
665

 
(56
)
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Cash and Investments
 
8.9

 
29.3

 
(20.4
)
 
 
8.9

 
29.3

 
(20.4
)
 
Debt Outstanding
 
29.9

 
33.9

 
(4.0
)
 
 
29.9

 
33.9

 
(4.0
)
 
Stockholders' Equity
 
9.7

 
12.5

 
(2.8
)
 
 
9.7

 
12.5

 
(2.8
)
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Note: Numbers may not add due to rounding
 
 
 
 
 
 
 
 
 
 
 
 
 
 





AMGEN REPORTS FOURTH QUARTER AND FULL YEAR 2019 FINANCIAL RESULTS
Page 8

2020 Guidance
For the full year 2020, the Company expects:
Total revenues in the range of $25.0 billion to $25.6 billion.
On a GAAP basis, EPS in the range of $10.85 to $11.65 and a tax rate in the range of 10.5% to 11.5%.
On a non-GAAP basis, EPS in the range of $14.85 to $15.60 and a tax rate in the range of 13.5% to 14.5%.
Capital expenditures to be approximately $700 million.
Fourth Quarter Product and Pipeline Update
The Company provided the following updates on selected product and pipeline programs:
Otezla
Data from the Phase 3 study in patients with mild-to-moderate psoriasis are expected by mid-year 2020.
A supplemental New Drug Application (sNDA) to expand the Prescribing Information to include data from the Phase 3 scalp psoriasis study is under review by the U.S. Food and Drug Administration (FDA) with a Prescription Drug User Fee Act target action date in April 2020.

EVENITY
In December 2019, the European Commission (EC) granted marketing authorization for EVENITY for the treatment of severe osteoporosis in postmenopausal women at high risk of fracture.

KYPROLIS
In January, an sNDA was submitted to the FDA to expand the Prescribing Information to include KYPROLIS in combination with dexamethasone and DARZALEX® (daratumumab) for patients with relapsed or refractory multiple myeloma based on data from the Phase 3 CANDOR study.
In November, a marketing authorization application (MAA) was accepted by the China National Medical Products Administration (NMPA) for the use of KYPROLIS plus dexamethasone for the treatment of relapsed and refractory multiple myeloma.
 
BLINCYTO
In December, the China NMPA granted priority review for the MAA for the treatment of adults with relapsed or refractory B-cell acute lymphoblastic leukemia.






AMGEN REPORTS FOURTH QUARTER AND FULL YEAR 2019 FINANCIAL RESULTS
Page 9

AMG 510
A potentially pivotal Phase 2 monotherapy study in advanced non-small cell lung cancer (NSCLC) completed enrollment and data are expected in 2020.
A Phase 2 monotherapy study is enrolling advanced colorectal cancer patients.
A Phase 1b study in combination with MEK inhibition is enrolling advanced colorectal and non-small cell lung cancer patients.
The ongoing Phase 1 monotherapy study is also enrolling treatment naïve NSCLC patients.
In 2020, additional data are expected from the first-in-human monotherapy study in patients with multiple solid tumors, and initial data are expected from a Phase 1 study in combination with KEYTRUDA® (pembrolizumab) in patients with advanced NSCLC.
In January, the Company announced strategic collaborations with leading diagnostic companies, Guardant Health, Inc. and QIAGEN N.V., to develop blood- and tissue-based companion diagnostics, respectively.

Omecamtiv mecarbil
Data from the event driven Phase 3 GALACTIC-HF cardiovascular outcomes study are expected in Q4 2020.

AVSOLA™ (infliximab-axxq)
In December, the FDA approved AVSOLA for all approved indications of the reference product, Remicade® (infliximab).

ABP 798 (biosimilar rituximab)
In December, a Biologics License Application was submitted to the FDA for ABP 798, a biosimilar candidate to Rituxan® (rituximab).

