THOUSAND
OAKS, Calif., May 2, 2024
/PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced financial
results for the first quarter 2024.
"With many of our innovative products
delivering strong growth and promising new medicines advancing
through our pipeline, we are excited about delivering attractive
long-term growth," said Robert A. Bradway, chairman and chief
executive officer.
Key results include:
- For the first quarter, total revenues increased 22% to
$7.4 billion in comparison to the
first quarter of 2023. Product sales grew 22%, driven by 25% volume
growth.
- Ten products delivered at least double-digit volume growth in
the first quarter, including Repatha® (evolocumab),
TEZSPIRE® (tezepelumab-ekko), EVENITY®
(romosozumab-aqqg), BLINCYTO® (blinatumomab), and
TAVNEOS® (avacopan).
- U.S. volume grew 29% and ex-U.S. volume grew 17%.
- Our performance included $914
million of sales from our Horizon Therapeutics (Horizon)
acquisition, driven by several first-in-class, early-in-lifecycle
medicines, including TEPEZZA® (teprotumumab-trbw),
KRYSTEXXA® (pegloticase) and UPLIZNA®
(inebilizumab-cdon).
- Excluding sales from Horizon, our product sales grew 6%, driven
by volume growth of 9%.
- GAAP loss per share was $0.21 for
the first quarter of 2024 compared with GAAP earnings per share
(EPS) of $5.28 for the first quarter
of 2023, driven by a mark-to-market loss on our BeiGene, Ltd.
equity investment and higher operating expenses, including higher
amortization expense from Horizon-acquired assets and incremental
expenses from Horizon, partially offset by higher revenues.
- GAAP operating income decreased from $1.9 billion to $1.0
billion, and GAAP operating margin decreased 19.0 percentage
points to 13.9%.
- Non-GAAP EPS decreased 1% from $3.98 to $3.96, due
to higher operating and interest expenses driven by the Horizon
acquisition, partially offset by higher revenues.
- Non-GAAP operating income increased from $2.8 billion to $3.1
billion, and non-GAAP operating margin decreased 5.1
percentage points to 43.2%.
- The Company generated $0.5
billion of free cash flow for the first quarter of 2024
versus $0.7 billion in the first
quarter of 2023. This decrease was driven by an $800 million tax deposit, partially offset by
timing of working capital items.
|
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.
|
Product Sales Performance
Total product sales increased 22% for the first quarter of 2024
versus the first quarter of 2023, driven by 25% volume growth.
General Medicine
- Repatha® sales increased 33% year-over-year
to $517 million in the first quarter,
driven by 44% volume growth, partially offset by 13% lower net
selling price. Repatha remains the global proprotein convertase
subtilisin/kexin type 9 (PCSK9) segment leader, with over 2.9
million patients treated since launch.
- Prolia® (denosumab) generated $999 million of sales in the first quarter. Sales
increased 8% year-over-year primarily driven by volume growth.
- EVENITY® sales increased 35% year-over-year
to $342 million for the first
quarter, primarily driven by volume growth.
Oncology
- BLINCYTO® sales increased 26% year-over-year
to $244 million for the first
quarter, driven by broad prescribing across academic and community
segments for patients with B-cell precursor acute lymphoblastic
leukemia (B-ALL).
- Vectibix® (panitumumab) generated
$247 million of sales in the first
quarter. Sales increased 6% year-over-year driven by higher net
selling price and volume growth, partially offset by unfavorable
foreign exchange impact.
- KYPROLIS® (carfilzomib) sales increased 5%
year-over-year to $376 million for
the first quarter, primarily driven by volume growth outside the
U.S.
- LUMAKRAS®/LUMYKRAS™ (sotorasib) sales
increased 11% year-over-year to $82
million for the first quarter, driven by volume growth.
- XGEVA® (denosumab) sales increased 5%
year-over-year to $561 million for
the first quarter, primarily driven by volume growth outside the
U.S. and higher net selling price, partially offset by lower volume
in the U.S.
- Nplate® (romiplostim) generated $317 million of sales in the first quarter. Sales
decreased 12% year-over-year, primarily driven by volume decline in
comparison to the first quarter of 2023, which included a U.S.
government order of $82 million.
Excluding the U.S. government order from this comparison, Nplate
sales grew 13% year-over-year, primarily driven by volume
growth.
- MVASI® (bevacizumab-awwb) generated
$202 million of sales in the first
quarter. Sales were flat year-over-year for the first quarter.
Volume growth was largely offset by lower net selling price and
unfavorable changes to estimated sales deductions. Going forward we
expect continued net selling price erosion driven by
competition.
Inflammation
- TEZSPIRE® generated $173 million of sales in the first quarter. Sales
increased 80% year-over-year, primarily driven by volume growth.
Healthcare providers recognize TEZSPIRE's unique, differentiated
profile and its broad potential to treat the 2.5 million patients
worldwide with severe asthma who are uncontrolled, without any
phenotypic or biomarker limitation.
- Otezla® (apremilast) generated $394 million of sales in the first quarter. Sales
increased 1% year-over-year for the first quarter.
- Enbrel® (etanercept) generated $567 million of sales in the first quarter. Sales
decreased 2% year-over-year driven by volume decline, partially
offset by higher inventory levels. Moving forward, we expect modest
volume growth offset by declining net selling price.
Otezla and Enbrel typically have lower sales in
the first quarter relative to subsequent quarters due to the impact
of benefit plan changes, insurance reverifications and increased
co-pay expenses as U.S. patients work through deductibles.
- AMJEVITA®/AMGEVITA™ (adalimumab) generated
$168 million of sales in the first
quarter. Sales increased 2% year-over-year primarily driven by
international growth, partially offset by lower inventory levels
and unfavorable change to estimated sales deductions.
Rare Disease
Except for TAVNEOS®, the products listed below were
added through the acquisition of Horizon on Oct. 6, 2023.
- TEPEZZA® (teprotumumab-trbw) generated
$424 million of sales in the first
quarter. TEPEZZA is the first and only FDA-approved treatment for
thyroid eye disease (TED).
- KRYSTEXXA® (pegloticase) generated
$235 million of sales in the first
quarter. KRYSTEXXA is the first and only FDA-approved treatment for
chronic refractory gout.
- UPLIZNA® (inebilizumab-cdon) generated
$80 million of sales in the first
quarter. UPLIZNA is used to treat adults with neuromyelitis optica
spectrum disorders.
- TAVNEOS® generated $51
million of sales in the first quarter. Sales increased 122%
year-over-year, driven by volume growth.
- Ultra rare products, which consist of
RAVICTI® (glycerol phenylbutyrate),
PROCYSBI® (cysteamine bitartrate),
ACTIMMUNE® (interferon gamma-1b),
BUPHENYL® (sodium phenylbutyrate) and
QUINSAIR® (levofloxacin), generated $169 million of sales in the first quarter.
