THOUSAND OAKS, Calif.,
Aug. 3, 2021 /PRNewswire/
-- Amgen (NASDAQ:AMGN) today announced financial results for
the second quarter of 2021. Key results include:
- Total revenues increased 5% to $6.5
billion in comparison to the second quarter of 2020, driven
by higher unit demand, partially offset by lower net selling
prices.
-
- Product sales increased 3% globally, driven by double digit
volume growth across a number of our products including
Prolia® (denosumab), Repatha® (evolocumab)
and our biosimilar products MVASI® (bevacizumab-awwb)
and KANJINTI® (trastuzumab-anns).
- GAAP earnings per share (EPS) decreased 73% to $0.81 driven by the write-off of $1.5 billion in acquired in-process research
& development (acquired IPR&D) associated with our
acquisition of Five Prime Therapeutics, partially offset by
increased revenues.
-
- GAAP operating income decreased 64% to $0.8 billion and GAAP operating margin decreased
25.8 percentage points to 13.5%.
- Non-GAAP EPS increased 4% to $4.38 driven by increased revenues and the impact
of fewer weighted average shares outstanding.
-
- Non-GAAP operating income decreased 4% to $3.1 billion and non-GAAP operating margin
decreased 4.1 percentage points to 50.9%.
- The Company generated $1.7 billion of free cash flow in the second
quarter versus $2.7 billion in the
second quarter of 2020 driven by a difference in the timing of tax
payments.
- 2021 total revenues guidance reaffirmed at $25.8-$26.6
billion; EPS guidance revised to $8.84-$9.90 on a
GAAP basis, and reaffirmed at $16.00-$17.00 on a
non-GAAP basis.
"We achieved solid, volume-driven growth in
the quarter as our business recovered from the effects of the
pandemic," said Robert A. Bradway,
chairman and chief executive officer. "As we look to the balance of
the year, we are excited to be launching LUMAKRAS™, a
first-in-class lung cancer treatment, and advancing a robust
pipeline of potential new medicines to meet the demands of patients
around the world."
$Millions, except
EPS, dividends paid per share and percentages
|
|
Q2
'21
|
|
Q2
'20
|
|
YOY
Δ
|
Total
Revenues
|
|
$
|
6,526
|
|
$
|
6,206
|
|
5%
|
GAAP Operating
Income
|
|
$
|
828
|
|
$
|
2,323
|
|
(64%)
|
GAAP Net
Income
|
|
$
|
464
|
|
$
|
1,803
|
|
(74%)
|
GAAP EPS
|
|
$
|
0.81
|
|
$
|
3.05
|
|
(73%)
|
Non-GAAP Operating
Income
|
|
$
|
3,111
|
|
$
|
3,247
|
|
(4%)
|
Non-GAAP Net
Income
|
|
$
|
2,522
|
|
$
|
2,484
|
|
2%
|
Non-GAAP
EPS
|
|
$
|
4.38
|
|
$
|
4.20
|
|
4%
|
Dividends Paid Per
Share
|
|
$
|
1.76
|
|
$
|
1.60
|
|
10%
|
References in this release to "non-GAAP" measures, measures
presented "on a non-GAAP basis" and to "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. For comparability of results to the
prior year, non-GAAP net income and non-GAAP EPS amounts for 2020
have been revised to reflect the update to our non-GAAP policy that
excludes gains and losses on certain equity investments. Refer to
Non-GAAP Financial Measures below for further discussion.
Product Sales Performance
COVID-19 update: Compared to the first quarter of 2021,
we have seen gradual recovery from the impacts of the COVID-19
pandemic. Patient visits and lab test procedure trends continued to
improve but remained below pre-COVID-19 levels. The cumulative
decrease in diagnoses over the course of the pandemic has
suppressed the volume of new patients starting treatment, which we
expect to continue to impact our business during the second half of
the year.
Total product sales increased 3% for the second quarter
of 2021 versus the second quarter of 2020. Unit volumes grew 8%
while net selling price declined 5%. On a sequential basis, product
sales grew 9% quarter-over-quarter, driven by 6% volume growth.
Results for individual products are as follows:
- Prolia sales increased 24% year-over-year for the second
quarter, driven by 20% volume growth as new and repeat patient
volumes continued to recover from the pandemic. With osteoporosis
diagnosis rates remaining at approximately 90% of pre-COVID-19
levels in the quarter, we are focused on driving patient growth and
are optimistic about Prolia's continued strength in the second half
of the year.
- EVENITY® (romosozumab-aqqg) sales increased
30% year-over-year for the second quarter, driven by 32% volume
growth. U.S. sales nearly doubled year-over-year, driven by 97%
volume growth as we continued to focus on new patient activation.
Rest of world (ROW) sales decreased 15% year-over-year due in part
to the timing of purchases by our partner Astellas during the first
half of 2020.
- Repatha sales increased 43% year-over-year for the
second quarter, driven by 49% volume growth. In the U.S., volumes
grew 37% year-over-year, and outside the U.S. volumes grew 66%
year-over-year. Volume growth in the quarter was partially offset
by lower net selling price as a result of an increase in the number
of U.S. Medicare Part D patients receiving Repatha and entering the
coverage gap. We expect further reduction in the net selling price
on a sequential basis as the number of Medicare Part D patients
receiving Repatha increases. Repatha has now been prescribed for
more than one million patients.
- Aimovig (erenumab-aooe) sales decreased 16%
year-over-year for the second quarter. Unit volume growth of 11%
was offset by lower net selling price and unfavorable changes to
estimated sales deductions. Aimovig retains strong payer coverage
and remains the segment leader within the preventive calcitonin
gene-related peptide (CGRP) class. To date, more than 500,000
patients worldwide have been prescribed Aimovig for the preventive
treatment of migraine.
- Otezla (apremilast) sales decreased 5% year-over-year
for the second quarter, primarily driven by unfavorable changes to
estimated sales deductions and lower net selling price, partially
offset by 5% volume growth. In the U.S., Otezla continued to
maintain first-line share leadership in psoriasis. New-to-brand
prescription (NBRx) volumes grew 10% year-over-year, even as
patient visits to dermatologists remained 15% below pre-pandemic
levels. The number of new patients that started treatment with
Otezla in Q2 was near pre-pandemic levels, but those gains were
largely offset by a lower percentage of 90-day prescriptions and
lower prescription refill rates. We expect that recovery in the
dermatology segment will continue to progress over the coming
quarters. Looking forward, we are preparing for the anticipated
approval of the mild-to-moderate psoriasis indication in the U.S.,
and continued geographic expansion, including the launch in
China.
- Enbrel (etanercept) sales decreased 8% year-over-year
for the second quarter, primarily driven by lower net selling price
and unfavorable changes in estimated sales deductions. On a
year-over-year basis volumes declined 1%. Going forward, we expect
net selling price to continue to decline year-over-year.
- AMGEVITA™ (adalimumab) sales increased 73%
year-over-year for the second quarter, primarily driven by volume
growth. AMGEVITA continued to be the most prescribed adalimumab
biosimilar in Europe.
- LUMAKRASTM (sotorasib) has been well received
by the oncology community. LUMAKRAS has been added to the National
Comprehensive Cancer Network (NCCN) guidelines and unaided
awareness among oncologists has increased significantly since
launch. KRAS testing of patients with metastatic non-small
cell lung cancer (NSCLC) now stands at approximately 70%, driven by
increased next generation sequencing (NGS) utilization and
KRAS G12C educational efforts, and 46 of the 50 top testing
laboratories are now identifying the KRAS G12C mutation as
actionable in their lab reports.
- KYPROLIS® (carfilzomib) sales increased 11%
year-over-year for the second quarter, primarily driven by volume
growth and net selling price. For the remainder of the year, we
expect continued growth from Kyprolis use in combination with CD38
antibodies.
- XGEVA® (denosumab) sales increased 12%
year-over-year for the second quarter, driven by volume growth as
the segment recovered from the earlier effects of the
pandemic.
- Vectibix® (panitumumab) sales increased 23%
year-over-year for the second quarter, driven by 20% volume growth
that benefited from increased shipments to Takeda, our partner in
Japan. We expect lower demand from
Takeda in the third quarter.
- Nplate® (romiplostim) sales increased 27%
year-over-year for the second quarter, driven by 17% volume growth
and higher inventory levels.