EVENITY is developed in collaboration with UCB globally, as well as our joint venture partner Astellas in Japan
Omecamtiv mecarbil is being developed under a collaboration between Amgen and Cytokinetics, with funding and strategic support from Servier
KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co. Inc.
Remicade is a registered trademark of Janssen Biotech Inc.
Rituxan is a registered trademark of Biogen Inc.






AMGEN REPORTS FOURTH QUARTER AND FULL YEAR 2019 FINANCIAL RESULTS
Page 10

Non-GAAP Financial Measures
In this news release, management has presented its operating results for the fourth quarters and full years of 2019 and 2018, in accordance with U.S. Generally Accepted Accounting Principles (GAAP) and on a non-GAAP basis. In addition, management has presented its full year 2020 EPS and tax rate guidance in accordance with GAAP and on a non-GAAP basis. These non-GAAP financial measures are computed by excluding certain items related to acquisitions, restructuring and certain other items from the related GAAP financial measures. Reconciliations for these non-GAAP financial measures to the most directly comparable GAAP financial measures are included in the news release. Management has also presented Free Cash Flow (FCF), which is a non-GAAP financial measure, for the fourth quarters and full years of 2019 and 2018. FCF is computed by subtracting capital expenditures from operating cash flow, each as determined in accordance with GAAP.
The Company believes that its presentation of non-GAAP financial measures provides useful supplementary information to and facilitates additional analysis by investors. The Company uses certain non-GAAP financial measures to enhance an investor’s overall understanding of the financial performance and prospects for the future of the Company’s ongoing business activities by facilitating comparisons of results of ongoing business operations among current, past and future periods. The Company believes that FCF provides a further measure of the Company’s liquidity.
The Company uses the non-GAAP financial measures set forth in the news release in connection with its own budgeting and financial planning internally to evaluate the performance of the business, including to allocate resources and to evaluate results relative to incentive compensation targets. The non-GAAP financial measures are in addition to, not a substitute for, or superior to, measures of financial performance prepared in accordance with GAAP.
About Amgen
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people’s lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world’s leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
For more information, visit www.amgen.com and follow us on www.twitter.com/amgen.
Forward-Looking Statements
This news release contains forward-looking statements that are based on the current expectations and beliefs of Amgen. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including any statements on the outcome, benefits and synergies of collaborations with any other company, including BeiGene, Ltd., or the Otezla acquisition, including anticipated Otezla sales growth and the timing of non-GAAP EPS accretion, as well as estimates of revenues, operating margins, capital expenditures, cash, other financial metrics, expected legal, arbitration, political, regulatory or clinical results or practices, customer and prescriber patterns or practices, reimbursement activities and outcomes and other such estimates and results. Forward-looking statements involve significant risks and uncertainties, including those discussed below and more fully described in the Securities and Exchange Commission reports filed by Amgen, including our most recent annual report on Form 10-K and any subsequent periodic reports on Form 10-Q and current reports on Form 8-K. Unless otherwise noted, Amgen is providing this information as of the date of this news release and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise.





