THOUSAND OAKS, Calif.,
Feb. 2, 2017 /PRNewswire/
-- Amgen (NASDAQ:AMGN) today announced financial results for
the fourth quarter and full year of 2016. Key results include:
- For the fourth quarter, total revenues increased 8 percent
versus the fourth quarter of 2015 to $6.0
billion.
- Product sales grew 6 percent driven by Enbrel®
(etanercept), Prolia® (denosumab), Repatha®
(evolocumab) and KYPROLIS® (carfilzomib).
- For the full year, total revenues increased 6 percent to
$23.0 billion, with 5 percent product
sales growth.
- GAAP earnings per share (EPS) increased 9 percent in the fourth
quarter to $2.59 and 13 percent for
the full year to $10.24, driven by
higher revenues and higher operating margins.
- GAAP operating income increased 22 percent in the fourth
quarter to $2.5 billion and 16
percent for the full year to $9.8
billion.
- Non-GAAP EPS increased 11 percent in the fourth quarter to
$2.89 and 12 percent for the full
year to $11.65, driven by higher
revenues and higher operating margins.
- Non-GAAP operating income increased 21 percent in the fourth
quarter to $2.9 billion and 14
percent for the full year to $11.4
billion.
- 2017 total revenues guidance of $22.3-$23.1 billion; EPS guidance of $10.45-$11.31 on a GAAP basis and $11.80-$12.60 on a non-GAAP basis.
- The Company generated $9.6
billion of free cash flow for the full year versus
$9.1 billion in 2015 driven by higher
net income.
"We finished the year with strong operating performance,"
said Robert A. Bradway, chairman and
chief executive officer. "We anticipate several new product
development opportunities and launches in 2017, and are excited
about the Repatha cardiovascular outcomes data we released today.
We have established a firm foundation for longer-term
growth."
$Millions, except EPS
and percentages
|
|
Q4'16
|
|
Q4'15
|
|
YOY
Δ
|
|
FY
'16
|
|
FY
'15
|
|
YOY
Δ
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
Revenues
|
|
$ 5,965
|
|
$ 5,536
|
|
8%
|
|
$ 22,991
|
|
$ 21,662
|
|
6%
|
GAAP Operating
Income
|
|
$ 2,485
|
|
$ 2,033
|
|
22%
|
|
$
9,794
|
|
$
8,470
|
|
16%
|
GAAP Net
Income
|
|
$ 1,935
|
|
$ 1,800
|
|
8%
|
|
$
7,722
|
|
$
6,939
|
|
11%
|
GAAP EPS
|
|
$
2.59
|
|
$
2.37
|
|
9%
|
|
$
10.24
|
|
$
9.06
|
|
13%
|
Non-GAAP Operating
Income
|
|
$ 2,859
|
|
$ 2,366
|
|
21%
|
|
$ 11,446
|
|
$ 10,052
|
|
14%
|
Non-GAAP Net
Income
|
|
$ 2,160
|
|
$ 1,985
|
|
9%
|
|
$
8,785
|
|
$
7,954
|
|
10%
|
Non-GAAP
EPS
|
|
$
2.89
|
|
$
2.61
|
|
11%
|
|
$
11.65
|
|
$
10.38
|
|
12%
|
|
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 increased 6 percent for the fourth
quarter of 2016 versus the fourth quarter of 2015. The increase was
driven primarily by ENBREL, Prolia, Repatha and KYPROLIS. Product
sales increased 5 percent for the full year.
- ENBREL sales increased 14 percent for the fourth quarter
driven by net selling price and favorable changes in inventory
levels, offset partially by the impact of competition. Sales
increased 11 percent for the full year driven by net selling price,
offset partially by the impact of competition.
- Neulasta® (pegfilgrastim) sales decreased 3
percent for the fourth quarter and 1 percent for the full year
driven by lower unit demand.
- Aranesp® (darbepoetin alfa) sales increased 5
percent for the fourth quarter and 7 percent for the full year
driven by higher unit demand due to a shift by some U.S. dialysis
customers from EPOGEN® (epoetin alfa) to Aranesp, offset
partially by unfavorable changes in net selling price.
- Prolia sales increased 22 percent for the fourth quarter
and 25 percent for the full year driven by higher unit demand.
- Sensipar/Mimpara® (cinacalcet) sales
increased 7 percent for the fourth quarter driven by net selling
price. Sales increased 12 percent for the full year driven by net
selling price and higher unit demand.
- XGEVA® (denosumab) sales increased 6 percent
for the fourth quarter and 9 percent for the full year driven by
higher unit demand.
- EPOGEN sales decreased 8 percent for the fourth quarter
and 31 percent for the full year driven by the impact of
competition and a shift by some U.S. dialysis customers to
Aranesp.
- KYPROLIS sales increased 24 percent for the fourth
quarter and 35 percent for the full year driven by higher unit
demand.
- NEUPOGEN® (filgrastim) sales decreased 34
percent for the fourth quarter and 27 percent for the full year
driven primarily by the impact of competition in the U.S.
- Nplate® (romiplostim) sales increased 9
percent for the fourth quarter and 11 percent for the full year
driven by higher unit demand.
- Vectibix® (panitumumab) sales increased 6
percent for the fourth quarter and 11 percent for the full year
driven by higher unit demand.
- Repatha sales growth for the fourth quarter and full
year was driven by higher unit demand.
- BLINCYTO® (blinatumomab) sales increased 32
percent for the fourth quarter and 49 percent for the full year
driven by higher unit demand.
