THOUSAND
OAKS, Calif., Nov. 3, 2022
/PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced financial
results for the third quarter of 2022. Key results include:
- Total revenues decreased 1% to $6.7
billion in comparison to the third quarter of 2021,
resulting from a 1% decline in global product sales, which
reflected 8% volume growth offset primarily 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 2%.
-
- Volumes grew double-digits for a number of products including
LUMAKRAS®/LUMYKRAS™ (sotorasib), Repatha®
(evolocumab), EVENITY® (romosozumab-aqqg),
Parsabiv® (etelcalcetide), and Vectibix®
(panitumumab).
- GAAP earnings per share (EPS) increased from $3.31 to $3.98
driven by a decrease in operating expenses due to a $0.4 billion licensing-related upfront payment to
Kyowa Kirin Co., Ltd. (KKC) in Q3 2021 and lower weighted-average
shares outstanding in Q3 2022.
-
- GAAP operating income increased from $2.4 billion to $2.7
billion, and GAAP operating margin increased 5.0 percentage
points to 42.6%.
- Non-GAAP EPS increased from $4.08
to $4.70 driven by a decrease in
operating expenses due to a $0.4
billion licensing-related upfront payment to KKC in Q3 2021
and lower weighted-average shares outstanding in Q3 2022.
-
- Non-GAAP operating income increased from $3.1 billion to $3.3
billion, and non-GAAP operating margin increased 4.2
percentage points to 52.5%.
- The Company generated $2.8
billion of free cash flow for the third quarter versus
$2.2 billion in the third quarter of
2021.
- 2022 total revenues guidance revised to $26.0-$26.3
billion; EPS guidance revised to $11.46-$12.17 on a
GAAP basis, and $17.25-$17.85 on a non-GAAP basis.
"Our medicines generated 8% volume growth
in the quarter globally, with 11 products achieving record
quarterly sales," said Robert A.
Bradway, chairman and chief executive officer. "This growth
reflects the strong underlying demand for our medicines and the
value they bring to patients."
Non-GAAP EPS has been recast due to an update to our non-GAAP
policy effective January 1, 2022,
resulting in a $0.59 reduction of
previously-reported non-GAAP EPS for the third quarter of
2021. Refer to Non-GAAP Financial Measures below for further
discussion.
$Millions, except EPS,
dividends paid per share and
percentages
|
|
Q3
'22
|
|
Q3
'21
|
|
YOY Δ
|
Total
Revenues
|
|
$
6,652
|
|
$
6,706
|
|
(1 %)
|
GAAP Operating
Income
|
|
$
2,660
|
|
$
2,378
|
|
12 %
|
GAAP Net
Income
|
|
$
2,143
|
|
$
1,884
|
|
14 %
|
GAAP EPS
|
|
$
3.98
|
|
$
3.31
|
|
20 %
|
Non-GAAP Operating
Income
|
|
$
3,277
|
|
$
3,052
|
|
7 %
|
Non-GAAP Net
Income
|
|
$
2,530
|
|
$
2,324
|
|
9 %
|
Non-GAAP EPS
|
|
$
4.70
|
|
$
4.08
|
|
15 %
|
Dividends Paid Per
Share
|
|
$
1.94
|
|
$
1.76
|
|
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) and
"total revenues adjusted for foreign currency 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) 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 third quarter
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 decreased 1% for the third quarter of 2022
versus the third quarter of 2021. Unit volumes grew 8% but were
more than offset by 5% lower net selling price, 2% negative impact
from foreign exchange, 1% lower inventory levels and 1% unfavorable
changes to estimated sales deductions.
General Medicine
- Prolia® sales increased 7%
year-over-year for the third quarter, driven by 8% volume
growth.
- EVENITY® sales increased 35%
year-over-year to a record $201
million for the third quarter, driven by strong volume
growth across our markets. U.S. volumes grew 45% year-over-year and
volumes outside the U.S. grew 30%.
- Repatha® sales increased 14%
year-over-year for the third quarter, driven by 52% volume growth,
partially offset by lower net selling price. In the U.S., sales
grew 2%, driven by 32% volume growth, offset by lower net selling
price resulting from higher rebates to support and expand access
for patients. Outside the U.S., sales grew 26%, driven by 73%
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 1.2 million patients treated since launch.
- Aimovig® (erenumab-aooe) sales
increased 35% year-over-year for the third quarter, driven by
favorable changes to estimated sales deductions and higher net
selling price, partially offset by a 7% decline in volume.
Inflammation
- TEZSPIRE® (tezepelumab-ekko)
generated $55 million of sales in the
third quarter, driven by continued 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 and biomarker limitation.
- Otezla® (apremilast) sales
increased 3% year-over-year for the third quarter, driven by 9%
volume growth, partially offset by lower inventory levels and
unfavorable foreign exchange impact. We expect continued volume
growth given Otezla's unique, broad indication to treat patients
suffering from mild, moderate or severe psoriasis.
- Enbrel® (etanercept) sales
decreased 14% year-over-year for the third quarter, driven by lower
net selling price, a 5% decline from unfavorable changes to
estimated sales deductions, and a 3% decline in volume. The 5%
unfavorable impact of changes to estimated sales deductions results
from a $114 million favorable
adjustment in the third quarter of 2021, more than offsetting a
$47 million favorable adjustment in
this quarter. Going forward, we expect net selling price to
continue to decline year-over-year, driven by increased
competition.
- AMGEVITA™ (adalimumab) sales increased 5% year-over-year
for the third quarter, driven by 27% volume growth, partially
offset by 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™ (sotorasib)
generated $75 million of sales for
the third quarter, driven by volume growth. Quarter-over-quarter
sales declined 3% driven by lower net selling price due to an
unfavorable price adjustment resulting from a reimbursement
approval in Germany, partially
offset by 15% volume growth. In the U.S., LUMAKRAS has been
prescribed to over 3,700 patients by over 2,200 physicians in both
academic and community settings. Outside the U.S., LUMYKRAS has now
been approved in over 45 countries around the world. We are
actively launching in 30 markets and pursuing reimbursement in the
remaining countries.
- KYPROLIS® (carfilzomib) sales
increased 9% year-over-year for the third quarter, driven by 11%
volume growth.
- XGEVA® (denosumab) sales
decreased 4% year-over-year for the third quarter, driven by a 3%
decline in volume, lower inventory levels, and unfavorable foreign
exchange impact, partially offset by higher net selling price.