AMGEN REPORTS FOURTH QUARTER AND FULL YEAR 2019 FINANCIAL RESULTS
Page 11

No forward-looking statement can be guaranteed and actual results may differ materially from those we project. Our results may be affected by our ability to successfully market both new and existing products domestically and internationally, clinical and regulatory developments involving current and future products, sales growth of recently launched products, competition from other products including biosimilars, difficulties or delays in manufacturing our products and global economic conditions. In addition, sales of our products are affected by pricing pressure, political and public scrutiny and reimbursement policies imposed by third-party payers, including governments, private insurance plans and managed care providers and may be affected by regulatory, clinical and guideline developments and domestic and international trends toward managed care and healthcare cost containment. Furthermore, our research, testing, pricing, marketing and other operations are subject to extensive regulation by domestic and foreign government regulatory authorities. We or others could identify safety, side effects or manufacturing problems with our products, including our devices, after they are on the market. Our business may be impacted by government investigations, litigation and product liability claims. In addition, our business may be impacted by the adoption of new tax legislation or exposure to additional tax liabilities. If we fail to meet the compliance obligations in the corporate integrity agreement between us and the U.S. government, we could become subject to significant sanctions. Further, while we routinely obtain patents for our products and technology, the protection offered by our patents and patent applications may be challenged, invalidated or circumvented by our competitors, or we may fail to prevail in present and future intellectual property litigation. We perform a substantial amount of our commercial manufacturing activities at a few key facilities, including in Puerto Rico, and also depend on third parties for a portion of our manufacturing activities, and limits on supply may constrain sales of certain of our current products and product candidate development. We rely on collaborations with third parties for the development of some of our product candidates and for the commercialization and sales of some of our commercial products. In addition, we compete with other companies with respect to many of our marketed products as well as for the discovery and development of new products. Discovery or identification of new product candidates or development of new indications for existing products cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate or development of a new indication for an existing product will be successful and become a commercial product. Further, some raw materials, medical devices and component parts for our products are supplied by sole third-party suppliers. Certain of our distributors, customers and payers have substantial purchasing leverage in their dealings with us. The discovery of significant problems with a product similar to one of our products that implicate an entire class of products could have a material adverse effect on sales of the affected products and on our business and results of operations. Our efforts to collaborate with or acquire other companies, products or technology, and to integrate the operations of companies or to support the products or technology we have acquired, may not be successful. A breakdown, cyberattack or information security breach could compromise the confidentiality, integrity and availability of our systems and our data. Our stock price is volatile and may be affected by a number of events. Our business performance could affect or limit the ability of our Board of Directors to declare a dividend or our ability to pay a dividend or repurchase our common stock. We may not be able to access the capital and credit markets on terms that are favorable to us, or at all.

###

CONTACT: Amgen, Thousand Oaks
Trish Hawkins, 805-447-5631 (media)
Arvind Sood, 805-447-1060 (investors)






AMGEN REPORTS FOURTH QUARTER AND FULL YEAR 2019 FINANCIAL RESULTS
Page 12

Amgen Inc.
Consolidated Statements of Income - GAAP
(In millions, except per-share data)
(Unaudited)
 
 
Three months ended
December 31,
 
Years ended
December 31,
 
2019
 
2018
 
2019
 
2018
Revenues:
 
 
 
 
 
 
 
Product sales
$
5,881

 
$
6,001

 
$
22,204

 
$
22,533

Other revenues
316

 
229

 
1,158

 
1,214

Total revenues
6,197

 
6,230

 
23,362

 
23,747

 
 
 
 
 
 
 
 
Operating expenses:
 
 
 
 
 
 
 
Cost of sales
1,253

 
1,096

 
4,356

 
4,101

Research and development
1,312

 
1,182

 
4,116

 
3,737

Selling, general and administrative
1,513

 
1,559

 
5,150

 
5,332

Other
71

 
11

 
66

 
314

Total operating expenses
4,149

 
3,848

 
13,688

 
13,484

 
 
 
 
 
 
 
 
Operating income
2,048

 
2,382

 
9,674

 
10,263

 
 
 
 
 
 
 
 
Interest expense, net
301

 
352

 
1,289

 
1,392

Interest and other income, net
236

 
155

 
753

 
674

 
 
 
 
 
 
 
 
Income before income taxes
1,983

 
2,185

 
9,138

 
9,545

 
 
 
 
 
 
 
 
Provision for income taxes
280

 
257

 
1,296

 
1,151

 
 
 
 
 
 
 
 
Net income
$
1,703

 
$
1,928

 
$
7,842

 
$
8,394

 
 
 
 
 
 
 
 
Earnings per share:
 
 
 
 
 
 
 
Basic
$
2.87

 
$
3.04

 
$
12.96

 
$
12.70

Diluted
$
2.85

 
$
3.01

 
$
12.88

 
$
12.62

 
 
 
 
 
 
 
 