Product Sales
Detail by Product and Geographic Region
|
|
|
|
|
|
|
|
|
|
$Millions, except
percentages
|
|
Q4'16
|
|
Q4'15
|
|
YOY
Δ
|
|
|
US
|
ROW
|
TOTAL
|
|
TOTAL
|
|
TOTAL
|
|
|
|
|
|
|
|
|
|
Enbrel®
|
|
$1,582
|
$62
|
$1,644
|
|
$1,441
|
|
14%
|
Neulasta®
|
|
943
|
173
|
1,116
|
|
1,156
|
|
(3%)
|
Aranesp®
|
|
286
|
240
|
526
|
|
499
|
|
5%
|
Prolia®
|
|
293
|
170
|
463
|
|
380
|
|
22%
|
Sensipar®
/ Mimpara®
|
|
330
|
81
|
411
|
|
384
|
|
7%
|
XGEVA®
|
|
273
|
103
|
376
|
|
356
|
|
6%
|
EPOGEN®
|
|
316
|
0
|
316
|
|
342
|
|
(8%)
|
KYPROLIS®
|
|
143
|
40
|
183
|
|
148
|
|
24%
|
NEUPOGEN®
|
|
116
|
57
|
173
|
|
263
|
|
(34%)
|
Nplate®
|
|
88
|
62
|
150
|
|
137
|
|
9%
|
Vectibix®
|
|
57
|
86
|
143
|
|
135
|
|
6%
|
Repatha®
|
36
|
22
|
58
|
|
7
|
|
*
|
BLINCYTO®
|
24
|
5
|
29
|
|
22
|
|
32%
|
Other**
|
|
19
|
56
|
75
|
|
59
|
|
27%
|
|
|
|
|
|
|
|
|
|
Total product
sales
|
|
$4,506
|
$1,157
|
$5,663
|
|
$5,329
|
|
6%
|
|
|
|
|
|
|
|
|
|
* Change in excess of
100%
|
|
|
|
|
** Other includes MN
Pharma, Bergamo, IMLYGIC®and
Corlanor®
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$Millions, except
percentages
|
|
FY
'16
|
|
FY
'15
|
|
YOY
Δ
|
|
|
US
|
ROW
|
TOTAL
|
|
TOTAL
|
|
TOTAL
|
|
|
|
|
|
|
|
|
|
Enbrel®
|
|
$5,719
|
$246
|
$5,965
|
|
$5,364
|
|
11%
|
Neulasta®
|
|
3,925
|
723
|
4,648
|
|
4,715
|
|
(1%)
|
Aranesp®
|
|
1,082
|
1,011
|
2,093
|
|
1,951
|
|
7%
|
Prolia®
|
|
1,049
|
586
|
1,635
|
|
1,312
|
|
25%
|
Sensipar®
/ Mimpara®
|
|
1,240
|
342
|
1,582
|
|
1,415
|
|
12%
|
XGEVA®
|
|
1,115
|
414
|
1,529
|
|
1,405
|
|
9%
|
EPOGEN®
|
|
1,282
|
0
|
1,282
|
|
1,856
|
|
(31%)
|
NEUPOGEN®
|
|
534
|
231
|
765
|
|
1,049
|
|
(27%)
|
KYPROLIS®
|
|
554
|
138
|
692
|
|
512
|
|
35%
|
Vectibix®
|
|
229
|
382
|
611
|
|
549
|
|
11%
|
Nplate®
|
|
350
|
234
|
584
|
|
525
|
|
11%
|
Repatha®
|
|
101
|
40
|
141
|
|
10
|
|
*
|
BLINCYTO®
|
|
85
|
30
|
115
|
|
77
|
|
49%
|
Other**
|
|
60
|
190
|
250
|
|
204
|
|
23%
|
|
|
|
|
|
|
|
|
|
Total product
sales
|
|
$17,325
|
$4,567
|
$21,892
|
|
$20,944
|
|
5%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
* Change in excess of
100%
|
|
|
|
** Other includes MN
Pharma, Bergamo, IMLYGIC®and
Corlanor®
|
|
Operating Expense, Operating Margin and Tax Rate
Analysis
On a GAAP basis:
- Total Operating Expenses decreased 1 percent in the
fourth quarter and were flat for the full year, with all expense
categories reflecting savings from our transformation and process
improvement efforts. Cost of Sales margin improved by 1.3
percentage points in the fourth quarter and 1.2 percentage points
for the full year driven primarily by manufacturing efficiencies.
Research & Development (R&D) expenses were flat for
the fourth quarter. For the full year, R&D expenses decreased 6
percent driven primarily by lower spending required to support
certain later-stage clinical programs and transformation and
process improvement efforts, offset partially by external business
development activities. Selling, General & Administrative
(SG&A) expenses decreased 7 percent in the fourth quarter
due to the Oct. 31, 2016, expiration
of ENBREL residual royalty payments. For the full year, SG&A
expenses increased 4 percent driven primarily by investments in new
product launches, offset partially by the expiration of ENBREL
residual royalty payments. Other expenses increased in the
fourth quarter and for the full year as the prior year periods
included gains from the sale of assets related to our site
closures.
- Operating Margin improved by 5.8 percentage points in
the fourth quarter to 43.9 percent, and 4.3 percentage points for
the full year to 44.7 percent.
- Tax Rate for the fourth quarter increased 9.3 percentage
points driven primarily by changes in the geographic mix of
earnings and the discrete impact of the enactment of the federal
R&D credit in the fourth quarter of 2015. The full year tax
rate increased 2.7 percentage points driven by changes in the
geographic mix of earnings, offset partially by the benefit of
adopting Accounting Standards Update 2016-09, Improvements to
Employee Share-Based Payment Accounting (ASU 2016-09).
On a non-GAAP basis:
- Total Operating Expenses decreased 2 percent in the
fourth quarter and 1 percent for the full year, with all expense
categories reflecting savings from our transformation and process
improvement efforts. Cost of Sales margin improved by 1.0
percentage points in the fourth quarter and 1.2 percentage points
for the full year driven primarily by manufacturing efficiencies.
R&D expenses were flat in the fourth quarter. For the full
year, R&D expenses decreased 4 percent driven primarily
by lower spending required to support certain later-stage clinical
programs and transformation and process improvement efforts, offset
partially by external business development activities. SG&A
expenses decreased 4 percent in the fourth quarter due to the
Oct. 31, 2016, expiration of ENBREL
residual royalty payments. For the full year, SG&A
expenses increased 5 percent driven primarily by investments in new
product launches, offset partially by the expiration of ENBREL
residual royalty payments.
- Operating Margin improved by 6.1 percentage points in
the fourth quarter to 50.5 percent, and 4.3 percentage points for
the year to 52.3 percent.