- Vectibix® (panitumumab) sales
increased 24% year-over-year for the third quarter, driven by
volume growth. In the third quarter, volume growth benefited from
the timing of shipments to Takeda, our partner in Japan.
- Nplate® (romiplostim) sales
increased 5% year-over-year for the third quarter, primarily driven
by 12% volume growth, partially offset by unfavorable changes to
estimated sales deductions. In the third quarter, volume growth
benefited from increased shipments to KKC, our partner in
Japan.
- BLINCYTO® (blinatumomab) sales
increased 14% year-over-year for the third quarter, driven by
volume growth.
- MVASI® sales decreased 24%
year-over-year for the third quarter, primarily driven by lower net
selling price. The most recently published Average Selling Price
(ASP) for MVASI in the U.S. declined 37% year-over-year and 12%
quarter-over-quarter. Looking forward, we expect continued net
selling price erosion and declining volume driven by increased
competition and continued ASP erosion.
- KANJINTI® (trastuzumab-anns)
sales decreased 38% year-over-year for the third quarter, primarily
driven by lower net selling price and decline in volume, partially
offset by favorable changes to estimated sales deductions. The most
recently published ASP for KANJINTI in the U.S. declined 38%
year-over-year and 11% quarter-over-quarter. Going forward, we
expect continued net selling price deterioration and volume
declines driven by increased competition and continued ASP
erosion.
Established Products
- Total sales of our established products, which include
Neulasta® (pegfilgrastim), NEUPOGEN®
(filgrastim), EPOGEN® (epoetin alfa),
Aranesp® (darbepotein alfa),
Parsabiv® (etelcalcetide), and
Sensipar®/Mimpara™ (cinacalcet), decreased 17%
year-over-year for the third quarter, primarily driven by lower net
selling price and lower inventory levels. In the third quarter, the
published ASP for Neulasta in the U.S. declined 24% year-over-year
and 7% quarter-over-quarter. In the aggregate, we expect the
year-over-year net selling price and volume erosion for this
portfolio of products to continue.
Product Sales Detail by Product and Geographic Region
$Millions, except
percentages
|
|
Q3
'22
|
|
Q3
'21
|
|
YOY Δ
|
|
|
US
|
|
ROW
|
|
TOTAL
|
|
TOTAL
|
|
TOTAL
|
Prolia®
|
|
$
590
|
|
$
272
|
|
$
862
|
|
$
803
|
|
7 %
|
EVENITY®
|
|
136
|
|
65
|
|
201
|
|
149
|
|
35 %
|
Repatha®
|
|
142
|
|
167
|
|
309
|
|
272
|
|
14 %
|
Aimovig®
|
|
103
|
|
4
|
|
107
|
|
79
|
|
35 %
|
TEZSPIRE®
|
|
55
|
|
—
|
|
55
|
|
—
|
|
NM
|
Otezla®
|
|
529
|
|
98
|
|
627
|
|
609
|
|
3 %
|
Enbrel®
|
|
1,086
|
|
20
|
|
1,106
|
|
1,289
|
|
(14 %)
|
AMGEVITA™
|
|
—
|
|
117
|
|
117
|
|
111
|
|
5 %
|
LUMAKRAS®/LUMYKRAS™
|
|
61
|
|
14
|
|
75
|
|
36
|
|
*
|
KYPROLIS®
|
|
217
|
|
101
|
|
318
|
|
293
|
|
9 %
|
XGEVA®
|
|
363
|
|
132
|
|
495
|
|
517
|
|
(4 %)
|
Vectibix®
|
|
106
|
|
141
|
|
247
|
|
200
|
|
24 %
|
Nplate®
|
|
162
|
|
126
|
|
288
|
|
273
|
|
5 %
|
BLINCYTO®
|
|
84
|
|
58
|
|
142
|
|
125
|
|
14 %
|
MVASI®
|
|
139
|
|
70
|
|
209
|
|
274
|
|
(24 %)
|
KANJINTI®
|
|
58
|
|
14
|
|
72
|
|
116
|
|
(38 %)
|
Neulasta®
|
|
205
|
|
42
|
|
247
|
|
415
|
|
(40 %)
|
NEUPOGEN®
|
|
21
|
|
14
|
|
35
|
|
52
|
|
(33 %)
|
EPOGEN®
|
|
136
|
|
—
|
|
136
|
|
138
|
|
(1 %)
|
Aranesp®
|
|
128
|
|
230
|
|
358
|
|
396
|
|
(10 %)
|
Parsabiv®
|
|
61
|
|
39
|
|
100
|
|
61
|
|
64 %
|
Sensipar®/Mimpara™
|
|
4
|
|
13
|
|
17
|
|
19
|
|
(11 %)
|
Other
products**
|
|
80
|
|
34
|
|
114
|
|
93
|
|
23 %
|
Total product
sales
|
|
$ 4,466
|
|
$ 1,771
|
|
$ 6,237
|
|
$ 6,320
|
|
(1 %)
|
|
|
|
|
|
|
|
|
|
|
|
* Change in excess of
100%
|
|
|
|
|
|
|
|
|
|
|
** Other products
include Corlanor®,AVSOLA®,IMLYGIC®
andRIABNI®, as well as sales byGENSENTA andBergamo
subsidiaries
|
NM = not
meaningful
|
|
|
|
|
|
|
|
|
|
|
Operating Expense, Operating Margin and Tax Rate
Analysis
On a GAAP basis:
- Total Operating Expenses decreased 8%. Cost of
Sales margin remained flat. Research & Development
(R&D) expenses decreased 22% primarily due to a
$400 million licensing-related
upfront payment to KKC in 2021. Selling, General &
Administrative (SG&A) expenses decreased 1%.
- Operating Margin as a percentage of product sales
increased 5.0 percentage points to 42.6%.
- Tax Rate decreased 2.2 percentage points
primarily due to the prior year nondeductible Acquired In-Process
Research & Development (Acquired IPR&D) expense arising
from the acquisition of Five Prime Therapeutics and net favorable
items, partially offset by a nondeductible loss from a nonstrategic
divestiture.
On a non-GAAP basis:
- Total Operating Expenses decreased 8%. Cost of
Sales margin increased 0.3 percentage points driven by changes
in product mix, partially offset by lower manufacturing cost and
lower costs associated with COVID-19 antibody shipments.
