THOUSAND OAKS, Calif.,
Jan. 30, 2020 /PRNewswire/ -- 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."
$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.
- 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.
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®.
|
$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.
- 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
|
|
|
|
|
|
|
|
$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%)
|
|
$
|
—
|
|
|
$
|
—
|
|
|
0.0%
|
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
|
|
|
|
|
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.
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.
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.
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 in
support of 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
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
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
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
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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
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
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
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%
|
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SOURCE Amgen