- Tax Rate for the fourth quarter increased 7.1 percentage
points driven primarily by changes in the geographic mix of
earnings and the discrete impact of the enactment of the federal
R&D credit in the fourth quarter of 2015. The full year tax
rate increased 2.0 percentage points driven by changes in the
geographic mix of earnings, offset partially by the benefit of
adopting ASU 2016-09.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$Millions, except
percentages
|
|
|
|
|
|
|
|
|
|
|
|
|
GAAP
|
|
Non-GAAP
|
|
|
|
|
Q4'16
|
|
Q4'15
|
|
YOY
Δ
|
|
Q4'16
|
|
Q4'15
|
|
YOY
Δ
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of
Sales
|
$1,067
|
|
$1,071
|
|
(0%)
|
|
$753
|
|
$764
|
|
(1%)
|
|
|
% of product
sales
|
18.8%
|
|
20.1%
|
|
(1.3) pts
|
|
13.3%
|
|
14.3%
|
|
(1) pts
|
Research &
Development
|
$1,078
|
|
$1,093
|
|
(1%)
|
|
$1,056
|
|
$1,057
|
|
0%
|
|
|
% of product
sales
|
19.0%
|
|
20.5%
|
|
(1.5) pts
|
|
18.6%
|
|
19.8%
|
|
(1.2) pts
|
Selling, General
& Administrative
|
$1,323
|
|
$1,416
|
|
(7%)
|
|
$1,297
|
|
$1,349
|
|
(4%)
|
|
|
% of product
sales
|
23.4%
|
|
26.6%
|
|
(3.2) pts
|
|
22.9%
|
|
25.3%
|
|
(2.4) pts
|
Other
|
$12
|
|
($77)
|
|
*
|
|
$0
|
|
$0
|
|
0%
|
TOTAL Operating
Expenses
|
$3,480
|
|
$3,503
|
|
(1%)
|
|
$3,106
|
|
$3,170
|
|
(2%)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
Margin
|
|
|
|
|
|
|
|
|
|
|
|
|
|
operating income as a
% of product sales
|
43.9%
|
|
38.1%
|
|
5.8 pts
|
|
50.5%
|
|
44.4%
|
|
6.1 pts
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Tax
Rate
|
15.2%
|
|
5.9%
|
|
9.3
pts
|
|
18.7%
|
|
11.6%
|
|
7.1
pts
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
* Change in excess of
100%
|
|
|
|
|
|
|
|
|
|
|
pts: percentage
points
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$Millions, except
percentages
|
|
|
|
|
|
|
|
|
|
|
|
GAAP
|
|
Non-GAAP
|
|
|
|
|
FY
'16
|
|
FY
'15
|
|
YOY
Δ
|
|
FY
'16
|
|
FY
'15
|
|
YOY
Δ
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of
Sales
|
$4,162
|
|
$4,227
|
|
(2%)
|
|
$2,913
|
|
$3,033
|
|
(4%)
|
|
|
% of product
sales
|
19.0%
|
|
20.2%
|
|
(1.2) pts
|
|
13.3%
|
|
14.5%
|
|
(1.2) pts
|
Research &
Development
|
$3,840
|
|
$4,070
|
|
(6%)
|
|
$3,755
|
|
$3,917
|
|
(4%)
|
|
|
% of product
sales
|
17.5%
|
|
19.4%
|
|
(1.9) pts
|
|
17.2%
|
|
18.7%
|
|
(1.5) pts
|
Selling, General
& Administrative
|
$5,062
|
|
$4,846
|
|
4%
|
|
$4,877
|
|
$4,660
|
|
5%
|
|
|
% of product
sales
|
23.1%
|
|
23.1%
|
|
0 pts
|
|
22.3%
|
|
22.2%
|
|
0.1 pts
|
Other
|
$133
|
|
$49
|
|
*
|
|
$0
|
|
$0
|
|
0%
|
TOTAL Operating
Expenses
|
$13,197
|
|
$13,192
|
|
0%
|
|
$11,545
|
|
$11,610
|
|
(1%)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
Margin
|
|
|
|
|
|
|
|
|
|
|
|
|
|
operating income as a
% of product sales
|
44.7%
|
|
40.4%
|
|
4.3 pts
|
|
52.3%
|
|
48.0%
|
|
4.3 pts
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Tax
Rate
|
15.7%
|
|
13.0%
|
|
2.7
pts
|
|
18.8%
|
|
16.8%
|
|
2
pts
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
* Change in excess of
100%
|
|
|
|
|
|
|
|
|
|
|
pts: percentage
points
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash Flow and Balance Sheet
- The Company generated $2.9
billion of free cash flow in the fourth quarter of 2016
versus $1.9 billion in the fourth
quarter of 2015 due primarily to the timing of tax and other
payments, as well as higher net income. The Company generated
$9.6 billion of free cash flow in
2016 versus $9.1 billion in 2015 due
to higher net income.
- The Company's first quarter 2017 dividend of $1.15 per share declared on Dec. 20, 2016, will be paid on March 8, 2017, to all stockholders of record as
of Feb. 15, 2017. This represents a
15 percent increase from that paid in each of the previous four
quarters.
- During the fourth quarter, the Company repurchased 6.7 million
shares of common stock at a total cost of $1.0 billion. For the full year, the Company
repurchased 19.7 million shares of common stock at a total cost of
$3.0 billion. At the end of 2016, the
Company had $4.1 billion remaining
under its stock repurchase authorization.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$Billions, except
shares
|
Q4'16
|
|
Q4'15
|
|
YOY
Δ
|
|
FY
'16
|
|
FY
'15
|
|
YOY
Δ
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating Cash
Flow
|
$3.1
|
|
$2.1
|
|
$1.0
|
|
$10.4
|
|
$9.7
|
|
$0.6
|
Capital
Expenditures
|
0.2
|
|
0.2
|
|
0.0
|
|
0.7
|
|
0.6
|
|
0.1
|
Free Cash
Flow
|
2.9
|
|
1.9
|
|
1.0
|
|
9.6
|
|
9.1
|
|
0.5
|
Dividends
Paid
|
0.7
|
|
0.6
|
|
0.2
|
|
3.0
|
|
2.4
|
|
0.6
|
Share
Repurchase
|
1.0
|
|
0.2
|
|
0.8
|
|
3.0
|
|
1.9
|
|
1.1
|
Avg. Diluted Shares
(millions)
|
748
|
|
761
|
|
(13)
|
|
754
|
|
766
|
|
(12)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and
Investments
|
38.1
|
|
31.4
|
|
6.7
|
|
38.1
|
|
31.4
|
|
6.7
|
Debt
Outstanding
|
34.6
|
|
31.4
|
|
3.2
|
|
34.6
|
|
31.4
|
|
3.2
|
Stockholders'
Equity
|
29.9
|
|
28.1
|
|
1.8
|
|
29.9
|
|
28.1
|
|
1.8
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Note: Numbers may not
add due to rounding
|
|
|
|
|
|
|
2017 Guidance
For the full year 2017, the Company expects:
- Total revenues in the range of $22.3 billion to $23.1 billion.