Weighted-average shares used in calculation of earnings per share:
 
 
 
 
 
 
 
Basic
593

 
635

 
605

 
661

Diluted
598

 
640

 
609

 
665







AMGEN REPORTS FOURTH QUARTER AND FULL YEAR 2019 FINANCIAL RESULTS
Page 13

Amgen Inc.
Consolidated Balance Sheets - GAAP
(In millions)

 
December 31,
 
2019
 
2018
 
(Unaudited)
 
 
Assets
Current assets:
 
 
 
Cash, cash equivalents and marketable securities
$
8,911

 
$
29,304

Trade receivables, net
4,057

 
3,580

Inventories
3,584

 
2,940

Other current assets
1,888

 
1,794

Total current assets
18,440

 
37,618

 
 
 
 
Property, plant and equipment, net
4,928

 
4,958

Intangible assets, net
19,413

 
7,443

Goodwill
14,703

 
14,699

Other assets
2,223

 
1,698

Total assets
$
59,707

 
$
66,416

 
 
 
 
Liabilities and Stockholders' Equity
Current liabilities:
 
 
 
Accounts payable and accrued liabilities
$
9,882

 
$
9,069

Current portion of long-term debt
2,953

 
4,419

Total current liabilities
12,835

 
13,488

 
 
 
 
Long-term debt
26,950

 
29,510

Long-term deferred tax liabilities
606

 
864

Long-term tax liabilities
8,037

 
8,770

Other noncurrent liabilities
1,606

 
1,284

Total stockholders’ equity
9,673

 
12,500

Total liabilities and stockholders’ equity
$
59,707

 
$
66,416

 
 
 
 
Shares outstanding
591

 
630







AMGEN REPORTS FOURTH QUARTER AND FULL YEAR 2019 FINANCIAL RESULTS
Page 14

Amgen Inc.
GAAP to Non-GAAP Reconciliations
(Dollars in millions)
(Unaudited)

 
Three months ended
December 31,
 
Years ended
December 31,
 
2019
 
2018
 
2019
 
2018
GAAP cost of sales
$
1,253

 
$
1,096

 
$
4,356

 
$
4,101

Adjustments to cost of sales:
 
 
 
 
 
 
 
Acquisition-related expenses (a)
(463
)
 
(276
)
 
(1,291
)
 
(1,099
)
Certain net charges pursuant to our restructuring initiatives

 
(1
)
 

 
(1
)
Total adjustments to cost of sales
(463
)
 
(277
)
 
(1,291
)
 
(1,100
)
Non-GAAP cost of sales
$
790

 
$
819

 
$
3,065

 
$
3,001

 
 
 
 
 
 
 
 
GAAP cost of sales as a percentage of product sales
21.3
%
 
18.3
%
 
19.6
%
 
18.2
%
Acquisition-related expenses (a)
-7.9

 
-4.7

 
-5.8

 
-4.9

Certain net charges pursuant to our restructuring initiatives
0.0

 
0.0

 
0.0

 
0.0

Non-GAAP cost of sales as a percentage of product sales
13.4
%
 
13.6
%
 
13.8
%
 
13.3
%
 
 
 
 
 
 
 
 
GAAP research and development expenses
$
1,312

 
$
1,182

 
$
4,116

 
$
3,737

Adjustments to research and development expenses:
 
 
 
 
 
 
 
Acquisition-related expenses (a)
(25
)
 
(19
)
 
(87
)
 
(78
)
Certain net charges pursuant to our restructuring initiatives
(2
)
 
(1
)
 
(2
)
 
(2
)
Total adjustments to research and development expenses
(27
)
 
(20
)
 
(89
)
 
(80
)
Non-GAAP research and development expenses
$
1,285

 
$
1,162

 
$
4,027

 
$
3,657

 
 
 
 
 
 
 
 