- BLINCYTO® (blinatumomab), our
BiTE® immunotherapy, sales increased 16% year-over-year
for the second quarter, driven by 18% volume growth as we benefited
from broader adoption in the community hospital setting.
- MVASI sales increased 71% year-over-year for the second
quarter, driven by strong volume growth, partially offset by lower
net selling price. In the U.S., MVASI continued to hold leading
volume share with 50% of the bevacizumab segment in the quarter.
Sales were flat quarter-over-quarter as volume growth was offset by
unfavorable changes to estimated sales deductions. Going forward on
a sequential basis, we expect continued worldwide volume growth to
be more than offset by declines in net selling price due to
increased competition.
- KANJINTI sales increased 27% year-over-year for the
second quarter, primarily driven by volume growth, partially offset
by lower net selling price. In the U.S., KANJINTI continued to hold
leading volume share with 42% of the trastuzumab segment in the
quarter. Sales decreased 3% quarter-over-quarter, primarily driven
by unfavorable changes to estimated sales deductions. Going
forward, we expect sales to decline sequentially in the second half
of the year driven by net selling price.
- Neulasta® (pegfilgrastim) sales decreased 18%
year-over-year for the second quarter, driven by declines in both
net selling price and volume, partially offset by a $75 million year-over-year benefit from favorable
changes in reimbursement mix, resulting from the comparison of a
$39 million favorable adjustment to
estimated sales deductions in the quarter to a $36 million unfavorable adjustment in the second
quarter last year. In the long-acting granulocyte
colony-stimulating factor (G-CSF) segment, Neulasta
Onpro® continued to be the preferred choice for
physicians and patients with volume share of 52% in the quarter.
The most recent published Average Selling Price for Neulasta in the
U.S. declined 35% year-over-year and 12% quarter-over-quarter.
Going forward, we expect increased competition to result in further
declines in net selling price.
- NEUPOGEN® (filgrastim) sales increased 4%
year-over-year for the second quarter, driven by favorable changes
in estimated sales deductions, partially offset by volume
declines.
- EPOGEN® (epoetin alfa) sales decreased 19%
year-over-year for the second quarter, driven by volume declines
and lower net selling price resulting from our contractual
commitment with DaVita.
- Aranesp® (darbepoetin alfa) sales decreased
5% year-over-year for the second quarter, driven by lower net
selling price due to competition.
- Parsabiv® (etelcalcetide) sales decreased 62%
year-over-year for the second quarter, driven by volume declines.
With Parsabiv's inclusion in the U.S. end-stage renal disease
(ESRD) bundled payment system, dialysis clinics rapidly implemented
new treatment protocols, switching patients from Parsabiv to
generic oral cinacalcet. As a result, we expect a 50-60%
year-over-year Parsabiv sales decline in 2021. For patients on
hemodialysis, Parsabiv is the only IV-administered calcimimetic
that treats secondary hyperparathyroidism and provides the
opportunity to reduce patient pill burden.
- Sensipar®/Mimpara™ (cinacalcet) sales
decreased 70% year-over-year for the second quarter, primarily
driven by volume declines in response to generic competition.
Product Sales Detail by Product and Geographic Region
$Millions, except
percentages
|
|
Q2
'21
|
|
Q2
'20
|
|
YOY
Δ
|
|
|
US
|
|
ROW
|
|
TOTAL
|
|
TOTAL
|
|
TOTAL
|
Prolia®
|
|
$
|
538
|
|
|
$
|
276
|
|
|
$
|
814
|
|
|
$
|
659
|
|
|
24%
|
EVENITY®
|
|
79
|
|
|
52
|
|
|
131
|
|
|
101
|
|
|
30%
|
Repatha®
|
|
143
|
|
|
143
|
|
|
286
|
|
|
200
|
|
|
43%
|
Aimovig®
|
|
82
|
|
|
—
|
|
|
82
|
|
|
98
|
|
|
(16%)
|
Otezla®
|
|
423
|
|
|
111
|
|
|
534
|
|
|
561
|
|
|
(5%)
|
Enbrel®
|
|
1,113
|
|
|
31
|
|
|
1,144
|
|
|
1,246
|
|
|
(8%)
|
AMGEVITA™
|
|
—
|
|
|
107
|
|
|
107
|
|
|
62
|
|
|
73%
|
KYPROLIS®
|
|
190
|
|
|
90
|
|
|
280
|
|
|
253
|
|
|
11%
|
XGEVA®
|
|
355
|
|
|
133
|
|
|
488
|
|
|
435
|
|
|
12%
|
Vectibix®
|
|
92
|
|
|
147
|
|
|
239
|
|
|
195
|
|
|
23%
|
Nplate®
|
|
136
|
|
|
109
|
|
|
245
|
|
|
193
|
|
|
27%
|
BLINCYTO®
|
|
62
|
|
|
46
|
|
|
108
|
|
|
93
|
|
|
16%
|
MVASI®
|
|
206
|
|
|
88
|
|
|
294
|
|
|
172
|
|
|
71%
|
KANJINTI®
|
|
132
|
|
|
24
|
|
|
156
|
|
|
123
|
|
|
27%
|
Neulasta®
|
|
434
|
|
|
52
|
|
|
486
|
|
|
593
|
|
|
(18%)
|
NEUPOGEN®
|
|
36
|
|
|
15
|
|
|
51
|
|
|
49
|
|
|
4%
|
EPOGEN®
|
|
130
|
|
|
—
|
|
|
130
|
|
|
161
|
|
|
(19%)
|
Aranesp®
|
|
135
|
|
|
232
|
|
|
367
|
|
|
387
|
|
|
(5%)
|
Parsabiv®
|
|
37
|
|
|
34
|
|
|
71
|
|
|
186
|
|
|
(62%)
|
Sensipar®/Mimpara™
|
|
4
|
|
|
20
|
|
|
24
|
|
|
81
|
|
|
(70%)
|
Other**
|
|
47
|
|
|
30
|
|
|
77
|
|
|
60
|
|
|
28%
|
Total product
sales
|
|
$
|
4,374
|
|
|
$
|
1,740
|
|
|
$
|
6,114
|
|
|
$
|
5,908
|
|
|
3%
|
|
|
|
|
|
|
|
|
|
|
|
** Other includes
Corlanor®, GENSENTA, IMLYGIC®,
LUMAKRAS™, AVSOLA®, Bergamo, and
RIABNI®
|
Operating Expense, Operating Margin and Tax Rate
Analysis
On a GAAP basis:
- Total Operating Expenses increased 47% primarily driven
by the recent acquisition of Five Prime Therapeutics. Cost of
Sales margin increased 1.6 percentage points primarily due to
product mix, including COVID-19 antibody shipments to Eli Lilly and
Company (Lilly) that began this quarter, profit share and
royalties, partially offset by lower amortization expense from
acquisition-related assets. Research & Development
(R&D) expenses increased 12% primarily due to higher
research and early pipeline spend and late-stage development
program spend, including our recent business development
activities. Acquired IPR&D expenses in 2021 were driven
by the Five Prime Therapeutics acquisition. Selling, General
& Administrative (SG&A) expenses increased 7% driven by
marketed product support due to increased customer engagement in
response to the pandemic recovery and investment in new product
launches.
- Operating Margin as a percentage of product sales
decreased 25.8 percentage points to 13.5%.
- Tax Rate increased 5.6 percentage points primarily
driven by the non-deductible acquired IPR&D expense arising
from the acquisition of Five Prime Therapeutics.
On a non-GAAP basis:
- Total Operating Expenses increased 15%. Cost of
Sales margin increased 4.1 percentage points primarily due to
product mix, including COVID-19 antibody shipments to Lilly that
began this quarter, profit share and royalties. R&D
expenses increased 11% primarily due to higher research and early
pipeline spend and late-stage development program spend, including
our recent business development activities. SG&A
expenses increased 6% driven by marketed product support due to
increased customer engagement in response to the pandemic recovery
and investment in new product launches.
- Operating Margin as a percentage of product sales
decreased 4.1 percentage points to 50.9%.
- Tax Rate decreased 1.0 percentage points primarily
driven by a prior year change in foreign loss utilization.