- On a GAAP basis, EPS in the range of $10.45 to $11.31 and a tax rate in the
range of 16 percent to 18 percent.
- On a non-GAAP basis, EPS in the range of $11.80 to $12.60 and a tax rate in the
range of 18.5 percent to 19.5 percent.
- Capital expenditures to be approximately $700 million.
- Share repurchases of approximately $2.5 billion to $3.5 billion.
Fourth Quarter
Product and Pipeline Update
|
Key development
milestones:
|
|
|
|
Clinical
Program
|
Indication
|
Projected
Milestone
|
Repatha
|
Hyperlipidemia
|
Phase 3 CV outcomes
data presentation Q1 2017*
|
KYPROLIS
|
Relapsed or
refractory
multiple myeloma
|
Phase 3 study
initiation with DARZALEX®
|
XGEVA
|
Prevention of SREs
in
multiple myeloma
|
Global regulatory
submissions
|
BLINCYTO
|
Diffuse large
B-cell
lymphoma
|
Phase 2/3 study
initiations
|
EVENITY™
(romosozumab)†
|
Postmenopausal
osteoporosis
|
U.S. regulatory
review
Active controlled
Phase 3 fracture data Q2 2017*
|
Erenumab (AMG
334)
|
Migraine
prophylaxis
|
Global regulatory
submissions
|
Parsabiv™
(etelcalcetide)†
|
Secondary
hyperparathyroidism
|
U.S. regulatory
review
|
ABP 215
(biosimilar
bevacizumab)
|
Oncology
|
Global regulatory
reviews
|
ABP 501
(biosimilar
adalimumab)
|
Inflammatory
diseases
|
Ex-U.S. regulatory
reviews
|
ABP 980
(biosimilar
trastuzumab)
|
Breast
cancer
|
Global regulatory
submissions
|
*Event driven study; †Trade name
provisionally approved by FDA; CV = cardiovascular; SRE
=
skeletal-related event
The Company provided the following updates on selected product
and pipeline programs:
Repatha
- In December, the Committee for Medicinal Products for Human Use
(CHMP) of the European Medicines Agency (EMA) adopted a positive
opinion for an extension to the marketing authorization of a new
420 mg single-dose delivery option.
- Data from a Phase 3 study evaluating the effects of Repatha on
cardiovascular outcomes that met its primary composite endpoint and
key secondary composite endpoint will be presented at the American
College of Cardiology 66th Annual Scientific Session on
March 17.
Omecamtiv mecarbil
- Enrollment of the Phase 3 cardiovascular outcomes study in
chronic heart failure patients commenced in Q1 2017.
KYPROLIS
- The primary endpoint in a Phase 3 study of once weekly KYPROLIS
administration in relapsed and refractory multiple myeloma patients
(ARROW) has been modified from overall response rate to
progression-free survival, an event driven endpoint, with results
expected in 2019.
- In November, a collaboration was established with Janssen
Biotech, Inc. (Janssen) to evaluate the combination of KYPROLIS and
Janssen's DARZALEX® (daratumumab) in multiple clinical
studies in patients with multiple myeloma.
- A Phase 3 registrational study evaluating KYPROLIS in
combination with DARZALEX and dexamethasone compared to KYPROLIS
and dexamethasone alone in patients with multiple myeloma who have
had one, two or three prior lines of therapy is anticipated to
begin enrollment in Q2 2017.
XGEVA
- Regulatory submissions for the prevention of skeletal-related
events in multiple myeloma patients are expected in 2017.
BLINCYTO
- Regulatory submissions for Philadelphia chromosome-positive relapsed or
refractory (R/R) B-cell precursor acute lymphoblastic leukemia
(ALL) are expected in 2017. BLINCYTO is currently approved
for the treatment of adult and pediatric patients with Philadelphia chromosome-negative R/R B-cell
precursor ALL.
- Phase 2/3 studies in patients with diffuse large B-cell
lymphoma will enroll patients in 2017.
EVENITY™ (romosozumab)
- In December, an application for marketing approval for the
treatment of osteoporosis for men and women at high risk for
fracture was submitted to the Pharmaceuticals and Medical Devices
Agency in Japan. This follows the postmenopausal osteoporosis
U.S. filing in 2016 with a U.S. Food and Drug Administration (FDA)
Prescription Drug User Fee Act (PDUFA) target action date of
July 19, 2017.
- Primary results from an event driven active controlled Phase 3
fracture study (ARCH) in postmenopausal women with osteoporosis are
expected in Q2 2017.
Erenumab
- In November, a second Phase 3 study met its primary endpoint,
demonstrating statistically significant reductions from baseline in
monthly migraine days in patients with episodic migraine treated
with either 70 mg or 140 mg erenumab compared with placebo.
- Regulatory submissions for the prevention of episodic and
chronic migraine are expected in Q2 2017.
CNP520
- In December, FDA granted fast track designation to CNP520, a
small molecule beta-site amyloid precursor protein-cleaving
enzyme-1 (BACE) inhibitor for the potential treatment of
Alzheimer's disease.
Parsabiv
- FDA has set a Feb. 9, 2017, PDUFA
target action date for the review of Parsabiv for the treatment of
secondary hyperparathyroidism (sHPT) in adult patients with chronic
kidney disease (CKD) on hemodialysis.
