THOUSAND
OAKS, Calif., Feb. 6, 2024
/PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced financial
results for the fourth quarter and full year 2023 versus comparable
periods in 2022.
"2023 was another year of performance and
progress for our company," said Robert A.
Bradway, chairman and chief executive officer. "Our marketed
products are reaching many more patients around the world, and we
anticipate more than a dozen significant pipeline milestones in
2024."
Key results include:
- For the fourth quarter, total revenues increased 20% to
$8.2 billion in comparison to the
fourth quarter of 2022. Product sales grew 20%, driven by 23%
volume growth, partially offset by 3% lower net selling price.
- Nine brands(1) achieved record sales in the quarter,
and Repatha® (evolocumab), EVENITY®
(romosozumab-aqqg), Prolia® (denosumab) and
BLINCYTO® (blinatumomab) delivered double-digit volume
growth globally.
- U.S. volume grew 26% and ex-U.S. volume grew 15%, including 46%
volume growth in the Asia Pacific
region.
- Our performance included $954
million of sales for the period of Oct. 6 - Dec. 31 from our recent Horizon
Therapeutics (Horizon) acquisition, driven by several
first-in-class, early-in-lifecycle medicines such as
TEPEZZA® (teprotumumab-trbw), KRYSTEXXA®
(pegloticase) and UPLIZNA® (inebilizumab-cdon).
Excluding the impact of these sales from Horizon, our product sales
grew 5%, driven by volume growth of 9%.
- For the full year, total revenues increased 7% to $28.2 billion, resulting from a 9% increase in
product sales. Product sales growth was driven by 15% volume
growth, partially offset by 3% lower net selling price, 1%
unfavorable changes from estimated sales deductions and 1% negative
impact from foreign exchange.
- GAAP earnings per share (EPS) decreased 53% from $3.00 to $1.42 in
the fourth quarter, driven by acquisition-related expenses and
incremental operating expenses from Horizon, partially offset by
increased revenues. For the full year, GAAP EPS increased 3% from
$12.11 to $12.49 driven by net gains on our BeiGene, Ltd
equity investment in 2023 and higher revenues, partially offset by
higher operating expenses, including acquisition-related expenses
and incremental expenses from Horizon.
- For the fourth quarter, GAAP operating income decreased from
$2.2 billion to $1.3 billion, and GAAP operating margin decreased
17.8 percentage points to 16.2%. For the full year, GAAP operating
income decreased from $9.6 billion to
$7.9 billion, and GAAP operating
margin decreased 9.3 percentage points to 29.3%.
- Non-GAAP EPS increased 15% from $4.09 to $4.71 in
the fourth quarter and increased 5% from $17.69 to $18.65
for the full year, driven by increased revenues, partially offset
by higher operating expenses, including incremental expenses from
Horizon. Fourth quarter non-GAAP EPS was also unfavorably impacted
by higher interest expense.
- For the fourth quarter, non-GAAP operating income increased
from $3.0 billion to $3.7 billion, and non-GAAP operating margin
increased 0.8 percentage points to 46.7%. For the full year,
non-GAAP operating income increased from $12.8 billion to $13.4
billion, and non-GAAP operating margin decreased 1.7
percentage points to 49.8%.
- The Company generated $7.4
billion of free cash flow for the full year versus
$8.8 billion in 2022. The decrease in
2023 was primarily driven by transaction expenses related to the
Horizon acquisition and higher repatriation tax payments.
(1) Includes product sales
for the full fourth quarter of 2023 from UPLIZNA and KRYSTEXXA in
connection with Horizon acquisition.
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),
"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.
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 20% for the fourth quarter of
2023 versus the fourth quarter of 2022. Volume grew 23%, partially
offset by 3% lower net selling price. Full year product sales
increased 9% versus 2022, driven by 15% volume growth, partially
offset by 3% lower net selling price, 1% unfavorable changes from
estimated sales deductions and 1% negative impact from foreign
exchange.
General Medicine
- Repatha® sales increased 25% year-over-year
for the fourth quarter, driven by 35% volume growth, partially
offset by lower net selling price. Full year sales increased 26%,
driven by 37% volume growth, partially offset by lower net selling
price. Repatha remains the global proprotein convertase
subtilisin/kexin type 9 (PCSK9) segment leader, with over 2.5
million patients treated since launch.
- Prolia® sales increased 12% year-over-year,
to a record $1.1 billion for the
fourth quarter, and 12% for the full year, primarily driven by
volume growth and higher net selling price. Volume grew 10% for the
quarter and 9% for the full year. In 2023, over 7.5 million
patients were treated with Prolia.
- EVENITY® sales increased 41% year-over-year
to a record $318 million for the
fourth quarter and 47% for the full year, driven by strong volume
growth. U.S. volume grew 44% year-over-year and volume outside the
U.S. grew 55% for the full year.
- Aimovig® (erenumab-aooe) sales decreased 32%
year-over-year for the fourth quarter and 22% for the full year,
driven by lower net selling price.
Oncology
- BLINCYTO® sales increased 47% year-over-year
to a record $241 million for the
fourth quarter and 48% for the full year, driven by 55% and 49%
volume growth, respectively. Volume growth was supported by broad
prescribing across academic and community settings for patients
with B-cell precursor acute lymphoblastic leukemia.
- Vectibix® (panitumumab) sales increased 5%
year-over-year for the fourth quarter and 10% for the full year,
driven by 5% and 10% volume growth, respectively.
- KYPROLIS® (carfilzomib) sales increased 8%
year-over-year for the fourth quarter and 13% for the full year,
driven by 8% and 12% volume growth, respectively.
- LUMAKRAS®/LUMYKRAS™ (sotorasib) sales
increased 8% year-over-year for the fourth quarter, driven by 5%
volume growth and higher net selling price. Full year sales
decreased 2%, driven by unfavorable changes to estimated sales
deductions, including changes related to ongoing reimbursement
negotiations in France. Full year
sales were also impacted by lower net selling price and lower
inventory levels, partially offset by 16% volume growth.
- XGEVA® (denosumab) sales increased 9%
year-over-year for the fourth quarter and 5% for the full year,
primarily driven by higher net selling price.
- Nplate® (romiplostim) sales decreased 18%
year-over-year for the fourth quarter, driven by volume decline
related to timing of orders placed by the U.S. government,
partially offset by volume growth across our U.S. and ex-U.S.
regions. U.S. government orders were $207
million in Q4'22 compared to $62
million in Q4'23. Full year sales increased 13%, primarily
driven by volume growth, including U.S. government orders. U.S.
government orders were $207 million
for FY'22 compared to $286 million
for FY'23. Excluding these U.S. government orders, Nplate
sales grew 23% year-over-year for the fourth quarter and 8% for the
full year.
- MVASI® (bevacizumab-awwb) sales decreased 8%
year-over-year for the fourth quarter, primarily driven by lower
net selling price, partially offset by 12% volume growth. Full year
sales decreased 11%, primarily driven by lower net selling price,
partially offset by 13% volume growth. Going forward, we expect
continued net selling price erosion driven by increased
competition.
- KANJINTI® (trastuzumab-anns) sales decreased
33% year-over-year for the fourth quarter and 50% for the full
year, driven by lower net selling price and volume decline.
Inflammation
- TEZSPIRE® (tezepelumab-ekko) generated
$177 million of sales in the fourth
quarter. Quarter-over-quarter sales increased 10%, driven by 18%
volume growth that benefited from the pre-filled, single-use pen,
which was approved for self-administration by the U.S. Food and
Drug Administration (FDA) in the first quarter. Healthcare
providers recognize 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.
- Otezla® (apremilast) sales increased 2%
year-over-year for the fourth quarter, driven by favorable changes
to estimated sales deductions and 3% volume growth, partially
offset by lower inventory levels and lower net selling price. Full
year sales decreased 4%, driven by lower net selling price and
lower inventory levels, partially offset by 2% volume growth.
We expect future growth for Otezla to be driven by its established
efficacy and safety profile, strong payer coverage with limited
prior authorization requirements and ease of administration. Otezla
remains the only approved oral systemic therapy with a broad
indication and is well-positioned to help the 1.5 million U.S.
patients with mild-to-moderate psoriasis who cannot be optimally
addressed by a topical and can benefit from a systemic treatment
like Otezla.