Established Products
- Our established products, which consist of
EPOGEN® (epoetin alfa), Aranesp®
(darbepoetin alfa), Parsabiv® (etelcalcetide)
and Neulasta® (pegfilgrastim), generated
$613 million of sales. Sales
decreased 19% year-over-year for the first quarter, driven by
unfavorable changes to estimated sales deductions and volume
declines. In the aggregate, we expect the year-over-year volume
declines for this portfolio of products to continue.
Product Sales Detail by Product and Geographic Region
$Millions, except
percentages
|
|
Q1
'24
|
|
Q1
'23
|
|
YOY Δ
|
|
|
US
|
|
ROW
|
|
TOTAL
|
|
TOTAL
|
|
TOTAL
|
Repatha®
|
|
$
273
|
|
$
244
|
|
$
517
|
|
$
388
|
|
33 %
|
Prolia®
|
|
657
|
|
342
|
|
999
|
|
927
|
|
8 %
|
EVENITY®
|
|
236
|
|
106
|
|
342
|
|
254
|
|
35 %
|
BLINCYTO®
|
|
153
|
|
91
|
|
244
|
|
194
|
|
26 %
|
Vectibix®
|
|
120
|
|
127
|
|
247
|
|
233
|
|
6 %
|
KYPROLIS®
|
|
234
|
|
142
|
|
376
|
|
358
|
|
5 %
|
LUMAKRAS®/LUMYKRAS™
|
|
53
|
|
29
|
|
82
|
|
74
|
|
11 %
|
XGEVA®
|
|
366
|
|
195
|
|
561
|
|
536
|
|
5 %
|
Nplate®
|
|
190
|
|
127
|
|
317
|
|
362
|
|
(12 %)
|
MVASI®
|
|
105
|
|
97
|
|
202
|
|
202
|
|
— %
|
TEZSPIRE®
|
|
173
|
|
—
|
|
173
|
|
96
|
|
80 %
|
Otezla®
|
|
293
|
|
101
|
|
394
|
|
392
|
|
1 %
|
Enbrel®
|
|
561
|
|
6
|
|
567
|
|
579
|
|
(2 %)
|
AMJEVITA®/AMGEVITA™
|
|
30
|
|
138
|
|
168
|
|
164
|
|
2 %
|
TEPEZZA®**
|
|
419
|
|
5
|
|
424
|
|
—
|
|
N/A
|
KRYSTEXXA®**
|
|
235
|
|
—
|
|
235
|
|
—
|
|
N/A
|
UPLIZNA®**
|
|
70
|
|
10
|
|
80
|
|
—
|
|
N/A
|
TAVNEOS®
|
|
45
|
|
6
|
|
51
|
|
23
|
|
*
|
Ultra rare
products**
|
|
166
|
|
3
|
|
169
|
|
—
|
|
N/A
|
EPOGEN®
|
|
41
|
|
—
|
|
41
|
|
60
|
|
(32 %)
|
Aranesp®
|
|
100
|
|
249
|
|
349
|
|
355
|
|
(2 %)
|
Parsabiv®
|
|
65
|
|
40
|
|
105
|
|
91
|
|
15 %
|
Neulasta®
|
|
87
|
|
31
|
|
118
|
|
249
|
|
(53 %)
|
Other
products***
|
|
301
|
|
56
|
|
357
|
|
309
|
|
16 %
|
Total product
sales
|
|
$ 4,973
|
|
$ 2,145
|
|
$ 7,118
|
|
$ 5,846
|
|
22 %
|
|
|
|
|
|
|
|
|
|
|
|
*Change in excess of
100%
|
|
|
|
|
|
|
|
|
|
|
**Horizon-acquired
products, and the Ultra rare products consist of
RAVICTI®, PROCYSBI®, ACTIMMUNE®,
BUPHENYL®, and QUINSAIR®
|
***Consists of (i)
KANJINTI®, Aimovig®, RIABNI®,
Corlanor®, NEUPOGEN®,
AVSOLA®, IMLYGIC®,
Sensipar®/Mimpara™, BEKEMV™, and
WEZLANA™/WEZENLA™, where Biosimilars
total $176 million in Q1 '24 and $121 million in Q1 '23; and (ii)
Horizon-acquired products including RAYOS®,
PENNSAID®, and DUEXIS®
|
N/A = not
applicable
|
|
|
|
|
|
|
|
|
|
|
Operating Expense, Operating Margin and Tax Rate
Analysis
On a GAAP basis:
- Total Operating Expenses increased 54%. Cost of
Sales as a percentage of product sales increased 15.6
percentage points driven by higher amortization expense from
Horizon acquisition-related assets and, to a lesser extent, higher
profit share and royalty expense, partially offset by the
Puerto Rico excise tax.
Research & Development (R&D) expenses increased 27%
due to higher spend in later-stage clinical programs and marketed
product support, including Horizon-acquired programs. Selling,
General & Administrative (SG&A) expenses increased 44%
primarily driven by commercial expenses related to Horizon-acquired
products, general and administrative expenses, and
acquisition-related costs. Other operating expenses
consisted primarily of a net impairment charge for an in-process
R&D asset and changes in contingent consideration liabilities,
both related to our Teneobio, Inc. acquisition from 2021.
- Operating Margin as a percentage of product sales
decreased 19.0 percentage points in the first quarter to
13.9%.
- Tax Rate decreased 83.7 percentage points primarily due
to the GAAP net loss described above and the change in earnings mix
as a result of the inclusion of the Horizon business.
On a non-GAAP basis:
- Total Operating Expenses increased 33%. Cost of
Sales as a percentage of product sales increased 1.4 percentage
points driven by higher profit share and royalty expense, partially
offset by the Puerto Rico excise
tax. R&D expenses increased 26% due to higher spend in
later-stage clinical programs and marketed product support,
including Horizon-acquired programs. SG&A expenses
increased 40%, primarily driven by commercial expenses related to
Horizon-acquired products, and general and administrative
expenses.
- Operating Margin as a percentage of product sales
decreased 5.1 percentage points in the first quarter to 43.2%.
- Tax Rate decreased 2.4 percentage points primarily due
to the change in earnings mix as a result of the inclusion of the
Horizon business and net favorable items in the quarter.