$Millions, except
percentages
|
|
GAAP
|
|
Non-GAAP
|
|
|
Q2
'21
|
|
Q2
'20
|
|
YOY
Δ
|
|
Q2
'21
|
|
Q2
'20
|
|
YOY
Δ
|
Cost of
Sales
|
|
$
|
1,637
|
|
|
$
|
1,488
|
|
|
10%
|
|
$
|
1,034
|
|
|
$
|
758
|
|
|
36%
|
% of product
sales
|
|
26.8%
|
|
|
25.2%
|
|
|
1.6 pts
|
|
16.9%
|
|
|
12.8%
|
|
|
4.1 pts
|
Research &
Development
|
|
$
|
1,082
|
|
|
$
|
964
|
|
|
12%
|
|
$
|
1,036
|
|
|
$
|
936
|
|
|
11%
|
% of product
sales
|
|
17.7%
|
|
|
16.3%
|
|
|
1.4 pts
|
|
16.9%
|
|
|
15.8%
|
|
|
1.1 pts
|
Acquired
IPR&D
|
|
$
|
1,505
|
|
|
$
|
—
|
|
|
*
|
|
$
|
—
|
|
|
$
|
—
|
|
|
—%
|
% of product
sales
|
|
24.6%
|
|
|
—%
|
|
|
24.6 pts
|
|
—%
|
|
|
—%
|
|
|
0 pts
|
Selling, General
& Administrative
|
|
$
|
1,384
|
|
|
$
|
1,295
|
|
|
7%
|
|
$
|
1,345
|
|
|
$
|
1,265
|
|
|
6%
|
% of product
sales
|
|
22.6%
|
|
|
21.9%
|
|
|
0.7 pts
|
|
22.0%
|
|
|
21.4%
|
|
|
0.6 pts
|
Other
|
|
$
|
90
|
|
|
$
|
136
|
|
|
(34%)
|
|
$
|
—
|
|
|
$
|
—
|
|
|
—%
|
Total Operating
Expenses
|
|
$
|
5,698
|
|
|
$
|
3,883
|
|
|
47%
|
|
$
|
3,415
|
|
|
$
|
2,959
|
|
|
15%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
Margin
|
|
|
|
|
|
|
|
|
|
|
|
|
operating income as %
of product sales
|
|
13.5%
|
|
|
39.3%
|
|
|
(25.8) pts
|
|
50.9%
|
|
|
55.0%
|
|
|
(4.1) pts
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Tax
Rate
|
|
16.8%
|
|
|
11.2%
|
|
|
5.6
pts
|
|
12.6%
|
|
|
13.6%
|
|
|
(1.0)
pts
|
|
|
|
|
|
|
|
|
|
|
|
|
|
pts: percentage
points
|
|
|
|
|
|
|
|
|
* Change in excess of
100%
|
|
|
|
|
|
|
|
|
Cash Flow and Balance Sheet
- The Company generated $1.7
billion of free cash flow in the second quarter of 2021
versus $2.7 billion in the second
quarter of 2020, driven by a difference in the timing of tax
payments.
- The Company's second quarter 2021 dividend of $1.76 per share was declared on March 3, 2021, and was paid on June 8, 2021, to all stockholders of record as of
May 17, 2021, representing a 10%
increase from 2020.
- During the second quarter, the Company repurchased 6.5 million
shares of common stock at a total cost of $1.6 billion. At the end of the second quarter,
the Company had $3.9
billion authorization remaining under its stock repurchase
program.
- Cash and investments totaled $8.1
billion and debt outstanding totaled $32.8 billion as of June
30, 2021.
$Billions, except
shares
|
|
Q2
'21
|
|
Q2
'20
|
|
YOY
Δ
|
Operating Cash
Flow
|
|
$
|
1.9
|
|
|
$
|
2.8
|
|
|
$
|
(0.9)
|
|
Capital
Expenditures
|
|
$
|
0.2
|
|
|
$
|
0.2
|
|
|
$
|
0.0
|
|
Free Cash
Flow
|
|
$
|
1.7
|
|
|
$
|
2.7
|
|
|
$
|
(0.9)
|
|
Dividends
Paid
|
|
$
|
1.0
|
|
|
$
|
0.9
|
|
|
$
|
0.1
|
|
Share
Repurchases
|
|
$
|
1.6
|
|
|
$
|
0.6
|
|
|
$
|
1.0
|
|
Average Diluted
Shares (millions)
|
|
576
|
|
|
592
|
|
|
(16)
|
|
|
|
|
|
|
|
|
Note: Numbers may not
add due to rounding
|
|
|
|
|
|
|
|
$Billions
|
|
6/30/21
|
|
12/31/20
|
|
YTD
Δ
|
Cash and
Investments
|
|
$
|
8.1
|
|
|
$
|
10.6
|
|
|
$
|
(2.6)
|
|
Debt
Outstanding
|
|
$
|
32.8
|
|
|
$
|
33.0
|
|
|
$
|
(0.2)
|
|
|
|
|
|
|
|
|
Note: Numbers may not
add due to rounding
|
|
|
|
|
|
|
2021 Guidance
For the full year 2021, the Company now expects:
- Total revenues in the range of $25.8 billion to $26.6
billion, unchanged from previous guidance.
- On a GAAP basis, EPS in the range of $8.84 to $9.90 and
a tax rate in the range of 13.0% to 14.5%.
-
- Previously, the Company expected GAAP EPS in the range of
$9.11 to $10.71 and a tax rate in the range of 14.0% to
15.5%.
- On a non-GAAP basis, EPS in the range of $16.00 to $17.00,
unchanged from previous guidance and a tax rate in the
range of 13.5% to 14.5%, also unchanged from previous
guidance.
- Capital expenditures to be approximately
$900 million.
- Share repurchases at the upper end of our previous
guidance of $3.0 billion to
$5.0 billion.
Second Quarter Product and Pipeline Update
The Company provided the following updates on selected product
and pipeline programs:
LUMAKRAS
- In May, the U.S. Food and Drug Administration (FDA) approved
LUMAKRAS for the treatment of adult patients with KRAS
G12C-mutated locally advanced or metastatic NSCLC, as determined by
an FDA-approved test, who have received at least one prior systemic
therapy. LUMAKRAS received accelerated approval based on overall
response rate and duration of response. Continued approval for this
indication may be contingent upon verification and description of
clinical benefit in a confirmatory trial(s).
- Regulatory reviews continue in Europe, Japan
and other jurisdictions.
- Top-line results from the event-driven confirmatory Phase 3
study comparing LUMAKRAS to docetaxel in patients with KRAS
G12C-mutated advanced NSCLC are expected in H1 2022.
- Primary results from the Phase 2 monotherapy study in patients
with advanced KRAS G12C-mutated colorectal cancer (CRC) have
been submitted for publication.
- Additional data from the Phase 1/2 CodeBreaK 100 monotherapy
study in advanced NSCLC have been accepted for presentation at the
World Conference on Lung Cancer in September, including biomarker
analyses and post hoc analyses of efficacy and safety in patients
with stable brain metastases. Enrollment continues in a cohort of
patients with active brain metastases in the CodeBreaK 101
study.
- Exploration of LUMAKRAS in multiple Phase 1b combination cohorts continues to
progress.
-
- Initial data from LUMAKRAS in combination with Vectibix in
patients with advanced KRAS G12C-mutated CRC have been
accepted for presentation at the European Society for Medical
Oncology Congress in September.
- Initial data from LUMAKRAS in combination with a
mitogen-activated protein kinase kinase (MEK) inhibitor and
LUMAKRAS in combination with an oral EGFR inhibitor are planned to
be submitted for presentation at a Q4 2021 medical conference.
- The Company is collaborating with Novartis on a LUMAKRAS
combination study with their SHP-2
inhibitor TNO155. A cohort is expected to initiate in the CodeBreaK
101 study in Q3 2021. Enrollment continues in a combination cohort
with Revolution Medicine's SHP-2
inhibitor RMC-4630.
- Initiation of a Phase 2 study is planned for Q3 2021 in
first-line patients with KRAS G12C mutated NSCLC whose
tumors express < 1% programmed death-ligand 1 (PD-L1) and/or
serine/threonine kinase 11 (STK11) mutations.
- Data from the Phase 2 monotherapy study in patients with
KRAS G12C-mutated solid tumors other than NSCLC and CRC are
expected in H1 2022.
