THOUSAND
OAKS, Calif., Oct. 31,
2023 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today
announced financial results for the third quarter of
20231.
"We are excited about our pipeline progress
and our operating performance in the third quarter," said
Robert A. Bradway, chairman and
chief executive officer. "With the completion of the Horizon
acquisition, Amgen has added rare disease medicines that fit well
with our broad innovative portfolio."
Key results include:
- Total revenues increased 4% to $6.9
billion in comparison to the third quarter of 2022,
resulting from a 5% increase in product sales. Product sales growth
was driven by 11% volume growth, partially offset by 3% lower net
selling price and 3% unfavorable changes to estimated sales
deductions.
- Volume growth of 11% included double-digit volume growth from
BLINCYTO® (blinatumomab), EVENITY®
(romosozumab-aqqg), Repatha® (evolocumab) and
Nplate® (romiplostim).
- U.S. volume grew 11% and ex-U.S. volume grew 12%, including 27%
volume growth in the Asia Pacific
region.
- GAAP earnings per share (EPS) decreased 19% from $3.98 to $3.22,
driven by a net impairment charge in Q3 2023 of approximately
$650 million following a decision to
discontinue development of AMG 340, partially offset by increased
revenues.
- GAAP operating income decreased from $2.7 billion to $2.0
billion, and GAAP operating margin decreased 11.7 percentage
points to 30.9%.
- Non-GAAP EPS increased 6% from $4.70 to $4.96,
driven by increased revenues, partially offset by higher operating
expenses.
- Non-GAAP operating income increased from $3.3 billion to $3.4
billion, and non-GAAP operating margin decreased 0.5
percentage points to 52.0%.
- The Company generated $2.5
billion of free cash flow for the third quarter of 2023
versus $2.8 billion in the third
quarter of 2022.
References in this release to "non-GAAP" measures, measures
presented "on a non-GAAP basis" and "free cash flow" (computed by
subtracting capital expenditures from operating cash flow) refer to
non-GAAP financial measures. Adjustments to the most directly
comparable GAAP financial measures and other items are presented on
the attached reconciliations. Refer to Non-GAAP Financial Measures
below for further discussion.
1 The accounting impact of this
acquisition and the results of operations for Horizon Therapeutics
plc will be included in our consolidated financial statements
beginning in the fourth quarter of 2023.
|
Product Sales Performance
Total product sales increased 5% for the third quarter of 2023
versus the third quarter of 2022. Unit volumes grew 11%, partially
offset by 3% lower net selling price and 3% unfavorable changes to
estimated sales deductions.
General Medicine
- Repatha® sales increased 31% year-over-year
for the third quarter, driven by 44% volume growth, partially
offset by lower net selling price. In the U.S., sales grew 29%,
driven by 45% volume growth, partially offset by lower net selling
price resulting from higher rebates to support and expand access
for patients. Outside the U.S., sales grew 34%, driven by 43%
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 million patients treated since
launch.
- Prolia® (denosumab) sales increased 14%
year-over-year for the third quarter, primarily driven by 7% volume
growth and higher net selling price. We are on track to treat over
7 million patients with Prolia in 2023.
- EVENITY® sales increased 53% year-over-year
to a record $307 million for the
third quarter, driven by strong volume growth. U.S. volumes grew
41% year-over-year and volumes outside the U.S. grew 63%.
- Aimovig® (erenumab-aooe) sales decreased 12%
year-over-year for the third quarter, driven by lower net selling
price, partially offset by favorable changes to estimated sales
deductions.
Inflammation
- TEZSPIRE® (tezepelumab-ekko) generated
$161 million of sales in the third
quarter. Quarter-over-quarter sales increased 21%, 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 are increasingly recognizing TEZSPIRE's unique,
differentiated profile and its broad potential to treat the 2.5
million patients worldwide with severe asthma who are uncontrolled,
without any phenotypic or biomarker limitation.
- TAVNEOS® (avacopan) generated $37 million of sales in the third quarter.
Quarter-over-quarter sales increased 23%, driven by volume growth.
U.S. volumes grew 18% quarter-over-quarter. In the U.S.,
approximately 2,300 patients have now been treated with
TAVNEOS.
- Otezla® (apremilast) sales decreased 10%
year-over-year for the third quarter, driven by lower net selling
price, unfavorable changes to estimated sales deductions and lower
inventory levels, partially offset by 1% volume growth. In the
U.S., net selling price declined, driven by higher rebates to
support and expand access for commercial and Medicare Part D
patients. Otezla demand in the quarter continued to be impacted by
free drug programs for newly launched competition. For the
remainder of 2023, we expect demand to be affected by these free
drug programs.
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 6%
year-over-year for the third quarter, primarily driven by an 8%
decline from unfavorable changes to estimated sales deductions,
resulting from a $47 million
favorable adjustment in the third quarter of 2022 compared to a
$37 million unfavorable adjustment in
this quarter. Year-over-year volume increased 1% in the third
quarter, driven by an increase in new patients starting treatment
as a result of improved payer coverage. For the remainder of 2023,
we expect this improved coverage will lead to growth in new
patients and declining net selling price.
- AMJEVITA®/AMGEVITA™ (adalimumab) sales
increased 30% year-over-year for the third quarter, driven by 53%
volume growth, partially offset by lower net selling price. Ex-U.S.
sales increased 10% year-over-year, driven by 22% volume growth,
partially offset by lower net selling price. U.S. sales increased
21% quarter-over-quarter, driven by 41% volume growth, partially
offset by lower inventory levels.
Hematology-Oncology
- BLINCYTO® sales increased 55% year-over-year
to a record $220 million for the
third quarter, driven by 56% volume growth, supported by broad
prescribing for patients with B-cell precursor acute lymphoblastic
leukemia.
- Vectibix® (panitumumab) sales increased 2%
year-over-year for the third quarter to a record $252 million, driven by higher net selling price
and 4% volume growth, partially offset by unfavorable foreign
exchange impact.
- KYPROLIS® (carfilzomib) sales increased 10%
year-over-year for the third quarter, primarily driven by 8% volume
growth.