- Enbrel® (etanercept) sales decreased 8%
year-over-year for the fourth quarter, driven by a 4% impact from
unfavorable changes to estimated sales deductions and lower net
selling price. Full year sales decreased 10%, driven by lower net
selling price, lower inventory levels and a 3% impact from
unfavorable changes to estimated sales deductions. Year-over-year
volume remained flat, with U.S. volume growing 1% in the fourth
quarter, supported by an increase in new patients starting
treatment as a result of improved payer coverage. Going forward, we
expect net selling price to continue to decline year-over-year,
driven by higher rebates to maintain broad first-line payer
coverage and changes in patient mix.
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.
- AMJEVITA®/AMGEVITA™ (adalimumab) sales
increased 34% year-over-year for the fourth quarter and 36% for the
full year, primarily driven by 35% and 46% volume growth,
respectively. Ex-U.S. sales increased 9% for the full year, driven
by 20% volume growth, partially offset by lower net selling price.
U.S. sales increased 43% quarter-over-quarter, driven by higher
inventory levels and higher net selling price, partially offset by
volume decline.
Rare Disease
Excluding TAVNEOS®, the products listed below were
acquired from our Horizon transaction on Oct. 6, 2023. Sales figures reflect only sales in
the period from Oct. 6 2023 through
the end of the year, and not the full quarter.
- TEPEZZA® (teprotumumab-trbw) generated
$448 million of sales for the period.
TEPEZZA is the first and only FDA-approved treatment for
thyroid eye disease (TED).
- KRYSTEXXA® (pegloticase) generated
$272 million of sales for the period.
KRYSTEXXA is the first and only FDA-approved treatment for chronic
refractory gout.
- UPLIZNA® (inebilizumab-cdon) generated
$65 million of sales for the period.
UPLIZNA is used to treat adults with neuromyelitis optica
spectrum disorders (NMOSD).
- TAVNEOS® (avacopan) generated $44 million of sales in the fourth quarter.
Quarter-over-quarter sales increased 19%, primarily driven by
volume growth. U.S. volume grew 23% quarter-over-quarter. In the
U.S., approximately 2,700 patients have now been treated with
TAVNEOS.
- Ultra rare products, which consist of
RAVICTI® (glycerol phenylbutyrate),
PROCYSBI® (cysteamine bitartrate),
ACTIMMUNE® (interferon gamma-1b),
BUPHENYL® (sodium phenylbutyrate) and
QUINSAIR® (levofloxacin) generated $164 million of sales for the period.
Established Products
- Total sales of our established products, which consist of
EPOGEN® (epoetin alfa), Aranesp®
(darbepoetin alfa), Parsabiv® (etelcalcetide)
and Neulasta® (pegfilgrastim), decreased 10%
year-over-year for the fourth quarter, primarily driven by lower
net selling price and volume declines, partially offset by
favorable changes to estimated sales deductions. Full year sales
decreased 19%, driven by lower net selling price and volume
declines. In the aggregate, we expect the year-over-year net
selling price and volume declines for this portfolio of products to
continue.
Product Sales Detail by Product and Geographic Region
$Millions, except
percentages
|
|
Q4
'23
|
|
Q4
'22
|
|
YOY Δ
|
|
|
US
|
|
ROW
|
|
TOTAL
|
|
TOTAL
|
|
TOTAL
|
Repatha®
|
|
$
201
|
|
$
216
|
|
$
417
|
|
$
333
|
|
25 %
|
Prolia®
|
|
746
|
|
361
|
|
1,107
|
|
992
|
|
12 %
|
EVENITY®
|
|
239
|
|
79
|
|
318
|
|
225
|
|
41 %
|
Aimovig®
|
|
73
|
|
5
|
|
78
|
|
114
|
|
(32 %)
|
BLINCYTO®
|
|
148
|
|
93
|
|
241
|
|
164
|
|
47 %
|
Vectibix®
|
|
116
|
|
135
|
|
251
|
|
238
|
|
5 %
|
KYPROLIS®
|
|
222
|
|
128
|
|
350
|
|
325
|
|
8 %
|
LUMAKRAS®/LUMYKRAS™
|
|
51
|
|
26
|
|
77
|
|
71
|
|
8 %
|
XGEVA®
|
|
382
|
|
145
|
|
527
|
|
484
|
|
9 %
|
Nplate®
|
|
252
|
|
134
|
|
386
|
|
469
|
|
(18 %)
|
MVASI®
|
|
127
|
|
61
|
|
188
|
|
205
|
|
(8 %)
|
KANJINTI®
|
|
31
|
|
11
|
|
42
|
|
63
|
|
(33 %)
|
TEZSPIRE®
|
|
177
|
|
—
|
|
177
|
|
79
|
|
*
|
Otezla®
|
|
526
|
|
103
|
|
629
|
|
616
|
|
2 %
|
Enbrel®
|
|
1,005
|
|
10
|
|
1,015
|
|
1,098
|
|
(8 %)
|
AMJEVITA®/AMGEVITA™
|
|
33
|
|
127
|
|
160
|
|
119
|
|
34 %
|
TEPEZZA®**
|
|
441
|
|
7
|
|
448
|
|
—
|
|
NM
|
KRYSTEXXA®**
|
|
272
|
|
—
|
|
272
|
|
—
|
|
NM
|
UPLIZNA®**
|
|
60
|
|
5
|
|
65
|
|
—
|
|
NM
|
TAVNEOS®
|
|
42
|
|
2
|
|
44
|
|
21
|
|
*
|
Ultra rare
products**
|
|
162
|
|
2
|
|
164
|
|
—
|
|
NM
|
EPOGEN®
|
|
55
|
|
—
|
|
55
|
|
114
|
|
(52 %)
|
Aranesp®
|
|
107
|
|
212
|
|
319
|
|
348
|
|
(8 %)
|
Parsabiv®
|
|
57
|
|
32
|
|
89
|
|
93
|
|
(4 %)
|
Neulasta®
|
|
208
|
|
31
|
|
239
|
|
221
|
|
8 %
|
Other
products***
|
|
137
|
|
38
|
|
175
|
|
160
|
|
9 %
|
Total product
sales
|
|
$ 5,870
|
|
$ 1,963
|
|
$ 7,833
|
|
$ 6,552
|
|
20 %
|
|
|
|
|
|
|
|
|
|
|
|
*Change in excess of
100%
|
|
**Products were
acquired from our Horizon acquisition on Oct. 6, 2023, and include
product sales from the
acquisition date through Dec. 31, 2023. Ultra rare products
consist of RAVICTI®, PROCYSBI®,
ACTIMMUNE®,
BUPHENYL® and QUINSAIR®
|
|
***Consists of (i)
RIABNI®, AVSOLA®, Corlanor®,
NEUPOGEN®, IMLYGIC®,
Sensipar®/Mimpara™ and
BEKEMV™,
where Biosimilars total $93 million in Q4 '23 and $52 million in Q4
'22; (ii) RAYOS®, PENNSAID® and
DUEXIS®
product sales from our Horizon acquisition on Oct. 6, 2023 through
Dec. 31, 2023; and (iii) sales prior to the
divestiture of our Bergamo and Gensenta subsidiaries in the second
quarter of 2023 and fourth quarter of
2022, respectively
|
|
NM = not
meaningful
|
|
|
|
|
|
|
|
|
|
|
$Millions, except
percentages
|
|
FY
'23
|
|
FY
'22
|
|
YOY Δ
|
|
|
US
|
|
ROW
|
|
TOTAL
|
|
TOTAL
|
|
TOTAL
|
Repatha®
|
|
$
793
|
|
$
842
|
|
$ 1,635
|
|
$ 1,296
|
|
26 %
|
Prolia®
|
|
2,733
|
|
1,315
|
|
4,048
|
|
3,628
|
|
12 %
|
EVENITY®
|
|
809
|
|
351
|
|
1,160
|
|
787
|
|
47 %
|
Aimovig®
|
|
303
|
|
20
|
|
323
|
|
414
|
|
(22 %)
|
BLINCYTO®
|
|
566
|
|
295
|
|
861
|
|
583
|
|
48 %
|
Vectibix®
|
|
461
|
|
523
|
|
984
|
|
893
|
|
10 %
|
KYPROLIS®
|
|
921
|
|
482
|
|
1,403
|
|
1,247
|
|
13 %
|
LUMAKRAS®/LUMYKRAS™
|
|
197
|
|
83
|
|
280
|
|
285
|
|
(2 %)
|
XGEVA®
|
|
1,527
|
|
585
|
|
2,112
|
|
2,014
|
|
5 %
|
Nplate®
|
|
996
|
|
481
|
|
1,477
|
|
1,307
|
|
13 %
|
MVASI®
|
|
511
|
|
289
|
|
800
|
|
901
|
|
(11 %)
|
KANJINTI®
|
|
109
|
|
50
|
|
159
|
|
316
|
|
(50 %)
|
TEZSPIRE®
|
|
567
|
|
—
|
|
567
|
|
170
|
|
*
|
Otezla®
|
|
1,777
|
|
411
|
|
2,188
|
|
2,288
|
|
(4 %)
|
Enbrel®
|
|
3,650
|
|
47
|
|
3,697
|
|
4,117
|
|
(10 %)
|
AMJEVITA®/AMGEVITA™
|
|
126
|
|
500
|
|
626
|
|
460
|
|
36 %
|
TEPEZZA®**
|
|
441
|
|
7
|
|
448
|
|
—
|
|
NM
|
KRYSTEXXA®**
|
|
272
|
|
—
|
|
272
|
|
—
|
|
NM
|
UPLIZNA®**
|
|
60
|
|
5
|
|
65
|
|
—
|
|
NM
|
TAVNEOS®
|
|
126
|
|
8
|
|
134
|
|
21
|
|
*
|
Ultra Rare
products**
|
|
162
|
|
2
|
|
164
|
|
—
|
|
NM
|
EPOGEN®
|
|
226
|
|
—
|
|
226
|
|
506
|
|
(55 %)
|
Aranesp®
|
|
452
|
|
910
|
|
1,362
|
|
1,421
|
|
(4 %)
|
Parsabiv®
|
|
228
|
|
134
|
|
362
|
|
382
|
|
(5 %)
|
Neulasta®
|
|
710
|
|
138
|
|
848
|
|
1,126
|
|
(25 %)
|
Other
products***
|
|
549
|
|
160
|
|
709
|
|
639
|
|
11 %
|
Total product
sales
|
|
$
19,272
|
|
$ 7,638
|
|
$
26,910
|
|
$
24,801
|
|
9 %
|
|
|
|
|
|
|
|
|
|
|
|
*Change in excess of
100%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
**Products were
acquired from our Horizon acquisition on Oct. 6, 2023, and include
product sales from the acquisition date through Dec. 31, 2023.
