AMGEN ALSO PROVIDES 2023 GUIDANCE EXCLUDING
ANY CONTRIBUTION FROM THE ANNOUNCED ACQUISITION OF HORIZON
THERAPEUTICS
THOUSAND
OAKS, Calif., Jan. 31, 2023 /PRNewswire/ -- Amgen
(NASDAQ: AMGN) today announced financial results for the fourth
quarter and full year 2022 versus comparable periods in 2021.
"We executed effectively in 2022,
delivering strong volume growth, advancing numerous first-in-class
medicines in our pipeline, and staying on track to achieve our
long-term growth objectives," said Robert
A. Bradway, chairman and chief executive officer. "The
announced acquisition of Horizon Therapeutics, which we expect to
complete in the first half of this year, represents a compelling
opportunity to serve more patients and strengthen our growth
profile."
Key results include:
- For the fourth quarter, total revenues were $6.8 billion, largely unchanged from Q4 2021. Q4
revenues benefited from a 4% increase in product sales, offset by
lower Other Revenue from our COVID-19 manufacturing collaboration.
Product sales growth was driven by 10% volume growth, partially
offset by 3% lower net selling price and 2% negative impact from
foreign exchange. Excluding the 2% negative impact of foreign
exchange on product sales, total revenues increased 2%.
-
- Volume growth of 10% included double-digit volume growth for a
number of products including LUMAKRAS®/LUMYKRAS™
(sotorasib), Nplate® (romiplostim), EVENITY®
(romosozumab-aqqg), Repatha® (evolocumab),
Parsabiv® (etelcalcetide), AMGEVITA™ (adalimumab),
KYPROLIS® (carfilzomib), and Prolia®
(denosumab).
- For the full year, total revenues increased 1% to $26.3 billion, resulting from a 2% increase in
product sales driven by a 9% increase in volume, partially offset
by 5% lower net selling price and 2% negative impact from foreign
exchange. Excluding the 2% negative impact of foreign exchange on
product sales, total revenues increased 3% for the full year.
- GAAP earnings per share (EPS) decreased 11% from $3.36 to $3.00 in
the fourth quarter driven by increased other expense, partially
offset by lower weighted-average shares outstanding in Q4 2022. For
the full year, GAAP EPS increased 18% from $10.28 to $12.11,
primarily driven by the write-off of $1.5
billion in Acquired In-Process Research & Development
(Acquired IPR&D) associated with our acquisition of Five Prime
Therapeutics in 2021.
-
- For the fourth quarter, GAAP operating income decreased from
$2.3 billion to $2.2 billion, and GAAP operating margin decreased
2.7 percentage points to 34.0%. For the full year, GAAP operating
income increased from $7.6 billion to
$9.6 billion, and GAAP operating
margin increased 7.2 percentage points to 38.6%.
- Non-GAAP EPS decreased 7% from $4.40 to $4.09 in
the fourth quarter, driven by increased other expense, partially
offset by lower weighted-average shares outstanding in Q4 2022. For
the full year, non-GAAP EPS increased 27% from $13.92 to $17.69
driven by the write-off of $1.5
billion in Acquired IPR&D associated with our
acquisition of Five Prime Therapeutics in 2021 and lower
weighted-average shares outstanding in 2022.
-
- For the fourth quarter, non-GAAP operating income remained
unchanged at $3.0 billion, and
non-GAAP operating margin decreased 1.9 percentage points to 45.9%.
For the full year, non-GAAP operating income increased from
$10.5 billion to $12.8 billion, and non-GAAP operating margin
increased 8.2 percentage points to 51.5%.
- The Company generated $8.8
billion of free cash flow for the full year versus
$8.4 billion in 2021.
Non-GAAP EPS has been recast due to an update to our non-GAAP
policy effective January 1, 2022,
resulting in a $0.04 increase for the
fourth quarter of 2021 and a $3.18
decrease for the full year 2021 of previously-reported non-GAAP
EPS. Refer to Non-GAAP Financial Measures below for further
discussion.
$Millions, except EPS,
dividends paid per share and percentages
|
|
Q4
'22
|
|
Q4
'21
|
|
YOY Δ
|
|
FY
'22
|
|
FY
'21
|
|
YOY Δ
|
Total
Revenues
|
|
$
6,839
|
|
$
6,846
|
|
— %
|
|
$ 26,323
|
|
$ 25,979
|
|
1 %
|
GAAP Operating
Income
|
|
$
2,230
|
|
$
2,304
|
|
(3 %)
|
|
$
9,566
|
|
$
7,639
|
|
25 %
|
GAAP Net
Income
|
|
$
1,616
|
|
$
1,899
|
|
(15 %)
|
|
$
6,552
|
|
$
5,893
|
|
11 %
|
GAAP EPS
|
|
$
3.00
|
|
$ 3.36
|
|
(11 %)
|
|
$
12.11
|
|
$
10.28
|
|
18 %
|
Non-GAAP Operating
Income
|
|
$
3,009
|
|
$
2,997
|
|
— %
|
|
$ 12,761
|
|
$ 10,519
|
|
21 %
|
Non-GAAP Net
Income
|
|
$
2,202
|
|
$
2,487
|
|
(11 %)
|
|
$
9,570
|
|
$
7,978
|
|
20 %
|
Non-GAAP EPS
|
|
$
4.09
|
|
$ 4.40
|
|
(7 %)
|
|
$
17.69
|
|
$
13.92
|
|
27 %
|
Dividends Paid Per
Share
|
|
$
1.94
|
|
$ 1.76
|
|
10 %
|
|
$ 7.76
|
|
$ 7.04
|
|
10 %
|
References in this release to "non-GAAP" measures, measures
presented "on a non-GAAP basis," "free cash flow" (computed by
subtracting capital expenditures from operating cash flow), "total
revenues and product sales adjusted for foreign currency exchange
rate impact" (computed by converting our current period local
currency product sales using the prior period foreign currency
exchange rates and comparing that to our current period product
sales), "EBITDA, or earnings before interest, taxes, depreciation
and amortization" (computed by adding interest expense, provision
for income taxes, and depreciation and amortization expense to GAAP
net income) and "debt leverage ratio" (calculated as the ratio of
GAAP total debt to EBITDA) refer to non-GAAP financial measures.
Beginning January 1, 2022, the
Company's non-GAAP financial measures no longer exclude adjustments
for upfront license fees, development milestones and IPR&D
expenses of pre-approval programs related to licensing,
collaboration and asset acquisition transactions. For purposes of
comparability, the non-GAAP financial results for the fourth
quarter and full year of 2021 have been updated to reflect this
change. Adjustments to the most directly comparable GAAP financial
measures and other items are presented on the attached
reconciliations. Refer to Non-GAAP Financial Measures below for
further discussion.
Product Sales Performance
Total product sales increased 4% for the fourth quarter of 2022
versus the fourth quarter of 2021. Unit volumes grew 10%, partially
offset by 3% lower net selling price and 2% negative impact from
foreign exchange. Product sales for the full year increased 2%
versus 2021, driven by 9% volume growth, partially offset by 5%
lower net selling price and 2% negative impact from foreign
exchange.
General Medicine
- Prolia® sales increased 14%
year-over-year to a record $992
million for the fourth quarter and 12% for the full year,
primarily driven by volume growth. Volumes grew 11% for the quarter
and 10% for the full year.
- EVENITY® sales increased 57%
year-over-year to a record $225
million for the fourth quarter and 48% for the full year,
driven by strong volume growth across our markets. Volumes grew 62%
for the quarter and 52% for the full year.
- Repatha® sales increased 22%
year-over-year to a record $333
million for the fourth quarter and 16% for the full year.
Volume growth of 31% for the quarter and 47% for the full year was
partially offset by lower net selling price. In the U.S., sales
grew 9% for the full year, driven by 36% volume growth, partially
offset by lower net selling price resulting from higher rebates to
support and improve access for patients. Outside the U.S., sales
grew 23% for the full year, driven by 58% volume growth, partially
offset by lower net selling price. This volume growth and lower net
selling price were both impacted by the inclusion of Repatha on
China's National Reimbursement
Drug List as of January 1, 2022.
Repatha remains the global proprotein convertase subtilisin/kexin
type 9 (PCSK9) segment leader, with over 1.5 million patients
treated since launch.
- Aimovig® (erenumab-aooe) sales
increased 27% year-over-year to a record $114 million for the fourth quarter and 31% for
the full year, driven by higher net selling price, partially offset
by lower volume. Going forward, we expect net selling price to
decline to maintain broad formulary access for patients due to
competitive dynamics.
- EPOGEN® (epoetin
alfa) sales decreased 11% year-over-year for the fourth
quarter, primarily driven by lower net selling price. For
the full year, sales decreased 3%, driven by lower net selling
price and lower inventory levels, partially offset by a 4% increase
in volume. Going forward, we expect further declines in net
selling price and volume erosion as we transition through the
expiration of our contract with DaVita.