- LUMAKRAS®/LUMYKRAS™ (sotorasib) generated
$52 million of sales for the third
quarter. Year-over-year sales decreased 31% for the third quarter,
primarily driven by unfavorable changes to estimated sales
deductions related to ongoing reimbursement negotiations in
France.
- XGEVA® (denosumab) sales increased 5%
year-over-year for the third quarter, driven by higher net selling
price.
- Nplate® sales increased 45% year-over-year
for the third quarter, driven by 43% volume growth resulting from a
$142 million order from the U.S.
government.
- MVASI® (bevacizumab-awwb) sales increased 2%
year-over-year for the third quarter, driven by 17% volume growth
and favorable changes to estimated sales deductions, partially
offset by lower net selling price. The published third quarter
Average Selling Price (ASP) for MVASI in the U.S. declined 19%
year-over-year and 1% quarter-over-quarter. Going forward, we
expect continued net selling price erosion driven by increased
competition.
- KANJINTI® (trastuzumab-anns) sales decreased
72% year-over-year for the third quarter, driven by lower net
selling price, unfavorable changes to estimated sales deductions
and volume declines.
Established Products
- Total sales of our established products, which include
EPOGEN® (epoetin alfa), Aranesp®
(darbepoetin alfa), Parsabiv® (etelcalcetide)
and Neulasta® (pegfilgrastim), decreased 30%
year-over-year for the third quarter, driven by lower net selling
price and volume declines. 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
'23
|
|
Q3
'22
|
|
YOY Δ
|
|
|
US
|
|
ROW
|
|
TOTAL
|
|
TOTAL
|
|
TOTAL
|
Repatha®
|
|
$
183
|
|
$
223
|
|
$
406
|
|
$
309
|
|
31 %
|
Prolia®
|
|
673
|
|
313
|
|
986
|
|
862
|
|
14 %
|
EVENITY®
|
|
214
|
|
93
|
|
307
|
|
201
|
|
53 %
|
Aimovig®
|
|
88
|
|
6
|
|
94
|
|
107
|
|
(12 %)
|
TEZSPIRE®
|
|
161
|
|
—
|
|
161
|
|
55
|
|
*
|
TAVNEOS®
|
|
32
|
|
5
|
|
37
|
|
—
|
|
NM
|
Otezla®
|
|
462
|
|
105
|
|
567
|
|
627
|
|
(10 %)
|
Enbrel®
|
|
1,026
|
|
9
|
|
1,035
|
|
1,106
|
|
(6 %)
|
AMJEVITA®/AMGEVITA™
|
|
23
|
|
129
|
|
152
|
|
117
|
|
30 %
|
BLINCYTO®
|
|
147
|
|
73
|
|
220
|
|
142
|
|
55 %
|
Vectibix®
|
|
116
|
|
136
|
|
252
|
|
247
|
|
2 %
|
KYPROLIS®
|
|
231
|
|
118
|
|
349
|
|
318
|
|
10 %
|
LUMAKRAS®/LUMYKRAS™
|
|
48
|
|
4
|
|
52
|
|
75
|
|
(31 %)
|
XGEVA®
|
|
374
|
|
145
|
|
519
|
|
495
|
|
5 %
|
Nplate®
|
|
322
|
|
97
|
|
419
|
|
288
|
|
45 %
|
MVASI®
|
|
140
|
|
73
|
|
213
|
|
209
|
|
2 %
|
KANJINTI®
|
|
7
|
|
13
|
|
20
|
|
72
|
|
(72 %)
|
EPOGEN®
|
|
50
|
|
—
|
|
50
|
|
136
|
|
(63 %)
|
Aranesp®
|
|
107
|
|
216
|
|
323
|
|
358
|
|
(10 %)
|
Parsabiv®
|
|
59
|
|
36
|
|
95
|
|
100
|
|
(5 %)
|
Neulasta®
|
|
92
|
|
32
|
|
124
|
|
247
|
|
(50 %)
|
Other
products**
|
|
136
|
|
31
|
|
167
|
|
166
|
|
1 %
|
Total product
sales
|
|
$ 4,691
|
|
$ 1,857
|
|
$ 6,548
|
|
$ 6,237
|
|
5 %
|
|
|
|
|
|
|
|
|
|
|
|
*Change in excess of
100%
|
|
|
|
|
|
|
|
**Consists of
AVSOLA®, RIABNI®, Corlanor®,
NEUPOGEN®, IMLYGIC®,
Sensipar®/Mimpara™ and BEKEMV™, as
well as sales in prior periods of our divested Bergamo and GENSENTA
subsidiaries.
|
NM = not
meaningful
|
|
|
|
|
|
|
|
Operating Expense, Operating Margin and Tax Rate
Analysis
On a GAAP basis:
- Total Operating Expenses increased 22%. Cost of
Sales margin increased 2.1 percentage points, primarily driven
by higher profit share, higher amortization expense from
acquisition-related assets and changes in product mix. Research
& Development (R&D) expenses decreased 3%, as lower
spend in research and early pipeline was partially offset by higher
spend in later-stage clinical programs and marketed products.
Selling, General & Administrative (SG&A) expenses
increased 5%, primarily driven by higher general and administrative
expenses, including higher acquisition-related expenses.
Other operating expenses consisted of a net impairment
charge for AMG 340.
- Operating Margin as a percentage of product sales
decreased 11.7 percentage points to 30.9%.
- Tax Rate increased 0.7 percentage points, primarily
driven by the 2022 Puerto Rico tax law change that replaced the
excise tax with an income tax beginning in 2023, partially offset
by net favorable items and earnings mix, including the tax benefit
from the net impairment charge for AMG 340.
On a non-GAAP basis:
- Total Operating Expenses increased 4%. Cost of
Sales margin increased 1.3 percentage points, primarily driven
by higher profit share and changes in product mix. R&D
expenses decreased 2%, as lower spend in research and early
pipeline was partially offset by higher spend in later-stage
clinical programs and marketed products. SG&A expenses
increased 1%.
- Operating Margin as a percentage of product sales
decreased 0.5 percentage points in the third quarter to 52.0%.
- Tax Rate increased 3.2 percentage points, primarily due
to the 2022 Puerto Rico tax law change that replaced the excise tax
with an income tax beginning in 2023 and earnings mix.