R&D expenses decreased 22% primarily due to a
$400 million licensing-related
upfront payment to KKC in 2021. Without the one-time KKC upfront
payment, R&D expenses increased 10% primarily due to higher
late-stage program support and research and early pipeline spend,
partially offset by lower marketed product support. SG&A
expenses increased 1%.
- Operating Margin as a percentage of product sales
increased 4.2 percentage points to 52.5%.
- Tax Rate decreased 0.4 percentage points primarily due
to net favorable items during the quarter as compared to the prior
year.
$Millions, except
percentages
|
|
GAAP
|
|
Non-GAAP
|
|
|
Q3
'22
|
|
Q3
'21
|
|
YOY Δ
|
|
Q3
'22
|
|
Q3
'21
|
|
YOY Δ
|
Cost of
Sales
|
|
$
1,588
|
|
$
1,609
|
|
(1 %)
|
|
$
1,003
|
|
$
997
|
|
1 %
|
% of product
sales
|
|
25.5 %
|
|
25.5 %
|
|
— pts
|
|
16.1 %
|
|
15.8 %
|
|
0.3 pts
|
Research &
Development
|
|
$
1,112
|
|
$
1,422
|
|
(22 %)
|
|
$
1,096
|
|
$
1,397
|
|
(22 %)
|
% of product
sales
|
|
17.8 %
|
|
22.5 %
|
|
(4.7) pts
|
|
17.6 %
|
|
22.1 %
|
|
(4.5) pts
|
Acquired
IPR&D
|
|
$
—
|
|
$
—
|
|
NM
|
|
$
—
|
|
$
—
|
|
NM
|
% of product
sales
|
|
— %
|
|
— %
|
|
NM
|
|
— %
|
|
— %
|
|
NM
|
Selling, General &
Administrative
|
|
$
1,287
|
|
$
1,305
|
|
(1 %)
|
|
$
1,276
|
|
$
1,260
|
|
1 %
|
% of product
sales
|
|
20.6 %
|
|
20.6 %
|
|
— pts
|
|
20.5 %
|
|
19.9 %
|
|
0.6 pts
|
Other
|
|
$
5
|
|
$
(8)
|
|
*
|
|
$
—
|
|
$
—
|
|
NM
|
Total Operating
Expenses
|
|
$
3,992
|
|
$
4,328
|
|
(8 %)
|
|
$
3,375
|
|
$
3,654
|
|
(8 %)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
Margin
|
|
|
|
|
|
|
|
|
|
|
|
|
operating income as %
of product sales
|
|
42.6 %
|
|
37.6 %
|
|
5.0 pts
|
|
52.5 %
|
|
48.3 %
|
|
4.2 pts
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Tax
Rate
|
|
10.4 %
|
|
12.6 %
|
|
(2.2)
pts
|
|
12.9 %
|
|
13.3 %
|
|
(0.4)
pts
|
|
|
|
|
|
|
|
|
|
|
|
|
|
pts: percentage
points
|
|
|
|
|
|
|
|
|
|
|
|
|
* change in excess of
100%
|
|
|
|
|
|
|
|
|
|
|
|
|
NM = not
meaningful
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash Flow and Balance Sheet
- The Company generated $2.8
billion of free cash flow in the third quarter of 2022
versus $2.2 billion in the third
quarter of 2021 primarily driven by favorable changes in working
capital.
- The Company's third quarter 2022 dividend of $1.94 per share was declared on August 3, 2022, and was paid on September 8, 2022, to all stockholders of record
as of August 18, 2022, representing a
10% increase from 2021.
- During the third quarter, 1.5 million shares of common stock
were retired in connection with the final settlement of accelerated
share repurchase agreements that the Company entered into in
February 2022.
- Cash and investments totaled $11.5
billion and debt outstanding totaled $38.7 billion as of September 30, 2022.
$Billions, except
shares
|
|
Q3
'22
|
|
Q3
'21
|
|
YOY Δ
|
Operating Cash
Flow
|
|
$ 3.0
|
|
$ 2.4
|
|
$ 0.6
|
Capital
Expenditures
|
|
$ 0.2
|
|
$ 0.2
|
|
$
(0.1)
|
Free Cash
Flow
|
|
$ 2.8
|
|
$ 2.2
|
|
$ 0.6
|
Dividends
Paid
|
|
$ 1.0
|
|
$ 1.0
|
|
$ 0.0
|
Share
Repurchases
|
|
$
—
|
|
$ 1.1
|
|
$
(1.1)
|
Average Diluted Shares
(millions)
|
|
538
|
|
570
|
|
(32)
|
|
|
|
|
|
|
|
Note: Numbers may not
add due to rounding
|
|
|
|
|
|
|
|
$Billions
|
|
9/30/22
|
|
12/31/21
|
|
YTD Δ
|
Cash and
Investments
|
|
$
11.5
|
|
$ 8.0
|
|
$ 3.4
|
Debt
Outstanding
|
|
$ 38.7
|
|
$ 33.3
|
|
$ 5.4
|
|
|
|
|
|
|
|
Note: Numbers may not
add due to rounding
|
|
|
|
|
|
|
2022 Guidance
For the full year 2022, the Company now expects:
- Total revenues in the range of $26.0 billion to $26.3
billion.
- On a GAAP basis, EPS in the range of $11.46 to $12.17,
and a tax rate in the range of 11.0% to 12.5%.
- On a non-GAAP basis, EPS in the range of $17.25 to $17.85,
and a tax rate in the range of 13.5% to 14.5%.
- Capital expenditures to be approximately $950 million, unchanged from previous
guidance.
- Share repurchases in the range of $6.0 billion to $7.0
billion, unchanged from previous guidance.
Third Quarter Product and Pipeline Update
The Company provided the following updates on selected product
and pipeline programs:
General Medicine
Repatha
- An abstract based on data from the Repatha FOURIER and
FOURIER-open label extension studies highlighting the association
between the significant and sustained achievement of low and very
low, low-density lipoprotein cholesterol (LDL-C) levels and lower
rates of major cardiovascular events has been accepted as a
late-breaking abstract at the American Heart Association Scientific
Sessions (AHA) in November.
Olpasiran (AMG 890)
- An abstract based on the end-of-treatment analysis data from a
Phase 2 study of olpasiran, a small interfering RNA molecule that
reduces Lipoprotein(a) (Lp(a)) synthesis in the liver in subjects
with elevated Lp(a) has been accepted as a late-breaking clinical
trial presentation at AHA in November.
AMG 133
- 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, has completed
enrollment.