GAAP research and development expenses as a percentage of product sales
22.3
%
 
19.7
%
 
18.5
%
 
16.6
%
Acquisition-related expenses (a)
-0.4

 
-0.3

 
-0.4

 
-0.4

Certain net charges pursuant to our restructuring initiatives
0.0

 
0.0

 
0.0

 
0.0

Non-GAAP research and development expenses as a percentage of product sales
21.9
%
 
19.4
%
 
18.1
%
 
16.2
%
 
 
 
 
 
 
 
 
GAAP selling, general and administrative expenses
$
1,513

 
$
1,559

 
$
5,150

 
$
5,332

Adjustments to selling, general and administrative expenses:
 
 
 
 
 
 
 
Acquisition-related expenses (a)
(12
)
 
(19
)
 
(38
)
 
(84
)
Certain net charges pursuant to our restructuring initiatives

 
(8
)
 
1

 
(16
)
Total adjustments to selling, general and administrative expenses
(12
)
 
(27
)
 
(37
)
 
(100
)
Non-GAAP selling, general and administrative expenses
$
1,501

 
$
1,532

 
$
5,113

 
$
5,232

 
 
 
 
 
 
 
 
GAAP selling, general and administrative expenses as a percentage of product sales
25.7
%
 
26.0
%
 
23.2
%
 
23.7
%
Acquisition-related expenses (a)
-0.2

 
-0.3

 
-0.2

 
-0.4

Certain net charges pursuant to our restructuring initiatives
0.0

 
-0.2

 
0.0

 
-0.1

Non-GAAP selling, general and administrative expenses as a percentage of product sales
25.5
%
 
25.5
%
 
23.0
%
 
23.2
%
 
 
 
 
 
 
 
 
GAAP operating expenses
$
4,149

 
$
3,848

 
$
13,688

 
$
13,484

Adjustments to operating expenses:
 
 
 
 
 
 
 
Adjustments to cost of sales
(463
)
 
(277
)
 
(1,291
)
 
(1,100
)
Adjustments to research and development expenses
(27
)
 
(20
)
 
(89
)
 
(80
)
Adjustments to selling, general and administrative expenses
(12
)
 
(27
)
 
(37
)
 
(100
)
Certain net charges pursuant to our restructuring initiatives
(46
)
 
(1
)
 
(44
)
 
7

Certain other expenses

 

 

 
(25
)
Acquisition-related adjustments (b)
(25
)
 
(10
)
 
(22
)
 
(296
)
Total adjustments to operating expenses
(573
)
 
(335
)
 
(1,483
)
 
(1,594
)
Non-GAAP operating expenses
$
3,576

 
$
3,513

 
$
12,205

 
$
11,890

 
 
 
 
 
 
 
 
GAAP operating income
$
2,048

 
$
2,382

 
$
9,674

 
$
10,263

Adjustments to operating expenses
573

 
335

 
1,483

 
1,594

Non-GAAP operating income
$
2,621

 
$
2,717

 
$
11,157

 
$
11,857

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 





AMGEN REPORTS FOURTH QUARTER AND FULL YEAR 2019 FINANCIAL RESULTS
Page 15

 
Three months ended
December 31,
 
Years ended
December 31,
 
2019
 
2018
 
2019
 
2018
GAAP operating income as a percentage of product sales
34.8
%
 
39.7
%
 
43.6
%
 
45.5
%
Adjustments to cost of sales
7.9

 
4.7

 
5.8

 
4.9

Adjustments to research and development expenses
0.4

 
0.3

 
0.4

 
0.4

Adjustments to selling, general and administrative expenses
0.2

 
0.5

 
0.2

 
0.5

Certain net charges pursuant to our restructuring initiatives
0.8

 
0.0

 
0.2

 
0.0

Certain other expenses
0.0

 
0.0

 
0.0

 
0.0

Acquisition-related adjustments (b)
0.5

 
0.1

 
0.0

 
1.3

Non-GAAP operating income as a percentage of product sales
44.6
%
 
45.3
%
 
50.2
%
 
52.6
%
 
 
 