$Millions, except
percentages
|
|
GAAP
|
|
Non-GAAP
|
|
|
Q3
'23
|
|
Q3
'22
|
|
YOY Δ
|
|
Q3
'23
|
|
Q3
'22
|
|
YOY Δ
|
Cost of
Sales
|
|
$
1,806
|
|
$
1,588
|
|
14 %
|
|
$
1,137
|
|
$
1,003
|
|
13 %
|
% of product
sales
|
|
27.6 %
|
|
25.5 %
|
|
2.1 pts
|
|
17.4 %
|
|
16.1 %
|
|
1.3 pts
|
Research &
Development
|
|
$
1,079
|
|
$
1,112
|
|
(3 %)
|
|
$
1,070
|
|
$
1,096
|
|
(2 %)
|
% of product
sales
|
|
16.5 %
|
|
17.8 %
|
|
(1.3) pts
|
|
16.3 %
|
|
17.6 %
|
|
(1.3) pts
|
Selling, General &
Administrative
|
|
$
1,353
|
|
$
1,287
|
|
5 %
|
|
$
1,293
|
|
$
1,276
|
|
1 %
|
% of product
sales
|
|
20.7 %
|
|
20.6 %
|
|
0.1 pts
|
|
19.7 %
|
|
20.5 %
|
|
(0.8) pts
|
Other
|
|
$ 644
|
|
$
5
|
|
*
|
|
$ —
|
|
$ —
|
|
NM
|
Total Operating
Expenses
|
|
$
4,882
|
|
$
3,992
|
|
22 %
|
|
$
3,500
|
|
$
3,375
|
|
4 %
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
Margin
|
|
|
|
|
|
|
|
|
|
|
|
|
operating income as %
of product sales
|
|
30.9 %
|
|
42.6 %
|
|
(11.7) pts
|
|
52.0 %
|
|
52.5 %
|
|
(0.5) pts
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Tax
Rate
|
|
11.1 %
|
|
10.4 %
|
|
0.7
pts
|
|
16.1 %
|
|
12.9 %
|
|
3.2
pts
|
|
|
|
|
|
|
|
|
|
|
|
|
|
pts: percentage
points
|
|
|
|
|
|
|
|
|
|
|
|
|
* change in excess of
100%
|
|
|
|
|
|
|
|
|
|
|
|
|
NM = not
meaningful
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash Flow and Balance Sheet
- The Company generated $2.5
billion of free cash flow in the third quarter of 2023
versus $2.8 billion in the third
quarter of 2022.
- The Company's third quarter 2023 dividend of $2.13 per share was declared on August 1, 2023, and was paid on September 8, 2023, to all stockholders of record
as of August 18, 2023, representing a
10% increase from 2022.
- Cash and investments totaled $34.7
billion and debt outstanding totaled $60.5 billion as of September 30, 2023.
$Billions, except
shares
|
|
Q3
'23
|
|
Q3
'22
|
|
YOY Δ
|
Operating Cash
Flow
|
|
$
2.8
|
|
$
3.0
|
|
$
(0.2)
|
Capital
Expenditures
|
|
$
0.2
|
|
$
0.2
|
|
$
0.1
|
Free Cash
Flow
|
|
$
2.5
|
|
$
2.8
|
|
$
(0.3)
|
Dividends
Paid
|
|
$
1.1
|
|
$
1.0
|
|
$
0.1
|
Share
Repurchases
|
|
$
—
|
|
$
—
|
|
$
0.0
|
Average Diluted Shares
(millions)
|
|
538
|
|
538
|
|
0
|
|
|
|
|
|
|
|
Note: Numbers may not
add due to rounding
|
|
|
|
|
|
|
$Billions
|
|
9/30/23
|
|
12/31/22
|
|
YTD Δ
|
Cash and
Investments
|
|
$ 34.7
|
|
$
9.3
|
|
$ 25.4
|
Debt
Outstanding
|
|
$ 60.5
|
|
$ 38.9
|
|
$ 21.5
|
|
|
|
|
|
|
|
Note: Numbers may not
add due to rounding
|
|
|
|
|
2023 Guidance
For the full year 2023, the Company now expects:
- Total revenues in the range of $28.0 billion to $28.4
billion.
- On a GAAP basis, EPS in the range of $11.23 to $12.73,
and a tax rate in the range of 14.0% to 15.5%.
- On a non-GAAP basis, EPS in the range of $18.20 to $18.80,
and a tax rate in the range of 16.5% to 17.0%.
- Capital expenditures to be approximately
$950 million.
- Share repurchases not to exceed $500 million.
Third Quarter Product and Pipeline Update
The Company provided the following updates on selected product
and pipeline programs:
Oncology
Tarlatamab (AMG 757)
- In October, data were presented from the global Phase 2
DeLLphi-301 study and simultaneously published in the New
England Journal of Medicine, evaluating tarlatamab, a
first-in-class investigational delta-like ligand 3 (DLL3) targeting
BiTE® (bispecific T-cell engager) molecule, in patients with
advanced-stage small cell lung cancer (SCLC) who had failed two or
more prior lines of treatment. With a median follow-up of 10.6
months, an intention-to-treat analysis that included 100 patients
at the selected 10 mg dose for tarlatamab demonstrated an objective
response rate (ORR; primary endpoint) of 40% (97.5% confidence
interval: 29-52). There were no new safety signals observed
compared to the Phase 1 study.
- Data from the DeLLphi-301 study are being submitted to the U.S.
Food and Drug Administration (FDA) which recently granted
Breakthrough Therapy Designation to tarlatamab for the treatment of
adult patients with extensive-stage SCLC with disease progression
on or after platinum-based chemotherapy.
- DeLLphi-304, a Phase 3 study comparing tarlatamab with standard
of care chemotherapy in second-line SCLC, is enrolling
patients.
- Two additional Phase 3 studies of tarlatamab in earlier lines
of SCLC are planned.
- 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, has completed enrollment.