- Data from the single- and multiple-dose cohorts of this Phase 1
study will be presented at the 20th World Congress on Insulin
Resistance, Diabetes, and Cardiovascular Disease (WCIRDC) Hybrid
Conference in December.
Webcast call Monday, November. 7, 2022
- David M. Reese, M.D., executive
vice president of Research and Development at Amgen, along with
members of Amgen's R&D team and a clinical investigator, will
discuss the Phase 2 data on olpasiran, data from the Repatha
FOURIER and FOURIER-open label extension studies and will provide
an update on a Phase 1 study of AMG 133 during the call. The
webcast will be broadcast over the internet simultaneously and will
be available to members of the news media, investors and the
general public.
Inflammation
Otezla
- In September, results were presented from:
-
- The Phase 3 SPROUT study, evaluating Otezla in pediatric
patients (ages 6 through 17) with moderate to severe plaque
psoriasis. Otezla treatment resulted in significant improvements in
measures of disease severity at week 16 compared with placebo.
- The Phase 3 DISCREET study, evaluating Otezla in adult patients
with moderate to severe genital psoriasis. Otezla treatment showed
a clinically meaningful and statistically significant improvement
in genital psoriasis, including improvements in skin clearance,
itch, and quality of life at week 16 compared with placebo.
- In both studies, safety findings were consistent with the known
profile of Otezla; no new signals were identified.
- Based on these results, discussions with the FDA are ongoing
for DISCREET to add clinical data to Otezla U.S. prescribing
information. Discussions with regulatory authorities globally for
SPROUT are forthcoming.
TEZSPIRE
- In September, TEZSPIRE was approved
-
- in the European Union as an add-on maintenance treatment in
adults and adolescents 12 years and older with severe asthma who
are inadequately controlled despite high-dose inhaled
corticosteroids plus another medicinal product for maintenance
treatment.
- by the Japanese Ministry of Health, Labour, and Welfare for the
treatment of bronchial asthma in patients with severe or refractory
disease in whom asthma symptoms cannot be controlled with mid- or
high-dose inhaled corticosteroids and other long-term maintenance
therapies.
- Regulatory reviews continue in other jurisdictions.
- In severe asthma, the PASSAGE Phase 4 real-world effectiveness
study, the WAYFINDER Phase 3b study,
and the SUNRISE Phase 3 study are enrolling patients.
- A Phase 3 study continues to enroll patients with chronic
rhinosinusitis with nasal polyps.
- Planning is underway for a Phase 3 study in patients with
eosinophilic esophagitis.
- A Phase 2b study in patients with
chronic spontaneous urticaria is fully enrolled, with data readout
anticipated in H1-2023.
- A Phase 2 study continues to enroll patients with chronic
obstructive pulmonary disease.
Rocatinlimab (AMG 451 / KHK4083)
- In September, data were presented
-
- from a Phase 2 study of rocatinlimab, an anti-OX40 monoclonal
antibody, which demonstrated improvement in head and neck atopic
dermatitis in patients with moderate to severe disease.
- demonstrating that rocatinlimab provides durable normalization
of atopic dermatitis inflammation-related gene expression in skin
biopsies from atopic dermatitis patients.
- The ROCKET Phase 3 program evaluating rocatinlimab in patients
with moderate to severe atopic dermatitis was initiated in June.
Following additional discussions with regulators and our partner,
we are amending the studies to further improve patient convenience
and investigate a range of doses. Amendments are not related to
safety or efficacy issues.
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, continues to enroll patients with systemic
lupus erythematosus (SLE).
Efavaleukin alfa (AMG 592)
- A Phase 2b study of efavaleukin
alfa, an interleukin-2 (IL-2) mutein Fc fusion protein, continues
to enroll patients with SLE while a Phase 2b study continues to enroll patients with
ulcerative colitis.
Ordesekimab (AMG 714 / PRV-015)
- A Phase 2b study of AMG 714, a
monoclonal antibody that binds interleukin-15, continues to enroll
patients with nonresponsive celiac disease.
Oncology
LUMAKRAS/LUMYKRAS
- In August, data were presented demonstrating that
-
- in a mostly pretreated advanced non-small cell lung cancer
(NSCLC) population, lead-in cohorts treated with LUMAKRAS followed
by a combination of LUMAKRAS and immunotherapy demonstrated durable
clinical activity with lower rates of grade 3-4 Treatment-Related
Adverse Events (TRAEs) compared to concurrently treated cohorts.
Dose expansion is ongoing in treatment-naïve patients using
lower-dose LUMAKRAS lead-in followed by combination of LUMAKRAS
with pembrolizumab.
- LUMAKRAS given in combination with Src homology region
2-containing protein tyrosine phosphatase 2 (SHP2) inhibitor RMC-4630 demonstrated promising
clinical activity in patients with KRAS G12C-mutated NSCLC, most
notably in KRAS G12C inhibitor-naïve patients.
- In September, data were presented demonstrating that
-
- in the global Phase 3 CodeBreaK 200 trial, LUMAKRAS treatment
led to increased progression-free survival (PFS) (primary endpoint)
and a significantly higher objective response rate (ORR) (key
secondary endpoint) in patients with KRAS G12C-mutated NSCLC
compared with intravenous chemotherapy docetaxel. Patient-reported
outcomes (a key secondary endpoint) also favored LUMAKRAS versus
docetaxel.
- in the Phase 1b CodeBreaK 101
study, LUMAKRAS combined with Vectibix demonstrated encouraging
efficacy and safety in patients with chemo-refractory metastatic
colorectal cancer (CRC). This combination delivered a 30% ORR with
a median PFS of 5.7 months. With a median follow up of 8.8 months,
median overall survival (OS) was not yet reached. A Phase 3 trial
continues to enroll using this combination.
- The Company is planning to initiate a Phase 3 study of LUMAKRAS
plus chemotherapy in first-line KRAS G12C mutant and PD-L1 negative
advanced/metastatic NSCLC.
BLINCYTO
- Eastern Cooperative Oncology Group and the American College of
Radiology Imaging Network (ECOG-ACRIN) Cancer Research Group
announced that a National Cancer Institute sponsored, registration
enabling BLINCYTO randomized controlled trial (E1910) in adults
with newly diagnosed Philadelphia
chromosome negative B-cell acute lymphoblastic leukemia, met the
primary endpoint of statistically significant improvement in OS at
a predefined interim analysis. This study investigated the addition
of BLINCYTO to standard of care chemotherapy. Data were submitted
to a medical congress taking place later this year and will be
submitted to regulatory authorities in due course.