- Aranesp® (darbepoetin
alfa) sales decreased 4% year-over-year for the fourth
quarter, driven by unfavorable foreign exchange and lower net
selling price, partially offset by increased volume. Sales
decreased 4% for the full year, driven by lower net selling price
and unfavorable foreign exchange impact, partially offset by
favorable changes to estimated sales deductions and increased
volume.
- Parsabiv® sales increased 35%
year-over-year for the fourth quarter and 36% for the full year,
primarily driven by volume growth resulting from 2022 purchases
from a large dialysis organization following decreased usage in
2021.
- Sensipar®/Mimpara™ (cinacalcet)
sales decreased 61% year-over-year for the fourth quarter,
primarily driven by unfavorable changes in estimated sales
deductions and unfavorable foreign exchange impact. Full year sales
decreased 24%, primarily driven by volume declines in response to
generic competition.
Inflammation
- TEZSPIRE® (tezepelumab-ekko)
generated $79 million of sales in the
fourth quarter and $170 million in
its first year of launch, driven by strong adoption in the U.S. by
both allergists and pulmonologists across patients with all types
of severe asthma. Healthcare providers acknowledge TEZSPIRE's
unique, differentiated profile and its broad potential to treat the
2.5 million patients worldwide with severe asthma who are
uncontrolled, without any phenotypic or biomarker limitation.
- TAVNEOS® (avacopan) was
acquired on October 20, 2022 and
generated $21 million of sales in the
fourth quarter. TAVNEOS is a recently launched, first-in-class
treatment for severe active ANCA-associated vasculitis (AAV), an
autoimmune disease that leads to inflammation and eventual
destruction of small blood vessels.
- Otezla® (apremilast) sales
decreased 2% year-over-year for the fourth quarter, driven by lower
net selling price and unfavorable changes to estimated sales
deductions, partially offset by 7% volume growth. Full year sales
increased 2%, primarily driven by 7% volume growth, partially
offset by lower net selling price largely because of enhancements
to our co-pay and patient assistance programs to support new
patients starting treatment as well as additional rebates to
improve the quality of coverage.
- Enbrel® (etanercept) sales
decreased 1% year-over-year for the fourth quarter, driven by
declines in volume and net selling price, partially offset by
higher year-end inventory levels. Full year sales decreased 8%,
driven by a 5% unfavorable impact of changes to estimated sales
deductions related to prior periods, 3% decline in volume and lower
net selling price. Going forward, we expect further declines in net
selling price year-over-year, driven by increased competition.
We expect Otezla and Enbrel to follow the historical pattern of
lower sales in the first quarter relative to subsequent quarters
due to the impact of benefit plan changes, insurance reverification
and increased co-pay expenses as U.S. patients work through
deductibles.
- AMGEVITA™ sales increased 3% year-over-year to a record
$119 million for the fourth quarter
and 5% for the full year, driven by 25% volume growth for both
periods, partially offset by unfavorable foreign exchange impact
and lower net selling price resulting from increased competition.
AMGEVITA continued to be the most prescribed adalimumab biosimilar
in Europe.
Hematology-Oncology
- LUMAKRAS®/LUMYKRAS™ generated
$71 million of sales for the fourth
quarter and $285 million for the full
year. Quarter-over-quarter sales declined 5%, driven by lower net
selling price and unfavorable changes to estimated sales
deductions, partially offset by 12% volume growth. Outside the
U.S., LUMYKRAS has been approved in over 45 countries around the
world. We are actively launching in 30 markets and pursuing
reimbursement in the remaining countries.
- KYPROLIS® sales increased 14%
year-over-year to a record $325
million for the fourth quarter and 13% for the full year,
driven by 13% and 14% volume growth, respectively.
- XGEVA® (denosumab) sales
decreased 11% year-over-year for the fourth quarter, primarily
driven by 4% decline in volume and unfavorable changes to estimated
sales deductions, partially offset by higher net selling price.
Full year sales were relatively unchanged year-over-year as higher
net selling price was offset by a 2% decline in volume and
unfavorable foreign exchange impact. Going forward, we expect
volume will continue to be impacted by competitive dynamics.
- Vectibix® (panitumumab) sales
decreased 2% year-over-year for the fourth quarter, driven by
unfavorable foreign exchange impact, partially offset by higher net
selling price. Full year sales increased 2% year-over-year, driven
by higher net selling price and volume growth, partially offset by
unfavorable foreign exchange impact.
- Nplate® sales increased 66%
year-over-year to a record $469
million for the fourth quarter and 27% for the full year,
driven by volume growth. Nplate sales in the fourth quarter
included $207 million related to a
one-time order from the U.S. government.
- BLINCYTO® (blinatumomab) sales
increased 24% year-over-year to a record $164 million for the fourth quarter, primarily
driven by favorable changes to estimated sales deductions and
higher net selling price. Sales increased 24% for the full year,
driven by volume growth and higher net selling price.
- MVASI® (bevacizumab-awwb) sales
decreased 33% year-over-year for the fourth quarter, primarily
driven by lower net selling price. Sales decreased 23% for the full
year, driven by lower net selling price, partially offset by volume
growth. The most recently published Average Selling Price (ASP) for
MVASI in the U.S. declined 38% year-over-year and 12%
quarter-over-quarter. Looking forward, we expect continued net
selling price erosion and declining volume driven by increased
competition.
- KANJINTI® (trastuzumab-anns)
sales decreased 55% year-over-year for the fourth quarter, driven
by lower net selling price and unfavorable changes to estimated
sales deductions. Sales decreased 45% for the full year, driven by
lower net selling price and decline in volume. The most recently
published ASP for KANJINTI in the U.S. declined 51% year-over-year
and 22% quarter-over-quarter. Going forward, we expect continued
net selling price deterioration and volume declines driven by
increased competition.
- Neulasta® (pegfilgrastim) sales
decreased 37% year-over-year for the fourth quarter and 35% for the
full year, driven by declines in both net selling price and volume.
The most recent published Average Selling Price for Neulasta in the
U.S. declined 29% year-over-year and 16% quarter-over-quarter.
Going forward, we expect increased competition to result in further
declines in net selling price and volume.
- NEUPOGEN® (filgrastim) sales
increased 10% year-over-year for the fourth quarter, primarily
driven by favorable changes in estimated sales deductions,
partially offset by volume declines. Full year sales decreased 14%
year-over-year, driven by volume declines.