BLINCYTO
- In September, based upon the E1910 study, the FDA granted
Breakthrough Therapy Designation to BLINCYTO for the treatment of
adult and pediatric patients with CD19-positive, Philadelphia chromosome-negative (Ph-), B-cell
precursor acute lymphoblastic leukemia (B-ALL) during the
consolidation phase of multiphase therapy. Global regulatory
authority submissions are planned in late 2023 to early 2024 for
the Phase 3 E1910 study conducted by the National Cancer Institute,
the Eastern Cooperative Oncology Group and the American College of
Radiology Imaging Network (ECOG ACRIN) Cancer Research Group.
- In October, National Comprehensive Cancer Network®
Clinical Practice Guidelines in Oncology1 (NCCN
Guidelines®) for Pediatric Acute Lymphoblastic Leukemia
were updated to broaden the recommendation for BLINCYTO as
consolidation to include both early and late first relapse patients
with bone marrow relapse with or without extramedullary involvement
and adding the COG1331 regimen to the list of recommended treatment
regimens.
- Golden Gate, a Phase 3 study of BLINCYTO alternating with
low-intensity chemotherapy in older adults with newly diagnosed Ph-
B-ALL, continues to enroll patients.
- A Phase 1/2 study of subcutaneous BLINCYTO in adults with
relapsed or refractory Ph- B-ALL continues to enroll patients.
Xaluritamig (AMG 509)
- In October, initial data from a Phase 1b study were presented and simultaneously
published in Cancer Discovery on xaluritamig, a
first-in-class bispecific molecule targeting six-transmembrane
epithelial antigen of prostate 1 (STEAP1) demonstrating encouraging
anti-tumor activity in heavily pretreated patients with metastatic
castrate-resistant prostate cancer (mCRPC). Efficacy was greater at
higher doses (doses ≥0.75 mg target dose) where PSA50 was 59%
(n=44) and RECIST objective response rate was 41% (n=37). The
safety profile was clinically manageable, with CRS that was
generally low grade and primarily in cycle 1.
- A Phase 1b monotherapy and
combination dose-escalation and expansion study of xaluritamig in
mCRPC continues to enroll patients.
- Two additional Phase 1 studies of xaluritamig to evaluate
preliminary efficacy and safety in patients with early prostate
cancer are planned.
AMG 193
- Initial results from a Phase 1/1b
study of AMG 193, a first-in-class small molecule
methylthioadenosine (MTA)-cooperative protein arginine
methyltransferase 5 (PRMT5) inhibitor, demonstrate promising
monotherapy activity across six methylthioadenosine phosphorylase
(MTAP)-null tumor types. Dose-limiting adverse events and treatment
discontinuations were typically due to gastrointestinal events and
were manageable and reversible.
- This Phase 1/1b/2 study of AMG
193 continues to enroll patients with advanced MTAP-null solid
tumors.
- A Phase 1/2 study of AMG 193 in combination with IDE397, an
investigational methionine adenosyltransferase 2A (MAT2A)
inhibitor, is enrolling patients.
LUMAKRAS/LUMYKRAS
- In October, data were presented and simultaneously published in
the New England Journal of Medicine from the global Phase 3
CodeBreaK 300 trial evaluating two doses of LUMAKRAS (960 mg or 240
mg) in combination with Vectibix. Both doses demonstrated a
statistically significant superiority in PFS over the
investigator's choice of standard therapy in patients with
chemorefractory KRAS G12C-mutated metastatic colorectal cancer
(CRC). No new safety signals were observed. Discussions continue
with regulatory agencies on a potential approval pathway for this
indication.
- In September, LUMAKRAS was included in the colon cancer and the
rectal cancer NCCN Guidelines®1 (category 2A) and is
recommended for treatment of previously treated metastatic
colorectal or rectal cancer with KRAS G12C-mutated tumors in
combination with cetuximab or panitumumab.
- The Company is planning to initiate a Phase 3 study of LUMAKRAS
in combination with Vectibix and FOLFIRI in first-line KRAS
G12C-mutated CRC.
- In September, data were presented from an arm of the CodeBreaK
101 clinical trial, a Phase 1b study
evaluating LUMAKRAS with carboplatin and pemetrexed in adult
patients with KRAS G12C-mutated advanced NSCLC. LUMAKRAS treatment
resulted in encouraging objective response rates and disease
control rates in first-line and second-line patients.
- A global, randomized 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 NSCLC was initiated.
- Regulatory review by the FDA and the European Medicines Agency
(EMA) of the CodeBreaK 200 Phase 3 trial of previously treated
patients with KRAS G12C-mutated advanced NSCLC, along with data
from the Phase 2 dose comparison substudy, is ongoing.
- In November, data2 comparing sotorasib 960 mg versus
240 mg in adults with pretreated KRAS G12C-mutated advanced NSCLC
will be presented at a European Society for Medical Oncology (ESMO)
Virtual Plenary session.
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 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.
- FORTITUDE-201, a Phase 1b study
of bemarituzumab monotherapy and in combination with standard of
care therapy, in squamous NSCLC with FGFR2b overexpression, will be
discontinued.
AMG 340
- A Phase 1 dose-escalation study of AMG 340, a lower T-cell
affinity BiTE molecule targeting prostate-specific membrane antigen
(PSMA), in mCRPC will be discontinued.
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.
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 AMG 133 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 participants with atherosclerotic cardiovascular
disease and elevated Lp(a) continues to enroll patients.
- In August, data were presented from the final analysis of the
Phase 2 OCEAN(a)-DOSE study. The results from the off-treatment
extension period (at least 24 weeks since the last dose) show that
patients previously dosed every 12 weeks for up to 36 weeks with ≥
75 mg of olpasiran sustained a ~ 40-50% placebo-adjusted
percent reduction in Lp(a) nearly a year after the last dose.
No new safety concerns were identified during the off-treatment
extension period.
Repatha
- New data from the FOURIER Open Label Extension (OLE) study
reinforcing the safety and efficacy of Repatha, including results
from the evaluation of long-term neurocognitive safety in
atherosclerotic cardiovascular disease patients treated with
Repatha, will be presented at the American Heart Association
Scientific Sessions in November.
- EVOLVE-MI, a Phase 4 study of Repatha administered shortly
after an acute myocardial infarction and designed to reduce the
risk of cardiovascular events in hospitalized acute coronary
syndrome patients, 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.