Ultra rare products consist of RAVICTI®,
PROCYSBI®, ACTIMMUNE®, BUPHENYL®
and QUINSAIR®
|
|
***Consists of (i)
AVSOLA®, RIABNI®, Corlanor®,
NEUPOGEN®, IMLYGIC®,
Sensipar®/Mimpara™ and BEKEMV™,
where Biosimilars total $331 million in FY '23 and $154 million in
FY '22; (ii) RAYOS®, PENNSAID® and
DUEXIS® product sales from our Horizon acquisition on
Oct. 6, 2023 through Dec. 31, 2023; and (iii) sales prior to the
divestiture of our Bergamo and Gensenta subsidiaries in the second
quarter of 2023 and fourth quarter of 2022, respectively
|
|
NM = not
meaningful
|
|
|
|
|
|
|
|
|
|
|
Operating Expense, Operating Margin and Tax Rate
Analysis
On a GAAP basis:
- Total Operating Expenses increased 50%
year-over-year for the fourth quarter. For the full year, Total
Operating Expenses increased 21%. Cost of Sales as a
percentage of product sales increased 13.0 percentage points in the
fourth quarter primarily driven by higher amortization expense from
acquisition-related assets as well as higher profit share and
royalties, partially offset by Puerto
Rico excise tax, changes in product mix, and lower
manufacturing cost. For the full year, cost of sales as a
percentage of product sales increased 5.6 percentage points
primarily driven by higher amortization expense from
acquisition-related assets, higher profit share and royalties, and
changes in product mix, partially offset by Puerto Rico excise tax. Research &
Development (R&D) expenses increased 16% in the fourth
quarter and increased 8% for the full year driven by higher spend
in later-stage clinical programs and marketed products support,
including spend from programs acquired from the Horizon
acquisition. Selling, General & Administrative
(SG&A) expenses increased 45% in the fourth quarter and
increased 14% for the full year primarily driven by higher
acquisition-related costs, in addition to commercial and general
administrative expenses related to the Horizon acquisition. For the
full year, this was partially offset by a decline in other marketed
product spend. Other operating expenses for the full year
consisted of net impairment charges for AMG 340 and Teneobio
IPR&D assets in addition to expenses related to our
restructuring plan initiated in the first quarter of 2023.
- Operating Margin as a percentage of product sales
decreased 17.8 percentage points to 16.2% in the fourth quarter and
decreased 9.3 percentage points for the full year to 29.3%.
- Tax Rate increased 2.4 percentage points in the fourth
quarter and increased 3.7 percentage points for the full year,
primarily driven by the 2022 Puerto Rico tax law change that
replaced the excise tax with an income tax beginning in 2023. For
the fourth quarter this was partially offset by the change in
earnings mix.
On a non-GAAP basis:
- Total Operating Expenses increased 18% for the fourth
quarter and increased 9% for the full year. Cost of
Sales as a percentage of product sales remained flat in
the fourth quarter primarily driven by higher profit share and
royalties, offset by Puerto Rico
excise tax, changes in product mix, and lower manufacturing cost.
For the full year, cost of sales as a percentage of product sales
increased 1.1 percentage points primarily driven by higher profit
share and royalties and changes in product mix, partially offset by
Puerto Rico excise tax.
R&D expenses increased 16% in the fourth quarter and
increased 8% for the full year driven by higher spend in
later-stage clinical programs and marketed products support,
including spend from programs acquired from the Horizon
acquisition. SG&A expenses increased 20% in the fourth
quarter and increased 5% for the full year primarily driven by
higher commercial and general administrative expenses related to
the Horizon acquisition. For the full year, this was partially
offset by a decline in other marketed product spend.
- Operating Margin as a percentage of product sales
increased 0.8 pts. percentage points to 46.7% in the fourth quarter
and decreased 1.7 percentage points for the full year to 49.8%.
- Tax Rate increased 2.5 percentage points in the
fourth quarter and increased 2.7 percentage points for the full
year primarily due to the 2022 Puerto Rico tax law change that
replaced the excise tax with an income tax beginning in 2023.