Product Sales Detail by Product and Geographic Region
$Millions, except
percentages
|
|
Q4
'22
|
|
Q4
'21
|
|
YOY Δ
|
|
|
US
|
|
ROW
|
|
TOTAL
|
|
TOTAL
|
|
TOTAL
|
Prolia®
|
|
682
|
|
310
|
|
992
|
|
873
|
|
14 %
|
EVENITY®
|
|
157
|
|
68
|
|
225
|
|
143
|
|
57 %
|
Repatha®
|
|
147
|
|
186
|
|
333
|
|
273
|
|
22 %
|
Aimovig®
|
|
109
|
|
5
|
|
114
|
|
90
|
|
27 %
|
EPOGEN®
|
|
114
|
|
—
|
|
114
|
|
128
|
|
(11 %)
|
Aranesp®
|
|
124
|
|
224
|
|
348
|
|
362
|
|
(4 %)
|
Parsabiv®
|
|
64
|
|
29
|
|
93
|
|
69
|
|
35 %
|
Sensipar®/Mimpara™
|
|
(3)
|
|
10
|
|
7
|
|
18
|
|
(61 %)
|
TEZSPIRE®
|
|
79
|
|
—
|
|
79
|
|
—
|
|
NM
|
TAVNEOS®
|
|
16
|
|
5
|
|
21
|
|
—
|
|
NM
|
Otezla®
|
|
520
|
|
96
|
|
616
|
|
630
|
|
(2 %)
|
Enbrel®
|
|
1,079
|
|
19
|
|
1,098
|
|
1,108
|
|
(1 %)
|
AMGEVITA™
|
|
—
|
|
119
|
|
119
|
|
115
|
|
3 %
|
LUMAKRAS®/LUMYKRAS™
|
|
62
|
|
9
|
|
71
|
|
45
|
|
58 %
|
KYPROLIS®
|
|
224
|
|
101
|
|
325
|
|
284
|
|
14 %
|
XGEVA®
|
|
358
|
|
126
|
|
484
|
|
545
|
|
(11 %)
|
Vectibix®
|
|
109
|
|
129
|
|
238
|
|
243
|
|
(2 %)
|
Nplate®
|
|
374
|
|
95
|
|
469
|
|
282
|
|
66 %
|
BLINCYTO®
|
|
96
|
|
68
|
|
164
|
|
132
|
|
24 %
|
MVASI®
|
|
134
|
|
71
|
|
205
|
|
304
|
|
(33 %)
|
KANJINTI®
|
|
50
|
|
13
|
|
63
|
|
139
|
|
(55 %)
|
Neulasta®
|
|
187
|
|
34
|
|
221
|
|
351
|
|
(37 %)
|
NEUPOGEN®
|
|
22
|
|
12
|
|
34
|
|
31
|
|
10 %
|
Other
products*
|
|
90
|
|
29
|
|
119
|
|
106
|
|
12 %
|
Total product
sales
|
|
$ 4,794
|
|
$ 1,758
|
|
$ 6,552
|
|
$ 6,271
|
|
4 %
|
|
|
|
|
|
|
|
|
|
|
|
* Other products
include Corlanor®, AVSOLA®,
IMLYGIC® and RIABNI®, as well as sales by
GENSENTA and Bergamo subsidiaries
|
NM = not
meaningful
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$Millions, except
percentages
|
|
FY
'22
|
|
FY
'21
|
|
YOY Δ
|
|
|
US
|
|
ROW
|
|
TOTAL
|
|
TOTAL
|
|
TOTAL
|
Prolia®
|
|
2,465
|
|
1,163
|
|
3,628
|
|
$ 3,248
|
|
12 %
|
EVENITY®
|
|
533
|
|
254
|
|
787
|
|
530
|
|
48 %
|
Repatha®
|
|
608
|
|
688
|
|
1,296
|
|
1,117
|
|
16 %
|
Aimovig®
|
|
398
|
|
16
|
|
414
|
|
317
|
|
31 %
|
EPOGEN®
|
|
506
|
|
—
|
|
506
|
|
521
|
|
(3 %)
|
Aranesp®
|
|
521
|
|
900
|
|
1,421
|
|
1,480
|
|
(4 %)
|
Parsabiv®
|
|
253
|
|
129
|
|
382
|
|
280
|
|
36 %
|
Sensipar®/Mimpara™
|
|
10
|
|
54
|
|
64
|
|
84
|
|
(24 %)
|
TEZSPIRE®
|
|
170
|
|
—
|
|
170
|
|
—
|
|
NM
|
TAVNEOS®
|
|
16
|
|
5
|
|
21
|
|
—
|
|
NM
|
Otezla®
|
|
1,886
|
|
402
|
|
2,288
|
|
2,249
|
|
2 %
|
Enbrel®
|
|
4,044
|
|
73
|
|
4,117
|
|
4,465
|
|
(8 %)
|
AMGEVITA™
|
|
—
|
|
460
|
|
460
|
|
439
|
|
5 %
|
LUMAKRAS®/LUMYKRAS™
|
|
222
|
|
63
|
|
285
|
|
90
|
|
*
|
KYPROLIS®
|
|
850
|
|
397
|
|
1,247
|
|
1,108
|
|
13 %
|
XGEVA®
|
|
1,480
|
|
534
|
|
2,014
|
|
2,018
|
|
— %
|
Vectibix®
|
|
396
|
|
497
|
|
893
|
|
873
|
|
2 %
|
Nplate®
|
|
848
|
|
459
|
|
1,307
|
|
1,027
|
|
27 %
|
BLINCYTO®
|
|
336
|
|
247
|
|
583
|
|
472
|
|
24 %
|
MVASI®
|
|
602
|
|
299
|
|
901
|
|
1,166
|
|
(23 %)
|
KANJINTI®
|
|
257
|
|
59
|
|
316
|
|
572
|
|
(45 %)
|
Neulasta®
|
|
959
|
|
167
|
|
1,126
|
|
1,734
|
|
(35 %)
|
NEUPOGEN®
|
|
87
|
|
57
|
|
144
|
|
168
|
|
(14 %)
|
Other
products**
|
|
296
|
|
135
|
|
431
|
|
339
|
|
27 %
|
Total product
sales
|
|
$
17,743
|
|
$ 7,058
|
|
$
24,801
|
|
$
24,297
|
|
2 %
|
|
|
|
|
|
|
|
|
|
|
|
* Change in excess of
100%
|
|
|
|
|
|
|
|
|
|
|
** Other products
include Corlanor®, AVSOLA®,
IMLYGIC® and RIABNI®, as well as sales by
GENSENTA and Bergamo subsidiaries
|
NM = not
meaningful
|
|
|
|
|
|
|
|
|
|
|
Operating Expense, Operating Margin and Tax Rate
Analysis
On a GAAP basis:
- Total Operating Expenses increased 1% year-over-year for
the fourth quarter. For the full year, Total Operating Expenses
decreased 9%. Cost of Sales margin decreased 0.7 percentage
points in the fourth quarter and decreased 0.8 percentage points
for the full year, primarily driven by lower COVID-19 antibody
shipments and lower manufacturing cost, partially offset by
acquisition-related charges and changes in our product mix.
Research & Development (R&D) expenses decreased 2%
in the fourth quarter and decreased 8% for the full year, primarily
due to higher business development activity in 2021 and lower
marketed product support, partially offset by higher late stage
program support and research and early pipeline spend. Selling,
General & Administrative (SG&A) expenses increased 10%
in the fourth quarter and increased 1% for the full year primarily
driven by expenses related to the ChemoCentryx acquisition.
- Operating Margin as a percentage of product sales
decreased 2.7 percentage points to 34.0% in the fourth quarter and
increased 7.2 percentage points for the full year to 38.6%.
- Tax Rate decreased 3.3 percentage points in the fourth
quarter and decreased 1.3 percentage points for the full year. The
fourth quarter tax rate decrease was primarily due to the Five
Prime Therapeutics non-deductible Acquired IPR&D expense in the
prior year and net favorable items, partially offset by a
nondeductible loss from a nonstrategic divestiture. The full year
tax rate decrease was primarily due to the Five Prime Therapeutics
non-deductible Acquired IPR&D expense in the prior year,
partially offset by a nondeductible loss from a nonstrategic
divestiture and net unfavorable items.
On a non-GAAP basis:
- Total Operating Expenses were unchanged for the fourth
quarter and decreased 12% for the full year. Cost of Sales
margin decreased 1.2 percentage points in the fourth quarter and
decreased 0.5 percentage points for the full year, driven by lower
COVID-19 antibody shipments and lower manufacturing cost, partially
offset by changes in our product mix. R&D expenses
decreased 2% in the fourth quarter and decreased 8% for the full
year, primarily due to higher business development activity in 2021
and lower marketed product support, partially offset by higher
late-stage program support and research and early pipeline spend.
SG&A expenses increased 2% in the fourth quarter driven
by higher marketed product support. For the full year, SG&A
expenses were unchanged.
- Operating Margin as a percentage of product sales
decreased 1.9 percentage points in the fourth quarter to 45.9%, and
increased 8.2 percentage points to 51.5% for the full year.
- Tax Rate increased 2.8 percentage points in the fourth
quarter and decreased 0.7 percentage points for the full year. The
fourth quarter tax rate increase was primarily due to earnings mix
and net favorable items in the prior year as compared to the
current quarter. The full year tax rate decrease is primarily due
to the Five Prime Therapeutics non-deductible Acquired IPR&D
expense in the prior year, partially offset by net unfavorable
items in the current year as compared to the prior year.