- In November, the EMA granted marketing authorization for the
treatment of sHPT in adult patients with CKD on hemodialysis.
ENBREL
- In November, FDA approved the supplemental Biologics License
Application (BLA) for the expanded use to treat pediatric patients
(ages 4-17) with chronic moderate-to-severe plaque psoriasis.
ABP 215 (biosimilar bevacizumab)
- In January 2017, a BLA was
accepted by FDA with a Sept. 14,
2017, Biosimilar User Fee target action date.
- In December, a Marketing Authorization Application was
submitted to the EMA.
ABP 501 (biosimilar adalimumab)
- In January 2017, the CHMP adopted
a positive opinion for the Marketing Authorization of ABP 501,
recommending approval for all available indications. ABP 501 has
been recommended for approval for the treatment of certain
inflammatory diseases in adults, including moderate-to-severe
rheumatoid arthritis, psoriatic arthritis, severe ankylosing
spondylitis (AS), severe axial spondyloarthritis without
radiographic evidence of AS, moderate-to-severe chronic plaque
psoriasis, moderate-to-severe hidradenitis suppurativa,
non-infectious intermediate, posterior and panuveitis,
moderate-to-severe Crohn's disease and moderate-to-severe
ulcerative colitis. The CHMP opinion also recommends approval for
the treatment of certain pediatric inflammatory diseases, including
moderate-to-severe Crohn's disease (ages six and older), severe
chronic plaque psoriasis (ages four and older), enthesitis-related
arthritis (ages six and older) and polyarticular juvenile
idiopathic arthritis (ages two and older).
Erenumab and CNP520 are developed in collaboration with
Novartis AG
Omecamtiv mecarbil is developed in
collaboration with Cytokinetics and in an alliance with Servier for
certain territories.
EVENITY™ is developed in
collaboration with UCB globally, as well as our joint venture
partner Astellas in Japan
DARZALEX® is a
registered trademark of Janssen Biotech, Inc.
Non-GAAP Financial Measures
In this news release,
management has presented its operating results for the fourth
quarters and full years of 2016 and 2015, in accordance with U.S.
Generally Accepted Accounting Principles (GAAP) and on a non-GAAP
basis. In addition, management has presented its full year 2017 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 2016 and 2015. 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 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 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 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 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. 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 cannot be
guaranteed and movement from concept to product is uncertain;
consequently, there can be no guarantee that any particular product
candidate 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 acquire other
companies or products and to integrate the operations of companies
we have acquired may not be successful. We may not be able to
access the capital and credit markets on terms that are favorable
to us, or at all. We are increasingly dependent on information
technology systems, infrastructure and data security. 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.
Amgen
Inc.
|
|
|
|
|
|
|
|
|
Consolidated
Statements of Income - GAAP
|
|
|
|
|
|
(In millions,
except per share data)
|
|
|
|
|
|
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months
ended
|
|
Years
ended
|
|
|
|
|
December
31,
|
|
December
31,
|
|
|
|
|
2016
|
|
2015
|
|
2016
|
|
2015
|
Revenues:
|
|
|
|
|
|
|
|
|
|
Product
sales
|
|
$
5,663
|
|
$
5,329
|
|
$
21,892
|
|
$
20,944
|
|
Other
revenues
|
|
302
|
|
207
|
|
1,099
|
|
718
|
|
|
Total
revenues
|
|
5,965
|
|
5,536
|
|
22,991
|
|
21,662
|
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
|
Cost of
sales
|
|
1,067
|
|
1,071
|
|
4,162
|
|
4,227
|
|
Research and
development
|
|
1,078
|
|
1,093
|
|
3,840
|
|
4,070
|
|
Selling, general and
administrative
|
|
1,323
|
|
1,416
|
|
5,062
|
|
4,846
|
|
Other
|
|
12
|
|
(77)
|
|
133
|
|
49
|
|
|
Total operating
expenses
|
|
3,480
|
|
3,503
|
|
13,197
|
|
13,192
|
|
|
|
|
|
|
|
|
|
|
|
Operating
income
|
|
2,485
|
|
2,033
|
|
9,794
|
|
8,470
|
|
|
|
|
|
|
|
|
|
|
|
Interest expense,
net
|
|
328
|
|
284
|
|
1,260
|
|
1,095
|
Interest and other
income, net
|
|
126
|
|
164
|
|
629
|
|
603
|
|
|
|
|
|
|
|
|
|
|
|
Income before income
taxes
|
|
2,283
|
|
1,913
|
|
9,163
|
|
7,978
|
|
|
|
|
|
|
|
|
|
|
|
Provision for income
taxes
|
|
348
|
|
113
|
|
1,441
|
|
1,039
|
|
|
|
|
|
|
|
|
|
|
|
Net income
|
|
$
1,935
|
|
$
1,800
|
|
$
7,722
|
|
$
6,939
|
|
|
|
|
|
|
|
|
|
|
|
Earnings per
share:
|
|
|
|
|
|
|
|
|
|
Basic
|
|
$
2.61
|
|
$
2.39
|
|
$
10.32
|
|
$
9.15
|
|
Diluted
|
|
$
2.59
|
|
$
2.37
|
|
$
10.24
|
|
$
9.06
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average
shares used in calculation of earnings per share:
|
|
|
|
|
|
|
Basic
|
|
742
|
|
754
|
|
748
|
|
758
|
|
Diluted
|
|
748
|
|
761
|
|
754
|
|
766
|
Amgen
Inc.