BLINCYTO
- In June, the European Commission approved an expanded
indication for the use of BLINCYTO in the treatment of pediatric
patients aged 1 year or older with high-risk first relapsed
Philadelphia chromosome negative
CD19 positive B-precursor acute lymphoblastic leukemia as part of
the consolidation therapy.
Bemarituzumab
- The Company has initiated discussions with regulators on the
Phase 3 study design for bemarituzumab, a first-in-class
anti-fibroblast growth factor receptor 2b (FGFR2b) antibody for the treatment of
patients with human epidermal growth factor receptor 2 (HER2)
negative, FGFR2b-positive gastric and gastroesophageal junction
cancer. Initiation of the registrational program is planned for Q4
2021.
- Bemarituzumab has been granted Breakthrough Therapy Designation
by the FDA as first-line treatment for patients with at least 10%
FGFR2b overexpression and HER2-negative metastatic and locally
advanced gastric and gastroesophageal adenocarcinoma in combination
with modified FOLFOX6 (fluoropyrimidine, leucovorin, and
oxaliplatin).
- Planning is underway for bemarituzumab clinical studies in
other solid tumors, including squamous NSCLC.
Acapatamab (AMG 160)
- A dose expansion cohort of acapatamab, a half-life extended
(HLE) BiTE molecule targeting prostate-specific membrane antigen
(PSMA), has completed enrollment of patients with metastatic
castrate resistant prostate cancer (mCRPC). Enrollment of
acapatamab is ongoing in cohorts with reduced levels of monitoring
during cycle one to explore outpatient administration.
- An acapatamab dose escalation study has initiated for patients
with NSCLC expressing PSMA.
- A master protocol evaluating combinations of acapatamab with
AMG 404, an anti-programmed cell death 1 (PD-1) antibody, or the
novel hormone therapies enzalutamide or abiraterone, continues to
enroll patients with earlier-line mCRPC.
Tarlatamab (AMG 757)
- The Company has begun planning a potentially pivotal Phase 2
study and will initiate discussions with regulators for tarlatamab,
an HLE BiTE molecule targeting delta-like ligand 3 (DLL3), in
patients with relapsed or refractory small cell lung cancer.
- A Phase 1b study of tarlatamab
has begun recruiting patients with neuroendocrine prostate
cancer.
- A Phase 1b study of tarlatamab in
combination with AMG 404 is planned to initiate in Q3 2021 for
patients with small cell lung cancer.
Additional Phase 1 Oncology Programs
- AMG 509, a bivalent T-cell engager XmAb® 2+1
antibody targeting six transmembrane epithelial antigen of the
prostate 1 (STEAP1) was recently granted Fast Track designation by
the FDA and continues to enroll patients with mCRPC.
- Pavurutamab (AMG 701), an HLE BiTE® molecule
targeting B-cell maturation antigen (BCMA), has resumed enrolling
patients with relapsed or refractory multiple myeloma.
- AMG 330, a BiTE® molecule targeting CD33, continues
to enroll patients with acute myeloid leukemia.
- Enrollment has been paused in the Phase 1 study of AMG 427, a
BiTE® molecule targeting fms-like tyrosine kinase 3
(FLT3) for patients with acute myeloid leukemia.
- HLE BiTE® molecules AMG 199 and AMG 910, targeting
mucin 17 (MUC17) and claudin 18.2 (CLDN18.2), respectively,
continue to enroll patients with gastric and gastroesophageal
junction cancer.
- AMG 176, a small molecule inhibitor of myeloid cell leukemia 1
(MCL-1), continues to enroll patients with hematologic
malignancies.
- AMG 256, a multispecific interleukin-21 receptor agonist,
continues to enroll patients with PD-1 positive solid tumors.
Tezepelumab
- In July, the FDA accepted the Biologics License Application and
granted Priority Review for tezepelumab for the treatment of
asthma. Regulatory reviews are also underway in the EU and
Japan.
- A Phase 3 study has begun enrolling patients with chronic
rhinosinusitis with nasal polyps.
- A Phase 2b study continues to
enroll patients with chronic spontaneous urticaria.
- A Phase 2 study continues to enroll patients with chronic
obstructive pulmonary disease.
Otezla
- In May, the Company announced that the FDA accepted the
supplemental New Drug Application for Otezla for the treatment of
adults with mild-to-moderate plaque psoriasis who are candidates
for phototherapy or systemic therapy. The FDA has assigned a
Prescription Drug User Fee Act action date of December 19, 2021.
- Phase 3 planning is underway for Otezla for the treatment of
Japanese patients with palmoplantar pustulosis.
- The Company has stopped enrollment in the Otezla arms of
ongoing platform trials designed to evaluate the efficacy and
safety of potential treatments for patients hospitalized with
COVID-19.
AMG 451 / KHK4083
- The Company expects to commence discussions with regulators
soon for AMG 451, an anti-OX40 monoclonal antibody, for the
treatment of atopic dermatitis, with Phase 3 development
anticipated to begin in H1 2022.
Rozibafusp alfa (AMG 570)
- A Phase 2b study of rozibafusp
alfa, a multispecific antibody-peptide conjugate that
simultaneously blocks inducible T-cell costimulatory ligand (ICOSL)
and B-cell activating factor (BAFF) activity, continues to enroll
patients with systemic lupus erythematosus (SLE).
Efavaleukin alfa (AMG 592)
- A Phase 2b study of efavaleukin
alfa, an interleukin-2 mutein Fc fusion protein, is enrolling
patients with SLE.
- Data from a Phase 1b SLE study
have been submitted to a Q4 2021 medical conference.
- A Phase 2 study of efavaleukin alfa is planned to initiate in
H2 2021 for patients with ulcerative colitis.
AMG 714 / PRV-015
- A Phase 2b study of AMG 714, a
monoclonal antibody that binds interleukin-15, continues to enroll
patients with non-responsive celiac disease.
Repatha
- A Phase 3 cardiovascular outcomes study (VESALIUS-CV) continues
to enroll patients at high cardiovascular risk without prior
myocardial infarction or stroke.
Olpasiran (AMG 890)
- Results from a Phase 2 study in patients with elevated
lipoprotein(a) are expected in H1 2022 with publication expected in
H2 2022.
Aimovig
- In June, the Japanese Ministry of Health, Labour and Welfare
granted marketing approval for Aimovig for the suppression of onset
of migraine attacks in adults.
Biosimilars
- A Phase 3 study of ABP 654, a biosimilar candidate to
STELARA® (ustekinumab), has completed enrollment.
- A Phase 3 study of ABP 938, a biosimilar candidate to
EYLEA® (aflibercept) continues to enroll patients.
- A Phase 3 study of ABP 959, a biosimilar candidate to
SOLIRIS® (eculizumab), is ongoing.
Amgenpipeline.com
- A listing of additional ongoing clinical programs can be found
at Amgenpipeline.com
Tezepelumab is being developed in collaboration with
AstraZeneca
AMG 451 (also known as KHK4083) is being
developed in collaboration with Kyowa Kirin
AMG 714 (also
known as PRV-015) is being developed in collaboration with
Provention Bio
DARZALEX and STELARA are a registered
trademarks of Janssen Pharmaceutica NV
EYLEA is a
registered trademark of Regeneron Pharmaceuticals,
Inc.
SOLIRIS is a registered trademark of Alexion
Pharmaceuticals, Inc.
XmAb is a registered trademark of
Xencor, Inc.
U.S. Manufacturing Facilities
In anticipation of future demand for our medicines, we will
invest approximately $1 billion to
build two new manufacturing facilities – a packaging plant in
Ohio and a drug substance plant in
North Carolina. Both of these
facilities will be built faster and at a lower cost than
traditional plants, and both also will utilize cutting-edge
technologies to be more efficient and environmentally friendly than
traditional plants.
U.S. Tax Petition
In July 2021, we filed a petition
in the U.S. Tax Court to contest notices of deficiencies received
from the IRS during the quarter for 2010, 2011 and 2012. These
notices seek to increase our U.S. taxable income by an amount that
would result in additional federal tax of approximately
$3.6 billion, plus interest. Any
additional tax that could be imposed would be reduced by up to
approximately $900 million of
repatriation tax previously accrued on our foreign earnings. We
firmly believe that the IRS's positions in the notices are without
merit and we will vigorously contest the notices through the
judicial process.