$Millions, except
percentages
|
|
GAAP
|
|
Non-GAAP
|
|
|
Q4
'22
|
|
Q4
'21
|
|
YOY Δ
|
|
Q4
'22
|
|
Q4
'21
|
|
YOY Δ
|
Cost of
Sales
|
|
$
1,747
|
|
$
1,718
|
|
2 %
|
|
$
1,071
|
|
$
1,096
|
|
(2 %)
|
% of product
sales
|
|
26.7 %
|
|
27.4 %
|
|
(0.7) pts
|
|
16.3 %
|
|
17.5 %
|
|
(1.2) pts
|
Research &
Development
|
|
$
1,324
|
|
$
1,348
|
|
(2 %)
|
|
$
1,291
|
|
$
1,319
|
|
(2 %)
|
% of product
sales
|
|
20.2 %
|
|
21.5 %
|
|
(1.3) pts
|
|
19.7 %
|
|
21.0 %
|
|
(1.3) pts
|
Selling, General &
Administrative
|
|
$
1,572
|
|
$
1,425
|
|
10 %
|
|
$
1,468
|
|
$
1,434
|
|
2 %
|
% of product
sales
|
|
24.0 %
|
|
22.7 %
|
|
1.3 pts
|
|
22.4 %
|
|
22.9 %
|
|
(0.5) pts
|
Other
|
|
$ (34)
|
|
$ 51
|
|
*
|
|
$ —
|
|
$ —
|
|
NM
|
Total Operating
Expenses
|
|
$
4,609
|
|
$
4,542
|
|
1 %
|
|
$
3,830
|
|
$
3,849
|
|
— %
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
Margin
|
|
|
|
|
|
|
|
|
|
|
|
|
operating income as %
of product sales
|
|
34.0 %
|
|
36.7 %
|
|
(2.7) pts
|
|
45.9 %
|
|
47.8 %
|
|
(1.9) pts
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Tax
Rate
|
|
7.6 %
|
|
10.9 %
|
|
(3.3)
pts
|
|
13.4 %
|
|
10.6 %
|
|
2.8
pts
|
|
|
|
|
|
|
|
|
|
|
|
|
|
pts: percentage
points
|
|
|
|
|
|
|
|
|
|
|
|
|
* change in excess of
100%
|
|
|
|
|
|
|
|
|
|
|
|
|
NM = not
meaningful
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$Millions, except
percentages
|
|
GAAP
|
|
Non-GAAP
|
|
|
FY
'22
|
|
FY
'21
|
|
YOY Δ
|
|
FY
'22
|
|
FY
'21
|
|
YOY Δ
|
Cost of
Sales
|
|
$
6,406
|
|
$
6,454
|
|
(1 %)
|
|
$
3,951
|
|
$
3,994
|
|
(1 %)
|
% of product
sales
|
|
25.8 %
|
|
26.6 %
|
|
(0.8) pts
|
|
15.9 %
|
|
16.4 %
|
|
(0.5) pts
|
Research &
Development
|
|
$
4,434
|
|
$
4,819
|
|
(8 %)
|
|
$
4,341
|
|
$
4,696
|
|
(8 %)
|
% of product
sales
|
|
17.9 %
|
|
19.8 %
|
|
(1.9) pts
|
|
17.5 %
|
|
19.3 %
|
|
(1.8) pts
|
Acquired
IPR&D
|
|
$ —
|
|
$
1,505
|
|
NM
|
|
$ —
|
|
$
1,505
|
|
NM
|
% of product
sales
|
|
— %
|
|
6.2 %
|
|
NM
|
|
— %
|
|
6.2 %
|
|
NM
|
Selling, General &
Administrative
|
|
$
5,414
|
|
$
5,368
|
|
1 %
|
|
$
5,270
|
|
$
5,265
|
|
— %
|
% of product
sales
|
|
21.8 %
|
|
22.1 %
|
|
(0.3) pts
|
|
21.2 %
|
|
21.7 %
|
|
(0.5) pts
|
Other
|
|
$
503
|
|
$
194
|
|
*
|
|
$ —
|
|
$ —
|
|
NM
|
Total Operating
Expenses
|
|
$
16,757
|
|
$
18,340
|
|
(9 %)
|
|
$
13,562
|
|
$
15,460
|
|
(12 %)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
Margin
|
|
|
|
|
|
|
|
|
|
|
|
|
operating income as %
of product sales
|
|
38.6 %
|
|
31.4 %
|
|
7.2 pts
|
|
51.5 %
|
|
43.3 %
|
|
8.2 pts
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Tax
Rate
|
|
10.8 %
|
|
12.1 %
|
|
(1.3)
pts
|
|
13.8 %
|
|
14.5 %
|
|
(0.7)
pts
|
|
|
|
|
|
|
|
|
|
|
|
|
|
pts: percentage
points
|
|
|
|
|
|
|
|
|
|
|
|
|
* change in excess of
100%
|
|
|
|
|
|
|
|
|
|
|
|
|
NM = not
meaningful
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash Flow and Balance Sheet
- The Company generated $2.3
billion of free cash flow in the fourth quarter of 2022
versus $2.5 billion in the fourth
quarter of 2021. The Company generated $8.8
billion of free cash flow for the full year 2022 versus
$8.4 billion in 2021.
- The Company's fourth quarter 2022 dividend of $1.94 per share was declared on October 28, 2022, and was paid on December 8, 2022, to all stockholders of record
as of November 17, 2022, representing
a 10% increase from 2021.
- During the fourth quarter, there were no repurchases of common
stock. 26.1 million shares of common stock were repurchased in
2022.
- Cash and investments totaled $9.3
billion and debt outstanding totaled $38.9 billion as of December 31, 2022. Debt leverage was
approximately 3.2 times EBITDA as of December 31, 2022.
$Billions, except
shares
|
|
Q4 '22
|
|
Q4 '21
|
|
YOY Δ
|
FY '22
|
|
FY '21
|
|
YOY Δ
|
|
Operating Cash
Flow
|
|
$ 2.6
|
|
$ 2.8
|
|
$
(0.2)
|
$ 9.7
|
|
$ 9.3
|
|
$ 0.5
|
|
Capital
Expenditures
|
|
$ 0.3
|
|
$ 0.3
|
|
$ 0.1
|
$ 0.9
|
|
$ 0.9
|
|
$ 0.1
|
|
Free Cash
Flow
|
|
$ 2.3
|
|
$ 2.5
|
|
$
(0.2)
|
$ 8.8
|
|
$ 8.4
|
|
$ 0.4
|
|
Dividends
Paid
|
|
$ 1.0
|
|
$ 1.0
|
|
$ 0.1
|
$ 4.2
|
|
$ 4.0
|
|
$ 0.2
|
|
Share
Repurchases
|
|
$
—
|
|
$ 1.5
|
|
$
(1.5)
|
$ 6.3
|
|
$ 5.0
|
|
$ 1.3
|
|
Average Diluted Shares
(millions)
|
|
539
|
|
565
|
|
(26)
|
541
|
|
573
|
|
(32)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Note: Numbers may not
add due to rounding
|
|
|
|
|
|
|
|
|
|
|
|
|
$Billions
|
|
12/31/22
|
|
12/31/21
|
|
YTD Δ
|
Cash and
Investments
|
|
$ 9.3
|
|
$ 8.0
|
|
$ 1.3
|
Debt
Outstanding
|
|
$ 38.9
|
|
$ 33.3
|
|
$ 5.6
|
|
|
|
|
|
|
|
Note: Numbers may not
add due to rounding
|
|
|
|
|
|
|
2023 Guidance (Excludes any contribution from the announced
acquisition of Horizon Therapeutics)
For the full year 2023, excluding any contribution from the
announced acquisition of Horizon Therapeutics, the Company
expects:
- Total revenues in the range of $26.0 billion to $27.2
billion.
- On a GAAP basis, EPS in the range of $13.16 to $14.41,
and a tax rate in the range of 17.0% to 18.5%.
- On a non-GAAP basis, EPS in the range of $17.40 to $18.60,
and a tax rate in the range of 18.0% to 19.0%.
- Capital expenditures to be approximately $925 million.
- Share repurchases not to exceed $500 million.
Fourth Quarter Product and Pipeline Update
The Company provided the following updates on selected product
and pipeline programs:
General Medicine
Repatha
- In November, results were presented from the Repatha FOURIER
and FOURIER-open label extension studies demonstrating a direct
relationship between lower achieved low-density lipoprotein
cholesterol (LDL-C) levels, down to very low LDL-C levels <20
mg/dL, with a lower risk of cardiovascular outcomes in the long
term. There was no increase in adverse safety events during the
extended follow-up period of up to 8.6 years.
- The 2022 American College of Cardiology Expert Consensus
Decision Pathway on the Role of Non-statin Therapies for
LDL-Cholesterol Lowering indicated that "there appears to be no
LDL-C level below which benefit ceases" for atherosclerotic
cardiovascular disease patients at very high risk. Additionally,
LDL-C recommendations were updated to reflect a reduction in target
LDL-C levels in highest risk patients from 70 mg/dl to 55 mg/dl; a
level that is not attainable for a large number of patients without
PCSK9 inhibitor therapy.
Olpasiran (AMG 890)
- In November, results were presented from a Phase 2 study of
olpasiran, a small interfering RNA molecule that reduces
Lipoprotein(a) (Lp(a)) synthesis in the liver, demonstrating that
patients with very high Lp(a) levels who received olpasiran dosed
at 75 mg or above every 12 weeks had a 95% or greater reduction in
Lp(a) compared to placebo at week 36. Overall, the rates of adverse
events were similar in the olpasiran and placebo arms. The most
common treatment-related adverse events were injection site
reactions, primarily pain. These data were presented at the
American Heart Association Scientific Sessions and simultaneously
published in The New England Journal of Medicine.
- The Company has begun enrolling the double-blind, randomized,
placebo-controlled, multicenter Phase 3 cardiovascular outcomes
study that assesses the impact of olpasiran treatment on major
cardiovascular events in participants with atherosclerotic
cardiovascular disease and elevated Lp(a).