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.
- 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.
- A Phase 2b study of TEZSPIRE in
chronic spontaneous urticaria did not meet the primary endpoint
comparing tezepelumab with placebo in the overall and
anti-IgE-naïve populations at week 16. By the end of the study at
week 32 (18 weeks after last dose), a sustained treatment effect
was observed in both tezepelumab dose groups in anti-IgE naïve
patients. The Company and its partner AstraZeneca are determining
next steps for this indication and plan to publish full results in
the future.
Rocatinlimab (AMG 451/KHK4083)
- In October, three posters of post-hoc analysis data from the
Phase 2b study of rocatinlimab, a
first-in-class anti-OX40 monoclonal antibody, in patients with
moderate to severe atopic dermatitis were presented. These included
patient reported outcomes data demonstrating the benefit of
rocatinlimab.
- The ROCKET Phase 3 program, composed of seven studies
evaluating rocatinlimab in moderate to severe atopic dermatitis,
continues to enroll adult and adolescent patients. To date, over
1,500 patients have been randomized into the ROCKET program.
- A Phase 2 study of rocatinlimab in moderate to severe
uncontrolled asthma is planned.
Otezla
- In October, results were presented from the DISCREET Phase 3
study which demonstrated that Otezla treated patients across
subgroups experienced greater improvement in genital psoriasis and
genital itch at week 16 compared to placebo, with women achieving
numerically greater responses.
- A Phase 3 study evaluating the efficacy and safety of Otezla in
Japanese patients with palmoplantar pustulosis successfully met the
primary and secondary endpoints.
TAVNEOS
- Data will be presented from the ADVOCATE study at the American
College of Rheumatology and American Society of Nephrology
Scientific sessions in November on the efficacy and safety of
TAVNEOS in key sub-groups including patients 65 years old and older
and patients with renal involvement.
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 continues to enroll 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 was initiated.
- The FDA accepted the Biologics License Application for ABP 938,
an investigational biosimilar to EYLEA®
(aflibercept).
1National Comprehensive Cancer
Network® (NCCN®) makes no warranties
of any kind whatsoever regarding their content, use or application
and disclaims any responsibility for their application or use in
any way.
2 Previously provided in the publicly available
ODAC briefing book.
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.
EYLEA is a registered
trademark of Regeneron Pharmaceuticals, Inc.
Non-GAAP Financial Measures
In this news release, management has presented its operating
results for the third quarters 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
2023 EPS and tax guidance in accordance with GAAP and on a non-GAAP
basis. These non-GAAP financial measures are computed by excluding
certain items related to acquisitions, divestitures, restructuring
and certain other items from the related GAAP financial measures.
Beginning January 1, 2022, following
industry guidance from the U.S. Securities and Exchange Commission,
the Company no longer excludes adjustments for upfront license
fees, development milestones and 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 third
quarters of 2023 and 2022. FCF is computed by subtracting capital
expenditures from operating cash flow, each as determined in
accordance with GAAP.
The Company believes that its presentation of non-GAAP financial
measures provides useful supplementary information to and
facilitates additional analysis by investors. The Company uses
certain non-GAAP financial measures to enhance an investor's
overall understanding of the financial performance and prospects
for the future of the Company's 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 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
Therapeutics plc (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 acquisition
or 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
September
30,
|
|
Nine months
ended
September
30,
|
|
2023
|
|
2022
|
|
2023
|
|
2022
|
Revenues:
|
|
|
|
|
|
|
|
Product
sales
|
$
6,548
|
|
$
6,237
|
|
$
19,077
|
|
$
18,249
|
Other
revenues
|
355
|
|
415
|
|
917
|
|
1,235
|
Total
revenues
|
6,903
|
|
6,652
|
|
19,994
|
|
19,484
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
Cost of
sales
|
1,806
|
|
1,588
|
|
5,339
|
|
4,659
|
Research and
development
|
1,079
|
|
1,112
|
|
3,250
|
|
3,110
|
Selling, general and
administrative
|
1,353
|
|
1,287
|
|
3,905
|
|
3,842
|
Other
|
644
|
|
5
|
|
874
|
|
537
|
Total operating
expenses
|
4,882
|
|
3,992
|
|
13,368
|
|
12,148
|
|
|
|
|
|
|
|
|
Operating
income
|
2,021
|
|
2,660
|
|
6,626
|
|
7,336
|
|
|
|
|
|
|
|
|
Other income
(expense):
|
|
|
|
|
|
|
|
Interest expense,
net
|
(759)
|
|
(368)
|
|
(2,054)
|
|
(991)
|
Other income (expense),
net
|
685
|
|
100
|
|
2,431
|
|
(747)
|
|
|
|
|
|
|
|
|
Income before income
taxes
|
1,947
|
|
2,392
|
|
7,003
|
|
5,598
|
|
|
|
|
|
|
|
|
Provision for income
taxes
|
217
|
|
249
|
|
1,053
|
|
662
|
|
|
|
|
|
|
|
|
Net income
|
$
1,730
|
|
$
2,143
|
|
$
5,950
|
|
$
4,936
|
|
|
|
|
|
|
|
|
Earnings per
share:
|
|
|
|
|
|
|
|
Basic
|
$ 3.23
|
|
$ 4.01
|
|
$
11.12
|
|
$ 9.16
|
Diluted
|
$ 3.22
|
|
$ 3.98
|
|
$
11.06
|
|
$ 9.11
|
|
|
|
|
|
|
|
|
Weighted-average shares
used in calculation of earnings per share:
|
|
|
|
|
|
|
|
Basic
|
535
|
|
535
|
|
535
|
|
539
|
Diluted
|
538
|
|
538
|
|
538
|
|
542
|
Amgen
Inc.