Non-GAAP Financial Measures
In this news release, management has presented its operating
results for the second quarters of 2021 and 2020, in accordance
with U.S. Generally Accepted Accounting Principles (GAAP) and on a
non-GAAP basis. In addition, management has presented its full year
2021 EPS and tax rate 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, restructuring and
certain other items from the related GAAP financial measures.
Reconciliations for these non-GAAP financial measures to the most
directly comparable GAAP financial measures are included in the
news release. Management has also presented Free Cash Flow (FCF),
which is a non-GAAP financial measure, for the second quarters of
2021 and 2020. 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 ongoing business activities by
facilitating comparisons of results of ongoing business operations
among current, past and future periods. The Company believes that
FCF provides a further measure of the Company's liquidity.
Beginning January 1, 2021, we
began to exclude the gains and losses on our investments in equity
securities from our non-GAAP measures that are recorded to Other
income (expense). This exclusion will not apply to our share of the
earnings and losses of our strategic investments in corporations
accounted for under the equity method of accounting, such as our
investment in BeiGene. The Company will be excluding gains and
losses from equity investments for the purpose of calculating the
non-GAAP financial measures presented because the Company believes
the results of such gains and losses are not representative of our
normal business operations. We are making this change beginning in
2021 because, as we have increased our investments in these
companies, we recognized that the resulting variability can impede
comparability between periods of our financial performance for our
ongoing business operations. For comparability of results to the
prior year, non-GAAP net income and non-GAAP EPS amounts for 2020
have been revised to reflect the update to our non-GAAP policy that
excludes gains and losses on certain equity investments.
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.
For more information, visit www.amgen.com and follow us on
www.twitter.com/amgen.
Forward-Looking Statements
This news release contains forward-looking statements that are
based on the current expectations and beliefs of Amgen. All
statements, other than statements of historical fact, are
statements that could be deemed forward-looking statements,
including any statements on the outcome, benefits and synergies of
collaborations, or potential collaborations, with any other company
(including BeiGene, Ltd. or any collaboration to manufacture
therapeutic antibodies against COVID-19), the performance of Otezla
(including anticipated Otezla sales growth and the timing of
non-GAAP EPS accretion), or the Five Prime Therapeutics, Inc.
acquisition, as well as estimates of revenues, operating margins,
capital expenditures, cash, other financial metrics, expected
legal, arbitration, political, regulatory or clinical results or
practices, customer and prescriber patterns or practices,
reimbursement activities and outcomes, effects of pandemics or
other widespread health problems such as the ongoing COVID-19
pandemic on our business, outcomes, progress, or effects relating
to studies of Otezla as a potential treatment for COVID-19, and
other such estimates and results. Forward-looking statements
involve significant risks and uncertainties, including those
discussed below and more fully described in the Securities and
Exchange Commission reports filed by Amgen, including our most
recent annual report on Form 10-K and any subsequent periodic
reports on Form 10-Q and current reports on Form 8-K. Unless
otherwise noted, Amgen is providing this information as of the date
of this news release and does not undertake any obligation to
update any forward-looking statements contained in this document as
a result of new information, future events or otherwise.
No forward-looking statement can be guaranteed and actual
results may differ materially from those we project. Our results
may be affected by our ability to successfully market both new and
existing products domestically and internationally, clinical and
regulatory developments involving current and future products,
sales growth of recently launched products, competition from other
products including biosimilars, difficulties or delays in
manufacturing our products and global economic conditions. In
addition, sales of our products are affected by pricing pressure,
political and public scrutiny and reimbursement policies imposed by
third-party payers, including governments, private insurance plans
and managed care providers and may be affected by regulatory,
clinical and guideline developments and domestic and international
trends toward managed care and healthcare cost containment.
Furthermore, our research, testing, pricing, marketing and other
operations are subject to extensive regulation by domestic and
foreign government regulatory authorities. We or others could
identify safety, side effects or manufacturing problems with our
products, including our devices, after they are on the market. Our
business may be impacted by government investigations, litigation
and product liability claims. In addition, our business may be
impacted by the adoption of new tax legislation or exposure to
additional tax liabilities. If we fail to meet the compliance
obligations in the corporate integrity agreement between us and the
U.S. government, we could become subject to significant sanctions.
Further, while we routinely obtain patents for our products and
technology, the protection offered by our patents and patent
applications may be challenged, invalidated or circumvented by our
competitors, or we may fail to prevail in present and future
intellectual property litigation. We perform a substantial amount
of our commercial manufacturing activities at a few key facilities,
including in Puerto Rico, and also
depend on third parties for a portion of our manufacturing
activities, and limits on supply may constrain sales of certain of
our current products and product candidate development. An outbreak
of disease or similar public health threat, such as COVID-19, and
the public and governmental effort to mitigate against the spread
of such disease, could have a significant adverse effect on the
supply of materials for our manufacturing activities, the
distribution of our products, the commercialization of our product
candidates, and our clinical trial operations, and any such events
may have a material adverse effect on our product development,
product sales, business and results of operations. We rely on
collaborations with third parties for the development of some of
our product candidates and for the commercialization and sales of
some of our commercial products. In addition, we compete with other
companies with respect to many of our marketed products as well as
for the discovery and development of new products. Discovery or
identification of new product candidates or development of new
indications for existing products cannot be guaranteed and movement
from concept to product is uncertain; consequently, there can be no
guarantee that any particular product candidate or development of a
new indication for an existing product will be successful and
become a commercial product. Further, some raw materials, medical
devices and component parts for our products are supplied by sole
third-party suppliers. Certain of our distributors, customers and
payers have substantial purchasing leverage in their dealings with
us. The discovery of significant problems with a product similar to
one of our products that implicate an entire class of products
could have a material adverse effect on sales of the affected
products and on our business and results of operations. Our efforts
to collaborate with or acquire other companies, products or
technology, and to integrate the operations of companies or to
support the products or technology we have acquired, may not be
successful. A breakdown, cyberattack or information security breach
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. 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
Trish Rowland, 805-447-5631
(media)
Arvind Sood, 805-447-1060
(investors)
Amgen Inc.