|
Consolidated
Balance Sheets - GAAP
|
|
|
(In
millions)
|
|
|
|
|
|
|
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December
31,
|
|
December
31,
|
|
|
|
|
|
|
|
2016
|
|
2015
|
Assets
|
|
|
|
|
|
|
|
Current
assets:
|
|
|
|
|
|
|
|
Cash, cash
equivalents and marketable securities
|
|
$
38,085
|
|
$
31,382
|
|
Trade receivables,
net
|
|
3,165
|
|
2,995
|
|
Inventories
|
|
2,745
|
|
2,435
|
|
Other current
assets
|
|
2,015
|
|
1,703
|
|
|
|
Total current
assets
|
|
46,010
|
|
38,515
|
Property, plant and
equipment, net
|
|
4,961
|
|
4,907
|
Intangible assets,
net
|
|
10,279
|
|
11,641
|
Goodwill
|
|
14,751
|
|
14,787
|
Other
assets
|
|
1,625
|
|
1,599
|
Total
assets
|
|
$
77,626
|
|
$
71,449
|
|
|
|
|
|
|
|
|
|
|
Liabilities and
Stockholders' Equity
|
|
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
|
|
|
Accounts payable and
accrued liabilities
|
|
$
6,801
|
|
$
6,417
|
|
Current portion of
long-term debt
|
|
4,403
|
|
2,247
|
|
|
|
Total current
liabilities
|
|
11,204
|
|
8,664
|
Long-term
debt
|
|
30,193
|
|
29,182
|
Long-term deferred
tax liability
|
|
2,436
|
|
2,239
|
Long-term tax
liability
|
|
|
|
|
2,419
|
|
1,973
|
Other noncurrent
liabilities
|
|
1,499
|
|
1,308
|
Stockholders'
equity
|
|
29,875
|
|
28,083
|
Total liabilities and
stockholders' equity
|
|
$
77,626
|
|
$
71,449
|
|
|
|
|
|
|
|
|
|
|
Shares
outstanding
|
|
738
|
|
754
|
Amgen
Inc.
|
|
|
|
|
|
|
|
GAAP to Non-GAAP
Reconciliations
|
|
|
|
|
|
|
|
(In
millions)
|
|
|
|
|
|
|
|
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months
ended
|
|
Years
ended
|
|
|
December
31,
|
|
December
31,
|
|
|
2016
|
|
2015
|
|
2016
|
|
2015
|
|
|
|
|
|
|
|
|
|
|
GAAP cost of
sales
|
$1,067
|
|
$
1,071
|
|
$
4,162
|
|
$
4,227
|
|
Adjustments to
cost of sales:
|
|
|
|
|
|
|
|
|
Acquisition-related
expenses (a)
|
(314)
|
|
(297)
|
|
(1,248)
|
|
(1,142)
|
|
Certain net charges
pursuant to our restructuring initiative
|
-
|
|
(10)
|
|
(1)
|
|
(52)
|
|
Total adjustments
to cost of sales
|
(314)
|
|
(307)
|
|
(1,249)
|
|
(1,194)
|
|
Non-GAAP cost of
sales
|
$
753
|
|
$
764
|
|
$
2,913
|
|
$
3,033
|
|
|
|
|
|
|
|
|
|
|
GAAP cost of sales
as a percentage of product sales
|
18.8%
|
|
20.1%
|
|
19.0%
|
|
20.2%
|
|
Acquisition-related
expenses(a)
|
-5.5
|
|
-5.6
|
|
-5.7
|
|
-5.5
|
|
Certain net charges
pursuant to our restructuring initiative
|
0.0
|
|
-0.2
|
|
0.0
|
|
-0.2
|
|
Non-GAAP cost of
sales as a percentage of product sales
|
13.3%
|
|
14.3%
|
|
13.3%
|
|
14.5%
|
|
|
|
|
|
|
|
|
|
|
GAAP research and
development expenses
|
$1,078
|
|
$
1,093
|
|
$
3,840
|
|
$
4,070
|
|
Adjustments to
research and development expenses:
|
|
|
|
|
|
|
|
|
Acquisition-related
expenses (a)
|
(20)
|
|
(20)
|
|
(78)
|
|
(89)
|
|
Certain net charges
pursuant to our restructuring initiative
|
(2)
|
|
(16)
|
|
(7)
|
|
(64)
|
|
Total adjustments
to research and development expenses
|
(22)
|
|
(36)
|
|
(85)
|
|
(153)
|
|
Non-GAAP research
and development expenses
|
$1,056
|
|
$
1,057
|
|
$
3,755
|
|
$
3,917
|
|
|
|
|
|
|
|
|
|
|
GAAP research and
development expenses as a percentage of product
sales
|
19.0%
|
|
20.5%
|
|
17.5%
|
|
19.4%
|
|
Acquisition-related
expenses (a)
|
-0.4
|
|
-0.4
|
|
-0.3
|
|
-0.4
|
|
Certain net charges
pursuant to our restructuring initiative
|
0.0
|
|
-0.3
|
|
0.0
|
|
-0.3
|
|
Non-GAAP research
and development expenses as a percentage of product
sales
|
18.6%
|
|
19.8%
|
|
17.2%
|
|
18.7%
|
|
|
|
|
|
|
|
|
|
|
GAAP selling,
general and administrative expenses
|
$1,323
|
|
$
1,416
|
|
$
5,062
|
|
$
4,846
|
|
Adjustments to
selling, general and administrative expenses:
|
|
|
|
|
|
|
|
|
Acquisition-related
expenses (b)
|
(26)
|
|
(46)
|
|
(180)
|
|
(130)
|
|
Certain net charges
pursuant to our restructuring initiative
|
-
|
|
(21)
|
|
(5)
|
|
(56)
|
|
Total adjustments
to selling, general and administrative expenses
|
(26)
|
|
(67)
|
|
(185)
|
|
(186)
|
|
Non-GAAP selling,
general and administrative expenses
|
$1,297
|
|
$
1,349
|
|
$
4,877
|
|
$
4,660
|
|
|
|
|
|
|
|