Vectibix
- American Society of Clinical Oncology (ASCO) guidelines in the
U.S. and European Society for Medical Oncology (ESMO) guidelines in
Europe were updated to indicate
anti-EGFR monoclonal antibodies are preferred treatment over
bevacizumab in patients with RAS wild type (RAS/BRAF wild type by
ESMO) metastatic CRC and left-sided tumors. These updates were
based on the Vectibix PARADIGM study that was presented at ASCO,
where data demonstrated that the mFOLFOX6 + Vectibix combination
provides a statistically significant improvement in OS over the
mFOLFOX6 + bevacizumab combination as first-line treatment for
metastatic CRC patients with a left-sided primary tumor and in the
overall population.
Bemarituzumab
- FORTITUDE-101, a Phase 3 study of bemarituzumab a fibroblast
growth factor receptor 2b (FGFR2b)
targeting monoclonal antibody, plus chemotherapy, versus placebo
plus chemotherapy in first-line gastric cancer with FGFR2b
overexpression continues to enroll patients.
- FORTITUDE-102, a Phase 1b/3 study
of bemarituzumab plus chemotherapy and nivolumab versus
chemotherapy and nivolumab in first-line gastric cancer with FGFR2b
overexpression is enrolling patients in the Phase 3 portion of the
study.
- FORTITUDE-103, a Phase 1b study
of bemarituzumab plus oral chemotherapy regimens in first-line
gastric cancer is enrolling patients.
- FORTITUDE-201, a Phase 1b study
of bemarituzumab monotherapy and in combination with standard of
care therapy continues to enroll patients with squamous NSCLC with
FGFR2b overexpression.
- FORTITUDE-301, a Phase 1b/2
basket study evaluating the safety and efficacy of bemarituzumab
monotherapy in solid tumors with FGFR2b overexpression is enrolling
patients.
Tarlatamab (AMG 757)
- In August, Phase 1 data from DeLLphi-300 were presented
demonstrating that in heavily pretreated patients with small-cell
lung cancer (SCLC), tarlatamab, a half-life extended (HLE)
bispecific T-cell engager (BiTE®) molecule targeting
delta-like ligand 3 (DLL3), delivered a confirmed ORR of 23%, a
median duration of response of 13.0 months and a median OS of 13.2
months. DeLLphi-301, a potentially registrational Phase 2 study of
tarlatamab continues to enroll patients in this setting.
- DeLLphi-300, a Phase 1 study of tarlatamab, continues to enroll
patients with relapsed/refractory SCLC.
- DeLLphi-302, a Phase 1b study of
tarlatamab in combination with AMG 404, an anti-programmed cell
death-1 monoclonal antibody, continues to enroll patients with
second-line or later SCLC.
- DeLLphi-303, a Phase 1b study of
tarlatamab in combination with standard of care in first-line SCLC,
is enrolling patients.
- DeLLpro-300, a Phase 1b study of
tarlatamab, continues to enroll patients with de novo or
treatment-emergent neuroendocrine prostate cancer.
AMG 509
- A Phase 1 dose-escalation study of AMG 509, a bispecific
molecule targeting six-transmembrane epithelial antigen of prostate
1 (STEAP1) continues to enroll patients with metastatic
castrate-resistant prostate cancer (mCRPC).
AMG 340
- A Phase 1 dose-escalation study of AMG 340, a lower T-cell
affinity BiTE molecule targeting prostate-specific membrane antigen
(PSMA), continues to enroll patients with mCRPC.
AMG 193
- A Phase 1/1b/2 study of AMG 193,
a novel 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
- In August, the Company announced positive top-line results from
the DAHLIA study, a randomized, double-blind, active-controlled,
two-period crossover Phase 3 study evaluating the efficacy and
safety of ABP 959, a biosimilar candidate to SOLIRIS®
(eculizumab), compared with SOLIRIS in adult patients with
paroxysmal nocturnal hemoglobinuria (PNH).
- The primary analysis of a randomized, double-blind, active
controlled, Phase 3 study evaluating the efficacy and safety of ABP
938, an investigational biosimilar to EYLEA®
(aflibercept) compared with EYLEA met its primary endpoint in
subjects with neovascular age-related macular degeneration; final
analysis is expected in 2023.
- A Phase 3 study evaluating the efficacy and safety of ABP 654
compared to STELARA® (ustekinumab) in adult patients
with moderate to severe plaque psoriasis has completed, and these
data were submitted to the FDA to support U.S. approval.
- A Phase 3 study to support an interchangeability designation in
the U.S. for ABP 654 is ongoing.
- A Phase 3 study to support an interchangeability designation in
the U.S. for AMJEVITA™ (adalimumab-atto) is ongoing.
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 third quarters 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
2022 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 third quarter
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 third quarters of 2022 and
2021. FCF is computed by subtracting capital expenditures from
operating cash flow, each as determined in accordance with GAAP.
Management has also presented Total Revenues Adjusted for Foreign
Currency Impact, which is a non-GAAP financial measure, for the
third quarter of 2022. Total Revenues Adjusted for Foreign Currency
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.
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. Further,
the Company believes Total Revenues Adjusted for Foreign Currency
Impact provides supplementary information on the Company's product
sales performance by excluding changes in foreign currency exchange
rates between comparative periods.
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 Amgen.com and follow us
on Twitter, LinkedIn, Instagram, TikTok and YouTube.