$Millions, except
percentages
|
|
GAAP
|
|
Non-GAAP
|
|
|
Q4
'23
|
|
Q4
'22
|
|
YOY Δ
|
|
Q4
'23
|
|
Q4
'22
|
|
YOY Δ
|
Cost of
Sales
|
|
$
3,112
|
|
$
1,747
|
|
78 %
|
|
$
1,278
|
|
$
1,071
|
|
19 %
|
% of product
sales
|
|
39.7 %
|
|
26.7 %
|
|
13.0 pts
|
|
16.3 %
|
|
16.3 %
|
|
— pts
|
Research &
Development
|
|
$
1,534
|
|
$
1,324
|
|
16 %
|
|
$
1,494
|
|
$
1,291
|
|
16 %
|
% of product
sales
|
|
19.6 %
|
|
20.2 %
|
|
(0.6) pts
|
|
19.1 %
|
|
19.7 %
|
|
(0.6) pts
|
Selling, General &
Administrative
|
|
$
2,274
|
|
$
1,572
|
|
45 %
|
|
$
1,764
|
|
$
1,468
|
|
20 %
|
% of product
sales
|
|
29.0 %
|
|
24.0 %
|
|
5.0 pts
|
|
22.5 %
|
|
22.4 %
|
|
0.1 pts
|
Other
|
|
$
5
|
|
$ (34)
|
|
*
|
|
$
—
|
|
$
—
|
|
NM
|
Total Operating
Expenses
|
|
$
6,925
|
|
$
4,609
|
|
50 %
|
|
$
4,536
|
|
$
3,830
|
|
18 %
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
Margin
|
|
|
|
|
|
|
|
|
|
|
|
|
operating income as %
of product sales
|
|
16.2 %
|
|
34.0 %
|
|
(17.8) pts
|
|
46.7 %
|
|
45.9 %
|
|
0.8 pts
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Tax
Rate
|
|
10.0 %
|
|
7.6 %
|
|
2.4
pts
|
|
15.9 %
|
|
13.4 %
|
|
2.5
pts
|
|
|
|
|
|
|
|
|
|
|
|
|
|
pts: percentage
points
|
|
|
|
|
|
|
|
|
|
|
|
|
* change in excess of
100%
|
|
|
|
|
|
|
|
|
|
|
|
|
NM = not
meaningful
|
|
|
|
|
|
|
|
|
|
|
|
|
$Millions, except
percentages
|
|
GAAP
|
|
Non-GAAP
|
|
|
FY
'23
|
|
FY
'22
|
|
YOY Δ
|
|
FY
'23
|
|
FY
'22
|
|
YOY Δ
|
Cost of
Sales
|
|
$
8,451
|
|
$
6,406
|
|
32 %
|
|
$ 4,573
|
|
$ 3,951
|
|
16 %
|
% of product
sales
|
|
31.4 %
|
|
25.8 %
|
|
5.6 pts
|
|
17.0 %
|
|
15.9 %
|
|
1.1 pts
|
Research &
Development
|
|
$
4,784
|
|
$
4,434
|
|
8 %
|
|
$ 4,700
|
|
$ 4,341
|
|
8 %
|
% of product
sales
|
|
17.8 %
|
|
17.9 %
|
|
(0.1) pts
|
|
17.5 %
|
|
17.5 %
|
|
— pts
|
Selling, General &
Administrative
|
|
$
6,179
|
|
$
5,414
|
|
14 %
|
|
$ 5,518
|
|
$ 5,270
|
|
5 %
|
% of product
sales
|
|
23.0 %
|
|
21.8 %
|
|
1.2 pts
|
|
20.5 %
|
|
21.2 %
|
|
(0.7) pts
|
Other
|
|
$ 879
|
|
$ 503
|
|
75 %
|
|
$
—
|
|
$
—
|
|
NM
|
Total Operating
Expenses
|
|
$
20,293
|
|
$
16,757
|
|
21 %
|
|
$
14,791
|
|
$
13,562
|
|
9 %
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
Margin
|
|
|
|
|
|
|
|
|
|
|
|
|
operating income as %
of product sales
|
|
29.3 %
|
|
38.6 %
|
|
(9.3) pts
|
|
49.8 %
|
|
51.5 %
|
|
(1.7) pts
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Tax
Rate
|
|
14.5 %
|
|
10.8 %
|
|
3.7
pts
|
|
16.5 %
|
|
13.8 %
|
|
2.7
pts
|
|
|
|
|
|
|
|
|
|
|
|
|
|
pts: percentage
points
|
|
|
|
|
|
|
|
|
|
|
|
|
NM = not
meaningful
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash Flow and Balance Sheet
- The Company generated $0.3
billion of free cash flow in the fourth quarter of 2023
versus $2.3 billion in the fourth
quarter of 2022, primarily driven by timing of federal and
repatriation tax payments. The Company generated $7.4 billion of free cash flow for the full year
2023 versus $8.8 billion in
2022.
- The Company's fourth quarter 2023 dividend of $2.13 per share was declared on October 24,
2023, and was paid on December 8, 2023, to all stockholders of
record as of November 17, 2023, representing a 10% increase
from 2022.
- During the fourth quarter, there were no repurchases of shares
of common stock.
- Cash and investments totaled $10.9
billion and debt outstanding totaled $64.6 billion as of December 31, 2023. Debt leverage was
approximately 4.4 times EBITDA as of December 31, 2023.
$Billions, except
shares
|
|
Q4
'23
|
|
Q4
'22
|
|
YOY Δ
|
FY
'23
|
|
FY
'22
|
|
YOY Δ
|
|
Operating Cash
Flow
|
|
$
0.5
|
|
$
2.6
|
|
$
(2.1)
|
$ 8.5
|
|
$ 9.7
|
|
$ (1.3)
|
|
Capital
Expenditures
|
|
$
0.2
|
|
$
0.3
|
|
$
(0.1)
|
$ 1.1
|
|
$ 0.9
|
|
$ 0.2
|
|
Free Cash
Flow
|
|
$
0.3
|
|
$
2.3
|
|
$
(2.0)
|
$ 7.4
|
|
$ 8.8
|
|
$ (1.4)
|
|
Dividends
Paid
|
|
$
1.1
|
|
$
1.0
|
|
$
0.1
|
$ 4.6
|
|
$ 4.2
|
|
$ 0.4
|
|
Share
Repurchases
|
|
$
—
|
|
$
—
|
|
$
0.0
|
$
—
|
|
$ 6.3
|
|
$ (6.3)
|
|
Average Diluted Shares
(millions)
|
|
540
|
|
539
|
|
1
|
538
|
|
541
|
|
(3)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Note: Numbers may not
add due to rounding
|
|
|
|
|
|
|
|
|
|
|
$Billions
|
|
12/31/23
|
|
12/31/22
|
|
YTD Δ
|
Cash and
Investments
|
|
$ 10.9
|
|
$
9.3
|
|
$
1.6
|
Debt
Outstanding
|
|
$ 64.6
|
|
$ 38.9
|
|
$ 25.7
|
|
|
|
|
|
|
|
Note: Numbers may not
add due to rounding
|
|
|
|
|
2024 Guidance
For the full year 2024, the Company expects:
- Total revenues in the range of $32.4 billion to $33.8 billion.
- On a GAAP basis, EPS in the range of $8.42 to $9.87, and
a tax rate in the range of 11.5% to 13.0%.
- On a non-GAAP basis, EPS in the range of $18.90 to $20.30,
and a tax rate in the range of 16.0% to 17.0%.
- Capital expenditures to be approximately $1.1 billion.
- 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
Maridebart cafraglutide (AMG 133)
- A Phase 2 study of maridebart cafraglutide, a multispecific
molecule that inhibits the gastric inhibitory polypeptide receptor
(GIPR) and activates the glucagon like peptide 1 (GLP-1) receptor,
in overweight or obese adults with or without type 2 diabetes
mellitus has completed enrollment, with topline data anticipated in
late 2024. The Company recently added a Part 2 to this study which
explores durable weight loss beyond 52 weeks.
- Planning for a comprehensive Phase 3 program across multiple
indications remains on track.
- In February 2024, results of
preclinical studies and the Phase 1 study of maridebart
cafraglutide were published in Nature Metabolism.
AMG 786
- A Phase 1 study of AMG 786, a small molecule obesity program,
is ongoing with initial data readout anticipated in H1 2024. This
molecule has a different target than maridebart cafraglutide
and is not an incretin-based therapy.
Olpasiran (AMG 890)
- A Phase 3 cardiovascular outcomes study of olpasiran, a
potentially best-in-class small interfering ribonucleic acid
(siRNA) molecule that reduces lipoprotein(a) (Lp(a)) synthesis in
the liver, in patients with atherosclerotic cardiovascular disease
and elevated Lp(a) continues to enroll patients. To date,
over 7,000 patients have been enrolled, with enrollment completion
anticipated in H1 2024.
Repatha
- EVOLVE-MI, a Phase 4 study of Repatha administered within 10
days of an acute myocardial infarction to reduce the risk of
cardiovascular events, continues to enroll patients.
- A Phase 3 cardiovascular outcomes study (VESALIUS-CV) in
patients at high cardiovascular risk without prior myocardial
infarction or stroke is ongoing.
Oncology
Tarlatamab (AMG 757)
- The U.S. Food and Drug Administration (FDA) has granted
Priority Review for the Company's Biologics License Application
(BLA) for tarlatamab, a first-in-class investigational delta-like
ligand 3 (DLL3) targeting BiTE® (bispecific T-cell
engager) molecule. The BLA is based on the results from the Phase 2
DeLLphi-301 clinical trial, which demonstrated antitumor activity
with a durable response and encouraging survival outcomes in
previously treated small cell lung cancer (SCLC). The safety
profile was consistent with the Phase 1 trial. Based on the
Priority Review designation, the Prescription Drug User Fee Act
(PDUFA) date for tarlatamab is June 12,
2024.
- DeLLphi-304, a Phase 3 study comparing tarlatamab with standard
of care chemotherapy in second-line SCLC, continues to enroll
patients.
- DeLLphi-306, a Phase 3 study comparing tarlatamab with placebo
in limited-stage SCLC, was initiated.
- DeLLphi-305, a Phase 3 study comparing tarlatamab and
durvalumab with durvalumab alone in first-line, extensive-stage
SCLC, will be initiated in H1 2024.
- 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 protein 1 (PD1) monoclonal antibody, in second-line or later
SCLC, is ongoing.
- 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, is ongoing.
BLINCYTO
- The FDA granted Priority Review for the Company's supplemental
BLA for BLINCYTO in early-stage, CD19-positive B-cell precursor
acute lymphoblastic leukemia (B-ALL) based in part on the Phase 3
E1910 study conducted by the National Cancer Institute, the Eastern
Cooperative Oncology Group and the American College of Radiology
Imaging Network Cancer Research Group. Based on the Priority Review
designation, the PDUFA date for BLINCYTO is June 21, 2024. Additional global regulatory
authority submissions are underway.