$Millions, except
percentages
|
|
GAAP
|
|
Non-GAAP
|
|
|
Q1
'24
|
|
Q1
'23
|
|
YOY Δ
|
|
Q1
'24
|
|
Q1
'23
|
|
YOY Δ
|
Cost of
Sales
|
|
$
3,200
|
|
$
1,720
|
|
86 %
|
|
$
1,340
|
|
$
1,016
|
|
32 %
|
% of product
sales
|
|
45.0 %
|
|
29.4 %
|
|
15.6 pts
|
|
18.8 %
|
|
17.4 %
|
|
1.4 pts
|
Research &
Development
|
|
$
1,343
|
|
$
1,058
|
|
27 %
|
|
$
1,317
|
|
$
1,044
|
|
26 %
|
% of product
sales
|
|
18.9 %
|
|
18.1 %
|
|
0.8 pts
|
|
18.5 %
|
|
17.9 %
|
|
0.6 pts
|
Selling, General &
Administrative
|
|
$
1,808
|
|
$
1,258
|
|
44 %
|
|
$
1,712
|
|
$
1,224
|
|
40 %
|
% of product
sales
|
|
25.4 %
|
|
21.5 %
|
|
3.9 pts
|
|
24.1 %
|
|
20.9 %
|
|
3.2 pts
|
Other
|
|
$ 105
|
|
$ 148
|
|
(29 %)
|
|
$
—
|
|
$
—
|
|
N/A
|
Total Operating
Expenses
|
|
$
6,456
|
|
$
4,184
|
|
54 %
|
|
$
4,369
|
|
$
3,284
|
|
33 %
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
Margin
|
|
|
|
|
|
|
|
|
|
|
|
|
operating income as %
of product sales
|
|
13.9 %
|
|
32.9 %
|
|
(19.0) pts
|
|
43.2 %
|
|
48.3 %
|
|
(5.1) pts
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Tax
Rate
|
|
(66.2) %
|
|
17.5 %
|
|
(83.7)
pts
|
|
15.4 %
|
|
17.8 %
|
|
(2.4)
pts
|
|
|
|
|
|
|
|
|
|
|
|
|
|
pts: percentage
points
|
|
|
|
|
|
|
|
|
|
|
|
|
N/A = not
applicable
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash Flow and Balance Sheet
- The Company generated $0.5
billion of free cash flow in the first quarter of 2024
versus $0.7 billion in the first
quarter of 2023. This decrease was driven by an $800 million tax deposit, partially offset by
timing of working capital items.
- The Company's first quarter 2024 dividend of $2.25 per share was declared on December 12, 2023, and was paid on March 7, 2024, to all stockholders of record as
of February 16, 2024, representing a
6% increase from this same period in 2023.
- Cash and investments totaled $9.7
billion and debt outstanding totaled $64.0 billion as of March
31, 2024.
$Billions, except
shares
|
|
Q1
'24
|
|
Q1
'23
|
|
YOY Δ
|
Operating Cash
Flow
|
|
$
0.7
|
|
$
1.1
|
|
$
(0.4)
|
Capital
Expenditures
|
|
$
0.2
|
|
$
0.3
|
|
$
(0.1)
|
Free Cash
Flow
|
|
$
0.5
|
|
$
0.7
|
|
$
(0.3)
|
Dividends
Paid
|
|
$
1.2
|
|
$
1.1
|
|
$
0.1
|
Share
Repurchases
|
|
$
—
|
|
$
—
|
|
$
—
|
Average Diluted Shares
(millions)
|
|
536
|
|
538
|
|
(2)
|
|
|
|
|
|
|
|
Note: Numbers may not
add due to rounding
|
|
|
|
|
$Billions
|
|
3/31/24
|
|
12/31/23
|
|
YTD Δ
|
Cash and
Investments
|
|
$
9.7
|
|
$ 10.9
|
|
$
(1.2)
|
Debt
Outstanding
|
|
$ 64.0
|
|
$ 64.6
|
|
$
(0.6)
|
|
|
|
|
|
|
|
Note: Numbers may not
add due to rounding
|
|
|
|
|
2024 Guidance
For the full year 2024, the Company now expects:
- Total revenues in the range of $32.5 billion to $33.8
billion.
- On a GAAP basis, EPS in the range of $7.15 to $8.40, and
a tax rate in the range of 9.5% to 11.0%.
- On a non-GAAP basis, EPS in the range of $19.00 to $20.20,
and a tax rate in the range of 15.0% to 16.0%.
- Capital expenditures to be approximately $1.1 billion.
- Share repurchases not to exceed $500 million.
First Quarter Product and Pipeline Update
The Company provided the following updates on selected product
and pipeline programs:
General Medicine
MariTide (maridebart cafraglutide,
AMG 133)
- A Phase 2 study of MariTide, a multispecific molecule that
inhibits the gastric inhibitory polypeptide receptor (GIPR) and
activates the glucagon like peptide 1 (GLP-1) receptor, in adults
with overweight or obesity with or without type 2 diabetes mellitus
is ongoing, with topline data anticipated in late 2024.
- Planning for a comprehensive Phase 3 program across multiple
indications remains on track.
AMG 786
- A Phase 1 study of AMG 786, a small molecule obesity program,
is complete.
Olpasiran (AMG 890)
- The Ocean(a)-Outcomes trial, a Phase 3 cardiovascular outcomes
study of olpasiran in patients with atherosclerotic cardiovascular
disease and elevated Lp(a), is fully enrolled. Olpasiran is a
potentially best-in-class small interfering ribonucleic acid
(siRNA) molecule that reduces lipoprotein(a) (Lp(a)) synthesis in
the liver.
Repatha
- EVOLVE-MI, a Phase 4 study of Repatha administered within 10
days of an acute myocardial infarction to reduce the risk of
cardiovascular (CV) events, continues to enroll patients.
- VESALIUS-CV, a Phase 3 CV outcomes study of Repatha in patients
at high CV risk without prior myocardial infarction or stroke, is
ongoing.
- In April, data were presented from the FOURIER trial
demonstrating that intensive LDL-C lowering with Repatha may lead
to greater relative and absolute CV event reduction in patients
with autoimmune or inflammatory diseases.
- In April, data were presented from the FOURIER and FOURIER-OLE
studies demonstrating that elderly patients (≥75 years) with
atherosclerotic cardiovascular disease derived similar to greater
CV benefit compared to younger patients (<75 years) with early
initiation of Repatha and up to 8.6 years of treatment with no
significant safety concerns.
Oncology
Tarlatamab (AMG 757)
- The U.S. Food and Drug Administration (FDA) review of the
Biologics License Application (BLA) for tarlatamab, a
first-in-class investigational delta-like ligand 3 (DLL3) targeting
BiTE® (bispecific T-cell engager) molecule in previously
treated small cell lung cancer (SCLC) continues under priority
review with a Prescription Drug User Fee Act (PDUFA) date of
June 12, 2024. Additional regulatory
submissions are underway or complete in countries outside of the
U.S.
- Advancing a comprehensive global clinical development program
in SCLC:
- DeLLphi-304, a Phase 3 study comparing tarlatamab with
standard of care chemotherapy in second-line SCLC, continues to
enroll patients.
- DeLLphi-305, a Phase 3 study comparing tarlatamab and
durvalumab with durvalumab alone in first-line, extensive-stage
SCLC, was initiated.
- DeLLphi-306, a Phase 3 study comparing tarlatamab with
placebo following concurrent chemoradiation therapy in
limited-stage SCLC is enrolling patients.
- DeLLphi-300, a Phase 1 study of tarlatamab in
relapsed/refractory SCLC is ongoing.
- DeLLphi-302, a Phase 1b study
of tarlatamab in combination with AMG 404, an anti-programmed
cell death protein 1 (PD1) monoclonal antibody, in second-line or
later SCLC, is ongoing.
- DeLLphi-303, a Phase 1b study
of tarlatamab in combination with standard of care in
first-line SCLC, continues to enroll patients.
- DeLLpro-300, a Phase 1b study of
tarlatamab in de novo or treatment-emergent neuroendocrine prostate
cancer, is ongoing. Initial data from this study will be presented
at the American Society of Clinical Oncology (ASCO) annual meeting
in June.