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., Generate
Biomedicines, Inc., Arrakis Therapeutics, Inc., Plexium, Inc., 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, or the ChemoCentryx,
Inc. acquisition 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
September
30,
|
|
Nine months
ended
September
30,
|
|
2022
|
|
2021
|
|
2022
|
|
2021
|
Revenues:
|
|
|
|
|
|
|
|
Product
sales
|
$
6,237
|
|
$
6,320
|
|
$
18,249
|
|
$
18,026
|
Other
revenues
|
415
|
|
386
|
|
1,235
|
|
1,107
|
Total
revenues
|
6,652
|
|
6,706
|
|
19,484
|
|
19,133
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
Cost of
sales
|
1,588
|
|
1,609
|
|
4,659
|
|
4,736
|
Research and
development
|
1,112
|
|
1,422
|
|
3,110
|
|
3,471
|
Acquired in-process
research and development
|
—
|
|
—
|
|
—
|
|
1,505
|
Selling, general and
administrative
|
1,287
|
|
1,305
|
|
3,842
|
|
3,943
|
Other
|
5
|
|
(8)
|
|
537
|
|
143
|
Total operating
expenses
|
3,992
|
|
4,328
|
|
12,148
|
|
13,798
|
|
|
|
|
|
|
|
|
Operating
income
|
2,660
|
|
2,378
|
|
7,336
|
|
5,335
|
|
|
|
|
|
|
|
|
Other income
(expense):
|
|
|
|
|
|
|
|
Interest expense,
net
|
(368)
|
|
(296)
|
|
(991)
|
|
(862)
|
Other income (expense),
net
|
100
|
|
73
|
|
(747)
|
|
97
|
|
|
|
|
|
|
|
|
Income before income
taxes
|
2,392
|
|
2,155
|
|
5,598
|
|
4,570
|
|
|
|
|
|
|
|
|
Provision for income
taxes
|
249
|
|
271
|
|
662
|
|
576
|
|
|
|
|
|
|
|
|
Net income
|
$
2,143
|
|
$
1,884
|
|
$
4,936
|
|
$
3,994
|
|
|
|
|
|
|
|
|
Earnings per
share:
|
|
|
|
|
|
|
|
Basic
|
$ 4.01
|
|
$ 3.32
|
|
$ 9.16
|
|
$ 6.98
|
Diluted
|
$ 3.98
|
|
$ 3.31
|
|
$ 9.11
|
|
$ 6.93
|
|
|
|
|
|
|
|
|
Weighted-average shares
used in calculation of earnings per share:
|
|
|
|
|
|
|
|
Basic
|
535
|
|
567
|
|
539
|
|
572
|
Diluted
|
538
|
|
570
|
|
542
|
|
576
|
Amgen
Inc. Consolidated Balance Sheets - GAAP (In
millions)
|
|
|
September
30,
|
|
December
31,
|
|
2022
|
|
2021
|
|
(Unaudited)
|
|
|
Assets
|
Current
assets:
|
|
|
|
Cash, cash equivalents
and marketable securities
|
$
11,478
|
|
$
8,037
|
Trade receivables,
net
|
5,326
|
|
4,895
|
Inventories
|
4,757
|
|
4,086
|
Other current
assets
|
2,501
|
|
2,367
|
Total current
assets
|
24,062
|
|
19,385
|
|
|
|
|
Property, plant and
equipment, net
|
5,188
|
|
5,184
|
Intangible assets,
net
|
13,266
|
|
15,182
|
Goodwill
|
14,845
|
|
14,890
|
Other noncurrent
assets
|
6,339
|
|
6,524
|
Total assets
|
$
63,700
|
|
$
61,165
|
|
|
|
|
Liabilities and
Stockholders' Equity
|
Current
liabilities:
|
|
|
|
Accounts payable and
accrued liabilities
|
$
12,788
|
|
$
12,097
|
Current portion of
long-term debt
|
1,543
|
|
87
|
Total current
liabilities
|
14,331
|
|
12,184
|
|
|
|
|
Long-term
debt
|
37,161
|
|
33,222
|
Long-term tax
liabilities
|
5,680
|
|
6,594
|
Other noncurrent
liabilities
|
2,875
|
|
2,465
|
Total stockholders'
equity
|
3,653
|
|
6,700
|
Total liabilities and
stockholders' equity
|
$
63,700
|
|
$
61,165
|
|
|
|
|
Shares
outstanding
|
534
|
|
558
|
Amgen
Inc. GAAP to Non-GAAP Reconciliations (Dollars
in millions) (Unaudited)
|
|
|
Three months
ended
September
30,
|
|
Nine months
ended
September
30,
|
|
2022
|
|
2021
|
|
2022
|
|
2021
|
GAAP cost of
sales
|
$
1,588
|
|
$
1,609
|
|
$
4,659
|
|
$
4,736
|
Adjustments to cost
of sales:
|
|
|
|
|
|
|
|
Acquisition-related expenses (a)
|
(585)
|
|
(606)
|
|
(1,779)
|
|
(1,827)
|
Other
|
—
|
|
(6)
|
|
—
|
|
(11)
|
Total
adjustments to cost of sales
|
(585)
|
|
(612)
|
|
(1,779)
|
|
(1,838)
|
Non-GAAP cost of
sales
|
$
1,003
|
|
$
997
|
|
$
2,880
|
|
$
2,898
|
|
|
|
|
|
|
|
|
GAAP cost of sales
as a percentage of product sales
|
25.5 %
|
|
25.5 %
|
|
25.5 %
|
|
26.3 %
|
Acquisition-related
expenses (a)
|
(9.4)
|
|
(9.6)
|
|
(9.7)
|
|
(10.1)
|
Other
|
0.0
|
|
(0.1)
|
|
0.0
|
|
(0.1)
|
Non-GAAP cost of
sales as a percentage of product sales
|
16.1 %
|
|
15.8 %
|
|
15.8 %
|
|
16.1 %
|
|
|
|
|
|
|
|
|
GAAP research and
development expenses
|
$
1,112
|
|
$
1,422
|
|
$
3,110
|
|
$
3,471
|
Adjustments to
research and development expenses:
|
|
|
|
|
|
|
|
Acquisition-related expenses (a)
|
(16)
|
|
(25)
|
|
(60)
|
|
(94)
|
Non-GAAP research
and development expenses
|
$
1,096
|
|
$
1,397
|
|
$
3,050
|
|
$
3,377
|
|
|
|
|
|
|
|
|
GAAP research and
development expenses as a percentage of product
sales
|
17.8 %
|
|
22.5 %
|
|
17.0 %
|
|
19.3 %
|
Acquisition-related expenses (a)
|
(0.2)
|
|
(0.4)
|
|
(0.3)
|
|
(0.6)
|
Non-GAAP research
and development expenses as a percentage of product
sales
|
17.6 %
|
|
22.1 %
|
|
16.7 %
|
|
18.7 %
|
|
|
|
|
|
|
|
|
GAAP selling,
general and administrative expenses
|
$
1,287
|
|
$
1,305
|
|
$
3,842
|
|
$
3,943
|
Adjustments to
selling, general and administrative expenses:
|
|
|
|
|
|
|
|
Acquisition-related expenses (a)
|
(11)
|
|
(16)
|
|
(40)
|
|
(67)
|
Other
|
—
|
|
(29)
|
|
—
|
|
(45)
|
Total
adjustments to selling, general and administrative
expenses
|
(11)
|
|
(45)
|
|
(40)
|
|
(112)
|
Non-GAAP selling,
general and administrative expenses
|
$
1,276
|
|
$
1,260
|
|
$
3,802
|
|
$
3,831
|
|
|
|
|
|
|
|
|
GAAP selling,
general and administrative expenses as a percentage of product
sales
|
20.6 %
|
|
20.6 %
|
|