- Golden Gate, a Phase 3 study of BLINCYTO alternating with
low-intensity chemotherapy in older adults with newly diagnosed
Philadelphia chromosome-negative
(Ph-) B-ALL, continues to enroll patients.
- The Company is planning to amend the Golden Gate Phase 3 study
to include an evaluation of blinatumomab subcutaneous
administration with initiation anticipated in H2 2024.
- A Phase 1/2 study of subcutaneous blinatumomab in adults with
relapsed or refractory Ph- B-ALL continues to enroll patients.
Xaluritamig (AMG 509)
- A Phase 1b monotherapy and
combination dose-escalation and -expansion study of xaluritamig, a
first-in-class bispecific T-cell engager targeting
six-transmembrane epithelial antigen of prostate 1 (STEAP1) in
metastatic castrate resistant prostate cancer continues to enroll
patients in the dose-expansion portion of the study, where
enrollment is almost complete. A reduced monitoring cohort was also
initiated.
- Two additional Phase 1 studies of xaluritamig to evaluate
preliminary efficacy and safety in patients with early prostate
cancer are planned.
AMG 193
- The Phase 1/1b/2 study of AMG
193, a first-in-class small molecule methylthioadenosine
(MTA)-cooperative protein arginine methyltransferase 5 (PRMT5)
inhibitor, continues to enroll patients with advanced
methylthioadenosine phosphorylase (MTAP)-null solid tumors.
To date, responses have been seen in nine patients across seven
tumor types.
- Master protocols in thoracic and gastrointestinal malignancies
exploring combinations with standard of care will be initiated in
H1 2024.
- A Phase 1/2 study of AMG 193 in combination with IDE397, an
investigational methionine adenosyltransferase 2A (MAT2A)
inhibitor, is enrolling patients.
Nplate
- A Phase 3 study of Nplate in chemotherapy-induced
thrombocytopenia in gastrointestinal, pancreatic, or colorectal
malignancies is fully enrolled. Data readout is anticipated in H2
2024.
LUMAKRAS/LUMYKRAS
- A U.S. regulatory submission is planned for the Phase 3
CodeBreaK 300 trial in H1 2024. This study evaluated two doses of
LUMAKRAS (960 mg or 240 mg) in combination with Vectibix in
patients with chemorefractory KRAS G12C-mutated metastatic
colorectal cancer (CRC).
- A Phase 3 study of LUMAKRAS in combination with Vectibix and
FOLFIRI in first-line KRAS G12C-mutated CRC was initiated.
- A Phase 3 study of LUMAKRAS plus chemotherapy vs. pembrolizumab
plus chemotherapy in first-line KRAS G12C-mutated and programmed
cell death protein ligand-1 (PD-L1) negative advanced non-small
cell lung cancer (NSCLC) is enrolling patients.
- Regulatory review by the European Medicines Agency (EMA) of the
CodeBreaK 200 Phase 3 trial of adults with previously treated
locally advanced or metastatic KRAS G12C-mutated NSCLC along with
data from the Phase 2 dose-comparison substudy is ongoing.
- The FDA completed its review of the Company's supplemental New
Drug Application seeking full approval of LUMAKRAS based on the
CodeBreaK 200 trial results. The FDA issued a new postmarketing
requirement for an additional confirmatory study to support full
approval to be completed no later than February 2028, while also concluding that
LUMAKRAS at 960 mg once-daily will remain the dose for patients
with KRAS G12C-mutated NSCLC under accelerated approval.
Bemarituzumab
- FORTITUDE-101, a Phase 3 study of bemarituzumab, a
first-in-class 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/2 study
of bemarituzumab plus oral chemotherapy regimens with or without
nivolumab in first-line gastric cancer, continues to enroll
patients.
- FORTITUDE-301, a Phase 1b/2
basket study of bemarituzumab monotherapy in solid tumors with
FGFR2b overexpression, is ongoing.
Inflammation
TEZSPIRE
- In severe asthma, the WAYFINDER Phase 3b study is fully enrolled. The PASSAGE Phase 4
real-world effectiveness study and the SUNRISE Phase 3 study
continue to enroll patients.
- A Phase 3 study of TEZSPIRE in chronic rhinosinusitis with
nasal polyps is fully enrolled. Primary analysis is
anticipated in H2 2024.
- A Phase 3 study of TEZSPIRE in eosinophilic esophagitis
continues to enroll patients.
- A Phase 2 study of TEZSPIRE in chronic obstructive pulmonary
disease is fully enrolled. Data readout is anticipated in H1
2024.
Rocatinlimab (AMG 451/KHK4083)
- The ROCKET Phase 3 program, now composed of eight studies
evaluating rocatinlimab, a first in class monoclonal antibody
targeting OX40, in moderate to severe atopic dermatitis, continues
to enroll adult and adolescent patients. To date, over 2,400
patients have been enrolled in the ROCKET program.
- The Phase 3 HORIZON study (part of the ROCKET program)
evaluating rocatinlimab monotherapy vs. placebo in adults with
moderate to severe atopic dermatitis is fully enrolled. Data
readout is anticipated in H2 2024.
- A Phase 2 study of rocatinlimab in asthma will be initiated in
H1 2024 and a Phase 3 study of rocatinlimab in prurigo nodularis
will be initiated in H2 2024.
Otezla
- In November 2023, data were
presented from the MOSAIC and FOREMOST studies:
- In the MOSAIC Phase 4 study, primary and key secondary outcomes
highlighted that Otezla led to better inflammatory disease control
in psoriatic arthritis patients with moderate clinical disease
activity than in patients with high disease activity.
- In the FOREMOST Phase 4 study, Otezla when added to standard of
care, significantly improved disease activity in patients with
early oligoarticular (few joints involved) psoriatic arthritis at
16 weeks compared to placebo.
Efavaleukin alfa (AMG 592)
- A Phase 2b study of efavaleukin
alfa, an interleukin 2 (IL 2) mutein Fc fusion protein, 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 has completed enrollment.
Rare Disease
TAVNEOS
- In November 2023, data were
presented from the Phase 3 ADVOCATE trial demonstrating that
outcomes in patients with anti-neutrophil cytoplasmic antibody
(ANCA)-associated vasculitis favored TAVNEOS versus a prednisone
taper across subgroups of patients 65 years and older, patients
with kidney involvement and albuminuria, and patients with diffuse
alveolar hemorrhage at baseline.
TEPEZZA
- In December 2023, TEPEZZA
received orphan drug designation in Japan for patients with moderate to severe
active thyroid eye disease (TED).
- A New Drug Application was submitted for TEPEZZA in
Japan based on the results from
the OPTIC-J study evaluating TEPEZZA in patients with active
TED.
- A Phase 3 study of TEPEZZA in Japan for chronic or low clinical activity
score (CAS) TED continues to enroll patients.
- The Company plans to initiate a Phase 3 study evaluating the
subcutaneous route of administration of TEPEZZA in patients with
TED in H1 2024.
UPLIZNA
- A Phase 3 study of UPLIZNA in myasthenia gravis is fully
enrolled. Data readout is anticipated in H2 2024.
- A Phase 3 study of UPLIZNA for the prevention of flare in
immunoglobulin G4- (IgG4) related disease is fully enrolled. Data
readout is anticipated in H2 2024.
Dazodalibep
- A Phase 3 study of dazodalibep, a cluster of differentiation 40
(CD40) ligand inhibitor fusion protein in Sjögren's syndrome is
enrolling patients.
Daxdilimab
- A Phase 2 study of daxdilimab, a fully human monoclonal
antibody targeting immunoglobulin-like transcript 7 (ILT7), in
moderate-to-severe active primary discoid lupus erythematosus
refractory to standard of care is enrolling patients.
- A Phase 2 study of daxdilimab in dermatomyositis and
antisynthetase inflammatory myositis is enrolling patients.
Fipaxalparant (formerly AMG 670 / HZN 825)
- A Phase 2 study of fipaxalparant, a lysophosphatidic acid
receptor 1 (LPAR1) antagonist, in idiopathic pulmonary fibrosis is
enrolling patients. Data readout is anticipated in H2 2024.
- A Phase 2 study of fipaxalparant in diffuse cutaneous systemic
sclerosis is enrolling patients.