AMG 133
- In December, results were presented from a Phase 1 study of AMG
133 a multispecific that inhibits the gastric inhibitory
polypeptide receptor (GIPR) and activates the glucagon-like peptide
1 (GLP-1) receptor, demonstrating that following three monthly
doses of AMG 133, participants experienced a mean percentage
reduction in body weight of 14.5% at the highest dose (420 mg Q4W)
by day 85. Weight loss was durable at the higher doses tested, with
reductions observed for up to 150 days after the final (third) AMG
133 administration. Most treatment-emergent adverse events were
mild and transient, with the majority being GI-related and
resolving within 48 hours.
- The Company has begun enrolling patients in a randomized,
placebo-controlled, double-blind, dose-ranging Phase 2 study to
evaluate the efficacy, safety, and tolerability of AMG 133 in
overweight or obese adult patients, with or without type 2 diabetes
mellitus.
AMG 786
- A small molecule, continues to enroll patients in a Phase 1
study. This molecule has a different target than AMG 133 and other
incretin based therapies.
Inflammation
TEZSPIRE
- In January 2023, TEZSPIRE
received a positive opinion from the European Medicine Agency's
Committee for Medicinal Products for Human Use (CHMP) for a
variation adding a new prefilled, single-use pen presentation for
self-administration by patients aged 12 years and older with severe
asthma. The CHMP opinion can be implemented without the need for a
European Commission decision, due to the nature of the Type-II
label variation.
- In severe asthma, the PASSAGE Phase 4 real-world effectiveness
study, the WAYFINDER Phase 3b study
and the SUNRISE Phase 3 study continue to enroll patients.
- A Phase 3 study of TEZSPIRE in chronic rhinosinusitis with
nasal polyps continues to enroll patients.
- A Phase 3 study of TEZSPIRE in patients with eosinophilic
esophagitis has started.
- A Phase 2b study of TEZSPIRE in
chronic spontaneous urticaria is fully enrolled. Data readout is
anticipated in H1 2023.
- A Phase 2 study of TEZSPIRE in chronic obstructive pulmonary
disease is fully enrolled.
Rocatinlimab (AMG 451 / KHK4083)
- The ROCKET Phase 3 program evaluating rocatinlimab, a
first-in-class anti-OX40 monoclonal antibody, is enrolling adult
and adolescent patients with moderate to severe atopic
dermatitis.
- In December, the results from the rocatinlimab Phase
2b multicenter, double-blind,
placebo-controlled study of adults with moderate to severe atopic
dermatitis were published in The Lancet.
Rozibafusp alfa (AMG 570)
- A Phase 2b study of rozibafusp
alfa, an antibody-peptide conjugate that simultaneously blocks
inducible T-cell costimulatory ligand (ICOSL) and B-cell activating
factor (BAFF) activity, in systemic lupus erythematosus (SLE),
continues to enroll patients.
Efavaleukin alfa (AMG 592)
- A Phase 2b study of efavaleukin
alfa, an interleukin-2 (IL-2) mutein Fc fusion protein, in SLE
continues to enroll patients.
- A Phase 2b study of efavaleukin
alfa in ulcerative colitis, continues to enroll patients.
Ordesekimab (AMG 714 / PRV-015)
- A Phase 2b study of AMG 714, a
monoclonal antibody that binds interleukin-15, in nonresponsive
celiac disease, continues to enroll patients.
Oncology
BLINCYTO
- In December, results were presented from the
registration-enabling E1910 study conducted by the National Cancer
Institute, the Eastern Cooperative Oncology Group and the American
College of Radiology Imaging Network (ECOG-ACRIN) Cancer Research
Group that demonstrated superior overall survival with BLINCYTO
treatment added to consolidation chemotherapy over standard-of-care
consolidation chemotherapy in newly diagnosed adult patients with
Philadelphia chromosome-negative
B-cell acute lymphoblastic leukemia who were measurable residual
disease (MRD)-negative following induction and intensification
chemotherapy.
- In December, results were presented from a Phase 1b dose-escalation study of subcutaneously
administered BLINCYTO that demonstrated an acceptable safety
profile and anti-leukemia activity in patients with
relapsed/refractory B-cell acute lymphoblastic leukemia.
Pharmacokinetic exposures and pharmacodynamic profiles were
consistent with those reported for the continuous intravenous
infusion regimen of BLINCYTO. The Company will continue to
investigate BLINCYTO in earlier lines of treatment and in the
subcutaneous route of administration.
LUMAKRAS/LUMYKRAS
- A Phase 3 study of LUMAKRAS in combination with Vectibix in
third-line colorectal cancer continues to enroll patients. Data
readout is anticipated in H2 2023.
- The Company continues to explore novel combinations and is
advancing a comprehensive global clinical development program in
non-small cell lung cancer, colorectal cancer, and other solid
tumors to further explore the potential of LUMAKRAS.
Bemarituzumab
- FORTITUDE-101, a Phase 3 study of bemarituzumab, a fibroblast
growth factor receptor 2b (FGFR2b)
targeting monoclonal antibody, plus chemotherapy in first-line
gastric cancer, continues to enroll patients.
- FORTITUDE-102, a Phase 1b/3 study
of bemarituzumab plus chemotherapy and nivolumab in first-line
gastric cancer, continues to enroll patients in the Phase 3 portion
of the study.
- FORTITUDE-103, a Phase 1b study
of bemarituzumab plus oral chemotherapy regimens with or without
nivolumab in first-line gastric cancer, continues to enroll
patients.
- FORTITUDE-201, a Phase 1b study
of bemarituzumab monotherapy and in combination with
standard-of-care therapy, in squamous NSCLC with FGFR2b
overexpression, continues to enroll patients.
- FORTITUDE-301, a Phase 1b/2
basket study of bemarituzumab monotherapy in solid tumors with
FGFR2b overexpression, continues to enroll patients.
Tarlatamab (AMG 757)
- DeLLphi-301, a potentially registrational Phase 2 study of
tarlatamab, a half-life extended BiTE molecule being studied in
heavily pretreated patients with small-cell lung cancer (SCLC),
continues to enroll patients. In November, a recommended Phase 2
dose was agreed to with the U.S. Food and Drug Administration. Data
readout is anticipated in H2 2023.
- DeLLphi-300, a Phase 1 study of tarlatamab in
relapsed/refractory SCLC, continues to enroll patients.
- DeLLphi-302, a Phase 1b study of
tarlatamab in combination with AMG 404, an anti-programmed cell
death-1 monoclonal antibody, in second-line or later SCLC is
ongoing, with data readout anticipated in H2 2023.
- DeLLphi-303, a Phase 1b study of
tarlatamab in combination with standard-of-care in first-line SCLC,
continues to enroll patients.
- DeLLpro-300, a Phase 1b study of
tarlatamab, in de novo or treatment-emergent neuroendocrine
prostate cancer, continues to enroll patients.
- The Company plans to initiate a Phase 3 study of tarlatamab in
second-line SCLC in H1 2023.
AMG 509
- A Phase 1 dose-escalation/expansion study of AMG 509, a
bispecific molecule targeting six-transmembrane epithelial antigen
of prostate 1 (STEAP1) in metastatic castrate-resistant prostate
cancer (mCRPC) continues to enroll patients. Preliminary data
readout is anticipated in H2 2023.
AMG 340
- A Phase 1 dose-escalation study of AMG 340, a lower T-cell
affinity BiTE molecule targeting prostate-specific membrane antigen
(PSMA), in mCRPC, continues to enroll patients.
AMG 193
- A Phase 1/1b/2 study of AMG 193,
a small-molecule methylthioadenosine (MTA)-cooperative protein
arginine methyltransferase 5 (PRMT5) molecular glue continues to
enroll patients with advanced methylthioadenosine phosphorylase
(MTAP)-null solid tumors.
Biosimilars
- A Phase 3 study to support an interchangeability designation in
the U.S. for ABP 654, an investigational biosimilar to
STELARA® (ustekinumab) is ongoing, with data readout
anticipated in H1 2023.
- A Phase 3 study to support an interchangeability designation in
the U.S. for AMJEVITA™ (adalimumab-atto) is ongoing, with data
readout anticipated in H1 2023.
- The final analysis from a Phase 3 study evaluating the efficacy
and safety of ABP 938, an investigational biosimilar to
EYLEA® (aflibercept) compared with EYLEA in patients
with neovascular age-related macular degeneration, is expected in
H1 2023.
TEZSPIRE is being developed in collaboration with
AstraZeneca.
Rocatinlimab, formerly AMG 451 / KHK4083 is
being developed in collaboration with KKC.
Ordesekimab
formerly AMG 714 and also known as PRV-015 is being developed in
collaboration with Provention Bio.
AMG 509 is being
developed in collaboration with Xencor.
STELARA is a
registered trademark of Janssen Pharmaceutica NV.
EYLEA
is a registered trademark of Regeneron Pharmaceuticals,
Inc.
SOLIRIS is a registered trademark of Alexion
Pharmaceuticals, Inc.