21.1 %
|
|
21.9 %
|
Acquisition-related
expenses (a)
|
(0.1)
|
|
(0.2)
|
|
(0.3)
|
|
(0.4)
|
Other
|
0.0
|
|
(0.5)
|
|
0.0
|
|
(0.2)
|
Non-GAAP selling,
general and administrative expenses as a percentage of product
sales
|
20.5 %
|
|
19.9 %
|
|
20.8 %
|
|
21.3 %
|
|
|
|
|
|
|
|
|
GAAP operating
expenses
|
$
3,992
|
|
$
4,328
|
|
$ 12,148
|
|
$ 13,798
|
Adjustments to
operating expenses:
|
|
|
|
|
|
|
|
Adjustments to
cost of sales
|
(585)
|
|
(612)
|
|
(1,779)
|
|
(1,838)
|
Adjustments to
research and development expenses
|
(16)
|
|
(25)
|
|
(60)
|
|
(94)
|
Adjustments to
selling, general and administrative expenses
|
(11)
|
|
(45)
|
|
(40)
|
|
(112)
|
Certain charges
pursuant to our cost savings initiatives
|
8
|
|
(1)
|
|
7
|
|
(129)
|
Certain other
expenses (b)
|
(13)
|
|
9
|
|
(544)
|
|
(14)
|
Total
adjustments to operating expenses
|
(617)
|
|
(674)
|
|
(2,416)
|
|
(2,187)
|
Non-GAAP operating
expenses
|
$
3,375
|
|
$
3,654
|
|
$
9,732
|
|
$ 11,611
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months
ended
September
30,
|
|
Nine months
ended
September
30,
|
|
2022
|
|
2021
|
|
2022
|
|
2021
|
GAAP operating
income
|
$
2,660
|
|
$
2,378
|
|
$
7,336
|
|
$
5,335
|
Adjustments to
operating expenses
|
617
|
|
674
|
|
2,416
|
|
2,187
|
Non-GAAP operating
income
|
$
3,277
|
|
$
3,052
|
|
$
9,752
|
|
$
7,522
|
|
|
|
|
|
|
|
|
GAAP operating
income as a percentage of product sales
|
42.6 %
|
|
37.6 %
|
|
40.2 %
|
|
29.6 %
|
Adjustments to cost of
sales
|
9.4
|
|
9.7
|
|
9.7
|
|
10.2
|
Adjustments to
research and development expenses
|
0.2
|
|
0.4
|
|
0.3
|
|
0.6
|
Adjustments to
selling, general and administrative expenses
|
0.1
|
|
0.7
|
|
0.3
|
|
0.6
|
Certain charges
pursuant to our cost savings initiatives
|
0.0
|
|
0.0
|
|
0.0
|
|
0.7
|
Certain other expenses
(b)
|
0.2
|
|
(0.1)
|
|
2.9
|
|
0.0
|
Non-GAAP operating
income as a percentage of product sales
|
52.5 %
|
|
48.3 %
|
|
53.4 %
|
|
41.7 %
|
|
|
|
|
|
|
|
|
GAAP other income
(expense), net
|
$
100
|
|
$
73
|
|
$
(747)
|
|
$
97
|
Adjustments to
other income (expense), net:
|
|
|
|
|
|
|
|
Equity method
investment basis difference amortization
|
47
|
|
44
|
|
143
|
|
128
|
Net (gains)/losses
from equity investments
|
(150)
|
|
(191)
|
|
401
|
|
(335)
|
Total adjustments
to other income (expense), net
|
(103)
|
|
(147)
|
|
544
|
|
(207)
|
Non-GAAP other
income (expense), net
|
$
(3)
|
|
$
(74)
|
|
$
(203)
|
|
(110)
|
|
|
|
|
|
|
|
|
GAAP income before
income taxes
|
$
2,392
|
|
$
2,155
|
|
$
5,598
|
|
$
4,570
|
Adjustments to
income before income taxes:
|
|
|
|
|
|
|
|
Adjustments to
operating expenses
|
617
|
|
674
|
|
2,416
|
|
2,187
|
Adjustments to other
income (expense), net
|
(103)
|
|
(147)
|
|
544
|
|
(207)
|
Total adjustments
to income before income taxes
|
514
|
|
527
|
|
2,960
|
|
1,980
|
Non-GAAP income
before income taxes
|
$
2,906
|
|
$
2,682
|
|
$
8,558
|
|
$
6,550
|
|
|
|
|
|
|
|
|
GAAP provision for
income taxes
|
$
249
|
|
$
271
|
|
$
662
|
|
$
576
|
Adjustments to
provision for income taxes:
|
|
|
|
|
|
|
|
Income tax
effect of the above adjustments (c)
|
122
|
|
58
|
|
527
|
|
466
|
Other income
tax adjustments (d)
|
5
|
|
29
|
|
1
|
|
17
|
Total
adjustments to provision for income taxes
|
127
|
|
87
|
|
528
|
|
483
|
Non-GAAP provision
for income taxes
|
$
376
|
|
$
358
|
|
$
1,190
|
|
$
1,059
|
|
|
|
|
|
|
|
|
GAAP tax as a
percentage of income before taxes
|
10.4 %
|
|
12.6 %
|
|
11.8 %
|
|
12.6 %
|
Adjustments to
provision for income taxes:
|
|
|
|
|
|
|
|
Income tax
effect of the above adjustments (c)
|
2.3
|
|
(0.3)
|
|
2.1
|
|
3.3
|
Other income
tax adjustments (d)
|
0.2
|
|
1.0
|
|
0.0
|
|
0.3
|
Total
adjustments to provision for income taxes
|
2.5
|
|
0.7
|
|
2.1
|
|
3.6
|
Non-GAAP tax as a
percentage of income before taxes
|
12.9 %
|
|
13.3 %
|
|
13.9 %
|
|
16.2 %
|
|
|
|
|
|
|
|
|
GAAP net
income
|
$
2,143
|
|
$
1,884
|
|
$
4,936
|
|
$
3,994
|
Adjustments to net
income:
|
|
|
|
|
|
|
|
Adjustments to
income before income taxes, net of the income tax effect
|
392
|
|
469
|
|
2,433
|
|
1,514
|
Other income
tax adjustments (d)
|
(5)
|
|
(29)
|
|
(1)
|
|
(17)
|
Total
adjustments to net income
|
387
|
|
440
|
|
2,432
|
|
1,497
|
Non-GAAP net
income
|
$
2,530
|
|
$
2,324
|
|
$
7,368
|
|
$
5,491
|
|
|
|
|
|
|
|
|
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
September 30,
2022
|
|
Three months
ended
September 30,
2021
|
|
GAAP
|
|
Non-GAAP
|
|
GAAP
|
|
Non-GAAP
|
Net income
|
$
2,143
|
|
$
2,530
|
|
$
1,884
|
|
$
2,324
|
|
|
|
|
|
|
|
|
Weighted-average
shares for diluted EPS
|
538
|
|
538
|
|
570
|
|
570
|
|
|
|
|
|
|
|
|
Diluted EPS
|
$
3.98
|
|
$
4.70
|
|
$
3.31
|
|
$
4.08
|
|
|
|
|
|
|
|
|
|
Nine months
ended
September 30,
2022
|
|
Nine months
ended
September 30,
2021
|
|
GAAP
|
|
Non-GAAP
|
|
GAAP
|
|
Non-GAAP
|
Net income
|
$
4,936
|
|
$
7,368
|
|
$
3,994
|
|
$
5,491
|
|
|
|
|
|
|
|
|
Weighted-average
shares for diluted EPS
|
542
|
|
542
|
|
576
|
|
576
|
|
|
|
|
|
|
|
|
Diluted EPS
|
$
9.11
|
|
$
13.59
|
|
$
6.93
|
|
$
9.53
|
|
|
|
(a)
|
|
The adjustments related
primarily to noncash amortization of intangible assets from
business acquisitions.