Biosimilars
- The clinical comparative study portion of a randomized,
double-blind pivotal study evaluating pharmacokinetic (PK)
similarity of ABP 206 compared with OPDIVO® (nivolumab)
in resected stage III or stage IV melanoma patients in the adjuvant
setting is enrolling patients.
TEZSPIRE is being developed in collaboration with
AstraZeneca.
Rocatinlimab, formerly AMG 451/KHK4083, is
being developed in collaboration with Kyowa
Kirin.
Ordesekimab, formerly AMG 714 and also known as
PRV-015, is being developed in collaboration with Provention Bio, a
Sanofi Company. For the purposes of the collaboration,
Provention Bio conducts a clinical trial and leads certain
development and regulatory activities for the
program.
Xaluritamig, formerly AMG 509, is being
developed pursuant to a research collaboration with Xencor,
Inc.
IDE397 is an investigational MAT2A inhibitor
from IDEAYA Biosciences.
OPDIVO is a registered trademark
of Bristol-Myers Squibb Company.
Non-GAAP Financial Measures
In this news release, management has presented its operating
results for the fourth quarters and full years of 2023 and 2022, in
accordance with U.S. Generally Accepted Accounting Principles
(GAAP) and on a non-GAAP basis. In addition, management has
presented its full year 2024 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 in-process research and development (IPR&D)
expenses of pre-approval programs related to licensing,
collaboration and asset acquisition transactions from its non-GAAP
financial measures. Management has presented Free Cash Flow (FCF),
which is a non-GAAP financial measure, for the fourth quarters and
full years of 2023 and 2022. FCF is computed by subtracting capital
expenditures from operating cash flow, each as determined in
accordance with GAAP. Management has also presented Earnings Before
Interest, Taxes, Depreciation and Amortization (EBITDA) and debt
leverage ratio for 2023, 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 normal and recurring business
activities by facilitating comparisons of results of normal and
recurring 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 its debt leverage
ratio provides a supplemental operating metric for the full year
period as it compares the amount of cash generated by our
operations for the year.
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
2023, Amgen was named one of "America's Greatest Workplaces" by
Newsweek, one of "America's Climate Leaders" by USA Today and one of the "World's Best
Companies" by TIME.
For more information, visit Amgen.com and follow us on X
(formerly known as Twitter), LinkedIn, Instagram, TikTok, YouTube
and Threads.
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. or Kyowa Kirin Co., Ltd.), the performance
of Otezla® (apremilast) (including anticipated Otezla
sales growth and the timing of non-GAAP EPS accretion), our
acquisitions of Teneobio, Inc., ChemoCentryx, Inc., or Horizon
(including the prospective performance and outlook of Horizon's
business, performance and opportunities and any potential strategic
benefits, synergies or opportunities expected as a result of such
acquisition, and any projected impacts from the Horizon acquisition
on our acquisition-related expenses going forward), 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
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. There can be no guarantee that we will be able to
realize any of the strategic benefits, synergies or opportunities
arising from the Horizon acquisition, and such benefits, synergies
or opportunities may take longer to realize than expected. We may
not be able to successfully integrate Horizon, and such integration
may take longer, be more difficult or cost more than expected. 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)
Justin Claeys, 805-313-9775
(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,
|
|
2023
|
|
2022
|
|
2023
|
|
2022
|
Revenues:
|
|
|
|
|
|
|
|
Product
sales
|
$
7,833
|
|
$
6,552
|
|
$
26,910
|
|
$
24,801
|
Other
revenues
|
363
|
|
287
|
|
1,280
|
|
1,522
|
Total
revenues
|
8,196
|
|
6,839
|
|
28,190
|
|
26,323
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
Cost of
sales
|
3,112
|
|
1,747
|
|
8,451
|
|
6,406
|
Research and
development
|
1,534
|
|
1,324
|
|
4,784
|
|
4,434
|
Selling, general and
administrative
|
2,274
|
|
1,572
|
|
6,179
|
|
5,414
|
Other
|
5
|
|
(34)
|
|
879
|
|
503
|
Total operating
expenses
|
6,925
|
|
4,609
|
|
20,293
|
|
16,757
|
|
|
|
|
|
|
|
|
Operating
income
|
1,271
|
|
2,230
|
|
7,897
|
|
9,566
|
|
|
|
|
|
|
|
|
Other income
(expense):
|
|
|
|
|
|
|
|
Interest expense,
net
|
(821)
|
|
(415)
|
|
(2,875)
|
|
(1,406)
|
Other income (expense),
net
|
402
|
|
(67)
|
|
2,833
|
|
(814)
|
|
|
|
|
|
|
|
|
Income before income
taxes
|
852
|
|
1,748
|
|
7,855
|
|
7,346
|
|
|
|
|
|
|
|
|
Provision for income
taxes
|
85
|
|
132
|
|
1,138
|
|
794
|
|
|
|
|
|
|
|
|
Net income
|
$ 767
|
|
$
1,616
|
|
$
6,717
|
|
$
6,552
|
|
|
|
|
|
|
|
|
Earnings per
share:
|
|
|
|
|
|
|
|
Basic
|
$ 1.43
|
|
$ 3.02
|
|
$
12.56
|
|
$
12.18
|
Diluted
|
$ 1.42
|
|
$ 3.00
|
|
$
12.49
|
|
$
12.11
|
|
|
|
|
|
|
|
|
Weighted-average shares
used in calculation of earnings per share:
|
|
|
|
|
|
|
|
Basic
|
535
|
|
535
|
|
535
|
|
538
|
Diluted
|
540
|
|
539
|
|
538
|
|
541
|
Amgen
Inc.
|
Consolidated Balance
Sheets - GAAP
|
(In
millions)
|
|
|
December
31,
|
|
December
31,
|
|
2023
|
|
2022
|
|
(Unaudited)
|
|
|
Assets
|
Current
assets:
|
|
|
|
Cash, cash equivalents
and marketable securities
|
$
10,944
|
|
$
9,305
|
Trade receivables,
net
|
7,268
|
|
5,563
|
Inventories
|
9,518
|
|
4,930
|
Other current
assets
|
2,602
|
|
2,388
|
Total current
assets
|
30,332
|
|
22,186
|
|
|
|
|
Property, plant and
equipment, net
|
5,941
|
|
5,427
|
Intangible assets,
net
|
32,641
|
|
16,080
|
Goodwill
|
18,629
|
|
15,529
|
Other noncurrent
assets
|
9,611
|
|
5,899
|
Total assets
|
$
97,154
|
|
$
65,121
|
|
|
|
|
Liabilities and
Stockholders' Equity
|
Current
liabilities:
|
|
|
|
Accounts payable and
accrued liabilities
|
$
16,949
|
|
$
14,096
|
Current portion of
long-term debt
|
1,443
|
|
1,591
|
Total current
liabilities
|
18,392
|
|
15,687
|
|
|
|
|
Long-term
debt
|
63,170
|
|
37,354
|
Long-term deferred tax
liabilities
|
2,354
|
|
11
|
Long-term tax
liabilities
|
4,680
|
|
5,757
|
Other noncurrent
liabilities
|
2,326
|
|
2,651
|
Total stockholders'
equity
|
6,232
|
|
3,661
|
Total liabilities and
stockholders' equity
|
$
97,154
|
|
$
65,121
|
|
|
|
|
Shares
outstanding
|
535
|
|
534
|
Amgen
Inc.