- Additional data from the DeLLphi-301 Phase 2 trial,
highlighting the efficacy and safety of tarlatamab analyzed by the
presence of brain metastasis, will be presented at the ASCO annual
meeting in June.
BLINCYTO
- The FDA review of the supplemental BLA for BLINCYTO in
early-stage, CD19-positive B-cell precursor acute lymphoblastic
leukemia (B-ALL) continues under priority review, with a PDUFA date
of June 21, 2024. Additional
regulatory submissions are underway or complete in countries
outside of the U.S.
- Golden Gate, a Phase 3 study of BLINCYTO alternating with
low-intensity chemotherapy in older adults with newly diagnosed
Philadelphia chromosome-negative
(Ph-) B-ALL, continues to enroll patients.
- The Company is planning to advance blinatumomab subcutaneous
administration through a registration enabling study, with
initiation anticipated H2 2024 to H1 2025.
- A Phase 1/2 study of subcutaneous blinatumomab in adults with
relapsed or refractory Ph- B-ALL continues to enroll patients.
Xaluritamig (AMG 509)
- A Phase 1 monotherapy dose-expansion study of xaluritamig, a
first-in-class bispecific T-cell engager targeting
six-transmembrane epithelial antigen of prostate 1 (STEAP1) in
metastatic castrate resistant prostate cancer has completed initial
enrollment in the monotherapy portion of the study and continues to
enroll subjects to explore reduced monitoring after treatment
administration. An outpatient treatment cohort has also been
initiated to improve administration convenience.
- A Phase 1 combination with abiraterone or enzalutamide
continues to enroll patients in the dose-escalation phase, with
plans to initiate expansion cohorts.
- Two additional Phase 1 studies of xaluritamig to evaluate
preliminary efficacy and safety in patients with early prostate
cancer are planned.
AMG 193
- A Phase 1/1b/2 study of AMG 193,
a first-in-class small molecule methylthioadenosine
(MTA)-cooperative protein arginine methyltransferase 5 (PRMT5)
inhibitor, continues to enroll patients with advanced
methylthioadenosine phosphorylase (MTAP)-null solid tumors in the
dose-expansion portion of the study.
- A Phase 1b study of AMG 193 alone
or in combination with other therapies in patients with advanced
MTAP-null thoracic tumors was initiated.
- A Phase 1b study of AMG 193 in
combination with other therapies in patients with advanced
MTAP-null gastrointestinal, biliary tract, or pancreatic cancers
was initiated.
- A Phase 1/2 study of AMG 193 in combination with IDE397, an
investigational methionine adenosyltransferase 2A (MAT2A)
inhibitor, is enrolling patients.
Nplate
- A Phase 3 study of Nplate in chemotherapy-induced
thrombocytopenia in gastrointestinal, pancreatic, or colorectal
malignancies is fully enrolled. Data readout is anticipated in H2
2024.
LUMAKRAS/LUMYKRAS
- A Phase 3 study of LUMAKRAS in combination with Vectibix and
FOLFIRI in first-line KRAS G12C–mutated CRC is enrolling
patients.
- A U.S. regulatory submission for the Phase 3 CodeBreaK 300
trial is on track for H1 2024. This study evaluated two doses of
LUMAKRAS (960 mg or 240 mg) in combination with Vectibix in
patients with chemorefractory KRAS G12C–mutated metastatic
colorectal cancer (CRC).
- Overall survival (OS) data from the Phase 3 CodeBreaK 300 study
of LUMAKRAS plus Vectibix vs. investigator's choice of therapy in
KRAS G12C–mutated metastatic CRC will be presented at the ASCO
annual meeting in June.
- A Phase 3 study of LUMAKRAS plus chemotherapy vs. pembrolizumab
plus chemotherapy in first-line KRAS G12C–mutated and programmed
cell death protein ligand-1 (PD-L1) negative advanced non-small
cell lung cancer (NSCLC) is enrolling patients.
- Regulatory review by the European Medicines Agency (EMA) of the
CodeBreaK 200 Phase 3 trial of adults with previously treated
locally advanced or metastatic KRAS G12C–mutated NSCLC along with
data from the Phase 2 dose-comparison substudy is ongoing.
- Updated analysis from the CodeBreaK 101 trial investigating
LUMAKRAS plus carboplatin and pemetrexed in KRAS G12C advanced
NSCLC will be presented at the ASCO annual meeting in June.
Bemarituzumab
- FORTITUDE-101, a Phase 3 study of bemarituzumab, a
first-in-class fibroblast growth factor receptor 2b (FGFR2b) targeting monoclonal antibody, plus
chemotherapy in first-line gastric cancer, continues to enroll
patients.
- FORTITUDE-102, a Phase 1b/3 study
of bemarituzumab plus chemotherapy and nivolumab in first-line
gastric cancer, continues to enroll patients in the Phase 3 portion
of the study.
- FORTITUDE-103, a Phase 1b/2 study
of bemarituzumab plus oral chemotherapy regimens with or without
nivolumab in first-line gastric cancer, continues to enroll
patients.
- FORTITUDE-301, a Phase 1b/2
basket study of bemarituzumab monotherapy in solid tumors with
FGFR2b overexpression, is ongoing.
Inflammation
TEZSPIRE
- A Phase 2 study of TEZSPIRE in chronic obstructive pulmonary
disease (COPD) is complete. Overall, TEZSPIRE numerically reduced
the annualized rate of moderate or severe COPD exacerbations vs.
placebo by 17% (90% CI: −6, 36; p=0.1042). Of note, more reductions
were observed in a subgroup of patients with baseline BEC ≥ 150
cells/μL (37% [95% CI: 7, 57]). The trend in reduction was greater
in a small number of subjects with BEC ≥ 300 cells/µL. Data will be
presented at the American Thoracic Society Conference (ATS) later
this month.
- A Phase 3 study of TEZSPIRE in chronic rhinosinusitis with
nasal polyps is fully enrolled. Primary analysis is anticipated in
H2 2024.
- 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 eosinophilic esophagitis
continues to enroll patients.
Rocatinlimab (AMG 451/KHK4083)
- The ROCKET Phase 3 program, evaluating rocatinlimab, a first in
class monoclonal antibody targeting OX40, in moderate to severe
atopic dermatitis, is composed of eight studies enrolling adult and
adolescent patients. To date, over 2,800 patients have been
enrolled in the ROCKET program with three studies having completed
enrollment.
- The Phase 3 HORIZON study (part of the ROCKET program),
evaluating rocatinlimab monotherapy vs. placebo in adults with
moderate to severe atopic dermatitis, is fully enrolled. Data
readout is anticipated in H2 2024.
- A Phase 2 study of rocatinlimab in moderate to severe asthma
was initiated.
- A Phase 3 study of rocatinlimab in prurigo nodularis will be
initiated in H2 2024.
Otezla
- In April, the FDA granted pediatric exclusivity and approved
Otezla for the treatment of pediatric patients 6 years of age and
older and weighing at least 20 kg with moderate to severe plaque
psoriasis who are candidates for phototherapy or systemic therapy.