Consolidated Statements of Income - GAAP (In millions,
except per-share data) (Unaudited)
|
|
|
Three months
ended
June
30,
|
|
Six months
ended
June
30,
|
|
2021
|
|
2020
|
|
2021
|
|
2020
|
Revenues:
|
|
|
|
|
|
|
|
Product
sales
|
$
|
6,114
|
|
|
$
|
5,908
|
|
|
$
|
11,706
|
|
|
$
|
11,802
|
|
Other
revenues
|
412
|
|
|
298
|
|
|
721
|
|
|
565
|
|
Total
revenues
|
6,526
|
|
|
6,206
|
|
|
12,427
|
|
|
12,367
|
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
Cost of
sales
|
1,637
|
|
|
1,488
|
|
|
3,127
|
|
|
3,001
|
|
Research and
development
|
1,082
|
|
|
964
|
|
|
2,049
|
|
|
1,916
|
|
Acquired in-process
research and development
|
1,505
|
|
|
—
|
|
|
1,505
|
|
|
—
|
|
Selling, general and
administrative
|
1,384
|
|
|
1,295
|
|
|
2,638
|
|
|
2,611
|
|
Other
|
90
|
|
|
136
|
|
|
151
|
|
|
161
|
|
Total operating
expenses
|
5,698
|
|
|
3,883
|
|
|
9,470
|
|
|
7,689
|
|
|
|
|
|
|
|
|
|
Operating
income
|
828
|
|
|
2,323
|
|
|
2,957
|
|
|
4,678
|
|
|
|
|
|
|
|
|
|
Other income
(expense):
|
|
|
|
|
|
|
|
Interest expense,
net
|
(281)
|
|
|
(296)
|
|
|
(566)
|
|
|
(642)
|
|
Other income,
net
|
11
|
|
|
3
|
|
|
24
|
|
|
14
|
|
|
|
|
|
|
|
|
|
Income before income
taxes
|
558
|
|
|
2,030
|
|
|
2,415
|
|
|
4,050
|
|
|
|
|
|
|
|
|
|
Provision for income
taxes
|
94
|
|
|
227
|
|
|
305
|
|
|
422
|
|
|
|
|
|
|
|
|
|
Net income
|
$
|
464
|
|
|
$
|
1,803
|
|
|
$
|
2,110
|
|
|
$
|
3,628
|
|
|
|
|
|
|
|
|
|
Earnings per
share:
|
|
|
|
|
|
|
|
Basic
|
$
|
0.81
|
|
|
$
|
3.07
|
|
|
$
|
3.67
|
|
|
$
|
6.16
|
|
Diluted
|
$
|
0.81
|
|
|
$
|
3.05
|
|
|
$
|
3.65
|
|
|
$
|
6.12
|
|
|
|
|
|
|
|
|
|
Weighted-average
shares used in calculation of earnings per share:
|
|
|
|
|
|
|
|
Basic
|
573
|
|
|
588
|
|
|
575
|
|
|
589
|
|
Diluted
|
576
|
|
|
592
|
|
|
578
|
|
|
593
|
|
Amgen
Inc. Consolidated Balance Sheets - GAAP (In
millions)
|
|
|
June
30,
|
|
December
31,
|
|
2021
|
|
2020
|
|
(Unaudited)
|
|
|
Assets
|
Current
assets:
|
|
|
|
Cash, cash equivalents
and marketable securities
|
$
|
8,082
|
|
|
$
|
10,647
|
|
Trade receivables,
net
|
4,479
|
|
|
4,525
|
|
Inventories
|
4,115
|
|
|
3,893
|
|
Other current
assets
|
2,423
|
|
|
2,079
|
|
Total current
assets
|
19,099
|
|
|
21,144
|
|
|
|
|
|
Property, plant and
equipment, net
|
4,906
|
|
|
4,889
|
|
Intangible assets,
net
|
15,308
|
|
|
16,587
|
|
Goodwill
|
14,676
|
|
|
14,689
|
|
Other noncurrent
assets
|
5,784
|
|
|
5,639
|
|
Total
assets
|
$
|
59,773
|
|
|
$
|
62,948
|
|
|
|
|
|
Liabilities and
Stockholders' Equity
|
Current
liabilities:
|
|
|
|
Accounts payable and
accrued liabilities
|
$
|
10,261
|
|
|
$
|
11,562
|
|
Current portion of
long-term debt
|
4,324
|
|
|
91
|
|
Total current
liabilities
|
14,585
|
|
|
11,653
|
|
|
|
|
|
Long-term
debt
|
28,458
|
|
|
32,895
|
|
Long-term tax
liabilities
|
6,428
|
|
|
6,968
|
|
Other noncurrent
liabilities
|
2,055
|
|
|
2,023
|
|
Total stockholders'
equity
|
8,247
|
|
|
9,409
|
|
Total liabilities and
stockholders' equity
|
$
|
59,773
|
|
|
$
|
62,948
|
|
|
|
|
|
Shares
outstanding
|
570
|
|
|
578
|
|
Amgen
Inc. GAAP to Non-GAAP Reconciliations (Dollars
in millions) (Unaudited)
|
|
|
Three months
ended
June
30,
|
|
Six months
ended
June
30,
|
|
2021
|
|
2020*
|
|
2021
|
|
2020*
|
GAAP cost of
sales
|
$
|
1,637
|
|
|
$
|
1,488
|
|
|
$
|
3,127
|
|
|
$
|
3,001
|
|
Adjustments to cost
of sales:
|
|
|
|
|
|
|
|
Acquisition-related
expenses (a)
|
(598)
|
|
|
(730)
|
|
|
(1,221)
|
|
|
(1,472)
|
|
Other
|
(5)
|
|
|
—
|
|
|
(5)
|
|
|
—
|
|
Total adjustments
to cost of sales
|
(603)
|
|
|
(730)
|
|
|
(1,226)
|
|
|
(1,472)
|
|
Non-GAAP cost of
sales
|
$
|
1,034
|
|
|
$
|
758
|
|
|
$
|
1,901
|
|
|
$
|
1,529
|
|
|
|
|
|
|
|
|
|
GAAP cost of sales
as a percentage of product sales
|
26.8
|
%
|
|
25.2
|
%
|
|
26.7
|
%
|
|
25.4
|
%
|
Acquisition-related
expenses (a)
|
(9.8)
|
|
|
(12.4)
|
|
|
(10.4)
|
|
|
(12.4)
|
|
Other
|
(0.1)
|
|
|
0.0
|
|
|
(0.1)
|
|
|
0.0
|
|
Non-GAAP cost of
sales as a percentage of product sales
|
16.9
|
%
|
|
12.8
|
%
|
|
16.2
|
%
|
|
13.0
|
%
|
|
|
|
|
|
|
|
|
GAAP research and
development expenses
|
$
|
1,082
|
|
|
$
|
964
|
|
|
$
|
2,049
|
|
|
$
|
1,916
|
|
Adjustments to
research and development expenses:
|
|
|
|
|
|
|
|
Acquisition-related
expenses (a)
|
(46)
|
|
|
(28)
|
|
|
(69)
|
|
|
(53)
|
|
Non-GAAP research
and development expenses
|
$
|
1,036
|
|
|
$
|
936
|
|
|
$
|
1,980
|
|
|
$
|
1,863
|
|
|
|
|
|
|
|
|
|
GAAP research and
development expenses as a percentage of product
sales
|
17.7
|
%
|
|
16.3
|
%
|
|
17.5
|
%
|
|
16.2
|
%
|
Acquisition-related
expenses (a)
|
(0.8)
|
|
|
(0.5)
|
|
|
(0.6)
|
|
|
(0.4)
|
|
Non-GAAP research
and development expenses as a percentage of product
sales
|
16.9
|
%
|
|
15.8
|
%
|
|
16.9
|
%
|
|
15.8
|
%
|
|
|
|
|
|
|
|
|
GAAP acquired
IPR&D
|
$
|
1,505
|
|
|
$
|
—
|
|
|
$
|
1,505
|
|
|
$
|
—
|
|
Adjustments to
acquired IPR&D:
|
|
|
|
|
|
|
|
Five Prime acquisition
IPR&D expense
|
(1,505)
|
|
|
—
|
|
|
(1,505)
|
|
|
—
|
|
Non-GAAP acquired
IPR&D
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
|
|
|
|
|
|
|
GAAP acquired
IPR&D expenses as a percentage of product sales
|
24.6
|
%
|
|
—
|
%
|
|
12.9
|
%
|
|
—
|
%
|
Five Prime acquisition
IPR&D expense
|
(24.6)
|
|
|
0.0
|
|
|
(12.9)
|
|
|
0.0
|
|
Non-GAAP acquired
IPR&D expenses as a percentage of product sales
|
—
|
%
|
|
—
|
%
|
|
—
|
%
|
|
—
|
%
|
|
|
|
|
|
|
|
|
GAAP selling,
general and administrative expenses
|
$
|
1,384
|
|
|
$
|
1,295
|
|
|
$
|
2,638
|
|
|
$
|
2,611
|
|
Adjustments to
selling, general and administrative expenses:
|
|
|
|
|
|
|
|
Acquisition-related
expenses (a)
|
(39)
|
|
|
(30)
|
|
|
(51)
|
|
|
(59)
|
|
Other
|
—
|
|
|
—
|
|
|
(16)
|
|
|
—
|
|
Total adjustments
to selling, general and administrative expenses
|
(39)
|
|
|
(30)
|
|
|
(67)
|
|
|
(59)
|
|
Non-GAAP selling,
general and administrative expenses
|
$
|
1,345
|
|
|
$
|
1,265
|
|
|
$
|
2,571
|
|
|
$
|
2,552
|
|
|
|
|
|
|
|
|
|
GAAP selling,
general and administrative expenses as a percentage of product