Non-GAAP Financial Measures
In this news release, management has presented its operating
results for the fourth quarters and full years of 2022 and 2021, in
accordance with U.S. Generally Accepted Accounting Principles
(GAAP) and on a non-GAAP basis. In addition, management has
presented its full year 2023 EPS and tax 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, divestitures, restructuring and certain other items
from the related GAAP financial measures. Beginning January 1, 2022, following industry guidance from
the U.S. Securities and Exchange Commission, the Company no longer
excludes adjustments for upfront license fees, development
milestones and IPR&D expenses of pre-approval programs related
to licensing, collaboration and asset acquisition transactions from
its non-GAAP financial measures. For purposes of comparability, the
non-GAAP financial results for the fourth quarter and full year of
2021 have been updated to reflect this change. Reconciliations for
these non-GAAP financial measures to the most directly comparable
GAAP financial measures are included in the news release.
Management has presented Free Cash Flow (FCF), which is a non-GAAP
financial measure, for the fourth quarters and full years of 2022
and 2021. FCF is computed by subtracting capital expenditures from
operating cash flow, each as determined in accordance with GAAP.
Management has presented Total Revenues and Product Sales Adjusted
for Foreign Currency Exchange Rate Impact, which is a non-GAAP
financial measure, for the fourth quarter and full year of 2022.
Total Revenues and Product Sales Adjusted for Foreign Currency
Exchange Rate Impact is computed by converting our current period
local currency product sales using the prior period foreign
currency exchange rates and comparing that to our current period
product sales. Management has also presented Earnings Before
Interest, Taxes, Depreciation and Amortization (EBITDA) and debt
leverage ratio for 2022, both of which are non-GAAP financial
measures. EBITDA is computed by adding interest expense, provision
for income taxes, and depreciation and amortization expense to GAAP
net income. Debt leverage ratio is calculated as the ratio of GAAP
total debt to EBITDA.
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 believes Total Revenues and Product Sales Adjusted for
Foreign Currency Exchange Rate Impact provides supplementary
information on the Company's product sales performance by excluding
changes in foreign currency exchange rates between comparative
periods. The Company believes its debt leverage ratio provides an
important ongoing operating metric as it compares the amount of
cash generated by our operations during a given period relative to
our debt obligations outstanding for the same period.
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.
Amgen is one of the 30 companies that comprise the Dow Jones
Industrial Average and is also part of the Nasdaq-100 index. In
2022, Amgen was named one of the "World's Best Employers" by Forbes
and one of "America's 100 Most Sustainable Companies" by
Barron's.
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, or potential collaborations, with any other company
(including BeiGene, Ltd., Kyowa-Kirin Co., Ltd., or any
collaboration to manufacture therapeutic antibodies against
COVID-19), the performance of Otezla® (apremilast)
(including anticipated Otezla sales growth and the timing of
non-GAAP EPS accretion), the Five Prime Therapeutics, Inc.
acquisition, the Teneobio, Inc. acquisition, the ChemoCentryx, Inc.
acquisition, or the proposed acquisition of Horizon Therapeutics
plc, 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, effects of pandemics or
other widespread health problems such as the ongoing COVID-19
pandemic on our business, outcomes, progress, 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. An outbreak
of disease or similar public health threat, such as COVID-19, and
the public and governmental effort to mitigate against the spread
of such disease, could have a significant adverse effect on the
supply of materials for our manufacturing activities, the
distribution of our products, the commercialization of our product
candidates, and our clinical trial operations, and any such events
may have a material adverse effect on our product development,
product sales, business and results of operations. 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
of our information technology systems 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 and operations may be negatively affected
by the failure, or perceived failure, of achieving our
environmental, social and governance objectives. The effects of
global climate change and related natural disasters could
negatively affect our business and operations. Global economic
conditions may magnify certain risks that affect our business. 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
Jessica Akopyan, 805-440-5721
(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,
|
|
Twelve months
ended
December
31,
|
|
2022
|
|
2021
|
|
2022
|
|
2021
|
Revenues:
|
|
|
|
|
|
|
|
Product
sales
|
$
6,552
|
|
$
6,271
|
|
$
24,801
|
|
$
24,297
|
Other
revenues
|
287
|
|
575
|
|
1,522
|
|
1,682
|
Total
revenues
|
6,839
|
|
6,846
|
|
26,323
|
|
25,979
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
Cost of
sales
|
1,747
|
|
1,718
|
|
6,406
|
|
6,454
|
Research and
development
|
1,324
|
|
1,348
|
|
4,434
|
|
4,819
|
Acquired in-process
research and development
|
—
|
|
—
|
|
—
|
|
1,505
|
Selling, general and
administrative
|
1,572
|
|
1,425
|
|
5,414
|
|
5,368
|
Other
|
(34)
|
|
51
|
|
503
|
|
194
|
Total operating
expenses
|
4,609
|
|
4,542
|
|
16,757
|
|
18,340
|
|
|
|
|
|
|
|
|
Operating
income
|
2,230
|
|
2,304
|
|
9,566
|
|
7,639
|
|
|
|
|
|
|
|
|
Other income
(expense):
|
|
|
|
|
|
|
|
Interest expense,
net
|
(415)
|
|
(335)
|
|
(1,406)
|
|
(1,197)
|
Other (expense) income,
net
|
(67)
|
|
162
|
|
(814)
|
|
259
|
|
|
|
|
|
|
|
|
Income before income
taxes
|
1,748
|
|
2,131
|
|
7,346
|
|
6,701
|
|
|
|
|
|
|
|
|
Provision for income
taxes
|
132
|
|
232
|
|
794
|
|
808
|
|
|
|
|
|
|
|
|
Net income
|
$
1,616
|
|
$
1,899
|
|
$
6,552
|
|
$
5,893
|
|
|
|
|
|
|
|
|
Earnings per
share:
|
|
|
|
|
|
|
|
Basic
|
$ 3.02
|
|
$ 3.38
|
|
$
12.18
|
|
$
10.34
|
Diluted
|
$ 3.00
|
|
$ 3.36
|
|
$
12.11
|
|
$
10.28
|
|
|
|
|
|
|
|
|
Weighted-average shares
used in calculation of earnings per share:
|
|
|
|
|
|
|
|
Basic
|
535
|
|
562
|
|
538
|
|
570
|
Diluted
|
539
|
|
565
|
|
541
|
|
573
|
Amgen
Inc. Consolidated Balance Sheets - GAAP (In
millions)
|
|
|
December
31,
|
|
December
31,
|
|
2022
|
|
2021
|
|
(Unaudited)
|
|
|
Assets
|
Current
assets:
|
|
|
|
Cash, cash equivalents
and marketable securities
|
$
9,305
|
|
$
8,037
|
Trade receivables,
net
|
5,563
|
|
4,895
|
Inventories
|
4,930
|
|
4,086
|
Other current
assets
|
2,388
|
|
2,367
|
Total current
assets
|
22,186
|
|
19,385
|
|
|
|
|
Property, plant and
equipment, net
|
5,427
|
|
5,184
|
Intangible assets,
net
|
16,080
|
|
15,182
|
Goodwill
|
15,529
|
|
14,890
|
Other noncurrent
assets
|
5,899
|
|
6,524
|
Total assets
|
$
65,121
|
|
$
61,165
|
|
|
|
|
Liabilities and
Stockholders' Equity
|
Current
liabilities:
|
|
|
|
Accounts payable and
accrued liabilities
|
$
14,096
|
|
$
12,097
|
Current portion of
long-term debt
|
1,591
|
|
87
|
Total current
liabilities
|
15,687
|
|
12,184
|
|
|
|
|
Long-term
debt
|
37,354
|
|
33,222
|
Long-term tax
liabilities
|
5,757
|
|
6,594
|
Other noncurrent
liabilities
|
2,662
|
|
2,465
|
Total stockholders'
equity
|
3,661
|
|
6,700
|
Total liabilities and
stockholders' equity
|
$
65,121
|
|
$
61,165
|
|
|
|
|
Shares
outstanding
|
534
|
|
558
|