This is the first pediatric indication for Otezla.
- In March, data were presented from:
- the SPROUT Phase 3 study, where 52 weeks of treatment with
Otezla demonstrated sustained efficacy and safety in pediatric
patients with moderate to severe plaque psoriasis.
- a Phase 3 study in Japanese Palmoplantar Pustulosis (PPP)
patients where 16 weeks of treatment with Otezla demonstrated
statistical significance for the primary efficacy endpoint, PPPASI
50 response, and for all secondary endpoints. Otezla improved
disease severity, symptoms, and quality of life, with no new safety
signals identified. These data will be submitted to regulators in
Japan.
Efavaleukin alfa (AMG 592)
- A Phase 2b study of efavaleukin
alfa, an interleukin 2 (IL 2) mutein Fc fusion protein, in
ulcerative colitis continues to enroll patients.
Ordesekimab (AMG 714/PRV-015)
- A Phase 2b study of AMG 714, a
monoclonal antibody that binds interleukin-15, in nonresponsive
celiac disease has completed enrollment.
AMG 104 (AZD8630)
- The Company plans to present data from the Phase 1 study of AMG
104, an inhaled anti-thymic stromal lymphopoietin (TSLP) fragment
antigen-binding (Fab), in healthy volunteers and patients with
asthma, at ATS later this month.
Rare Disease
TAVNEOS
- A Phase 3, open-label, uncontrolled single-arm study to
evaluate the efficacy, pharmacokinetics, and safety of TAVNEOS in
combination with Rituximab or a cyclophosphamide-containing regimen
in children from 6 years to < 18 years of age with active
ANCA-associated vasculitis will be initiated in H2 2024.
TEPEZZA
- Regulatory review of the New Drug Application (NDA) for TEPEZZA
in Japan continues.
- Regulatory submissions for TEPEZZA were completed in
Australia, Canada, Great
Britain and the European Medicines Agency (EMA).
- A Phase 3 study of TEPEZZA in Japan for chronic or low clinical activity
score TED continues to enroll patients.
- A Phase 3 study evaluating the subcutaneous route of
administration of TEPEZZA in patients with TED was initiated.
KRYSTEXXA
- The Phase 4 AGILE study of KRYSTEXXA with methotrexate
evaluating a shorter infusion duration was completed. At the
60-minute infusion duration, 67.2% of patients (78 of 116) achieved
a response. The safety profile was in line with the current
administration of KRYSTEXXA with methotrexate over no less than 120
minutes. Detailed data will be presented at a future medical
conference.
UPLIZNA
- A Phase 3 study of UPLIZNA in myasthenia gravis is fully
enrolled. Data readout is anticipated in H2 2024.
- A Phase 3 study of UPLIZNA for the prevention of flare in
immunoglobulin G4- (IgG4) related disease is fully enrolled. Data
readout is anticipated in H2 2024.
Dazodalibep
- Two Phase 3 studies of dazodalibep, a CD40 (cluster of
differentiation 40) ligand inhibitor fusion protein, in Sjögren's
disease are enrolling patients. The first study is in patients with
moderate to severe systemic disease activity, and the second study
is in patients with moderate to severe symptomatic burden and low
to no systemic disease activity.
- A manuscript based on data from the Phase 2 Dazodalibep
Sjogren's disease study has been accepted for publication in
Nature Medicine.
Daxdilimab
- A Phase 2 study of daxdilimab, a fully human monoclonal
antibody targeting immunoglobulin-like transcript 7 (ILT7), in
moderate to severe active primary discoid lupus erythematosus
refractory to standard of care is enrolling patients.
- A Phase 2 study of daxdilimab in dermatomyositis and
antisynthetase inflammatory myositis is enrolling patients.
Fipaxalparant (formerly AMG 670/HZN 825)
- A Phase 2 study of fipaxalparant, a lysophosphatidic acid
receptor 1 (LPAR1) antagonist, in idiopathic pulmonary fibrosis has
completed enrollment. Data readout is anticipated in H2 2024.
- A Phase 2 study of fipaxalparant in diffuse cutaneous systemic
sclerosis is enrolling patients.
Biosimilars
- The clinical comparative study portion of a randomized,
double-blind pivotal study evaluating pharmacokinetic (PK)
similarity of ABP 206 compared with OPDIVO® (nivolumab)
in resected stage III or stage IV melanoma patients in the adjuvant
setting is enrolling patients.
- The Company initiated a randomized, double-blind Phase 3 study
to compare efficacy, pharmacokinetics, safety, and immunogenicity
between ABP 234 and Keytruda® (pembrolizumab) in
subjects with advanced or metastatic non-squamous non-small cell
lung cancer.
TEZSPIRE is being developed in collaboration with
AstraZeneca.
AMG 104 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.
KEYTRUDA is a registered
trademark of Merck & Co., Inc.
Non-GAAP Financial Measures
In this news release, management has presented its operating
results for the first quarters of 2024 and 2023, in accordance with
U.S. Generally Accepted Accounting Principles (GAAP) and on a
non-GAAP basis. In addition, management has presented its full year
2024 EPS and tax guidance in accordance with GAAP and on a non-GAAP
basis. These non-GAAP financial measures are computed by excluding
certain items related to acquisitions, divestitures, restructuring
and certain other items from the related GAAP financial measures.
Management has presented Free Cash Flow (FCF), which is a non-GAAP
financial measure, for the first quarters of 2024 and 2023. 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 discovers, develops, manufactures and
delivers innovative medicines to help millions of patients in their
fight against some of the world's toughest diseases. More than 40
years ago, Amgen helped to establish the biotechnology industry and
remains on the cutting-edge of innovation, using technology and
human genetic data to push beyond what's known today. Amgen is
advancing a broad and deep pipeline that builds on its existing
portfolio of medicines to treat cancer, heart disease,
osteoporosis, inflammatory diseases and rare
diseases.
In 2024, Amgen was named one of the "World's Most
Innovative Companies" by Fast Company and one of "America's Best
Large Employers" by Forbes, among other external recognitions.
Amgen is one of the 30 companies that comprise the Dow Jones
Industrial Average®, and it is also part of the
Nasdaq-100 Index®, which includes the largest and most
innovative non-financial companies listed on the Nasdaq Stock
Market based on market capitalization.
For more information, visit Amgen.com and follow
Amgen on X, LinkedIn, Instagram, TikTok, YouTube and Threads.