Consolidated Balance
Sheets - GAAP
(In
millions)
|
|
|
September
30,
|
|
December
31,
|
|
2023
|
|
2022
|
|
(Unaudited)
|
|
|
Assets
|
Current
assets:
|
|
|
|
Cash, cash equivalents
and marketable securities
|
$
34,741
|
|
$
9,305
|
Trade receivables,
net
|
6,145
|
|
5,563
|
Inventories
|
5,026
|
|
4,930
|
Other current
assets
|
2,565
|
|
2,388
|
Total current
assets
|
48,477
|
|
22,186
|
|
|
|
|
Property, plant and
equipment, net
|
5,563
|
|
5,427
|
Intangible assets,
net
|
13,150
|
|
16,080
|
Goodwill
|
15,509
|
|
15,529
|
Other noncurrent
assets
|
7,835
|
|
5,899
|
Total assets
|
$
90,534
|
|
$
65,121
|
|
|
|
|
Liabilities and
Stockholders' Equity
|
Current
liabilities:
|
|
|
|
Accounts payable and
accrued liabilities
|
$
15,526
|
|
$
14,096
|
Current portion of
long-term debt
|
1,428
|
|
1,591
|
Total current
liabilities
|
16,954
|
|
15,687
|
|
|
|
|
Long-term
debt
|
59,040
|
|
37,354
|
Long-term tax
liabilities
|
4,579
|
|
5,757
|
Other noncurrent
liabilities
|
2,305
|
|
2,662
|
Total stockholders'
equity
|
7,656
|
|
3,661
|
Total liabilities and
stockholders' equity
|
$
90,534
|
|
$
65,121
|
|
|
|
|
Shares
outstanding
|
535
|
|
534
|
Amgen
Inc.
GAAP to Non-GAAP
Reconciliations
(Dollars in
millions)
(Unaudited)
|
|
|
Three months
ended
September
30,
|
|
Nine months
ended
September
30,
|
|
2023
|
|
2022
|
|
2023
|
|
2022
|
GAAP cost of
sales
|
$
1,806
|
|
$
1,588
|
|
$
5,339
|
|
$
4,659
|
Adjustments to cost
of sales:
|
|
|
|
|
|
|
|
Acquisition-related expenses (a)
|
(668)
|
|
(585)
|
|
(2,008)
|
|
(1,779)
|
Certain net
charges pursuant to our restructuring and cost savings
initiatives
|
(1)
|
|
—
|
|
(36)
|
|
—
|
Total
adjustments to cost of sales
|
(669)
|
|
(585)
|
|
(2,044)
|
|
(1,779)
|
Non-GAAP cost of
sales
|
$
1,137
|
|
$
1,003
|
|
$
3,295
|
|
$
2,880
|
|
|
|
|
|
|
|
|
GAAP cost of sales
as a percentage of product sales
|
27.6 %
|
|
25.5 %
|
|
28.0 %
|
|
25.5 %
|
Acquisition-related expenses (a)
|
(10.2)
|
|
(9.4)
|
|
(10.5)
|
|
(9.7)
|
Certain net
charges pursuant to our restructuring and cost savings
initiatives
|
0.0
|
|
0.0
|
|
(0.2)
|
|
0.0
|
Non-GAAP cost of
sales as a percentage of product sales
|
17.4 %
|
|
16.1 %
|
|
17.3 %
|
|
15.8 %
|
|
|
|
|
|
|
|
|
GAAP research and
development expenses
|
$
1,079
|
|
$
1,112
|
|
$
3,250
|
|
$
3,110
|
Adjustments to
research and development expenses:
|
|
|
|
|
|
|
|
Acquisition-related expenses (a)
|
(9)
|
|
(16)
|
|
(27)
|
|
(60)
|
Certain net
charges pursuant to our restructuring and cost savings
initiatives
|
—
|
|
—
|
|
(17)
|
|
—
|
Total
adjustments to research and development expenses
|
(9)
|
|
(16)
|
|
(44)
|
|
(60)
|
Non-GAAP research
and development expenses
|
$
1,070
|
|
$
1,096
|
|
$
3,206
|
|
$
3,050
|
|
|
|
|
|
|
|
|
GAAP research and
development expenses as a percentage of product
sales
|
16.5 %
|
|
17.8 %
|
|
17.0 %
|
|
17.0 %
|
Acquisition-related expenses (a)
|
(0.2)
|
|
(0.2)
|
|
(0.1)
|
|
(0.3)
|
Certain net
charges pursuant to our restructuring and cost savings
initiatives
|
0.0
|
|
0.0
|
|
(0.1)
|
|
0.0
|
Non-GAAP research
and development expenses as a percentage of product
sales
|
16.3 %
|
|
17.6 %
|
|
16.8 %
|
|
16.7 %
|
|
|
|
|
|
|
|
|
GAAP selling,
general and administrative expenses
|
$
1,353
|
|
$
1,287
|
|
$
3,905
|
|
$
3,842
|
Adjustments to
selling, general and administrative expenses:
|
|
|
|
|
|
|
|
Acquisition-related expenses (a)
|
(47)
|
|
(11)
|
|
(138)
|
|
(40)
|
Certain net
charges pursuant to our restructuring and cost savings
initiatives
|
(13)
|
|
—
|
|
(13)
|
|
—
|
Total
adjustments to selling, general and administrative
expenses
|
(60)
|
|
(11)
|
|
(151)
|
|
(40)
|
Non-GAAP selling,
general and administrative expenses
|
$
1,293
|
|
$
1,276
|
|
$
3,754
|
|
$
3,802
|
|
|
|
|
|
|
|
|
GAAP selling,
general and administrative expenses as a percentage of product
sales
|
20.7 %
|
|
20.6 %
|
|
20.5 %
|
|
21.1 %
|
Acquisition-related expenses (a)
|
(0.8)
|
|
(0.1)
|
|
(0.7)
|
|
(0.3)
|
Certain net
charges pursuant to our restructuring and cost savings
initiatives
|
(0.2)
|
|
0.0
|
|
(0.1)
|
|
0.0
|
Non-GAAP selling,
general and administrative expenses as a percentage of product
sales
|
19.7 %
|
|
20.5 %
|
|
19.7 %
|
|
20.8 %
|
|
|
|
|
|
|
|
|
GAAP operating
expenses
|
$
4,882
|
|
$
3,992
|
|
$ 13,368
|
|
$ 12,148
|
Adjustments to
operating expenses:
|
|
|
|
|
|
|
|
Adjustments to
cost of sales
|
(669)
|
|
(585)
|
|
(2,044)
|
|
(1,779)
|
Adjustments to
research and development expenses
|
(9)
|
|
(16)
|
|
(44)