sales
|
22.6
|
%
|
|
21.9
|
%
|
|
22.5
|
%
|
|
22.1
|
%
|
Acquisition-related
expenses (a)
|
(0.6)
|
|
|
(0.5)
|
|
|
(0.4)
|
|
|
(0.5)
|
|
Other
|
0.0
|
|
|
0.0
|
|
|
(0.1)
|
|
|
0.0
|
|
Non-GAAP selling,
general and administrative expenses as a percentage of product
sales
|
22.0
|
%
|
|
21.4
|
%
|
|
22.0
|
%
|
|
21.6
|
%
|
|
|
|
|
|
|
|
|
GAAP operating
expenses
|
$
|
5,698
|
|
|
$
|
3,883
|
|
|
$
|
9,470
|
|
|
$
|
7,689
|
|
Adjustments to
operating expenses:
|
|
|
|
|
|
|
|
Adjustments to cost of
sales
|
(603)
|
|
|
(730)
|
|
|
(1,226)
|
|
|
(1,472)
|
|
Adjustments to
research and development expenses
|
(46)
|
|
|
(28)
|
|
|
(69)
|
|
|
(53)
|
|
Adjustments to
acquired IPR&D
|
(1,505)
|
|
|
—
|
|
|
(1,505)
|
|
|
—
|
|
Adjustments to
selling, general and administrative expenses
|
(39)
|
|
|
(30)
|
|
|
(67)
|
|
|
(59)
|
|
Certain charges
pursuant to our cost savings initiatives
|
(76)
|
|
|
2
|
|
|
(128)
|
|
|
4
|
|
Certain other expenses
(b)
|
(14)
|
|
|
(138)
|
|
|
(23)
|
|
|
(165)
|
|
Total adjustments
to operating expenses
|
(2,283)
|
|
|
(924)
|
|
|
(3,018)
|
|
|
(1,745)
|
|
Non-GAAP operating
expenses
|
$
|
3,415
|
|
|
$
|
2,959
|
|
|
$
|
6,452
|
|
|
$
|
5,944
|
|
|
|
|
|
|
|
|
|
GAAP operating
income
|
$
|
828
|
|
|
$
|
2,323
|
|
|
$
|
2,957
|
|
|
$
|
4,678
|
|
Adjustments to
operating expenses
|
2,283
|
|
|
924
|
|
|
3,018
|
|
|
1,745
|
|
Non-GAAP operating
income
|
$
|
3,111
|
|
|
$
|
3,247
|
|
|
$
|
5,975
|
|
|
$
|
6,423
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months
ended
June
30,
|
|
Six months
ended
June
30,
|
|
2021
|
|
2020*
|
|
2021
|
|
2020*
|
GAAP operating
income as a percentage of product sales
|
13.5
|
%
|
|
39.3
|
%
|
|
25.3
|
%
|
|
39.6
|
%
|
Adjustments to cost of
sales
|
9.9
|
|
|
12.4
|
|
|
10.5
|
|
|
12.5
|
|
Adjustments to
research and development expenses
|
0.8
|
|
|
0.5
|
|
|
0.6
|
|
|
0.4
|
|
Acquired
IPR&D
|
24.7
|
|
|
0.0
|
|
|
12.9
|
|
|
0.0
|
|
Adjustments to
selling, general and administrative expenses
|
0.6
|
|
|
0.5
|
|
|
0.5
|
|
|
0.5
|
|
Certain charges
pursuant to our cost savings initiatives
|
1.2
|
|
|
0.0
|
|
|
1.1
|
|
|
0.0
|
|
Certain other expenses
(b)
|
0.2
|
|
|
2.3
|
|
|
0.1
|
|
|
1.4
|
|
Non-GAAP operating
income as a percentage of product sales
|
50.9
|
%
|
|
55.0
|
%
|
|
51.0
|
%
|
|
54.4
|
%
|
|
|
|
|
|
|
|
|
GAAP other income,
net
|
$
|
11
|
|
|
$
|
3
|
|
|
$
|
24
|
|
|
$
|
14
|
|
Adjustments to
other income (expense), net:
|
|
|
|
|
|
|
|
Equity method
investment basis difference amortization
|
42
|
|
|
36
|
|
|
84
|
|
|
36
|
|
Net (gains)/losses
from equity investments
|
1
|
|
|
(44)
|
|
|
(144)
|
|
|
(5)
|
|
Gain from legal
judgment proceeds
|
—
|
|
|
(72)
|
|
|
—
|
|
|
(72)
|
|
Total adjustments
to other income (expense), net
|
43
|
|
|
(80)
|
|
|
(60)
|
|
|
(41)
|
|
Non-GAAP other
income (expense), net
|
$
|
54
|
|
|
(77)
|
|
|
$
|
(36)
|
|
|
(27)
|
|
|
|
|
|
|
|
|
|
GAAP income before
income taxes
|
$
|
558
|
|
|
$
|
2,030
|
|
|
$
|
2,415
|
|
|
$
|
4,050
|
|
Adjustments to
income before income taxes
|
|
|
|
|
|
|
|
Adjustments to
operating expenses
|
2,283
|
|
|
924
|
|
|
3,018
|
|
|
1,745
|
|
Adjustments to other
income, net
|
43
|
|
|
(80)
|
|
|
(60)
|
|
|
(41)
|
|
Total adjustments
to income before income taxes
|
2,326
|
|
|
844
|
|
|
$
|
2,958
|
|
|
$
|
1,704
|
|
Non-GAAP income
before income taxes
|
$
|
2,884
|
|
|
$
|
2,874
|
|
|
$
|
5,373
|
|
|
$
|
5,754
|
|
|
|
|
|
|
|
|
|
GAAP provision for
income taxes
|
$
|
94
|
|
|
$
|
227
|
|
|
$
|
305
|
|
|
$
|
422
|
|
Adjustments to
provision for income taxes:
|
|
|
|
|
|
|
|
Income tax effect of
the above adjustments (c)
|
277
|
|
|
154
|
|
|
408
|
|
|
334
|
|
Other income tax
adjustments (d)
|
(9)
|
|
|
9
|
|
|
(12)
|
|
|
8
|
|
Total adjustments
to provision for income taxes
|
268
|
|
|
163
|
|
|
396
|
|
|
342
|
|
Non-GAAP provision
for income taxes
|
$
|
362
|
|
|
$
|
390
|
|
|
$
|
701
|
|
|
$
|
764
|
|
|
|
|
|
|
|
|
|
GAAP tax as a
percentage of income before taxes
|
16.8
|
%
|
|
11.2
|
%
|
|
12.6
|
%
|
|
10.4
|
%
|
Adjustments to
provision for income taxes:
|
|
|
|
|
|
|
|
Income tax effect of
the above adjustments (c)
|
(4.0)
|
|
|
2.1
|
|
|
0.6
|
|
|
2.7
|
|
Other income tax
adjustments (d)
|
(0.2)
|
|
|
0.3
|
|
|
(0.2)
|
|
|
0.2
|
|
Total adjustments
to provision for income taxes
|
(4.2)
|
|
|
2.4
|
|
|
0.4
|
|
|
2.9
|
|
Non-GAAP tax as a
percentage of income before taxes
|
12.6
|
%
|
|
13.6
|
%
|
|
13.0
|
%
|
|
13.3
|
%
|
|
|
|
|
|
|
|
|
GAAP net
income
|
$
|
464
|
|
|
$
|
1,803
|
|
|
$
|
2,110
|
|
|
$
|
3,628
|
|
Adjustments to net
income:
|
|
|
|
|
|
|
|
Adjustments to income
before income taxes, net of the income tax effect
|
2,049
|
|
|
690
|
|
|
2,550
|
|
|
1,370
|
|
Other income tax
adjustments (d)
|
9
|
|
|
(9)
|
|
|
12
|
|
|
(8)
|
|
Total adjustments
to net income
|
2,058
|
|
|
681
|
|
|
2,562
|
|
|
1,362
|
|
Non-GAAP net
income
|
$
|
2,522
|
|
|
2,484
|
|
|
$
|
4,672
|
|
|
$
|
4,990
|
|
|
|
|
|
|
|
|
|
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
June 30,
2021
|
|
Three months
ended
June 30,
2020*
|
|
GAAP
|
|
Non-GAAP
|
|
GAAP
|
|
Non-GAAP
|
Net income
|
$
|
464
|
|
|
$
|
2,522
|
|
|
$
|
1,803
|
|
|
$
|
2,484
|
|
|
|
|
|
|
|
|
|
Weighted-average
shares for diluted EPS
|
576
|
|
|
576
|
|
|
592
|
|
|
592
|
|
|
|
|
|
|
|
|
|
Diluted
EPS
|
$
|
0.81
|
|
|
$
|
4.38
|
|
|
$
|
3.05
|
|
|
$
|
4.20
|
|
|
|
|
|
|
|
|
|
|
Six months
ended
June 30,
2021
|
|
Six months
ended
June 30,
2020*
|
|
GAAP
|
|
Non-GAAP
|
|
GAAP
|
|
Non-GAAP
|
Net income
|
$
|
2,110
|
|
|
$
|
4,672
|
|
|
$
|
3,628
|
|
|
$
|
4,990
|
|
|
|
|
|
|
|
|
|
Weighted-average
shares for diluted EPS
|
578
|
|
|
578
|
|
|
593
|
|
|
593
|
|
|
|
|
|
|
|
|
|
Diluted
EPS
|
$
|
3.65
|
|
|
$
|
8.08
|
|
|
$
|
6.12
|
|
|
$
|
8.41
|
|
|
|
*Effective January
2021, we began to exclude the gains and losses on our investments
in equity securities from our non-GAAP measures that are recorded
to Other income, net pursuant to an update to our non-GAAP policy.