Forward-Looking Statements
This news release contains forward-looking statements that are
based on the current expectations and beliefs of Amgen. All
statements, other than statements of historical fact, are
statements that could be deemed forward-looking statements,
including any statements on the outcome, benefits and synergies of
collaborations, or potential collaborations, with any other company
(including BeiGene, Ltd. or Kyowa Kirin Co., Ltd.), the performance
of Otezla® (apremilast) (including anticipated Otezla
sales growth and the timing of non-GAAP EPS accretion), our
acquisitions of Teneobio, Inc., ChemoCentryx, Inc., or Horizon
(including the prospective performance and outlook of Horizon's
business, performance and opportunities and any potential strategic
benefits, synergies or opportunities expected as a result of such
acquisition, and any projected impacts from the Horizon acquisition
on our acquisition-related expenses going forward), as well as
estimates of revenues, operating margins, capital expenditures,
cash, other financial metrics, expected legal, arbitration,
political, regulatory or clinical results or practices, customer
and prescriber patterns or practices, reimbursement activities and
outcomes, effects of pandemics or other widespread health problems
on our business, outcomes, progress, and other such estimates and
results. Forward-looking statements involve significant risks and
uncertainties, including those discussed below and more fully
described in the Securities and Exchange Commission reports filed
by Amgen, including our most recent annual report on Form 10-K and
any subsequent periodic reports on Form 10-Q and current reports on
Form 8-K. Unless otherwise noted, Amgen is providing this
information as of the date of this news release and does not
undertake any obligation to update any forward-looking statements
contained in this document as a result of new information, future
events or otherwise.
No forward-looking statement can be guaranteed and actual
results may differ materially from those we project. Our results
may be affected by our ability to successfully market both new and
existing products domestically and internationally, clinical and
regulatory developments involving current and future products,
sales growth of recently launched products, competition from other
products including biosimilars, difficulties or delays in
manufacturing our products and global economic conditions. In
addition, sales of our products are affected by pricing pressure,
political and public scrutiny and reimbursement policies imposed by
third-party payers, including governments, private insurance plans
and managed care providers and may be affected by regulatory,
clinical and guideline developments and domestic and international
trends toward managed care and healthcare cost containment.
Furthermore, our research, testing, pricing, marketing and other
operations are subject to extensive regulation by domestic and
foreign government regulatory authorities. We or others could
identify safety, side effects or manufacturing problems with our
products, including our devices, after they are on the market. Our
business may be impacted by government investigations, litigation
and product liability claims. In addition, our business may be
impacted by the adoption of new tax legislation or exposure to
additional tax liabilities. If we fail to meet the compliance
obligations in the corporate integrity agreement between us and the
U.S. government, we could become subject to significant sanctions.
Further, while we routinely obtain patents for our products and
technology, the protection offered by our patents and patent
applications may be challenged, invalidated or circumvented by our
competitors, or we may fail to prevail in present and future
intellectual property litigation. We perform a substantial amount
of our commercial manufacturing activities at a few key facilities,
including in Puerto Rico, and also
depend on third parties for a portion of our manufacturing
activities, and limits on supply may constrain sales of certain of
our current products and product candidate development. An outbreak
of disease or similar public health threat, such as COVID-19, and
the public and governmental effort to mitigate against the spread
of such disease, could have a significant adverse effect on the
supply of materials for our manufacturing activities, the
distribution of our products, the commercialization of our product
candidates, and our clinical trial operations, and any such events
may have a material adverse effect on our product development,
product sales, business and results of operations. We rely on
collaborations with third parties for the development of some of
our product candidates and for the commercialization and sales of
some of our commercial products. In addition, we compete with other
companies with respect to many of our marketed products as well as
for the discovery and development of new products. Discovery or
identification of new product candidates or development of new
indications for existing products cannot be guaranteed and movement
from concept to product is uncertain; consequently, there can be no
guarantee that any particular product candidate or development of a
new indication for an existing product will be successful and
become a commercial product. Further, some raw materials, medical
devices and component parts for our products are supplied by sole
third-party suppliers. Certain of our distributors, customers and
payers have substantial purchasing leverage in their dealings with
us. The discovery of significant problems with a product similar to
one of our products that implicate an entire class of products
could have a material adverse effect on sales of the affected
products and on our business and results of operations. Our efforts
to collaborate with or acquire other companies, products or
technology, and to integrate the operations of companies or to
support the products or technology we have acquired, may not be
successful. There can be no guarantee that we will be able to
realize any of the strategic benefits, synergies or opportunities
arising from the Horizon acquisition, and such benefits, synergies
or opportunities may take longer to realize than expected. We may
not be able to successfully integrate Horizon, and such integration
may take longer, be more difficult or cost more than expected. A
breakdown, cyberattack or information security breach of our
information technology systems could compromise the
confidentiality, integrity and availability of our systems and our
data. Our stock price is volatile and may be affected by a number