|
|
(60)
|
Adjustments to
selling, general and administrative expenses
|
(60)
|
|
(11)
|
|
(151)
|
|
(40)
|
Certain net
charges pursuant to our restructuring and cost savings initiatives
(b)
|
(16)
|
|
8
|
|
(183)
|
|
7
|
Certain other
expenses (c)
|
(628)
|
|
(13)
|
|
(691)
|
|
(544)
|
Total
adjustments to operating expenses
|
(1,382)
|
|
(617)
|
|
(3,113)
|
|
(2,416)
|
Non-GAAP operating
expenses
|
$
3,500
|
|
$
3,375
|
|
$ 10,255
|
|
$
9,732
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months
ended
September
30,
|
|
Nine months
ended
September
30,
|
|
2023
|
|
2022
|
|
2023
|
|
2022
|
GAAP operating
income
|
$
2,021
|
|
$
2,660
|
|
$
6,626
|
|
$
7,336
|
Adjustments to
operating expenses
|
1,382
|
|
617
|
|
3,113
|
|
2,416
|
Non-GAAP operating
income
|
$
3,403
|
|
$
3,277
|
|
$
9,739
|
|
$
9,752
|
|
|
|
|
|
|
|
|
GAAP operating
income as a percentage of product sales
|
30.9 %
|
|
42.6 %
|
|
34.7 %
|
|
40.2 %
|
Adjustments to cost of
sales
|
10.2
|
|
9.4
|
|
10.7
|
|
9.7
|
Adjustments to
research and development expenses
|
0.2
|
|
0.2
|
|
0.2
|
|
0.3
|
Adjustments to
selling, general and administrative expenses
|
1.0
|
|
0.1
|
|
0.8
|
|
0.3
|
Certain net charges
pursuant to our restructuring and cost savings initiatives
(b)
|
0.2
|
|
0.0
|
|
1.0
|
|
0.0
|
Certain other expenses
(c)
|
9.5
|
|
0.2
|
|
3.7
|
|
2.9
|
Non-GAAP operating
income as a percentage of product sales
|
52.0 %
|
|
52.5 %
|
|
51.1 %
|
|
53.4 %
|
|
|
|
|
|
|
|
|
GAAP interest
expense, net
|
$
(759)
|
|
$
(368)
|
|
$ (2,054)
|
|
$
(991)
|
Adjustments to
interest expense, net:
|
|
|
|
|
|
|
|
Interest expense on
acquisition-related debt (d)
|
332
|
|
—
|
|
788
|
|
—
|
Non-GAAP interest
expense, net
|
$
(427)
|
|
$
(368)
|
|
$ (1,266)
|
|
$
(991)
|
|
|
|
|
|
|
|
|
GAAP other income
(expense), net
|
$
685
|
|
$
100
|
|
$
2,431
|
|
$
(747)
|
Adjustments to
other income (expense), net
|
|
|
|
|
|
|
|
Interest income and
other expenses on acquisition-related debt (d)
|
(313)
|
|
—
|
|
(607)
|
|
—
|
Equity method
investment basis difference amortization
|
—
|
|
47
|
|
—
|
|
143
|
Net (gains)/losses
from equity investments (e)
|
(170)
|
|
(150)
|
|
(1,305)
|
|
401
|
Total
adjustments to other income (expense), net
|
(483)
|
|
(103)
|
|
(1,912)
|
|
544
|
Non-GAAP other
income (expense), net
|
$
202
|
|
$
(3)
|
|
$
519
|
|
$
(203)
|
|
|
|
|
|
|
|
|
GAAP income before
income taxes
|
$
1,947
|
|
$
2,392
|
|
$
7,003
|
|
$
5,598
|
Adjustments to
income before income taxes:
|
|
|
|
|
|
|
|
Adjustments to
operating expenses
|
1,382
|
|
617
|
|
3,113
|
|
2,416
|
Adjustments to
interest expense, net
|
332
|
|
—
|
|
788
|
|
—
|
Adjustments to other
income (expense), net
|
(483)
|
|
(103)
|
|
(1,912)
|
|
544
|
Total
adjustments to income before income taxes
|
1,231
|
|
514
|
|
1,989
|
|
2,960
|
Non-GAAP income
before income taxes
|
$
3,178
|
|
$
2,906
|
|
$
8,992
|
|
$
8,558
|
|
|
|
|
|
|
|
|
GAAP provision for
income taxes
|
$
217
|
|
$
249
|
|
$
1,053
|
|
$
662
|
Adjustments to
provision for income taxes:
|
|
|
|
|
|
|
|
Income tax
effect of the above adjustments (f)
|
271
|
|
122
|
|
442
|
|
527
|
Other income
tax adjustments (g)
|
23
|
|
5
|
|
6
|
|
1
|
Total
adjustments to provision for income taxes
|
294
|
|
127
|
|
448
|
|
528
|
Non-GAAP provision
for income taxes
|
$
511
|
|
$
376
|
|
$
1,501
|
|
$
1,190
|
|
|
|
|
|
|
|
|
GAAP tax as a
percentage of income before taxes
|
11.1 %
|
|
10.4 %
|
|
15.0 %
|
|
11.8 %
|
Adjustments to
provision for income taxes:
|
|
|
|
|
|
|
|
Income tax
effect of the above adjustments (f)
|
4.2
|
|
2.3
|
|
1.6
|
|
2.1
|
Other income
tax adjustments (g)
|
0.8
|
|
0.2
|
|
0.1
|
|
0.0
|
Total
adjustments to provision for income taxes
|
5.0
|
|
2.5
|
|
1.7
|
|
2.1
|
Non-GAAP tax as a
percentage of income before taxes
|
16.1 %
|
|
12.9 %
|
|
16.7 %
|
|
13.9 %
|
|
|
|
|
|
|
|
|
GAAP net
income
|
$
1,730
|
|
$
2,143
|
|
$
5,950
|
|
$
4,936
|
Adjustments to net
income:
|
|
|
|
|
|
|
|
Adjustments to
income before income taxes, net of the income tax effect
|
960
|
|
392
|
|
1,547
|
|
2,433
|
Other income
tax adjustments (g)
|
(23)
|
|
(5)
|
|
(6)
|
|
(1)
|
Total
adjustments to net income
|
937
|
|
387
|
|
1,541
|
|
2,432
|
Non-GAAP net
income
|
$
2,667
|
|
$
2,530
|
|
$
7,491
|
|
$
7,368
|
|
|
|
|
|
|
|
|
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,
2023
|
|
Three months
ended
September 30,
2022
|
|
GAAP
|
|
Non-GAAP
|
|
GAAP
|
|
Non-GAAP
|
Net income
|
$
1,730
|
|
$
2,667
|
|
$
2,143
|
|
$
2,530
|
|
|
|