Amgen
Inc. GAAP to Non-GAAP Reconciliations (Dollars
in millions) (Unaudited)
|
|
|
Three months
ended
December
31,
|
|
Twelve months
ended
December
31,
|
|
2022
|
|
2021
|
|
2022
|
|
2021
|
GAAP cost of
sales
|
$
1,747
|
|
$
1,718
|
|
$
6,406
|
|
$
6,454
|
Adjustments to cost
of sales:
|
|
|
|
|
|
|
|
Acquisition-related
expenses (a)
|
(676)
|
|
(616)
|
|
(2,455)
|
|
(2,443)
|
Other
|
—
|
|
(6)
|
|
—
|
|
(17)
|
Total adjustments
to cost of sales
|
(676)
|
|
(622)
|
|
(2,455)
|
|
(2,460)
|
Non-GAAP cost of
sales
|
$
1,071
|
|
$
1,096
|
|
$
3,951
|
|
$
3,994
|
|
|
|
|
|
|
|
|
GAAP cost of sales
as a percentage of product sales
|
26.7 %
|
|
27.4 %
|
|
25.8 %
|
|
26.6 %
|
Acquisition-related
expenses (a)
|
(10.4)
|
|
(9.8)
|
|
(9.9)
|
|
(10.1)
|
Other
|
0.0
|
|
(0.1)
|
|
0.0
|
|
(0.1)
|
Non-GAAP cost of
sales as a percentage of product sales
|
16.3 %
|
|
17.5 %
|
|
15.9 %
|
|
16.4 %
|
|
|
|
|
|
|
|
|
GAAP research and
development expenses
|
$
1,324
|
|
$
1,348
|
|
$
4,434
|
|
$
4,819
|
Adjustments to
research and development expenses:
|
|
|
|
|
|
|
|
Acquisition-related
expenses (a)
|
(33)
|
|
(29)
|
|
(93)
|
|
(123)
|
Non-GAAP research
and development expenses
|
$
1,291
|
|
$
1,319
|
|
$
4,341
|
|
$
4,696
|
|
|
|
|
|
|
|
|
GAAP research and
development expenses as a percentage of product
sales
|
20.2 %
|
|
21.5 %
|
|
17.9 %
|
|
19.8 %
|
Acquisition-related
expenses (a)
|
(0.5)
|
|
(0.5)
|
|
(0.4)
|
|
(0.5)
|
Non-GAAP research
and development expenses as a percentage of product
sales
|
19.7 %
|
|
21.0 %
|
|
17.5 %
|
|
19.3 %
|
|
|
|
|
|
|
|
|
GAAP selling,
general and administrative expenses
|
$
1,572
|
|
$
1,425
|
|
$
5,414
|
|
$
5,368
|
Adjustments to
selling, general and administrative expenses:
|
|
|
|
|
|
|
|
Acquisition-related
expenses (a)
|
(104)
|
|
(20)
|
|
(144)
|
|
(87)
|
Other
|
—
|
|
29
|
|
—
|
|
(16)
|
Total adjustments
to selling, general and administrative expenses
|
(104)
|
|
9
|
|
(144)
|
|
(103)
|
Non-GAAP selling,
general and administrative expenses
|
$
1,468
|
|
$
1,434
|
|
$
5,270
|
|
$
5,265
|
|
|
|
|
|
|
|
|
GAAP selling,
general and administrative expenses as a percentage of product
sales
|
24.0 %
|
|
22.7 %
|
|
21.8 %
|
|
22.1 %
|
Acquisition-related
expenses (a)
|
(1.6)
|
|
(0.3)
|
|
(0.6)
|
|
(0.4)
|
Other
|
0.0
|
|
0.5
|
|
0.0
|
|
0.0
|
Non-GAAP selling,
general and administrative expenses as a percentage of product
sales
|
22.4 %
|
|
22.9 %
|
|
21.2 %
|
|
21.7 %
|
|
|
|
|
|
|
|
|
GAAP operating
expenses
|
$
4,609
|
|
$
4,542
|
|
$ 16,757
|
|
$ 18,340
|
Adjustments to
operating expenses:
|
|
|
|
|
|
|
|
Adjustments to cost of
sales
|
(676)
|
|
(622)
|
|
(2,455)
|
|
(2,460)
|
Adjustments to
research and development expenses
|
(33)
|
|
(29)
|
|
(93)
|
|
(123)
|
Adjustments to
selling, general and administrative expenses
|
(104)
|
|
9
|
|
(144)
|
|
(103)
|
Certain charges
pursuant to our cost savings initiatives
|
1
|
|
(1)
|
|
8
|
|
(130)
|
Certain other expenses
(b)
|
33
|
|
(50)
|
|
(511)
|
|
(64)
|
Total adjustments
to operating expenses
|
(779)
|
|
(693)
|
|
(3,195)
|
|
(2,880)
|
Non-GAAP operating
expenses
|
$
3,830
|
|
$
3,849
|
|
$ 13,562
|
|
$ 15,460
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months
ended
December
31,
|
|
Twelve months
ended
December
31,
|
|
2022
|
|
2021
|
|
2022
|
|
2021
|
GAAP operating
income
|
$
2,230
|
|
$
2,304
|
|
$
9,566
|
|
$
7,639
|
Adjustments to
operating expenses
|
779
|
|
693
|
|
3,195
|
|
2,880
|
Non-GAAP operating
income
|
$
3,009
|
|
$
2,997
|
|
$ 12,761
|
|
$ 10,519
|
|
|
|
|
|
|
|
|
GAAP operating
income as a percentage of product sales
|
34.0 %
|
|
36.7 %
|
|
38.6 %
|
|
31.4 %
|
Adjustments to cost of
sales
|
10.4
|
|
9.9
|
|
9.9
|
|
10.2
|
Adjustments to
research and development expenses
|
0.5
|
|
0.5
|
|
0.4
|
|
0.5
|
Adjustments to
selling, general and administrative expenses
|
1.6
|
|
(0.2)
|
|
0.6
|
|
0.4
|
Certain charges
pursuant to our cost savings initiatives
|
0.0
|
|
0.0
|
|
0.0
|
|
0.5
|
Certain other expenses
(b)
|
(0.6)
|
|
0.9
|
|
2.0
|
|
0.3
|
Non-GAAP operating
income as a percentage of product sales
|
45.9 %
|
|
47.8 %
|
|
51.5 %
|
|
43.3 %
|
|
|
|
|
|
|
|
|
GAAP interest
expense, net
|
$
(415)
|
|
$
(335)
|
|
$ (1,406)
|
|
$ (1,197)
|
Adjustments to
interest expense, net:
|
|
|
|
|
|
|
|
Acquisition-related
interest expense (c)
|
5
|
|
—
|
|
5
|
|
—
|
Non-GAAP interest
expense, net
|
$
(410)
|
|
$
(335)
|
|
$ (1,401)
|
|
(1,197)
|
|
|
|
|
|
|
|
|
GAAP other (expense)
income, net
|
$
(67)
|
|
$
162
|
|
$
(814)
|
|
$
259
|
Adjustments to
other (expense) income, net:
|
|
|
|
|
|
|
|
Equity method
investment basis difference amortization
|
49
|
|
45
|
|
192
|
|
173
|
Net (gains)/losses
from equity investments
|
(39)
|
|
(86)
|
|
362
|
|
(421)
|
Total adjustments
to other (expense) income, net
|
10
|
|
(41)
|
|
554
|
|
(248)
|
Non-GAAP other
(expense) income, net
|
$
(57)
|
|
$
121
|
|
$
(260)
|
|
11
|
|
|
|
|
|
|
|
|
GAAP income before
income taxes
|
$
1,748
|
|
$
2,131
|
|
$
7,346
|
|
$
6,701
|
Adjustments to
income before income taxes:
|
|
|
|
|
|
|
|
Adjustments to
operating expenses
|
779
|
|
693
|
|
3,195
|
|
2,880
|
Adjustments to
interest expense, net
|
5
|
|
—
|
|
5
|
|
—
|
Adjustments to other
(expense) income, net
|
10
|
|
(41)
|
|
554
|
|
(248)
|
Total adjustments
to income before income taxes
|
794
|
|
652
|
|
3,754
|
|
2,632
|
Non-GAAP income
before income taxes
|
$
2,542
|
|
$
2,783
|
|
$ 11,100
|
|
$
9,333
|
|
|
|
|
|
|
|
|
GAAP provision for
income taxes
|
$
132
|
|
$
232
|
|
$
794
|
|
$
808
|
Adjustments to
provision for income taxes:
|
|
|
|
|
|
|
|
Income tax effect of
the above adjustments (d)
|
163
|
|
78
|
|
690
|
|
544
|
Other income tax
adjustments (c)
|
45
|
|
(14)
|
|
46
|
|
3
|
Total adjustments
to provision for income taxes
|
208
|
|
64
|
|
736
|
|
547
|
Non-GAAP provision
for income taxes
|
$
340
|
|
$
296
|
|
$
1,530
|
|
$
1,355
|
|
|
|
|
|
|
|
|
GAAP tax as a
percentage of income before taxes
|
7.6 %
|
|
10.9 %
|
|
10.8 %
|
|
12.1 %
|
Adjustments to
provision for income taxes:
|
|
|
|
|
|
|
|
Income tax effect of
the above adjustments (d)
|
4.0
|
|
0.2
|
|
2.6
|
|
2.4
|
Other income tax
adjustments (c)
|
1.8
|
|
(0.5)
|
|
0.4
|
|
0.0
|
Total adjustments
to provision for income taxes
|
5.8
|
|
(0.3)
|
|
3.0
|
|
2.4
|
Non-GAAP tax as a
percentage of income before taxes
|
13.4 %
|
|
10.6 %
|
|
13.8 %
|
|
14.5 %
|
|
|
|
|
|
|
|
|
GAAP net
income
|
$
1,616
|
|
$
1,899
|
|
$
6,552
|
|
$
5,893
|
Adjustments to net
income:
|
|
|
|
|
|
|
|
Adjustments to income
before income taxes, net of the income tax effect
|
631
|
|
574
|
|
3,064
|
|
2,088
|
Other income tax
adjustments (c)
|
(45)
|
|
14
|
|
(46)
|
|
(3)
|
Total adjustments
to net income
|
586
|
|
588
|
|
3,018
|
|
2,085
|
Non-GAAP net
income
|
$
2,202
|
|
$
2,487
|
|
$
9,570
|
|
$
7,978
|
|
|
|
|
|
|
|
|
Note: Numbers may not
add due to rounding
|
|
|
|
|
|
|
|
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,
2022
|
|
Three months
ended
December 31,
2021
|
|
GAAP
|
|
Non-GAAP
|
|
GAAP
|
|
Non-GAAP
|
Net income
|
$
1,616
|
|
$
2,202
|
|
$
1,899
|
|
$
2,487
|
|
|
|
|
|
|
|
|
Weighted-average
shares for diluted EPS
|
539
|
|
539
|
|
565
|
|
565
|
|
|
|
|
|
|
|
|
Diluted EPS
|
$
3.00
|
|
$
4.09
|
|
$
3.36
|
|
$
4.40
|
|
|
|
|
|
|
|
|
|
Twelve months
ended
December 31,
2022
|
|
Twelve months
ended
December 31,
2021
|
|
GAAP
|
|
Non-GAAP
|
|
GAAP
|
|
Non-GAAP
|
Net income
|
$
6,552
|
|
$
9,570
|
|
$
5,893
|
|
$
7,978
|
|
|
|
|
|
|
|
|
Weighted-average
shares for diluted EPS
|
541
|
|
541
|
|
573
|
|
573
|
|
|
|
|
|
|
|
|
Diluted EPS
|
$
12.11
|
|
$
17.69
|
|
$
10.28
|
|
$
13.92
|
|
|
|
(a)
|
|
The adjustments related
primarily to noncash amortization of intangible assets from
business acquisitions.