 
 
 
 
 
GAAP interest and other income, net
$
236

 
$
155

 
$
753

 
$
674

Adjustments to other income (c)

 

 

 
(68
)
Non-GAAP interest and other income, net
$
236

 
$
155

 
$
753

 
$
606

 
 
 
 
 
 
 
 
GAAP income before income taxes
$
1,983

 
$
2,185

 
$
9,138

 
$
9,545

Adjustments to operating expenses
573

 
335

 
1,483

 
1,594

Adjustments to other income (c)

 

 

 
(68
)
Non-GAAP income before income taxes
$
2,556

 
$
2,520

 
$
10,621

 
$
11,071

 
 
 
 
 
 
 
 
GAAP provision for income taxes
$
280

 
$
257

 
$
1,296

 
$
1,151

Adjustments to provision for income taxes:
 
 
 
 
 
 
 
Income tax effect of the above adjustments (d)
99

 
77

 
329

 
362

Other income tax adjustments (e)
3

 

 
(32
)
 
(15
)
Total adjustments to provision for income taxes
102

 
77

 
297

 
347

Non-GAAP provision for income taxes
$
382

 
$
334

 
$
1,593

 
$
1,498

 
 
 
 
 
 
 
 
GAAP tax as a percentage of income before taxes
14.1
%
 
11.8
%
 
14.2
%
 
12.1
%
Adjustments to provision for income taxes:
 
 
 
 
 
 
 
Income tax effect of the above adjustments (d)
0.7

 
1.5

 
1.1

 
1.6

Other income tax adjustments (e)
0.1

 
0.0

 
-0.3

 
-0.2

Total adjustments to provision for income taxes
0.8

 
1.5

 
0.8

 
1.4

Non-GAAP tax as a percentage of income before taxes
14.9
%
 
13.3
%
 
15.0
%
 
13.5
%
 
 
 
 
 
 
 
 
GAAP net income
$
1,703

 
$
1,928

 
$
7,842

 
$
8,394

Adjustments to net income:
 
 
 
 
 
 
 
Adjustments to income before income taxes, net of the income tax effect
474

 
258

 
1,154

 
1,164

Other income tax adjustments (e)
(3
)
 

 
32

 
15

Total adjustments to net income
471

 
258

 
1,186

 
1,179

Non-GAAP net income
$
2,174

 
$
2,186

 
$
9,028

 
$
9,573

 
 
 
 
 
 
 
 






AMGEN REPORTS FOURTH QUARTER AND FULL YEAR 2019 FINANCIAL RESULTS
Page 16

Amgen Inc.
GAAP to Non-GAAP Reconciliations
(In millions, except per-share data)
(Unaudited)

The following table presents the computations for GAAP and non-GAAP diluted earnings per share:

 
Three months ended
December 31, 2019
 
Three months ended
December 31, 2018
 
GAAP
 
Non-GAAP
 
GAAP
 
Non-GAAP
Net income
$
1,703

 
$
2,174

 
$
1,928

 
$
2,186

 
 
 
 
 
 
 
 
Weighted-average shares for diluted EPS
598

 
598

 
640

 
640

 
 
 
 
 
 
 
 
Diluted EPS
$
2.85

 
$
3.64

 
$
3.01

 
$
3.42

 
 
 
 
 
 
 
 
 
Year ended
December 31, 2019
 
Year ended
December 31, 2018
 
GAAP
 
Non-GAAP
 
GAAP
 
Non-GAAP
Net income
$
7,842

 
$
9,028

 
$
8,394

 
$
9,573

 
 
 
 
 
 
 
 
Weighted-average shares for diluted EPS
609

 
609

 
665

 
665

 
 
 
 
 
 
 
 
Diluted EPS
$
12.88

 
$
14.82

 
$
12.62

 
$
14.40


(a)
 
The adjustments related primarily to noncash amortization of intangible assets acquired in business combinations.
 