|
|
|
|
|
Weighted-average
shares for diluted EPS
|
538
|
|
538
|
|
538
|
|
538
|
|
|
|
|
|
|
|
|
Diluted EPS
|
$
3.22
|
|
$
4.96
|
|
$
3.98
|
|
$
4.70
|
|
|
|
|
|
|
|
|
|
Nine months
ended
September 30,
2023
|
|
Nine months
ended
September 30,
2022
|
|
GAAP
|
|
Non-GAAP
|
|
GAAP
|
|
Non-GAAP
|
Net income
|
$
5,950
|
|
$
7,491
|
|
$
4,936
|
|
$
7,368
|
|
|
|
|
|
|
|
|
Weighted-average
shares for diluted EPS
|
538
|
|
538
|
|
542
|
|
542
|
|
|
|
|
|
|
|
|
Diluted EPS
|
$
11.06
|
|
$
13.92
|
|
$
9.11
|
|
$
13.59
|
|
|
(a)
|
The adjustments related
primarily to noncash amortization of intangible assets from
business acquisitions.
|
|
|
(b)
|
For the three and nine
months ended September 30, 2023, the adjustments related primarily
to separation costs associated with our restructuring plan
initiated in early 2023.
|
|
|
(c)
|
For the three and nine
months ended September 30, 2023, the adjustments related primarily
to a net impairment charge for AMG 340. For the three months ended
September 30, 2022, the adjustments related primarily to an
impairment charge associated with an in-process research and
development asset. For the nine months ended September 30, 2022,
the adjustments related primarily to cumulative foreign currency
translation adjustments from the divestiture of
Gensenta.
|
|
|
(d)
|
For the three and nine
months ended September 30, 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 Therapeutics plc.
|
|
|
(e)
|
For the nine months
ended September 30, 2023, the adjustments related primarily to our
BeiGene, Ltd. equity fair value adjustment.
|
|
|
(f)
|
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 nine months ended September 30, 2023, were 22.0% and
22.2%, respectively, compared to 23.7% and 17.8% for the
corresponding periods of the prior year.
|
|
|
(g)
|
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,
|
|
2023
|
|
2022
|
|
2023
|
|
2022
|
Net cash provided by
operating activities
|
$
2,760
|
|
$
2,978
|
|
$ 7,933
|
|
$ 7,072
|
Net cash (used in)
provided by investing activities
|
(262)
|
|
(267)
|
|
885
|
|
(2,571)
|
Net cash (used in)
provided by financing activities
|
(2,005)
|
|
1,588
|
|
18,294
|
|
(2,988)
|
Increase in cash and
cash equivalents
|
493
|
|
4,299
|
|
27,112
|
|
1,513
|
Cash and cash
equivalents at beginning of period
|
34,248
|
|
5,203
|
|
7,629
|
|
7,989
|
Cash and cash
equivalents at end of period
|
$
34,741
|
|
$
9,502
|
|
$
34,741
|
|
$ 9,502
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months
ended
September
30,
|
|
Nine months
ended
September
30,
|
|
2023
|
|
2022
|
|
2023
|
|
2022
|
Net cash provided by
operating activities
|
$
2,760
|
|
$
2,978
|
|
$ 7,933
|
|
$ 7,072
|
Capital
expenditures
|
(248)
|
|
(160)
|
|
(863)
|
|
(596)
|
Free cash
flow
|
$
2,512
|
|
$
2,818
|
|
$ 7,070
|
|
$ 6,476
|
Amgen
Inc.
Reconciliation of
GAAP EPS Guidance to Non-GAAP
EPS Guidance for the
Year Ending December 31, 2023
(Unaudited)
|
|
|
GAAP diluted EPS
guidance
|
|
$ 11.23
|
—
|
$ 12.73
|
Known adjustments to
arrive at non-GAAP*:
|
|
|
|
|
Acquisition-related
expenses (a)
|
|
7.60
|
—
|
8.35
|
Net charges related to
restructuring and cost savings initiatives
|
|
0.38
|
—
|
0.53
|
Net (gains)/losses
from equity investments
|
|
|
(1.90)
|
|
Other
|
|
|
(0.01)
|
|
Non-GAAP diluted EPS
guidance
|
|
$ 18.20
|
—
|
$ 18.80
|
|
|
* The known adjustments
are presented net of their related tax impact, which amount to
approximately $1.50 - $1.69 per share.
|
|
|
(a)
|
The adjustments include
noncash amortization of intangible assets and fair value step-up of
inventory acquired in business combinations and the net impairment
charge for AMG 340, as well as transaction, integration and
employee-related costs. Adjustments above include a preliminary
range for the projected impact from the October 6, 2023 Horizon
Therapeutics plc (Horizon) acquisition to be recognized in the
fourth quarter of 2023. The initial accounting for the Horizon
acquisition is incomplete, pending identification and measurement
of assets acquired and liabilities assumed, and as a result this
preliminary projected range of adjustments related to this
acquisition is subject to change.
|
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, 2023
(Unaudited)
|
|
GAAP tax rate
guidance
|
|
14.0 %
|
|
—
|
15.5 %
|
Tax rate of known
adjustments discussed above
|
|
1.5 %
|
|
—
|
2.5 %
|
Non-GAAP tax rate
guidance
|
|
16.5 %
|
|
—
|
17.0 %
|
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SOURCE Amgen