of events. Our business and operations may be negatively affected
by the failure, or perceived failure, of achieving our
environmental, social and governance objectives. The effects of
global climate change and related natural disasters could
negatively affect our business and operations. Global economic
conditions may magnify certain risks that affect our business. Our
business performance could affect or limit the ability of our Board
of Directors to declare a dividend or our ability to pay a dividend
or repurchase our common stock. We may not be able to access the
capital and credit markets on terms that are favorable to us, or at
all.
###
CONTACT: Amgen, Thousand
Oaks
Jessica Akopyan, 805-440-5721
(media)
Justin Claeys, 805-313-9775
(investors)
Amgen Inc. Consolidated Statements
of (Loss) Income - GAAP (In millions, except per-share
data) (Unaudited)
|
|
|
Three months
ended
March
31,
|
|
2024
|
|
2023
|
Revenues:
|
|
|
|
Product
sales
|
$
7,118
|
|
$
5,846
|
Other
revenues
|
329
|
|
259
|
Total
revenues
|
7,447
|
|
6,105
|
|
|
|
|
Operating
expenses:
|
|
|
|
Cost of
sales
|
3,200
|
|
1,720
|
Research and
development
|
1,343
|
|
1,058
|
Selling, general and
administrative
|
1,808
|
|
1,258
|
Other
|
105
|
|
148
|
Total operating
expenses
|
6,456
|
|
4,184
|
|
|
|
|
Operating
income
|
991
|
|
1,921
|
|
|
|
|
Other income
(expense):
|
|
|
|
Interest expense,
net
|
(824)
|
|
(543)
|
Other (expense) income,
net
|
(235)
|
|
2,064
|
|
|
|
|
(Loss) income before
income taxes
|
(68)
|
|
3,442
|
|
|
|
|
Provision for income
taxes
|
45
|
|
601
|
|
|
|
|
Net (loss)
income
|
$ (113)
|
|
$
2,841
|
|
|
|
|
(Loss) earnings per
share:
|
|
|
|
Basic
|
$
(0.21)
|
|
$ 5.32
|
Diluted
|
$
(0.21)
|
|
$ 5.28
|
|
|
|
|
Weighted-average shares
used in calculation of (loss) earnings per share:
|
|
|
|
Basic
|
536
|
|
534
|
Diluted
|
536
|
|
538
|
Amgen Inc. Consolidated Balance
Sheets - GAAP (In millions)
|
|
|
March
31,
|
|
December
31,
|
|
2024
|
|
2023
|
|
(Unaudited)
|
|
|
Assets
|
Current
assets:
|
|
|
|
Cash and cash
equivalents
|
$
9,708
|
|
$
10,944
|
Trade receivables,
net
|
6,776
|
|
7,268
|
Inventories
|
8,724
|
|
9,518
|
Other current
assets
|
2,821
|
|
2,602
|
Total current
assets
|
28,029
|
|
30,332
|
|
|
|
|
Property, plant and
equipment, net
|
6,002
|
|
5,941
|
Intangible assets,
net
|
31,372
|
|
32,641
|
Goodwill
|
18,570
|
|
18,629
|
Other noncurrent
assets
|
9,007
|
|
9,611
|
Total assets
|
$
92,980
|
|
$
97,154
|
|
|
|
|
Liabilities and
Stockholders' Equity
|
Current
liabilities:
|
|
|
|
Accounts payable and
accrued liabilities
|
$
15,755
|
|
$
16,949
|
Current portion of
long-term debt
|
3,959
|
|
1,443
|
Total current
liabilities
|
19,714
|
|
18,392
|
|
|
|
|
Long-term
debt
|
60,061
|
|
63,170
|
Long-term deferred tax
liabilities
|
1,862
|
|
2,354
|
Long-term tax
liabilities
|
3,964
|
|
4,680
|
Other noncurrent
liabilities
|
2,357
|
|
2,326
|
Total stockholders'
equity
|
5,022
|
|
6,232
|
Total liabilities and
stockholders' equity
|
$
92,980
|
|
$
97,154
|
|
|
|
|
Shares
outstanding
|
536
|
|
535
|
Amgen Inc. GAAP to
Non-GAAP Reconciliations (Dollars in
millions) (Unaudited)
|
|
|
Three months
ended
March
31,
|
|
2024
|
|
2023
|
GAAP cost of
sales
|
$
3,200
|
|
$
1,720
|
Adjustments to cost
of sales:
|
|
|
|
Acquisition-related
expenses (a)
|
(1,860)
|
|
(669)
|
Certain net charges
pursuant to our restructuring and cost savings
initiatives
|
—
|
|
(35)
|
Total adjustments
to cost of sales
|
(1,860)
|
|
(704)
|
Non-GAAP cost of
sales
|
$
1,340
|
|
$
1,016
|
|
|
|
|
GAAP cost of sales
as a percentage of product sales
|
45.0 %
|
|
29.4 %
|
Acquisition-related
expenses (a)
|
(26.2)
|
|
(11.4)
|
Certain net charges
pursuant to our restructuring and cost savings
initiatives
|
0.0
|
|
(0.6)
|
Non-GAAP cost of
sales as a percentage of product sales
|
18.8 %
|
|
17.4 %
|
|
|
|
|
GAAP research and
development expenses
|
$
1,343
|
|
$
1,058
|
Adjustments to
research and development expenses:
|
|
|
|
Acquisition-related
expenses (b)
|
(26)
|
|
(14)
|
Non-GAAP research
and development expenses
|
$
1,317
|
|
$
1,044
|
|
|
|
|
GAAP research and
development expenses as a percentage of product
sales
|
18.9 %
|
|
18.1 %
|
Acquisition-related
expenses (b)
|
(0.4)
|
|
(0.2)
|
Non-GAAP research
and development expenses as a percentage of product
sales
|
18.5 %
|
|
17.9 %
|
|
|
|
|
GAAP selling,
general and administrative expenses
|
$
1,808
|
|
$
1,258
|
Adjustments to
selling, general and administrative expenses:
|
|
|
|
Acquisition-related
expenses (b)
|
(96)
|
|
(34)
|
Non-GAAP selling,
general and administrative expenses
|
$
1,712
|
|
$
1,224
|
|
|
|
|
GAAP selling,
general and administrative expenses as a percentage of product
sales
|
25.4 %
|
|
21.5 %
|
Acquisition-related
expenses (b)
|
(1.3)
|
|
(0.6)
|
Non-GAAP selling,
general and administrative expenses as a percentage of product
sales
|
24.1 %
|
|
20.9 %
|
|
|
|
|
GAAP operating
expenses
|
$
6,456
|
|
$
4,184
|
Adjustments to
operating expenses:
|
|
|
|
Adjustments to cost of
sales
|
(1,860)
|
|
(704)
|
Adjustments to
research and development expenses
|
(26)
|
|
(14)
|
Adjustments to
selling, general and administrative expenses
|
(96)
|
|
(34)
|
Certain net charges
pursuant to our restructuring and cost savings initiatives
(c)
|
1
|
|
(141)
|
Certain other expenses
(d)
|
(106)
|
|
(7)
|
Total adjustments
to operating expenses
|
(2,087)
|
|
(900)
|
Non-GAAP operating
expenses
|
$
4,369
|
|
$
3,284
|
|
|
|
|
|
|
|
|
|
Three months
ended
March
31,
|
|
2024
|
|
2023
|
GAAP operating
income
|
$
991
|
|
$
1,921
|
Adjustments to
operating expenses
|
2,087
|
|
900
|
Non-GAAP operating
income
|
$
3,078
|
|
$
2,821
|
|
|
|
|
GAAP operating
income as a percentage of product sales
|
13.9 %
|
|
32.9 %
|
Adjustments to cost of
sales
|
26.2
|
|
12.0
|
Adjustments to
research and development expenses
|
0.4
|
|
0.2
|
Adjustments to
selling, general and administrative expenses
|
1.3
|
|
0.6
|
Certain net charges
pursuant to our restructuring and cost savings initiatives
(c)
|
0.0
|
|
2.5
|
Certain other expenses
(d)
|
1.4
|
|
0.1
|
Non-GAAP operating
income as a percentage of product sales
|
43.2 %
|
|
48.3 %
|
|
|
|
|
GAAP interest
expense, net
|
$
(824)
|
|
$
(543)
|
Adjustments to
interest expense, net:
|
|
|
|
Interest expense on
acquisition-related debt (e)
|
—
|
|
123
|
Non-GAAP interest
expense, net
|
$
(824)
|
|
$
(420)
|
|
|
|
|
GAAP other (expense)
income, net
|
$
(235)
|
|
$
2,064
|
Adjustments to
other (expense) income, net
|
|
|
|
Interest income and
other expenses on acquisition-related debt (e)
|
—
|
|
(6)
|
Net losses (gains)
from equity investments (f)
|
510
|
|
(1,853)
|
Total adjustments
to other (expense) income, net
|
510
|
|
(1,859)
|
Non-GAAP other
income, net
|
$
275
|
|
$
205
|
|
|
|
|
GAAP (loss) income