|
|
|
|
(b)
|
|
For the three months
ended September 30, 2022, the adjustments related primarily to an
impairment-related charge associated with an intangible asset
acquired in a business combination. For the nine months ended
September 30, 2022, the adjustments related primarily to cumulative
foreign currency translation adjustments from a nonstrategic
divestiture. For the three and nine months ended September 30,
2021, the adjustments related primarily to the change in fair
values of contingent consideration liabilities.
|
|
|
|
(c)
|
|
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 nine months ended
September 30, 2022, were 23.7% and 17.8%, respectively, compared to
11.0% and 23.5% for the corresponding period of the prior
year.
|
|
|
|
(d)
|
|
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
September
30,
|
|
Nine months
ended
September
30,
|
|
2022
|
|
2021
|
|
2022
|
|
2021
|
Net cash provided by
operating activities
|
$ 2,978
|
|
$ 2,418
|
|
$ 7,072
|
|
$ 6,453
|
Net cash (used in)
provided by investing activities
|
(267)
|
|
73
|
|
(2,571)
|
|
963
|
Net cash provided by
(used in) financing activities
|
1,588
|
|
2,848
|
|
(2,988)
|
|
(1,713)
|
Increase in cash and
cash equivalents
|
4,299
|
|
5,339
|
|
1,513
|
|
5,703
|
Cash and cash
equivalents at beginning of period
|
5,203
|
|
6,630
|
|
7,989
|
|
6,266
|
Cash and cash
equivalents at end of period
|
$ 9,502
|
|
$
11,969
|
|
$ 9,502
|
|
$
11,969
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months
ended
September
30,
|
|
Nine months
ended
September
30,
|
|
2022
|
|
2021
|
|
2022
|
|
2021
|
Net cash provided by
operating activities
|
$ 2,978
|
|
$ 2,418
|
|
$ 7,072
|
|
$ 6,453
|
Capital
expenditures
|
(160)
|
|
(242)
|
|
(596)
|
|
(593)
|
Free cash
flow
|
$ 2,818
|
|
$ 2,176
|
|
$ 6,476
|
|
$ 5,860
|
Amgen
Inc. Reconciliation of Total Revenues Adjusted for
Foreign Currency Impact (Dollars in
millions) (Unaudited)
|
|
|
Three months
ended
September
30,
|
|
|
|
|
|
|
|
|
|
|
|
2022
|
|
2021
|
|
Change
|
|
FX impact $
(a)
|
|
Three months
ended
September
30, 2022
excluding FX
|
|
FX impact %
(a)
|
|
Change
excluding FX
|
Total
Revenues
|
$
6,652
|
|
$
6,706
|
|
(1 %)
|
|
$
(160)
|
|
$
6,812
|
|
(2 %)
|
|
2 %
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(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 EPS Guidance to Non-GAAP
EPS Guidance for the Year Ending December 31, 2022
(Unaudited)
|
|
GAAP diluted EPS
guidance
|
|
$
11.46
|
—
|
$ 12.17
|
Known adjustments to
arrive at non-GAAP*:
|
|
|
|
|
Acquisition-related
expenses (a)
|
|
4.08
|
—
|
4.19
|
Loss on divestiture
(b)
|
|
|
1.04
|
|
Net losses from equity
investments
|
|
|
0.58
|
|
Other
|
|
|
(0.02)
|
|
Non-GAAP diluted EPS
guidance
|
|
$
17.25
|
—
|
$ 17.85
|
|
|
* The known
adjustments are presented net of their related tax impact, which
amount to approximately $1.29 - $1.30 per share.
|
|
|
(a)
|
The adjustments relate
primarily to noncash amortization of intangible assets acquired in
business acquisitions.
|
(b)
|
The adjustment
primarily relates to a cumulative foreign currency translation
adjustment from a nonstrategic divestiture.
|
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, divestitures, asset
impairments, litigation, changes in fair value of our contingent
consideration obligations and changes in fair value of our equity
investments. The GAAP adjustments from the acquisition of
ChemoCentryx, Inc. are included in the GAAP diluted EPS
guidance.
Reconciliation of
GAAP Tax Rate Guidance to Non-GAAP Tax Rate Guidance for
the Year Ending December 31,
2022 (Unaudited)
|
|
GAAP tax rate
guidance
|
|
11.0 %
|
—
|
12.5 %
|
Tax rate of known
adjustments discussed above
|
|
2.0 %
|
—
|
2.5 %
|
Non-GAAP tax rate
guidance
|
|
13.5 %
|
—
|
14.5 %
|
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SOURCE Amgen