For comparability of results to the prior year, non-GAAP Other
income, net, non-GAAP Net income and non-GAAP EPS amounts for 2020
have been revised to reflect the update to our non-GAAP
policy.
|
|
|
|
(a)
|
|
The adjustments
related primarily to noncash amortization of intangible assets from
business acquisitions.
|
|
|
|
(b)
|
|
For the three and six
months ended June 30, 2021, the adjustments related primarily to
the change in fair values of contingent consideration liabilities.
For the three months ended June 30, 2020, the adjustment related
primarily to legal settlement expenses. For the six months ended
June 30, 2020, the adjustment related primarily to legal settlement
expenses and an impairment charge associated with an in-process
research and development asset.
|
|
|
|
(c)
|
|
The tax effect of the
adjustments between our GAAP and non-GAAP results takes into
account the tax treatment and related tax rate(s) that apply to
each adjustment in the applicable tax jurisdiction(s). Generally,
this results in a tax impact at the U.S. marginal tax rate for
certain adjustments, including the majority of amortization of
intangible assets, whereas the tax impact of other adjustments,
including restructuring initiatives, depends on whether the amounts
are deductible in the respective tax jurisdictions and the
applicable tax rate(s) in those jurisdictions. Acquired IPR&D
expense from the Five Prime acquisition was not tax deductible. Due
to these factors, the effective tax rates for the adjustments to
our GAAP income before income taxes, for the three and six months
ended June 30, 2021, were 11.9% and 13.8%, compared to 18.2% and
19.6% for the corresponding periods of the prior year.
|
|
|
|
(d)
|
|
The adjustments
related to certain acquisition items, prior period and other items
excluded from GAAP earnings.
|
Amgen
Inc. Reconciliations of Cash Flows (In
millions) (Unaudited)
|
|
|
Three months
ended
June
30,
|
|
Six months
ended
June
30,
|
|
2021
|
|
2020
|
|
2021
|
|
2020
|
Net cash provided by
operating activities
|
$
|
1,931
|
|
|
$
|
2,842
|
|
|
$
|
4,035
|
|
|
$
|
4,976
|
|
Net cash provided by
(used in) investing activities
|
1,209
|
|
|
(2,159)
|
|
|
890
|
|
|
(2,389)
|
|
Net cash (used in)
provided by financing activities
|
(2,622)
|
|
|
775
|
|
|
(4,561)
|
|
|
521
|
|
Increase in cash and
cash equivalents
|
518
|
|
|
1,458
|
|
|
364
|
|
|
3,108
|
|
Cash and cash
equivalents at beginning of period
|
6,112
|
|
|
7,687
|
|
|
6,266
|
|
|
6,037
|
|
Cash and cash
equivalents at end of period
|
$
|
6,630
|
|
|
$
|
9,145
|
|
|
$
|
6,630
|
|
|
$
|
9,145
|
|
|
|
|
|
|
Three months
ended
June
30,
|
|
Six months
ended
June
30,
|
|
2021
|
|
2020
|
|
2021
|
|
2020
|
Net cash provided by
operating activities
|
$
|
1,931
|
|
|
$
|
2,842
|
|
|
$
|
4,035
|
|
|
$
|
4,976
|
|
Capital
expenditures
|
(185)
|
|
|
(158)
|
|
|
(351)
|
|
|
(300)
|
|
Free cash
flow
|
$
|
1,746
|
|
|
$
|
2,684
|
|
|
$
|
3,684
|
|
|
$
|
4,676
|
|
Amgen
Inc. Reconciliation of GAAP EPS Guidance to
Non-GAAP EPS Guidance for the Year Ending December 31,
2021 (Unaudited)
|
|
GAAP diluted EPS
guidance
|
|
$
|
8.84
|
|
—
|
$
|
9.90
|
|
Known adjustments
to arrive at non-GAAP*:
|
|
|
|
|
Acquisition-related
and licensing expenses (a)
|
|
4.46
|
|
—
|
4.52
|
|
Acquired IPR&D
(b)
|
|
|
2.62
|
|
Certain charges
pursuant to our cost savings initiatives
|
|
|
0.20
|
|
Net gains from equity
investments
|
|
|
(0.20)
|
|
Legal
proceedings
|
|
|
0.02
|
|
Non-GAAP diluted EPS
guidance
|
|
$
|
16.00
|
|
—
|
$
|
17.00
|
|
|
* The known
adjustments are presented net of their related tax impact, which
amount to approximately $1.18 per share.
|
|
(a) The adjustments
relate primarily to noncash amortization of intangible assets
acquired in business acquisitions.
|
(b) The adjustment
relates to in-process research & development (IPR&D)
expense as a result of acquiring Five Prime Therapeutics in April
2021. The acquired IPR&D is not tax deductible.
|
|
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 the fair
value of our contingent consideration and changes in fair value of
our equity investments. The GAAP adjustments from the recently
announced acquisition of Teneobio (expected to close in the second
half of 2021) are included in the GAAP diluted EPS
guidance.
|
Reconciliation of
GAAP Tax Rate Guidance to Non-GAAP Tax Rate Guidance for
the Year Ending December 31,
2021 (Unaudited)
|
|
GAAP tax rate
guidance
|
|
13.0
|
%
|
—
|
14.5
|
%
|
Tax rate of known
adjustments discussed above
|
|
0.0
|
%
|
—
|
0.5
|
%
|
Non-GAAP tax rate
guidance
|
|
13.5
|
%
|
—
|
14.5
|
%
|
Reconciliation of
2020 Non-GAAP Financial Information As Reported to Updated Non-GAAP
Policy 2020 Non-GAAP Financial Results - Excluding gains
and losses from equity
investments (Unaudited)
|
|
Effective January
2021, we began to exclude the gains and losses on our investments
in equity securities from our non-GAAP measures that are recorded
to Other income, net pursuant to an update to our non-GAAP policy.
This policy update excludes our share of the earnings and losses of
our strategic investments in corporations accounted for under the
equity method of accounting, such as our investment in BeiGene.
This updated non-GAAP policy is the basis for our comparisons
starting in 2021 and is reflected in our 2021 guidance. The
reconciliations below show the effects of the application of the
new policy as if it had been adopted at the beginning of
2020.
|
|
$Millions, except
EPS
|
|
Q1
'20
|
|
Q2
'20
|
|
Q3
'20
|
|
Q4
'20
|
|
FY
'20
|
|
|
|
|
|
|
|
|
|
|
|
Net income (as
reported)
|
|
$2,476
|
|
$2,518
|
|
$2,572
|
|
$2,229
|
|
$9,795
|
|
|
|
|
|
|
|
|
|
|
|
Equity securities
losses (gains)
|
|
39
|
|
(44)
|
|
(134)
|
|
(265)
|
|
(404)
|
Tax impact
|
|
(9)
|
|
10
|
|
29
|
|
58
|
|
88
|
|
|
|
|
|
|
|
|
|
|
|
Net income
(adjusted)
|
|
$2,506
|
|
$2,484
|
|
$2,467
|
|
$2,022
|
|
$9,479
|
|
|
|
|
|
|
|
|
|
|
|
Diluted
shares
|
|
594
|
|
592
|
|
589
|
|
585
|
|
590
|
|
|
|
|
|
|
|
|
|
|
|
Diluted EPS (as
reported)
|
|
$4.17
|
|
$4.25
|
|
$4.37
|
|
$3.81
|
|
$16.60
|
Diluted EPS
(adjusted)
|
|
$4.22
|
|
$4.20
|
|
$4.19
|
|
$3.46
|
|
$16.07
|
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SOURCE Amgen