before income taxes
|
$
(68)
|
|
$
3,442
|
Adjustments to
(loss) income before income taxes:
|
|
|
|
Adjustments to
operating expenses
|
2,087
|
|
900
|
Adjustments to
interest expense, net
|
—
|
|
123
|
Adjustments to other
(expense) income, net
|
510
|
|
(1,859)
|
Total adjustments
to (loss) income before income taxes
|
2,597
|
|
(836)
|
Non-GAAP income
before income taxes
|
$
2,529
|
|
$
2,606
|
|
|
|
|
GAAP provision for
income taxes
|
$
45
|
|
$
601
|
Adjustments to
provision for income taxes:
|
|
|
|
Income tax effect of
the above adjustments (g)
|
359
|
|
(117)
|
Other income tax
adjustments (h)
|
(15)
|
|
(19)
|
Total adjustments
to provision for income taxes
|
344
|
|
(136)
|
Non-GAAP provision
for income taxes
|
$
389
|
|
$
465
|
|
|
|
|
GAAP tax as a
percentage of income before taxes
|
(66.2) %
|
|
17.5 %
|
Adjustments to
provision for income taxes:
|
|
|
|
Income tax effect of
the above adjustments (g)
|
82.2
|
|
1.0
|
Other income tax
adjustments (h)
|
(0.6)
|
|
(0.7)
|
Total adjustments
to provision for income taxes
|
81.6
|
|
0.3
|
Non-GAAP tax as a
percentage of income before taxes
|
15.4 %
|
|
17.8 %
|
|
|
|
|
GAAP net (loss)
income
|
$
(113)
|
|
$
2,841
|
Adjustments to net
(loss) income:
|
|
|
|
Adjustments to (loss)
income before income taxes, net of the income tax effect
|
2,238
|
|
(719)
|
Other income tax
adjustments (h)
|
15
|
|
19
|
Total adjustments
to net (loss) income
|
2,253
|
|
(700)
|
Non-GAAP net
income
|
$
2,140
|
|
$
2,141
|
|
|
|
|
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
March 31,
2024
|
|
Three months
ended
March 31,
2023
|
|
GAAP
|
|
Non-GAAP
|
|
GAAP
|
|
Non-GAAP
|
Net (loss)
income
|
$
(113)
|
|
$
2,140
|
|
$
2,841
|
|
$
2,141
|
|
|
|
|
|
|
|
|
Shares
(Denominator):
|
|
|
|
|
|
|
|
Weighted-average
shares for basic (loss) earnings per share
|
536
|
|
536
|
|
534
|
|
534
|
Effect of dilutive
securities (i)
|
—
|
|
5
|
|
4
|
|
4
|
Weighted-average
shares for diluted (loss) earnings per share (i)
|
536
|
|
541
|
|
538
|
|
538
|
|
|
|
|
|
|
|
|
Diluted (loss) earnings
per share
|
$
(0.21)
|
|
$
3.96
|
|
$
5.28
|
|
$
3.98
|
|
|
|
|
|
|
|
|
|
|
|
(a)
|
|
The adjustments related
primarily to noncash amortization of intangible assets and fair
value step-up of inventory acquired from business
acquisitions.
|
|
|
|
(b)
|
|
For the three months
ended March 31, 2024, the adjustments related primarily to
acquisition-related costs related to our Horizon acquisition. For
the three months ended March 31, 2023, the adjustments related
primarily to noncash amortization of intangible assets from
business acquisitions.
|
|
|
|
(c)
|
|
For the three months
ended March 31, 2023, the adjustments related primarily to
separation costs associated with our restructuring plan initiated
in early 2023.
|
|
|
|
(d)
|
|
For the three months
ended March 31, 2024, the adjustments related primarily to a net
impairment charge for an in-process R&D asset and changes in
contingent consideration liabilities, both related to our Teneobio,
Inc. acquisition from 2021. For the three months ended March 31,
2023, the adjustments related to changes in contingent
consideration liabilities.
|
|
|
|
(e)
|
|
For the three months
ended March 31, 2023, the adjustments included (i) interest expense
and income on senior notes issued in March 2023 and (ii) debt
issuance costs and other fees related to our bridge credit and term
loan credit agreements, incurred prior to the closing of our
acquisition of Horizon.
|
|
|
|
(f)
|
|
For the three months
ended March 31, 2024 and 2023, the adjustments related primarily to
our BeiGene, Ltd. equity fair value adjustment.
|
|
|
|
(g)
|
|
The tax effect of the
adjustments between our GAAP and non-GAAP results takes into
account the tax treatment and related tax rate(s) that apply to
each adjustment in the applicable tax jurisdiction(s). Generally,
this results in a tax impact at the U.S. marginal tax rate for
certain adjustments, including the majority of amortization of
intangible assets and certain gains and losses on our investments
in equity securities, whereas the tax impact of other adjustments,
including the amortization of acquired inventory and 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
months ended March 31, 2024, was 13.8% compared to 14.0% for the
corresponding period of the prior year.
|
|
|
|
(h)
|
|
The adjustments related
to certain acquisition items, prior period and other items excluded
from GAAP earnings.
|
|
|
|
(i)
|
|
During periods of net
loss, diluted loss per share is equal to basic loss per share as
the anti-dilutive effect of potential common shares is
disregarded.
|
Amgen Inc. Reconciliations of
Cash Flows (In
millions) (Unaudited)
|
|
|
Three months
ended
March
31,
|
|
2024
|
|
2023
|
Net cash provided by
operating activities
|
$ 689
|
|
$
1,064
|
Net cash (used in)
provided by investing activities
|
(217)
|
|
1,358
|
Net cash (used in)
provided by financing activities
|
(1,708)
|
|
21,509
|
(Decrease) increase in
cash and cash equivalents
|
(1,236)
|
|
23,931
|
Cash and cash
equivalents at beginning of period
|
10,944
|
|
7,629
|
Cash and cash
equivalents at end of period
|
$
9,708
|
|
$
31,560
|
|
|
|
|
|
|
|
Three months
ended
March
31,
|
|
2024
|
|
2023
|
Net cash provided by
operating activities
|
$ 689
|
|
$
1,064
|
Capital
expenditures
|
(230)
|
|
(344)
|
Free cash
flow
|
$ 459
|
|
$ 720
|
Amgen Inc. Reconciliation of GAAP
EPS Guidance to Non-GAAP EPS Guidance for the Year Ending
December 31, 2024 (Unaudited)
|
|
GAAP diluted EPS
guidance
|
|
$
7.15
|
—
|
$
8.40
|
Known adjustments to
arrive at non-GAAP*:
|
|
|
|
|
Acquisition-related
expenses (a)
|
|
10.98
|
—
|
11.03
|
Net losses from equity
investments
|
|
|
0.74
|
|
Other
|
|
|
0.08
|
|
Non-GAAP diluted EPS
guidance
|
|
$ 19.00
|
—
|
$ 20.20
|
* The known adjustments are presented net of their related tax
impact, which amount to approximately $2.61 per share.
(a) The adjustments primarily include noncash amortization of
intangible assets and fair value step-up of inventory acquired in
business combinations.
Our GAAP diluted EPS guidance does not include the effect of
GAAP adjustments triggered by events that may occur subsequent to
this press release such as acquisitions, asset impairments,
litigation, changes in fair value of our contingent consideration
obligations and changes in fair value of our equity
investments.
Reconciliation of
GAAP Tax Rate Guidance to Non-GAAP Tax Rate Guidance for
the Year Ending December 31,
2024 (Unaudited)
|
|
GAAP tax rate
guidance
|
|
9.5 %
|
—
|
11.0 %
|
Tax rate of known
adjustments discussed above
|
|
5.0 %
|
—
|
5.5 %
|
Non-GAAP tax rate
guidance
|
|
15.0 %
|
—
|
16.0 %
|
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SOURCE Amgen