|
GAAP to Non-GAAP
Reconciliations
|
(Dollars in
millions)
|
(Unaudited)
|
|
|
Three months
ended
December
31,
|
|
Twelve months
ended
December
31,
|
|
2023
|
|
2022
|
|
2023
|
|
2022
|
GAAP cost of
sales
|
$
3,112
|
|
$
1,747
|
|
$
8,451
|
|
$
6,406
|
Adjustments to cost
of sales:
|
|
|
|
|
|
|
|
Acquisition-related
expenses (a)
|
(1,834)
|
|
(676)
|
|
(3,842)
|
|
(2,455)
|
Certain net charges
pursuant to our restructuring and cost savings
initiatives
|
—
|
|
—
|
|
(36)
|
|
—
|
Total adjustments
to cost of sales
|
(1,834)
|
|
(676)
|
|
(3,878)
|
|
(2,455)
|
Non-GAAP cost of
sales
|
$
1,278
|
|
$
1,071
|
|
$
4,573
|
|
$
3,951
|
|
|
|
|
|
|
|
|
GAAP cost of sales
as a percentage of product sales
|
39.7 %
|
|
26.7 %
|
|
31.4 %
|
|
25.8 %
|
Acquisition-related
expenses (a)
|
(23.4)
|
|
(10.4)
|
|
(14.3)
|
|
(9.9)
|
Certain net charges
pursuant to our restructuring and cost savings
initiatives
|
0.0
|
|
0.0
|
|
(0.1)
|
|
0.0
|
Non-GAAP cost of
sales as a percentage of product sales
|
16.3 %
|
|
16.3 %
|
|
17.0 %
|
|
15.9 %
|
|
|
|
|
|
|
|
|
GAAP research and
development expenses
|
$
1,534
|
|
$
1,324
|
|
$
4,784
|
|
$
4,434
|
Adjustments to
research and development expenses:
|
|
|
|
|
|
|
|
Acquisition-related
expenses (a)
|
(28)
|
|
(33)
|
|
(55)
|
|
(93)
|
Certain net charges
pursuant to our restructuring and cost savings
initiatives
|
(12)
|
|
—
|
|
(29)
|
|
—
|
Total adjustments
to research and development expenses
|
(40)
|
|
(33)
|
|
(84)
|
|
(93)
|
Non-GAAP research
and development expenses
|
$
1,494
|
|
$
1,291
|
|
$
4,700
|
|
$
4,341
|
|
|
|
|
|
|
|
|
GAAP research and
development expenses as a percentage of product
sales
|
19.6 %
|
|
20.2 %
|
|
17.8 %
|
|
17.9 %
|
Acquisition-related
expenses (a)
|
(0.3)
|
|
(0.5)
|
|
(0.2)
|
|
(0.4)
|
Certain net charges
pursuant to our restructuring and cost savings
initiatives
|
(0.2)
|
|
0.0
|
|
(0.1)
|
|
0.0
|
Non-GAAP research
and development expenses as a percentage of product
sales
|
19.1 %
|
|
19.7 %
|
|
17.5 %
|
|
17.5 %
|
|
|
|
|
|
|
|
|
GAAP selling,
general and administrative expenses
|
$
2,274
|
|
$
1,572
|
|
$
6,179
|
|
$
5,414
|
Adjustments to
selling, general and administrative expenses:
|
|
|
|
|
|
|
|
Acquisition-related
expenses (b)
|
(510)
|
|
(104)
|
|
(648)
|
|
(144)
|
Certain net charges
pursuant to our restructuring and cost savings
initiatives
|
—
|
|
—
|
|
(13)
|
|
—
|
Total adjustments
to selling, general and administrative expenses
|
(510)
|
|
(104)
|
|
(661)
|
|
(144)
|
Non-GAAP selling,
general and administrative expenses
|
$
1,764
|
|
$
1,468
|
|
$
5,518
|
|
$
5,270
|
|
|
|
|
|
|
|
|
GAAP selling,
general and administrative expenses as a percentage of product
sales
|
29.0 %
|
|
24.0 %
|
|
23.0 %
|
|
21.8 %
|
Acquisition-related
expenses (b)
|
(6.5)
|
|
(1.6)
|
|
(2.4)
|
|
(0.6)
|
Certain net charges
pursuant to our restructuring and cost savings
initiatives
|
0.0
|
|
0.0
|
|
(0.1)
|
|
0.0
|
Non-GAAP selling,
general and administrative expenses as a percentage of product
sales
|
22.5 %
|
|
22.4 %
|
|
20.5 %
|
|
21.2 %
|
|
|
|
|
|
|
|
|
GAAP operating
expenses
|
$
6,925
|
|
$
4,609
|
|
$ 20,293
|
|
$ 16,757
|
Adjustments to
operating expenses:
|
|
|
|
|
|
|
|
Adjustments to cost of
sales
|
(1,834)
|
|
(676)
|
|
(3,878)
|
|
(2,455)
|
Adjustments to
research and development expenses
|
(40)
|
|
(33)
|
|
(84)
|
|
(93)
|
Adjustments to
selling, general and administrative expenses
|
(510)
|
|
(104)
|
|
(661)
|
|
(144)
|
Certain net charges
pursuant to our restructuring and cost savings initiatives
(c)
|
(2)
|
|
1
|
|
(185)
|
|
8
|
Certain other expenses
(d)
|
(3)
|
|
33
|
|
(694)
|
|
(511)
|
Total adjustments
to operating expenses
|
(2,389)
|
|
(779)
|
|
(5,502)
|
|
(3,195)
|
Non-GAAP operating
expenses
|
$
4,536
|
|
$
3,830
|
|
$ 14,791
|
|
$ 13,562
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months
ended
December
31,
|
|
Twelve months
ended
December
31,
|
|
2023
|
|
2022
|
|
2023
|
|
2022
|
GAAP operating
income
|
$
1,271
|
|
$
2,230
|
|
$
7,897
|
|
$
9,566
|
Adjustments to
operating expenses
|
2,389
|
|
779
|
|
5,502
|
|
3,195
|
Non-GAAP operating
income
|
$
3,660
|
|
$
3,009
|
|
$ 13,399
|
|
$ 12,761
|
|
|
|
|
|
|
|
|
GAAP operating
income as a percentage of product sales
|
16.2 %
|
|
34.0 %
|
|
29.3 %
|
|
38.6 %
|
Adjustments to cost of
sales
|
23.4
|
|
10.4
|
|
14.4
|
|
9.9
|
Adjustments to
research and development expenses
|
0.4
|
|
0.5
|
|
0.3
|
|
0.4
|
Adjustments to
selling, general and administrative expenses
|
6.5
|
|
1.6
|
|
2.6
|
|
0.6
|
Certain net charges
pursuant to our restructuring and cost savings initiatives
(c)
|
0.1
|
|
0.0
|
|
0.7
|
|
0.0
|
Certain other expenses
(d)
|
0.1
|
|
(0.6)
|
|
2.5
|
|
2.0
|
Non-GAAP operating
income as a percentage of product sales
|
46.7 %
|
|
45.9 %
|
|
49.8 %
|
|
51.5 %
|
|
|
|
|
|
|
|
|
GAAP interest
expense, net
|
$
(821)
|
|
$
(415)
|
|
$ (2,875)
|
|
$ (1,406)
|
Adjustments to
interest expense, net:
|
|
|
|
|
|
|
|
Interest expense on
acquisition-related debt (e)
|
19
|
|
5
|
|
807
|
|
5
|
Non-GAAP interest
expense, net
|
$
(802)
|
|
$
(410)
|
|
$ (2,068)
|
|
$ (1,401)
|
|
|
|
|
|
|
|
|
GAAP other income
(expense), net
|
$
402
|
|
$
(67)
|
|
$
2,833
|
|
$
(814)
|
Adjustments to
other income (expense), net
|
|
|
|
|
|
|
|
Interest income and
other expenses on acquisition-related debt (e)
|
(18)
|
|
—
|
|
(625)
|
|
—
|
Equity method
investment basis difference amortization
|
—
|
|
49
|
|
—
|
|
192
|
Net (gains)/losses
from equity investments (f)
|
(217)
|
|
(39)
|
|
(1,522)
|
|
362
|
Total adjustments
to other income (expense), net
|
(235)
|
|
10
|
|
(2,147)
|
|
554
|
Non-GAAP other
income (expense), net
|
$
167
|
|
$
(57)
|
|
$
686
|
|
$
(260)
|
|
|
|
|
|
|
|
|
GAAP income before
income taxes
|
$
852
|
|
$
1,748
|
|
$
7,855
|
|
$
7,346
|
Adjustments to
income before income taxes:
|
|
|
|
|
|
|
|
Adjustments to
operating expenses
|
2,389
|
|
779
|
|
5,502
|
|
3,195
|
Adjustments to
interest expense, net
|
19
|
|
5
|
|
807
|
|
5
|
Adjustments to other
income (expense), net
|
(235)
|
|
10
|
|
(2,147)
|
|
554
|
Total adjustments
to income before income taxes
|
2,173
|
|
794
|
|
4,162
|
|
3,754
|
Non-GAAP income
before income taxes
|
$
3,025
|
|
$
2,542
|
|
$ 12,017
|
|
$ 11,100
|
|
|
|
|
|
|
|
|
GAAP provision for
income taxes
|
$
85
|
|
$
132
|
|
$
1,138
|
|
$
794
|
Adjustments to
provision for income taxes:
|
|
|
|
|
|
|
|
Income tax effect of
the above adjustments (g)
|
404
|
|
163
|
|
846
|
|
690
|
Other income tax
adjustments (h)
|
(7)
|
|
45
|
|
(1)
|
|
46
|
Total adjustments
to provision for income taxes
|
397
|
|