|
|
|
GAAP selling,
general and administrative expenses as a percentage of product
sales
|
23.4%
|
|
26.6%
|
|
23.1%
|
|
23.1%
|
|
Acquisition-related
expenses (b)
|
-0.5
|
|
-0.9
|
|
-0.8
|
|
-0.6
|
|
Certain net charges
pursuant to our restructuring initiative
|
0.0
|
|
-0.4
|
|
0.0
|
|
-0.3
|
|
Non-GAAP selling,
general and administrative expenses as a percentage of product
sales
|
22.9%
|
|
25.3%
|
|
22.3%
|
|
22.2%
|
|
|
|
|
|
|
|
|
|
|
GAAP operating
expenses
|
$3,480
|
|
$
3,503
|
|
$13,197
|
|
$
13,192
|
|
Adjustments to
operating expenses:
|
|
|
|
|
|
|
|
|
Adjustments to cost
of sales
|
(314)
|
|
(307)
|
|
(1,249)
|
|
(1,194)
|
|
Adjustments to
research and development expenses
|
(22)
|
|
(36)
|
|
(85)
|
|
(153)
|
|
Adjustments to
selling, general and administrative expenses
|
(26)
|
|
(67)
|
|
(185)
|
|
(186)
|
|
Certain net charges
pursuant to our restructuring initiative (c)
|
(9)
|
|
99
|
|
(24)
|
|
58
|
|
Expense related to
various legal proceedings
|
-
|
|
(18)
|
|
(105)
|
|
(91)
|
|
Acquisition-related
adjustments (d)
|
(3)
|
|
(4)
|
|
(4)
|
|
(16)
|
|
Total adjustments
to operating expenses
|
(374)
|
|
(333)
|
|
(1,652)
|
|
(1,582)
|
|
Non-GAAP operating
expenses
|
$3,106
|
|
$
3,170
|
|
$11,545
|
|
$
11,610
|
|
|
|
|
|
|
|
|
|
|
GAAP operating
income
|
$2,485
|
|
$
2,033
|
|
$
9,794
|
|
$
8,470
|
|
Adjustments to
operating expenses
|
374
|
|
333
|
|
1,652
|
|
1,582
|
|
Non-GAAP operating
income
|
$2,859
|
|
$
2,366
|
|
$11,446
|
|
$
10,052
|
|
|
|
|
|
|
|
|
|
|
GAAP operating
income as a percentage of product sales
|
43.9%
|
|
38.1%
|
|
44.7%
|
|
40.4%
|
|
Adjustments to cost
of sales
|
5.5
|
|
5.8
|
|
5.7
|
|
5.7
|
|
Adjustments to
research and development expenses
|
0.4
|
|
0.7
|
|
0.3
|
|
0.7
|
|
Adjustments to
selling, general and administrative expenses
|
0.5
|
|
1.3
|
|
0.8
|
|
0.9
|
|
Certain net charges
pursuant to our restructuring initiative (c)
|
0.2
|
|
-1.9
|
|
0.2
|
|
-0.3
|
|
Expense related to
various legal proceedings
|
0.0
|
|
0.3
|
|
0.6
|
|
0.4
|
|
Acquisition-related
adjustments(d)
|
0.0
|
|
0.1
|
|
0.0
|
|
0.0
|
|
Non-GAAP operating
income as a percentage of product sales
|
50.5%
|
|
44.4%
|
|
52.3%
|
|
47.8%
|
|
|
|
|
|
|
|
|
|
|
GAAP income before
income taxes
|
$2,283
|
|
$
1,913
|
|
$
9,163
|
|
$
7,978
|
|
Adjustments to
operating expenses
|
374
|
|
333
|
|
1,652
|
|
1,582
|
|
Non-GAAP income
before income taxes
|
$2,657
|
|
$
2,246
|
|
$10,815
|
|
$
9,560
|
|
|
|
|
|
|
|
|
|
|
GAAP provision for
income taxes
|
$
348
|
|
$
113
|
|
$
1,441
|
|
$
1,039
|
|
Adjustments to
provision for income taxes:
|
|
|
|
|
|
|
|
|
Income tax effect of
the above adjustments to operating expenses (e)
|
113
|
|
92
|
|
525
|
|
496
|
|
Other income tax
adjustments (f)
|
36
|
|
56
|
|
64
|
|
71
|
|
Total adjustments
to provision for income taxes
|
149
|
|
148
|
|
589
|
|
567
|
|
Non-GAAP provision
for income taxes
|
$
497
|
|
$
261
|
|
$
2,030
|
|
$
1,606
|
|
|
|
|
|
|
|
|
|
|
GAAP tax rate as a
percentage of income before taxes
|
15.2%
|
|
5.9%
|
|
15.7%
|
|
13.0%
|
|
Adjustments to
provision for income taxes:
|
|
|
|
|
|
|
|
|
Income tax effect of
the above adjustments to operating expenses (e)
|
2.1
|
|
3.2
|
|
2.5
|
|
3.0
|
|
Other income tax
adjustments (f)
|
1.4
|
|
2.5
|
|
0.6
|
|
0.8
|
|
Total adjustments
to provision for income taxes
|
3.5
|
|
5.7
|
|
3.1
|
|
3.8
|
|
Non-GAAP tax rate
as a percentage of income before taxes
|
18.7%
|
|
11.6%
|
|
18.8%
|
|
16.8%
|
|
|
|
|
|
|
|
|
|
|
GAAP net
income
|
$1,935
|
|
$
1,800
|
|
$
7,722
|
|
$
6,939
|
|
Adjustments to net
income:
|
|
|
|
|
|
|
|
|
Adjustments to income
before income taxes, net of the income tax effect
|
261
|
|
241
|
|
1,127
|
|
1,086
|
|
Other income tax
adjustments (f)
|
(36)
|
|
(56)
|
|
(64)
|
|
(71)
|
|
Total adjustments
to net income
|
225
|
|
185
|
|
1,063
|
|
1,015
|
|
Non-GAAP net
income
|
$2,160
|
|
$
1,985
|
|
$
8,785
|
|
$
7,954
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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
EPS.