|
|
|
|
(b)
|
|
For the three months
ended December 31, 2022, the adjustments related primarily to the
change in fair values of contingent consideration liabilities. For
the twelve months ended December 31, 2022, the adjustments related
primarily to cumulative foreign currency translation adjustments
from a nonstrategic divestiture. For the three and twelve months
ended December 31, 2021, the adjustments related primarily to the
change in fair values of contingent consideration
liabilities.
|
|
|
|
(c)
|
|
The adjustments related
to certain acquisition items, prior period and other items excluded
from GAAP earnings.
|
|
|
|
(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 rate for the adjustments to our GAAP
income before income taxes, for the three and twelve months ended
December 31, 2022, were 20.5% and 18.4%, respectively, compared to
12.0% and 20.7% for the corresponding period of the prior
year.
|
Amgen
Inc. Reconciliations of Cash Flows (In
millions) (Unaudited)
|
|
|
Three months
ended
December
31,
|
|
Twelve months
ended
December
31,
|
|
2022
|
|
2021
|
|
2022
|
|
2021
|
Net cash provided by
operating activities
|
$ 2,649
|
|
$ 2,808
|
|
$ 9,721
|
|
$ 9,261
|
Net cash (used in)
provided by investing activities
|
(3,473)
|
|
(230)
|
|
(6,044)
|
|
733
|
Net cash used in
financing activities
|
(1,049)
|
|
(6,558)
|
|
(4,037)
|
|
(8,271)
|
(Decrease) increase in
cash and cash equivalents
|
(1,873)
|
|
(3,980)
|
|
(360)
|
|
1,723
|
Cash and cash
equivalents at beginning of period
|
9,502
|
|
11,969
|
|
7,989
|
|
6,266
|
Cash and cash
equivalents at end of period
|
$ 7,629
|
|
$ 7,989
|
|
$ 7,629
|
|
$ 7,989
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months
ended
December
31,
|
|
Twelve months
ended
December
31,
|
|
2022
|
|
2021
|
|
2022
|
|
2021
|
Net cash provided by
operating activities
|
$ 2,649
|
|
$ 2,808
|
|
$ 9,721
|
|
$ 9,261
|
Capital
expenditures
|
(340)
|
|
(287)
|
|
(936)
|
|
(880)
|
Free cash
flow
|
$ 2,309
|
|
$ 2,521
|
|
$ 8,785
|
|
$ 8,381
|
Amgen
Inc. Reconciliation of Total Revenues and Product Sales
Adjusted for Foreign Currency Exchange Rate Impact
(Dollars in millions) (Unaudited)
|
|
|
Three months
ended
December
31,
|
|
|
|
|
|
|
|
|
|
|
|
2022
|
|
2021
|
|
Change
|
|
FX impact $
(a)
|
|
Three months
ended
December 31,
2022
excluding FX
|
|
FX impact %
(a)
|
|
Change
excluding FX
|
Product
Sales
|
$
6,552
|
|
$
6,271
|
|
4 %
|
|
$
(155)
|
|
$
6,707
|
|
(2 %)
|
|
7 %
|
Total
Revenues
|
$
6,839
|
|
$
6,846
|
|
— %
|
|
$
(155)
|
|
$
6,994
|
|
(2 %)
|
|
2 %
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Twelve months
ended
December
31,
|
|
|
|
|
|
|
|
|
|
|
|
2022
|
|
2021
|
|
Change
|
|
FX impact $
(a)
|
|
Twelve
months
ended December 31,
2022
excluding FX
|
|
FX impact %
(a)
|
|
Change
excluding FX
|
Product
Sales
|
$ 24,801
|
|
$ 24,297
|
|
2 %
|
|
$
(548)
|
|
$ 25,349
|
|
(2 %)
|
|
4 %
|
Total
Revenues
|
$ 26,323
|
|
$ 25,979
|
|
1 %
|
|
$
(548)
|
|
$ 26,871
|
|
(2 %)
|
|
3 %
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(a)
|
|
Foreign currency
impact was calculated by converting our current period local
currency Product sales using the prior period foreign currency
exchange rates and comparing that to our current period Product
sales.
|
Amgen
Inc. Reconciliation of GAAP Net Income to EBITDA and Debt
Leverage Ratio Calculation (Dollars in
millions) (Unaudited)
|
|
|
Twelve months ended
December 31, 2022
|
|
GAAP Net Income
|
$
6,552
|
Depreciation and
amortization
|
3,417
|
Interest expense,
net
|
1,406
|
Provision for income
taxes
|
794
|
EBITDA
|
$
12,169
|
|
|
|
As of December 31,
2022
|
|
Current portion of
long-term debt
|
$
1,591
|
Long-term
debt
|
37,354
|
Total Debt
|
$
38,945
|
|
|
|
As of December 31,
2022
|
|
Total Debt
|
$
38,945
|
EBITDA
|
$
12,169
|
Debt leverage ratio
|
3.2
|
Amgen Inc.
Reconciliation of GAAP EPS Guidance to Non-GAAP
EPS Guidance for the Year Ending December 31, 2023
(Unaudited)
|
|
|
GAAP diluted EPS
guidance
|
|
$
13.16
|
—
|
$ 14.41
|
Known adjustments to
arrive at non-GAAP*:
|
|
|
|
|
Acquisition-related
expenses (a)
|
|
4.19
|
—
|
4.24
|
Non-GAAP diluted EPS
guidance
|
|
$
17.40
|
—
|
$ 18.60
|
|
* The known adjustments
are presented net of their related tax impact, which amount to
approximately $1.15 per share.
|
|
(a) The adjustments
relate primarily to noncash amortization of intangible assets
acquired in business acquisitions.
|
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, including any impact of
the proposed Horizon Therapeutics plc acquisition, divestitures,
asset impairments, litigation, changes in fair value of our
contingent consideration obligations and changes in fair value of
our equity investments.
Reconciliation of
GAAP Tax Rate Guidance to Non-GAAP Tax Rate Guidance for
the Year Ending December 31,
2023 (Unaudited)
|
|
GAAP tax rate
guidance
|
|
17.0 %
|
—
|
18.5 %
|
Tax rate of known
adjustments discussed above
|
|
0.5 %
|
—
|
1.0 %
|
Non-GAAP tax rate
guidance
|
|
18.0 %
|
—
|
19.0 %
|
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SOURCE Amgen