208
|
|
845
|
|
736
|
Non-GAAP provision
for income taxes
|
$
482
|
|
$
340
|
|
$
1,983
|
|
$
1,530
|
|
|
|
|
|
|
|
|
GAAP tax as a
percentage of income before taxes
|
10.0 %
|
|
7.6 %
|
|
14.5 %
|
|
10.8 %
|
Adjustments to
provision for income taxes:
|
|
|
|
|
|
|
|
Income tax effect of
the above adjustments (g)
|
6.1
|
|
4.0
|
|
2.0
|
|
2.6
|
Other income tax
adjustments (h)
|
(0.2)
|
|
1.8
|
|
0.0
|
|
0.4
|
Total adjustments
to provision for income taxes
|
5.9
|
|
5.8
|
|
2.0
|
|
3.0
|
Non-GAAP tax as a
percentage of income before taxes
|
15.9 %
|
|
13.4 %
|
|
16.5 %
|
|
13.8 %
|
|
|
|
|
|
|
|
|
GAAP net
income
|
$
767
|
|
$
1,616
|
|
$
6,717
|
|
$
6,552
|
Adjustments to net
income:
|
|
|
|
|
|
|
|
Adjustments to income
before income taxes, net of the income tax effect
|
1,769
|
|
631
|
|
3,316
|
|
3,064
|
Other income tax
adjustments (h)
|
7
|
|
(45)
|
|
1
|
|
(46)
|
Total adjustments
to net income
|
1,776
|
|
586
|
|
3,317
|
|
3,018
|
Non-GAAP net
income
|
$
2,543
|
|
$
2,202
|
|
$ 10,034
|
|
$
9,570
|
|
|
|
|
|
|
|
|
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,
2023
|
|
Three months
ended
December 31,
2022
|
|
GAAP
|
|
Non-GAAP
|
|
GAAP
|
|
Non-GAAP
|
Net income
|
$
767
|
|
$
2,543
|
|
$
1,616
|
|
$
2,202
|
|
|
|
|
|
|
|
|
Weighted-average
shares for diluted EPS
|
540
|
|
540
|
|
539
|
|
539
|
|
|
|
|
|
|
|
|
Diluted EPS
|
$
1.42
|
|
$
4.71
|
|
$
3.00
|
|
$
4.09
|
|
|
|
|
|
|
|
|
|
Twelve months
ended
December 31,
2023
|
|
Twelve months
ended
December 31,
2022
|
|
GAAP
|
|
Non-GAAP
|
|
GAAP
|
|
Non-GAAP
|
Net income
|
$
6,717
|
|
$ 10,034
|
|
$
6,552
|
|
$
9,570
|
|
|
|
|
|
|
|
|
Weighted-average
shares for diluted EPS
|
538
|
|
538
|
|
541
|
|
541
|
|
|
|
|
|
|
|
|
Diluted EPS
|
$
12.49
|
|
$
18.65
|
|
$
12.11
|
|
$
17.69
|
|
(a)
|
The adjustments related
primarily to noncash amortization of intangible assets from
business acquisitions
|
|
|
(b)
|
For the three and
twelve months ended December 31, 2023, the adjustments related
primarily to acquisition-related costs related to our Horizon
acquisition
|
|
|
(c)
|
For the three and
twelve months ended December 31, 2023, the adjustments related
primarily to separation costs associated with our restructuring
plan initiated in early 2023
|
|
|
(d)
|
For the twelve months
ended December 31, 2023, the adjustments related primarily to a net
impairment charge for AMG 340. 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 the
divestiture of Gensenta
|
|
|
(e)
|
For the three and
twelve months ended December 31, 2023, the adjustments included (i)
interest expense and income on senior notes issued in March 2023
and (ii) debt issuance costs and other fees related to our bridge
credit and term loan credit agreements, incurred prior to the
closing of our acquisition of Horizon
|
|
|
(f)
|
For the twelve months
ended December 31, 2023, the adjustments related primarily to our
BeiGene, Ltd. equity fair value adjustment
|
|
|
(g)
|
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 and certain gains and losses on our investments
in equity securities, whereas the tax impact of other adjustments,
including expenses related to restructuring and cost savings
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, 2023, were 18.6% and
20.3%, respectively, compared to 20.5% and 18.4% for the
corresponding periods of the prior year
|
|
|
(h)
|
The adjustments related
to certain acquisition items, prior period and other items excluded
from GAAP earnings
|
|
|
|
|
|
|
|
|
|
Amgen
Inc.
|
Reconciliations of
Cash Flows
|
(In
millions)
|
(Unaudited)
|
|
|
Three months
ended
December
31,
|
|
Twelve months
ended
December
31,
|
|
2023
|
|
2022
|
|
2023
|
|
2022
|
Net cash provided by
operating activities
|
$ 538
|
|
$
2,649
|
|
$ 8,471
|
|
$ 9,721
|
Net cash used in
investing activities
|
(27,089)
|
|
(3,473)
|
|
(26,204)
|
|
(6,044)
|
Net cash provided by
(used in) financing activities
|
2,754
|
|
(1,049)
|
|
21,048
|
|
(4,037)
|
(Decrease) increase in
cash and cash equivalents
|
(23,797)
|
|
(1,873)
|
|
3,315
|
|
(360)
|
Cash and cash
equivalents at beginning of period
|
34,741
|
|
9,502
|
|
7,629
|
|
7,989
|
Cash and cash
equivalents at end of period
|
$
10,944
|
|
$
7,629
|
|
$
10,944
|
|
$ 7,629
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months
ended
December
31,
|
|
Twelve months
ended
December
31,
|
|
2023
|
|
2022
|
|
2023
|
|
2022
|
Net cash provided by
operating activities
|
$ 538
|
|
$
2,649
|
|
$ 8,471
|
|
$ 9,721
|
Capital
expenditures
|
(249)
|
|
(340)
|
|
(1,112)
|
|
(936)
|
Free cash
flow
|
$ 289
|
|
$
2,309
|
|
$ 7,359
|
|
$ 8,785
|
Amgen
Inc.
|
Reconciliation of
GAAP Net Income to EBITDA and Debt Leverage Ratio
Calculation
|
(Dollars in
millions)
|
(Unaudited)
|
|
|
Twelve months
ended
December 31, 2023
|
GAAP Net
Income
|
$
6,717
|
Depreciation and
amortization
|
4,071
|
Interest expense,
net
|
2,875
|
Provision for income
taxes
|
1,138
|
EBITDA(a)
|
$
14,801
|
|
|
|
As of December 31,
2023
|
Current portion of
long-term debt
|
$
1,443
|
Long-term
debt
|
63,170
|
Total GAAP
Debt
|
$
64,613
|
|
|
|
As of December 31,
2023
|
Total GAAP
Debt
|
$
64,613
|
EBITDA
|
$
14,801
|
Debt leverage
ratio
|
4.4
|
|
|
|
(a)
|
|
2023 EBITDA was
impacted by $1,209 million in mark-to-market gains on our equity
investment in BeiGene. In the first quarter of 2023, we began to
account for our equity investment in BeiGene at fair value, with
changes in fair value recorded in our GAAP earnings.
|
Amgen
Inc.
|
Reconciliation of
GAAP EPS Guidance to Non-GAAP
|
EPS Guidance for the
Year Ending December 31, 2024
|
(Unaudited)
|
|
GAAP diluted EPS
guidance
|
|
$
8.42
|
—
|
$
9.87
|
Known adjustments to
arrive at non-GAAP*:
|
|
|
|
|
Acquisition-related
expenses (a)
|
|
10.43
|
—
|
10.48
|
Non-GAAP diluted EPS
guidance
|
|
$ 18.90
|
—
|
$ 20.30
|
* The known adjustments are presented net of their related tax
impact, which amount to approximately $2.60 per share.
(a) The adjustments include noncash amortization of intangible
assets and fair value step-up of inventory acquired in business
combinations.
Our GAAP diluted EPS guidance does not include the effect of
GAAP adjustments triggered by events that may occur subsequent to
this press release such as acquisitions, asset impairments,
litigation, 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, 2024
|
(Unaudited)
|
|
GAAP tax rate
guidance
|
|
11.5 %
|
—
|
13.0 %
|
Tax rate of known
adjustments discussed above
|
|
4.0 %
|
—
|
4.5 %
|
Non-GAAP tax rate
guidance
|
|
16.0 %
|
—
|
17.0 %
|
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SOURCE Amgen