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months
ended
|
|
Three months
ended
|
|
|
December 31,
2016
|
|
December 31,
2015
|
|
|
GAAP
|
|
Non-GAAP
|
|
GAAP
|
|
Non-GAAP
|
|
|
|
|
|
|
|
|
|
|
Net income
|
$1,935
|
|
$
2,160
|
|
$
1,800
|
|
$
1,985
|
|
Weighted-average
shares for diluted EPS
|
748
|
|
748
|
|
761
|
|
761
|
|
Diluted
EPS
|
$
2.59
|
|
$
2.89
|
|
$
2.37
|
|
$
2.61
|
|
|
|
|
|
|
|
|
|
|
|
Year
ended
|
|
Year
ended
|
|
|
December 31,
2016
|
|
December 31,
2015
|
|
|
GAAP
|
|
Non-GAAP
|
|
GAAP
|
|
Non-GAAP
|
|
|
|
|
|
|
|
|
|
|
Net income
|
$7,722
|
|
$
8,785
|
|
$
6,939
|
|
$
7,954
|
|
Weighted-average
shares for diluted EPS
|
754
|
|
754
|
|
766
|
|
766
|
|
Diluted
EPS
|
$10.24
|
|
$
11.65
|
|
$
9.06
|
|
$
10.38
|
|
|
|
|
|
|
|
|
|
(a)
|
The adjustments
related primarily to non-cash amortization of intangible assets
acquired in business combinations.
|
|
|
|
|
|
|
|
|
|
(b)
|
For the three months
and years ended December 31, 2016 and 2015, the adjustments related
primarily to non-cash amortization of intangible assets acquired in
business combinations. For the year ended December 31, 2016, the
adjustments also included a $73-million charge resulting from the
reacquisition of Prolia®, XGEVA®and
Vectibix® license agreements in certain markets from
Glaxo Group Limited.
|
|
|
|
|
|
|
|
|
|
(c)
|
For the three months
and year ended December 31, 2016, the adjustments related primarily
to asset-related charges from our site closures. For the three
months ended December 31, 2015, the adjustments related primarily
to a gain recognized on the sale of assets related to our site
closures. The adjustments for the year ended December 31, 2015,
related primarily to gains recognized on the sale of assets related
to our site closures, partially offset by severance
expenses.
|
|
|
|
|
|
|
|
|
|
(d)
|
The adjustments
related primarily to the impairment of non-key contract assets
acquired as part of a business combination and the change in fair
values of contingent consideration.
|
|
|
|
|
|
|
|
|
|
(e)
|
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 expense, 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,
2016, were 30.2% and 31.8%, respectively, compared with 27.6% and
31.4% for the corresponding periods of the prior year.
|
|
|
|
|
|
|
|
|
|
(f)
|
The adjustments
related to certain acquisition items and prior period items
excluded from non-GAAP earnings.
|
Amgen
Inc.
|
|
|
|
|
|
|
|
|
|
Reconciliations of
Cash Flows
|
|
|
|
|
|
|
|
|
|
(in
millions)
|
|
|
|
|
|
|
|
|
|
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months
ended
|
|
Years
ended
|
|
|
|
|
|
December
31,
|
|
December
31,
|
|
|
|
|
|
2016
|
|
2015
|
|
2016
|
|
2015
|
|
|
Net cash provided by
operating activities
|
$ 3,100
|
|
$ 2,073
|
(a)
|
$
10,354
|
|
$ 9,731
|
(a)
|
|
Net cash used in
investing activities
|
(1,222)
|
|
(233)
|
|
(8,658)
|
|
(5,547)
|
|
|
Net cash used in
financing activities
|
(2,122)
|
|
(922)
|
|
(2,599)
|
|
(3,771)
|
|
|
(Decrease) increase
in cash and cash equivalents
|
(244)
|
|
918
|
|
(903)
|
|
413
|
|
|
Cash and cash
equivalents at beginning of period
|
3,485
|
|
3,226
|
|
4,144
|
|
3,731
|
|
|
Cash and cash
equivalents at end of period
|
$ 3,241
|
|
$ 4,144
|
|
$
3,241
|
|
$ 4,144
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months
ended
|
|
Years
ended
|
|
|
|
|
|
December
31,
|
|
December
31,
|
|
|
|
|
|
2016
|
|
2015
|
|
2016
|
|
2015
|
|
|
Net cash provided by
operating activities
|
$ 3,100
|
|
$ 2,073
|
(a)
|
$
10,354
|
|
$ 9,731
|
(a)
|
|
Capital
expenditures
|
(227)
|
|
(205)
|
|
(738)
|
|
(594)
|
|
|
Free cash
flow
|
$ 2,873
|
|
$ 1,868
|
|
$
9,616
|
|
$ 9,137
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(a) Restated
to include $13 million and $654 million for the three months and
year ended December 31, 2015, respectively, which was previously
included in Net cash used in financing activities, as a result of
the adoption of Accounting Standards Update 2016-09,
Improvements to Employee Share-Based Payment
Accounting.
|
|
Reconciliation of
GAAP EPS Guidance to Non-GAAP
|
|
|
EPS Guidance for
the Year Ending December 31, 2017
|
|
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GAAP diluted EPS
guidance
|
|
$ 10.45
|
-
|
$ 11.31
|
|
|
|
|
|
|
|
|
|
|
|
Known adjustments
to arrive at non-GAAP*:
|
|
|
|
|
|
|
|
|
Acquisition-related
expenses
|
(a)
|
|
1.22
|
|
|
|
|
|
Restructuring
charges
|
|
0.07
|
-
|
0.13
|
|
|
|
|
|
|
|
|
|
|
|
Non-GAAP diluted
EPS guidance
|
|
$ 11.80
|
-
|
$ 12.60
|
|
|
|
|
|
|
|
|
|
|
|
*
|
The known adjustments
are presented net of their related tax impact which amount to
approximately $0.61 to $0.64 per share,
in the aggregate.
|
|
|
|
|
|
|
|
|
(a)
|
The adjustments
relate primarily to non-cash amortization of intangible assets
acquired in prior year business combinations.
|
Reconciliation of
GAAP Tax Rate Guidance to Non-GAAP
|
|
|
Tax Rate Guidance
for the Year Ending December 31, 2017
|
|
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2017
|
|
|
|
|
|
|
|
|
|
|
|
GAAP tax rate
guidance
|
|
16.0%
|
-
|
18.0%
|
|
|
|
|
|
|
|
|
|
|
|
|
Tax rate effect of
known adjustments discussed above
|
|
1.5%
|
-
|
2.5%
|
|
|
|
|
|
|
|
|
|
|
|
Non-GAAP tax rate
guidance
|
|
18.5%
|
-
|
19.5%
|
|
|
CONTACT: Amgen, Thousand
Oaks
Trish Hawkins, 805-447-5631
(media)
Arvind Sood, 805-447-1060
(investors)
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/amgen-reports-fourth-quarter-and-full-year-2016-financial-results-300401566.html
SOURCE Amgen