 
 
(b)
 
For the year ended December 31, 2018, the adjustment related primarily to an impairment charge associated with a nonkey in-process research and development asset.
 
 
 
(c)
 
For the year ended December 31, 2018, the adjustment related to the net gain associated with the Kirin-Amgen, Inc., share acquisition.
 
 
 
(d)
 
The tax effect of the adjustments between our GAAP and non-GAAP results takes into account the tax treatment and related tax rate(s) that apply to each adjustment in the applicable tax jurisdiction(s). Generally, this results in a tax impact at the U.S. marginal tax rate for certain adjustments, including the majority of amortization of intangible assets, whereas the tax impact of other adjustments, including restructuring initiatives, depends on whether the amounts are deductible in the respective tax jurisdictions and the applicable tax rate(s) in those jurisdictions. Due to these factors, the effective tax rates for the adjustments to our GAAP income before income taxes, for the three months and year ended December 31, 2019, were 17.3% and 22.2%, compared with 23.0% and 23.7% for the corresponding periods of the prior year.
 
 
 
(e)
 
The adjustments related primarily to certain acquisition items and prior-period items excluded from GAAP earnings.
 
 
 







AMGEN REPORTS FOURTH QUARTER AND FULL YEAR 2019 FINANCIAL RESULTS
Page 17

Amgen Inc.
Reconciliations of Cash Flows
(In millions)
(Unaudited)


 
Three months ended
December 31,
 
Years ended
December 31,
 
2019
 
2018
 
2019
 
2018
Net cash provided by operating activities
$
2,514

 
$
3,194

 
$
9,150

 
$
11,296

Net cash (used in) provided by investing activities
(5,963
)
 
(4,637
)
 
5,709

 
14,339

Net cash used in financing activities
(1,929
)
 
(3,568
)
 
(15,767
)
 
(22,490
)
(Decrease) increase in cash and cash equivalents
(5,378
)
 
(5,011
)
 
(908
)
 
3,145

Cash and cash equivalents at beginning of period
11,415

 
11,956

 
6,945

 
3,800

Cash and cash equivalents at end of period
$
6,037

 
$
6,945

 
$
6,037

 
$
6,945

 
 
 
 
 
Three months ended
December 31,
 
Years ended
December 31,
 
2019
 
2018
 
2019
 
2018
Net cash provided by operating activities
$
2,514

 
$
3,194

 
$
9,150

 
$
11,296

Capital expenditures
(188
)
 
(225
)
 
(618
)
 
(738
)
Free cash flow
$
2,326

 
$
2,969

 
$
8,532

 
$
10,558







AMGEN REPORTS FOURTH QUARTER AND FULL YEAR 2019 FINANCIAL RESULTS
Page 18

Amgen Inc.
Reconciliation of GAAP EPS Guidance to Non-GAAP
EPS Guidance for the Year Ending December 31, 2020
(Unaudited)


GAAP diluted EPS guidance
 
$
10.85


$
11.65

Known adjustments to arrive at non-GAAP*:
 
 
 
 
Acquisition-related expenses (a)
 
3.95


4.00

Non-GAAP diluted EPS guidance
 
$
14.85


$
15.60


* The known adjustments are presented net of their related tax impact, which amount to approximately $1.10 to $1.11 per share.

(a) The adjustments relate primarily to noncash amortization of intangible assets acquired in business combinations.

Our GAAP diluted EPS guidance does not include the effect of GAAP adjustments triggered by events that may occur subsequent to this press release such as acquisitions, asset impairments, litigation and changes in the fair value or our contingent consideration.

Reconciliation of GAAP Tax Rate Guidance to Non-GAAP
Tax Rate Guidance for the Year Ending December 31, 2020
(Unaudited)

GAAP tax rate guidance
 
10.5
%

11.5
%
Tax rate of known adjustments discussed above
 
 
3
%
 
Non-GAAP diluted EPS guidance
 
13.5
%

14.5
%